CSC Regulatory Frameworks & Compliance 2

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?

Accepted Answer

Design History File (DHF)

Answer

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?

Accepted Answer

Surgical Services Standards

Answer

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?

Accepted Answer

Medical staff credentialing and privileging review

Answer

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?

Accepted Answer

EF ≤ 35%

Answer

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:

Accepted Answer

Share only the echo report relevant to the referral question

Answer

HIPAA's Minimum Necessary Standard requires that only the information reasonably necessary to accomplish the intended purpose be disclosed in treatment communications.

CSC - Cardiac Subspecialty Certification Exam Practice Test

CSC - Cardiac Subspecialty Certification Exam Practice Test

CSC Regulatory Frameworks & Compliance 2