CCTC Regulatory and Quality Compliance 2 — Questions and Answers
Question 1: Which federal agency has primary oversight authority over organ transplantation in the United States?
- Centers for Medicare & Medicaid Services (CMS)
- Health Resources and Services Administration (HRSA) (Correct answer)
- Food and Drug Administration (FDA)
- Joint Commission on Accreditation of Healthcare Organizations
Correct answer: Health Resources and Services Administration (HRSA)
HRSA oversees the national organ transplant system through the OPTN contract and administers the National Organ Transplant Act (NOTA).
Question 2: Under UNOS policy, what is the maximum allowable cold ischemia time for a standard criteria deceased donor kidney before it must be reported as a deviation?
- 24 hours
- 36 hours
- 48 hours
- Cold ischemia time alone does not trigger a mandatory deviation report (Correct answer)
Correct answer: Cold ischemia time alone does not trigger a mandatory deviation report
Cold ischemia time alone does not automatically trigger a UNOS deviation report; the OPTN requires reporting of patient safety events and policy non-compliance, not specific CIT thresholds.
Question 3: A transplant program discovers that a donor-derived infection was not reported to the OPTN within the required timeframe. This constitutes a:
- Internal quality improvement opportunity only
- Mandatory reportable event requiring MPSC review (Correct answer)
- Voluntary safety report with no regulatory consequence
- CMS condition of participation violation only
Correct answer: Mandatory reportable event requiring MPSC review
Failure to report donor-derived disease transmission within OPTN-required timeframes is a policy violation subject to Membership and Professional Standards Committee (MPSC) review.
Question 4: Which document outlines the minimum requirements a transplant hospital must meet to participate in the Medicare program?
- UNOS Bylaws
- CMS Conditions of Participation (CoPs) for Transplant Centers (Correct answer)
- Joint Commission Transplant Standards
- AOPO Standards for Procurement Organizations
Correct answer: CMS Conditions of Participation (CoPs) for Transplant Centers
CMS Conditions of Participation (42 CFR Part 482) establish the federal minimum standards transplant centers must meet to receive Medicare and Medicaid reimbursement.
Question 5: Under CMS CoPs, a transplant center must submit data to the OPTN for all of the following EXCEPT:
- Waitlisted candidates
- Transplant recipients
- Living donors
- Potential donors who were not recovered (Correct answer)
Correct answer: Potential donors who were not recovered
CMS CoPs require data submission for waitlisted candidates, recipients, and living donors, but potential donors who were not recovered are the OPO's reporting responsibility.
Question 6: When a transplant center's observed-to-expected (O/E) outcomes ratio triggers a flagging threshold, CMS requires the center to:
- Immediately suspend transplant operations
- Submit a written response and corrective action plan to CMS (Correct answer)
- Report the outcomes to the state health department within 30 days
- Notify all current waitlist patients of the outcomes data
Correct answer: Submit a written response and corrective action plan to CMS
When flagged by CMS, a transplant center must provide a written response explaining outcomes and submit a corrective action plan demonstrating steps to improve performance.
Question 7: Which entity is responsible for certifying that an OPO is in compliance with federal performance standards?
- UNOS MPSC
- HRSA Division of Transplantation
- CMS through the OPO certification process (Correct answer)
- State Department of Health
Correct answer: CMS through the OPO certification process
CMS certifies OPOs and holds them to federal performance standards including donation rates; OPOs must be recertified every four years.
CCTC Regulatory and Quality Compliance 2
Which federal agency has primary oversight authority over organ transplantation in the United States?