OPTN Evaluation Plan - Organ Procurement and Transplantation ...

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OPTN Member Evaluation PlanUpdated January 1, 2015Policy 14.6: Registration and Blood Type Verification of Living Donors beforeDonationEffective Date: 7/3/2014At Living Donor recovery hospitals, site surveyors will:Review the living donor recovery hospital’s internal policies, procedures and/or protocols to verify that the hospitalhas developed and implemented written protocols that address:⦁ Verification by someone other than the person who entered the ABO on the living donor feedback formthat:⦁ ABO was entered correctly⦁ ABO was entered using the ABO source documents from an initial and second determinationReview a sample of living donor medical records, and any material incorporated into the medical record byreference, to verify that data reported through UNet℠ is consistent with source documentation, including:⦁ That the ABO information entered for the donor at registration is correct, by comparing the results inUNet℠ with the blood type source documents from an initial and second determination⦁ Verifying that the dates and times shown on the source documents are prior to the date and time of theblood type data entry into UNet℠ for donor registrationRecovery hospitals will provide:The requested sample of living donor recordsThe recovery hospital's internal policies, procedures and protocols for the care of living donorsEvidence as needed to verify complianceAdditional Guidance:A hospital's electronic medical record (EMR) can be a source document for lab results when the performing lab'sresults are directly uploaded into the EMR.Source documentation for blood type results must be lab results.36
OPTN Member Evaluation PlanUpdated January 1, 2015Policy 15.1: Patient Safety ContactEffective Date: 2/1/2014At OPOs, site surveyors will:Review a sample of deceased donor records for the following documentation:⦁ Reporting of post-recovery cultures relevant to potential transmission of disease or medical conditions to allrecipient transplant programsOPOs will provide:The requested sample of deceased donor medical recordsPolicy 15.3: Informed Consent of Transmissible Disease RiskEffective Date: 2/1/2014At transplant hospitals, site surveyors will:Review a sample of medical records, and any material incorporated into the medical record by reference, fordocumentation that:⦁ The potential recipient gave consent when the organ offered met PHS increased risk criteriaTransplant hospitals will provide:The requested sample of medical recordsPolicy 15.4.A: Transplant Program RequirementsEffective Date: 2/1/2014At OPOs, site surveyors will:Review a sample of deceased donor records for the following documentation:⦁ Reporting through the patient safety portal of all malignancies or infectious diseases discovered afterrecoveryOPOs will provide:The requested sample of deceased donor medical records37
Page 1 and 2: OPTN Member Evaluation PlanUpdated
Page 3 and 4: 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 39: OPTN Member Evaluation PlanUpdated
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
Page 55 and 56: Bylaws Appendix D.5: Transplant Pro
Page 57 and 58: Transplant hospitals must:Address e
Page 61 and 62: Bylaws Appendix D.10.A: Transplant
Page 63 and 64: Bylaws Appendix F.6.E: Conditional
Page 67 and 68: Bylaws Appendix K.4.A: Notice to th

OPTN Evaluation Plan - Organ Procurement and Transplantation ...

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