UNOS Update: Site Audits of Living Donor Programs

[Clark]

http://optn.transplant.hrsa.gov/downloadables/calendar/UNOS%20UPDATE_10%20(2).pdf

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Most Common Bylaws Violations Identified

Independent Donor Advocate (IDA):
Transplant program’s own protocols often do not include description of IDA’s responsibility to provide donor with information about the benefit and need for follow-up.
The IDA’s documentation of consultations with the potential donor is often vague or minimal (especially if the living donor coordinator was also filling the role of the IDA).

Policy 12.8.1:
Centers often fail to register their donors with the OPTN via the living donor feedback form prior to surgery; this must be done in order to generate a donor ID.
Donor ID is required for tracking aborted LD procedures and for verifying appropriate donor/recipient pair before surgery

Policy 3.1.2:
Centers often fail to document that the UNOS donor ID was verified
prior to implantation.
Centers often fail to document that the ABO of the donor
and of the recipient was verified between procurement and implantation

Policy 12.8.3 and Accuracy of data submitted in TIEDI®:
Centers submitted inaccurate or discrepant information on Living Donor Feedback forms, LDR (Living Donor Registration) and the LDF (Follow-up) forms.

Other Observations
Policy 12.8.2: “The follow-up period for living donors will be a minimum of two years.”
Centers submitted Living Donor Follow- up forms according to policy but forms were incomplete or blank.
Information was often entered directly into TIEDI® but could not be verified due to poor or missing documentation in the donor medical record.
Out for public comment now is a proposal that requires certain follow up information on 90% of Follow-up forms.

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What should I expect after a report?
Living donor adverse event or other Safety Event
 Formal OPTN/UNOS inquiry:
 Root cause of the event.
 Potential policy violations involved (if any).
 Corrective actions implemented to prevent recurrence, etc.
 The goal of the initial inquiry is to assure that there is no ongoing threat to other patients.
 MPSC involvement if there is a potential policy violation and/or there is threat to patient health or public safety.

Living Donor Adverse Outcome Review Process
Expedited process for LDAO review!
Conditions Requiring Expedited Handling by Leadership and MPSC (Category 1 Potential Violation)
 Directly associated with the organ removal surgery  Occurs during the donation hospitalization
 Occurs within 30 days of organ removal surgery
Process is outlined in Bylaws. Applies to certain other safety events also.
If there is no agreed upon imminent patient safety danger, the review reverts back to the previously described process.

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[Donna Luebke]

Clark

Thanks for sharing this information.  Finally just maybe--there is leadership at the Department of Health and Human Services which I understand is coming from Dr. Koh who is the Asst. Sec of DHHS.  Finally a focus on safety, outcomes, and accountability to submit data and address adverse events, noncompliance with policies/bylaws, etc.  Time for UNOS or ASTS to stop cherry picking public members to serve on the OPTN Board and Committee.  Time to educate more of the public to be involved because the OPTN Final Rule recognized the value of public input.  Some of us were treated as if we could not possibly understand the complexities of rules, policies, allocation issues, etc. when we took the time and put forth the effort to educate ourselves and very much understand all too well.   

Time for donors to attend OPTN Region meetings, ACOT meetings, and respond to public comment.  Our voices have to be heard even if some do not want us at the table.  It is unacceptable that a 'contractor' has had this much power and control.  I am very proud of our local Organ Procurement Organization. I have been on the Board fo 5 years now.  We are a community based board with a broad range of expertise.  We hired the CEO and we can fire him; we evaluate him and the performance of the organization quarterly.  Not once during my 3 years on the UNOS Board, did we ever evaluate UNOS or its staff.  OPOs are under strict rules by the IRS and CMS--why not UNOS?  Each transplant center has one representative to the OPO Board--the Medical Advisory Committee is separate and reports to the Board via its represtative.  CMS has made changes to the composition of the MAB which is great. Where is CMS and HRSA regarding the composition of the OPTN Board and Committees? No one should serve more than one term--here is where conflicts of interest develop.  The Nominating Committee process should be open and public.  Time to have two separate Boards--one that oversees the non-profit and one that develops policy and monitors for compliance, etc.

Not sure what the Joint Societies Working Group will accomplish for living donors.  All of these organizations had representation at the OPTN and ACOT level--just another case of spinning their wheels and nothing changes.  All should read and follow what this JSWG is doing and monitor for outcomes.  We have the ability to put pressure on the feds, the OPTN which is not only a membership organization but actually as a non-profit is owned by the taxpayers, and the transplant centers. 

Does anyone know at the CMS level who is in the key person for transplantation policy?  Since Dr. James Bowman came over to HRSA from CMS, not sure who?? Those I have met at meetings or had contact with are not most helpful.  A CMS person I had contact with did not even know the difference between 'candidate' and 'recipient'!!

Then there is the issue of surveyors who review an adverse event--not just at the OPTN level but the state and CMS level.  Who trains them, assures competency, and makes sure they actually know what to look for--and when a transplant surgeon is using a new technique (Example: laparoscopic live donor nephrectomy or laparoscopic live donor liver resection), a new piece of equipment or doing research, who assures the donor is 'fully' informed?  who reviews the donor's testing information and reviews with the donor and if is a medically complex or marginal donor--does the donor get what this means?  Who makes sure the Independent Donor Advocate is really independent?


One last comment.  What does it mean to be an OPTN approved live donor liver or kidney program?  This requirement is so low of a bar it could never assure competency let alone proficiency or expertise & does not even require the surgery to be done on a live donor.  It speaks only to the surgeon not the additional resources needed for donors.  In essence, it is meaningless.  There is a perpetuated myth that living donation is safe when it takes a much more skilled operator to procure an organ or part of from a live donor than to say, remove a kidney from someone with cancer--live donors need more and deserve more.   We know living donation is not 'evidence-based' since we have no reliable and comprehensive data.  The facts speak for themselves.  Clark--again, thanks.