Parenteral nutrition production: audit of practices targeting the risk of microbiological contamination

4 October 2023

F. Gaume, A. Ifrah, S. Valy, S. Vrignaud
Centre Hospitalier Universitaire d’Angers, France

The production of parenteral nutrition is a high-risk activity, and preparations must be sterile and produced under optimum safety conditions, as described in the 2022 Good Preparation Practices. As the hospital pharmacy technician (HPT) represents a major risk of microbial contamination during aseptic handling, it was decided to carry out an assessment of professional practices in the form of an observational practice audit targeting the risk of microbiological contamination in our production unit (301 personalized parenteral nutrition bags and 2130 vitamin-lipid syringes in 2022 in a class B Controlled Atmosphere Zone (CAZ) under a horizontal laminar airflow hood). The aim of this work was to create an audit tool to measure discrepancies between observed and expected practices, in relation to the internal quality documents derived from the 2022 Good Preparation Practices.

From January to March 2023, a group of experts made up of 2 pharmacists, 1 pharmacy resident, 1 senior hospital quality technician, 1 healthcare executive and 1 referring hospital pharmacy technician worked on drawing up an audit grid. The grid comprises 99 items targeting the risk of microbiological contamination, divided into 5 key stages of the production process: dressing (22 items), biocleaning (18 items), decontamination (27 items), assistant handler role (18 items) and handler role (14 items).
From March 28 to June 30, 2023, 12 HPTs authorized to produce parenteral nutrition were individually audited in 2 stages, with the grid containing items covering both the handler and assistant handler roles. The audit was carried out by a pharmacy resident and took 34 hours.
Data entry and analysis were carried out using Sphinx Declic® software.

12 assessments were carried out. Overall compliance was 85%. 94.7% of items concerning dressing were compliant, 86.6% for biocleaning, 80.4% for decontamination, 79.6% for the role of assistant handler and 85.5% for the role of handler. The critical points raised concerned: compliance with disinfectant exposure time, identification of the right times for change gloves, and the performance of surface sampling by HPTs.

The audit highlighted quite a few excesses. An improvement action plan will be put in place, focusing in particular on the importance of the exposure time of the equipment to the disinfectant, raising the team’s awareness of the need to change gloves, and re-training on how to take surface samples.
As a follow-up to the audit, a self-assessment questionnaire will be sent to agents, so they can compare their responses with the audit results.

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