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Country Leadership and Policy Are Critical Factors for Implementing Laboratory Accreditation in Developing Countries
A Study on Uganda

Alex Opio PhD, Winnie Wafula MMed, Jackson Amone MMed, Henry Kajumbula MMed, John N. Nkengasong PhD
DOI: http://dx.doi.org/10.1309/AJCP6KMOTCLISGJ3 381-387 First published online: 1 September 2010

Abstract

Accreditation of laboratories is one means to promote quality laboratory services, underscoring the need to document factors that facilitate laboratory accreditation. A desk review and key informant’s interviews were conducted to determine the roles of country leadership and policies in laboratory accreditation.

Overall, the review revealed that Uganda has enabling factors for laboratory accreditation, putting the country in a state of accreditation-readiness and including strong leadership that provides stewardship and availability of a national health laboratory policy with an explicit statement on laboratory accreditation. A National Laboratory Technical and Policy Committee coordinated the development of the policy. Laboratory training schools provide leadership in training laboratory professionals, while the Association of Medical Laboratory Technologists provides professional leadership. Although there is no national accreditation system, some laboratories are participating in international laboratory accreditation. Key informants expressed strong support for and observed that laboratory accreditation is beneficial and can be implemented in Uganda.

Lessons from this study can benefit countries planning to implement laboratory accreditation. Countries that have not developed national laboratory policies and strategic plans should do so to guide the strengthening of laboratory systems and services as a part of health systems strengthening, which would be a springboard for laboratory accreditation.

Key Words:
  • Leadership
  • Policy
  • Laboratory accreditation
  • Developing countries

Laboratory systems and services are a key component of national health systems as they are essential for the provision of quality health care. Therefore, accurate and reliable laboratory testing should be available in every country to deal effectively with detection, treatment, and prevention of diseases of public health importance.1 Furthermore, it should be noted that early detection and management of disease outbreaks can be accomplished only if responsive laboratories are in place. Because poor laboratory services lead to ineffective treatment, are costly, and lead to wastage of scarce resources, quality laboratory services are an imperative for the population in need. Moreover, poor laboratory services are a concern to many stakeholders because they lead to loss of economic productivity of the population owing to chronic illnesses and loss of life resulting from inappropriate treatment. To address these concerns, measures that promote quality laboratory services need to be implemented. Accreditation of laboratories ensures that quality laboratory services are sustained because by addressing the requirements for quality and safety, laboratories would automatically be heading toward accreditation.

By definition, accreditation is the process of recognizing a laboratory as capable of providing quality laboratory services. Recognition is made by an accrediting body after the minimum standards for accreditation have been met. Through facilitating the adherence of laboratory practices to set standards and guidelines, accreditation aims at promoting the provision of quality laboratory services.

Implementing laboratory accreditation involves deciding on the type of accreditation scheme to apply (national or international). Examples of international accreditation systems include the International Organization for Standardization (ISO); Clinical and Laboratory Standards Institute; European Committee for Standardization; the World Health Organization (WHO) disease-specific accreditation of diagnostic laboratories including HIV serology, polio, tuberculosis, influenza, and measles; and the South African National Accreditation System. Owing to resource constraints, national accreditation systems are likely to be more applicable and feasible for the majority of laboratories in developing countries such as Uganda.

In this article and based on our study, we argue that country leadership and policy are critical factors for implementing laboratory accreditation in developing countries.

Rationale and Objectives

It is important to study the linkages between laboratory accreditation and country leadership and policy. This is so because there is evidence indicating that leadership is crucial in the success of programs, including health-related programs. For example, in Uganda, political and civic leadership has been one of the cornerstones for the success of the national response to the HIV/AIDS epidemic. Similarly, leadership is expected to have a critical role in the implementation of accreditation of laboratory services.2 To elucidate this, a study was conducted in Uganda. The main objective of the study was to determine whether country leadership and enabling policy environment exist for the implementation of laboratory accreditation.

