CCTC Regulatory and Quality Compliance 5 — Questions and Answers
Question 1: Which of the following best describes the purpose of the OPTN's Identification of Patients at High-Risk for Non-Compliance (IPHRC) review?
- To remove non-compliant patients from the waitlist automatically
- To ensure programs have processes for identifying and managing patients with adherence challenges (Correct answer)
- To report individual patient non-compliance to CMS
- To mandate psychiatric evaluation for all waitlist candidates
Correct answer: To ensure programs have processes for identifying and managing patients with adherence challenges
IPHRC review ensures transplant programs have systematic processes to identify patients at risk for non-adherence and provide appropriate support, not to penalize patients.
Question 2: A transplant center is undergoing a CMS survey. Surveyors request the program's data on living donor follow-up at 6 months and 24 months. Which CoP is being evaluated?
- 482.68 — Patient and Living Donor Selection
- 482.70 — Organ Recovery and Receipt
- 482.74 — Living Donor Protections (Correct answer)
- 482.76 — Patient and Living Donor Records
Correct answer: 482.74 — Living Donor Protections
CMS 42 CFR §482.74 (Living Donor Protections) specifically requires transplant centers to conduct and document follow-up of living donors at defined intervals including 6 months and 24 months post-donation.
Question 3: An OPO's conversion rate is defined as the percentage of:
- Brain-dead donors who become actual organ donors among all ICU deaths
- Eligible deaths that result in at least one organ transplanted (Correct answer)
- Families approached for consent who agree to donation
- Procured organs that are ultimately transplanted
Correct answer: Eligible deaths that result in at least one organ transplanted
CMS defines OPO conversion rate as the proportion of eligible deaths in the OPO's DSA that result in transplantation of at least one organ, used as a federal performance metric.
Question 4: Under OPTN policy, which situation REQUIRES a transplant program to submit a variance request before proceeding?
- Accepting an organ outside standard allocation sequence due to logistical constraints
- Using a non-standard immunosuppression protocol approved by pharmacy
- Performing a living donor transplant without an ILDA for a documented medical emergency (Correct answer)
- Listing a patient at a second center while active at the primary center
Correct answer: Performing a living donor transplant without an ILDA for a documented medical emergency
Bypassing the ILDA requirement for living donor evaluation requires a formal OPTN variance because ILDA involvement is a core policy protection that cannot be waived unilaterally.
Question 5: The 'look-back' investigation triggered by a newly identified donor-derived disease transmission must include:
- Testing of all recipients from donors at the same OPO in the prior year
- Notification and testing of all recipients who received organs from the implicated donor (Correct answer)
- A UNOS-mandated suspension of the OPO pending investigation results
- Mandatory disclosure to the implicated donor's family within 48 hours
Correct answer: Notification and testing of all recipients who received organs from the implicated donor
A donor-derived disease look-back requires identification and notification of all recipients who received organs from the implicated donor, along with appropriate testing and follow-up.
Question 6: Which quality metric is used by the Scientific Registry of Transplant Recipients (SRTR) to compare transplant program outcomes across centers?
- Raw graft survival rate
- Risk-adjusted observed-to-expected (O/E) outcome ratios (Correct answer)
- Absolute number of transplants performed annually
- Median wait time for patients on the active waitlist
Correct answer: Risk-adjusted observed-to-expected (O/E) outcome ratios
SRTR uses risk-adjusted O/E ratios to compare outcomes across programs, controlling for differences in patient population complexity and donor quality.
Question 7: A transplant coordinator is asked by a research team to access recipient records for a retrospective study without individual patient consent. This is permissible ONLY if:
- The research team holds a federal research grant
- An IRB has approved a waiver of authorization under HIPAA
- The data is de-identified per HIPAA Safe Harbor or Expert Determination method (Correct answer)
- The transplant program medical director provides written approval
Correct answer: The data is de-identified per HIPAA Safe Harbor or Expert Determination method
PHI may be used for research without individual authorization only if it has been de-identified per HIPAA's Safe Harbor or Expert Determination standards, or if an IRB grants a waiver of HIPAA authorization.
CCTC Regulatory and Quality Compliance 5
Which of the following best describes the purpose of the OPTN's Identification of Patients at High-Risk for Non-Compliance (IPHRC) review?