NOTICE. The Board of Directors of the Kaweah Delta Health Care District will meet in an open Board of

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1 July 21, 2017 NOTICE The Board of Directors of the Kaweah Delta Health Care District will meet in an open Board of Directors meeting at 5:15PM on Monday, July 24, 2017 in the Kaweah Delta Medical Center Mineral King Wing Blue Room {400 W. Mineral King, Visalia}. The Board of Directors of the Kaweah Delta Health Care District will meet in a closed Board of Directors meeting at 5:31PM on Monday, July 24, 2017 in the Kaweah Delta Medical Center Mineral King Wing Blue Room {400 W. Mineral King, Visalia} pursuant to Government Code (d)(1), Health and Safety Code 32155, Health & Safety Code The Board of Directors of the Kaweah Delta Health Care District will meet in an open Board of Directors meeting at 6:00PM on Monday July 24, 2017 in the Kaweah Delta Medical Center Mineral King Wing Blue Room {400 W. Mineral King, Visalia}. The Board of Directors of the Kaweah Delta Health Care District will meet in a closed Board of Directors meeting immediately following the 6:00PM open meeting on Monday, July 24, 2017 in the Kaweah Delta Medical Center Mineral King Wing Blue Room {400 W. Mineral King, Visalia} pursuant to Government Code 54957(b)(1). All Kaweah Delta Health Care District regular board meeting and committee meeting notices and agendas are posted 72 hours prior to meetings (special meetings are posted 24 hour prior to meetings) in the Kaweah Delta Medical Center, Mineral King Wing entry corridor between the Mineral King lobby and the Emergency Department waiting room. The disclosable public records related to agendas are available for public inspection at the Kaweah Delta Medical Center Acequia Wing, Executive Offices (Administration Department) {1st floor}, 400 West Mineral King Avenue, Visalia, CA and on the Kaweah Delta Health Care District web page KAWEAH DELTA HEALTH CARE DISTRICT Lynn Havard Mirviss, Secretary/Treasurer Cindy Moccio Board Clerk & Executive Assistant to CEO DISTRIBUTION: Governing Board Legal Counsel Executive Team Chief of Staff West Mineral King Avenue Visalia, CA (559)

2 KAWEAH DELTA HEALTH CARE DISTRICT BOARD OF DIRECTORS Kaweah Delta Medical Center {400 West Mineral King Avenue} Mineral King Wing Basement (Blue Room) Monday, July 24, 2017 OPEN MEETING AGENDA {5:15PM} Call to order Approve agenda Public / Medical Staff participation Members of the public or the medical staff may comment on agenda items before action is taken and after the item has been discussed by the Board. Each speaker will be allowed five minutes. Members of the public wishing to address the Board concerning items not on the agenda and within the subject matter jurisdictions of the Board are requested to identify themselves at this time. 1. Approval of Closed Agenda as follows: Closed Meeting Agenda Kaweah Delta Medical Center Blue Room 5:31PM 1.1. Conference with Legal Counsel Anticipated Litigation Significant exposure to litigation pursuant to Government Code (d)(2) 17 Cases - Kassie Waters, Interim Risk Manager & Dennis Lynch, Legal Counsel 1.2. Credentialing - Medical Executive Committee (07/18/17) request that the appointment, reappointment and other credentialing activity regarding clinical privileges and staff membership recommended by the respective department chiefs, the credentials committee and the Medical Executive Committee be reviewed for approval pursuant to Health and Safety Code 1461 and 32155, medical staff privileges Byron Mendenhall, MD, Vice Chief of Staff 1.3. Approval of closed meeting minutes {06/26/17} 2. Cardiac Cath Lab Tour of Kaweah Delta Medical Center Cath Lab 5 Benton Duckett, RN, BSN, MBA, Director of Cardiac & Surgical Services Adjourn CLOSED MEETING AGENDA {5:31PM} Call to order 1. Conference with Legal Counsel Anticipated Litigation Significant exposure to litigation pursuant to Government Code (d)(2) 17 Cases - Kassie Waters, Interim Risk Manager & Dennis Lynch, Legal Counsel 2. Credentialing - Medical Executive Committee (07/18/17) request that the appointment, reappointment and other credentialing activity regarding clinical privileges and staff membership recommended by the respective department chiefs, the credentials committee Herb Hawkins Zone I Lynn Havard Mirviss Zone II John Hipskind, MD Zone III Carl Anderson Zone IV Nevin House Zone V Board Member Secretary/Treasurer Board Member President Board Member Page 2 of 391

3 and the Medical Executive Committee be reviewed for approval pursuant to Health and Safety Code 1461 and 32155, medical staff privileges Byron Mendenhall, MD, Vice Chief of Staff 3. Approval of closed meeting minutes {06/26/17} Action Requested: Approval of the 06/26/17 closed meeting minutes. Adjourn OPEN MEETING AGENDA {6:00PM} Call to order Approve agenda Public / Medical Staff participation Members of the public or the medical staff may comment on agenda items before action is taken and after the item has been discussed by the Board. Each speaker will be allowed five minutes. Members of the public wishing to address the Board concerning items not on the agenda and within the subject matter jurisdictions of the Board are requested to identify themselves at this time. Closed Session Action Taken Report on actions taken in closed session. 1. Recognitions 1.1. Director Anderson presentation of Resolution 1960 to Damon Rolfo, Maintenance III (10 Years), for the Service Excellence Award July Director Anderson presentation of Resolution 1961 to Susan Wallen, LVN, retiring from duty from Kaweah Delta after thirty two (32) years of service Director Anderson presentation of Resolution 1962 to Sue Lord, Registered Nurse, retiring from duty from Kaweah Delta after thirty eight (38) years of service Director Anderson presentation of Resolution 1963 to Ellen Burch, Unit Secretary, retiring from duty from Kaweah Delta after twenty-seven (27) years of service. 2. Chief Executive Officer Recruitment Members of the public may comment relative to the recruitment of the Chief Executive Officer of Kaweah Delta Health Care District. 3. Consent Calendar (All matters under the Consent Calendar will be approved by one motion, unless a Board member request separate action on a specific item). Recommended Action: Approve the July 24, 2017 Consent Calendar 4. Quality Report Hospital Acquired Pressure Ulcers Katie Roepke-Brenner, RN 5. Kaweah Delta Medical Foundation Kaweah Delta Medical Foundation physician recruitment status report - Rick Strid, Kaweah Delta Medical Foundation Administrator and CEO/VMC Executive Director 6. Future Needs For Kaweah Delta Health Care District (KDHCD) Grand Jury report response Review of the draft KDHCD response to the Tulare County Grand Jury report - Carl Anderson, Board President Recommended Action Approval of the KDHCD response to the Tulare County Grand Jury report. Monday, July 24, 2017 Page 2 of 4 Herb Hawkins Zone I Lynn Havard Mirviss Zone II John Hipskind, MD Zone III Carl Anderson Zone IV Nevin House Zone V Board Member Secretary/Treasurer Board Member President Board Member Page 3 of 391

4 7. Community Advisory Committees Review and request for approval for the creation of community advisory committees - Dena Cochran, Vice President of Development Recommended Action Approval of the establishment of community advisory committees; Community Relations, Healthcare for Today and Tomorrow, and The Hospital of the Future as reviewed by the Board Marketing and Public Affairs Committee on July 11, Credentialing Medical Executive Committee (07/18/17) request that the appointment, reappointment and other credentialing activity regarding clinical privileges and staff membership recommended by the respective department chiefs, the credentials committee and the Medical Executive Committee be reviewed for approval Byron Mendenhall, MD, Vice Chief of Staff Recommended Action: Whereas a thorough review of all required information and supporting documentation necessary for the consideration of initial applications, reappointments, request for additional privileges, advance from provision al status and release from proctoring and resignations (pursuant to the Medical Staff bylaws) has been completed by the Directors of the clinical services, the Credentials Committee, and the Executive Committee of the Medical Staff, for all of the medical staff scheduled for reappointment, Whereas the basis for the recommendations now before the Board of Trustees regarding initial applications, reappointments, request for additional privileges, advance from provision al status and release from proctoring and resignations has been predicated upon the required reviews, including all supporting documentation, Be it therefore resolved that the following medical staff be approved or reappointed (as applicable), as attached, to the organized medical staff of Kaweah Delta Health Care District for a two year period unless otherwise specified, with physician-specific privileges granted as recommended by the Chief of Service, the Credentials Committee, and the Executive Committee of the Medical Staff and as will be documented on each medical staff member s letter of initial application approval and reappointment from the Board of Trustees and within their individual credentials files. 9. Chief of Staff Report Update from the Chief of Staff relative to Medical Staff issues - Byron Mendenhall, MD, Vice Chief of Staff 10. Chief Executive Officer Report Report relative to current events and issues - Thomas Rayner, Interim Chief Executive Officer & Chief Operating Officer CMS SNF certification survey Good Grief Camp KD HUB Update Doug Leeper, Vice President & Chief Information Officer Employee Art Show July Board President Report Report from the Board President relative to current events and issues Carl Anderson, Board President 12. Approval of Closed Agenda as follows: Closed Meeting Agenda Kaweah Delta Medical Center Blue Room Immediately following the open session Adjourn Interim Chief Executive Officer Evaluation Discussion of with the Board and the Interim Chief Executive Officer relative to the evaluation of the Interim Chief Executive Officer pursuant to Government Code 54957(b)(1) Dennis Lynch, Legal Counsel, Thomas Rayner, Interim Chief Executive Officer & Chief Operating Officer & Board of Directors Monday, July 24, 2017 Page 3 of 4 Herb Hawkins Zone I Lynn Havard Mirviss Zone II John Hipskind, MD Zone III Carl Anderson Zone IV Nevin House Zone V Board Member Secretary/Treasurer Board Member President Board Member Page 4 of 391

5 Call to order CLOSED MEETING AGENDA {following the 6:00PM Open Meeting} 1. Interim Chief Executive Officer Evaluation Discussion of with the Board and the Interim Chief Executive Officer relative to the evaluation of the Interim Chief Executive Officer pursuant to Government Code 54957(b)(1) Dennis Lynch, Legal Counsel, Thomas Rayner, Interim Chief Executive Officer & Chief Operating Officer & Board of Directors Adjourn In compliance with the Americans with Disabilities Act, if you need special assistance to participate at this meeting, please contact the Board Clerk (559) Notification 48 hours prior to the meeting will enable the District to make reasonable arrangements to ensure accessibility to the Kaweah Delta Health Care District Board of Directors meeting. Monday, July 24, 2017 Page 4 of 4 Herb Hawkins Zone I Lynn Havard Mirviss Zone II John Hipskind, MD Zone III Carl Anderson Zone IV Nevin House Zone V Board Member Secretary/Treasurer Board Member President Board Member Page 5 of 391

6 BOARD OF DIRECTORS MEETING CLOSED SESSION KAWEAH DELTA HEALTH CARE DISTRICT BOARD OF DIRECTORS MEETING MONDAY JULY 24, 2017 CLOSED MEETING SUPPORTING DOCUMENTS PAGES

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19 Service Excellence July 2017 Damon Rolfo, Maintenance III (10 Years) Nominated By: Marketing Department Comments: Damon is one of those rare individuals who brings a smile to the face of everyone he encounters. Damon is always ready with a smile and a "yes, of course" response to each request made of him. He is ready and willing to offer assistance along with his creative skills to help our team make each event special and unique. Not only does he complete his duties through the typical work day, but he offers his craftsman skills to construct unique decorations, or something as simple (to him) as assembling a bicycle for the blood donor drawing on his personal time. Over the years the marketing department has asked Damon to do a myriad of projects from making cut-out boots to rod iron flower stands. He does these projects on his own time and with his equipment. Damon also is a great team player at work. When asked to assist with special projects such as setting up the Christmas decorations he helps out by picking up the supplies at the warehouse and teaming up with the volunteers to get the job completed. We have watched him work with others on his team and he is always smiling and has a great team spirit. He is safety conscious and he always has a great Kaweah Care can do attitude. He goes out of his way to help others whether it is staff with projects and repairs or our guests and getting them through the maze of hallways. He has been observed interacting with staff as he makes his way through the halls, and they all continue on their way with a smile. He has even been observed paying for a selection from the vending machine for a patient and patient's family when they didn't have quite enough money. Damon is truly the epitome of Kaweah Care, he does his work with passion, he is compassionate and very professional and represents our District well in the community. He is very deserving of this award. DIRECTORS: Rob DiBernardo & Steve Gloeckler BOARD MEMBER: Carl Anderson Page 19 of 391

20 RESOLUTION 1961 WHEREAS, Susan Wallen, LVN, is retiring from duty at Kaweah Delta Health Care District after 32 years of service; and, WHEREAS, the Board of Directors of the Kaweah Delta Health Care District is aware of her loyal service and devotion to duty; NOW, THEREFORE, BE IT RESOLVED that the Board of Directors of the Kaweah Delta Health Care District, on behalf of themselves, the Hospital Staff and the community they represent, hereby extend their appreciation to Susan Wallen for 32 years of faithful service and, in recognition thereof, have caused this resolution to be spread upon the minutes of this meeting. PASSED AND APPROVED this 24 th day of July 2017 by a unanimous vote of those present. ATTEST: President, Kaweah Delta Health Care District Secretary/Treasurer, Kaweah Delta Health Care District and of the Board of Directors, thereof Page 20 of 391

21 RESOLUTION 1962 WHEREAS, Sue Lord, RN, is retiring from duty at Kaweah Delta Health Care District after 38 years of service; and, WHEREAS, the Board of Directors of the Kaweah Delta Health Care District is aware of her loyal service and devotion to duty; NOW, THEREFORE, BE IT RESOLVED that the Board of Directors of the Kaweah Delta Health Care District, on behalf of themselves, the Hospital Staff and the community they represent, hereby extend their appreciation to Sue Lord for 38 years of faithful service and, in recognition thereof, have caused this resolution to be spread upon the minutes of this meeting. PASSED AND APPROVED this 24 th day of July 2017 by a unanimous vote of those present. ATTEST: President, Kaweah Delta Health Care District Secretary/Treasurer, Kaweah Delta Health Care District and of the Board of Directors, thereof Page 21 of 391

22 RESOLUTION 1963 WHEREAS, Ellen Burch is retiring from duty at Kaweah Delta Health Care District after 27 years of service; and, WHEREAS, the Board of Directors of the Kaweah Delta Health Care District is aware of her loyal service and devotion to duty; NOW, THEREFORE, BE IT RESOLVED that the Board of Directors of the Kaweah Delta Health Care District, on behalf of themselves, the Hospital Staff and the community they represent, hereby extend their appreciation to Ellen Burch for 27 years of faithful service and, in recognition thereof, have caused this resolution to be spread upon the minutes of this meeting. PASSED AND APPROVED this 24 th day of July 2017 by a unanimous vote of those present. ATTEST: President, Kaweah Delta Health Care District Secretary/Treasurer, Kaweah Delta Health Care District and of the Board of Directors, thereof Page 22 of 391

23 KAWEAH DELTA HEALTH CARE DISTRICT BOARD OF DIRECTORS - CONSENT CALENDAR Kaweah Delta Medical Center {400 West Mineral King Avenue} Mineral King Wing Basement (Blue Room) Monday, July 24, :00PM NOTE: All items listed on the Consent Calendar are considered to be routine by the District Board of Directors, and will be enacted by one motion. There will be no separate discussion of these items unless a Board Member so requests, in which event, the item will be removed from the Consent Calendar and considered in its normal sequence on the regular agenda Reports A. Medical Staff Recruitment Report B. Quail Park C. Risk Management D. Medical Education E. Sequoia Surgery Center F. Performance Improvement Dashboard 3.2. Policies: A. ADMINISTRATIVE 1. Records retention and destruction AP.75 Revised 2. Conflict of Interest AP.23 Revised 3. Policy Manuals AP.38 Revised 4. Abandoned Newborn AP.99 Reviewed 5. Conditions of Admissions AP.02 Reviewed 6. Outside Source Patient Care Services AP.65 Reviewed B. BOARD OF DIRECTORS 1. Chief Executive Officer BOD3 Revised 2. Conflict of Interest BOD5 Revised 3. Orientation of a new board member BOD1 Reviewed 4. Chief Executive Officer (CEO) Transition BOD2 Reviewed 5. Executive Compensation BOD4 Reviewed 6. Board reimbursement for travel and service BOD6 Reviewed 7. Presentation of claims and service process BOD7 Reviewed C. CHEMISTRY CLINICAL LABORATORY 1. Instrument or Equipment Repair Performance Verification CH NEW 2. Urine Albumin-AU680 CH NEW Consent Calendar July 24, 2017 Page 1 of 3 Page 23 of 391

24 3. Chemistry Maximum Dilutions for AU680 CH NEW 4. Immunochemistry Analytical Measurable Range (AMR) and Clinical Reportable Range (CRR) for DXI600 CH NEW 5. VIDAS 3 PROCALCITONIN PROCEDURE CH NEW 6. Accuracy of Automatic Pipetting CH NEW 7. Carryover Procedure For Automatic Pipetting Systems CH Reviewed 8. Vidas-Brahms Procalcitonin CH Deleted 9. AU680 Dilution Protocols CH Deleted D. HEMATOLOGY CLINICAL LABORATORY 1. Alternate Methodology, or Instrument, Reference Laboratory HE Revised 2. Retained Patient Specimen QC HE Revised 3. APTT-ACL TOP 300 HE Revised 4. Fibrinogen-QFA-ACL TOP 300 HE Revised 5. Prothrombin Time-ACL TOP 300 HE Revised 6. Annual Competency Review for CLS HE Revised 7. D-Dimer HS ACL Top 300 HE Revised 8. Iris Automated Urinalysis, IQ 200 & ichem Velocity HE New 9. Sysmex DI-60 Automated Digital Cell Morphology Analyzer HE New E. IMAGING AND SRCC RADIATION ONCOLOGY SERVICES 1. Imaging Services Manual Review IS 1.0 Revised 2. Radiation Protection Program IS 5.6A Revised 3. MRI Stent Screening Policy IS 5.9 Deleted 4. Radiation Protection IS 5.6 Deleted F. MENTAL HEALTH 1. Tarasoff Duty to Warn and Protect MH42.01 Revised G. RENAL SERVICES 1. Blood Transfusion During Dialysis RS-L.06 Revised 2. Chronic Outpatient Assessment During Hemodialysis RS-L.14 Revised 3. Cannulation of New Fistula RS-L.24 Revised 4. Rinseback Technique RS-L.44 Revised 5. Dialysis Blood Flow Rate Management RS-L.56 Revised 6. Exterior Cleaning of Hemodialysis Equipment RS-N.16 Revised 7. Patients at Risk for Involuntary Discharge RS-Q.03 Revised 8. Communication with ESRD Network 18 RS-Q.02 Reviewed H. SECURITY 1. Forensic Staff Education and Responsibility SEC.108 Revised I. SLEEP DISORDERS CENTER 1. Infection Prevention SA-02 Revised 2. Cleaning and Maintenance of Equipment EQ-01 Revised 3.3. Approval of the Board of Directors meeting open meeting minutes 06/26/17. Consent Calendar July 24, 2017 Page 2 of 3 Page 24 of 391

25 3.4. Approve the recommendations from the Medical Executive Committee 07/18/17. a) Carts & Kits 1. Epidural Tray (Revised) 2. Kaweah Dialysis Emergency Box (Revised) b) Pharmacy Policies 1. RX Security Pharmacy Area (Revised) 2. RX Personal Management: Public Protection & Reporting Requirements (Revised) c) Rural Health Clinic Policies 1. RCP.47 Emergency Equipment, Drugs and Supplies (Revised) d) Imaging Services Policies 1. IS Radiology Arthrogram (Wrist, Shoulder, Knee, Hip, with MRI to follow) (Revised) e) Order Sets 1. GM IV Insulin Infusion (New - Cerner) 2. GM IV Insulin Infusion (CVS) (New - Cerner) 3. GM IV Insulin Infusion (OB) (New - Cerner) 4. GM Subcut CUSTOM Eating (basal/bolus + correction) (New - Cerner) 5. GM Subcut CUSTOM NPO/Continuous Enteral Feeding (bolus + correction) (New - Cerner) 6. GM Subcut Eating (basal/bolus + correction) (New - Cerner) 7. GM Subcut NPO/Continuous Enteral Feeding (basal + correction) (New - Cerner) 8. GM Subcut TRANSITION Eating (basal/bolus + correction) (New - Cerner) 9. GM Subcut TRANSITION NPO/Continuous Enteral Feeding (basal + correction) (New - Cerner) 10. ED Gastrointestinal Bleed (New - Cerner) 11. SURG POST Splenectomy Vaccination (New - Cerner) 12. Common IV Fluids (New - Cerner) 13. PED Adolescent (14-18 Years of Age) Admission (New - Cerner) 14. General Telemetry (New - Cerner) 15. NICU Observation Admission (New - Cerner) 16. IV Iron (Revised) 17. Tylenol #3 Removal from selected Post Partum/Pediatric order sets (Revised) 18. Outpatient Hemodialysis Admission Orders (Revised) f) Core privileges Advanced Practice Provider Acute/Critical Care Approve Resolution 1964, a Resolution of the Board of Directors, Kaweah Delta Health Care District, directing Tulare County, California, to levy a tax to pay the principal of an interest on general obligation bonds for the fiscal year beginning July 1, 2017 and ending June 30, Approval of Resolution 1965 rejecting the claim of William McIntyre, Russell McIntyre, Sharon McIntyre, and Michelle McIntyre vs. Kaweah Delta Health Care District. Consent Calendar July 24, 2017 Page 3 of 3 Page 25 of 391

26 Medical Staff Recruitment Report - July 2017 Prepared by: Brittany Taylor, Physician/Leadership Recruiter btaylor@kdhcd.org - (559) Date prepared: 7/12/2017 Kaweah Delta Medical Foundation IQ Surgical Associates Adult Primary Care 2 General Surgery (Colorectal or other subspecialty) 1 Cardiology (Invasive/Non-Interventional) 1 Dermatology 1 Valley Children's Health Care Gastroenterology 4 Maternal Fetal Medicine 2 Neurology 1 Pediatric Hospitalist 3 Orthopedic Surgery 1 Pediatrics 1 Valley Hospitalist Medical Group Urology 1 Hospitalist 4 Kaweah Exeter Medical Group Other Recruitment Adult Primary Care 1 Neurosurgery 2 OB/Gyn 1 Palliative Medicine 1 Pediatrics 1 CEP - Family Medicine Clinic Family Medicine Core Faculty 1 Golden State Cardiac & Thoracic Surgery Cardiac & Thoracic Surgery 1 Horizon Critical Care Intensivists 2 Page 26 of 391

27 Specialty Group Last Name First Name Availability Board Certification Miscellaneous Current Status Adult Primary Care - Family Medicine Candidate Activity Open Howard, M.D. Ryan 07/18 American Board of Family Medicine, Eligible No CA License; Completing residency in AZ; Candidate reached out directly on 7/10/17. Currently under review; Initial call 7/13/17 at 12:30PM. Adult Primary Care - Internal Medicine Kaweah Delta Medical Foundation Atchabahian, M.D. Lara 10/17 American Board of Internal Medicine, Eligible CA Licensed; Spouse, Dr. Edward Samourjian, Site Visit: 4/24/17; Offer Vascular Surgeon, joining Accepted. Tentative Start Visalia group. Candidate Date: 10/2017 reached out directly on 4/4/17. Cardiology - EP Sequoia Cardiology Medical Group Haija, M.D. Basil 07/17 American Board of Internal Medicine, Certified; American Board of Cardiovascular Disease, certified. CA licensed; Currently completing EP fellowship Site visit - 3/10/17; Offer at University of NC accepted; Signed contract Hospital, Center of Heart should be rec'd 4/6/17. and Vascular Care; Tentative start date: Presented on 2/2/17 by 9/15/17. Pacific Companies. Cardiology, Interventional Cardiac & Thoracic Surgery Endocrinology Sequoia Cardiology Medical Group Golden State Cardiac & Thoracic Surgery, Inc. Kaweah Delta Medical Foundation Gupta, M.D. Ankur 07/17 Lee, M.D. Richard TBD Saif, M.D. Noman TBD - pending CA License American Board of Internal Medicine, Certified; Certification Board of Nuclear Cardiology, Certified; National Board of Echocardiography, Certified; American Board of Cardiovascular Disease, certification pending. American Board of Surgery, Certified; American Board of Thoracic Surgery, Certified American Board of Internal Medicine, Certified; American Board of Internal Medicine - Endocrinology, Certified CA Licensed; Presented on 11/15/16 by Pacific Companies. CA licensed; Family lives in San Jose, CA; Presented by Pacific Companies 2/9/16. CA license in process; Currently practicing in Longview, TX; Brother is moving to Fresno. Presented by Cejka on 2/1/17. Site visit: 1/13/17; Contract signed; Tentative start date 8/15/17. Site Visit: 4/27/16; Candidate not ready to make a move yet. Remains active for future f/up. Site Visit: 3/9/17; Offer accepted. Page 27 of 391

28 Specialty Group Last Name First Name Availability Board Certification Miscellaneous Current Status Gastroenterology Kaweah Delta Medical Foundation Ameer, M.D. Adnan 07/18 American Board of Internal Medicine, Certified CA licensed; Advanced Endoscopy Therapeutic Fellowship at Harbor-UCLA; Referred by Dr. Oberer on 2/3/17. Initial site visit: 2/17/17; 2nd Site visit: 4/10/17. Offer extended. Will make decision August Gastroenterology Kaweah Delta Medical Foundation Kumar, M.D. Vivek TBD - pending CA License American Board of Internal Medicine, Certified; American Board of Internal Medicine Gastroenterology, Certified No CA license; Currently practicing in Williamsport, PA. Candidate reached out directly on 6/12/17. Reviewing immigration sponsorship options. Gastroenterology Gastroenterology Kaweah Delta Medical Foundation Kaweah Delta Medical Foundation Kutty, M.D. Geeta 07/18 Pua, M.D. Shirley TBD - pending CA License American Board of Internal Medicine, Certified American Board of Internal Medicine, Diplomate; American Board of Internal Medicine Gastroenterology, Certified CA license in progress; friends in Fresno; presented by Fidelis Partners on 5/23/17. CA license in progress; presented by Integro Healthcare on 4/19/17. Tentative date: 7/25/2017 Currently under review. Met at conference 5/8/17. Site visit: 7/11/17 Gastroenterology Kaweah Delta Medical Foundation Rehman, M.D. Abdul TBD - pending CA License American Board of Internal Medicine, Certified; American Board of Internal Medicine Gastroenterology, Certified CA License in progress, will start process; Currently practicing with Gundersen Health System La Crosse in WI; Referred by Dr. Lovelace and Dr. Attaran. Site Visit: 5/26/17; pending additional f/up 6/27/17. Gastroenterology (Hospitalist) IQ Surgical Associates Al-Khedr, M.D. Hany 07/18 General Surgery IQ Surgical Associates Calin, M.D. Marius 11/17 American Board of Internal Medicine, Certified American Board of Surgery - General Surgery, Certified No CA license. Completing Gastroenterology & Hepatology fellowship 6/2017. Presented by Physician Empire on 5/11/17. CA Licensed; Presented on 6/12/17 by Fidelis Partners. Phone Interview: 6/22/17; F/up scheduled for 1/2017. Current under review. Page 28 of 391

29 Specialty Group Last Name First Name Availability Board Certification Miscellaneous Current Status No CA License; American Board of General Surgery (Hepato- Presented by Dr. IQ Surgical Associates Royall, M.D. Nelson 07/18 Surgery - General Site visit: 6/16/17 Pancreato-Biliary Surgery) Sebastiano Cassaro on Surgery, Certified 5/12/17. General Surgery (Trauma/Surgical Critical Care) Open Jeffcoach, M.D. David 08/18 American Board of Surgery - General Surgery, Eligible Visalia native interested in returning after fellowship. Wife is a PA. Trauma/Surgical Critical Site Visit: 7/21/2016; Care Fellowship in Dinner with Dr. Sebastiano Fresno, completion date - Cassaro on 4/24/17 at 6PM. 7/2017. CV rec'd directly from Dr. Jeffcoach on 7/17/15. GME Family Medicine Faculty (full-time) Hospitalist Hospitalist CEP Ramirez, M.D. Magda 07/17 Valley Hospitalist Group Valley Hospitalist Group Boparai, M.D. Namrita 09/17 Digdigan, M.D. Leevaneigh 08/17 American Board of Family Medicine, Eligible American Board of Internal Medicine, Eligible American Board of Family Medicine, Certified Completing residency in NM; Presented through CEP recruitment team 1/3/17. CV rec'd directly through CareerMD posting on 4/26/17. CA licensed; Hospitalist at Sierra View District Hospital. Candidate reached out directly on 5/2/17. Site Visit: 1/25/17; Offer accepted. Anticipated start date: 8/2017 Currently under review. Site Visit: 5/12/17 Hospitalist Valley Hospitalist Group Sattar, D.O. Hammad 09/18 American Board of Internal Medicine, Eligible No CA license; Interested in Nocturnist hours; Presented by Physician Empire on 5/11/17. Currently under review. Hospitalist Maternal Fetal Medicine Valley Hospitalist Group Valley Children's Healthcare Win, M.D. Shine 08/18 Shah, M.D. Bharat 01/17 American Board of Internal Medicine, Eligible American Board of Obstetrics and Gynecology, Diplomat; American Board of Obstetrics and Gynecology, Maternal- Fetal Medicine - Diplomat Family lives in CA; Presented by Physician Empire on 6/30/17 CA licensed; currently practicing in Las Vegas, NV. CV presented by Children's on 10/14/16. Site visit - 11/11/16; pending 2nd visit. 7/12/17 - ed Valley Children's to f/up status. Page 29 of 391

30 Specialty Group Last Name First Name Availability Board Certification Miscellaneous Current Status American Board of No CA license; Currently Pediatrics, Certified; Valley Children's practicing in IA. CV Neonatology Dosado, M.D. Jose 07/17 American Board of Healthcare presented by Children's Pediatrics - Neonatalon 1/20/17. Perinatal, Certified. Neonatology Neurology OB/GYN OB/GYN Orthopedic Surgeon, Adult Reconstruction Valley Children's Healthcare Kaweah Delta Medical Foundation Kaweah Exeter Medical Group Kaweah Exeter Medical Group Orthopaedic & Associates Younis, M.D. Usama Mohamed 07/17 Joshi, M.D. Rohini ASAP Dhillon, M.D. Satwant TBD Sabogal, M.D. Juan Carlos 04/17 Galan, M.D. Timothy 07/18 American Board of Pediatrics, Certified; American Board of Pediatrics - Neonatal- Perinatal, Certified. American Board of Internal Medicine, Certified American Board of Obstetrics and Gynecology, Certified American Board of Obstetrics and Gynecology, Diplomat American Board of Orthopedic Surgery, Eligible No CA license; Currently practicing in SD. CV presented by Children's on 1/20/17. CA Licensed; Current VMC Independent Contractor interested in Full-Time. CA Licensed; Currently practicing in Porterville, CA. Candidate reached out directly. CA Licensed; Currently practicing at Family Health Care Network in Visalia since CA Licensed; Currently completing Orthopaedic Surgery Residency in Fresno. Attending Adult Reconstruction fellowship in Florida 7/2017-6/2018. Presented by Fidelis Partners on 1/10/17. Site Visit - 1/24/17; Offer accepted; start date - 7/31/17 Site Visit - 1/23/17; Offer accepted; start date - 7/10/17 6/23/17 - Rick Strid will call Dr. Joshi to f/up. Site Visit: 4/12/17; Remains under review. Site Visit: 11/29/17; Offer accepted, Start date: 4/1/17 Site Visit: 2/24/17; 2nd site visit: 3/27/17. Meeting with Orthopedic & Associates 4/25/17. Extended offer for VMC and Orthopedic & Associates. Updated offer 6/30/2017. Orthopedic Surgeon, Hand & Upper Extremity Orthopaedic & Associates Kolahi, M.D. Kourosh Michael 07/18 American Board of Orthopedic Surgery, Eligible CA Licensed; Currently completing Orthopaedic Surgery Residency in Fresno. Attending Hand & Upper Extremity Surgery fellowship in New Mexico 7/2017-6/2018. Referred by Dr. Bruce Le on 1/25/17. Site Visit: 4/7/17; F/up in process. Page 30 of 391

31 Specialty Group Last Name First Name Availability Board Certification Miscellaneous Current Status Pediatric Hospitalist Valley Children's Hospital Abebe, M.D. Samuel TBD - pending CA License No CA license; Currently working locums assignments; Presented by VCH on 6/1/17. Site Visit: 6/7/17 Pediatric Hospitalist Valley Children's Hospital Al Horany, M.D. Bassel 07/18 Completing residency in Toledo, OH; Presented by VCH on 6/21/17. Site Visit: 7/17/17 Pediatric Hospitalist Valley Children's Hospital Burger, M.D. Craig TBD - pending CA License American Board of Pediatrics, Certified No CA license; Currently practicing in Fort Lewis, WA; Presented by VCH on 7/3/17. Site Visit: 7/27/17 Pediatric Hospitalist Valley Children's Hospital Morrison, M.D. Jennifer 07/18 American Board of Pediatrics, Certified No CA License; Completing residency in Syracuse, NY; Presented by VCH on 6/28/17. Site Visit: 7/14/17 Pediatric Hospitalist Valley Children's Hospital Zakieh, M.D. Abdulhafiz 07/17 CA licensed; Completing residency in Alabama. Presented by VCH on 3/28/17. Site Visit: 4/3/17; Offer accepted, tentative start date July 2017 Urology Kaweah Delta Medical Foundation Ford, M.D. Joseph 07/18 No CA License; Completing Oncology fellowship ; Presented by Fidelis Partners on 6/14/17. Currently under review. Site Visit: 7/7/17 Vascular Surgery South Valley Vascular Hamdi, M.D. Abdulrahman 07/17 American Board of General Surgery, Eligible Completing Vascular Surgery Fellowship at Maryland University Medical Center 06/2017 Site Visit: 5/23/2016; Offer accepted, contract signed; Tentative start date 8/2017 Page 31 of 391

32 Kaweah Delta Health Care District Annual Report to the Board of Directors Quail Park Dena Cochran Vice President of Development July 7, 2017 Summary Issue/Service Considered Quail Park is a 114 unit senior retirement village owned 44 percent by Kaweah Delta Health Care District and 56 percent by Living Care Senior Housing. Denis Bryant from Living Care is the Managing Member. The 40 unit Memory Care Center is an Alzheimer s/dementia facility located east of the Rehabilitation Hospital on Kaweah Delta s west campus. It has the same ownership percentage split as Quail Park. Denis Bryant is the manager of both entities. Lynn Havard Mirviss and Dena Cochran represent Kaweah Delta on the Quail Park and Memory Care Center Boards of Members. Cathy Boshaw and Elling Halverson represent Living Care Senior Housing on the two boards. Kaweah Delta and Living Care have equal voting rights on the boards. Quality/Performance Improvement Data Quail Park is currently 93.7 percent occupied. Its average monthly occupancy for the past year is 95.1 percent which mirrors its occupancy levels for most of its 15 plus years of operation. During 2017 Quail Park paid profit distributions to Kaweah Delta totaling $385,000 based on Kaweah Delta s 44 percent ownership. Quail Park has paid Kaweah Delta profit distributions totaling $7,122,000 through the first quarter of The first profit distributions were made in The Memory Care Center, which opened in July, 2012, is currently 100 percent occupied and has averaged 99.8 percent occupancy during the past year. During 2016 the Memory Care Center paid profit distributions totaling $198,000 to Kaweah Delta. The Memory Care Center has paid Kaweah Delta a total of $1,661,000 through the first quarter of Policy, Strategic or Tactical Issues In 2014 the Kaweah Delta District Board approved a proposal by the Quail Park Board of Members to expand the 12-unit Enhanced Assisted Living (EAL) building on the Quail Park campus to 25 units with an 8,000 square foot addition. Construction was completed last fall. Occupancy of the expanded EAL is now at 80 percent. Last year Kaweah Delta approved construction of a new 120-unit senior living project called Quail Park at Shannon Ranch near the intersection of Demaree and Flagstaff in M:\MOCCIO\BOARD\BOARD 2017\AGENDA\ \CONSENT CALENDAR\REPORTS\3.1 B Quail Park.doc Page 32 of 391

33 northwest Visalia. Kaweah Delta owns 33 and one third percent of the new project. Other partners are Shannon Senior Care, LLC, BTV Senior Housing, LLC, and Millennium Advisors. Shannon Senior care is owned by members of the Shannon family; BTV is owned by Bernard te Velde, Jr., and Millennium Advisors is owned primarily by Denis Bryant, the current managing partner of Quail Park and the Memory Care Center. Groundbreaking on the new project is scheduled for early September and construction will begin this fall. The approximately $33 million project is slated to be completed in early All Kaweah Delta equity contributions to the project have originated from the Bettie Quilla Fund at Kaweah Delta Hospital Foundation. The Quilla Fund is restricted by the donor for support of a senior living project in collaboration with Kaweah Delta Health Care District. Recommendations/Next Steps Continue to operate Quail Park and the Memory Care facility as high level senior retirement centers with services ranging from independent living to assisted living to expanded dementia care. Begin construction of Quail Park at Shannon Ranch. Approvals/Conclusions Quail Park is filling a significant health care need in our community and at the same time generating an income stream for Kaweah Delta. Quail Park at Shannon Ranch will do the same. M:\MOCCIO\BOARD\BOARD 2017\AGENDA\ \CONSENT CALENDAR\REPORTS\3.1 B Quail Park.doc Page 33 of 391

34 Risk Management Report Open 1 st and 2 nd Quarter 2017 July 24, 2017 Kassie Waters Interim Director of Risk Management Page 34 of 391

35 Risk Management Goals 1. Reduce frequency and severity of harm (patient and non-patient). Zero incidents of never events 2. Reduce frequency and severity of claims. 3. Promote a safety culture as a proactive risk reduction strategy. An assessment of the Risk Management Program is in progress. In the future, additional information will be reported that will include analysis and trends. Page 35 of 391

36 Claims Frequency Page 36 of 391

37 Severity of Claims Professional Liability Indemnity Paid Legal Costs Page 37 of 391

38 Annual Insurance Premiums General Liability Insurance Premium Professional Liability Insurance Premium Auto Liability Insurance Premium Page 38 of 391

39 # Complaints & Grievances Filed by Quarter Trends: Ineffective physician/staff communication Quality of Care Excessive wait times ED Page 39 of 391

40 KAWEAH DELTA HEALTH CARE DISTRICT Continuing Medical Education Program Annual Report to the Board of Directors July 2016 June 2017 Mark Sobers, MD Chair, CME Committee (805) Jennae Goodrich CME Coordinator, Quality Dept (559) Page 40 of 391

41 Continuing Medical Education (CME) - Report to Board of Directors July 2016 June 2017 I. PROGRAMS Kaweah Delta Health Care District CME Department has presented the following: A. REGULARLY SCHEDULED SERIES (RSS): Our ongoing conferences are some of our best attended events and help maintain accreditation in several areas such as Surgery and Tumor Board. In August of 2016, a monthly Critical Care M&M was developed under the direction of Dr. Ashraf Elsayegh. The following is a list of all additional active series: Name of RSS Frequency of Meeting Physicians Others Total Cardiovascular Grand Rounds First Wednesday of the Month Cardiovascular M&M Third Wednesday of the Month Critical Care M&M Second Monday of the Month Derm/Pathology Monthly Faculty Development Ad Lib Committee Practice-Based Learning Every Tuesday Surgery Grand Rounds Radiology M&M Monthly Trauma Grand Rounds First Tuesday of the Month Tumor Board Every Tuesday B. OTHER SCHEDULED ACTIVITIES: Date/Time Name of Activity/Speaker(s) Physicians Others Total June 28, 2016 A Provider Discussion on Glucommander PM in Blue Room Melanie E. Mabrey, D. N.P. August 25, 2016 Coronary Revascularization PM in Blue Room Dr. Leheb Araim October 13, th Annual Norman Sharrer Symposium: PM Visalia Country Club The Diabetic Crisis Dr. Dean Schillinger November 10, 2016 Transfusion Therapy PM in Blue Room February 23, PM in Blue Room March 21, :30AM-2:30PM Visalia Convention Center Dr. Leland Beggs CHF and Services Available to CHF Patients at the Chronic Disease Management Clinic Dr. Harry Lively Tools & Strategies To Improve Patient safety Dawn Allbee, MA, Eric Hayler and Melinda Sawyer, MSN, RN P age Page 41 of 391

42 April 6, PM in Blue Room April 26, AM-12Pm, 2PM-5PM Tulare Health and Human Services Agency Building Plain Language: Creating a Health Literate Organization Janet Delgado, ANP, Deborah Robinson, MSN, Fernando Pineda, CMI Beyond Diversity: Cultural Differences in the LGBT Consumer Population & Innovative HIV Prevention Tools Tulare HHSA Staff II. Topics Identified by Quality and Patient Safety: The CME Program had a very successful year in In collaboration with the Quality and Patient Safety Department, opportunities for improvement were identified in patient safety, patient satisfaction, and patient outcomes. With the implementation of Glucommander, the CME Program was able to help deliver education for this important piece in the Kaweah Delta Healthcare system. The CME Committee agreed that continued focus should remain in the areas of diabetes, congestive heart failure, and chronic disease management. Kaweah Delta s 2017 Patient Safety Symposium held on March 21 st, provided proven resources, tools, and programs that attendees were able to utilize such as rapid process improvements, LEAN Six Sigma methods and technical and adaptive skills to eliminate preventable harm. There were 333 attendees and 7 of them were Kaweah Delta physicians. Based upon the data collected through participant evaluations from this symposium, 202 of 230 participants felt that the activity fully met the listed objectives. 26 of 230 participants felt that the activity partially met the listed objectives. 2 of 230 participants felt that the activity did not meet the listed objectives. Comments regarding the content of the presentation included the Symposium provided enlightening ideas from experts in the field pertaining to 5s and eliminating patient harm, content was mostly applicable to all in healthcare with a few comments recommending the LEAN six sigma examples be more healthcare relevant, valuable information was provided, the ideas shared at the Symposium can be used to engage the entire District to improve patient and workplace safety. III. Upcoming CME Activities: The following topics are tentatively scheduled presentations in connection with Quality and Patient Safety Department and/or Professional Practice Gaps: Month Topics Speakers TBD Tentative: TEG, Statin Therapy and Updates in Stroke Prevention Dr. Jeffrey Saver and Dr. Sean Oldroyd 10/12/17 36 th Annual Norman Sharrer Symposium: Narcotic Overuse and Opioid Addiction TBD 11/4/17 Visalia Valve and Vascular Symposium Dr. Makar, Medical Director, Cedars Sinai Cardiac Cath Lab Dr. Bhambi, Medical Director, Bakersfield Heart Hospital 3 P age Page 42 of 391

43 Kaweah Delta Health Care District Report to the Board of Directors Sequoia Surgery Center July 2017 Gary Herbst, SVP/CFO Summary Issue/Service Considered Sequoia Surgery Center (SSC), a California limited liability company (LLC), was formed on August 1, 2010 upon the merger of Cypress Surgery Center (CSC) and the Center for Ambulatory Medicine & Surgery (CAMS). SSC operates a four-suite ambulatory surgery center, performing approximately 6,200 outpatient surgeries and endoscopic procedures each year. Surgery services include orthopedics, general, gynecological, urological, plastic, podiatric, and ENT. SSC gastroenterologists also perform a significant number of endoscopic procedures at the Center, primarily colonoscopies, which accounted for approximately 45% of SSC s annual case volume in In March 2017, Dr. Jeff Brown, a 10% owner in SSC and the busiest gastroenterologist on staff, moved to the Central Coast and closed his Visalia practice. SSC also recently learned that Dr. Chad Oberer, also a gastroenterologist on staff, will be moving back to Chicago in October Recruitment for replacement gastroenterologists is a critical priority for SSC as well as KDHCD and the community. SSC is owned by sixteen (16) surgeons and Kaweah Delta Health Care District. SSC is owned 69.4% by physicians and 30.6% by the District. SSC is governed and managed by a formal Board of LLC members, including the District, elected to the Board by the LLC members, and is jointly chaired by Drs. Alex Lechtman and Burton Redd. Director Herb Hawkins serves as the District representative on the SSC Board of Members. Anesthesiology services are provided by independent anesthesiologists led by Dr. Todd Gibbs, SSC s medical director. In conjunction with the merger of CSC and CAMS, CSC created a separate limited liability company, Cypress Company, LLC (CyCo), to which it transferred all real estate assets (land and building), along with the associate mortgage debt, as well as cash, accounts receivable and certain debt incurred with the buy-out of partner interests. CyCo leases the surgery facility to SCC under a long-term operating lease. CyCo is owned by ten (10) surgeons (all former members of CSC) and Kaweah Delta Health Care District. CyCo is owned 60.0% by physicians and 40.0% by the District. 1 Page 43 of 391

44 Financial/Statistical Information January 1 to December 31 (Compiled Financial Statements): Net Operating Net Year Case Volume Revenue Costs Income ,180 $10,673,924 $8,488,045 $2,185, ,339 9,769,734 8,495,992 1,272, ,361 9,052,046 8,146, , ,427 9,327,822 7,783,658 1,544, ,156 9,853,076 8,092,721 1,760,355 Quality/Performance Improvement Data 1. SSC is fully accredited by the Accreditation Association for Ambulatory Health Care (AAAHC). AAAHC awards three-year accreditations similar to the JCAHO. SSC was last surveyed by AAAHC in October 2014, receiving very positive feedback from surveyors. Policy, Strategic or Tactical Issues 1. SSC s primary competition for outpatient surgery includes the District, Sierra Pacific Orthopedic Center (Fresno), and private physician offices. 2. SSC s primary strategy for growing and retaining its business is to selectively offer ownership interests to active, community surgeons with an interest in actively managing and using the Center. Additionally, SSC management and physician leaders actively reach out to new physicians that enter the marketplace, offering SSC as an alternative to Kaweah Delta and other surgical facilities. With the departure of Dr. Jeff Brown in March 2017 and the anticipated retirement of Dr. Jim Guadagni, orthopedic surgeon, SSC is actively soliciting interest from potential new surgeons and owners. 3. Over the past several months, SSC has discovered the presence of significant water damage to its facility s roof, walls and internal infrastructure apparently caused by flaws in the original design and construction of the facility. Seals Construction has submitted a bid of approximately $967,000 to complete the necessary repairs and renovations over the next 3-4 months. Citizens Business Bank has proposed to finance the project with a line of credit secured by the real estate and personal guarantees of the physician owners of CyCo. CyCo is solely responsible for the cost of these repairs. 4. In conjunction with item #3, SSC and CyCo have also been evaluating the physical expansion of its facility to create a dedicated comprehensive outpatient GI center. This interest and opportunity was solidified by Kaweah Delta s decision to not build a freestanding GI Center on the west side of its downtown hospital campus but rather to pursue a joint-venture expansion with SSC and CyCo. The various parties are working with Darden Architects to evaluate expansion options. 2 Page 44 of 391

45 Recommendations/Next Steps/Approvals/Conclusions SSC will continue to emphasize high-quality, customer-oriented, and personal outpatient surgery services to physicians and patients of Visalia with the objective of differentiating itself from the more institutional feel of a large hospital system. It will actively evaluate opportunities to recruit new physicians to its Center and offer membership ownership opportunities when appropriate. It will continue to evaluate low margin services and replace them with high margin services. It will continue to evaluate opportunities to reduce supply costs through consolidation or change of vendors and more efficient utilization and it will focus on improving overall economies of scale made possible by the merger of CSC and CAMS. 3 Page 45 of 391

46 Board of Directors PI Dashboard 2nd Quarter 2017 Value Based Purchasing (VBP) Measures Measure CMS Benchmark / *TJC National Rate Trends (Red Line = Benchmark) Last Data Point (green = benchmark achieved) Compl Due Date Comments / Actions PCM-01 Early Elective Deliveries - down trend positive (Clinical Staff Sponsor - Tracie Plunkett) *2.42% 0% Apr 2017 Jan 2016 No Fallouts - Benchmark Maintained Emergency Department (Core Measure) ED Patient Throughput (Quarterly Report) August April 2017 (Dan Allain) Benchmark (Hospital Compare Average) Trends (Red Line = Benchmark) Last Data Point (green = benchmark achieved) Compl Due Date Comments / Actions 1) Median ED Arrival time to ED Departure Time for In-patients {minutes} - (down Trend Positive) 423 Minutes 392 Minutes Apr 2017 Apr /5/17, with the support of the hospitalist physician discharge orders are being written earlier resulting in earlier bed availability for the patients being admitted from the ED. Dr. Seng the new medical director for the emergency department arrived on June 1st. Provider scheduling will be a reviewed to better match the patient arrival times thereby improving throughput. Patient Satisfaction A) Inpatient (Ed Largoza): Benchmark (Internal) Trends (Red Line = Benchmark) Last Data Point (green = benchmark achieved) Compl Due Date Comments / Actions 1) Inpatient Satisfaction - HCAHPS Performance data (up trend positive) 74.5% 77.8% Jun 2017 Jun 2017 Benchmark Maintained 1 Page 46 of 391

47 B) ED (Dan Allain / Ed Largoza): Benchmark (Internal) Trends (Red Line = Benchmark) Last Data Point (green = benchmark achieved) Compl Due Date Comments / Actions 1) ED Patient Satisfaction - not included in HCAHPS (mean score - up trend positive) 50th Percentile 1st percentile May 2017 Jun /5/17, HealthStream, Patient satisfaction is an top priority for the nursing leaders as well as the new medical director. From a nursing perspective, UBC has been reviewing the top priorities and will be working with Ed Largoza to further refine actions that can be taken to enhance the patient experience while in the ED. C) Physician Satisfaction (every 2 years, due 2011; up trend positive) 46 percentile 75th Percentile 2009; 37 in 2007 n/a Pending data update D) Employee Satisfaction (every 2 years - due 2017; up tend positive) N/A n/a 2015 results under review A) Employee Turnover 2nd qtr st qtr 2017 (Dianne Cox) (reported quarterly): Benchmark (CHA - changes quarterly) Trends (Red Line = Benchmark) Human Resources Last Data Point (green = benchmark achieved) Compl Due Date Comments / Actions 1) All Employees Turnover (down trend positive) 2) RN Turnover (down trend positive) 2.5% 2.7% 1.8% 1st qtr % 1st qtr 2017 Oct nd qtr 2017 KDHCD's current RN vacancy rate is statistically much lower than the CHA. With our recent hiring event on June 1, 2017 we offered 52 RN's position and have only 35 positions open. B) Contracted / Traveler Staff - June 2017: 33 out of 4501 total staff (down trend positive) 0.33% (internal benchmark) 0.73% Jun 2017 Jan 2017 March update: 31 travelers used in March; goal is to reduce the number of travelers to 15 by July 1, Page 47 of 391

48 Finance A) Capital Structure (Gary Herbst) (up trend positive): Benchmark (Budget FY 2017) Trends (Red Line = Benchmark) Last Data Point (green = benchmark achieved) Compl Due Date Comments / Actions 1) Maximum Annual Debt Service Coverage: net income available to cover debt payments May 2017 Jun 2017 Debt service on budget but net income fell short of budget for the eleven months ended May 31, 2017 due to the unrealized loss on the District s investment portfolio. B) Liquidity: 1) Days Cash on Hand: number of days operating expenses covered by cash May 2017 Jun 2017 Operating expenditures exceeds budget and the increase in IGT, PRIME and Humana capitated contract floor receivable amounts impact this indicator. 2) Net Days in Accounts Receivable: average number of days to collect a patient account (down trend positive) May 2017 Jun 2017 Patient Financial Services had several open positions in March and April which impacted the ability to post payments timely, especially in the Medicare payer group. As of 6/30/17, preliminary days in AR are which is a significant decrease from May. C) Profitability (up trend positive): 1) Operating Margin: profit from corebusiness revenue and expenses 2.1% 2.1% May 2017 Feb 2017 Benchmark maintained 2) Operating Cash Flow Margin: cash flow available to pay debt & purchase capital assets 7.0% 6.6% May 2017 Jun 2017 Depreciation expense is under budget, which impacts this indicator as a non-cash expenditure. If depreciation was on budget this ratio for May 2017 would have been 7.0% Abbreviations CMS = Centers for Medicare & Medicaid Services CHA = California Hospital Association PSAT = Patient Satisfaction Action Tool TJC = The Joint Commission Color Code Benchmark Achieved Within 10% of Benchmark >10% From Benchmark 3 Page 48 of 391

49 Policy Submission Summary Manual Name: Administrative Date: 07/13/17 Support Staff Name: Cindy Moccio Policy/Procedure Title # Status New, Revised, Reviewed, or Deleted * Name and phone extension of person who wrote or revised policy - * for New and Revised policies only Records retention and destruction AP.75 Revised Ben Cripps Conflict of Interest AP.23 Revised Cindy Moccio Policy Manuals AP.38 Revised Kathie Allred Abandoned Newborn AP.99 Reviewed Liz Pasillas-Mace & Tracie Plunkett Conditions of Admissions AP.02 Reviewed Malinda Tupper Outside Source Patient Care Services AP.65 Reviewed Gary Herbst Page 49 of 391

50 Administrative, Administrative Manual Policy Number: AP75 Date Created: No Date Set Document Owner: Cindy Moccio (Board Clerk/Exec Date Approved: Not Approved Yet Assist-CEO) Approvers: Board of Directors (Administration) Records Retention and Destruction Printed copies are for reference only. Please refer to the electronic copy for the latest version. POLICY: Kaweah Delta Health Care District will retain all pertinent records that pertain to all District operations in accordance with state and federal statute of limitations and regulatory retention requirements. A record is defined as any document, book, paper, photograph, recording or other material regardless of physical form or characteristics, made or received pursuant to law or in connection with the transaction of official business. This definition includes those records created, used and maintained in electronic form. PROCEDURE: 1. Medical Records A. Medical records on adults, minors and emancipated minors shall be maintained and retained in accordance with state and federal records retention requirements. B. Records may be kept in either paper or electronic format. Where an electronic format exists, the paper format may be destroyed in accordance with Procedure IX Destruction upon Expiration or Electronic Storage. 2. Master Patient Index Master Patient Index shall be maintained permanently either electronically or in hard copy format. 3. Tumor Registry Reports (Abstracts), Birth Logs, Emergency Room Logs Tumor Registry Reports (Abstracts), Birth Logs, and Emergency Room Logs shall be maintained permanently. 4. Surgery Logs, Radiology Films A. Surgery Logs and Radiology films or digital images shall be maintained for a period of tenseven (107) years following the date of service and 25 years for minors. B. Port films for radiation oncology shall be maintained permanently. Page 50 of 391

51 Records Retention and Destruction 2 5. Annual Reports to Governmental Agencies Annual reports to governmental agencies shall be permanently maintained. 6. Utilization Review Worksheets, Physician Certification and Recertification Utilization Review Worksheets, Physician Certification and Recertification, shall be maintained for a period of six (6) years. 7. Medical Staff Records and Reports Medical Staff Committee Reports/Minutes, Physician Files, Physician Continuing Educational Records, Physician Agreements, Physician Applications for Privileges that have been rejected and allied health professional files shall be maintained permanently. 8. Financial Records All financial records shall be maintained in accordance with the California Hospital Association Record and Retention Schedule, current edition. 9. Contracts and Grants Contract and Grant terms should be carefully reviewed to determine whether they contain any record retention obligations. Financial, statistical and non expendable property records and any other records pertinent to U.S. Department of Health and Human Services must be retained for three years from the date of submission of the final expenditure report, or until resolution of any litigation and federal audit findings. 10. Destruction upon Expiration or Electronic Storage Upon expiration of the record retention period or electronic storage, the record may be destroyed by shredding. Shredding authorization shall be under the authority of the Director of Medical Records. Certifications of destruction shall be provided by the shredding service and shall be maintained as a permanent record. 11. Electronic mail ( ) Active electronic mail ( ) on the District servers will be archived, retained and purged following these specific timeframes. All will be retained based on the following guidelines except in situations where a Legal Hold has been requested by the Compliance Officer, Director of Risk Management, or Vice President of Human Resources (see below): Retention within for six (6) years for the Management, Leadership, and Executive Team Members. Retention period for all other positions is three (3) years. Exception to the three year policy for non-management staff can be made at the discretion of the Compliance Officer or a member of the Page 51 of 391

52 Records Retention and Destruction 3 Executive Team. After a specified amount of time (to be determined based on the performance of the active exchange server), the record will be archived automatically and backed-up on a routine basis as described below. Microsoft User Outlook Accounts (Exchange Server): 6 years of Inbox and Personal Folders 2 years of Sent Items 2 years of Deleted Items Terminated employees - 1 year (all folders) from the date of termination Retention within archive 6 years, all folders, all employees (active and terminated) A Legal Hold refers to the suspension of normal disposition procedures in the event of pending or actual litigation or investigation. In situations where District Legal Counsel has requested a Legal Hold, the Compliance Officer, Director of Risk Management, or Vice President of Human Resources will work directly with the Information System Services Management to impose and withdraw (when appropriate) the Legal Hold. Formatted: Bulleted + Level: 1 + Aligned at: 0.75" + Indent at: 1" Formatted: Indent: Left: 0", First line: 0.5" Formatted: Bulleted + Level: 1 + Aligned at: 0.75" + Indent at: 1" Formatted: Indent: Left: 0" The Information Systems Services (ISS) Department has implemented timely and accurate backup processes that enable systems and data are backed up on a consistent and routine basis and that data is retrievable. See ISS Policy ISSW.2 Information Systems Backup and Restores. Multiple copies of the will be retained both at onsite and offsite locations. 12. References and Resources: The following sources were used as references: The California Hospital Association Consent Manual, current edition; the California Hospital Association Records Retention Schedule, current edition and the California Department of Public Health Title 22. The California Hospital Association Record and Data Retention Schedule can be found on the following link: It is the Department Director's responsibility, where the California Hospital Association Record Retention Schedule is not specific enough or the law is unclear, to consult with the Director of Health Information Management (HIM), the Director of Risk Management, or the Compliance and Privacy Officer for further guidance. "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 52 of 391

53 Administrative, Administrative Manual Policy Number: AP23 Date Created: 11/01/1995 Document Owner: Cindy Moccio (Board Clerk/Exec Date Approved: Not Approved Yet Assist-CEO) Approvers: Board of Directors (Administration) Conflict of Interest Printed copies are for reference only. Please refer to the electronic copy for the latest version. POLICY: Government Code Section requires each state and local government agency to adopt and promulgate a Conflict of Interest Code. The Fair Political Practices Commission has adopted Section of Title 2 of the California Code of Regulations, which contains the terms of a model conflict of interest code (hereinafter "Standard Code") which may be adopted by reference by any state or local agency which desires to do so. For the purpose of providing a conflict of interest code for Kaweah Delta Health Care District, its Board of Directors, and its employees, the terms of the Standard Code and any amendments to it duly adopted by the Fair Political Practices Commission are hereby incorporated by reference and made a part hereof as if set forth herein at length, and, along with Exhibits A and B attached hereto, in which officials and employees are designated and disclosure categories are set forth, such Standard Code shall constitute the Conflict of Interest Code for Kaweah Delta Health Care District, its Board of Directors, and its employees. The Chief Executive Officer shall ensure that a current copy of the Standard Code is kept on file in the District s administrative office with this Conflict of Interest Code. A copy of the current version of the Standard Code is attached hereto as Exhibit C for information purposes only. PROCEDURE: Pursuant to Section 4 of the Standard Code, designated employees shall file statements of economic interests with the Chief Executive Officer of Kaweah Delta Health Care District. Upon receipt of the statements filed by the designated employees of the department, the Chief Executive Officer shall make and retain a copy and forward the original of these statements to the code reviewing body, which in this case is the Tulare County Board of Supervisors. Adopted by the Board of Directors of Kaweah Delta Health Care District effective November 29, I. Members, Board of Directors and Chief Executive Officer All members of the Kaweah Delta Health Care District Board of Directors and the individual occupying the position of Chief Executive Officer must complete and file Statements of Economic Interest with the Office of the Chief Executive Officer. Disclosure must include items listed in Exhibit B Page 53 of 391

54 Conflict of Interest 2 II. Other Affected Positions Individuals occupying positions as noted in Exhibit A are also required to complete and file, with the office of the Chief Executive Officer of Kaweah Delta Health Care District, Statements of Economic Interest. The types of interest to be disclosed are identified on Exhibit B per position held with the District. III. Filing Deadlines Individuals required to complete and file Statements of Economic Interest must do so with the appropriate office: A. within thirty (30) days after the effective date of the adoption of the Conflict of Interest Code, ; B. within thirty (30) days after assuming a position requiring filing such Statement; C. within thirty (30) days after leaving a position requiring filing of such Statement; and, D. annually, during the month of January, no later than April 1, for each year in which the individual occupies a position requiring a Statement. Page 54 of 391

55 Conflict of Interest 3 EXHIBIT "A KAWEAH DELTA HEALTH CARE DISTRICT CONFLICT OF INTEREST CODE Disclosure Categories Designated Positions Category of Interests Required to be Disclosed Members of the Board of Directors 1 Employees Chief Executive Officer 1 Senior Vice President, Chief Financial Officer 1 Senior Vice President, Chief Operating Officer 1 Vice President, Graduate Medical Education 1 Vice President, Medical Staff Affairs 1 Vice President, Chief Quality, Patient Safety, and /Medical Officer 1 Vice President, Chief Nursing Officer 1 Vice President, Chief Information Officer 1 Vice President of Human Resources 1 Vice President of Development 1 District Compliance & Privacy Officer 1 Director - Internal Audit Director of Procurement and Logistics Material Management 1 Kaweah Delta Medical Foundation Chief Executive Officer 1 Kaweah Delta Medical Foundation Chief Financial Officer 1 Director of Risk Management 1 Director of Facilities and Support Services 1 Director of Facilities Planning 1 All Directors of Kaweah Delta Health Care District 4B District Risk Manager 4A Director - Facilities Planning 3, 4A Director - Financial & Logistical Planning 4A Director Cardiovascular Service Line/Cardiovascular Co-management Program 4B Director - Case Management 4B Director - Clinical Education 4B Director - Clinical Information Services 4B Director - Community Outreach 4B Director - Emergency Department/Critical Care 4B Director - Employee Assistance Program 4B Director - Employee Relations 4B Page 55 of 391

56 Conflict of Interest 4 Director - Environmental Services & Safety Director - Facility Operations Director - Finance Director - Food Services Director - Health Information Management Director - Human Resources IS Director - Imaging Services Director - Information Technology Services Director ISS Applications Director - Kaweah Kids Director - Laboratory Director - Managed Care Director - Marketing & Communications Director - Maternal Child Health Director - Medical/Surgical Services Director - Mental Health Services Director - Nursing Practice Director - Oncology Business Services Director - Patient Access Director - Patient Financial Services Director - Performance Improvement & Patient Safety Director - Pharmacy Director - Private Home Care Director - Recruitment Director - Rehab Services Director - Renal Services Director - Respiratory Services Director - San Juan Health Center Director Security Services Director - Skilled & Home Services Director - Strategic Planning Director - Surgical Services Director - The Lifestyle Center Director Therapy (RHC) Director - Transitional Care Services Manager Hospice Program 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B Consultants Legal Counsel to the Board of Directors 1 [ Consultants may be designated employees who must disclose financial interests as determined on a case-by-case basis. The District must make a written determination whether a consultant must disclose financial interests. The determination shall include a description of the consultant s duties and a statement of the extent of the disclosure requirements, if any, based upon that description. All such determinations are public records and shall be retained for public inspection with this conflict of interest code. Page 56 of 391

57 Conflict of Interest 5 [ Consultants can be deemed to participate in making a governmental decision when the consultant, acting within the authority of his or her position: (1) Negotiates, without significant substantive review, with a governmental entity or private person regarding certain governmental decisions; or (2) Advises or makes recommendations to the decision-maker either directly or without significant intervening substantive review, by: a. Conducting research or making an investigation, which requires the exercise of judgment on the part of the person and the purpose of which is to influence a governmental decision; or b. Preparing or presenting a report, analysis, or opinion, orally or in writing, which requires the exercise of judgment on the part of the person and the purpose of which is to influence the decision. (From the Tulare County Counsel) {A consultant is also subject to the disclosure requirements if he/she acts in a staff capacity (i.e., performs the same or substantially all the same duties that would otherwise be performed by an individual holding a position specified in the Code).] Page 57 of 391

58 Conflict of Interest 6 EXHIBIT "B 1. Full Disclosure: KAWEAH DELTA HEALTH CARE DISTRICT CONFLICT OF INTEREST CODE Disclosure Categories Designated persons in this category must report: All interests in real property located entirely or partly within this District s jurisdiction or boundaries, or within two miles of this District s jurisdiction or boundaries or of any land owned or used by this District. Such interests include any leasehold, ownership interest or option to acquire such interest in real property. All investments, business positions, ownership and sources of income, including gifts, loans and travel payments. 2. Full Disclosure (excluding interests in real property): All investments, business positions, ownership and sources of income, including gifts, loans and travel payments. 3. Interests in Real Property (only): All interests in real property located entirely or partly within this District s jurisdiction or boundaries, or within two miles of this District s jurisdiction or boundaries or of any land owned or used by this District. Such interests include any leasehold, ownership interest or option to acquire such interest in real property. 4. General Contracting (two options): A. All investments, business positions, ownership and sources of income, including gifts, loans and travel payments, from sources that provide, or have provided in the last two years, leased facilities, goods, supplies, materials, equipment, vehicles, machinery, services, or the like, including training or consulting services, of the type utilized by the District. [Intended for employees whose duties and decisions involve contracting and purchasing for the entire District.] B. All investments, business positions, ownership and sources of income, including gifts, loans and travel payments, from sources that provide, or have provided in the last two years, leased facilities, goods, supplies, materials, equipment, Page 58 of 391

59 Conflict of Interest 7 vehicles, machinery, services, or the like, including training or consulting services, of the type utilized by the employee s department or division. [Intended for employees whose duties and decisions involve contracting and purchasing for a specific department or division of the District] 5. Regulatory, Permit or Licensing Duties: All investments, business positions, ownership and sources of income, including gifts, loans and travel payments, from sources that are subject to the regulatory, permit or licensing authority of, or have an application for a license or permit pending before, the employee s department or division, or the District. 6. Grant/Service Providers/Departments that Oversee Programs: A. All investments, business positions, ownership and sources of income, including gifts, loans and travel payments, or income from a nonprofit organization, if the source is of the type to receive grants or other monies from or through a specific department or division of the District. [Intended for employees whose duties and decision involve awards of monies or grants to organizations or individuals.] Page 59 of 391

