Module 5: Laboratory Infrastructure

Maputo Declaration

Laboratories are the backbone of the entire public health surveillance system. Correct laboratory diagnosis is essential for treatment and data collection of many diseases. A large barrier to laboratory access in developing countries is the distance between the patient and the laboratory. Many patients cannot afford to make one trip to a clinic for tests, and then make another return trip weeks later (after their specimens have been shipped long distances to be scrutinized) to view their results. To solve this problem, POC tests would be ideal in developing countries. However, POC tests are often unreliable or non-existent for many diseases with high health burdens.(1) For these diseases, traditional laboratory diagnostic procedures are necessary, and lab turn-around time is crucial in determining the patient’s outcome.(2)

In 2008, representatives from many areas of the WHO met together in Maputo, Mozambique to discuss the importance of clinical laboratory enhancement worldwide. They put forth the Maputo Declaration on Strengthening of Laboratory Systems, which called for a more united laboratory system that was integrated in its approach to controlling the burden of priority diseases—HIV, malaria, and tuberculosis.(3)

Objectives of the Maputo meeting included:(4)

In developing countries, there is an increasing need for the improvement of individual labs, as well as a building and reshaping of entire lab networks. This need is increasingly apparent with regard to the AIDS epidemic, as a quarter of the 37 million people around the world with HIV are unaware that they are infected.(5)

Changes Since the Maputo Declaration

Following the Maputo Declaration in 2008, the creation of the Stepwise Laboratory (Quality) Improvement Process Towards Accreditation System, and the National Laboratory Strategic Plans, among others, made progress toward regional improvements in laboratory systems.(6) The primary focus of these strategies has been the establishment of a tiered system that provides high-quality and efficient testing services for the entire population in an integrated, nationally accessible network. In October 2015, the Freetown Declaration officially endorsed the integrated tiered model as the cornerstone of effective health care. The model emphasizes the integrated network of various tiers collaborating to work more efficiently and effectively.(7)

Definition of Laboratory Tiers(8)


TIER 1—Primary care/health center laboratories serving mostly outpatients in a community, performing POCT/single-use tests and referring more complex work to either tier 2 or 3. It will be staffed at the technician level. 

TIER 2—Laboratories in district hospitals that receive specimens from their own patients and receive referrals from tier 1 facilities. Usually will have a surgical, medical, and pathology clinician and perform a selected number of routine tests. 

TIER 3—Laboratories in regional or provincial hospitals that receive specimens from their own patients and receive referrals from tier 1 and 2 facilities. They will have significant numbers of pathology staff and cover all routine testing in the major pathology disciplines. 

TIER 4—Laboratories in national or teaching hospitals that receive specimens from their own patients and receive referrals from tier 1, 2, and 3 facilities. In addition to routine tests, they provide highly specialized tests and education and training for the network. In small countries, this facility may be a regional one shared by more than one country. 

Note: As each country and region will have a somewhat different burden of disease and availability of staff, there may be some shifting of capacity across the tier boundaries. For example, if trained staff were available (eg, via a regular visit by the tier 2 pathologist), then fine-needle aspiration cytology could be performed and reported in a tier 1 laboratory.

The West African Biomedical Analysis Laboratory Network (RESAOLAB) is one example of a successful launched network that focuses on lab personnel training, quality assurance, and epidemiological surveillance in seven West African countries.(9) The network has grown from three to seven countries since 2009, and includes the laboratory that first diagnosed the new variant of Ebola virus in Guinea in 2014.(10) Despite this growth, the Ebola outbreak in West Africa in 2014-2015 demonstrated the weaknesses in the laboratory networks throughout Africa and the need for continued improvements.

