OPTN Comment due 12/23/11: #9: Living Donor Follow Up

[Clark]

All comment solicited:
http://optn.transplant.hrsa.gov/policiesAndBylaws/publicComment/proposals.asp

This proposal:
http://optn.transplant.hrsa.gov/PublicComment/pubcommentPropSub_294.pdf

Exhibit:
http://optn.transplant.hrsa.gov/PublicComment/pubcommentPropSurveyExhibit_37.pdf

Precis:
Living Donor Committee: Proposal To Establish Minimum Requirements for Living Kidney Donor Follow-Up 
This proposal would require transplant programs to report required fields on the Living Donor Follow-up (LDF) form at required post-operative reporting periods (6, 12, and 24 months). The OPTN currently relies on Living Donor Follow-up (LDF) forms to collect data on the short-term health status of living donors. Data on living donors who donated in 2006 through 2009 demonstrate that many programs do not report meaningful living donor follow-up information at required reporting intervals. Consequently, to allow for meaningful analyses to objectively study the short-term effects of living donation, the transplant community must collectively improve patient information on the LDF form. The proposed minimum reporting requirements are based on recommendations from the Joint Society Work Group, which is composed of representatives from the American Society of Transplantation (AST), the American Society of Transplant Surgeons (ASTS), and the North American Transplant Coordinators Organization (NATCO) to the OPTN/UNOS Living Donor Committee.

Please read the two pdf files and discuss them in this thread.  If you are moved to formally submit your comments at http://optn.transplant.hrsa.gov/policiesAndBylaws/publicComment/submitYourComment.asp?PropID=318 , please consider providing a copy here.  Thanks!

[Clark]

http://communication.unos.org/2011/08/fall-2011-regional-business-meetings-schedule/

Fall 2011 Regional Business Meetings Schedule

Here’s the schedule of upcoming fall 2011 regional business meetings, where transplant professionals can participate in discussions and learn about regional business, committee activity, and policy and bylaw proposals that are out for public comment. All UNOS members are welcome. There is no registration fee and no need to pre-register.

• Region 6 Business Meeting: September 23, 2011 in Honolulu, HI
• Region 1 Business Meeting: September 26, 2011 in Worcester, MA
• Region 10 Business Meeting: September 30, 2011 in Dayton, OH
• Region 9 Business Meeting: October 12, 2011 in Albany, NY
• Region 7 Business Meeting: October 14, 2011 in Chicago, IL
• Region 3 Business Meeting: October 14, 2011 in Atlanta, GA
• Region 11 Business Meeting: October 14, 2011 in Atlanta, GA
• Region 2 Business Meeting: October 28, 2011 in Philadelphia, PA
• Region 4 Business Meeting: December 2, 2011 in Houston, TX
• Region 8 Business Meeting: December 2, 2011 in Kansas City, MO
• Region 5 Business Meeting: December 15, 2011 in Las Vegas, NV

Visit the UNOS Calendar on www.unos.org  for more information or contact the UNOS administrator responsible for your region.

• Regions 1,4,9: Shannon Edwards – Shannon.Edwards@unos.org
• Regions 2, 6, 8: Betsy L. Gans – Betsy.Gans@unos.org
• Regions 5, 7, 10: Chrystal Graybill – Chrystal.Graybill@unos.org
• Regions 3, 11: Clifton McClenney – Clifton.McClenney@unos.org

FYI, here's a link to the regional map for those who don't know which one they're in.  Do try to attend, and identify yourself to the Regional Counselor, who will chair the meeting.  http://optn.transplant.hrsa.gov/latestData/stateData.asp?type=region

[Clark]

FYI, I plan to attend Monday's Region 1 meeting.  See you there?

[Clark]

While today's Region 1 meeting attendees were at pains to explicitly make clear that they were in favor of this in principle and in almost every detail, it was voted down, 4-6, with the highest abstention rate I've seen in 7 years of attending.  The single issue they couldn't accept was the 90% success rate required to be compliant in follow up.  The comment they'll forward is a suggestion/request that some paper trail demonstrating how hard they tried to reach the ones they've lost, presumably far more than 10%, be accepted to show compliance.

