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[医院药房肠外营养制剂生产中的人员资质认定]

[Staff accreditation in parenteral nutrition production in hospital pharmacy].

作者信息

Vrignaud S, Le Pêcheur V, Jouan G, Valy S, Clerc M-A

机构信息

Pharmacie centrale, CHU d'Angers, 4, rue Larrey, 49933 Angers cedex 9, France.

Pharmacie centrale, CHU d'Angers, 4, rue Larrey, 49933 Angers cedex 9, France.

出版信息

Ann Pharm Fr. 2016 Sep;74(5):389-403. doi: 10.1016/j.pharma.2015.12.005. Epub 2016 Jan 27.

DOI:10.1016/j.pharma.2015.12.005
PMID:26826792
Abstract

OBJECTIVES

This work aims to provide staff accreditation methodology to harmonize and secure practices for parenteral nutrition bags preparation.

METHODS

The methodology used in the present study is inspired from project management and quality approach. Existing training supports were used to produce accreditation procedure and evaluation supports.

RESULTS AND DISCUSSION

We first defined abilities levels, from level 1, corresponding to accredited learning agent to level 3, corresponding to expert accredited agent. Elements assessed for accreditation are: clothing assessment either by practices audit or by microbiologic test, test bags preparation and handling assessment, bag production to assess aseptic filling for both manual or automatized method, practices audit, number of days of production, and non-conformity following. At Angers Hospital, in 2014, production staff is composed of 12 agents. Staff accreditation reveals that 2 agents achieve level 3, 8 agents achieve level 2 and 2 agents are level 1. We noted that non-conformity decreased as accreditation took place from 81 in 2009 to 0 in 2014.

CONCLUSION

To date, there is no incident due to parenteral bag produced by Angers hospital for neonatal resuscitation children. Such a consistent study is essential to insure a secured nutrition parenteral production. This also provides a satisfying quality care for patients.

摘要

目的

本研究旨在提供员工认证方法,以统一和确保肠外营养袋制备的规范操作。

方法

本研究采用的方法源自项目管理和质量方法。利用现有的培训资料制作认证程序和评估资料。

结果与讨论

我们首先定义了能力水平,从1级(对应经认证的学习型操作人员)到3级(对应经认证的专家型操作人员)。认证评估的要素包括:通过操作审核或微生物检测进行的着装评估、测试袋制备和处理评估、手动或自动化方法的无菌灌装袋生产评估、操作审核、生产天数以及后续不符合项。在昂热医院,2014年生产人员由12名操作人员组成。员工认证显示,2名操作人员达到3级,8名操作人员达到2级,2名操作人员为1级。我们注意到,随着认证的推进,不符合项从2009年的81项降至2014年的0项。

结论

迄今为止,昂热医院为新生儿复苏患儿生产的肠外营养袋未引发任何事故。这样一项连贯的研究对于确保安全的肠外营养生产至关重要。这也为患者提供了令人满意的优质护理。

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