The Process

We studied Uganda’s leadership and policies with a view of determining whether they provide enabling factors in the form of stewardship and good policy for implementing laboratory accreditation. A desk review was conducted to determine the existence and effectiveness of leadership, policies, laboratory quality assurance (QA) programs, and coordination structures for laboratory accreditation. The documents reviewed included the National Health Policy 1,3 Health Sector Strategic Plan I,4 Health Sector Strategic Plan II,5 National Health Laboratory Policy,6 the Maputo Declaration on Laboratory Services,7 and laboratory-related technical reports of the WHO.8

Because the laboratory quality system Figure 1 serves as the framework for developing laboratories toward accreditation, the desk review looked at the elements of this system to determine, within context, whether the country leadership and policy environment are likely to influence them. The elements of the system consist of organization of laboratory services, laboratory personnel and equipment, purchasing and inventory, process control, documents and records, information management, laboratory assessment, process improvement, customer services, facilities, and safety.

Figure 1

Laboratory quality system. From the Clinical and Laboratory Standards Institute, Wayne, PA. Document GP26-A3.

Finally, key informant’s interviews were conducted using topic guides to discuss and determine the existence and effectiveness of laboratory-related policies and QA services, as well as their coordination structures and institutional framework. This approach provided an opportunity for getting deeper insight into the subject and generating information that would complement the findings of the desk review. It also provided an opportunity for soliciting the most current viewpoints of a cross-section of representatives of stakeholder organizations. We interviewed 20 key informants; they were drawn from the Ministry of Health, WHO country office, Centers for Disease Control and Prevention (CDC) office in Uganda, Central Public Health Laboratories (CPHL), and African Medical Research Foundation (AMREF). The key informants were asked 4 basic questions: (1) What is your view on the feasibility of implementing laboratory accreditation in Uganda? (2) What do you think are the roles of country leadership and policy in laboratory accreditation? (3) What are the benefits of laboratory accreditation? (4) Do you support the introduction of laboratory accreditation in Uganda? If yes, which type of accreditation? The results of the interviews were summarized under the 4 themes.

Outcomes

The review revealed that through the leadership of the Ministry of Health, steps have been taken to strengthen national laboratory services. Leadership and policies are in place to facilitate laboratory accreditation. There are also coordination and management structures that can facilitate the accreditation of laboratories.

National Laboratory Technical and Policy Committee

The National Laboratory Technical and Policy Committee (LTC) was established in 2007 by the leadership of the Ministry of Health and is operational. It brings together a multisectoral group of people representing different institutions or partners that support laboratory services in the country. Members come from the Ministry of Health, CDC, WHO, Foundation for Innovative New Diagnostics, AMREF, and the Association of Medical Laboratory Technologists.

The main aim of the committee is to provide leadership and coordination of laboratory services in the country; its specific scope of work and the deliverables are as follows: (1) Ensure that national health laboratory services are coordinated. To date, the LTC has held regular (quarterly) coordination meetings, facilitated information sharing, and designed strategies to promote better coordination of laboratory services. (2) Develop a comprehensive national health laboratory services policy for Uganda in line with the national health policy. The LTC spearheaded the development and launching of the national health laboratory policy. Currently, the LTC is arranging for the dissemination of the policy. Funds used for the development of the policy were mobilized by the committee. (3) Oversee the development of the national health laboratories strategic plan. Under the leadership of the LTC, the laboratory strategic plan is being developed, with involvement and support of partners. The strategic plan development process is being cofunded by partners. (4) Develop and periodically review health laboratory services standards and guidelines for programs and projects within the health sector. A number of guidelines have been developed by the QA subcommittee of the LTC. Examples include QA guidelines and the standard list of essential laboratory tests to be performed at different levels of health laboratories. (5) Oversee and conduct the monitoring and evaluation of laboratory services, conduct regular assessment of laboratory infrastructure, and provide guidance on the rational distribution of resources for laboratory services. Members of the LTC have been involved in monitoring and evaluation of laboratory services, eg, through support supervision visits and site assessments. The assessment results have informed the development of distribution lists of laboratory equipment and supplies. (6) Guide the development of a national health laboratory management information system and conduct a regular review of the system. Through guidance of the LTC, an electronic laboratory management information system has been developed and is being pilot tested and validated.

