Storage and Use of Newborn Screening Blood Spot Cards New Requirements June 1, 2012
|
|
|
- Arthur Bruce
- 5 years ago
- Views:
Transcription
1 Storage and Use of Newborn Screening Blood Spot Cards New Requirements June 1, 2012
2 HB 1672 and HB 411 Page 2
3 Agenda History HB 1672, HB 411 Comparison of Requirements under Different Laws New Forms for HB 411 starting June 1, 2012 New Healthcare Provider Responsibilities for HB 411 Logistics of Transition HB 411 Points of Contact / Resources Page 3
4 History of Blood Spot Storage and Use Laws May HB 1672 Outlined allowable uses of residual blood spots Required healthcare providers to give a form to the parents when the newborn screen was collected Information about the uses of the blood spots Parental request for destruction of the blood spots Page 4
5 History of Blood Spot Storage and Use Laws May HB 411 Effective June Strengthens the DSHS management review and approval processes of proposed post-screening uses Effective June 1, Requires parental consent for: Storage longer than 2 years External public health research uses New Decision Form Page 5
6 Comparison of Timeframe Requirements Storage of Residual Blood Spots Allowed Uses Internal DSHS External Research Parent Options May 27, 2009 HB 1672 June 1, 2012 HB 411 Page 6
7 Blood Spot Storage Length of Storage after Completion of the Newborn Screen Test Prior to May 27, 2009 Up to 25 years Destroyed in February 2010 per legal settlement May 27, 2009 through May 2012 (HB 1672) To be determined Page 7 Beginning June 1, 2012 (HB411) All blood spots are stored for up to 2 years and then destroyed unless the parent submits a completed decision form allowing for longer storage.
8 Protection of Patient Privacy IMPORTANT: No information that identifies the child or parent can be released outside DSHS without specific written OK from the parent Specimens are stored safely and securely Page 8
9 Allowed DSHS Uses Allowed uses include: Quality assurance to make sure lab tests, equipment, and supplies are working right Developing new tests; and/or DSHS studies of diseases that affect public health. Page 9
10 Public Health Research Use outside of DSHS During all timeframes: DSHS IRB and management approval required De-identified blood spots only May 27, 2009 through May 2012 June 1, 2012 or Later Not allowed without study specific parental consent. Allowed only if parent provides written consent (decision form). Uses must follow DSHS policy for required management and IRB approvals. Page 10
11 Parent Options May 27, 2009 through May 2012 HB 1672 June 1, 2012 or Later HB 411 Parents may direct DSHS to destroy their child s blood spots within 60 days Parents may choose to have the blood spots stored for up to 25 years and to possibly be used for de-identified public health research uses outside of DSHS. Page 11
12 New Forms June 1, 2012 New Forms for HB 411 Page 12
13 New Forms June 1, 2012 HB 411 requires the distribution of 2 new forms to parents upon collection of each newborn screen Effective date: June 1, 2012 Explains parent options Gives parents a means to allow or refuse longterm storage and use of specimens Replaces requirement to distribute current Parent Copy and Disclosure / Directive to Destroy forms Page 13
14 New Forms June 1, 2012 Goals of Form Development Team Ensure parents understand their choices Ensure compliance with parental choices Streamline healthcare provider distribution Ensure compliance with law Streamline DSHS processing Ensure enough information is requested on forms to match forms to specimens Maximize parent / patient privacy Improve general Newborn Screening education Page 14
15 New Forms June 1, 2012 Development Summary 22 draft versions Developed with input from: Professional medical organizations including TMA, TPS, and THA Parents Submitting facility physicians, nurses, and technologists DSHS Laboratory and Clinical Care Coordination staff Legal advisors Reviewed by DSHS Executive Leadership Texas Legislative Offices Healthcare Provider Stakeholders Page 15
16 Parent Information Form Page 1 of 2012 Kits (Replaces Page 1 of previous kits) English / Spanish Front / Back Distribute to parent upon collection of each specimen Parents should take form received at collection of first screen to their baby s doctor when the baby is 7 to 14 days of age Will be OK to still distribute older version beginning June 1. Medicaid / CHIP / Charity Page 16 Insurance / Self-Pay
17 Parent Information Form Parent instructions to take form received at 1 st screen to doctor when baby is 7 to 14 days of age Information about residual specimen storage / use and Parental Decision form (Page 2) Expanded and simplified general newborn screening information Page 17 Contact phone number and web address
