Taking the Chaos out of Accreditation Surveys in Sterile Processing

SHC Taking the Chaos out of Accreditation Surveys in Sterile Processing Objectives Identify accreditation standards that pertain to highlevel disinfection and sterilization. Describe current published standards and recommended practices that healthcare facilities will be surveyed to. Develop a plan for how to be prepared for your next accreditation survey. Rose Seavey MBA, BS, RN CNOR, CRCST, CSPDT SEAVEY HEALTHCARE CONSULTING STERILE PROCESSING SURGICAL SERVICES. Established in 2003 3 4 Risk Reduction and Process Improvement are the Heart and Soul of Accreditation Surveys Accreditation Survey Improving the quality of health care Peer review Focus on safety, quality, and process improvement Condition of payment Private insurance companies Federal funding Measures compliance Published recommended practices Accreditation standards and supporting documents Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014. 1

5 Centers for Medicare & Medicaid Services (CMS) Compliance with Medicare Conditions 6 Accrediting organization with deeming authority by CMS Accreditation Association for Ambulatory Healthcare (AAAHC) Accreditation Commission for Healthcare (ACHC) American Association for Accreditation of Ambulatory Surgery Facilities (AAASF) American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFPA) Center for Improvement of Healthcare Quality (CIHQ) - new 8/9/2013 Community Health Accreditation Program (CHAP) DNV Healthcare (DNV) The Joint Commission (TJC) Independent, nonprofit Accredits and certifies over 18,000 health care organizations and programs including: Hospitals, Doctor s offices, Nursing Homes, Office-based surgeries, Behavioral health treatment facilities, and Providers of home care services. Nationally recognized as symbol of quality Policy and Requirements for an Application for Deeming Authority. Accessed 7/12/2012 at: http://www.cms.gov/medicare/provider- EnrollmentandCertification/SurveyCertificationGenInfo/downloads//applicationrequirements.pdf 7 8 Submit an application Pay a fee TJC Survey Process Resurveyed within three years 2006 unannounced survey process Between 18 and 39 months after previous survey Morning of survey Biographies and pictures of surveyors assigned Eiland, John E, Surveyor, The Joint Commission. Joint Commission presentation at IAHCSMM annual meeting in May 2013. Presentation available on flash drive provided to attendees. Joint Commission Resources Nonprofit affiliate of TJC, publishes the official handbooks used in the TJC survey process Comprehensive Accreditation Manual for Hospitals: The Official Handbook (CAMH) Comprehensive Accreditation Manual for Ambulatory Care (CAMAC) 2013 Comprehensive Accreditation Manual for Office-Based Surgery Practices (CAMOBS) 2

10 Standards = performance objectives Rationales = describe importance Elements of Performance (EPs) = meet goals Scores determine the compliance Minimum score of 90% on every EP Accreditation Standards Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014. Standards relating to reprocessing Environment of Care Human Resources Infection Prevention and Control Leadership Performance Improvement TJC Focus on Reprocessing fbeginning in 2010, surveyors have spent additional time during survey evaluating the cleaning, disinfection, and sterilization (CDS) processes Surveyors received in-depth training on sterilization processes through AAMI Survey to ANSI/AAMI ST79 ST79 Available to staff http://www.jointcommission.org/assets/1/18/jconline_july_20_11.pdf Eiland, John E, Surveyor, The Joint Commission. Joint Commission presentation at IAHCSMM annual meeting in May 2013. Presentation available on flash drive provided to attendees. 11 TJC Focus on Reprocessing After TJC surveyor training citing related to non-compliance for Sterilization/high-level disinfectants(hld) more than tripled From 10% to 40% * One non-compliance in Sterilization/HLD = citing Others may be up to three non-compliance issues Red Flag: Processing in more than one area TJC Second Generation Tracer - 2012 Cleaning, Disinfection & Sterilization (CDS) * Louise Kuhny, TJC Survey Process: Second Generation Tracers. AORN webinar 9/22/2011. 3

