National Health Laboratory Services Strategic Plan 2021 – 2025

1.1 Introduction ..................................................................................................................................... 13

1.2 Strategic objective ........................................................................................................................... 13 CHAPTER 2: BACKGROUND AND INTRODUCTION.......................................................................... 14

2.1 Country profile ................................................................................................................................ 14

2.2 Health financing landscape for healthcare services ........................................................................... 14

2.3 Legislative context of health services ............................................................................................... 14

2.4 Health system administration ........................................................................................................... 15

2.5 National healthcare system ............................................................................................................... 15

2.6 Epidemiology profile of leading causes of mortality ......................................................................... 16

2.6.1 Non-communicable diseases .......................................................................................................................... 17

2.6.2 Communicable diseases ................................................................................................................................. 17 2.7 HIV/TB/malaria/COVID-19 programmes– a vehicle for integrating laboratory services ................................ 17

2.8 The role and need for comprehensive quality laboratory services and their essential components................... 18 CHAPTER 3: SITUATIONAL ANALYSIS: ACHIEVEMENTS AND CHALLENGES ........................... 19 Point-of-Care Testing (POCT) Services .................................................................................................................. 22 3.1 The National Health Laboratory service structure and networking .................................................... 28 3.2 Organization and management of the National Health Laboratory Service structure and network ..... 28

3.3 Laboratory services: the major constraints ........................................................................................ 29

3.3.1 Organization and management ....................................................................................................................... 30

3.3.2 Laboratory services ........................................................................................................................................ 30

3.3.3 Infrastructure, Laboratory biosafety and biosecurity...................................................................................... 31 | 3.3.4 THELaboratory support GAMBIA NATIONAL systems: HEALTH LABORATORYequipment and supplies SERVICES STRATEGIC – 2025 .................................................................................... PLAN 2021 31

3.3.5 Laboratory support systems: human resources ............................................................................................... 32

3.3.6 Laboratory quality management system ......................................................................................................... 32

3.3.7 Laboratory information management systems ............................................................................................... 33

3.3.8 Research and development (R&D) ................................................................................................................. 33

3.3.9 Point-of-Care Testing (POCT) Services ......................................................................................................... 33

3.3.10 Networking and collaboration ...................................................................................................................... 34

3.3.11 Legal and regulatory framework .................................................................................................................. 34

3.3.12 Monitoring and evaluation ........................................................................................................................... 34

3.3.13 Financing and accountability........................................................................................................................ 35

3.3.14 Laboratory service ethics and community engagement ................................................................................ 35 CHAPTER 4: STRATEGIC PLANNING .................................................................................................. 36 4.1 Context and rationale of the National Laboratory Strategic Plan ....................................................... 36

4.2 Vision statement, core values and guiding principles ........................................................................ 37 3

4.3 Objectives of the strategic plan ........................................................................................................ 38

4.4 Strategic directions of the plan ......................................................................................................... 40 1. Organization and management ........................................................................................................................ 40 2. Laboratory Services .......................................................................................................................................... 40 CHAPTER 5: IMPLEMENTATION FRAMEWORK................................................................................ 45

5.1 Institutional framework .................................................................................................................... 45

5.2 System of planning and implementation framework ......................................................................... 45

5.3 Monitoring and evaluation ............................................................................................................... 45 NATIONAL LABORATORY STRATEGIC PLAN MATRIX .................................................................. 46 LIST OF CONTRIBUTORS ...................................................................................................................... 70 4 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] LIST OF TABLES Table 1: Results of the strengths, weaknesses, opportunities and threats analysis of National Public Health Laboratory Services ....................................................................................................................................19 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 5 LIST OF FIGURES Figure 1. Trends in the major causes of mortality in The Gambia, 2009 to 2019 ..........................................17 6 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] FOREWORD Information provided by medical laboratories underpins the practice of modern medicine; by defining the incidence and prevalence of disease, it allows government and other agencies to plan the provision of healthcare services and monitor their effectiveness. An efficient laboratory service is an essential part of a functional health service. Laboratories provide confirmatory diagnosis and improve management of disease, enable timely detection, and share essential public health information for disease surveillance. Laboratory assessments and other reports have revealed that the Directorate of National Health Laboratory Services (DNHLS) lacks the policies and strategic plans to comprehensively govern and coordinate its services to achieve better healthcare, as has been envisaged in the National Health Policy and Strategic Plan of the Gambia Ministry of Health, the Sustainable Development Goals and the Global Health Security Agenda. The Ministry of Health and partners, together with assistance from the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), the Foundation for Innovative New Diagnostics (FIND), and the World Health Organization (WHO), have developed a five-year National Health Laboratory Service Strategic Plan (NHLSSP) 2021–2025, to address evidence-based gaps in the delivery of quality laboratory services. To help maintain quality standards, this NHLSSP will play a critical role in creating an environment where there is increasing participation of the public and private sector in healthcare delivery towards the attainment of universal health coverage, health insurance demands initiatives, Sustainable Development Goal (SDG) 3 and the Global Health Security Agenda, in addition to a Ministry of Health strategic plan. Thus, the NHLSSP will support the delivery of quality laboratory services at all levels. The Ministry of Health is committed to assist in the implementation of the NHLSSP to complement the National Health Strategic Plan, with prudent use of available funding and to solicit from other donor’s assistance towards the provision of better health for all Gambians. I also hope that all donors and other collaborators will align their activities towards achieving the targets set in the NHLSSP. My Ministry will establish a Laboratory Technical Working Group (NLTWG) to advise the Directorate of National Health Laboratory Services towards attaining the objectives laid out in the NHLSSP. | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 Honourable Dr Ahmadou Lamin Samateh Minister of Health May, 2021 7 ACKNOWLEDGEMENTS I wish to thank all those who were involved in the development of the NHLSSP and especially our partners who have provided not only technical but also financial support: GFATM, FIND, WHO and The Gambia Ministry of Health. We wish to thank all those involved in the development of the NHLSSP, especially our partners who have provided technical and financial support: GFATM, FIND, and WHO. We recognised the immense contribution of Dr. Mamading Cham, Dr. Haddy Bah, Mr Musa Ceesay, Mr Alphonse Mendy, Mr Haruna S Jallow, Mr Alieu Faal, Mr Abdoulie M. Sanyang, Mariama Drammeh and Yaya Barjo.We appreciated the leadership and mentorship of Dr Juliana Ndasi, Dr. Dave Mills, Kim Lewis (FIND international consultants) LALI Zira (WHO international consultant).We thank Mr Bakary Sanneh and Sheriffo Jagne for their leadership, stamina and firmness to walking this document to the end. This could not have happen without the contribution of the following stakeholder who are well appreciated: Department of Livestock Services, Ministry of Agriculture, Ministry of Higher Education, Research, Science and Technology, the Ministry of Finance and Economic Affairs, the Personnel Management Office, Medical Research Council at London School of Hygiene Tropical Medicine The Gambia, Afrimed Clinic Laboratory, Jobot Laboratories, Pakala Clinic, West Africa Holistic Medical Centre Laboratories, and BIO-MED Laboratories. Finally, I would like to acknowledge the contributions made by the Directorate of Planning and Information and all staff in the Ministry of Health during the development of the policy Sheriffo Jagne Director, National Public Health Laboratory Services May, 2021 8 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] EXECUTIVE SUMMARY The Ebola outbreak in West Africa during 2014, the COVID-19 pandemic in 2020, and other potential public health challenges have led to calls for the immediate strengthening of the healthcare system, especially the laboratory component, for the early detection of such disease outbreaks and better management of patients. These phenomena reminded the governments of developing countries and The Gambia specifically about the World Health Organization Africa Regional Office (WHO-AFRO) Regional Committee meeting held in Yaoundé, Cameroon, in September 2008, where member states committed to formulating National Health Laboratory Policies and Strategic Plans. The development of this National Health Laboratory Services Strategic Plan (NHLSSP) is underpinned by reports from a health system analysis, notably the National Health Laboratory Services (NHLS) Policy, Stepwise Laboratory Quality Improvement Process towards Accreditation SLIPTA audits, Health Technology Assessments and WHO Joint External Evaluation reports. These plans aim to facilitate the development and strengthening of national laboratory systems and support the health system in surveillance, prevention and control of diseases. Therefore, in line with these and other more recent recommendations and the implementation of International Health Regulation (IHR) (2005), the MoH of The Gambia, in collaboration with Global Fund, FIND, WHO and other stakeholders, has developed this NHLSSP as a tool to facilitate the implementation of the NHLS policy through Annual Operational Plans. This NHLSSP will strengthen the NHLS to effectively and efficiently support the health system in The Gambia. The NHLSSP has been formulated with a view to having a framework for the development and delivery of an integrated laboratory service in The Gambia. The development of the NHLSSP has benefited from the input of many experts in laboratory sciences and other related fields from within The Gambia, under the supervision of an international consultant. This development borrowed considerably from the experiences and structures in other countries within the African region and broadly followed WHO, Centres for Disease Prevention and Control (CDC) and Association of Public Health Laboratories (APHL) recommendations for the key elements of an NHLSSP. In addition, the NHLSSP has been aligned to the National Health Policy Framework 2021–2030 and the National Health Sector Strategic Plan 2021–2025 of the Gambia. The Ministry of Health, through the Directorate of National Health Laboratory Services will coordinate the implementation, monitoring and evaluation of this strategic plan. Government | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 directorates and departments involved in the delivery of laboratory services will complement DNHLS. Development partners and national stakeholders will contribute to the implementation of this strategic plan by working with ministries, directorates and departments. There will also be monitoring and mentorship guidelines from the National Laboratory Technical Working Group (NLTWG) to advise the Directorate of National Health Laboratory Services on the attainment of set goals. The implementation of the NHLSSP will ensure the establishment of a functional laboratory council, which will regulate laboratory staff and practices in both public and private institutions. The oversight function of the NLTWG will facilitate the Directorate of National Public Health Laboratory Services to achieve set health goals as described by the Ministry of Health, SDG 3, WHO, WAHO, the Global Health Security Agenda and in its policy. The creation of functional laboratory networking, sample transportation systems and laboratory quality and biosafety systems will enhance attainment of universal health coverage, provide a laboratory test menu for the Essential Health Package, facilitate 9 the implementation of healthcare insurance schemes, catalyse the resource-based financial scheme, and enable the prompt detection of pathogens of global security threat. 10 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] ABBREVIATIONS AND AC RONYMS AMR Antimicrobial resistance ASLM African Society for Laboratory Medicine AIDS Acquired immunodeficiency syndrome BF Blood film BL Biosafety level CDC Centres for Disease Prevention and Control CEO Chief Executive Officer CMD Chief Medical Officer CEmONC Comprehensive Emergency Obstetrics and Neonatal Care DNHLS Directorate of National Health Laboratory Services DNPHLS Directorate of National Public Health Laboratory Service DHIS2 District of Health Information Software 2 EDCTP European-Developing Countries Clinical Trial Partnership EFSTH Edward Francis Small Teaching Hospital EQA External quality assessment FETP Field Epidemiology Training Programme GF Global Fund IATA International Air Transport Association IDSR Integrated disease surveillance and response Hb Haemoglobin HMIS Health management information system HIV Human immunodeficiency virus IATA International Air Transport Association LIMS Laboratory information management system LIS Laboratory information system LMIC Low- and middle-income country LS Laboratory services LQMS Laboratory quality management systems NLTWG National Laboratory Technical Working Group M&E| THE GAMBIA NATIONAL HEALTH LABORATORY Monitoring and evaluation SERVICES STRATEGIC PLAN 2021 – 2025 MoFEA Ministry of finance and Economic Affairs MRCG Medical Research Council The Gambia MoH Ministry of Health and Social Welfare NBTS National Blood Transfusion Service NHLS National Health Laboratory Service NHLSSP National Health Laboratory Service Strategic Plan NHP National Health Policy NHSP National Health Strategic Plan NPHRL Neglected tropical disease NTD National Public Health Reference Laboratories NTRL National Tuberculosis Reference Laboratory PS Permanent Secretary PCR Polymerase chain reaction 11 PCU Project Coordinator Unit PoCT Point-of-Care Test(ing) PPE Personal protective equipment PPPH Public–Private Partnership for Health R&D Research and development RCH Reproductive and Child Health RDT Rapid diagnostic test RHD Regional Health Directorate OIC Officer-in-Charge SLIPTA Stepwise Laboratory Quality Improvement Process Towards Accreditation SOP Standard operating procedure STI Sexually transmitted infection SWOT Strengths weaknesses opportunities and threats TB Tuberculosis UNDP United Nations Development Programme UNICEF United Nations Children Emergency Fund UNFPA United Nations Family Planning Agency WAHO West African Health Organization WHO World Health Organization 12 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] CHAPTER 1: PURPOSE OF THE STRAT EGIC P LAN

1.1 Introduction Laboratory services are an integral component of health service delivery. They play a key role in disease surveillance, providing essential data for health systems planning, case management, research, and disease prevention and control. National Health Laboratory Service is faced with numerous challenges, including weak quality management systems, inadequately trained staff, weak biosafety and waste management systems, no regulation of laboratory personnel and premises, high rate of attrition of critical staff and intermittent stock-outs of supplies and reagents.1,2 Therefore, there is an urgent need for the development and implementation of a functional National Health Laboratory Services Strategic Plan (NHLSSP) to resolve these issues.

