AJCP / Original Article

Laboratory Quality Improvement in Tanzania Linda R. Andiric, EdD,1 and Charles G. Massambu, Mmed Path2 From the 1American Society for Clinical Pathology, Chicago, IL, and 2Tanzania Ministry of Health and Social Welfare, Dar es Salaam. Key Words: Laboratory quality improvement; SLMTA; SLIPTA; WHO AFRO accreditation; Tanzanian medical laboratories; Stepwise laboratory accreditation Am J Clin Pathol  April 2015;143:566-572

CME/SAM

DOI: 10.1309/AJCPAB4A6WWPYIEN

ABSTRACT Objectives: The article describes the implementation and improvement in the first groups of medical laboratories in Tanzania selected to participate in the training program on Strengthening Laboratory Management Toward Accreditation (SLMTA). Methods: As in many other African nations, the selected improvement plan consisted of formalized hands-on training (SLMTA) that teaches the tasks and skills of laboratory management and provides the tools for implementation of best laboratory practice. Implementation of the improvements learned during training was verified before and after SLMTA with the World Health Organization African Region Stepwise Laboratory Improvement Process Towards Accreditation checklist. Results: During a 4-year period, the selected laboratories described in this article demonstrated improvement with a range of 2% to 203% (cohort I) and 12% to 243% (cohort II) over baseline scores. Conclusions: The article describes the progress made in Tanzania’s first cohorts, the obstacles encountered, and the lessons learned during the pilot and subsequent implementations.

566 Am J Clin Pathol  2015;143:566-572 DOI: 10.1309/AJCPAB4A6WWPYIEN

Upon completion of this activity you will be able to: • compare the World Health Organization’s Stepwise Laboratory Improvement Process Towards Accreditation with other accreditation schemes such as College of American Pathologists, Joint Commission, or the International Organization for Standardization (ISO 15189). • describe the benefits of a teaching method for prescriptive, hands-on learning for laboratory improvement such as Strengthening Laboratory Management Toward Accreditation. • compare total staff involvement in laboratory improvement with improvement implemented only by laboratory management. • list some reasons why progress in improvement in Tanzania was not successful or sustained. 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 606. Exam is located at www.ascp.org/ajcpcme.

In 2005, health care in sub-Saharan Africa was focused on infectious diseases, most notably human immunodeficiency virus (HIV), AIDS, tuberculosis (TB), and malaria. However, laboratory testing to confirm diagnosis or monitor treatment was both underused and undervalued. Misdiagnosis regularly occurred and not only increased mortality but also masked the true prevalence of any specific disease.1 Reyburn et al2 found that among 4,670 patients admitted to hospitals in Tanzania and treated for malaria, fewer than 50% actually had malaria confirmed by a blood smear. Clinicians often rationalized that laboratory tests were an unnecessary additional cost because diagnoses and treatment protocols were based only on the physician’s clinical judgment. If or when laboratory data were available, they were

© American Society for Clinical Pathology

AJCP / Original Article

perceived as unreliable. If test results were received and were contradictory to clinical impressions, those test results were frequently ignored, and only the clinical indicators were considered.1 The allocation of funding earmarked to provide a better laboratory system was also largely ignored, even as billions of dollars from donors such as the World Bank, Global Fund, the US President’s Emergency Fund for AIDS Relief (PEPFAR), and other private foundations were channeled almost exclusively toward disease prevention and medicines for treatment. Furthermore, laboratory infrastructure and personnel were thwarted by a lack of resources but also a deficiency in expertise and experience in the implementation of reliable laboratory practice.1,3 From 2008 to 2009, recognition began to emerge that a quality laboratory service was the foundation of a strong health care system. Laboratory medicine began at last to receive attention. Six landmark events took place ❚Table 1❚ throughout Africa that served to build consensus and to focus attention for a systematic and standardized approach to improve African national health laboratory systems.3 In addition, there must be an established clear indicator of improvement, including an indicator that could assess the sustainment of improvements once they were made. This indicator was the number of laboratories that achieved and maintained accreditation.4,5 In 2009, President Obama renewed the US commitment for strengthening health systems with a $63 billion comprehensive Global Health Initiative. From this and other private allocations (including the World Bank), a significant amount of money was dedicated to strengthening laboratory systems in a holistic manner and to establish comprehensively a functional tiered laboratory network without regard to any specific disease. Individual country health system leadership was asked to commit and coordinate efforts and to develop a national strategic plan for laboratory improvement. Integral to these plans was the provision of adequate laboratory infrastructure and a framework for improvement that included the core elements and quality essentials for good laboratory practice.5 Critical factors for success were public-private collaborations and partnerships that assisted in laboratory capacity building.6-8 Tanzania, like other African countries, quickly joined in the laboratory improvement scheme as called for at the Kigali Conference in 2009, which specified the World Health Organization African Region Stepwise Laboratory Improvement Process Towards Accreditation (WHO AFRO SLIPTA) that was officially initiated in 2012 and the laboratory training program, Strengthening Laboratory Management Toward Accreditation (SLMTA), begun in 2010.9 For the first cohort, 12 laboratories were selected from around the country (six regional laboratories and six

