Qualification of new pharmacotechnical operators
CHU de Bordeaux Groupe Hospitalier Pellegrin,
Introduction
The sterile preparation unit of the Pellegrin Hospital Group (Bordeaux) performs annually 23,000 sterile preparations divided into three areas: preparation of anticancer drugs, pediatric parenteral nutritions and ophthalmic preparations.
In April 2013, arrival in the team of a new operator was an opportunity to test the training program and to establish a theoretical and practical assessment system of new agents.
Materials and Methods
The process of qualification of the new operator was carried out in several steps:
Step 1: Completion of a questionnaire assessment of theoretical and practical knowledge necessary to work in controlled atmosphere area (dressing, regulatory requirement, anticancer drug, physiology premature ...)
Step 2: Delivery of a personalized training plan and referent trainers presentation by area.
Step 3: Practical and theoretical training itself.
Step 4: The final evaluation was characterized by:
- The implementation of Aseptic Media-Fill Test simulating the production of 10 parenteral nutrition bags with the controller EM2400,
- realization of chemotherapy measuring accuracy and repeatability of preparations concentration made by spectrophotometry UV / IR,
- And realization of knowledge final test in the form of a questionnaire.
Results
No parenteral nutrition preparation has proved positive in the Mediafill Test. The average error rate was 4.5 % (against 3.5% for the evaluator) for accuracy testing and 6% for the repeatability test. The final score of the evaluation questionnaire was 15/20.
Conclusion
The new operator is qualified to work in the sterile preparation unit. Although this qualification is a good tool for evaluating agents, it does not provide the perfect autonomy of preparers during their beginnings. In service training is essential in a sterile production unit.