1.2 Strategic objective The objective of this NHLSSP 2021–2025 is to guide the implementation of the National Health Laboratory Services Policy 2021–2025, which is geared towards the attainment of high quality and accessible laboratory services at all levels of healthcare service delivery. The NHLSSP should provide a framework to guide investment from government, donors and other partners towards the development of an efficient laboratory service within the 5 years. | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 1 Health Technology Assessment report,2019 2 World Health Organization Mission Report, 2017: Joint External Evaluation of IHR Core Capacities of the Republic of The Gambia 13 CHAPTER 2: BACKGROUND AND INTRO DUCTION

2.1 Country profile The Gambia, in Western Africa, has an area of 11,300 sq. km, of which 10,000 sq. km borders either side of the River Gambia, forming a narrow enclave into the Republic of Senegal, except for a short seaboard on the Atlantic coastline. It has an estimated population of 2,348,0003, a Human Development Index ranking of 174 out of 189 countries, and had a gross national income per capita of $710 in 2018.4 The country has a population density of 176 individuals per km2,4 one of the highest population densities in Africa; this imposes extreme pressure on productive land and the provision of social services and healthcare in particular.

2.2 Health financing landscape for healthcare services The healthcare sector is mostly funded by external donors; National Health Account reports for 2016 and 2017 show donors contributed 28.83% and 45.49% of the total health funding, respectively, while government health expenditure as a percentage of total health expenditure dwindled from 38.60% in 2016 to 30.65% in 2017.5 According to a Health Technology Assessment (HTA) conducted in 2019, external donors contributed to 80% of procured commodities for laboratory services.1 In addition, the cost of providing healthcare continues to rise, due to increasing demand, changes in diagnostic and therapeutic technologies, inflation, and currency fluctuations. Although there is an impressive revenue collection system enacted by The Gambia Revenue Authority, and opportunities for progressive economic development through local government and civil service reforms as well as attracting investment from the private sector, funding to the health sector is still below the Abuja Declaration of 15% of annual budget allocations.6

2.3 Legislative context of health services The Ministry of Health (MoH) is mandated to oversee and implement health services through its policies and strategic plan. The Directorate of National Health Laboratory Services (DNHLS) was established in 2007 to coordinate and supervise laboratories to complement healthcare management. However, since the inception of DNPHL there has been no regulatory system for laboratory services, which is a great concern for the quality of the services and could be responsible for dishonest, frauds laboratory services.1 Therefore, there is an urgent need to establish a Medical Laboratory Council which will be mandated with registering all laboratory practitioners and laboratories. There are a few laboratories in the private sector that are associated with private clinics and which are registered with the Medicines Board. Given the importance of health laboratories in making medical decisions that depend on laboratory results, the need for a Medical Laboratory Council cannot be overemphasized. 1 Health Technology Assessment report,2019 3 The Gambia Census report,2013 4 https://countryeconomy.com/countries/gambia 5 The Gambia Health Account reports for 2016 and 2017 6 https://www.who.int/healthsystems/publications/Abuja10.pdf 14 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here]

2.4 Health system administration The MoH is responsible for overall policy formulation, planning, organization and coordination for health in The Gambia. Bodies the MoH oversees include directorates, technical programme units, hospital administrations, health professional councils and other bodies that help the MoH in the execution of its roles and functions. Among the directorates is the Directorate of National Public Health Laboratories (DNPHL), which is tasked with overseeing and providing leadership for all laboratory activities and services in the country (both public and private), including blood transfusion services.2

2.5 National healthcare system A. The public health sector The public health laboratories serve at a national level, providing overarching support and instituting quality control systems. Key functions include the establishment of norms and standards, emergency and outbreak responses, high-end technology testing that is not cost effective at other levels of the healthcare system, targeted training to improve and strengthen human resources, surveillance, and operational research. Public health service in The Gambia is delivered at one of three different levels:  Primary level (village health services and community clinics)  Secondary level (minor and major health centres and district hospitals)  Tertiary level (general, teaching and specialised hospitals and the national Public Health Reference Laboratories) Primary level This level is the first point of contact and comprises village clinics, Reproductive and Child Health (RCH) tracking stations and minor health centres. This is the lowest level of healthcare, where basic laboratory services are offered, including urinalysis, blood film (BF) microscopy for malaria, stool microscopy, | haemoglobin THE GAMBIA NATIONAL (Hb) HEALTH estimation, LABORATORY blood PLAN SERVICES STRATEGIC glucose measurement, sickle cell testing, and rapid 2021 – 2025 diagnostic tests (RDTs) for malaria, syphilis and HIV. All of these tests are performed at minor health centres, with the exception of RDTs, which are mainly offered at village clinics. Secondary level This level consists of major health Centres and district hospitals, also referred to as Comprehensive Emergency Obstetrics and Neonatal Care (CEmONC). In addition to the services provided at the primary level, secondary level facilities provide haematology and blood transfusion services, basic microbiology and clinical chemistry. 15 Tertiary level This level consists of general, specialized and teaching hospitals. These hospitals provide more advanced health and laboratory services, including a full range of haematology, blood transfusion, histology, cytology, clinical chemistry and medical microbiology services to name but a few. In addition, teaching hospitals serve as a training centre for healthcare professionals, including laboratory personnel. The National Public Health Reference Laboratories (NPHRL) conduct quality control and assurance for HIV, syphilis, tuberculosis (TB), and malaria RDTs, provide foodborne disease and antimicrobial resistance surveillance, food chemistry testing and in-service training. B. The private health sector This category of healthcare providers includes private-for-profit and private-not-for-profit providers and practitioners of traditional medicine, which are not integrated with the government system and provide services for fees paid by patients. Some of these facilities offer laboratory services. There are also several stand-alone private laboratories and Universities laboratories, private research laboratories (Medical Research Council Laboratories at London School of Hygiene and Tropical stations at Fajara, Keneba and Basse) across the country. These provide a range of laboratory tests, depending on the financial status of the service provider.

2.6 Epidemiology profile of leading causes of mortality What causes the most deaths? 16 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] Figure 1. Trends in the major causes of mortality in The Gambia, 2009 to 2019 (Courtesy of http://www.healthdata.org/gambia)

2.6.1 Non-communicable diseases A ten-year (2009–2019) analysis report on mortality revealed significant increases related to non- communicable diseases in The Gambia (Figure 1). Ischemic heart disease increased from being ranked fifth among all causes of mortality in 2009 to second in 2019, while stroke-associated deaths increased from being ranked eighth in 2009 to fifth in 2019. Other non-communicable diseases associated with an increased number of deaths from 2009 to 2019 include cirrhosis and cancer. Following investment to improve maternal management, deaths associated with maternal disorders have decreased from being ranked ninth in 2009 to thirteenth in 2019.7 This shows that there has been a progressive shift in national disease burden from communicable to non-communicable diseases; hence, there is need for a functional laboratory policy and strategic plan to ensure timely diagnosis to better inform treatment and management of such diseases.7

2.6.2 Communicable diseases Some communicable diseases have shown a declining trend in total associated mortality, such as malaria, which went from being the fourth-ranked cause of mortality in 2009 to seventh in 2019, a change of -42%. HIV associated deaths decreased slightly, from being ranked third in 2009 to fourth in 2019, a change of -9.3%. Furthermore, with national integrated investment to reduce deaths linked with neonatal disorders, these deaths have decreased from being rank first in 2009 to third in 2019, a change of -25.0%. The introduction of rotavirus vaccination, along with other improvements to disease management, resulted in a reduction in associated mortality from 2009 to 2019.7 However, despite investment to control, prevent and better manage TB and lower respiratory tract infections, deaths from TB have increased slightly, from being ranked seventh to the sixth leading cause of death, while lower respiratory tract infections increased from being ranked second to the leading cause of deaths in 2019, with changes of 0.6% and 1.6%, respectively. Therefore, there is a need to align the NHLSSP to strengthen the gains made in reducing diseases such as malaria, HIV and diarrhoea. The diagnosis, management and prevention to improve outcomes from lower respiratory tract infections must be addressed, while intensifying testing for sexually transmitted infections (STIs), skin infections, fevers of unknown origin and neglected tropical diseases (NTDs) should be prioritized. | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025

2.7 HIV/TB/malaria/COVID-19 programmes– a vehicle for integrating laboratory services The Global Fund has actively supported the strengthening of laboratory services capacity, mainly to support the surveillance and management of diseases such as malaria, TB and HIV, for the last two decades. The national public and private health laboratories have been strengthened to respond to and monitor COVID-19 since WHO declared the epidemic and subsequently the pandemic and more concerted efforts are needed to scale-up testing in provincial laboratories.8 These funded programs exist in silos within the national laboratory system because of the lack of a well-designed laboratory network. Disease-specific reference laboratories conduct parallel supervisory visits and training, as planned in their intervention strategies. However, other disease conditions without assured sustainable funding, such as non-communicable diseases, are the most vulnerable to supply stock- 7 http://www.healthdata.org/gambia 8 http://www.moh.gov.gm/wp-content/uploads/2020/07/The-Gambia-Revised-COVID-19-Plan-June-2020.pdf 17 outs when trying to confirm diagnosis. Therefore, significant consideration was made with this NHLSSP to better inform the development of a laboratory network that will harmonize all of the work on these diseases supported by the Global Fund. In addition, COVID-19 funding can be used to leverage the opportunity for holistic disease laboratory testing systems to maximize the prudent use of government and donor resources. Regional laboratories will be strengthened to supervise minor laboratories, while the reference laboratories will oversee the regional laboratories for all disease conditions.

