CSPT Quality Assurance Protocols 2 — Questions and Answers
Question 1: What is the purpose of gloved fingertip sampling in a sterile compounding competency assessment?
- To test glove quality
- To evaluate whether garbing and hand hygiene adequately control microbial contamination on fingertips (Correct answer)
- To check for latex allergies
- To measure finger dexterity
Correct 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.
After completing the full garbing procedure, the technician touches a contact plate with all fingertips. The plates are incubated and any CFUs counted. This should be performed initially and at least annually thereafter.
Question 2: How frequently must personnel complete media-fill testing to maintain competency?
- Only once upon hiring
- At least annually or more frequently per facility policy (Correct answer)
- Every 5 years
- Only when an error occurs
Correct answer: At least annually or more frequently per facility policy
Media-fill testing must be performed initially and at least annually thereafter.
Additional testing is required after extended leave, new PEC types, changes to garbing procedures, or adverse events. Any microbial growth indicates failure requiring remedial training and re-testing.
Question 3: What is the proper method for performing a bubble point test on a sterilizing filter?
- Submerge in water and look for bubbles
- Wet the filter, apply gradually increasing air pressure, and note when the first steady bubble stream appears (Correct answer)
- Heat the filter and observe for melting
- Weigh the filter before and after use
Correct 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.
If the observed bubble point is below the manufacturer specification, the filter has a defect and filtration must be repeated with a new filter. Automated testers provide more precise results.
Question 4: What is the significance of environmental monitoring action levels versus alert levels?
- They are the same thing
- Alert levels signal potential drift and prompt increased monitoring; action levels indicate a definite problem requiring immediate investigation (Correct answer)
- Alert levels are more serious
- Neither requires any response
Correct 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.
Alert levels are facility-defined based on historical data. Action levels are defined by USP 797. The two-tier system allows catching deteriorating conditions before they become critical.
Question 5: What records must be maintained for personnel competency assessments?
- Only the pass/fail result
- Complete records including dates, methods, results, any failures with remedial actions, and assessor identity (Correct answer)
- Only records for failed assessments
- No records if the person passed
Correct answer: Complete records including dates, methods, results, any failures with remedial actions, and assessor identity
Complete competency records must be maintained for all personnel.
During inspections, regulators routinely request personnel competency records as evidence of a trained, competent workforce. Records must be retained per state regulations.
Question 6: What is the purpose of a cleaning and disinfection verification program?
- To find the cheapest cleaning products
- To verify that cleaning procedures are effective at maintaining required cleanliness levels (Correct answer)
- To schedule custodial staff
- To test products for marketing
Correct 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.
If verification sampling shows inadequate cleaning, corrective actions include retraining, changing agents or procedures, or increasing frequency.
CSPT Quality Assurance Protocols 2
What is the purpose of gloved fingertip sampling in a sterile compounding competency assessment?