Clinical Laboratory Testing Harmonization and Equipment Standardization at Different Levels of a Tiered Health Laboratory System

Transcription

1 Maputo Conference / The Tanzania Experience The Tanzania Experience Clinical Laboratory Testing Harmonization and Equipment Standardization at Different Levels of a Tiered Health Laboratory System Charles Massambu, BDS, MMed(Path), 1 and Christina Mwangi, MBChB, MMed(Path) 2 Key Words: HIV; Antiretroviral therapy; Harmonization of tests DOI: /AJCP3ZAAFUPCIXIG Abstract The rapid scale-up of the care and treatment programs in Tanzania during the preceding 4 years has greatly increased the demand for quality laboratory services for diagnosis of HIV and monitoring patients during antiretroviral therapy. Laboratory services were not in a position to cope with this demand owing to poor infrastructure, lack of human resources, erratic and/or lack of reagent supply and commodities, and slow manual technologies. With the limited human resources in the laboratory and the need for scaling up the care and treatment program, it became necessary to install automated equipment and train personnel for the increased volume of testing and new tests across all laboratory levels. With the numerous partners procuring equipment, the possibility of a multitude of equipment platforms with attendant challenges for procurement of reagents, maintenance of equipment, and quality assurance arose. Tanzania, therefore, had to harmonize laboratory tests and standardize laboratory equipment at different levels of the laboratory network. The process of harmonization of tests and standardization of equipment included assessment of laboratories, review of guidelines, development of a national laboratory operational plan, and stakeholder advocacy. This document outlines this process. In 2001, the Ministry of Health and Social Welfare (MOHSW) in Tanzania instituted a National Care and Treatment Plan for patients with HIV/AIDS. The plan outlined key areas in the health care system to care for approximately 2.2 million people affected with HIV/AIDS. Implementation of the plan commenced in 2004 and has since seen a rapid scale-up of the program with more than 148,000 people with an HIV diagnosis receiving treatment by the end of This scale-up demanded a functional laboratory system for the diagnosis of HIV and the monitoring of people receiving antiretroviral therapy. However, over the years and due to a multitude of challenges such as limited budget allocation, the change of role of the central pathology laboratory from a central laboratory with public health functions to a hospital-based laboratory, lack of staff retention strategies, lack of advancement and modernization, absent equipment maintenance and replacement plans, and scarcity of reagents and other supplies, the laboratory services network deteriorated and became the weakest link in the provision of HIV/AIDS diagnosis, care, and treatment services in the country. 1 The MOHSW, in collaboration with development partners such as the Centers for Disease Control and Prevention (CDC) funded by the President s Emergency Plan for AIDS Relief (PEPFAR), The Global Fund, the Clinton HIV/AIDS Initiative, the Abbot Fund, 5 PEPFAR-supported care and treatment partners, Italian cooperation, and GTZ (the German Technical Assistance), among others, have made tremendous efforts to build laboratory capacity and improve the quality of health laboratory services to support care and treatment of people with HIV/AIDS in Tanzania. 1-3 This plethora of partners with the capacity to procure equipment created a fertile ground for a multitude of equipment to be procured and Am J Clin Pathol 2009;131: DOI: /AJCP3ZAAFUPCIXIG 861

2 Massambu and Mwangi / The Tanzania Experience placed in the care and treatment centers. A multiplicity of testing platforms would have created a problem for the MOHSW for procurement of reagents, maintenance of equipment, and quality assurance. Tanzania, therefore, had to harmonize laboratory tests and standardize laboratory equipment at the different levels of the laboratory network. 4-6 The standardization and harmonization of laboratory equipment involved the assessment of laboratories, review of the National Health Laboratory Policy Guidelines to harmonize them with the National Guidelines for HIV/AIDS Care and Treatment, development of the National Laboratory Operational Plan in support of HIV/AIDS care and treatment, advocacy to stakeholders on the need to have standardized and harmonized laboratory tests and equipment, selection of testing platforms, and ongoing monitoring of the distribution of laboratory equipment in the country. 