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The World Health Organization African Region Laboratory Accreditation Process
Improving the Quality of Laboratory Systems in the African Region

Guy-Michel Gershy-Damet PhD, Philip Rotz, David Cross MS, El Hadj Belabbes MD, Fatim Cham PhD, Jean-Bosco Ndihokubwayo MD, MSc, MPH, Glen Fine MS, MBA, CAE, Clement Zeh MS, Patrick A. Njukeng PhD, Souleymane Mboup MD, Daniel E. Sesse PhD, Tsehaynesh Messele MD, Deborah L. Birx MD, John N. Nkengasong PhD
DOI: http://dx.doi.org/10.1309/AJCPTUUC2V1WJQBM 393-400 First published online: 1 September 2010

Abstract

Few developing countries have established laboratory quality standards that are affordable and easy to implement and monitor. To address this challenge, the World Health Organization Regional Office for Africa (WHO AFRO) established a stepwise approach, using a 0- to 5-star scale, to the recognition of evolving fulfillment of the ISO 15189 standard rather than pass-fail grading. Laboratories that fail to achieve an assessment score of at least 55% will not be awarded a star ranking. Laboratories that achieve 95% or more will receive a 5-star rating.

This stepwise approach acknowledges to laboratories where they stand, supports them with a series of evaluations to use to demonstrate improvement, and recognizes and rewards their progress. WHO AFRO’s accreditation process is not intended to replace established ISO 15189 accreditation schemes, but rather to provide an interim pathway to the realization of international laboratory standards. Laboratories that demonstrate outstanding performance in the WHO-AFRO process will be strongly encouraged to enroll in an established ISO 15189 accreditation scheme. We believe that the WHO-AFRO approach for laboratory accreditation is affordable, sustainable, effective, and scalable.

Key Words:
  • Laboratory medicine
  • Standards
  • Accreditation
  • Africa

The last 5 years have seen tremendous increases in development funding for global health, with nearly $22 billion available in 2007 alone.1 Support for health systems in developing countries has become a major focus of many donors, including the World Bank; the US President’s Emergency Fund for AIDS Relief; the Global Fund for AIDS, Tuberculosis and Malaria; the Global Health Initiative; bilateral government support; and private foundations.2

Efficient and reliable laboratory services and networks are essential and fundamental components of effective, well-functioning health systems. High-quality laboratory testing is critical for patient care, prevention, disease surveillance, and outbreak investigations.

In sub-Saharan Africa, laboratory infrastructure and personnel are adversely affected by a lack of resources and prioritization, hampering laboratory systems in efforts to fulfill their important role in the fight against infectious and chronic diseases. As a result, the accessibility of laboratory testing and the quality of available services remains a serious challenge. It is therefore imperative that laboratory systems be strengthened within broader efforts toward health system strengthening.

Efforts to strengthen laboratory systems in the African region have received increased attention in recent years. In the 2008–2009 period, 6 landmark events were of particular significance for national health laboratory services. These events are described in the following paragraphs.

  1. January 2008 (Maputo, Mozambique): Thirty-three countries—together with the World Health Organization (WHO), the World Bank, and the Global Fund for AIDS, Tuberculosis and Malaria—issued the Maputo Declaration to strengthen laboratory systems in developing countries.

  2. April 2008 (Lyon, France): WHO and the US Centers for Disease Control and Prevention (CDC) issued a statement regarding laboratory quality systems, calling for countries with limited resources to consider a staged approach toward laboratory accreditation. It was suggested that national laboratory standards establish minimum requirements for all laboratories, although national reference laboratories were encouraged to meet international standards, such as ISO 15189.

  3. September 2008 (Yaounde, Cameroon): During the 58th session of the Regional Committee, member states adopted the resolution AFR/RC58/R2, strengthening public health laboratories in the WHO African region,3 emphasizing the urgency to strengthen public health laboratories at all levels of the health care system in addition to requesting that the WHO Regional Office for Africa (AFRO) support member states to mobilize, access, and sustain resources to strengthen laboratory services.

  4. September 2008 (Dakar, Senegal): At the fifth meeting of the Regional HIV/AIDS Network for Public Health Laboratories, it was agreed that the network should broaden its scope beyond HIV/AIDS and HIV/AIDS-associated diseases to become an integrated network encompassing all laboratories, without the limitation of a disease specific designation.

