CCTC Regulatory and Quality Compliance 4 — Questions and Answers
Question 1: Under OPTN policy, which of the following is a required element of a transplant program's Written Agreement with its OPO?
- Guaranteed organ allocation sequence
- Defined roles and responsibilities for donor management (Correct answer)
- Pricing schedules for procurement fees
- Joint liability provisions for adverse outcomes
Correct answer: Defined roles and responsibilities for donor management
OPTN policy requires transplant programs and OPOs to have written agreements that clearly delineate roles and responsibilities in the donation and procurement process.
Question 2: A transplant coordinator receives a directed living donation request where the donor is a coworker of the recipient. Which regulatory concern must be specifically addressed?
- ABO compatibility waiver
- Absence of coercion or financial inducement under NOTA (Correct answer)
- UNOS pre-approval for non-family living donation
- State licensure of the evaluating social worker
Correct answer: Absence of coercion or financial inducement under NOTA
NOTA prohibits the transfer of any human organ for valuable consideration; the evaluation must rule out coercion or financial inducement, which is particularly scrutinized in non-family directed donations.
Question 3: When documenting a deceased donor's medical and social history, which source is considered the most reliable for regulatory purposes?
- Family-reported verbal history
- Electronic health records from the donor's treating hospital (Correct answer)
- Primary care physician records
- Coroner or medical examiner report
Correct answer: Electronic health records from the donor's treating hospital
Electronic health records from the treating hospital are the most verifiable and regulatory-compliant documentation source because they contain authenticated clinical data.
Question 4: Which accreditation standard specifically addresses transplant program infection control practices related to donor-derived disease transmission?
- Joint Commission National Patient Safety Goal 7 (Correct answer)
- AABB Standards for Cellular Therapy
- FACT Standards for Hematopoietic Cellular Therapy
- AOPO Standards Section 7: Donor Testing and Disease Transmission
Correct answer: Joint Commission National Patient Safety Goal 7
Joint Commission NPSG 7 (Infection Prevention) applies to transplant programs and includes requirements for monitoring and preventing donor-derived infections.
Question 5: CMS requires transplant centers to have a written patient selection process that is:
- Based solely on UNOS allocation algorithms
- Non-discriminatory and consistently applied to all candidates (Correct answer)
- Approved by the state health department annually
- Restricted to patients referred by contracted physicians
Correct answer: Non-discriminatory and consistently applied to all candidates
CMS CoPs require transplant programs to have non-discriminatory written patient selection criteria that are applied consistently across all candidates regardless of protected characteristics.
Question 6: A transplant program's data coordinator notices a discrepancy between OPTN-submitted outcomes and internal registry data. The appropriate first step is to:
- Correct the OPTN data submission immediately without internal review
- Conduct an internal reconciliation and notify the OPTN if submission errors are confirmed (Correct answer)
- Report the discrepancy directly to CMS as a potential compliance violation
- Flag the data for the next annual CMS survey review
Correct answer: Conduct an internal reconciliation and notify the OPTN if submission errors are confirmed
Internal reconciliation should occur first to confirm the nature of the discrepancy, after which confirmed submission errors must be corrected with the OPTN as required by policy.
Question 7: Under OPTN policy, a transplant program must notify the OPTN within how many business days of a change in the Transplant Program Director?
- 3 business days
- 5 business days
- 10 business days (Correct answer)
- 30 calendar days
Correct answer: 10 business days
OPTN policy requires programs to notify the OPTN within 10 business days of any change in key personnel, including the Transplant Program Director.
CCTC Regulatory and Quality Compliance 4
Under OPTN policy, which of the following is a required element of a transplant program's Written Agreement with its OPO?