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