Implementation of a national external quality assessment program for medical laboratories in Burkina Faso: challenges, lessons learned, and perspectives.

OBJECTIVES: The National External Quality Assessment (NEQA) program of Burkina Faso is a proficiency testing program mandatory for all laboratories in the country since 2006. The program runs two cycles per year and covers all areas of laboratories. METHODS: All panels were validated by the expert committee before dispatch under optimal storage and transport conditions to participating laboratories along with report forms. RESULTS: Performance in the last 5 years varied by panel, with average annual performance of bacteriology panels for all laboratories rising from 75% in 2006 to 81% in 2010 and with a best average performance of 87% in 2007 and 2008. During the same period, malaria microscopy performance varied from 85% to 94%, with a best average performance of 94% in 2010; chemistry performance increased from 87% to 94%, with a best average annual performance of 97% in 2009. Hematology showed more variation in performance, ranging from 61% to 86%, with a best annual average performance of 90% in 2008. Average annual performance for immunology varied less between 2006 and 2010, recording 97%, 90%, and 95%. Except for malaria microscopy, annual performances for enrolled panels varied substantially from year to year, indicating some difficulty in maintaining consistency in quality. CONCLUSIONS: The main challenges of the NEQA program observed between 2006 to 2010 were funding, sourcing, and safe transportation of quality panels to all laboratories countrywide.

Scaling up HIV rapid testing in developing countries: comprehensive approach for implementing quality assurance.

In the last few years, the use of HIV rapid testing has expanded worldwide in response to the call for universal access to prevention, care, and treatment by UNAIDS and the World Health Organization. HIV rapid testing is performed by people with varied skills in laboratory and nonlaboratory settings. Accurate HIV diagnostic testing is the first step to identifying infected persons for follow-up referral and care. However, there are several challenges related to test kit quality, test selection, testing algorithms, training, quality assurance (QA), quality of new lots, and postmarket performance. We highlight various issues that impact the quality of HIV rapid testing and provide solutions to monitor and improve test accuracy, especially in resource-limited settings. These include the use of validated kits, training with emphasis on QA, use of a standardized log book, dried-tube specimen-based proficiency testing, new kit lot verification, and postmarket surveillance. Systematic implementation of these tools should greatly enhance the quality of HIV rapid testing.

Laboratory systems and services are critical in global health: time to end the neglect?

The $63 billion comprehensive global health initiative (GHI) emphasizes health systems strengthening (HSS) to tackle challenges, including child and maternal health, HIV/AIDS, family planning, and neglected tropical diseases. GHI and other initiatives are critical to fighting emerging and reemerging diseases in resource-poor countries. HSS is also an increasing focus of the $49 billion program of the US President's Emergency Plan for AIDS Relief and the Global Fund to Fight AIDS, Tuberculosis and Malaria. Laboratory systems and services are often neglected in resource-poor settings, but the funding offers an opportunity to end the neglect. To sustainably strengthen national laboratory systems in resource-poor countries, the following approaches are needed: (1) developing integrative national laboratory strategic plans and policies and building systems to address multiple diseases; (2) establishing public-private partnerships; (3) ensuring effective leadership, commitment, and coordination by host governments of efforts of donors and partners; (4) establishing and/or strengthening centers of excellence and field epidemiology and laboratory training programs to meet short- and medium-term training and retention goals; and (5) establishing affordable, scalable, and effective laboratory accreditation schemes to ensure quality of laboratory tests and bridge the gap between clinicians and laboratory experts on the use of test results.

The World Health Organization African region laboratory accreditation process: improving the quality of laboratory systems in the African region.

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.

World Health Organization/HIVResNet Drug Resistance Laboratory Strategy.

With rapidly increasing access to antiretroviral drugs globally, HIV drug resistance (HIVDR) has become a significant public health issue. This requires a coordinated and collaborative response from country level to international level to assess the extent of HIVDR and the establishment of efficient and evidence-based strategies to minimize its appearance and onward transmission. In parallel with the rollout of universal access to HIV treatment, countries are developing protocols based on the recommendations of the World Health Organization (WHO) to measure, at a population level, both transmitted HIVDR and HIVDR emerging during treatment. The WHO in collaboration with international experts (HIVResNet Laboratory Working Group), has developed a laboratory strategy, which has the overall goal of delivering quality-assured HIV genotypic results on specimens derived from the HIVDR surveys. The results will be used to help control the emergence and spread of drug resistance and to guide decision makers on antiretroviral therapy policy at national, regional and global level. The HIVDR Laboratory Strategy developed by the WHO includes several key aspects: the formation of a global network of national, regional and specialized laboratories accredited to perform HIVDR testing using a common set of WHO standard and performance indicators; recommendations of acceptable methods for collection, handling, shipment and storage of specimens in field conditions; and the provision of laboratory technical support, capacity building and quality assurance for network laboratories. The WHO/HIVResNet HIVDR Laboratory Network has been developed along the lines of other successful laboratory networks coordinated by the WHO. As of August 2007, assessment for accreditation has been conducted in 30 laboratories, covering the WHO's African, South-East Asia, Western Pacific, and the Caribbean Regions.