National Health Laboratory Policy

Uganda recognizes that laboratories are important to support the delivery of the Uganda National Minimum Health Care Package (UNMHCP). To provide guidance on the strengthening of laboratory services, the country developed a national health laboratory policy.6 The policy was developed through a consultative process involving a wide range of stakeholders. It has clearly defined the expected laboratory standards and put in place the quality management system. The policy has the following objectives: (1) to put in place an organizational and management structure for coordinating laboratory services; (2) to develop, deploy, motivate, and retain adequate numbers of human resources for laboratories; (3) to mobilize the financial and logistical resources required to support the delivery of quality laboratory services; and (4) to establish a system for monitoring and evaluation of laboratory services.

Section 4.6.6 of the policy has an explicit statement on the accreditation of laboratories and calls for the establishment of an accreditation system for laboratories for different levels of services. Another relevant strategy of the policy is under section 4.6.5, which states, “Develop an effective mechanism for internal and external quality assessment (EQA) at national level, and establish links with internationally recognized EQA bodies.”

Commitment to Strengthen National Laboratory Network

Uganda’s commitment to building the laboratory network and strengthening laboratory infrastructure is shown by the following: (1) The draft national health policy 2 clearly identifies laboratory infrastructure development as one of the key priority areas. (2) The Health Sector Strategic plans I and II provide for the establishment of the national laboratory network Figure 2. (3) Laboratory services have been clearly and explicitly identified as one of the important support services for the delivery of the UNMHCP. (4) The Ministry of Health has developed a national health laboratory policy to provide guidance. (5) the Ministry of Health mobilized and is collaborating with a number of development partners to strengthen the laboratory network and implement laboratory infrastructure development. (6) The Ministry of Health recently decided to raise the profile (clout) of the laboratory management structure within the management structure of the Ministry. The CPHL will be made a semiautonomous organization to be headed by an executive officer at the level of director. This will give CPHL high status and clout, as well as power and independence to make decisions.

Figure 2

Levels of the laboratory network in Uganda.

The laboratory network being strengthened covers the national level laboratories located at the national referral hospitals and laboratory centers of excellence, regional laboratories located at the regional referral hospitals, district laboratories located at the general hospitals, subdistrict laboratories located at health centers level IV, and the community level laboratories located at health centers level III. The network is composed of public and private laboratories. In 2004, an assessment carried out by the Ministry of Health revealed that there were more than 2,000 laboratories in the country.9 It is believed that the number has increased since then.

Laboratory Quality Management Program

The analysis revealed that Uganda has active laboratory quality management programs, including external QA (EQA). Laboratory QA refers to planned and systematic activities to provide adequate confidence that requirements for quality will be met. It is EQA when the activities are planned and coordinated by an entity that is separate from the laboratories in question. On the other hand, internal QA is what a particular laboratory puts in place to ensure the quality of its own services.

EQA has 3 aspects: (1) proficiency testing (PT), (2) on-site evaluation, and (3) retesting (rechecking) of specimens. A combination of PT and on-site evaluation is used in unique situations, such as during follow-up support supervision of newly trained staff or when a new HIV testing site has been established.

Currently, there are 3 PT schemes in Uganda. The CPHL recently established a National External Quality Assessment Scheme (NEQAS), including a PT scheme for HIV/AIDS, malaria, tuberculosis (TB), and opportunistic infections. The NEQAS is being rolled out in a phased approach with an initial target of 250 laboratories at the level of Health Centre IV and above to cover public and private laboratories. With support from the CDC, the CPHL is also coordinating a countrywide PT scheme for CD4 testing laboratories. In the second PT scheme, stabilized whole blood panels are sent from the UK National External Quality Assessment Service and distributed to 75 laboratories. The laboratories then test the panels and submit their results to the UK National External Quality Assessment Service using an online system. Staff from the participating laboratories received the necessary training as part of the support from public-private partnership initiative by Becton Dickinson and the US President’s Emergency Plan for AIDS Relief. The third PT scheme is the regional EQA scheme. This mainly targets primary health care laboratories in Kenya, Tanzania, and Uganda. The tests addressed in this PT scheme include malaria (thick and thin films), hemoglobin estimation, Ziehl-Neelsen staining, Gram staining, and stool and urine examination for parasites.