5-7 Assessment of Laboratories An assessment of laboratories was undertaken by the MOHSW and CDC in 2002 to determine the status of laboratory services. The assessment team comprised consultants from MOHSW, members from CDC Tanzania, CDC Atlanta, the Clinical and Laboratory Standards Institute, and the National Aids Control Programme. The teams used questionnaires and standardized checklists that assessed test-specific equipment, ancillary equipment, reagents, and consumables; physical facility attributes such as internal finishing, office and storage space, security, electrical and water supply systems, and temperature control; general laboratory supplies; and laboratory safety, data management, human resources availability and capacity, quality management systems, and training and laboratory management. The sample included 35 representative laboratories, including those in public zonal, regional, and district hospitals and in private and faith-based facilities. The findings of the assessment were used to guide the process for harmonization of tests and standardization of equipment. Assessment Findings The findings from the 35 assessed laboratories showed that most laboratories lacked modern operational equipment and/or appropriately trained staff and a reliable reagent supply chain, and many laboratories had inadequate physical facilities, among other key laboratory elements. The outcomes of the assessment formed the basis for review of the national health laboratory policy guidelines and development of the national laboratory operational plans in support of HIV/ AIDS care and treatment to harmonize tests and standardize laboratory equipment at the different levels of the laboratory facilities. 4-8 Guideline Review Table 1 Type of Test and Frequency Required to Support Care and Treatment Program The National Guidelines for the Care and Treatment of HIV/AIDS in Tanzania outlines the laboratory tests and frequency of testing required to support antiretroviral therapy within the public health laboratory system. 9 These tests include the following: HIV diagnostic assays (HIV rapid assays, enzyme-linked immunosorbent assay, polymerase chain reaction); disease staging and monitoring assays (CD4 count); drug safety assays (hematology and clinical chemistry); and tests for the diagnosis of common and treatable sexually transmitted infections (syphilis) and opportunistic infections (tuberculosis), as required by routine standards of care. Other tests, not essential to the initial start of the program, include viral load and drug-resistance testing, the capacity for which may be developed once clinical guidelines for the use of these assays are established and the required laboratory infrastructure is developed Table 1. In 2003, the national laboratory standard policy guidelines were reviewed to keep pace with the changing service demands. 5,7,8 The guideline review and the development of the operational plan were undertaken with the participation of stakeholders. 3,5,6,10-12 Several consensus meetings were held, resulting in the finalized documents that were released Type of Test Tests Frequency HIV diagnosis Rapid test, ELISA, DNA PCR As needed Disease staging and monitoring CD4 count T0, mo 1, * mo 2, mo 3, mo 6, every 6 mo Drug safety Hematology T0, mo 1, * mo 2, mo 3, mo 6, every 6 mo Chemistry (ALT) T0, wk 2, wk 4, wk 8, every 6 mo Diagnosis of STDs Syphilis On clinical indication Diagnosis of opportunistic infections TB screening T0 or clinical indication ALT, alanine aminotransferase; ELISA, enzyme-linked immunosorbent assay; PCR, polymerase chain reaction; STDs, sexually transmitted diseases; T0, baseline; TB, tuberculosis. * For patients taking zidovudine. For patients taking nevirapine. 862 Am J Clin Pathol 2009;131: DOI: /AJCP3ZAAFUPCIXIG

3 Maputo Conference / Special Article in 2004 and It was necessary to obtain stakeholder buyin to support the standardization and harmonization of tests and laboratory equipment. This exercise was supported by the Public Procurement Act, 2004, which emphasizes that any laboratory equipment imported or procured must be registered by the Private Health Laboratory Board. 13,14 Integral parts of this review were the following: (1) set management organizational structure for laboratory services; (2) set minimum standards of physical infrastructure; (3) provide a guide to equipping and setting the range of essential tests at each level of laboratory services; (4) set minimum personnel requirements at all health laboratory levels; (5) set methods of standardization; and (6) develop performance assessment systems. It was, therefore, decided that at the health center level there would be mainly manual, low-throughput equipment run by laboratory personnel with certificate level of training. At the zonal and national levels, there would be automated high-throughput equipment run by laboratory personnel (technicians, technologists, and scientists) with at least an advanced diploma level of training. The medium-throughput laboratory equipment run by personnel with a minimum of a diploma would be found at the regional and district laboratories Table 2. There are 6 tiered levels of laboratory services in Tanzania, with the