2.8 The role and need for comprehensive quality laboratory services and their essential components The National Health Policy 2021–2030 advocates the “provision of quality and affordable Health Services for All”.2 to achieve this goal, laboratory services should function effectively and efficiently. Laboratory services are an essential component in the delivery of quality and affordable health services, yet laboratory services in The Gambia receive less attention in terms of budgetary allocation than vaccines and essential medicines. A well-functioning public health laboratory service should include the following attributes: 1. Provides vital information needed for proper planning and utilization of health resources; 2. Enhances evidence-based diagnosis, patient management and prevents/eliminates diagnosing patients based on clinical symptoms alone; 3. Contributes immensely towards health research, disease surveillance, disease outbreak detection and management, and pathological and forensic investigations; and 4. Monitors the efficacy of antibiotics and the detection of antimicrobial resistance (AMR). Globalization, cross-border diseases and the ever-increasing risk of bioterrorism have thrown the spotlight on the need to have quality assured clinical and diagnostic services alongside integrated disease surveillance and response strategies capable of effective containment of outbreaks before they become a national or global emergency. Without diagnostics, the management of medical conditions/diseases is blind and yet diagnostics receive much less attention than vaccines and drugs. Despite recent investments in global health diagnostics, the potential for diagnostics to generate value for patients and health systems has not been met across all settings; particularly in low- and middle-income countries (LMICs) where disease burdens are high and diagnosis remains a big gap within the healthcare domain. This NHLSSP aims to strengthen laboratory services to execute their core functions and deliver quality assured laboratory services acceptable at both national and international standards. 2 World Health Organization Mission Report, 2017: Joint External Evaluation of IHR Core Capacities of the Republic of The Gambia 18 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] CHAPTER 3: S ITUATION AL ANALYSIS: ACHIEVE MENTS AND CHALLENGES In 2017, the MoH senior management team, together with other partners, conducted a comprehensive situational analysis; which is being used as the main baseline in the development of this strategic plan. These findings were updated using the HTA report of 2019 and the SLIPTA assessment report of 2020.1,9 The central team, used a pretested questionnaire to collect data from all public health facilities as well as offices of the Regional Health Directorates. Furthermore, the team carried out in-depth discussions on the issues/challenges affecting the delivery of laboratory services at the various levels of service delivery. Table 1 shows a summary of this SWOT analysis. Table 1: Results of the strengths, weaknesses, opportunities and threats analysis of National Public Health Laboratory Services Thematic area Strength Weakness Organization 1. Collaborations and support from 1. Weak organizational structure and the MoH 2. Insufficient number of qualified management 2. Establishment of a DNHLS staff 3. Existence of a tiered laboratory 3. Weak linkage among public and system between public and private health 4. Support from development sector laboratories partners (GF, WHO, UNICEF, 4. Limited implementation UNFPA, UNDP, WAHO, CDC, capabilities EDCTP, MRCG, Africa CDC, 5. Lack of an organizational chart ASLM) depicting lines of communication and roles and responsibilities of key laboratory staff 6. Weak supervision of the overall laboratory system 7. Inadequate finances and human resources | Opportunity THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 Threat Collaboration with development 1. Indequate quality of laboratory partners (GF, WHO, UNICEF, service delivery UNFPA, UNDP, WAHO, CDC, 2. Donor fatigue EDCTP, MRCG, Africa CDC, 3. No laboratory policy or strategic ASLM) plan 4. No Medical Laboratory Council Act 1 Health Technology Assessment report, 2019 9 SLIPTA assessment of National Public Health Reference Laboratories report, November 2020. 19 Laboratory Strength Weakness infrastructure 1. Peripheral laboratories upgraded 1. Unsuitable and substandard 2. Provision of a biosafety level national reference laboratory (BSL) III laboratory facilities 3. Existence of laboratory structures 2. Inappropriate operational environment e.g. uncontrolled ambient temperature, intermittent power failure, inadequate water supply 3. Culture of periodic maintenance of laboratory facilities no longer in place 4. Inadequate investments in laboratory infrastructure 5. Limited of monitoring of laboratory environmental controls 6. Absence of a national standard for laboratory infrastructure 7. inadequately ventilated laboratories at primary and secondary levels 8. Lack of a National Blood Transfusion Service Centre Opportunity Threat 1. Availability of donor/partner 1. Inadequate funding to address supported model laboratories laboratory infrastructure 2. Availability of local partnership in 2. Inadequate safety and security for infrastructural development personnel in working (GAMWORKS) environments 3. Frequent interruption in water and electricity supplies from the national grid Laboratory Strength Weakness services 1. Availability of an array of routine 1. No national list of at least 10 tests at the peripheral laboratories priority diseases (JEE 2017) 2. Availability of some specialized 2. Inadequate reports from regional tests at regional and reference laboratories laboratories 3. Lack of or non-functional 3. A functional National Blood equipment for specialized tests Transfusion Service (NBTS) 4. Inadequate funding for laboratory 4. Availability of the IDSR guideline consumables and list of diseases 5. Weak biomedical engineering 5. Availability of a national servicing to support maintenance reference laboratory of equipment 20 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] 6. Inadequate coordination of laboratory services across the three healthcare tiers 7. Insufficient resources to support specialized testing services 8. Prolonged turnaround times 9. Weak of a sample referral system 10. Indeaquate cold chain system in place Opportunity Threat 1. Partner support and funding for 1. High rate of staff attrition equipment, training and supplies 2. Improperly maintained laboratory equipment leading to increased equipment downtime 3. Insufficient number of trained staff at all levels and a compromised staff to workload ratio resulting in delayed treatment 4. Intermittent stock-outs for testing of diseases with epidemic potential Laboratory Strength Weakness support 1. Involvement of laboratory 1. Inadequate presence of up-to-date systems: management in the procurement technology to meet current needs Equipment and of equipment and supplies 2. Unreliable supply of reagents and supplies 2. Existing budget line on consumables, resulting in frequent government estimates stock-outs 3. Equipment user manuals available 3. Limited budget for procurement for training purposes of equipment and supplies to | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 match national health demands 4. Inadequate and inappropriate basic laboratory equipment at all levels 5. Weak inventory management 6. Weak of established preventative maintenance programmes 7. Weak of equipment management systems 8. Lack of equipment user maintenance training 9. Lack of equipment standardization 21 Opportunity Threat 1. External partnerships and support 1. Limited government support programmes from Regional 2. Few biomedical engineers to Reference Laboratories (MRCG address in-country equipment (Medical Research Council maintenance needs Gambia), Dakar, Accra and 3. Service interruption due to lack of Abidjan) spares 2. Ability to establish service 4. Limited budget line to purchase contacts with equipment vendors equipment and maintenance 5. Inaccessible budget line for government estimates Point-of-Care Strengthen Weakness Testing 1. Availability of sustainable 1. No policy and validated (POCT) point of care test nationally guideline for the use of point for malaria,HIV, TB, etc of care test Services 2. Established of Medical 2. No guideline and protocol for Control agency for regulation validation of point of care test medical products and devices 3. No laboratory based task 3. Availability MoH budget to shifting policy and guideline procure point of care test for the use of point of care test 4. Limited NEQA system for point of care test Opportunity Threat 1. Willing of donor such as 1. Weak regulation of the point GF,WHO,WB UNICEF to of care test procure point of care test 2. No NEQAS programme for 2. Engagement of MRCG and point of care test other research institute for the 3. Limited training programme evaluations of point of care for the use of point of care test test 3. Availability of WHO requalified list of Point of Care test Laboratory Strength Weakness support 1. Qualified laboratory professionals 1. Low remuneration of staff systems: 2. Availability of different cadres of 2. High rates of staff attrition and an human laboratory professionals insufficient number of qualified resources (medical/scientific) staff development 3. Existence of trainable personnel 3. Unavailability of specialist and 4. Availability of a Field training in biomedical sciences management Epidemiology Training locally Programme (FETP) 4. Limited in-service training 5. Refresher training at DNHLS 5. Limited accommodation arrangements at the regional level 22 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] 6. Lack of competency assessments 7. Lack of professional development and continuing education programmes 8. Weak of maintenance of personnel records (education, qualifications and experience) 9. Lack of staff retention strategies 10. No appraisal and work job description system Opportunity Threat 1. Availability of partner support 1. Limited motivation 2. Training of laboratory staff at the 2. Unqualified personnel working in University of The Gambia and laboratories America International University 3. No human resources for of West Africa laboratory plan Laboratory Strength Weakness quality 1. Availability of a national quality 1. Inadequately trained staff management unit at the MoH 2. Lack of a laboratory quality system management system (LQMS) 3. Limited participation in international EQA 4. Inadequate supporting infrastructure and equipment Opportunity Threat 1. Availability of partner support to 1. High costs of implementation of strengthen LQMS quality programmes Biosafety and Strength Weakness biosecurity | 1.HEALTH THE GAMBIA NATIONAL Existing biosafety LABORATORY manualPLAN 2021 – 2025 1. Lack of laboratory health and SERVICES STRATEGIC safety officers and committees 2. Occasional stock-outs of PPE 3. Inadequate waste management facilities (incinerators) 4. Inadequate training and compliance with safety and security measures 5. Absence of safety inspections 6. Inadequate training and procedures for the safe transport of infectious materials 23 7. Lack of defined roles and responsibilities related to bio-risk management 8. Inadequate funding for biosafety 9. Lack of biosafety and biosecurity protocols Opportunity Threat 1. Existing programmes to support 1. Lack of awareness of bio-risk laboratory biosafety and training: management African Society for Laboratory 2. Exposure to highly pathogenic Medicine (ASLM), CDC organisms 2. Availability of external funding sources for training on biosafety Ethics and Strength Weakness community 1. Existence of a national ethics 1. Lack of an ethics committee that committee that oversees scientific oversees the ethics of laboratory research proposals practice 2. Poor awareness of good ethical practice 3. Lack of a mechanism for the enforcement of ethics regulations 4. Lack of a national code of conduct for laboratory personnel 5. Lack of in-service ethics training Opportunity Threat 1. Ethics training opportunities for 1. Compromised professional accreditation of laboratories conduct through cover-ups of 2. Sanctions for breaches of ethics at ethical breaches a professional level 3. Continuing professional development and training regarding ethics Laboratory Strength Weakness information 1. Existing laboratory information 1. Lack of IT infrastructure in management management information system laboratories for the efficient system (LIMS) and health management management of laboratory data, information system (HMIS) supplies and equipment within the MoH 2. Poor internet connectivity and 2. Existence of IDSR other utilities 3. Inefficient dissemination of information 24 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] 4. Lack of laboratory data management guidelines and data collection tools 5. Weak LIMS system Opportunity Threat 1. Opportunity to improve existing 1. No back-up system to prevent loss LIMS of laboratory data 2. Existing programme to support 2. No data security mechanisms LIMS and HMIS 3. LIMS as part of continuing professional development Research and Strength Weakness development 1. Ongoing R&D activities 1. Low number of trained scientific 2. Existence of research institutions staff at postgraduate level with research experience 2. Inadequate facilities to conduct research 3. Difficulty in retaining qualified staff 4. Limited resources to conduct research 5. Few R&D activities undertaken 6. Lack of a laboratory research database 7. Lack of NPHLS and EFSTH laboratories getting accreditation 8. No budget line for operational research Opportunity Threat 1. Existence of national training 1. Lack of translation of research institutions findings into national policies | 2. Existence THE GAMBIA NATIONAL HEALTH ofSERVICES LABORATORY a research directorate STRATEGIC PLAN 2021 – 2025 2. PhD graduates are tempted to quit 3. Networking among researchers their jobs 4. National and international involvement and support for R&D Networking Strength Weakness and 1. Existence of scientific and 1. Poor communication between collaboration professional organizations that public and private sector support meetings laboratories 2. Opportunities for networking and 2. Minimal linkages with other collaboration (WAHO, UN bodies relevant ministries, such as and MRCG) Agriculture, Fisheries, Higher Education, etc. 25 3. Laboratory staff participation in 3. Existing surveillance networks are central, regional and facility not comprehensive and focus on meetings endemic diseases surveillance 4. Existence of surveillance 4. Existing surveillance networks networks not adequately integrated with the laboratory system 5. Poor communication among health laboratories Opportunity Threat 1. Existence of a monthly national 1. Delayed IDSR seminar organized by MRCG 2. Communication challenges Legal and Strength Weakness regulatory 1. Reference laboratories participate 1. Absence of legislation to regulate framework in national quality control the operation of laboratories activities 2. Lack of licensing of laboratories 3. Lack of registration and licensing of laboratory personnel 4. Non-conformity to policies and regulations 5. No laboratory is accredited to any international standard 6. No laboratory is participating in quality audits Opportunity Threat 1. Political will for regulatory and 1. Deception leading to misdiagnosis licensure apparatus establishment and high levels of antimicrobial 2. Growing country ownership of resistance integrated laboratory programmes 3. Collaboration and support from national and international organizations to promote 4. accreditation, quality management and training Monitoring and Strength Weakness evaluation 1. Partner support for specific 1. Lack of core M&E tools specific diseases to laboratories 2. Small country with a good road 2. Weak supervision and inadequate network knowledge of M&E 3. Lack of qualified M&E personnel specific to laboratories 26 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] Opportunity Threat 1. Availability of partner funding 1. Inability to measure progress Financing and Strength Weakness accountability 1. Government funding available to 1. Inadequate government budget for support laboratory services laboratory services 2. Donor and private sector funding 2. Inadequate cost recovery mechanism in all public health facilities 3. Inadequate funding allocated for laboratory capacity building, staff education and training 4. Insufficient funding to support surveillance networks and other public health activities Opportunity Threat 1. Additional sources of funding 1. Unregulated pricing systems for becoming available costing laboratory tests 2. Overdependence on external support Subsequently, the situational analysis was complemented by a desk review of normative documents of the MoH; key documents reviewed were: 1. Ministry of Health and Social Welfare Banjul, The Gambia, 2012/2020: National Health Policy 2. Ministry of Health and Social Welfare Banjul The Gambia, 2014/2020: National Health Sector Strategic Plan 3. Ministry of Health Social Welfare Directorate of Planning and Information, 2016: Annual Report: Service Statistics Report | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 4. The Gambia Health Sector Investment Case for Accelerating Progress towards the SDGs, 2013– 2015 5. National Strategic Plan for HIV/AIDS, 2015/2019 6. Ministry of Health and Social Welfare Banjul, The Gambia; 2017–2030: Health Financing Policy: Resourcing the Pathway to Universal Health Coverage 7. WHO Consultant Report, 2018: The HRH Assessment Report; For Input into the Comprehensive Health System Assessment of The Gambia 8. The Gambian National AIDS Secretariat, 2019: Health Technology Assessment 27 9. Ministry of Health and Social Welfare Banjul, The Gambia; 2018: Gambia Health Information System and Monitoring and Evaluation Report 10. World Health Organization Mission Report, 2017: Joint External Evaluation of IHR Core Capacities of the Republic of The Gambia 11. Africa Society of Laboratory Medicine Report (ASLM), 2015: Country Summary Landscape Report The Gambia 12. National Nutrition Agency (NaNA)-Gambia, UNICEF, Gambia Bureau of Statistics (GBOS), Ground Work. Gambia National Micronutrient Survey 2018. Banjul, Gambia; 2019 13. National Health Policy, Republic of the Gambia 2021–2030

