CTP Transplantation Regulations & Guidelines 5 — Questions and Answers
Question 1: Which organization publishes the annual Scientific Registry of Transplant Recipients (SRTR) program-specific reports used to evaluate transplant center performance?
- UNOS
- HRSA (Health Resources & Services Administration)
- The SRTR contractor (currently MPHI) (Correct answer)
- CMS Office of Inspector General
Correct answer: The SRTR contractor (currently MPHI)
SRTR reports are produced by the SRTR contractor (currently the Minneapolis Medical Research Foundation / MPHI) under contract with HRSA.
Question 2: Which ethical principle is most directly invoked when an OPO coordinator follows a hospital's 'designated requestor' policy and involves a trained requestor in the family approach?
- Non-maleficence
- Justice
- Respect for autonomy (Correct answer)
- Beneficence
Correct answer: Respect for autonomy
Using trained designated requestors ensures that families receive accurate, unbiased information to make an autonomous, informed decision about donation.
Question 3: Expanded Criteria Donors (ECD) for kidney transplantation were redefined under KAS 2014. The current equivalent metric is:
- DCD classification
- KDPI > 85% (Correct answer)
- Donor age > 60 years
- GFR < 30 mL/min at time of procurement
Correct answer: KDPI > 85%
KAS 2014 replaced the ECD label with the continuous KDPI score, where KDPI >85% corresponds roughly to the old ECD criteria and requires recipient informed consent.
Question 4: The OPTN Board of Directors is required to submit proposed policy changes for public comment for a minimum of how many days before final adoption?
- 15 days
- 30 days
- 45 days (Correct answer)
- 60 days
Correct answer: 45 days
OPTN bylaws require a minimum 45-day public comment period for proposed policy changes before the Board can vote on final adoption.
Question 5: An OPO's Conversion Rate metric is calculated as:
- Number of organs transplanted divided by organs recovered
- Number of actual donors divided by number of eligible deaths (medically suitable referrals) (Correct answer)
- Number of family approaches divided by number of authorizations obtained
- Number of kidneys procured divided by total organ procurement costs
Correct answer: Number of actual donors divided by number of eligible deaths (medically suitable referrals)
Conversion Rate = Actual Donors / Eligible Deaths, measuring how effectively the OPO converts medically suitable referrals into actual donors.
Question 6: Under OPTN policy, if a transplant center's observed-to-expected (O/E) ratio for graft failure is flagged, the center is first required to submit:
- A corrective action plan immediately
- A self-assessment to the MPSC within a defined timeframe (Correct answer)
- Proof of reaccreditation from The Joint Commission
- A list of all transplants performed in the flagged period
Correct answer: A self-assessment to the MPSC within a defined timeframe
When a center is flagged for statistical outlier performance, MPSC policy requires the center to submit a self-assessment report before any formal sanction process begins.
Question 7: Which US law requires hospitals participating in Medicare/Medicaid to establish protocols ensuring that families of potential donors are offered the opportunity to donate?
- National Organ Transplant Act (NOTA)
- Required Request Laws codified in 42 CFR Part 482.45 (Correct answer)
- Uniform Anatomical Gift Act (UAGA)
- Emergency Medical Treatment and Labor Act (EMTALA)
Correct answer: Required Request Laws codified in 42 CFR Part 482.45
42 CFR Part 482.45 (CMS Hospital Conditions of Participation) mandates that hospitals have protocols for identifying donors and offering families the opportunity to donate.
Which organization publishes the annual Scientific Registry of Transplant Recipients (SRTR) program-specific reports used to evaluate transplant center performance?