18 Parental Decision for Storage and Use of NBS Blood Spot Cards Page 2 of 2012 Kits (Replaces Page 2 of previous kits) English / Spanish Front / Back (Vietnamese online) By law, starting June 1, 2012, MUST be distributed to parent upon collection of each specimen Intent is that all parents make a decision one way or the other Parents may: Complete form and return to healthcare provider to be shipped with any regular newborn screening specimen shipment; OR Mail in at a later date Page 18
19 Parental Decision for Storage and Use of NBS Blood Spot Cards Explanation of Choices Forms without a signature or a selection will default to No Parents only need to complete form once per child Signature is required to process OK selection Page 19
20 New Healthcare Provider Responsibilities for HB 411 Page 20
21 Healthcare Provider Responsibilities Step 1: Distribute to parents upon collection of each newborn screening specimen. Texas Newborn Screening Parent Information (Page 1 of 2012 Kits) and Parental Decision for Storage and Use of Newborn Screening Blood Spot Cards (Decision form) (Page 2 of 2012 Kits) Page 21
22 Healthcare Provider Responsibilities STEP 2: Advise parents that they should : Read Page 1 Texas Newborn Screening Parent Information. Take the form given to them upon collection of the first screen to their child s healthcare provider when the child is 7 to 14 days of age. Read Page 2, Parental Decision for Storage and Use of Newborn Screening Blood Spot Cards, select an option, and return to DSHS. Parents may return the form to the healthcare provider at the time of collection or mail it into DSHS at a later date. Page 22
23 Healthcare Provider Responsibilities STEP 3: Check the box on the demographic form (Page 3) that the Use and Storage form was given to the parent. STEP 4: If requested by parent, return the completed form to DSHS along with any regular newborn screening specimen shipment Page 23
24 Older Collection Kits What do Healthcare Providers do with the older collection kits (2010 and 2011) starting on June 1, 2012? Continue to use the 2010 and 2011 collection kits through the kit expiration date. Page 24 8 ½ X 11 form is available at:
25 Educational Resources Official notification letter Monthly NBS listserv updates Kit order inserts Website updates Webinars CE modules Video Pamphlets / flyers Page 25
26 Resources Web Phone: , ext. 7333, or Page 26
Leveraging the Attention
Leveraging the Attention HOW TEXAS TOOK ADVANTAGE OF HEIGHTENED NATIONAL AWARENESS TO EXPEDITE ONGOING SPECIMEN TRANSIT QUALITY IMPROVEMENT EFFORTS B RENDAN R EILLY P ROGRAM S PECIALIST Texas DSHS Newborn
MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH POLICY ON THE RETENTION, STORAGE, AND USE OF NEWBORN SCREENING DATA AND RESIDUAL SPECIMENS DECEMBER 2015
MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH POLICY ON THE RETENTION, STORAGE, AND USE OF NEWBORN SCREENING DATA AND RESIDUAL SPECIMENS DECEMBER 2015 I. Introduction II. Background III. Definitions IV. Rationale
Preparing Birthing Hospitals to Implement Parental Consent for the Michigan BioTrust for Health Challenges and Successes One Year Later
Preparing Birthing Hospitals to Implement Parental Consent for the Michigan BioTrust for Health Challenges and Successes One Year Later Kevin Cavanagh, PhD Bureau of Laboratories Michigan Department of
Massachusetts Newborn Screening Public Health Service, Research and. Public Trust
Massachusetts Newborn Screening Public Health Service, Research and Anne Marie Comeau, Ph.D Deputy Director, New England Newborn Screening Program Professor of Pediatrics, UMMS 2016 APHL Annual Meeting
Research and Survey Application Manual
Research and Survey Application Manual Updated: October 18, 2016 Table of Contents INTRODUCTION... 1 APPLICATIONS FOR RESEARCH APPLICATION REQUIREMENTS... 2 FEE STRUCTURE... 4 DATA... 4 ROLE OF RESEARCH
Pertussis, Strep Throat testing & Resources. Michelle Anguiano C.A.R.E. Unit Manager
Pertussis, Strep Throat testing & Resources Michelle Anguiano C.A.R.E. Unit Manager Pertussis, Strep Throat testing & Resources Michelle Anguiano C.A.R.E. Unit Manager Adult vaccination recommended Pregnant
California Newborn Screening Program Update
California Newborn Screening Program Update Robin Thomas, BSN, MPA Nurse Consultant, Specialist Genetic Disease Screening Program May 10, 2018 Goal of Screening Screening is a public health service designed
APPLICATION FOR RESEARCH REQUESTING AN IRB WAIVER OF CONSENT AND HIPAA AUTHORIZATION
FORM W/H-01 APPLICATION FOR RESEARCH REQUESTING AN IRB WAIVER OF CONSENT AND HIPAA AUTHORIZATION Research for which this form is appropriate generally involves only existing patient records or specimens.