13 14 TJC Second Generation Tracer 2013 The organization reduces the risk of infections associated with medical equipment, devices, and supplies Deficiencies: 47% Hospitals 43% Critical access hospitals 37% Ambulatory care organizations 26% Office based-surgery practices Leadership, IPC, OR, Sterile Processing, ES, and Engineering all play a CRITICAL ROLE in reprocessing. Standardizing the use of HLD and sterilization practices The Joint Commission. High-level Disinfection and Sterilization: Know Your Practice. Feb. 2014; 34(2):9-13 Facilities Out of Compliance 1. Lack of having or using CURRENT evidence-based guidelines (EBG) (IC.01.05.01 EP 1) 2. Orientation, Training, and Competency (IC.02.02.01)! Initial and ongoing! Complete and current documentation! Conducted by personnel COMPLETELY trained on RECENT EBG and instructions for use (IFU). 3. Lack of quality control! Using nonvalidated conditions (concentration, exposure times, and temps) The Joint Commission. High-level Disinfection and Sterilization: Know Your Practice. Feb. 2014; 34(2):9-13 15 16 Facilities Out of Compliance (cont.) 4. Lack of participation and collaboration (IC.0202.01)! Supervisory or managerial oversight should have CURRENT education, training, and experience! Work closely with IPC staff 5. Lapses in recordkeeping and incomprehensible or non-standardized logs (IC.0202.01 EP 2)! TRACEABLE path to the PATIENT and product identification in the event of a recall (AAMI ST79 section 10.3) The Joint Commission. High-level Disinfection and Sterilization: Know Your Practice. Feb. 2014; 34(2):9-13 TJC Personnel Considerations HR.01.06.01: Staff are competent to perform their responsibilities EP 1. The facility defines the competencies it requires of its stafff EP 2. The facility uses assessment methods to determine the individual s competencef Test taking, return demonstration, or the use of simulation. EP 3. An individual with the educational background, experience, or knowledge fassesses competence. The Joint Commission. 2014 Hospital Accreditation Standards (HAS) 4

17 18 Leadership Standards and EPs LD.04.01.11: The hospital makes space and equipment available as needed for the provision of care, treatment, and services. EP 2. The arrangement and allocation of space supports safe, efficient, and effective care, treatment, and services. Need for sufficient space to adequately reprocess EP 5. The leaders provide for equipment, supplies, and other resources. The Joint Commission. 2014 Hospital Accreditation Standards (HAS) CMS Surveyor Worksheets Focus on patient safety and reducing Healthcare Acquired Infections (HAI) 1. Quality Assessment and Performance Improvement Worksheet 2. Infection Control Worksheet! Module 1: Infection Control/Prevention Program! Module 2: General Infection Control Elements! Module 3: Equipment Reprocessing! Module 4: Patient Tracers! Module 5: Special Care Environments 3. Discharge Planning Worksheet https://www.cms.gov/medicare/provider-enrollment-and- Certification/SurveyCertificationGenInfo/downloads/SCLetter12_01.pdf 19 CMS Pre-Decisional Surveyor Worksheet Module 1: Infection Control/Prevention Program 1. A.3 The Infection Control Officer(s) can provide evidence that the hospital has developed general infection control policies and procedures that are based on nationally recognized guidelines and applicable state and federal law. August 29, 2014, 9 Page Memo TO: State Survey Agency Directors FROM: Director Survey and Certification Group Change in terminology and update of survey and certification (S&C) memorandum 09-55 regarding immediate use steam sterilization (IUSS) in surgical settings Outmoded Term - fails to communicate time, number of steps and safeguards IUSS Position statement https://www.cms.gov/medicare/provider-enrollment-and- Certification/SurveyCertificationGenInfo/downloads/SCLetter12_01.pdf http://www.cms.gov/medicare/provider-enrollment-and- Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf - accessed 12/21/2014 20 5

