Implementing a training and evaluation procedure for preparation technicians joining Clinical Research Units (CRUs)

9 October 2010

M. Lefebvre, M. Rossignol, P. Hild, F. Cabrera, C. Niepceron Pharmacie, Centre Hospitalier de Roanne, France

A training procedure for technicians joining CRUs was drawn up in 2007. Its purpose is to bring preparation technicians up to the level of skill required for them to be integrated into a team which is already accredited. This training combines fundamental theoretical material (knowledge) with technical and operational rigour (practical skills) and an understanding of bacteriological and chemical contamination (responsibility). Each stage is assessed by an evaluating technician (ET); final accreditation is given by the pharmacist in charge of the unit.

The training is tailored to the operating method of our classic extractor fan without continuous flow. Each work station is covered by a number of monitoring documents made up of individual assessment points. The technicians undergoing the training rate their own level of competence in the elements covered by each document, and comment on their reading and understanding of the related procedures. Successful completion of one document allows the trainee to progress to the next stage. This progression through the stages is recorded on an individual training log which then serves to qualify the technician.

When the CRU was opened the preparation technicians were given initial training. This framework helped us to devise and develop our own procedure. Final evaluation of technicians is conducted via three series of eight surface samples: the assessors then look for evidence of fluorouracil or cyclophosphamide contamination in the preparations and on the exterior of the extractor unit. The results must show contamination levels below the stipulated thresholds (defined in relation to the average results of the ‘accredited’ team members).

We had the opportunity to test all stages of this training process on a technician who joined the CRU at the end of 2008. The advantage of this new procedure is that it allows for step-by-step integration, with a hierarchical organisation of the different technical stages which gives the trainee time to fully absorb the details of the fabrication process. As a pharmacist oversees and approves the whole training process, the accreditation dossier becomes a genuinely useful qualification document for the trainee. The difficulties experienced with the process related to the time constraints which limited the availability of the supervisors (evaluating technician and pharmacist) and the complex nature of the near-constant updates which such a tool requires. The technician who underwent the training is currently under assessment, and we are awaiting the results from her surface sample tests.

Finally, we are currently devising a means of incorporating the monitoring of dosage precision in preparations (subcontracted by a partner hospital) as the final stage of the technician accreditation process.

Diapos-Mise en place d'une procédure de formation Diapos-Mise en place d’une procédure de formation

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