AJCP / Original Article

Implementation of a National External Quality Assessment Program for Medical Laboratories in Burkina Faso Challenges, Lessons Learned, and Perspectives Jean Sakandé,PhD,1, 2 Abdoulaye Nikièma,PharmD,1 Elie Kabré,PhD,2 Charles Sawadogo,PharmD,1 Eric W. Nacoulma, MD,3 Mamadou Sanou, PharmD,4 Lassana Sangaré, PhD,4 Rasmata Traoré-Ouédraogo, PhD,4 Mamadou Sawadogo, PhD,2 and Guy Michel Gershy-Damet, PhD5

Key Words: External quality assessment; Laboratory network; Burkina Faso DOI: 10.1309/AJCPXC83HIBBSRDT

ABSTRACT 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.

© American Society for Clinical Pathology

Upon completion of this activity you will be able to: • list the challenges faced and lessons learned in the implementation of an External Quality Assessment (EQA) program in a sub-Saharan country. • describe the steps in an EQA survey. • describe the statistical methods used in proficiency testing. The ASCP is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The ASCP designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 Credit ™ per article. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This activity qualifies as an American Board of Pathology Maintenance of Certification Part II Self-Assessment Module. The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose. Questions appear on p 292. Exam is located at www.ascp.org/ajcpcme.

Burkina Faso is a landlocked country in the Sahel region of West Africa. Its size is about 274,200 sq km (105,900 sq miles), with an estimated population of 14,017,262 and an annual population growth rate of 3.1%.1 With a gross national per capita income estimated in 2008 to be US $1,215 annually, Burkina Faso is among the least developed countries.2 Surveys show a crude mortality rate of about 11.8% in 2006. The most prevalent diseases of public health importance are malaria, acute respiratory infections, diarrheal diseases, tuberculosis, AIDS, and sexually transmitted infections. The epidemiologic profile of the country is also marked by a progressive increase in the burden of noncommunicable diseases such as diabetes, hypertension, and cancers.3 The crucial role played by laboratories in surveillance and treatment of diseases such as AIDS and tuberculosis is

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From the 1Department of Laboratories, Ministry of Health, Ouagadougou, Burkina Faso; Laboratories of 2Biochemistry, 3Hematology, and 4Microbiology, University of Ouagadougou, Burkina Faso; and 5World Health Organization, IST/West Africa.

Sakandé et al / NEQA Program in Burkina Faso

now recognized.4-7 Thus, in 2002 the government of Burkina Faso created a specific department for clinical laboratories within the Ministry of Health whose mission is to coordinate the development of laboratory medicine.8 In 2004, the Department of Laboratories conducted a situation analysis on the status of clinical laboratory services in Burkina Faso.9 The study found that the laboratory system consisted of 160 public and private laboratories (national reference laboratories, regional hospital laboratories, and district medical center laboratories). Most laboratories (80%) failed to meet the basic requirements for adequate functioning: lack of laboratory supplies, reagents, equipment, and poor laboratory infrastructure (unique room for all laboratory works, cracked walls, broken ceilings, and no water and electricity supply). The results of this evaluation led to the development and adoption in 2006 of a national laboratory policy and strategic plan.10 One of the objectives of this policy was to improve the quality of laboratory services. We describe herein the implementation and challenges of a National External Quality Assessment (NEQA) program in Burkina Faso that was established in 2006 through a Ministry of Health decree.11 Participation in the NEQA program is mandatory for all laboratories and free of charge.

Materials and Methods The operational activities of the NEQA program are coordinated by an expert committee composed of professors at the University of Ouagadougou, Burkina Faso, and specialists at reference laboratories. Proficiency testing panels are sent out twice a year and cover laboratory testing areas of bacteriology, virology, parasitology, immunology, clinical chemistry, and hematology. The analytes covered and frequencies of surveys are listed in ❚Table 1❚. In Burkina Faso, district laboratories are headed by technicians, regional laboratories by pharmacists, and national and private laboratories by pharmacists or specialist physicians. Participation in the NEQA program was anonymous, with laboratories identified by a permanent identification code. The NEQA program consisted of the following steps. Information to the Participating Laboratories An information letter endorsed and signed by the Permanent Secretary of the Ministry of Health was sent to the laboratories at least 2 weeks before the NEQA proficiency panels were sent. This letter indicates the period of the survey. Preparation of NEQA Specimens Specimens of known characteristics were prepared by the reference laboratories according to their area of expertise

