1. Clarify Informed Consent of Transmittable Conditions
The second issue I want to present is the proposal to “Clarify Informed Consent of Transmittable Conditions” proposal put forward by the DTAC.
Ad Hoc Disease Transmission Advisory Committee (DTAC)

2. What 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 programs
Difficult to monitor and enforce
The problem we are trying to solve revolves around a particular clause in current informed consent policy prior to transplant that is vague and has caused confusion.
Currently, specific consent is required on an organ 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”.
The Membership and Professional Standards Committee (MPSC) sent a memo to the DTAC asking for clarification. They expressed concerns that a broad interpretation of current policy implies the need to get individual consent for any and every positive result including EBV and CMV results or positive donor cultures. Implementing that in practice might not be reasonable and cause an undue burden for programs. In addition, it is currently very difficult, if not impossible, to monitor and enforce. Accordingly, the DTAC made the decision to propose to revise and clarify the policy.

3. What are the proposed solutions?
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 management
Tie the consent process to conditions screened by UNetsm
Tests named in current OPTN policy 5.3.B
Provides clear and enforceable policy
Keep other informed consent requirements when using donor organs:
The DTAC leadership discussed this issue with the MPSC including the policy history. The DTAC had never intended for common organisms such as EBV and CMV to be broadly included as part of this policy and felt that some changes to the policy could help to remove the ambiguity.
First, we rearranged the policy order to emphasize the general discussion and education requirement of potential candidates that occurs at the time of listing a candidate
The proposal also adds a clause to this general discussion at the time of wait listing to have transplant hospitals highlight that donor results can affect post-transplant care and management.
After much deliberation as to what recognized transmissible conditions should be included in policy, we propose to tie the specific consent process to conditions that candidates are screened for in UNet according to OPTN Policy 5.3.B. Tests in this policy will be shown on the next slide in more detail.
This provides for a clear and enforceable policy as requested by MPSC
We keep the other informed consent requirements at transplant such as when using donor organs that are PHS increased risk.

4. What are the proposed solutions?
Adapted from Table 5-1: Donor Infectious Disease Screening Options
If the donor tests positive for:
Then pre-transplant informed consent would be required for the following organs:
Cytomegalovirus (CMV)
Intestine
Hepatitis B core antibody (HBcAb)
Heart, Intestine, Kidney, Liver, Lung, Pancreas, Heart-Lung, Kidney-Pancreas
Hepatitis B Nucleic Acid Test (NAT)
Hepatitis C (HCV) Antibody
Hepatitis C Nucleic Acid Test (NAT)
Human 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.
Here are the candidate screening conditions that exist in current Policy 5.3.B Infectious Disease Screening Criteria. If any of these are positive (including CMV for intestines only) then transplant centers would need to obtain informed consent prior to transplant.
The proposed policy would apply to recipients receiving organs from all donor types (living and deceased).
We have not prescribed or modified how transplant programs obtain or document informed consent.

5. Supporting Evidence

6. EBV and CMV positive donors are the norm not the exception
Out 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 CMV
EBV and CMV positive donors are the norm NOT the exception.
As you can see, review of data from over 10,000 deceased donors from whom at least one organ was recovered shows that about 9,000 or 89% tested positive for EBV and over 6,000 or 61% tested positive for CMV.
Data Source: UNet data from October 1, 2016 and September 30, 2017

7. EBV and CMV are standard
EBV Mismatches:
85% of EBV-negative recipients received an EBV-positive donor organ
2,289 out of 2,691 EBV-negative recipients
CMV Mismatches:
57% of CMV-negative recipients received a CMV-positive donor organ
5,687 out of 10,003 CMV-negative recipients
Data Source: UNet data from October 1, 2016 and September 30, 2017
Mismatches (transplants between a positive donor and negative recipient) are common. 85% of the EBV seronegative recipients received an EBV positive organ. Likewise the same was true for over half of the CMV seronegative recipients, with 57% of CMV negative recipients receiving a CMV positive donor organ.
For this reason, the issue is better discussed as a possibility at time of general consent rather than trying to explain the complexity during the time that an organ becomes available.