CMS Change in IUSS Terminology IUSS not an appropriate substitute for maintaining a sufficient inventory of instruments. IUSS survey procedure Using IUSS in a manner that places patients at risk No to any survey questions Infection Control Citation http://www.aami.org/publications/standards/st79_immediate_use_statement.pdf http://www.cms.gov/medicare/provider-enrollment-and- Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf - accessed 12/21/2014 22 CMS- Defining IUSS Practice Not equivalent to short cycle Not a substitute for sufficient instrument inventory Not stored for later use Must accomplish all steps before, during and after In compliance with manufacturer s IFU Device Sterilizer Container Cleaning performed in a designated decontam area CMS - Defining IUSS Practice Con t Increased risks: Contamination during transfer Related to wet instruments Potential for burns- Pt. and staff Limited to situations: Urgent need, and Insufficient time for terminal sterilization http://www.cms.gov/medicare/provider-enrollment-and- Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf - 23 accessed 12/21/2014 http://www.cms.gov/medicare/provider-enrollment-and- Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf - 24 accessed 12/21/2014 6

Surveyors Specific IUSS Questions No to any question: warrants an infection control citation IUSS reserved for emergent situations? Process in place to ensure IUSS is not used for: Implants, Patients with known or suspected CJD, Loads not validated with the specific cycle, and Single-use devices Instruments first cleaned and disinfected following the manufacturer s IFU? 25 Surveyors IUSS Questions con t Evidence that all of the personnel have : Necessary time, equipment, supplies, Trained and able to correctly follow the MFR IFU, and Competency initially verified before they undertake IUSS and periodically thereafter? Evidence cycle is indicated in the IFU? Physical monitors documented? Evidence sterilizer is maintained? Rigid container consistent with MFR IFU? 26 Surveyors IUSS Questions con t CI labeled for cycle by the MFR? CI outside each container/package Unless CI inside package is visible Class 4, 5 or 6 CI in each container? BI labeled for cycle by MFR? implantable device - BI and Class 5 CI labeled? All monitoring test results by trained personnel? Instruments aseptically transported and cooled? Evidence of monitoring for adherence to policy? http://www.cms.gov/medicare/provider-enrollment-and- Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf - accessed 12/21/2014 27 Centers for Medicare and Medicaid Services September 4, 2009 - CMS released a memo to state survey agency directors regarding sterilization practices. 28 If manufacturers instructions are not followed, then the outcome of the sterilizer cycle is guesswork, and the ASC s practices should be cited as a violation of 42 CFR 416.44(b)(5). (CMS, 2009) http://www.ascquality.org/library/sterilizationhighleveldisinfectiontoolkit/cms%20flash% 20Sterilization%20Memorandum.pdf 7

CMS Letter Endnotes Association for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST 79:2010 &A1:2010 & A2:2011 & A3:2012&A4:2013 (consolidated text) www.aami.org AORN. Recommended practices for sterilization in the perioperative practice setting. Perioperative Standards and Recommended Practices. Denver, CO: AORN, 2014. www.aorn.org Centers for Disease Control (CDC). Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008. Seavey R. Immediate use steam sterilization: Moving beyond current policy. American Journal of Infection Control. 2013;41:S46-S48. http://www.cms.gov/medicare/provider-enrollment-and- Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf - accessed 12/21/2014 29 Calculating IUSS Rates? No national benchmark Divide IUSS by number of procedures * Identify trends to determine: Service Types of instruments Type of procedures Specific surgeons Time of day Reason for IUSS * Denholm, B. Clinical Issues: Calculating flash sterilization rates. AORN J. 2011:93 (2):296-297 31 OSHA Fines Hospital for Unsafe Practices August, 2014 - Melrose MA $28,000 fine Bloodborne Pathogen Standard violation Disposable blades are included with instruments sent to decontamination area Scrub person did not disassemble and wipe down used instruments Transporting in open or loosely covered basins Biohazard liquids and contaminated instruments transported in loosely covered basins that leaked United States Department of Labor. Occupational Health and Safety Administration. Inspection 974812.015 - Hallmark Health - Melrose Wakefield Hospital. https://www.osha.gov/pls/imis/establishment.inspection_detail?id=974812.015. Accessed December 29, 2014. Standards, Recommendations Guidelines AORN Guidelines for Perioperative Practices, 2015 AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 &A4:2013 AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities AAMI ST41:2008 (R2012) Ethylene Oxide Sterilization In Health Care Facilities: Safety And Effectiveness CDC Guideline for Decontamination and Sterilization in Healthcare Facilities, 2008 32 8

