Regulatory Frameworks & Compliance Flashcards

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?

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.

Which CMS condition of participation requires hospitals to have a written plan for the care of patients undergoing cardiac procedures?

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.

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?

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.

The Heart Rhythm Society's standards for ICD implantation require documentation of which minimum ejection fraction threshold for primary prevention ICD therapy?

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.

Under HIPAA's Minimum Necessary Standard, a cardiologist sharing a patient's echocardiogram results with a referring physician should:

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.

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?

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.

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?

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.