CIS CIS - Certified Instrument Specialist Regulatory Compliance and Standards Questions and Answers 2 — Questions and Answers
Question 1: Which AAMI document provides guidance specifically on the design and qualification of sterilization process monitoring using biological indicators?
- ST79 (Correct answer)
- ST33
- ST46
- TIR34
Correct answer: ST79
AAMI ST79 is the comprehensive steam sterilization standard that includes guidance on biological indicator use, placement, and interpretation for process monitoring.
Question 2: Under CDC Guidelines for Disinfection and Sterilization, which Spaulding classification applies to surgical instruments that enter sterile tissue?
- Non-critical
- Semi-critical
- Critical (Correct answer)
- Restricted
Correct answer: Critical
The Spaulding Classification defines items that enter sterile tissue or the vascular system as 'critical' items, requiring sterilization before use.
Question 3: What does CMS (Centers for Medicare and Medicaid Services) Condition of Participation require regarding reprocessing of surgical instruments in accredited hospitals?
- Only instruments used on Medicare patients must be sterilized
- Facilities must follow nationally recognized guidelines for sterilization and disinfection (Correct answer)
- CMS delegates all reprocessing standards to individual state health departments only
- Flash sterilization is preferred and required by CMS for all instruments
Correct answer: Facilities must follow nationally recognized guidelines for sterilization and disinfection
CMS Conditions of Participation require accredited hospitals to follow nationally recognized infection control guidelines, which includes AAMI and CDC standards for instrument reprocessing.
Question 4: Which OSHA standard requires healthcare employers to implement an Exposure Control Plan for employees who handle contaminated instruments?
- 29 CFR 1910.1000 (Air Contaminants)
- 29 CFR 1910.1030 (Bloodborne Pathogens) (Correct answer)
- 29 CFR 1910.134 (Respiratory Protection)
- 29 CFR 1910.147 (Lockout/Tagout)
Correct answer: 29 CFR 1910.1030 (Bloodborne Pathogens)
OSHA 29 CFR 1910.1030 (Bloodborne Pathogens Standard) requires employers to establish an Exposure Control Plan to protect workers from bloodborne pathogen exposure during instrument handling.
Question 5: What is the regulatory definition of 'immediate use steam sterilization' (IUSS) as referenced in AAMI ST79?
- Any sterilization cycle completed in under 10 minutes
- Sterilization of an item intended for immediate use without being stored after the cycle (Correct answer)
- Emergency sterilization using ethylene oxide gas
- Sterilization of implants without biological indicator testing
Correct answer: Sterilization of an item intended for immediate use without being stored after the cycle
IUSS (formerly called 'flash sterilization') refers to sterilization of an item intended for immediate use without drying, storage, or transport in a covered or enclosed container.
Question 6: According to Joint Commission standards, how often should sterilizer performance be verified using biological indicators in a hospital setting?
- Once a year during accreditation surveys only
- Every sterilization load must include a biological indicator
- At least weekly, or with each load for implantable devices (Correct answer)
- Only when a new sterilizer is installed
Correct answer: At least weekly, or with each load for implantable devices
TJC and AAMI standards require biological indicator testing at least weekly for routine loads, and with every load containing implantable devices, to verify sterilizer performance.
CIS CIS - Certified Instrument Specialist Regulatory Compliance and Standards Questions and Answers 2
Which AAMI document provides guidance specifically on the design and qualification of sterilization process monitoring using biological indicators?