33 34 AORN Recommended Practices for Sterilization and Disinfection ST 79 Editions! Anesthesia Equipment Cleaning and Disinfection! Disinfection High Levels! Flexible Endoscopes Cleaning and Processing! Instruments Cleaning and Care of (updated 11-2014)! Packaging Systems Selection and Use! Sterilization! Evidence-based and rated! Customizable policy and procedure template 2006 and A1:2008 & A2:2009 2010 & A1:2010 2010 &A1:2010 & A2:2011 & A3:2012 & A4:2013 ANSI/AAMI ST79 Recommended Practice If You Have This AAMI Document ANSI/AAMI ST79: 2006 ANSI/AAMI ST79:2006 and A1:2008 & A2:2009 ANSI/AAMI ST79:2010 & A1:2010 (Consolidated Text) What To Purchase Purchase ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2011 Purchase ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 What To Download Free Download A2:2011 PDF and replace pages Then download A3:2012 PDF and replace pages ANSI/AAMI ST79 Recommended Practice If You Have This AAMI Document ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 (Consolidated Text) ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 What To Purchase Most-up-do-date What To Download Free Download A3:2012 PDF and replace pages 35 36 9

38 CDC Guideline for Decontamination and Sterilization July 2011 - CDC Guide - CDC Checklist Nationally recognized and are referenced by accreditation and professional organizations http://www.cdc.gov/hicpac/pdf/guidelines/disinfection_nov_2008.pdf www.cdc.gov/hai/pdfs/guidelines/standards-of-ambulatory-care-7-2011.pdf www.cdc.gov/hai/pdfs/guidelines/ambulatory-care-checklist-07-2011.pdf 39 40 CDC Outpatient Settings Every outpatient setting have individual with training as an Infection Preventionist (IP) Regularly available to the facility Involved in the development of policies based on: regulations, evidence-based guidelines, and national published standards. Unacceptable Excuses Not Following Standards and Guidelines Didn t know about the standards/guidelines Standards/guidelines not available to staff Available but not current/up-to-date No one designed as subject matter expert Personnel are not trained on standards/guidelines etc. Not enough personnel and/or time Necessary equipment and tools not available http://www.cdc.gov/hai/pdfs/guidelines/standatds-of-ambulatory-care-7-2011.pdf 10

41 Processing Policies & Procedures Facility design and housekeeping, Personnel qualifications, training, and continuing education, Dress code - PPE, Sterilization monitoring, Receiving purchased or borrowed items, Loaner instrumentation (minimum 24 hour lead time) Handling, collection, and transport of contaminated items, Assembly, package configurations, and sterilization monitoring, Following manufacturer s written IFU, Maintenance and repair of medical devices, etc. Reference to current published standards Not because it is a TJC or CMS standard! 42 Preparing for a Processing Audit Accreditation Documents Relevant Professional Standards and Recommended Practices Accreditation Preparation Committee Committee representatives should include: Sterile Processing, Operating room, Infection prevention and control, Clinical/biomedical engineering, Endoscopy, Risk management, Quality, Safety, Education, Administration, and Materials management, etc. 43 44 Self assessment Surveys Preparation Subject Matter Experts Verify that each element of performance (EP) in each standard is addressed Front line staff involvement Cite the EP (not just the standard) Describe how that expectation is met Accreditation Preparation Resource Sterile Processing In Healthcare Facilities: Preparing for Accreditation Surveys 2 nd Ed. Hospitals Ambulatory Care Office-Based Surgery Practice Current professional guidelines AORN, AAMI, SGNA, CDC Current Accreditation standards CMS, TJC, AAAASF http://www.aami.org/publications/books/sphc.html Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014 11

