Assessment and validation of the operators working in cytotoxics preparation unit

5 October 2012

M. Fourtage, V. Graff, F. Couturier Pharmacie, Clinique Ste Anne,
Strasbourg, France

A well trained and regularly assessed staff guarantees the quality of the injectable cytotoxic drugs preparations. In this purpose, the operators working in cytotoxics preparation unit were evaluated in practical and theoritical terms.

Four operators were assessed through 3 different application tests : the media fill test evaluating the microbiological contamination in the course of the preparation ; the fluorescein test that estimates the chemical contamination ; the direct observation of the manipulation by means of a rating table, evaluating the compliance with good handling practices. Furthermore, the whole team (8 operators) was evaluated through a theorical test which examines four fields of knowledge in a written quiz.
The results show that all the media fill test were negative. Concerning the fluorescein test, 3 operators have contaminated their gloves while they were adjusting the volume or by an air intake leak; the external surface of the needles container has been contaminated because of the introduction of a dirty compress.

Two out of the six handling stages were judged as being critical : on the one hand the freeze-dried product reconstitution and on the other hand the injection into the solvent bag ; half of the operators haven’t performed as advised.

The operators’ average mark for the theorical test was 12.2/20 (from 9.25 to 15.25). The recommendations on hygiene, working clothes and legislation seem to be assimilated whereas there are some technical lacks (controlled atmosphere areas, isolator).

Following these results, several caution measures have been considered : defining a new changing gloves frequency, setting a visual training tool to help proper handling, implementing short theorical trainings.

The other 4 operators who work in the unit will be evaluated in the near future through the same practical tests and the whole assessments will be performed every year.

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