CER Quality Assurance and Documentation Questions and Answers 5

Question 1

Which organization publishes the primary guidelines (MIFU-based protocols) that facilities must follow for endoscope reprocessing?

Accepted Answer

The endoscope and disinfectant manufacturers, supported by SGNA, APIC, and AORN guidelines

Answer

Reprocessing must follow the manufacturer's instructions for use (MIFU) for each device and chemical, with professional guidelines from SGNA, APIC, and AORN providing additional framework.

Question 2

What is the appropriate response when a chemical test strip for glutaraldehyde reads below the MEC but is within its expiration date?

Accepted Answer

Retest with a new test strip; if it still fails, discard the solution and document

Answer

Retesting with a fresh strip rules out a defective strip as the cause; a confirmed sub-MEC result requires discarding the solution and documenting the event.

Question 3

In endoscope reprocessing documentation, what does 'chain of custody' refer to?

Accepted Answer

The documented sequence of who handled the scope from patient use through reprocessing and storage

Answer

Chain of custody in reprocessing documents each step and person responsible from the point of patient use through decontamination, HLD/sterilization, and storage.

Question 4

A new AER is installed in the endoscopy unit. Before using it for patient scopes, what QA step is required?

Accepted Answer

Qualification testing (IQ/OQ/PQ) and validation per manufacturer and facility protocol

Answer

New AERs must undergo installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) to confirm the unit performs as intended before clinical use.

Question 5

Which scenario would most likely trigger a mandatory reprocessing-related incident report?

Accepted Answer

A scope is used on a patient before its HLD soaking time was completed

Answer

Using a scope with an incomplete HLD soak time constitutes a reprocessing breach and requires an incident report and potential patient notification.

CER - Certified Endoscope Reprocessor Practice Test

CER - Certified Endoscope Reprocessor Practice Test

CER Quality Assurance and Documentation Questions and Answers 5