CSPT Personnel Competency Assessment and Qualification — Questions and Answers
Question 1: According to USP <797>, what is the action limit for gloved fingertip and thumb sampling (GFT) results?
- ≤5 CFU per contact plate
- ≤10 CFU total across both hands
- 0 CFU (no growth detected on any plate) (Correct answer)
- ≤1 CFU per hand
Correct answer: 0 CFU (no growth detected on any plate)
USP <797> 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.
Question 2: What is the primary purpose of a media fill test in sterile compounding personnel qualification?
- To verify that the growth media used in microbiological testing is not contaminated
- To simulate actual compounding using a microbiological growth medium to detect any contamination introduced by the technician's technique (Correct answer)
- To validate the sterilization cycle of the autoclave used in the cleanroom
- To assess the endotoxin burden in a batch of compounded preparations
Correct 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.
Question 3: How many contact agar plates are required per gloved fingertip and thumb sampling event for a compounder performing Category 2 CSPs?
- One plate total for the dominant hand only
- One plate per hand (two plates total), sampling all five fingertips and thumb of each hand (Correct answer)
- Five plates total, one per finger of the dominant hand
- Three plates: one per hand and one shared thumb plate
Correct answer: One plate per hand (two plates total), sampling all five fingertips and thumb of each hand
USP <797> 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.
Question 4: Under USP <797>, how frequently must Category 2 CSP compounders complete gloved fingertip and thumb sampling re-qualification?
- Only once when initially hired — no re-testing is required
- Every 6 months
- Initially and at least annually thereafter, plus after any identified contamination event or significant gap in compounding activity (Correct answer)
- Only when a new drug product is being compounded for the first time
Correct answer: Initially and at least annually thereafter, plus after any identified contamination event or significant gap in compounding activity
USP <797> 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.
Question 5: A compounding technician fails their media fill test (turbid units are found after incubation). What is the REQUIRED immediate action?
- The technician may continue compounding Category 1 CSPs only while the investigation is underway
- The technician must be removed from sterile compounding until an investigation is complete, retraining is performed, and a passing media fill is demonstrated (Correct answer)
- The technician repeats the media fill once; if they pass, no further action is needed
- The facility must notify the state board of pharmacy within 24 hours and cease all compounding operations
Correct 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.
Question 6: Which of the following is a required component of INITIAL competency qualification for personnel who will compound Category 2 CSPs under USP <797>?
- Oral examination administered by the director of pharmacy
- Shadowing an experienced compounder for a minimum of 40 hours
- Written or oral competency assessment, aseptic technique observation, successful media fill, and passing gloved fingertip/thumb sampling (Correct answer)
- Completion of a nationally accredited pharmacy technician training program
Correct answer: Written or oral competency assessment, aseptic technique observation, successful media fill, and passing gloved fingertip/thumb sampling
USP <797> 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.
CSPT Personnel Competency Assessment and Qualification
According to USP , what is the action limit for gloved fingertip and thumb sampling (GFT) results?