lowest level being the dispensary laboratory, followed by health center, district, regional, and zonal referral laboratories, and the national reference and public health laboratory (the public health laboratory is at the inception stage) Figure 1. Equipment Standardization The restriction of potential equipment platforms for the various tests is to ensure that the national laboratory instruments and reagent supply would not be fragmented and costinefficient owing to a multitude of different instruments within the laboratory network. Equipment harmonization would lead to the establishment of an instrumentation infrastructure based on robust testing platforms of high quality and performance; allow for cost saving on equipment and reagent procurement based on economies of scale and, therefore, sustainable costeffective laboratory services; allow the establishment of an efficient and responsive service and maintenance infrastructure; limit overreliance on single platforms and vulnerability to supply bottlenecks; and permit instruments and reagents to be shared during breakdowns or stock shortages. The MOHSW collaborated with laboratory stakeholders and agreed on equipment selection criteria. The criteria were designed to promote harmonization in instrument choice and provide the appropriate testing capacity at each level of the Table 2 Distribution of Types of Tests According to the Level of Laboratory Facilities Test Health Referral Region District Center Rapid HIV test HIV enzyme immunoassay + + Viral detection + CD4 count Chemistry Hematology Opportunistic infection , available;, not available. Ministry of Health and Social Welfare Diagnostic Services Section National Reference and Public Health Laboratory (1) Referral/Zonal laboratories (4) Regional laboratories (21) District laboratories (132) Dispensaries and health center laboratories (5,160) Figure 1 Levels and categories of health laboratories in Tanzania. laboratory. The selection criteria and assessment of instrument platforms addressed the following: local and international track record and reliability of equipment; local and international track record of manufacturer; local track record of manufacturer or designated distributor; previous and current experience with the instrument in Tanzania or within the East African Region (robust and reliable performance of selected instruments, ease of use, frequency of breakdowns); reasonable cost of instrument and reagents; availability and reliability of maintenance and service in-country and/or regionally; and reliability and flexibility of reagent supply. Based on the proposed testing guidelines of the different levels of laboratory and the projected test volumes, a minimum configuration of instrumentation was required. This was categorized into high volume, medium volume, and low volume, and appropriate specifications were described. A review of available technology and instrumentation was undertaken, and, on the basis of these evaluations, testing platforms were Am J Clin Pathol 2009;131: DOI: /AJCP3ZAAFUPCIXIG 863

4 Massambu and Mwangi / The Tanzania Experience selected as most appropriate for diagnostic testing and monitoring of patients receiving antiretroviral therapy in Tanzania according to the level of laboratory facilities 6 Table 3 and Table 4. Table 4 Distribution of Health Laboratory Equipment According to Type of Equipment and Ownership of the Laboratory Facility Test/Equipment Public FBO Research Private Total Implementation The Operational Plan for the National Laboratory System to Support HIV/AIDS Care and Treatment was released in 2005 and describes a plan for which the laboratory system would develop the necessary capacity to provide the services required by Tanzania s National Care and Treatment Program. 1,6,9 The operational plan describes, in a stepwise manner, the modifications to the physical infrastructure, the procurement and installation of equipment, the training of personnel, the procurement of reagents, the implementation of quality management systems including data capture and its management, equipment maintenance, and oversight for the implementation of the plan. Results Laboratory equipment and tests at any one level of the government public hospital laboratory network are the same throughout the country and correspond with the level of education and skills of the laboratory personnel and the complexity of the equipment, including the throughput, degree of automation, and demand for equipment maintenance. 