Attoh Seth, Tetteh Francis K M, McAddy Mary, Ackah Kingsley, Kyei Richmond, Moroti Marcus, Boateng Cynthia, Adusu-Donkor Laurinda, Boafo Joseph, Yakubu Alhassan, Kwao Sarah, Sarkodie Emmanuel, Koranteng Nana-Banyin, Addo Monica A, Hobenu Frederick, Agyeman-Bediako Kwasi, Fatchu Raymond D
JM Wadhwani Department of Anatomical Pathology, Pathology Division Laboratory, 37 Military Hospital, Accra, Ghana.
Department of Microbiology, Pathology Division Laboratory, 37 Military Hospital, Accra, Ghana.
Afr J Lab Med. 2022 Jul 19;11(1):1448. doi: 10.4102/ajlm.v11i1.1448. eCollection 2022.
Accreditation is important for all medical laboratories, particularly public health laboratories in developing countries. Several laboratories in Ghana implemented the requirements of the International Organization for Standardization (ISO) 15189 but were unable to proceed to accreditation. This article describes the challenges faced by the Pathology Division Laboratory of the 37 Military Hospital, Accra, Ghana, during the acquisition of ISO 15189 accreditation and suggests solutions for a better approach.
Following ISO 15189 accreditation in 2017, an online survey was conducted between 01 and 30 March 2020 among the laboratory staff. Respondents were required to grade, on a scale of 0 (least) to 5 (most), the extent to which 16 key challenges influenced the process of obtaining accreditation. Key informant interviews were also held with laboratory personnel who were directly involved in the establishment of the quality management system in the laboratory and the accreditation acquisition process.
Documentation, laboratory safety measures, laboratory management support, and reagent unavailability were estimated as the challenges that most affected the acquisition of laboratory accreditation. Challenges such as poor communication, staff apathy and workload had the least effect on the accreditation process. There was no difference in challenges identified between persons who worked in the laboratory before or after accreditation ( = 0.11).
To surmount the anticipated challenges, there is the need for national strategic direction for laboratory accreditation, hospital and laboratory management support for the accreditation acquisition and maintenance processes, and sufficient technical assistance in the form of training and mentorship.
认可对所有医学实验室都很重要，对发展中国家的公共卫生实验室尤为如此。加纳的几家实验室实施了国际标准化组织（ISO）15189的要求，但未能进入认可程序。本文描述了加纳阿克拉37军医院病理科实验室在获取ISO 15189认可过程中面临的挑战，并提出了改进方法的解决方案。
在2017年获得ISO 15189认可后，于2020年3月1日至30日对实验室工作人员进行了在线调查。要求受访者对16项关键挑战影响认可过程的程度进行评分，范围从0（最小）到5（最大）。还与直接参与实验室质量管理体系建立和认可获取过程的实验室人员进行了关键信息访谈。
文件记录、实验室安全措施、实验室管理支持和试剂供应不足被认为是最影响实验室认可获取的挑战。沟通不畅、员工冷漠和工作量等挑战对认可过程的影响最小。认可前后在实验室工作的人员所识别出的挑战没有差异（P = 0.11）。
为克服预期挑战，需要国家层面的实验室认可战略指导、医院和实验室管理对认可获取和维持过程的支持，以及以培训和指导形式提供的充分技术援助。
