Quality Assurance and Documentation Questions and Answers Flashcards
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Read the first 7 Quality Assurance and Documentation Questions and Answers flashcards as text
Which organization publishes the primary guidelines (MIFU-based protocols) that facilities must follow for endoscope reprocessing?
Answer: The endoscope and disinfectant manufacturers, supported by SGNA, APIC, and AORN guidelines
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.
What is the appropriate response when a chemical test strip for glutaraldehyde reads below the MEC but is within its expiration date?
Answer: Retest with a new test strip; if it still fails, discard the solution and document
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.
In endoscope reprocessing documentation, what does 'chain of custody' refer to?
Answer: The documented sequence of who handled the scope from patient use through reprocessing and storage
Chain of custody in reprocessing documents each step and person responsible from the point of patient use through decontamination, HLD/sterilization, and storage.
A new AER is installed in the endoscopy unit. Before using it for patient scopes, what QA step is required?
Answer: Qualification testing (IQ/OQ/PQ) and validation per manufacturer and facility protocol
New AERs must undergo installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) to confirm the unit performs as intended before clinical use.
Which scenario would most likely trigger a mandatory reprocessing-related incident report?
Answer: A scope is used on a patient before its HLD soaking time was completed
Using a scope with an incomplete HLD soak time constitutes a reprocessing breach and requires an incident report and potential patient notification.
Why is it important to document the 'drying' step during endoscope reprocessing?
Answer: Inadequate drying promotes microbial regrowth, so documenting it confirms patient safety and regulatory compliance
Residual moisture in endoscope channels supports microbial growth during storage, making documented drying a critical patient safety step.
What is the role of an 'internal audit' in an endoscope reprocessing quality assurance program?
Answer: To systematically review reprocessing practices and documentation for compliance gaps and improvement opportunities
Internal audits proactively identify non-compliance, documentation gaps, and process weaknesses before they result in patient harm or regulatory citations.