6,7,15 A review of the equipment procured and placed in the country by the end of 2007 showed that approximately 387 items of laboratory equipment had been procured to support the care and treatment of HIV/AIDS in Tanzania. Of 387 pieces of equipment, 365 (94.3%) conformed to the harmonization guidelines; 84.9% of the hematology analyzers (n = 144) conformed to the guidelines; and 99.2% of the chemistry analyzers (n = 124) were in conformity. All CD4 equipment (n = 81) conformed to the guidelines. Of the equipment, 81.1% belonged to public hospital laboratories (n = 314), Molecular biology RNA PCR DNA PCR Flow cytometry FACSCalibur FACS Count Chemistry Cobas Integra AxSYM Fully Screen Master Others Hematology ACT5 DIFF Pentra Micro Others HIV serology ELISA Multiscan AxSYM Total ELISA, enzyme-linked immunosorbent assay; FBO, faith-based organizations. faith-based organizations accounted for 14.2% (n = 55), and private health laboratories accounted for 4.7% (n = 18). The MOHSW continues to monitor equipment procurement and placement through supervisory visits and quarterly development partner meetings. Conclusion Table 3 Distribution of Equipment to Health Laboratory Levels Based on Throughput Harmonization of testing and standardization of laboratory equipment required strong MOHSW leadership and coordination. The benefits have included reduced procurement costs for equipment, reagents, and service contracts by using economies of scale, hence, sustainable cost-effective laboratory services, 16 and easier implementation of quality assurance and comparability of results between laboratories. 17 It has been easier to standardize training modules, plan training Equipment Referral (High Throughput) Regional (Medium Throughput) District (Low Throughput) ELISA Multiscan Multiscan AxSYM RNA PCR Cobas TaqMan DNA PCR Cobas Ampliprep Flow cytometer FACSCalibur FACSCount FACSCount Chemistry Cobas Integra Fully Screen Master; Micro Lab 200 Hematology ACT5 DIFF Pentra 80 Micro 60 ELISA, enzyme-linked immunosorbent assay; PCR, polymerase chain reaction. 864 Am J Clin Pathol 2009;131: DOI: /AJCP3ZAAFUPCIXIG

5 Maputo Conference / Special Article of end users and maintenance personnel, and reduce the number of standard operational procedures. Harmonized tests and standardized equipment have enhanced the coordination of public and private sectors and development partner contributions and improved planning of preventive maintenance and the procurement of service contracts and the establishment of an efficient, cost-effective, and responsive service and maintenance infrastructure. With the harmonization of tests and standardization of equipment, instruments and reagents can now be shared during breakdowns or stock shortages, thereby reducing laboratory services downtime. 3,7,15 The drawback, however, is overreliance on similar platforms and vulnerability to supply bottlenecks. Challenges Faced In Tanzania, the Public Procurement Act requires the use of an open competitive tendering system that uses generic specifications. 13 After harmonization, there was equipment for which there is only 1 manufacturer, agent, or supplier. The Public Procurement Act, therefore, counteracts the principles underpinning harmonization of equipment, as the prohibition of the use of branded, trade, or specific names during procurement of equipment or reagents allows vendors to quote for any equipment or reagents meeting the generic specifications, but that may not be what is intended for procurement. 3,7,13 Most donated equipment tended to be different from the standardized equipment. 7 The risk of depending on a single manufacturer or vendor for equipment, reagents, or spare parts is the creation of a monopoly in which the MOHSW may lose control on pricing or there may be cessation of production, thus crippling the system. 3 It has taken a long time for a sole agent or supplier to install all the equipment, which is widely distributed in the country, and train the laboratory personnel 7 owing to geographic challenges and human resource constraints on the part of the vendors. In some cases, such as with the private sector, harmonization of equipment may not be within the fiscal capacity of individual facilities. 3,7,14,18 Recommendations Strong advocacy needs to be made for equipment manufacturers to have several suppliers in the country to make the open competitive tendering system possible and for equipment manufacturers to manufacture equipment with open systems or to open the existing systems to simplify the specification process and allow open competitive bidding. There needs to be a review of the procurement process to allow more single sourcing of reagents or equipment when it is known there is only 1 manufacturer of the desired equipment or reagents. The use of brand names in such cases would allow for a faster and smoother procurement process. Equipment placement (where the vendor owns the equipment and is responsible for its maintenance) rather than equipment procurement (where the buyer owns the equipment and is responsible for its maintenance) should be advocated for, especially for very expensive, highly sophisticated equipment. This mode of procurement has the advantages of a nonexistent initial capital outlay, lower pertest price, flexibility to respond to changes in technology, and equipment management issues being transferred largely