CIS CIS - Certified Instrument Specialist Regulatory Compliance and Standards Questions and Answers 3

Question 1

What is the primary purpose of the IAHCSMM Certified Instrument Specialist (CIS) credential?

Accepted Answer

To validate specialized knowledge in the care and handling of surgical instruments

Answer

To qualify technicians to perform surgical procedures

Answer

To certify technicians as sterile processing managers

Answer

To license instrument repair technicians under federal law

Question 2

Which standard provides guidance for testing and performance requirements of rigid sterilization containers used to package surgical instruments?

Accepted Answer

ISO 11607

Answer

AAMI ST33

Answer

AAMI ST77

Answer

ASTM F1608

Question 3

Under AAMI ST79, what is required before a facility can routinely use a new sterilization cycle or a new type of packaging material?

Accepted Answer

Cycle development and validation testing to confirm efficacy

Answer

Only a verbal approval from the infection control officer

Answer

A 30-day trial period without testing

Answer

Manufacturer warranty documentation only

Question 4

What is the role of the chemical indicator (CI) placed inside a sterilization package?

Accepted Answer

It indicates that sterilant has penetrated into the package interior during the cycle

Answer

It confirms the package has achieved full sterilization (SAL 10⁻⁶)

Answer

It replaces the need for biological indicator testing

Answer

It measures the exact temperature reached inside the package

Question 5

Which regulatory concept requires that all steps in the sterile processing workflow be documented to allow reconstruction of events following a patient infection?

Accepted Answer

Traceability

Answer

Chain of custody

Answer

Continuous quality improvement

Answer

Root cause analysis

Question 6

Under AAMI ST79, what corrective action is required when a biological indicator (BI) test result returns positive (growth) from a routine steam sterilization load?

Accepted Answer

Quarantine all items from that load, investigate the failure, and reprocess before release

Answer

Repeat the BI test once and release the load if the second result is negative

Answer

Release the load but flag it in the sterilization log for review

Answer

Notify the OR charge nurse and allow surgeons to decide whether to use the instruments