HSPA Regulations and Standards Compliance 2 — Questions and Answers
Question 1: Which organization publishes the ST79 guide for steam sterilization?
- CDC
- OSHA
- AAMI (Correct answer)
- FDA
Correct answer: AAMI
AAMI publishes ST79, the definitive guide for steam sterilization in healthcare facilities.
AAMI ST79 covers the complete sterilization process and is referenced by Joint Commission, CMS, and state agencies as the benchmark during inspections.
Question 2: What is the FDA's role in regulating sterile processing?
- FDA inspects hospital SPDs
- FDA regulates medical devices and sterilization equipment and requires manufacturers to provide validated IFU (Correct answer)
- FDA sets SPD staffing requirements
- FDA certifies SP technicians
Correct 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.
The FDA clears sterilizers and indicators, requires manufacturers to provide validated reprocessing IFU, and issues safety alerts and recalls. It does not directly inspect hospital SPDs.
Question 3: What does OSHA's Bloodborne Pathogens Standard require of SPDs?
- Annual sterilizer calibration
- Exposure control plan, PPE, Hepatitis B vaccination offer, and post-exposure procedures (Correct answer)
- Only sharps containers
- Monthly blood tests
Correct 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.
Requirements include written exposure control plan, free PPE, Hepatitis B vaccination, engineering controls, work practice controls, regulated waste management, post-exposure evaluation, and annual training.
Question 4: What does Joint Commission expect for SPD quality monitoring?
- Quality monitoring is optional
- Ongoing quality programs including cleaning verification, sterilization monitoring, and documented compliance (Correct answer)
- Only annual reports
- Only infection control's responsibility
Correct 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.
Surveyors conduct tracer activities following instruments from OR through every processing step, evaluating compliance at each point against AAMI ST79 and other standards.
Question 5: What are the legal implications of not following manufacturer reprocessing IFU?
- No legal implications
- May void warranty, create liability, result in citations, and breach standard of care (Correct answer)
- Only manufacturer can take action
- Issues only apply if patient is harmed
Correct 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.
Regulatory agencies cite for non-compliance. In malpractice litigation, IFU non-compliance is a breach of standard of care. Several disease outbreaks have been traced to IFU non-compliance.
Question 6: What is the significance of CMS Conditions of Participation for sterile processing?
- CMS has no authority over SPD
- CMS sets minimum health and safety standards hospitals must meet for Medicare/Medicaid reimbursement, including infection control (Correct answer)
- CMS only regulates billing
- Standards only apply to government hospitals
Correct 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.
Since virtually all US hospitals depend on Medicare/Medicaid reimbursement, CMS CoPs effectively function as mandatory standards. Non-compliance can result in loss of participation.
HSPA Regulations and Standards Compliance 2
Which organization publishes the ST79 guide for steam sterilization?