Regulatory and Quality Compliance Flashcards
7 cards from real CCTC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory and Quality Compliance flashcards as text
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:
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.
The OPTN Policy requiring informed consent for living donors is intended to ensure that donors:
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.
Under HIPAA, sharing a transplant recipient's protected health information (PHI) with the donor family requires:
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.
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:
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.
Which OPTN policy governs the minimum number of transplants a program must perform annually to maintain active status?
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.
An OPO coordinator is reviewing a potential donor and notes the medical examiner has not yet released the case. The coordinator should:
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.
The primary purpose of sentinel event reporting in transplant programs is to:
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.