Individual Lab Enhancement

The quality of individual laboratories is often assessed using the following criteria:(11)

Laboratories in developing countries often fall short on many of these criteria, compared to laboratories in the developed world. Of particular importance is improved training of laboratory staff. Studies show that in developing countries, the quality of trained staff personnel and their distance from a capital city are positively correlated.(12) This is especially problematic when many citizens live in rural areas. Developing countries also tend to lack mechanisms for assessing laboratory quality.(13) This is problematic because without surveillance of laboratory work, there is no way to ensure the usefulness of the lab’s existence.

Planning a National Laboratory Network

The Association of Public Health Laboratories collaborated with the WHO-Geneva, WHO-Regional Office for Africa, and the CDC to develop the Guidance for Development of National Laboratory Strategic Plans. This document serves as a “guidance tool for country leaders for the development of NLSP and provides information on organizations available to support countries with technical expertise and funding”.(14) The publication helps countries organize to create an interconnected system of quality laboratories.

Description: http://ajcp.ascpjournals.org/content/134/3/368/F2.large.jpg

http://ajcp.ascpjournals.org/content/134/3/368/F2.expansion.html

The laboratory network that developing countries create should be a tiered referral system (see chart above) that serves patients with its interconnectivity and ability to rapidly disseminate diagnoses.(15) There should be a primary federal reference laboratory linked to multiple regional district laboratories.(16) Standardization across laboratories is critical for easy and fluid communication within the system.

Important parts of a national plan to develop a network of laboratories in developing countries include:(17)

The establishment of functioning, tiered, quality laboratory systems in developing countries depends on public-private partnerships, political will from the country’s government, and extensive planning.(18) Stakeholders should work together to pool resources and ensure that there are no wasted materials in new lab-building initiatives. The training of lab technicians is also very important in ensuring that labs function properly.(19) Major global health organizations (including the WHO and CDC) continue to create standardized sets of manuals and materials that can be used in training to assure the quality of human resources.(20) It is also important for those involved in building laboratory capacity to advocate for more resources from public and private sources. Without a functioning laboratory system for diagnostic and statistical reporting, public health initiatives in developing countries are blindly attacking health problems with no facts to support their programs.

Case Study: Building Laboratory Infrastructure in Tanzania

Insufficient disease surveillance in many countries in Africa has contributed to a breakdown in the medical system. In Tanzania, the main laboratory network required extensive updating. The slow generation of results was hampering the success of HIV/AIDS interventions and other infectious disease programs. As the AIDS epidemic progressed, Abbot, a global health company, partnered with the government Tanzania to strengthen the laboratory surveillance system. Abbott has a philanthropic foundation called the Abbott Fund, which financed this project (http://www.abbottfund.org/). Abbott started by supporting the renovation of the Central Pathology Laboratory in Muhimbili. This renovation included updating equipment, stocking the laboratory with reagents, and supplying the lab with experts to ensure that it ran smoothly. With the help and input of the Tanzanian government, Abbott then started to renovate the 23 other labs across the country.

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Laboratory in Tanzania before Abbott project

Description: http://www.abbottfund.org/images/thumbnails/08b_AF_TanzaniaRegional/08b_AF_TanzaniaRegional_04_1000x800.jpg

 

 

 

 

 

 

 

Laboratory after upgrade (http://www.abbottfund.org/project/17/67/Modernizing-Regional-Level-Labs-in-Tanzania)

Standardization was the focus of laboratory upgrades, with the goal that the standardization of the labs would facilitate collaboration and communication between them. Each lab reconstruction cost approximately $500,000. The new labs show great improvements in many areas including a rise in the number of tests performed per year (15,000 to 134,000) and a decrease in the turnaround time (previous average was 3 to 14 days, while the new average is less than 24 hours). The new laboratories must report their activity on a weekly basis so that Abbott can monitor the effectiveness of the program. The most frequent logistical problems that the new laboratories encountered were shortages of trained personnel and reagents needed to conduct tests. The program is constantly being changed and improved to solve these problems in the system—another demonstration of the importance of surveillance in public health programming. One way that Abbott is working to alleviate the health care worker shortage is by funding more than 100 scholarships to the Bugando University College of Health Sciences for medical technologists every year. Not only are these scholarships improving the laboratory staff in the region, but they are also demonstrating to the Tanzanian public that laboratories and public health surveillance is a key part of the health care system.