3.1 The National Health Laboratory service structure and networking Currently, most health facilities across the nation have laboratories that render services ranging from the most basic at a minor health centre level to the most specialized laboratory services at teaching hospital laboratories, private research laboratories and the National Public Health Reference Laboratories. A comprehensive National Health Laboratory Services Policy, along with the Medical Laboratory Council Act, will enhance the establishment of a Medical Laboratory Council.1 the council shall implement the regulation and licensing of laboratory personnel and premises in both public and private laboratories for assured quality and reliable service delivery in the country. Some laboratories operate in silos, as the network in practice exists without official mandate/policy, terms of reference (TORs), guidelines and a medical laboratory council, hence the urgent need to better position the laboratory services. The development of a holistic National Health Laboratory Service Policy would encompass all of these laboratories and facilitate the decentralization of laboratory services.

3.2 Organization and management of the National Health Laboratory Service structure and network A director currently oversees the National Public Health Laboratories (NPHLs), which house the HIV, TB, malaria and bacteriology reference laboratories, the NBTS, and the remaining National Health Laboratory Service (NHLS) laboratories. The director coordinates the employment, training and deployment of laboratory staff, mainly to health facilities at minor and major health centres and district hospitals. Teaching and general hospitals are semi-autonomous and thus employ their own laboratory staff. The director of the NHLS, in consultation with the Directorate of Pharmaceutical Services, procures laboratory equipment, reagents and consumables for all laboratories under the MoH and other private laboratories supported by the Global Fund. This policy will address the mandate and TORs of the director of the NHLS to extend beyond the NPHL and how autonomous and semi-autonomous laboratories will interface with the network. It will also give autonomy to the director of the NHLS to procure laboratory equipment, reagents and consumables, in consultation 28 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] with senior management. Besides delineating clear TORs for each laboratory, the different laboratory levels will be linked to laboratory test menus, a sample referral system and ultimately the laboratory quality management system to avoid conflicts of interest.

3.3 Laboratory services: the major constraints The major constraints to the laboratory sector effectively contributing to healthcare delivery include:  No mandate, ToRs or guidelines that clearly explain how the components of the laboratory network should work together  No flow chart of the laboratory network exists that could dictate sample collection and transportation/referral for more advanced testing  No guidelines or weak systems for sample transportation  Weak laboratory governance and coordination  Low number of qualified laboratory personnel across the various levels of the health sector  The absence of an efficient capacity building and continuous professional development system using a clearly defined professional development strategic plan  The lack of national standards for the establishment of medical laboratories and the absence of a comprehensive quality management system  Inadequate basic components necessary for effective functioning and efficient service delivery by medical laboratories, including basic physical infrastructure, laboratory equipment and supplies and the unreliable supply of utilities such as electricity and water  Limited participation by and communication with laboratory management in the procurement of equipment, reagents and consumables, leading to frequent stock-outs and a lack of spare | parts THE at NATIONAL GAMBIA all laboratory levels SERVICES STRATEGIC PLAN 2021 – 2025 HEALTH LABORATORY  Limited systems for monitoring laboratory supplies  Low level of preparedness for epidemic specimen management  No National Blood Transfusion Centre  No molecular-based screening for blood-borne infections  Limited SOPs in place at all levels of the laboratory service  No policy or guidelines for reporting and archiving laboratory results 29  Weak laboratory information management system  Weak biosafety and biosecurity systems throughout the national laboratory network  Inadequate funding support for continuous services of the Essential Health Package at all levels of the laboratory system  Lack of specialized laboratories, such as toxicology, forensic science and bio-bank laboratories for the storage of tissues/isolates These inadequacies hinder effective clinical care and do very little to inform positive public health decisions.

3.3.1 Organization and management The NPHL provides laboratory support by acting as a national reference laboratory. It also carries out coordination and supervision functions for all clinical laboratories providing diagnostic services within all public and private health facilities, including stand-alone laboratories. There is thus a need to provide a comprehensive organogram, including standardized term of references, for all jobs under the NPHL and other clinical laboratories. This would help to clearly define and separate the roles and functions of these laboratories within the NHLS network. It is envisaged that one principal laboratory scientist should be posted at each Regional Health Directorate (RHD) to facilitate coordination of activities, oversee the operations of all satellite laboratories and report to the central level, which is the Directorate of the National Public Health Laboratory Service (DNPHLS), which shall be housed at the National Public Health Reference Laboratories (NPHRLs). Currently, this system is not functional due to a lack of policy for effective human resources distribution across the country and motivation for retention in service. There is weak national laboratory governance, an inadequate number of qualified laboratory personnel, and generally non-existent linkage among public and private health sector laboratories.1

3.3.2 Laboratory services The Directorate of the NPHLS has not ensured access to a minimum package of laboratory services appropriate to each level of care in the public and private sectors. This should be ensured for equity and access to a functional specimen referral system that provides services at all levels. Where samples are referred to other laboratories, efforts are not made to ensure quick turn-around times for clinicians and patients. There exist the integrated disease surveillance and response guideline wherein 42 diseases of public health importance have the highlight for the national surveillance system and notably, diseases such as measles, rubella, yellow fever, meningitis, polio, malaria, HIV, TB and COVID 19 had a well-established laboratory surveillance system and all the report. Although according WHO joint external evaluation report, there is no laboratory-based list of at least ten priority diseases14, limited regular reports from regional laboratories, and inadequate coordination of laboratory services across the three health care tiers. Laboratory services within both the public and private sectors are not audited to ensure standardization in service delivery to improve the quality of services rendered to the general public. 30 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here]

3.3.3 Infrastructure, Laboratory biosafety and biosecurity The infrastructural capacity of several laboratories has been improved with support from development partners. However, many facilities that were built some decades ago are now dilapidated and in need of renovation or upgrading to meet current recommended infrastructural standards. There is inadequate investment in laboratory infrastructure, with unreliable sources of utilities such as water and electricity, uncontrolled ambient temperature, and no effective mechanisms for fire safety and infection control system structures. There are no standard regulations for laboratory infrastructure. The risk of laboratory-acquired infections is ever present among personnel handling pathogenic organisms. This risk is compounded by low awareness, inadequate training and an inability to adhere to recognized SOPs. In many countries, including The Gambia, the disposal of medical waste is often not regulated. There is also a potential danger in many laboratory premises due to unauthorized access by non-laboratory staff. This can lead to exposure to highly pathogenic organisms (e.g. the virus that causes COVID-19). It is therefore essential that all laboratories take precautions to protect staff and the environment and control access to the laboratory. Most facilities do not have designated safety officers, sufficient personal protective equipment (PPE), safe waste-disposal mechanisms, infection prevention and control mechanisms, adequate waste-management facilities (incinerators), or adequate training and compliance with SOPs. Hence, there is a need to recruit and train a health and safety officer who will advise employers on the measures needing to be taken in the interests of safety and health at a place of work. The safety officer should also inspect places of work, to determine whether there are any hazards liable to cause bodily injury, and investigate any accidents, near misses, dangerous occurrences, or occupational poisoning or disease. The safety officer shall ensure that staff receive adequate training on health and safety at work, strictly adhere to rules, and safely manage the disposal of waste. Laboratory staff currently have no access to health insurance schemes for themselves and their families, thus making the profession insecure and risky. 3.3.4| THE Laboratory support GAMBIA NATIONAL systems:SERVICES HEALTH LABORATORY equipment STRATEGICand supplies PLAN 2021 – 2025 Laboratory consumables and equipment are procured by the MoH through the procurement unit. Development partners also procure laboratory consumables and equipment for the MoH. The storage and distribution of these consumables and equipment are coordinated by the Directorate of Pharmaceutical Services (DPS). Generally, higher-level facilities are relatively better equipped than lower-level facilities. Non-government sector facilities are usually better equipped and better stocked with reagents and supplies, but in general there are weak and poorly coordinated inventory and procurement systems to ensure uninterrupted supply and service delivery. Many facilities experience regular stock-outs of essential reagents as well as equipment downtime, limiting their ability to carry out basic tests. Laboratories at all levels are ill-equipped, with most lacking up to date equipment required to provide basic microbiology, haematology and clinical chemistry services. Equipment in some facilities lacks 31 either skilled users or is not adequately maintained, thus leading to wastage of resources. This is usually due to the limited inclusion of maintenance agreements in purchase contracts and the limited of training programmes for users in the use and basic maintenance of equipment. There is a limited budget for the procurement of equipment, replacement parts and supplies to match national health demands. The Biomedical Unit is poorly furnished and therefore should be well-equipped in order to maintain other available equipment. Generally, laboratory users are not actively involved in the procurement process.

3.3.5 Laboratory support systems: human resources The shortage of human resources to work in diagnostic laboratories is serious and is affecting the quality of healthcare at our facilities. There is a huge challenge in providing and retaining adequate numbers of laboratory professionals in public sector healthcare laboratories, especially in rural and remote areas. A countrywide tour to conduct a comprehensive assessment of the status of public health laboratories was performed by a consultant in 2019, and the biggest challenge highlighted was the shortage of appropriately trained staff.1 Thus, many laboratories do not meet the recommended staffing norms and instead resort to employing unqualified personnel, referred to as laboratory attendants. This cadre of staff has no formal technical training and therefore are a cause for concern in terms of the quality of service they can provide. Currently, in The Gambia, there are limited institutions where biomedical scientists can be trained. The University of The Gambia and the American International University, West Africa (AIUWA) only train laboratory technicians.10 Although the former also trains biologists, these trainees only graduate with a BSc in biology and hence fall short of the requisite training to become a biomedical scientist. There are limited highly qualified personnel to fill the available positions at both the technician and scientist levels. There is widespread dissatisfaction among laboratory practitioners, with complaints of low pay and poor working conditions. This leads to high rates of staff attrition and a shortage of qualified staff, which further worsens the human resources crisis in the country’s health sector. Simply addressing the absolute number of laboratory professionals without dealing with career progression and continued opportunities for education or in-service training will not result in developing and maintaining key personnel. All these factors result in demotivation, which further compromises the quality of services delivered. There are limited highly qualified personnel available who are able to fill vacant positions at the technician and scientist levels.

3.3.6 Laboratory quality management system There is no clearly developed and well-coordinated quality management system for internal and external quality assessment that could lead to the continuous quality improvement of standard laboratory services; resulting in accreditation.2 The establishment of a quality management system for every laboratory is essential to ensure quality testing services. Inadequacies in the infrastructure, human resources, equipment, supplies and other aspects compromise the quality of laboratory services delivered at all facilities.2 10 Human Resources for Health, Assessment report, 2019. 32 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] Standard laboratory guidelines, manuals, and standard operating procedures (SOPs) are absent in most facilities, and a number of laboratories receive no technical support or supervision due to limited capacity and resources for the supervision and monitoring team. Only facilities involved in vertical programmes, such as those related to TB, malaria and HIV/AIDS, receive some periodic in-service training and supervision.

