Infectious Disease Verification to Enhance Patient Safety

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

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. What are the proposed solutions? • Data elements added to pre-recovery and pre-transplant verifications • HBV, HCV, and HIV results • CMV results (only for deceased intestinedonors) • 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

4. Supporting Evidence • 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

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

6. How will members implement this proposal? 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

7. How will members implement this proposal? 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

8. How will members implement this proposal? 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. How will the OPTN implement this proposal? • 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

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

11. Extra Slides

12. OPO Pre-Recovery Verification Infectious Disease Additions Only Table 2-2: Pre-Recovery Verification Requirements The host OPO must document any required infectious disease testing results that are pending at the time of verification.

13. Living Donor Pre-Recovery Verification Infectious Disease Additions Only Table 14-12: Pre-Recovery Verification Requirements

14. Pre-Transplant Verification Prior to Organ Receipt Infectious Disease Additions Only Table 5-2: Pre-Transplant Verification Prior to Organ Receipt Requirements

15. Pre-Transplant Verification Upon Organ Receipt Infectious Disease Additions Only 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: Verification of donor infectious disease testing results was completed according to Policy 5.8.A: Pre-Transplant Verification Prior to Organ Receipt All required infectious disease testing results for HIV, HBV, HCV, and CMV (intestines only) were completed, available and verified