The on-site evaluation, the second method of EQA, is also coordinated by the CPHL with additional resource persons from the LTC. Central support supervision is done on a quarterly basis to the district level laboratories, general hospitals, and regional referral hospitals. The district laboratory focal person, however, is facilitated to make the supervision visits to the lower level facilities, preferably on a monthly basis. A standard checklist is used during the on-site evaluation, and feedback is given immediately and after data entry and analysis have been done.

The HIV Reference and Quality Assurance Laboratory (HRL) and the National TB Reference Laboratory conduct retesting or rechecking as the basis of their EQA schemes. More than 600 testing sites have been enrolled in this EQA scheme under the HRL at the Uganda Virus Research Institute. The supervisors from the HRL make quarterly visits to the testing centers and obtain a randomly selected set of plasma samples from those already tested. The retesting is done at the Uganda Virus Research Institute, and results are returned during the subsequent visit. In addition to plasma specimens, the HRL offers retesting of dry blood spots for home-based HIV counseling and testing programs. The HRL has now started a concurrent PT scheme that has greater potential for expansion to reach more testing sites and laboratories. The National TB Reference Laboratory runs a rechecking scheme for TB slides. The scheme and supervisory visits are coordinated through regional EQA officers based in the districts. The regional EQA officers and district laboratory focal persons regularly organize coordination meetings during which information is shared.

Regulation of Laboratory Services: Allied Health Professional Council

The review also established that the Allied Health Professional Council (AHPC) has been established by an act of parliament to spearhead the regulation of laboratory services.10 According to this act, it is a requirement that private laboratories be registered before they can offer services. The aim of this registration is to ensure that laboratories meet the minimum standards required to offer good quality services. However, to date, the AHPC has registered only a few laboratories to provide laboratory services. The AHPC has some limitations, including inadequate staff to traverse the whole country to inspect the laboratories. In 2004, the Ministry of Health established that there were more than 2,000 laboratories scattered all over the country. Most of these laboratories were located in urban settings. Our analysis further revealed that the new laboratory policy has a provision to reinforce the implementation of the regulatory framework. One of its policy objectives states that “National legal and regulatory framework components shall be established to strengthen, enforce licensing, registration and control of all laboratory services.”

Ongoing Laboratory Accreditation

Our review further revealed that, at the moment, Uganda does not have a national laboratory accreditation system and body. There are, however, a few laboratories that are already engaged in the accreditation process, but with international bodies. For example, Ebenezer Laboratory, which is a private facility, has enrolled in the accreditation program of the South African National Accreditation System, leading to being accredited under ISO 15189. The Joint Clinical Research Center has enrolled in the accreditation program of the College of American Pathologists. To date, 10 laboratories have been accredited by international accreditation bodies Table 1. The costs of these accreditation schemes are, however, high. Anecdotal reports indicate that the cost of preparing 1 laboratory for accreditation under these schemes ranges from $50,000 to $100,000 (in US dollars).

Laboratory Training Schools (Leadership in Training)

The analysis revealed that Uganda recognizes that human resources in the form of laboratory staff are crucial for successful implementation of any accreditation scheme and that the human resources should be competent and in the right numbers (laboratory policy). In this regard, there are a number of laboratory training schools that are championing laboratory staff development. Different levels of training are being run, including at the certificate, diploma, and graduate levels. Postgraduate degree courses in pathology are offered at the Makerere University School of Medicine, Mulago, Uganda.