❚Table 1❚ Types of Participating Laboratories, Tests Performed, and Number of Surveys From 2006 to 2010a Types of Laboratories

Tests Performed

No. of Surveys

District laboratories (n = 66) Malaria microscopy Bacteriology Gram staining for meningitis pathogens TB microscopy (Ziehl-Neelsen staining) HIV serological diagnosis Chemistry (glucose, urea, creatinine, uric acid, AST, ALT, and cholesterol) Hematology Peripheral blood smear Hemoglobin measurement Regional laboratories (n = 9) Malaria microscopy Bacteriology Gram staining for meningitis pathogens TB microscopy (Ziehl-Neelsen staining) Culture HIV serological diagnosis Hepatitis B antigen diagnosis Chemistry (glucose, urea, creatinine, uric acid, AST, ALT, cholesterol,   magnesium, calcium, sodium, and potassium) Hematology Peripheral blood smear Hemoglobin measurement Blood typing CD4 lymphocyte counting National laboratories (n = 9) Same tests performed at the regional level Private laboratories (n = 70) Same tests performed at the regional level

6 8 1 4 10 6 2 6 8 1 2 4 3 10 6 2 3 1

ALT, alkaline transaminase; AST, alkaline transaminase; HIV, human immunodeficiency virus; TB, tuberculosis. a The CD4 lymphocytes counting survey was performed only once. This was due to difficulties in obtaining and maintaining the panels. There was also a lack of immunology specimens in 2008 and 2010. A tuberculosis microscopy survey had been performed once because a similar program was implemented by the National Tuberculosis Program

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following standard operating procedures or purchased from private companies. In-House Prepared Panels Bacteriology: Gram-stained smears, Ziehl-Neelsen-stained   smears, and bacteria strains in culture media. Hematology: May-Grunwald Giemsa-stained blood smears   for WBC differential count. Parasitology: Giemsa-stained blood smears for malaria  microscopy. Immunology: Pooled serum samples for the serologic   diagnosis of human immunodeficiency virus and hepatitis   B infections. Purchased Ready-Made Panels Clinical chemistry panels were acquired from bioMérieux SA (Marcy l’Etoile, France) and Spinreact (Vall D’en Bas, Spain). Clinical chemistry parameters to be measured included glucose, urea, creatinine, uric acid, aspartate transaminase, alanine transaminase, cholesterol, magnesium, calcium, sodium, and potassium. Each panel had two levels (normal and abnormal range). Whole blood material (normal and abnormal range) for hemoglobin measurement were from HORIBA ABX SAS (Parc Euromédecine, Montpellier, France); CD4+ cell isolation tubes were from Becton Dickinson (Franklin Lakes, NJ). All panels were validated by the expert committee before dispatch. The validation included retesting all panels in triplicate by different experts to verify the correct status of each analyte and to check correct labeling and reproducibility of the sample production. Distribution of EQA Specimens The technical staff sent out the challenge specimens, along with report forms, to the enrolled laboratories under optimal storage and transport conditions using coolers and ice and slide boxes. Because of poor postal services, Ministry of Health vehicles were used for transporting samples. A time frame of 2 weeks was given to the participating laboratories to send back their findings.

❚Table 2❚ Scoring System for Quantitative Tests (Chemistry, Hematology) Value (V) Obtained by Participating Laboratory

Scoring

Interpretation

M – 2 SD ≤ V ≤ M + 2 SD M – 3 SD < V < M +3 SD V ≤ M – 3 SD or V ≥ M + 3 SD

A B C

Satisfactory Acceptable Nonsatisfactory

M, median; SD, standard deviation.

