Living Donors Online Message Board
Living Donation Discussion and News => Living Donation Forum => Topic started by: Clark on September 20, 2011, 09:30:50 AM
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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!
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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
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FYI, I plan to attend Monday's Region 1 meeting. See you there?
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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.
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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.
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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.
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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
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Anybody else been to a meeting? Anybody submitted comments yet?
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Just about a month left to concentrate your thoughts and get your public comments in!
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Due Friday!
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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!
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Comments from Donna Luebke: https://livingdonorsonline.org/UNOSProposals/DLuebke-LivingDonorFollowUpDec2011.pdf
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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.)
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My submitted comment: http://sirencristy.blogspot.com/2011/12/public-comment-on-optn-living-kidney.html (http://sirencristy.blogspot.com/2011/12/public-comment-on-optn-living-kidney.html)
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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.
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Bill
One piece missing in any of these proposals is a section on the Electronic Medical Record (EMR). EMRs are going to be mandatory by 2014 or Medicare will not reimburse a hospital for services. I am familiar with EPIC. EPIC has a "My Chart" access for patients to get into their own records, schedules, etc. Also includes ways to contact providers, etc.
EPIC has flagged me during visits with my physicians since have a diagnosis of 'donor nephrectomy.' I was flagged to get the Pneumovax as someone with a chronic medical condition. My PCP gets an eGFR each visit since our lab standard calculates this information using my age, gender and last creatinine. The EMR is invaluable for donors.
I very much support a model where donors can access what is submitted to UNOS on their behalf. We should verify our data for accuracy, completeness and that is our record. I would not consider it complete until a donor verifies it. The Living Donor Data Task Force conclusions included that some of the SS#s submitted were the recipient's so whatever data they had was not the donor's; cases where data was submitted at 6 mos when the donor was not seen at that time which is falsification of records; and donors who never moved/changed phone numbers yet were marked lost to followup.
Someone at each center should be designated as the person responsible for followup. There should be sanctions for noncompliance. A history of 'no consequences' perpetuates the disrespect for a mandatory policy. Since we are 'donors of organs' we have always been part of this policy.
Thanks for all who shared their public comment.
Clark--can you tell us more about the Region 1 vote. Were these propoals voted down since not enough or still too prescriptive?
Donor99--maybe you can share more about the JSWG.
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Comments from Jane Zill:
Regarding: Proposal to Establish Minimum Requirements for Living Kidney Donor Follow-up
The OPTN has been contractually required by DHS to collect data on donors since 1999. Yet, centers are still balking at collecting data for two years, the OPTN has very narrowly defined the data to be collected, donor self reports about their short-term experience will not be collected, and the data to be collected will never speak to the long-term health of living organ donors. Although much of this is clearly acknowledged in the proposal, acknowledging the reality does not change it.
The time frame for this proposal, along with the plan to monitor compliance by peers and colleagues assigned to UNOS/OPTN Committees, will mean that in another 12 years, in 2023, another Living Donor Data Task Force (LDDTF) will likely conclude that OPTN data is “woefully inadequate.”
We need a prospective registry of living donors now, conceptualized and managed independently from those with professional and commercial interest in transplantation. Current data collection efforts should be about the legacy we leave our children and grandchildren. The lesson learned from UNOS/OPTN data collection to date is this: We should not allow UNOS/ OPTN to continue involvement in donor data collection.
Although this proposed program for data collection may enable UNOS/OPTN to meet contractual obligations with DHS to collect donor data, it will not enhance the safety and the environment pertaining to living donation The proposed data collection will mean wasted health care dollars. For future generations of living organ donors it will mean inadequate informed consent.
The title of the proposal should be changed to delete references to follow-up. The proposal does not provide for medical follow-up.
Any research effort is only as good as the data obtained – garbage in, garbage out. The proposal allows for information to be provided by mail, the recipient, the donor, or a health care facility. The donor may never return to the center; the source and veracity of the data submitted from remote locations will not be verifiable.
Data collected on creatinine is obsolete without data on gender, age, and weight. The standard measurement for renal function now, even though imperfect, is GFR. We want to know about detriments in GFR in donors. Efforts to cross reference information at a later date or collect other needed information to determine changes in GFR would be laborious and expense.
There is literature on living organ donors that suggests that decline in GFR accompanies changes in other biomedical markers that are associated with cardiovascular risk. There is evidence of insulin resistance after donation. This is the type of short-term information we need to understand the risks of kidney donation.
We obviously want to know about donors who need dialysis within two years of the donation, but this would be rare since time from the donation is the greatest risk factor for ESRD. Collecting this data appears to be about framing the risks about donation to the public in a positive way – it is about marketing donation, not about promoting public safety.
However, there is evidence that a significant percentage of donors experience major depression after donation surgery, which is not directly related to the outcome of the recipient. Data about this specific, devastating, short-term complication is not addressed: The DSM-IV states, “ the number of prior episodes predicts the likelihood of developing a subsequent Major Depressive Episode….. …About 5% to 10% of individuals with Major Depressive Disorder, Sinlge Episode, subsequently develop a Manic Episode (pages 341-342). “In addition, depression is increasingly recognized as a risk factor for a variety of illnesses - whether as a consequence, an exacerbation, or a cause. In medical settings, those with Major Depressive Disorder have more pain, physical illness, and decreased physical, social, and role functioning’ (DSM –IV, p. 340.)
Capturing other new diagnoses after donation is important, but, again, the “who” and “where” of this will be problematic, especially since a significant amount of donors do not have health insurance and there are not provisions for medical follow-up.
The issues at stake here regarding the expenditures of public dollars on health care are pressing. In this era of wild promotion of living organ donation as the solution to the national epidemic of ESRD, the challenges to public safety are menacing. We cannot continue along this path of useless OPTN efforts to collect data on living donors.
Contact Jane Zill for information sources.
Jane Zill, Kidney Donor 1991
Living Donor Committee, OPTN 2007-2009
Data Subcommittee, Evaluation Subcommittee
Living Donor Data Task Force, OPTN 2008