Alemnji George, Edghill Lisa, Guevara Giselle, Wallace-Sankarsingh Sacha, Albalak Rachel, Cognat Sebastien, Nkengasong John, Gabastou Jean-Marc
Centers for Disease Control and Prevention (CDC), Caribbean Regional Office, Bridgetown, Barbados.
Caribbean Public Health Agency (CARPHA), Port of Spain, Trinidad and Tobago.
Afr J Lab Med. 2017 Feb 24;6(1):496. doi: 10.4102/ajlm.v6i1.496. eCollection 2017.
Implementing quality management systems and accrediting laboratories in the Caribbean has been a challenge.
We report the development of a stepwise process for quality systems improvement in the Caribbean Region.
The Caribbean Laboratory Stakeholders met under a joint Pan American Health Organization/US Centers for Disease Control and Prevention initiative and developed a user-friendly framework called 'Laboratory Quality Management System - Stepwise Improvement Process (LQMS-SIP) Towards Accreditation' to support countries in strengthening laboratory services through a stepwise approach toward fulfilling the ISO 15189: 2012 requirements.
This approach consists of a three-tiered framework. Tier 1 represents the minimum requirements corresponding to the mandatory criteria for obtaining a licence from the Ministry of Health of the participating country. The next two tiers are quality improvement milestones that are achieved through the implementation of specific quality management system requirements. Laboratories that meet the requirements of the three tiers will be encouraged to apply for accreditation. The Caribbean Regional Organisation for Standards and Quality hosts the LQMS-SIP Secretariat and will work with countries, including the Ministry of Health and stakeholders, including laboratory staff, to coordinate and implement LQMS-SIP activities. The Caribbean Public Health Agency will coordinate and advocate for the LQMS-SIP implementation.
This article presents the Caribbean LQMS-SIP framework and describes how it will be implemented among various countries in the region to achieve quality improvement.
在加勒比地区实施质量管理体系并对实验室进行认证一直是一项挑战。
我们报告了加勒比地区质量体系改进的逐步流程的制定情况。
加勒比实验室利益相关者在泛美卫生组织/美国疾病控制与预防中心的联合倡议下会面，开发了一个名为“实验室质量管理体系——迈向认证的逐步改进流程（LQMS - SIP）”的用户友好型框架，以支持各国通过逐步满足ISO 15189:2012要求的方式加强实验室服务。
该方法包括一个三层框架。第一层代表与从参与国卫生部获得许可证的强制标准相对应的最低要求。接下来的两层是通过实施特定质量管理体系要求实现的质量改进里程碑。满足三层要求的实验室将被鼓励申请认证。加勒比地区标准与质量组织主办LQMS - SIP秘书处，并将与各国（包括卫生部）以及利益相关者（包括实验室工作人员）合作，协调和实施LQMS - SIP活动。加勒比公共卫生机构将协调并倡导LQMS - SIP的实施。
本文介绍了加勒比地区的LQMS - SIP框架，并描述了它将如何在该地区的各个国家实施以实现质量改进。