Passionate, articulate speakers spoke on both sides.  I did not, as I had not yet formulated the responses I'll share below, and was left at the time with, "me too."

1) No one can get all their donors to follow up.

  Incorrect.  Dozens of centers get 100% consistently, and many more get above 90% consistently.

2) Who will pay for the uninsured?

  A) Why assume that a self insured donor candidate, who has been educated about this being in his or her own best interest, after donating, would not pay?

  B) If you're unwilling to cover the cost of three blood test series, and you think the donor will be unable to, why is this donor candidate continuing to be considered?

3) Agreed, 90% compliance for a mandated policy is unacceptable, it should be 100% compliance like every other policy, just as dictated in the Federal Register HHS directive of 2006 requiring equal treatment in policy development for living and deceased donors.

4) Why assume the status quo, that an unfollowed donor is alive and well, is acceptable, when it is demonstrably untrue for all donors, consistently, year after year?  Why not presume during an OPTN or CMS audit that an unfollowed donor is either dead or so gravely ill that he or she cannot reach the center?  Why not report center success rates including "missing, presumed dead."  Donor candidate perceptions of the differences between the standards of care among transplant centers might reasonably be expected to clarify dramatically.


  If you attend regional, LDComm, or board meetings, and have a chance to speak these or your own thoughts, I hope you'll post about it here.  I don't know how much of this will make it into my public comment submission, but I know I'll be making one.

[Clark]

I've received some informal feedback about the public comment received to date and it can be summarized in two words: sparse and negative.  Don't let this be all that the committee and the board sees!  Get your comments in, attend the regional meetings, be a visible witness!  There's time to get your comments in, but the regional meetings are upon us.

[Clark]

My thoughts on this have been marinating.  For you all attending upcoming regional meetings, or those of you on OPTN committees or the board, when push back about the 90% compliance rate requirement arises, I hope you'll consider a few talking points in response:

1) The 90% compliance rate proposed is inconsistent with all other OPTN policies, and may be rejected by HHS as still not complying with the 2006 Federal Register notice.

2) It is misleading, if not unconscionably misrepresenting the information available about living donation in general and at each transplant center to presume that those not followed are without complicating morbidities or mortality, short term or long term.  Whether 90% or 100% follow up is required, some donors may truly be hard to find, or refuse further contact, despite good faith efforts to reach them or their primary care physicians.  I suggest verifiable, detailed documentation of the attempts made be accepted as compliant, with the proviso that during the informed consent process, the transplant center's complete history of follow up compliance must be disclosed, with the explicit statement that as they have not followed these donors, they do not know their condition, and CAN NOT warrant that they are all well, free of complications, or even alive or dead.

3) This is a minimum standard, a best practices guideline already adopted and in place.  Any center not already making all appropriate efforts to follow up at 6, 12, and 24 months is not meeting a best practices minimum standard, and this should be explicitly disclosed in the informed consent process, verifiably available for inspection by the MPSC audit team.

  I hope, if you agree, you'll find these helpful.  Do tell.  thanks.

[WilliamLFreeman]

Clark,

Thanks very much for your careful & well-expressed thoughts.  I assume you will send them to UNOS as public comments.  I & other members of the Living Donor Committee who are faithful readers [and sometimes posters] of LDO will bring your comments to our meeting as well.

Anyone else with comments?

Bill

[Clark]

Anybody else been to a meeting?  Anybody submitted comments yet?

[Clark]

Just about a month left to concentrate your thoughts and get your public comments in!

[Clark]

Due Friday!

[jatopa]

Thanks for the reminder, Clark.  Perhaps I will work on something the next few days.  I am very surprised that my transplant center does not have a recommended regimen for follow up...I would think there would be a schedule to follow for checking creatinine, proteinuria and blood pressure, and a decision tree developed based on results.  My only advice is to return to my primary care.  Lucky me, I have a friend who is a nephrologist who will monitor me!