Newborn Genetic Testing & Surveillance System
New Hampshire Newborn Genetic Testing & Surveillance System State NH Statute/ Rule STATUTE: Title X, Chapter 132:10-a to c RULE: Chapter He-P 3000 Language Specific to Genetic Testing and Surveillance
Translational Research in Newborn Screening: Development of a Virtual Repository of Residual Dried Blood Spots
Translational Research in Newborn Screening: Development of a Virtual Repository of Residual Dried Blood Spots Amy Hoffman, MPH Newborn Screening Translational Research Network (NBSTRN) Outline The NBSTRN
HIPAA Privacy Regulations Governing Research
HIPAA Privacy Regulations Governing Research HIPAA Health Insurance Portability and Accountability Act In a Nutshell The Privacy Regulations govern a provider s use and disclosure of health information
Newborn Genetic Testing & Surveillance System
Oregon Newborn Genetic Testing & Surveillance System State OR Statute/ Rule STATUTE: ORS Title 36, Chapter 433 RULE: OAR Chapter 333 Language Specific to Genetic Testing and Surveillance System 433.285
Grambling State University Application for Human Subjects Review IRB Protocol. 1. Principal Investigator [Last Name, First Name, Middle Initial]
![Grambling State University Application for Human Subjects Review IRB Protocol. 1. Principal Investigator [Last Name, First Name, Middle Initial]](/thumbs/72/66952388.jpg "Grambling State University Application for Human Subjects Review IRB Protocol. 1. Principal Investigator [Last Name, First Name, Middle Initial]")
SUBMIT CITI COMPLETION CERTIFICATION WITH FORM 1. Principal Investigator [Last Name, First Name, Middle Initial] Email Phone 2. Department 3. University Status (Check one) a. Faculty b. Staff c. Undergraduate
MEDICAL POWER OF ATTORNEY
MEDICAL POWER OF ATTORNEY DESIGNATION OF HEALTH CARE AGENT. I, (insert your name) appoint: Phone: as my agent to make any and all health care decisions for me, except to the extent I state otherwise in
New HIPAA Privacy Regulations Governing Research. Karen Blackwell, MS Director, HIPAA Compliance
New HIPAA Privacy Regulations Governing Research Karen Blackwell, MS Director, HIPAA Compliance kblackwe@kumc.edu 913-588 588-0942 HIPAA Health Insurance Portability and Accountability Act In a Nutshell
The Queen s Medical Center HIPAA Training Packet for Researchers
The Queen s Medical Center HIPAA Training Packet for Researchers 1 The Queen s Medical Center HIPAA Training Packet for Researchers Table of Contents Overview of HIPAA and Research 3 Penalties for violations
JUST THE FAX NOTIFICATION: CALIFORNIA PRENATAL SCREENING PROGRAM
JUST THE FAX www.molinahealthcare.com November 26, 2014 Page 1 of 6 THIS CA UPDATE HAS BEEN SENT TO THE FOLLOWING: COUNTIES: Imperial Riverside/San Bernardino Los Angeles Sacramento San Diego LINES OF
Study Initiation Meeting
Puerto Rico Clinical and Translational Research Consortium Study Initiation Meeting I. Procedure Title: Study Initiation Meeting II. Overview/Procedure Description: 1. The Clinical Research Resources and
Scripps Clinic Medical Group (SCMG) and SCRIPPS HEALTH INFORMED CONSENT STATEMENT FOR. Study Title: SCMG & Scripps Health Bio-Repository
Scripps Clinic Medical Group (SCMG) and SCRIPPS HEALTH INFORMED CONSENT STATEMENT FOR Study Title: SCMG & Scripps Health Bio-Repository Collection and Storage of Human Biological Materials for Research
The Children's Clinic Patient Information Form
The Children's Clinic Patient Information Form Patient Name: Patient Demographics of Birth: Social Security #: Mother's Name: Parent Demographics Maiden Name: Address: City/Zip: Home Phone #: Alternate
Disclosure Statement for Medical Power of Attorney
Disclosure Statement for Medical Power of Attorney THIS IS AN IMPORTANT LEGAL DOCUMENT. BEFORE SIGNING THIS DOCUMENT, YOU SHOULD KNOW THESE IMPORTANT FACTS: Except to the extent you state otherwise, this
HIPAA COMPLIANCE APPLICATION
1 HIPAA COMPLIANCE APPLICATION PROJECT TITLE: PRINCIPAL INVESTIGATOR Name (Last, First): Please complete this form if you intend to use/disclose protected health information (PHI) in your research. An
Parkland Health & Hospital System Department of Pathology Research Support
Parkland Health & Hospital System Department of Pathology Research Support The Road to Successful Request for Pathology Research Services Kim Coston, MT(AMT) Pathology Research & Client Services Coordinator
UCLA Newborn Screening Symposium 2018
UCLA Newborn Screening Symposium 2018 Facility Feedback HEPP Reports and Graphs How to Best Utilize These Reports for Optimal Outcomes Timeliness in Specimen Collection and Transit TRF Completion Early/Missing
Compliance Policy C-FMS Clinical Research Project Approval Application
Internal Use Only: Business Unit: Fresenius Medical Services Region: RVP: Area Manager: Facility # Compliance Policy C-FMS-009.2 of Investigator or Study Coordinator completes the following: Facility Name
SCREENING PROCEDURES: WHAT IS COVERED BY A
SCREENING PROCEDURES: WHAT IS COVERED BY A PARTIAL HIPAA WAIVER AND WHAT IS NOT? IRB Webinar March 12, 2015 BEFORE WE START Currently there is a lot of discussion at Emory on HIPAA and recruitment practices.
