CIS CIS - Certified Instrument Specialist Regulatory Compliance and Standards Questions and Answers 1 — Questions and Answers
Question 1: Which organization publishes the ST79 standard that serves as the primary guidance document for steam sterilization in US healthcare facilities?
- CDC
- OSHA
- AAMI (Correct answer)
- The Joint Commission
Correct answer: AAMI
AAMI (Association for the Advancement of Medical Instrumentation) publishes ST79, the comprehensive guideline for steam sterilization used as the industry standard in US healthcare.
Question 2: Under OSHA's Bloodborne Pathogen Standard (29 CFR 1910.1030), which personal protective equipment is required when handling contaminated surgical instruments?
- Safety glasses only
- Gloves only
- Gloves, gown, mask, and eye protection (Correct answer)
- Respirator and full-body suit only
Correct answer: Gloves, gown, mask, and eye protection
OSHA's Bloodborne Pathogen Standard requires gloves, gown, mask, and eye protection when handling contaminated instruments to protect workers from exposure to blood and body fluids.
Question 3: Which federal agency classifies medical devices and regulates reprocessing instructions for surgical instruments in the United States?
- CDC
- FDA (Correct answer)
- OSHA
- CMS
Correct answer: FDA
The FDA (Food and Drug Administration) classifies medical devices into three classes and regulates the Instructions for Use (IFU) that manufacturers must provide for reprocessing.
Question 4: What is the significance of an instrument manufacturer's Instructions for Use (IFU) in a sterile processing department?
- IFUs are optional guidelines that may be followed at the facility's discretion
- IFUs are legally binding instructions that must be followed exactly for safe reprocessing (Correct answer)
- IFUs apply only to robotic instruments
- IFUs are only required for single-use devices
Correct answer: IFUs are legally binding instructions that must be followed exactly for safe reprocessing
Manufacturer IFUs are validated reprocessing instructions that must be followed exactly; deviating from them can compromise patient safety and create regulatory and liability issues.
Question 5: Which accrediting body surveys US hospitals for compliance with sterile processing standards and can require immediate corrective action for deficiencies?
- IAHCSMM
- AAMI
- The Joint Commission (TJC) (Correct answer)
- APIC
Correct answer: The Joint Commission (TJC)
The Joint Commission surveys healthcare organizations for regulatory compliance, including sterile processing, and has authority to require immediate corrective action for serious deficiencies.
Question 6: What is the purpose of maintaining a sterilization log in a sterile processing department?
- To track employee vacation schedules
- To provide documentation for regulatory compliance, traceability, and investigation of sterilization failures (Correct answer)
- To record the cost of sterilization supplies used
- To schedule preventive maintenance only
Correct answer: To provide documentation for regulatory compliance, traceability, and investigation of sterilization failures
Sterilization logs provide the documentation trail required for regulatory compliance, enable traceability for recall events, and support investigation when sterilization failures occur.
CIS CIS - Certified Instrument Specialist Regulatory Compliance and Standards Questions and Answers 1
Which organization publishes the ST79 standard that serves as the primary guidance document for steam sterilization in US healthcare facilities?