60 Conflict of Interest 8 EXHIBIT "C KAWEAH DELTA HEALTH CARE DISTRICT CONFLICT OF INTEREST CODE Standard Code Provisions of Conflict of Interest Codes. (a) Incorporation by reference of the terms of this regulation along with the designation of employees and the formulation of disclosure categories in the Appendix referred to below constitute the adoption and promulgation of a conflict of interest code within the meaning of Government Code section or the amendment of a conflict of interest code within the meaning of Government Code section if the terms of this regulation are substituted for terms of a conflict of interest code already in effect. A code so amended or adopted and promulgated requires the reporting of reportable items in a manner substantially equivalent to the requirements of article 2 of chapter 7 of the Political Reform Act, Government Code sections 81000, et seq. The requirements of a conflict of interest code are in addition to other requirements of the Political Reform Act, such as the general prohibition against conflicts of interest contained in Government Code section 87100, and to other state or local laws pertaining to conflicts of interest. (b) The terms of a conflict of interest code amended or adopted and promulgated pursuant to this regulation are as follows: (1) Section 1. Definitions. The definitions contained in the Political Reform Act of 1974, regulations of the Fair Political Practices Commission (2 Cal. Code of Regs. sections 18100, et seq.), and any amendments to the Act or regulations, are incorporated by reference into this conflict of interest code. (2) Section 2. Designated Employees. The persons holding positions listed in the Appendix are designated employees. It has been determined that these persons make or participate in the making of decisions which may foreseeably have a material effect on economic interests. (3) Section 3. Disclosure Categories. This code does not establish any disclosure obligation for those designated employees who are also specified in Government Code section if they are designated in this code in that same capacity or if the geographical jurisdiction of this agency is the same as or is wholly included within the jurisdiction in which those persons must report their economic interests pursuant to article 2 of chapter 7 of the Political Reform Act, Government Code sections 87200, et seq. In addition, this code does not establish any disclosure obligation for any designated employees who are designated in a conflict of interest code for another agency, if all of the Page 60 of 391

61 Conflict of Interest 9 following apply: (A) The geographical jurisdiction of this agency is the same as or is wholly included within the jurisdiction of the other agency; (B) The disclosure assigned in the code of the other agency is the same as that required under article 2 of chapter 7 of the Political Reform Act, Government Code section 87200; and (C) The filing officer is the same for both agencies. 1 Such persons are covered by this code for disqualification purposes only. With respect to all other designated employees, the disclosure categories set forth in the Appendix specify which kinds of economic interests are reportable. Such a designated employee shall disclose in his or her statement of economic interests those economic interests he or she has which are of the kind described in the disclosure categories to which he or she is assigned in the Appendix. It has been determined that the economic interests set forth in a designated employee s disclosure categories are the kinds of economic interests which he or she foreseeably can affect materially through the conduct of his or her office. (4) Section 4. Statements of Economic Interests: Place of Filing. The code reviewing body shall instruct all designated employees within its code to file statements of economic interests with the agency or with the code reviewing body, as provided by the code reviewing body in the agency s conflict of interest code. 2 (5) Section 5. Statements of Economic Interests: Time of Filing. (A) Initial Statements. All designated employees employed by the agency on the effective date of this code, as originally adopted, promulgated and approved by the code reviewing body, shall file statements within 30 days after the effective date of this code. Thereafter, each person already in a position when it is designated by an amendment to this code shall file an initial statement within 30 days after the effective date of the amendment. (B) Assuming Office Statements. All persons assuming designated positions after the effective date of this code shall file statements within 30 days after assuming the designated positions, or if subject to State Senate confirmation, 30 days after being nominated or appointed. (C) Annual Statements. All designated employees shall file statements no later than April 1. (D) Leaving Office Statements. All persons who leave designated positions shall file statements within 30 days after leaving office. (5.5) Section 5.5. Statements for Persons Who Resign Prior to Assuming Office. Any person who resigns within 12 months of initial appointment, or within 30 days of the date of notice provided by the filing officer to file an assuming office statement, is not deemed to have assumed office or left office, provided he or she did not make or participate in the making of, or use his or her position to influence any decision and did not receive or become entitled to receive any form of payment as a result of his or her Page 61 of 391

62 Conflict of Interest 10 appointment. Such persons shall not file either an assuming or leaving office statement. (A) Any person who resigns a position within 30 days of the date of a notice from the filing officer shall do both of the following: (1) File a written resignation with the appointing power; and (2) File a written statement with the filing officer declaring under penalty of perjury that during the period between appointment and resignation he or she did not make, participate in the making, or use the position to influence any decision of the agency or receive, or become entitled to receive, any form of payment by virtue of being appointed to the position. (6) Section 6. Contents of and Period Covered by Statements of Economic Interests. (A) Contents of Initial Statements. Initial statements shall disclose any reportable investments, interests in real property and business positions held on the effective date of the code and income received during the 12 months prior to the effective date of the code. (B) Contents of Assuming Office Statements. Assuming office statements shall disclose any reportable investments, interests in real property and business positions held on the date of assuming office or, if subject to State Senate confirmation or appointment, on the date of nomination, and income received during the 12 months prior to the date of assuming office or the date of being appointed or nominated, respectively. (C) Contents of Annual Statements. Annual statements shall disclose any reportable investments, interests in real property, income and business positions held or received during the previous calendar year provided, however, that the period covered by an employee s first annual statement shall begin on the effective date of the code or the date of assuming office whichever is later, or for a board or commission member subject to Government Code section , the day after the closing date of the most recent statement filed by the member pursuant to 2 Cal. Code Regs. section (D) Contents of Leaving Office Statements. Leaving office statements shall disclose reportable investments, interests in real property, income and business positions held or received during the period between the closing date of the last statement filed and the date of leaving office. (7) Section 7. Manner of Reporting. Statements of economic interests shall be made on forms prescribed by the Fair Political Practices Commission and supplied by the agency, and shall contain the following information: (A) Investments and Real Property Disclosure. Page 62 of 391

63 Conflict of Interest 11 When an investment or an interest in real property 3 is required to be reported, 4 the statement shall contain the following: 1. A statement of the nature of the investment or interest; 2. The name of the business entity in which each investment is held, and a general description of the business activity in which the business entity is engaged; 3. The address or other precise location of the real property; 4. A statement whether the fair market value of the investment or interest in real property equals or exceeds two thousand dollars ($2,000), exceeds ten thousand dollars ($10,000), exceeds one hundred thousand dollars ($100,000), or exceeds one million dollars ($1,000,000). (B) Personal Income Disclosure. When personal income is required to be reported, 5 the statement shall contain: 1. The name and address of each source of income aggregating five hundred dollars ($500) or more in value, or fifty dollars ($50) or more in value if the income was a gift, and a general description of the business activity, if any, of each source; 2. A statement whether the aggregate value of income from each source, or in the case of a loan, the highest amount owed to each source, was one thousand dollars ($1,000) or less, greater than one thousand dollars ($1,000), greater than ten thousand dollars ($10,000), or greater than one hundred thousand dollars ($100,000); 3. A description of the consideration, if any, for which the income was received; 4. In the case of a gift, the name, address and business activity of the donor and any intermediary through which the gift was made; a description of the gift; the amount or value of the gift; and the date on which the gift was received; 5. In the case of a loan, the annual interest rate and the security, if any, given for the loan and the term of the loan. (C) Business Entity Income Disclosure. When income of a business entity, including income of a sole proprietorship, is required to be reported, 6 the statement shall contain: 1. The name, address, and a general description of the business activity of the business entity; 2. The name of every person from whom the business entity received payments if the filer s pro rata share of gross receipts from such person was equal to or greater than ten thousand dollars ($10,000). (D) Business Position Disclosure. When business positions are required to be reported, a designated employee shall list the name and address of each business entity in which he or she is a director, officer, partner, trustee, employee, or in which he or she holds any position of management, a description of the business activity in which the business entity is engaged, and the designated employee s position with the business entity. Page 63 of 391

64 Conflict of Interest 12 (E) Acquisition or Disposal During Reporting Period. In the case of an annual or leaving office statement, if an investment or an interest in real property was partially or wholly acquired or disposed of during the period covered by the statement, the statement shall contain the date of acquisition or disposal. (8) Section 8. Prohibition on Receipt of Honoraria. (A) No member of a state board or commission, and no designated employee of a state or local government agency, shall accept any honorarium from any source, if the member or employee would be required to report the receipt of income or gifts from that source on his or her statement of economic interests. This section shall not apply to any part time member of the governing board of any public institution of higher education, unless the member is also an elected official. Subdivisions (a), (b), and (c) of Government Code section shall apply to the prohibitions in this section. This section shall not limit or prohibit payments, advances, or reimbursements for travel and related lodging and subsistence authorized by Government Code section (8.1) Section 8.1 Prohibition on Receipt of Gifts in Excess of $390. (A) No member of a state board or commission, and no designated employee of a state or local government agency, shall accept gifts with a total value of more than $390 in a calendar year from any single source, if the member or employee would be required to report the receipt of income or gifts from that source on his or her statement of economic interests. This section shall not apply to any part time member of the governing board of any public institution of higher education, unless the member is also an elected official. Subdivisions (e), (f), and (g) of Government Code section shall apply to the prohibitions in this section. (8.2) Section 8.2. Loans to Public Officials. (A) No elected officer of a state or local government agency shall, from the date of his or her election to office through the date that he or she vacates office, receive a personal loan from any officer, employee, member, or consultant of the state or local government agency in which the elected officer holds office or over which the elected officer s agency has direction and control. (B) No public official who is exempt from the state civil service system pursuant to subdivisions (c), (d), (e), (f), and (g) of Section 4 of Article VII of the Constitution shall, while he or she holds office, receive a personal loan from any officer, employee, member, or consultant of the state or local government agency in which the public official holds office or over which the public official s agency has direction and control. This subdivision shall not apply to loans made to a public official whose duties are solely secretarial, clerical, or manual. (C) No elected officer of a state or local government agency shall, from the date of his or her election to office through the date that he or she vacates office, receive a personal loan from any person who has a contract with the state or local government agency to which Page 64 of 391

65 Conflict of Interest 13 that elected officer has been elected or over which that elected officer s agency has direction and control. This subdivision shall not apply to loans made by banks or other financial institutions or to any indebtedness created as part of a retail installment or credit card transaction, if the loan is made or the indebtedness created in the lender s regular course of business on terms available to members of the public without regard to the elected officer s official status. (D) No public official who is exempt from the state civil service system pursuant to subdivisions (c), (d), (e), (f), and (g) of Section 4 of Article VII of the Constitution shall, while he or she holds office, receive a personal loan from any person who has a contract with the state or local government agency to which that elected officer has been elected or over which that elected officer s agency has direction and control. This subdivision shall not apply to loans made by banks or other financial institutions or to any indebtedness created as part of a retail installment or credit card transaction, if the loan is made or the indebtedness created in the lender s regular course of business on terms available to members of the public without regard to the elected officer s official status. This subdivision shall not apply to loans made to a public official whose duties are solely secretarial, clerical, or manual. (E) This section shall not apply to the following: 1. Loans made to the campaign committee of an elected officer or candidate for elective office. 2. Loans made by a public official s spouse, child, parent, grandparent, grandchild, brother, sister, parent-in-law, brother-in-law, sister-in-law, nephew, niece, aunt, uncle, or first cousin, or the spouse of any such persons, provided that the person making the loan is not acting as an agent or intermediary for any person not otherwise exempted under this section. 3. Loans from a person which, in the aggregate, do not exceed five hundred dollars ($500) at any given time. 4. Loans made, or offered in writing, before January 1, (8.3) Section 8.3. Loan Terms. (A) Except as set forth in subdivision (B), no elected officer of a state or local government agency shall, from the date of his or her election to office through the date he or she vacates office, receive a personal loan of five hundred dollars ($500) or more, except when the loan is in writing and clearly states the terms of the loan, including the parties to the loan agreement, date of the loan, amount of the loan, term of the loan, date or dates when payments shall be due on the loan and the amount of the payments, and the rate of interest paid on the loan. (B) This section shall not apply to the following types of loans: 1. Loans made to the campaign committee of the elected officer. 2. Loans made to the elected officer by his or her spouse, child, parent, grandparent, Page 65 of 391

66 Conflict of Interest 14 grandchild, brother, sister, parent-in-law, brother-in-law, sister-in-law, nephew, niece, aunt, uncle, or first cousin, or the spouse of any such person, provided that the person making the loan is not acting as an agent or intermediary for any person not otherwise exempted under this section. 3. Loans made, or offered in writing, before January 1, (C) Nothing in this section shall exempt any person from any other provision of Title 9 of the Government Code. (8.4) Section 8.4. Personal Loans. (A) Except as set forth in subdivision (B), a personal loan received by any designated employee shall become a gift to the designated employee for the purposes of this section in the following circumstances: 1. If the loan has a defined date or dates for repayment, when the statute of limitations for filing an action for default has expired. 2. If the loan has no defined date or dates for repayment, when one year has elapsed from the later of the following: a. The date the loan was made. b. The date the last payment of one hundred dollars ($100) or more was made on the loan. c. The date upon which the debtor has made payments on the loan aggregating to less than two hundred fifty dollars ($250) during the previous 12 months. (B) This section shall not apply to the following types of loans: 1. A loan made to the campaign committee of an elected officer or a candidate for elective office. 2. A loan that would otherwise not be a gift as defined in this title. 3. A loan that would otherwise be a gift as set forth under subdivision (A), but on which the creditor has taken reasonable action to collect the balance due. 4. A loan that would otherwise be a gift as set forth under subdivision (A), but on which the creditor, based on reasonable business considerations, has not undertaken collection action. Except in a criminal action, a creditor who claims that a loan is not a gift on the basis of this paragraph has the burden of proving that the decision for not taking collection action was based on reasonable business considerations. 5. A loan made to a debtor who has filed for bankruptcy and the loan is ultimately discharged in bankruptcy. (C) Nothing in this section shall exempt any person from any other provisions of Title 9 of the Government Code. (9) Section 9. Disqualification. Page 66 of 391

67 Conflict of Interest 15 No designated employee shall make, participate in making, or in any way attempt to use his or her official position to influence the making of any governmental decision which he or she knows or has reason to know will have a reasonably foreseeable material financial effect, distinguishable from its effect on the public generally, on the official or a member of his or her immediate family or on: (A) Any business entity in which the designated employee has a direct or indirect investment worth two thousand dollars ($2,000) or more; (B) Any real property in which the designated employee has a direct or indirect interest worth two thousand dollars ($2,000) or more; (C) Any source of income, other than gifts and other than loans by a commercial lending institution in the regular course of business on terms available to the public without regard to official status, aggregating five hundred dollars ($500) or more in value provided to, received by or promised to the designated employee within 12 months prior to the time when the decision is made; (D) Any business entity in which the designated employee is a director, officer, partner, trustee, employee, or holds any position of management; or (E) Any donor of, or any intermediary or agent for a donor of, a gift or gifts aggregating $390 or more provided to, received by, or promised to the designated employee within 12 months prior to the time when the decision is made. (9.3) Section 9.3. Legally Required Participation. No designated employee shall be prevented from making or participating in the making of any decision to the extent his or her participation is legally required for the decision to be made. The fact that the vote of a designated employee who is on a voting body is needed to break a tie does not make his or her participation legally required for purposes of this section. (9.5) Section 9.5. Disqualification of State Officers and Employees. In addition to the general disqualification provisions of section 9, no state administrative official shall make, participate in making, or use his or her official position to influence any governmental decision directly relating to any contract where the state administrative official knows or has reason to know that any party to the contract is a person with whom the state administrative official, or any member of his or her immediate family has, within 12 months prior to the time when the official action is to be taken: (A) Engaged in a business transaction or transactions on terms not available to members of the public, regarding any investment or interest in real property; or (B) Engaged in a business transaction or transactions on terms not available to members of the public regarding the rendering of goods or services totaling in value one thousand dollars ($1,000) or more. (10) Section 10. Disclosure of Disqualifying Interest. Page 67 of 391

68 Conflict of Interest 16 When a designated employee determines that he or she should not make a governmental decision because he or she has a disqualifying interest in it, the determination not to act may be accompanied by disclosure of the disqualifying interest. (11) Section 11. Assistance of the Commission and Counsel. Any designated employee who is unsure of his or her duties under this code may request assistance from the Fair Political Practices Commission pursuant to Government Code section and 2 Cal. Code Regs. sections and or from the attorney for his or her agency, provided that nothing in this section requires the attorney for the agency to issue any formal or informal opinion. (12) Section 12. Violations. This code has the force and effect of law. Designated employees violating any provision of this code are subject to the administrative, criminal and civil sanctions provided in the Political Reform Act, Government Code sections In addition, a decision in relation to which a violation of the disqualification provisions of this code or of Government Code section or has occurred may be set aside as void pursuant to Government Code section NOTE: Authority cited: Section 83112, Government Code. Reference: Sections 87103(e), , 89501, and 89503, Government Code. 1 Designated employees who are required to file statements of economic interests under any other agency s conflict of interest code, or under article 2 for a different jurisdiction, may expand their statement of economic interests to cover reportable interests in both jurisdictions, and file copies of this expanded statement with both entities in lieu of filing separate and distinct statements, provided that each copy of such expanded statement filed in place of an original is signed and verified by the designated employee as if it were an original. See Government Code section See Government Code section and 2 Cal. Code of Regs. section for the duties of filing officers and persons in agencies who make and retain copies of statements and forward the originals to the filing officer. 3 For the purpose of disclosure only (not disqualification), an interest in real property does not include the principal residence of the filer. 4 Investments and interests in real property which have a fair market value of less than $2,000 are not investments and interests in real property within the meaning of the Political Reform Act. However, investments or interests in real property of an individual include those held by the individual s spouse and dependent children as well as a pro rata share of any investment or interest in real property of any business entity or trust in which the individual, spouse and dependent children own, in the aggregate, a direct, indirect or beneficial interest of 10 percent or greater. 5 A designated employee s income includes his or her community property interest in the income of his or her spouse but does not include salary or reimbursement for expenses Page 68 of 391

69 Conflict of Interest 17 received from a state, local or federal government agency. 6 Income of a business entity is reportable if the direct, indirect or beneficial interest of the filer and the filer s spouse in the business entity aggregates a 10 percent or greater interest. In addition, the disclosure of persons who are clients or customers of a business entity is required only if the clients or customers are within one of the disclosure categories of the filer. Page 69 of 391

70 Conflict of Interest 18 "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 70 of 391

71 Effective Date: 04/14/14 Policy #: AP.38 Supersedes Policy Dated: 12/12/11 Date Last Reviewed: POLICY MANUALS * TEMPLATES AVAILABLE ON Policy Tech * ADMINISTRATIVE POLICY MANUAL PURPOSE: To clearly define requirements and/or expectations regarding writing, revising or deleting a policy or procedure. POLICY: Written statements of District policies and procedures are found in several manuals that are reviewed, approved, and published by the Kaweah Delta Health Care District Administration and/or Board of Directors on a regular schedule. Among these are; A. Administrative Policy Manual B. Human Resources Policy Manual C. Environment of Care Manual D. Infection Prevention Policy Manual E. Patient Care/Nursing Services Manual F. Medical Staff Order Sets & Protocols G. Manuals for specific department and/or services within the organization All policies and procedures will reflect the use of the best evidence to support decision-making and will be written, revised, or deleted from the applicable policy manuals in accordance with the procedure illustrated below. Any staff member, in collaboration with their manager and/or director, may write a new policy or make changes to an existing policy. Policies and procedures will be reviewed at least every three years. 12/12/11 Page 1 of 22 Page 71 of 391

72 Policy Manuals AP38 PROCEDURE: I. Definition and Maintenance of Policy and Procedure Manuals A. Administrative Policy Manual: policies are written statements that have no direct involvement in clinical patient care issues but which are interdepartmental in nature. Policy maintenance is the responsibility of District Administration. B. Human Resources Policy Manual: Policies are written statements providing information and direction in the management of individuals employed by the District. Policy maintenance is the responsibility of the Human Resources Department. C. Environment of Care Manual: Policies describe the District s management plans regarding safety, security, hazardous materials and waste management, emergency preparedness, and life safety. Policy maintenance is the responsibility of the Safety Officer, delegated to the Safety Management Committee. D. Infection Prevention Policy Manual: Policies ensure patient and employee safety through evidence based practice and regulatory guidelines. Policy maintenance is the responsibility of the Infection Prevention Coordinator in conjunction with the Infection Prevention Committee. E. Patient Care/Nursing Services Manual: Policies and procedures contained within this manual may be specific to as few as two departments, services, or disciplines, or may provide direction to every department within the District responsible for the provision of patient care. Policy maintenance is the responsibility of the Chief Nurse Officer, delegated to the Patient Care Policy and Procedures Committee. F. Medical Staff Order Sets and Protocols: Maintenance of physician preprinted order sets and protocols is the responsibility of the Chief Medical and Quality Officer, delegated to the Clinical Order Set/Protocol CommitteeOrders Review Committee. G. Department or Service Specific Manuals: Policy maintenance is the responsibility of the Department Director/Manager of each department maintaining a Departmental Policy Manual. II. Development of New and/or Revisions to Existing Policy Manuals and Necessary Approvals for Inclusion II. A. Policy development and revisions will be completeddone within the Policy Tech software system. Assigned reviewers and approvers will complete those tasks within the software. In order to ensure that changes made Formatted: Indent: Left: 0.5", No bullets or numbering, Tab stops: 1", Left + Not at 0.5" 04/14/14 Page 2 of 22 Page 72 of 391

73 Policy Manuals AP38 during the review and revision process are visible to the Board of Directors, document owners will decline changes that are not approved, and leave all approved changes in place, but don t accept them, as this would turn off the track changes in the document. B. For policy submission to the Board of Directors for approval, the policy owner will submit a policy submission summary (Appendix C.1 & C.2D) no less than ten days prior to the Board meeting and it with all revised and deleted new policies for Board review and request for approval. Policies that are reviewed with no changes (reviewed) or deleted do not need to be sent with the policy submission summary. To facilitate this, policy owners should use the Document Report, Change Summary with Version History and Documents Replaced from the Policy Tech software system. If there are too many policies to the policies can be delivered on a thumb drive to the office of the Board Clerk to download. Upon Board approval, the approval status will be updated in Policy Tech by the Board Clerk. C. A completed Approvals Page can be found in the Document Overview within the Policy Tech software. C. The Policy Submission Summary should include the listing of all policies being submitted for initial approval (new), policies being revised (revised), reviewed with no changes (reviewed) and deleted, in that order on the policy submission summary. For each new policy or revised policy, the name and phone number for the staff member responsible for the policy should be included on the policy submission summary. Formatted: Indent: Left: 0", First line: 0", Tab stops: 1", Left Formatted: Tab stops: 1", Left ", Left + Not at 0.5" Formatted: Indent: Left: 0.56", Hanging: 0.44", Tab stops: 1", List tab + Not at 1.06" 04/14/14 Page 3 of 22 Page 73 of 391

74 Policy Manuals AP38 D. Administrative Policy Manual Policy developed, reviewed/revised by department leadership with input from key stakeholders Formatted Formatted: Heading 3, No bullets or numbering, Tab stops: Not at 1" Policies that are strategically or organizationally important requires approval of the Executive Team If not strategically or organizationally important, only requires approval of CEO, Sr. Vice President or Vice President Board of Directors (BOD) E. Human Resource Policy Manual Policy developed, reviewed/revised with input from key stakeholders Vice President Human Resources Policies that are strategically or organizationally important requires approval of Executive Team If not strategically or organizationally important, only requires approval of CEO, Sr. Vice President or Vice President Board of Directors (BOD) F. Environment of Care Manual Policy developed, reviewed/revised by department leadership with input from key stakeholders Environment of Care Committee Board of Directors (BOD) 04/14/14 Page 4 of 22 Page 74 of 391

75 Policy Manuals AP38 G. Infection Prevention Policy Manual Policy which does not affect patient care developed, reviewed/revised by department leadership with input from key stakeholders Infection Prevention Committee Board of Directors (BOD) Policy which does affect patient care developed, reviewed/revised by department leadership with input from key stakeholders Infection Prevention Committee Present information to Patient Care Policy & Procedure Committee Medical Executive Committee (MEC) Board of Directors (BOD) H. Patient Care / Nursing Services and Department or Service Specific Policy Manuals 1. Policy/Procedure Format a. A specific format has been adopted for policies and procedures. This policy is a non- inclusive example of the adopted format. (1) All policies must include the following language: These guidelines, procedures or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bi-ethical circumstances may provide sound reasons for 04/14/14 Page 5 of 22 Page 75 of 391

76 Policy Manuals AP38 alternative approaches; even through they are not described in this document. (2) Evidence Based Practice (EBP): (a) Use of EBP is based on the belief that science is the ideal source of knowledge underlying clinical decisions (Stevens & Ledbetter as cited in Schoenfelder, 2007, p. 7). (b) Policies and procedures will demonstrate the use of the best clinical evidence (i.e., disciplined research and/or professional nursing organization standards) through citation of appropriate references in a format that identifies the source for readers and enables them to locate the information. Refer to for automated assistance. b. Any policy/procedure submitted which is incomplete, lacking information necessary for processing, or submitted in a format other than that which has been adopted for these policies, will be returned to its originator until compliance is met. 2. Committee Review a. Nursing policies and procedures will be reviewed for compliance with standards of nursing care and nursing practice. All policies and procedures affecting clinical outcomes and medical practice must be reviewed and approved by appropriate physician leadership. b. The author (or their designee) must present the policy/procedure at the committee meeting. c. The Patient Care Policy/Procedure Committee, along with the author of the policy, will determine the level and content of staff education needed and who is responsible for staff education, as part of the policy approval process. 3. Submission of Policy/Procedure for Committee Review a. All policies submitted for committee review must be processed via PolicyTech ed to the Policy and Procedure secretary 6 business days prior to the next scheduled committee meeting. Policies submitted after that Formatted: Indent: Left: 1.5", Hanging: 0.5", Tab stops: 2", List tab + Not at 1.75" 04/14/14 Page 6 of 22 Page 76 of 391

77 Policy Manuals AP38 date will be reviewed at the next scheduled meetingwith the following month s submissions. b. Complete Policy Submission Summary (see Appendix C.1 & C.2D) Formatted: Indent: Left: 1.5", Hanging: 0.5", Tab stops: Not at 1.75" 4. Approval Process a. Patient Care Policy Manual (see Appendix A) b. Department or Service Specific Manuals (see Appendix B.1 & B.2) 5. Routing Process a. Patient Care Policy Manual (see Appendix A) b. Department or Service Specific Manuals (see Appendix B.1 & B.2) 6. Non-approval Notification a. If a policy is not approved the recording secretary will communicate the reasons for rejection to the policy owner. Formatted: Indent: Left: 1.5", Hanging: 0.5", Tab stops: 2", List tab + Not at 1.75" 7. Temporary Approval a. Occasionally, because of change of practice or regulation, it becomes necessary to implement a policy more quickly than it is possible for it to move through all approving bodies. The Chief Nursing Officer (or designee) may grant temporary policy approval, in concert with the Chief of Staff (Chief of Staff approval required only if policy directly affects patient care). When granted, the policy will be valid for ninety days (90) or until the end of the third month from the date of signature by these individuals. b. Policies granted temporary approval will: i. Have clear indication on the policy s front page that the policy is temporary and next review date will be set for 90 days in Policy Tech. contain a valid through date. ii. iii. Be listed in the manual index as Temporary Policy Type the letter T after the policy number to indicate that it is a temporary policy. (Example PC.154T) By adding the T this will enable the revised document to continue processing through appropriate approval committees. Formatted: Indent: Left: 1.5", Hanging: 0.5", Tab stops: 2", List tab + Not at 1.75" Formatted: Indent: Left: 1.5", Hanging: 0.5", Tab stops: Not at 1.75" Formatted: Indent: Left: 2", Hanging: 0.5", Tab stops: 2.5", Left ", List tab 04/14/14 Page 7 of 22 Page 77 of 391

78 Policy Manuals AP38 iv. Once revised policy is approved and published, archive the temporary version of the policy. ii. c. Policy owner is responsible for development and dissemination of temporary policy communication and education plans. Formatted: Tab stops: 5.1", Left + Not at 2.5" Formatted: Indent: Left: 1.5", Hanging: 0.5", Tab stops: 2", List tab + Not at 1.75" 8. Deletion of Policies/Procedures Policies/Procedures that need to be deleted go through the same approval process as for development or revision of a policy or procedure. (See Flow Diagram) I. Medical Staff Order Sets and Protocols: Formatted: Indent: Left: 0" Formatted: Left 1. A specific format has been adopted for physician pre-printed order sets and protocols. a) Evidence Based Practice (EBP): (1) Use of EBP is based on the belief that science is the ideal source of knowledge underlying clinical decisions (Stevens & Ledbetter as cited I Schoenfelder, 2007, p.7). b)a) c)b) d)c) Pre-printed oorder sets and protocols will demonstrate the use of best clinical evidence (i.e. disciplined research and/or professional medical organization). Any pre-printed order set or protocol submitted which is incomplete, lacking information necessary for processing, or submitted in a format other than that which has been adopted for these pre-printed order sets or protocols, will be returned to its originator until compliance is met.the sponsor (i.e. medical, medical staff department chair, or district department director as appropriate or designee) will work with subject matter experts, stakeholders, and Information System Services (ISS) to design and build content in Computerized Physician Order Entry (CPOE) prior to submission to the Orders Review Committee (ORC). Committee ORC Review: Physician pre-printed order sets and protocols. (1) Physician pre-printed order sets and protocols will be reviewed for compliance with evidence-based clinical practice and medical standards of care. 04/14/14 Page 8 of 22 Page 78 of 391

79 Policy Manuals AP38 (2) The author sponsor (or their designee) must presents the pre-printed order set or protocol at the committee meetingorc meeting. (3) The Clinical Order Set/Protocol CommitteeORC will recommend the level and content of staff education needed and who is responsible for staff education, as part of the approval process. e) Submission of Pre-printed Order Set or Protocol for Committee Review. Sponsor (or designee) submission of orders or protocol change requests: (1)(4) Submit all orders and protocol change requests to the IS Orders Analyst or Chief Clinical Information Officer using the Introduction, Situation, Background, Assessment, Recommendation, Questions (ISBARQ) Change Request form (Aappendix DE) All pre-printed order sets and protocols submitted for committee review must be ed to the Performance Improvement RN-Clinical Analyst representing the Clinical Order Set/Protocol Committee 6 business days prior to the next scheduled committee meeting. Pre-printed order sets or protocols submitted after that date will be reviewed with the following month s submissions. (2) Complete Pre-printed Order Set or Protocol Approval Page (see Appendix K) f)d) g)e) h)f) Approval Process See Appendix DC Routing ISBARQ Change Request Form Process See Appendix EDC Non-approval Notification (1) If a pre-printed order set or protocol is not approved the recording secretaryorders analyst will communicate the reasons for rejection to the order set ownersponsor. i)g) Temporary Approval (1) Occasionally, because of change of practice or regulation, it becomes necessary to implement a preprinted an order set or protocol more quickly than it is possible for it to move through all approving bodies. The Chair of Pharmacy & Therapeutics, Chief of Staff, Chief Nursing Officer and Pharmacy Director (or 04/14/14 Page 9 of 22 Page 79 of 391

80 Policy Manuals AP38 designee) may grant temporary pre-printed order sets or protocols approval. The order set or protocol will be placed on the next monthly ORC, P&T, MEC, and Board upcoming agendas for approval. When granted, the pre-printed order sets or protocols will be valid for ninety days (90) or until the end of the third month from the date of signature by these individuals. (2) Order set or protocol granted temporary approval will: (a) (b) Have a clear indication on the pre-printed order set or protocol front page that the order set or protocol is temporary and contain a valid through date. Be listed in the manual index as Temporary Policy (3)(2) Development and dissemination of temporary policy communication and education plans for pre-printed order sets or protocols will represent a collaborative effort between Clinical Education, Quality and Patient Safety Performance Improvement RN-Clinical Analyst, ISS orders team and order set/protocol ownersponsor. j)h) Deletion Removal of Pre-printed Order Sets and Protocols Pre-printed Oorder sets and protocols may be deleted removed by the physician championsponsor of that preprinted order set/protocol in concert with the Department ChiefChair. (See Flow Diagram Appendix C) Formatted: Left, Indent: Left: 2" Formatted: Left 04/14/14 Page 10 of 22 Page 80 of 391

81 Policy Manuals AP38 Patient Care Policy Manual Policy or Standardized Procedure developed, reviewed/revised by staff & leadership with input from medical staff leadership (or designee) and key stakeholders Appendix A Patient Care Manual (Policies & Standardized Procedures) Directly Affects Patient Care Patient Care Policy & Procedure Committee Policy or Standardized Procedure? Interdisciplinary Practice Committee (IPC) Standardized Procedure Policy Pharmacy & Therapeutics Committee (P&T) Yes Meds or treatments involved? No Medical Executive Committee (MEC) Policy Submission Summary posted to the KDNet BOD Secretary Board of Directors (BOD) P&P Secretary s notification to: Professional Practice Council (PPC) Owner Publish policy in Policy Tech, prior School of Nursing notification version automatically archivedarchive old policy with Risk Mgmt 04/14/14 Page 11 of 22 Page 81 of 391

82 Policy Manuals AP38 Department or Service Specific Manuals Policy developed, reviewed/revised by staff & leadership with key stakeholder input, including Unit Based Council (UBC) Appendix B.1 Department or Service Specific Policies Directly Affects Patient Care Department Director in collaboration with Medical Director (if applicable) Appropriate Medical Staff Department Meds or treatments involved? Yes Pharmacy & Therapeutics Committee (P&T) No Medical Executive Committee Formatted: Font: 9 pt Policy Submission Summary posted to the KDNet BOD SecretaryCl erk Board of Directors (BOD) Department Admin Support As applicable: Unit Based Council (UBC) & Nursing Practice Council (NPC) Archive old policy with Risk Mgmt Publish policy in Policy Tech, prior version automatically archived 04/14/14 Page 12 of 22 Page 82 of 391

83 Policy Manuals AP38 Department or Service Specific Manuals (continued) Policy developed, reviewed/revised by staff & leadership with key stakeholder input, including Unit Based Council (UBC) Appendix B.2 Department or Service Specific Policies Does NOT Directly Affect Patient Care Department Director in collaboration with Medical Director (if applicable) Policy Submission Summary posted to the KDNet BOD Secretary Board of Directors (BOD) Department Admin Support As applicable: Unit Based Council (UBC) & Nursing Practice Council (NPC) Archive old policy with Risk Mgmt Publish policy in Policy Tech, prior version automatically archived Formatted: Centered 04/14/14 Page 13 of 22 Page 83 of 391

84 Policy Manuals AP38 Appendix C.1 Policy Submission Summary Manual Name: Date: Support Staff Name: Routed To: Approved By: (Name/Committee - Department Director Medical Director (if applicable) Medical Staff Department (if applicable) Patient Care Policy (if applicable) Pharmacy & Therapeutics (if applicable) Interdisciplinary Practice (if applicable) Executive Team (if applicable) Medical Executive Committee (if applicable) Board of Directors Policy/Procedure Title # Status (New, Revised, Reviewed, Deleted) Name and Phone # of person who wrote the new policy or revised an existing policy Formatted: Font: (Default) Arial, Not Bold Formatted: Font: (Default) Arial, Not Bold Formatted Table Formatted Table Formatted Table Formatted: Centered 04/14/14 Page 14 of 22 Page 84 of 391

85 Policy Manuals AP38 Appendix C.2 Policy Submission Summary (Multiple Committee Review) Date: Manual Name: Support Staff Name: Routed To: (Select appropriate departments/committees) Department Director Medical Director Medical Staff Department Pharmacy & Therapeutics Medical Executive Committee Board of Directors Policy/Procedure Title # Date Approved: Status (New, Revised, Reviewed or Deleted) Name and Phone # of person who wrote new policy or revised an existing policy 04/14/14 Page 15 of 22 Page 85 of 391

86 Policy Manuals AP38 Orders and Protocols Approval Process, Appendix DC Formatted: Font: (Default) Arial 04/14/14 Page 16 of 22 Page 86 of 391

87 Policy Manuals AP38 Formatted: Centered Medical Staff Order Sets and Protocols Pre-printed order set or protocol developed, reviewed/revised by physician champion/department chief and key hospital staff stakeholders. Appendix C Medical Staff Order Sets and Protocols Formatted: Justified Clinical Order Set/Protocol Committee: includes representation by medical staff, nursing, pharmacy and ancillary services Approved? No Return to physician champion/ stakeholders for revision and resubmit to Clinical Order Set Committee. If denied approval at P & T or MEC return to Clinical Order Set Committee. Yes No Pharmacy & Therapeutics (P&T) approval? Yes 04/14/14 Page 17 of 22 Page 87 of 391

88 Policy Manuals AP38 Medical Executive Committee (MEC) Education of appropriate staff per education plan. Upon completion of staff education, order set/ protocol is available as paper document and CPOE. Formatted Formatted: Justified Ratified by Board of Directors (BOD) Medical Staff Office notified of action taken by the Board of Directors 04/14/14 Page 18 of 22 Page 88 of 391

89 Policy Manuals AP38 References: Schoenfelder, D. P. (2007). Simply the best: Teaching gerontological nursing students to teach evidencebased practice. Journal of Gerontological Nursing, 33(8), Formatted Formatted: Justified 04/14/14 Page 19 of 22 Page 89 of 391

90 Policy Manuals AP38 Appendix ED ISBARQ [Title of Change Requested] [Date] Introduction: [Your contact info, title,etc] Situation: [Problem and/or change requested] Background: Requested by: Justification: [literature support, patient safety risk, etc] Assessment Category of Change Requested: [Patient Safety, Regulatory, Enhancement, etc] Description of issues the changes will resolve and implications: Suggested changes to order sets: [summary of changes] Recommended Communication/Education for affected disciplines (nursing, physicians, pharmacy, etc.: [Monthly education bundle, essential information, nursing unit huddles, etc] Recommendation [Specific bulleted Recommendation e.g., approve the changes, approve design, including screenshots if appropriate] Questions: [Contact information again] 04/14/14 Page 20 of 22 Page 90 of 391

91 Policy Manuals AP38 Policy Submission Summary Manual Name: Support Staff Name: Policy/Procedure Title # Status (New, Revised, Reviewed w/no Revision, Deleted) Date: Name and Phone # of person who wrote the new policy or revised an existing policy References: Schoenfelder, D. P. (2007). Simply the best: Teaching gerontological nursing students to teach evidencebased practice. Journal of Gerontological Nursing, 33(8), /14/14 Page 21 of 22 Page 91 of 391

92 Policy Manuals AP38 These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." 04/14/14 Page 22 of 22 Page 92 of 391

93 Policy Submission Summary Manual Name: Board of Directors Date: 07/13/17 Support Staff Name: Cindy Moccio Policy/Procedure Title # Status New, Revised, Reviewed, or Deleted * Name and phone extension of person who wrote or revised policy - * for New and Revised policies only Chief Executive Officer BOD3 Revised Cindy Moccio & Dennis Lynch Conflict of Interest BOD5 Revised Cindy Moccio & Dennis Lynch Orientation of a new board member BOD1 Reviewed Cindy Moccio x2330 & Dennis Lynch Chief Executive Officer (CEO) Transition BOD2 Reviewed Cindy Moccio x2330 & Dennis Lynch Executive Compensation BOD4 Reviewed Cindy Moccio x2330 & Dennis Lynch Board reimbursement for travel and BOD6 Reviewed Cindy Moccio x2330 & Dennis Lynch service Presentation of claims and service process BOD7 Reviewed Cindy Moccio x2330 & Dennis Lynch Page 93 of 391

94 Board of Directors Policy Number: BOD3 Date Created: 11/02/1999 Document Owner: Cindy Moccio (Board Clerk/Exec Date Approved: Not Approved Yet Assist-CEO) Approvers: Board of Directors (Administration) Chief Executive Officer (CEO) Criteria Printed copies are for reference only. Please refer to the electronic copy for the latest version. The Board has determined that the criteria to be used in the selection of the Chief Executive Officer will be as follows: I. Education A. A graduate degree in healthcare management is required. Such degree could be from a variety of graduate schools such as a business school, a school of public health, school of public administration or a school with an interdisciplinary program. An equivalency to a graduate degree in health administration will be considered if the candidate has bachelor s degree with professional certification and a minimum of five years experience in an executive leadership position in a hospital or healthcare system. B. The prospective candidate should be a Fellow in the American College of Healthcare Executives or a member committed to advancement in this professional organization. C. The candidate should possess business ability and financial acumen that has been demonstrated in past executive management or leadership positions. The candidate in this regard should be familiar with business proformas, budgets, financial statements, and decision-making tools. D. The candidate should demonstrate a social conscience in terms of specific activities, which relates to development or implementation of services related to the improvement of health or the quality of life in the population being served. II. Spirit of Service A. The candidate should have values that are patient centered and compatible with the values of the District. B. The candidate should demonstrate skills and competency in the requirements of leadership and organizational development. C. The candidate should possess imagination and creativity and should show results which demonstrate this characteristic. D. The candidate should have initiative and be able to work independently and without supervision to carry out the policies of the Board and the strategic plan of the District. E. The candidate must possess executive ability, which involves maintaining a sound organization that has both human and fiscal resources necessary to carry out the Mission of the District. Page 94 of 391

95 Chief Executive Office (CEO) Criteria 2 F. The candidate should have a track record of diplomacy and effectiveness in dealing with a wide variety of constituents and a record of being successful in handling difficult and complex situations. "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 95 of 391

96 Board of Directors Policy Number: BOD5 Date Created: 11/01/2011 Document Owner: Cindy Moccio (Board Clerk/Exec Date Approved: Not Approved Yet Assist-CEO) Approvers: Board of Directors (Administration) Conflict of Interest Printed copies are for reference only. Please refer to the electronic copy for the latest version. POLICY: Government Code Section requires each state and local government agency to adopt and promulgate a Conflict of Interest Code. The Fair Political Practices Commission has adopted Section of Title 2 of the California Code of Regulations, which contains the terms of a model conflict of interest code (hereinafter "Standard Code") which may be adopted by reference by any state or local agency which desires to do so. For the purpose of providing a conflict of interest code for Kaweah Delta Health Care District, its Board of Directors, and its employees, the terms of the Standard Code and any amendments to it duly adopted by the Fair Political Practices Commission are hereby incorporated by reference and made a part hereof as if set forth herein at length, and, along with Exhibits A and B attached hereto, in which officials and employees are designated and disclosure categories are set forth, such Standard Code shall constitute the Conflict of Interest Code for Kaweah Delta Health Care District, its Board of Directors, and its employees. The Chief Executive Officer shall ensure that a current copy of the Standard Code is kept on file in the District s administrative office with this Conflict of Interest Code. A copy of the current version of the Standard Code is attached hereto as Exhibit C for information purposes only. Pursuant to Section 4 of the Standard Code, designated employees shall file statements of economic interests with the Chief Executive Officer of Kaweah Delta Health Care District. Upon receipt of the statements filed by the designated employees of the department, the Chief Executive Officer shall make and retain a copy and forward the original of these statements to the code reviewing body, which in this case is the Tulare County Board of Supervisors. Adopted by the Board of Directors of Kaweah Delta Health Care District effective August 12, 2013November 29, Page 96 of 391

97 Conflict of Interest 2 PROCEDURE: I. Members, Board of Directors and Chief Executive Officer All members of the Kaweah Delta Health Care District Board of Directors and the individual occupying the position of Chief Executive Officer must complete and file Statements of Economic Interest with the Office of the Chief Executive Officer. Disclosure must include items listed in Exhibit B II. Other Affected Positions Individuals occupying positions as noted in Exhibit A are also required to complete and file, with the office of the Chief Executive Officer of Kaweah Delta Health Care District, Statements of Economic Interest. The types of interest to be disclosed are identified on Exhibit B per position held with the District. III. Filing Deadlines Individuals required to complete and file Statements of Economic Interest must do so with the appropriate office: A. within thirty (30) days after the effective date of the adoption of the Conflict of Interest Code, ; B. within thirty (30) days after assuming a position requiring filing such Statement; C. within thirty (30) days after leaving a position requiring filing of such Statement; and, D. annually, during the month of January, no later than April 1, for each year in which the individual occupies a position requiring a Statement. Page 97 of 391

98 Conflict of Interest 3 EXHIBIT "A KAWEAH DELTA HEALTH CARE DISTRICT CONFLICT OF INTEREST CODE Disclosure Categories Designated Positions Category of Interests Required to be Disclosed Members of the Board of Directors 1 Employees Chief Executive Officer 1 Senior Vice President, Chief Financial Officer 1 Senior Vice President, Chief Operating Officer 1 Vice President, Graduate Medical Education 1 Vice President, Medical Staff Affairs 1 Vice President, Chief Quality, Patient Safety, and Medical Officer 1 Vice President, Chief Nursing Officer 1 Vice President, Chief Information Officer 1 Vice President of Human Resources 1 Vice President of Development 1 District Compliance & Privacy Officer 1 Director - Internal Audit 1 Director of Procurement and Logistics Material Management 1 Kaweah Delta Medical Foundation Chief Executive Officer 1 Kaweah Delta Medical Foundation Chief Financial Officer 1 Director of Risk Management 1 Director of Facilities and Support Services 1 Director of Facilities Planning 1 All Directors of Kaweah Delta Health Care District 4B District Risk Manager 4A Director - Facilities Planning 3, 4A Director - Financial & Logistical Planning 4A Director Cardiovascular Service Line/Cardiovascular Co-management Program 4B Director - Case Management 4B Director - Clinical Education 4B Director - Clinical Information Services 4B Director - Community Outreach 4B Director - Emergency Department/Critical Care 4B Director - Employee Assistance Program 4B Director - Employee Relations 4B Director - Environmental Services & Safety 4B Director - Facility Operations 4B Page 98 of 391

99 Conflict of Interest 4 Director - Finance Director - Food Services Director - Health Information Management Director - Human Resources IS Director - Imaging Services Director - Information Technology Services Director ISS Applications Director - Kaweah Kids Director - Laboratory Director - Managed Care Director - Marketing & Communications Director - Maternal Child Health Director - Medical/Surgical Services Director - Mental Health Services Director - Nursing Practice Director - Oncology Business Services Director - Patient Access Director - Patient Financial Services Director - Performance Improvement & Patient Safety Director - Pharmacy Director - Private Home Care Director - Recruitment Director - Rehab Services Director - Renal Services Director - Respiratory Services Director - San Juan Health Center Director Security Services Director - Skilled & Home Services Director - Strategic Planning Director - Surgical Services Director - The Lifestyle Center Director Therapy (RHC) Director - Transitional Care Services Manager Hospice Program 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B 4B Consultants Legal Counsel to the Board of Directors 1 [ Consultants may be designated employees who must disclose financial interests as determined on a case-by-case basis. The District must make a written determination whether a consultant must disclose financial interests. The determination shall include a description of the consultant s duties and a statement of the extent of the disclosure requirements, if any, based upon that description. All such determinations are public records and shall be retained for public inspection with this conflict of interest code. [ Consultants can be deemed to participate in making a governmental decision when the consultant, acting within the authority of his or her position: Page 99 of 391

100 Conflict of Interest 5 (1) Negotiates, without significant substantive review, with a governmental entity or private person regarding certain governmental decisions; or (2) Advises or makes recommendations to the decision-maker either directly or without significant intervening substantive review, by: a. Conducting research or making an investigation, which requires the exercise of judgment on the part of the person and the purpose of which is to influence a governmental decision; or b. Preparing or presenting a report, analysis, or opinion, orally or in writing, which requires the exercise of judgment on the part of the person and the purpose of which is to influence the decision. (From the Tulare County Counsel) {A consultant is also subject to the disclosure requirements if he/she acts in a staff capacity (i.e., performs the same or substantially all the same duties that would otherwise be performed by an individual holding a position specified in the Code).] Page 100 of 391

101 Conflict of Interest 6 EXHIBIT "B 1. Full Disclosure: KAWEAH DELTA HEALTH CARE DISTRICT CONFLICT OF INTEREST CODE Disclosure Categories Designated persons in this category must report: All interests in real property located entirely or partly within this District s jurisdiction or boundaries, or within two miles of this District s jurisdiction or boundaries or of any land owned or used by this District. Such interests include any leasehold, ownership interest or option to acquire such interest in real property. All investments, business positions, ownership and sources of income, including gifts, loans and travel payments. 2. Full Disclosure (excluding interests in real property): All investments, business positions, ownership and sources of income, including gifts, loans and travel payments. 3. Interests in Real Property (only): All interests in real property located entirely or partly within this District s jurisdiction or boundaries, or within two miles of this District s jurisdiction or boundaries or of any land owned or used by this District. Such interests include any leasehold, ownership interest or option to acquire such interest in real property. 4. General Contracting (two options): A. All investments, business positions, ownership and sources of income, including gifts, loans and travel payments, from sources that provide, or have provided in the last two years, leased facilities, goods, supplies, materials, equipment, vehicles, machinery, services, or the like, including training or consulting services, of the type utilized by the District. [Intended for employees whose duties and decisions involve contracting and purchasing for the entire District.] B. All investments, business positions, ownership and sources of income, including gifts, loans and travel payments, from sources that provide, or have provided in the last two years, leased facilities, goods, supplies, materials, equipment, vehicles, machinery, services, or the like, including Page 101 of 391

102 Conflict of Interest 7 training or consulting services, of the type utilized by the employee s department or division. [Intended for employees whose duties and decisions involve contracting and purchasing for a specific department or division of the District.] 5. Regulatory, Permit or Licensing Duties: All investments, business positions, ownership and sources of income, including gifts, loans and travel payments, from sources that are subject to the regulatory, permit or licensing authority of, or have an application for a license or permit pending before, the employee s department or division, or the District. 6. Grant/Service Providers/Departments that Oversee Programs: A. All investments, business positions, ownership and sources of income, including gifts, loans and travel payments, or income from a nonprofit organization, if the source is of the type to receive grants or other monies from or through a specific department or division of the District. [Intended for employees whose duties and decision involve awards of monies or grants to organizations or individuals.] Page 102 of 391

103 Conflict of Interest 8 EXHIBIT "C KAWEAH DELTA HEALTH CARE DISTRICT CONFLICT OF INTEREST CODE Standard Code Provisions of Conflict of Interest Codes. (a) Incorporation by reference of the terms of this regulation along with the designation of employees and the formulation of disclosure categories in the Appendix referred to below constitute the adoption and promulgation of a conflict of interest code within the meaning of Government Code section or the amendment of a conflict of interest code within the meaning of Government Code section if the terms of this regulation are substituted for terms of a conflict of interest code already in effect. A code so amended or adopted and promulgated requires the reporting of reportable items in a manner substantially equivalent to the requirements of article 2 of chapter 7 of the Political Reform Act, Government Code sections 81000, et seq. The requirements of a conflict of interest code are in addition to other requirements of the Political Reform Act, such as the general prohibition against conflicts of interest contained in Government Code section 87100, and to other state or local laws pertaining to conflicts of interest. (b) The terms of a conflict of interest code amended or adopted and promulgated pursuant to this regulation are as follows: (1) Section 1. Definitions. The definitions contained in the Political Reform Act of 1974, regulations of the Fair Political Practices Commission (2 Cal. Code of Regs. sections 18100, et seq.), and any amendments to the Act or regulations, are incorporated by reference into this conflict of interest code. (2) Section 2. Designated Employees. The persons holding positions listed in the Appendix are designated employees. It has been determined that these persons make or participate in the making of decisions which may foreseeably have a material effect on economic interests. (3) Section 3. Disclosure Categories. This code does not establish any disclosure obligation for those designated employees who are also specified in Government Code section if they are designated in this code in that same capacity or if the geographical jurisdiction of this agency is the same as or is wholly included within the jurisdiction in which those persons must report their economic interests pursuant to article 2 of chapter 7 of the Political Reform Act, Government Code sections 87200, et seq. In addition, this code does not establish any disclosure obligation for any designated employees who are designated in a conflict of interest code for another agency, if all of the following apply: Page 103 of 391

104 Conflict of Interest 9 (A) The geographical jurisdiction of this agency is the same as or is wholly included within the jurisdiction of the other agency; (B) The disclosure assigned in the code of the other agency is the same as that required under article 2 of chapter 7 of the Political Reform Act, Government Code section 87200; and (C) The filing officer is the same for both agencies. 1 Such persons are covered by this code for disqualification purposes only. With respect to all other designated employees, the disclosure categories set forth in the Appendix specify which kinds of economic interests are reportable. Such a designated employee shall disclose in his or her statement of economic interests those economic interests he or she has which are of the kind described in the disclosure categories to which he or she is assigned in the Appendix. It has been determined that the economic interests set forth in a designated employee s disclosure categories are the kinds of economic interests which he or she foreseeably can affect materially through the conduct of his or her office. (4) Section 4. Statements of Economic Interests: Place of Filing. The code reviewing body shall instruct all designated employees within its code to file statements of economic interests with the agency or with the code reviewing body, as provided by the code reviewing body in the agency s conflict of interest code. 2 (5) Section 5. Statements of Economic Interests: Time of Filing. (A) Initial Statements. All designated employees employed by the agency on the effective date of this code, as originally adopted, promulgated and approved by the code reviewing body, shall file statements within 30 days after the effective date of this code. Thereafter, each person already in a position when it is designated by an amendment to this code shall file an initial statement within 30 days after the effective date of the amendment. (B) Assuming Office Statements. All persons assuming designated positions after the effective date of this code shall file statements within 30 days after assuming the designated positions, or if subject to State Senate confirmation, 30 days after being nominated or appointed. (C) Annual Statements. All designated employees shall file statements no later than April 1. (D) Leaving Office Statements. All persons who leave designated positions shall file statements within 30 days after leaving office. (5.5) Section 5.5. Statements for Persons Who Resign Prior to Assuming Office. Any person who resigns within 12 months of initial appointment, or within 30 days of the date of notice provided by the filing officer to file an assuming office statement, is not deemed to have assumed office or left office, provided he or she did not make or participate in the making of, or use his or her position to influence any decision and did not receive or become entitled to receive any form of payment as a result of his or her appointment. Such persons shall not file either an assuming or leaving office statement. Page 104 of 391

105 Conflict of Interest 10 (A) Any person who resigns a position within 30 days of the date of a notice from the filing officer shall do both of the following: (1) File a written resignation with the appointing power; and (2) File a written statement with the filing officer declaring under penalty of perjury that during the period between appointment and resignation he or she did not make, participate in the making, or use the position to influence any decision of the agency or receive, or become entitled to receive, any form of payment by virtue of being appointed to the position. (6) Section 6. Contents of and Period Covered by Statements of Economic Interests. (A) Contents of Initial Statements. Initial statements shall disclose any reportable investments, interests in real property and business positions held on the effective date of the code and income received during the 12 months prior to the effective date of the code. (B) Contents of Assuming Office Statements. Assuming office statements shall disclose any reportable investments, interests in real property and business positions held on the date of assuming office or, if subject to State Senate confirmation or appointment, on the date of nomination, and income received during the 12 months prior to the date of assuming office or the date of being appointed or nominated, respectively. (C) Contents of Annual Statements. Annual statements shall disclose any reportable investments, interests in real property, income and business positions held or received during the previous calendar year provided, however, that the period covered by an employee s first annual statement shall begin on the effective date of the code or the date of assuming office whichever is later, or for a board or commission member subject to Government Code section , the day after the closing date of the most recent statement filed by the member pursuant to 2 Cal. Code Regs. section (D) Contents of Leaving Office Statements. Leaving office statements shall disclose reportable investments, interests in real property, income and business positions held or received during the period between the closing date of the last statement filed and the date of leaving office. (7) Section 7. Manner of Reporting. Statements of economic interests shall be made on forms prescribed by the Fair Political Practices Commission and supplied by the agency, and shall contain the following information: (A) Investments and Real Property Disclosure. Page 105 of 391

106 Conflict of Interest 11 When an investment or an interest in real property 3 is required to be reported, 4 the statement shall contain the following: 1. A statement of the nature of the investment or interest; 2. The name of the business entity in which each investment is held, and a general description of the business activity in which the business entity is engaged; 3. The address or other precise location of the real property; 4. A statement whether the fair market value of the investment or interest in real property equals or exceeds two thousand dollars ($2,000), exceeds ten thousand dollars ($10,000), exceeds one hundred thousand dollars ($100,000), or exceeds one million dollars ($1,000,000). (B) Personal Income Disclosure. When personal income is required to be reported, 5 the statement shall contain: 1. The name and address of each source of income aggregating five hundred dollars ($500) or more in value, or fifty dollars ($50) or more in value if the income was a gift, and a general description of the business activity, if any, of each source; 2. A statement whether the aggregate value of income from each source, or in the case of a loan, the highest amount owed to each source, was one thousand dollars ($1,000) or less, greater than one thousand dollars ($1,000), greater than ten thousand dollars ($10,000), or greater than one hundred thousand dollars ($100,000); 3. A description of the consideration, if any, for which the income was received; 4. In the case of a gift, the name, address and business activity of the donor and any intermediary through which the gift was made; a description of the gift; the amount or value of the gift; and the date on which the gift was received; 5. In the case of a loan, the annual interest rate and the security, if any, given for the loan and the term of the loan. (C) Business Entity Income Disclosure. When income of a business entity, including income of a sole proprietorship, is required to be reported, 6 the statement shall contain: 1. The name, address, and a general description of the business activity of the business entity; 2. The name of every person from whom the business entity received payments if the filer s pro rata share of gross receipts from such person was equal to or greater than ten thousand dollars ($10,000). (D) Business Position Disclosure. When business positions are required to be reported, a designated employee shall list the name and address of each business entity in which he or she is a director, officer, partner, trustee, employee, or in which he or she holds any position of management, a description of the business activity in which the business entity is engaged, and the designated employee s position with the business entity. Page 106 of 391

107 Conflict of Interest 12 (E) Acquisition or Disposal During Reporting Period. In the case of an annual or leaving office statement, if an investment or an interest in real property was partially or wholly acquired or disposed of during the period covered by the statement, the statement shall contain the date of acquisition or disposal. (8) Section 8. Prohibition on Receipt of Honoraria. (A) No member of a state board or commission, and no designated employee of a state or local government agency, shall accept any honorarium from any source, if the member or employee would be required to report the receipt of income or gifts from that source on his or her statement of economic interests. This section shall not apply to any part time member of the governing board of any public institution of higher education, unless the member is also an elected official. Subdivisions (a), (b), and (c) of Government Code section shall apply to the prohibitions in this section. This section shall not limit or prohibit payments, advances, or reimbursements for travel and related lodging and subsistence authorized by Government Code section (8.1) Section 8.1 Prohibition on Receipt of Gifts in Excess of $390. (A) No member of a state board or commission, and no designated employee of a state or local government agency, shall accept gifts with a total value of more than $390 in a calendar year from any single source, if the member or employee would be required to report the receipt of income or gifts from that source on his or her statement of economic interests. This section shall not apply to any part time member of the governing board of any public institution of higher education, unless the member is also an elected official. Subdivisions (e), (f), and (g) of Government Code section shall apply to the prohibitions in this section. (8.2) Section 8.2. Loans to Public Officials. (A) No elected officer of a state or local government agency shall, from the date of his or her election to office through the date that he or she vacates office, receive a personal loan from any officer, employee, member, or consultant of the state or local government agency in which the elected officer holds office or over which the elected officer s agency has direction and control. (B) No public official who is exempt from the state civil service system pursuant to subdivisions (c), (d), (e), (f), and (g) of Section 4 of Article VII of the Constitution shall, while he or she holds office, receive a personal loan from any officer, employee, member, or consultant of the state or local government agency in which the public official holds office or over which the public official s agency has direction and control. This subdivision shall not apply to loans made to a public official whose duties are solely secretarial, clerical, or manual. (C) No elected officer of a state or local government agency shall, from the date of his or her election to office through the date that he or she vacates office, receive a personal loan from any person who has a contract with the state or local government agency to which Page 107 of 391

108 Conflict of Interest 13 that elected officer has been elected or over which that elected officer s agency has direction and control. This subdivision shall not apply to loans made by banks or other financial institutions or to any indebtedness created as part of a retail installment or credit card transaction, if the loan is made or the indebtedness created in the lender s regular course of business on terms available to members of the public without regard to the elected officer s official status. (D) No public official who is exempt from the state civil service system pursuant to subdivisions (c), (d), (e), (f), and (g) of Section 4 of Article VII of the Constitution shall, while he or she holds office, receive a personal loan from any person who has a contract with the state or local government agency to which that elected officer has been elected or over which that elected officer s agency has direction and control. This subdivision shall not apply to loans made by banks or other financial institutions or to any indebtedness created as part of a retail installment or credit card transaction, if the loan is made or the indebtedness created in the lender s regular course of business on terms available to members of the public without regard to the elected officer s official status. This subdivision shall not apply to loans made to a public official whose duties are solely secretarial, clerical, or manual. (E) This section shall not apply to the following: 1. Loans made to the campaign committee of an elected officer or candidate for elective office. 2. Loans made by a public official s spouse, child, parent, grandparent, grandchild, brother, sister, parent-in-law, brother-in-law, sister-in-law, nephew, niece, aunt, uncle, or first cousin, or the spouse of any such persons, provided that the person making the loan is not acting as an agent or intermediary for any person not otherwise exempted under this section. 3. Loans from a person which, in the aggregate, do not exceed five hundred dollars ($500) at any given time. 4. Loans made, or offered in writing, before January 1, (8.3) Section 8.3. Loan Terms. (A) Except as set forth in subdivision (B), no elected officer of a state or local government agency shall, from the date of his or her election to office through the date he or she vacates office, receive a personal loan of five hundred dollars ($500) or more, except when the loan is in writing and clearly states the terms of the loan, including the parties to the loan agreement, date of the loan, amount of the loan, term of the loan, date or dates when payments shall be due on the loan and the amount of the payments, and the rate of interest paid on the loan. (B) This section shall not apply to the following types of loans: 1. Loans made to the campaign committee of the elected officer. 2. Loans made to the elected officer by his or her spouse, child, parent, grandparent, Page 108 of 391

109 Conflict of Interest 14 grandchild, brother, sister, parent-in-law, brother-in-law, sister-in-law, nephew, niece, aunt, uncle, or first cousin, or the spouse of any such person, provided that the person making the loan is not acting as an agent or intermediary for any person not otherwise exempted under this section. 3. Loans made, or offered in writing, before January 1, (C) Nothing in this section shall exempt any person from any other provision of Title 9 of the Government Code. (8.4) Section 8.4. Personal Loans. (A) Except as set forth in subdivision (B), a personal loan received by any designated employee shall become a gift to the designated employee for the purposes of this section in the following circumstances: 1. If the loan has a defined date or dates for repayment, when the statute of limitations for filing an action for default has expired. 2. If the loan has no defined date or dates for repayment, when one year has elapsed from the later of the following: a. The date the loan was made. b. The date the last payment of one hundred dollars ($100) or more was made on the loan. c. The date upon which the debtor has made payments on the loan aggregating to less than two hundred fifty dollars ($250) during the previous 12 months. (B) This section shall not apply to the following types of loans: 1. A loan made to the campaign committee of an elected officer or a candidate for elective office. 2. A loan that would otherwise not be a gift as defined in this title. 3. A loan that would otherwise be a gift as set forth under subdivision (A), but on which the creditor has taken reasonable action to collect the balance due. 4. A loan that would otherwise be a gift as set forth under subdivision (A), but on which the creditor, based on reasonable business considerations, has not undertaken collection action. Except in a criminal action, a creditor who claims that a loan is not a gift on the basis of this paragraph has the burden of proving that the decision for not taking collection action was based on reasonable business considerations. 5. A loan made to a debtor who has filed for bankruptcy and the loan is ultimately discharged in bankruptcy. (C) Nothing in this section shall exempt any person from any other provisions of Title 9 of the Government Code. (9) Section 9. Disqualification. Page 109 of 391

110 Conflict of Interest 15 No designated employee shall make, participate in making, or in any way attempt to use his or her official position to influence the making of any governmental decision which he or she knows or has reason to know will have a reasonably foreseeable material financial effect, distinguishable from its effect on the public generally, on the official or a member of his or her immediate family or on: (A) Any business entity in which the designated employee has a direct or indirect investment worth two thousand dollars ($2,000) or more; (B) Any real property in which the designated employee has a direct or indirect interest worth two thousand dollars ($2,000) or more; (C) Any source of income, other than gifts and other than loans by a commercial lending institution in the regular course of business on terms available to the public without regard to official status, aggregating five hundred dollars ($500) or more in value provided to, received by or promised to the designated employee within 12 months prior to the time when the decision is made; (D) Any business entity in which the designated employee is a director, officer, partner, trustee, employee, or holds any position of management; or (E) Any donor of, or any intermediary or agent for a donor of, a gift or gifts aggregating $390 or more provided to, received by, or promised to the designated employee within 12 months prior to the time when the decision is made. (9.3) Section 9.3. Legally Required Participation. No designated employee shall be prevented from making or participating in the making of any decision to the extent his or her participation is legally required for the decision to be made. The fact that the vote of a designated employee who is on a voting body is needed to break a tie does not make his or her participation legally required for purposes of this section. (9.5) Section 9.5. Disqualification of State Officers and Employees. In addition to the general disqualification provisions of section 9, no state administrative official shall make, participate in making, or use his or her official position to influence any governmental decision directly relating to any contract where the state administrative official knows or has reason to know that any party to the contract is a person with whom the state administrative official, or any member of his or her immediate family has, within 12 months prior to the time when the official action is to be taken: (A) Engaged in a business transaction or transactions on terms not available to members of the public, regarding any investment or interest in real property; or (B) Engaged in a business transaction or transactions on terms not available to members of the public regarding the rendering of goods or services totaling in value one thousand dollars ($1,000) or more. (10) Section 10. Disclosure of Disqualifying Interest. Page 110 of 391

111 Conflict of Interest 16 When a designated employee determines that he or she should not make a governmental decision because he or she has a disqualifying interest in it, the determination not to act may be accompanied by disclosure of the disqualifying interest. (11) Section 11. Assistance of the Commission and Counsel. Any designated employee who is unsure of his or her duties under this code may request assistance from the Fair Political Practices Commission pursuant to Government Code section and 2 Cal. Code Regs. sections and or from the attorney for his or her agency, provided that nothing in this section requires the attorney for the agency to issue any formal or informal opinion. (12) Section 12. Violations. This code has the force and effect of law. Designated employees violating any provision of this code are subject to the administrative, criminal and civil sanctions provided in the Political Reform Act, Government Code sections In addition, a decision in relation to which a violation of the disqualification provisions of this code or of Government Code section or has occurred may be set aside as void pursuant to Government Code section NOTE: Authority cited: Section 83112, Government Code. Reference: Sections 87103(e), , 89501, and 89503, Government Code. 1 Designated employees who are required to file statements of economic interests under any other agency s conflict of interest code, or under article 2 for a different jurisdiction, may expand their statement of economic interests to cover reportable interests in both jurisdictions, and file copies of this expanded statement with both entities in lieu of filing separate and distinct statements, provided that each copy of such expanded statement filed in place of an original is signed and verified by the designated employee as if it were an original. See Government Code section See Government Code section and 2 Cal. Code of Regs. section for the duties of filing officers and persons in agencies who make and retain copies of statements and forward the originals to the filing officer. 3 For the purpose of disclosure only (not disqualification), an interest in real property does not include the principal residence of the filer. 4 Investments and interests in real property which have a fair market value of less than $2,000 are not investments and interests in real property within the meaning of the Political Reform Act. However, investments or interests in real property of an individual include those held by the individual s spouse and dependent children as well as a pro rata share of any investment or interest in real property of any business entity or trust in which the individual, spouse and dependent children own, in the aggregate, a direct, indirect or beneficial interest of 10 percent or greater. 5 A designated employee s income includes his or her community property interest in the income of his or her spouse but does not include salary or reimbursement for expenses Page 111 of 391

