Global lab standards: a big step forward

Nov. 1, 2011

“This is a new dawn for African countries.” That's how Professor Peter Anyang Nyong'o, Minister for Medical Services in Kenya, described the creation of ASLM—the African Society for Laboratory Medicine—earlier this year. By setting a standard for lab accreditation and professionalism in nations throughout Africa, ASLM will not only advance lab standards but positively impact the lives of millions.

The new dawn began March 14, the first day of a three-day meeting convened in Addis Ababa, Ethiopia, to formally launch ASLM. The creation of the pan-African organization, dedicated to advancing the laboratory profession and supporting medical laboratories throughout the continent, was significant not only for labs across Africa, but for healthcare delivery in general in a continent where labs in many developing nations face enormous challenges. ASLM will define and implement laboratory guidelines and develop a network of labs and systems for accrediting training programs. It will work with global partners to meet those goals.

African nations were well represented at the March launch, which included officials from eight African Ministries of Health. International partners which have been helping to get ASLM up and running were also represented, including the American Society for Clinical Pathology (ASCP), the World Health Organization (WHO), the U.S. Center for Disease Control and Prevention (CDC), the United States Agency for International Development (USAID), and the Foundation for Innovative New Diagnostics (FIND). Former President Bill Clinton, representing the Clinton Health Access Initiative, spoke to the conferees in Addis Ababa via videoconference.

ASLM Board of Directors chair John Nkengasong, PhD, called the establishment of ASLM the “culmination of years of concerted efforts led by African institutions and international development partners to ensure that laboratory medicine in Africa meets the highest scientific standards.” Those efforts include the Maputo [Mozambique] Declaration of 2008, in which WHO-Africa called for international efforts to strengthen laboratory services in developing countries; the Yaounde [Cameroon] Resolution of 2008, which called the improvement of labs in Africa critical to disease control; the 2009 Kigali [Rwanda] conference, which launched the first-ever step-wise lab accreditation process, a procedure for certifying laboratory medicine training; and the Kampala [Uganda] Statement of 2010, which laid the groundwork for the establishment of ASLM.

As a unified organization dedicated to standardizing practices and procedures of African labs, ASLM is the direct result of these and other earlier efforts. It has already begun working to plot the course for the development of laboratory networks and to guide the process of certifying training in laboratory medicine. It is also dedicated to integrating the laboratory systems within and among nations, and funneling support to the facilities in a “single stream” to create a feeling of ownership among stakeholders. Dr. Tedros Adhanom Ghebreyesus, who is Ethiopia's Minister of Health and also chair of the Board of the Global Fund to Fight AIDS, Tuberculosis, and Malaria, notes that “ownership reinforces commitment, and commitment, in turn, yields results and assures long-term sustainability.”

Such organizational and strategic issues aside, the implications of ASLM for the human beings who depend on Africa's healthcare system are enormous. Dr. Giorgio Roscigno, chief executive officer of FIND, says that “ASLM will contribute to raise the visibility and the importance of good, reliable laboratory systems and will contribute to the overall strengthening of health systems in Africa.” Says ASCP Executive Vice President E. Blair Holladay, PhD: “The creation of ASLM is an initiative aimed directly at the target of improving patient healthcare worldwide.”

Just before the March meeting that formally created ASLM, Dr, Nkengasong emphasized the importance of the work that lay before the new organization by citing sobering statistics: “Excluding those in South Africa, only 8.2 percent of laboratories in sub-Saharan Africa are accredited. And as recently as 2010, only 28 of an estimated one million laboratories in all of Africa were accredited based on international standards.”

ASLM has been busy since its March launch, Shannon Heard Castle, director, American Society for Clinical Pathology (ASCP) Global Outreach, stresses that her organization has helped ASLM lay the groundwork for a peer-reviewed publication, “The African Journal of Laboratory Medicine.” Glen Fine, MS, MBA, CAE, Executive Vice President, Global Health Partnerships, Clinical and Laboratory Standards Institute (CLSI), says that ASLM has all of the elements for success in place: grant funding, commitment from U.S.-based and international stakeholders, and support from major professional societies. In addition to his own organization and ASCP, Fine singles out the Association of Public Health Laboratories (APHL) and the American Society of Microbiology (ASM) as major supporters of ASLM.

Fine also stresses six “pillars” of success for ASLM, six major areas of focus in which activity has already begun: “lab accreditation preparedness and standards; laboratory workforce development; professional publications; technical assistance (from partners that can provide expertise for building the sustainable lab capacity); clinical interface; and a lab network strategy that keeps labs from having to work in isolation.” ASLM, he says, has not only a clear, compelling mission, but the leadership, funding, and membership base that can make success possible. With this foundation in place, ASLM has hired key staff, including Dr. Roscigno as chief operating officer. Tsehaynesh Messele, who has been an outstanding leader in Ethiopia in public health emergency management, health and nutrition, and AIDS research, is ASLM's chief executive officer. The organization's board of directors has been selected.

Efforts to upgrade global laboratory standards are not limited to Africa. Heard Castle notes that ASCP has been working with the National Public Health Reference Lab in the South American nation of Guyana to prepare it for accreditation. “ASCP has been working with the department heads to improve documentation, SOPs, quality control, quality assurance, and human resources issues.” The Guyana national lab is using ISO 15189 standards and plans to apply for accreditation early next year.

Karen McClure, PhD, MLS(ASCP), SBB, Vice President, Global Health Partnership, CLSI, notes that several nations of central Asia, including Kazakhstan, Tajikistan, Armenia, and Azerbaijan, “don't have a lot of standards in place for monitoring their laboratories, and are seeking ways to improve their compliance with standards. Those countries have received some assistance.” In addition, she says, a number of Caribbean nations are looking for help in strengthening their laboratory standards, along with some Central American and Latin American countries. Nations in Indochina are seeking help too. “Vietnam, Cambodia, and Laos are some other countries where laboratories also need assistance” and are seeking accreditation from international groups, McClure adds. Some countries, such as Nigeria, are looking to form their own accrediting bodies.

In general, then, developing nations are seeking to create and maintain accreditation standards. What is the key to success for nations that are working to upgrade and standardize their medical laboratories? According to Fine, “having the political capital and will” may be the answer. He points to the African nation of Tanzania, where five major laboratories are ready to go for accreditation. “It's not just putting a system in place,” McClure adds. “It's the education of the individuals who work in the labs, educating them to work within that system. It's important that individuals learn to utilize the tools they are provided with so they can pass that on.” Partners from developed nations can act as mentors to help put the infrastructure in place—but laboratorians in the developing nations must make it self-sustaining.

Robert Michel, editor-in-chief of The Dark Report, calls the creation of ASLM “one more step toward the globalization of laboratory medicine. There is growing awareness that medical laboratory testing is essential to a robust healthcare system.” It's no surprise, Michel concludes, that “both developed and developing countries have adopted stricter accreditation and licensing standards.”