Collection of Participating Laboratory Results Several options were available for return of results by the laboratory, including private transport companies, e-mail, or fax. Analysis of Results Data were analyzed using EPI-INFO 2000 software, version 3.3 (Centers for Disease Control and Prevention, Atlanta, GA). The results of quantitative tests performed by participating laboratories were evaluated using target values for every scheme. Target values for each analyte were calculated using the median (M) 50th percentile of all participants’ results. The standard deviation (SD) was calculated using the Tukey nonparametric method.12 The following formula based on percentiles (P) was used: SD = (P75 – P25)/1.349. ❚Table 2❚ lists the performance assessment criteria for quantitative tests. For qualitative tests in bacteriology, parasitology, and immunology, participating laboratories were evaluated against expected results established by reference laboratories.13 The performance of the laboratories was assessed as shown in ❚Table 3❚. Results Reporting and Feedback After analysis and review of submitted results by the laboratories, the NEQA program produces standard reports that are sent to each laboratory confidentially through private couriers. A standard NEQA report contains (1) the participating laboratory’s identification number, (2) the panel/cycle number, (3) laboratory results, (4) expected results, (5) the

❚Table 3❚ Scoring System for Qualitative Tests (Microbiology, Immunology) Score Result Definition

Performance Assessment

4 Completely correct result A result accepted as the most correct and clinically relevant result 3 Almost completely correct result A result not entirely correct but having little or no clinical impact; a deviation   from what is considered the most clinically relevant result 1 A significantly incorrect result A clinically relevant result that could lead to a diagnosis or treatment error 0 Completely incorrect result A clinically relevant result that could lead to a major diagnosis or treatment error

Correct

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❚Table 4❚ Evolution of Targeted Laboratories in the National External Quality Assessment Program From 2006 to 2010 Year

Targeted Laboratories

2006 82 2007 87 2008 154 2009 138 2010 135

Responding Laboratories

%

78 85 135 103 119

95.1 97.7 87.7 74.6 88.2

laboratory’s score/appreciation as determined by the expert committee, (6) performance of all other participating laboratories (without identifiers), (7) comments on unsatisfactory results, and (8) description of the problems encountered by the laboratory and corrective actions to be taken. A general report is published twice a year through NEQA annals and presented during the Ministry of Health cabinet meeting as a way to monitor the National Laboratory Quality Plan.

Results ❚Table 4❚ shows the rollout and performance of the

Percentage of Satisfactory Results

NEQA program between 2006 and 2010 when a total of 10

surveys were conducted. The total number of laboratories that participated in the two mandatory surveys each year was 82, 87, 154, 138, and 135 in 2006, 2007, 2008, 2009, and 2010, respectively. ❚Figure 1❚ displays the evolution of the laboratories’ performances by area from 2006 to 2010. Total adequate performance in bacteriology rose from 75% of challenges in 2006 to 87% in 2007 and 2008 (a significant improvement; P < .05) and then fell to 82% in 2009 and 81% in 2010 ❚Table 5❚. Total adequate performance in malaria microscopy increased from 76% of challenges in 2006 to 85% in 2007 and rose to 90%, 91%, and 94% in 2008, 2009, and 2010, respectively (a significant improvement at the P < .001 level) (Table 5). Immunology scores, in contrast, fell significantly from 97% in 2006 to 90% in 2007 (P < .05) and then rose insignificantly to 95% in 2009 (Table 5). Clinical chemistry performance remained in the mid80% range in 2006, 2007, and 2008 (87%, 85%, and 86%) and then rose to the mid-90% range in 2009 and 2010 (97% and 94%). The latter two performances were significantly better than the first three (P < .05) ❚Table 6❚. For hematology, the swings in performance were significant from year to year. They went from 61% and 68% in 2006 and 2007 to 90% in 2008 and then decreased to 69% in 2009 before increasing to 86% in 2010 (P < .01) (Table 6).

100 90 80 70 60 50 40 30 20 10 0

2006 2007 2008 2009 2010

Biochemistry

Bacteriology

Parasitology

Hematology

Immunology

Areas of the EQA

❚Figure 1❚ Laboratory performances by area from 2006 to 2010. EQA, External Quality Assessment. ❚Table 5❚ Evolution of Infectious Disease–Related Laboratory Performance (Rate of Satisfaction) According to Laboratory Level From 2006 to 2010

Bacteriology, % by Year

Laboratory Level

Malaria Microscopy, % by Year

Immunology, % by Year

2006 2007 2008 2009 2010 2006 2007 2008 2009 2010 2006 2007 2008 2009 2010

District laboratories 72 81 81 77 70 72 84 87 89 90 93 89 --- 92 --Regional laboratories 73 84 85 78 75 73 84 89 90 92 95 88 --- 94 --National laboratories 78 92 92 86 89 82 86 92 93 98 100 92 --- 98 --Private laboratories 78 90 90 87 89 79 87 91 92 98 100 91 --- 96 --Total 75 87a 87a 82 81 76 85 90b 91b 94b 97 90a --- 95 --a b

P < .05. P < .001.