112 Conflict of Interest 17 received from a state, local or federal government agency. 6 Income of a business entity is reportable if the direct, indirect or beneficial interest of the filer and the filer s spouse in the business entity aggregates a 10 percent or greater interest. In addition, the disclosure of persons who are clients or customers of a business entity is required only if the clients or customers are within one of the disclosure categories of the filer. "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 112 of 391

113 Manual Name: Chemistry Support Staff Name: Diahanna Caldwell Policy/Procedure Title # Policy Submission Summary Status (New, Revised, Reviewed, Deleted) Date:06/28/17 Name and Phone # of person who wrote the new policy or revised an existing policy Instrument or Equipment Repair CH NEW Samantha Rudd Performance Verification Urine Albumin-AU680 CH NEW Samantha Rudd Chemistry Maximum Dilutions CH NEW Diahanna Caldwell for AU680 Immunochemistry Analytical Measurable Range (AMR) and Clinical Reportable Range (CRR) for DXI600 CH NEW Diahanna Caldwell VIDAS 3 PROCALCITONIN CH NEW Diahanna Caldwell PROCEDURE Accuracy of Automatic Pipetting CH NEW Diahanna Caldwell Carryover Procedure For CH Reviewed Samantha Rudd Automatic Pipetting Systems Vidas-Brahms Procalcitonin CH Deleted AU680 Dilution Protocols CH Deleted Page 113 of 391

114 CLINICAL LABORATORY Procedure Number: CH Effective Date: January 24, 2016 Page 1 of 3 Instrument or Equipment Repair Performance Verification Principle: In addition to routine calibration and quality control (QC) procedures (CH-00103) and (CH-00046), subsequent calibration and QC may be necessary after instrument repairs and/or replacement of critical components of an instrument or item of equipment. Procedure: Any instrument troubleshooting that requires technical support from the manufacturer s representative (ex. field technicians) is documented by the instrument QA log with a reference number for the incident. Depending on the type of Preventative Maintenance or instrument repair performed, the company field technician may be able to advise performing QC or if not sufficient, performing calibration and QC. At completion of the service request, the CLS/MLT will perform the appropriate amount of performance verification (calibration and QC or QC alone if sufficient) and document QC in LIS as per the Quality Assurance Policy (LG-00011) and if necessary, respond according to Corrective Action For Out-Of-Control Values (CH-00350). After receiving the service report from the field technician, a copy of the Service Report will be placed in the Service tab of the pertaining instrument maintenance binder. Page 114 of 391

115 CLINICAL LABORATORY Procedure Number: CH Effective Date: January 24, 2016 Page 2 of 3 Instrument or Equipment Repair Performance Verification Example QA LOG: DATE QA INSTRUMENT LOG Instrument: TECH INITIALS FUNCTIONAL PROBLEM CORRECTIVE ACTION KAWEAH DELTA HOSPITAL LABORATORY - HEMATOLOGY DEPARTMENT QC VALIDATION SUPERVISOR REVIEW: Page 115 of 391

116 CLINICAL LABORATORY Procedure Number: CH Effective Date: January 24, 2016 Page 3 of 3 Instrument or Equipment Repair Performance Verification DEPARTMENT-/SERVICE-SPECIFIC POLICY OR PROCEDURE APPROVALS Name/Signature of Individual, Committee Chair, or Signing Authority Author/Developed/Revised by the Interim Chemistry Section Chief Samantha K. Rudd, CLS Department Director by Date Randall J. Kokka, MPH Medical Director David S. Hewitt, M.D. TO BE COMPLETED UPON REVISION/DELETION OF POLICY/PROCEDURE Title of Policy or procedure: Date Effective: Supersedes: Date Revised/ Deleted: If this Policy was replaced by another policy, name of replacement policy: Date Replacement Policy became Effective: SUBSEQUENT REVIEW DATES & APPROVAL(S) Date Signature of Signing Authority Date Signature of Signing Authority Page 116 of 391

117 CLINICAL LABORATORY CHEMISTRY SECTION Procedure Number: CH Effective Date: Revised Date: Urine Albumin - AU680 August 1, 2015 Page 1 of 9 PRINCIPLE: The earliest clinical evidence of nephropathy is the appearance of low, but abnormal levels (> 30 mg/day or 20 μg/min) of albumin in the urine, and patients with moderately increased urine albumin are referred to as having incipient nephropathy. Conventional qualitative tests (chemical strips or dipsticks) for albuminuria do not detect the small increases in urinary albumin excretion seen in early stages of nephropathy. For this purpose, tests for moderately increased urine albumin are used. Moderately increased urine albumin is defined as an albumin excretion rate between mg/24h on 2 of 3 urine collections. Increased urinary albumin loss is considered a clinically important indicator of deteriorating renal function in diabetic subjects and regular screening of urinary albumin loss is valuable in monitoring type 1 and type 2 diabetes. Prospective studies have demonstrated that increased urinary albumin excretion precedes and is highly predictive of diabetic nephropathy, end stage renal disease, cardiovascular mortality, and total mortality in patients with diabetes mellitus. In addition, increased urinary albumin excretion identifies a group of non-diabetic subjects at increased risk for coronary artery disease. The degree of permeability of the blood-csf barrier may be evaluated by the simultaneous measurement of serum and CSF albumin. CSF albumin measurements may also be used to determine the IgG CSF/albumin CSF ratio, which is an important factor in differentiating between intrathecal and localized synthesis of IgG. Reference 1,2,3,4,5 INTENDED USE: The Urine/CSF Albumin reagent is intended to be used for the quantitation of albumin concentration in human urine and cerebrospinal fluid (CSF) on the Beckman Coulter AU clinical chemistry systems as an aid in the diagnosis of kidney diseases. METHODOLOGY: Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the Beckman Coulter AU procedure, the measurement of the decrease in light transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigenantibody reaction, is the basis of this assay. M:\MOCCIO\BOARD\BOARD 2017\AGENDA\ \CONSENT CALENDAR\POLICIES\CHEMISTRY CLINICAL LABORATORY\CH Urine Albumin Au680.docm Page 117 of 391

118 Procedure Number: CH Effective Date: Revised Date: Urine Albumin - AU680 August 1, 2015 Page 2 of 9 SPECIMEN: PATIENT PREPARATION: None required. Additional instructions for patient preparation as designated by this laboratory: Refer to Laboratory Patient Services Manual TYPE: URINE MAY BE USED. THE URINE SPECIMEN SHOULD BE A FRESH OR A 24 HOUR URINE. URINE MAY BE DILUTED 1 IN 10 ON-BOARD THE ANALYZER WITH EITHER 0.9% SALINE OR DEIONIZED WATER USING AUTOMATIC DILUTION FUNCTION. REFER TO USER S GUIDE FOR DETAILED INSTRUCTIONS. HANDLING CONDITIONS: Urine 6,7 : Stable for 1 month when stored refrigerated (2-8 C). Stable for 6 months when stored frozen at -20 C. EQUIPMENT AND MATERIALS: EQUIPMENT: Beckman AU680 Analyzer MATERIALS: Beckman Coulter AU System Urine/CSF Albumin Reagents (B38858) Final concentration of reactive ingredients: Phosphate buffer 18 mmol/l Goat Anti-human Albumin Antibody Variable Polyethylene glycol % Sodium Azide (used as a preservative) <0.1% (w/w) Reagent storage location in this laboratory: Walk-in Refrigerator Chemistry Department Refrigerator Beckman Coulter Urine/CSF Calibrator (Ref. B38859) Storage location of the calibrator in this laboratory: Walk-in Refrigerator Chemistry Department Refrigerator Page 118 of 391

119 Procedure Number: CH Effective Date: Revised Date: Urine Albumin - AU680 August 1, 2015 Page 3 of 9 Precautions: 1. For in vitro diagnostic use. 2. Do not ingest reagent or calibrator. Harmful if swallowed. 3. Contains sodium azide as a preservative that may react with lead joints in copper plumbing to form explosive compounds. Even though the reagent contains minute quantities of sodium azide, drains should be well flushed with water when discarding the reagent or calibrators. 4. WARNING: POTENTIAL BIOHAZARDOUS MATERIAL. The calibrator is manufactured from human serum. No test method can offer complete assurance that HIV- 1/2, HCV, Hepatitis B, or other infectious agents are absent from biological materials, all calibrator material should be handled at the Biosafety Level 2 as recommended for any infectious human serum or blood specimen in the CDC/National Institutes of Health manual, Biosafety in Microbiological and Biomedical Laboratories, PREPARATION: The Beckman Coulter AU System Urine Albumin reagent is ready for use and can be placed directly on board the instrument. The Beckman Coulter Microalbumin Calibrators (B38859) are liquid, ready for use as supplied. Mix by gentle inversion to achieve a homogenous mixture prior to use. Storage Requirements: 1. The unopened reagents and calibrators are stable until the expiration date printed on the label when stored at 2-8 C. 2. Opened bottles of reagent are stable for 60 days when stored in the refrigerated compartment of the Beckman Coulter AU analyzers. 3. Opened bottles of calibrator are stable until the expiration date printed on the label providing that the stoppers and caps are replaced immediately after each use. The Urine Albumin calibrators should be stored at 2 8 C when not in use. Indications of Deterioration: Discoloration of the reagent or calibrators, visible signs of microbial growth, turbidity or precipitation in reagent or calibrators may indicate degradation and warrant discontinuance of use. Page 119 of 391

120 Procedure Number: CH Effective Date: Revised Date: Urine Albumin - AU680 August 1, 2015 Page 4 of 9 PERFORMANCE PARAMETERS: Data contained within this section is representative of performance on Beckman Coulter systems. Data obtained in this laboratory may differ from these values. PRECISION: 7 Correctly operating AU Systems should exhibit precision values less than or equal to the following for both Urine & CSF applications: Repeatability 5% CV or 1 mg/l (0.1 mg/dl) Within Laboratory Precision 10% CV or 2 mg/l (0.2 mg/dl) Estimates of imprecision based on CLSI recommendations 14 are consistent with typical performance. Comparative performance data for the AU5800 system evaluated using the CLSI approved guideline EP05-A2 appears in the table below. Each laboratory should characterize their own instrument performance for comparison purposes The following data was obtained on an AU5800 analyzer using 3 Urine pools analyzed over 20 days: TYPE OF IMPRECISION SAMPLE TYPE No. Data Points Mean SD %CV mg/l mg/dl mg/l mg/dl Repeatability Urine Pool Within Laboratory METHODS COMPARISON: Urine Pool Urine Pool Urine Pool Urine Pool Urine Pool Reference 13 Patient Urine samples were run to compare this Urine Albumin assay on the AU5800 analyzer against another commercially available assay. Results of Deming regression analysis were as follows: Slope Intercept r n Sample Range mg/l (0.03 mg/dl) mg/l ( mg/dl) Page 120 of 391

121 Procedure Number: CH Effective Date: Revised Date: Urine Albumin - AU680 August 1, 2015 Page 5 of 9 CALIBRATION: STANDARD PREPARATION: This calibrator has not been tested for use with any other Chemistry Systems other than those listed above. The results obtained using this calibrator are dependent upon several factors, including proper storage of the calibrator and proper technique in use of the Beckman Coulter AU Clinical Chemistry analyzers and their respective reagents. CALIBRATION PROCEDURE: Recalibration is required when any of the following conditions occur: 1. A reagent lot number has changed or there is an observed shift in control values. 2. Major preventative maintenance was performed on the analyzer. 3. A critical part was replaced. QUALITY CONTROL: During operation of the Beckman Coulter AU analyzer at least two levels of appropriate control material of human origin only should be tested a minimum of once a day. In addition, these controls should be performed after calibration, with each new lot of reagents, and after specific maintenance or troubleshooting steps described in the appropriate AU User s Guide. Quality control testing should be performed in accordance with regulatory requirements and each laboratory s standard procedure. REF NO CONTROL UNOPENED STABILITY Quantimetrix Dropper Urine Until Expiration Date Chemistry Control Level 1 at 2 to 8 C Quantimetrix Dropper Urine Until Expiration Date Chemistry Control Level 2 at 2 to 8 C OPENED STABILITY Until Expiration Date at 2 to 8 C Until Expiration Date at 2 to 8 C Storage Location of Control: Walk-in Refrigerator Chemistry Department Refrigerator Page 121 of 391

122 Procedure Number: CH Effective Date: Revised Date: Urine Albumin - AU680 August 1, 2015 Page 6 of 9 ANALYZER PARAMETERS: A complete list of test parameters and operating procedures can be found in the appropriate User s Guide and at CALCULATIONS: The Beckman Coulter AU analyzers automatically compute every determination at the same time interval. REPORTING RESULTS: REFERENCE RANGES: Urine 5 : 24-hr collection (mg/24h) Timed collection ug/min Spot collection ug/mg creatinine Normal < 30 < 20 < 30 Moderately Increased Clinical albuminuria > 300 > 200 > 300 Expected values may vary with age, sex, diet and geographical location. Each laboratory should determine its own expected values as dictated by good laboratory practice. Expected reference ranges in this laboratory: Adult: <30 mg/24hr PROCEDURES FOR ABNORMAL RESULTS: Abnormal results are flagged by the listed analyzers according to the normal values entered by the user into the instrument parameters. REPORTING FORMAT: Results are automatically printed out for each sample in mg/dl at 37 C. Page 122 of 391

123 Procedure Number: CH Effective Date: Revised Date: Urine Albumin - AU680 August 1, 2015 Page 7 of 9 LIMITATIONS: 1. Samples with Albumin concentrations > 20,000 mg/l (2,000 mg/dl) can generate false low results without appropriate "Z" flags due to excess antigen in the sample. 2. The albumin result of a urine sample may be elevated when it immediately follows a serum sample. In order to eliminate this effect it is recommended to: Calibrate the Urine/CSF albumin assay separately to serum assays. Avoid requisition of a urine sample following a serum sample. For the AU2700, AU5400, AU480, AU680 and AU5800 Analyzers sample contamination parameters are available on the Beckman Coulter website. These parameters were added to the AU680 in this laboratory. 3. Samples with extremely abnormal optical characteristics, including turbidity, interfere with test results. Extremely turbid samples should not be run. INTERFERING SUBSTANCES: Reference 10 Results of studies conducted show that the following substances may interfere with this procedure: The criteria for no significant interference (NSI) is recovery within 10% or 2 mg/l (0.2 mg/dl) of the initial value. Urine: Creatinine: NSI up to 300 mg/dl Creatinine Glucose: NSI up to 3000 mg/dl Glucose Urea: NSI up to 5000 mg/dl Urea Ascorbate: NSI up to 500 mg/dl Ascorbate Citrate: NSI up to 50 mg/dl Citrate Magnesium: NSI up to 400 mg/dl Magnesium Oxalate: NSI up to 30 mg/dl Oxalate Conjugated Bilirubin: NSI up to 40 mg/dl Conjugated Bilirubin Hemoglobin: NSI up to 500 mg/dl Hemoglobin Acetone: NSI up to 350 mg/dl Acetone Uric Acid: NSI up to 10 mg/dl Uric Acid Urobilinogen: NSI up to 2.25 mg/dl Urobilinogen Acetaminophen: NSI up to 300 mg/dl Acetaminophen Ibuprofen: NSI up to 400 mg/dl Ibuprofen Metronidazole: NSI up to 600 mg/dl Metronidazole 5-Aminosalicylate: NSI up to 150 mg/dl 5-Aminosalicylate Calcium: NSI up to 78 mg/dl Calcium. Concentrations above this interfere with the test result Page 123 of 391

124 Procedure Number: CH Effective Date: Revised Date: Urine Albumin - AU680 August 1, 2015 Page 8 of 9 The information presented is based on results from Beckman Coulter studies and is current at the date of publication. Beckman Coulter Ireland Inc. makes no representation about the completeness or accuracy of results generated by future studies. For further information on interfering substances, refer to Young11 for a compilation of reported interferences with this test. REFERENCES: 1. American Diabetes Association. Diabetic Nephropathy. Diabetes Care, 2002; 25:(Suppl. 1):S85-S Sacks DB, Bruns DE, Goldstein DE, MacLaren NK, McDonald JM, Parrot M. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem 2002;48: Hortin GL. Aminoacids, peptides and Proteins. In Burtis CA, Ashwood ER, Bruns DE, eds. Tietz textbook of clinical chemistry and molecular diagnostics, 2012:507pp. 4. Lamb EJ, Price CP. Kidney Function Tests. In Burtis CA, Ashwood ER, Bruns DE, eds. Tietz textbook of clinical chemistry and molecular diagnostics, 2012:669pp. 5. Sacks DB. Diabetes Mellitus In Burtis CA, Ashwood ER, Bruns DE, eds. Tietz textbook of clinical chemistry and molecular diagnostics, 2012:1415pp. 6. Ehret W, Heil W, Schmitt Y, Töpfer G, Wisser H, Zawta B, et al. Use of anticoagulants in diagnostic laboratory investigations and stability of blood, plasma and serum samples. WHO/DIL/LAB/99.1 Rev.2: p46 & p Tietz NW, ed Clinical guide to laboratory tests, 3rd ed. Philadelphia WB Saunders Company, 1995:p22 & p24 8. Current Intelligence Bulletin 13: Explosive Azide Hazard, August 16, DHHS (NIOSH) Publication Number Painter PC, Cope JY, Smith JL. Reference information for the clinical laboratory. In: Burtis CA, Ashwood ER, eds. Tietz textbook of clinical chemistry. Philadelphia:WB Saunders Company, 1999; 1800pp. 10. Clinical and Laboratory Standards Institute. Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition. CLSI document EP07-A2, Wayne PA Young DS. Effects of Drugs on Clinical Laboratory Tests, AACC, 5th ed. AACC Press, Clinical and Laboratory Standards Institute. Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition. CLSI document EP17-A2, Wayne PA Clinical and Laboratory Standards Institute. Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Third Edition. CLSI document EP09-A3, Wayne PA Clinical and Laboratory Standards Institute. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition. CLSI document EP05-A2, Wayne PA Data is on file for specific AU analyzers. Page 124 of 391

125 Procedure Number: CH Effective Date: Revised Date: Urine Albumin - AU680 August 1, 2015 Page 9 of 9 DEPARTMENT-/SERVICE-SPECIFIC POLICY OR PROCEDURE APPROVALS Author/Developed/Revised by Samantha K. Rudd, CLS Interim Section Chief Department Dir. by Name/Signature of Individual, Committee Chair, or Signing Authority Date Randall Kokka, MPH Medical Director David S. Hewitt, M.D. TO BE COMPLETED UPON REVISION/DELETION OF POLICY/PROCEDURE Title of Policy or procedure: Date Effective: Urine Albumin AU680 Supersedes: Microalbumin CH If this Policy was replaced by another policy, name of replacement policy: Date Revised/ Deleted: Date Replacement Policy became Effective: SUBSEQUENT REVIEW DATES & APPROVAL(S) Date Signature of Signing Authority Date Signature of Signing Authority Page 125 of 391

126 Chemistry: Policy Number: CH Date Created: 03/17/2016 Document Owner: Diahanna Caldwell (Laboratory Date Approved: Not Approved Yet Section Chief) Approvers: Board of Directors (Administration), Cindy Moccio (Board Clerk/Exec Assist-CEO), David Hewitt (Pathology) Chemistry Maximum Dilutions for AU680 Printed copies are for reference only. Please refer to the electronic copy for the latest version. 1. Purpose: The purpose of this procedure is to outline the dilution protocols for the AU680 Chemistry analyser. The Laboratory Section Chief, Laboratory Manager, Laboratory Director, and Laboratory Medical Director are responsible for ensuring compliance with these protocols. 2. Dilution Protocols: a. When a result for an analyte is greater than the AMR, the result will flag with an (F) in Remisol. Remisol will order an initial on board dilution for the analyte. The automation line will retrieve the sample from the stockyard and repeat the sample with the dilution programmed. The result will post to the original sample. b. If an automatic dilution cannot be scheduled by Remisol, or the repeat result is still greater than the AMR, a manual dilution should be performed. Retrieve the specimen and dilute it using the appropriate ratio and diluent outlined for that assay (See Appendix A and Chart A). Program the sample in Remisol with the manual dilution and a unique identifier. Remisol will calculate the final result. Repeat the dilution up to the defined maximum dilution if necessary. b1. Refer to the Program a Dilution section in the Remisol manual for further information. 3. Examples of Appropriate Dilutions: a. The dilution chart below gives examples of appropriate dilution ratios and volumes that may be used when performing manual dilutions: Chart A DILUTION RATIO TOTAL PARTS DILUTION VOLUMES ALTERNATIVE DILUTION VOLUMES 1:2 1 part sample: 1 part diluent 100 ul sample:100 diluent 200 ul sample:200 diluent OR 300 ul sample:300 ul diluent OR 400 ul sample:400 ul diluent 1:3 1 part sample: 2 parts diluent 100 ul sample:200 ul diluent 200 ul sample:400 diluent 1:5 1 part sample: 4 parts diluent 100 ul sample:400 ul diluent 50 ul sample:200 ul diluent OR 200 ul sample:800 ul diluent 1:6 1 part sample: 5 parts diluent 100 ul sample:500 ul diluent 50 ul sample:250 ul diluent 1:10 1 part sample: 9 parts diluent 50 ul sample:450 ul diluent 100 ul sample:900 ul diluent 1:20 1 part sample: 19 parts diluent 10 ul sample:190 ul diluent 20 ul sample:380 ul diluent 1:25 1 part sample: 24 parts diluent 10 ul sample:240 ul diluent 20 ul sample:480 ul diluent 1:50 1 part sample: 49 parts diluent 10 ul sample:490 ul diluent 20 ul sample:980 ul diluent 1:100 1 part sample: 99 parts diluent 10 ul sample:990 ul diluent N/A Page 126 of 391

127 Chemistry Maximum Dilutions for AU680 2 Appendix A Analyte Initial Onboard Dilution Serum/Plasma Max Dilution Guidelines Max Manual Dilution Max Reportable ACETAMINOPHEN X3 See Initial >600 DI Water Initial Onboard Manual Diluent Dilution Urine Max Dilutions Guidelines Max Manual Dilution Max Reportable Manual Diluent Fluids (if different than serum) ALBUMIN X3 See Initial >18.0 DI Water X10 See Initial >4,500 DI Water ALP X5 X10 >15000 DI Water ALT X5 X50 >25,000 DI Water AMMONIA X2 X5 >3,000 DI Water AMYLASE X5 See Initial >10,000 DI Water X50 X100 > DI Water AMIKACIN X2 See Initial >100 AMKN Cal 0 AST X5 X50 >50,000 DI Water BHY X2 X3 >24.0 DI Water BILIRUBIN, DIRECT X2 X3 >30 DI Water BILIRUBIN, TOTAL X2 X3 >90 DI Water BUN X3 X5 >650 DI Water X5 X10 >13,000 DI Water C3 X3 See Initial >1,500 DI Water C4 X3 See Initial >450 DI Water CALCIUM Do not dilute Do not dilute >18.0 N/A X3 X3 >60.0 DI Water CARBAMAZAPINE X3 X5 >100.0 DI Water CHOLESTEROL X3 See Initial >2100 DI Water CK X10 X100 >200,000 DI Water CL Do not dilute Do not dilute >200 N/A Do not dilute Do not dilute >400 N/A CO2 X2 X3 >45 DI Water CREATININE Do not dilute Do not dilute >25.0 N/A X2 X3 >900.0 DI Water CRPH X3 See Initial > DI Water DIGOXIN X2 See Initial >10 DIG 0 calibrator EtOH (ALCOHOL) Do not dilute Do not dilute >600 N/A Do not dilute Do not dilute >600 N/A FE (IRON) X2 See Initial >2000 DI Water GENTAMICIN X3 X5 >50 DI Water GGT X5 See Initial >6000 DI Water GLUCOSE X3 See Initial >2400 DI Water X3 See Initial >2100 DI Water HDL X3 See Initial >600 DI Water IGA X20 X50 >35000 DI Water IGG X20 X20 >60,000 DI Water IGM X20 X100 >50,000 DI Water K Do not dilute Do not dilute >10.0 N/A Do not dilute Do not dilute >200.0 N/A run as urine LACTIC ACID X3 See Initial >30.0 DI Water LDH X5 X50 >60,000 DI Water LDL X3 See Initial >1200 DI Water LITHIUM Do not dilute Do not dilute >5.0 N/A LIPASE X3 X10 >6000 DI Water MG X3 See Initial >24.0 DI Water X3 X10 >100.0 DI Water NA Do not dilute Do not dilute >200 N/A Do not dilute Do not dilute >400 N/A PHENOBARBITAL X3 See Initial >240.0 DI Water PHENYTOIN X3 X5 >200.0 DI Water PHOS X3 See Initial >60 DI Water X3 X5 >1000 DI Water PRE-ALBUMIN X3 X20 >1,600 DI Water RHF NONE X25 OFFLINE >3,000 SALINE SALICYLATE X3 X5 >400.0 DI Water THEOPHYLLINE X3 X5 >200.0 DI Water TRIGLYCERIDE X5 X10 >10,000 DI Water TRANSFERRIN X3 See Initial >2,250 DI Water TOBRAMYCIN X3 X5 >50.0 DI Water TP X2 See Initial >24.0 DI Water M-TP X3 X25 >5,000 DI Water X6 X25 >5,000 DI Water URIC ACID X2 See Initial >60.0 DI Water X3 X3 >240.0 DI Water VANCOMYCIN X3 X5 >250.0 DI Water VALPROIC ACID X2 X5 >750 DI Water Page 127 of 391

128 Chemistry, Clinical Laboratory Policy Number: CH Date Created: 03/09/2016 Document Owner: Diahanna Caldwell (Laboratory Date Approved: Not Approved Yet Section Chief) Approvers: Board of Directors (Administration); Hewitt, David; Moccio, Cindy Immunochemistry Analytical Measurable Range (AMR) and Clinical Reportable Range (CRR) for DXI600 Printed copies are for reference only. Please refer to the electronic copy for the latest version. ANALYTE AMR CRR DILUENT MAX DILUTION IF > MAX DILUTION OR CRR REPORT AS: Dil A OR AFP ng/ml ng/ml Dil AFP 1:100 > ng/ml *BNP pg/ml pg/ml N/A N/A >5000 pg/ml If > perform 1:5 onboard auto B12 Dil S0 pg/ml pg/ml >7500 pg/ml dilution CA 15.3 U/mL U/mL Dil A 1:10 >10000 U/mL CA 19.9 U/mL U/mL Dil A 1:10 >20000 U/mL CA U/mL U/mL Dil A 1:10 >50000 U/mL CEA Dil OR CEA ng/ml ng/ml S0 1:10 >10000 ng/ml *CKMB ng/ml ng/ml N/A N/A > 300 ng/ml *Cortisol µg/dl µg/dl N/A N/A >60 µg/dl *Estradiol Ferritin pg/ml ng/ml pg/ml ng/ml N/A N/A >4800 pg/ml DIL A OR S0 If >1500 perform onboard 1:10 auto dilution Dil-Fer. >15000 ng/ml FSH MIU/mL MIU/mL Dil A OR S0 1:2 >400 MIU/mL *Folate ng/ml ng/ml N/A N/A >24.8 ng/ml *FT pg/ml pg/ml N/A N/A >30 pg/ml *FRT4 ng/ml ng/ml N/A N/A >6.0 ng/ml HCGQ MIu/mL MIu/mL Dil A If >1350 perform onboard 1:200 auto dilution. > MIu/mL LH MIU/mL MIU/mL Dil A OR S0 1:2 >500 MIU/mL Dil S0 OR Dil Prolactin ng/ml ng/ml A 1:10 >2000 ng/ml PSA ng/ml ng/ml PSA Dil 1:10 >1500 ng/ml PTH-Intact pg/ml pg/ml Dil A 1:10 >35000 pg/ml *Rubella IU/mL IU/mL N/A N/A >500 IU/mL Testosterone ng/ml ng/ml Dil S0 1:2 >32 ng/ml *TNI ng/ml ng/ml N/A N/A >80 ng/ml Page 128 of 391

129 Immunochemistry Analytical Measurable Range (A and Clinical Reportable Range (CRR) for DXI TSH uiu/ml uiu/ml Dil A OR S0 1:5 >500 uiu/ml *T ng/ml ng/ml N/A N/A >8.0 ng/ml *T3 % Uptake NA N/A N/A N/A If T3 >8.0 report as >48.4% *T ug/dl ug/ml N/A N/A >30 ng/ml *Results greater than the Analytical Measurable Range will be reported as >. No further dilution is necessary for these analytes. 1. If initial result obtained is < AMR/CRR report as < the lowest point on the AMR. Any samples with questionably low test results should be checked for specimen integrity and then repeated if needed. If warranted, all critical values are repeated and verified for acceptability before reporting results. 2. If initial result is greater than the Analytical Measurable Range, manually dilute the specimen with the appropriate diluent. Assign the diluted specimen a unique identifier, reassay and multiply result by dilution factor to yield a reportable result. If the result is still > Clinical Reportable Range after dilution, report as (>) upper limit of CRR. 3. B12, Ferritin, and HCGQ can be diluted using an on board dilution. If the on board dilution does not automatically run, retrieve the sample, ensure the dilution has been scheduled using the correct dilution factor, and place the sample on the instrument. The final reportable result will be calculated by the instrument. 4. See dilution chart below for examples of appropriate dilution ratios and volumes: DILUTION RATIO TOTAL PARTS DILUTION VOLUMES ALTERNATIVE DILUTION VOLUMES 1:2 1 part sample: 1 part diluent 100 ul sample:100 diluent 200 ul sample:200 diluent OR 300 ul sample:300 ul diluent OR 400 ul sample:400 ul diluent 1:5 1 part sample: 4 parts diluent 100 ul sample:400 ul diluent 50 ul sample:200 ul diluent OR 200 ul sample:800 ul diluent 1:10 1 part sample: 9 parts diluent 1:100 1 part sample: 99 parts diluent 1:200 1 part diluent: 199 parts sample 50 ul sample:450 ul diluent 10 ul sample:990 ul diluent 10 ul sample:1990 ul diluent 100 ul sample:900 ul diluent N/A N/A Page 129 of 391

130 Chemistry: Policy Number: CH Date Created: 2/2/2017 Document Owner: Diahanna Caldwell (Laboratory Date Approved: Not Approved Yet Section Chief) Approvers: Board of Directors (Administration), Cindy Moccio (Board Clerk/Exec Assist-CEO), David Hewitt (Medical Director) VIDAS 3 PROCALCITONIN PROCEDURE Printed copies are for reference only. Please refer to the electronic copy for the latest version. I. METHOD II. PRINCIPLE VIDAS B R A H M S PCT (PCT) is an automated test for use on the instruments of the VIDAS family for the determination of human procalcitonin in human serum or plasma (lithium heparinate) using the ELFA (Enzyme-Linked Fluorescent Assay) technique. The VIDAS B R A H M S PCT (PCT) is intended for use in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock. The assay principle combines a one-step immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR ) serves as the solid phase as well as the pipetting device. Reagents for the assay are ready-to-use and pre-dispensed in the sealed reagent strips. All of the assay steps are performed automatically by the instrument. The sample is transferred into the wells containing anti-procalcitonin antibodies labeled with alkaline phosphatase (conjugate). The sample/conjugate mixture is cycled in and out of the SPR several times. This operation enables the antigen to bind with the immunoglobulins fixed to the interior wall of the SPR and the conjugate to form a sandwich. Unbound compounds are eliminated during washing steps. Two detection steps are performed successively. During each step, the substrate (4-Methyl-umbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of antigen present in the sample. At the end of the assay, results are automatically calculated by the instrument in relation to two calibration curves corresponding to the two detection steps. A fluorescence threshold value determines the calibration curve to be used for each sample. The results are then printed out. Page 130 of 391

131 VIDAS 3 PROCALCITONIN PROCEDURE 2 III. REAGENTS AND MATERIALS A. Reagents and Materials Needed to Perform Assay 1. PCT Reagent Strips*. 2. PCT SPRs*. 3. PCT Calibrators (S1 & S2)*. 4. PCT Kit Controls (C1 and C2)*. 5. Calibrated pipette to dispense 2 ml and 200 μl. 6. Disposable pipette tips. 7. Powderless disposable gloves. *Refrigerate these unopened materials from 2 to 8 C. Do not freeze the reagent kit. B. Reagent Preparation and Storage 1. PCT Calibrator - Reconstitute with 2 ml of reagent grade water. Wait 5-10 minutes and then mix. After reconstitution, the calibrator is stable for 8 hours at 2 to 8 C or until the expiration date of the kit at C. When done using the calibrators place them in the freezer until the next use. When you need to calibrate again take the calibrators out of the refrigerator and let them thaw at room temperature. Mix thoroughly before assaying. Mark the lid of the calibrator with a hash mark each time it is thawed in order to track the freeze/thaw cycles. The calibrators are stable for 5 freeze/thaw cycles. 2. PCT Controls - Reconstitute with 2 ml of reagent grade water. Wait 5-10 minutes and then mix. After reconstitution, the controls are stable for 8 hours at 2 to 8 C or until the expiration date of the kit at C. When done using the controls place them in the freezer until the next use. When you need to run controls again take the controls out of the refrigerator and let them thaw at room temperature. Mix thoroughly before assaying. Mark the lid of the control with a hash mark each time it is thawed in order to track the freeze/thaw cycles. The controls are stable for 5 freeze/thaw cycles. IV. SPECIMEN COLLECTION, STORAGE AND PREPARATION A. Specimen Type: 1. Collect Human Serum or Plasma with Lithium Heparinate. 2. For a given patient, the PCT assays must be performed on the same type of sample tube. 3. Since EDTA causes a decrease in the values measured, plasma collected on EDTA should not be used. Samples containing suspended fibrin particles or erythrocyte stroma should be centrifuged before testing. B. Sample Preparation and Storage: 1. After collecting the samples, if applicable wait for samples to coagulate and centrifuge according to the tube manufacturer s recommendations to eliminate fibrin. 2. The sera or plasma separated from the clot can be stored at 2-8 C in stoppered tubes for up to 48 hours; if longer storage is required, freeze at -25 ± 6 C. Six-month storage of frozen samples does not affect the quality of results. Three freeze/thaw cycles are validated. V. INTERFERENCES 1. None of the following factors have been found to significantly influence this assay: Hemolysis - after spiking samples with hemoglobin, up to 347 μmol/l (monomer). Lipemia - after spiking samples with lipids, up to 30 g/l equivalent in triglycerides. Bilirubinemia - after spiking samples with bilirubin, up to 547 μmol/l. Page 131 of 391

132 VIDAS 3 PROCALCITONIN PROCEDURE 3 VI. CALIBRATION A.VIDAS PTC Protocol Data Entry When using the assay for the first time and before reading the MLE data, scan the barcode (at the end of the package insert) using the instrument barcode reader. This reading will allow the VIDAS PTC protocol data to be transferred to the instrument software for its update. These data should only be read the first time the assay is used. B. Master Lot Data Entry 1. When using the assay for the first time, enter the VIDAS PTC protocol (barcode at the end of the package insert) before reading the MLE data. If the MLE data have been read before the VIDAS PTC protocol, read the MLE data again. Before each new lot of reagents is used, specifications (or factory master calibration data) must be entered into the instrument using a master lot entry (MLE) card included in each kit. If this operation is not performed before initiating the tests, the instrument will not be able to print results. The master lot entry (MLE) need only be entered once for each lot. 2. It is possible to enter MLE data manually or automatically. For complete instructions refer to the Operator s Manual. C. Calibration 1. Calibration, using the two calibrators provided in the kit, must be performed each time a new lot of reagents are opened, after the master lot data has been entered, and then every 28 days. This operation provides instrument-specific calibration curves and compensates for possible minor variations in assay signal throughout the shelf life of the kit. 2. The calibrators, identified by S1 and S2, must be tested in duplicate in the same run (see Operator s Manual). The calibration values must be within the set Relative Fluorescence Value (RFV) found in the MLE data. If this is not the case, recalibrate using S1 and S2. 3. After a valid calibration is obtained two levels of controls must be run. Patient results cannot be reported until there is a valid calibration and quality control is within range. VII. QUALITY CONTROL Two controls are included in each VIDAS B.R.A.H.M.S PCT kit. These controls must be performed immediately after opening a new kit to ensure that reagent performance has not been altered. Each calibration must also be checked using these controls. The instrument will only be able to check the control values if they are identified as C1 and C2. Results cannot be validated if the controls deviate from the expected values. Samples tested in the same run must be reassayed. Page 132 of 391

133 VIDAS 3 PROCALCITONIN PROCEDURE 4 VIII. PROCEDURE IX. RESULTS 1. Remove the required reagents from the refrigerator and/or freezer. Let thaw if applicable. 2. Mix the calibrators and/or controls to ensure homogeneity. Patient sample do not need mixed. 3. Use one "PCT" strip and one "PCT" SPR for each sample, control or calibrator to be tested. Make sure the storage pouch has been carefully resealed after the required SPRs have been removed. 4. The test is identified by the "PCT" code on the instrument. The calibrators must be identified by "S1" and by S2, and tested in duplicate. If the controls need to be tested, they should be identified by C1 and C2 and tested singly. Patient samples should be identified using the specimen number. 5. Mix the calibrators and/or controls. 6. Insert the "PCT" SPRs and strips into the appropriate position on the instrument. 7. Aliquot 200 μl of the calibrator, control, and/or sample into the 1 st compartment on the reagent strip. 8. Initiate the assay immediately. All the assay steps are performed automatically by the instrument. 9. Reclose the vials and return them to the required temperature after pipetting. 10. The assay will be completed within approximately 20 minutes. After the assay is completed, remove the SPRs and strips from the instrument. 11. Dispose of used reagent strips and SPRs in an appropriate waste receptacle. 1. Once the assay is completed, results are analyzed automatically by the computer using two calibration curves which are stored by the instrument; the concentrations are expressed in ng/ml 2. With VIDAS PC, if a result which is < 0.05 ng/ml is obtained, the printed report will include the alarm J2 > J4 & J2 J0 < RFV threshold and *** will be indicated for the RFV. This alarm, which is linked with the reading mode of the VIDAS B R A H M S PCT (PCT) technique (dual reading), does not call into question the concentration measured. 3. As no international standard is available, VIDAS B R A H M S PCT is calibrated against an internal panel of human sera with known procalcitonin concentrations. In case of patient follow-up, it is recommended to use the same PCT assay technique. 4. Samples with procalcitonin concentrations greater than 200 ng/ml should be retested after dilution by 1/10 (1 volume of sample + 9 volumes of PCT negative sample). See the table below for examples of dilutions. DILUTION RATIO TOTAL PARTS DILUTION VOLUMES ALTERNATIVE DILUTION VOLUMES 1:10 1 part sample: 9 parts diluent 100 ul sample: 900 ul diluent 50 ul sample: 450 ul diluent OR 25 ul sample: 225 ul diluent LIMITATIONS OF THE ASSAY Interference may be encountered with certain samples containing antibodies directed against reagent components. For this reason, assay results should be interpreted taking into consideration the patient's history and the results of any other tests performed. X. REFERENCE VIDAS B R A H M S PCT (PCT) package insert. Refer to the insert for the complete details, references, and performance of the product. "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 133 of 391

134 Chemistry: Policy Number: CH Date Created: 03/16/2017 Document Owner: Diahanna Caldwell (Laboratory Date Approved: Not Approved Yet Section Chief) Approvers: Board of Directors (Administration), Cindy Moccio (Board Clerk/Exec Assist-CEO), David Hewitt (Pathology) Accuracy of Automatic Pipetting Printed copies are for reference only. Please refer to the electronic copy for the latest version. Policy: The purpose of this policy is to explain the semi-annual evaluation of the accuracy of automatic pipetting when performing dilutions. This evaluation will be performed semi-annually. Responsibility: The Laboratory Medical Director is responsible for establishing this policy. The Laboratory Section Chief is responsible for maintaining this document and ensuring that the Laboratory Medical Director reviews the procedure biennially. Procedure: 1. Check the accuracy of dilutions using the Accuracy of Automatic Pipettes Form. a. Beckman Coulter AU680 and DXI600 i. If needed refer to the Program a Dilution section in the Remisol manual for further information on scheduling dilutions. ii. The system will make a dilution of an analyte chosen by the CLS. This dilution will be scheduled using Remisol. iii. The CLS will make a manual dilution using the same specimen and dilution parameters used for the system dilution. This dilution will also be scheduled in Remisol. iv. The results of the two dilutions will be compared using the Accuracy of Automatic Pipettes Form. v. Acceptable limits are +/-10%. Related Documents: Accuracy of Automated Pipettes Form "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 134 of 391

135 POLICY SUBMISSION SUMMARY Manual Name: Hematology Date:5/23/17 Support Staff Name: Patsy Turner/Lorrie Anderson Policy/Procedure Title: Policy/Procedure # Status (New, Revised, Alternate Methodology, or Instrument, Reference Laboratory Name & Phone # of Person who wrote new Reviewed, Deleted) policy or revised one HE Revised Patsy Turner X 5059 Retained Patient Specimen QC HE Revised Patsy Turner X 5059 APTT-ACL TOP 300 HE Revised Patsy Turner X 5059 Fibrinogen-QFA-ACL TOP 300 HE Revised Patsy Turner X 5059 Prothrombin Time-ACL TOP 300 HE Revised Patsy Turner X 5059 Annual Competency Review for HE Revised Patsy Turner X 5059 CLS D-Dimer HS ACL Top 300 HE Revised Patsy Turner x 5059 Iris Automated Urinalysis, IQ 200 & ichem Velocity Sysmex DI-60 Automated Digital Cell Morphology Analyzer HE New Patsy Turner x 5059 HE New Patsy Turner x 5059 Page 135 of 391

136 Clinical Laboratory, Hematology Policy Number: HE Date Created: Not Set Document Owner: Patricia Turner (Laboratory Date Approved: Not Set Section Chief) Approvers: Board of Directors (Administration), David Hewitt (Pathology) Alternate Methodology or Instrument, Reference Laboratory Printed copies are for reference only. Please refer to the electronic copy for the latest version. OBJECTIVE: To be able to perform, generate laboratory test result(s) without jeopardizing turnaround time, integrity of specimens when primary instrument is down. I. DEPARTMENT a. Hematology - CBC, Reticulocyte Primary Instrument: Sysmex XN 3000 right instrument Secondary Instrument: Sysmen XN 3000 left instrument Third Alternate: Tulaure District Hospital Laboratory or ARUP b. Coagulation PT, APTT, Fibrinogen, DDimer, anti Xa Primary Instrument: ACL TOP 1 Secondary Instrument: ACL TOP 2 Third Alternate: Tulaure District Hospital Laboratory or ARUP c. Urinalysis Primary Instrument: Iris IQ 200 Secondary Instrument: Bayer Clinitek Status + Third Alternate: Tulaure District Hospital Laboratory or ARUP d. PFA 100 Secondary: Hanford District Hospital: e. TEG Primary Instrument: TEG 1, 2, 3, or 4 Secondary Instrument: TEG 5,6,7 or 8 f. ESR Stat Plus Primary: Alcor ised instrument 1 Secondary: Alcor ised instrument 2 II. REFRIGERATION Primary refrigerator: Fisher Double Wide Secondary refrigerator: Jewitt Double Wide Third Alternate: Walk-in refrigerator Page 136 of 391

137 Alternate Methodology or Instrument, Reference Laboratory 2 "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 137 of 391

138 Clinical Laboratory, Hematology Policy Number: HE Date Created: Not Set Document Owner: Patricia Turner (Laboratory Date Approved: Not Set Section Chief) Approvers: Board of Directors (Administration), David Hewitt (Pathology) Retained Patient Specimen QC Printed copies are for reference only. Please refer to the electronic copy for the latest version. OBJECTIVE: To enhance consistency instruments and procedure quality control. 5 ParaRetained sample is used as a longitudinal process. SPECIMEN: 1. CBC tube for Sysmex retained sample (EDTA) 5 Para (EDTA) 2. Retained patient specimen previously analysed analyzed post control results. 3. Coagulation: Previously analysed analyzed citrate plasma specimen. Remove plasma from cells < 2 hours of draw. Do not use plasma that has been in contact with cells > than 2 hours. 4. Normal range specimen should be selected. PRESERVATION: 1. CBC specimens hold at room temperature. 2. Platelet-poor plasma from PT, APTT specimen is best stored at room temperature. RECOMMENDED RESULTS AND LIMITS: WBC: 5-12 cu mm +/- 0.4 RBC: cu mm +/ HGB: gm/l +/- 0.4 MCV: fl +/- 3.0 PLT: cu mm +/- 24 PT: secs +/- 0.5 APTT: secs +/- 2.5 ACTIVITIES: 1. Re-analyze 5 Parameterretained sample post instrument maintenance or reagent verification ParameterRetained sample may be used every 30 to 50 specimen samples to verify instrument function. 3. Record results on worksheet or in instrument control file. Page 138 of 391

139 Retained Patient Specimen QC 2 "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 139 of 391

140 Clinical Laboratory, Hematology Policy Number: HE Date Created: Not Set Document Owner: Patricia Turner (Laboratory Date Approved: Not Set Section Chief) Approvers: Board of Directors (Administration), David Hewitt (Pathology) APTT-ACL TOP 300 Printed copies are for reference only. Please refer to the electronic copy for the latest version. Purpose This procedure provides instructions for the analysis of Activated Partial Thromboplastin Time (APTT) using HemosIL SynthASil or APTT-SP on the ACL TOP Family. The test is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test, and the monitoring of heparin therapy. 1,6 Principles of the Procedure A plasma sample is incubated with an optimal quantity of phospholipids and a negatively charged contact activator which initiates the activation of the intrinsic coagulation pathway. Calcium is added after incubating at 37 C for a specific period of time, and the time for clot formation is measured. 1,6 Interpretation of Results Prolonged clotting times may be observed in the following situations: deficiency of Factors II, V, VIII, IX, X, XI, XII or fibrinogen, liver diseases, Vitamin K deficiency, presence of heparin, lupus anticoagulant or other inhibitor. 1,6 Product Information HemosIL APTT-SP Kit (PN ) Contains: APTT Reagent: 5 x 9mLvials of colloidal silica dispersion with synthetic phospholipids, buffer and preservatives. Calcium Chloride: 5 x 8mL vials of calcium chloride (0.025 mol/l) with preservative. HemosIL SynthASil Kit (PN ) Contains: APTT Reagent: 5 x 10mL vials of a buffered synthetic phospholipid reagent containing a colloidal silica activator, stabilizers and a preservative. Calcium Chloride: 5 x 10mL vials of an aqueous solution of calcium chloride (0.020 Mol/L) and a preservative. Please refer to the package inserts for further detail. 1,6 The following are not supplied with the kits and those required may be purchased separately. 1,6 HemosIL Normal Control UNASSAYED HemosIL Low Abnormal Control UNASSAYED HemosIL High Abnormal Control UNASSAYED HemosIL Normal Control ASSAYED HemosIL Low Abnormal Control ASSAYED Page 140 of 391

141 APTT-ACL TOP HemosIL High Abnormal Control ASSAYED Reagent Preparation SynthASil: Each vial of APTT reagent must be equilibrated at C for at least 15 minutes and mixed thoroughly before use. 1 Calcium Chloride (packaged with either reagent): ready for use. 1,6 Reagent Storage and Stability Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8 C. APTT Reagents: Opened reagents are stable 30 days at 2-8 C in the original vial and 5 days (APTT-SP) or 10 days (SynthASil) at 15 C on the ACL TOP Family. Do not freeze. Calcium Chloride 0.020M: Opened reagent is stable 30 days at 2-30 C. Calcium Chloride 0.025M: Opened reagent is stable 30 days at 2-8 C. For optimal stability remove reagents from the system and store at 2-8 C in the original vial. 1,6 Warnings and Precautions Avoid contact with skin and eyes. Do not empty into drains. Wear suitable protective clothing. 1,6 The Calcium Chloride in both kits, APTT-SP and SynthASil contains sodium azide that may form explosive azides in metal plumbing. Use proper disposal procedures. 6 Please refer to the Material Safety Data Sheet for this product for more detailed safety information. These products are for in vitro diagnostic use. 1,6 Specimen Collection and Preparation Nine parts of freshly drawn venous blood are collected into one part trisodium citrate. 1 Refer to the most recent Clinical and Laboratory Standards Institute Document H21-A5 for further instructions on specimen collection, handling and storage. 3 Page 141 of 391

142 APTT-ACL TOP Remedial Action for Unaccepted Samples See also HE for specimen rejection criteria. 1. Visual inspection of sample and clot detected. 2. Clot detected by applicator stick check 3. APTT < 20.0 seconds or PT < Collection tube filled less than or greater than 10% of fill line 5. Specimen must be </= 4 hours, stored at room temperature, or plasma stored frozen > -20 for 72 hours Limitations of the Procedure SynthASil Results on the ACL TOP Family are not affected by: Hemoglobin up to 500 mg/dl Bilirubin up to 26 mg/dl Triglycerides up to 1000 mg/dl Refer to the appropriate insert sheet for additional information. Quality Control Normal and abnormal controls are recommended for a complete quality control program. HemosIL controls are designed for this program. Each laboratory should establish its own mean and standard deviation and should establish a quality control program to monitor laboratory testing. Controls should be analyzed, at least once every 8 hour shift, in accordance with good laboratory practice and CLSI guidelines. 1,5,6 Refer to Westgard et al for identification and resolution of out-ofcontrol situations. 1,4,6 QC Frequency : at least once every 8 hour shift Procedure 1. Define Materials if necessary (Setup, Material List). Select the appropriate materials from the Material List. 2. Define Results Units and Rerun Rules in the APTT Test Definition if necessary (Setup, Test List, Test Code, Result Units and Rerun Rules). 3. Create/Edit QC files, if necessary (Setup, QC List, Test Code, to access the QC Definition Screen. 4. Add APTT test code to the Test/Profiles Programming Window, if necessary (Setup, Display, and Test Programming Window). 5. Add the appropriate APTT reagent and Calcium Chloride to the Materials Programming Window if necessary (Setup, Display, Materials Programming Window). 6. Load the APTT reagent and Calcium Chloride materials onto the ACL TOP Family instrument. 7. Place QC materials with the barcodes facing out in a Diluent Rack and load onto the ACL TOP Family instrument in a Diluent track. (If running the QC from the sample rack, refer to Quality Control, Performing a QC Test in the ACL TOP Family On-Line Help Manual). 8. Choose QC from the Main Menu and select Test Status List. 9. Double-click on line item to reveal the Test Materials Definition tree. 10. Select the box in front of the APTT Control and choose the Program QC icon. This will run all QC levels for that test 11. Place sample tubes in a sample rack with barcodes facing outwards. 12. Select an available sample track and load the sample rack when the barcode reader is in position. 13. Verify the samples have been identified and have a test ordered. If not, program the sample ID manually and/or order the test manually from the test and programming window. Page 142 of 391

143 APTT-ACL TOP Choose the Run icon if the ACL TOP Family instrument is not currently running. 2 For instructions on loading samples without barcodes or LIS, please refer to Samples Analysis, Managing Patient Samples, Programming Bar Coded Samples and Programming Non-Bar Coded Samples in the ACL TOP Family On-Line Help Manual. 2 Remedial Action for Unaccepted Quality Control Results See HE for out of control values and corrective action instructions Results Patient results may be reported in seconds. 1 If any flags or alarms are present, refer to ACL TOP Family On-Line Help Manual. 2 Linearity Limits APTT with extended mode is seconds. Reporting limits per laboratory protocol is >200.0 seconds. Expected Values Current laboratory reference range for ACL TOP Family Instrument Serial Number / Reagent Lot Number APTT Normal Range (seconds) Date / Signature Remedial Action: Reporting Abnormal results See HE for reporting critical values and unexpected abnormal test values. Specific Performance Characteristics Precision: Within-run and total (run to run and day to day) precision was assessed over multiple runs using both normal and abnormal control samples. Please refer to the appropriate package insert for precision study results. 1,6 Heparin Therapy: Example dose response curves are on the appropriate reagent package insert. Due to many variables (i.e. different source of heparin) which may affect the clotting times, each laboratory should establish its own heparin therapeutic range. 1,6 Current laboratory UFH therapeutic range for ACL TOP Family Heparin Range (U/mL) Corresponding APTT Range (seconds) Date / Signature Page 143 of 391

144 APTT-ACL TOP For further indications on therapeutic ranges and duration of treatment make reference to local guidelines. 1,6 Intrinsic Factor Sensitivity: Studies have shown SynthASil to be sensitive to decreased concentration of intrinsic factors resulting in an abnormal APTT value when factors VIII, IX, XI and XII levels were in the 35-60% range for SynthASil. 1 References 1. HemosIL SynthASil (PN ) package insert 2. ACL TOP Family On-Line Help Manual 3. Clinical and Laboratory Standards Institute. Collection, Transport and Processing of Blood Specimens for Testing Plasma-Based Coagulation and Molecular Haemostasis Assays; Approved Guideline Fifth Edition, CLSI Document H21-A5; Vol. 28 No Westgard JO, and Barry PL. Cost-Effective Quality Control; Managing the Quality and Productivity of Analytical Process, AACC Press, Clinical and laboratory Standards Institute. One Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline Second Edition, CLSI Document H47-A2; Vol. 28 No HemosIL APTT-SP (PN ) package insert Page 144 of 391

145 Clinical Laboratory, Hematology Policy Number: HE Date Created: 06/01/2014 Document Owner: Patricia Turner (Laboratory Date Approved: Not Set Section Chief) Approvers: Board of Directors (Administration), David Hewitt (Pathology) Fibrinogen-Q.F.A.- ACL Top 300 Printed copies are for reference only. Please refer to the electronic copy for the latest version. Fibrinogen-Q.F.A. - ACL TOP 300 Purpose This procedure provides instructions for Quantitative Fibrinogen Analysis (QFA) using HemosIL QFA on the ACL TOP Family. 1,2 Principles of the Procedure The fibrinogen in the diluted test sample is converted to fibrin by the addition of an excess of thrombin and the resulting clotting time value is measured. The log of the clotting time value is inversely proportional to the log of the fibrinogen concentration. A fibrinogen reference curve is plotted from the clotting time results of the known referenced plasma dilutions having different fibrinogen values. The concentration of fibrinogen in patient plasma samples is determined by comparing clotting time values to the reference curve. 1,2 Interpretation of Results When unexplained bleeding or abnormal clotting occurs it may be of clinical importance to quantitate fibrinogen. Fibrinogen is also a useful marker in the evaluation of several disease states including Disseminated Intravascular Coagulation, liver disease and inflammatory diseases. 1,2 Product Information The HemosIL Q.F.A. Thrombin (Bovine) kits (PN or PN ) consist of: Q.F.A. Thrombin (Bovine): 10 x 5 ml (PN ) vials of lyophilized bovine thrombin (approx 100 UNIH/mL) containing buffer, an antiheparin agent and a preservative. 1 Q.F.A. Thrombin (Bovine): 10 x 2 ml (PN ) vials of lyophilized bovine thrombin (approx 100 UNIH/mL) containing buffer, an antiheparin agent and a preservative. 2 The following are not supplied with the kit and those required may be purchased separately. 1,2 HemosIL Calibration Plasma HemosIL Normal Control HemosIL Low Fibrinogen Control HemosIL Low Abnormal Control HemosIL Factor diluent HemosIL Cleaning agent (Clean B) Page 145 of 391

146 Fibrinogen-Q.F.A.- ACL Top Reagent Preparation Bovine Thrombin: Dissolve the contents of each vial (volume appropriate to the vial size, 5 ml or 2 ml) with CLSI CLR water or equivalent. 5 Replace the stopper and swirl gently. Make sure of complete reconstitution of the product. Keep the reagent at C for 30 minutes and invert to mix before use. Do not shake. 1,2 Cleaning Agent (Clean B Diluted): Dilute Cleaning Agent 1:8 with CLSI CLRW Type (or equivalent) water (1+7). 5 Reagent Storage and Stability Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8 C. Stability after reconstitution: 7 days at 2-8 C or 7 days at 15 C on the ACL TOP Family. For optimal stability remove reagent from the system and store it at 2-8 C in the original vial. 1,2 Reagent, Calibrator, Control Storage To maximize stability, store QFA controls in 2-8 C refrigerator when not in use. Warnings and Precautions Toxic to aquatic organisms. This material and its container must be disposed of in a safe way. Use appropriate container to avoid environmental contamination. Avoid release to the environment. All animal products should be treated as potentially infectious. Avoid contact with skin and eyes. Do not empty into drains. Wear suitable protective clothing. 1,2 Please refer to the Material Safety Data Sheet for this product for more detailed safety information. This product is for in vitro diagnostic use. 1,2 Specimen Collection and Preparation Nine parts of freshly drawn venous blood are collected into one part of trisodium citrate. Refer to CLSI Document H21-A5 for further instructions on specimen collection, handling and storage. 1,2,4 Remedial Action for Unaccepted Samples See also HE for specimen rejection criteria. 1. Visual inspection of sample and clot detected. 2. Clot detected by applicator stick check. 3. Collection tube filled less than or greater than 10% of fill line 4. Specimen >4 hours, stored at room temperature, or plasma not frozen Limitations of the Procedure Fibrinogen assay results may be affected by degradation (fibrin or fibrinogen) in the plasma assayed. 1,2 No interference on the ACL TOP Family up to: 1,2 Hemoglobin up to 375 mg/dl Bilirubin up to 23 mg/dl Triglycerides up to 880 mg/dl Heparin up to 2 U/mL Page 146 of 391

147 Fibrinogen-Q.F.A.- ACL Top Calibration Details Calibration and storage of a valid Fibrinogen QFA calibration curve are required to obtain Fibrinogen results. Calibration is performed: With a change of reagent lot numbers After major parts replacement To satisfy local regulatory requirements At laboratory discretion Method for Calibration (if necessary): 1. Define Materials if necessary (Setup, Material List). Select the appropriate materials from the Material List. 2. Add Q.F.A. Thrombin reagents (Q.F.A Thrombin), Calibration Plasma, Factor Diluent & Diluted Clean B to the Materials Programming Window if necessary (Setup, Display, Materials Programming Window). 3. Define Results Units and Rerun Rules in the Q.F.A. Thrombin Test Definition if necessary (Setup, Test List, Test Code, Result Units and Rerun Rules). 4. Choose Setup, Materials List. 5. Double-click on the appropriate calibration plasma to open the Materials Definition screen. 6. Choose the Lot Specific Information tab and enter the Calibration Plasma lot number and Expiration Date. 7. Enable Lot Management from the Lot Specific Information tab. 8. Select the Save icon to store the lot number. Once the lot number is saved, the Assign Values icon becomes available. 9. Select the Assign Values icon. 10. Enter the calibration value from the Calibration Plasma package insert. Press OK. 11. Choose the Previous Screen icon to exit. 12. Load the Q.F.A. Thrombin (Bovine) reagent, Calibration Plasma, Diluted Clean B and Factor Diluent on to the ACL TOP Family instrument. 13. Select Calibration, Status List. 14. Double-click on Q.F.A. Thrombin Test Code to open the Calibration Details screen. 15. Choose the Run icon. 16. Select OK at the Do you confirm the operation? prompt. 17. Choose the Previous Screen icon to exit. 18. Verify the Job Status for the Q.F.A. Test says Active. Once the calibration is complete, review calibration results. An acceptable r 2 - value is > If there are no errors/failures and the calibration is acceptable, choose the Validate icon to validate the calibration curve. 3 Note: The QFA Low calibration curve must also be validated. Page 147 of 391

148 Fibrinogen-Q.F.A.- ACL Top Quality Control Normal and abnormal controls are recommended for a complete quality control program. The HemosIL Controls listed above are designed for this program. Each laboratory should establish its own mean and standard deviation and should establish a quality control program to monitor laboratory testing. Controls should be analyzed at least once every 8 hour shift in accordance with good laboratory practice. Refer to the ACL TOP Family On-Line Help Manual for additional information. Refer to Westgard et al for identification and resolution of out-ofcontrol situations. 1,2,3 QC Frequency at least once every 8 hour shift. Procedure 1. Create/Edit QC files, if necessary (Setup, QC List, Test Code, to allow access to the QC Definition Screen). 2. Add Q.F.A. Thrombin and/or Q.F.A Thrombin Low test code(s) to the Test/Profiles Programming Window, if necessary (Setup, Display, Test Programming Window). 3. Load reagent and Clean B Diluted onto the ACL TOP Family instrument. 4. Place QC materials with the barcodes facing out in a Diluent Rack and load onto the ACL TOP Family instrument in a Diluent track. (If running the QC from the sample rack, refer to Quality Control, Performing a QC Test in the ACL TOP Family On-Line Help Manual). 5. Choose QC from the Main Menu and select Test Status List. 6. Double-click on a Test Code to reveal the Test Materials Definition tree. 7. Select any Q.F.A. Thrombin QC Control and choose the Program QC icon. This will run all QC levels for that test. 8. Place sample tubes in a sample rack with barcodes facing outwards. 9. Select an available sample track and load the sample rack when the barcode reader is in position. 10. Verify the samples have been identified and have a test ordered. If not, program the sample ID manually and/or order the test manually from the test and programming window. Note: Q.F.A. Low test should only be used for samples that are below the linear range for the standard tests. 11. Choose the Run icon if the ACL TOP Family instrument is not currently running. 12. For instructions on loading samples without barcodes or LIS, please refer to Samples Analysis, Managing Patient Samples, Programming Bar Coded Samples and Programming Non-Bar Coded Samples in the ACL TOP Family On-Line Help Manual. 3 Remedial Action for Unaccepted Quality Control Results See HE for out of control values and corrective action instructions. Results Fibrinogen results may be reported in seconds, mg/dl or g/l. Refer to the ACL TOP Family On-Line Help Manual for additional information. If any flags or alarms are present, refer to the ACL TOP Family On-Line Help Manual for details including viewing individual clot curves. 1,2,3 Page 148 of 391

149 Fibrinogen-Q.F.A.- ACL Top Expected Values A normal range study was performed using Q.F.A. Thrombin reagent. System N Range (unit) ACL TOP Family mg/dl These results were obtained using a specific lot of reagent. Due to many variables which may affect results, each laboratory should establish its own QFA normal range. 1,2 Current laboratory reference range for ACL TOP Family Instrument Serial Number Reagent lot Number QFA Thrombin Normal Range Date / Signature (mg/dl) /22/14 Remedial Action: Reporting Abnormal results See HE for reporting critical values and unexpected abnormal test values. Specific Performance Characteristics Precision: Within-run and total (run to run and day to day) precision was assessed over multiple runs using both normal and abnormal control samples. Please refer to the package insert for precision study results. 1,2 Linearity limits mg/dl References 1. HemosIL Q.F.A. Thrombin (Bovine) (PN ) package insert 2. HemosIL Q.F.A. Thrombin (Bovine) (PN ) package insert 3. ACL TOP Family On-Line Help Manual 4. Clinical and Laboratory Standards Institute. Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation and Molecular Hemostasis Assays; Approved Guideline - Fifth Edition, CLSI Page 149 of 391

150 Fibrinogen-Q.F.A.- ACL Top Document H21-A5; Vol. 28 No Reference Clinical and Laboratory Standards Institute.Preparation and Testing of Reagent Water in the Clinical Laboratory;Approved Guideline. Fourth Edition, CLSI Document C3-A4;Vol.26 No.22 Page 150 of 391

151 Clinical Laboratory, Hematology Policy Number: HE Date Created: 06/01/2014 Document Owner: Patricia Turner (Laboratory Date Approved: Not Set Section Chief) Approvers: Board of Directors (Administration), David Hewitt (Pathology) Prothrombin Time-ACL Top 300 Printed copies are for reference only. Please refer to the electronic copy for the latest version. Prothrombin Time - ACL TOP 300 Purpose This procedure provides instructions for the analysis of Prothrombin Time (PT) using a thromboplastin reagent on the ACL TOP Family. The test is used for the evaluation of the extrinsic coagulation pathway and the monitoring of oral anticoagulant therapy (OAT). 1,4,6 Principles of the Procedure The addition of tissue thromboplastin and calcium ions (PT reagent) to the patient plasma initiates the activation of the extrinsic pathway. This results in the conversion of fibrinogen to fibrin, with formation of a solid gel. The time required for clot formation is measured. 1,4,6 Interpretation of Results These products are particularly suited to the monitoring of oral anticoagulant 1, 4,6 therapy and factors of the extrinsic pathway. Product Information HemosIL RecombiPlasTin 2G (PN (8 ml) or (20 ml)) contains 1 : RecombiPlasTin 2G (RTF): 5 x 8 or 20 ml vials of lyophilized recombinant human tissue factor, synthetic phospholipids with stabilizers, preservative and buffer. RecombiPlasTin 2G Diluent (RTF Diluent): 5 x 8 or 20 ml vials of an aqueous solution of calcium chloride, polybrene and a preservative. The following are not supplied with the kits and those required may be purchased separately. 1,4,6 HemosIL Calibration Plasma HemosIL Normal Control UNASSAYED HemosIL Normal Control ASSAYED HemosIL Low Abnormal Control UNASSAYED HemosIL Low Abnormal Control ASSAYED HemosIL High Abnormal Control UNASSAYED HemosIL High Abnormal Control ASSAYED HemosIL Low Fibrinogen Control HemosIL Factor Diluent HemosIL Cleaning Agent (Clean B) Page 151 of 391

152 Prothrombin Time-ACL Top Reagent Preparation RecombiPlasTin 2G: Allow each vial of reagent and diluent to equilibrate at C for at least 15 minutes before reconstitution. Pipette the exact amount required (either 8 ml or 20 ml) of diluent into the vial of reagent. DO NOT POUR the contents of the diluent vial into the vial of RecombiPlasTin 2G. Replace the stopper and swirl gently. Let sit for 15 to 20 minutes at C and invert to mix before use. 1 Cleaning Agent (Clean B Diluted): Dilute Cleaning Agent 1:8 with CLSI CLRW Type (or equivalent) water (1+7). 8 Reagent Storage and Stability Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8 C. RecombiPlasTin 2G: Stability after reconstitution: 10 days at 2-8 C, 5 days at C in the original vial or 10 days at 15 C on the ACL TOP Family. 1 No stir bar required. Reagent, Calibrator, Control Storage To maximize stability, store control materials in 2-8 C refrigerator when not in use. Warnings and Precautions Harmful if swallowed. Avoid contact with skin and eyes. Do not empty into drains. Wear suitable protective clothing. 1,4,6 HemosIL RecombiPlasTin 2G and HemosIL PT-Fibrinogen HS PLUS buffer contain sodium azide that may form explosive azides in metal plumbing. Use proper disposal procedures. 1,4,9 PT-Fibrinogen contains bovine material. All donor animals were sourced from BSE-free herds. The material should be treated as potentially infectious. 9 Please refer to the Material Safety Data Sheet for these products for more detailed safety information. These products are for in vitro diagnostic use. 1,4,6 Specimen Collection and Preparation Nine parts of freshly drawn venous blood are collected into one part trisodium citrate. 1 Refer to the most recent Clinical and Laboratory Standards Institute (CLSI) Document H21-A5 for further instructions on specimen collection, handling and storage. 3 Page 152 of 391