[Michael]

Comments from Donna Luebke: https://livingdonorsonline.org/UNOSProposals/DLuebke-LivingDonorFollowUpDec2011.pdf

[Clark]

Comments submitted:

I support this proposal with a significant reservation.  90% compliance, as proposed, is unacceptably low.  This would become the only OPTN policy not requiring 100% compliance, hardly equitable treatment of living donor policy development.  A mechanism for donors to opt out, in writing, with informed consent, could be considered as a means to allow a donor candidate reluctant to agree to follow up to become a donor.  Good faith transplant center efforts to follow up, with appropriate, auditable documentation, should be acceptable as compliance. Finally, I recommend a requirement that the transplant center disclose its history of compliance success on living donor follow up, from the first donor candidate contact with their program to the present, as part of informed consent education of donor candidates.  It’s not too late, for most of us, to be contacted and numbered among donors followed, and not lost to follow up.

(Identity slug.)

[livingdonor101]

My submitted comment: http://sirencristy.blogspot.com/2011/12/public-comment-on-optn-living-kidney.html

[WilliamLFreeman]

Part of my submitted comment [much shorter than Medical Evaluation]   

SUMMARY:  I strongly support adopting / approving the Proposal.  However, I propose a possible alternative and an addition for future consideration.

A.  SUGGESTIONS SPECIFIC FOR THIS PROPOSAL.

First, the problem this Proposal addresses is not solely under the control of the transplant centers.  To achieve follow-up requires the participation and action of two parties:  the transplant center; and  all living donors, or (if deceased or incapacitated) their families/contact people.  In such situations of standards written for only one party, the proposal can take one of two approaches, or both:
   1]  set a reasonable, expected, "no show / no cooperation / no response" rate by the other party (i.e., by the party to which the standard is not addressed) -- in this proposal, it is acceptable that up to 10% of donors will not cooperate); or
   2]  establish actions that the party addressed by the standards must perform to meet the standard (e.g., minimum number of letters, of calls, etc.).

The proposal adopted the first approach, probably in part because there are not yet good data about the different possible levels of effort -- how much increase in response from the donors does each increased level of effort accomplish, and for what cost of personnel time.

The information referred to in Figure 1 of the proposal may help in that regard, but may not be sufficient at present to switch to the second approach, above.  I recommend that the LDC and UNOS obtain enough information about elements of effort and their additional outcomes and additional costs, to consider switching to the second approach in the future.  With that switch, the Policy can require 100% compliance with the standard of reasonable, effective, effort.

Second, the data to be asked for in the future should include Quality of Life (QOL) indicators, related to psycho-emotional-socio-economic questions.  Often QOL indicators are more important to Living Kidney Donors than is GFR.  The scientific field of QOL Indicators is now quite advanced, and can be relied on in this setting.

I propose this addition for future consideration.  I do not want my additional suggestion to postpone implementation of this Proposal.

B.  GENERAL SUGGESTION.

The current process of proposed standards and policies being developed by the Joint Society Policy Steering Group is excellent.  One concern, however, is that for standards and policies related to Living Donors, a group representing living donors themselves are not in either that Steering Group or in the later process of development and issuing the standards and policies.

I recognize that the Living Donor Committee (LDC) has living donors and is involved in the process thereafter; I am a living donor member of the LDC.  I also recognize that individual living donors can comment on the proposed standards and policies during the public comment period.  And, I recognize there is not yet a group composed of living donors in which those living donors themselves choose their representatives to be involved in this process.

If living donors form such a group, I strongly recommend that UNOS then formally incorporate that group into the process of development, as the "stakeholder" with the special expertise of having been a living donor.  The representatives of that group would supplement quite well the expertises of living donor members of the LDC -- just as the Joint Society Policy Steering Group supplements the expertises of the ATS, ACTS, NATO, OPEN/UNOS, and HRSA members of the LDC.