http://optn.transplant.hrsa.gov/PublicComment/pubcommentPropSub_306.pdf
Comment Deadline: June 15, 2012
Your opinion counts! Public comments on proposed policies are vital to the policy development process. Voice your support for, opposition against, or neutral stance on the proposed policies listed below.
http://optn.transplant.hrsa.gov/policiesAndBylaws/publicComment/submitYourComment.asp?PropID=330
Proposal to Require Reporting of Unexpected Potential and Proven Disease Transmission Involving Living Organ Donors
Affected/Proposed Policies: Policy 4.5 (Post-Transplant Reporting of Potential Transmission of Disease or Medical Conditions, Including Malignancies) and Policy 12.2 (Informed Consent of Living Donors).
Living Donor Committee
Under this proposal, existing policy would be modified to require members to report to the OPTN Contractor any unexpected potential or proven living donor-derived disease transmission, including infections or malignancies. Current OPTN/UNOS policy requires specific infectious disease testing for all deceased organ donors. It also requires that any unexpected potential or proven disease transmission, including infections and malignancies, discovered after donation be reported to the OPTN Contractor.
Although rare, unexpected potential or proven disease transmissions involving a living donor have occurred. The types of events reported to date include small renal cell carcinomas (RCC) found in the living donor during recovery and malignancies and viral infections identified in the recipient or the donor after donation. This policy change is being proposed to help improve the reporting of disease transmissions involving living donors.
Affected Groups
Directors of Organ Procurement OPO Executive Directors
OPO Medical Directors
OPO Coordinators
Transplant Administrators Transplant Data Coordinators Transplant Physicians/Surgeons PR/Public Education Staff Transplant Program Directors Transplant Social Workers Organ Recipients
Organ Candidates Living Donors
Donor Family Members General Public
Number of Potential Living Donors and Candidates Affected
In 2010 there were 6562 living donors. A disease or malignancy transmission involving a living organ donor should be a rare event.
Background: Transmitting a disease by a donated organ is a rare event, whether from a deceased or living donor. From 2006 through 2011, 15 "unexpected" transmissions have occurred: 8 cases transmitted cancer, 7 transmitted an infection, often a viral infection such as HIV or Hepatitis C Virus. (An "expected" transmission would be when the donor is known to be, for instance, Hepatitis C postive and is donating to a recipient who already has Hepatitis C.) Most unexpected transmissions have occurred in deceased organ donation -- as expected, because living organ donors are screened extensively and over a prolonged period of time. Nevertheless, I shuddered (as did many living donors) upon hearing the news in March 2011 that a living kidney donor had transmitted HIV to the recipient.
For years, UNOS has had a policy to require reporting of unexpected disease transmission for deceased organ donation. This proposal would require the same reporting for living organ donations.
For living donors, the reporting could happen in either direction. One direction is from recipient back to donor: if the recipient developed a disease that might have been transmitted by the donated organ, the donor would be notified -- thus informing the donor of a possible disease potentially needing treatment that the donor was not aware she/he had. The other direction is from donor to recipient: if the donor developed a disease that could have been transmitted in the donated organ, the recipient will be informed -- thus informing the recipient of a possible disease potentially needing treatment that the recipient was not aware she/he had.
The reporting would be limited to the first two years after donation, the interval within which disease transmitted by a donated organ would develop.
Possible issues special for Living Donors:
1] The recipient will learn details about the donor's health. The LDC asked us living donors on the LDC whether or not we would want our recipient notified that we had a specific disease -- especially a disease that is stigmatizing or embarrassing (e.g., HIV, Hepatitis C).
QUESTION: Would you have wanted your recipient to be notified if it turned out your organ (that is, you) may have transmitted HIV or cancer to your recipient?
2] Screening for, and preventing, high risk behavior is not in this Proposal. (This is an issue no-one has mentioned, as far as I know.) At the beginning of my evaluation to be a living donor, I was asked about past behaviors with high risk to acquire HIV, Hepatitis C, etc. I was not re-asked just before the actual donation, however, (for instance, when my blood was drawn for the final cross-match). Were you re-asked? Yet every time I/we donate blood, even frequent donors, we are re-asked those questions. To prevent organ donation transmission of infections acquired usually through high risk behavior, CDC has recommended counseling potential organ donors not to do high risk behavior during the (long) evaluation process (MMWR. "HIV Transmitted from a Living Organ Donor --- New York City, 2009." March 18, 2011. Vol 60, Issue 10, p, 297-301. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6010a1.htm?s_cid=mm6010a1_w ). If we were donating blood, we would have been re-ask about doing high risk behavior just before donating. But those steps are not in the proposal.
QUESTION: Should those steps be added to this Proposal? (Please think about your own experience. Would you have been insulted if you had been counseled not to do high risk behavior after you started your evaluation, and to be re-asked about high risk behaviors just before donating?)
PLEASE SEND YOUR OPINIONS AND IDEAS TO UNOS ABOUT THESE ISSUES, OR ANY OTHER ASPECT OF THIS POLICY.
Thanks,
Bill
Y'all, Below is my response to UNOS about this proposal. Bill
I am a living kidney donor, non-directed, and a physician. I STRONGLY support the proposal, and I believe most living organ donors would also support it. The reason is that we want to help the recipient, not cause harm. My support, however, has one comment.
COMMENT. Cases of possible transmission by a living organ donor (LOD) are rare. But when they occur, the LOD is likely to suffer intense emotional distress. For LODs, then, it is not sufficient just to notify the donor that the required reporting will occur. Rather, the transplant center should deal with the likely distress at the same time and also with follow-up. (For instance, the communication should be preferably face-to-face, with plenty of time for the communication, much like "pre-test counseling" by genetic counselors.)