153 Prothrombin Time-ACL Top Remedial Action for Unaccepted Samples See also HE for specimen rejection criteria. 1. Visual inspection of sample and clot detected. 2. Clot detected by applicator stick check 3. APTT < 20.0 seconds or PT < Collection tube filled less than or greater than 10% of fill line 5. Specimen must be </=24 hours, stored at room temperature. Limitations of the Procedure PT results may be affected by many commonly administered drugs. Further studies should be made to determine the source of unexpected abnormal results. RecombiPlasTin 2G results on the ACL TOP Family are not affected by: PT Heparin, up to: 1.0 U/mL Hemoglobin, up to: 500 mg/dl Bilirubin, up to: 30 mg/dl Triglycerides, up to: 1000 mg/dl Please refer to the appropriate package insert(s) for interfering substances. 1,4,6 Calibration Details Calibration is required for reporting of PT in % Activity or PT-based Fibrinogen. Calibration is not required for seconds or INR. However, INR calculation must be set up for each lot number. 2 Important Warning: If the INR calculation is not properly set up, then erroneous patient results may be reported. This process must be repeated with every new lot of PT reagent. Setup to obtain INR results for each new lot of PT reagent: 1. Enable ISI Value: Setup, Material List, Select appropriate Prothrombin reagent. Select the Lot Specific Information tab, and add the ISI value from the appropriate Reagent Lot number Insert Sheet. Select the Save icon to store the ISI value. Choose the Previous Screen icon to exit. 2. Verify/update the (geometric) mean normal range: 7 To enter this updated value; select Setup, Test List, PT test code. Select NPP, and enter the mean normal result in seconds. Select the Save icon to store the ISI value. Choose the Previous Screen icon to exit. Method for Calibration (if necessary): 1. Define Materials if necessary (Setup, Material List). Select the appropriate materials from the Material List. 2. Add appropriate Prothrombin Time Reagent, Calibration Plasma, Factor Diluent and Diluted Clean B to the Materials Programming Window if necessary (Setup, Display, Materials Programming Window). 3. Define Results Units and Rerun Rules in the specific Prothrombin Time Test Definition if necessary (Setup, Test List, Test Code, Result Units and Rerun Rules). 4. Choose Setup, Materials List. 5. Double-click on the appropriate calibrator to open the Materials Definition screen. 6. Choose the Lot Specific Information tab and enter the Calibrator lot number and Expiration Date. 7. Enable Lot Management from the Lot Specific Information tab. 8. Select the Save icon to store the lot number. Once the lot number is saved, the Assign Values icon becomes available. 9. Select the Assign Values icon. Page 153 of 391

154 Prothrombin Time-ACL Top Enter the calibration value of 100 for the unit % Activity of the corresponding PT test, in the Assigned Value Active Lot Field. Press OK. 11. Choose the Previous Screen icon to exit. 12. Load the appropriate Prothrombin Time Reagents, Calibration Plasma, Factor Diluent and Clean B Diluted on to the ACL TOP Family instrument. 13. Select Calibration, Status List. 14. Double-click on the appropriate Prothrombin Time test code to open the Calibration Details screen. 15. Choose the Run icon. 16. Select OK at the Do you confirm the operation? prompt. 17. Choose the Previous Screen icon to exit. 18. Verify the Job Status for the Factor Assay test code says Active. 4. Once the calibration is complete, review calibration results. An acceptable r 2 - value is > If there are no errors/failures and the calibration is acceptable, choose the Validate icon to validate the calibration curve. 2 Quality Control Normal and abnormal controls are recommended for a complete quality control program. HemosIL Controls for Prothrombin Time are designed for this program. Each laboratory should establish its own mean and standard deviation and should establish a quality control program to monitor laboratory testing. Controls should be analyzed at least once every 8 hour shift in accordance with good laboratory practice. 1 Refer to Westgard et al for identification and resolution of out-ofcontrol situations. 7 QC Frequency : at least once every 8 hour shift. Procedure 1. Create/Edit QC files, if necessary (Setup, QC List, Test Code, this will bring up the QC Definition Screen). 2. Add the appropriate Prothrombin Time Test Code to the Test/Profiles Programming Window, if necessary (Setup, Display, Test Programming Window). 3. Load appropriate Prothrombin Time reagents and Clean B Diluted onto the ACL TOP Family. 4. Place QC materials with the barcodes facing out in a Diluent Rack and load onto an ACL TOP Family instrument in a Diluent track. (If running the QC from the sample rack, refer to Quality Control, Performing a QC Test the ACL TOP Family On-Line Help Manual). 5. Choose QC from the Main Menu and select Test Status List. 6. Double-click on a test code to reveal the Test Materials Definition tree. 7. Select the box in front of the Prothrombin QC Control and choose the Program QC icon. This will run all QC levels for that test. 8. Place sample tubes in a sample rack with barcodes facing outwards. 9. Select an available sample track and load the sample rack when the barcode reader is in position 10. Verify the samples have been identified and have a test ordered. If not, program the sample ID manually and/or order the test manually from the test and programming window 11. Choose the Run icon if the ACL TOP Family instrument is not currently running. For instructions on loading samples without barcodes or LIS, please refer to Samples Analysis, Managing Patient Samples, Programming Bar Coded Samples and Programming Non-Bar Coded Samples in the ACL TOP Family On-Line Help Manual. 2 Page 154 of 391

155 Prothrombin Time-ACL Top Remedial Action for Unaccepted Quality Control Results See HE for out of control values and corrective action instructions. Results Prothrombin Time results may be reported in seconds, % activity, ratio and/or INR. If any flags or alarms are present, refer to the ACL TOP Family On-Line Help Manual. 2 Result Reporting Format Prothrombin results are reported in seconds and INR. Expected Values Normal Range: ACL TOP Family N Range (seconds) PT-RP The results were obtained using specific lots of reagent. Due to many variables which may affect clotting times, each laboratory should establish its own normal range. 1,4,6 Current laboratory normal range for ACL TOP Family Instrument Serial Number:_ , Reagent lot Number: PT Normal Range (seconds) Mean (geometric) Normal value for ISI Date/ Signature Therapeutic Range Remedial Action: Reporting Abnormal results Refer to local guidelines for oral anticoagulants indications and duration of treatment. 1,4,6 See HE for reporting critical values and unexpected abnormal test values. Specific Performance Characteristics Precision: Within-run and total (run to run and day to day) precision was assessed over multiple runs using both normal and abnormal control samples. Page 155 of 391

156 Prothrombin Time-ACL Top Please refer to the appropriate package insert for precision study results. 1,4,6 Page 156 of 391

157 Prothrombin Time-ACL Top References 1. HemosIL RecombiPlasTin 2G (PN / ) package insert 2. ACL TOP Family On-Line Help Manual 3. Clinical and Laboratory Standards Institute. Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation and Molecular Hemostasis Assays; Approved Guideline - Fifth Edition, CLSI Document H21-A5; Vol. 28 No HemosIL PT-Fibrinogen HS PLUS (PN ) package insert 5. Clinical and Laboratory Standards Institute. One Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline Second Edition, CLSI Document H47-A2; Vol. 28 No HemosIL PT-Fibrinogen (PN ) package insert 7. Westgard JO, and Barry PL. Cost-Effective Quality Control: Managing the Quality and Productivity of Analytical Process, AACC Press Clinical and Laboratory Standards Institute.Preparation and Testing of Reagent Water in the Clinical Laboratory;Approved Guideline. Fourth,Edition, CLSI Document C3-A4;Vol.26 No.22 Page 157 of 391

158 Clinical Laboratory, Hematology Policy Number: HE Date Created: Not Set Document Owner: Patricia Turner (Laboratory Date Approved: Not Set Section Chief) Approvers: Board of Directors (Administration), David Hewitt (Pathology) Annunal Competency Review for CLS Printed copies are for reference only. Please refer to the electronic copy for the latest version. I. Annual Competency Review Clinical Laboratory Scientist assigned to the Hematology Section is required to complete the annual competency review. The review consist of three review sections. Section 1 Review of CAP - Kodacromes - Hematology Section 2 On-line competency and exams, MTS Lab Training Library Urine, Hematology, Coagulation, CSF, Serous, Synovial, Seminal Fluids Section 3 Procedure Manual Review and signature page II. Instruction A. Section 1: -Power Point Cell identification forhematology 1. Examine selected KodachromesPower Point cell identification program and identify the cell types or prominent elements. 2. Record results on answer sheet. 3. Reference manuals may be use. 4. Work Independently 4.5. Complete Competency Exercise; see Section Chief for current year s exercise. B. Section 2: Urinalysis (on-line competency) 1. Urinalysis a. Complete competency assessment. b. Print exam results, sign, date and include with evaluation forms. C. Section 3: Body Fluids (on-line competency) 1. Cerebrospinal 2. Serous 3. Synovial 4. Seminal a. Complete each competency assessment highlighted. b. Print exam results, sign, date and include with evaluation forms. D. Section 4: PPM Assessment 1. Complete PPM assessments. 2. Print exam results, sign, date and include with evaluation forms. Page 158 of 391

159 Annunal Competency Review for CLS 2 E. Section 5: Hematology and Coagulation (on-line competency) 1. Complete Hematology and Coagulation assessments. 2. Print exam results, sign, date and include with evaluation forms. F. Section 5: Procedure Manual Review 1. Review procedure manuals Hematology a. Hematology b. Urinalysis c. Coagulation d. Miscellaneous 2. Sign review documentation page in each procedure manual. III. Answer Sheet Section 1 CAP Kodachromes B. Signatures Staff Signature Date CLS Supervisor "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 159 of 391

160 Clinical Laboratory, Hematology Policy Number: HE Date Created: 06/01/2014 Document Owner: Patricia Turner (Laboratory Date Approved: Not Set Section Chief) Approvers: Board of Directors (Administration), David Hewitt (Pathology) D-Dimer HS ACL TOP 300 Printed copies are for reference only. Please refer to the electronic copy for the latest version. Purpose This procedure provides instructions for the analysis of D-Dimer using HemosIL D- Dimer HS on the ACL TOP Family. 1 Principles of the Procedure D-Dimer is contained in the soluble derivatives formed upon plasmin degradation of Factor XIIIa cross-linked fibrin (XDP). These soluble fibrin degradation products contain a neoantigen (D-Dimer domain), which is not present on the original fibrinogen molecule, its degradation products or on soluble fibrin. The D-Dimer HS Latex Reagent is a suspension of polystyrene latex particles of uniform size coated with the F(ab ) 2 fragment of a monoclonal antibody highly specific for the D-Dimer domain included in fibrin soluble derivatives. The use of the F(ab ) 2 fragment allows a more specific D-Dimer detection avoiding the interference of some endogenous factors like the Rheumatoid Factor. When plasma, which contains D-Dimer, is mixed with the Latex Reagent and the Reaction Buffer included in the D-Dimer kit, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of D-Dimer in the sample and is determined by measuring the decrease of the transmitted light caused by the aggregates (turbidimetric immunoassay). 1 Interpretation of Results The determination of D-Dimer is becoming a widespread tool for diagnosing thrombosis and monitoring thrombolytic therapy. Elevated levels of D-Dimer are found in clinical conditions such as deep vein thrombosis (DVT, pulmonary embolism (PE) and disseminated intravascular coagulation (DIC). D-Dimer levels also rise during the normal pregnancy but very high levels are associated with complications. A negative D-Dimer result when combined with a clinical assessment of low pretest probability has been shown to have a high negative predictive value for DVT or PE. D-Dimer results in human citrated plasma from IL Coagulation systems in conjunction with a clinical pretest probability (PTP) assessment model can exclude venous thromboembolism in outpatients suspected of deep venous thrombosis and pulmonary embolism. 1 While a positive D-Dimer alone is not diagnostic of DVT or PE, a negative D- Dimer can be used to exclude the diagnosis of venous thrombosis. There are a number of articles available that discuss the choice of cut-off value for ruling out venous thrombosis. 6 Page 160 of 391

161 D-Dimer HS ACL TOP Product Information The HemosIL D-Dimer HS kit (PN ) consists of: 1 Latex Reagent: 3 x 2 ml vials of a lyophilized suspension of polystyrene latex particles coated with F(ab ) 2 fragment of a mouse antibody (MA-8D3) directed against D-Dimer. The reagent contains bovine serum albumin, buffer, stabilizers and preservative. Reaction Buffer: 4 x 8 ml vials of phosphate buffer containing bovine serum albumin, stabilizers and preservative. D-Dimer Calibrator: 2 x 1 ml vials of a lyophilized solution of D-Dimer partially purified from human fibrin digested with human plasmin. It contains bovine serum albumin, buffer, stabilizers and preservative. The HemosIL D-Dimer (D-D) Controls kit (PN ) consists of: 2 Low D-D Control: 5 x 1 ml vials of a lyophilized solution of D-Dimer partially purified from human fibrin digested with human plasmin. The control contains bovine serum albumin, buffer, stabilizers and preservative. High D-D Control: 5 x 1 ml vials of a lyophilized solution of D-Dimer partially purified from human fibrin digested with human plasmin. The control contains bovine serum albumin, buffer, stabilizers and preservative. Materials Required But Not Provided The following are not supplied with the kit(s) and those required may be purchased separately: HemosIL D-Dimer Controls PN HemosIL Factor Diluent PN Reagent Preparation Latex Reagent: Dissolve the contents of each vial with 2 ml of CLSI CLR water or equivalent. 5 Replace the stopper and swirl gently. Ensure the complete reconstitution of the product. Keep the reagent at o C for 30 minutes and invert to mix before use. Do not shake. Reaction Buffer: Gently invert to mix before use. The reagent is ready for use. Do not shake. D-Dimer Calibrator: Dissolve the contents of each vial with 1 ml of CLSI CLR water or equivalent. 5 Replace the stopper and swirl gently. Make sure of the complete reconstitution of the product. Keep the reagent at o C for 30 minutes and invert to mix before use. Do not shake. Note: Avoid foam formation when homogenizing reconstituted reagents and calibrator. Bubbles on top of the liquids may interfere with the instruments liquid sensors. 1 D-Dimer Controls: Dissolve the contents of each vial with 1 ml of CLSI CLR water or equivalent. 5 Replace the stopper and swirl gently. Make sure of the complete reconstitution of the product. Keep the reagent at o C for 30 minutes Page 161 of 391

162 D-Dimer HS ACL TOP and invert to mix before use. Do not shake. 2 Reagent Storage and Stability Unopened reagents and calibrator are stable until the expiration date shown on the vial when stored at 2-8 o C. For optimum stability remove reagents from the system and store them at 2-8 o C in the original vial. Latex reagent is stable after reconstitution 1 month at 2-8 o C in the original vial or 4 days at 15 C on the ACL TOP Family. Do not freeze. Reaction Buffer is stable when opened 1 month at 2-8 o C in the original vial or 4 days 15 C on the ACL TOP Family. D-Dimer Calibrator is stable after reconstitution 3 days at o C, 1 month at 2-8 o C or 2 months at 20 o C in the original vial. Frozen Calibrator may be thawed at 37 o C and gently mixed before use. Do not refreeze. 1 D-Dimer Controls are stable after reconstitution 8 hours at C onboard ACL TOP Family, 1 month at 2-8 C or 2 months at 20 C in the original vial. Frozen controls may be thawed at 37 C and gently mixed before use. Do not refreeze. 2 Reagent, Calibrator, Control Storage To maximize stability of materials, store D-Dimer reagent, buffer and controls in 2-8 C refrigerator when not in use. Warnings and Precautions The Latex Reagent and the Reaction Buffer contains animal source material, therefore should be treated as potentially infectious. 1 Reaction Buffer: Safety Phrases: Avoid contact with skin and eyes In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. After contact with skin, wash immediately with plenty of water. Wear suitable protective clothing, gloves and eye/face protection). 1 The Calibrator contains human source material that product was tested and found nonreactive for Hepatitis B Surface Antigen (HbsAg), Anti-HCV and HIV (1 & 2) antibodies. Handle as if potentially infectious. 1 Please refer to the Material Safety Data Sheet for this product for more detailed safety information. Page 162 of 391

163 D-Dimer HS ACL TOP Specimen Collection and Preparation Nine parts of freshly drawn venous blood are collected into one part trisodium citrate. Refer to CLSI Document H21-A5 for further instructions on specimen collection, handling and storage. 4 Thaw frozen specimens rapidly at 37 o C and centrifuge plasma before testing. After thawing the assay must be performed within 2 hours. 1 Remedial Action for Unaccepted Samples See also HE for specimen rejection criteria. 1. Visual inspection of sample and clot detected. 2. Clot detected by applicator stick check. 3. Collection tube filled less than or greater than 10% of fill line 4. Specimen >4 hours, stored at room temperature, or plasma not frozen Limitations of the Procedure D-Dimer HS results are not affected by: Hemoglobin up to 500 mg/dl Bilirubin up to 18 mg/dl Triglycerides up to 1327 mg/dl Rheumatoid Factor up to 1400 IU/mL. 1 Calibration Details Calibration and storage of valid D-Dimer HS calibration curve are required to obtain D-Dimer HS results. Samples cannot be analyzed on the same run as the calibration curve. Calibration is performed: With a change of reagent lot numbers After major parts replacement To satisfy local regulatory requirements At laboratory discretion Method for Calibration (if necessary): 1. Define Materials if necessary (Setup, Material List). Select the appropriate materials from the Material List. 2. Add D-Dimer HS Latex, D-Dimer HS Buffer, D-Dimer HS Calibrator and Factor Diluent to the Materials Programming Window if necessary (Setup, Display, Materials Programming Window). 3. Define Results Units and Rerun Rules in the DD HS Test Definition if necessary (Setup, Test List, Test Code, Result Units and Rerun Rules). 4. Choose Setup, Materials List. 5. Double-click on the D-Dimer HS calibrator to open the Materials Definition screen. 6. Choose the Lot Specific Information tab and enter the Calibrator lot number and Expiration Date. 7. Enable Lot Management from the Lot Specific Information tab. 8. Select the Save icon to store the lot number. Once the lot number is saved, the Assign Values icon becomes available. 9. Select the Assign Values icon. 10. Enter the calibration value from the D-Dimer HS package insert. Press OK. 11. Choose the Previous Screen icon to exit. 12. Load the D-Dimer HS Latex, D-Dimer HS Buffer, D-Dimer HS Calibrator and Factor Diluent onto the ACL TOP Family instrument. 13. Select Calibration, Status List. 14. Double-click on the DDHS test code to open the Calibration Details screen. 15. Choose the Run icon. 16. Select OK at the Do you confirm the operation? prompt. 17. Choose the Previous Screen icon to exit. Page 163 of 391

164 D-Dimer HS ACL TOP Verify the Job Status for the DD HS test code says Active. 19. Once the calibration is complete, review calibration results. This calibration uses a spline curve fit, therefore there are no slope, intercept or r 2 values displayed. If the calibration is acceptable, choose the Validate icon to validate the calibration curve. 3 Quality Control Two levels of control are recommended for a complete quality control program. Low and High D-Dimer Controls are designed for this program. Each laboratory should establish its own mean and standard deviation and should establish a quality control program to monitor laboratory testing. Controls should be analyzed at least once every 8 hour shift in accordance with good laboratory practice. Refer to Westgard et al for identification and resolution of out-of-control situations. 7 QC Frequency at least once every 8 hour shift. Procedure 1. Create/Edit QC files, if necessary (Setup, QC List, Test Code, to allow access to the QC Definition Screen). 2. Add D-Dimer HS test code (DDHS) to the Test/Profiles Programming Window, if necessary (Setup, Display Test Programming Window). 3. Load D-Dimer HS Latex, D-Dimer HS Buffer and Factor Diluent materials onto the ACL TOP Family instrument. 4. Calibrate, if necessary (see calibration section of this procedure). 5. Place QC materials with the barcodes facing out in a Diluent Rack and load onto the ACL TOP Family instrument in a Diluent track. (If running the QC from the sample rack refer to Quality Control Performing a QC Test in the ACL TOP On-Line Help Manual) 6. Choose QC from the Main Menu and select Test Status List. 7. Double-click on D-Dimer HS (DDHS) test code to reveal the Test Materials Definition tree. 8. Select any D-Dimer HS QC Control and choose the Program QC icon. This will run all QC levels for that test. 9. Place sample tubes in a sample rack with barcodes facing outwards. 10. Select an available sample track and load the sample rack when the barcode reader is in position. 11. Verify the samples have been identified and have a test ordered. If not, program the sample ID manually and/or order the test manually from the test and programming window. 12. Choose the Run icon if the ACL TOP Family instrument is not currently running. 13. For instructions on loading samples without barcodes or LIS, please refer to Samples Analysis, Managing Patient Samples, Programming Bar Coded Samples and Programming Non-Bar Coded Samples in the ACL TOP Family On-Line Help Manual. 3 Remedial Action for Unaccepted Quality Control Results See HE for out of control values and corrective action instructions. Calibrated D-Dimer HS results are reported in ng/ml. Refer to the ACL TOP On- Page 164 of 391

165 D-Dimer HS ACL TOP Results Line Help Manual for additional information. 3 Note: Due to the lack of an International Reference Standard some manufacturers express D-Dimer results in FEU (Fibrinogen Equivalent Unit). The equivalence between these two measurement units is approximately 2 FEU ~ 1 ng/ml. 1 Refer to D-Dimer HS reagent package insert for more details on assay performance and cutoff value. 1 Expected Values A normal range study was performed using 234 (N) individual blood bank donor samples. Reportable Range: <200 ng/ml to >5250 ng/ml Reportable Range: <200 ng/ml to >5250 ng/ml System N Upper Normal Range (units) ACL TOP Family (ng/ml) Due to many variables, which may affect results (including the population age); each laboratory should establish its own normal range. The assay results should be used with other information, including the clinical context, in forming a diagnosis. 1 Remedial Action: Reporting Abnormal results See HE for reporting critical values and unexpected abnormal test values. Specific Performance Characteristics Precision: Within-run and total (run to run and day to day) precision was assessed over multiple runs using both normal pool and abnormal control samples. Please refer to the package insert for precision study results. 1 Detection limit: ACL TOP Family 21 ng/ml Linearity: System Auto Rerun Off Auto Rerun On ACL TOP Family 150-3,680 ng/ml ,000 ng/ml When the rerun capability of the instrument is activated, the instrument makes an on-board dilution and corrects the final result for the dilution factor thereby expanding the test range to 69,000 ng/ml. If the result still exceeds the expanded range, i.e. samples reporting above 69,000 ng/ml, then the sample should be manually diluted 1:100 with Factor diluent (20 µl of sample µl of Factor diluent) and reassayed in the standard assay. The result in ng/ml must be multiplied by 100 to correct for the dilution. The assay does not show prozone effect up to 197,000 ng/ml. Refer to D-Dimer HS reagent package insert for more details on assay performance and cutoff value. 1 Page 165 of 391

166 D-Dimer HS ACL TOP References 1. HemosIL D-Dimer HS package insert 2. HemosIL D-Dimer Controls package insert 3. ACL TOP Family On-Line Help Manual 4. Clinical and Laboratory Standards Institute. Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation and Molecular Hemostasis Assays; Approved Guideline - Fifth Edition, CLSI Document H21-A5; Vol. 28 No Reference Clinical and Laboratory Standards Institute.Preparation and Testing of Reagent Water in the Clinical Laboratory;Approved Guideline. Fourth,Edition, CLSI Document C3-A4;Vol.26 No Westgard JO, and Barry PL. Cost-Effective Quality Control; Managing the Quality and Productivity of Analytical Process, AACC Press, 1986 Page 166 of 391

167 Hematology Policy Number: HE Date Created: 06/05/2017 Document Owner: Patricia Turner (Laboratory Date Approved: Not Set Section Chief) Approvers: Board of Directors (Administration), Cindy Moccio (Board Clerk/Exec Assist-CEO), David Hewitt (Pathology) Iris Automated Urinalysis, iq 200 and ichem Velocity Printed copies are for reference only. Please refer to the electronic copy for the latest version. Iris Automated Urinalysis: iricell Procedure SW version 7.0 Template (North American) Page 3 Purpose Overview Topic 3-4 Materials Reagents Supplies Equipment 5 Sample Information: [Patient Preparation, Specimen Type, Specimen Rejection Criteria, Specimen Volume, Specimen Handling/Transport, Specimen Stability] Safety Precautions 6 Quality Control 7 Running QC: ichemvelocity analyzer 8 Running QC: iq200 analyzer 9 Preparing Patient Specimens Logging on to the System 10 Enabling Edit-Free Release and Setting the Particle Verification Range (PVR) 11 Enabling Auto-Release Exceptions 12 Operating the iricell System Locating Auto-Released results Performing On-Screen Verification of Results Assaying Diluted Specimens Performing a Search 18 Creating a Consolidated Patient Report 19 Creating a Urine Culture Candidates Report Creating a No Urine Culture Indicators Observed Report 20 Accessing Consumables Traceability Handling an Expired Consumables Alarm 21 Changing the lot number and expiration date of Chemistry QC Page 167 of 391

168 Iris Automated Urinalysis, iq 200 and ichem Velocity 2 Utilizing the HELP menu Enabling and Disabling Automatic Bacteria Grading 22 Restoring Settings Saving and ing Settings Enabling the Detailed Audit Trail Page 168 of 391

169 Iris Automated Urinalysis, iq 200 and ichem Velocity 3 Overview continued Page Interpretation/Results/Alert values Topic Reference Intervals Supplemental Material 27 Method Performance Specifications Result Reporting References Related Procedures Appendices Appendix A: Theory of Operation and Principle Appendix B: Clinical Significance of Urine Chemistry Results Appendix C: Limitations and Interferences Appendix D: Expected Results Page 169 of 391

170 Iris Automated Urinalysis, iq 200 and ichem Velocity 4 Iris Automated Urinalysis: iricell Procedure SW version 7.0 Procedure (North American) Purpose This procedure template provides instructions for the Iris Automated Urinalysis: iricell. NOTE: The following procedure template is designed to assist laboratories in developing their own working laboratory procedure. This procedure template does not supersede the Operator s Manual or product inserts. Areas requiring facility-specific input are bolded, underlined and are preceded by XXX. Search for XXX using the Find function: o Click on Edit. o o Choose Find from the dropdown menu or Choose Ctrl+F. Type XXX into the box next to Find and click on Find Next. The program will take you to the first XXX. o Edit the section to insert the information specific to your facility s laboratory. Materials/ Consumables and Equipment Part Number ichemvelocity Consumables ichemvelocity Strips [ ] ichem Wash Solution and Wash Filter [ ] IRISpec CA/CB/CC [ ] ichemvelocity CalChek Kit: Strips [ ] ichemvelocity CalChek Kit: Reagents [ ] Storage Room temperature. Stable unopened until expiration date on bottle. Open vial stability=5 days Room temperature. Stable unopened until expiration date on bottle. Open bottle stability=3 months Refrigerate 2-8 C. Unopened stability= date on bottle. Bring poured aliquot to room temperature before use. Open stability= 15 days. Record open and expiration date on bottle. Room temperature Stable unopened until expiration date on bottle. Open stability=calchek strips are single use only. Room temperature Stable unopened until expiration date on bottle. Open tube stability=8 hours Packaging and Use Bottle of 100 strips; 1 each. Use daily. 4 bottles/case; 5.5ml/test. Use daily. 9 bottles (3 bottles of each control); 2 ml of each per day. Use daily. 2 vials/kit; 1 vial /quarter; single use. Use quarterly. 2 sets/kit; 1 set/quarter; single use. Use quarterly. Materials/ Equipment iq200 Consumables Consumables Part Number and Storage Packaging and Use Page 170 of 391

171 Iris Automated Urinalysis, iq 200 and ichem Velocity 5 IQ Lamina [ ] Iris System Cleanser [ ] Iris Diluent [ ] iq Calibrator [ ] iq Control/Focus Set [ ] Dilution Code labels [ ] 16x100mm polystyrene tubes [ ] or polystyrene plastic tubes Room temperature. Unopened stability= date on bottle. Change filter when replacing first bottle from a new case of 4. Room temperature Unopened stability= date on bottle. Room temperature Unopened stability= date on bottle. Refrigerate 2-8 C. Unopened stability= date on bottle. Open bottle stability=24 hours Refrigerate 2-8 C. Unopened stability= date on bottle. Open bottle stability=30 days N/A N/A 4 bottles/cs; 7000 ml/bottle; 14mL/test. Use daily. 4 bottles/cs 475 ml/bottle; 3ml/test. Use daily. 4 bottles/cs 475 ml/bottle; 3 ml/test. Use daily. 4 bottles/cs 125 ml/bottle; 2ml/test. Use monthly. 1 bottle ea Pos/Neg; 2 bottles of Focus; 125 ml/bottle; Lot-specific Barcodes: Positive control, Negative control; Focus reagent; 3ml of Control/test; 6 ml of Focus/test. Use daily. 1 set; 1 each /test as needed. Use as needed. Box of 200; 1 each/test. Use daily. Sample Patient Preparation: Give patient instructions to collect a clean catch urine specimen in a clean and/or sterile container. Specimen Type: A freshly voided urine sample collected by the clean catch method is the specimen of choice. First morning urine yields the most meaningful results. A clean catch urine is recommended to prevent the possibility of a positive leukocyte test Page 171 of 391

172 Iris Automated Urinalysis, iq 200 and ichem Velocity 6 caused by leukocytes external to the renal-urinary system. Specimen Rejection Criteria: Reject grossly bloody specimens for the ichemvelocity chemistry analysis; dilute grossly bloody specimens for iq200 microscopy analysis. Reject gray top tubes, mislabeled specimens, improperly stored specimens. Specimen Volume: The specimen volume placed on the iricell must be at least 4 ml. If testing on the ichemvelocity urine chemistry analyzer alone, the minimum volume is 2 ml. If testing on the iq200 urine microscopy analyzer alone, the minimum volume is 3 ml. Specimen Handling/Transport: Specimens should be delivered to the laboratory as soon as possible after collection. Do not add disinfectant or detergent to the specimen. Do not centrifuge the specimen. Specimen Stability: Urines, kept at room temperature, are stable for one hour. If the specimen is not processed within one hour after collection, cap the container tightly and store at 2-8 C. Specimens must be at or brought to room temperature before analysis. Urines that are refrigerated are stable for 12 hours. Special safety precautions Use Universal Precautions due to the potential presence of pathogenic material. Page 172 of 391

173 Iris Automated Urinalysis, iq 200 and ichem Velocity 7 Quality Control Assay QC once every 24 hours for both chemistry and microscopy modules. QC material for microscopy module: iq Positive Control iq Negative Control iq Focus reagent. QC material for chemistry module: IRISpec CA/CB/CC controls Dipsticks: Sticks are checked for reactivity and accuracy once every 24 hours by running the CA/CB/CC control material. Test control material additionally when a new shipment/new lot number of ichemvelocity test strips is received. Parallel testing between the old shipment or lot number and the new shipment or lot number ensures that the system is operating within acceptable criteria. Upper limits, lower limits and target values are encoded within the lot-specific barcodes for the Positive, Negative and Focus iq control material. Criteria for Acceptable Control Results: o Quality control material results must fall within the ranges provided by the manufacturer of the material. o Refer to the section below for corrective action(s) if the values fall outside of the published limits. Note: The system will lock out patient testing for microscopy when microscopy controls fail and patient testing for chemistry when chemistry controls fail. Running QC: ichemvelocity system Follow the activities in the table below to run QC on the ichemvelocity. Before you begin Make sure that only unexpired reagents are used Expired reagents will cause an ALARM Step Action Page 173 of 391

174 Iris Automated Urinalysis, iq 200 and ichem Velocity 8 1 Remove an ichemvelocity control rack. Pour 2 ml of the CA, CB and CC control into 3 separate 16x100mm glass (or polystyrene plastic) tubes. Return tightly capped controls to the refrigerator immediately. Allow aliquots to warm to room temperature. Use aliquots within one hour of pouring. 2 Place the CA control in position 8. [color coded on bottle and tube position as RED] Place the CB control in position 9. [color coded on bottle and tube position as BLUE] Place the CC control in position 10. [color coded on bottle and tube position as YELLOW] 3 Place the rack on the right side of the ichemvelocity sampler touching the edge nearest the operator. Note: The rack will automatically advance forward [blue MEASURE light will appear]. 4 Control results will automatically print on the Quality Review screen as CA, CB and CC. 5 Look at QC results. If Then QC Failed Look at the result printout to see why the control failed. Adjust positions, if necessary. Re-pour and re-run all controls. If results are still not acceptable check strips loaded in instrument for discoloration. If discolored, discard and add new strips and repeat. If results are still not acceptable, notify your local distributor, your Iris Product Specialist or Iris Clinical Support. See also HE for Out of Control procedure. Running QC: iq200 analyzer. Follow the activities in the table below to Run QC on the iq200 analyzer. Before you begin If control is refrigerated, bring control set to room temperature before use. Make sure that only unexpired reagents are used Expired reagents will cause an ALARM Step Action 1 Place appropriate barcode labels on 16x100mm glass (or polystyrene plastic) tubes [Positive, Negative, Focus]. Mix iq Positive control and iq Focus by holding the bottle upside down and giving five hard sharp shakes followed by five gentle inversions. Page 174 of 391

175 Iris Automated Urinalysis, iq 200 and ichem Velocity 9 2 Pour the following into 16x100 mm glass (or polystyrene plastic) tubes and place in the iq200 QC rack: Position 1: 3ml of Iris Cleanser Position 2: 3ml of Iris Diluent Position 3: 3ml of Iris Diluent Position 4: Leave Empty Position 5: 6 ml of Focus reagent Position 6: 3 ml of Positive Control Position 7: 3 ml of Negative Control Control rack must be run immediately after pouring focus and controls. 3 Place the rack on the iq200 sampler. Press the START button located at the upper left corner of the iq200, if the instrument is in the standby mode (green light). o If in measure mode (blue light), the rack will be detected and processed automatically. 4 Review results under: Quality Review screen QC Statistics If Then QC Failed Look at message code to see why the control failed. Note: If control failed due to an identification error or QC out of order, resolve this error. Pour fresh aliquots and re-run control. If results are still not acceptable, notify Iris Clinical Support. See HE for Out of Control procedure. Preparing Patient Specimens: Follow the activities in the table below to Prepare Patient Specimens Step Action 1 Bring Samples to room temperature 2 Label an empty 16 x100mm glass tube (or polystyrene plastic) with patient identifier. Apply the barcode to the tube so that the start of the barcode (not the label edge) is approximately ½ inches from the top of the tube. Note: This leaves room for the dilution label should it be required. 3 Mix sample thoroughly by inversion. 4 Pour 4ml of well-mixed specimen into labeled tube. 5 Put the sample tube in position number 1 on the sample rack Note: The rack s black barcode should be facing to the right. The tube s barcode should face the instrument. 6 Load up to 10 samples in each rack in consecutive positions. Page 175 of 391

176 Iris Automated Urinalysis, iq 200 and ichem Velocity 10 Logging on to the iricell: Follow the activities in the table below to Log on to the iricell: Step Action 1 Access the Instrument Screen. Click on the Logon button. 2 Click on the down arrow. Select your identifier (Do Not type in your identifier). Press tab. 3 Enter your password. 4 Click on OK. Note: The current user s name will now appear at the top of the Instrument screen. Enabling Edit-Free Release and Setting the Particle Verification Range (PVR) Follow the activities in the table below to Enable Edit-Free Release and Set the Particle Verification Range (PVR). Before you Begin It is recommended to consult with an Iris Product Specialist or Clinical and Customer Care Specialist before altering a setting. Step Action 1 Access the Instrument Screen Click on the Logon button. Log on as a Manager 2 Go OFF LINE Click YES at the Confirm window 3 Select SETTINGS 4 Select Urine Auto-Release 5 Select Enable Auto-Release Note: The following will also be automatically enabled: (1) Enable Automatic Bacteria Grading [Enabled to allow automatic bacteria grading] (2) Review When Linearity is Exceeded [Enabled to prompt user to review any images exceeding manufacturer s linearity] 6 If Automatic Bacteria Grading is not desired, uncheck the box If Review when linearity is exceeded is not desired, uncheck this box 7 User-defined Abnormal Thresholds will automatically populate in the PVR box. Enter the Minimum and Maximum Ranges for RBC s, SQEPS and WBC s. Page 176 of 391

177 Iris Automated Urinalysis, iq 200 and ichem Velocity 11 8 Enter any user-defined exceptions to Auto-Release under Exceptions [Refer to Enabling Auto-Release Exceptions] Enabling Auto-Release Exceptions Follow the activities in the table below to Enable Auto-Release Exceptions Before you Begin Suggested Auto-Release criteria are listed in Appendix E of this procedure. The Auto-Release function is suggested for specimen results falling below the abnormal threshold (normal or negative). It is recommended to consult with an Iris Product Specialist or Clinical and Customer Care Specialist before altering a setting. Step Action 1 Access the Instrument Screen Click on the Logon button. Log on as a Manager 2 Go OFF LINE Click YES at the Confirm window 3 Select SETTINGS 4 Select Urine Auto-Release 5 Enable Auto-Release Exceptions by selecting the Enable this screen checkbox [Note 10 screens are available for 10 different sets of exception criteria] 6 Choose appropriate column to set up auto-release exception criteria [Prevent Auto-Release if all selected particles are greater than zero or Prevent Auto- Release if any checked particle exceeds its threshold.] Note: The user-defined abnormal threshold is commonly selected for the value entered in the threshold window. Choose the demographic group [Location or Age]to whom the Auto-Release Exceptions criteria will apply 7 Press OK [Note: Press Next if more criteria will be entered] 8 Press OK again to return to the Instrument screen Note: Specimens not meeting the criteria to prevent auto-release will be autoreleased and will be found on the Found List [Exception: Flagged specimens will display on the Work List]. Page 177 of 391

178 Iris Automated Urinalysis, iq 200 and ichem Velocity 12 Operating the iricell System Before You Begin Follow the activities in the table below to Operate the iricell System Each iricell System will be set up with parameters that are unique to each facility. For facilities that report out Sperm, it is recommended to enable the optional Sperm Present and/or Previous Sample Had Sperm Flags. For those who do not report out Sperm, it is recommended to set the Minimum to Auto- Classify to prevent automatic classification. For both activities, refer to the iq200 Operator s Manual, your local distributor, your Iris Product Specialist, your Clinical and Customer Care Specialist or the Iris Diagnostics Call Solutions Center. Step Action 1 Ensure that sufficient supplies and consumables are loaded. 2 Load up to 10 samples in each rack in consecutive positions. 3 Place rack(s) on right hand side of the ichemvelocity. Ensure that the notch of the rack base is placed onto the Sampler track ridge. Note: The instrument will automatically advance the rack. 4 REMAINDER OF THE PROCESSING IS PERFORMED AUTOMATICALLY ON THE SYSTEM: 1. The sample rack will be moved along the sample transport tray to the barcode reader. 2. After the barcode is read, the probe mixes the sample, aspirates an aliquot, analyzes the SG, color, clarity and dispenses the sample onto a test strip. 3. When the sample processing is complete, the sample rack will be automatically transferred, via the bridge, to the iq200 Analyzer. 4. If the specimen does not need to be run on the iq200 Analyzer, remove the rack from the instrument at this point. If the rack is to be run on the iq200 Analyzer, allow the rack to transfer across the bridge. 5. After the rack is transferred via the bridge to the iq200 Analyzer, the sample rack will be moved along the iq200 Sampler to the barcode reader. 6. The iq200 Analyzer barcode reader reads the specimen barcode. 7. If a microscopic examination is to be done (as determined by the userdefined criteria), the probe will mix the sample, aspirate an aliquot and perform the microscopic examination. If a microscopic examination is not to be performed, the tube will be passed. 8. After sample processing is complete, unload the sample racks from the left side of the iq200 Analyzer. Page 178 of 391

179 Iris Automated Urinalysis, iq 200 and ichem Velocity 13 5 Note: Completed, auto-released results will appear on the Found List. Verify any pending, flagged results on the Work List as follows in next section of this document. Locating Autoreleased Results Follow the activities in the table below to Locating Autoreleased Results Note: The majority of results will have been auto-released. Results can be printed to the printer, the LIS or the screen Step Action 1 Click on the Search button to access the Found List 2 Specimens results will appear as user defined. 3 No further action is necessary Performing On-Screen Follow the activities in the table below for Performing On-Screen Verification of Results Verification of Results Note: If the auto-release feature has been enabled, the majority of results will have been auto-released. Verify results only for those specimens not auto-released [i.e. specimens appearing on the Work List]. Verify only Yellow-colored categories Verify using FULL EDIT Before You Begin Green and Red colored categories will be autoreleased Yellow categories require on-screen review Step Action 1 Click on the Work List button located on the top right part of the instrument screen to bring up all unreleased samples. Note: Samples may be sorted by Specimen ID, Date-Time, Rack/Pos or Status by header at the top of the row. (Clicking a second time will reverse the order.) 2 Highlight the specimen to be verified as follows: Click on Specimen Identifier: Click on the Specimen button. Verify consolidated Chemistry and Microscopy results. 3 Clear flags that are displayed before results are verified or deleted as follows: To Review Flagged Specimen: o Click Review Flagged Specimen button. o Click Accept. To Delete Specimen results (if the result must be discarded): o Click Delete Flagged Specimen button. o Click Accept. Continued on next page Page 179 of 391

180 Iris Automated Urinalysis, iq 200 and ichem Velocity 14 Performing On-Screen Verification of Results continued Step Action continued 4 Verify auto-classified particles as follows: Click on Edit Note: You will be directed to the first yellow particle category If Then The classification of the Continue the verification by clicking on the particle is acceptable, right arrow to move forward. The classification is not acceptable, Note: The Yellow category will appear. Reclassify the misidentified particle(s) as follows: Determine whether or not reclassification will make a clinical difference. Reclassify particles only when it will make a clinical difference. Click on the particle type that the image(s) should be classified into (use right-hand button). Click on the image(s) to be moved. Press the forward arrow to proceed to the next category. Note: If all images of a category are misclassified, click on the particle type and then click on the right arrow to move to the next category. 5 Press ACCEPT to release the results when verification is complete. 6 Return to the microscope for the following: Oval fat bodies (to view using polarized light) Fat (to view using polarized light) Trichomonas (to observe motility) Cellular Casts (only necessary when the operator cannot make a definite identification of the cell type using the iq) Assaying Diluted Specimens Follow the activities in the table below to Assay Diluted Specimens Page 180 of 391

181 Iris Automated Urinalysis, iq 200 and ichem Velocity 15 Before you Begin Dilutions must be prepared for the iq for the following specimens: Grossly bloody Mucoid Dense/Viscous Short Samples Note: Dilutions are run on the iq200 urine microscopy analyzer only Do Not perform dilutions for the ichemvelocity urine chemistry analyzer. Identify specimens that require a dilution before placing specimen on the iricell. Step Action 1 Select dilution and corresponding dilution code (refer to Dilutions under Formed Particles or Fluid Type under Settings on the Instrument Screen). If Then You have barcodes Obtain a Dilution Rack Fix identical patient barcode onto two unlabeled tubes. Pour 3 ml urine into the first tube. Place the tube in the dilution rack and run on the Chemistry analyzer. Note: The rack will proceed to the iq, but will not be aspirated. Remove the rack from the Chemistry analyzer. Label the matching second tube with the appropriate secondary barcode dilution label (fix label below the patient barcode). Prepare the dilution, in this tube, using Iris Diluent. Replace the undiluted sample that was used for the Chemistry analyzer with the diluted tube and place the specimen into a patient rack. Put rack on the iq analyzer Press START to run the sample. Results will consolidate. If auto-release has been enabled, results will auto-release as the user has defined, unless flagged. Verify results only for non-autoreleased samples (refer to previous sections of this document). Page 181 of 391

182 Iris Automated Urinalysis, iq 200 and ichem Velocity 16 Assaying Diluted Specimens continued If continued You do not have barcodes Then continued Obtain a dilution rack Click on Manual Orders Choose the patient rack and position number that will be used to run the assay. Identify the specimen ID, select URN, Dilution code and Work order=run. Put the sample into the correct position in Dilution rack number 23. Pour 3 ml urine into the corresponding unlabelled tube. Place rack on the right hand side of the Chemistry analyzer and run. [Note: the Dilution rack will not be aspirated by the iq] The Chemistry Result will be displayed as ID_ERROR. After Chemistry has completed, remove rack. Perform appropriate dilution. Place the diluted sample in the patient rack and position number that was programmed [refer to second bullet). Place the rack on the iq analyzer. Press START to run the sample. Consolidate results. If auto-release has been enabled, results will auto-release, as the user has defined, unless flagged. Verify results only for non-autoreleased samples (refer to previous sections of this document). Performing a Search Follow the activities in the table below to Perform a Search. Step Action 1 Access the Work List List Select SEARCH Page 182 of 391

183 Iris Automated Urinalysis, iq 200 and ichem Velocity 17 2 Clear all previous entries by Clicking Clear. To Search by Then Specimen ID Enter specimen identifier Press OK Sequence number Enter desired Sequence number Press OK Operator Enter Operator Log-in ID Press OK Date and Time Enter the specific date and time Press OK 24 hours Select 24 hours Press OK Today Select Today Press OK Lot Select Lot number Select specific lot from lots displayed Select OK [Note: This function enables the user to search for Results Tied to a Specific Lot number] Last Name Enter the Last Name or range of last names. Press OK First Name Enter First Name or range of first names. Press OK Age Enter in the specific age expressed in decimals (For example: 10 years and 5 months is entered as 10 and 5/12=10.42) Press OK Continued on next page Page 183 of 391

184 Iris Automated Urinalysis, iq 200 and ichem Velocity 18 Performing a Search Step Action continued Location Enter Location Press OK Note: Location must match the LIS entry exactly. Urine Additional Criteria Enter Urine Culture Candidates or No Urine Culture Indicators Observed. Press OK Specimens awaiting transmission Check Show Specimens Awaiting Transmission Only and only these specimens will appear Press OK. Released specimens Check Show Released Specimens Only and only released specimens will appear. Press OK Note: Imported images appear as Released specimens. Incomplete Specimens Check Show Incomplete Specimens Only and only incomplete or specimens in progress will appear. Press OK Creating a Consolidated Patient Result Report Follow the activities in the table below to Create a Consolidated Patient Result Report. Step Action 1 Perform a Search using desired criteria (as directed above) 2 Access the Found List 3 Click on RE-REPORT 4 Go to the Section listed All Rows 5 Click on Consolidated Report 6 Go to Destination section and Select Screen and/ or Printer 7 Click OK. Note: A Consolidated report will appear. This report is not sent to the LIS. Creating a Urine Culture Candidates Report Follow the activities in the table below to Create a Urine Culture Candidates Report Step Action 1 Make certain that ASP is set properly. Refer to Setting ASP section below. 2 Perform a Search for Urine Additional criteria as indicated above selecting Urine Culture Candidates. Page 184 of 391

185 Iris Automated Urinalysis, iq 200 and ichem Velocity 19 3 Access the Found List 4 Click on RE-REPORT 5 Go to the Section listed All Rows 6 Click on Urine Culture Candidates Report 7 Go to Destination section and Select Screen and/ or Printer 8 Click OK. Note: A Urine Culture Candidates report will appear. This report is not sent to the LIS. Creating a No Urine Culture Indicators Observed Report Follow the activities in the table below to Create a No Urine Culture Indicators Observed Report Step Action 1 Make certain that ASP is set properly. Refer to Setting ASP section below. 2 Perform a Search for Urine Additional criteria as indicated above selecting No Urine Culture Candidates Observed. 3 Access the Found List 4 Click on RE-REPORT 5 Go to the Section listed All Rows 6 Click on No Urine Culture Candidates Observed Report 7 Go to Destination section and Select Screen and/ or Printer 8 Click OK. Note: A No Urine Culture Indicators Observed report will appear. This report is not sent to the LIS. Accessing Consumables Traceability Follow the activities in the table below to Access Consumables Traceability Step Action 1 Log in as Manager 2 Go OFFLINE 3 Access Consumables 4 Select Traceability 5 View all reagents that have been automatically entered by the reagent s barcode 6 Manually enter reagents that do not have barcodes as follows: Enter Reagent expiration date, start date, etc. Select ADD Select Update Page 185 of 391

186 Iris Automated Urinalysis, iq 200 and ichem Velocity 20 7 Delete manually entered reagents as follows: Enter a Deletion Comment Select Update Note: The reagent will not disappear completely but will be removed from the queue. Handling an Expired Consumables Alarm Before you begin Follow the activities in the table below to Handle an Expired Consumables Alarm If an expired reagent or strip is run on the instrument, a red alarm will appear. Step Action 1 If the alarm indicates that an expired Chemistry control or strip was run: Check under Chemistry QC to make certain that the correct information has been added. Correct information if incorrect (refer to Changing the lot number and expiration date of Chemistry QC) Re-run control or strip 2 If the alarm was due to another consumable: o Obtain an unexpired consumable o Re-run Changing the lot number and expiration date of Chemistry QC Follow the activities in the table below to Change the lot number and expiration date of Chemistry QC Step Action 1 Select Consumables 2 Select Chemistry QC 3 Enter Strip lot and Expiration date listed on the urine chemistry strips 5 Select Next 6 Enter Chemistry control CA lot and expiration date listed on the reagent box 7 Select Next 8 Enter Chemistry control CB lot and expiration date listed on the reagent box 9 Select Next 10 Enter Chemistry control CC lot and expiration date listed on the reagent box 11 Select OK Utilizing the HELP menu Follow the activities in the table below to Utilize the HELP menu Step Action Page 186 of 391

187 Iris Automated Urinalysis, iq 200 and ichem Velocity 21 1 Access Instrument Screen 2 Select? icon 3 Operator s Manual will appear as a PDF 5 Click on PDF to open the manual 6 Find topic desired and click on Table of Contents Note: The operator will be directed to the appropriate section Enabling Automatic Bacteria Grading Follow the activities in the table below to Enable Automatic Bacteria Grading Step Action 1 Log-in as a Manager 2 Access SETTINGS 3 Access Urine Auto Release 4 Select Enable Auto release 5 Enable Automatic Bacteria Grading will automatically be enabled Restoring Settings Follow the activities in the table below to Restore Settings Step Action 1 Log on as a Manager 2 Select SETTINGS 3 Select View Log 4 Select Restore to Restore settings from a user-defined location or device [ex: USB] 5 Select Restore to Restore settings to a user-defined location or device [ex: USB] Saving and ing Settings Follow the activities in the table below to Save and Settings Step Action 1 Log on as a Manager 2 GO OFFLINE 3 Select SETTINGS 4 Select View Log 5 Select SAVE AS 6 Name file to desired location [ex: Desktop] Note: File will be saved as a.slf file 7 Click SAVE 8 Access the file under which the file was saved 9 Right click and rename the file with a.xml extension Page 187 of 391

188 Iris Automated Urinalysis, iq 200 and ichem Velocity the file to Global Service for troubleshooting in this format Enabling the Detailed Audit Trail Before You Begin Follow the activities in the table below to Enable the Detailed Audit Trail Note: The detailed Audit Trail will capture any change made to the system and record the name of the Operator who made the changes Enabling this function required to Edit Chemistry results Do Not Enable this Option without consulting with an Iris Product Specialist or Clinical and Customer Care Specialist before altering a setting. Step Action 1 Log on as a Manager 2 GO OFFLINE 3 Select SETTINGS 4 Select Specimen 5 Check Enable Detailed Audit Trail Adding Signature line to patient report Follow the activities in the table below to Add Signature line to patient report Step Action 1 Log on as a Manager 2 GO OFFLINE 3 Select SETTINGS 4 Access Laboratory Information 5 Add text to be displayed on the patient report [Ex: Signature line or Approved by] Note: The patient report or any re-reported patient report will include the selected message. Calculations None Page 188 of 391

189 Iris Automated Urinalysis, iq 200 and ichem Velocity 23 Interpretation/ Results/Alert values INTERPRETATION OF RESULTS: Glucose, protein, and ketones are reported semi-quantitatively as whole number, e.g. 10,50,200, etc mg/dl Bilirubin is reported semi-quantitatively as negative, negative, trace, small, moderate, large. Leukocytes are reported as a value negative, small, moderate, large. Urobilinogen is reported semi-quantitatively as mg/dl ph is reported in quantitative units. Blood is reported semi-quantitatively as negative, trace, small, moderate, large. Nitrite is reported semi-quantitatively as negative or positive. Specific Gravity is reported by refractive index quantitatively with a value to 3 decimal places, ranging from to >1.060 in increments. Clarity is reported as clear, hazy or turbid. These can be changed to meet the laboratory terminology. Color is reported as a color: colorless, yellow, orange, brown, red, violet, blue, green and Other by the ichemvelocity. Each color is also reported as light and dark. CLS must visually confirm the color. Color may be changed in LIS to reflect a pink or amber colored specimen. Grossly bloody specimen should be centrifuged and the supernatant tested manually on the Clinitk Status + instrument. The specemen can then be diluted and run on the iq200 to obtain microscopy result. Perform dilutions with Iris Diluent. 1?2 dilution on specimens containing <3ml. 1:5 dilution on specimens that are slightly cloudy. 1:10 dilution on cloudy and/or bloody specimens. If the diluted specimen is still cloudy, perform a manual microscopic review on the specimen to verify results. See Manual Microscopic Examination of Urine procedure if manual microscopic is necessary, HE Substances that cause abnormal urine color may affect the readability of test pads on urinalysis reagent strips. These substances include visible levels of blood or bilirubin and drugs containing dyes (e.g. Pyridium, Azo Gantrisin, Azo Ganatol), nitrofurantoin, or riboflavin. When interference is suspected add the $CI comment test may be invalid due to color interference to result in LIS. RBCs and WBCs are reported as cells per HPF. WBC clumps are reported reported qualitatively as few, moderate, many. Renal, transitional, and cells are enumerated per HPF. Squamous epithelial cells are reported reported per LPF. Bacteria are usually reported reported qualitatively as few, moderate, many. Page 189 of 391

190 Iris Automated Urinalysis, iq 200 and ichem Velocity 24 Interpretation/ Results/Alert values Continued Crystals are reported reported qualitatively, per HPF, as occ, few, moderate, many. All casts are reported by type and enumerated per LPF. Yeast is reported as present, per HPF. NOTES: 1. Iris recommends confirming any suspicious Sperm result that may have medicolegal implications by manual microscopy of the original specimen. 2. Manual microscopy will be performed on urines with: 1) Protein result => 300, to check for presence of oval fat bodies. Spin sample, examine sediment on glass slide with coverslip, check for refractile, polarized maltese cross elements 2) or when trichomonas is suspected (to observe motility), 3) or to confirm identification of cellular casts. 3. Confirmatory testing of Specific gravity <1.005 or >1.045 may be performed, using refractometer. 4. Analytical Measurement Range: ph measured from 5.0 to 9.0 in 0.5 increments; Specific Gravity is measured from to 1.045; microscopic particles (e.g. WBC and RBC) are measured from 0-185/HPF. Page 190 of 391

191 Iris Automated Urinalysis, iq 200 and ichem Velocity 25 Reference Intervals 1. Chemistry Results Specific Gravity ph Leukocyte Esterase Neg Nitrite Neg Protein, Qualitative Neg Glucose 0 mg/dl Ketones 0 mg/dl Urobilinogen <2 mg/dl Bilirubin 0 mg/dl Blood 0 mg/dl Color Colorless or Yellow Clarity Clear 2. Microscopy Results WBC F 0-5, M 0-3HPF RBC F 0-4 M 0-3/HPF Bacteria None seen Epithelial Cells Squamous Epi s <5/LPF Transitional Epi s <2/HPF Renal Epi 0/HPF Casts Hyaline Casts 0-2 /LPF Broad Casts 0 /LPF Granular Casts 0LPF Cellular Casts 0/LPF WBC Cast 0/LPF RBC Cast 0/LPF Waxy Cast 0/LPF Fatty Cast 0/LPF Epi Cell Cast 0/LPF Crystals 0/HPF Calcium Oxalate Cry. 0/HPF Amorphous Crystals 0/HPF Uric Acid Crystals 0/HPF Triple Phosphate Cry. 0/HPF Calcium Carbonate Cry. 0/HPF Calcium Phosphate Cry. 0/HPF Leucine Crystals 0/HPF Cystine Crystals 0/HPF Tyrosine Crystals 0/HPF Reference Intervals Continued 3. Miscellaneous Particles Yeast WBC Clumps Oval Fat Body Trichomonas Sperm Mucus 0/HPF 0/HPF or XXX 0/HPF 0/HPF 0/HPF or Present/Absent Page 191 of 391

192 Iris Automated Urinalysis, iq 200 and ichem Velocity 26 Method performance specifications ph is measured from 5.0 to 9.0 in 0.5 increments. Specific Gravity is measured via refractive index from to >1.060 in increments. Instrument linearity for microscopic particles is from /uL, 0-182/HPF, or /LPF. *Refer to ichemvelocity Urine Chemistry Strips for dipstick analytical sensitivity and report ranges. *Refer to Limitations and Interferences in the Appendix C of this procedure. Result reporting Complete auto-release process. Perform verification of results as listed above for those not auto-released. Note: Results are released to the LIS (or middleware) when the operator clicks on the Accept button. References 1) ichemvelocity Operators Manual 2) Iris iq200 Operators Manual 3) ichemvelocity urine chemistry strip insert 4) Fundamentals of Urine and Body Fluid Analysis, Nancy A. Brunzel, 2 nd edition, ) Urinalysis and Body Fluids, Susan King Strasinger, 5 th edition, ) GP16-A2: CLSI Urinalysis and Collection, Transportation, and Preservation of Urine Specimens; Approved Guideline-Second Edition Related procedures Appendices 1) Iris Automated Urinalysis: iricell System Maintenance Procedure A. Theory of Operation. B. Clinical Significance. C. Limitations and Interferences. D. Expected Values. APPENDIX A PRINCIPLE AND THEORY OF OPERATION: INTENDED USE: The iricell is an in-vitro diagnostic system. Distinguished by throughput, the workcell includes the iricell 2000 (iq 200 ELITE plus the ichemvelocity) and the iricell 3000 (iq 200 SPRINT plus the ichemvelocity). The workcell is composed of the Automated Urine Chemistry Analyzer module [The ichemvelocity], the iq Series Automated Urine Microscopy Module [iq Series], results/analysis processor, computer monitor, mouse and keyboard. The iricell provides a fully integrated, automated chemical and microscopic analysis of urine. This procedure provides instructions for performing a complete urinalysis using the iricell. THEORY OF OPERATION: The ichemvelocity performs the chemistry panel, determines the specific gravity, color and clarity of a urine specimen. The chemistry panel is performed using a test strip, which detects the presence of 9 elements glucose, protein, bilirubin, urobilinogen, ph, blood, ketones, nitrite, and leukocytes by wavelength reflectance. Specific gravity is determined by measuring the refractive index. Color is Page 192 of 391

193 Iris Automated Urinalysis, iq 200 and ichem Velocity 27 measured by transmitted light and clarity is measured by scattered light. The iq Series performs the microscopic portion of the urinalysis and provides a quantitative or qualitative count of formed elements such as cells, casts, crystals, and organisms. The iq Series photographs particles as they are passed in front of a digital camera. The images are classified, counted and stored for verification by the user. The workcell consists of a computer that is interfaced with an approved chemistry analyzer and the iq Series modules. At the workcell, results of the chemistry profile and the microscopic analysis are collated, compared to user-defined criteria for auto-release, and stored for auto-release or verified. The majority of specimens can be autoreleased if user-defined criteria are entered. The user can verify results including the images of the formed elements. As needed, the user may sub-classify or verify results. After verification the results may be sent to the host computer or printed. PRINCIPLE: ichemvelocity URINE CHEMISTRY SYSTEM The ichemvelocity is a urine chemistry analyzer that measures the chemical constituents of the urine using ichemvelocity strips, which are read by a dual wavelength reflectance system. The ichemvelocity strips consist of a plastic strip containing nine (9) pads impregnated with chemicals specific for the determination of a particular constituent. The nine analytes measured are: glucose, protein, bilirubin, urobilinogen, ph, blood, ketones, nitrite, leukocytes esterase, ascorbic acid and a color compensation pad. A color compensation pad is included on the strip to compensate for the natural color of urine and its effect on the color of the reaction pads. Test strips are placed onto a strip conveyor system by a mechanical extractor. The sample probe mixes the sample, aspirates an aliquot of urine and dispenses it onto each reagent pad. At defined wavelengths, the ichemvelocity analyzes the color changes and the intensity of reflected light from the reaction pads. These measurements are used to calculate clinically meaningful results. Page 193 of 391

194 Iris Automated Urinalysis, iq 200 and ichem Velocity 28 PRINCIPLE: iq200 MICROSCOPY SYSTEM The microscopic portion of a routine urinalysis is performed on the iq200 Analyzer. The iq200 Analyzer auto-identifies and processes specimens by mixing, sampling and analyzing the data obtained from the sample. Approximately 1mL of the mixed specimen is aspirated and is sandwiched between enveloping layers of a suspending fluid. This fluid or lamina is positioned exactly within the depth of focus and field of view of the objective lens of a microscope that is coupled to a video camera. The iq Lamina is used to position the formed elements in the best orientation that presents the particles with their largest profile facing the direction of view. The camera captures five hundred pictures per sample. The flash of a strobe lamp illuminates each field. The pictures are digitized and sent to the instrument processor. Individual particle images are classified into one of 12 categories using size, shape, contrast and texture. The autoclassified categories are RBCs, WBCs, WBC clumps (WBCC), hyaline casts, unclassified casts (UNCC), squamous epithelial cells, non-squamous epithelial cells (NSE), bacteria, budding yeast, unclassified crystals (UNCX), mucus, and sperm. Any images that do not classify into any one of these 12 categories are placed in the UNCL category. The particle concentration is calculated using the number of images, normalization factor and the volume scanned. User defined criteria for the auto-release of results is checked and results are sent either directly to the host computer and/or printer or to the system monitor for verification. Only non-autoreleased specimens will appear on the system screen for verification. During the verification process, individual images may be displayed. The operator may manually reclassify digital images when necessary and in accordance with the laboratory s policy. Unclassified crystals (UNCX), unclassified casts (UNCC), and non-squamous epithelial cells (NSE) may be further sub-classified during the verification process. Once the verification process has been completed and ACCEPT has been chosen, the results will be sent to the LIS, screen or printer. ichemvelocity DIPSTICK CHEMICAL REACTIONS: Bilirubin Urobilinogen Ketone Ascorbic Acid Glucose Protein Blood ph Nitrite Leukocytes This test is based on the coupling of bilirubin and diazonium salt in an acidic medium. A pinkish tan color proportional to bilirubin concentration is generated. This test is based on the coupling reaction of urobilinogen with a stable diazonium slat in buffer. A pink to red color proportional to the urobilinogen concentration is generated. This test is based on Legal s method in which the test pad contains sodium nitroprusside and glycine in an alkaline medium. A violet color proportional to methylketone is generated. This test is based on Tillman s reaction in which the presence of ascorbic acid leads to the decolorization of the pad from gray-blue to orange. This two-step enzymatic reaction uses glucose oxidase, peroxidase and a chromogen. Glucose oxidase catalyzes the formation of gluconic acid and hydrogen peroxide via the oxidation of glucose. Peroxidase then catalyzes the reaction of hydrogen peroxide with a chromogen via the oxidation of chromogen to colors ranging between green and gray-blue. This test is based on the protein error of ph indicators on the green color developed from the presence of protein. This dye-binding is particularly strong with albumin. This pseudo-enzymatic test contains organic peroxide and a chromogen. The peroxidase effect of hemoglobin and myoglobin causes a color change to green. This test contains a mixed indicator which assures a marked change in color between ph5 and ph9. Colors range from orange through yellow and green to cyan. This test is based on modified Griess reaction in which nitrite in the urine reacts with amide to form a diazonium compound. The subsequent coupling reaction yields a pink color in the presence of nitrite. Some Gram positive and non nitrite-forming bacteria are not detected in this test. This enzymatic test pad contains an indoxyl ester and a diazonium salt. Granulocyte esterases react with indoxyl ester and diazonium salt to generate a violet color. APPENDIX B CLINICAL SIGNIFICANCE OF URINE CHEMISTRY RESULTS: Glucose: The presence of glucose in the urine called glucosuria is caused by hyperglycemia Page 194 of 391

195 Iris Automated Urinalysis, iq 200 and ichem Velocity 29 or renal condition. Diabetes mellitus is the most common disease resulting in hyperglycermia. Renal conditions causing dysfunction of tubular reabsorption of glucose occur in many conditions including pregnancy. Protein: Bilirubin: The presence of protein in urine is often the first indicator of renal disease, but its appearance in the urine doesn t always signify renal disease. Although proteinuria may indicate nephritic syndrome, multiple myeloma, glomerulonephritis, and pre-eclampsia, a transient mild proteinuria can be present after exposure to cold, strenuous exercise, high fever, dehydration, or an acute phase of a severe illness. The strip is primarily sensitive to albumin. The appearance of urinary bilirubin can be a sign of liver disease or extra-or intra-hepatic biliary obstruction. Urobilinogen: The normal urine has a small amount of urobilinogen (less than or equal to 2.0 mg/dl). The strip is unable to detect a decreased amount, which may appear in infants, patients on antibiotic therapy, or patients with obstructive disease. Increased amounts appear in hemolytic anemias and liver dysfunction. ph: Blood: Ketones: Along with the lungs, the kidneys are the major regulator of acid-base balance. Freshly voided urine has a ph of The ph of urine can be controlled by dietary regulation and medication. A positive reaction for blood may indicate red cells, hemoglobin, or myoglobin present in the urine. Hematuria can be seen due to bleeding as a result of trauma or irritation (renal calculi, glomerulonephritis, tumors, toxic or chemical exposure). Hemoglobinuria occurs when there is lysis of red cells in the urinary tract, intravascular hemolysis or transfusion reactions. Very dilute or extremely alkaline urine can also lyse the cells. Myoglobinuria indicates muscular destruction that may appear in hypothermia, convulsions, and extensive exertions. Ketonuria appears when there is an increased use of fat instead of carbohydrate as a source of metabolism. Conditions of ketonuria include diabetes mellitus, vomiting, inadequate intake of carbohydrates due to starvation, weight reduction, or pregnancy. Page 195 of 391

