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Regulatory Frameworks & Compliance Flashcards

7 cards from real CSC 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. The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database uses risk-adjusted expected mortality to create 'observed-to-expected' (O/E) ratios. An O/E ratio below 1.0 indicates:

    Answer: Better-than-expected outcomes relative to national benchmarks

    An O/E ratio below 1.0 means the program's observed mortality is lower than statistically expected given its patient risk profile, indicating better-than-benchmark performance.

  2. Under EMTALA, a patient presenting to an ED with acute chest pain and ST-elevation on EKG must be:

    Answer: Provided a medical screening exam and stabilizing treatment before transfer

    EMTALA requires a Medical Screening Examination and stabilization of an emergency medical condition before any transfer, even for STEMI patients needing PCI.

  3. A cardiac electrophysiology lab is implementing a new remote monitoring platform for implanted devices. Under HIPAA's Security Rule, which safeguard type specifically applies to the electronic transmission of device interrogation data?

    Answer: Technical safeguards

    Technical safeguards under HIPAA's Security Rule govern the technology and related policies for protecting electronic PHI during transmission, including encryption requirements.

  4. The CMS Appropriate Use Criteria program requires that ordering clinicians consult a qualified Clinical Decision Support Mechanism (CDSM). Which exception would exempt a cardiologist from this requirement?

    Answer: The procedure is ordered during an emergency or inpatient stay

    CMS exempts AUC consultation requirements for patients in emergency situations, inpatient settings, or those receiving urgent care, where real-time decision support is impractical.

  5. A catheterization laboratory performs 150 PCIs annually. Under American College of Cardiology/SCAI guidelines, this volume is considered:

    Answer: Below the recommended minimum of 200 PCIs per year for elective programs

    ACC/SCAI guidelines recommend a minimum annual PCI volume of 200 procedures for elective PCI programs to maintain quality and outcomes, making 150 below threshold.

  6. Under the FDA's Medical Device Reporting (MDR) regulation (21 CFR Part 803), user facilities such as hospitals must report device-related deaths to the FDA within:

    Answer: 10 working days

    User facilities must report device-related or device-suspected deaths to both the FDA and the manufacturer within 10 working days of becoming aware of the event.

  7. Which accreditation body offers the Chest Pain Center accreditation specifically relevant to cardiac emergency care quality standards?

    Answer: American College of Cardiology / Society of Cardiovascular Patient Care (ACC/SCPC)

    The ACC and Society of Cardiovascular Patient Care offer Chest Pain Center accreditation, evaluating protocols, staffing, and processes for evaluating chest pain patients.