United States Naval Medical Research Unit -3 Ghana Detachment, Accra, Ghana.
PLoS One. 2012;7(6):e39098. doi: 10.1371/journal.pone.0039098. Epub 2012 Jun 29.
The recent drive towards accreditation of clinical laboratories in Africa by the World Health Organization-Regional Office for Africa (WHO-AFRO) and the U.S Government is a historic step to strengthen health systems, provide better results for patients and an improved quality of results for clinical trials. Enrollment in approved proficiency testing (PT) programs and maintenance of satisfactory performance is vital in the process of accreditation. Passing proficiency testing surveys has posed a great challenge to many laboratories across sub-Saharan Africa. Our study was aimed at identifying the causes of unsatisfactory PT results in clinical research laboratories conducting or planning to conduct malaria vaccine trials sponsored by the National Institutes of Health (NIH).
PT reports for 2009 and 2010 from the College of American Pathologists (CAP) for the laboratories were reviewed as part of the process. Errors accounting for unsatisfactory results were classified into clerical, methodological, technical, problem with PT materials, and random errors. A training program on good clinical laboratory practices (GCLP) was developed for each center to address areas for improvement.
The major cause of PT failure in the four centers was methodological. The application of GCLP improved the success rate in the PT surveys from 58% in 2009 to 88% in 2010. It also decreased the error rate on PT by 35%.
A previous report from the CAP- PT participating laboratories indicated that the major causes of error were clerical. These types of errors were predominantly made in laboratories in the US, with much more experience in quality control, and varied significantly from what we found. In our centers in sub-Saharan Africa, methodological errors, and not clerical errors, accounted for the vast majority of errors. A process was started for continuous improvement which has decreased methodological errors by 35%, but more improvement is needed.
世界卫生组织-非洲区域办事处（世卫组织非洲区域办事处）和美国政府最近推动非洲临床实验室认证，这是加强卫生系统的历史性步骤，可为患者提供更好的结果，并提高临床试验的结果质量。参加经过认可的能力验证（PT）计划并保持令人满意的表现，是认证过程中的关键。通过能力验证调查对撒哈拉以南非洲的许多实验室来说是一个巨大的挑战。我们的研究旨在确定正在进行或计划进行美国国立卫生研究院（NIH）赞助的疟疾疫苗试验的临床研究实验室中导致 PT 结果不满意的原因。
作为该过程的一部分，审查了 2009 年和 2010 年美国病理学家学院（CAP）为这些实验室提供的 PT 报告。将导致不满意结果的错误分为文书、方法、技术、PT 材料问题和随机错误。为每个中心制定了良好临床实验室实践（GCLP）培训计划，以解决改进领域。
四个中心中 PT 失败的主要原因是方法。应用 GCLP 将 PT 调查的成功率从 2009 年的 58%提高到 2010 年的 88%。它还将 PT 错误率降低了 35%。
CAP-PT 参与实验室的先前报告表明，错误的主要原因是文书。这些类型的错误主要出现在美国的实验室中，这些实验室在质量控制方面有更多的经验，与我们发现的有很大不同。在我们撒哈拉以南非洲的中心，方法错误，而不是文书错误，占绝大多数错误。已经开始了一个持续改进的过程，这将方法错误减少了 35%，但还需要更多的改进。
