CIS CIS - Certified Instrument Specialist Regulatory Compliance and Standards Questions and Answers 2

Question 1

Which AAMI document provides guidance specifically on the design and qualification of sterilization process monitoring using biological indicators?

Accepted Answer

ST79

Answer

ST33

Answer

ST46

Answer

TIR34

Question 2

Under CDC Guidelines for Disinfection and Sterilization, which Spaulding classification applies to surgical instruments that enter sterile tissue?

Accepted Answer

Critical

Answer

Non-critical

Answer

Semi-critical

Answer

Restricted

Question 3

What does CMS (Centers for Medicare and Medicaid Services) Condition of Participation require regarding reprocessing of surgical instruments in accredited hospitals?

Accepted Answer

Facilities must follow nationally recognized guidelines for sterilization and disinfection

Answer

Only instruments used on Medicare patients must be sterilized

Answer

CMS delegates all reprocessing standards to individual state health departments only

Answer

Flash sterilization is preferred and required by CMS for all instruments

Question 4

Which OSHA standard requires healthcare employers to implement an Exposure Control Plan for employees who handle contaminated instruments?

Accepted Answer

29 CFR 1910.1030 (Bloodborne Pathogens)

Answer

29 CFR 1910.1000 (Air Contaminants)

Answer

29 CFR 1910.134 (Respiratory Protection)

Answer

29 CFR 1910.147 (Lockout/Tagout)

Question 5

What is the regulatory definition of 'immediate use steam sterilization' (IUSS) as referenced in AAMI ST79?

Accepted Answer

Sterilization of an item intended for immediate use without being stored after the cycle

Answer

Any sterilization cycle completed in under 10 minutes

Answer

Emergency sterilization using ethylene oxide gas

Answer

Sterilization of implants without biological indicator testing

Question 6

According to Joint Commission standards, how often should sterilizer performance be verified using biological indicators in a hospital setting?

Accepted Answer

At least weekly, or with each load for implantable devices

Answer

Once a year during accreditation surveys only

Answer

Every sterilization load must include a biological indicator

Answer

Only when a new sterilizer is installed