CTP Transplantation Regulations & Guidelines 4 — Questions and Answers
Question 1: Under the Uniform Anatomical Gift Act (UAGA) 2006 revision, a first-person donor registration is considered legally binding, meaning:
- Family consent is still required before procurement can proceed
- Next of kin can veto the donation decision
- The registration alone authorizes donation and cannot be overridden by family (Correct answer)
- The OPO must seek court approval if family objects
Correct answer: The registration alone authorizes donation and cannot be overridden by family
The 2006 UAGA revision clarified that a signed donor registration is a legally enforceable anatomical gift that family members cannot legally revoke.
Question 2: What is the purpose of the OPTN's 'variance' process?
- To permanently exempt a center from OPTN membership requirements
- To allow temporary deviation from standard OPTN policy for research or pilot programs (Correct answer)
- To transfer an organ outside normal allocation channels for profit
- To appeal a rejected waitlist application
Correct answer: To allow temporary deviation from standard OPTN policy for research or pilot programs
OPTN variances allow member organizations to temporarily deviate from standard policies for approved research, quality improvement, or pilot program purposes.
Question 3: Which OPTN policy section addresses the mandatory reporting of transplant outcomes, including graft failure and recipient death?
- OPTN Policy 1 (Bylaws)
- OPTN Policy 18 (Data Submission Requirements) (Correct answer)
- OPTN Policy 6 (Transplant Program Requirements)
- OPTN Policy 14 (HLA)
Correct answer: OPTN Policy 18 (Data Submission Requirements)
OPTN Policy 18 governs data submission requirements, including mandatory follow-up reporting of transplant outcomes at defined intervals post-transplant.
Question 4: The PHS (Public Health Service) guideline on 'increased risk donors' (IRDs) requires transplant programs to:
- Refuse all IRD organs regardless of recipient benefit
- Obtain informed consent from recipients regarding the potential risks before transplant (Correct answer)
- Use IRD organs only for pediatric recipients
- Report IRD use to the DEA
Correct answer: Obtain informed consent from recipients regarding the potential risks before transplant
PHS guidelines require transplant programs to disclose IRD status to potential recipients and obtain informed consent acknowledging the residual risk of disease transmission.
Question 5: A Donation Service Area (DSA) is defined as:
- The geographic area where a transplant center can list patients
- The geographic region assigned to an OPO for donor identification and recovery (Correct answer)
- The hospital catchment area for trauma referrals
- The zip code radius around an OPO's headquarters
Correct answer: The geographic region assigned to an OPO for donor identification and recovery
A DSA is the specific geographic territory assigned by CMS to each OPO within which it holds exclusive responsibility for organ procurement activities.
Question 6: When a deceased donor's blood type is O, which organ recipients receive priority in most allocation algorithms?
- Type O recipients first, to prevent using scarce type-O organs for type-A or type-B patients (Correct answer)
- Type AB recipients first, since they are universal recipients
- All blood types are treated equally with no priority given
- Type B recipients first due to historical waitlist disadvantage
Correct answer: Type O recipients first, to prevent using scarce type-O organs for type-A or type-B patients
Blood type O donors are prioritized to O recipients because O organs are compatible with all types, and using them for non-O recipients would deprive O recipients who can only receive O organs.
Question 7: Which policy framework requires transplant hospitals to have a written agreement with an OPO and to notify the OPO of imminent deaths?
- Joint Commission Transplant Standards
- CMS Hospital Conditions of Participation (42 CFR Part 482) (Correct answer)
- OSHA Medical Surveillance Standard
- State Medical Practice Act
Correct answer: CMS Hospital Conditions of Participation (42 CFR Part 482)
42 CFR Part 482.45 (CMS Hospital Conditions of Participation) requires hospitals to have agreements with OPOs and to notify them in a timely manner of potential donors.
CTP Transplantation Regulations & Guidelines 4
Under the Uniform Anatomical Gift Act (UAGA) 2006 revision, a first-person donor registration is considered legally binding, meaning: