Due 6/15! Proposal to Establish Kidney Paired Donation (KPD) Policy

[Clark]

http://optn.transplant.hrsa.gov/PublicComment/pubcommentPropSub_302.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=326

Proposal to Establish Kidney Paired Donation (KPD) Policy

Affected/Proposed Policy and Bylaw: Policy 13 (Kidney Paired Donation); OPTN Bylaws,
Appendix E.5.F Kidney Paired Donation
Kidney Transplantation Committee
This proposal converts the existing OPTN Kidney Paired Donation (KPD) Pilot Program rules, housed in the OPTN KPD Pilot Program Operational Guidelines, into OPTN policy. The full range of adverse actions will be available to the MPSC for violations of KPD policy, up to and including designation of member not in good standing. The policy also includes additional elements of potential donor informed consent that are specific to KPD and requirements for how the OPTN Contractor will conduct matching in the OPTN KPD Program. The proposed changes would consolidate all rules for the OPTN KPD Program into a single location and allow the MPSC to follow its standard processes for potential violations of KPD policy.
Affected Groups
Lab Directors/Supervisors Transplant Administrators Transplant Physicians/Surgeons PR/Public Education Staff Transplant Program Directors Transplant Social Workers Kidney Candidates
Living Donors
Number of Potential Candidates Affected
This proposal will impact approximately 200 candidates currently in the OPTN KPD Pilot Program as well as any candidates who may join the OPTN KPD Program in the future.
Compliance with OPTN Strategic Goals and Final Rule
Overall, the OPTN KPD Program will increase the number of transplants. This proposal addresses the goals of promoting living donor safety and promoting transplant patient safety by addressing informed consent and blood type verification requirements.
Specific Requests for Comment
o Is it clear what the policy requirements are for Transplant Hospitals? Is it clear how the OPTN Contractor will audit these requirements?
o Is the process for matching participants in the OPTN KPD Program transparent?
o Are the informed consent elements that are specific to KPD appropriate and complete?

[Clark]

http://communication.unos.org/2012/02/everything-you-wanted-to-know-about-the-optn-kidney-paired-donation-program/

Everything You Wanted to Know about the OPTN Kidney Paired Donation Program

The OPTN kidney paired donation pilot program (KPDPP) continues to expand. More KDPPP transplants are taking place, with 18 total transplants completed by the end of January. Match run results for February show that the pace will continue to increase. So far, more than 100 transplant centers have agreed to participate. See a list of all participating centers.
http://communication.unos.org/wp-content/uploads/2012/02/KPDPP-Participating-Centers.doc
http://communication.unos.org/wp-content/uploads/2012/03/February_2012_Match_Run_Results.pdf

Interested in participating or learning more about the program? Links to resources and training are available below. If you have more questions, contact Ruthanne Hanto, KPD program manager, at ruthanne.hanto@unos.org or call her at (804) 836-4652. Hanto will be on hand at several upcoming spring meetings (regions 1, 9, 6, 4 and 7) and conferences (KPD consensus conference, Mar. 29-30; Transplant Administrators Forum, Apr. 25-27; ATC, Jun. 2-6; and NATCO, Aug. 12-15).

[WilliamLFreeman]

Background:  OPTN conducted a voluntary pilot for, initially, "paired donation or exchange" (involving two sets of willing kidney donor & recipient who were incompatible on matching, but who matched compatible across the pairs).  OPTN later expanded the pilot to include chains, probably well known to most of us.  OPTN kept the same name ("Kidney Paired Donation"), however, even though it included chains; if the name is confusing, just ignore it.

OPTN is ending the Pilot to make it a standard OPTN Program.  OPTN guided the pilot using "Pilot Program rules."  Making the pilot a standard OPTN Program requires that it be guided by "Policy."  This Proposal converts the "rules" to "Policy" with only minor changes.

Possible issues special for Living Donors:

The change from the current "Pilot Program rules" to "Policy" appears to be straightforward.

IMO, an issue possibly relevant to Living Donors, however, are the measures the current "rules" and future "Policy" used to measure how successful the Pilot was and Program will be.  As you can see in the Proposed Policy about 1/3 from the beginning. the 29 measures are divided into two general topics:
  a]   Questions or hypotheses guiding the evidence (13 measures); and
  b]   Policy performance measures (16 measures).
Only one measure directly concerns living donors:  "Living donor outcomes."  (Neither the rules nor the Policy state which outcomes.)  Almost all measures listed are numbers or percentages, that is, easily determined "quantities."  As far as I can see, no measure concerns qualities or feedback, presumably because they might be more difficult to determine.  Examples of "quality" and "feedback" measures might include:
   *   overall satisfaction by the living donors;
   *   difficulties experienced by living donors;
   *   suggestions for programmatic improvements by the living donors;
   *   reasons for not donating by potential living donors originally listed in the chain or paired exchange;
   *   etc.
QUESTION: Would you want to see the evaluation add "quality" measures about the experience of living donors, and asking for feedback by the living donors?

PLEASE SEND YOUR OPINIONS AND IDEAS TO UNOS ABOUT THIS ISSUE, OR ANY OTHER ASPECT OF THIS POLICY.

Thanks,

Bill

[WilliamLFreeman]

Y'all,   Below is my response to UNOS about this proposed policy.   Bill

I am a living kidney donor, non-directed, and a physician.  I support the proposal.

My support is, however, qualified for three reasons.

FIRST QUALIFICATION.  It is unclear how well this proposal is coordinated with another component in UNOS policy -- specifically, the proposed KPD Policy.
   How does this proposed OPTN KPD Policy fit in with another proposed OPTN Policy on the priority status of living organ donors (LODs) who develop ESRD and need a kidney transplant?  In KPD, every match receives 100 base points, plus additional points awarded for special categories.  The points for four categories range from 100 to 200 points, and for three other categories from 25 to 75 points.  In the great majority of circumstances, the 4 LOD-points will be swamped by the proposed KPD points, meaning that LODs will have only an insignificant priority regarding KPD matches.  I did not see how either proposal coordinated with the other proposal.

SECOND QUALIFICATION.  The data sought under "Plan for Evaluating the Proposal" appear to be focussed on the numbers and medical characteristics of transplantation accomplished and not accomplished.  I did not see any data sought about the experience of donors and recipients, e.g., causes of satisfaction and of dissatisfaction.  Such data should be included.  Recipients and donors are human beings, after all.

THIRD QUALIFICATION.  The "13.9  Rules for When Donors and Recipients Can Meet" component appears to be not informed by the range of current practice.  In some centers, the first interaction between chain donors and their recipients is a face-to-face meeting.  In other centers, however, the first communication is an exchange of written letters, or e-mails, or ....  The title thus should be, "13.9  Rules for When Donors and Recipients Can Communicate."  Moreover, the center is not "present" in those later first communications, although many centers are "involved" by verifying that both donor and recipient want to communicate with each other.