Study Start-Up SS STANDARD OPERATING PROCEDURE FOR PRE-STUDY SITE VISIT (PSSV)
Replaces previous version 203.01: 01 July 2014 Study Start-Up SS 203.01 STANDARD OPERATING PROCEDURE FOR PRE-STUDY SITE VISIT (PSSV) Approval: Nancy Paris, MS, FACHE President and CEO 24 May 2017 (Signature
To provide an integrated and coordinated approach to delivering Newborn Metabolic Screening (NMS) Program services to all infants born in Alberta.
TITLE NEWBORN METABOLIC SCREENING PROGRAM DOCUMENT # HCS-32 APPROVAL LEVEL Alberta Health Services Executive SPONSOR Population and Public Health CATEGORY Health Care and Services INITIAL APPROVAL DATE
Printed from the Texas Medical Association Web site.
Printed from the Texas Medical Association Web site. Medical Power of Attorney Patient and Health Care Provider Information September 1999 General Information To be read by the Patient and Health Care
BIMO SITE AUDIT CHECKLIST
Item AUTHORITY AND ADMINISTRATION FOR STUDIES INVOLVING HUMAN DRUGS, BIOLOGICS AND DEVICES 1. Compare the Investigator Agreement with the information provided by the assigning Center. Auditor will check
Williamson County & Cities Health District Epidemiologist I Foodborne Disease Epidemiologist
Williamson County & Cities Health District Epidemiologist I Foodborne Disease Epidemiologist Position Summary: Under the supervision of the Section Director, serves as a member of the Disease Control and
Institutional Review Board Student (Other Investigator) Instructions & Information. Do not begin work until written IRB approval is issued!
Institutional Review Board For Human Participant Research Rebecca Linger, Chair irb@ucwv.edu Institutional Review Board Student (Other Investigator) Instructions & Information Do not begin work until written
MEDICAL POWER OF ATTORNEY DESIGNATION OF HEALTH CARE AGENT.
MEDICAL POWER OF ATTORNEY DESIGNATION OF HEALTH CARE AGENT. I, (insert your name) appoint: Name Address Phone as my agent to make any and all health care decisions for me, except to the extent I state
Laboratory System Improvement Program (L SIP)
Colorado Department of Public Health and Environment Laboratory Services Division Laboratory System Improvement Program (L SIP) EXECUTIVE ASSESSMENT SUMMARY 2013 Colorado Department of Public Health and
If you require films or CD, kindly give us 48 hour notice or make technologist aware at the time of your study.
A Note to Our Patient: Your physician will be receiving a copy of your results via fax within two business days. Please contact your physician to go over your results and to obtain a copy of your report.
