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使用SLIPTA检查表评估实验室为国际联合委员会认证做好准备的情况。

Using the SLIPTA checklist to assess laboratory readiness for Joint Commission International accreditation.

作者信息

El Karaaoui Abdul K, Assaf Nada

机构信息

Department of Pathology and Laboratory Medicine, Faculty of Medicine, American University of Beirut, Beirut, Lebanon.

出版信息

Afr J Lab Med. 2023 Mar 15;12(1):2044. doi: 10.4102/ajlm.v12i1.2044. eCollection 2023.

Abstract

BACKGROUND

The Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) helps prepare laboratories in low- and middle-income countries to achieve international accreditation aligned with the ISO 15189:2012 standards. Accreditation by the Joint Commission International (JCI) is among the highest sought by hospitals worldwide. While the readiness of laboratories with a five-star SLIPTA score to undergo ISO 15189:2012 accreditation was recently assessed, the compliance of the SLIPTA checklist with JCI is still unknown.

OBJECTIVE

The study evaluated the SLIPTA checklist's utility in assessing laboratories to meet the JCI standards.

METHODS

We conducted a detailed gap analysis between SLIPTA and JCI laboratory standards from January 2021 to January 2022. We cross-matched the JCI standard requirements to SLIPTA clauses and categorised each standard into 'met', 'partially met', and 'not met'. We highlighted similarities, discrepancies, and improvement areas.

RESULTS

A total of 109 JCI standards were included. The SLIPTA checklist completely met 61 standards, partially met four, but did not meet 44. The unmet JCI standards focused on the quality planning, control, and improvement sections. Healthcare organisation management and quality control processes, including selecting an accredited reference laboratory, collecting quality management data, creating of post-analytical policies and procedures, and validating monitoring systems, constitute the basis of this preparation.

CONCLUSION

The SLIPTA checklist covers major quality management system elements of the JCI standards for laboratories. However, some components should be addressed to assure readiness for JCI accreditation.

WHAT THIS STUDY ADDS

This study identified additional areas not covered by the SLIPTA checklist that are required for JCI accreditation.

摘要

背景

迈向认可的实验室逐步改进流程(SLIPTA)有助于中低收入国家的实验室做好准备,以获得符合ISO 15189:2012标准的国际认可。国际联合委员会(JCI)的认可是全球医院最渴望获得的认可之一。虽然最近评估了获得五星级SLIPTA评分的实验室接受ISO 15189:2012认可的准备情况,但SLIPTA检查表与JCI的合规性仍然未知。

目的

本研究评估了SLIPTA检查表在评估实验室是否符合JCI标准方面的效用。

方法

我们在2021年1月至2022年1月期间对SLIPTA和JCI实验室标准进行了详细的差距分析。我们将JCI标准要求与SLIPTA条款进行交叉匹配,并将每个标准分为“符合”、“部分符合”和“不符合”。我们突出了相似之处、差异和改进领域。

结果

共纳入109项JCI标准。SLIPTA检查表完全符合61项标准,部分符合4项,但不符合44项。未满足的JCI标准集中在质量规划、控制和改进部分。医疗保健组织管理和质量控制流程,包括选择认可的参考实验室、收集质量管理数据、制定分析后政策和程序以及验证监测系统,构成了这一准备工作的基础。

结论

SLIPTA检查表涵盖了JCI实验室标准的主要质量管理体系要素。然而,应解决一些组成部分,以确保为JCI认可做好准备。

本研究的新增内容

本研究确定了SLIPTA检查表未涵盖的JCI认可所需的其他领域。

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