CER Quality Assurance and Documentation Questions and Answers 3

Question 1

What is the purpose of a Biological Indicator (BI) in endoscope reprocessing quality assurance?

Accepted Answer

To verify that sterilization conditions were sufficient to kill resistant spores

Answer

Biological indicators contain highly resistant spores (e.g., Geobacillus stearothermophilus) that confirm sterilization efficacy when they fail to grow after processing.

Question 2

Which document should be completed when an endoscope is found to have a defect during pre-cleaning inspection?

Accepted Answer

Equipment repair and maintenance report

Answer

Any defect found during inspection must be documented on an equipment repair and maintenance report and the scope must be removed from service.

Question 3

How frequently should MEC (Minimum Effective Concentration) testing of high-level disinfectant solutions be performed?

Accepted Answer

Before each use or per manufacturer's instructions, whichever is more frequent

Answer

MEC testing must be performed before each patient use or per the manufacturer's instructions to ensure the disinfectant remains above the minimum effective threshold.

Question 4

A failed MEC test result for a high-level disinfectant solution requires which immediate action?

Accepted Answer

Discard the solution and document the failure before reprocessing any scope

Answer

A failed MEC result means the solution no longer meets minimum effective concentration; it must be discarded immediately and the event documented.

Question 5

Which regulatory body requires that endoscope reprocessing logs be retained for a minimum period to support infection investigation?

Accepted Answer

FDA and The Joint Commission (TJC)

Answer

Both the FDA and The Joint Commission require that reprocessing records be maintained for a defined retention period to enable traceability in the event of an infection outbreak.

CER - Certified Endoscope Reprocessor Practice Test

CER - Certified Endoscope Reprocessor Practice Test

CER Quality Assurance and Documentation Questions and Answers 3