Family Cord Blood and Cord Tissue Banking Enrollment Documents Services Agreement
Family Cord Blood and Cord Tissue Banking Enrollment Documents Services Agreement The undersigned expectant parent(s) ( Client ) are electing to enter into the Services Agreement ( Agreement ) for CORD:USE
HIPAA & Research Overview for the Privacy Board March 22, UAMS HIPAA Office Vera M. Chenault, JD
HIPAA & Research Overview for the Privacy Board March 22, 2011 UAMS HIPAA Office Vera M. Chenault, JD The Privacy Board - YOU HIPAA Privacy Rule establishes the requirements for membership and role of
Use And Disclosure Of Protected Health Information (PHI) For Research
Current Status: Pending PolicyStat ID: 2558954 Origination: Last Approved: Last Revised: Next Review: Owner: Policy Area: References: Applicability: N/A N/A N/A 1 year after approval PAIGE ENGLISH: ASSOCIATE
JUST THE FAX NOTIFICATION: CALIFORNIA PRENATAL SCREENING PROGRAM
JUST THE FAX www.molinahealthcare.com November 26, 2014 Page 1 of 6 THIS CA UPDATE HAS BEEN SENT TO THE FOLLOWING: COUNTIES: Imperial Riverside/San Bernardino Los Angeles Sacramento San Diego LINES OF
Consent Form Requirements for Multicenter studies when CHOP Relies on an external IRB
Consent Form Requirements for Multicenter studies when CHOP Relies on an external IRB When the CHOP relies on an external IRB, that IRB (Reviewing IRB) is responsible for the review and approval the overall
Administration Manual Insulin Pump Program (IPP) Policies and Procedures Version 3.0
c Administration Manual Insulin Pump Program (IPP) Policies and Procedures Version 3.0 Health April 2018 2 Table of Contents SECTION 1: INTRODUCTION... 4 SECTION 2: ROLES AND RESPONSIBILITIES... 5 General
INFORMED CONSENT TO PARTICIPATE IN A DIABETES RESEARCH REGISTRY
INFORMED CONSENT TO PARTICIPATE IN A DIABETES RESEARCH REGISTRY PRINCIPAL INVESTIGATOR: Andrew S. Pumerantz, DO 795 E. Second Street, Suite 4 Pomona, CA 91766-2007 (909) 706-3779 CO-INVESTIGATORS: WDI
ELIGIBILITY SERVICES DEPARTMENTAL GUIDELINES AND PROCEDURES TITLE: COMMUNICATION TO PATIENT REGARDING FINANCIAL ASSISTANCE DETERMINATION
Page Number: 1 of 10 TITLE: COMMUNICATION TO PATIENT REGARDING FINANCIAL ASSISTANCE DETERMINATION PURPOSE: To define the documents and information to be shared with the client regarding the assigned financial
TEHDI CONTINUUM OF CARE FOR AUDIOLOGISTS
TEHDI CONTINUUM OF CARE FOR AUDIOLOGISTS COORDINATING CARE USING HEALTH INFORMATION TECHNOLOGY (HIT) 101 Presented By: Mary Catherine Hess, MA OZ Systems Sponsored by the Texas Early Hearing Detection
Record or Document Type Retention Period Relevant Legal Citation(s) IRB Records: Training Records;
TEXAS HEALTH RESOUCES Table 17-III. Record Retention Schedule Human Subject Research Records and Documents Approved by THR System Performance Council (SPC): 19 January 2010 Effective Date: October 14,
LifeBridge Health HIPAA Policy 4. Uses of Protected Health Information for Research
LifeBridge Health HIPAA Policy 4 Uses of Protected Health Information for Research This Policy contains the following Sections: I. Policy II. III. IV. Definitions Applicability Procedures A. Individual
Advance Directive Form
Advance Directive Form NOTE: This form is being provided to you as a public service. The attached forms are provided as is and are not the substitute for the advice of an attorney. By providing these forms
Oklahoma Health Care Authority (OHCA) Pharmacy Provider Attestation Hemophilia and Other Rare Bleeding Disorders Standards of Care
Page 1 Oklahoma Health Care Authority (OHCA) Pharmacy Provider Attestation Hemophilia and Other Rare Bleeding Disorders Standards of Care In order to be reimbursed for providing factor replacement products
Patient Instructions to Obtain Copies of Medical Records
Patient Instructions to Obtain Copies of Medical Records Thank you for allowing Ventura Orthopedics (VO) the opportunity to be your healthcare provider. Please review the following guidelines and instructions
Inventory of Biological Specimens, Registries, and Health Data and Databases REPORT TO THE LEGISLATURE
Inventory of Biological Specimens, Registries, and Health Data and Databases REPORT TO THE LEGISLATURE MARCH 2017 1 Inventory of Biological Specimens, Registries, and Health Data and Databases February
Common Pitfalls to the Non-Course-Based Research IRB Application. Revised December, 2013
IRB Information for Researchers Common Pitfalls to the Non-Course-Based Research IRB Application Revised December, 2013 Undergraduate/Graduate Students conducting non-exempt research, Faculty, and Doctoral