3.3.7 Laboratory information management systems The laboratory is often a valuable source of data for patient management and public health interventions. Data that are accurate, complete and timely are critical for public health interventions, including planning and outbreak responses. It is therefore important that a laboratory information management system (LIMS) be established nationally, and that all laboratory personnel are trained in IT to support clinical and public health programmes. Data collected at healthcare facility level are often incomplete and inaccurate. Currently, information is manually managed at the peripheral level and is not effectively used at many levels. The transfer of laboratory data among different levels and sectors is also not very effective. The use of modern computerized systems is limited, and systems for keeping laboratory records and collating data from testing laboratories are not standardized. This is due to limitations in laboratories in the IT infrastructure for efficient management of laboratory data, supplies and equipment; poor/lacking internet connectivity and other utilities; and a lack of laboratory data management guidelines and data collection tools. Therefore, the opportunity to introduce the LIMS system link to the District of Health Information Software 2 (DHIS2) for the management and reporting of COVID-19 results could be exploited to expand it for all laboratory services.

3.3.8 Research and development (R&D) R&D is an important pillar of any progressive laboratory service and is essential for any country that seeks to understand and find solutions to its problems. Laboratory scientists should be trained to initiate and conduct research activities. The potential exists to build on the available capacity to enhance laboratory-based research activities in the country in conjunction with the Directorate of Health | Research, Medical Research Council, Directorate of Research under the Ministry of Higher THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 Education and Research and other relevant partners. However, there is currently inadequate funding and facilities to conduct research, hence R&D is often neglected.

3.3.9 Point-of-Care Testing (POCT) Services The discovery and introduction of the point of care test has increase access and turnaround in the diagnoses and management of patients. This success stories has drastically increased to the access of testing and management for malaria, HIV and TB in the Gambia. Point of care tests are the mainstay test for blood screening for transfusion transmission infection nationally, though; it is ideal to introduce molecular-based diagnostic capacities for such services. There are no and weak regulation of use of point of care devices national and these devices may of dependable on their sensitivity and specificity for the desired result to be ascertain. Beside there no standardize external quality assurance programme for such devices such that their performance are ensured to be reliable. Therefore for the quest of laboratory service in the context of universal health coverage, it 33 paramount to embrace the used of WHO prequalified point of care tests which has to be locally regulated and dependable

3.3.10 Networking and collaboration Networking and collaboration are essential components in delivering quality laboratory services, due to the different categories of laboratories (e.g. diagnostic and reference laboratories). It is sometimes necessary to refer tests to other laboratories within or outside the country. It is now recognized and proven that a country can successfully organize a disease-specific or general laboratory network within the country to provide many patients with access to a range of tests. Networks are also important for sharing information and experience, strengthening the referral system, and training laboratory personnel. There is limited equipment and trained personnel to provide higher-level testing throughout the country. This leads to an alarmingly high rate of patient referrals, just because of the lack of on-site laboratory testing with no national sample referral system guidelines. This greatly hinders the timely management of clinical cases. There is also poor communication between public and private sector laboratories and weak linkages with other relevant ministries, such as Agriculture, Fisheries, Higher Education etc.14 Hence, the implementation of the National Public Health and Emergency Response Plan, which had all the structures for the implementation of One Health, would create a structure for inter- and intra-ministerial linkages for responses and coordination for diseases and other public events.11

3.3.11 Legal and regulatory framework There is no Medical Laboratory Council Act to regulate the operation of laboratories or the registration and licensing of laboratory personnel.2 Therefore, there is an urgent need to establish a Medical Laboratory Council, which will be mandated with registering and licensing all laboratory practitioners and laboratories. Besides council shall support the development and implementation of a code of conduct and maintenance of laboratory ethics and execution of disciplinary for the NHLS. Further, it will be strengthened to support the continuous professional development of the cadre. This unit shall be semi-autonomous and could liaise with the Directorate where relevant.

3.3.12 Monitoring and evaluation There are limited monitoring and evaluation (M&E) systems for the comprehensive assessment of laboratory performance for effectiveness and efficiency in the delivery of quality, affordable and timely health services in accordance with the National Health Policy 2021–2030. This system needs strengthening to track the progress and achievement of laboratory-based health outcomes on a regular basis. There is a limited, core M&E tool specific to laboratories, inadequate supervision and knowledge of M&E at the central level, and a lack of qualified M&E personnel specific to laboratories. Most of the parallel funded disease monitoring and evaluation programme will be oriented to cover other diseases. 2 World Health Organization Mission Report, 2017: Joint External Evaluation of IHR Core Capacities of the Republic of The Gambia 11 National Public Health and Emergency Response Plan, 2019 34 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here]

3.3.13 Financing and accountability The NHLS is grossly underfunded.2 there is a dedicated budget line for National Health Laboratory Services but this is not easily accessible and well below the amount required to guarantee equipment availability and no stock outs of reagents, test kits and laboratory supplies. There is also limited cost recovery mechanism for laboratory services in public health facilities. This must be urgently addressed via a laboratory policy, a clear organizational structure, and leadership at the appropriate level within the MoH to develop a laboratory business plan in the quest for cost recovery to sustain the continuity of laboratory services. Besides, it will be prudent to explore implementing a resource- based financing scheme paid for improving health care services in piloted health facilities in rural Gambia. Thus, facilities under such funding could include the cost of replenishment of reagents and consumables to reduce stock out and total dependence on limited NHLS budget lines.

3.3.14 Laboratory service ethics and community engagement There are currently no protocols or guidelines that comprise a laboratory code of conduct. The Medical Laboratory Council should enforce such codes, which will guarantee client respect, confidentiality, privacy and safety. There is no swearing of such a code of conduct when laboratory staff graduate; hence, weak regulations and limited guidance for laboratory ethics prevail in the system. There is a need to sensitize the wider community about the role played by laboratories in healthcare, as well as their rights and the rights of service provider. They could be sensitized on how to launch complain in case of any malicious practice for redress. | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 35 CHAPTER 4: STRATEGIC P LANNING

4.1 Context and rationale of the National Laboratory Strategic Plan The national laboratory strategic plan was developed to implement the National Health Laboratory Services Policy (NHLSP) 2021–2025, and is aligned with the following:  The National Health Policy (2021–2030), which recognizes the National Public Health Laboratory Service as the institution coordinating the services of a network of medical laboratory services  The Gambia National Health Sector Strategic Plan, 2021–2025, which proposed two strategic objectives: (1) availability of well-functioning laboratory services in all hospitals and all major and minor health centres by 2025, and (2) increasing access for all to quality laboratory services and blood transfusion services by 2025  The National Monitoring and Evaluation Plan for the National Health Sector Strategic Plan (NHSSP), 2021–2025 recognizes the need to strengthen the quality assurance/quality control systems for laboratory services and a linkage to a reference laboratory at the national level which needs further strengthening  Technical Guidelines for Integrated Disease Surveillance and Response in The Gambia; the Public Health Emergency Operation Centre, and the Health insurance scheme, which are all geared towards attainment of the following objectives for strengthening laboratory preparedness and responses to health emergencies: o Improve laboratory capacity for identifying pathogens and monitoring drug sensitivity o Strengthen the involvement of laboratory personnel in epidemiological surveillance The strategic plan is also aligned with regional and global initiatives focused on improving the quality of health laboratory services in Africa, notably: 1. Maputo Declaration, January 2008: the Maputo Declaration calls for the strengthening of laboratory systems in Africa and for scaling-up of services for improving laboratory support for TB, malaria and HIV/AIDS 2. Yaoundé, Cameroon Declaration; Resolution AFR/RC58/R2, September 2008: The Yaoundé, Cameroon Declaration calls for the strengthening of public health laboratories (PHLs) as centres of excellence for outbreak management in the WHO/AFRO sub region 3. Dakar, Senegal, September 2008, 5th Meeting of the Regional HIV/AIDS Public Health Laboratory Network; this meeting called for the strengthening of national HIV/AIDS testing for improved quality assurance services 4. Kigali, Rwanda, September 2009; Resolution AFR/RC59/WP/3: Policy orientations on the establishment of centres of excellence for disease surveillance, public health laboratories, and food and medicines regulation 36 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] 5. Sustainable Development Goal 3 6. Universal Health Coverage The implementation of this national laboratory strategic plan will take 5 years and will provide a national framework to guide investment in health laboratory services by the Government of The Gambia, health development partners and other stakeholders.

4.2 Vision statement, core values and guiding principles Vision Provision of high quality and accessible laboratory services at all levels of healthcare service delivery. Mission To provide high quality laboratory testing services where and when needed; support clinical care providers in the management of diseases and support disease surveillance systems and public health research. Goal To put in place high quality health laboratory service at all levels of healthcare delivery across the country. Core values and guiding principles The following core values and guiding principles shall apply in the management and delivery of laboratory services in the country. Quality testing: Ensuring quality assurance and management systems to guarantee that test results are accurate, reliable and timely. Equity: Laboratory resources and services are distributed equitably throughout the country. Accessibility: Laboratory services are affordable and within reach of all. | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 Relevance: Laboratory services are appropriate for the purpose and address the needs of individuals, families and communities. Partnership: Promote teamwork and team spirit among all laboratory personnel and afford networking and collaboration with stakeholders. Confidentiality: Promote professionalism and ethical practice among all staff and in their relationships with patients. Timeliness: Ensure laboratory results reach the caregiver and the patient on time and contribute to appropriate patient management. 37 Customer focus: Always bearing in mind who we are serving. The customer may be the community, patient, clinician, individual or the public. Ethics: Respect for autonomy, non-maleficence, beneficence and justice. Accountability: Decision-makers in laboratory services are accountable to the public and institutional stakeholders in the delivery of services. Effectiveness and efficiency: Processes and institutions should produce results that meet population needs and influence health outcomes, while making the best out of available resources.

4.3 Objectives of the strategic plan General objective statement The objective of this National Health Laboratory Strategic Service Plan is to establish authority and direction for the development of the required capacity of laboratory services and define standards for all aspects of health laboratory practice in the country. General strategies To establish a functional National Health Laboratory Service (NHLS) for the coordination of standardized and high-quality laboratory testing, disease surveillance, health research and data management. General sub-objectives 1) To restructure/transform the Directorate of NPHL to the Directorate of NHLS, with the capacity to effectively and efficiently manage laboratory services across The Gambia in the context of decentralization. 2) To provide the required number of staff with the necessary qualifications, skill sets, competence and motivation to deliver high-quality laboratory services across The Gambia. 3) To promote integrity, dignity and appropriate conduct in laboratory practices at all times and all levels. 4) To provide appropriate, functional laboratory equipment and sufficient consumables and supplies to guarantee uninterrupted laboratory service delivery at all levels of healthcare. 5) To have quality laboratory services at all health system levels to support effective patient management, disease surveillance, epidemic investigation, research, and other specialized services. 6) To provide outstanding contributions to key research outcomes to improve patient management, laboratory performance and disease control in line with the national health policy and strategy. 38 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] 7) To institute appropriately designed and standardized laboratory structures that meet the specific needs of each level of health facility. 8) To mobilize and advocate the provision of sufficient financial and logistical resources required to facilitate the delivery of continuous and high-quality health laboratory services. 9) To establish a quality management system in health facilities towards the accreditation of laboratories. 10) To establish a system for monitoring and evaluating laboratory service delivery at all levels of healthcare. 11) To establish the Gambia Medical Laboratory Council for the regulation of laboratory personnel and institutions across the country. 12) To put in place appropriate mechanisms that will guarantee laboratory personnel, users, visitors and the immediate environment. 13) To adopt best practices that comply with relevant and appropriate national and international laboratory information management systems (e.g. IDSR/HMIS). 14) To establish a National Laboratory Technical Working Group that advises the Directorate of the NHLS towards the attainment of policy objectives. 15) Promote networking among health facilities and public and private laboratories and all other relevant stakeholders. 16) To establish and maintain a robust legal framework for the regulation of all medical laboratories. 17) To institute a committee to ensure the accountability and transparency of laboratory services across all levels of healthcare in liaison with the project coordination unit and National | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 Laboratory Technical Working Group 18) To establish policies and guidelines for laboratory biosafety, biosecurity and waste management. 19) To establish a National Blood Transfusion Centre that has molecular-based blood testing facilities. 20) To review and update national blood transfusion policies, guidelines and strategies. 21) To establish antimicrobial resistance (AMR) policies and strategies for the surveillance and control of AMR. 39 22) To develop mechanisms to ensure the availability of laboratory financial protocols and guidelines for financial management and accountability. 23) To establish and maintain regulations and policies for introducing and monitoring the performance of the point of care test.

