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.
Read the first 7 Regulatory Frameworks & Compliance flashcards as text
Under ACC/AHA clinical practice guidelines, which classification indicates that a procedure or treatment is NOT recommended and may be harmful?
Answer: Class III: Harm
Class III: Harm designation indicates that the procedure or treatment has no benefit and may cause harm, representing the strongest recommendation against use.
The National Cardiovascular Data Registry (NCDR) CathPCI Registry requires data submission for which primary purpose?
Answer: Quality benchmarking and performance improvement
The NCDR CathPCI Registry collects data on PCI procedures to enable hospitals to benchmark their outcomes against national standards and drive quality improvement.
A hospital's cardiac surgery program has a 30-day mortality rate significantly above the STS national benchmark. Under CMS Hospital Value-Based Purchasing, what is the most likely consequence?
Answer: Reduction in Medicare base operating DRG payments
CMS Hospital VBP withholds a percentage of Medicare base operating DRG payments and redistributes them based on quality scores including outcomes measures.
Which regulatory framework specifically governs the safe handling, storage, and disposal of contrast media used in cardiac imaging procedures as a hazardous pharmaceutical?
Answer: CMS Pharmacy Services CoP
CMS Pharmacy Services Conditions of Participation (42 CFR 482.25) govern safe handling and storage of all pharmaceutical agents including contrast media in hospital settings.
Under CMS's Two-Midnight Rule, a patient admitted for cardiac monitoring after a low-risk chest pain evaluation would most appropriately be classified as:
Answer: Observation (outpatient), if physician expects less than two overnight stays
The Two-Midnight Rule classifies patients as inpatient only when the physician expects care to span two midnights; short cardiac monitoring stays typically qualify as observation.
A cardiologist is asked to participate in a pharmaceutical company's speakers bureau for a new anticoagulant. Under CMS Open Payments (Sunshine Act), this arrangement must be reported if it exceeds:
Answer: $10 aggregate per year
The Physician Payments Sunshine Act requires manufacturers to report all payments and transfers of value to physicians exceeding $10 in aggregate per year.
When a cardiac device manufacturer issues a Class I recall for a pacemaker lead due to a risk of cardiac perforation, the implanting facility's primary compliance obligation is to:
Answer: Notify affected patients and document the notification process
For Class I recalls, facilities must identify and notify all affected patients per the manufacturer's recall strategy and document this process, as explantation risk may exceed recall risk.