CCTC Regulatory and Quality Compliance 3 — Questions and Answers
Question 1: A transplant coordinator discovers a labeling error on a kidney that has already been shipped to the accepting center. The FIRST priority action is to:
- File an internal incident report within 24 hours
- Notify the receiving center immediately to place the organ on hold (Correct answer)
- Contact UNOS DonorNet to update the record
- Inform the transplant surgeon and wait for guidance
Correct answer: Notify the receiving center immediately to place the organ on hold
Immediate notification to the receiving center ensures the organ is not implanted until the discrepancy is resolved, prioritizing patient safety above documentation steps.
Question 2: The OPTN Policy requiring informed consent for living donors is intended to ensure that donors:
- Understand only the surgical risks of donation
- Receive a comprehensive evaluation by an Independent Living Donor Advocate (ILDA)
- Are informed of risks, benefits, and alternatives before any evaluation begins (Correct answer)
- Are approved by the UNOS Living Donor Committee
Correct answer: Are informed of risks, benefits, and alternatives before any evaluation begins
OPTN policy requires living donors to receive comprehensive information about risks, benefits, and alternatives before initiating any donation-related evaluation or testing.
Question 3: Under HIPAA, sharing a transplant recipient's protected health information (PHI) with the donor family requires:
- Written authorization from the recipient or their legal representative (Correct answer)
- Only verbal consent from the attending transplant physician
- No authorization because it is a covered entity-to-covered entity transfer
- Approval from the hospital's HIPAA compliance officer
Correct answer: Written authorization from the recipient or their legal representative
Sharing a recipient's PHI with the donor family requires written authorization from the recipient because it involves disclosure to a non-treatment third party.
Question 4: A quality improvement review reveals that 3 of the last 20 kidney transplants had delayed graft function exceeding program benchmarks. This finding should FIRST be:
- Reported to the MPSC as a patient safety event
- Presented to the transplant program's QI committee for root cause analysis (Correct answer)
- Disclosed to waiting patients as a material change in program performance
- Forwarded to CMS as a mandatory adverse event report
Correct answer: Presented to the transplant program's QI committee for root cause analysis
Outcomes outside benchmarks should first undergo internal root cause analysis through the QI committee to identify modifiable factors before external reporting thresholds are triggered.
Question 5: Which OPTN policy governs the minimum number of transplants a program must perform annually to maintain active status?
- OPTN Membership Policy
- OPTN Bylaws on Program Requirements (Correct answer)
- CMS 36-month lookback rule
- Joint Commission volume standards
Correct answer: OPTN Bylaws on Program Requirements
OPTN Bylaws establish minimum volume requirements (e.g., 10 transplants over a 12-month rolling period for most programs) that must be met to maintain active membership.
Question 6: An OPO coordinator is reviewing a potential donor and notes the medical examiner has not yet released the case. The coordinator should:
- Proceed with procurement as long as brain death is declared
- Contact the medical examiner to obtain release or permission to proceed (Correct answer)
- Request a waiver from UNOS to bypass medical examiner involvement
- Document the issue and defer the decision to the transplant surgeon
Correct answer: Contact the medical examiner to obtain release or permission to proceed
Medical examiner jurisdiction must be respected; the OPO coordinator must contact the ME to secure release or permission before procurement proceeds, regardless of brain death determination.
Question 7: The primary purpose of sentinel event reporting in transplant programs is to:
- Meet CMS adverse event reporting requirements
- Identify systemic failures and prevent recurrence through root cause analysis (Correct answer)
- Establish liability protections for the transplant team
- Generate data for national transplant outcome databases
Correct answer: Identify systemic failures and prevent recurrence through root cause analysis
Sentinel event reporting drives root cause analysis to identify systemic issues and implement corrective actions that prevent recurrence, improving overall patient safety.
CCTC Regulatory and Quality Compliance 3
A transplant coordinator discovers a labeling error on a kidney that has already been shipped to the accepting center.
The FIRST priority action is to: