To help improve the quality and accuracy of clinical pathology laboratory testing, many African nations are using ISO 15189 for laboratory accreditation
In many developing countries, both patients and medical laboratory professionals are making local headlines with their efforts to call attention the unacceptable number of errors made by clinical laboratories in their respective countries. This media scrutiny is a positive sign because problems must be recognized and acknowledged before they can be solved.
In recent weeks, Dark Daily published an ebriefing that described how pathologists and clinical laboratory professionals in Africa and the Caribbean were calling attention to unacceptably high rates of medical lab testing errors in their respective regions. (See Dark Daily: Public Outcry Over Inaccurate Medical Laboratory Test Results and Misdiagnoses Spurs Government Action in Developing Countries.)
The good news is that media reports about problems with medical laboratory testing quality in these developing countries have encouraged an organized international response. Medical laboratory professionals from developed nations are providing financing, equipment, onsite training and supervision specifically to raise the quality and accuracy of medical laboratory test results in many of these developing countries.
International collaborations aimed at building high-quality clinical laboratory services in developing countries are paying off. In some cases, this is directly related to the efforts of the President’s Emergency Plan for AIDS Relief (PEPFAR) and similar initiatives to improve the quality of clinical laboratory services in these resource-limited regions to support better disease detection and patient care.
Improving Quality of Medical Laboratories in Developing Countries
In many ways, this story began in 2003 when the United States established PEPFAR. Congress appropriated $15 billion over five years for the program specifically to combat HIV/AIDS in developing regions. However, these efforts to address the HIV/AIDS pandemic also strengthened the broader health systems in these regions.
PEPFAR supported the recent formation of the African Society for Laboratory Medicine (ASLM). “As [an] organization led by Africans and supported by the United States through PEPFAR, ASLM advances professional laboratory medicine practice, science, systems, and networks on the continent,” stated U.S. global AIDS Coordinator Eric Goosby, M.D., in a posting at DipNote, the U.S. Department of State official blog.
Goosby went on to write that “ASLM will not only advance the processes for accreditation of [medical] laboratories, but also serves as a forum for communication across laboratories, biomedical scientists and clinicians, the medical community, public health officials and policy makers to enhance the effectiveness of laboratory services and science.”
Ambassador Goosby also announced the launch of ASLM’s international peer-reviewed journal, the African Journal of Laboratory Medicine. The journal will highlight advances in the roles of medical laboratories in clinical care and public health efforts, Goosby stated.
Moving Laboratories in Resource-limited Regions toward ISO 15189
Another key initiative is the World Health Organization Regional Office for Africa (WHO-AFRO) is the Stepwise Laboratory (Quality) Improvement Process Towards Accreditation (SLIPTA) program. According to the program’s website, SLIPTA is a framework for improving quality of public health laboratories in developing countries to achieve ISO 15189 standards. SLIPTA uses a five-star, tiered approach to accreditation. The process involves a bi-annual, on-site audit of clinical laboratory operating procedures, practices, and performance.
Yet another tool in the movement to upgrade medical laboratories is Strengthening Laboratory Management Toward Accreditation (SLMTA). SLMTA is an alternative training approach in laboratory management and quality management systems aimed at producing measurable improvement and preparing laboratories for accreditation based on international clinical laboratory standards.
Speaking at the 2011 International Conference on AIDS and Sexually-Transmitted Infections in Africa (ICASA) in Addis Ababa, Ethiopia, John N. Nkengasong, Ph.D. of the Centers for Disease Control and Prevention (CDC) touted SLMTA’s effectiveness.
Nkengasong emphasized that the program has shown immediate, measurable improvement in medical laboratories in resource-limited settings in 22 countries. A total of 283 laboratories are enrolled in the program, and 865 people have been trained.
Nkengasong is Chief of the Division of Global HIV/AIDS (DGHA) International Laboratory Branch at CDC’s Center for Global Health (CGH). He spearheaded the recent creation of ASLM.
Convergence of Science and Policy in Medical Laboratory Testing
A recurring theme among those championing the effort to improve the quality of clinical laboratories in developing countries is the need for backing by policy makers. “[Medical] laboratories in most African countries are experiencing multiple challenges,” observed Fausta Mosha, M.D., Laboratory Training Coordinator at the Tanzania Ministry of Health and Social Welfare, and Secretary of the ASLM Board of Directors.
“[However, the] biggest challenges are advocating for the critical role of [clinical] laboratories in disease control and making laboratories a priority,” she stated in an interview in Lab Culture, ASLM’s newsletter, “The importance of the laboratory must be recognized in order for necessary resources and equipment to be allocated to them,” added Mosha.
For pathologists and clinical laboratory managers, the domestic implications of these international trends include further evidence of: 1) the accelerating pace of globalization of medical laboratory services; and, 2) the power of focused, collaborative efforts combined with political will to move entire health systems toward higher quality and cost effectiveness.
—Pamela Scherer McLeod