Information from this case study was adapted from the following article:(21)http://casestudiesforglobalhealth.org/case_study_PDFs/GHCS_30_LabSvcsTanzania.pdf.

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Footnotes

(1) Peeling, R. W., and D. Mabey. "Point-of-care tests for diagnosing infections in the developing world." Clinical microbiology and infection 16.8 (2010): 1062-1069.

(2) Nkengasong, J., Deborah Birx, and J. L. Sankalé. "Challenges in developing laboratory capacity and infrastructure to support HIV/AIDS care programs." From the ground up: Building comprehensive HIV/AIDS care programs in resource-limited settings (2009).

(3) World Health Organization.The Maputo Declaration on Strengthening of Laboratory Systems. (2008). https://www.who.int/diagnostics_laboratory/Maputo-Declaration_2008.pdf Retrieved on 19 November 2019.

(4) Ibid.

(5) UNAIDS. Live Life Positively: Know Your HIV Status. (2018) https://www.unaids.org/sites/default/files/media_asset/live-life-positively-know-your-hiv-status_en.pdf Retrieved on 19 November 2019.

(6) Best, M., & Sakande, J. (2016). Practical recommendations for strengthening national and regional laboratory networks in Africa in the Global Health Security era. African journal of laboratory medicine5(3), 1-10.

(7) Fleming, K. A., Naidoo, M., Wilson, M., Flanigan, J., Horton, S., Kuti, M., ... & Wang, J. (2017). An essential pathology package for low-and middle-income countries. American journal of clinical pathology147(1), 15-32.

(8) Ibid.

(9) Foundation Merieux. (2017). West African Network of Biomedical Analysis Laboratories: Inauguration in Togo of the Directorate of Pharmacy, Medicine and Laboratories, of the Center of External Quality Assessment and of the Center for Continuous Training. https://www.fondation-merieux.org/en/news/west-african-network-of-biomedical-analysis-laboratories-inauguration-in-togo-of-the-directorate-of-pharmacy-medicine-and-laboratories-of-the-center-of-external-quality-assessment-and-of-the-center/ Retrieved on 19 November 2019.

(10) Best, M., & Sakande, J. (2016). Practical recommendations for strengthening national and regional laboratory networks in Africa in the Global Health Security era. African journal of laboratory medicine5(3), 1-10.

(11) Otrompke, J., J.D. (2009). Standardizing Solutions to Change the Face of Laboratory Services in Tanzania. Alliance for Case Studies for Global Health. Retrieved on 21 May 2012.

(12) Nkengasong, J., Birx, D., & Sankalé, J. L. (2009). Challenges in developing laboratory capacity and infrastructure to support HIV/AIDS care programs. From the ground up: Building comprehensive HIV/AIDS care programs in resource-limited settings.

(13) Ibid.

(14) World Health Organization, Centers for Disease Control and Prevention, & Association of Public Health Laboratories. (2008). Guidance for the Development of National Laboratory Strategic Plans. https://www.who.int/hiv/amds/amds_guide_dev_nat_lab_strat.pdf Retrieved on 19 November 2019.

(15) Nkengasong, J., Birx, D., & Sankalé, J. L. (2009). Challenges in developing laboratory capacity and infrastructure to support HIV/AIDS care programs. From the ground up: Building comprehensive HIV/AIDS care programs in resource-limited settings.

(16) Ibid.

(17) Ibid.

(18) Ibid.

(19)Ibid.

(20) Ibid.

(21) Otrompke, J. (2009). Standardizing Solutions to Change the Face of Laboratory Services in Tanzania. Alliance for Case Studies for Global Health. Retrieved on 21 May 2012.