4.4 Strategic directions of the plan 1. Organization and management

1.1 Objective: Strengthen an organizational structure with appropriate authority to coordinate and manage the provision of comprehensive health laboratory services across the country. an structure with appropriate authority to coordinate and manage the provision of Strategies

1.2 Transform the Directorate of NPHL to the Directorate of NHLS with the capacity to effectively and efficiently manage laboratory services

1.3 Implement effective communication and representation of laboratory services at the seven Regional Health Directorates (RHDs)

1.4 Establish a technical oversight body (NLTWG) to coordinate and establish direction and standards for the NHLS

1.5 Provide training support for supervisors throughout the tiered laboratory network 2. Laboratory Services Objective: Provide quality laboratory testing services to all people Strategies

2.1 To have quality laboratory services at all levels of the health system that will support effective patient management, disease surveillance, epidemic investigation, research and other specialized services

2.2 Strengthen safe and secure specimen collection, packaging and transportation within the laboratory network and at the international level

2.3 Strengthen national laboratory testing capacity to support effective implementation of UHC

2.4 Conduct mapping of the outbreak response capacity of the national and regional reference laboratories in public and other sectors under the One-Health approach to guide specimen referral across the laboratory network for disease confirmation

2.5 Review/adapt, validate and print guidelines for the implementation of laboratory-based surveillance of AMR, vaccine preventable diseases, foodborne diseases and non-communicable diseases in the mainstream IDSR, One-Health context

2.6 Develop a plan and budget to support laboratory public health emergency responses, which is mainstreamed with the national health emergency response plan for early warning system

2.7 Develop and implement human resource competencies for specialized and clinical laboratories at the national and regional levels for the detection of agents of public health importance under the One-Health approach 3. Infrastructure, Biosafety and Biosecurity 40 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] Objective: Provide appropriate laboratory infrastructure to ensure the safety of personnel, community and the environment, and provide for security of materials and information. Strategies

3.1 Strengthen national laboratory biosafety and biosecurity system

3.2. Ensure that construction and renovation of health laboratory facilities conform to national infrastructure guidelines and standard

3.3 Establish maintenance programme for biosafety and biosecurity equipment

3.4 Establish an effective occupational health and safety programme for laboratory personnel in liaison with the occupational health unit of the MoH

3.5 Strengthen the coordination of biosafety and biosecurity activities through effective management at all levels

3.6 Strengthen human resource capacity for biosafety and biosecurity Program through trainings for improved practice 4. Equipment and Supplies Objective: Ensure availability of supplies and functional equipment that are appropriate at all levels to support uninterrupted routine and emergency laboratory services. Strategies

4.1. Strengthen the coordination of the laboratory supply chain management system across the network in liaison with National Pharmaceutical Services (NPS)

4.2 Establish pre- and post- market surveillance systems for laboratory commodities

4.3 Strengthen supply chain management to quantify, procure, distribute and monitor laboratory commodities across the network

4.4 Strengthen the ordering, storage and inventory management systems at all levels

4.5 Strengthen data management systems for laboratory logistics to meet routine and emergency services delivery

4.6 Strengthen capacity in laboratory logistics management, including BLIS

4.7 Develop and implement guidelines for equipment procurement and placement across the laboratory network

4.8 Strengthen equipment maintenance and management at all levels

4.9 Establish a system for monitoring equipment functionality and managing the disposal of | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 laboratory equipment and supplies

5.0 Human Resources Objective: Ensure that the laboratory sub-sector has an adequate workforce with the necessary competencies, remuneration and motivation to deliver quality laboratory services at all designated levels Strategies

5.1 Review and update current scheme of service for the laboratory work force

5.2 Recruit sufficient laboratory staff to fill vacant and new positions at all levels, in line with the revised scheme of service for laboratory professionals

5.3 Retain sufficient laboratory staff at all levels, in line with the revised scheme of service

5.4 Equip the laboratory workforce with the skills and competencies essential for quality service delivery 41 6. Quality Management System Objective: Strengthen the national laboratory quality management system to ensure quality service delivery that leads to national/ international laboratory certification and accreditation Strategies

6.1 Develop and establish national laboratory standards for laboratory quality 6.2 strengthen the coordination of activities for the implementation of the laboratory quality management system (QMS)

6.3 Strengthen National External Quality Assessment Schemes (NEQAS)

6.4 Strengthen the national capacity for implementation of quality management systems towards laboratory certification and/or accreditation

6.5 Provide training support for supervisors throughout the tiered laboratory network 7. Laboratory Information Management System Objective: Implement an integrated LIMS in the laboratory network for the management and utilization of patient data and other laboratory services data to facilitate evidence-based decision- making and operational research Strategies

7.1 Develop and implement an electronic, integrated LIMS in all laboratories in the network to improve laboratory data and information management

7.2 Strengthen standardized, paper-based LIMS at sites without electronic LIMS to facilitate data capture and reporting

7.3 Develop and implement an electronic, mobile and web-based platform for effective specimen tracking across the national sample transport network

7.4 Establish a system for the standardized collection, analysis and reporting of patient data to improve data use

7.5 Establish a forum for multi-sectoral data sharing among all laboratories and agencies with activities affecting human health, to enhance collaboration for implementing the One Health model

7.6 Establish an integrated database for managing non- clinical laboratory data to improve the coordination of laboratory services 8. Research and Development Objective: Undertake research of public health importance according to the research priorities of the National Health Sector Strategies

8.1 Develop a research agenda for the laboratory sub-sector

8.2 Build capacity of laboratory personnel involved in operational research

8.3 Develop and implement a national laboratory research database to track and disseminate research findings

9.0 Point-of-Care Testing (POCT) Services Objective: To increase access to testing services by complementing conventional laboratory testing services with approved and appropriate point-of-care technologies 42 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] Strategies

9.1 Strengthen coordination mechanism for POCT to improve provision of POCT services

9.2 Develop capacity for POCT as a means of increasing access to laboratory services

9.3 Develop and implement POCT communication strategy to improve access to POCT services at national, regional and community levels

9.4 Develop QA mechanism for POCT to improve quality of POCT services 10. Networking and Collaboration Objective: to Strengthen multi-sectoral, national, international, public and private partnerships to promote equitable access to quality laboratory services Strategies

10.1 Establish a system for sharing information, testing capacity and resources among sectors towards the One-Health strategy (e.g. for AMR, zoonotic and notifiable diseases, outbreaks, and food safety)

10.2 Establish mechanisms to outsource specialized laboratory services to increase efficiency and effectiveness in service delivery

10.3 Promote public–private partnerships for the provision of health laboratory services in accordance with PPPH policy

10.4 Support establishment of laboratory services for underserved areas by providers outside the public system 11. Regulatory and Legal Framework Objective: Ensure that the national laboratory legal and regulatory framework is enforced within the entire health laboratory network, in collaboration with relevant regulatory bodies Strategies

11.1 Establish and maintain a robust legal framework for the regulation of medical laboratories and laboratory personnel

11.2 Ensure that all health laboratories meet the required standards for registration and licensing

11.3 Ensure that all practising laboratory professionals are registered and licensed | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 12. Monitoring and Evaluation Objective: Create and implement mechanisms to effectively measure performance of the health laboratory sub-sector to facilitate management, planning, learning and policy formulation in the country Strategies

12.1 Establish an effective program to monitor and evaluate the implementation of the National Health Laboratory Strategic Plan

12.2 Establish M&E for laboratory logistics activities

12.3 Ensure regular assessment of the overall performance of laboratory services 13. Finance and Accountability 43 Objective: Establish resource mobilization and accountability mechanisms at national and sub- national levels to ensure availability and accessibility of adequate resources for the provision of sustainable laboratory services Strategies

13.1 Ensure a dedicated budget for laboratory services in the MOH

13.2 Coordinate partner funding activities for laboratory services

13.3 Mobilize funds to meet laboratory budget needs

13.4 Establish a transparent system to ensure programmatic and financial accountability of laboratory services 14. Ethics and Community Objective: Laboratory services shall be an integral part of the health service’s responsiveness to community needs and shall adhere to ethical and environmental standards Strategies

14.1 Promote integrity, dignity and appropriate conduct in laboratory practices and responses to community needs at all times and at all level

14.2 Develop strategies to increase community access to equitable quality testing services 44 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] CHAPTER 5: IMPLEMENT ATION FRAMEWORK

5.1 Institutional framework The strategic plan matrix (below) details the strategic objectives; activities and implementation timeframe; performance indicators; and responsibility and sources for resources that would need to be deployed to implement the National Health Laboratory Service Strategic Plan; 2021–2025.

5.2 System of planning and implementation framework The MoH, through the Directorate of the NHLS, will coordinate the implementation, monitoring and evaluation of this strategic plan. Government directorates and departments involved in the delivery of laboratory services will complement the DNHLS. Development partners and national stakeholders will contribute to the implementation of this strategy by working with line ministries, directorates and departments.

5.3 Monitoring and evaluation The monitoring and evaluation (M&E) of laboratory services was not given adequate consideration in the National Health Strategic Plan 2015–2020,12 making it a critical component to monitor the implementation of the NHLSSP for The Gambia 2021–2025. The methodology and framework developed to evaluate the progress and impact of the overall strategic goals are defined in this Monitoring and Evaluation (M&E) Plan. The M&E indicators will measure the degree to which activities achieve results, as defined in the M&E framework. The results the NHLSSP expects to achieve in particular focus areas are clearly presented in the M&E framework. The M&E plan will act as a tool for the routine tracking of laboratory performance. It will also serve as a guide for managing laboratory resources, enabling stakeholders to change goals and approaches, with the comprehensive data and information flows needed at each stage to assess impact. To ensure the implementation of M&E activities as outlined in the NHLSSP, strategic information and guidance on the progress of implementation of laboratory services should be provided. Also, the accomplishment | THE GAMBIA of targets, NATIONAL measureSERVICES HEALTH LABORATORY impact, and PLAN STRATEGICtimely feedback for decision making and planning 2021 – 2025 are also needed. 12 Ministry of Health and Social Welfare Banjul The Gambia, 2014/2020: National Health Sector Strategic Plan 45 NATIONAL LABORATORY STRATEGIC PLAN MATR IX 1. Organization and management Objective: Strengthen an organizational structure with appropriate Timeline authority to coordinate and manage the provision of comprehensive health laboratory services across the country. Strategies Sub- Objectives Funding Source Y1 Y2 Y3 Y4 Y5

1.1 Transform the MoH X Directorate of NPHL to 1.1.1 Enactment of DNHLS the Directorate of reform policy NHLS with the capacity

1.1.2 Define and institute an MoH, WHO, GF X to effectively and efficiently manage organogram which includes laboratory services national and regional coordinators and their corresponding job descriptions that ensure clear reporting lines within DNHLS and mainstream private laboratory linkages

1.1.3 Define and implement MoH, WHO, GF X roles and responsibilities for the different stakeholders in the tiers of the network to facilitate effective coordination of laboratory services in The Gambia

1.2 Implement effective 1.2.1 Institute regional MoH,PMO,PSC X X communication and coordination offices and representation of provide staff to coordinate laboratory services at laboratory services at regional the Regional Health level, mainstreaming into the Directorates (RHDs Regional Health Directorates 46 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here]

1.2.2 Institute and implement MoH,GF,WB X X X X annually retreat of the NHLS meeting of national and regional coordinators

1.3 Establish a technical 1.3.1 Establish a Laboratory GF, FIND, MoH X X X X X oversight body Technical Working Group (Laboratory Technical (LTWG) to provide linkages Working Group) to to programmes, partners and coordinate and establish other stakeholders to support direction and standards the National Strategic Plan for the NHLS for Laboratories