196 Iris Automated Urinalysis, iq 200 and ichem Velocity 30 APPENDIX B continued CLINICAL SIGNIFICANCE OF URINE CHEMISTRY RESULTS: Nitrite: Leukocytes: Specific Gravity: Bacteria, specifically gram negative organisms, are detected by this nitrite reducing reaction. In order for the reaction to take place there must be adequate dietary nitrates, and the urine must be in the bladder at least four hours for the bacteria to react with nitrate for a positive reaction. Unusually colored urine due to medication or dyes can interfere with this reaction. The presence of white blood cells in the urine is an indicator of inflammation. Lysed and intact WBCs are detected because both may have produced esterase. Specific gravity is a measure of the dissolved substances present in the urine. Specific gravity is one measure of the concentrating and diluting ability of the kidneys and hydration status of the patient. The specific gravity is obtained by measuring the refraction angles of light passing through a triangle prism. An LED emits a beam of light through a slit and a lens. The refractive index changes according to the specific gravity of the sample, the higher the specific gravity the greater is the angle of measurement. The change in the angle of the light is reported as the specific gravity. The result is automatically corrected for elevated protein or glucose concentrations as measured by the test strip. Color: Clarity: Color variation can indicate the presence of a disease process, metabolic abnormality, or an ingested food or drug, or the variation simply due to excessive physical activity or stress. The color of the specimen is measured by transmitted light. The colors obtained are colorless, yellow, orange, brown, red, violet, blue, green and other, including light and dark of each. Substances that cause urine turbidity may be pathologic or non-pathologic. The clarity or turbidity of a urine specimen is measured by passing a beam of light through the sample and measuring how the light is scattered. The amount of scattered light increases as the specimen becomes more turbid. The amount of clarity is reported as clear, turbid or extremely turbid. APPENDIX C LIMITATIONS AND INTERFERENCES: ANALYTE CAUSES OF FALSE NEGATIVE RESULTS CAUSES OF FALSE POSITIVE RESULTS Bilirubin Elevated concentrations of nitrite may inhibit the reaction. Bilirubin is light sensitive and prolonged exposure of urine specimens to light may result Some urine specimens may contain impurities such as food dyes and therapeutic pigments to produce a yellowish Page 196 of 391

197 Iris Automated Urinalysis, iq 200 and ichem Velocity 31 in diminished or false negative values or reddish discoloration of the test pad that may lead to the interference. Elevated Urobilinogen concentrations may slightly enhance the response to this test pad. Urobilinogen Ketones This test is inhibited by elevated concentrations of formaldehyde and nitrite 10 mg/dl. Prolonged exposure to light may lead to diminished or false negative values. Elevated concentrations of phenylpyruvic acid may interfere with the test pad and produce a variety of colors. Phthaleins and anthraquinone derivates exhibit a red color in alkaline medium and this may mask the response. Large amounts of levodopa and medications containing sulfhydrl groups may produce atypical color reactions. Food dyes and medications that have an intrinsic red color in acidic medium such as red beets, azo dyes, phenazopyridine and p-aminobenzoic acid may produce false positive results. N/A Ascorbic Acid No interferences reported No interference reported. Glucose Protein Ascorbic acid concentrations of up to 50 mg/dl did not interfere with glucose assay test results (no false negative results). Acetoacetic Acid concentrations of up to 200 mg/dl did not interfere with glucose assay test results (no false negative results). High specific gravity, acidic ph values and gentisic acid may inhibit color formation. Food dyes such as red beets and therapeutic pigments such as methylene blue and pyridium may mask the coloration of the test pad. Interference may occur with high specific gravity. Interference may also occur with disinfectants, wetting agents and blood substitutes (quaternary ammonium compounds, polyvinylpyrolidone, chlorohexidine). Cleaning agents such as hypochlorite and peroxide may lead to false positive results. Page 197 of 391

198 Iris Automated Urinalysis, iq 200 and ichem Velocity 32 APPENDIX C LIMITATIONS AND INTERFERENCES continued ANALYTE CAUSES OF FALSE NEGATIVE RESULTS CAUSES OF FALSE POSITIVE RESULTS Blood Reducing agents such as ascorbic acid, uric acid, glutathione and gentisic acid may cause false negative results. Samples with a ph of 5 may interfere with this test. High concentrations of Preservatives (formalin) and cleaning agents such as hypochlorite may result in false positives. nitrite can delay the reaction. ph No interferences reported. No interferences reported. Nitrite A negative response in the presence of bacteriuria may be caused by the following: nonnitrite producing microorganisms, low nitrate diet, antibiotic therapy, strong diuresis, or insufficient urinary retention time in the bladder. Food dyes and therapeutic pigments such as red beets and pyridium may cause false positive responses. Leukocytes High concentrations of protein, glucose, cephalexin and gentamicin may diminish the color response. The test can be negative in the presence of visible leukocytes if they have not lysed and/or are not granulocytes. False positive results may occur in the presence of preservatives such as formaldehyde and formalin. Test results may be positive in the absence of observable cells if the granulocytes have lysed. Specific Gravity N/A-measured by Refractometer N/A-measured by Refractometer Color N/A measured by scattered light N/A measured by scattered light APPENDIX D EXPECTED RESULTS: Page 198 of 391

199 Iris Automated Urinalysis, iq 200 and ichem Velocity 33 Bilirubin Urobilinogen Ketone Ascorbic Acid Glucose Blood In normal urine, no detectable level of bilirubin should be obtained. Positive results require further investigation. Performance Characteristics: The test is specifically developed for bilirubin. Biliverdin does not react with this test pad. In normal urine, urobilinogen is usually present at concentration up to 1 mg/dl. A result of 2 mg/dl represents the transition from normal to abnormal state and the specimen should be further investigated for possible liver disease and hemolytic disorders. Performance characteristics: The diazonium-based test is more specific for urobilinogen than Ehrlich s reagent based- test. Test strips cannot determine the absence of urobilinogen, which may be significant in biliary obstruction Detectable amounts of ketone do appear in the urine of normal specimens. Positive ketone values may result from the following conditions:starvation, dietary imbalance, diabetes mellitus, eclampsia, insulin dosage monitoring, vomiting and other metabolic disorders. Performance Characteristics: The test does not measure B-hydroxybutric acid and is only slightly sensitive to acetone. Ascorbic acid is found in various food supplies and dietary supplements. Concentrations of ascorbic acid greater than 20 mg/dl can be expected to cause strong interference with glucose, blood, and nitrite. Performance Characteristics: The oxidized form, dehydroascorbic acid, does not react with this test pad. A small amount of glucose (up to 20 mg/dl) may be present in normal urine. The detectable sensitivity of this test has been adjusted to exclude the minute amount of glucose. Therefore, any positive response should be further evaluated. Performance Characteristics: The test pad doe not react with other reducing sugars such as fructose and galactose. Normal urine contains no detectable hemoglobin or intact red blood cells. Any positive results should be further evaluated. Performance Characteristics: mg/dl blood ph The normal ph of urine can vary between ph 4.5and ph 8.0. Performance Characteristics: ph values are determined to within 0.5 unit over the range from 5.0 to 9.0. Nitrite Leukocytes Normal urine contains no detectable nitrite. However, a negative result does not rule out a urinary tract infection. Performance Characteristics: This test is specific for nitrite. Results may depend on the ability of bacteria to reduce nitrate to nitrite, the number of bacteria and the retention time of the urine in the bladder. A normal urine specimen should not produce a positive result. The test can be negative in the presence of observable leukocytes if they are not lysed/and or are not granulocytes (example:lymphocytes). The test may be positive in the absence of observable cells if the granulocytes have lysed. Performance Characteristics: Leukocyte test detects the presence of esterase in the granulocytic white blood cells. The test result is most frequently accompanied by the presence of bacteria that may or may not produce a nitrite positive reaction. "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 199 of 391

200 Iris Automated Urinalysis, iq 200 and ichem Velocity 34 Page 200 of 391

201 Hematology: Policy Number: HE Date Created: Not Set Document Owner: Patricia Turner (Laboratory Date Approved: Not Set Section Chief) Approvers: Board of Directors (Administration), Cindy Moccio (Board Clerk/Exec Assist-CEO), David Hewitt (Pathology) Sysmex DI-60 Automated DIgital Cell Morphology Analyzer Printed copies are for reference only. Please refer to the electronic copy for the latest version. Sysmex DI-60 Automated Digital Cell Morphology Analyzer CLSI Procedure Page 201 of 391

202 Sysmex DI-60 Peripheral Blood and Body Fluid Cell Morphology Analysis on the Sysmex DI-60 I. PRINCIPLE The Sysmex DI-60 is an automated digital cell locating device intended to aid morphologists in the location and classification of white blood cells and non-wbc s such as NRBC, the characterization of red cell morphology and estimation of platelets in peripheral blood. Monolayer smears are made and stained on the Sysmex SP-10, or by manual methods, transferred in cassettes via the Sysmex CF-60 (cassette feeder) to the DI-60 where slides are scanned one at a time. Using the 10X objective, XY coordinates of potential nucleated cells are located in the optimal monolayer area and the positions are recorded. Oil is applied to the slide and images are obtained through 50X magnification for red cell morphology. Each recorded 10X position is then examined using the 100X oil immersion objective to capture WBC images. The cells are analyzed by the Artificial Neural Network (ANN) and assigned a pre-classification. The operator reviews images to confirm or modify suggested classification of cell types. For body fluids, cytocentrifuge smears are prepared, stained and placed in cassettes on the CF-60 to be transferred to the DI-60 for analysis. The DI-60 locates and classifies white blood cells and other nucleated cells in the same manner as for peripheral blood. The operator reviews images to confirm or modify suggested classification of cell types. An overview image of the entire sample area is displayed for additional review. II. SPECIMEN REQUIREMENTS A. Peripheral Blood 1. Preferred specimen is whole blood anticoagulated with K3 EDTA. 2. Optimal time for smear preparation is within 4 hours of collection. If a smear cannot be prepared within 4 hours, some loss of cellular integrity may occur. B. Body Fluids 1. The following body fluid types are acceptable for analysis: cerebrospinal, serous and synovial. It is recommended that cell location test be reviewed for each new body fluid type analyzed. 2. Collect specimens according to established protocol for each fluid type. Page 202 of 391

203 Sysmex DI-60 Automated DIgital Cell Morphology Analyzer 3 3. Cytocentrifuge smears should be prepared as soon as possible after collection to maintain cellular integrity, ideally within 2 hours. 4. See HE for guidelines for cytospin preparation. III. SUPPLIES A. Frosted glass slides, with clipped or rounded corners. Acceptable slide dimensions in mm are: x x NOTE: Slides with circles should not be used for body fluid smear preparation. B. Barcode labels for manually prepared peripheral blood and body fluid smears C. CellaVision ER barcode labels D. CellaVision QC barcode labels E. CF-60 Slide Storage Magazines F. Immersion Oil Packs (Refractive index Viscosity 300 cst. PCB free) G. Lens paper H. Isopropyl alcohol I. SP-10 slide cassettes designated for re-use on CF-60/DI-60 J. Cytocentrifuge for preparation of body fluid smears IV. SLIDE PREPARATION A. Peripheral Blood Slides 1. Prepare peripheral blood smears using the Sysmex SP-10, manual wedge technique or mechanical spreader. For a good smear: There is no pooling of specimen at the point of application. Both sides of the film are less than 5mm from the edges of the slide. The feathered edge is relatively straight and not pointed. There must not be any streaks, troughs, ridges, holes or bubbles. The blood film must be at least 30 mm in length and terminate 5-15 mm from the end. The smear must not be too thick. A thick smear will interfere with the DI- 60 s ability to find a monolayer and with the Artificial Neural Network which may result in a large number of misclassified WBC s. Refer to DI-60 Instructions for Use, Appendix G for examples of good smears. Page 203 of 391

204 Sysmex DI-60 Automated DIgital Cell Morphology Analyzer 4 2. Smears made on the SP-10 will be stained automatically. Smears prepared manually should be stained using the manual mode of the SP-10. For appropriate cell classification, stain must be free of precipitate. Good pre-classification requires that PMN s have dark-stained nucleus and pink cytoplasm. 3. Slides require barcodes to process on the DI-60. B. Body fluid slides 1. Dilute samples with high WBC with saline to prevent cell clusters and ensure good distribution. It is recommended that the WBC be between 5x10^3/µL and 12x10^3/µL. 2. Prepare the smear with a cytocentrifuge, using the same slides as used for peripheral blood smears. 3. Smears can be stained using the manual mode of the SP-10. For appropriate cell classification, stain criteria is the same as listed above for peripheral bloods. 4. Slides require barcodes with a body fluid order to process on the DI-60. V. START-UP A. Start up the DI Switch on the Slide Scanning Unit (SSU) using the switch located on the front of the unit. 2. Switch on the system computer. 3. Wait until the red status lamp stops flashing and is off. 4. In the Log-on dialog box, type assigned Username and Password. 5. Select the appropriate database from the drop-down menu. 6. Click OK. 7. System Control view displays. Make certain the start-up test passes. System self-tests are performed during start-up that detect potential hardware or software problems. The DI-60 will not process slides if the startup test fails. B. Start up the CF-60 with the SP Place an empty slide storage magazine in the magazine supply unit of the CF- 60. Page 204 of 391

205 Sysmex DI-60 Automated DIgital Cell Morphology Analyzer 5 2. Start the SP-10. When the SP-10 starts up, the CF-60 also starts. The status indicator lights green when the CF-60 is ready. C. Start up the CF-60 without the SP Place an empty magazine in the magazine supply unit of the CF Press the startup switch. The status indicator lights green when the CF-60 is ready. VI. PROCEDURE A. Slide Processing Peripheral Blood 1. Slides prepared on the SP-10 are sent to the DI-60 for processing. a. Slide cassettes with stained slides are transferred from the SP-10 into the cassette supply conveyor of the CF-60. b. A slide is removed from a cassette by the gripper and inserted into the shuttle. c. The shuttle moves the slide to the DI-60 where the gripper removes it and the system checks for a readable barcode. If the barcode cannot be read, it is displayed as ERR + date and time (ERRYYYYMMDDhhmmss), in the System Control Log and Order List of the Database view. An image is taken of the barcode and displayed in Order Data. d. The slide is analyzed on the DI-60. System Control view displays ongoing slide processing. The System Control Log, located in the upper left of the System Control view, shows the processing status for each batch and slide. In Database view, Analyzing displays at the top of the screen. e. Following analysis, the slide is inserted into the shuttle then into a slide storage magazine. 2. Process manually prepared slides. a. Insert the stained slide into a slide cassette with the barcode facing the Sysmex logo. b. Place the cassette with the Sysmex logo facing forward into the CF-60 cassette supply unit. Page 205 of 391

206 Sysmex DI-60 Automated DIgital Cell Morphology Analyzer 6 Processing of the slide takes place the same as for automatic process. 3. Reanalyze a slide on DI-60. a. Prior to reanalyzing a slide on the DI-60, wipe the oil off. b. Place the slide in a cassette designated for re-use. c. Place the cassette in the cassette supply unit of the CF-60. NOTE: A cassette that has been re-used on the DI-60 should never be used on the SP-10. Oil in the cassette may contaminate the SP-10. B. Slide Processing Body Fluids To process a body fluid slide, it must have a barcode that contains an order for body fluid (e.g., lab-generated from LIS) or the sample ID (e.g. from a CellaVision ER label) must be entered as a pending order in Order Data on the DI For a slide with a barcode that does not contain the body fluid order: a. In the Database view, select Pending Orders tab. b. Click Add. c. Select Body Fluid in the dialog box. d. For Order ID, enter the barcode number for the slide. e. For the type of order, select Diff and Overview. f. Select 10x+50x. 2. Place the body fluid slide in a cassette and place the cassette in the CF-60 cassette supply conveyor. 3. The slide will be processed in the same manner as a peripheral blood slide on the DI-60. C. Slide Review Peripheral Blood Slides that are ready for review display in the Database view. An unopened order is in black text. Open orders display in blue text. Slides being reviewed by another user at a Remote Review Station display in red. Double-click on a slide/order to open the Verification view screen to review the images. WBC, RBC and PLT images are divided by tabs at the top of the screen. WBC REVIEW Page 206 of 391

207 Sysmex DI-60 Automated DIgital Cell Morphology Analyzer 7 Cells can be viewed in different formats. The Full Screen view displays all cells grouped by preclassification. The galleries display 1, 2, or 3 classes of cells in side-by-side format. In the gallery fields, select the cell type to view using a drop-down at the top of the field. When viewing in the gallery format, a WBC panel displays to the left with a list of all WBC and Non-WBC parameters. Check marks beside a parameter indicate that required review was performed. A library of reference cells is available for different cell classes. To view in gallery 2 or 3, select the checkbox Reference cells. Use the drop-down to select the reference cell type. Double clicking on a cell enlarges it. Use the mouse wheel to zoom in and out. All cell classes must be viewed prior to signing a slide. All unidentified cells must be classified. Demographic information, hemogram, auto differential and flags display on the far lower left of the screen. 1. Reclassification of WBC s a. Left click on the cell and drag it to the correct classification in a gallery or to the cell name in the WBC or Non-WBC panel to the left of the gallery. b. Right click on a cell and select the appropriate classification from a dropdown menu. c. To reclassify a grouping of cells, click on the first cell in the group, hold down the shift key and click on the last cell of the group; this marks the entire group. Click on the group and drag it to a classification or right click to reclassify with the drop-down menu. d. To reclassify non-consecutive multiple cells, hold down the ctrl key while clicking on each cell. Once all cells are marked, click on a cell to drag all cells to the appropriate classification or right click to display the drop-down menu, and select the appropriate classification. e. To split cells: If more than one cell appears in an image, click on the Cell Marker button to display a green box around the cells in each image. Right Page 207 of 391

208 Sysmex DI-60 Automated DIgital Cell Morphology Analyzer 8 click on the image and select Split Cell from the drop-down menu. Click on the unmarked cell in the box. Two pictures of the same image display. For each image, classify the cell that is marked by the red X. 2. Confirm Cell Counter a. Review cell classifications in full screen view for abnormal cells. b. If no abnormal cells are found, review cell counter (automated) differential displayed in the Patient Data field on the left side of the screen. c. Click Confirm Cell Counter to accept the automated differential results. 3. Adding Comments: a. WBC comments can be added for each slide. Click on the Comment icon next to the comment box to open the field. Enter a free-text comment in the comment field OR Select from the list of standard comments. To add a standard comment, highlight the comment and double click, or click Append. b. Comments can be added to a specific cell. Right clicking on a cell opens a field that allows a free-text cell-specific comment to be added. Cell-specific comments will not display on the report. RBC REVIEW The RBC panel is composed of 8-100X fields. 1. If there is no significant morphology, select Report all as O-Normal. 2. Red cell morphology can be graded 1+ to 3+ by selecting Use Characterization and selecting the appropriate radio buttons. 3. The Zoom feature can be used to enlarge the image by one of the following methods: a. Click on the magnifying glass icon (Zoom Mode) with +/- signs. Hold down the left mouse and move up or down on the image. Moving up zooms in; moving down zooms out. b. Zoom In by clicking on the magnifying glass icon with a + sign. By clicking on the icon 5 times, an image equal to a 100X field displays. Zoom Page 208 of 391

209 Sysmex DI-60 Automated DIgital Cell Morphology Analyzer 9 Out is identified by a magnifying glass with a - sign. Return to full view by clicking on Entire RBC Image icon. 4. Navigation within an image can be performed by using the Scroll (Hand) icon or by using the scroll bars on the bottom and right side of the screen. To use the Scroll mode, click on the Hand icon. Place the hand on the image and hold down the left side of the mouse to move the image from side to side and up/down. 5. Adding Comments: a. Click on the Comment icon. b. Enter a free-text comment or select from the list of standard comments. 6. Select Exclude RBC Analysis on the bottom of the screen if no RBC review is required. PLATELET REVIEW The PLT image corresponds to 8 100X fields. Gridlines can be added to aid in estimation by clicking Help Lines icon. These do not correspond to the grid squares used for PLT estimate entry. There are two (2) methods for PLT estimation. A PLT estimate factor is determined during validation and is entered in the PLT settings. SELECT THE METHOD USED IN YOUR LABORATORY- Use the Calculated Estimate Method. 1. Counting Platelets in the Overview Image a. Count PLTs per grid square: i. Select the Count PLTs per grid square radio button. ii. Select each field individually and enter the number of platelets counted in that field. Press tab to access each entry field until all grids have been viewed. b. Enter approximate PLT count per grid square. i. Select the Approximate PLTs per grid square: radio button. ii. Tab between entry fields to view grid squares. iii. Estimate the average PLT count per grid square and enter the value in the field. Page 209 of 391

210 Sysmex DI-60 Automated DIgital Cell Morphology Analyzer 10 c. Click Calculate PLT Result to obtain results following action a or b above. Two (2) options are available to report the PLT results calculated from the number of PLTs per HPF: i. Select Calculated estimate to report a number. Average PLTs/HPF are multiplied by the PLT estimate factor determined during the validation of the DI-60 and entered in settings. OR ii. Select Calculated level to report significantly decreased, decreased, normal or increased. The level is determined by multiplying the estimate by the estimate factor. NOTE: The User may override the calculated PLT results by selecting Manual Level and selecting one of the four levels. 2. Estimating the Platelet concentration level (Manual) a. Use the entry fields in the PLT image overview to estimate the PLT s in each grid. b. Select the concentration level from the drop-down menu. 3. Adding Comments: a. Click on the Comment icon. b. Enter a free-text comment or select from the list of Standard Comments. D. Slide Review Body Fluids Slides ready for review display on the Database view. Body Fluid slides are indicated by BF in the Order Type column. Double-click on a slide/order to open the Verification view screen to review the images. Diff and Overview tabs are available at the top of the screen. WBC (DIFF) REVIEW Body Fluid cells can be viewed in the same formats as listed for Peripheral Blood cell review. 1. Reclassification of WBC S Body Fluid Page 210 of 391

211 Sysmex DI-60 Automated DIgital Cell Morphology Analyzer 11 Reclassification of WBC s on body fluid slides is performed in the same manner as peripheral blood slides. Refer to procedure in this document. Basophils, Lymphoma cells, Atypical lymphocytes, Blasts and Tumor cells are automatically forwarded to Other classification by the DI Review Overview Images/Tag Regions of Interest a. Select the Overview tab to view enlargements of the sample area. b. The Mini map shown in Overview displays the entire sample area. c. Click in the Mini map to enlarge a specific area. The magnified area displays in the large image. In the Mini map, a red rectangle marks the displayed area. A blue trace marks already viewed areas. d. Move in the Mini map by using the keyboard arrow keys or the navigation arrows on the DI-60 screen. The mouse can also be used to scroll in any direction. Insert areas of the Mini map to be viewed and what cell types to look for, in your laboratory. e. Switch between 10X and 50X images (if analyzed using 10X+50X setting) by using the sliders in the Zoom panel or right clicking in the overview image. f. Save a Region of Interest (ROI) by clicking Tag Region. g. A comment can be added to the box that displays to identify the ROI. h. Copy an image to disk by selecting the ROI from the list, right-clicking to display the menu and selecting Copy Image to Disk. 3. Adding Comments: a. Body Fluid Diff comments can be added for each slide in the same manner as peripheral blood WBC comments. b. Comments can be added to a specific cell class in the same manner as for peripheral blood. VII. QUALITY CONTROL CELL LOCATION Page 211 of 391

212 Sysmex DI-60 Automated DIgital Cell Morphology Analyzer 12 A. Perform QC Cell Location Peripheral Blood 1. Select a blood sample with a WBC count of about 15x10 3 /µl to reduce the processing time. 2. Prepare a slide in the manual mode of the SP-10. a. Select Manual from the Menu screen. b. Enter the sample ID c. For Op. Mode select SmSt/SP to send the stained slide to the cassette output area of the SP Remove the cassette from the output area and label the slide with a QC label. 4. Place the cassette on the Cassette Supply conveyor of CF-60 for processing. The slide is scanned using the same method used to collect images for patient samples. 5. Once processing is complete, open the Tools menu and select Cell Location. Select the new slide at the top of the list. (Cell location results automatically delete after 5 days.) 6. Review each image for any missed nucleated cells. Double-click an area for magnification if necessary. Green boxes mark nucleated cells. The cell does NOT have to be completely inside the box. As long as there is a box associated with a cell, it indicates the system found the cell. Blue boxes mark artifacts or other objects. The number of these objects must not exceed 30%. Missed cells are those not marked with ANY box. Black boxes mark cells not needed in the 200 cell process for cell location. 7. Review all images by clicking the right arrow. For each image, enter the number of missed cells in the input field. When all images have been examined, the result will appear as a %. 8. Record results on the appropriate log. Results may also be printed by clicking Print Result. Results must be >_97_%. Page 212 of 391

213 Sysmex DI-60 Automated DIgital Cell Morphology Analyzer 13 If acceptable result for Cell Location test is not obtained, obtain another sample and repeat Cell Location test. A. Review Cell Location Body Fluids Cell Location is performed on every Body Fluid slide. 1. The cell location test for QC should be performed at least once per day. 2. Use a body fluid sample with a WBC of < 12 x 10^3/µL. 3. QC label is not required. 4. When analyzed for QC, the slide should be processed using 10X+50X. If initial analysis is performed using 10X+50X, proceed to step 5. a. In the Database view, select Pending Orders tab. b. Click Add. c. Select Body Fluid in the Dialog Box. d. For Order ID, enter the barcode number for the slide. e. For the type of order, select Diff and Overview. Select 10X+50X. Analysis will take approximately eight (8) minutes. 5. Insert the slide into a slide cassette and place it on the CF- 60. Process the same as routine body fluid smears. 6. When processing is complete, open the slide by clicking on it in the Database view. 7. Click on the Overview tab and Cell Location. 8. Navigate through the analysis area using the navigation arrows. Cells are marked in the same manner as indicated above for Peripheral Blood Cell Location. 9. Once review of the analysis area is complete, results are calculated. Verify results are within laboratory review limits. 10. Results can shall be printed daily by selecting Print Result. Save printed results with Hematology daily worksheets. Complete this section with your laboratory s policy for frequency of Cell Location Quality Control analysis and review. Cell Location will be performed 21_times per day at shift 1._ and 2. Page 213 of 391

214 Sysmex DI-60 Automated DIgital Cell Morphology Analyzer 14 Cell Location for body fluid slides will be performed _1 times per day at shift 1_. Supervisor will review Cell Location results every_week_month_. VIII. REPORTING RESULTS A. Once all tabs have been viewed, select the Sign Slide tab. All cell classes on the WBC tab must be viewed in order to sign the slide. All Unidentified images on the WBC tab must be reclassified. 1. The Sign Slide dialog displays if all ordered analyses have been viewed. 2. Enter Username and Password. 3. If not already selected (as default Settings), select Sign order when signing slide, Send to LIS and/or Print order. NOTE: The option to Sign order when signing slide is not available if the slide is part of a multi-slide order; all slides must be signed before the order can be signed. B. To merge multiple slides from an order, click the Slide Merge tab in Report View. Results from all slides in the order display. 1. Click in the checkbox next to a slide ID to include it in the results of the order. If a slide is excluded, a dialog displays to enter explanation of exclusion. C. Barcode errors on slides can be edited in Order Data and reported to the LIS. 1. Prior to reviewing the slide, click on the Order Data icon. An image of the barcode is displayed. 2. Edit the Order ID (at the top left of the dialog box) with the correct number. 3. When the order/slide is signed, the results will be sent to the LIS. IX. ARCHIVING / AUTODELETION / BACKUP Insert your laboratory s process and frequency for archiving or autodeletion for each database. Insert your laboratory s process and frequency for back-up. X. MAINTENANCE Page 214 of 391

215 Sysmex DI-60 Automated DIgital Cell Morphology Analyzer 15 Refer to DI-60 Instructions for Use and/or CF-60 Instructions for Use for details and images. A. Daily Maintenance 1. Shut down the CF-60 with the SP-10 a. Shut down the SP-10. b. The CF-60 shuts down after the magazine in the tower is ejected. If there are no slides in the magazine it will not be ejected. NOTE: If the CF-60 or DI-60 is in operation when the SP is shut down, the CF-60 will not shut down automatically. 2. Shut down the CF-60 independently. a. Ensure that the CF-60 status light is green. b. Hold down the startup switch on the front of the CF-60 for 2 seconds. c. The CF-60 shuts down after the magazine in the tower is ejected. If there are no slides in the magazine it will not be ejected. B. Weekly Maintenance 1. Clean the Objectives and LED table a. Open the hood of the DI-60. b. Gently clean the objectives and LED table with lens paper. NOTE: Take care not to get oil on the 10x objective. Use a different piece of lens paper to clean each objective. c. Use isopropyl alcohol when needed. NOTE: Bubbles, which can affect image quality, may form on the objectives when cleaned with alcohol. It is suggested to run 2 slides after the maintenance and then delete those slides from the database. 2. Delete Unsigned Orders a. In the Database view, select orders/slides for which the Order Status field is empty or there is a Failed indicator in the Process Status column. b. Click Delete at the bottom of the Database View for the selected orders/slides. 3. Clean Bottom Plate Page 215 of 391

216 Sysmex DI-60 Automated DIgital Cell Morphology Analyzer 16 a. Pull out bottom plate from lower rear of DI-60 and wipe clean of any immersion oil. Perform only when the DI-60 is not in operation. 4. Shut down the DI-60. a. Select Exit in the File menu on the computer. b. Press ctrl/alt/delete. c. Select Shutdown. d. Switch off the Slide Scanning Unit (SSU) using the switch on the front of the unit. C. As Needed Maintenance 1. Change Immersion Oil Pack a. Open the DI-60 hood. b. Place a blue clip on the oil hose. c. Push down on the oil hose connection and pull out the hose. d. Change the oil pack and connect the hose. e. Remove the clip from the hose. f. Go to Maintenance/Oil. g. Click Reset Oil Drop Counter. 2. Clean Slide Storage Magazines a. Clean slide storage magazines with a neutral detergent (dish soap) when they become dirty with oil. 3. Remove slide cassettes from the CF-60 storage conveyor. A maximum of 90 cassettes can be stored on the conveyor. a. Cassettes will be cleaned for re-use on the SP-10. b. Cassettes designated for re-use on DI-60, should never be used on the SP- 10. XI. CALCULATIONS N/A XII. TROUBLESHOOTING For comprehensive information on troubleshooting, refer to the Troubleshooting sections of the DI-60 Instructions for Use and/or CF-60 Instructions for Use. Page 216 of 391

217 Sysmex DI-60 Automated DIgital Cell Morphology Analyzer 17 A. If the DI-60 fails the start-up test, log off and power off the computer, and log back on before attempting other corrective action. B. When troubleshooting the DI-60, note the circumstances under which the error occurred and refer to the Troubleshooting Chart in the DI-60 Instructions for Use to determine resolutions. C. Use Gripper Service to remove broken or stuck slides. 1. Go to Maintenance / Gripper Service. 2. Click OK. 3. Wait until the gripper is in service position dialog displays. 4. Open the hood and remove the slide from the gripper. 5. Close the hood. 6. Restart the SSU and the software. D. When errors occur on the CF-60, an alarm sounds, the status light turns red and the error code displays on the control panel. When the error is related to a cassette or magazine, the corresponding position indicator LED lights orange. 1. Press the alarm reset switch. 2. Check the error code display and refer to the CF-60 Instructions for Use Troubleshooting section for corrective action. 3. Press the Start switch if required as part of corrective action. E. When an error occurs that requires that a slide, cassette or magazine be removed, the DI-60 cover (hood), CF-60 tower cover and/or CF-60 shuttle cover will need to be opened. Instructions are found in the CF-60 Instructions for Use. XIII. REFERENCES 1. Sysmex DI-60 Instructions for Use, Sysmex Corporation, Kobe, Japan 2. Sysmex CF-60 Instructions for Use, Sysmex Corporation, Kobe, Japan 3. Sysmex SP-10 Instructions for Use, Sysmex Corporation, Kobe, Japan 4. Release Information, CellaVision Body Fluid Application. Page 217 of 391

218 Sysmex DI-60 Automated DIgital Cell Morphology Analyzer 18 "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 218 of 391

219 Manual Name: Imaging & SRCC Radiation Oncology Services Support Staff Name: Carla Hernandez Board of Directors Policy/Procedure Title # Status (New, Revised, Reviewed, Deleted) July 12, 2017 Name and Phone # of person who wrote the new policy or revised an existing policy Imaging Services Manual Review IS 1.0 Revised Renee Lauck, ext Radiation Protection Program IS 5.6A Revised Renee Lauck, ext MRI Stent Screening Policy IS 5.9 Deleted Information obsolete. New policy IS 50.22, MRI Coronary Artery Stent Screening to replace. Tim Pedersen, ext Radiation Protection IS 5.6 Deleted Duplication of information covered in revised policy IS 5.6A, Radiation Protection Program Renee Lauck, ext Page 219 of 391

220 Imaging Services Policy Number: IS 1.0 Date Created: 11/01/2004 Document Owner: Carla Hernandez (Administrative Date Approved: Not Approved Yet Assistant) Approvers: Board of Directors (Administration), Carla Hernandez (Administrative Assistant), Daniel Hightower (Radiology), Deana Hale (Radiology Manager), Gordon Ah Tye (Dir Imaging & Radiation Svcs), Renee Lauck (Dir OP Rad Onc & Imaging Svcs) Imaging Services Manual Review Printed copies are for reference only. Please refer to the electronic copy for the latest version. Policy: Imaging Services staff and leadership team will review Policy and Procedure Manual every three years to insure accuracy of manual and assure that staff are informed and involved in the setting and observance of all policies and procedures contained therein. Procedure: Department Leadership Review Director, Manager, and Medical Director for Imaging Services will review department Policy and Procedure Manual every three years, to insure accuracy. Those items taken into account include; new technology, new procedures, new equipment, supplies or changes in hospital policies or procedures that may effectaffect current policies. II. Staff Review A. New Employees are required to review the Imaging Services, policy and procedure manual within 48 hours of employment. Existing employees are required to review annually along with review of all district manuals. Staff are encouraged to give feedback on current policies as well as give ideas for policies that may prove to be beneficial in providing service to our patients, physicians, and nursing or in the education within at KDHCD.. Staff who are interested in providing feedback are required to use the policy idea form. (Addendum 12.3 A) Formatted: Indent: Left: 1" Adjustments to Manual Any policies found to be insufficient or nonexistent will be created or revised upon completion of review. Page 220 of 391

221 Imaging Services Manual Review 2 Policies will be created to include; New procedures, changes in hours or location of services, exam-specific supplies, issues regarding employees, items identified to improve service to our customers, changes in job descriptions, and, or, any laws requiring adjustments. Related Documents: NONE References: NONE "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 221 of 391

222 Imaging Services, Nuclear Medicine, SRCC Policy Number: IS 5.6A Date Created: 07/12/2012 Document Owner: Carla Hernandez Date Approved: Not Approved Yet (Administrative Assistant) Approvers: Board of Directors (Administration), Carla Hernandez (Administrative Assistant), Daniel Hightower (Radiology), Deana Hale (Radiology Manager), Gordon Ah Tye (Dir Imaging & Radiation Svcs), Jose Thekkumthala (Clinical Radiation Physicist), Renee Lauck (Dir OP Rad Onc & Imaging Svcs) Radiation Protection Program Printed copies are for reference only. Please refer to the electronic copy for the latest version. References: Radiation Protection, Policy IS 5.6 RADIATION PROTECTION PROGRAM AT KAWEAH DELTA HEALTH CARE DISTRICT RADIATION PROTECTION PROGRAM AT KAWEAH DELTA HEALTH CARE DISTRICT Formatted: Centered, Indent: Left: 0", Pattern: Clear (Gray-12.5%) Formatted: Centered Formatted: Font: 18 pt Formatted: Centered Kaweah Delta Health Care District 400 W. Mineral King Ave Page 222 of 391

223 Radiation Protection Program 2 Visalia, CA TABLE OF CONTENTS 1. Organization and Administration 2. ALARA Program 3. Dosimetry Program a. Occupational Workers b. Pregnant Workers c. Dose to Fetus 4. Pregnant Patients 5. Area Monitoring and Control a. Area Radiation Monitoring b. Instrument Calibration and Maintenance c. Room Requirements d. Lead Shielding Devices e. Image Recording Devices f. Fluoroscopy 6. Radiological Controls a. Entry and Exit Controls b. Posting c. Disposal of Equipment 7. Emergency Exposure Situations and Radiation Accident DosimetryMisadministration 8. Record Keeping and Reporting 9. Reports to Individuals 10. Radiation Safety Training a. Operating and Safety Procedures b. Occupational Workers b. Non-Occupational Workers 11. Quality Assurance Program a. Radiation Oncology 12. Internal Audit Procedures Formatted: Right: 0.81" Formatted: Right: 0.44" Formatted: Indent: Left: 1", Hanging: 0.19", Numbered + Level: 1 + Numbering Style: a, b, c, + Start at: 3 + Alignment: Left + Aligned at: 0.97" + Indent at: 1.22" Formatted: Right: 2.63" Formatted: Right: 1.5" Formatted: Indent: Hanging: 0.08", Numbered + Level: 1 + Numbering Style: a, b, c, + Start at: 2 + Alignment: Left + Aligned at: 0.83" + Indent at: 1.08" Formatted: Left, Indent: Left: 0.58", Hanging: 0.14", Right: 2.94", Tab stops: 0.94", Left + 1", Left ", Left ", Left + Not at 0.97" Formatted: Tab stops: 0.88", Left Formatted: Indent: Left: 1", First line: 0", Numbered + Level: 1 + Numbering Style: a, b, c, + Start at: 1 + Alignment: Left + Aligned at: 0.83" + Indent at: 1.08", Tab stops: 1.19", Left Formatted: Indent: Left: 1", Tab stops: 1.19", Left Formatted: Indent: Left: 0.56", Tab stops: 0.88", Left Page 223 of 391

224 Radiation Protection Program 3 1. Organization and Administration ORGANIZATION CHART FOR RADIATION PROTECTION PROGRAM RADIATION SAFETY COMMITTEE Chairman Radiologist RSO Physicist 2. ALARA Program Imaging Radiology Surgery Endoscopy Nuc Med Onc. Svcs. 3S Med./Surg. SRCC Formatted: CCL Font: (Default) Arial Formatted: Font: (Default) Arial Formatted: Font: (Default) Arial Formatted: Font: (Default) Arial Formatted: Font: (Default) Arial Formatted: Font: (Default) Arial Formatted: Font: (Default) Arial Formatted: Font: (Default) Arial Formatted: Font: (Default) Arial The objective of this program is to maintain radiation exposure, both internal and external, at a level as low as reasonably achievable. The principle is to minimize the contamination of unrestricted areas at a level as low as reasonably achievable below established limits. ALARA requires careful design and choice of equipment as well as good radiation protection practices including good planning and the proper use of appropriate equipment by qualified, welltrained personnel. The primary mechanism for minimizing radiation exposure is an alert and knowledgeable worker. Adequate protection shall be available to provide a safe working environment for a radiation worker and general public. Such protections may include the use of shielding, exhaust hoods, glove boxes, spill pans, remote manipulators, protective apparels such as gloves, aprons etc. Secondary protective measures such as procedural controls and monitoring systems may be employed. Time, distance and shielding are three cardinal factors controlling the ALARA (As Low As Reasonably Achievable) concept: Minimize time of contact with radiation, increase distance to radiation source Page 224 of 391

225 Radiation Protection Program 4 and have shielding available in radiation environments. The RSO will make sure that procedures in a radiation environment are conducted as stipulated in RML. Along with physicist, RSO will investigate overexposure, accidents, spills, losses and thefts. Incidents, such as misadministration, must have to be investigated and policies be put in place to eliminate such incidents. ALARA investigational levels are as follows: SITE Whole Body (DDE; tissue depth 1cm) Eye Lens (LDE; depth = 0.3 cm) Skin (SDE; depth = cm averaged over area 1 cm2) ALARA1 Quarterly Limit (mrem) ALARA2 Quarterly Limit (mrem) Maximum Annual Permissible Dose MPD(mRem) Formatted: Font: (Default) Arial Formatted Table Formatted: Font: (Default) Arial Formatted: Font: (Default) Arial, 12 pt 3. Dosimetry Program The KDHCD shall control the occupational dose to individual adults for the following dose limits. Proper use and storage of dosimetry devices will be defined by the facility Radiation Safety Committee. The total effective dose equivalent being equal to 5 rems (0.05 Sv). The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, are: A lens dose equivalent of 15 rems (0.15 Sv), and A shallow-dose equivalent of 50 rem (0.5 Sv) to the skin of the whole body or to the skin of any extremity. A. Family, guests or children a. Family or guests of patients, will not be permitted in any xray room unless absolutely necessary to help hold patient. In these cases, the person will wear a lead apron, thyroid shield and gloves. A.b. For safety reasons and to assure staff are able to focus on the radiation safety of each patient, children (not receiving exam) will not be allowed in the x-ray room or surrounding areas, at any time. Formatted: Numbered + Level: 1 + Numbering Style: A, B, C, + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.25" Comment [JK1]: Suggestion: Radiation safety committee should have final approval for type of device for monitoring as well. Formatted B. Occupational Workers Page 225 of 391

226 Radiation Protection Program 5 All individuals who, on a regular basis, handle radioactive material that emits ionizing radiation will be issued a film and TLD finger monitor that will be processed by a contracted service (Landauer) on a monthly basis. These individuals are likely to receive radiation exposure in excess of 10% of the maximum permissible dose. All personnel who work with radioactive materials will be issued a whole-body badge as well as ring badge. Exposure readings on these badges will be reviewed quarterly by the RSC using ALARA levels. All individuals who are exposed to radiation on an occasional basis, such as Surgery Physicians and Personnel, will be issued a whole body monitor to be worn anytime radiation is used in the operating room. Other individuals who are exposed to radiation on an occasional basis, such as delivery personnel and nurses who have received diagnostic dosages will not normally be issued exposure monitors. Formatted: Tab stops: 0", Left + Not at 2.2" The ALARA program requires that each individual have their own exposure badge before working in an area of radiation exposure or be assigned a visitor badge until their regular badge has been delivered. All badges are to be ordered by the Department manager or his assistant as soon as new personnel have been hired. In addition, a control badge accompanies the monthly group of badges and should not be placed inside a badge holder. This control badge is kept in a secure place together with any other badges that are no longer active. Proper wearing of the personnel radiation badge indicates it should be worn closest to the source of radiation. Film badges will be interpreted monthly by the contracted service, and a report returned to the Department manager. This report is then posted in the Department readily accessible to all employees. If there is a case of overexposure the personnel involved is notified immediately along with the RSO and the Physicist. The RSO will investigate all unusually high exposures as well as maintain a permanent employeeexposure record, as required by ALARA program. Protective lead aprons must be worn by all personnel within an x-ray room during fluoroscopy and radiography. In addition, personnel required to place their hands within the direct radiation beam will wear protective lead gloves. The use of radiation safety thyroid shields will be at the discretion of each individual. Personnel not regularly exposed to radiation, for example, portable exams on units, Emergency Department, or use in surgery who do not have a film badge lead apron should be asked to leave the area during radiographic or fluoroscopic procedures. The Technologist will announce when an exposure is to be made. A distance of 15 to 20 feet will ordinarily result in minimal exposure. If one of the above personnel are required to stay in the vicinity of a radiation producing unit always wear a lead apron. If the Technologists do not have enough lead aprons with them, they are to be asked to retrieve one for each person involved. C. Pregnant Workers Declaration of pregnancy is governed by specific policy. Pregnant personnel are advised to notify their supervisors as soon as possible of their condition. Upon declaration of pregnancy, the radiation worker is issued a fetal badge that is worn at the waist level. The waist badge is to be worn at all times while on the job. Every Formatted: Numbered + Level: 1 + Numbering Style: A, B, C, + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.25", Tab stops: 0.25", Left + Not at 2.13" Page 226 of 391

227 Radiation Protection Program 6 effort will be made to keep radiation exposure level to the fetus below 500 mr during the entire gestation period or 50 mr in any given month during gestation period. Where possible, the pregnant radiation worker will be re-assigned responsibilities away from sources of radiation if RSO deems it necessary to keep fetal dose at ALARA level. Radiation safety counselcouncil may be sought with the RSO if pregnant radiation worker so desires. PREGNANCY DECLARATION FORM Page 227 of 391

228 Radiation Protection Program 7 Kaweah Delta Health Care District PREGNANCY DECLARATION FORM Kaweah Delta Health Care District PREGNANCY DECLARATION FORM Name of Employee: Name Date of Employee: supervisor Notified: Date supervisor Notified: Birthdate: SSN: Work Phone: Birthdate: SSN: Work Phone: Work Location: Work Location: Name of Supervisor/Principal Investigator: Name of Supervisor/Principal Investigator: Approximate Date of Conception: Approximate Date of Conception: Radionuclides: Radionuclides: Amounts: Due Date: Due Date: Forms: Forms: Radiation Emitting Devices: Amounts: Radiation Emitting Devices: Type of Dosimetry Worn: o Whole Body Badge o Collar o Ring o Wrist o Other Type of Dosimetry Worn: o Whole Body Badge o Collar o Ring o Wrist o Other Location of Dosimetry Worn: o Waist o Collar o Under Apron o Other Location of Dosimetry Worn: o Waist o Collar o Under Apron o Other Brief Description of Occupational Exposure: Brief Description of Occupational Exposure: Employee Signature: Employee Signature: Supervisor Signature: Supervisor Signature: Date: Date: Date: Date: B.D. Dose to Fetus Formatted: Font: (Default) Arial Page 228 of 391

229 Radiation Protection Program 8 Dose to the fetus is documented in the badge report. The report for this badge will be received and posted with the regular monthly reports. 4. Pregnant Patients A pregnant patient can receive radiotherapy depending upon the following factors: 1. The stage and aggressiveness of the tumor; 2. The location of the tumor; 3. Potential hormonal effects of pregnancy of the tumor; 4. Various therapies and their length, efficacy, and complications; 5. Impact of delaying therapy; 6. Expected effects of maternal ill-health on the fetus; 7. The stage of pregnancy; 8. Fetal assessment and monitoring; 9. How and when the baby could be safely delivered; 10. Whether the pregnancy should be terminated; 11. Legal, ethical, and moral issues. The fetal dose may be reduced if the following factors are kept in mind: The first consideration is if the treatment can be postponed until the fetus is at a later gestation age. If the decision is made that radiotherapy is necessary, it is important to calculate the dose to the fetus before the treatment is given. When external radiotherapy is used for treatment of tumors at some distance from the fetus, a very important factor in fetal dose is the distance from the edge of the radiation field. The American Association of Physicists in Medicine (AAPM) recommends that the following points be considered: 1. Complete all planning as though the patient were not pregnant. If the fetus is near the treatment beam, do not take portal localization films with open collimation and blocks removed. 2. Consider modifications to the treatment plan that would reduce the radiation dose to the fetus (e.g. changing field size, radiation energy). If possible use photon energies of less than 25 MV. 3. Estimate dose to the fetus using phantom measurements, a shield may be constructed with 4-5 half-value layers of lead. 4. Document the treatment plan and discuss it with the staff involved in patient set-up. Document the shielding (perhaps with a photograph). 5. Monitor the fetal size and growth throughout the course of treatment and reassess fetal dose if necessary. 6. On completion of treatment, document the total dose including the range of dose to the fetus during therapy. 7. Consider referring the patient to another institution if equipment 5. Area Monitoring and Control / Instrument Calibration and Maintenance A. Area Radiation Monitoring Radiation area monitoring is important to make sure exposure levels are within acceptable limit. It is also important that the radiation measuring instruments are Formatted: Indent: Left: 0" Formatted: Font: (Default) Arial Formatted: Indent: Left: 0" Formatted: Indent: Left: 0.19" Formatted: Indent: Left: 0" Formatted: Numbered + Level: 1 + Numbering Style: 1, 2, 3, + Start at: 1 + Alignment: Left + Aligned at: 0.25" + Indent at: 0.5" Formatted: Indent: Left: 0.25", First line: 0", Numbered + Level: 1 + Numbering Style: 1, 2, 3, + Start at: 1 + Alignment: Left + Aligned at: 0.25" + Indent at: 0.5" Formatted: Numbered + Level: 1 + Numbering Style: 1, 2, 3, + Start at: 1 + Alignment: Left + Aligned at: 0.25" + Indent at: 0.5" Formatted: Indent: Left: 0" Formatted: Numbered + Level: 1 + Numbering Style: A, B, C, + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.25", Widow/Orphan control, Adjust space between Latin and Asian text, Adjust space between Asian text and numbers, Tab stops: Not at 0.58" Formatted: Font color: Auto, Character scale: 100% Page 229 of 391

230 Radiation Protection Program 9 calibrated at periodic intervals and maintained properly. All electrometers and ionization chambers used in radiation output calibration are calibrated once every two years at Accredited Dose Calibration Laboratories (ADCL). They are K&S Associates, Inc. in Nashville, Tennessee. All survey meters are calibrated once annually by Sutter Health Medical Physics Center, Sacramento, CA Sealed sources possessed under the License shall be tested for leakage and/or contamination every six months, as required by Title 17, California Code of Regulations. The sources are Sr90 Pterygium and Co-57. The source Ir-192 is replaced in MHDR unit by Licensed Nucletron engineer and this happens five times per year. The source is leak-tested every time replacement takes place. B. Instrument Calibration and Maintenance The following calibration instruments and survey meters are used to perform QA measurements and surveysthe following calibration instruments and survey meters are used to perform QA measurements and surveys:: 1. Survey Meters a. Manufacturer s name: Ludlum, Manufacturer s model number: Model 3 (with model probe), Type of detector: Energy Compensated Thin Wall G-M Low Energy Scintillator, Number of instruments available:1, Minimum range: 0 mr/hr to 0.2 mr/hr, Maximum range: 0mr/hr to 200 mr/hr Formatted: Font color: Auto, Character scale: 100% Formatted: Font: (Default) Arial, 12 pt, Character scale: 100% Formatted: Font color: Auto, Character scale: 100% Formatted: Font: (Default) Arial, 12 pt, Font color: Auto, Character scale: 100% Formatted: Font: (Default) Arial, 12 pt, Character scale: 100% Formatted: Font: (Default) Arial, 12 pt, Character scale: 100% b. Manufacturer s name: Victoreen, Manufacturer s model number: 450, Type of detector: Ionization Chamber, Number of instruments available:2, Minimum range: 0 mr/hr to 0.l mr/hr, Maximum range: 0mr/hr to 5000 mr/hr c. Manufacturer s name: Ludlum, Manufacturer s model number: 14C (with model 44.9 probe), Type of detector: Pancake G-M, Number of instruments available:2, Minimum range: 0 mr/hr to 0.2 mr/hr, Maximum range: 0mr/hr to 2000 mr/hr 2. Dose Calibrator Manufacturer s name: Capintec Corp., Manufacturer s model number: CRC30BC, Number of instruments available: 1 3. Diagnostic Instruments Manufacturer s name: Siemens/Toshiba, Manufacturer s model number: E.Cam, Type of detector: Dual-Head Gamma Camera, Number of instruments available: 2 Formatted: Indent: Left: 0.5" 4. Ratemeter/Well Chamber Manufacturer s name: Ludlum, Manufacturer s model number: Scaler/Ratemeter 2200/203, Type of detector: Shielded Well Scintillator, Number of instruments available: 1 5. Room Monitor Page 230 of 391

231 Radiation Protection Program 10 Manufacturer s name: Ludlum, Manufacturer s model number: 177, Type of detector: End window G-M, Minimum range: 0 cpm to 500 cpm, Maximum range: 0cpm to 50,000 cpm, Number of instruments available: 1 All new sealed sources are ordered, received and delivered by RSO. The RSO will conduct a physical inventory every six months to account for all the sealed sources. Records of the inventories will be maintained for inspection. Any radioactive material with a physical half lifehalf-life of less than 65 days will be kept for decay in storage before disposal in ordinary trash provided (1) the radioactive waste to be disposed of in this manner shall be held in storage for at least half-lives livesand (2). bbefore disposal, radioactive waste will be surveyed to determine that the exposure shall not exceed the background level. C. Room Requirements All internal walls of rooms containing stationary radiation producing devices, such as stationary x-ray equipment will contain sufficient lead or lead composite material to prevent scattered radiation from leaving the area and thereby exposing other people in adjacent areas. All fixed radiation devices will have short exposure cables and switches preventing the operator from leaving the shielded area. A protective barrier is utilized to shield the control area for all fixed units. Operators must stand behind the protective barrier. Any x-ray unit malfunction (collimator malfunction, door interlock not working properly, etc.) should be reported immediately to the Administrative Director of Radiology or Supervisor. If the malfunction involves accidental/unwarranted exposure to a worker or patient the Radiation Safety Officer or Physicist will immediately be notified. After hours you will notify the Administrative Director or the Supervisor who will report the incident to the Radiation Safety Officer. There will be uniform and accepted radiation warning signs conforming to the prescribed format, posted throughout exposure areas. All doors of rooms containing radiation devices will be closed during radiological examinations. A viewing window should be used to observe the patient at all times. R Radiation devices will be equipped with collimation accessories which restrict the x-ray beam only to the part examined. Field size indicators should be referenced to determine collimation settings at various SID's. Calibration of diagnostic radiology equipment will be performed semi-annually by either the Biomedical Engineering department or a contracted service and confirmed at least annually by the Physicist according to state and/or federal regulations. A written calibration record will be kept. A radiation protection survey including calibration is also performed when radiologic equipment is initially installed, altered significantly, or relocated. Any x-ray unit malfunction (collimator malfunction, door interlock not working properly, etc.) should be reported immediately to the Administrative Director of Formatted: Bulleted + Level: 1 + Aligned at: 0.25" + Indent at: 0.5", Tab stops: 0.5", Left + Not at 2.13" Formatted: Bulleted + Level: 1 + Aligned at: 0.25" + Indent at: 0.5", Tab stops: 0.5", Left + 2.2", Left Formatted: Bulleted + Level: 1 + Aligned at: 0.25" + Indent at: 0.5", Tab stops: 0", Left + 0.5", Left + Not at 2.13" Formatted: Tab stops: 0.5", Left + 2.2", Left + Not at 2.13" Formatted: Tab stops: 0.5", Left + Not at 2.13" Formatted: Bulleted + Level: 1 + Aligned at: 0.25" + Indent at: 0.5", Tab stops: 0.5", Left + Not at 2.13" Formatted: Tab stops: 0.5", Left + Not at 2.13" Formatted: Tab stops: 0.5", Left + 2.2", Left Page 231 of 391

232 Radiation Protection Program 11 Radiology or Supervisor. If the malfunction involves accidental/unwarranted exposure to a worker or patient the Radiation Safety Officer or Physicist will immediately be notified. After hours you will notify the Administrative Director or the Supervisor who will report the incident to the Radiation Safety Officer. Formatted: No bullets or numbering D. Lead Shielding Devices All leaded gloves, aprons and other shielding devices used will be checked at least annually for signs of cracks, tears, or other damage which might result in radiation leakage. Such inspections will be documented by a Physicist report. The apron should first be visually examined for any obvious defects such as torn straps, ripped covering, and tears or holes in the lead equivalent material. If there are any such defects, the aprons are to be removed from service and repaired or replaced as necessary. Aprons that are visually satisfactory should be examined under fluoroscopy to determine existence of any defects that would unknowingly increase exposure to ionizing radiation. Such inspections will be documented by a Physicist report Any aprons that are determined to be unsatisfactory shall be removed from service. Radiographic film, intensifying screens, and other image recording devices should be as sensitive as is consistent with the requirement of the film manufacturer, the equipment manufacturer and the examination. Film processing materials and techniques should be those recommended or determined acceptable by the film manufacturer to insure maximum information content of the developed radiographs and, where practical, quality control methods should be employed to insure optimum results according to manufacturer s recommendations. E. Image Recording Devices F. Fluoroscopy Proper use and storage of dosimetry devices will be defined by the facility Radiation Safety Committee. Fluoroscopy will not be used as a substitute for radiography, but will be reserved for the study of dynamics or spatial relationships or for guidance in spot-film recording of critical details or for interventional radiology procedures. Guidelines for the fluoroscopist: The exposure rate in fluoroscopy should be as low as is consistent with the fluoroscopic requirements and shall not exceed 10 R/min measured at the position where the beam enters the patient. The smallest practical field sizes and shortest exposure times should be employed. The possibilities of reducing dose by techniques utilizing high tube potential and low current should be considered. Fluoroscopy should be performed only by or under the immediate supervision of physicians properly trained in fluoroscopic procedures. Extraneous light which interferes with the fluoroscopic examination should be eliminated. Special precautions, consistent with clinical needs, should be taken to minimize exposure of the gonads of potentially procreative patients and exposure of the embryo or fetus in patients known or suspected to be pregnant. Protective lead aprons of at least 2.5 mm lead equivalent should be worn by Formatted: Numbered + Level: 1 + Numbering Style: A, B, C, + Start at: 5 + Alignment: Left + Aligned at: 0" + Indent at: 0.25", Tab stops: 0.25", Left + Not at 2.13" Formatted: Bulleted + Level: 1 + Aligned at: 0.25" + Indent at: 0.5", Tab stops: 0.5", Left + Not at 2.13" Formatted: Bulleted + Level: 1 + Aligned at: 0.25" + Indent at: 0.5", Tab stops: 0.5", Left + Not at 2.13" Page 232 of 391

233 Radiation Protection Program 12 each person (except the patient). The hand of the fluoroscopist should not be placed in the useful beam unless the beam is attenuated by the patient and a protective glove of at least 2.5 mm lead equivalent is worn. Only persons whose presence is needed should be in the fluoroscopy room during the procedure. Patients: All radiographic examinations will be performed only when they conform to accepted clinical indications, or in cases requiring clarification the Radiologist and/or the ordering Physician will be questioned. Diagnostic examinations will be performed with such technical factors as to minimize exposure to diagnostic radiation and still satisfy the need for the desired information. All female patients of child bearing age will be questioned regarding the possibility of pregnancy prior to any exam. Gonad shields are to be provided for all children, young adults and females of child bearing age within the limitations of the examination desired. These general Radiation Safety Guidelines will be applicable throughout the medical facility. Any modifications requested must be referred to the Radiation Safety Officer, the Medical Director of Radiology or the Administrative Director of Radiology. Be sure you understand the studies requested. This will avoid retakes and unnecessary exposure to you and your patient. Advise unit personnel and requesting physicians when an x-ray request is a suspected duplicate to avoid necessary exposure. Advise the Director, Supervisor or the Radiologist of any requests that may seem excessive. Formatted: Indent: Left: 0.5", Tab stops: 0.5", Left + Not at 2.13" Formatted: Indent: Left: 0.25", Tab stops: 0.5", Left + Not at 2.13" Formatted: Bulleted + Level: 1 + Aligned at: 0.25" + Indent at: 0.5", Tab stops: 0.5", Left + Not at 2.13" Formatted: Indent: Left: 0.5", Tab stops: 0.5", Left + Not at 2.13" Formatted: Indent: Left: 0.25", Tab stops: 0.5", Left + Not at 2.13" 6. Radiological Controls A. Entry and Exit Controls Entry to controlled areas is managed by designated employees involved in radiation treatment or diagnostic procedures. Radiation warning signs also control the flow of radiation workers, public or patients. The emergency exit routes take personnel or other people through a path not going through controlled areas. B. Posting Signage will conform to NRC regulations. The Caution-Radiation Area sign bearing the radiation symbol will be posted just outside the room that either produces radiation or houses radioactive material. The Department manager is responsible to make sure that the appropriate radiation warning sign is posted. Formatted: Numbered + Level: 1 + Numbering Style: A, B, C, + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.25" Formatted: Indent: Hanging: 0.02", Tab stops: 0.56", Left Formatted: Numbered + Level: 1 + Numbering Style: A, B, C, + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.25", Tab stops: 0.56", Left Formatted: Numbered + Level: 1 + Numbering Style: A, B, C, + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.25" The two primary reasons for radiological posting are Page 233 of 391

234 Radiation Protection Program 13 to inform workers of the area s radiological conditions, and to inform workers of the entry requirements for the area. In order to maintain exposure to radiation ALARA, access to areas or devices in which one can receive more than 100 mrem per year is restricted. Areas controlled for radiological purposes must be posted with a black or magenta standard three-bladed radiological warning symbol. Postings and barriers must be clearly visible from all accessible directions. Postings on doors should remain visible when doors are open or closed. Postings should state the radiation dose rate and the entry requirements. If more than one radiological hazard exists in an area, the posting should identify each hazard. Postings that indicate an intermittent radiological condition should include a statement specifying when the condition exists such as; for example, when a red light is on. The same posting requirements apply for x-ray or gamma radiation as for any other type of radiation. The following documents are required to be posted: 1. A current copy of the 17 CCR, incorporated sections of 10 CFR 20, and a copy of operating and emergency procedures applicable to work with sources of radiation (If posting of documents specified above is not practicable, the registrant may post a notice which describes the document and states where it may be examined.) 2. A current copy NOTICE TO EMPLOYEES in a sufficient number of places to permit individuals working in or frequenting any portion of a restricted area to observe a copy on the way to or from such area. The following is copy of Notice to Employees : 3. Any notice of violation involving radiological working conditions or any order issued pursuant to the Radiation Control Law and any required response from the registrant. The following is copy of Notice to Employees : CALIFORNIA DEPARTMENT OF PUBLIC HEALTH NOTICE TO EMPLOYEES Formatted: Font: (Default) Arial, 12 pt Formatted: Normal, Pattern: Clear Formatted: Font: (Default) Arial, 20 pt, Bold Page 234 of 391

235 Radiation Protection Program 14 STANDARDS FOR PROTECTION AGAINST RADIATIONCALIFORNIA RADIATION CONTROL REGULATIONS (CALIFORNIA CODE OF REGULATIONS, TITLE 17, SECTION 30255) The California Radiation Control Regulations include standards for protection against radiation hazards. The State Department of Public Health has primary responsibility for administering these standards which apply to both employers and employees. Enforcement is carried out by the Department of Public Health or its authorized inspection agencies. EMPLOYEES RESPONSIBILITIES You should know and understand those California radiation protection standards and your employer s operating and emergency procedures which apply to your work. You should comply with these requirements for your own safety and the safety of others. Report promptly to your employer any condition which may lead to or cause a violation of these standards or employer s operating and emergency procedures. SCOPE OF THE STANDARDS The Standards for Protection Against Radiation define: 1. Limits on exposure to radiation and radioactive materials; Formatted: Normal, Line spacing: single, Pattern: Clear Formatted: Font: (Default) Arial, Bold Formatted: Font: (Default) Arial, 10 pt, Bold Formatted: Font: Arial, Bold Formatted: Font: (Default) Arial, 10 pt, Bold Formatted: Font: (Default) Arial, 12 pt Formatted: Font: (Default) Arial, 12 pt, Bold Formatted: Font: (Default) Arial, 12 pt Formatted: Font: (Default) Arial, 12 pt, Bold Formatted: Font: (Default) Arial, 12 pt Formatted: Normal, Pattern: Clear 2. Actions to be taken after accidental exposure; 3. Working conditions requiring personnel monitoring, safety surveys, engineered controls, and safety equipment; 4. Proper use of caution signs, labels, and safety interlock devices; 5. Requirements for keeping worker exposure records and reporting of such exposures; 6. The requirement for specific operating and emergency procedures for radiation work; and 7. The rights of workers regarding safety inspections. EMPLOYERS RESPONSIBILITIES Your employer is required to: 1. Comply with the requirements of the California Radiation Control Regulations, departmental orders, and license conditions; Formatted: Normal, Left, Line spacing: single, Pattern: Clear Formatted: Font: (Default) Arial, 12 pt, Bold Formatted: Font: (Default) Arial, 12 pt Formatted: Normal, Pattern: Clear 2. Post or make available to you copies of the Radiation Control Regulations, any license issued there under, and your operating and emergency procedures; 3. Post any notice of violation of radiological working conditions; and 4. Provide you with information on your exposure to radiation. Formatted: Normal, Left, Line spacing: single, Pattern: Clear Page 235 of 391

236 Radiation Protection Program 15 REPORTS ON YOUR RADIATION EXPOSURE HISTORY 1. California Radiation Control Regulations require your employer to give you a written report if you receive an exposure greater than the limits set in the radiation safety standards. Basic limits for occupational radiation exposure can be found in Section referencing title 10, Code of Federal Regulations, part 20. Limits on exposure to radiation and exposure to concentrations of radioactive material in air are specified in title 10, Code of Federal Regulations, part 20, subpart C. 2. If the radiation protection standard, under 10 CFR 20 (subpart F) requires that your radiation exposure be monitored, your employer must, upon your request, (a) give you a written report of your exposures upon termination of your employment, and (b) advise you of your exposures annually. INSPECTIONS The Department or one of its contractors will inspect your workplace from time to time to ensure that health and safety requirements are being followed and that these requirements are effective in protecting you. Inspectors may confer privately with you at the time of inspection. At that time you may direct the inspector s attention to any condition you believe is or was a violation of the safety requirements. In addition, if you believe at any time that any health and safety requirements are being violated, you or your workers representative may request that an inspection be made by sending a complaint to the Department of Public Health or other official agency. Your complaint must describe the specific circumstances of the apparent violation and must be signed by you or your workers representative. The Department is required to give your employer a copy of any such complaint. Names may be withheld at your request. You should understand, however, that the law protects you from being discharged or discriminated against in any way for filing a complaint or otherwise exercising your rights under the California Radiation Control Regulations. POSTING REQUIREMENTS Copies of this notice must be posted in a sufficient number of places in every establishment where employees are employed in activities regulated by the California Radiation Control Regulations, to permit employees working in or frequenting any portion of a restricted area to observe a copy on the way to or from their place of employment. FOR RADIOLOGICAL EMERGENCY ASSISTANCE (24/7), PHONE To contact the Radiologic Health Branch, phone (916) or go to: C. Disposal of Equipment KDHCD shall report in writing to the Department the sale, transfer, or discontinuance of use of any reportable source of radiation. We are governed by the following rules in this regard: Formatted: Font: (Default) Arial, 12 pt, Bold Formatted: Font: (Default) Arial, 12 pt Formatted: Font: (Default) Arial, 12 pt, Bold Formatted: Font: (Default) Arial, 12 pt Formatted: Font: (Default) Arial, 12 pt, Bold Formatted: Font: (Default) Arial, 12 pt Formatted: Font: (Default) Arial, 12 pt Formatted: Font: (Default) Arial, 12 pt, Bold Formatted: Font: (Default) Arial, 12 pt Formatted: Font: (Default) Arial, 12 pt, Font color: Auto Formatted: Font: 12 pt Formatted: Numbered + Level: 1 + Numbering Style: A, B, C, + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.25" We shall report the final disposition of the X-ray machine on the Radiation Machine Registration form (RH2261). Documentation on service reports evidencing Page 236 of 391