© American Society for Clinical Pathology

❚Table 1❚ Landmark Events Leading to Laboratory Quality Improvement in Africa3 1. January 2008 (Maputo, Mozambique): The Maputo Declaration to strengthen laboratory systems in developing countries was issued by 33 countries. 2. April 2008 (Lyon, France): A statement was issued by World Health Organization and the US Centers for Disease Control and Prevention calling for limited-resource countries to develop quality laboratory systems using a staged approach leading to accreditation. 3. September 2008 (Yaounde, Cameroon): Member states of the 58th session of the Regional Committee adopted a resolution to strengthen public health laboratories at all levels of the health care system. 4. September 2008 (Dakar, Senegal): At the fifth meeting of the Regional HIV/AIDS Network for Public Health Laboratories, it was agreed to include all laboratories rather than only those laboratories with a specific disease designation. 5. July 2009 (Kigali, Rwanda): A laboratory management tool called Strengthening Laboratory Management Toward Accreditation and a stepwise laboratory accreditation process were introduced. 6. September 2009 (Kigali, Rwanda): During the 69th session of the Regional Committee, member states adopted resolutions that called for strengthening public health laboratories.

district laboratories). All hospitals selected served a general inpatient and outpatient population either from midsized or larger cities (regional) or smaller community hospitals (district). Selection criteria for facilities to receive the improvement training were the following: (1) a suitable infrastructure (such as a temperature-controlled area for testing with adequate utilities and water), including adequate space to support quality laboratory testing; (2) a laboratory manager and quality officer in place in each laboratory to lead the effort; and (3) sufficient personnel to implement the improvements that would be learned from the training as well as to carry out patient testing. Following the pilot cohort in 2010-2011, Tanzania, with the support and assistance of the American Society for Clinical Pathology (ASCP), also held a Training of Trainers (TOT) workshop in 2012 to prepare in-country trainers for subsequent cohorts that would also receive this laboratory improvement training. This would enable the workshops to be facilitated in Kiswahili, the official native language of Tanzania.

Materials and Methods WHO AFRO SLIPTA to Measure Laboratory Improvement Laboratory quality standards for the WHO AFRO SLIPTA accreditation process are based on the International Organization for Standardization (ISO) standard 1518910 and are formatted as a checklist with subsections similar to



Am J Clin Pathol  2015;143:566-572 567 DOI: 10.1309/AJCPAB4A6WWPYIEN

Andiric and Massambu / Laboratory Quality Improvement in Tanzania

❚Table 2❚ Similarity of 12 CLSI Quality Essentials and WHO AFRO SLIPTA Checklist Headings CLSI Quality Essentials

WHO AFRO SLIPTA Checklist Sections

1. Organization 2. Personnel 3. Equipment 4. Purchasing & Inventory 5. Process Control/Quality Control & Specimen Management 6. Information Management 7. Documents & Records 8. Occurrence Management 9. Assessment 10. Process Improvement 11. Customer Service 12. Facilities & Safety

1. Documents & Records 2. Management Reviews 3. Organization and Personnel 4. Client Management & Customer Service 5. Equipment 6. Internal Audit 7. Purchasing & Inventory 8. Process Control/Internal & External Quality Assessment 9. Information Management 10. Corrective Action 11. Occurrence/Incident Management & Process Improvement 12. Facilities & Safety

CLSI, Clinical and Laboratory Standards Institute; WHO AFRO SLIPTA, World Health Organization African Region Stepwise Laboratory Improvement Process Towards Accreditation.

the Clinical and Laboratory Standards Institute’s (CLSI’s) Quality Systems Essentials11 as listed in ❚Table 2❚. Implied and addressed within the checklist (and also within the Quality Systems Essentials) are important specific requirements such as documented successful performance in quality assurance by participation in an externally provided proficiency testing program and attention focused on test turnaround time and test volume. The WHO AFRO laboratory accreditation checklist was given to each cohort participant as a resource to guide improvement. The 258-point WHO AFRO SLIPTA checklist, with 110 items, assigns a weighted value for each item based on the item’s complexity and/or importance. If there is incomplete compliance or fulfillment of a standard, but an effort toward compliance is recognized, credit is given as a “partial” score of 1 point. Laboratories are required to achieve at least 55% on the assessment to be awarded onestar recognition. When laboratories receive 95% or more compliance, they are awarded a five-star recognition and are considered to have progressed sufficiently to apply and receive full ISO 15189 accreditation. See ❚Table 3❚ for the breakdown of scores for star rating. This stepwise approach recognizes and rewards progress as well as ensures sustainment in that from assessment to assessment, the fulfillment of WHO AFRO SLIPTA standards must be maintained for continued recognition.3 NOTE: The WHO AFRO laboratory accreditation checklist, a precursor of the WHO AFRO SLIPTA checklist, was used for baseline and posttraining assessments for Tanzanian laboratories selected to undergo the first formalized laboratory quality improvement training in 2010. This initial checklist differed only slightly and had a total score of 250 compared with the final official SLIPTA checklist with a total score of 258. After the first training, subsequent cohorts used the official SLIPTA checklist for all assessments (ie, baseline and posttraining). 568 Am J Clin Pathol  2015;143:566-572 DOI: 10.1309/AJCPAB4A6WWPYIEN

❚Table 3❚ WHO AFRO SLIPTA Stepwise Accreditation Scheme No. of Stars

%

0 (0-141 points) 1 (142-165 points) 2 (166-191 points) 3 (192-217 points) 4 (218-243 points) 5 (244-258 points)

Laboratory quality improvement in Tanzania.

The article describes the implementation and improvement in the first groups of medical laboratories in Tanzania selected to participate in the traini...
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