8. HCV and HBV positive donors
Out of 10,326 deceased donors from whom at least one organ was recovered for transplant:
744 (7.2%) tested positive for HCV antibody
495 (4.8%) tested positive for HCV NAT
478 (4.6%) tested positive for HBV core antibody
15 (0.1%) tested positive for HBV NAT
On the other hand HCV and HBV positive donors are rarer events. They are not as common in the community at large and may impact a person’s decision to accept an organ.
Out of those same 10,326 deceased donors,
only 7.2 % tested positive for HCV and only 4.8% were positive for NAT. Likewise, HBV core antibody was found in only 4.6% of donors. HBV NAT was rare occurring in only 0.1%.
Data Source: UNet data from October 1, 2016 and September 30, 2017

9. What about other conditions?
Can still obtain informed consent if warranted
Transplant hospitals must still meet applicable informed consent requirements for:
State laws
CMS Conditions of Participation
The proposed OPTN policy is the minimum standard and transplant hospitals might elect to have more detailed informed consent requirements if warranted for other conditions depending on their practices.
Most transplant hospitals must still meet applicable state law and CMS Conditions of Participation informed consent requirements.

10. How will members implement this proposal?
Transplant hospitals will need to:
Examine and possibly revise their consent protocols and practices to comply with the revised policies
Examine practices at both time of listing a potential transplant recipient & at the time of organ offer
Provide staff training to understand and comply with the revised policies
Possibly revise their current informed consent form or documentation
OPOs will not need to make changes for implementation.
Transplant hospitals will need to:
Examine and possibly revise their consent protocols and practices to comply with the revised policies
Examine practices at both time of listing a potential transplant recipient & at the time of organ offer
Provide staff training to understand and comply with the revised policies
Possibly revise their current informed consent form or documentation

11. Specific Feedback Two questions
Should 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?
The DTAC is asking two specific feedback questions.
1.) Should policy specify patient signature or is documentation of discussion between the provider and the recipient (or next of kin) sufficient.
2.) In addition, are conditions named in policy for candidate screening and re-executing the match run still applicable and complete? Some have questioned if CMV and intestine screening is still clinically relevant and others have asked if hepatitis B surface antigen should be added.

12. How will the OPTN implement this proposal?
Anticipated Board Review date: June 11-12, 2018
Anticipated Implementation date: September 1, 2018
No programming in UNetSM
The DTAC anticipates that the proposal would go before the OPTN/UNOS Board of Directors in June 2018 with a standard implementation date of September 1, 2018 since no IT programming would be involved.

13. How will the OPTN implement this proposal?
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) antibody
Hepatitis C nucleic acid test (NAT)
An intestine was accepted from a donor who tested positive for cytomegalovirus (CMV)
The full policy 15.3 compliance plan is available on line. There will be some new elements with this proposal.
At site survey a sample of medical records will be reviewed for documentation that consent was obtained prior to transplant when an organ was transplanted from a donor positive for the conditions listed on the slide as reviewed earlier.
In addition, site surveyors will now review the hospital’s internal policies, procedures, and/or protocols and interview staff to verify that they have and follow a written protocol for post-transplant testing of recipients for HIV, hepatitis B, and hepatitis C.

14. Questions? Cameron Wolfe, MBBS(Hons), MPH, FIDSA
Ad Hoc Disease Transmission Advisory Committee Chair
Susan Tlusty
Ad Hoc Disease Transmission Advisory Committee Liaison

15. Extra Slides

16. Reporting table Donor: HCV Test Results
Recipient: Post-Transplant HCV Test Conversion
Report to OPTN?
Serology
NAT
Situation 1:
Negative
Positive
Positive Serology or NAT
Do Not Report: Expected Transmission
Situation 2:
Situation 3:
Positive NAT
Do Report: Unexpected Transmission
Situation 4:
Positive Serology but Negative NAT
This is just included for your reference .

17. Willingness to accept HBV or HCV positive organs varies
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.
Here are the data reflecting a candidate’s willingness to accept these types of positive organs when they are added to the waitlist.
Data Source: UNet data as of September 30, 2017

18. Increasing use of HBV and HCV positive organs
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)
These data give an idea of the number of HBV and HCV mismatch transplants which we know are increasing due to HCV treatment availability.
Only if asked:
HBV:
4 donors were positive by NAT, core antibody, and surface antigen
10 donors were positive by NAT and core antibody
750 donors were positive by core antibody only
1 donor was positive by NAT only
9 donors were positive by surface antigen only
HCV:
113 donors were positive by antibody and NAT
223 donors were positive by antibody only
6 donors were positive by NAT only

19. OPTN Bylaws Appendix L.15. OPTN Determinations and Actions
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.
This is just for your reference if needed.