Ad Hoc Disease Transmission Advisory Committee DTAC 2 What p roblem will the proposal solve Current informed consent policy prior to transplant is vague Specific consent required prior to transplant ID: 1044009
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1. 1Clarify Informed Consent of Transmittable ConditionsAd Hoc Disease Transmission Advisory Committee (DTAC)
2. 2What problem will the proposal solve? Current informed consent policy prior to transplant is vague Specific consent required prior to transplant “when the donor has a known medical condition that may, in the transplant hospital’s medical judgment, be transmissible to the recipient” MPSC concerned policy implies need for individual consent for every positive test result“Might not be reasonable and cause undue burden” for programsDifficult to monitor and enforce
3. Rearrange policy order to emphasize the education requirement of potential candidates at the time of listing Add clause to general consent policy at time of wait listing that results can affect post-transplant care and managementTie the consent process to conditions screened by UNetsmTests named in current OPTN policy 5.3.BProvides clear and enforceable policyKeep other informed consent requirements when using donor organs:What are the proposed solutions?3
4. If the donor tests positive for:Then pre-transplant informed consent would be required for the following organs:Cytomegalovirus (CMV)IntestineHepatitis B core antibody (HBcAb)Heart, Intestine, Kidney, Liver, Lung, Pancreas, Heart-Lung, Kidney-PancreasHepatitis B Nucleic Acid Test (NAT)Heart, Intestine, Kidney, Liver, Lung, Pancreas, Heart-Lung, Kidney-PancreasHepatitis C (HCV) AntibodyHeart, Intestine, Kidney, Liver, Lung, Pancreas, Heart-Lung, Kidney-PancreasHepatitis C Nucleic Acid Test (NAT)Heart, Intestine, Kidney, Liver, Lung, Pancreas, Heart-Lung, Kidney-PancreasHuman Immunodeficiency Virus (HIV); Organs from HIV positive donors may only be recovered and transplanted according to the requirements in the Final Rule.Kidney, Liver; Use of HIV positive donor organs is only permissible for kidney and liver transplantation at this time.What are the proposed solutions?4Adapted from Table 5-1: Donor Infectious Disease Screening Options
5. Supporting Evidence5
6. EBV and CMV positive donors are the norm not the exception6Out of 10,326 deceased donors from whom at least one organ was recovered for transplant:9,205 (89%) tested positive for EBV (IgG or IgM)6,283 (61%) tested positive for CMVData Source: UNet data from October 1, 2016 and September 30, 2017
7. EBV Mismatches: 85% of EBV-negative recipients received an EBV-positive donor organ2,289 out of 2,691 EBV-negative recipientsCMV Mismatches: 57% of CMV-negative recipients received a CMV-positive donor organ5,687 out of 10,003 CMV-negative recipientsData Source: UNet data from October 1, 2016 and September 30, 2017EBV and CMV are standard7
8. Out of 10,326 deceased donors from whom at least one organ was recovered for transplant:744 (7.2%) tested positive for HCV antibody495 (4.8%) tested positive for HCV NAT478 (4.6%) tested positive for HBV core antibody15 (0.1%) tested positive for HBV NATHCV and HBV positive donors8Data Source: UNet data from October 1, 2016 and September 30, 2017
9. Can still obtain informed consent if warranted Transplant hospitals must still meet applicable informed consent requirements for:State lawsCMS Conditions of ParticipationWhat about other conditions?9
10. Transplant hospitals will need to:Examine and possibly revise their consent protocols and practices to comply with the revised policiesExamine practices at both time of listing a potential transplant recipient & at the time of organ offerProvide staff training to understand and comply with the revised policiesPossibly revise their current informed consent form or documentationHow will members implement this proposal?10
11. Two questionsShould policy specify patient signature or documentation of discussion in medical record?Are conditions named in policy for candidate screening and re-executing the match run still applicable and complete?Specific Feedback 11
12. Anticipated Board Review date: June 11-12, 2018Anticipated Implementation date: September 1, 2018No programming in UNetSMHow will the OPTN implement this proposal?12
13. Evaluation for compliance (site survey new):Medical record documentation that a potential recipient or recipient’s agent gave consent before transplant when:An organ was accepted from a donor who tested positive for:Hepatitis B core antibody (HBcAb)Hepatitis B nucleic acid test (NAT)Hepatitis C (HCV) antibodyHepatitis C nucleic acid test (NAT)An intestine was accepted from a donor who tested positive for cytomegalovirus (CMV)How will the OPTN implement this proposal?13
14. Cameron Wolfe, MBBS(Hons), MPH, FIDSAAd Hoc Disease Transmission Advisory Committee Chair cameron.wolfe@duke.eduSusan TlustyAd Hoc Disease Transmission Advisory Committee Liaison Susan.tlusty@unos.orgQuestions?14
15. Extra Slides15
16. Donor: HCV Test Results Recipient: Post-Transplant HCV Test Conversion Report to OPTN?SerologyNATSituation 1:NegativePositivePositive Serology or NAT Do Not Report: Expected TransmissionSituation 2:PositivePositive Positive Serology or NATDo Not Report: Expected TransmissionSituation 3:PositiveNegativePositive NATDo Report: Unexpected TransmissionSituation 4:PositiveNegativePositive Serology but Negative NATDo Report: Unexpected TransmissionReporting table16
17. Out of 116,350 patients on the waitlist, the following would accept an organ:71,318 (61.3%) from a HBV core positive donor;8,021 (6.9%) from a HBV NAT positive donor;8,083 (6.9%) from a HCV antibody positive donor;1,931 (1.7%) from a HCV NAT positive donor.Out of 272 patients registered as waiting for an intestine:159 (58.5%) would accept an intestine from a CMV antibody positive donor.17Willingness to accept HBV or HCV positive organs variesData Source: UNet data as of September 30, 2017
18. HBV Mismatches: 774 HBV-negative recipients received an organ from a donor with at least one positive HBV test (among 24,883 HBV-negative recipients)HCV Mismatches: 342 HCV-negative recipients received an organ from a donor with at least one positive HCV test (among 23,879 HCV-negative recipients) CMV Mismatches (Intestines only): 21 CMV-negative recipients received donated intestines from a CMV-positive donor (among a total of 57 CMV-negative intestine recipients and a total of 110 intestine recipients)Increasing use of HBV and HCV positive organs18
19. OPTN actions may be imposed when a member: Fails to comply with OPTN Obligations as described in L.1. Member Compliance. Fails to submit or follow a corrective action plan or plan for quality improvement. Fails to meet personnel requirements. Acts in a way that poses a risk to patient health or public safety. Fails to act as necessary to avoid risk to patient health or public safety.OPTN Bylaws Appendix L.15. OPTN Determinations and Actions