237 Radiation Protection Program 16 disassembly or disabling of the machine, photos, sales contract, etc. will be furnished. We shall clearly demonstrate the disposition of the X-ray machine. Continued registration is required for X-ray machines that are not used but are physically present in a facility or are in storage. This guidance does not apply to particle accelerators. Although there is no residual radiation, there may be environmental restrictions on what components may go into a land-fill after disassembly, such as chemical contaminants in cooling oil. Any hazardous materials should be disposed of by appropriately licensed companies or authorities. We shall follow the disposal instructions provided by the manufacturer in the product manual, and/or contact the manufacturer for information and guidance. Formatted: No bullets or numbering When manufacturer guidance is not available: The X-ray machine components may be returned to a commercial X-Ray machine assembler or vendor; or The X-ray machine may be totally disabled and the components sold as scrap metal or disposed of according to our county s environmental requirements; or The X-ray machine may be rendered non-functional by disassembly and/or component removal such that repair and use may not be readily affected. Other Controls We shall evaluate the need for other controls in addition to those mentioned above. The following items will be considered: 1. Types of controls used to reduce or control exposure to radiation, such as positioning aids, gonad shielding, protective aprons, protective gloves, mobile shields, etc. 2. Procedures for routine inspection/maintenance of such controls. 7. Emergency Exposure Situations and Radiation Accident Dosimetryand Misadministration Events Formatted: Indent: Left: 0.25", Bulleted + Level: 1 + Aligned at: 0.5" + Indent at: 0.75", Tab stops: 0.5", Left + Not at 0.81" Formatted: Indent: Hanging: 0.5", Bulleted + Level: 1 + Aligned at: 0.5" + Indent at: 0.75" Formatted: Indent: Left: 0.06", Hanging: 0.31" Emergency exposure situations include radiation diagnostic machines such as X- ray machines, CT, fluoroscopy, mammography, linear accelerators, HDR unit and treatments/diagnostic procedures involving radioactive materials. Radiation accident is defined as incident where a radiation dose different from prescribed dose is delivered to patient. An incident report is generated citing causes that resulted in the overexposure. These incident reports function as valuable guide in preventing future occurrences. Misadministration means the administration of radiation therapy to wrong patient, an external treatment dose when the treatment consists of three or fewer fractions and the administered dose differs from the prescribed dose by more than 10%, or when the weekly doses differ by 30%, or total doses differ by 20%. In case of misadministration, the licensee must notify CDPH Radiation branch by telephone no later than the next calendar day. The licensee must submit a written Page 237 of 391

238 Radiation Protection Program 17 report within 15 days of the misadministration. The referring physician and the patient are notified within 24 hours, unless the physician takes the responsibility Of informing the patient. A written report should be sent to the patient within 15 days. 8. Record Keeping and Reporting We commit to comply with regulations governing record keeping and reporting. We shall maintain all records of the Radiation Protection Program, including annual program audits and program content review. The person responsible for maintaining all required records is the respective Department manager, who maintains it in paper form or computer file. The format is governed by the KDHCD on-line documentation. Mobile providers keep their own records that we have access to. 9. Reports to Individuals The KDHCD shall provide reports of individual exposure when requested in accordance with 17 CCR Monthly radiation badge report resides with each individual department after RSO completes the review. This report shall be posted in all applicable departments. Any employee getting exposure above the ALARA limits will be notified of the exposure, giving chance for the manager to reallocate the work site for that particular employee Radiation Safety Training A. Operating and Safety Procedures All machines have operating and safety procedure manual that resides with the machine. These safety procedures will be posted on the machine or where the operator can observe them while using the machine. All safety standards and procedures will be observed and practiced by employees as required by the California State department of Health, Title 17, for their own safety and that of the general public and patients. When new equipment is acquired, staff responsible for treatment use will be trained with either manufacturer on site or off-site or by radiation therapist or radiographer who has undergone training. Annual safety training is provided at the HDR machine. Any training including continuing education received by the staff will be documented. B. Occupational Workers KDHCD shall: 1. Inform all individuals working in or frequenting any portion of a controlled Formatted: Indent: Hanging: 0.19", Numbered + Level: 1 + Numbering Style: A, B, C, + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.25", Tab stops: 0.38", Left + Not at 0.57" Formatted: Indent: Left: 0.33", Right: 0.12", Space Before: 0 pt, Line spacing: single Formatted: Not Expanded by / Condensed by Formatted: Numbered + Level: 1 + Numbering Style: A, B, C, + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.25", Tab stops: 0.31", Left Formatted: Indent: Left: 0" Page 238 of 391

239 Radiation Protection Program area of the use of radiation in such portions of the controlled area; 2. Instruct such individuals in the health protection problems associated with exposure to radiation, in precautions or procedures to minimize exposure, instruct such individuals in, and instruct them to observe, to the extent within their control, the applicable provisions of Department regulations for the protection of personnel from exposures to radiation occurring in such areas; 3. Instruct such individuals of their responsibility to report promptly to the manager any condition which may lead to or cause a violation of department regulations or unnecessary exposure to radiation, and of the inspection provisions of 17 CCR 30254; 4. Instruct such individuals in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation and advise such individuals as to the radiation exposure reports which they may request pursuant to 17 CCR Quality Assurance Programs Quality Assurance checks at the treatment machines include daily checks, monthly checks and annual checks. Radiation checks and mechanical checks are performed. The checks are reviewed by the Physicist and appropriate action taken. These actions could be either in-house or in consultation with the machine vendor. A. Radiation Therapy We Kaweah Delta Health Care District commits to the policies practices as narrated below, in order to reduce unwanted exposures to patients and prevent any misadministration: 1. We do daily checksrequired QA I performed on each unit to insure their radiation output is within specified range. 2. We do more ddetailed monthly physics checks are performed monitoring beam output, symmetry and energy on radiation therapy units. 3. We do mmonthly mechanical checks oon the radiation therapy machines units are completed to assure various parameters appearing in the patient treatment are within acceptable tolerance. 4. We do a very Perform thorough annual calibration of our radiation machines, confirming data residing in our treatment planning system. 5. We do TLD checks on the radiation therapy machineunitss, which are independently verified by a RPC, Formatted: Indent: Hanging: 0.33" Formatted: Indent: Left: 0" Formatted: Indent: Left: 0" Formatted: Numbered + Level: 1 + Numbering Style: A, B, C, + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.25" Formatted: Indent: Left: -0.02" Page 239 of 391

240 Radiation Protection Program a federally funded agency 6. CconfirmConfirm the accuracy of our treatment planning systems by comparing their numbers with an independent manual calculation for each and every patient 7. Confirm the accuracy of dose delivery by a device called diode placed on patient s treatment site during treatment. 8. Perform kv images and portal images (MV) during treatment, confirming the location of treatment, as part of our Image Guided Radiation Therapy (IGRT). 9. Respiratory gating, part of IGRT, which enables beam cut off in the event treatment target wanders off the designated location. 10. Monitor and review of treatment errors and discuss them in our technical meeting as part of continuing education of our staff. Formatted: Numbered + Level: 1 + Numbering Style: 1, 2, 3, + Start at: 1 + Alignment: Left + Aligned at: 0.29" + Tab after: 0.54" + Indent at: 0.54" 12. Internal Audit Procedures We commit to audit the Radiation Protection Program on an annual basis. Documentation of the annual audits may be requested during inspection. KDHCD has right and obligation to contact the Radiologic Health Branch of the Department of Public Health of California for clarification on radiation protection issues. The address is as follows: Department of Public Health Radiologic Health Branch P.O. Box , MS-7610 Sacramento, CA Formatted: Right: 2.44" Page 240 of 391

241 Policy Submission Summary Date: 7/12/2017 Manual Title: Mental Health Support Staff Name: Kathryn Tunstall Policy / Procedure Title # Status (New, Revised, Reviewed or Deleted) Name and Phone # of person who wrote new policy or revised an existing policy Tarasoff - Duty to Warn and Protect MH Revised Don Myers (559) Page 241 of 391

242 Mental Health Policy Number: MH Date Created: 02/06/2017 Document Owner: Kathryn Tunstall (Administrative Date Approved: Not Approved Yet Assistant) Approvers: Board of Directors (Administration); Board of Directors (Mental Health); Laufer, Mary; Moccio, Cindy; Saadabadi, Abdolreza; Tunstall, Kathryn Tarasoff - Duty to Warn and Protect Printed copies are for reference only. Please refer to the electronic copy for the latest version. Policy: All Kaweah Delta clinicians and health care providers who are mandated reporters will and will comply*** CHn with the legal and ethical requirements set forth in Tarasoff v. Regents of the University of California (Civil Code Section 43.92) to warn and protect third parties threatened with bodily harm by a patient. Procedure: I. Any employee who receives communication from a patient, has been communicated by a pclose family member of the patient or a credible third party has communicatedof a patient s serious threat (which must be imminent in order to be serious) of imminent physical violence to a reasonably identifiable intended victim(s) completes the following: i. will ccontacts Therapists have a duty to protect when the patient, a close family member of the patient or a credible third party has communicated to hospital staff the patient s serious threat (which must be imminent in order to be serious) of physical violence to a reasonably identifiable (intended ) victim(s). The duty to warn and protect entails Patient & Family Services ( Patient & Family Services (PFS)) staff to further assess and, ii. ifif deemed credible, PFS completes a Tarasoff Report will bethat will includes completion of Duty to Warn assessment, and if deemed credible, making reasonable efforts to communicate the threat to the intended victim(s)victim(s) and to a law enforcement agency. Assessment of credibility of threat may include the use of the ACTION: Threat Assessment Tool for Violence [See Attachment A] Formatted: Indent: Left: 1" Upon PFS completion of Duty to Warn threat assessment and determination of credible threat to specified othernotification or witnessing patient threat of violence, patient family services (PFS) staff will: A. PFS places phone call to warn intended victim(s), as soon as possible and prior to discharge of patient, using available phone contacts (call PBX for hospital staff and physician phone contact numbers) at least 3 times or until confirmation from intended victim(s) that warning was received. If Page 242 of 391

243 confirmation of receipt of warning is not received from intended victim(s), prior to patient discharge, PFS contacts Risk Management for consultation. A.B. PFS places phone call to the police department or other local law enforcement agency with jurisdiction of the patient s residence and or residence of the intended victim s(s), place of residence and. Then then fffaxess pertinent information to the law enforcement agency (Attachment AB). i. PFS Dentersocument contact names, badge number, and and contact information in the clinical record. B.ii. PFS sends a certified letter (Attachment AB) to intended victim(s) no later than by the next day mail service.he.o Visalia Police Department, including name and credentials of person taking the report. PFS mmails certified letter (Attachment A)s stating hospital concerns to the intended victim(s)victim(s) and the law enforcement agencypolice department. C. PFS is responsible for follow-up communication or requests for additional information by intended victim(s) and/or law enforcement. D. PFS maintains a binder at the nurses station for reference by charge nurse or designee should the intended victim(s) and/or law enforcement call for more information outside of PFS business hours. The following documents are filed in the binder: i. Fax transmission log from law enforcement agency notification ii. Copy of letter sent to intended victim(s) iii. Proof of certified letter sent by next day mail service to intended victim(s) to place copy of letter to intended victim(s) in a binder to be maintained at the nursing station for reference by charge nurse or designee should the intended victim(s) and/or law enforcement call for more information outside of PFS business hours. E. Disclosures to the intended victim(s) are handled discretely, toward protecting the privacy of the patient, yet bewhile compatible with the intent to protect the intended victim(s). DDetails about the threat that may be conveyed to intended victim(s) to include (in patient s own words as appropriate): i. datedate, time and location when and where threat made; ii. nname and address of patient; iii. meansmeans (knife, firearm, explosives, etc.) of harm; Formatted: No bullets or numbering Formatted: Font: (Default) Arial, 12 pt Formatted Formatted: List Paragraph, No bullets or numbering Formatted: List Paragraph, No bullets or numbering Formatted: Font: (Default) Arial, 12 pt Formatted Formatted: No bullets or numbering Formatted: Indent: Left: 0.75", No bullets or numbering Formatted: List Paragraph, No bullets or numbering Formatted: List Paragraph, No bullets or numbering Formatted: Numbered + Level: 2 + Numbering Style: i, ii, iii, + Start at: 1 + Alignment: Left + Aligned at: 1" + Indent at: 1.25" Page 243 of 391

244 iv. pplan (location, date, time); and, C.v. aanticipated discharge date may be conveyed to intended victim(s). In general, HIPAA prohibits the disclosure of protected health information unless it meets one of the HIPAA regulatory exceptions set forth in 45 CFR (j). After the mass shootings in Newtown, Connecticut, and Aurora, Colorado, the U.S. Department of Health and Human Services released a letter to all healthcare providers making them "aware" that HIPAA does not prevent them from disclosing information about a patient they believe presents a "serious danger to himself or other people." The letter further clarifies that the provider is "presumed to have had a good faith belief when his or her belief is based upon the provider's actual knowledge (i.e., based on the provider's own interaction with the patient) or in reliance on a credible representation by a person with apparent knowledge or authority (i.e., based on a credible report from a family member of the patient or other person)." The letter specifically provides as an example a mental health professional whose patient has made a credible threat to inflict serious and imminent bodily harm on one or more individuals. ( F. Documentation of assessment risk: D. PFS documents all actions taken and enters information into the patient's medical record (e.g., what was said in therapy, any threats made by the patient, how violence was assessed, the reasoning behind a decision to take or not take action). i. Concerns or discussions of issues regarding clientpatient danger to others ii. Patient history of violence, psychiatric hospitalizations, substance abuse and impulsivity iii. Conclusions drawn from mental status exam iv. Clinician s thought process, what was done or not done, and the reasoning behind those decisions. iv.g. PFS completes event notification in MidasMIDAS for unusual clinical or notification concerns. II. Other Considerations If a clinician decides not to issue a warning related to a possible threat, either because the report of a threat is not believed or the threat itself is not deemed serious, the clinician will documents in the patient s record the facts and reasoning supporting the decision not to issue a warning, including consultation with physician and other clinicians. PFS arranges for consultation of Risk Management in cases where there is no consensus on decision not to report. A. The Presidential Threat Protection Act. It is a crime to threaten the president of the United States and other protectees. Therapists Formatted: Indent: Left: 1.25" Formatted: Indent: Left: 0.75", No bullets or numbering Formatted: Indent: Hanging: 0.25" Formatted: Indent: Left: 1" Formatted: Numbered + Level: 1 + Numbering Style: A, B, C, + Start at: 1 + Alignment: Left + Aligned at: 0.5" + Indent at: 0.75" Formatted: Numbered + Level: 1 + Numbering Style: A, B, C, + Start at: 1 + Alignment: Left + Aligned at: 0.5" + Indent at: 0.75" Formatted: List Paragraph, Indent: Left: 1.25", No bullets or numbering Formatted: Indent: Left: 1", No bullets or numbering Formatted Formatted: Indent: Left: 0.5", No bullets or numbering Page 244 of 391

245 must assess the seriousness of the threat and whether the individual has taken overt actions and decide when to contact the Secret Service. Although the federal threat statute (18 USC 871) simply states that a "threat" is enough to trigger the statute, therapists determine seriousness of threat through clinical assessment should make some sort of clinical assessment as to the threat's seriousness before contacting the Secret Service, who will conduct their own violence risk assessment or investigation and decide whether to prosecute that person (Zitek et al.). II. *If you as a mandated reporter believe that a report should be made, but the Social Worker thinks that a report is not necessary, then YOU, as a mandated reporter are still required to report utilizing the format as specified in this policy. Formatted: Indent: Left: 1", No bullets or numbering Formatted: Indent: Left: 0.5", No bullets or numbering Formatted: Indent: Left: 0.25", No bullets or numbering "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 245 of 391

246 MH Appendix A ACTION: Threat Assessment Violence A Guideline Appraisal of risk in a Tarasoff situation would be better guided by a method that is primarily fact-based and deductive rather than by the more formal risk assessment approach for general violence. Using the acronym ACTION, the following six areas of inquiry guide the appraisal of risk (Borum & Reddy, 2001): A Attitudes that support or Does the client believe that the use of violence is justified under facilitate violence the circumstances? C Capacity Does the patient have the ability to carry out the type of violent act threatened? Does the patient have the physical and intellectual capacity, access to means (such as weapons), access to target (perhaps the target is particularly vulnerable to attack when walking home alone), and opportunity to commit the act? T Thresholds crossed Is the patient engaging in behaviors that further the plan, especially behaviors that involve breaking the law, such as violating a court's temporary restraining order? What steps has the patient already taken to further that plan? For example, has the patient secured or practiced with weapons, followed or stalked the target, or made a will and given away personal items? I Intent Does the plan convey information, such as specificity or access to means to carry out the plan, which allows inference of intent? Do other directly observed behaviors, such as expressing a willingness to die or be incarcerated or expressions of "nothing to lose" or a lack of options, indicate a commitment to action? O Others' reactions Has the patient talked to anyone about the plan for violence? If so, have others discouraged or condemned the plans, offered no judgment, or supported or escalated the violent idea? N Noncompliance with risk reduction interventions How willing is the patient to participate in interventions to reduce or mitigate the risk? Is the patient taking prescribed medications? Borum, R., & Reddy, M. (2001). Assessing violence risk in Tarasoff situations: A fact-based model of inquiry. Behavioral Sciences and the Law, 19, ( ). Retrieved from MH rev Page 246 of 391

247 Today s Date To: Address: Phone #: Date and Time of Attempted Phone Contact Initial Attempt: 2 nd Attempt: 3 rd Attempt: Kaweah Delta has sent this notice to you in compliance with State law that requires us to notify you of credible threats of harm made by persons while under our care. This notice is generally referred to as a Tarasoff Warning and this notice is made to both the intended victim and the local law enforcement agency of the address of record of the intended victim(s) and/or person making threat. Law Enforcement Report Agency Name: Name/Badge # of Person Taking Report: Contact Phone #: Date and Time of Report: Person who Made Threat Name: Address: Intended victim received verbal warning by staff member / Date: Intended victim was sent Tarasoff Warning letter by Date: We are required to contact you by telephone and by certified mail to advise you of credible threats to harm you. We make every effort to contact you by phone; however, accurate phone contact information may not be known or available. The specific threat follows: Date, time and location the threat was made: Content of threat (in verbatim words of person making threat, as possible) to include date, time and location of threat, means of threat and plan: Estimated Discharge Date: (Print Name, Credentials) (Signature) (Date) (Time) Kaweah Delta Health Care District Tarasoff Warning Contact Phone # (559) (Business Hours) or after business hours. MH rev Page 247 of 391

248 Policy Submission Summary Manual Name: Renal Services Date: 6/21/17 Support Staff Name: Nicole Rhodes Routed To: Approved By: (Name/Committee Date) Department Director Medical Director (if applicable) Medical Staff Department (if applicable) Patient Care Policy (If applicable) Pharmacy & Therapeutics (if applicable) Interdisciplinary Practice (if applicable) Executive Team (if applicable) Medical Executive Committee (if applicable) Board of Directors Jon Knudsen Roger Haley Status Name and phone number Policy/Procedure Title # (New, Revised, of person who wrote the Reviewed, Deleted) new policy or revised an existing policy Blood Transfusion During Dialysis RS-L.06 Revised Darrell Chudej Cathy Gage-Ivers RS-L.14 Revised Darrell Chudej Cathy Gage-Ivers Chronic Outpatient Assessment During Hemodialysis Cannulation of New Fistula RS-L.24 Revised Darrell Chudej Cathy Gage-Ivers Rinseback Technique RS-L.44 Revised Darrell Chudej Cathy Gage-Ivers Dialysis Blood Flow Rate Management RS-L.56 Revised Darrell Chudej Cathy Gage-Ivers Exterior Cleaning of Hemodialysis Equipment RS-N.16 Revised Darrell Chudej Cathy Gage-Ivers Patients at Risk for Involuntary Discharge RS-Q.03 Revised Darrell Chudej Cathy Gage-Ivers Communication with ESRD Network 18 RS-Q.02 Reviewed Darrell Chudej Cathy Gage-Ivers Page 248 of 391

249 Chronic Dialysis Policy Number: RS-L.06 Date Created: 06/02/1997 Document Owner: Nicole Rhodes (Database Date Approved: Not Approved Yet Reporting Analyst) Approvers: Board of Directors (Administration), Jon Knudsen (Dir of Renal & Oncology Svcs), Nicole Rhodes (Database Reporting Analyst), Roger Haley (Medical Director), Tariq Javed (MD) Blood Transfusion During Dialysis Printed copies are for reference only. Please refer to the electronic copy for the latest version. Policy: To safely administer blood transfusion in conjunction with KDHCD policy CPPC.28 IV Therapy: Transfusion of Blood, and Blood Components, while patient is on hemodialysis. Procedure: I. Type and Cross match will be obtained up to 72 hours before blood transfusion is given and is part of the order for transfusion (i.e. separate order for type and cross match is not needed). A. An armband will be placed on the patient s wrist prior to lab collection. The armband will contain a unique 4-digit number. This is an identifier for the patient and the blood to be given. Without this number, the lab will not process the blood. B. Patient will be instructed not to remove this armband until transfusion is complete. AC. Collection of the 7-ml pink top blood bank tube will be drawn be drawn at initiation of dialysis by the registered nurse at chair or bedside and verified by another RN. They will both initial the tube for verification of the unique 4-digit number. The unique 4 digit number must be handwritten on the lab tube patient label for verification and sent to the laboratory. B An armband will be placed on the patient s wrist, which includes a 4-digit number. This 4-digit number must be handwritten on the lab tube C. This is an identifier for the patient and the blood to be given. Without this number, the lab will not process the blood. D. In the chronic setting the armband must remain on the patient until the day of the transfusion. Formatted: Font: Not Bold Formatted: Font: Not Bold Formatted: Font: Not Bold Formatted: Font: Not Bold II. Ensure that the physician has informed the patient of the need for a blood transfusion and has discussed the possible reactions, which might occur as a result. Give the patient the pamphlet, If You Need Blood and have the patient sign the consent. The blood consent is available in English and Page 249 of 391

250 Blood Transfusion During Dialysis 2 Spanish. If the patient is unable to sign the patient s care taker or significant other may sign. III. On the day of transfusion, two licensed staff, one being the transfusionist, will check the identifying information on the blood bag against the information on the lab blood slip, and the patient s armband. Both licensed staff/registered nurses will complete the lab slip. IV. Take the patient s vital signs and record the temperature, pulse, and blood pressure on the lab blood slip. Document in the patient s electronic record the vital signs and the unit number of the blood bag. V. Wearing gloves spike the blood IV pump set to administration port of the blood bag using care not to contaminate or to puncture side of bag. VI. VII. VIII. IX. Prime the administration blood infusion set with the blood squeezing the drip chamber so that the blood is above the filter. Prime tubing with blood to end of the IV line. Ref Policy PC.28 IV Therapy: Transfusion of Blood & Blood Components Clamp the administration line and place tubing in IV pump. Attach the blood administration line to the arterialsaline pig tail port. The blood must be infused via the arterial port to run through the dialyzer to remove excess potassium. Blood may be infused in no less than 45 minutes and no longer than 2 hours while on dialysis. Blood and packed cells held in the dialysis facility for more than four (4) hours are considered contaminated. Packing blood box cooler must remain sealed. X. Infuse the first 50 ml slowlyslowly over a period of 15 minutes. Observe the patient for the first 15 minutes of the transfusion. Ref Policy PC.28 IV Therapy: Transfusion of Blood & Blood Components X. Comment [JK1]: May want to simply instruct to follow lab s infusion guidelines Formatted: No bullets or numbering XI. XI. Monitor vital signs and assess patient after the first 5 minutes of the transfusion, 10 minutes later, then every 30 minutes x 2. Continue vitals signs hourly until unit is finished. Record vital signs at each interval. Document on the blood bag slip and the electronic medical record the patient s vital signs for each interval. Continue to observe and assess patient every 30 minutes during transfusion. Since some blood reactions are delayed, continue to observe patient up to one-hour post transfusion. Make sure to record any adverse findings in electronic medical record. Once the transfusion has started, obtain vital signs at the frequency noted on the Transfusion Record. Formatted: Outline numbered + Level: 1 + Numbering Style: I, II, III, + Start at: 1 + Alignment: Left + Aligned at: 0" + Tab after: 0.5" + Indent at: 0.5", Don't hyphenate Formatted: Indent: Left: 0.5", Don't hyphenate Page 250 of 391

251 Blood Transfusion During Dialysis 3 1. Licensed nurse should monitor for any changes in vital signs and patient assessment throughout the transfusion. Formatted: Font: Not Bold XII. XIII. XIV. 2. Record vital signs in the transfusion record. 3. Because some reactions are delayed, patients should be monitored for up to one-hour post transfusion. Observe patient for signs of possible blood reaction i.e.; chills, chest pain, dyspnea, hypertension, low back pain, headache, urticaria or fever > 1.8 F over baseline. If reaction occurs: See policy CPC.28 IV Therapy: Transfusion of Blood & Blood Components IV Therapy: Transfusion of Blood, and blood Components, page. 4, roman numeralletter U in the Patient Care Policy Manual. After the transfusion is completed, clamp the blood administration line at the saline port. Reconnect normal saline line to saline outlet port. Formatted: Indent: Left: 0.5", No bullets or numbering Formatted: Indent: Left: 1", Don't hyphenate XV.XIV. Dispose of transfusion bag and tubing in biohazardous waste container. XVI.XV. Chart the time completed and evidence of reaction, if any, on the lab blood slip. If any reaction noted, document in the patient s electronic record. XVII.XVI. On discharge, assess patient and educate on signs and symptoms of post transfusion reactions. See Roman Numeral XII above. give to patient Post Transfusion Reaction instructions. Page 251 of 391

252 Blood Transfusion During Dialysis 4 "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 252 of 391

253 Chronic Dialysis Policy Number: RS-L.14 Date Created: 10/01/2004 Document Owner: Nicole Rhodes (Database Date Approved: Not Approved Yet Reporting Analyst) Approvers: Board of Directors (Administration), Jon Knudsen (Dir of Renal & Oncology Svcs), Nicole Rhodes (Database Reporting Analyst), Roger Haley (Medical Director), Tariq Javed (MD) Chronic Outpatient Assessment During Hemodialysis Printed copies are for reference only. Please refer to the electronic copy for the latest version. Policy: To provide a safe and effective hemodialysis treatment by assessing the patient and monitoring equipment prior to initiation of dialysis, during dialysis, and post dialysis. The initial, first assessment for a new patient will be performed by a Registered Nurse (RN) prior to starting dialysis. The pre-assessment will be performed by a RN before dialysis is started. Prior to initiating any hemodialysis treatment, an assessment must be performed and documented by an RN. During the dialysis treatment, the patient s general condition must be observed and documented. This is to include at least half hour vital signs. The post-assessment will be performed by the RN during dialysis or after the dialysis treatment has ended. Data collection can be gathered by a CHT or LVN, but and abnormals must be reporteds to athe RN. Observation during the dialysis treatment by a RN, LVN, or CHT shall be done every half-hour or more often should the condition of the patient warrant it. The patient s general condition shall be observed throughout the procedure. Documentation of the patient s condition mustwill be entered into the patient s electronic record. Post dialysis assessment will be by a RNThe postassessment will be performed by the RN at the conclusion of the dialysis treatment. Procedure: I. Assessment Data collection prior to initiation of dialysis A. Vital Signs: blood pressure, temperature, and heart rate, and respirations rate; B. Weight of the patient in kilograms; C. Ascertain from Asking patient if of any physical or emotional symptoms they mightmay have occurred had between dialysis treatments (shortness of breath, swelling, N/V, diarrhea, depression etc.); D. Physical assessment of the patient by the RN is to include: listening to breathe sounds, presence Page 253 of 391

254 Chronic Outpatient Assessment During Hemodialysis 2 determining amount of edema, and heart rate, home medication review, and patient s dialysis access. E. Assessment of the patient s access will be performed. F.E. Additional assessment of the patient, as warranted, will be include but not be limited to: a. abuse assessment b. pain assessment b.c. DRHI protocol c. any new or changes to their home medications II. Assessment During Dialysis A. Vital signs are to be done every half-hour or more frequently prn should the patient s condition warrant it. B. Evaluate and document The patient s condition and any complaints. are to be evaluated. The patient may need medication or a specific treatment for relief. The type of iintervention(s) addressing patient s complaints will be is to be documented in the patient s electronic medical record. 1. If applicable, monitor and document crit line monitor per RS-L.36 Crit Line Monitor for Blood Volume Monitoring Policy Formatted: Numbered + Level: 1 + Numbering Style: 1, 2, 3, + Start at: 1 + Alignment: Left + Aligned at: 2" + Indent at: 2.25" C. Observation of the patient access is to be assessed frequently and each half-hour when vital signs are performed. Observe patient vascular access ensuring it is visible at all times. All accesses are to be Graft/fistula access lines are to be secured and assessed for blood leaking from the needle insertion or connection site.s; central line accesses are to be secure with the bloodlines from the machine. Patients will be monitored and instructed and monitored to keep access site visible at all times. D. Monitor chambers and lines for leaks. E.D. Monitor dialysate flow, conductivity, blood flow rate, arterial pressure, venous pressure, transmembrane pressure, transducer, heparin dose delivered, heparin pump, venous chamber, and machine temperature. Page 254 of 391

255 Chronic Outpatient Assessment During Hemodialysis 3 F. Monitor dialysis blood flow rate. G. Monitor arterial pressure, venous pressure, and transmembrane pressure. H. Monitor heparin infusion pump; be aware of time to discontinue heparin infusion. I. Monitor air foam detector. J.E. Observe that normal saline inlet line is double clamped, patient is on correct dialysate bath, and the amount of fluid removed is consistent with the goal set. K. Observe correct dialysate bath. L. Observe that the amount of fluid that has been removed is consistent with set goal. III. Post Dialysis Assessment A. Vital Signs: blood pressure, temperature, heart rate, access, and respirations A. Obtain and document the patient s vital signs and weight. The patient should be at approximately their dry weight, and their blood pressure should be lower. Their temperature may be slightly elevated due to the warming of the blood by the machine. Should there be a two (2) degree rise in temperature post dialysis, the patients physician will be notified. An access will be readily available for antibiotics if prescribed by the MD. A patient with the above will be encouraged not to leave the premises until their physician returns the RN s phone call. If the patient requests to leave, an AMA form will be filled out and signed by the patient and the nurse. B. Should there be a 2 degree rise in temperature post dialysis, the patient s physician will be notified Formatted: Indent: Left: 2", No bullets or numbering B. Pain assessment is required. C. The graft/fistula access should have a pressure dressing. Do not tape around arm as this can have a tourniquet affect and damage access to occlude the flow of blood. Patients should be instructed to feel for the patency of their graft or fistula each morning. For those patients with a Central Venous Access Device, there should be Page 255 of 391

256 Chronic Outpatient Assessment During Hemodialysis 4 sterile caps on the port ends, and bridge taped for security. C. If the patient has a lower blood pressure than 90mm/Hg that has declined from predialysis value by more than 15 mm/hg, dizziness, or general malaise following dialysis, they may be given a normal saline infusion to normalize their blood pressure. If this does not improve their blood pressure or general malaise is still present, the physician is to be notified. D. If the patient has a lower blood pressure than 90 mm/hg, dizziness, or general malaise following dialysis, they may be given a normal saline infusion to normalize their blood pressure. If this does not improve their blood pressure or general malaise is still present, the physician is to be notified. D. Documentation of the patient s post dialysis assessment is to be in the patient s electronic medical record. E. Documentation of the patient s post dialysis assessment is to be in the patient s electronic medical record. E. Document online KT/V data in the electronic record Formatted: List Paragraph, No bullets or numbering, Hyphenate Formatted: Numbered + Level: 1 + Numbering Style: A, B, C, + Start at: 1 + Alignment: Left + Aligned at: 1.5" + Tab after: 2" + Indent at: 2", Don't hyphenate Formatted: Numbered + Level: 1 + Numbering Style: A, B, C, + Start at: 1 + Alignment: Left + Aligned at: 1.5" + Tab after: 2" + Indent at: 2" Page 256 of 391

257 Chronic Outpatient Assessment During Hemodialysis 5 "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 257 of 391

258 Chronic Dialysis Policy Number: RS-L.24 Date Created: 07/11/2005 Document Owner: Nicole Rhodes (Database Date Approved: Not Approved Yet Reporting Analyst) Approvers: Board of Directors (Administration), Jon Knudsen (Dir of Renal & Oncology Svcs), Nicole Rhodes (Database Reporting Analyst), Roger Haley (Medical Director), Tariq Javed (MD) Cannulation of New Fistula Printed copies are for reference only. Please refer to the electronic copy for the latest version. Policy: To successfully cannulate new arteriovenous fistulas and to prevent infiltration, a newly created primary AV fistula shall be allowed to develop for at least 8-12 weeks prior to cannulation. Initial attempts to perform dialysis via new fistula shall proceed with caution. Without exception, fistulas shall not be progressed faster than these guidelines without MD order. Procedure: I. General Cannulation Instructions: A. Obtain order from vascular surgeon or Nephrologist to begin cannulation of fistula 8 to 12 weeks after creation. B. Only experienced staff identified as demonstrating best cannulation practice techniques should be assigned to cannulate NEWLYnewly developing fistula. C. ALWAYS USE A TOURNIQUET, even with well-developed fistulas. NO EXCEPTIONS!Use a tourniquet, without exception, with all fistulas. D. Explain procedure to the patient. Comment [JK1]: Feels subjective and emotional. At the very least, remove the exclamation point and rephrase with Use a tourniquet, without exception, with all fistulas or something like that Formatted: Font: Not Bold E. Educate patient on: 1. Checking the fistula daily for a thrill and for signs and symptoms of infection. 2. Performing fistula exercises to promote maturation process. 3. Understanding that hematoma could occur most likely during the first two weeks of using the access. 4. For infiltrations, provide written material about icing, elevation and heat application. Page 258 of 391

259 Cannulation of New Fistula 2 II. Cannulation Instructions: Week one A. Check with charge/lead nurse for anticoagulation changes. Anticoagulant load and maintenance should be decreased by half of the ordered dose for the first week to prevent bleeding into the surrounding tissue. It may be necessary to initiate saline flushes during this week of decreased anticoagulation. B. Visually inspect access for signs of infection (redness, swelling, drainage, pain, and skin temperature). C. Assess for patency of AV fistula. Do not cannulate AV fistula without the presence of a bruit or thrill. D. If no other access present, use two 17-gauge needles. ALWAYSAlways stay at least from the anastomosis. Formatted: Font: Not Bold E. If catheter present, use 17-gauge needle as the arterial, and use the catheter for venous return. F. Using a 25-degree angle, cannulate the fistula. G. Stabilize the wings with tape. Secure the access with a chevron. H. Instruct the patient not to move access extremity, in order to prevent infiltration. I. Remove needles at the same angle as the angle of insertion. Never apply pressure before the needle is completely out. Apply pressure with two fingers for 10 minutes, without peeking - NO EXCEPTIONSno exceptions. J. Clamps are NOTnot to be used. K. Schedule an appointment with the surgeon at the end of the first week of successful cannulation to have PC removed. For week one: Use 17-gauge needle at a blood flow rate (BFR) of ml/min. If BFR not tolerated, reduce to ml/min. Report any cannulation or BFR problems to the charge nurse and the Nephrologist for possible change in dialysis orders. ONLY INCREASE BLOOD FLOW RATES IF NO EVIDENCE OF INFILTRATION OR OTHER PROBLEMS NOTEDOnly increase blood flow rates if no evidence of infiltration or other problems noted. Page 259 of 391

260 Cannulation of New Fistula 3 III. Cannulation Instructions: Week Two A. If the first week is successful, cannulate with 16-gauge needles, rotating cannulation sites. B. Blood flow rate recommended: ml/min IV. Cannulation Instructions: Week Three A. Either repeat procedure for week two or may attempt to progress to prescribed BFR and needle gauge. When increasing BFR, recommend matching needle gauge to BFR as shown in the chart below. V. Infiltration Instructions A. If the fistula infiltrates, let it rest for one week and then go back to smaller gauge needles. B. If the fistula infiltrates a second time, wait another two weeks and then go back to smaller gauge needles. C. If the fistula infiltrates a third time, notify surgeon. VI. Catheter Removal Instructions A. The patient s catheter is not to be removed until the patient has had SIX CONSECUTIVE SUCCESSFULsix consecutive successful arterial/venous needle cannulations at the prescribed BFR and needle gauge. RECOMMENDED: It is important to match needle gauge to blood flow rate. Formatted: Font: Not Bold BLOOD FLOW RATE RECOMMENDED NEEDLE GAUGE Less than 300 ml/min 17-gauge ml/min 16-gauge Greater than ml/min 15-gauge Greater than 450 ml/min 15-guage Note: These are minimum recommended gauges for the BFR settings. Larger needles, when feasible will reduce (make less negative) pre-pump arterial pressure and increase delivered blood flow. Formatted: Font: Not Bold Page 260 of 391

261 Cannulation of New Fistula 4 References: NKF-K/DOQI Vascular Access Clinical Practice Guidelines 2000 Update Summary Fistula First Cannulation of New Fistula Policy and Procedure Page 261 of 391

262 Cannulation of New Fistula 5 "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 262 of 391

263 Acute Dialysis, Chronic Dialysis Policy Number: RS-L.44 Date Created: 06/28/2012 Document Owner: Nicole Rhodes (Database Date Approved: Not Approved Yet Reporting Analyst) Approvers: Board of Directors (Administration), Jon Knudsen (Dir of Renal & Oncology Svcs), Nicole Rhodes (Database Reporting Analyst), Roger Haley (Medical Director), Tariq Javed (MD) Rinseback Technique Printed copies are for reference only. Please refer to the electronic copy for the latest version. Policy: Dialysis staff will use aseptic rinseback technique when returning patients blood. Procedure: AVF/AVG & Central Venous Access Device Make sure there is at least 500ml normal saline (N.S.) in the bag. Obtain 10ml syringes filled with normal saline (N.S.). I. Stop treatment II. III. IV. Stop blood pump Clamp the arterial bloodline and the arterial access line. Disconnect arterial access line from the arterial blood line, keeping the bloodline sterile. Attach sterile N.S. filled syringe to arterial access port. Keep line clamped. V. Aseptically connect end of arterial bloodline to the pigtail port of the saline line VI. VII. Open the saline line, the arterial bloodline, and access line Restart the blood pump at no more than 200ml/min VIII. Flush arterial access line with N.S. 10ml, filled syringe and reclamp arterial access line. IX. Rinse patient s blood back until the venous chamber and bloodlines are pink tinged in color. Turn blood pump off X. Clamp the venous access line and the venous bloodline. Disconnect venous blood line. Line should be contained by applying a cap or inserting end of line into an extracorporeal circuit line. If Central Venous access device: flush venous access line with N.S. 10mls. XI. If using access caps other than TEGO connectors, then flush per physician order. Page 263 of 391

264 Rinseback Technique 2 "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 264 of 391

265 Chronic Dialysis Policy Number: RS-L.56 Date Created: 11/17/2014 Document Owner: Nicole Rhodes (Database Date Approved: Not Approved Yet Reporting Analyst) Approvers: Board of Directors (Administration), Jon Knudsen (Dir of Renal & Oncology Svcs), Nicole Rhodes (Database Reporting Analyst), Roger Haley (Medical Director), Tariq Javed (MD) Dialysis Blood Flow Rate Management Printed copies are for reference only. Please refer to the electronic copy for the latest version. Purpose: Policy: Definitions: To optimize dialysis clearances and minimize complications. We will define the and Maximum Blood Flow Rates by access type andtype, and by Physician order.bfr will be established by physician s order. Field Code Changed Blood Flow Rates (BFR) Dialysate Flow Rates (DFR) Type of Access- Arteriovenous Fistula (AVF), Arteriovenous Graft (AVG), Dialysis Catheter tunneled or temporary TDCVCTDC) Procedure: I. Minimum BFR depends upon type of access and the target BFR. Minimum BFR will define the action. Minimum acceptable blood flow is 25 ml/min BELOW target BFR.: Are they continuously not meeting by 25 ml/min for more than one treatment?. Formatted: English (U.S.) II. Target BFR- set by Physician order A. Acceptable Range is +/- 50ml/min below or 50ml/min above of BFR - patients who run at a minimum of their target BFR (Target BFR 25 below? to maximum) B. Maximum BFR - patients who run at the maximum of up to 50 ml/min above target BFR C. BFR Range: is the BFR between these two numbers. Formatted: Strikethrough Formatted: English (U.S.) Formatted: Indent: Left: 0.5", Hanging: 0.5" Formatted: English (U.S.) III. Actionable Interventions - when patient IIIIV. Expected BFR Management Page 265 of 391

266 Dialysis Blood Flow Rate Management 2 A. As prescribed by the Nephrologist, the BFR may range between the minimum BFR and Maximum Target BFR 1. AVF/AVG-maximum target BFR 500 ml/min 2. TDCVCTDC-maximum target BFR 350ml400 ml/min (unless otherwise ordered by the unnlessnephrologist) III.IV B. Actionable interventions when mean BFR cannot be achieved or is less than 50mL/min below targetis below Range range (if BFR cannot be achieved ) Formatted: Plain Text, Indent: Left: 0.5", Tab stops: Not at -1" Formatted: English (U.S.) Formatted: English (U.S.) A. 1. Initiate the following interventions 1. a. Check position of needles (AVF/AVG) 2. b. Check for kinked lines 3. c. Look for clots in venous chamber 4. d. Assess arm position (AVF/AVG) 5. e. Re-position patient to optimize flow (CVCTDC) 6. f. Assess for high venous pressure g. If no improvement notify nephrologist during or end of treatment D, Lower than target BFR range is permissible as long as criteria for interventions below are not met 7. h. IV. Document actions: assessment, interventions and/or call to physician BV. 2. For all access types - a difference of 100ml/min less than prescribed BFR for 3 consecutive treatments and no improvement with actionable intervetions, notify nephrologist for intervention VI. If BFR is 50mL/min above target x 3, notify nephrologist for new BFR order. 1. If no improvement notify nephrologist during or at the end of treatment C. 3. For all access types - a difference of 25 50ml/min forx 3 consecutive treatments days (no space here) Use interventions above. If no improvement at the end of 3 consecutive treatments days, notify physician. D. 5. Tunneled Catheter or Temporary Catheter Also pplease refer to Alteplase Instillation Protocol to determine if applicable Comment [JK1]: Why was this deleted? If we dialyzed below the acceptable ordered range the physician needs to be called and also need to be documented. The policy below says to call MD but only if above range. Formatted: Indent: Left: 0.75", First line: 0" Formatted: Font color: Auto Formatted: English (U.S.) Formatted: Indent: Left: 0", First line: 0" Formatted: Indent: Left: 0" Formatted: English (U.S.) Formatted: Indent: Left: 0.5", First line: 0.5" Formatted: Indent: Left: 0", First line: 0.5" Formatted: Indent: Left: 0.5" Formatted: Indent: Left: 0.5", First line: 0" Formatted: Indent: Left: 0.5", First line: 0.5" Formatted: Indent: Left: 0", First line: 0" Formatted: Indent: Left: 0" Formatted: Indent: Left: 1", Hanging: 0.5" Related Documents: NONE Page 266 of 391

267 Dialysis Blood Flow Rate Management 3 References: A. NONE Page 267 of 391

268 Dialysis Blood Flow Rate Management 4 "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 268 of 391

269 Acute Dialysis, Chronic Dialysis Policy Number: RS-N.16 Date Created: 08/26/2001 Document Owner: Nicole Rhodes (Database Date Approved: Not Approved Yet Reporting Analyst) Approvers: Board of Directors (Administration), Jon Knudsen (Dir of Renal & Oncology Svcs), Nicole Rhodes (Database Reporting Analyst), Roger Haley (Medical Director), Tariq Javed (MD) Exterior Cleaning of Hemodialysis Equipment Printed copies are for reference only. Please refer to the electronic copy for the latest version. Policy: The exterior of the dialysis machine, patient chair, monitors (ie. Crit Line), will be cleaned and disinfected after each dialysis treatment. Computer on wheels (COW) will be cleaned after being in the patient treatment area. and frequently touched surfaces in the patient zone will be cleaned and disinfected after each dialysis treatment. Application of new tubing is not to be done while the patient from the same treatment is in the chair. Appropriate PPE is to be worn with application of tubing, machine and chair cleaning. Equipment: Cleaning cloth(s) soaked in dilute bleach solution 1:100, prepared at least daily or other hhospital approved germicidal wipes. Procedure: I. Before beginning routine disinfection of the dialysis station, ensure that the patient has left the dialysis station.perform hand hygiene before and after cleaning the patient station II. Perform hand hygiene before and after cleaning the patient station Formatted: Indent: Left: 0", Hanging: 0.5", Line spacing: single Formatted: Highlight III. IVII. IV. - VI. Don - PPE per policy RS-L.42, gloves, gown, and mask with eye protection or full face shield. Obtain cleaning cloth(s)wipes with solution just prior to cleaning. Two SsSeparate clothswipes should be used when cleaning different equipment the chair and the machine.per manufacturer s recommendation. Allow time to dry. when moving to a different object in the patient zone. Clean all frequently touched surfaces in the patient zone-area: chair, armrests, chair side table, bedside table (if applicable), exterior of the dialysis machine (including knobs, back of machine and IV pole and Critline monitor if present), counters (if applicable), computer keyboard and trash cans (inside and outside) outside of sharps containers, if applicable. Page 269 of 391

270 Exterior Cleaning of Hemodialysis Equipment 2 VII. VIII. Computer on wheels will be cleaned once daily at the end of day by closing staff. a. If COW is taken into the patient treatment area, it must be cleaned, top to bottom, immediately coming out of patient treatment area. Clean the top of an object first and work down to avoid soiling surfaces just cleaned. Formatted: Numbered + Level: 1 + Numbering Style: a, b, c, + Start at: 1 + Alignment: Left + Aligned at: 0.5" + Indent at: 0.75" IXVII. Using friction,- eensure the entire surface is wet per manufacturer recommendation and allow to air dry. XVIII. If object to be cleaned has movable parts (i.e. arms of chair and footrest) these should be opened for cleaning. If arms of chairs do not open, special attention should be paid to cleaning down the insides of the arms of chair. IXI Blue clamps should be cleaned after every use. a. a. In the chronic unit the clamps will be openedy will be and soaked in a dilute bleach solution 1:100 for 10 minutes contact time, rinsed and allowed to air dry in clean area. b. In acutes dialysis they will be thoroughly cleaned with hospital approved wipes per manufacturer recommendations, hung up in open position, and allowed to air dry on clean IV pole. Formatted: Numbered + Level: 1 + Numbering Style: a, b, c, + Start at: 1 + Alignment: Left + Aligned at: 0.5" + Indent at: 0.75" Formatted: Indent: First line: 0" XII. XIII. Avoid getting too much solution on the computer and Crit line screens. When screen dries, use a dry paper towel or cloth to wipe any residue off. a. Avoid getting cleaning solution inside the clip of the Crit line. If cleaning needed, use cotton tip applicator and window type cleaner. IV poles with pumps attached and oxygen concentrators must be cleaned between patient use and before storage. Formatted: Numbered + Level: 1 + Numbering Style: a, b, c, + Start at: 1 + Alignment: Left + Aligned at: 0.5" + Indent at: 0.75" Formatted: Indent: Left: 0.75", First line: 0" XIVII. Dispose of used clothswipes in trash can located in the respective patient zone. appropriate receptacle.. Note: See policy RS-N.01 Dialysis Machine Cleaning and Disinfection for internal disinfection of dialysis machines. Page 270 of 391

271 Exterior Cleaning of Hemodialysis Equipment 3 Page 271 of 391

272 Exterior Cleaning of Hemodialysis Equipment 4 "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 272 of 391

273 Chronic Dialysis, Renal Services Administration Policy Number: RS-Q.02 Date Created: 01/30/2013 Document Owner: Nicole Rhodes (Database Date Approved: Not Approved Yet Reporting Analyst) Approvers: Board of Directors (Administration), Jon Knudsen (Dir of Renal & Oncology Svcs), Nicole Rhodes (Database Reporting Analyst), Roger Haley (Medical Director), Tariq Javed (MD) Communication with ESRD Network 18 Printed copies are for reference only. Please refer to the electronic copy for the latest version. Policy: The chronic dialysis clinic leadership ensures open communication with ESRD Network 18 I. The clinic participates in Network 18 activities and goals to improve quality of care and patient outcomes. II. III. IV. The clinic leadership takes appropriate action on recommendations from (ESRD) Network 18 The clinic provides Network 18 with required information in a timely manner. As appropriate, the clinic leadership consults with Network 18 personnel. Page 273 of 391

274 Communication with ESRD Network 18 2 "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 274 of 391

275 Chronic Dialysis, Renal Services Administration Policy Number: RS-Q.03 Date Created: 08/26/2013 Document Owner: Nicole Rhodes (Database Date Approved: Not Approved Yet Reporting Analyst) Approvers: Board of Directors (Administration), Jon Knudsen (Dir of Renal & Oncology Svcs), Nicole Rhodes (Database Reporting Analyst), Roger Haley (Medical Director), Tariq Javed (MD) Patients at Risk for Involuntary Discharge Printed copies are for reference only. Please refer to the electronic copy for the latest version. Policy: The dialysis clinics of Kaweah Delta Health Care District seek to create a patientcentered, holistic, caring environment for all dialysis patients. Staff members will establish and support professional boundaries to promote a healthy, caring for each patient environment. Those patients at risk for future involuntary discharge are identified and the clinic s, direct-care staff, health care providers, and interdisciplinary team members institute proactive interventions reduce the likelihood of instituting an involuntary discharge. This policy addresses the specific behavior of the patient, and their family/friends on the entire premises of the dialysis facility, not just inside waiting room and treatment area. 1. On admission and within the First 30 Days A. The patient will receive information regarding Patient Rights and Responsibilities, including expectations of behavior, Rules of Conduct, and boundaries at the dialysis clinic to provide a safe, healing environment for patients and a safe work site for employees. B. If a risk to self, others, or the facility is identified. 1. Assessments will be conducted and Plan of Care meetings scheduled 2. The multidisciplinary team will discuss concerns with the patient, possible underlying root causes and/or triggers will be sought, and interventions will be developed with the patient, as the patient permits. 3. See #V. below - Action Steps toward Management of Unacceptable Patient Behavior(s) Page 275 of 391

276 Patients at Risk for Involuntary Discharge 2 II. Ongoing if Unacceptable Behavior Emerges A. If a risk to self, others, or the facility is identified, 1. The patient will be identified as unstable. 2. Assessments will be conducted and Plan of Care meetings scheduled 3. The multidisciplinary team will discuss concerns with the patient, possible underlying root causes and/or triggers will be sought, and interventions will be developed with the patient, as the patient permits. 4. See #V. below - Action Steps toward Management of Unacceptable Patient Behavior(s) III. Risk Categories A. Risk to Self 1. Some examples: Non-adherence to medical advice - self - imposed alterations in treatment times: coming late, shortening or missing treatment. Refusal of saline for hypotension B. Risk to Others 1. Some examples: Disruptive and/or aggressive behavior - Acts of abuse, battery, harassment, and threats C. Risk to Facility 1. Some examples: No-show for treatments, disruptive behavior, attention seeking behavior, acting-out behavior, non-payment IV. Examples of Unacceptable Behavior A. Verbal Actions 1. Use of obscenities and curse words 2. Shouting, screaming 3. Name calling, racial or derogatory remarks, sexual/suggestive remarks B. Physical Actions: Actual or perceived violent/threatening behavior 1. Throwing of objects Page 276 of 391

277 Patients at Risk for Involuntary Discharge 3 2. Hitting staff, pinching, slapping, inappropriate touching, stalking 3. Yanking out needles, blood spray 4. Abuse of drugs/alcohol C. Threats: Written or Verbal 1. Display of/or threat of a weapon. In order for immediate (abbreviated) involuntary discharge to be considered, management must believe that patient has both a means and motive for carrying out the threat) D. Interference with facility operations 1. Manipulation of dialysis machine 2. Slanderous and/or libelous statements regarding staff, the operations of the facility, or other patients in the facility, or other patients in the facility. 3. Destruction of equipment 4. Trespassing into unauthorized areas 5. Unauthorized visitors a) All efforts will be made to keep a patient s support system intact while setting appropriate boundaries for the disruptive or abusive guest. 6. Non-Payment of four consecutive months or four out of six months due to a patients unwillingness to pursue and procure viable solutions to resolve non-payment. a) All efforts will be made by the facility to assist the patient in establishing and maintaining appropriate insurance or funding source. V. Action Steps toward Management of Unacceptable Patient Behavior(s) A. The patient will be identified as at risk. 1. Director and Medical Director will be notified. 2. Assessments will be conducted and Plan of Care meetings scheduled. Formatted: Normal, Space Before: 0 pt, Line spacing: single, Don't keep lines together Formatted: Font: (Default) Arial, 12 pt Formatted: Normal, Indent: Left: 1", Hanging: 0.5", Space Before: 0 pt, Line spacing: single, Don't keep lines together Formatted: Font: (Default) Arial, 12 pt Formatted: Font: (Default) Arial, Not Italic Formatted: Font: (Default) Arial, 12 pt Formatted: Font: (Default) Arial, 12 pt Comment [JK1]: and Risk Management Formatted: Font: (Default) Arial, 12 pt Page 277 of 391

278 Patients at Risk for Involuntary Discharge Interdisciplinary team member(s) would seek to a) Discover barriers the patient may be experiencing (e.g. transportation or child care issues creating a risk to self) b) As appropriate, gain additional services or resources for the patient that may have a positive impact (e.g. mental health needs creating a risk to others) c) Inform and educate the patient on standards of behavior and expected outcomes if expectations are not met (e.g. ETOH abuse resulting in no-show for several treatments creating a risk to self and facility) 24. A letter summarizing the meeting, including goals and expectations, will be provided to the patient. 35. In a consultative role, ESRD Network 18 will be called and the concerns discussed. B. An Agreement of Expectations may be initiated. This is letter includes positive states regarding the patient expectations of the facility and treatment team, the facilities expectations of the patient and family members/significant others if applicable, and specific actions that may be taken if one or the other is not met. 1. In a consultative role, ESRD Network 18 will be called and the concerns discussed. C. Patient Behavioral Contract: If unacceptable patient behavior continues, a Patient Behavioral Contract may be initiated 1. The contract is a corrective action tool with a clear description of the 1) problem behavior, a) why it is unacceptable, b) expectations for improvement, c) responsibilities of the dialysis staff members to the patient, d) timeline(s) for improvement,, e) actions that will be taken if the timeline(s) are not met (f) including a statement that the patient s continued negative behavior may cause the dialysis facility to begin the involuntary discharge process (g) including when it may begin. 2. In a consultative role, ESRD Network 18 will be called and the concerns discussed. D. Involuntary Discharge: If unacceptable patient behavior continues and/or timelines are not met, the next step may be Involuntary Discharge Page 278 of 391

279 Patients at Risk for Involuntary Discharge 5 1. Refer to Renal Services Policy #RS-L.41 Involuntary Discharge Reference Centers for Medicare and Medicaid. (2003). Decreasing dialysis patient-provider conflict Page 279 of 391

280 Patients at Risk for Involuntary Discharge 6 (DPC).Retrieved from the website of Network 18 of Southern California at r%20conflict/dpc_manual.pdf ESRD Network 18.(2011 August). How to improve the patient provider relationship: Guidelines for managing disruptive, abusive, threatening and challenging behaviors. Retrieved from the website of Network 18 of Southern California at nt/guidelines_for_mgmt_disruptive_abusive_patients.php Appendix A: Decreasing Patient-Provider Conflict Pathway Page 280 of 391

281 Patients at Risk for Involuntary Discharge 7 Decreasing Patient Provider Conflict Pathway Conflict Incident Occurs Determine Type of Conflict(s) Occurring 1. Nonadherence 2. Verbal/written abuse 3. Verbal/written threat 4. Physical threat 5. Physical harm 6. Property damage/theft 7. Lack of payment Assess type of risk Risk to patient? Risk to Facility? Risk to Others? Team member to counsel staff or patient on behavior. Ongoing monitoring. Yes Mild behavior or first incident? No Team meeting to discuss causes of behavior, severity of risk and intervention options* Team meeting to review facility policies/procedures, notify administration and discuss intervention options* Notify ESRD Network office of incident and team recommendations,receive guidance. Immediate safety risk? No Team meeting to discuss risk to others/ intervention options* Yes Notify security, appropriate authorities. Take immediate action. Notify ESRD Network office of incident and team recommendations, receive guidance. Team or individual meeting with patient or staff to explain policy and intervention. Notify ESRD Network of incident and team recommendations. receive guidance. Act on determined intervention Ongoing assessment, followup as necessary Ongoing assessment, followup as necessary Act on determined intervention Ongoing assessment, followup as necessary * Intervention options: Rule out any metabolic causes for behavior, then consider patient/staff counseling, patient/staff education, patient/family meetings including review of care plan, review of policies/procedures, ethics committee review, patient psychiatric evaluation referral and treatment, patient behavior contract, patient dismissal/discharge or staff suspension or termination only if all other interventions have failed or there is an immediate safety risk or harmful environment (no patient dismissal if the risk of the behavior does not affect others and is only a risk to the patient). "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Page 281 of 391

282 Patients at Risk for Involuntary Discharge 8 Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 282 of 391

283 Policy Submission Summary Manual Name: Security Date: 07/2017 Support Staff Name: Miguel Morales Policy/Procedure Title # Forensic Staff Education and Responsibility Status (New, Revised, Reviewed, Deleted) Name and Phone # of person who wrote the new policy or revised an existing policy SEC.108 Revised Miguel Morales, (559) Page 283 of 391

284 Forensic Staff Education and Responsibilities 1 Security Policy Number: SEC 108 Date Created: 12/09/2010 Document Owner: Miguel Morales (Security Date Approved: Not Approved Yet Services Manager) Approvers: Board of Directors (Administration), Environment of Care Committee Forensic Staff Education and Responsibilities Printed copies are for reference only. Please refer to the electronic copy for the latest version. POLICY: It is the policy of Kaweah Delta Health Care District to orient all forensic staff (civilian and military police representatives, city or county police agencies, state highway patrol, military security officers, security officers, correctional officers, US Marshals, etc., accompanying patients to healthcare facilities) to their role in those procedures that may become necessary during the time the forensic staff are in the facility. This includes emergency procedures such as fire and disaster procedures; internal routine emergency procedures (cardiopulmonary arrest codes, security emergencies, i.e., threat of violence ); guarded patient procedure possibilities (clinical restraint versus administrative restraint); as well as routine procedures such as number of visitors allowed in patient room/treatment area, orientation to locations in facility, etc. PROCEDURE: Upon receiving a forensic patient into a patient unit, the patient s nurse will notify the ssecurity Services Department who will provide the accompanying forensic officer staff with the LAW-ENFORCEMENT (FORENSIC STAFF) ORIENTATION INFORMATION packet. After reviewing the material, the forensic officer will complete the GUIDELINES AGREEMENT FORM (last page in the packet) and will be provided with a retain the Forensic Staff Member copy. The original copy will be retained by delivered to the patient nurse, who will then forward a copy faxed to the Human ResourcesSecurity Services Department by faxing toat (559) Signed forms will be filed for a period of one year. The Human Resources Department will retain copies on file for a period of one (1) year. Forensic Staff who arrives to Kaweah Delta Medical Center for outpatient care services or Emergency Room services will receive the LAW-ENFORCEMENT (FORENSIC STAFF) ORIENTATION PACKET by Patient Access Department staff at the time of registration. Formatted: Indent: First line: 0" Page 284 of 391

285 Forensic Staff Education and Responsibilities 2 The signed GUIDELINES AGREEMENT FORM will then be forwarded to the Security Services Department management office. "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 285 of 391

286 ORIENTATION PACKET FOR LAW-ENFORCEMENT (FORENSIC STAFF) WHO ACCOMPANY IN-CUSTODY PATIENTS ORIENTATION PACKET Forensic Staff should review all information in this packet. Forensic Staff should must read and sign the last piece of paper in this packet called LAW-ENFORCEMENT (FORENSIC STAFF) GUIDELINES AGREEMENT FORM. Once signed, please forward which should then be forwarded to the Security Services Department. Formatted: Font: Not Italic, Character scale: 100% Page 286 of 391

287 LAW-ENFORCEMENT (FORENSIC STAFF) ORIENTATION INFORMATION Welcome to Kaweah Delta Heath Care District. In efforts to keep you and all our guests safewith safety for all in mind, we require that all forensic agency staff review this packet prior to starting their agency work assignment. This packet must be reviewed immediately. Please read through the entire packet. It contains vital safety information that all forensic staff are required to know. Once you have completed this packet please sign and date the form at the end of the packet and tum turn it in to the Security Services Department. Kaweah Delta Health Care District MISSION STATEMENT To provide safe, high quality, customer-oriented and financially strong healthcare services to meet the needs of those we serve. OUR VISION Delivering Excellence. OUR VALUES Vision, Integrity, Care, Accountability, Respect, MISSION STATEMENT To provide safe, high quality, customer-oriented and financially strong healthcare services to meet the needs of those we serve. PROCEDURES FOR RESPONDING TO INCIDENTS AND CODES PROTECTIVE HOLDS Welfare & Institution Code 5150 Mental Health Hold (a) When a person, as a result of a mental health disorder, is a danger to others, or to himself or herself, or gravely disabled, a peace officer, professional person in charge of a facility designated by the county for evaluation and treatment, member of the attending staff, as defined by regulation, of a facility designated by the county for evaluation and treatment, designated members of a mobile crisis team, or professional person designated by the county may, upon probable cause, take, or cause to be taken, the person into custody for a period of up to 72 hours for assessment, evaluation, and crisis intervention, or placement for evaluation and treatment in a facility designated by the county for evaluation and treatment and approved by the State Department of Health Care Services. Health & Safety Code Medical Hold (Danger to Self, Others or Gravely Disabled) (a) Subject to subdivision (b), a licensed general acute care hospital, as defined in subdivision (a) of Section 1250, that is not a county-designated facility pursuant to Section 5150 of the Welfare and Institutions Code, a licensed acute psychiatric hospital, as defined in subdivision (b) of Section 1250, that is not a county-designated facility pursuant to Section 5150 of the Welfare and Institutions Code, licensed professional staff of those hospitals, or any physician and surgeon, providing emergency medical services in any department of those hospitals to a person at the hospital shall not be civilly or criminally liable for detaining a person if all of the following conditions exist during the detention: Page 287 of 391

288 (1) The person cannot be safely released from the hospital because, in the opinion of the treating physician and surgeon, or a clinical psychologist with the medical staff privileges, clinical privileges, or professional responsibilities provided in Section , the person, as a result of a mental disorder, presents a danger to himself or herself, or others, or is gravely disabled. For purposes of this paragraph, "gravely disabled" means an inability to provide for his or her basic personal needs for food, clothing, or shelter. HOSPITAL EMERGENCY CODES At times codes may be announced. If you hear the following codes wait for instruction from unit staff. CODE BLUE: Medical Emergency Adult CODE GRAY: Combative Person CODE GREEN: Patient Elopement CODE ORANGE: Haz-Mat Spill CODE PINK: Infant Abduction CODE PURPLE: Child Abduction CODE RED: Fire CODE SILVER: Weapon/Hostage-/Stay Away CODE TRIAGE ALERT: Potential Disaster CODE WHITE: Medical Emergency Pediatric CODE YELLOW: Bomb Threat TRIAGE ALERT: Actual Disaster UNLAWFUL OR SEXUAL HARASSMENT Kaweah Delta is committed to providing a work environment that is free of discrimination of any type. In keeping with this commitment, the Hospital maintains a strict policy prohibiting unlawful or sexual harassment. Harassment by any staff member, manager, physician, vendor, volunteer, patient or any other person associated with the Hospital is a violation of state and federal law as well as Hospital policy and will under no circumstances be tolerated or condoned. ABUSE REPORTING Any abuse of patients in our care will not be tolerated. Health professionals are mandated by law to report all known or suspected instances of abuse of a child, abuse of an elder/dependent adult or instances of domestic violence in which a patient states she/he is receiving medical treatment for a non-accidental physical condition or injury inflicted on the patient or by another person. "Abuse means the willful infliction of injury, unreasonable confinement, intimidation or punishment with resulting physical harm, pain or mental anguish." (42 CFR ) This also includes the depravation by an individual, including a caretaker, of goods or services that are necessary to attain or maintain physical, mental, and psychosocial well-being. This presumes that instances of abuse of any patient, even those in a coma, cause physical harm, or pain or mental anguish. Health Insurance Portability and Accountability Act (HIPAA)PATIENT PRIVACY AND CONFIDENTIALITY Kaweah Delta respects the rights of patients and will make all reasonable efforts to ensure that a patient's medical information is kept confidential and be used only to effect appropriate treatment, payment, internal operations or a specifically pre-authorized by the patient. It is the intent of KDHCD to fully comply with all applicable HIPAA federal and state Pprivacy Rregulations. The hospitalkaweah Delta understands that medical information about our patients is personal and we are fully committed to protecting the integrity of such information. All Law Enforcement Forensic staff is subject to following Kaweah Delta s privacy policies. It is not appropriate to access or discuss patient information outside the course of one s professional duty. Formatted: English (U.S.) Formatted: English (U.S.) Page 288 of 391

289 RESTRAINTS Clinical restraints may be used when less restrictive means would not be effective to protect the physical safety of patients, a staff member or others. Clinical restraints are only initiated by a licensed independent practitioner who is responsible for the patient or by a registered nurse. The decision to use administrative restraints (shackles, handcuffs, etc.) is the responsibility of the forensic staff. Keys must be readily available at all times. COMMUNICATION- FINDING THE PERSON YOU NEED Each department in the organization has a Department Director or Manager who oversees the day-to-day operation of the department. The Department Director or Manager is accountable to the operating Vice President for all aspects of the department operation, including the provision of coordinated patient care. Patient care is provided under the overall direction of the physician primarily responsible for the patient. A registered nurse assesses the patient's need for nursing care. The registered nurse reports to a clinical supervisor and/or manager. House Supervisor approval needs to be obtained prior to law enforcement officers issuing citations or conducting patient interviews. Upon arrival Law Enforcement should contact the House Supervisor by dialing 0 on any District phone and the operator will connect you to the House Supervisor. Staff performing clinical procedures on the guarded patient will provide you with instruction in how you may be involved in that procedure to ensure support and not hinder the therapeutic goals set for the patient. Patients may require therapeutic restraints for their protection and safety. In the event these are required, staff will provide you with instructions. VISITATION The law enforcement agency having custody of the patient is responsible for granting visitation(s) and supervising visitors during the visit. Routinely, only two visitors are allowed in the patient room at any time. Larger groups need to be coordinated with the patient s nurse. FORENSIC STAFF REST AND MEAL BREAKS It is the responsibility of the law enforcement agency to provide the forensic officer with rest and meal breaks. Hospital Security does not provide prisoner security. QUESTIONS If you have any questions or concerns, please don t hesitate to contact the on-duty Security Lead at (559) or the Security Manager s office at (559) Page 289 of 391