Staff Training. Understanding Healthix Patient Consent
Staff Training Understanding Healthix Patient Consent Healthix Facilitates Exchange of Data Healthix Policy and Patient Consent Work Responsibilities: Training, Documenting and Preparing for Audit 1. Let
CLOSE OUT VISIT REPORT (NO CRF TO MONITOR)
Date: Page: 1 of 8 CLOSE OUT VISIT REPORT (NO CRF TO MONITOR) Protocol: PI Name: PI Address: Date of Visit: Monitor(s): Other Sponsor Personnel Present: Site Personnel Present at Visit (include names and
Initially Submitted on 11/24/2009 Final Submission By Test6 CA on 11/24/2009 1:51 PM Approval By student13 student13 on 11/24/2009 1:52 PM Attendees
Location: Los Angeles Research Institute: Los Angeles, CA Investigation Product/Test Article: Laftr Visit Mechanism: On-site Initially Submitted on 11/24/2009 Final Submission By Test6 CA on 11/24/2009
AN ACT. SECTION 1. Title 4, Civil Practice and Remedies Code, is amended by CHAPTER 74A. LIMITATION OF LIABILITY RELATING TO HEALTH INFORMATION
AN ACT relating to the exchange of health information in this state; creating a criminal offense. BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: SECTION 1. Title 4, Civil Practice and Remedies
Preparing for Audits and Post Approval Monitoring April 29, 2015
Preparing for Audits and Post Approval Monitoring April 29, 2015 Presented By: Piper Hawkins Green, CIP Olga Jonas, CIP IRB Compliance Analyst IRB Compliance Analyst Presentation Agenda Regulatory background
Medical Power of Attorney Designation of Health Care Agent 2 Witnesses. I, (insert your name) appoint: Name: Address:
Medical Power of Attorney Designation of Health Care Agent 2 Witnesses I, (insert your name) appoint: Phone: as my agent to make any and all health care decisions for me, except to the extent I state otherwise
UNIVERSITY MEDICAL CENTER NEW ORLEANS RESEARCH REVIEW APPLICATION
UNIVERSITY MEDICAL CENTER NEW ORLEANS RESEARCH REVIEW APPLICATION Submission and Approval Process 1. Submit complete RRC application to Office of Research as early as possible in study process. 2. Quality
POLICY AND REGULATIONS MANUAL TITLE: HOSPITALIZATION & MEDICAL NECESSITY REVIEW
Page Number: 1 of 21 TITLE: HOSPITALIZATION & MEDICAL NECESSITY REVIEW PURPOSE: To provide guidelines for the hospitalization of patients and for assignment of the appropriate Status to patients in the
PCMH 2014 Recognition Checklist
1 PCMH1: Patient Centered Access 10.00 points Element A - Patient-Centered Appointment Access ~~ MUST PASS 4.50 points 1 Providing same-day appointments for routine and urgent care (Critical Factor) Policy
PURDUE UNIVERSITY WEST LAFAYETTE, INDIANA SCHOOL OF NURSING STUDENT DRUG TESTING POLICY PRIOR TO PARTICIPATION IN CLINICAL ACTIVITIES
PURDUE UNIVERSITY WEST LAFAYETTE, INDIANA SCHOOL OF NURSING EFFECTIVE DATE: 02/17/12 REVISED DATE: REVIEW DATE: Introduction STUDENT DRUG TESTING POLICY PRIOR TO PARTICIPATION IN CLINICAL ACTIVITIES This
OPEN Person Types and Business Rules Revision 2
CTSU Cancer Trials Support Unit Revision 2 August 21, 2017 Document Information Revision Information for the Revision History # Date By Description 1 2017/07/25 Mark Stauffer 2017/07/20: Created the initial
Karen W. Dyer MT(ASCP), DLM Director, Division of Laboratory Services Centers for Medicare & Medicaid Services CLIA
Karen W. Dyer MT(ASCP), DLM Director, Division of Laboratory Services Centers for Medicare & Medicaid Services Objectives Basics Certificate of Waiver (CoW) laboratories Triagency responsibilities FDA
PATIENT INFORMATION. In Case of Emergency Notification
PATIENT INFORMATION Patient Name Date Nickname DOB Age Sex Race/Ethnicity Language(s) spoken at home Person completing form Relation to Patient Patient Address City State Zip Phone # Other Phone Medical
December 2015 Research Administration Working Group WELCOME OFFICE OF THE VICE PRESIDENT FOR RESEARCH
December 2015 Research Administration Working Group WELCOME Open Mike Fringe Rates FY17 proposed Budget v. Charging Distribution of Indirects PI award letter out & accounts funded Departments- this month
Health organizations integrate variety of clinical information and administrative types of information systems. These systems collect, process, and
Health organizations integrate variety of clinical information and administrative types of information systems. These systems collect, process, and distribute patient centered data to aid in managing and
10 STEPS TO IRB APPROVAL