1.4 Provide training 1.4.1 Institute training for GF, FIND, MoH X X support for supervisors Laboratory Head, throughout the tiered coordinators and supervisors laboratory network in the lab network for lab oratory management course 2. Laboratory services Timeline Objective: Provide quality laboratory testing services to all people Strategies Sub-Objective Funding Source Y1 Y2 Y3 Y4 Y5

2.1 To have quality 2.1.1 Institute the Essential MoH, WHO, X laboratory services at Health Package of test WAHO, Afro all levels of the health services at all laboratory tiers CDC system that will support to suit the MoH-approved effective patient standards public and private management, disease laboratories surveillance, epidemic | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 investigation, research and other specialized 2.1.2 Strengthen laboratory MoH, WHO, X X X X services services for surveillance and WAHO, Afro public health emergency CDC investigations and management at all laboratory tiers, including the private sector 47

2.2 Strengthen safe and 2.2.1 Institute and implement MoH, GF, FIND X X X X X secure specimen integrated guidelines for collection, packaging specimen collection, and transportation packaging and transportation within the laboratory to ensure safe and effective network and at the referral of sample international level

2.2.2 Develop an electronic MoH, GF, X specimen-tracking system for FIND, WHO samples in transit

2.2.3 Initiate and follow up MoH, GF, X X X X X the procurement and FIND, WHO distribution of appropriate specimen packaging materials at all tiers of national health laboratory service 2.2.4 specimen referral MoH, GF X X X X services into the DNHLS MoH budget

2.2.5 Institute training to MoH, WHO, X X build a skills development WAHO plan for safe and secure shipment of specimens and facilitating IATA certification of staff in the laboratory network

2.3 Strengthen national 2.3.1 Update laboratory test MoH, WB, GF X X X laboratory testing menus and technologies at all capacity to support levels to increase accessibility effective to laboratory services to implementation of UHC support the implementation of UHC

2.3.2 Improve access to MoH, WB, GF X X X laboratory services for vulnerable and most at-risk population

2.3.3 Determine the cost of MoH, WB, GF X X X laboratory testing services at all levels for effective implementation of UHC 48 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here]

2.3.4 Identify laboratory tests MoH, WB, GF X X X and technologies that have the potential of leading to catastrophic expenditure and impoverishing household incomes for inclusion in the MOH health insurance package

2.4 Conduct mapping of 2.4.1 Hire consultants to MoH, WHO, X X the outbreak response conduct mapping and WAHO, Afri capacity of the national development of laboratory CDC and regional reference based costed strategic plan laboratories in public and guideline for response to and other sectors under outbreak in the context of the One-Health Onehealth approach to guide specimen referral across the laboratory network for disease confirmation

2.5 Develop, validate 2.5.1 Develop and implement MoH, WHO, X X and print guidelines for a cost plan and guideline for WAHO, Afri the implementation of laboratory- based CDC laboratory-based implementation of the surveillance of AMR, Surveillance infectious vaccine preventable diseases using the strategy of diseases, foodborne the IDSR diseases and non- communicable diseases in the mainstream IDSR, One-Health context

2.6 Develop a plan and 2.6.1 Hire a consultant to MoH, WHO, X budget to support develop costed laboratory WAHO, Afri laboratory public health public health emergency | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 CDC emergency responses, responses plan which is mainstreamed with the national health emergency response plan for early warning system 49 Develop and implement 2.7.1 Develop training plan to MoH, WHO, X human resource strengthen the capacity of WAHO, Afri competencies for laboratory staff with CDC specialized and clinical specialized diagnostic laboratories at the technique for the detect and response to pathogens and national and regional other aetiological agents of levels for the detection public health importance of agents of public health importance under the Onehealth approach 3. Infrastructure, Biosafety and Biosecurity Objective: Provide appropriate laboratory infrastructure to ensure Timeline the safety of personnel, community and the environment, and provide for security of materials and information. Strategies Sub-Objectives Funding Source Y1 Y2 Y3 Y4 Y5

3.1 Strengthen national 3.1.1 Establish a national MoH, WB X X X X X laboratory biosafety and laboratory biosafety and biosecurity system biosecurity program

3.2 Ensure that 3.2.1 Develop, validate and MoH, Gambia X X construction and disseminate laboratory Standard renovation of health infrastructure guidelines and Bureau, laboratory facilities standards GAMWORKS conform to national infrastructure guidelines and standard 3.2.2 Assess the status of MoH, WB X X X X X laboratory infrastructure to identify gaps and non- conformities

3.2.3 Construct/ renovate/ MoH X X X X refurbish and maintain laboratories in conformity with national guidelines and standard

3.2.4 Advocate for adequate MoH X X X X budget for infrastructure improvement

3.3 Establish 3.3.1 Develop and implement MoH, WB X X X X X maintenance guidelines for maintenance programme for and servicing of biosafety and biosafety and biosecurity equipment at all biosecurity equipment levels to enhance the safety of personnel and infectious material 50 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here]

3.3.2 Plan and implement MoH, WB X X X X X certification of biosafety and biosecurity equipment for optimum performance

3.3.3 Develop and update a MoH, WB X national list of biosafety and biosecurity equipment and kits necessary at each laboratory tier

3.4 Establish an 3.4.1 Develop and MoH, WB X X effective occupational disseminate guidelines for health and safety monitoring the health of programme for laboratory personnel to laboratory personnel in improve the management of liaison with the personal safety in liaison with occupational health unit the occupational health unit of the MoH

3.4.2 Develop and implement MoH, WB X X a plan for effective monitoring of health laboratory personnel for appropriate intervention and deployment

3.5 Strengthen the 3.5.1 Create a biosafety and MoH X X X X X coordination of biosecurity unit at the biosafety and national level to coordinate biosecurity activities the national biosafety and through effective biosecurity programme management at all levels

3.5.2 Develop a biosafety and MoH X X X X X biosecurity unit within the regional office with staff to | coordinate biosafety and THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 biosecurity in each region

3.6 Strengthen human 3.6.1 Develop and regularly DNHLS X X X X X resource capacity for update a database for national Biosafety and biosafety and biosecurity biosecurity Program training to determine the skill through trainings for levels of personnel improved practice 51

3.6.2 Develop and validate a MoH, GF X X X X X biosafety and biosecurity training plan for laboratory workers, managers and non- technical laboratory personnel in both public and private laboratories

3.6.3 Conduct training of MoH, GF X X X X X trainers (Tot) for biosafety and biosecurity training to increase the capacity of trainers

3.6.4 Finalize biosafety and MoH/GF X X X X X biosecurity training curriculum

3.6.5 Train officers using the MoH, GF X X X X X biosafety and biosecurity curriculum 4. Equipment and Supplies Objective: Ensure availability of supplies and functional equipment Timeline that are appropriate at all levels to support uninterrupted routine and emergency laboratory services. Strategies Sub-Objectives Funding Source Y1 Y2 Y3 Y4 Y5

4.1 Strengthen the 4.1.1 Establish focal point for X X X X coordination of the the management and laboratory supply chain coordination of laboratory management system supply chain logistic across the network in liaison with National 4.1.2 Conduct quarterly MoH, GF X X X X Pharmaceutical logistics coordination Services (NPS) meetings at central and regional levels to review the performance of logistics activities

4.1.3 Define roles and MoH/GF X responsibilities of stakeholders in supply chain management to avoid duplication.

4.2 Establish pre- and 4.2.1 Develop and implement MoH, GF X X X X post- market guidelines for pre-and post- surveillance systems for market surveillance to ensure laboratory commodities product quality using the existing structure of the NPS 52 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here]

4.2.2 Strengthen the quality MoH, GF X assurance laboratory to effectively coordinate quality control, batch testing/lot to lot testing of new laboratory commodities at DNHLS and NPS, in collaboration with MCA, NPS and MRC

4.2.3 Perform pre- and post- MoH, GF X X X X market surveillance of laboratory commodities in the system

4.3 Strengthen supply 4.3.1 Review and update MoH X X X chain management to laboratory supply lists and quantify, procure, catalogues distribute and storage of laboratory supplies 4.3.2 Conduct annual national MoH X X X X X laboratory supply quantification, with quarterly reviews, to assess and address the ongoing needs at all tiers of laboratory service and mainstreaming into the existing MoH supply quantification structures

4.3.3 Prepare and implement MoH X guidelines for procurement and distribution of laboratory commodities for facilities to avert stock-outs, using the MoH procurement and distribution structure | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025

4.4 Strengthen the 4.4.1 Revise, update and MoH X X X X ordering, storage and harmonize laboratory inventory management supplies request forms across system at all levels the national stores

4.4.2 Provide adequate MoH X X X X storage capacity for laboratory commodities, in accordance with infrastructure standards at all levels 53

4.4.3 Procure cold storage MoH X X X X facilities for laboratory commodities at national, district and health facility levels for maintenance of reagent potency, in collaboration with national warehouses

4.4.4 Develop and MoH X X X X disseminate guidelines for proper storage of laboratory commodities and ensure easy access and retrieval of supplies

4.4.5 Develop and implement MoH X X X X an inventory management system for laboratory commodities across the network, to avoid stock-outs and expiry of vital commodities

4.5 Strengthen data 4.5.1 Revise, update and MoH X management systems harmonize logistics data management tools for system

4.6 Strengthen capacity 4.6.1 Develop laboratory GF X in laboratory logistics Basic Laboratory Information management, including System (BLIS) training Basic Laboratory curriculum Information System

4.6.2 Conduct Tot for GF X X laboratory BLIS

4.6.3 Conduct facility training MoH, GF X X for laboratory BLIS

4.7 Develop and 4.7.1 Conduct equipment MoH, GF X X X implement guidelines harmonization reviews every for equipment three years procurement and

4.7.2 Develop equipment MoH, GF X placement across the specifications and standards laboratory network for all laboratory equipment across the laboratory network 54 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here]

4.7.3 Establish and harmonize MoH, GF X X guidelines for the regulation and maintenance of equipment, in collaboration with the Biomedical Unit

4.8 Strengthen 4.8.1 Increase places for MoH, GF X X X equipment maintenance laboratory equipment and management at all biomedical engineers and levels technicians at national and regional workshops

4.8.2 Establish positions for MoH, GF X X X X laboratory equipment biomedical supervisors at the national level to oversee laboratory equipment maintenance

4.8.3 Procure spare parts for MoH, GF X X X X preventive maintenance and repair of laboratory equipment

4.8.4 Support biomedical MoH, GF X X X X engineers to conduct preventive and curative maintenance of medical laboratory equipment

4.8. Develop guidelines for MoH, GF X X X X X laboratory equipment verification and calibration

4.8.6 Establish a calibration MoH/GF X X X X centre for laboratory | equipment THE GAMBIA NATIONAL HEALTH LABORATORY at the SERVICES national STRATEGIC PLAN 2021 – 2025 level

4.9 Establish a system 4.9.1 Develop and implement MoH, GF X X X X X for monitoring guidelines for reporting equipment functionality equipment breakdown at all and managing the levels disposal of laboratory equipment and supplies

4.9.2 Develop and implement MoH, GF X X X X national guidelines for laboratory equipment and laboratory supplies disposal in line with PPDA guidelines 55

4.9.3 Conduct training of MoH, GF X X laboratory staff at national and regional laboratories in procedures for the proper disposal of obsolete laboratory equipment and expired reagents 5. Human Resources Objective: Ensure that the laboratory sub-sector has an adequate Timeline workforce with the necessary competencies, remuneration and motivation to deliver quality laboratory services at all designated levels Strategies Sub-Objectives Funding Source Y1 Y2 Y3 Y4 Y5

5.1 Review and update 5.1.1 Fast-track the review of MoH X current scheme of the scheme of service for service for the laboratory professionals laboratory work force

5.1.2 Review and conduct MoH X stakeholder consultation on the reviewed scheme of service

5.1.3 Engage with the MoH X X Ministry of Public Service and the Ministry of Finance to approve and operationalize the revised scheme of service

5.2 Recruit sufficient 5.2.1 Engage the sector to MoH,,PSC, X X X laboratory staff to fill adopt the revised laboratory PMO vacant and new scheme of service positions at all levels, in line with the revised scheme of service for laboratory professionals 56 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here]