to the vendor, which includes the servicing of the equipment. With the bulk of testing and the fact that this option is tied to reagent procurement, this system would be advantageous to most ministries of health. From the 1 Ministry of Health and Social Welfare, Tanzania; and 2 US Health and Human Services Centers for Disease Control and Prevention, Tanzania. Address reprint requests to Dr Mwangi: CDC-Tanzania, P.O. Box 2193, Dar Es Salaam, Tanzania. Acknowledgments: We are very grateful to WHO, CDC, and MOHSW for supporting this work and providing the facilities that made it possible; PEPFAR for providing financial assistance through the CDC to support laboratory services in Tanzania; and for the laboratory service support of development partners and stakeholders from US government partners: American Society for Clinical Pathology, American International Health Alliance, Clinical and Laboratory Standards Institute, Association of Public Health Laboratories, Columbia University (New York, NY) International AIDS Program, Elizabeth Glaser Pediatric AIDS Foundation, Harvard University, Family Health International, Department of Defense Walter Reed Project, Catholic Relief Services-AIDS Relief, PharmAccess; and non-us government partners: Clinton HIV/AIDS Initiative, Abbott Fund, Axios, WHO, Japan International Cooperation Agency, GTZ, Danish International Development Agency, Swedish International Development Cooperation Agency, African Medical and Research Foundation, Norway, Italy, and South Korea. Special thanks to John Nkengasong, PhD, for tireless support and encouragement in writing this article and to Stefan Wiktor, MD, MPH, for support for laboratory strengthening in Tanzania. References 1. National AIDS Control Programme. National Care and Treatment Plan (NCTP) for Patients With HIV/AIDS. Dar es Salaam, Tanzania: National AIDS Control Programme; Centers for Disease Control and Prevention, Ministry of Health and Social Welfare. Cooperative agreement U62/ CCUO : Enhancement of antenatal care services and blood safety for preventing transmission of HIV, syphilis and malaria in the United Republic of Tanzania. Atlanta, GA: Centers for Disease Control and Prevention; and Dar es Salaam, Tanzania: Ministry of Health and Social Welfare; Ngowi HP. Public Private Partnership (PPP) in service delivery: application, reasons, procedure, results and challenges in Tanzania local government authorities (LGAs). Paper presented at the 28th African Association for Public Administration and Management; December 4-8, 2006; Arusha, Tanzania. Am J Clin Pathol 2009;131: DOI: /AJCP3ZAAFUPCIXIG 865

6 Massambu and Mwangi / The Tanzania Experience 4. Ministry of Health and Social Welfare. National Quality Assurance Framework. Dar es Salaam, Tanzania: Ministry of Health and Social Welfare; Ministry of Health and Social Welfare. National Standard Guidelines for Health Laboratory Services. Dar es Salaam, Tanzania: Ministry of Health and Social Welfare; Ministry of Health and Social Welfare. Operational Plan for the National Laboratory System to Support HIV/AIDS Care and Treatment. Dar es Salaam, Tanzania: Ministry of Health and Social Welfare; Ministry of Health and Social Welfare. National Health Care Technology Policy Guideline. Dar es Salaam, Tanzania: Ministry of Health and Social Welfare; Ministry of Health and Social Welfare. National HIV Early Infant Diagnosis Guideline. Dar es Salaam, Tanzania: Ministry of Health and Social Welfare; National AIDS Control Programme. The National Guidelines for the Care and Treatment of HIV/AIDS in Tanzania. Dar es Salaam, Tanzania; Ministry of Health and Social Welfare. Minutes of the First HIV Early Infant Diagnosis Steering Committee; 2006; Dar es Salaam, Tanzania. 11. Ministry of Health and Social Welfare. Minutes of the First Laboratory Development Partners Meeting; October 2006; Dar es Salaam, Tanzania. 12. Ministry of Health and Social Welfare. Minutes of the Second Laboratory Development Partners Meeting; February 2007; Dar es Salaam, Tanzania. 13. Parliament of the United Republic of Tanzania. Public Procurement Act, No. 21 of 2004 (November 11, 2004). 14. Parliament of the United Republic of Tanzania. The Private Health Laboratories Regulation. No. 10 of 1997 (February 6, 1997). 15. National AIDS Control Programme. Inventory for Laboratory Equipment to Support Care and Treatment of HIV/AIDS. Dar es Salaam, Tanzania: National AIDS Control Programme; World Health Organization. WHO Bulk Procurement Scheme. Geneva, Switzerland: World Health Organization; American Society for Clinical Pathology. Laboratory Management Training Manual. Chicago, IL: American Society for Clinical Pathology; Ministry of Health. Manual for Quantification of National Requirements of Equipment and Supplies for Laboratory, Radiology, Dental and Health Care Technical Services in Tanzania. Dar es Salaam, Tanzania: Ministry of Health; Am J Clin Pathol 2009;131: DOI: /AJCP3ZAAFUPCIXIG