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❚Table 6❚ Evolution of Chemistry and Hematology Laboratory Performance (Rate of Satisfaction) According to Laboratory Level From 2006 to 2010

Clinical Chemistry, % by Year

Laboratory Level

Hematology, % by Year

2006 2007 2008 2009 2010 2006 2007 2008 2009 2010

District laboratories 80 79 81 95 90 49 55 Regional laboratories 84 82 83 96 92 54 60 National laboratories 92 90 90 100 95 73 82 Private laboratories 94 89 90 99 98 67 75 Total 87 85 86 97a 94b 61 68 a b

80 58 81 86 63 83 98 84 91 95 71 89 90a 69 86a

P < .001. P< .05.

Discussion The introduction of the NEQA program in Burkina Faso provided an opportunity for laboratories in the country to participate in an external quality assessment (EQA) program for monitoring the quality of laboratory results. Improvements in performance were shown between 2006 and 2008, and a decline was observed between 2009 and 2010. Nevertheless, final 2010 performances remained well above initial 2006 levels. Compared with 2006, the NEQA program showed statistical improvement in bacteriology, malaria microscopy, clinical chemistry, and hematology. Except for malaria microscopy, annual performances continued to vary substantially from year to year, indicating some difficulty in maintaining consistent quality. The levels of performance documented here are similar to those reported by Ibrahim and colleagues14 from clinical trial centers in Burkina Faso and Ghana but lower than the performance of laboratories in developed countries.15,16 The observed performance can be considered satisfactory within the context of services in Burkina Faso, a resource-limited country. The laboratory services of Burkina Faso have problems similar to those observed in other African countries,17 including inadequate supply of consumables, insufficient skilled personnel, fluctuations in the supply of electricity, poor storage and transport of reagents, lack of controls and calibration materials, unqualified suppliers, lack of postmarketing quality control (QC), and lack of equipment maintenance. Most laboratories (85%) using semiautomatic spectrophotometers were not trained in manual QC monitoring and real-time plotting of Levey Jennings charts; therefore, Westgard statistical QC rules were not implemented as recommended. Observed variations in laboratory performances must be explored to identify factors contributing to unsatisfactory performance. The Clinical and Laboratory Standards Institute guideline has classified errors that account for unsatisfactory proficiency test results into clerical, methodological, © American Society for Clinical Pathology

technical, testing materials, and random errors.18 In the study by Ibrahim et al14 conducted in the same region of sub-Saharan Africa, methodological errors accounted for 55% of errors. The NEQA program encountered a number of challenges. Although the production of high-quality specimens remained essential in the implementation of the NEQA program, there were challenges in consistently accessing high-quality survey slides, which is pivotal because they have a direct impact on the credibility of the program. Some of the financial and technical challenges affected the performance of the program in some surveys. For example, CD4 lymphocyte counting was performed only once (2009) because of difficulties in obtaining and maintaining the panels that require expensive special tubes. Similarly, there were no survey samples for immunology in 2008 and 2010. Only one tuberculosis microscopy survey was conducted (2008) because the National Tuberculosis Program conducted a similar program. An effective mechanism by which to deliver survey samples was critical for the success of the NEQA program. The lack of a reliable postal distribution network within the country forced the NEQA program to use special vehicles to deliver the specimens, which was rather costly. The management of NEQA program results was another key issue. Survey results from the first 3 years of the NEQA program were analyzed and presented to the Minister of Health and his cabinet members. At that meeting, the laboratory performance, the NEQA program’s capacity to support the health system, and the impact of the allocated resources were reviewed. The Ministry of Health requested the identities of laboratories performing below standards so as to reprimand them, but the NEQA program maintained its nondisclosure policy because it is convinced that the EQA scheme is a tool for continuous improvement and not punitive. From a review of the survey period, it was evident that implementation of the NEQA program requires sustainable and consistent financial support. The budget allocated to the

