Personnel Competency Assessment and Qualification Flashcards

According to USP , what is the action limit for gloved fingertip and thumb sampling (GFT) results?

Answer: 0 CFU (no growth detected on any plate)

USP sets the action limit for GFT sampling at 0 CFU — no microbial growth should be detected on any contact plate. Any growth triggers an investigation, retraining, and re-qualification of the personnel member before they may resume Category 2 compounding.

What is the primary purpose of a media fill test in sterile compounding personnel qualification?

Answer: To simulate actual compounding using a microbiological growth medium to detect any contamination introduced by the technician's technique

In a media fill, a microbiological growth medium (such as soybean casein digest medium/TSB) replaces the actual drug product. The filled containers are incubated for 14 days and inspected for turbidity. Any growth indicates a break in aseptic technique, disqualifying the technician from compounding until remediation is complete.

How many contact agar plates are required per gloved fingertip and thumb sampling event for a compounder performing Category 2 CSPs?

Answer: One plate per hand (two plates total), sampling all five fingertips and thumb of each hand

USP requires sampling all fingertips and thumbs of both hands. One contact agar plate is used per hand (pressing all five fingertips and thumb onto the plate surface), resulting in two plates per testing event. Both plates must show 0 CFU for the compounder to pass.

Under USP , how frequently must Category 2 CSP compounders complete gloved fingertip and thumb sampling re-qualification?

Answer: Initially and at least annually thereafter, plus after any identified contamination event or significant gap in compounding activity

USP requires initial qualification and annual re-qualification at minimum. Re-qualification is also triggered by contamination events, extended absence from compounding, or identified technique failures. This ensures ongoing competency, not just initial proficiency.

A compounding technician fails their media fill test (turbid units are found after incubation). What is the REQUIRED immediate action?

Answer: The technician must be removed from sterile compounding until an investigation is complete, retraining is performed, and a passing media fill is demonstrated

A failed media fill disqualifies the technician from performing sterile compounding for any risk category until the root cause is investigated, the technician receives remedial training, and they successfully complete a new media fill evaluation. Continuing to compound while under investigation is not permitted.

Which of the following is a required component of INITIAL competency qualification for personnel who will compound Category 2 CSPs under USP ?

Answer: Written or oral competency assessment, aseptic technique observation, successful media fill, and passing gloved fingertip/thumb sampling

USP requires a comprehensive initial competency assessment for Category 2 compounders that includes: (1) written or oral knowledge assessment, (2) direct observation of aseptic technique, (3) successful media fill, and (4) passing GFT sampling results. All four components must be successfully completed before independent compounding is permitted.