  5. July 2009 (Kigali, Rwanda): WHO AFRO, in collaboration with the CDC, the Clinton Health Access Initiative, the American Society for Clinical Pathology, and other partners, launched a stepwise laboratory accreditation process in the presence of government health officials from 13 African countries.4 The WHO-AFRO accreditation process will recognize and encourage year-over-year progress toward fulfillment of the requirements of ISO 15189.

  6. September 2009 (Kigali, Rwanda): During the 59th session of the Regional Committee, member states adopted the following resolutions: AFR/RC59/R2, drug resistance related to AIDS, tuberculosis, and malaria: issues, challenges, and the way forward; and AFR/RC59/WP/3, policy orientations on the establishment of centers of excellence for disease surveillance, public health laboratories, food, and medicines regulation.5,6 These resolutions call for the strengthening of public health laboratories and other centers of excellence to improve disease prevention and control.

These meetings built consensus and focused critical attention on the call for systematic and standardized approaches for strengthening the African region’s national health laboratory systems and the attendant need for national and regional efforts to implement laboratory quality standards.

Implementation of Laboratory Standards in Africa

Implementation of laboratory standards is verified through the process of accreditation. Laboratory accreditation schemes assess laboratories in accordance with accepted standards, providing external validation that assures clients that laboratory services are accurate, traceable, and reproducible. Accredited medical laboratories must demonstrate a well-functioning quality management system, technical competence, and timely and customer-focused services that contribute to patient care. Accreditation requires leadership, time, attention, resources, and continuous commitment to evaluation and improvement.

In many developed countries, accreditation of medical laboratories has been established for several decades.710 However, in sub-Saharan Africa, South Africa alone has amassed significant accreditation experience, boasting a network of several hundred accredited facilities, many of which are in the private sector.11,12 In fact, a July 2009 survey of online registers of leading accreditation providers found that 312 of 340 accredited laboratories in sub-Saharan Africa were in South Africa Figure 1. Although government-run laboratories conduct the bulk of patient testing in most countries, the continent’s remaining 28 accredited laboratories were almost exclusively private, parastatal, or donor-supported research facilities (G.-M. G.-D., et al. Examination of CAP [College of American Pathologists], JCI [Joint Commission International], SANAS [South African National Accreditation System], UKAS [United Kingdom Accreditation Service], CPA [Clinical Pathology Accreditation (UK), Ltd], and NATA [National Association of Testing Authorities (Australia)] online registers for accredited laboratories in sub-Saharan Africa; unpublished data; July 2009).

Figure 1

Internationally accredited laboratories in Africa. Few laboratories in Africa (only 340) are currently accredited. The majority of the accredited laboratories are in South Africa; only 28 (8.2%) are in sub-Saharan Africa. Of the accredited laboratories in South Africa, fewer than 10% are public sector laboratories.

It is not surprising that participation in laboratory accreditation schemes in Africa has generally been skewed toward facilities conducting testing for private patients or clinical trials. Fulfilling the requirements of international and/or regional laboratory accreditation schemes—such as CAP, Joint Commission International, and the Southern African Development Community Accreditation Service—is not commonly perceived as immediately feasible because of the current state of most public laboratories, lack of trained laboratory experts, weak quality management systems, and the high cost of participation in international accreditation schemes.

To ensure that the millions of patients in the African region who rely on public laboratories receive services that meet international standards, it was resolved in Dakar, in September 2008, that WHO AFRO would establish a stepwise accreditation approach for the region consistent with the Lyon statement.13

In this, affordable and effective stepwise models from other regions were considered. Between 2002 and 2009, Thailand developed national standards based on ISO 15189, and the Thailand Medical Technology Council assessed 50% of the country’s 1,400 clinical laboratories. Of the 724 laboratories assessed, 197 (27.2%) were accredited, and the remaining 72.8% demonstrated at least 70% compliance.14 In Argentina, Fundación Bioquímica Argentina established national minimum standards, assessed laboratories nationwide, and subsequently developed a more demanding standard and implemented it.15,16 In the last 15 years, Fundación Bioquímica Argentina has conducted more than 7,000 laboratory assessments and boasts 1,100 nationally accredited laboratories in 19 of Argentina’s 24 provinces.17