290 LAW-ENFORCEMENT (FORENSIC STAFF) GUIDELINES AGREEMENT FORM Instructions: Review attached orientation material, which you should keep for your information. Sign and date the bottom of this agreement form. You will be provided with a copy of this form. The Security Services Department will retain the original copy. I have read the orientation material which includes the following information Kaweah Delta Hospital Vision, Values and Mission statement Protective Holds (W&I 5150 and H&S ) Hospital Emergency Codes Unlawful or Sexual Harassment Abuse Reporting Health Insurance Portability and Accountability Act (HIPAA)- protected health informationpatient Rights and Responsibilities Restraints of Patients- Distinctions between the need for restraints for clinical purposes and for security purposes Communication issues- hospital contact persons Responding to clinical events or procedures In-custody Patient Visitations Forensic staff rest and meal breaks I shall hold as absolutely confidential all information that I may obtain directly or indirectly concerning patients, doctors or employees, and not seek to obtain confidential information from anyone. I understand that if injured at KDHCDKaweah Delta, KDHCD agrees to provide firsti can seek first aid treatment if such care is required. KDHCD Kaweah Delta is not obligated to provide any other professional services and that the agency that employs me is responsible for payment and worker's compensation coverage. I agree to all guidelines, procedures, and conditions presented in the orientation material. Print Name Date Law Enforcement (Forensic Staff) Signature Law Enforcement Agency ORIGINAL: Security Services Department COPY: Forensic Staff Member Page 290 of 391

291 Policy Submission Summary Manual Name: Sleep Disorders Center Date: 7/14/2016 Support Staff Name: Sasha Nevarez Policy/Procedure Title # Status (New, Revised, Reviewed w/no Revision, Deleted) Name and Phone # of person who wrote the new policy or revised an existing policy Infection Prevention SA-02 Revised Eric Altamirano 6797 Cleaning and Maintenance of Equipment EQ-01 Revised Eric Altamirano 6797 Page 291 of 391

292 Sleep Disorders Center Policy Number: SA-02 Date Created: 06/01/1999 Document Owner: Eric Altamirano Date Approved: Not Approved Yet (Sleep/Neurodiagnostics Manager) Approvers: Board of Directors (Administration), Board of Directors (ENDO/PF/IC/RT), Dept of Critical Care, Infection Prevention Committee, Harjoth Malli (MD), Kristy Samuels (Administrative Assistant) Sleep Center Infection Control Printed copies are for reference only. Please refer to the electronic copy for the latest version. Purpose: Policy: Standard procedures to reduce the spread of infection and help assure the safety of the staff and patients. All sleep staff will follow Standard Precautions and Blood borne Pathogen Standards for contact with all patients in addition to following all District policies related to infection prevention guidelines for maintaining optimal patient safety. I. Indicate any required safety classes that all employees must attend. A. All personnel who have patient contact are required to follow these guidelines and complete the annual competency testing. for Employee Health and meet the mandatory in service requirements annually. Procedure: I. Indicate that technicians wash their hands before and after contact with patients. A. Hands should always be washed before and after contact with patients even when gloves are used. Waterless hand wash should be available to use in emergent situations or when leaving an isolation room. Staff should wash their hands with soap and water as soon as feasible. B. Waterless hand sanitizer is available in all patient rooms II. Indicate if gloves are used for hookup or other contact with the patient. A. Gloves will be used whenever cleaning or assembling equipment. Gloves must be changed and hands washed between the cleaning and assembling process. Page 292 of 391

293 Sleep Center Infection Control 2 III. Indicate any common infectious conditions that would result in the technician or patient being rescheduled (cold, flu, etc.). A. Patients with suspected or known airborne or contact transmissible disease will be rescheduled to reduce the risk of transmission of illness. 1. Common conditions may include gastrointestinal, respiratory, skin, or wound infections. 2. Written notice of lack of persisting contagion will be required from the referring physician prior to rescheduling. IV. Indicate the location of Personal Protective Equipment (PPEs) in the center, if available. A. Personal Protection Equipment (P.P.E.) is required to be worn if aerosolization, splattering or direct contact with blood and/or body fluids is likely to occur or during isolation precautions. Masks, eye protection and fluid resistant gowns should be available for use. Sleep patients found to require this level of precaution (such as respiratory isolation) will not be accepted for study in this center. PPE equipment can be found in hookup room 1each of the hook up rooms stored in the cabinets above the sink area. B. Sleep Center staff is occasionally involved in exposure-prone situations. It is imperative that everyone observes Standard Precaution practices, CDC s Tuberculosis Standards, and OSHA s Blood borne Pathogens Standards in their daily work practices. In addition, staff must follow departmental policy for proper handling and disposal of Regulated Medical Waste and additional Hazard Communication practices. (Patients suspected to have contagious disease will not be studied in our center.) C. All job related puncture wounds (needle sticks, cuts, etc.) and all accidental exposure to blood or body fluids are to be reported immediately per District policy to Employee Health Department. D. For large volume blood and/or body fluid spills, contain the spill and contact Housekeeping for cleanup. E. A tuberculocidal disinfectant will be used for all general disinfecting of blood and/or body fluid spills. Specify name: Ph7Q/Ph7Q ultra (Ecolab). VII. Infection Control Manual A. Access KDCentral>Employees>Manuals>Infection ControlPolicy Tech > Infection Control Manual Page 293 of 391

294 Sleep Center Infection Control 3 "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 294 of 391

295 Sleep Disorders Center Policy Number: EQ-01 Date Created: 06/01/1999 Document Owner: Eric Altamirano Date Approved: Not Approved Yet (Sleep/Neurodiagnostics Manager) Approvers: Board of Directors (Administration), Board of Directors (ENDO/PF/IC/RT), Dept of Critical Care, Infection Prevention Committee, Harjoth Malli (MD), Kristy Samuels (Administrative Assistant) Cleaning And Maintenance Of Equipment Printed copies are for reference only. Please refer to the electronic copy for the latest version. Purpose: Policy: A routine schedule for the cleaning, disinfection, and maintenance maintenance of equipment helps to assure the accurate operation of equipment throughout the study. All patient related equipment will be cleaned, disinfected, and maintained on a regular basisafter each patient use consistent with manufacturer recommendations, facility and OSHA requirements. Preventative maintenance will be performed on all equipment to prolong equipment life and to ensure efficient operation and reliability of the equipment. Procedure: I. List each piece of equipment and frequency of cleaning, disinfection and maintenance. A. SD 32 Digital amplifiersn7000 Unit 1. Calibrate System Before each use 2. Clean Unit unit with 70% Isopropyl alcohol wipe WeeklyAfter each use 3. Reset Internal Clock After time change B. Portable monitoring devices 1. Calibrate recorder As needed 2. Clean/disinfect unit After each use 3. Disinfect using an undiluted solution of Cavacide applied to all surfaces of the device. After each use Formatted: List Paragraph, No bullets or numbering Formatted: List Paragraph, No bullets or numbering Page 295 of 391

296 Cleaning And Maintenance Of Equipment 2 4. Oximeter Sensor Cleaned with a 70% Isopropyl alcohol wipe After each use 2.5. Effort Belt wash by hand using a mild detergent Formatted: List Paragraph, No bullets or numbering C. Pulse Oximeter 1. Clean/disinfect the Unit After each patient use 2. Calibrate System Weekly D.C. VPAP TX Clinical SystemOmniLab Advance+ 1. Clean/disinfect the outside of the uunit with a 70% Isopropyl alcohol wipe After each patient use 2. Replace Filter Every 6 months30 days or PRN 3. Calibrate System prior to each patient and or 3. alteration to the circuitas appropriate 4. Performance verification Weekly Formatted: Numbered + Level: 1 + Numbering Style: 1, 2, 3, + Start at: 1 + Alignment: Left + Aligned at: 1" + Tab after: 1.5" + Indent at: 1.5" E.D. Etco2 Monitor 1. Clean/disinfect the uunit with a dampened cloth using a non abrasive commercial cleaner After each patient use 2. Calibrate System As required E. Olympic Sterile Drier 1. Weekly maintenance, using a soft cloth dampened with a mild detergent, wipe exterior of the drier, including it s power cord. Use a second cloth to dry all exterior surfaces 2. Change the prefilter every 2 to 3 months 2.3. Replace HEPA Filter every 3 years II. Indicate the type of disinfectant used and the manner of cleaning for each piece of patient related equipment.(approved disinfectant used unless manufacture recommendation differs.) A. KDHCD approved disinfectant PH 7 Q. Formatted: List Paragraph, No bullets or numbering Formatted: Indent: Hanging: 1", Numbered + Level: 1 + Numbering Style: A, B, C, + Start at: 5 + Alignment: Left + Aligned at: 1" + Tab after: 1.5" + Indent at: 1.5" Formatted: Indent: Left: 1.5", No bullets or numbering Formatted: Numbered + Level: 4 + Numbering Style: 1, 2, 3, + Start at: 1 + Alignment: Left + Aligned at: 1.75" + Indent at: 2" Formatted: Indent: Left: 2", No bullets or numbering Formatted: Numbered + Level: 4 + Numbering Style: 1, 2, 3, + Start at: 1 + Alignment: Left + Aligned at: 1.75" + Indent at: 2" Formatted: List Paragraph, No bullets or numbering Formatted: Numbered + Level: 4 + Numbering Style: 1, 2, 3, + Start at: 1 + Alignment: Left + Aligned at: 1.75" + Indent at: 2" Formatted: Indent: Left: 0.75", No bullets or numbering Page 296 of 391

297 Cleaning And Maintenance Of Equipment 3 1. Wipe or spray on KDHCD approved disinfectant minimum contact time 10 minutes, air dry. B. KDHCD approved disinfectant PDI Sani-Cloth germicidal disposable wipe 1. Wipe electrode and allow a 2 minute minimum contact time. III.b. Indicate who is responsible for cleaning and maintaining each piece of equipment. B. All Sleep Center technical staff are responsible for the cleaning, disinfection, and maintenance of all equipment. Formatted: Numbered + Level: 2 + Numbering Style: a, b, c, + Start at: 1 + Alignment: Left + Aligned at: 0.75" + Indent at: 1" lv. Cleaning Sleep Lab Equipment: A. EEG Electrodes 1. Soaked in soapy water. 1. EEG Cup electrodes are single patient use only and are dipsoded of appropriately. 2. Sprayed/ Wiped with a KDHCD approved disinfectant. 3. Air dried before plugging into the electrode head box. 4. If using new electrodes, spray with a KDHCD approved disinfectant. 5. If contaminated with blood electrodes will be disposed of. BC. Snap Electrodes 1. After cleaning with a soap solution ssprayed/ wiped with a KDHCD approved disinfectant. 2. Air dry completely before plugging into electrode head box. 3. If contaminated with blood electrodes will be disposed of CD. Nasal Thermistors: 1. Sprayed/ wiped with a KDHCD approved disinfectant Air dry. Page 297 of 391

298 Cleaning And Maintenance Of Equipment 4 1. If contaminated with blood sensor will be disposed ofnasal thermistors are single patient use only and are disposed of appropriately. DC. Chest Belts 1. Disconnect belt straps and clean with KDHCD approved disinfectant.soak in a warm solution of hospital grade laundry detergent and water 2. Clean sensor with a solution of KDHCD approved disinfectant. 2. The snap lock and sensor plugs should not be soaked. Instead wipe the black snap lock clean with a moist cloth of hospital laundry detergent and water.. 3. Air dry. 4. If contaminated with blood belts and or sensor will be disposed of E. Oximeter Sensor 1. Sensor should be cleaned with a 70% Isopropyl alcohol wipe after each use F. Snore Sensor 4.1. Wipe the sensor and cable with a non corrosive cleanser to clean before use I. SpO 2 Sensor/Cable A. Remove disposable adhesive and dispose. B. Wipe sensor and cable spray with a solution KDHCD approved disinfectant.. Formatted: List Paragraph, No bullets or numbering Formatted: List Paragraph, No bullets or numbering Formatted: Numbered + Level: 1 + Numbering Style: A, B, C, + Start at: 1 + Alignment: Left + Aligned at: 0.5" + Tab after: 1" + Indent at: 1" Formatted: Indent: Left: 1", No bullets or numbering Formatted: Indent: Left: 0.44", Hanging: 0.56", No bullets or numbering Formatted: Indent: Hanging: 0.75", Numbered + Level: 1 + Numbering Style: A, B, C, + Start at: 6 + Alignment: Left + Aligned at: 1" + Indent at: 1.25" Formatted: Indent: Left: 1.25", No bullets or numbering Formatted: Indent: First line: 0", Numbered + Level: 2 + Numbering Style: 1, 2, 3, + Start at: 1 + Alignment: Left + Aligned at: 0.75" + Indent at: 1" C. Air dry. D. If contaminated with blood sensor will be disposed of I. PAP interface components/ PAP hose/ Humidifier canister A. Place PAP interface components, PAP hose and humidifier canister into PastuermaticAll PAP accessories including the interface, hose and humidifier canister will be disposed of after each patient use. 1. Pastuermatic is set for 167 degrees. Page 298 of 391

299 Cleaning And Maintenance Of Equipment 5 2. Fully emersed, set timer for 30 minutes. 3. Remove after set time is completed. 4. Technician to sign off on calendar log each day indicating this process was completed 5. Place in Olympic dryer 6. Start drying cycle. 7. Remove and store when drying is complete. 8. Pastuermatic water is changed out weekly as per manufacturer recommendation II. CPAP Unit A. Using a cloth slightly dampened with water and hospital approved disinfectant, wipe the outside of the unit and the remote. B. Let the unit dry before plugging in. III.II. Linens A. Blankets, sheets, and pillowcases need to be changed between patients. B. Dirty linens should be placed in impervious bags. C. Dirty linens are sent to the laundry department for cleaning after each patient. C.D. Mattress and pillow covers are wiped down after each patient use with an approved disinfectant Formatted: List Paragraph, No bullets or numbering, Tab stops: Not at 1" Note: Please reference the manufacture cleaning and disinfecting instructions for equipment, devices and re-usable electrodes. A copy of these instructions are on hand and available upon request. "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 299 of 391

300 Cleaning And Maintenance Of Equipment 6 Page 300 of 391

301 MINUTES OF THE OPEN MEETING OF THE KAWEAH DELTA HEALTH CARE DISTRICT BOARD OF DIRECTORS HELD MONDAY JUNE 26, :30PM, IN THE BLUE ROOM AT THE KAWEAH DELTA MEDICAL CENTER MINERAL KING WING, CARL ANDERSON PRESIDING PRESENT: Directors Anderson, Havard Mirviss, Hipskind, Hawkins & House; T. Rayner, Interim CEO / SVP & COO; D. Boken, MD, Chief of Staff; G. Herbst, SVP & CFO,; E. Hirsch, VP & CMO/CQO; R. Sawyer, VP & CNO, D. Cox, VP of HR, D. Cochran, VP of Development; D. Leeper, VP & CIO; D. Lynch, Legal Counsel; R. Salinas, Legal Counsel; C. Moccio, Board Clerk The meeting was called to order at 5:30PM by Director Anderson. Director Anderson asked for approval of the agenda. MMSC (Hawkins/House) to approve the agenda. This was supported unanimously by those present. Vote: Yes Anderson, Havard Mirviss, Hawkins, House & Hipskind Public participation none Director Anderson called for the approval of the closed agenda. 1. Approval of Closed Agenda as follows: Closed Meeting Agenda Kaweah Delta Medical Center Blue Room 5:31PM 1.1. Credentialing - Medical Executive Committee (06/20/17) request that the appointment, reappointment and other credentialing activity regarding clinical privileges and staff membership recommended by the respective department chiefs, the credentials committee and the Medical Executive Committee be reviewed for approval pursuant to Health and Safety Code 1461 and 32155, medical staff privileges Dan Boken, MD, Chief of Staff 1.2. Credentialing pursuant to Health and Safety Code 1461 and 32155, medical staff privileges Dan Boken, MD, Chief of Staff 1.3. Approval of closed meeting minutes {05/22/17} 1.4. Conference with Legal Counsel Existing Litigation Pursuant to Government Code (d)(1) State of California et al., ex rel. OnTheGo Wireless, LLC vs. Cellco Partnership, doing business as Verizon Wireless, et al. - Dennis Lynch, Legal Counsel} MMSC (Hawkins/House) to approve the closed agenda. This was supported unanimously by those present. Vote: Yes Anderson, Havard Mirviss, Hawkins, House & Hipskind Adjourn - Meeting was adjourned at 5:30PM Carl Anderson, President Kaweah Delta Health Care District and the Board of Directors Thereof ATTEST: Lynn Havard Mirviss, Secretary/Treasurer Kaweah Delta Health Care District Board of Directors Page 301 of 391

302 MINUTES OF THE OPEN MEETING OF THE KAWEAH DELTA HEALTH CARE DISTRICT BOARD OF DIRECTORS HELD MONDAY JUNE 26, :00PM, IN THE BLUE ROOM AT THE KAWEAH DELTA MEDICAL CENTER MINERAL KING WING, CARL ANDERSON PRESIDING PRESENT: Directors Anderson, Havard Mirviss, Hipskind, Hawkins & House; T. Rayner, Interim CEO / SVP & COO; D. Boken, MD, Chief of Staff; E. Hirsch, VP & CMO/CQO; R. Sawyer, VP & CNO, D. Cox, VP of HR, D. Cochran, VP of Development; D. Leeper, VP & CIO; D. Lynch, Legal Counsel; R. Salinas, Legal Counsel; C. Moccio, Board Clerk The meeting was called to order at 6:00pm by Director Anderson. Director Anderson asked for approval of the agenda. MMSC (Hawkins/House) to approve the agenda. This was supported unanimously by those present. Vote: Yes Anderson, Havard Mirviss, Hawkins, House & Hipskind Closed Session Action Taken: Approval of the closed meeting minutes 05/22/17. April 24, 2017; MMSC (Hipskind/House) to authorize District management to negotiate and execute one or more leases or lease amendments with the Lindsay Hospital District to expand facility space operated by Kaweah Delta Health Care District as the Kaweah Delta Lindsay Health Clinic in Lindsay, California. This authorization is subject to management's successful effort with the U.S. Postal Service to consolidate all currentlyleased and proposed-to-be-leased space into a single, consolidated address, necessary to qualify the newly-leased space as rural health clinic space. This was supported unanimously by those present. Vote: Yes Anderson, Havard Mirviss, Hawkins, House & Hipskind Director Anderson asked if there were any comments from the public or the medical staff. Mr. Sam Sciacca presented information relative to downtown units that he has developed for physicians and nurses who need downtown housing. Mr. Sciacca proposed that the District consider purchasing a unit that could be used for physicians and or nurses that need to be close to the hospital. Recognitions - Director Havard Mirviss presentation of Resolution 1953 to Sean Nourie, IT Support, for the Service Excellence Award June Chief Executive Officer (CEO) Recruitment Members of the public may comment relative to the recruitment of the Chief Executive Officer of Kaweah Delta Health Care District. Director Anderson noted that our consultant who is leading our recruitment process has completed a nationwide search contacting hundreds of candidates. The Kaweah Delta Board will be interviewing 5-6 individuals in mid-july. The next round of interviews will be in early August. No public comment was made relative to the CEO recruitment. Consent Calendar Director Anderson requested the approval of the consent calendar (copy attached to the original of these minutes and considered a part thereof). Director Anderson requested that the Board members submit any individual questions on reports or policies they can be potentially be answered and address prior to the regular Board meeting. Director Page 302 of 391

303 Anderson inquired how Dr. Hipskind handles his review of the consent calendar. Director Hipskind noted that if he finds a typographical errors or clarification that he needs it is addressed ahead of time. If there is an issue or clarification that needs to have full Board discussion he will request its removal for discussion at the Board meeting. Director House requested the removal of 2.3A1 and 2.3F2. Director Havard Mirviss requested the removal of 2.6b. MMSC (Havard Mirviss/House) to approve the consent calendar with the removal of items 2.3A1 {Policies Administrative Records retention and destruction AP.75} and 2.3F2 {Policies Mental Health Tarasoff Duty to Warn and Protect MH42.01}, and 2.6b (Retirement Resolution Resolution 1959, William Blair, Director of Strategic Planning retiring from duty from Kaweah Delta Health Care District after thirty-three years of service}. This was supported unanimously by those present. Vote: Yes Anderson, Havard Mirviss, Hawkins, House & Hipskind. 2.3A1 - Policies Administrative Records retention and destruction AP.75 Director House noted that relative to item 4A the text states seven however the number is 10, noted we need to clarify if it is seven or ten years. This policy will be tabled for clarification. 2.3F2 - Policies Mental Health Tarasoff Duty to Warn and Protect MH42.01 Director House inquired what ***CHn was and noted that there are some typographical errors within the policy. This policy will be tabled for clarification. Director Havard Mirviss, on behalf of the entire Board, presented resolution 1959 to William Blair William Blair, Director of Strategic Planning retiring from duty from Kaweah Delta Health Care District after thirty-three years of service. Chronic Disease Management Clinic Review of the Chronic Disease Management Clinic - Ryan Gates, Director of Population Health Management Chronic Disease Management Clinic (copy attached to the original of these minutes and considered a part thereof). 2017/2018 annual operating and capital budget Presentation and request for approval of the 2017/2018 annual operating and capital budget - Gary Herbst Senior Vice President & Chief Financial Officer (copy attached to the original of these minutes and considered a part thereof). MMSC (Havard Mirviss/Hawkins) to approve the 2017/2018 annual operating and capital budget. This was supported unanimously by those present. Vote: Yes Anderson, Havard Mirviss, Hawkins, House & Hipskind. Credentialing Dan Boken, MD Chief of Staff - Medical Executive Committee (06/20/17) request that the appointment, reappointment and other credentialing activity regarding clinical privileges and staff membership recommended by the respective department chiefs, the credentials committee and the Medical Executive Committee be reviewed for approval. Director Anderson requested a motion for the approval of the credentials report (06/20/17), excluding the Emergency Medicine providers a highlighted on Exhibit A {copy attached to the original of these minutes and considered a part thereof}. MMSC (House/Hipskind) Whereas a thorough review of all required information and supporting documentation necessary for the consideration of initial applications, Board of Directors Meeting - Open Page 2 of 5 Page 303 of 391

304 reappointments, request for additional privileges, advance from provisional status and release from proctoring and resignations (pursuant to the Medical Staff bylaws) has been completed by the Directors of the clinical services, the Credentials Committee, and the Executive Committee of the Medical Staff, for all of the medical staff scheduled for reappointment, Whereas the basis for the recommendations now before the Board of Trustees regarding initial applications, reappointments, request for additional privileges, advance from provision al status and release from proctoring and resignations has been predicated upon the required reviews, including all supporting documentation, Be it therefore resolved that the following medical staff, excluding Emergency Medicine Providers as highlighted on Exhibit A (copy attached to the original of these minutes and considered a part thereof), be approved or reappointed (as applicable), to the organized medical staff of Kaweah Delta Health Care District for a two year period unless otherwise specified, with physician-specific privileges granted as recommended by the Chief of Service, the Credentials Committee, and the Executive Committee of the Medical Staff and as will be documented on each medical staff member s letter of initial application approval and reappointment from the Board of Trustees and within their individual credentials files. Vote: Director Anderson, Havard Mirviss, House, Hawkins & Hipskind Yes. Director John Hipskind, MD left the room for the vote on the credentials, for the Emergency Medicine providers as highlighted on Exhibit A {copy attached to the original of these minutes and considered a part thereof}. MMSC (Hawkins/Havard Mirviss) Whereas a thorough review of all required information and supporting documentation necessary for the consideration of initial applications, reappointments, request for additional privileges, advance from provisional status and release from proctoring and resignations (pursuant to the Medical Staff bylaws) has been completed by the Directors of the clinical services, the Credentials Committee, and the Executive Committee of the Medical Staff, for all of the Emergency Medicine providers scheduled for reappointment. Whereas the basis for the recommendations now before the Board of Trustees regarding initial applications, reappointments, request for additional privileges, advance from provision al status and release from proctoring and resignations has been predicated upon the required reviews, including all supporting documentation, Be it therefore resolved that the following medical staff Emergency Medicine providers be approved or reappointed (as applicable), to the organized medical staff of Kaweah Delta Health Care District for a two year period unless otherwise specified, with physician-specific privileges granted as recommended by the Chief of Service, the Credentials Committee, and the Executive Committee of the Medical Staff and as will be documented on each medical staff member s letter of initial application approval and reappointment from the Board of Trustees and within their individual credentials files. Vote: Director Anderson, Havard Mirviss, House & Hawkins Yes. Director Hipskind Absent 202 WEST WILLOW, LLC - Review and request for approval to accept the gifted interest in the 202 West Willow property from Dr. Rupinder Malli Dennis Lynch, Legal Counsel Mr. Lynch reviewed the gift to Kaweah Delta Health Care District (KDHCD). Dr. Malli wants to gift her interest in the 202 West Willow, LLC, approximately 30% of the LLC, to KDHCD. The gift is an interest in the LLC. No individual member is responsible for the debts of the business (the LLC) so KDHCD would not be liable for any of the LLC s debts. The value of the gift is estimated to be $850,000 at this time and this value will go up in time. It is an extraordinary gift. Board of Directors Meeting - Open Page 3 of 5 Page 304 of 391

305 The action requested tonight is to authorize the District to accept the gift and KDHCD to become a member of Kaweah Delta LLC. Director Anderson noted that Dr. Malli should be formally recognized and thanked by the Board. Mr. Rayners noted that we plan on recognizing her at the next Board meeting. Ms. Cochran is to coordinate this recognition. MMSC (Hawkins/Havard Mirviss) to accept the transfer of the interest in the 202 West Willow, LLC as gifted by Dr. Rupinder Malli to Kaweah Delta Health Care District and to authorize its officers to execute the necessary documents to complete the gift and have Kaweah Delta become a member of the 202 West Willow, LLC.and to authorize Gary Herbst to be the District representative in the 202 West Willow LLC. This was supported unanimously by those present. Vote: Yes Anderson, Havard Mirviss, Hawkins, House & Hipskind. CHIEF OF STAFF REPORT Report from Dan Boken, MD, Chief of Staff: Dr. Lively the new Chief of Staff is the first cardiologist to be Chief of Staff Dr. Manga will be the new Secretary/Treasurer and will bring a good connection to the medical staff. Director Anderson thanked Dr. Boken for his service and assured him that the medical staff will be involved in the CEO recruitment process. CHIEF EXECUTIVE OFFICER REPORT Report from Thomas Rayner, Interim Chief Executive Officer: Family Health Care Network (FHCN) o Working with FHCN - we have put together task forces to enhance the working relationship between FHCN and KDHCD. Family Medicine Residents o Relative to the board certification exam 380 is what is required to pass the exam - our residents scores started in the 500 s and all seven residents passed on their first attempt. Neurosurgery Update Gary Herbst Senior Vice President & Chief Financial Officer & Edward Hirsch, Vice President & Chief Medical and Quality Officer o Dr. Hirsch noted we are working towards a September 1st start date with the goal to have two physicians by the end of year one and adding staff for neuro subspecialties. o We are completing a fair market value study being prepared by ECG. o Mr. Herbst noted that Dr. Joseph Chen and Dr. Lew are on the USC faculty. Medical Foundation Update - Gary Herbst Senior Vice President & Chief Financial Officer o The Kaweah Delta Medical Foundation has opened an office in Tulare, the former location of the practice of Dr. Lin, who before he retired was one of the forming members of Sequoia Cardiology and due to the law change requiring a 1206(d) clinic to be located within 250 yards of the acute hospital, it was determined that this clinic should be a 1206(l) clinic and a division of the Kaweah Delta Medical Foundation staffed by Visalia Medical Clinic Foundation physicians. Kaweah Delta through the Foundation now has a presence in Tulare and it is being well received by the residents of Tulare. Service Awards luncheon June 27, 2017 o Visalia Convention Center Director and interim changes. o Don Myers, Mental Health Director (Mary Laufer) Board of Directors Meeting - Open Page 4 of 5 Page 305 of 391

306 o Eric Lyons (Chris Lynch) o Venus Buckner (Kassie Waters) BOARD PRESIDENT REPORT Report from Mr. Carl Anderson, Board President Kaweah Delta Health Care District Bylaws proposed change o Director Anderson had no report. Adjourn - Meeting was adjourned at 8:17PM Carl Anderson, Board President Kaweah Delta Health Care District and the Board of Directors Thereof ATTEST: Lynn Havard Mirviss, Secretary/Treasurer Kaweah Delta Health Care District Board of Directors Board of Directors Meeting - Open Page 5 of 5 Page 306 of 391

307 Filled By: Checked By: Exp. Date: 2 East Epidural Tray QT Medication Strength (total) Volume Form Drug Code 1 Atropine 1 mg/ml 1 ml Inj Vial Atropine 1 mg (0.1 mg/ml) 10 ml Inj Syringe Calcium Chloride 1 gram ( ml Inj Syringe % mg/ml) 2 Ephedrine 5 mg/ml 5 ml Inj Syringe Epinephrine 1 mg/ml 1 ml Inj ampule Epinephrine 1 mg (0.1 mg/ml) 10 ml Inj Syringe Lidocaine MPF 1% (10 mg/ml) 5 ml Inj Vial Lidocaine MPF w/ 2% (20 mg/ml) w/ 20 ml Inj Vial 835 Epi epi 1:200,000 1 Lidocaine 2% 5 ml Topical 2384 Jelly 1 Lidocaine 2% 100 mg 5 ml Inj Syringe Lidocaine MPF 1.5% (15 mg/ml) 20 ml Inj % NaCl (PF) 10 ml Inj Vial Naloxone 0.4 mg/ml 1 ml Inj Ampule Ropivacaine 0.2% (2 mg/ml) 20 ml Inj 850 (Naropin ) 1 Ropivacaine 0.2% (2 mg/ml) 100 ml Inj 851 (Naropin ) 1 Sodium 50 meq (1 50 ml Inj Syringe 581 Bicarbonate 8.4% meq/ml) 3 Bupivacaine MPF 0.25% ( ml Inj Vial 3427 mg/ml) 5 Bupivacaine MPF 0.5% (5 mg/ml) 10 ml Inj Vial 3132 Amount Used Commented [BA1]: Anesthesia approved the removal of sodium bicarb from the tray. Access will still be available in the crash carts on each floor. Patient Sticker Date Used: Page 307 of 391

308 Kaweah Delta Dialysis Facilities Emergency Medication Box Quantity Medication Strength Volume Form Exp. Date 1 Atropine 0.1 mg/ml 10 ml Preloaded Syringe 1 Dextrose 50% 0.5 g/ml 50 ml Preloaded Syringe 1 Epinephrine 1:10, mg/mll 10 mll Preloaded Syringe 1 Sodium Bicarbonate 1 meq/ml 50 ml Preloaded Syringe 1 Lidocaine 100 mg 5 ml Preloaded Syringe 1 Calcium Chloride 1 gram 10 ml Preloaded Syringe 3 Non-Bacteriostatic 10 ml Inj. Vial Normal Saline 1 Methyl Prednisolone 62.5mg/mLl 2mlL Inj Vial sodium succinate 3 EpiPen Auto-Injector 0.3 mg 0.3 ml Inj Pen First drug(s) to Expire: Expiration Date: Checked By: Date: Page 308 of 391

309 Policy Manuals AP38 Appendix D Policy Submission Summary Manual Name: Pharmacy Date: 6/26/17 Support Staff Name: Policy/Procedure Title # Status (New, Revised, Reviewed, Deleted) Security-Pharmacy Area Revised Rheta Sandoval 5301 Personal management: Public Protection & reporting Requirements Revised Rheta Sandoval 5301 Name and Phone # of person who wrote the new policy or revised an existing policy 04/14/14 Page 15 of 16 Page 309 of 391

310 Pharmacy Policy Number: RX Date Created: No Date Set Document Owner: Chelsea Stafford (Administrative Date Approved: Not Approved Yet Assistant) Approvers: Board of Directors (Administration), Medical Executive Committee, Pharmacy and Therapeutics, James McNulty (Director of Pharmacy) Security - Pharmacy Area Printed copies are for reference only. Please refer to the electronic copy for the latest version. Purpose: Policy: The pharmacy department shall be a secured area. Staff members will follow procedures that ensure pharmacy security at all times. Procedure: I. The pharmacy doors are locked at all times. A. Outside doors of the pharmacy are set so that they lock automatically. B. Only District staff assigned to the main pharmacy who are registered with the State Board of Pharmacy shall have knowledge of the primary access code. 1. Exception: At the Director of Pharmacy s discretion, Department staff not registered with the State Board of Pharmacy may have knowledge of the primary access code so long as a secondary access code is activated by the pharmacist in times of temporary absence of the pharmacist for breaks and lunch periods. C. The access codes may be changed, but not limited to the following events: 1. Change of pharmacy personnel 2. Reason to believe the security of pharmacy has been compromised D. Other security measures such as video cameras, doorbells, and peep through doors will be utilized. E. At the discretion of the Pharmacist-in-Charge, the pharmacist on duty may leave temporarily for breaks and meal periods and allow for ancillary staff to remain in the pharmacy as long as he or she Page 310 of 391

311 Security - Pharmacy Area 2 reasonably believes the security of the dangerous drug/devices will be maintained in his or her absence. 1. During the pharmacist s temporary absence, no prescription medication may be provided to staff member for patient use, or to an automated dispensing cabinet unless it has been previously checked by the Pharmacist. Formatted 2. All ancillary staff, which includes but is not limited to a pharmacy technician or pharmacy clerical staff, may continue to perform non-discretionary duties authorized to them by pharmacy law. However, any duty performed by any member of the ancillary staff shall be checked by the pharmacist upon his or her return. D.3. The pharmacist shall close the pharmacy and remove all ancillary staff from the pharmacy during his or her absence if in the professional judgment of the pharmacist this is determined to be necessary to maintain security. II. Pharmacy personnel are clearly identified. A. Authorized pharmacy personnel shall wear visible hospital name badges at all times. B. Unauthorized and unidentified personnel are not allowed in the inner pharmacy unattended. III. When not in use, scheduled medications are stored in a locked cabinet or room within the pharmacy at all times with the exception of medications requiring refrigerated storage. These medications are stored in the pharmacy refrigerator in plain view of staff and are inventoried daily. A. Surveillance cameras are used as a diversion deterrent. Surveillance tapes are reviewed at the discretion of the Director of Pharmacy. IV. Theft or Break in Reference: A. In the event of a theft, the Director of Pharmacy shall be notified immediately. Administrative Manual Policy AP.110 Reporting Requirements for Drug Diversion, Illegal Substance Abuse or Controlled Substance Abuse and Pharmacy Manual Policy Dangerous Drugs: Theft/Loss will be followed for district and agency reporting requirements. Section 512 of the Labor Code and the orders of the Industrial Welfare Commission. Business and Professions Code 4115 [g]. Page 311 of 391

312 Security - Pharmacy Area 3 California Code of Regulation (f). "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 312 of 391

313 Pharmacy: Policy Number: RX Date Created: 06/22/2017 Document Owner: Chelsea Stafford (Administrative Date Approved: Not Approved Yet Assistant) Approvers: Board of Directors (Administration), Medical Executive Committee, Pharmacy and Therapeutics, April McKee (Medical Staff Coordinator), Cindy Moccio (Board Clerk/Exec Assist-CEO), James McNulty (Director of Pharmacy), Teresa Boyce (Director of Medical Staff Svcs) Personnel Management: Public Protection & Reporting Requirements Printed copies are for reference only. Please refer to the electronic copy for the latest version. Purpose: Policy: To outline procedures for taking action to protect the public when a licensed individual employed by or with the pharmacy is discovered or known to be chemically, mentally, or physically impaired to the extent it effects his or her ability to practice the profession or occupation authorized by his or her license, or is discovered or known to have engaged in the theft, diversion, or self-use of dangerous drugs. The Department of Pharmacy, in the interest of protecting the public, follows established procedures designed to address pharmacy personnel chemical, mental or physical impairment to the extent it affects their ability to practice the profession or occupation authorized by his or her license. Additionally, established procedures are followed in the event a licensed individual employed by or with the pharmacy is discovered or known to have engaged in the theft, diversion, or selfuse of dangerous drugs. Procedure: I. Chemical Impairment, Drugs and Alcohol A. The Department of Pharmacy follows Human Resources Policy HR.200 Drugs and Alcohol. II. Physical or Mental Impairment A. The Department of Pharmacy follows Human Resources Policy HR.200 Drugs and Alcohol. B. Any recognized or self-reported impairment of a staff member to the extent it affects his or her ability to practice the profession or occupation authorized by his or her license will be addressed promptly by the Department of Pharmacy working in collaboration with Human Resources and/or Employee Health. Page 313 of 391

314 Personnel Management: Public Protection & Reporting Requirements 2 1. Examples of recognition of impairment include but is not limited to: a) Cognitive impairment - lack of concentration, confusion, forgetfulness, difficulty thinking/speaking b) Mental impairment disruption in thinking, feeling, moods, and ability to relate to others c) Physical impairment (resulting in the inability to provide optimal patient care) loss of motor skills, problems with balance, poor coordination and clumsiness. III. Drug Diversion or Theft A. The Department of Pharmacy follows Pharmacy Manual Policy Security: Pharmacy Area, Policy Controlled Substances: Theft/Loss and Administrative Policy Manual AP.110 Reporting Requirements for Drug Diversion, Illegal Substance Abuse or Controlled Substance Abuse. IV. Reporting Requirements A. The Director of Pharmacy (or designee) shall report to the California Board of Pharmacy (BOP), within 14 days of the receipt or development of the following information with regard to any licensed individual employed by or with the pharmacy: 1. Any admission by a licensed individual of chemical, mental, or physical impairment affecting his or her ability to practice. 2. Any admission by a licensed individual of theft, diversion, or self-use of dangerous drugs. 3. Any video or documentary evidence demonstrating theft, diversion, or self-use of dangerous drugs by a licensed individual Any video or documentary evidence demonstrating chemical, mental, or physical impairment of licensed individual to the extent it affects his or her ability to practice. 5. Any termination based on chemical, mental, or physical impairment of a licensed individual to the extent it effects his or her ability to practice. Page 314 of 391

315 Personnel Management: Public Protection & Reporting Requirements Any termination of a licensed individual based on theft, diversion, or self-use of dangerous drugs. B. In the event of a theft, the Director of Pharmacy (or designee) will follow Administrative Policy AP.110 Reporting Requirements for Drug Diversion, Illegal Substance Abuse or Controlled Substance Abuse and Pharmacy Manual Policy Controlled Substances: Theft/Loss. Business and Professions Code 4104 Formatted: Font: (Default) Arial "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 315 of 391

316 Manual Name: Rural Health Clinics Support Staff Name: Maria Barba Policy Submission Summary Policy/Procedure Title # Status (New, Revised, Reviewed w/no Revision, Deleted) Date: Emergency Equipment, Drugs and Supplies RCP.47 Revised Mary Jo Dyck (559) Page 316 of 391

317 General Policies, Rural Health Clinic Policy Number: RCP.47 Date Created: No Date Set Document Owner: Maria Barba (Administrative Date Approved: Not Approved Yet Assistant) Approvers: Board of Directors (Administration), Board of Directors (Rural Health Clinics), Pharmacy and Therapeutics, David Garrett (Dir Outpatient Health Clinics), William Roach MD () EMERGENCY EQUIPMENT, DRUGS AND SUPPLIES Printed copies are for reference only. Please refer to the electronic copy for the latest version. PURPOSE: To ensure that the Clinic Providers haves available drugs available used for use in an emergency in the clinic cal settings. PROCEDURES: 1. The clinic shall maintain a separate, portable and sealed supply of drugs for emergency use. 2. The type of se emergency drugs and supplies kept in the kit shall be determined by the Medical Director, Kaweah Delta Pharmacy and licensed staff, and approved by KD P&T committee.. 3. The contents of the emergency medication supply kit shall be is listed on the outside of the sealed Emergency Drug Kit. 4. Clinic staff will check the emergency kit lock daily, noting that it is still intact in order to assure that no products have been used out of the kit Clinic staff will notify the KDHCD pharmacist when if medications are were used and need to be replaced The contents of the emergency kit supply shall be checked and logged at least monthly by the KDHCD pharmacist A portable oxygen tank with delivery system will be available at the clinic site. The level content of the oxygen tank will be checked weekly by clinic staff. A log with sign-off by staff will be kept for audit purposes An ambu bag will be located next to the oxygen tank An AED defibrillator will be onsite. Only staff trained in the use of the AED will operate the device. Staff will monitor the AED on a daily basis to assure batteries are functional. A log with sign-off by staff will be kept. Page 317 of 391

318 EMERGENCY EQUIPMENT, DRUGS AND SUPPLIES 2 "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 318 of 391

319 Policy Manuals AP38 Appendix D Policy Submission Summary Manual Name: Imaging Services Date: June 16, 2017 Support Staff Name: Carla Hernandez Policy/Procedure Title # Radiology Arthrogram (Wrist, Shoulder, Knee, Hip with MRI to follow) Status (New, Revised, Reviewed, Deleted) Name and Phone # of person who wrote the new policy or revised an existing policy IS Revised Replaced Betadine with Chloraprep with tint. Windy Vaughn, ext Page 319 of 391

320 Imaging Services, Radiology Policy Number: IS Date Created: 10/01/2007 Document Owner: Carla Hernandez (Administrative Date Approved: Not Approved Yet Assistant) Approvers: Board of Directors (Administration), Medical Executive Committee, Pharmacy and Therapeutics, Carla Hernandez (Administrative Assistant), Daniel Hightower (Medical Director), Deana Hale (Radiology Manager), Gordon Ah Tye (Dir Imaging & Radiation Svcs), Renee Lauck (Dir OP Rad Onc & Imaging Svcs) Radiology Arthrogram (Wrist, Shoulder, Knee, Hip with MRI to follow) Printed copies are for reference only. Please refer to the electronic copy for the latest version. Policy: When performing Arthrograms, staff will adhere to the following procedure. Procedure: I. Technologist sets up supplies using sterile technique, under the direction of the Radiologist. A. Arthrogram Tray B. Betadine Chloraprep with tint B. C. Isovue 200 D. Saline E. Lidocaine F. 25g (red) needle G. 22g spinal needle H. Gadolinium I. Sterile Gloves J. Black Sharpie-Marker K. Metal hemostat L. Tape M. Trash Bin II. Fill out the Radiology Procedure Record (See Addendum 11 A) and document the following: A. Explain the basics of procedure to patient. B. Patient assessment by RN if necessary. C. Allergies and medications. D. Two Identifiers checked E. Contrast Used and amount F. Reactions II. III. Patient Education A. Bring patient to room Page 320 of 391

321 Radiology Arthrogram (Wrist, Shoulder, Knee, Hip with MRI to follow) 2 B. Review written physicians order C. Review medical history with patient D. Explain procedure to patient E. Inform Radiologist regarding exam and patients medical history F. Radiologist must go over procedure and obtain Consent Form filled out and signed by patient. III. Preparation for most radiologists Radiologist to draw up A. Draw 7cc 1% Lidocaine for local anesthetic B. Mix the following in a 20cc syringe; 1. 7cc Lidocaine 2. 7cc Isovue cc Saline C. Draw.1cc Gadolinium use TB syringe to measure D. Mix.1cc Gadolinum to mixture above ***Double mixture in a 50cc syringe if performing a KNEE arthrogram*** Specific Radiologist protocol Dr. Macaluso- A. Inject 1cc Gadolinium in a.9 Sodium Chloride bag 250 ml (in MRI) B. Draw 5-7cc lidocaine in a 10cc syringe C. Draw 10cc Isovue 200 in a 10cc syringe D. Prepare an extra 10cc and 5cc syringe Dr. Griswold- A. 10cc 1% Lidocaine with 25g needle B. In a 20cc syringe mix the following 10cc Isovue cc Sensorcaine.25% C. Draw.1cc Gadolinium. Use TB syringe to measure (DO NOT PUT IN MIXTURE) D. Have non latex gloves ready (blue) Related Documents: NONE References: NONE "These guidelines, procedures, or policies herein do not represent the only medically or legally acceptable approach, but rather are presented with the recognition that acceptable approaches exist. Deviations under appropriate circumstances do not represent a breach of a medical standard of care. New knowledge, new techniques, clinical or research data, clinical experience, or clinical or bio-ethical circumstances may provide sound reasons for alternative approaches, even though they are not described in the document." Page 321 of 391

322 Unique Plan Description: GM IV Insulin Infusion Plan Selection Display: GM IV Insulin Infusion PlanType: Medical Version: 1 Begin Effective Date: 12/7/ :59 End Effective Date: Current Available at all facilities GM IV Insulin Infusion Patient Care Glucommander Settings Glucommander IV Insulin Start Date/Time: T;N Monitoring Blood Glucose Monitoring POC Per glucommander recommendations Communication Order T,N, Constant order, For a POC glucose greater than 400 mg/dl - Order STAT serum blood glucose. Notify Treating Practitioner T;N, If STAT serum blood glucose is greater than 349 mg/dl Continuous Infusions insulin regular 100 units/ns 100 ml IV (IVS)* Sodium Chloride 0.9% drip (Titratable) 100 ml, IV, Goal: See Glucommander Order, Per Glucommander, Start Date: T;N Comments: For initial tubing and whenever tubing is changed, flush and discard the first 20 ml through he tubing before connecting to the patient. insulin regular (human) IV additive 100 units Communication Order T,N, Constant order, If TPN or tube feeds are inturrupted for longer than 30 minutes, begin D10W IV at 50 ml/hr and notify provider. Dextrose 10% in Water Glucommander Order Per Glucommander, IV Piggyback, Soln-IV, PRN, PRN other (see comment) Comments: If TPN or Tube Feeds are interrupted for more than 30 minutes, begin and notify physician. Medications All oral anti-diabetic medications, and non-insulin anti-diabetic injectables should be discontinued prior to starting Glucommander.(NOTE)* Pharmacy Communication T;N Comments: All oral anti-diabetic medications, and non-insulin anti-diabetic injectables should be discontinued prior to starting Glucommander. Hypoglycemia Treatment glucagon 1 mg, IM, Injection, PRN, PRN other (see comment) Comments: Blood Glucose less than 50 and if no IV access. Treat and notify Physician. Dextrose 50% vial Per Glucommander, IV Push, Injection, PRN, PRN other (see comment) Comments: Blood Glucose less than 70. Treat and notify physician. Laboratory Hemoglobin A1c (Glycosylated) Blood, Routine, T;N, Once Comments: Not recommended if the patient has received a Hemoglobin A1c in the last 60 days. Non Categorized Page 322 of 391

323 Initial Approval Date Annual Review Date *Report Legend: DEF - This order sentence is the default for the selected order GOAL - This component is a goal IND - This component is an indicator INT - This component is an intervention IVS - This component is an IV Set NOTE - This component is a note Rx - This component is a prescription SUB - This component is a sub phase Page 323 of 391

324 Unique Plan Description: GM IV Insulin Infusion (CVS) Plan Selection Display: GM IV Insulin Infusion (CVS) PlanType: Medical Version: 1 Begin Effective Date: 3/29/ :03 End Effective Date: Current Available at all facilities GM IV Insulin Infusion (CVS) Patient Care Glucommander Settings Glucommander IV Insulin Target Range (blood glu): mg/dl (cardiac surgery post op), Start Date/Time: T;N, Glucommander Multiplier: 0.05 (cardiac surgery post op) Monitoring Blood Glucose Monitoring POC Per Glucommander recommendations Communication Order T,N, Constant order, For a POC glucose greater than 400 mg/dl - Order STAT serum blood glucose. Notify Treating Practitioner T;N, If STAT serum blood glucose is greater than 349 mg/dl Continuous Infusions insulin regular 100 units/ns 100 ml IV (IVS)* Sodium Chloride 0.9% drip (Titratable) 100 ml, IV, Goal: See Glucommander Order, Per Glucommander, Start Date: T;N Comments: For initial tubing and whenever tubing is changed, flush and discard the first 20 ml through he tubing before connecting to the patient. insulin regular (human) IV additive 100 units Communication Order T,N, Constant order, If TPN or tube feeds are inturrupted for longer than 30 minutes, begin D10W IV at 50 ml/hr and notify provider. Dextrose 10% in Water Glucommander Order Per Glucommander, IV Piggyback, Soln-IV, PRN, PRN other (see comment) Comments: Blood Glucose less than ml/hr if tube feeding/tpn interupted Medications All oral anti-diabetic medications, and non-insulin anti-diabetic injectables should be discontinued prior to starting Glucommander.(NOTE)* Pharmacy Communication T;N Comments: All oral anti-diabetic medications, and non-insulin anti-diabetic injectables should be discontinued prior to starting Glucommander. Hypoglycemia Treatment glucagon 1 mg, IM, Injection, PRN, PRN other (see comment) Comments: Blood Glucose less than 50 and if no IV access. Treat and notify Physician. Dextrose 50% vial Per Glucommander, IV Push, Injection, PRN- See comments, PRN other (see comment) Comments: Blood Glucose less than 70. Treat and notify physician. Laboratory Hemoglobin A1c (Glycosylated) Blood, Routine, T;N, Once Comments: Not recommended if the patient has received a Hemoglobin A1c in the last 60 days. Non Categorized Page 324 of 391

325 Initial Approval Date Annual Review Date *Report Legend: DEF - This order sentence is the default for the selected order GOAL - This component is a goal IND - This component is an indicator INT - This component is an intervention IVS - This component is an IV Set NOTE - This component is a note Rx - This component is a prescription SUB - This component is a sub phase Page 325 of 391

326 Unique Plan Description: GM IV Insulin Infusion (OB) Plan Selection Display: GM IV Insulin Infusion (OB) PlanType: Medical Version: 1 Begin Effective Date: 3/29/ :48 End Effective Date: Current Available at: KD Med Cntr GM IV Insulin Infusion (OB) Patient Care Glucommander Settings Glucommander IV Insulin Target Range (blood glu): mg/dl (obstetric), Start Date/Time: T;N, Glucommander Multiplier: 0.03 (resistant, high steroid, OB) Monitoring Blood Glucose Monitoring POC Per Glucommander recommendations Communication Order T,N, Constant order, For a POC glucose greater than 400 mg/dl - Order STAT serum blood glucose. Notify Treating Practitioner T;N, If STAT serum blood glucose is greater than 349 mg/dl Continuous Infusions insulin regular 100 units/ns 100 ml IV (IVS)* Sodium Chloride 0.9% drip (Titratable) 100 ml, IV, Goal: See Glucommander Order, Per Glucommander, Start Date: T;N insulin regular (human) IV additive 100 units IV fluid infusion will alternate between NS and D5LR based on blood glucose results.(note)* Sodium Chloride 0.9% 1,000 ml, IV, 125 ml/hr Comments: When blood glucose more than or equal to 141. Dextrose 5% in Lactated Ringers 1,000 ml, IV, 125 ml/hr Comments: When blood glucose less than or equal to 140. Medications All oral anti-diabetic medications, and non-insulin anti-diabetic injectables should be discontinued prior to starting Glucommander.(NOTE)* Pharmacy Communication T;N Comments: All oral anti-diabetic medications, and non-insulin anti-diabetic injectables should be discontinued prior to starting Glucommander. Hypoglycemia Treatment glucagon 1 mg, IM, Injection, PRN- See comments, PRN other (see comment) Comments: Blood Glucose less than 50 and if no IV access. Treat and notify Physician. Dextrose 50% vial Per Glucommander, IV Push, Injection, PRN- See comments, PRN other (see comment) Comments: Blood Glucose less than 70. Treat and notify physician. Laboratory Hemoglobin A1c (Glycosylated) Blood, Routine, T;N, Once Comments: Not recommended if the patient has received a Hemoglobin A1c in the last 60 days. Communication Orders Communication Order Page 326 of 391

327 T,N, Constant order, If TPN or tube feeds are inturrupted for longer than 30 minutes, begin D10W IV at 50 ml/hr and notify provider. Communication Order T,N, Constant order, For initial tubing and whenever tubing is changed, flush and discard the first 20 ml through he tubing before connecting to the patient. *Report Legend: DEF - This order sentence is the default for the selected order GOAL - This component is a goal IND - This component is an indicator INT - This component is an intervention IVS - This component is an IV Set NOTE - This component is a note Rx - This component is a prescription SUB - This component is a sub phase Page 327 of 391

328 Unique Plan Description: GM Subcut CUSTOM Eating (basal/bolus + correction) Plan Selection Display: GM Subcut CUSTOM Eating (basal/bolus + correction) PlanType: Medical Version: 2 Begin Effective Date: 11/1/ :41 End Effective Date: Current Available at: KD Med Cntr GM Subcut CUSTOM Eating (basal/bolus + correction) Patient Care Custom dosing recommended for patients well controlled on known insulin doses(note)* For patients who are eating meals.(note)* Glucommander Settings Glucommander Custom Subcut Orderset Type: Basal/Bolus + Correction, T;N, Bolus Insulin: Insulin Lispro (Humalog), Basal Insulin: Insulin Glargine (Lantus) Monitoring Blood Glucose Monitoring POC T;N, Per Glucommander Recommendations Communication Order If Blood Glucose is greater than 500 mg/dl order STAT serum glucose Notify Treating Practitioner Laboratory Results Glucose more than 300 (DEF)* Glucose more than 400 Glucose more than 200 Medications Enter initial dose of the Lantus and HumaLOG orders in the Orders Comments for each order.(note)* Pharmacy Communication T;N Comments: All oral anti-diabetic medications, and non-insulin anti-diabetic injectables should be discontinued prior to starting Glucommander. Basal Insulin Lantus Ongoing Dose: Custom Glucommander, Subcut, Injection, QHS (DEF)* Comments: Subsequent doses to be adjusted by Glucommander. Ongoing Dose: Custom Glucommander, Subcut, Injection, every morning Comments: Subsequent doses to be adjusted by Glucommander. Ongoing Dose: Custom Glucommander, Subcut, Injection, BID Comments: Subsequent doses to be adjusted by Glucommander. Correctional Insulin HumaLOG Ongoing Dose: Custom Glucommander, Subcut, PCHS and 3 AM, Injection Comments: Dosing will be used to initiate glucommander customization. Subsequent doses to be adjusted by Glucommander. PRN Insulin HumaLOG Ongoing Dose: Custom Glucommander, Subcut, Injection, PRN, PRN blood glucose Hypoglycemia Treatment glucagon 1 mg, IM, Injection, PRN, PRN other (see comment) Comments: Blood Glucose less than 50 and if no IV access. Treat and notify Physician. Dextrose 50% vial Per Glucommander, IV Push, Injection, PRN, PRN other (see comment) Comments: Blood Glucose less than 70. Treat and notify physician. Laboratory Not recommended if the patient has received a Hemoglobin A1C in the last 60 days.(note)* Page 328 of 391

329 Hemoglobin A1c (Glycosylated) Blood, Routine, T;N, Once Non Categorized Initial Approval Date Annual Review Date *Report Legend: DEF - This order sentence is the default for the selected order GOAL - This component is a goal IND - This component is an indicator INT - This component is an intervention IVS - This component is an IV Set NOTE - This component is a note Rx - This component is a prescription SUB - This component is a sub phase Page 329 of 391

330 Unique Plan Description: GM Subcut CUSTOM NPO/Continuous Enteral Feeding (bolus + correction) Plan Selection Display: GM Subcut CUSTOM NPO/Continuous Enteral Feeding (bolus + correction) Plan Synonyms: Glucommander PlanType: Medical Version: 2 Begin Effective Date: 5/1/ :52 End Effective Date: Current Available at all facilities GM Subcut CUSTOM NPO/Continuous Enteral Feeding (bolus + correction) Patient Care Custom dosing recommended for patients well controlled on known insulin doses(note)* For patients who are NPO or on continuous feeding.(note)* Glucommander Settings Glucommander Custom Subcut Orderset Type: Basal + Correction (for NPO, continuous), T;N, Bolus Insulin: Insulin Lispro (Humalog), Basal Insulin: Insulin Glargine (Lantus) Monitoring Blood Glucose Monitoring POC T;N, Per Glucommander Recommendations Communication Order If Blood Glucose is greater than 500 mg/dl order STAT serum glucose Notify Treating Practitioner Laboratory Results Glucose more than 300 (DEF)* Glucose more than 400 Glucose more than 200 Medications Enter initial dose of the Lantus and HumaLOG orders in the Orders Comments for each order.(note)* Pharmacy Communication T;N Comments: All oral anti-diabetic medications, and non-insulin anti-diabetic injectables should be discontinued prior to starting Glucommander. Basal Insulin Lantus Ongoing Dose: Custom Glucommander, Subcut, Injection, QHS (DEF)* Comments: Subsequent doses to be adjusted by Glucommander. Ongoing Dose: Custom Glucommander, Subcut, Injection, every morning Comments: Subsequent doses to be adjusted by Glucommander. Ongoing Dose: Custom Glucommander, Subcut, Injection, BID Comments: Subsequent doses to be adjusted by Glucommander. Correctional Insulin HumaLOG Ongoing Dose: Custom Glucommander, Subcut, Injection, every 4 hr (DEF)* Comments: Dosing per Glucommander. Ongoing Dose: Custom Glucommander, Subcut, Injection, every 6 hr Comments: Dosing per Glucommander. PRN Insulin HumaLOG Ongoing Dose: Custom Glucommander, Subcut, Injection, PRN, PRN blood glucose Hypoglycemia Treatment Dextrose 50% vial Per Glucommander, IV Push, Injection, PRN, PRN other (see comment) Comments: Blood Glucose less than 70. Treat and notify physician. glucagon 1 mg, IM, Injection, PRN, PRN other (see comment) Comments: Blood Glucose less than 50 and if no IV access. Treat and notify Physician. Page 330 of 391

331 Laboratory Not recommended if the patient has received a Hemoglobin A1C in the last 60 days.(note)* Hemoglobin A1c (Glycosylated) Blood, Routine, T;N, Once Non Categorized Initial Approval Date Annual Review Date *Report Legend: DEF - This order sentence is the default for the selected order GOAL - This component is a goal IND - This component is an indicator INT - This component is an intervention IVS - This component is an IV Set NOTE - This component is a note Rx - This component is a prescription SUB - This component is a sub phase Page 331 of 391

332 Unique Plan Description: GM Subcut Eating (basal/bolus + correction) Plan Selection Display: GM Subcut Eating (basal/bolus + correction) PlanType: Medical Version: 1 Begin Effective Date: 12/1/ :29 End Effective Date: Current Available at: KD Med Cntr GM Subcut Eating (basal/bolus + correction) Patient Care For patients who are eating meals.(note)* Glucommander Settings Glucommander Subcut Orderset Type: Basal/Bolus + Correction, Bolus Insulin: HumaLog, Basal Insulin: Lantus, Basal % of TDD: 50% (Standard) Monitoring Blood Glucose Monitoring POC T,N, Per Glucommander Recommendations Communication Order If Blood Glucose is greater than 500 mg/dl order STAT serum glucose Notify Treating Practitioner Laboratory Results Glucose more than 300 (DEF)* Glucose more than 400 Glucose more than 200 Medications All oral anti-diabetic medications, insulin, and non-insulin anti-diabetic injectables should be discontinued prior to starting Glucommander.(NOTE)* Pharmacy Communication T;N Comments: All oral anti-diabetic medications, and non-insulin anti-diabetic injectables should be discontinued prior to starting Glucommander. Basal Insulin Lantus Ongoing Dose: Per Glucommander, Subcut, Injection, QHS (DEF)* Ongoing Dose: Per Glucommander, Subcut, Injection, every morning Ongoing Dose: Per Glucommander, Subcut, Injection, BID Meal Bolus and Correction Insulin HumaLOG Ongoing Dose: Per Glucommander, Subcut, Injection, PCHS and 3 AM HumaLOG Ongoing Dose: Per Glucommander, Subcut, Injection, PRN, PRN blood glucose Hypoglycemia Treatment glucagon 1 mg, IM, Injection, PRN, PRN other (see comment) Comments: Blood Glucose less than 50 and if no IV access. Treat and notify Physician. Dextrose 50% vial Per Glucommander, IV Push, Injection, PRN, PRN other (see comment) Comments: Blood Glucose less than 70. Treat and notify physician. Laboratory Not recommended if the patient has received a Hemoglobin A1C in the last 60 days.(note)* Hemoglobin A1c (Glycosylated) Blood, Routine, T;N, Once *Report Legend: DEF - This order sentence is the default for the selected order GOAL - This component is a goal Page 332 of 391

333 IND - This component is an indicator INT - This component is an intervention IVS - This component is an IV Set NOTE - This component is a note Rx - This component is a prescription SUB - This component is a sub phase Page 333 of 391

334 Unique Plan Description: GM Subcut NPO/Continuous Enteral Feeding (basal + correction) Plan Selection Display: GM Subcut NPO/Continuous Enteral Feeding (basal + correction) PlanType: Medical Version: 1 Begin Effective Date: 3/22/ :48 End Effective Date: Current Available at: KD Med Cntr GM Subcut NPO/Continuous Enteral Feeding (basal + correction) Patient Care For patients who are NPO or on continuous feeding.(note)* Glucommander Settings Glucommander Subcut Orderset Type: Basal + Correction (for NPO, continuous, Basal % of TDD: 50% (Standard) Monitoring Blood Glucose Monitoring POC T,N, Per Glucommander Recommendations Communication Order If Blood Glucose is greater than 500 mg/dl order STAT serum glucose Notify Treating Practitioner Laboratory Results Glucose more than 300 (DEF)* Glucose more than 400 Glucose more than 200 Continuous Infusions Dextrose 10% in Water Glucommander Order Per Glucommander, IV Piggyback, Soln-IV, PRN, PRN other (see comment) Comments: Blood Glucose less than ml/hr if tube feeding/tpn interupted Medications All oral anti-diabetic medications, insulin, and non-insulin anti-diabetic injectables should be discontinued prior to starting Glucommander.(NOTE)* Pharmacy Communication T;N Comments: All oral anti-diabetic medications, and non-insulin anti-diabetic injectables should be discontinued prior to starting Glucommander. Basal Insulin Lantus Ongoing Dose: Per Glucommander, Subcut, Injection, QHS (DEF)* Ongoing Dose: Per Glucommander, Subcut, Injection, every morning Ongoing Dose: Per Glucommander, Subcut, Injection, BID Correctional Insulin HumaLOG Ongoing Dose: Per Glucommander, Subcut, Injection, every 4 hr (DEF)* Ongoing Dose: Per Glucommander, Subcut, Injection, every 6 hr PRN Insulin HumaLOG Ongoing Dose: Per Glucommander, Subcut, Injection, PRN, PRN blood glucose Hypoglycemia Treatment glucagon 1 mg, IM, Injection, PRN, PRN other (see comment) Comments: Blood Glucose less than 50 and if no IV access. Treat and notify Physician. Dextrose 50% vial Per Glucommander, IV Push, Injection, PRN, PRN other (see comment) Comments: Blood Glucose less than 70. Treat and notify physician. Laboratory Not recommended if the patient has received a Hemoglobin A1C in the last 60 days.(note)* Page 334 of 391

335 Hemoglobin A1c (Glycosylated) Blood, Routine, T;N, Once *Report Legend: DEF - This order sentence is the default for the selected order GOAL - This component is a goal IND - This component is an indicator INT - This component is an intervention IVS - This component is an IV Set NOTE - This component is a note Rx - This component is a prescription SUB - This component is a sub phase Page 335 of 391

336 Unique Plan Description: GM Subcut TRANSITION Eating (basal/bolus + correction) Plan Selection Display: GM Subcut TRANSITION Eating (basal/bolus + correction) PlanType: Medical Version: 1 Begin Effective Date: 12/7/ :36 End Effective Date: Current Available at: KD Med Cntr GM Subcut TRANSITION Eating (basal/bolus + correction) Patient Care Glucommander Settings Glucommander Subcut Transition Orderset Type: Basal/Bolus + Correction, Basal % of TDD: 50% (Standard) Monitoring Blood Glucose Monitoring POC T,N, Per Glucommander Recommendations Communication Order If Blood Glucose is greater than 500 mg/dl draw STAT serum glucose Notify Treating Practitioner Laboratory Results Glucose more than 300 (DEF)* Glucose more than 400 Glucose more than 200 Continuous Infusions insulin regular 100 units/ns 100 ml IV (IVS)* Sodium Chloride 0.9% drip (Titratable) 100 ml, IV, Goal: See Glucommander Order, Per Glucommander (0-100 units/hr), Order Duration: 6 hr, Start Date: T;N Comments: As needed for transition discontinue once transition is complete. insulin regular (human) IV additive 100 units Medications Transition Basal Insulin Lantus Ongoing Dose: Per Glucommander, Subcut, Injection, Once Basal Insulin Lantus Ongoing Dose: Per Glucommander, Subcut, Injection, QHS (DEF)* Ongoing Dose: Per Glucommander, Subcut, Injection, every morning Ongoing Dose: Per Glucommander, Subcut, Injection, BID Meal Bolus and Correction Insulin HumaLOG Ongoing Dose: Per Glucommander, Subcut, Injection, PCHS and 3 AM PRN Insulin HumaLOG Ongoing Dose: Per Glucommander, Subcut, Injection, PRN, PRN blood glucose Hypoglycemia Treatment glucagon 1 mg, IM, Injection, PRN, PRN other (see comment) Comments: Blood Glucose less than 50 and if no IV access. Treat and notify Physician. Dextrose 50% vial Per Glucommander, IV Push, Injection, PRN, PRN other (see comment) Comments: Blood Glucose less than 70. Treat and notify physician. *Report Legend: DEF - This order sentence is the default for the selected order GOAL - This component is a goal Page 336 of 391

337 IND - This component is an indicator INT - This component is an intervention IVS - This component is an IV Set NOTE - This component is a note Rx - This component is a prescription SUB - This component is a sub phase Page 337 of 391

338 Unique Plan Description: GM Subcut TRANSITION NPO/Continuous Enteral Feeding (basal + correction) Plan Selection Display: GM Subcut TRANSITION NPO/Continuous Enteral Feeding (basal + correction) PlanType: Medical Version: 1 Begin Effective Date: 3/22/ :02 End Effective Date: Current Available at all facilities GM Subcut TRANSITION NPO/Continuous Enteral Feeding (basal + correction) Patient Care For patients who are NPO or on continuous feeding.(note)* Glucommander Settings Glucommander Subcut Transition Orderset Type: Basal + Correction (for NPO, continuous), Basal % of TDD: 50% (Standard) Monitoring Blood Glucose Monitoring POC T,N, Per Glucommander Recommendations Communication Order If Blood Glucose is greater than 500 mg/dl draw STAT serum glucose Notify Treating Practitioner Laboratory Results Glucose more than 300 (DEF)* Glucose more than 400 Glucose more than 200 Continuous Infusions insulin regular 100 units/ns 100 ml IV (IVS)* Sodium Chloride 0.9% drip (Titratable) 100 ml, IV, Goal: See Glucommander Order, Per Glucommander (0-100 units/hr), Order Duration: 6 hr, Start Date: T;N Comments: As needed for transition discontinue once transition is complete. insulin regular (human) IV additive 100 units Dextrose 10% in Water Glucommander Order Per Glucommander, IV Piggyback, Soln-IV, PRN for 12 hr, PRN other (see comment) Comments: Blood Glucose less than ml/hr if tube feeding/tpn interupted Medications Transition Basal Insulin Lantus Ongoing Dose: Per Glucommander, Subcut, Injection, Once Basal Insulin Lantus Ongoing Dose: Per Glucommander, Subcut, Injection, QHS (DEF)* Ongoing Dose: Per Glucommander, Subcut, Injection, every morning Ongoing Dose: Per Glucommander, Subcut, Injection, BID Correctional Insulin HumaLOG Ongoing Dose: Per Glucommander, Subcut, Injection, every 4 hr (DEF)* Ongoing Dose: Per Glucommander, Subcut, Injection, every 6 hr PRN Insulin HumaLOG Ongoing Dose: Per Gluccomander, Subcut, Injection, PRN, PRN blood glucose Hypoglycemia Treatment glucagon 1 mg, IM, Injection, PRN, PRN other (see comment) Comments: Blood Glucose less than 50 and if no IV access. Treat and notify Physician. Dextrose 50% vial Page 338 of 391