45 Crosswalk TJC Standards Linked to Current AAMI ST79 Crosswalk http://www.aami.org/publications/books/sphc.html Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014 TJC Design Considerations EC.01.01.01: The hospital plans activities to minimize risks in the environment of care. EC.02.02.01: The hospital manages risks related to hazardous materials and waste. EC.02.04.01: The hospital manages medical equipment risks. IC.02.02.01: The organization reduces the risk of infections associated with medical equipment, devices, and supplies. LD.03.01.01: Leaders create and maintain a culture of safety and quality throughout the organization. LD.03.03.01: Leaders use hospital-wide planning to establish structures and processes that focus on safety and quality. LD.04.01.07: The organization has policies and procedures that guide and support patient care, treatment, or services. LD.04.01.11: The hospital makes space and equipment available as needed for the provision of care, treatment, and services. LD.04.04.07: The hospital considers clinical practice guidelines when designing or improving processes Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. AAMI 2014. ANNEX G 48 ST 79 Relative to TJC Design Considerations Functional workflow patterns (3.2.3) Traffic control (3.2.4) Electrical systems (3.3.3) Steam for sterile processing (3.3.4) Steam quality (3.3.4.2) Steam purity (3.3.4.3) Utility monitoring and alarm systems (3.3.5) General area requirements (3.3.6) Ventilation (3.3.6.4) Temperature (3.3.6.5) Humidity (3.3.6.6) Special area requirements and restrictions (3.3.7) Decontamination area (3.3.7.1) Preparation area (3.3.7.2) Sterile storage (3.3.7.4) Break-out area (3.3.7.8) Emergency eyewash/shower equipment (3.3.8) Housekeeping (3.4) Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014. ANNEX G Personnel Considerations Reprocessing responsibilities only assigned to: Qualified individuals Demonstrated and documented competencies in all areas (cleaning, decontamination, packaging, monitoring, sterilizing, etc.) All staff should be certified within two years Certification helps develop: Basic level of understanding and knowledge Consistencies and standardization Professional element to the department Self-esteem, confidence, and authority ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section 4 12

49 50 Personnel Considerations Supervisors Certified - SP supervisory or management level Demonstrate comprehensive understanding of: Relevant state and federal regulations OSHA bloodborne pathogens exposure control plan Engineering and work-practice controls Actively participate in committees such as: Infection prevention and control Quality improvement Safety, and Product evaluation and standardization Staff Competencies Surveyors will be looking for staff competencies: Demonstration, Certification, and Involvement with professional associations They will want to see: Job descriptions which match responsibilities, Documented skills checklists, and Training-based annual evaluations forms 52 Competency Tools and Job Descriptions The Joint Commission (TJC) Role-specific and JD RN Manager Technician Practice-specific HLD Endoscopes Instruments Packaging Sterilization Sterilization competencies Steam Dry Heat Ethylene Oxide Hydrogen Peroxide Gas Plasma Hydrogen Peroxide Vapor Ozone Peracetic Acid Standard IC.01.03.01 The hospital identifies risks for acquiring and transmitting infections. Element of Performance # 4 The hospital reviews and identifies its risks at least annually and whenever significant changes occur with input from, at a minimum, infection control personnel, medical staff, nursing, and leadership. http://www.aorn.org/competencytools 13

53 54 Quality Process Improvement Addressing and reducing risks Objective is to proactively identify the risks to reduce the likelihood of a process failure. Risk Reduction Tools Root Cause Analysis Failure Modes and Effects Analysis (FMEA) Tracers Risk Assessment can be your best friend in survey Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. AAMI 2014. IUSS Common High-Risk Areas P&Ps not standardized Loaner instrumentation Torn wrappers No IFUs Sets weighing more than 25 pounds Sterilization process failures Inefficient staff orientation No standardization Lack of competency documentation 55 56 Risk Analysis of the Sterilization Process Klacik, Sue. Risky business: Risk analysis in CSSD. HPN Aug 2010, available at: http://www.hpnonline.com/ce/pdfs/1008cetest.pdf Klacik, Sue. Worth the Risk, HealthVI.com, May 2011, available at: http://solutions.3m.com/wps/portal/3m/en_us/sterilization /3MSterileU/Home/InServiceArticles/?WT.svl=5 Instruments Held Completely Open? Three facilities issued Immediate Jeopardy (IJ) by CMS! All instruments must be held completely open with no tips touching.! Stringers are not adequate to hold completely open. 14