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NEQA program declined over the years because of reduced external funding. To alleviate these financial constraints, the NEQA program trained two of its personnel as data managers, thereby reducing the costs of coordination and data analysis. The freed funds made it possible to increase the number of participating laboratories from 82 to 135 between 2006 and 2010. To address the sustainability of the NEQA program as it is currently financed through external partnerships, discussions are under way to create a specific line item for the NEQA program within the national budget. Vital lessons were learned from implementation of the NEQA program of Burkina Faso. Ministry of Health involvement both enforced and increased the participation of laboratories, as evidenced by the data presented. Full government support was an important factor in acceptance of the program by laboratories. Key factors for success included the Ministry of Health’s enforcement of mandatory participation, their followup of nonparticipating laboratories, issuance of written warnings, and withdrawal of practice certificates for repeated nonparticipation. Timely feedback from the NEQA program to the laboratory was key for continued participation of laboratories. Institution of the NEQA program in 2006 was a tool of governance for the new laboratory department created in 2002 by the government of Burkina Faso. Indeed, based on the results of the NEQA program, the department has acted to improve the laboratory system by (1) development of national laboratory standards and guidelines and a quality plan19-21; (2) training in maintenance, quality assurance, parasitology, hematology, and immunology22,23; and (3) implementation of a system of reagent assessment and registration.24,25 The NEQA program was also instrumental in the success of the laboratory management tool, “Strengthening Laboratory Management Toward Accreditation”, and the World Health Organization (WHO) AFRO Strengthening Quality Improvement Process Towards Accreditation that were launched in Kigali, Rwanda, in 2009.26 These two initiatives by the WHO and its partners are meant to assist laboratories in gaining ISO 15189–based international accreditation whereby participation in an EQA program is mandatory.27 To further strengthen the NEQA program, testing procedures and the integrity of challenge materials will need to be improved. In response to this need, a NEQA program unit is being established in the Department of Laboratories at the Ministry of Health to facilitate the production of high-quality specimens. This action is supported by the Fondation Merieux (Lyon, France) through the RESAOLAB (West African Laboratories Network) project. The medium-term objective is to certify the NEQA program management system according to the 2008 ISO 9001 standard, with the long-term objective to have the NEQA program accredited according to 2010 ISO/ IEC 17043 standards.28

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This NEQA program was supported by the Centers for Disease Control and Prevention, Atlanta, GA, and Sanitary Development Program of Burkina Faso. Address reprint requests to Dr Sakandé: National Laboratory Network of Burkina Faso, 01 PO Box 7009, Ouagadougou 01, Burkina Faso; [email protected].

References 1. Ministère de l’économie et des finances. Recensement général de la population et de l’habitation RGPH de 2006 du Burkina Faso. 2008. http://cns.bf/IMG/pdf/Depliant_Resultats_ Definitifs_du_RGPH_2006.pdf. Accessed September 26, 2011. 2. United Nations Development Programme. Human Development Report 2010: 20th Anniversary Edition. New York, NY: UNDP; 2010. 3. Ministère de la Santé du Burkina Faso. Annuaire statistique 2009. Ouagadougou, Burkina Faso: DEP/MS, 2009. 4. World Health Organization Regional Committee for Africa. Resolution AFR/RC48/R2: integrated epidemiological surveillance of diseases: regional strategy for communicable diseases. In: Forty-Eighth Session of the WHO Regional Committee for Africa: Final Report. Harare, Zimbabwe: World Health Organization, Regional Office for Africa; 1998:5-6. 5. World Health Organization Regional Committee for Africa. Resolution AFR/RC58/R2: strengthening public health laboratories in the WHO African region: a critical need for disease control. In: Final Report: 58th Session of the WHO Regional Committee for Africa. Brazzaville, Republic of the Congo: World Health Organization Regional Committee for Africa; 2008:11-13. 6. World Health Organization. The Maputo Declaration on Strengthening of Laboratory Systems. January 2008. http://www. who.int/diagnostics_laboratory/Maputo-Declaration2008.pdf. Accessed September 26, 2011. 7. World Health Organization. Joint WHO-CDC conference on health laboratory quality systems, Lyon, April 2008: joint statement and recommendations. Wkly Epidemiol Rep. 2008;83:285-287. 8. Ministère de la santé. Organisation du Ministère de la santé. Décret N° 2002-464/PRES/PM/MS du October 28, 2002. 9. Direction Générale de la pharmacie, du médicament et des laboratoires. Rapport de l’analyse de la situation des laboratoires d’analyses de biologie médicale. 2004. 10. Ministère de la santé. Document cadre de politique nationale en matière d’analyses de biologie médicale au Burkina Faso. Décret N°2007-213/PRES/PM/MS du April 24, 2007. 11. Ministère de la santé. Contrôle National de qualité des analyses de biologie médicale au Burkina Faso. Arrêté N°2007-203/MS/ CAB du May 28, 2007. 12. Tukey JW. Exploratory Data Analysis. Readling, MA: Addison-Wesley; 1977. 13. World Health Organization. Policies and Procedures of the WHO/NICD Microbiology External Quality Assessment Programme in Africa. Years 1 to 4, 2002-2006. Geneva, Switzerland: World Health Organization; 2007. WHO document no. WHO/CDS/EPR/LYO/2007.3. 14. Ibrahim F, Dosoo D, Kronmann KC, et al. Good clinical laboratory practices improved proficiency testing performance at clinical trials centers in Ghana and Burkina Faso. PLoS One. 2012;7:e39098. © American Society for Clinical Pathology

