OPTN Evaluation Plan - Organ Procurement and Transplantation ...

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Policy 16.1: Organs Not Requiring Transport 38Policy 16.6: Verification of Information before Shipping 39Policy 16.7.A: Vessel Recovery and Transplant Use 39Policy 16.7.B: Vessel Storage 40Policy 18.1: Data Submission Requirements 41Policy 18.2: Timely Collection of Data 42Policy 18.5.A: Reporting Requirements after Living Kidney Donation 43Policy 18.5.B: Reporting Requirements after Living Liver Donation 44Bylaws Appendix B.1: OPO Compliance 45Bylaws Appendix B.2: OPO Performance Requirements 46Bylaws Appendix B.4: OPO Personnel 47Bylaws Appendix C.5: Changes in Key Laboratory Personnel 48Bylaws Appendix C.6.D: Regulatory Adverse Actions 49Bylaws Appendix D.1: Transplant Hospital Compliance 50Bylaws Appendix D.5: Transplant Program Key Personnel 51Bylaws Appendix D.5.B: Surgeon and Physician Coverage (Program Coverage Plan) 52Bylaws Appendix D.6: Changes in Key Transplant Program Personnel 54Bylaws Appendix D.6.D: Reinstatement of Previously Designated Primary Surgeon or Primary 55PhysicianBylaws Appendix D.9: Review of Transplant Program Functional Activity 56Bylaws Appendix D.10.A: Transplant Program Performance Reviews 57Bylaws Appendix D.10.B: Patient Notification Requirements for Waiting List Inactivation 58Bylaws Appendix F.6.E: Conditional Program Approval Status 59Bylaws Appendix K.1.A: Program Component Cessation 60Bylaws Appendix K.3.A: Notice to the OPTN Contractor of Long-term Inactive Status 61Bylaws Appendix K.3.B: Notice to the Patients of Long-term Inactive Status 62Bylaws Appendix K.4.A: Notice to the OPTN Contractor 63Bylaws Appendix K.4.B: Notice to the Patients 64Bylaws Appendix K.5: Transition Plan during Long-term Inactivity, Termination, or Withdrawal 65
OPTN Member Evaluation PlanUpdated January 1, 2015Policy 2.2: OPO ResponsibilitiesEffective Date: 2/1/2014At OPOs, site surveyors will:Review a sample of deceased donor records for the following documentation:⦁ An authorization to donate⦁ Reasons for excluding any donors from the eligible death definition⦁ Declaration of death note, including⦁ Date and time of pronouncement of death⦁ Signature(s) of the person(s) required under the relevant state's laws⦁ Serum archival noted in the donor chartReview a sample of deceased donor records to verify that data reported through UNet℠ is consistent with sourcedocumentation, including:⦁ HLA typing⦁ SerologiesOPOs will provide:The requested sample of deceased donor medical recordsPolicy 2.3: Evaluating and Screening Potential Deceased DonorsEffective Date: 2/1/2014At OPOs, site surveyors will:Review a sample of deceased donor records for the following documentation:⦁ That the OPO reviewed the donor's medical record⦁ That the OPO completed a physical exam including vital signs⦁ That the OPO attempted to obtain the donor's medical and behavioral historyOPOs will provide:The requested sample of deceased donor medical records1
Page 1 and 2: OPTN Member Evaluation PlanUpdated
Page 3: Policy 8.5.A: Candidate Classificat
Page 9 and 10: Policy 2.8: Required Deceased Donor
Page 11 and 12: Policy 2.11.B: Required Information
Page 17 and 18: Policy 6.1.A: Adult Heart Status 1A
Page 21 and 22: Policy 8.5.E: Allocation of Kidneys
Page 25 and 26: Policy 9.3.H: MELD/PELD Score Excep
Page 27 and 28: Policy 13.2: Potential KPD Donor Re
Page 35 and 36: Policy 14.4.B: Living Kidney Donor
Page 37 and 38: ⦁ Personal history of:⦁ Hyperte
Page 47 and 48: Policy 18.5.A: Reporting Requiremen
Page 49 and 50: Bylaws Appendix B.1: OPO Compliance
Page 51 and 52: Bylaws Appendix B.4: OPO PersonnelO
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Bylaws Appendix D.5: Transplant Pro
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Transplant hospitals must:Address e
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OPTN Member Evaluation PlanUpdated
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Bylaws Appendix D.10.A: Transplant
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Bylaws Appendix F.6.E: Conditional
Page 65 and 66:
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Bylaws Appendix K.4.A: Notice to th
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OPTN Evaluation Plan - Organ Procurement and Transplantation ...

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