1. 1 Infectious Disease Verification to Enhance Patient Safety Operations and Safety Committee

2. 2 What problem will the proposal solve?  Prevent unintended disease transmission of:  Hepatitis B virus (HBV)  Hepatitis C virus (HCV)  Human immunodeficiency virus (HIV)  Cytomegalovirus (CMV)

3.  Data elements added to pre-recovery and pre-transplant verifications  HBV, HCV, and HIV results  CMV results (only for deceased intestine donors)  Receipt of all results or that results are pending (deceased donors)  Donor positive infectious disease testing results are acceptable to intended recipient according to Policy 15.3: Informed Consent of Transmissible Disease Risk **See detailed policy requirements in public comment document, including acceptable sources What are the proposed solutions? 3

4.  Identified events of near-miss and actual HCV transmission  Process issues  Mistake in data entry (entered as negative when should have been positive)  Not examining the most recent test result data  Not reviewing or acting upon positive results  Growing use of organs positive for HBV, HCV, and HIV  HOPE Act  HCV positive to HCV negative Supporting Evidence 4

5.  Pros and cons of allowing verifications to take place in the pre- operative area  Suggestions for a working definition of the pre-operative area Feedback requested 5

6. OPOs  Revise verification policies, procedures, and/or protocols  Verify available HIV, HBV, and HCV results during the pre-recovery verification. Add CMV if recovering intestines.  Document any required testing results pending at verification How will members implement this proposal? 6

7. Transplant Hospitals  Revise verification policies, procedures, and/or protocols  Verify HIV, HBV, and HCV results at pre-transplant verification(s). Add CMV if transplanting intestines.  Verify that all results have been received or results are still pending (deceased donor)  If test results are positive, verify that positive results are acceptable to recipient How will members implement this proposal? 7

8. 8 Living donor recovery hospitals  Revise verification policies, procedures, and/or protocols  Verify HIV, HBV, and HCV results at pre-recovery verification  If test results are positive, verify that positive results are acceptable to recipient

9.  Board review date: December 2016  Programming Yes, add infectious disease results to organ Required?verification link  Implementation: Upon programming and notification  Monitoring:Review internal policies, procedures, and/or protocols for inclusion of required infectious disease policy elements Review medical record samples for OPOs, transplant hospitals (verification upon organ receipt), and living donor recovery hospitals for specific documentation of verification, test results, pending results where applicable, and acceptability of results How will the OPTN implement this proposal? 9

10. David Marshman, CPTC,BS Committee Chair david_marshman@lifenethealth.org Susan Tlusty Committee Liaison susan.tlusty@unos.org Questions? 10

11. Extra Slides 11

12. The host OPO must verify all of the following information: Using at least one of these sources: By both of the following individuals: Donor infectious disease testing results available at the time of verification for HIV, hepatitis B, and hepatitis C Donor infectious disease testing source documents 1.On-site recovering surgeon 2.Qualified health care professional If recovering intestines, donor infectious disease testing results available at the time of verification for cytomegalovirus Donor infectious disease testing source documents 1.On-site recovering surgeon 2.Qualified health care professional OPO Pre-Recovery Verification Infectious Disease Additions Only 12 The host OPO must document any required infectious disease testing results that are pending at the time of verification. Table 2-2: Pre-Recovery Verification Requirements

13. Living Donor Pre-Recovery Verification Infectious Disease Additions Only 13 Table 14-12: Pre-Recovery Verification Requirements The recovery hospital must verify all of the following information: Using at least one of these sources: By both of the following individuals: All required donor infectious disease testing results for HIV, hepatitis B, and hepatitis C  Donor infectious disease testing source documents  Recovery surgeon  Licensed health care professional Donor positive infectious disease testing results are acceptable to intended recipient according to Policy 15.3: Informed Consent of Transmissible Disease Risk  Recipient medical record  Attestation following verification of donor infectious disease testing results  Recovery surgeon  Licensed health care professional

14. Pre-Transplant Verification Prior to Organ Receipt Infectious Disease Additions Only 14 The transplant hospital must verify all of the following information: Using at least one of these sources: By the following individuals: Donor infectious disease testing results available at the time of verification for HIV, hepatitis B, and hepatitis C  Donor infectious disease testing source documents  OPTN computer system  OPTN organ tracking system Two licensed health care professionals If transplanting intestines, donor infectious disease testing results available at time of verification for cytomegalovirus (CMV)  Donor infectious disease testing source documents  OPTN computer system  OPTN organ tracking system Two licensed health care professionals Receipt of all expected donor infectious disease testing results for HIV, hepatitis B, hepatitis C, and CMV (intestines only) or report that results are pending  OPTN computer system  OPTN organ tracking system Two licensed health care professionals Expected donor’s positive infectious disease testing results are acceptable to recipient according to Policy 15.3: Informed Consent of Transmissible Disease Risk  Recipient medical record  Attestation following verification of donor infectious disease testing results Two licensed health care professionals Table 5-2: Pre-Transplant Verification Prior to Organ Receipt Requirements

15. Pre-Transplant Verification Upon Organ Receipt Infectious Disease Additions Only 15 The transplant hospital must verify all of the following information: Using at least one of these sources: By the following individuals: Donor infectious disease testing results for HIV, HBV, and HCV  Donor infectious disease testing source documents  Documentation in the recipient medical record of test results for deceased donor organs communicated from the OPO  OPTN computer system  OPTN organ tracking system  Transplant surgeon  Licensed health care professional If transplanting intestines, donor infectious disease testing results for CMV  Donor infectious disease testing source documents  Documentation in the recipient medical record of test results for deceased donor organs communicated from the OPO  OPTN computer system  OPTN organ tracking system  Transplant surgeon  Licensed health care professional Receipt of all required donor infectious disease testing results for HIV, HBV, HCV, and CMV (intestines only) or report that results are pending  OPTN computer system  OPTN organ tracking system  Transplant surgeon  Licensed health care professional Donor positive infectious disease testing results are acceptable to recipient according to Policy 15.3: Informed Consent of Transmissible Disease Risk  Recipient medical record  Attestation following verification of donor infectious disease testing results  Transplant surgeon  Licensed health care professional Table 5-3: Pre-Transplant Verification Upon Organ Receipt Requirements Pre-transplant verification of donor infectious disease testing results does not need to be completed if all the following are true: 1.Verification of donor infectious disease testing results was completed according to Policy 5.8.A: Pre-Transplant Verification Prior to Organ Receipt 2.All required infectious disease testing results for HIV, HBV, HCV, and CMV (intestines only) were completed, available and verified