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15. Ricós C, Ramón F, Salas A, et al; Interdisciplinary Expert Committee for Quality Specifications in Clinical Laboratory. Minimum analytical quality specifications of inter-laboratory comparisons: agreement among Spanish EQAP organizers. Clin Chem Lab Med. 2011;50:455-461. 16. Annales du Contrôle National de Qualité des Analyses de biologie Clinique. ansm.sante.fr/content/download/41292/ 537423/version/1/.../an10bio.pdf. Accessed November 7, 2012. 17. Frean J, Perovic O, Fensham V, et al. External quality assessment of national public health laboratories in Africa, 2002-2009. Bull World Health Organ. 2012;90:191-199. 18. Clinical and Laboratory Standards Institute (CLSI). Using Proficiency Testing to Improve the Clinical Laboratory: Approved Guideline—Second Edition. Wayne, PA: Clinical and Laboratory Standards Institute; 2007. CLSI document GP27A2. 19. Direction Générale de la pharmacie, du médicament et des laboratoires. Plan Qualité Pour les Laboratoires D’Analyses de Biologie Médicale du Burkina. 2010. 20. Ministère de la santé. Guide de bonne exécution des analyses de biologie médicale au Burkina Faso. Arrêté N°2009-247/MS/ CAB. August 24, 2009. 21. Direction Générale de la pharmacie, du médicament et des laboratoires. Guide de Maintenance Préventive des Principaux Équipements de Laboratoire. 2007.

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22. Direction Générale de la pharmacie, du médicament et des laboratoires. Plan de Formation Continue des Personnels des Laboratoires D’Analyses de Biologie Médicale du Burkina. 2010. 23. Direction Générale de la pharmacie, du médicament et des laboratoires. Normes en Matière de Laboratoires D’Analyse de Biologie Médicale: Infrastructures, Équipements et Analyses Essentielles par Niveau des Formations Sanitaires Publiques. 2009. 24. Ministère de la santé. Conditions D’Évaluation des Réactifs de Dépistage et de Confirmation des Anticorps anti-VIH au Burkina Faso. Arrêté N°2007-204/MS/CAB du May 28, 2007. 25. Ministère de la santé. Création, Attributions, Composition et Fonctionnement du Comité D’Experts Chargé de L’Étude des Dossiers D’Enregistrement des Réactifs de Laboratoires D’Analyses de Biologie Médicale. Arrêté N°2007-202/MS/CAB du May 28, 2007. 26. Gershy-Damet GM, Rotz P, Cross D, et al. The World Health Organization African region laboratory accreditation process: improving the quality of laboratory systems in the African region. Am J Clin Pathol. 2010;134:393-400. 27. ISO 15189. Medical Laboratories: Particular Requirements for Quality and Competence. 2007. 28. ISO/IEC 17043. Conformity Assessment: General Requirements for Proficiency Testing. 2010.

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

The National External Quality Assessment (NEQA) program of Burkina Faso is a proficiency testing program mandatory for all laboratories in the country...
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