Quality Management & Regulatory Compliance Flashcards
6 cards from real IAHCSMM practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Quality Management & Regulatory Compliance flashcards as text
Which federal agency regulates medical devices including sterilization equipment in the United States?
Answer: FDA (Food and Drug Administration)
The FDA regulates medical devices under the Federal Food, Drug, and Cosmetic Act, including sterilizers, reusable medical devices, and their reprocessing instructions.
What does the term 'Instructions for Use' (IFU) mean in the context of medical device reprocessing?
Answer: The manufacturer's validated, legally binding instructions for cleaning, disinfection, and sterilization of a device
The IFU is the manufacturer's validated and legally binding document specifying exactly how a device must be reprocessed; deviating from it creates liability and may harm patients.
What is the role of The Joint Commission (TJC) in sterile processing?
Answer: Accrediting healthcare facilities and setting standards that include CS/SPD practices
TJC accredits healthcare facilities and surveys compliance with standards including sterile processing practices, which facilities must meet to participate in Medicare/Medicaid.
What does a 'corrective action report' (CAR) document in a CS quality program?
Answer: Identification of a process deviation, root cause analysis, and corrective actions taken to prevent recurrence
A CAR is a formal quality document that captures deviations from standard processes, investigates root causes, and records corrective actions to improve the system.
OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030) requires CS departments to:
Answer: Provide PPE, training, hepatitis B vaccination, and exposure control plans to protect workers
OSHA's Bloodborne Pathogens Standard mandates that employers protect workers from exposure to bloodborne pathogens through PPE, training, vaccines, and written exposure control plans.
Which document serves as the primary reference for steam sterilization practices in US healthcare facilities?
Answer: AAMI ST79
AAMI ST79 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities) is the primary US standard for steam sterilization practice.