CTP Transplantation Regulations & Guidelines 3 — Questions and Answers
Question 1: The OPTN Kidney Allocation System (KAS) introduced in 2014 uses which primary scoring metric to rank deceased donor kidney candidates?
- Panel Reactive Antibody (PRA) level only
- Kidney Donor Profile Index (KDPI) matched with Estimated Post-Transplant Survival (EPTS) (Correct answer)
- Time on dialysis alone
- Geographic proximity to the donor hospital
Correct answer: Kidney Donor Profile Index (KDPI) matched with Estimated Post-Transplant Survival (EPTS)
KAS matches KDPI scores of donor kidneys to EPTS scores of recipients, aiming to maximize graft survival by giving longer-lasting kidneys to candidates likely to benefit most.
Question 2: Under HIPAA, which category of information about a transplant donor or recipient is considered Protected Health Information (PHI)?
- Organ type being transplanted only
- Any individually identifiable health information in any form (Correct answer)
- Surgical technique used during procurement
- Cold ischemia time of the organ
Correct answer: Any individually identifiable health information in any form
PHI includes any individually identifiable health information regardless of form (electronic, paper, or verbal) that relates to a person's health condition or care.
Question 3: Which OPTN policy governs the acceptable infectious disease testing requirements for deceased organ donors?
- OPTN Policy 2.0
- OPTN Policy 18.1 (Donor Testing Requirements) (Correct answer)
- OPTN Policy 14.3
- OPTN Policy 1.0
Correct answer: OPTN Policy 18.1 (Donor Testing Requirements)
OPTN Policy 18.1 specifies the required infectious disease screening tests (e.g., HIV, HBV, HCV, CMV, EBV) that must be completed for all deceased donors.
Question 4: A transplant center that fails a MPSC (Membership and Professional Standards Committee) review may be subject to which consequence?
- Loss of CMS certification only
- Probation, membership suspension, or inactivation from OPTN (Correct answer)
- Mandatory staff re-training only
- Automatic loss of all state licenses
Correct answer: Probation, membership suspension, or inactivation from OPTN
The MPSC can impose sanctions ranging from requiring a performance improvement plan to probation, suspension, or termination of OPTN membership.
Question 5: The '25-mile rule' in legacy kidney allocation was replaced by which geographic framework under modern UNOS policy?
- Donor Service Area (DSA) boundaries only
- Fixed 250-mile radius circles centered on the donor hospital
- Concentric distance-based zones with national sharing for highly sensitized patients (Correct answer)
- State-based allocation with no radius limits
Correct answer: Concentric distance-based zones with national sharing for highly sensitized patients
Modern kidney allocation uses proximity-based zones (local/regional/national) with distance circles and mandatory national sharing for CPRA ≥99% candidates.
Question 6: Which federal law prohibits the buying and selling of human organs in the United States?
- Health Insurance Portability and Accountability Act (HIPAA)
- National Organ Transplant Act (NOTA) of 1984 (Correct answer)
- Uniform Anatomical Gift Act (UAGA)
- Emergency Medical Treatment and Labor Act (EMTALA)
Correct answer: National Organ Transplant Act (NOTA) of 1984
NOTA Section 301 makes it illegal to acquire, receive, or transfer any human organ for valuable consideration for use in transplantation.
Question 7: Which entity is responsible for conducting the mandatory death record review (DRR) audit required by CMS for OPO performance assessment?
- The OPO itself through self-audit
- An independent third-party CMS contractor (Correct answer)
- UNOS/OPTN auditors
- State health department inspectors
Correct answer: An independent third-party CMS contractor
CMS uses an independent contractor to conduct death record reviews comparing OPO-reported donors to actual deaths in the DSA to assess referral and conversion rates.
CTP Transplantation Regulations & Guidelines 3
The OPTN Kidney Allocation System (KAS) introduced in 2014 uses which primary scoring metric to rank deceased donor kidney candidates?