Personnel Training & Evaluation - USP 797
Personnel training and evaluation is an important component of USP 797 compliance. It’s an important indicator of proper aseptic technique within your facility. Personnel sampling involves gloved fingertip testing and media fill testing.
Who Must Train: Any person who compounds or has direct oversight of compounding personnel must be initially trained and qualified by demonstrating their compentency.
The Training Program: A designated person within the facility is responsible for creating and implementing a training program. This training program must describe the required training, frequency of training, and the process for evaluating personnel performance. The program must be set up so personnel are able to acquire the knowledge and skills to perform their assigned tasks.
How Often: Training and competency evaluation must be completed initially before any CSPs are prepared. Regular, ongoing competency evaluations are also required at the following intervals as outlined in USP 797:
Every 3 months - For personnel compounding category 3 CSPs
Every 6 months - For personnel compounding category 1 and 2 CSPs
Every 12 months - For personnel who have direct oversight of compounding personnel, but do not compound
Tips for Personnel Sampling
Use one sampling device (we recommend these plates) per hand
Label each plate with the personnel name, right or left hand, post-garb or post-mediafill, and the date and time of sampling
Do not apply 70% IPA to gloves immediately before touching the media surface- this can cause a false-negative result
Don’t dig nails/fingers into media- roll fingertip pads lightly over the agar surface
Tips for Media-Fill Testing
Read instructions from kit prior to sampling- we recommend these kits
Manipulate in a manner that simulates the most difficult and challenging aseptic compounding procedures that you will encounter
After performing the simulation, perform a gloved fingertip and thumb sample from each hand while in the PEC
A proper training program helps a facility identify training gaps, verify competency, monitor trends, and strengthen your company’s accountability. LAB 797 offers kits to fully equip your facility for personnel testing. We offer media and mediafill kits online at our store and can ship directly to your facility when you need it!