CCTC Regulatory and Quality Compliance 2

Question 1

Which federal agency has primary oversight authority over organ transplantation in the United States?

Accepted Answer

Health Resources and Services Administration (HRSA)

Answer

Centers for Medicare & Medicaid Services (CMS)

Answer

Food and Drug Administration (FDA)

Answer

Joint Commission on Accreditation of Healthcare Organizations

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?

Accepted Answer

Cold ischemia time alone does not trigger a mandatory deviation report

Answer

24 hours

Answer

36 hours

Answer

48 hours

Question 3

A transplant program discovers that a donor-derived infection was not reported to the OPTN within the required timeframe. This constitutes a:

Accepted Answer

Mandatory reportable event requiring MPSC review

Answer

Internal quality improvement opportunity only

Answer

Voluntary safety report with no regulatory consequence

Answer

CMS condition of participation violation only

Question 4

Which document outlines the minimum requirements a transplant hospital must meet to participate in the Medicare program?

Accepted Answer

CMS Conditions of Participation (CoPs) for Transplant Centers

Answer

UNOS Bylaws

Answer

Joint Commission Transplant Standards

Answer

AOPO Standards for Procurement Organizations

Question 5

Under CMS CoPs, a transplant center must submit data to the OPTN for all of the following EXCEPT:

Accepted Answer

Potential donors who were not recovered

Answer

Waitlisted candidates

Answer

Transplant recipients

Answer

Living donors

Question 6

When a transplant center's observed-to-expected (O/E) outcomes ratio triggers a flagging threshold, CMS requires the center to:

Accepted Answer

Submit a written response and corrective action plan to CMS

Answer

Immediately suspend transplant operations

Answer

Report the outcomes to the state health department within 30 days

Answer

Notify all current waitlist patients of the outcomes data

Question 7

Which entity is responsible for certifying that an OPO is in compliance with federal performance standards?

Accepted Answer

CMS through the OPO certification process

Answer

UNOS MPSC

Answer

HRSA Division of Transplantation

Answer

State Department of Health