Development of a camera-assisted educational tool for the training and evaluation of operators in a cytotoxic production unit.

28 September 2021

Herlin.A1 ; Claraz.P1; Meghnagi.R1; Bourdon.O1; Storme.T1
1 Pharmacy department, Hôpital Robert Debré, 48 boulevard Sérurier 75019 Paris

According to Good Preparation Practices (BPP), carrying out sterile preparations requires special training for the personnel assigned to this task in order to adapt knowledge and skills. Since July 2020, our production unit has been equiped from camera-assisted preparation control. Thus, it has become necessary to set up the control tool for the training and evaluation of new operators.
The objective of this work is to develop an educational tool for the training and evaluation of our operators in a real production situation.

Material and method
A protocol of 3 different preparations: intrathecal, syringe and bag was created on our prescription software to generate a preparation scenario on the video control tool. In accordance with GPP, the products used are not cytotoxic and the preparations are not intended for the patient. Strict asepsis is assessed using a culture medium the trypcase-soybean as the dilution / reconstitution solvent. The preparations are made in the isolator and then placed in an oven at 30 ° C for 14 days. The appearance of turbidity in the solutions is checked regularly. The absence of inhibition of bacterial growth has been previously validated in accordance with chapter 2.6.1 of the Ph Eur 10.1.
A first set of 30 preparations made by all skill level operators (students, pharmacy technician, resident and pharmacist) is analyzed by two different and independent qualified operators. Behaviors likely to generate a risk (microbiological or chemical) are collected and weighted according to their level of criticality (from 1 to 3, from the lowest to the most important).
After a practical training, the operators carry out the test in real situation and their videos are analyzed.
Observation of errors leading to a score greater than 9 and / or the appearance of turbidity leads to the non-validation of the training and therefore a new training / evaluation cycle.

Among the 93 tests performed, no preparation showed bacterial contamination. 27 operators were evaluated. 4 operators required retraining. This consisted of viewing the video with the operator to point out critical point, practical re-training and then reassessment according to the same protocol. The 4 operators were all authorized in the 2nd session.

This tool made it possible to train and evaluate the operator in the production of chemotherapy assisted by camera, in complete autonomy, in a real production situation and in a discriminating manner. In the future, a protocol of periodic reassessments will make it possible to maintain the authorizations of operators and to detect any deviations.

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