The WHO-AFRO Stepwise Accreditation Approach

Recognizing the gap between the current state of laboratories and the requirements of ISO 15189, the WHO-AFRO approach provides laboratories with stepwise recognition of evolving fulfillment of the ISO 15189 standard rather than binary pass-fail grading. This program is not intended to replace established ISO 15189 accreditation schemes, but rather to provide an interim pathway for measuring, monitoring, and recognizing improvement toward the realization of international laboratory standards and subsequent application to full ISO 15189 schemes.

The WHO-AFRO accreditation process provides a framework to establish an effective quality management system for medical laboratory testing, characterized by strong programs for quality assurance, quality control, and quality improvement. All testing areas and processes are included, from preanalytical through postanalytical procedures, as are laboratory safety and ethics.

Following assessment, laboratories will be recognized on a 0- to 5-star ascending scale. Laboratories that fail to achieve at least 55% on assessment will not be awarded a star ranking. Laboratories that achieve 95% or more will receive a 5-star rating Figure 2. Once assessed, laboratories are expected to maintain their star status and work toward the next star. Laboratories awarded 5 stars will be strongly encouraged to enroll in an established ISO 15189 accreditation scheme.

This stepwise approach acknowledges laboratories where they stand, supports them with a series of assessment opportunities, and recognizes and rewards progress over time. The WHO-AFRO program benchmarks current performance, evaluates the distance remaining to achieve international standards, and establishes a mechanism for tracking progress toward these goals. Technical support will be intensified by AFRO and partners to help countries meet their accreditation goals. The program is expected to have a catalytic effect, encouraging the incorporation of accreditation goals into national strategic and operational plans, sensitizing policy makers and laboratory staff on accreditation, and nurturing the development of laboratories in the African region.

Figure 2

World Health Organization (WHO) Regional Office for Africa (AFRO) accreditation scheme showing the stepwise recognition of laboratory performance. Based on the percentage score, laboratories are assigned an accreditation level, based on 1 to 5 stars. Laboratories that receive a 5-star rating are strongly encouraged to transition to an internationally established accreditation scheme. The purpose of the WHO-AFRO accreditation is not to replace CAP, ISO, SANAS, or SADCAS accreditation, but to serve as an accreditation scheme to assist the laboratories in obtaining these internationally recognized accreditation standards. CAP, College of American Pathologists; ISO, International Organization for Standardization; JCI, Joint Commission International; SADCAS, South African Development Community Accreditation Service; SANAS, South African National Accreditation System.

Comparative Advantages of WHO-AFRO Accreditation

The WHO-AFRO laboratory accreditation process has 4 key comparative advantages: accessibility, affordability, scalability, and sustainability. Like the process itself, these advantages build on each other in a stepwise manner.

Accessibility

The stepwise approach described above makes the WHO-AFRO accreditation process accessible to public sector laboratories at various levels of development. Rather than deferring participation until the requirements of ISO 15189 are in place, countries can enroll in the WHO-AFRO program now and, through it, track the achievement of their laboratories toward upper-tier status. The WHO-AFRO program benefits countries that lack a national accreditation body and/or find that the services of international and regional bodies may not yet be easily accessible.

Affordability

The WHO-AFRO accreditation process is available to countries free of charge, eliminating a critical barrier to enrollment. This enables health officials and policy makers to begin to immediately develop national strategic plans that prioritize accreditation across their laboratory networks without undue financial constraints. To address other key costs encountered in the drive to accreditation, WHO AFRO will provide member countries with free proficiency testing (PT) services from a center currently being established in Senegal, and affordable calibration services are also being developed. These services will complement the WHO-sponsored PT panels currently provided to member countries. Rather than paying for external services, countries should instead dedicate their resources to strengthening laboratory quality systems.

Scalability

The accessibility and affordability of the program make it scalable for countries in the African region. The stepwise approach and limited cost to the user make it feasible for ministries of health to develop plans that, for example, involve their regional, provincial, and district laboratories in the space of a few years.

