Regulations and Standards Compliance Flashcards
6 cards from real HSPA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Regulations and Standards Compliance flashcards as text
Which organization publishes the ST79 guide for steam sterilization?
Answer: AAMI
AAMI publishes ST79, the definitive guide for steam sterilization in healthcare facilities.
What is the FDA's role in regulating sterile processing?
Answer: FDA regulates medical devices and sterilization equipment and requires manufacturers to provide validated IFU
The FDA regulates devices through 510(k) clearance and requires validated reprocessing IFU from manufacturers.
What does OSHA's Bloodborne Pathogens Standard require of SPDs?
Answer: Exposure control plan, PPE, Hepatitis B vaccination offer, and post-exposure procedures
OSHA requires a comprehensive exposure control plan including PPE, vaccination, sharps safety, and post-exposure protocols.
What does Joint Commission expect for SPD quality monitoring?
Answer: Ongoing quality programs including cleaning verification, sterilization monitoring, and documented compliance
Joint Commission expects ongoing quality monitoring including cleaning verification, sterilization monitoring, and documented compliance.
What are the legal implications of not following manufacturer reprocessing IFU?
Answer: May void warranty, create liability, result in citations, and breach standard of care
Non-compliance can void warranties, trigger regulatory citations, create malpractice liability, and breach the standard of care.
What is the significance of CMS Conditions of Participation for sterile processing?
Answer: CMS sets minimum health and safety standards hospitals must meet for Medicare/Medicaid reimbursement, including infection control
CMS Conditions of Participation establish mandatory minimum standards including infection prevention requirements.