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Regulatory and Quality Compliance Flashcards

7 cards from real CCTC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

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  1. Which of the following best describes the purpose of the OPTN's Identification of Patients at High-Risk for Non-Compliance (IPHRC) review?

    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.

  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?

    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.

  3. An OPO's conversion rate is defined as the percentage of:

    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.

  4. Under OPTN policy, which situation REQUIRES a transplant program to submit a variance request before proceeding?

    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.

  5. The 'look-back' investigation triggered by a newly identified donor-derived disease transmission must include:

    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.

  6. Which quality metric is used by the Scientific Registry of Transplant Recipients (SRTR) to compare transplant program outcomes across centers?

    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.

  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:

    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.