CSC Regulatory Frameworks & Compliance 2 — Questions and Answers
Question 1: Under the FDA's Quality System Regulation (21 CFR Part 820), which document must be maintained to demonstrate that a cardiac device meets its design specifications?
- Device History Record (DHR)
- Design History File (DHF) (Correct answer)
- Device Master Record (DMR)
- Corrective Action Report (CAR)
Correct answer: Design History File (DHF)
The Design History File (DHF) contains records demonstrating that the device design was developed in accordance with the approved design plan and regulatory requirements.
Question 2: Which CMS condition of participation requires hospitals to have a written plan for the care of patients undergoing cardiac procedures?
- Medical Staff Bylaws
- Quality Assessment and Performance Improvement (QAPI)
- Nursing Services Standards
- Surgical Services Standards (Correct answer)
Correct answer: Surgical Services Standards
CMS Surgical Services Standards (42 CFR 482.51) require hospitals to have organized surgical services with written policies covering cardiac and other surgical procedures.
Question 3: A cardiac catheterization laboratory wants to perform a new ablation procedure not previously offered. Under The Joint Commission standards, what must occur before routine clinical use?
- FDA 510(k) submission only
- Institutional Review Board approval only
- Medical staff credentialing and privileging review (Correct answer)
- State health department notification
Correct answer: Medical staff credentialing and privileging review
TJC requires that practitioners be granted specific privileges by the medical staff before performing new procedures, ensuring competence through credentialing review.
Question 4: The Heart Rhythm Society's standards for ICD implantation require documentation of which minimum ejection fraction threshold for primary prevention ICD therapy?
- EF ≤ 35% (Correct answer)
- EF ≤ 40%
- EF ≤ 45%
- EF ≤ 50%
Correct answer: EF ≤ 35%
Current ACC/AHA/HRS guidelines and CMS coverage criteria require documentation of EF ≤ 35% for primary prevention ICD implantation in eligible patients.
Question 5: Under HIPAA's Minimum Necessary Standard, a cardiologist sharing a patient's echocardiogram results with a referring physician should:
- Share the complete medical record to ensure context
- Share only the echo report relevant to the referral question (Correct answer)
- Obtain written authorization before any sharing
- De-identify all data before transmission
Correct answer: Share only the echo report relevant to the referral question
HIPAA's Minimum Necessary Standard requires that only the information reasonably necessary to accomplish the intended purpose be disclosed in treatment communications.
Question 6: A cardiac program receives a CMS survey finding citing deficient practice in its QAPI program. What is the required initial response timeline for submitting a Plan of Correction?
- 10 calendar days
- 30 calendar days (Correct answer)
- 45 calendar days
- 60 calendar days
Correct answer: 30 calendar days
CMS requires hospitals to submit a Plan of Correction within 10 calendar days of receiving the Statement of Deficiencies (CMS-2567), though the standard correction completion window is often cited at 30–45 days.
Question 7: Which federal law governs the Appropriate Use Criteria (AUC) program for advanced diagnostic imaging in cardiac care, requiring ordering physicians to consult AUC before ordering studies like cardiac CT?
- Affordable Care Act
- MACRA / Merit-based Incentive Payment System Act
- Protecting Access to Medicare Act (PAMA) (Correct answer)
- 21st Century Cures Act
Correct answer: Protecting Access to Medicare Act (PAMA)
PAMA (2014) mandated the AUC consultation requirement for advanced diagnostic imaging services billed to Medicare, including cardiac CT and nuclear studies.
CSC Regulatory Frameworks & Compliance 2
Under the FDA's Quality System Regulation (21 CFR Part 820), which document must be maintained to demonstrate that a cardiac device meets its design specifications?