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
Which federal agency has primary oversight authority over organ transplantation in the United States?
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).
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?
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.
A transplant program discovers that a donor-derived infection was not reported to the OPTN within the required timeframe. This constitutes a:
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.
Which document outlines the minimum requirements a transplant hospital must meet to participate in the Medicare program?
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.
Under CMS CoPs, a transplant center must submit data to the OPTN for all of the following EXCEPT:
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.
When a transplant center's observed-to-expected (O/E) outcomes ratio triggers a flagging threshold, CMS requires the center to:
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.
Which entity is responsible for certifying that an OPO is in compliance with federal performance standards?
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.