10 STEPS TO IRB APPROVAL STEP 1: OBTAIN CITI TRAINING CERTIFICATE ALL STUDY PERSONNEL MUST TAKE AN ONLINE HUMAN SUBJECTS TRAINING EDUCATION PROGRAM. THE CERTIFICATES OF COMPLETION ARE NEEDED FOR ALL STUDY
General Procedure - Institutional Review Board
General Procedure - Institutional Review Board Purpose: The primary purpose of the Institutional Review Board (IRB) is to protect the welfare of human subjects used in research. All research requests meeting
THIS IS AN IMPORTANT LEGAL DOCUMENT. BEFORE SIGNING THIS DOCUMENT, YOU SHOULD KNOW THESE IMPORTANT FACTS:
Medical Power of Attorney (Part I: Disclosure Statement) THIS IS AN IMPORTANT LEGAL DOCUMENT. BEFORE SIGNING THIS DOCUMENT, YOU SHOULD KNOW THESE IMPORTANT FACTS: Except to the extent you state otherwise,
System of Records Notice (SORN) Checklist
System of Records Notice (SORN) Checklist Do not use any tabs, bolding, underscoring, or italicization in the system of records notice submissions to the Defense Privacy Office. Use this as a checklist
Effective Date: November 12, 2015 Policy Number: MHC_RP0306. Corporate Director, HRPP Institutional Official, HRPP
Policy Title: Education and Training In Human Subject Research Effective Date: November 12, 2015 Policy Number: Review Date: November 12, 2015 Section: Revised Date: Administrative Responsibility: Oversight
Sterilization Consent Form Instructions
Sterilization Consent Form Per Title 42 Code of Federal Regulations (CFR) 441, Subpart F, all sterilization procedures require a valid consent form regardless of the funding source. For timely processing,
Transportation Advisory Board Regional Program Year Policy
Transportation Advisory Board Regional Program Year Policy - The Regional Program Year Policy is intended to manage the development and timely delivery of transportation projects awarded federal funds
Patient Section. Patient Name: (Last) (First) (MI) Address: City: State: Zip: Date of Birth: / / Month Day Year Home Phone: ( ) - Cell Phone: ( ) -
Lilly Cares Foundation Patient Assistance Program PO Box 13185 La Jolla, CA 92039 1-800-545-6962 Fax: (844) 431-6650 www.lillycares.com Patient Name: (Last) (First) (MI) Address: City: State: Zip: Date
Sample. A guide to development of a hospital blood transfusion Policy at the hospital level. Effective from April Hospital Transfusion Committee
Sample A guide to development of a hospital blood transfusion Policy at the hospital level Name of Policy Blood Transfusion Policy Effective from April 2009 Approved by Hospital Transfusion Committee A
Transfusion Safety in Practice. Ana Lima Transfusion Safety Nurse Sunnybrook Health Sciences Centre Toronto, Ontario CANADA
Transfusion Safety in Practice Ana Lima Transfusion Safety Nurse Sunnybrook Health Sciences Centre Toronto, Ontario CANADA The Evolving Role of Nurses in Transfusion Hong Kong: 1 December 2017 Nurses and
Newborn bloodspot screening
Policy HUMAN GENETICS SOCIETY OF AUSTRALASIA ARBN. 076 130 937 (Incorporated Under the Associations Incorporation Act) The liability of members is limited RACP, 145 Macquarie Street, Sydney NSW 2000, Australia
Objectives. With the completion of this module the learner will:
Specimen Labeling Objectives With the completion of this module the learner will: Identify the appropriate procedure for collecting and labeling specimens. Define patient identification requirements at
Navigating HIPAA Regulations. Michelle C. Stickler, DEd Director, Research Subjects Protections
Navigating HIPAA Regulations Michelle C. Stickler, DEd Director, Research Subjects Protections mcstickler@vcu.edu 828-0131 Key Definitions Covered Entity: Organization that handles identifiable health
Provider Portal Hints & Tips Frequently Asked Questions
Provider Portal Hints & Tips Frequently Asked Questions 1 Medical Review-Claim Appeal Hints & Tips Claim Appeals The Dean Health Plan Medical Affairs Department reviews the claim and associated medical
PRIVACY POLICY 18/8/2016
PRIVACY POLICY Policy number: 2 Version 1 Drafted by : Kate de Josselin Revision No: Pages: 2 Approved By 18/8/2014 Scheduled Board on: Review Date 18/8/2016 1.0 Introduction The Board of Prader-Willi
Regulatory Binder Checklist for FDA-Regulated Sponsor/Sponsor-Investigator Studies
Regulatory Binder Checklist for FDA-Regulated Sponsor/Sponsor-Investigator Studies DIRECTIONS: 1. The purpose of a regulatory binder is to assure that all essential elements are maintained in an organized
If you would like your child to participate in the Life Health Center School Wellness Program, please complete pages 1-5.