Sustainability

Each of the 3 previously described advantages make the WHO-AFRO program a sustainable means for promoting laboratory accreditation. For those minding budgets, affordability may be the most important factor in the year-over-year viability of the program. However, the scalability of the program enables the development of vital experience in the operation of laboratories striving toward accreditation across a greater number of laboratories. This will build a broader experience base in the laboratory workforce that will aid the cascade and consolidation of national efforts. This experience base will aid the longer term development of national laboratory experts who can contribute to and lead regional and national accrediting bodies.

These advantages—accessibility, affordability, scalability, and sustainability—position the WHO-AFRO laboratory accreditation process to have a marked influence on improving the quality of laboratory systems in the African region during the next 5 years.

Building Blocks of the Accreditation Process

There are several key building blocks of the accreditation process: (1) the role of WHO AFRO, (2) standards and assessment tools, (3) assessors and assessor training, (4) equipment calibration and biosafety, (5) laboratory management training, and (6) a PT provider.

The Role of WHO AFRO

Few countries in Africa have their own accrediting body for ISO 15189. Although not an accrediting body, WHO AFRO has established this stepwise accreditation process for medical laboratories in accordance with the WHO mandate to “develop, establish, and promote international standards with respect to food, biological, pharmaceutical, and similar products”18 and the WHO AFRO efforts to strengthen the tiered laboratory systems of its member states. In this capacity, WHO has accredited laboratories for important diseases, including polio, measles, and influenza, and HIV drug resistance.

Accreditation will be a crucial capacity-building focus of the WHO AFRO–supported Laboratory Network. The governance structure of the WHO-AFRO Laboratory Network includes a technical advisory group on laboratories that will provide oversight of the accreditation process and advise the WHO-AFRO secretariat on laboratory capacity building in the African region.

Standards and Assessment Tools

The WHO-AFRO laboratory accreditation process is based on ISO standard 15189:2007(E). The process is accessible to ministries of health for all laboratories providing clinical testing services.

The accreditation checklist is organized into headings similar to the Clinical and Laboratory Standards Institute Quality Systems Essentials. These 12 areas of assessment cut across both sections of the ISO 15189 standard (management and technical requirements) and help to facilitate the inspection process Table 1. The accreditation checklist evaluates areas common to ISO 15189 and other laboratory standards, such as ISO 17025, the evaluation criteria of the CAP, and the standards Thailand’s Medical Technology Council developed for use in Thailand Table 2.

The checklist’s 12 sections provide assessment on the basis of 110 clauses and 250 total possible points. Each item has been assigned a weighted value of 2, 3, or 5 points based on complexity and/or relative importance. Incomplete fulfillment of an item can be scored as “partial” and awarded a single point, with written explanation. Some clauses in the checklist are “tick lists” and require the satisfactory presence of all subitems listed below the main heading to receive full credit.

Baseline assessments using the WHO-AFRO checklist can be analyzed and presented as a gap analysis for national accreditation efforts, revealing facility-specific challenges and systemic areas of need that must be prioritized and addressed. Over time, progress in strengthening laboratories can be tracked by comparing assessment findings. In Lesotho, the WHO-AFRO checklist has been used as a monitoring tool to evaluate laboratories receiving mentoring support; these assessments have already helped to quantify and demonstrate areas of laudable progress and continuing challenge Figure 3.

Assessors and Assessor Training

Accreditation will be awarded based on biannual assessments of laboratories conducted by assessors selected and trained by WHO AFRO. These assessors will be drawn from laboratories across sub-Saharan Africa. Assessors are being trained in 2 training centers, one in Kenya for English-speaking assessors, the other in Cameroon for French-speaking assessors.

Assessor teams will be led by a team leader, and their size and composition will vary based on the scope of the laboratory seeking accreditation. Assessors will not be permitted to assess laboratories in their country of residence and will not be financially compensated.

Calibration and Biosafety

WHO AFRO, in close collaboration with the African Field Epidemiology Network Laboratory in Kampala, Uganda, will provide training on equipment calibration and biosafety for countries engaged in the accreditation process.

