CTP Transplantation Regulations & Guidelines 2 — Questions and Answers
Question 1: Which federal agency oversees the regulation of organ procurement organizations (OPOs) in the United States?
- FDA
- CMS (Centers for Medicare & Medicaid Services) (Correct answer)
- CDC
- OSHA
Correct answer: CMS (Centers for Medicare & Medicaid Services)
CMS oversees OPOs through the Conditions for Coverage regulations that OPOs must meet to participate in Medicare and Medicaid.
Question 2: Under UNOS policy, what is the maximum allowable cold ischemia time guideline for a standard criteria kidney before transplantation is strongly discouraged?
- 12 hours
- 24 hours
- 36 hours (Correct answer)
- 48 hours
Correct answer: 36 hours
Standard criteria kidneys ideally should be transplanted within 24–36 hours; beyond 36 hours cold ischemia significantly increases primary non-function risk.
Question 3: The OPTN Final Rule requires that organs be allocated based primarily on which principle?
- Geographic proximity only
- Medical urgency and recipient waiting time
- Equitable access without regard to geography when possible (Correct answer)
- Financial ability to pay
Correct answer: Equitable access without regard to geography when possible
The OPTN Final Rule mandates organ allocation policies that increase equitable access and reduce geographic disparities.
Question 4: Which document must be completed by a donor's legal next of kin or legally authorized representative before procuring organs from a deceased donor who did not register as a donor?
- Donor Registration Card
- Next-of-Kin Authorization Form (Correct answer)
- Advance Directive
- POLST Form
Correct answer: Next-of-Kin Authorization Form
A Next-of-Kin Authorization Form (or Donor Authorization Form) provides legal consent for procurement when the donor had no first-person authorization on file.
Question 5: AOPO Standards require OPOs to maintain a hospital development program that includes at minimum how frequently meeting with designated requestors?
- Monthly
- Quarterly
- Annually (Correct answer)
- Every two years
Correct answer: Annually
AOPO standards require OPOs to conduct annual in-services or meetings with hospital designated requestors to maintain competency and collaboration.
Question 6: Per UNOS bylaws, which entity holds primary responsibility for verifying that a potential transplant recipient meets the listing criteria before adding them to the waitlist?
- UNOS national office
- The transplant center (Correct answer)
- The OPO coordinator
- CMS regional office
Correct answer: The transplant center
The transplant center is responsible for evaluating and listing patients according to UNOS/OPTN policies and its own institutional criteria.
Question 7: Which regulation specifies that OPOs must report all deaths and imminent deaths in their DSA hospitals to determine donor suitability?
- HIPAA Privacy Rule
- CMS Conditions for Coverage 42 CFR Part 486 (Correct answer)
- OSHA Bloodborne Pathogens Standard
- UNOS Policy 18.1
Correct answer: CMS Conditions for Coverage 42 CFR Part 486
42 CFR Part 486 Subpart G (CMS Conditions for Coverage for OPOs) requires hospitals to notify the OPO of all deaths and imminent deaths.
CTP Transplantation Regulations & Guidelines 2
Which federal agency oversees the regulation of organ procurement organizations (OPOs) in the United States?