339 Per Glucommander, IV Push, Injection, PRN, PRN other (see comment) Comments: Blood Glucose less than 70. Treat and notify physician. *Report Legend: DEF - This order sentence is the default for the selected order GOAL - This component is a goal IND - This component is an indicator INT - This component is an intervention IVS - This component is an IV Set NOTE - This component is a note Rx - This component is a prescription SUB - This component is a sub phase Page 339 of 391

340 Unique Plan Description: ED Gastrointestinal Bleed (GI) Plan Selection Display: ED Gastrointestinal Bleed (GI) PlanType: Medical Version: 1 Begin Effective Date: 10/26/ :49 End Effective Date: Current Available at: KD Med Cntr Plan Comment: MD Order Only-Upper GI Bleed, changed IVs to LR per Dr. Hipskind, 2/20/17 dsm; reviewed 3/9/17 dsm; Removed TXA after emily/hipskind meeting (bb) ED Gastrointestinal Bleed (GI) Patient Care Vital Signs T;N Comments: Per unit protocol Cardiac Monitoring ED T;N Oximetry - Continuous T,N Peripheral IV T,N, Large Bore Peripheral IV T,N, 2nd IV, Large Bore Rapid Fluid Warmer T;N Nasogastric (NG) Tube Insertion T,N, and place to low intermittent suction Nasogastric (NG) Tube Discontinue T,N Indwelling Urinary Catheter T,N, Indwelling, Reason: Critically Ill or Unstable Straight Catheter Once, Collect urine specimen Activity Bedrest (strict) T,N, Reason: Other (please specify) Diet/Nutrition NPO T,N, No Exceptions Continuous Infusions IV Maintenance Sodium Chloride 0.9% 1,000 ml, IV, 30 ml/hr Medications Nausea/Vomiting Zofran 4 mg, IV Push, Injection, every 30 min for 2 doses, PRN nausea Zofran ODT 4 mg, Oral, Tab-Dis, every 30 min for 2 doses, PRN nausea Proton Pump Inhibitors (PPI) Protonix IV 80 mg, IV Push, Injection, Once Comments: Over 3 minutes Miscellaneous Page 340 of 391

341 SandoSTATIN 1,250 mcg/ns 0.9% 250 ml IV (IVS)* Sodium Chloride 0.9% 250 ml, IV, 50 mcg/hr, Bolus Instructions: 50 mcg IV bolus octreotide IV additive 1,250 mcg, EB, 50 mcg/hr Reglan 10 mg, IV Push, Injection, Once Vitamin K1 10 mg/ml injectable solution 10 mg, IV Piggyback, Soln-IV, Once Antibiotic is indicated as prophylaxis if patient has concomitant cirrhosis(note)* Rocephin IVPB 1 g, IV Piggyback, Soln-IV, Once, Indication: ED - Empiric Laboratory CBC w/ Diff Blood, Stat, T;N, Nurse collect CMP Blood, Stat, T;N, Nurse collect Type and Screen Only Blood, Stat, T;N, Nurse collect VBG ED Alert Panel Blood, Stat, T;N, Nurse collect Fibrinogen Lvl Blood, Stat, T;N, Nurse collect Basic Teg Blood, Stat, T;N, Nurse collect Occult Blood Stool Stool, Stat Collect, T;N, Nurse collect Stool for Occult Blood POC T;N HCG, Beta Qual, Serum Blood, Stat, T;N, Nurse collect HCG Qualitative POC T;N Urinalysis Urine, Stat Collect, T;N, Nurse collect PT (with INR) Blood, Stat, T;N, Nurse collect PTT Blood, Stat, T;N, Nurse collect Blood Bank - Setup Red Blood Cells Leukoreduced ST Thawed Plasma ST Platelet Apheresis ST Comments: One unit if platelet less than 50 k or MA less than 50 mm Cryoprecipitate ST Blood Bank - Administer Transfuse Blood Product, Red Blood Cells, Leukoreduced Stat, ADMINister: 1, units, T;N (DEF)* Routine, ADMINister: 1, units, T;N Page 341 of 391

342 Transfuse Blood Product, Thawed Plasma Stat, ADMINister: 1, units, T;N (DEF)* Routine, ADMINister: 1, units, T;N Transfuse Blood Product, Plateletpheresis Stat, ADMINister: 1, units, T;N Comments: One unit if platelet less than 50 k or MA less than 50 mm Transfuse Blood Product, Cryoprecipitate Stat, ADMINister: 1, units, T;N Comments: If Fibrinogen Level less than 150 mg/dl or MA less than 50 mm Diagnostic Tests XR Chest 1 View Portable T;N, Stat, Reason: Other (please specify) XR Abdomen KUB 1 View T;N, Stat, Reason: Feeding tube placement Card/Vasc/Neuro Electrocardiogram 12 Lead Stat, Syncope Respiratory Oxygen Therapy Stat, Flow Rate (L/min): 2, SpO2 goal 94% or greater, Nasal Cannula, Contact MD if the pt. has an increase in O2 requirements or inability to maintain SpO2 as specified Respiratory Therapy to Evaluate T;N, Stat Consults/Referrals Consult to Gastroenterology (ED ONLY) Consult Reason: Gastrointestinal bleeding, Contact Provider on call Non Categorized Initial Approval Date Annual Review Date *Report Legend: DEF - This order sentence is the default for the selected order GOAL - This component is a goal IND - This component is an indicator INT - This component is an intervention IVS - This component is an IV Set NOTE - This component is a note Rx - This component is a prescription SUB - This component is a sub phase Page 342 of 391

343 Unique Plan Description: SURG POST Splenectomy Vaccination Plan Selection Display: SURG POST Splenectomy Vaccination PlanType: Medical Version: 1 Begin Effective Date: 5/11/ :50 End Effective Date: Current Available at: KD Med Cntr Plan Comment: built 5/11/17 from Soarian Post-Splenectomy Vaccination Order Set SURG POST Splenectomy Vaccination Medications Criteria: INCLUDED: Recent Splenectomy Recent determination LESS than 50% intact spleen(note)* Criteria: EXCLUDED: Immune-Compromised - DO NOT administer vaccines. On Chemotherapy - DO NOT administer vaccines.(note)* As the response to immunization is impacted by the degree of immunosuppression, vaccine administration should be re-evaluated on an outpatient basis(note)* Pneumovax ml, IM, Injection, Vaccine Comments: Administer 14 days post-splenectomy, or day of hospital discharge if sooner. If patient in ICU post-op day 14, contact surgeon to obtain order to hold or proceed with vaccination. ActHIB IM injection 10 mcg, IM, Injection, Vaccine Menactra intramuscular injection 0.5 ml, IM, Injection, Vaccine Comments: For patient ages 11 to 55 years. Administer 14 days post-splenectomy, or day of hospital discharge if sooner. If patient in ICU post-op day 14, contact surgeon to obtain order to hold or proceed with vaccination. Menomune A/C/Y/W-135 SDV subcut inj 0.5 ml, Subcut, Injection, Vaccine Comments: For patient age more than 55 years. Administer 14 days post-splenectomy, or day of hospital discharge if sooner. If patient in ICU post-op day 14, contact surgeon to obtain order to hold or proceed with vaccination. Non Categorized Initial Approval Date Annual Review Date *Report Legend: DEF - This order sentence is the default for the selected order GOAL - This component is a goal IND - This component is an indicator INT - This component is an intervention IVS - This component is an IV Set NOTE - This component is a note Rx - This component is a prescription SUB - This component is a sub phase Page 343 of 391

344 Unique Plan Description: Common IV Fluids Plan Selection Display: Common IV Fluids PlanType: Medical Version: 1 Begin Effective Date: 2/11/ :40 End Effective Date: Current Available at: KD Med Cntr Common IV Fluids Continuous Infusions Plain IV(s) Sodium Chloride 0.9% 1,000 ml, IV, ml/hr Sodium Chloride 0.45% 1,000 ml, IV, ml/hr Dextrose 5% in Water 1,000 ml, IV, ml/hr Dextrose 5% with 0.9% NaCl 1,000 ml, IV, ml/hr Dextrose 5% with 0.45% NaCl 1,000 ml, IV, ml/hr Dextrose 5% in Lactated Ringers 1,000 ml, IV, ml/hr Lactated Ringers Injection 1,000 ml, IV, ml/hr Plasma-Lyte A PH-7.4 1,000 ml, IV, ml/hr 0.45 NS W/KCl 0.45% NS w/kcl 10 meq 1,000 ml IV (IVS)* Sodium Chloride 0.45% 1,000 ml, IV, ml/hr potassium chloride IV Additive 10 meq, EB 0.45% NS w/kcl 20 meq 1,000 ml, IV, ml/hr 0.45% NS w/kcl 30 meq 1,000 ml IV (IVS)* Sodium Chloride 0.45% 1,000 ml, IV, ml/hr potassium chloride IV Additive 30 meq, EB 0.45% NS w/kcl 40 meq 1,000 ml IV (IVS)* Sodium Chloride 0.45% 1,000 ml, IV, ml/hr potassium chloride IV Additive 40 meq, EB 0.9 NS W/KCl 0.9% NS w/kcl 10 meq 1,000 ml IV (IVS)* Sodium Chloride 0.9% 1,000 ml, IV, ml/hr potassium chloride IV Additive 10 meq, EB 0.9% NS w/kcl 20 meq 1,000 ml, IV, ml/hr 0.9% NS w/kcl 30 meq 1,000 ml IV (IVS)* Sodium Chloride 0.9% Page 344 of 391

345 1,000 ml, IV, ml/hr potassium chloride IV Additive 30 meq, EB 0.9% NS w/kcl 40 meq 1,000 ml, IV, ml/hr D5W W/KCl D5W/KCl 10 meq 1,000 ml IV (IVS)* Dextrose 5% in Water 1,000 ml, IV, ml/hr potassium chloride IV Additive 10 meq, EB D5W/KCl 20 meq 1,000 ml IV (IVS)* Dextrose 5% in Water 1,000 ml, IV, ml/hr potassium chloride IV Additive 20 meq, EB D5W/KCl 40 meq 1,000 ml IV (IVS)* Dextrose 5% in Water 1,000 ml, IV, ml/hr potassium chloride IV Additive 40 meq, EB D5W/0.9% W/KCl D5W/0.9% NS/KCl 10 meq 1,000 ml IV (IVS)* Dextrose 5% with 0.9% NaCl 1,000 ml, IV, ml/hr potassium chloride IV Additive 10 meq, EB D5W/0.9% NS/KCl 20 meq 1,000 ml, IV, ml/hr D5W/0.9% NS/KCl 30 meq 1,000 ml IV (IVS)* Dextrose 5% with 0.9% NaCl 1,000 ml, IV, ml/hr potassium chloride IV Additive 30 meq, EB D5W/0.9% NS/KCl 40 meq 1,000 ml, IV, ml/hr D5W/0.45% W/KCl D5-0.45NaCl w/k10 1,000 ml, IV, ml/hr D5W/0.45% NS/20 meq KCl 1,000 ml, IV, ml/hr D5-0.45NaCl w/k30 1,000 ml, IV, ml/hr D5W/0.45% NS/40 meq KCl 1,000 ml, IV, ml/hr Sod Bicarb IV(s) D5W 850 ml/sod Bicarb 150 meq 1,000 ml IV (IVS)* Dextrose 5% Water (Titratable) 1,000 ml, IV, Titrate only if directed sodium bicarbonate 8.4% IV additive (Titratable) 150 meq, EB, 3 ml/kg/hr *Report Legend: DEF - This order sentence is the default for the selected order GOAL - This component is a goal Page 345 of 391

346 IND - This component is an indicator INT - This component is an intervention IVS - This component is an IV Set NOTE - This component is a note Rx - This component is a prescription SUB - This component is a sub phase Page 346 of 391

347 Unique Plan Description: PED Adolescent (14-18 years of age) Admission Plan Selection Display: PED Adolescent (14-18 years of age) Admission PlanType: Medical Version: 1 Begin Effective Date: 3/1/ :19 End Effective Date: Current Available at: KD Med Cntr Plan Comment: meds added during mtg with Leah 4/26/17 dsm; PED Adolescent (14-18 years of age) Admission Admit/Transfer/Discharge/Status Admission Status(SUB)* Patient Care General Telemetry(SUB)* Resuscitation Status Full Code (DEF)* Do Not Resuscitate Limited (Please Specify) Height/Length Once, Per Standard of Care Weight Once, On admission (DEF)* Once, on admission Vital Signs Notify Treating Provider for vital signs outside of parameters noted for telemetry or outside of range per standard of care guidelines. Intake and Output Q shift Peripheral IV Activity Up ad Lib Bedrest (strict) Bedrest with Bathroom Privileges Diet/Nutrition NPO Clear Liquid Diet Full Liquid Diet Ad Lib Regular Diet Diabetic Diet Consult to Registered Dietitian Continuous Infusions D5W/0.9% W/KCl D5W/0.9% NS/KCl 20 meq 1,000 ml, IV, Soln-IV, ml/hr Medications *** Consider ordering docusate sodium (Colace) when ordering narcotic pain medications ***(NOTE)* Pain and/or Fever Tylenol 325 mg, Oral, Tab, every 4 hr, PRN other (see comment) (DEF)* Comments: PRN pain or fever 650 mg, Oral, Tab, every 4 hr, PRN other (see comment) Comments: PRN pain or fever Page 347 of 391

348 Motrin 200 mg, Oral, Tab, every 6 hr, PRN other (see comment) (DEF)* Comments: prn pain or fever 400 mg, Oral, Tab, every 6 hr, PRN other (see comment) Comments: prn pain or fever 600 mg, Oral, Tab, every 6 hr, PRN other (see comment) Comments: prn pain or fever Pain (Moderate level 4-6) Toradol 15 mg, IV Push, Injection, every 6 hr for 4 doses (DEF)* 15 mg, IV Push, Injection, every 6 hr, PRN pain, moderate (scale 4-6) Norco 5 mg-325 mg oral tablet 1 tab, Oral, Tab, every 4 hr, PRN pain, moderate (scale 4-6) Pain (Severe level 7-10) Norco 10 mg-325 mg oral tablet 1 tab, Oral, Tab, every 4 hr, PRN pain, severe (scale 7-10) Dilaudid 0.5 mg, IV Push, Injection, every 4 hr, PRN pain, severe (scale 7-10) morphine 4 mg, IV Push, Injection, every 2 hr, PRN pain, severe (scale 7-10) Gastrointestinal Agents Pepcid 20 mg, IV Push, Injection, Daily Protonix 20 mg, Oral, Tab-DR, Daily (DEF)* 40 mg, Oral, Tab-DR, Daily Pruritis Benadryl 25 mg, Oral, Cap, every 6 hr, PRN itching/rash (DEF)* 50 mg, Oral, Cap, every 6 hr, PRN itching/rash Nausea/Vomiting Zofran ODT 4 mg, Oral, Tab-Dis, every 6 hr, PRN nausea/vomiting (DEF)* 8 mg, Oral, Tab-Dis, every 6 hr, PRN nausea/vomiting Zofran 4 mg, Oral, Tab, every 4 hr, PRN nausea/vomiting (DEF)* 8 mg, Oral, Tab, every 4 hr, PRN nausea/vomiting Miscellaneous LMX 4 topical cream 1 app, Topical, Cream, As Directed, PRN other (see comment) Comments: PRN lab draws/iv Insertions. Apply topically 20 minutes prior to IV start Emla 2.5%-2.5% topical cream 1 app, Topical, Cream, As Directed, PRN other (see comment) Comments: PRN lab draws/iv Insertions. Apply topically 45 minutes prior to IV start Laboratory BMP Basic Metabolic Panel Blood, Routine, T;N, Once CMP Blood, Routine, T;N, Once CBC w/ Diff Blood, Routine, T;N, Once CRP High Sensitivity (CV Risk) Blood, Routine, T;N, Once Mycoplasma IgM Ab Screen Page 348 of 391

349 Blood, Routine, T;N, Once Blood Culture Blood, Routine collect, RT - Routine, T;N, Once Urinalysis with Microscopic Urine, Nurse collect Nasal MRSA Screen Nasal, Routine collect, RT - Routine, T;N, Once Group A Strep Screen Throat, Routine Collect, T;N, Once Flu A / B Screen Nasal, Routine Collect, T;N, Once AM Labs Complete Metabolic Panel Blood, AM Draw (Inpatient Only), T+1;0330, Once C-Reactive Protein High Sensitivity (CV Risk) Blood, AM Draw (Inpatient Only), T+1;0330, Once ESR, Westergren Blood, AM Draw (Inpatient Only), T+1;0330, Once CBC with Diff Blood, AM Draw (Inpatient Only), T+1;0330, Once Diagnostic Tests XR Abdomen KUB 1 View Stat (DEF)* Routine T+1;0600, In AM XR Chest 1 View Portable Stat (DEF)* Routine T+1;0600, In AM XR Chest 2 Views Stat (DEF)* Routine T+1;0600, In AM US Abdomen Complete Stat (DEF)* Routine T+1;0600, In AM Respiratory Oxygen Therapy SpO2 goal 92% or greater, Nasal Cannula, Initiate supplemental oxygen for room air saturations less than 88% and notify Provider (DEF)* SpO2 goal 92% or greater Consults/Referrals Consult to Case Management Consult to PFS Communication Orders Nursing Communication Order Non Categorized Initial Approval Date Annual Review Date *Report Legend: DEF - This order sentence is the default for the selected order Page 349 of 391

350 GOAL - This component is a goal IND - This component is an indicator INT - This component is an intervention IVS - This component is an IV Set NOTE - This component is a note Rx - This component is a prescription SUB - This component is a sub phase Page 350 of 391

351 Unique Plan Description: General Telemetry Plan Selection Display: General Telemetry PlanType: Medical Version: 1 Begin Effective Date: 1/18/ :35 End Effective Date: Current Available at all facilities General Telemetry Patient Care Telemetry - General Class II for 2 Days Class II: Cardiac monitoring may be of benefit in some patients, but not essential for all Telemetry - General Class I for 3 Days Class I: Cardiac monitoring is indicated in most, if not all patients Communication Orders Nursing Communication Order DC tele with the absence of the following within 24 hrs of the order expiring: New 12-lead ECG changes; new Trop level above 0.04, or higher than previous level; avg of 10 PVC's/min over the last 24 hrs; Call MD with questions or if tele needs to continue *Report Legend: DEF - This order sentence is the default for the selected order GOAL - This component is a goal IND - This component is an indicator INT - This component is an intervention IVS - This component is an IV Set NOTE - This component is a note Rx - This component is a prescription SUB - This component is a sub phase Page 351 of 391

352 Unique Plan Description: NICU Observation Admission Plan Selection Display: NICU Observation Admission PlanType: Medical Version: 1 Begin Effective Date: 1/18/ :45 End Effective Date: Current Available at: KD Med Cntr Plan Comment: meds added "NICU Observation Order Set Post NICU Observation Order Set 2/13/17 ES; All meds removed 6/16/17 per ORC mtg; NICU Observation Admission Admit/Transfer/Discharge/Status Admission Status(SUB)* Patient Care Open Crib Vital Signs every 30 min, Duration: 4 times Vital Signs every 1 hr, To start after the q 30 min x 4 is complete Communication Order RN to record pre and post ductal blood pressure Blood Pressure On all 4 extremities Weight On arrival if not done within the previous 12 hours Head Circumference Measure and record if not done prior to arrival Height/Length Measure and record if not done prior to arrival Intake and Output every 12 hr Communication Order Oral Sucrose per Administration of Oral Sucrose to Infants Policy Notify Treating Practitioner Vital Signs HR greater than 160 beats/min, HR less than 80 beats/min, RR greater than 60 breaths/min, RR less than 40 breaths/min, Temp greater than 38 degrees Celsius, Temperature Less Than: 36.3 degrees Celsius, Or mean blood pressure outside the normal range per s Notify Practitioner If unable to keep oxygen saturation within ordered parameters, FiO2 need GREATER than 30% for one hour, increased work of breathing, respiratory distress, or worsening of condition despite interventions Diet/Nutrition NPO Pediatric Formula Breastfeeding Diet Human Milk Communication Order Advance feedings Blood Glucose Monitoring POC As Directed, PRN, POC glucose check once, then as per Screening and Management of Neonatal Hypoglycemia policy Laboratory CBC with Diff Page 352 of 391

353 Blood, Stat, T;N (DEF)* Blood, Routine, T;N Blood Culture Blood, Stat collect, ST - Stat, T;N Comments: within 1 hour of life POC ABG Blood, Stat collect, T;N POC Capillary Blood Gas Blood, Stat collect, T;N Drug Screen Urine Urine, Stat Collect, T;N Drug Panel Meconium Scrn w/rflx to Conf-ARUP SST Micro, Stat Collect, T;N Neonatal CMP STAT(SUB)* Respiratory Oxygen Therapy SpO2 goal Other (please specify), Titrate oxygen to keep Sp02 less than 92%. Nasal Cannula, wean Fi02, then liter flow to maintain Sa02 within parameters Consults/Referrals Consult to Infectious Diseases Specialist Antiretroviral (ARV) Notify Practitioner Notify Pediatrician/Neonatologist of newborn's birth Non Categorized Initial Approval Date Annual Review Date Perinatal Care Quality Measures *Report Legend: DEF - This order sentence is the default for the selected order GOAL - This component is a goal IND - This component is an indicator INT - This component is an intervention IVS - This component is an IV Set NOTE - This component is a note Rx - This component is a prescription SUB - This component is a sub phase Page 353 of 391

354 ISBARQ Revised IV iron order sets and protocols [3/31/2017] Introduction: Coleen Moriarity-Suggs, Pharm. D. Situation: The attached order sets and protocols have been updated to reflect revisions to dosing and frequency of administration of IV iron products as well as revisions to adverse reaction management. Background: Requested by: Coleen Moriarity-Suggs, Pharm. D., Roger Haley, M.D., F.A.C.P, Director of Renal Services Justification: literature support, improved patient management Assessment Category of Change Requested: Enhancement Description of issues the changes will involve and implications: IV iron dosing and frequency more in line with FDA approved labeling and literature recommendations, improved identification and treatment of adverse reactions to IV iron therapy, increased patient safety Suggested changes to order sets, protocols: See attached revisions Recommended Communication/Education for affected disciplines: Nursing, pharmacy Recommendation Approve the changes to the protocols and order sets for both paper and electronic versions (pending approval by ORC Committee) See attachments for specific edits Questions: Coleen Moriarity- Suggs, Pharm D X 6607 Page 354 of 391

355 Page 355 of 391

356 ISBARQ Deletion of acetaminophen w/codeine from post-partum and pediatric order sets 5/22/17 Introduction: Desiree Ferrel, PharmD, BCPS , Supported by Dr. Randolph (peds), Dr. Bencomo (OB) Situation: Requesting removal of acetaminophen w/codeine from all pediatric and post-partum order sets. Background: Requested by: Dr. Randolph, Dr. Bencomo The FDA has recently strengthened their recommendations against the use of codeine in pediatrics and nursing mothers. The use of codeine is now contraindicated in all pediatric patients under the age of 12 years in addition to the previous contraindication in pediatric surgery patients for tonsil or adenoid removal. The FDA also recommends against the use of codeine in adolescents who are obese or have other conditions such as obstructive sleep apnea or severe lung disease. In addition to the FDA strengthening their recommendation against the use of codeine in nursing mothers, the American College of Obstetricians and Gynecologists (ACOG) has advised against the use of codeine in nursing mothers. The new labeling is a result of concerns related to the potential of pediatric and neonatal respiratory depression possibly leading to death due to the possibility of ultra-rapid metabolizers converting codeine to morphine too quickly, resulting in a morphine overdose. Supporting literature: The American College of Obstetricians and Gynecologists. Practice advisory on codeine and tramadol for breastfeeding women. 4/2/ PracticeAdvisories/PracticeAdvisoryonCodeineandTramadolforBreastfeedingWomen?p=1. Food and Drug Administration. FDA drug safety communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children;recommends against use in breastfeeding women. 4/20/17. Drugs/DrugSafety/ucm htm?source=govdelivery. Assessment Category of Change Requested: Patient Safety Removal of acetaminophen w/codeine from pediatric and post-partum order sets will decrease the likelihood of adverse events related to morphine overdose in neonatal and pediatric patients due to ultrarapid metabolism of the drug into morphine. Suggested changes: removal of acetaminophen w/ codeine from the following order sets: Routine post-partum Post-appendectomy (pediatrics) C-section post-op Recommendation Approve the deletion of acetaminophen w/codeine from all post-partum and pediatric order sets. Questions: Desiree Ferrel, PharmD, BCPS ,dferrel@kdhcd.org Page 356 of 391

357 ISBARQ Change to Outpatient Chronic Hemodialysis Admission Orders 4/4/2017 Introduction: Darrell Chudej, RN, Nurse Manager, x3601 Situation: In review of policies, procedures, protocols, clarification needed on orders to match policy changes; Medical Director clarified med frequencies and usage; addition of dialysis hypoglycemia protocol; addition of Oxygen with parameters to medication list; addition/clarification of Pneumococcal vaccine dosing on medication list due to changes in dosing by CDC; ICD-10 for diagnosis Background: Requested by: Darrell Chudej, RN Justification: Policy changes to Blood Flow Rate policy, use of the product BiBag (to standardize Dialysate flow rate of 600), additions to/medications under Orders needed clarification, addition of protocol Assessment Category of Change Requested: Enchancement/improvement Description of issues the changes will resolve and implications: addition of items will match the policies which have been revised; diagnosis ICD-10 as requested by financial consultants, clarification of medication usage and frequencies Suggested changes to order sets: See changes on order sheet Recommended Communication/Education for affected disciplines (nursing, physicians, pharmacy, etc.: to staff regarding changes to the admission orders. Charges nurses and staff RN s specifically. Recommendation: Approve changes/additions; these changes are being made to satisfy recent survey recommendations** Questions: We need this process expedited please. Darrell Chudej, RN, Nurse Manager, Chronic Hemodialysis Facility Page 357 of 391

358 OUTPATIENT CHRONIC HEMODIALYSIS ADMISSION ORDERS Diagnosis: End Stage Renal Disease (N18.6) Acute Kidney Injury (N17.9) Other: Days of Dialysis: 31 x week 42 x week 3 x week 4 x week Duration of Dialysis: Dry Weight: Allergies and Reactions: See KDHCD Medical Record Access to Use: Fistula AV Graft Tunneled Cath Temporary Cath For catheters: Tego caps with 10 ml NS flush per catheter port; change q week Heparin 5,000 units/per ml Flush Concentration to catheter volume Heparin 10,000/per ml units Flush Concentration to catheter volume Dialyzer: 160 NR 200NR F180 F250NR Dialysate: 1 K+/2.5 Ca 2 K+/2.5 Ca 3 K+/2.5 Ca 4 K+ /2.5 Ca Citrasate Infuse 100 ml IV normal saline q 1 hour PRN clots in line or rising venous pressure Minimum Blood flow 250 ml/min. Dialysate flow rate: Standard order 600 ml/min or DFR ml/min=2 x Blood Flow (Maximum 600ml/min) Maximize Blood Flow Rate (BFR) (per policy +/- 100mL/min):, ( Minimum Maximum Maximum BFR 500 ml/min350400) Heparin Load: units per IVextracorporeal route Heparin maintenance: units per IVhour per extracorporeal route May Use Crit-line Monitor max BV change: < 8% <10% <15% Medication review with the Re-Evaluation Interdisciplinary Assessment (RIA) and after hospital discharge Diet: Renal Diabetic Fluid Restriction: Yes ml/per day Orders: (Check appropriate boxes) Use Dialysis Related Hemodynamic Instability (DRHI) protocol and policy to manage hemodynamic instability signs/symptoms during dialysis hemodynamic instability signs/symptoms during dialysis Acetaminophen (Tylenol) 325 mg po 2 tabs q 4 hrs prn mild pain Diphenhydramine (Benadryl) 12.5 mg IV q 4 hrs prnonce as needed for itching, May repeat once 1 hr after first dose, during dialysis OndansetronPromethazine (Zofran) 4 mg IV q 4 hrs prnonce as needed for nausea/vomiting, may repeat oncex 1 hour after first dose during dialysis Promethazine (Phenergan) 12.5mg IV q 4 hrs prn nausea/vomiting if ondansetron (Zofran) not used or ineffective Nitroglycerin (Nitrostat) 0.4 mg SL, prn chest pain, may repeat q 5 min, x 3 doses. If pt requires 3 doses call physician Cyanocobalamin (Vitamin B12) 1000 mcg IM, q month. Hepatitis B (Engerix-BRecombivax) vaccine (with consent) 40 mcg IM, at intervals, 0, 1, 2, 6 months, HBSAB 2 months post series; HBsAg monthly for susceptible patients PPD (intermediate) 0.1 ml intradermal on arm, examine site for induration hours after administration. Repeat annually. Influenza vaccine 0.5 ml IM on admission and annually Pneumococcal vaccine (Pneumovax 23) 0.5 ml IM on admission, then q 5 years until age 65 years or older. Only one dose (Prevnar 23) after patient is 65 years or older Lidocaine 2% 1 ml subcutaneously prn as local anesthetic for needle placement with graft or fistula. Oxygen 2L/min via nasal cannula prn sob, using Pulse Ox 90%, Crit Line Sat: Catheter < 60%, AVF/AVG <90% Gram stain and culture access site prn drainage, erythema, and/or tenderness Tego caps with 10 ml NS flush per catheter port; change q week Referral for arteriovenus fistula placement per Available Surgeon, Surgeon: TSH Indication: For patients with documented diagnosis for diabetes: Hgb A1c on admission and quarterly Protocols: May initiate each time a criterion is met 1. Lab Monitoring Protocol 12. Nutrition QI Laboratory Protocol 2. Anemia Management Protocol 13. Temperature Variation Protocol 3. IV Iron Management Protocol 14. Sodium Variation Protocol 4. Hepatitis Immunodeficiency Control Protocol 15. Ultrafiltration (UF) Profiling Protocol 5. Edema-Free Weight Adjustment Protocol 16. Blood Volume Monitoring for Estimated Dry Weight Protocol 6. Dialysate Potassium Adjustment Protocol 17. Hypoglycemia, Adult Administration of Dextrose in Chronic Dialysis 7. DRHI (Dialysis-Related Hem odynamic Instability) Chronic Dialysis Protocol 8. Hemodialysis Clinics Doxercalciferol Injection (Hectorol) Protocol Formatted: Right: 0.25" Formatted: Font: Not Bold Formatted: Right: -0.06" Formatted: Indent: Left: 0", Hanging: 0.25", Right: -0.15" Page 358 of 391

359 9. Suture Removal Protocol (for Tunneled Dialysis Catheters) 10. Alteplase (Cathflo Activase) Instillation Protocol (Treatment of Malfunctioning Tunneled Central Venous Catheter for Dialysis) 11. Prophylactic Antibiotic Administration for Catheter Repair Protocol Date/Time: Physician Signature: Physician # Current Version: 6/17/10 Initial Approval: 7/18/11 Annual Approval: 11/13/12 Formatted: Indent: Left: 3" Page 359 of 391

360 Provider Name: Date: Please Print Advanced Practice Provider Acute/Critical Care Location: Kaweah Delta Medical Center Kaweah Delta Rehab Hospital Specialty Assignment: ICU ICCU Cardiac Services Through-Put OB/GYN Pediatric Other: Initial Criteria Physician Assistant: Completion of an ARC-PA approved program; Current certification by the NCCPA (Obtain certification within one year of completion of PA program or granting of privileges); Current licensure to practice as a PA by the California board of medicine; OR Nurse Practitioner: Completion of a master s/post-masters or doctorate degree in an nursing program accredited by the Commission of Collegiate of Nursing Education (CCNE) or National League for Nursing Accrediting Commission (NLNAC) with emphasis on the NPs specialty area; current certification by the ANCC or AANP (Obtain certification within one year of completion of Masters/Doctorate program or granting of privileges) AND BLS and full schedule California DEA Clinical Experience: Documentation of patient care for 50 patients in the past two years OR completion of training program within the last 12 months Renewal Criteria: Documentation of patient care for 50 patients in the past 2 years AND maintenance of current certification by NCCPA, ANCC, or AANP ; AND current BLS and full schedule DEA FPPE: 25 cases by Direct Observation and Retrospective Chart Review at the supervising physicians discretion Request GENERAL CORE PRIVILEGES CORE Includes procedures on the following list and such other procedures that are extensions of the same techniques and skills: Approve Perform History & Physical/ MSE; Prescribe & Administer medications per formulary of designated certifying board Perform other emergency treatment Write Discharge Summaries and Instructions Apply, remove, and change dressings and bandages; Perform debridement and general care for superficial wounds and minor superficial surgical procedures Counsel and instruct patients, families, and caregivers as appropriate Direct care as specified by medical staff-approved protocols; Make daily rounds on hospitalized patients, as appropriate; Initiate appropriate referrals; Record progress notes; Order and initial interpretation of diagnostic testing and therapeutic modalities; Implement palliative care and end-of-life care through evaluation, modification, and documentation according to the patient s response to therapy, changes in condition, and to therapeutic interventions Implement therapeutic intervention for specific conditions when appropriate Remove arterial catheters, central venous catheters, chest tubes; Insert and remove nasogastric tube; provide tracheostomy care Perform field infiltrations of anesthetic solutions; incision and drainage of superficial abscesses; Short-term and indwelling urinary bladder catheterization; venous punctures for blood sampling, cultures, and IV catheterization; superficial surgical procedures Removal of drains, sutures, staples, & packing Outpatient Services at a Kaweah Delta Health Care District facilities. (Please identify) RURAL HEALTH CLINIC: Dinuba Exeter Lindsay Woodlake Family Medicine Clinic Chronic Disease Management Center Wound Care Center Hospice Dialysis Clinic Advanced Practice Provider Acute/Critical Care 1 Approved: Page 360 of 391

361 Provider Name: Date: Please Print SPECIAL NON-CORE PRIVILEGES Request Procedure Criteria Renewal Criteria Surgical Assistant (may not perform opening and/or closing surgical 10 in the last 2 10 in the last 2 procedures at or below the fascia on a patient under anesthesia without the years years personal presence of a supervising physician and surgeon). Perform non-pharmacological stress tests 10 in the last 2 10 in the last 2 years years Echocardiogram Bubble Study 10 in the last 2 10 in the last 2 years years Tilt Table 5 in the last 2 5 in the last 2 years years Contrast Echocardiography 5 in the last 2 5 in the last 2 years years Lumbar Puncture 3 in the last 2 3 in the last 2 years years Thoracentesis 5 in the last 2 years Insertion of Chest Tubes 5 in the last 2 years Insertion and removal of central venous access or dialysis catheters 5 in the last 2 years Insertion and removal of Arterial Lines 5 in the last 2 years Replacement of tracheostomy tubes >1 month since time of 5 in the last two tracheostomy years Removal of Intra-Aortic Balloon Pump 5 in the last two years Removal of Intra-cardiac lines or temporary Epicardial Pacer Wires 2 in the last 2 years Endotracheal extubation and intubation 5 in the last 2 years Paracentesis 5 in the last 2 years Remove & reinsert PEG tube 3 in the last 2 years 5 in the last 2 years 5 in the last 2 years 5 in the last 2 years 5 in the last 2 years 5 in the last 2 years 5 in the last 2 years 2 procedures in the last 2 years 5 in the last 2 years 5 in the last 2 years 3 in the last 2 years FPPE 2 concurrent 2 concurrent 2 concurrent 2 concurrent 2 concurrent 2 concurrent Minimum of 3 Minimum of 3 Minimum of 3- any site 5 concurrent 5 concurrent 5 concurrent 2 concurrent Minimum of 3 5 concurrent 2 concurrent Approve Acknowledgment of Practitioner: I have requested only those privileges for which by education, training, current experience and demonstrated performance I am qualified to perform and for which I wish to exercise and; I understand that: (a) (b) In exercising any clinical privileges granted, I am constrained by any Hospital and Medical Staff policies and rules applicable generally and any applicable to the particular situation. Emergency Privileges In case of an emergency, any member of the medical staff, to the degree permitted by his/her license and regardless of department, staff status, or privileges, shall be permitted to do everything reasonably possible to save the life of a patient from serious harm. Advanced Practice Provider Signature Date Supervising/Collaborating Physician Signature Date Advanced Practice Provider Acute/Critical Care 2 Approved: Page 361 of 391

362 Provider Name: Date: Please Print APPROPRIATE DEPARTMENT CHAIR SIGNATURE: Department of Cardiovascular Services Date Department of Critical Care, Pulmonary & Hospitalist Date Department of Emergency Medicine Date Department of Family Medicine Date Department of Internal Medicine Date Department of Pediatrics Date Advanced Practice Provider Acute/Critical Care 3 Approved: Page 362 of 391

363 BOARD OF DIRECTORS KAWEAH DELTA HEALTH CARE DISTRICT RESOLUTION 1964 A RESOLUTION DIRECTING TULARE COUNTY, CALIFORNIA, TO LEVY A TAX TO PAY THE PRINCIPAL OF AND INTEREST ON GENERAL OBLIGATION BONDS OF THE DISTRICT. WHEREAS, by Resolution No (the Ballot Resolution ) adopted by the Board of Directors of Kaweah Delta Health Care District (the Board ) on July 22, 2003, the Board determined and declared that public interest and necessity demanded the acquisition, construction and/or reconstruction, improvement and equipping of additional health care facilities to expand Kaweah Delta Hospital of Kaweah Delta Health Care District (the District ); and WHEREAS, by the Ballot Resolution, the Board duly called an election to be held on November 4, 2003, for the purpose of submitting to the electors of the District a proposition to incur bonded indebtedness to finance all works, property, parking and structures necessary or convenient for the acquisition, improvement, construction and/or reconstruction of an expansion to Kaweah Delta Hospital, as more fully defined herein (the Project ); and WHEREAS, an election was held in the District on November 4, 2003, for the purpose of submitting to the qualified voters of the District a proposition for incurring bonded indebtedness of the District in the aggregate principal amount not to exceed $51,000,000 to finance the Project; and WHEREAS, the Registrar of Voters of Tulare County, California, duly canvassed the return of said election and, as the result of such canvass, certified to the Board that more than two-thirds of the votes cast on said proposition favored the incurring of such bonded indebtedness; and WHEREAS, in 2004, the District issued its General Obligation Bonds, Election of 2003, Series 2004 (the 2004 Bonds ) in the aggregate principal amount of $51,000,000 for the purposes authorized and on the conditions set forth in Ordinance No (the "Ordinance ); and WHEREAS, on January 6, 2014, the Board adopted Resolution No authorizing the issuance of its General Obligation Refunding Bonds, Series 2014 (the 2014 Bonds ) in an amount sufficient to provide for the advance refunding and redemption, on August 1, 2014, of the 2004 Bonds maturing on or after August 1, 2015; and WHEREAS, on January 30, 2014, the Board issued its 2014 Bonds in the aggregate principal amount of $48,906,000 pursuant to Chapter 4, Division 23 (Sections Page 363 of 391

364 32300 et seq.) of the California Health & Safety Code (the Authorizing Law ), Chapter 3, Part 1, Division 2, Title 5 of the California Government Code and Resolution No. 1795; WHEREAS, pursuant to the Authorizing Law, the District is authorized to direct Tulare County, California, in which jurisdiction the District is located (the "County"), to levy an ad valorem tax on all property within the District for the purpose of paying the principal and interest coming due on the 2014 Bonds, NOW, THEREFORE, BE IT RESOLVED BY THE BOARD OF DIRECTORS OF KAWEAH DELTA HEALTH CARE DISTRICT AS FOLLOWS: Section 1. Recitals. All of the recitals herein are true and correct. To the extent that the Recitals relate to findings and determinations of the Board, the Board declares such findings or determinations to be made hereby. Section 2. Tax Levy. For the purpose of paying the principal of and interest on the 2014 Bonds, and subject to the provisions below, the Board hereby directs the County to levy and collect, in each successive fiscal year, commencing with the District's fiscal year beginning July 1, 2017, and ending June 30, 2018 a tax sufficient to pay the annual interest on the 2014 Bonds as the same becomes due and also such part of the principal thereof as becomes due before the proceeds of a tax levied at the time for making the next general tax levy can be made available for the payment of such interest or principal. Attached to this Resolution as Exhibit A is the annual debt service schedule for the 2014 Bonds. Attached to this Resolution as Exhibit B is the property tax rate set by the Board for the fiscal year ending June 30, The levy of taxes for the 2014 Bonds takes into account amounts on deposit in the General Obligation Refunding Bond Fund of the District established pursuant to Resolution No of the District to pay debt service on the 2014 Bonds during such year as estimated by the Chief Financial Officer. Said tax shall be in addition to all other taxes levied for District purposes, shall be levied and collected by the County at the same time and in the same manner as other taxes of the District are levied and collected, and shall be used only for the payment of the 2014 Bonds, and the interest thereon. Pursuant to Sections and of the California Health & Safety Code, all taxes collected by the County pursuant to this Section 2 shall be paid into the treasury of the District and deposited forthwith in a special account of the District as set forth in Resolution No of the District. Section 3. Request for Necessary County Actions. The Board of Supervisors, the Treasurer, the Tax Collector, the Auditor and other officials of the County are hereby requested to take and authorize such actions as may be necessary pursuant to law to provide for the levy and collection of a property tax on all taxable property within the District sufficient to provide for the payment of all principal of, redemption premium (if any), and interest on the 2014 Bonds, as the same shall become due and payable, and Page 2 of 5 Page 364 of 391

365 to transfer the tax receipts from such levy to the District for deposit into the District's General Obligation Refunding Bond Fund. The Chief Financial Officer is hereby authorized and directed to deliver certified copies of this Resolution to the clerk of the Board of Supervisors of the County, and the Treasurer, Tax Collector and Auditor of the County. Section 4. Ratification. All actions heretofore taken by officials, employees and agents of the District with respect to the request and direction for the tax levy described herein are hereby approved, confirmed and ratified. Section 5. General Authority. The President of the Board, the Secretary/Treasurer, the Chief Executive Officer and the Chief Financial Officer, and their respective designees, are each hereby authorized, empowered and directed in the name and on behalf of the District to take any and all steps, which they or any of them might deem necessary or appropriate in order to ensure that the County levies and collects the property taxes as described herein and otherwise to give effect to this Resolution. Section 6. This Resolution shall take effect immediately upon enactment. THE FOREGOING RESOLUTION WAS PASSED AND ADOPTED by the Board of Directors of Kaweah Delta Health Care District on July 24, 2017, by the following vote: AYES: NOES: ABSENT: Attest: Carl Anderson President, Board of Directors Kaweah Delta Health Care District Lynn Havard Mirviss Secretary/Treasurer, Board of Directors Kaweah Delta Health Care District Page 3 of 5 Page 365 of 391

366 Page 4 of 5 Page 366 of 391

367 EXHIBIT B TAX RATE FOR FISCAL YEAR per $100 of assessed value per $100 of assessed value Page 5 of 5 Page 367 of 391

368 RESOLUTION 1965 WHEREAS, a claim on behalf of William McIntyre, Russell McIntyre, Sharon McIntyre, and Michelle McIntyre has been presented on June 30, 2017 to the Board of Directors of the Kaweah Delta Health Care District, IT IS HEREBY RESOLVED AS FOLLOWS: 1. The aforementioned claim is hereby rejected. 2. In accordance with Government Code Section 913, the Secretary of the Board of Directors is hereby directed to give notice of rejection of said claim to William McIntyre, Russell McIntyre, Sharon McIntyre, and Michelle McIntyre, in the following form: "Notice is hereby given that the claim which you presented to the Board of Directors of the Kaweah Delta Health Care District on June 30, 2017, was rejected by the Board of Directors on July 24, 2017." WARNING "Subject to certain exceptions, you have only six (6) months from the date this notice was personally delivered or deposited in the mail to file a court action on this claim. See Government Code Section You may seek the advice of an attorney of your choice in connection with this matter. If you desire to consult an attorney, you should do so immediately." PASSED AND ADOPTED by unanimous vote of those present at a regular meeting of the Board of Directors of the Kaweah Delta Health Care District on July 24, President, Kaweah Delta Health Care District ATTEST: Secretary/Treasurer, Kaweah Delta Health Care District and of the Board of Directors thereof /cm Page 368 of 391

369 July 24, 2017 c/o Kevin L. Domecus, Esq. Walkup, Melodia, Kelly & Schoenberger 650 California Street, 26 th Floor San Francisco, CA Sent via Certified Mail No Return Receipt Required RE: Notice of Rejection of Claim of William McIntyre, Russell McIntyre, Sharon McIntyre, and Michelle McIntyre vs. Kaweah Delta Health Care District Notice is hereby given that the claim, which you presented to the Board of Directors of the Kaweah Delta Health Care District on June 30, 2017, was rejected on its merits by the Board of Directors July 24, 2017 WARNING Subject to certain exceptions, you have only six (6) months from the date this notice was personally delivered or deposited in the mail to file a court action on this claim. See Government Code Section Sincerely, Lynn Havard Mirviss Secretary/Treasurer, Board of Directors cc: Richard Salinas, Attorney at Law Page 369 of 391

370 2017 Hospital Acquired Pressure Injury QUALITY REPORT Katie Roepke-Brenner, BSN, PHN, CMSRN Andrea Gregory, BSN, WCC, WOCN, CFCN Beth Nelson, BSN Page 370 of 391

371 2017 Continued Implemented Improvement Processes New Hire Orientation/RN staff re-orientation Clinical Skin Institute (CSI) Weekly prevalence studies Mandatory 90 day action plans for Hospital Acquired Pressure Injury (HAPI) prevention for all acute care units. Continued use of Sacral Dressing as part of a comprehensive pressure injury prevention plan. Page 371 of 391

372 HAPI S Per 1,000 Patient Days From total HAPI S stage 2 and above at Main Campus have decreased by 32% per 1,000 patient days. Page 372 of 391

373 National Database of Nursing Quality Indictors (NDNQI) Quarterly Prevalence Study Data For the year 2016 we were above the mean for % Pt. s stage 2+ HAPI (weighted Z score). Q1 & Q prevalence study results are pending. Page 373 of 391

374 Reportable HAPI S California Department of Public Health has not yet exited on 1 case in 2017 Page 374 of 391

375 2017 Quality Improvement Goals Be at or below NDNQI mean for HAPI s stage 2 and above by end of year Page 375 of 391

376 2017 Plan of Correction Re-evaluate & streamline current implemented improvement processes to ensure continuity. Continue to brain storm with Quality and Patient Safety for further improvement opportunities. Wound RN presence at Nursing Practice Council (NPC) monthly meetings. After Cerner roll-out, look into getting guest speaker on HAPI prevention. Continue to adhere to known best practices for pressure injury prevention ( prevention dressings, pressure redistribution surfaces, frequent turning/repositioning). Page 376 of 391

377 2017 HAPI Quality Report Questions? Page 377 of 391

378 Recruitment Activity Specialty Provider Visit Offer Accepted: VMC Start Date Status Cardiology Dr. Guarav Banka Candidate declined / seeks larger city Dr. Ankur Gupta Candidate declined / accepted offer from Sequoia Cardiology Medical Group Dr. Ganiyu Oshodi Dr. Reza Rafie Dr. Shuja Rasool and Candidate declined / wife in AR medical school Dr. Paul Suri jobs in 15 years Dr. Nallathamby Thayapran and TBD Endocrinology Dr. Nancy Mora Becerra Candidate declined / went to LA Dr. Naseem Eisa Candidate declined / went to Bakersfield, accepted higher bid Dr. Anjana Harnoor phone call Candidate declined / seeks larger city Dr. N. Kwong Candidate declined / seeks larger city Dr. Yair Litvin No CA license Dr. Noman Saif TBD Await CA license Dr. Naga-Nalini Tirumalasetty Candidate declined / relocating to AZ for husband s job Family Medicine Dr. R.C of 2 references received Dr. Raul Perez Returning VMC provider Dr. Elizabeth Sasaki Gastroenterology Dr. Vimesh Akotia No response from candidate Dr. Adnan Ameer and fellowship / will make decision in August 2017 Dr. Mohammed Elbatta phone call Candidate not responding Dr. Abhishek Gulati No response from candidate Dr. Melissa Johnson J-1 Visa Dr. Alexander Kim Candidate declined offer / location, facilities, surgeons Page 378 of 391

379 Recruitment Activity Specialty Provider Visit Offer Accepted: VMC Start Date Status Gastroenterology (cont) Dr. Jayakrishnan Krishnakurup phone call Candidate declined / accepted fellowship in NY (candidate cancelled visit) Dr. Vivek Kumar phone call Visa Dr. Geeta Kutty phone call tentative site visit *Tentative Site Visit: Dr. Shirley Pua Will follow up with Dr. Pua on Dr. Abdul Rehman phone call visit, call Await CA license Dr. Rajiv Sharma phone call Candidate declined / seeks larger city Dr. Navjot Singh and Candidate declined / daughter in golf program Hospitalist Dr. Fahad Hashmat To Kaweah Delta Dr. Warit Jithpratuck Dr. Kamel Kamel phone call visit To Kaweah Delta Dr. Harshit Shah Dr. Marwan Zoghbi To Valley Hospitalist Group Internal Medicine Dr. Lara Atchabahian phone call visit Nephrology Dr. Tariq Javed Dr. Roger Haley Dr. Stephen Smith phone call visit Independent Contractor TBD OB/GYN Dr. Nick Weibell Moved out of the area Orthopedics Dr. Oluwaseun Akinbo phone call Candidate declined / seeks larger city Dr. Timothy Galan and Wants signing bonus and full loan repayment Dr. Jonathan Miller Dr. James Perry No response from candidate No response from candidate Dr. Jaspreet Sidhu Candidate declined / went to Stockton Ortho Page 379 of 391

380 Recruitment Activity Specialty Provider Visit Offer Accepted: VMC Start Date Status Pediatrics Dr. Ted Sobieralski Rejected by VMC/KDMF Surgery, General Dr. Russell Dounies Rejected by VMC/KDMF Dr. David Jeffcoach dinner Urology Dr. Joseph Chang Candidate declined relocating due to wife s health Dr. Joseph Ford visit and calls Dr. Haspreet Singh Candidate declined / no to CA *Nephrology Dr. Dhingra - Nephrology Group phone call visit Discussion re: renting VMC *Gastroenterology Fresno Gastroenterology Dr. Muhammad Sheikh Dr. Mandeep Singh visit phone call with Dr. Kingsford Arrived with Dr. Lechtman on and met with Rick Strid Page 380 of 391

381 KAWEAH DELTA HEALTHCARE DISTRICT MEMO To: From: Subject: Board of Directors Dena Cochran Date: July 11, 2017 Community Advisory Committees As part of the Community Engagement Plan for 2017, Edelman, our public relations firm, recommends that we create several community advisory committees. The intent of these committees will be to engage community members in Kaweah Delta activities, learn their thoughts and reactions to Kaweah Delta plans, and to solicit their input and advice regarding a wide variety of Kaweah Delta matters. Edelman first proposed that Kaweah Delta establish community advisory committees earlier this past spring. Advisory committees are a common way for organizations to solicit and seek community input on important policy matters. An advisory committee is comprised of a diverse set of District residents representing various consumer, community, and business interests and provides a venue for community members to learn more about and to participate in an advisory capacity in Kaweah Delta decision making. Convening groups representing these audiences will help inform and shape future decisions, and will also provide appropriate feedback and develop natural allies. Committees currently recommended by Edelman are: Community Relations Healthcare for Today and Tomorrow The Hospital of the Future (Kaweah Delta is already creating a patient experience advisory committee called the Patient and Family Advisory Council under the leadership of Regina Sawyer and Ed Largosa.) The process to creating the committees will begin by announcing the formation of the committees to Kaweah Delta staff via and News You Can Use on the District Daily followed by updating the Kaweah Delta website with information about the committees and placing a committee application on the website. Next the Marketing Department will distribute a news release regarding the committees to the local media and post the news release on the Kaweah Delta website. Once the announcement and news release are on the Kaweah Delta website staff will post the announcement and application on social media channels such as Facebook. These postings will include an online application form. Staff will also launch a paid media campaign on Facebook to solicit applicants. All announcements, postings, and forms will be translated into Spanish and distributed through the same channels as well as Spanish language media and social media. The process will allow 30 days for applications to be submitted. Once received applications will be reviewed by a Kaweah Delta/Edelman committee. Applicants may be interviewed as part of the selection process. Once committee members are selected all applicants will be notified of their status and thanked for their interest. Edelman has recommended that Kaweah Delta utilize the counsel and local expertise of QK (formerly Quad Knopf) to assist in the advisory committee recruitment and selection, and to support the overall execution of the committees. QK under the leadership of Harry Tow and Steve Brandt is currently assisting Edelman and Kaweah Delta in the community engagement project on a local basis. RECOMMENDATION: Approve implementation of the community advisory committees beginning immediately. Page 381 of 391

382 DRAFT July, 2017 DRAFT The Honorable Judge Brett Alldredge County Civic Center, Room S. Mooney Blvd. Visalia, CA RE: Response to Tulare County Grand Jury Report: Future Needs for Kaweah Delta Health Care District Dear Judge Alldredge: In connection with the report issued by the Tulare County Grand Jury, dated April 28, 2017 and released May 4, 2017 by Foreman Reba Grissom, I am pleased to provide Kaweah Delta Health Care District s written response on behalf of our Board of Directors and management. With respect to the four findings (F1 F4) and the two recommendations (R1 and R2) referenced in the Grand Jury report, our responses are as follows: Finding #1: There was a lack of transparency and accountability in informing the general public of the bond s cost to property owners. We disagree with this finding. Over the course of several months, our Chief Executive Officer at that time, Lindsay Mann, and a number of our senior executives, met many, many times with numerous City and County leaders and staff, individual citizens, community groups, service clubs, churches, public agencies, and others to present and comprehensively discuss our plans to construct a new hospital in replacement of the seismically-non-compliant Mineral King Wing, including how it would be financed and funded. These communications were in addition to thousands of phone calls made to voters living within the Kaweah Delta Health Care District by Friends of Kaweah Delta campaign members. Additionally, there were multiple mailings to District residents, postings on social media and a public forum was held at the Cellar Door in downtown Visalia. In each of these presentations, meetings and communications, our project description, our financing plan and the likely property tax impact on property owners was discussed. The project was estimated to cost approximately $550 million and would have been funded through a combination of approximately $123 million in District cash reserves, approximately $75 million in District-issued revenue bonds, approximately $25 million in grants and philanthropy, and a proposed $327 million general obligation bond. If approved, the general 1 Page 382 of 391

383 DRAFT obligation bond would have been issued in four separate series coinciding with the timing of construction and the corresponding need for funding, an approach intended to reduce the burden of higher tax rates on property owners. The bond series would consist of the following: $33 million at 4.0% interest issued on August 1, 2016 and maturing in 2046; $140 million at 4.5% interest issued on August 1, 2018 and maturing in 2048; $130 million at 5.0% interest issued on August 1, 2020 and maturing in 2050; and $24 million at 5.5% interest issued on August 1, 2028 and maturing in Each bond of the four-bond series would have a life of 30 years but because they would be issued at different points during construction and equipping of the new hospital, the last bond would not be fully paid by the taxpayers until 2058 (42 years between the first bond issued on August 1, 2016 and the last bond maturing in 2058). All of this was disclosed as part of the Board s effort to seek the approval of District voters. In order to estimate the amount of property taxes needed to pay the annual principal and interest amounts, we had to make assumptions about the interest rates that would be in effect at the time each bond series would be issued (as referenced above), and assumptions about the assessed values of taxable properties within the District boundaries. Working with the County Assessor s office, financial advisors and attorneys specializing in general obligation bonds, we adopted an assumption that assessed values of existing and future properties lying within the District s boundaries would grow at an annual rate of 5.25%, based on historical growth rates of District-based properties assessed values experienced over the past 25 years. Using these well-considered and appropriate interest rate and assessed value assumptions, we projected total principal and interest payments would be $1,320, in the first year of the initial bond series issued in 2016; and would rise to the highest level in 2046 when all four bond series were outstanding ($27.6 million in principal and interest payments); and then fall to $2.4 million in 2058, when only the final fourth bond series would be outstanding and now fully paid off. Based on these annual principal and interest payments, the first year payment equated to $9.92 per $100,000 of assessed value; the highest tax payment would be $88.60 in 2021 when three of the four bond series had been issued but assessed property values had only been growing for a few years; and the final year payment in 2058 would be $2.17. Over the entire 42-year period where general obligation bonds were outstanding, the total amount of property tax collected per $100,000 of assessed value would be $2,045.44, which would be $48.70 per year ($2,045.44/42) or $4.06 per month ($48.70/12) (See attached schedule of all calculations). Lastly, and in full compliance with California Elections Code Section 9401, the District appropriately and accurately included in its Measure H ballot text and Board Resolution No. 1888, an estimate of the tax rate necessary to fund the first fiscal year s principal and interest payment payable after the first sale of bonds (to be sold August 1, 2016) ($9.92 per $100,000 of assessed value); the tax rate necessary to fund the first fiscal year s principal and interest payment payable after the last sale of bonds (to be sold August 1, 2028) ($80.07 per $100,000 of assessed value); the highest tax rate that would be required to be levied to fund the bond issue ($88.60 per $100,000 of assessed value in 2021); and, the best estimate of the total debt 2 Page 383 of 391

384 DRAFT service, including principal and interest, that would be required to be repaid if all the bonds were issued and sold ($666,565,175). A copy of California Elections Code Section 9401 is attached hereto for your reference. Kaweah Delta consistently and openly communicated to our community through multiple methods and in numerous forums with the utmost transparency. In addition, Kaweah Delta provided any supporting documentation, calculations, construction and financing plans, etc., to anyone who asked. Of course, bond financing and property tax calculations are complex matters, and we can always improve on ways to explain and translate them into understandable information. However, with all of the above public communications, disclosures, and public outreach, Kaweah Delta was clearly transparent and accountable to voters and our community. Finding #2: To date, no facilities have been closed or services reduced. We partially agree with this finding. We assume this report is referring to statements made during the Measure H campaign that if a general obligation bond measure did not pass, the District would be forced to close, in accordance with state law, the seismically-non-compliant Mineral King Wing to acute inpatient care. This statement remains true. It was never stated or implied that the Mineral King Wing would immediately close if Measure H did not pass. The fact still remains the Mineral King Wing cannot be used for acute inpatient care beyond the year The Board was very clear the Mineral King Wing could remain open and available for acute inpatient care up to 2030, and that it could be used for outpatient and administrative services after Even though the bond measure failed, the need to replace our hospital within the next 12 years remains. In an unrelated matter, the District did recently close an outpatient dialysis center in Porterville. This decision was entirely unrelated to Measure H and was made after many months of careful evaluation of patient need. While Kaweah Delta has operated this dialysis center since 1985, it was opened at a time when no other dialysis centers were operating in the area and almost 30% of patients being treated in our Visalia dialysis center were coming from the Porterville area. There are now two other dialysis centers in Porterville that are fully capable of meeting the dialysis needs of the community, so the Kaweah Delta center was closed. Finding #3: KDHCD operates several health clinics outside of their district boundaries. We agree with this finding. Health clinics outside of the District s boundaries provide two important and direct benefits to the residents of the District: 1) These rural health clinics were purposely developed to reduce overcrowding in Kaweah Delta s emergency department ( ED ), one of the busiest EDs in the state. When we can provide a lower cost of care and more convenient service to patients who do not have true emergencies right in their own local community, it allows our ED team to focus on providing life-saving care to those who truly need it. These clinics also reducing waiting 3 Page 384 of 391

385 DRAFT time for people in the ED. Additionally, as the health of those living in the greater Tulare County improves, it is less likely patients will require care in the emergency department or require an extended hospital stay. These visits can be costly, and many go unpaid, with the costs then paid by the District. By providing care through health clinics located outside the District, it reduces delays for people needing care within the District. 2) These clinics generate revenue outside the District which helps to pay for costs inside the District a direct benefit to District taxpayers. The clinics outside of our District have been profitable every year. Due to their unique designation as federal and state hospital-based rural health clinics, we receive additional funding which helps us keep the doors of our acute care hospital open. In the fiscal year ending June 30, 2016, there was a combined net income of $6.1 million from the health clinics outside the District, which helped fund our community s hospital in the District, the only trauma center between Fresno and Bakersfield. Finding #4: Health clinics operated by KDHCD are profitable. We agree with this finding. During the fiscal year beginning July 1, 2017, we expect to see more than 114,000 patient visits to our rural health clinics in Exeter, Lindsay, Woodlake and Dinuba. Patients seeking primary and specialty care services in Adult Health, Pediatrics, Women s Health, Psychiatry, Cardiology, General Surgery, Pulmonology, Infectious Disease, Podiatry, Rheumatology, Dermatology, and others will help the District continue its goal of providing the very best health care to our patients, while maintaining a financially-strong organization. Kaweah Delta operates health clinics for two important reasons: 1) Doing so helps reduce overcrowding at the main hospital for the District, allowing our staff and medical teams to focus on providing more life-saving care in the hospital setting and reducing wait times for those people needing care at the hospital; and 2) Services provided to patients in health clinics generate profits which provide economic support to fund services for people receiving care inside the District s boundaries. Recommendation #1: The KDHCD Board of Directors develop an on-going dialogue, such as Town Hall Meetings, to develop a planning process with residents of the hospital district to determine future needs. The recommendation has already been partially implemented and will be fully implemented by Fall The Kaweah Delta Board of Directors intends to lead a two-year community engagement and education project that will assist the District in working with the community to determine future needs. The District welcomes community feedback in its efforts to continually improve and to make sure it is best meeting the health needs of our region. This dialogue will be accomplished through a variety of interactions with the residents of Kaweah Delta Health Care District. 4 Page 385 of 391

386 DRAFT Recommendation #2: KDHCD form a volunteer community advisory committee consisting of district residents. The recommendation has been partially implemented and will be fully implemented by Fall Kaweah Delta is already working to establish a variety of community advisory committees to help inform future District decisions in the areas of patient experience, community relations, community health needs and growth (including how we attain seismic compliance by 2030). On behalf of the Kaweah Delta Health Care District Board of Directors, thank you for the opportunity to respond to the findings and recommendations outlined in the report of the Tulare County Grand Jury. If you have any questions or need additional information, please feel free to contact me through Cindy Moccio, Board Clerk, at (559) or cmoccio@kdhcd.org. Thank you. Sincerely, Carl O. Anderson President, Board of Directors Kaweah Delta Health Care District 5 Page 386 of 391

387 Codes Display Text 7/6/17, 7'01 AM Home Bill Information California Law Publications Other Resources My Subscriptions My Favorites Code: Select Code Section: Search Up^ Add To My Favorites ELECTIONS CODE - ELEC DIVISION 9. MEASURES SUBMITTED TO THE VOTERS [ ] ( Division 9 enacted by Stats. 1994, Ch. 920, Sec. 2. ) CHAPTER 5. Bond Issues [ ] ( Chapter 5 enacted by Stats. 1994, Ch. 920, Sec. 2. ) Notwithstanding any other provision of law, this chapter applies to all bond issues proposed by a county, city and county, city, district, or other political subdivision, or by any agency, department, or board thereof, the security for which constitutes a lien on the property for ad valorem taxes within the jurisdiction and the proposal for which is required to be submitted to the voters for approval. (Amended by Stats. 2006, Ch. 289, Sec. 7. Effective January 1, 2007.) (a) In connection with each bond issue specified in Section 9400, a statement shall be mailed to the voters with the sample ballot for the bond election. The statement required by this section shall be filed with the elections official conducting the election not later than the 88th day before the election, and shall include all of the following: (1) The best estimate from official sources of the tax rate that would be required to be levied to fund that bond issue during the first fiscal year after the first sale of the bonds based on assessed valuations available at the time of the election or a projection based on experience within the same jurisdiction or other demonstrable factors. (2) The best estimate from official sources of the tax rate that would be required to be levied to fund that bond issue during the first fiscal year after the last sale of the bonds if the bonds are proposed to be sold in series, and an estimate of the year in which that rate will apply, based on assessed valuations available at the time of the election or a projection based on experience within the same jurisdiction or other demonstrable factors. (3) The best estimate from official sources of the highest tax rate that would be required to be levied to fund that bond issue, and an estimate of the year in which that rate will apply, based on assessed valuations available at the time of the election or a projection based on experience within the same jurisdiction or other demonstrable factors. (4) The best estimate from official sources of the total debt service, including the principal and interest, that would be required to be repaid if all the bonds are issued and sold. The estimate may include information about the assumptions used to determine the estimate. (b) In addition, the statement may contain a declaration of policy of the legislative or governing body of the applicable jurisdiction, proposing to use revenues other than ad valorem taxes to fund the bond issue, and the best estimate from official sources of these revenues and the reduction in the tax rate levied to fund the bond issue resulting from the substitution of revenue. (c) The words tax rate as used in this chapter means tax rate per one hundred dollars ($100) of assessed valuation on all property to be taxed to fund a bond issue described in Section (Amended by Stats. 2014, Ch. 908, Sec. 1. Effective January 1, 2015.) Page 1 of 2 Page 387 of 391

388 Codes Display Text 7/6/17, 7'01 AM All official materials, including any voter information guide prepared, sponsored, or distributed by the jurisdiction that has proposed the bond issue or that is financed in whole or part by funds furnished by that jurisdiction, directed at or including a bond issue proposal, but excluding a notice of election required by law to be posted or published, shall contain a statement of the tax rate data specified in Section (Amended by Stats. 2016, Ch. 422, Sec. 54. Effective January 1, 2017.) Failure to comply with this chapter shall not affect the validity of any bond issue following the sale and delivery of the bonds. (Enacted by Stats. 1994, Ch. 920, Sec. 2.) The Legislature declares that the essence of compliance with this chapter is good faith in presenting to voters the most accurate available information for their use in effecting comparisons and exercising judgment in casting their ballots. (Enacted by Stats. 1994, Ch. 920, Sec. 2.) Whenever the elections official is required to mail a statement, as provided in Section 9401, only one copy of the statement shall be mailed to a postal address where two or more registered voters have the same surname and the same postal address. This section shall only apply if the legislative body adopts this section and the election official conducting the election approves of the procedure. (Enacted by Stats. 1994, Ch. 920, Sec. 2.) Page 2 of 2 Page 388 of 391

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