Quality Assurance Protocols Flashcards

What is the purpose of gloved fingertip sampling in a sterile compounding competency assessment?

Answer: To evaluate whether garbing and hand hygiene adequately control microbial contamination on fingertips

Gloved fingertip sampling assesses whether the garbing and hand hygiene procedures effectively reduce microbial contamination.

How frequently must personnel complete media-fill testing to maintain competency?

Answer: At least annually or more frequently per facility policy

Media-fill testing must be performed initially and at least annually thereafter.

What is the proper method for performing a bubble point test on a sterilizing filter?

Answer: Wet the filter, apply gradually increasing air pressure, and note when the first steady bubble stream appears

The bubble point test wets the filter then applies increasing pressure. A steady bubble stream at or above the specified pressure confirms filter integrity.

What is the significance of environmental monitoring action levels versus alert levels?

Answer: Alert levels signal potential drift and prompt increased monitoring; action levels indicate a definite problem requiring immediate investigation

Alert levels serve as early warnings while action levels indicate conditions have exceeded acceptable limits.

What records must be maintained for personnel competency assessments?

Answer: Complete records including dates, methods, results, any failures with remedial actions, and assessor identity

Complete competency records must be maintained for all personnel.

What is the purpose of a cleaning and disinfection verification program?

Answer: To verify that cleaning procedures are effective at maintaining required cleanliness levels

The program uses surface sampling and other methods to confirm cleaning procedures achieve the required level of microbial control.