Professional leadership for laboratory services is also being provided by the schools and the Association of Medical Laboratory Technologists. The association has key responsibilities in developing, mentoring, and supervising laboratory professionals and for ensuring that their practices adhere to acceptable standards. They facilitate laboratory accreditation.

Public-Private Partnership Strategy

Uganda has found collaboration to be a cornerstone of health services delivery, including in the area of laboratory services strengthening. Under the Health Sector Strategic Plan, public-private partnership is one of the key strategies being implemented. The analysis further revealed that in the area of laboratory services, a number of partners are involved in the development of the laboratory network in Uganda under the leadership of the Ministry of Health. The partners include WHO, CDC, Foundation for Innovative New Diagnostics, AMREF, private laboratories, the Association of Allied Health Professionals, laboratory training schools, the Association of Private Hospitals, and so forth. Financial, logistical, and technical support are provided by the partners. Some of the specific collaborative activities that are being or were implemented in a joint manner include national health laboratory policy development, laboratory strategic plan development, strengthening of the laboratory services through laboratory infrastructure development, laboratory personnel training, laboratory commodity procurement, support supervision, and laboratory QA and control.

Key Informant Interviews

The results of the key informant interviews revealed overwhelming support for laboratory accreditation in Uganda as a means to promote and sustain the quality of laboratory services. Overall, respondents said it is feasible to implement laboratory accreditation in Uganda. However, some respondents noted that about $50,000 to $100,000 (in US dollars) are required for preparing 1 laboratory under the international accreditation scheme and that this is unaffordable by most laboratories in Uganda. Therefore, they concluded that national standards for accreditation are more feasible. Respondents also recommended that accreditation should follow a stepwise approach starting with laboratories focusing on a few diseases, then expanding later to incorporate more diseases.

View this table:
Table 1

Country leadership and policy were noted to have an important role in laboratory accreditation by ensuring stewardship, coordination of the different actors, and provision of guidance on how laboratory accreditation should be implemented. Leadership would also mobilize the required resources and monitor the implementation of the laboratory accreditation program. Policy would clearly define roles and responsibilities of the different actors and set standards for the national laboratory accreditation body.

Respondents cited a number of benefits that would arise from implementing laboratory accreditation, saying it will lead to standardization of laboratory services, delivery of good quality laboratory services, and customer satisfaction and confidence. Additional perceived benefits included promotion of continuous improvement of services, provision of the opportunity for laboratories to conduct self-assessment of their performance, compliance with national and international regulatory requirements, and creation of additional values for humanization of laboratory services, thus making laboratory services more cost-effective.

In regard to the WHO accreditation system and approaches to use, respondents supported use of the system but recommended that it should be reviewed and customized to fit Uganda. Furthermore, they pointed out a need for defining accreditation scope and criteria for accreditation, as well as setting of national accreditation guidelines and standards.

Finally, respondents identified challenges that should be addressed when implementing laboratory accreditation: the need to improve coordination of partners, mobilization of adequate funding, deployment of adequate numbers of laboratory personnel at all levels of laboratory service delivery, personnel training, improvement of laboratory infrastructure, and ensuring adherence to accreditation guidelines and standards.

Discussion

Our review has demonstrated that Uganda has an enabling environment for the accreditation of laboratories. These factors include leadership, existence of a national health laboratory policy with an explicit statement on laboratory accreditation, existence of well-defined laboratory standards and guidelines, existence of a human resource development program for laboratories, the presence of a logistics and laboratory information management system, laboratory infrastructure and equipment strengthening, existence of a laboratory QA and control program, and the presence of a regulatory framework for laboratory services.

The focus of work of the LTC, as alluded to earlier, can facilitate a state of accreditation readiness. Furthermore, one of the subcommittees of the LTC is responsible for developing and periodically reviewing the standards and guidelines of the health laboratory services in order to guide programs and projects within the health sector. It is also responsible for the promotion of the establishment of laboratory networks within the country. These structures are essential for and will facilitate laboratory accreditation.

