Clarify informed consent policies for transmittable disease risk
Sponsoring Committee: Ad Hoc Disease Transmission Advisory (DTAC)
Strategic Goal: Promote the efficient management of the OPTN
Policy notice (PDF - 61 K; 7/2018)
Board briefing paper (PDF - 227 K; 6/2018)
Read the full proposal (PDF - 131 K; 1/2018)
Current policy states that specific pre-transplant informed consent is required when, “The donor has a known medical condition that may, in the transplant hospital’s medical judgment, be transmissible to the recipient, including HIV.” The phrase “known medical condition” has led to questions and varying applications in practice. The Membership and Professional Standards Committee (MPSC) notes in a memo to the Ad Hoc Disease Transmission Advisory Committee (DTAC) that broad interpretation of this policy would require specific informed consent for any positive serology, culture, or other donor test result and that this would be cumbersome without adding patient benefit.
For example, Epstein-Barr virus (EBV) and cytomegalovirus (CMV) are common conditions and typically do not impact organ use except under unusual circumstances. Requiring specific informed consent prior to surgery for those serologies or other donor culture results may not be reasonable and leads to undue burden on the program.
The DTAC has consistently maintained that the policy was not meant to include transmissions that are common in organ transplantation. The DTAC expects that these would be included as part of routine pre-transplant education. Due to the interpretation concerns, the DTAC proposes changes to this policy.
This proposal specifies conditions requiring informed consent prior to transplant. The Committee proposes linking conditions that would require specific consent to those that exist in Policy 5.3.B Infectious Disease Screening Criteria. This policy specifies organ specific preferences that can be made in Waitlistsm for individual candidates on whether organ offers will be received from donors who have tested positive for certain transmittable conditions. Currently, this policy includes CMV for intestines only, as well as hepatitis B (HBV) core antibody and Nucleic Acid Test (NAT), hepatitis C (HCV) antibody and NAT for heart, intestine, kidney, liver, lung, pancreas, heart-lung, and kidney-pancreas listings. Organs from HIV positive donors may only be recovered and transplanted according to Final Rule requirements. Currently, use is only permissible for kidney and liver transplantation. Consent requirements for these organs, outlined in Policy 15.7.C Transplant Hospital Requirements for Transplantation of HIV Positive Organs, would not change.
Linking pre-transplant informed consent requirements to existing candidate screening conditions will provide consistency and specificity. It establishes the principle that if organ offers are screened based on a specific positive infectious disease result, and then positive results for those conditions will require pre-transplant informed consent. Future changes to the screening policy would cascade to the informed consent policy. These changes also address the growing use of positive organs for conditions such as HCV as effective treatments have become available. The proposal does not change required informed consent for US Public Health Service increased risk organs.
- Should informed consent policy include an actual patient signature or is discussion and medical record documentation sufficient?
- Do you have any concerns or comments about the list of conditions in the current candidate screening (Policy 5.3.B Infectious Disease Screening Criteria) and re-execute the match (5.5.B Host OPO and Transplant Hospital Requirements for Positive Hepatitis B, Hepatitis C, or Cytomegalovirus (CMV) Infectious Disease Results) policies?