57 58 Surveyor Opinions Cost Hospital Devices Used to Hold Open One faculty issued IJ 10 days to fix the problem Purchased approximately 230 clamps at $30 each ($6,900) Vendor questioned if the order was a mistake (8 to 10 is normal) Reprocessed every peel pack and instruments set Cost: packaging, sterilization costs, labor etc.? Impact on surgery schedulef 59 60 What does AORN Say? IX.a.1. In preparation for manual cleaning, instruments should be disassembled and ports, valves, stop cocks, ratchets, and joints should be opened. Opening and disassembling instruments facilitates contact of the cleaning solution with all surfaces of the instruments. What does AORN Say? (con t) IX.f.1.Surgical instruments and their containment devices and accessories should be positioned in the washer disinfector in a manner that ensures contact of the cleaning solution with all surfaces of the items. Instrument ratchets should be in the open position. Recommended practices for Cleaning and Care of Surgical Instruments 2015 Recommended practices for Cleaning and Care of Surgical Instruments 2015 15

61 62 What does AAMI ST79 say? 8.4 Preparation and assembly of surgical instrumentation 8.4.1 General considerations...instruments sets should be sterilized in perforated or wire-mesh-bottom trays, or in containment devicesf with all instruments held open and unlocked. What does AAMI ST79 say? (con t) 8.4.4 Instrument placement Instruments to be sterilized should be arranged according to the following guidelines: c) All jointed instruments should be in the open or unlocked position with ratchets not engaged... Racks, pins, stringers, or other specifically designed devices can be used to hold the instruments in the open position. Recommended Practice Wording Should - certain course of action is preferred but not required May - indicates that a course of action is permissible Can - statement of possibility and capability Must - used only to describe unavoidable situations including those mandated by government regulations (e.g.osha). State Department of Public Health CMS Health Facilities Evaluator Nurse from that State Department of Public Health (not the surveyor) Until there is something in writing from either AAMI or AORN the surveyor s interpretation stands and the facility will be held to it. Surgical Service Director asked AAMI to write a statement of clarification ST79 a consensus document 64 16

65 66 Personal Opinions Surveys vary by state and surveyor Do not be argumentative Be assertive, not aggressive Educate the surveyors on wording and interpretation Have documents available that support your case and how you meet the EPs. Policies Standards Recommend Practices IFU Unsubstantial or Personal Opinions? What reference is the surveyor basing their finding on? Unlocked ratchet is what is meant by the statements in AORN and AAMI. Decontamination is where clamps need to be held wide open. 67 68 Decontam Stringers Various types of stingers available used to hold instruments open for efficient cleaning. CMS surveyor CA Another interpretation? Peel packs for single item only! Figure 8 Example of single- and double-packaging with paper plastic pouches Reprinted from ANSI/AAMI/ISO 14971:2007/(R)2010 with permission of Association for the Advancement of Medical Instrumentation, Inc. (C) 2007 AAMI www.aami.org. All rights reserved. Further reproduction or distribution prohibited 17

69 70 Documentation a Hot Button Air flow documentation Daily temp and humidity logs Logs for LMA reprocessing Logs for phaco coaxial I/A tips limited usage Instrument set weight logs IUSS how facility is decreasing (PI standards) Premature release forms for implants, etc. Loaners Documentation standardized in all areas Documentation of failed loads Documenting the disinfection of brushes Documentation of cleaning (AORN RP XIV) Equipment Maintenance Logs TJC surveyor cited for not documenting when vaporizer plate on their hydrogen peroxide sterilizer was changed. User s guide (IFU) routine maintenance Every 30 days or 145 cycles, whichever come first. ST 79 section 9.7 Recordkeeping A maintenance record, in either paper or electronic format, should be kept for each sterilizer. 71 72 Improper Air Handling Self Assessment EC.02.05.01 EP 6 (Risk Element) 47% Identify all positive and negative locations When was your last assessment? What mechanism do staff have to routinely monitor? Tissue test Electronic monitor with alarm Ping pong ball in the wall Know when to notify facilities Helps with compliance Pass through kept closed, etc. Absorbent Material in Endoscope Cabinet Surveyors have looked for and cited Potential for dust accumulation, Scope stored while still wet, or Failure to discourage microbial contamination Recommendationf If used change daily and document April 2014 Patton Healthcare Consulting Newsletter 18