Because leadership and high-level political commitment have been demonstrated to have a key role in the success of the national response to the HIV/AIDS epidemic in Uganda, laboratory accreditation in Uganda is poised to benefit from similar leadership. The success of Uganda’s national response to the HIV/AIDS epidemic is attributed to the leadership and personal commitment of President Museveni, who championed the fight in 1987 by appealing to international communities that Uganda was facing a big scourge and required their support. He also championed pubic education against the epidemic and called on other leaders to follow suit.

In regard to laboratory services, the WHO, during the 58th session of the regional committee for Africa, underscored the need to establish and strengthen laboratory leadership.8 Countries were urged to establish strong laboratory leadership to ensure that the laboratory agenda is a central component of strengthening national health systems. From our review, Uganda has also demonstrated that it is committed to the building of the laboratory network and infrastructure. As alluded to earlier, in the ongoing restructuring of the Ministry of Health, a provisional agreement has been reached to make CPHL semi-autonomous and be headed by an executive officer at the level of director. Furthermore, given the importance of laboratory services in supporting the delivery of health services,7 Uganda has developed a national health laboratory policy. The policy provides a framework and guidance for strengthening the health laboratory services in Uganda to support the delivery of UNMHCP. With respect to management and coordinating structure, the existing LTC is additional evidence of the country’s commitment to strengthen laboratories. The scope of work of the LTC and its subcommittees addresses all aspects of the laboratory quality system that serve as the framework for developing laboratories toward accreditation. The laboratory policy takes care of the organization of the laboratory system by putting in place the management structures, reporting systems, guidelines, and advocacy for the other components of the laboratory quality management system. Its focus of work facilitates the creation of requisite conditions for laboratory accreditation. Once the conditions are established, they act as springboards for laboratory accreditation.

Through the various EQA schemes, the Ministry of Health in Uganda is able to measure laboratory performance, identify and rectify problem areas, provide continuing education, evaluate training activities, standardize techniques, and improve communication among clinical, laboratory, and public health staff. As the country prepares for laboratory accreditation, efforts are underway to strengthen and expand the EQA schemes. Furthermore, the newly developed national health laboratory policy provides for EQA.

Finally, there is evidence of willingness by the laboratories in Uganda to participate in the laboratory accreditation process. Respondents in the key informant interviews expressed overwhelming support for the introduction of laboratory accreditation in Uganda, and a number of laboratories are already participating in international laboratory accreditation programs. These are signs of willingness. Among the participating laboratories are laboratory centers of excellence and private laboratories. This is an opportunity on which the country can build to develop its own national accreditation system. One of the recommendations from the 2008 Lyon meeting as contained in the WHO-CDC joint statement is that each country should establish its own set of standards according to country-specific needs based on internationally agreed-on standards.1 This approach will enable resource-limited countries to implement laboratory accreditation on a wider scale compared with using international accreditation systems. This is so because the cost of meeting the ISO requirements is far too high for most laboratories in developing countries. In view of this, developing countries should emphasize developing national accreditation systems by adaptation of the newly proposed stepwise accreditation system of the WHO Regional Office for Africa.

Conclusions

The role of leadership and policy in facilitating the accreditation of laboratories cannot be overemphasized. Leadership and policy can provide an enabling environment for the accreditation of laboratory services. Laboratory accreditation is a critical component of strengthening national health systems because it is vital for promoting the delivery of quality health services. Country leadership has been demonstrated in the area of policy development, professional leadership, leadership to garner support from development partners, and leadership in advocacy for laboratory strengthening. All of these can facilitate the laboratory accreditation programs. Countries that have not yet developed their national laboratory policies and strategic plans should do so to guide the process of strengthening laboratory systems and services as an integral part of health systems strengthening.

Acknowledgments

We are grateful to the respondents of the key informants’ interviews. Special thanks go to all the people and stakeholders who participated in or supported the development of the national health laboratory policy. This document was vital in informing our review process.

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