Maina Robert N, Mengo Doris M, Mohamud Abdikher D, Ochieng Susan M, Milgo Sammy K, Sexton Connie J, Moyo Sikhulile, Luman Elizabeth T
Kenya Accreditation Service (KENAS), Kenya.
US Centers for Disease Control and Prevention, Atlanta, United States.
Afr J Lab Med. 2014 Nov 3;3(2):222. doi: 10.4102/ajlm.v3i2.222. eCollection 2014.
Kenya has implemented the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme to facilitate quality improvement in medical laboratories and to support national accreditation goals. Continuous quality improvement after SLMTA completion is needed to ensure sustainability and continue progress toward accreditation.
Audits were conducted by qualified, independent auditors to assess the performance of five enrolled laboratories using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist. End-of-programme (exit) and one year post-programme (surveillance) audits were compared for overall score, star level (from zero to five, based on scores) and scores for each of the 12 Quality System Essential (QSE) areas that make up the SLIPTA checklist.
All laboratories improved from exit to surveillance audit (median improvement 38 percentage points, range 5-45 percentage points). Two laboratories improved from zero to one star, two improved from zero to three stars and one laboratory improved from three to four stars. The lowest median QSE scores at exit were: internal audit; corrective action; and occurrence management and process improvement (< 20%). Each of the 12 QSEs improved substantially at surveillance audit, with the greatest improvement in client management and customer service, internal audit and information management (≥ 50 percentage points). The two laboratories with the greatest overall improvement focused heavily on the internal audit and corrective action QSEs.
Whilst all laboratories improved from exit to surveillance audit, those that focused on the internal audit and corrective action QSEs improved substantially more than those that did not; internal audits and corrective actions may have acted as catalysts, leading to improvements in other QSEs. Systematic identification of core areas and best practices to address them is a critical step toward strengthening public medical laboratories.
肯尼亚实施了“迈向认可强化实验室管理”(SLMTA)计划,以促进医学实验室质量提升并支持国家认可目标。在SLMTA完成后需要持续质量改进,以确保可持续性并朝着认可继续取得进展。
由合格的独立审核员进行审核,以使用“迈向认可的逐步实验室质量改进过程”(SLIPTA)检查表评估五个参与实验室的绩效。比较了计划结束时(退出)审核和计划结束后一年(监督)审核的总分、星级(基于分数从零到五)以及构成SLIPTA检查表的12个质量体系要素(QSE)领域中每个领域的分数。
所有实验室从退出审核到监督审核均有改进(中位数改进38个百分点,范围为5 - 45个百分点)。两个实验室从零星级提升到一星级,两个从零星级提升到三星级,一个实验室从三星级提升到四星级。退出审核时QSE得分中位数最低的是:内部审核、纠正措施以及事件管理和过程改进(<20%)。在监督审核时,12个QSE中的每一个都有显著改进,其中客户管理与客户服务、内部审核和信息管理改进最大(≥50个百分点)。总体改进最大的两个实验室非常注重内部审核和纠正措施QSE。
虽然所有实验室从退出审核到监督审核都有改进,但那些注重内部审核和纠正措施QSE的实验室比不注重的实验室改进幅度大得多;内部审核和纠正措施可能起到了催化剂的作用,导致其他QSE也得到改进。系统识别核心领域以及解决这些领域问题的最佳实践是加强公共医学实验室的关键一步。