If you would like your child to participate in the Life Health Center School Wellness Program, please complete pages 1-5. Student Name of Birth Sex: Male Female Address Street City State Zip Grade Room
MACOMB COUNTY COMMUNITY MENTAL HEALTH ACKNOWLEDGMENT AND CONSENT FORM
MACOMB COUNTY COMMUNITY MENTAL HEALTH ACKNOWLEDGMENT AND CONSENT FORM IDENTIFYING INFORMATION PROVIDED INFORMATION Consumer was provided with the following information: Membership Information 1. MCCMH
LIBERTY DENTAL PLAN. Dental Hygienist - Credentialing Application. City: State: DEGREE: City: State: DEGREE:
*Required Fields LIBERTY DENTAL PLAN Dental Hygienist - Credentialing Application Please complete one application per Dental Hygienist Demographic Information: Male Female *HYGIENIST NAME: RDH Other *DATE
REGISTERING A PATIENT
REGISTERING A PATIENT Patient Eligibility It is important for the institution staff to review all eligibility criteria and follow-up requirements. A patient failing to meet all protocol eligibility requirements
Office of Mental Health Continuous Quality Improvement Initiative for Health Promotion and Care Coordination: 2013 Project Activities and
Office of Mental Health Continuous Quality Improvement Initiative for Health Promotion and Care Coordination: 2013 Project Activities and Expectations March 2013 Overview Welcome 2013 CQI Project Options
UA New Common Rule Implementation
The New Common Rule - What does it all mean? This guide serves to assist University of Arizona researchers to understandthe New Common Rule ( new rule ) and how it will be implemented at the University
Self-Monitoring Tool
This form is designed for research personnel to use to assess their compliance with TTUHSC El Paso IRB policies and procedures, and federal regulations and guidance governing research with human subjects,
Patient Privacy Requirements Beyond HIPAA
Patient Privacy Requirements Beyond HIPAA Jane Hyatt Thorpe, J.D. School of Public Health and Health Services George Washington University Carrie Bill, J.D. Feldesman Tucker Leifer Fidell LLP The George
Authorization and Waiver Frequently Asked Questions
Authorization and Waiver Frequently Asked Questions Q. I obtain databases (of blood chemistry levels) from the Monroe County Health Department (MCHD) that I use to identify potential subjects for my studies.
Telemedicine Privacy and Security: Safeguarding Protected Health Information and Minimizing Risks of Disclosure
Presenting a live 90-minute webinar with interactive Q&A Telemedicine Privacy and Security: Safeguarding Protected Health Information and Minimizing Risks of Disclosure THURSDAY, AUGUST 13, 2015 1pm Eastern
Module: Research and HIPAA Privacy Protections ( )
Module: Research and HIPAA Privacy Protections (7-18-11) HIPAA's protections focus on individually identifiable health information HIPAA defines identifiable health information as (1) any form or medium"
Advanced Directive For Health Care
Advanced Directive For Health Care Your Right to Make Your Own Decisions About Medical Care The best source for more information about Advanced Directive is your attorney. Patients of Helen Keller Hospital
SARASOTA MEMORIAL HOSPITAL
SARASOTA MEMORIAL HOSPITAL TITLE: ISSUED FOR: NURSING PROCEDURE Nursing DATE: REVIEWED: PAGES: RESPONSIBILITY: RN, LPN I, LPN II Per Job Description 03/93 2/18 1 of 6 PURPOSE: KNOWLEDGE BASE: To provide
Inpatient orders and Physician Certification MUST BE authenticated PRIOR to discharge No EXCEPTIONS.
2 Midnight Rule for InPatient Admission On August 2, 2013 the Centers for Medicare & Medicaid Services (CMS) issued a final rule (CMS- 1599-F) updating Medicare payment policies which modifies and clarifies
QUALITY ASSURANCE PROGRAM
QUALITY ASSURANCE PROGRAM Elaine Armstrong, MS Quality Assurance Manager PURPOSE Verify accuracy of submitted data Verify compliance with protocol and regulatory requirements Provide educational support
EXHIBITOR & SPONSOR PROSPECTUS
SPONSOR & EXHIBITOR PROSPECTUS EXHIBITOR & SPONSOR PROSPECTUS All photo rights and credit to Travel Portland WELCOME MESSAGE FOR SPONSORS & EXHIBITORS The College Reading & Learning Association (CRLA)
The Privacy & Security of Protected Health Information
The Privacy & Security of Protected Health Information By the end of this course, you should: Be familiar with the patient s rights to privacy under HIPAA Privacy Act Be able to identify Protected Health
TELNET COURSE T2861 PART 1 (WEBINAR) TELNET COURSE T2864 PART 2 (WEBINAR) TELNET COURSE T2866 PART 3 (WEBINAR) DATE: SEPTEMBER 26, 2013
CMS Conditions of Participation (CoPs) for Critical Access Hospitals (CAHS): Ensuring Compliance This is a 3-part series; each program can be taken independent of the others. TELNET COURSE T2861 PART 1