73 74 Never Ever Defend a violation of your policy or an unsafe practice Build credibility Admit to the issue and commit to fixing it and not having it reoccur. Volunteer an answer you don t know Tell them you will find out soon Never Ever Tell a surveyor they are wrong! Tell them you don t remember seeing that in the standard! You had been following the community standard! You will need to take that to your committee to make that policy change! Ask which specific standard they are using 75 76 Be rude or disrespectful Interrupt Never Ever Ask why they are asking something Belittle a standard or regulation Contradict something in your minutes Suggest you have known of an issue for a prolonged time and done nothing or stopped trying Strange Idea and No Evidence or Standard Don t volunteer to change practice (if they have no standard or evidence) Tell surveyor you see their point but politely and gently suggest you won t be able to get it through the committee without more evidence 19

77 78 Survey Survival Give yes answer (if you can), but maybe not to the question they asked. e.g. Have you stopped vendor trays from getting dropped off without forcing you to use IUSS FACTS: You made a lot of strides but are stuck at 87% of trays getting to the facility in 24 hours Never claim perfection! Surveyors will cite you if you claim 100% sterilization documentation compliance and they see violations More willing to ignore if you say you are working on it STATEMENT: Our vendors know better than to do that. We have it in our contracts that they don t get paid for the tray if we don t have it 24 hours in advance (true). So we know our vendors are as motivated to get trays to us 24 hours ahead of time. 79 80 Know every document you give them Know everyone they spoke with and what they said Share this with other staff Know what questions are being asked Share this with staff Other Survey Hints Know where your deficiencies are and fix if possible before they leave (more apt to change a citing) Summary of Suggestions Be proud of your department Make a good first impression Treat surveyor as if they are there to help you Be assertive but have your ducks in a row Write policies referenced to standards/guidelines 20

81 Document and Display Your Success Stories Story boards for process improvement (PI) initiatives IUSS: Show process improvements (benchmark against self) Standardization Loaned instruments IFUs readily available Certification f demonstrated knowledge framed photos Constant and consistent preparation for an accreditation! The Final Wordf Risk reduction and process improvement are the heart and soul of surveys. Thank you 83 References Recommended Practices for Sterilization. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2015 Recommended Practices for Cleaning and Care of Surgical Instruments, In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2015. ST79 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014. Eiland, John E, Surveyor, The Joint Commission. Joint Commission presentation at IAHCSMM annual meeting in May 2013. Presentation available on flash drive provided to attendees. Kuhny, Louise. The Joint Commission Standards and Survey Process. AORN webinar 9/22/2011. To order access at: http://www.aorn.com/secondary.aspx?id=21189&terms= Webinars#axzz20596Ipvv 84 References CMS Director of Survey and Certification Group memo to State Survey Directors on Flash Sterilization Clarification-FY 2010 Ambulatory Surgical Center (ASC) surveys, September 4, 2009. Accessed 7/8/2012 at: http://www.cms.gov/surveycertificationgeninfo/downloads/scletter09_55.pdf Office of Clinical Standards & Quality/Survey & Certification to State Survey Agency Directors on CMS Survey & Certification Focus on Patient Safety and Quality-Draft surveyor Worksheets, Oct 14, 2011. Accessed 7/8/2012 at: https://www.cms.gov/medicare/provider-enrollment-and- Certification/SurveyCertificationGenInfo/downloads/SCLetter12_01.pdf Office of Clinical Standards & Quality/Survey & Certification to State Survey Agency Directors on Patient Safety Initiative Pilot Phase-Revised Draft Surveyor Worksheets on May 18, 2011. Accessed 7/8/2012 at: http://www.apic.org/resource_/tinymce Policy and Requirements for an Application for Deeming Authority. Accessed 7/12/2012 at: http://www.cms.gov/medicare/provider-enrollment-and- Certification/SurveyCertificationGenInfo/downloads//applicationrequirements.pdf 21