View this table:
Table 1

Laboratory Management Training and Mentoring

Strengthening Laboratory Management Toward Accreditation (SLMTA) is an innovative task- and competency-based training and mentoring tool kit jointly developed by the CDC, WHO AFRO, the Clinton Health Access Initiative, and the American Society for Clinical Pathology that equips laboratory managers preparing for accreditation.19 SLMTA begins with baseline assessments with the WHO-AFRO checklist and uses a multiple workshop model with supervised improvement projects conducted between trainings. A series of training sessions has been held at the African Center for Integrated Laboratory Training at the National Institute for Communicable Diseases, Johannesburg, South Africa, to build national training teams for SLMTA in 12 countries. Laboratory mentors who spend extended well-structured periods embedded in the daily life of a laboratory are also a valuable means of accelerating a laboratory’s path toward accreditation. The SLMTA training tool kit is well suited for use by mentors in facility-level work.

Proficiency Testing

The Department of Bacteriology and Virology of the Dantec Hospital, Dakar; Digital PT, Westford, MA; National Institute for Communicable Diseases; and National Health Laboratory Services, South Africa, will provide comprehensive PT for several analytes, including serology, microbiology, chemistry, hematology, and parasitological testing. The accreditation process will also accept PT programs by other recognized providers.

Specific Criteria

In addition to the 12-section, 250-point assessment checklist, several specific criteria are required to receive recognition in the WHO-AFRO accreditation process.

Turnaround Time

All laboratories seeking WHO-AFRO accreditation must be able to demonstrate that test results are reported within the stated turnaround times (TATs) that the laboratory has established in consultation with its clients. At least 80% of specimens received must be processed within the stated TATs to receive an accreditation rating. TATs will be interpreted as the time from receipt of the specimen in the laboratory until the reporting of results.

Volume of Testing

A sufficient number of tests must be performed on a quarterly basis to maintain laboratory competency. The number of tests for each test type required to meet this criterion will be determined by WHO AFRO.

Internal Quality Control

Internal quality control procedures must be practiced for all testing methods used by the laboratory. Ordinarily, each test kit has a set of positive and negative controls that are to be included in each test run. These controls included with the test kit are considered internal controls, whereas any other controls included in the run are referred to as external controls. Quality control data sheets and summaries of corrective action are retained for documentation and discussion with the assessor.

PT Performance

To be recognized by WHO AFRO, a laboratory must have scored, for each test, 80% or better on the 2 most recent PT panels. PT results must be reported in accordance with applicable deadlines. Unacceptable PT results must be addressed and corrective action taken and documented. Results will be accepted only from ISO accredited or WHO-AFRO approved PT providers.

Laboratories that receive less than 80% on 2 consecutive PT panels will lose their accreditation until they are able to successfully demonstrate achievement of 80% or greater on 2 consecutive PT panels. A laboratory that has failed to demonstrate achievement of 80% or greater on the 2 most recent PT panels will not be awarded any stars, regardless of the checklist score it received during the on-site assessment.

Figure 3

World Health Organization (WHO) Regional Office for Africa (AFRO) achievement before and after 10 weeks of embedded mentoring in the Mafeteng District Laboratory, Mafeteng, Lesotho. The laboratory was evaluated at baseline and following 10 weeks of on-site embedded mentoring. Achievement is represented as the percentage of the total possible points that were awarded in each of the 12 AFRO-WHO checklist sections. For example, at baseline, the laboratory was awarded 20% of the total points in the internal audit category. After 10 weeks of mentorship, the laboratory earned 60% of the points in the section. EQA, external quality assurance; IQC, internal quality control.

Summary

With the funding currently available for global health, it is imperative that the WHO and partners act now and act together to strengthen the quality of national health laboratory services in Africa. Developing a stepwise accreditation process for laboratories is a pragmatic and effective action to improve patient care, prevention, and disease surveillance. The newly established WHO-AFRO accreditation process offers a shift in paradigm for implementing standards in developing countries, away from binary pass-fail grading to a stepwise process for recognizing improvement toward the full requirements of ISO 15189. The WHO-AFRO laboratory accreditation process is accessible, affordable, scalable, and sustainable. In fact, more than 100 laboratories in Cameroon, Ethiopia, Côte d’Ivoire, Kenya, Lesotho, Nigeria, Rwanda, Tanzania, Zambia, and Zimbabwe have already begun preparing for the process.

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