5.3 Retain sufficient 5.3.1 Fill vacant laboratory MoH, PSC, X X X laboratory staff at all posts at the various tiers of PMO levels, in line with the the laboratory network revised scheme of service

5.3.2 Establish a well- MoH X X X defined career progression path within the laboratory scheme of service

5.4 Equip the laboratory 5.4.1 Develop and MoH X X X X workforce with the operationalize an incentive skills and competencies system to foster laboratory essential for quality staff retention service delivery

5.4.2 Ensure cadres from MoH, WB, GF X X X X certified educational institutions are licensed and registered to practice

5.4.3 Advocate the MoH X development and review of preservice training curricula with training schools/institutions, to meet the needs of the laboratory services

5.4.4 Adopt and implement MoH X X X X the national in-service training plan

5.4.5 Develop guidelines and MoH X criteria for accrediting professional bodies to | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 conduct continuing professional development (CPD) for laboratory professionals

5.4.6 Develop guidelines and MoH X X X criteria for certification of non-laboratory personnel involved in testing 6. Quality Management System Timeline 57 Objective: Strengthen the national laboratory quality management system to ensure quality service delivery that leads to national/ international laboratory certification and accreditation Strategies Sub-Objectives Funding Source Y1 Y2 Y3 Y4 Y5

6.1 Develop and 6.1.1 Develop comprehensive MoH, Gambia X X X X establish national national minimum standards Standard Bureau laboratory standards for of laboratory packages for laboratory quality laboratory compliance and certification

6.1.2 Develop guidelines and MoH X X procedures for effective implementation of quality management systems at all laboratory tiers/levels

6.1.3 Formulate standardized MoH X X X X laboratory indicators for monitoring performance 6.2 strengthen the 6.2.1 Establish the laboratory MoH, PMO, X X coordination of quality assurance (LQA) units PSC activities for the at a central level and focal implementation of the persons at regional levels for laboratory quality effective coordination management system (QMS)

6.2.2 Strengthen the capacity MoH X X X X of the laboratory workforce at a facility level to implement the laboratory QMS

6.3 Strengthen 6.3.1 Develop national MoH X National External NEQAS guidelines Quality Assessment Schemes (NEQAS) 6.3.2 Strengthen NEQAS MoH X X X capacity

6.3.3 Increase the number of MoH X X X laboratories participating in NEQA Schemes

6.4 Strengthen the 6.4.1 Establish a national MoH X X X national capacity for laboratory implementation of certification/accreditation unit quality management 58 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] systems towards 6.4.2 Train and certify MoH X laboratory certification Strengthening Laboratory and/or accreditation Management Toward Accreditation (SLMTA) trainers to facilitate effective implementation of the LQMS

6.4.3 Train and certify MoH X X X X SLIPTA auditors to help in assessment and mentorship of laboratories for accreditation readiness

6.4.4 Develop mentorship X X X X capacity for LQMS at all levels.

6.4.5 Develop and implement MoH X X X X a database for the LQMS with respect to the LIMS framework

6.4.6 Implement LQMS at MoH X X X X lower health facilities not enrolled in SLMTA

6.5 Provide training 6.5.1 Establish and MOH, GF, WB X support for supervisors implement supportive throughout the tiered supervision checklists for use laboratory network by supervisors throughout the tiered laboratory network 7. | Laboratory Information Management System THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 Objective: Implement an integrated LIMS in the laboratory network Timeline for the management and utilization of patient data and other laboratory services data to facilitate evidence-based decision-making and operational research Strategies Sub-Objectives Funding Source Y1 Y2 Y3 Y4 Y5 59

7.1 Develop and 7.1.1 Scale-up the MoH X X X implement an implementation of an electronic, integrated electronic LIMS in a phased LIMS in all laboratories approach in all 50 in the network to laboratories to improve data improve laboratory data quality for the effective and information monitoring of laboratory management services

7.1.2 Develop and conduct MoH X X X X X training on guidelines for laboratory data management

7.1.3 Conduct annual reviews MoH X X X X of laboratory data management guidelines to improve the system’s performance

7.1.4 Establish network MoH X X X X X infrastructure at all laboratories to support the electronic LIMS

7.1.5 Establish the LIMS MoH X X X X X central administration unit to effectively manage LIMS initiatives

7.1.6 Build LIMS human MoH X X X X X resources capacity in the laboratories to manage LIMS activities

7.1.7 Establish and MoH X X X X implement a national laboratory data warehouse to archive electronic laboratory data

7.2 Strengthen 7.2.1 Update and harmonize MoH X X X X X standardized, paper- paper-based LIMS to based LIMS at sites accommodate all laboratory without electronic data needs LIMS to facilitate data capture and reporting 7.2.2 Conduct training in the MoH X X X X X utilization of updated and standardized paper-based LIMS to improve data capture and reporting 60 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here]

7.3 Develop and 7.3.1 Conduct a needs MoH X implement an assessment to determine electronic, mobile and system and hardware needs web-based platform for for the specimen tracking effective specimen system tracking across the national sample 7.3.2 Implement a mobile and MoH, X X X X transport network web-based platform for specimen tracking to improve sample referrals

7.4 Establish a system 7.4.1 Develop and implement MoH X X X X for the standardized a comprehensive mechanism collection, analysis and for the collection, analysis reporting of patient data and reporting of all data, to improve data use including data on drug resistance, laboratory-based disease surveillance, notifiable diseases and outbreak investigation, to improve data use

7.42 Build capacity among MoH X X X X laboratory personnel at all levels on data usage to improve evidence-based planning and decision- making among stakeholders

7.4.3 Develop a laboratory MoH X X X X X | data communication plan to THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 standardize and streamline data reporting and feedback

7.5 Establish a forum 7.5.1 Conduct advocacy for MoH X X X X X for multi-sectoral data data sharing among all sharing among all sectors, including laboratories laboratories and undertaking activities that agencies with activities affect human health, to affecting human health, promote One Health to enhance 61 collaboration for 7.5.2 Develop a harmonized MoH X X implementing the One framework of data needs in Health model accordance with multi- sectoral guidelines to achieve One Health

7.5.3 Implement and maintain MoH X X X X a forum for multi-sectoral data sharing to achieve One Health

7.6 Establish an 7.6.1 Develop standards and MoH X X X integrated database for implement an integrated managing non- clinical database to manage non- laboratory data to clinical laboratory data improve the coordination of 7.6.2 Implement a web-based MoH X X X X laboratory services system to improve logistics and equipment management 8. Research and Development Timeline Objective: Undertake research of public health importance according to the research priorities of the National Health Sector Strategies Sub-Objectives Funding Source Y1 Y2 Y3 Y4 Y5

8.1 Develop a research 8.1.1 Establish a research and MoH X agenda for the development focal point to laboratory sub-sector undertake the role of research operationalization in the laboratory sector in conjunction with the director of health research at the MoH

8.1.2 Establish a national MoH X X laboratory research plan to outline priority areas and identify collaborating Directorates of Research and other collaborators

8.1.3 Develop an operational MoH X framework for research into laboratory services to guide research efforts

8.1.4 Implement the MoH X X X operational framework for research into laboratory services to generate information for better patient care and policy formulation 62 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here]

8.2 Build capacity of 8.2.1 Develop and implement MoH X X X laboratory personnel training program for involved in operational operational research research

8.2.2 Ensure that facilities MoH X X X have appropriate personnel, equipment and access to professional databases and publications to enable health research

8.3 Develop and 8.3.1 Establish collaborations MoH X X X implement a national and partnerships between laboratory research academic and private sector database to track and partners, research institutions disseminate research and service delivery findings institutions to encourage multi- disciplinary and multi- sectoral research

8.3.2 Implement the national MoH X X X laboratory research database to track and disseminate research findings on laboratory services

8.3.3 Promote the utilization MoH X X of research findings to inform decision-making at all levels, policy revisions, and improvements to practice 9. Point-of-Care Testing (POCT) Services Objective: to Increase access to testing services by complementing Timeline conventional laboratory testing services with approved and appropriate point-of-care technologies | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 Strategies Sub-Objectives Funding Source Y1 Y2 Y3 Y4 Y5

9.1 Strengthen 9.1.1 Develop and implement MoH X X X X coordination a POCT master plan to mechanism for POCT improve coordination of to improve provision of POCT activities POCT services

9.2 Develop capacity 9.2.1 Build physical and MoH X X X X for POCT as a means of human resource capacity for increasing access to POCT and implement it laboratory services within the laboratory services 63

9.2.2 Develop and implement MoH X policy and guidelines for all aspects of POCT, to standardize POCT services

9.2.3 Develop and implement MoH X X X X integrated information management mechanism for POCT to improve data capture, analysis and reporting

9.2.4 Develop and implement MoH X monitoring and evaluation guidelines for POCT

9.2.5 Conduct operational MoH X X X X research into POCT to guide policy formulation and service delivery

9.3 Develop and 9.3.1 Develop and MoH X implement POCT disseminate POCT communication strategy communication strategy to to improve access to improve access to POCT POCT services at services national, regional and community levels

9.4 Develop QA 9.4.1 Develop guidelines for MoH X X X X mechanism for POCT QA-POCT to streamline the to improve quality of implementation of POCT POCT services services

9.4.2 Establish facilities at MoH X X X X national and reference laboratories to produce POCT PT panels

9.4.3 Implement QA-POCT MoH X X X X activities across all levels to assess performance and improve the quality of POCT services

9.4.4 Develop and implement MoH X X X X X a plan for POCT site supervision 10. Networking and Collaboration . Timeline 64 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] Objective: to Strengthen multi-sectoral, national, international, public and private partnerships to promote equitable access to quality laboratory services Strategies Sub-Objectives Funding Source Y1 Y2 Y3 Y4 Y5

10.1 Establish a system 10.1.1 Establish a multi- MoH X for sharing information, sectoral Laboratory Technical testing capacity and Working Group (LTWG) to resources among oversee implementation of sectors towards the the One-Health strategy One-Health strategy (e.g. for AMR, zoonotic and notifiable diseases, outbreaks, and food safety)

10.1.2 Determine testing MoH X capacities and ensure there are sufficient resources to facilitate intersectoral referral services

10.1.3 Develop and MoH X implement mechanisms for information sharing to facilitate collaboration and the One-Health strategy (e.g. for AMR, zoonotic and notifiable diseases, outbreaks, and food safety)

10.2 Establish 10.2.1 Review the National MoH X mechanisms to Laboratory Test Menu to outsource specialized define which tests should be laboratory services to outsourced increase | efficiency and THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 effectiveness in service 10.2.2 Develop memoranda MoH X X X X delivery of understanding (MOUs) to commit to national and international specialized laboratories to perform the identified tests to be outsourced.

10.3 Promote public– 10.3.1 Develop criteria for MoH X private partnerships for identifying underserved areas the provision of health to be supported by providers laboratory services in outside the public system 65 accordance with PPPH 10.3.2 Identify alternative MoH X X policy funding mechanisms and devise incentives for partners to support under-served areas and discipline

10.4 Support 10.4.1 Identify priority Partners X establishment of underserved HSDs where laboratory services for providers outside the public underserved areas by system can provide laboratory providers outside the services public system

10.4.2 Link underserved Partners X X X HSDs to service providers outside the public system 11. Regulatory and Legal Framework Timeline Objective: Ensure that the national laboratory legal and regulatory framework is enforced within the entire health laboratory network, in collaboration with relevant regulatory bodies Strategies Sub-Objectives Funding Source Y1 Y2 Y3 Y4 Y5

11.1 Establish and 11.1.1 Develop and MoH X maintain a robust legal disseminate laboratory framework for the registration and licensing regulation of medical standards laboratories and laboratory personnel 11.1.2 Develop specific MoH X regulations for the enforcement of the laws

11.2 Ensure that all 11.2.1 Support regulatory MoH X X X health laboratories meet bodies to assess all the required standards laboratories for compliance for registration and with standards licensing

11.2.2 Support the regulatory MoH X X X bodies to review and update the current provisions for deterrent action and address any gaps identified

11.3 Ensure that all 11.3.1 Establish The Gambia MoH X X X X practising laboratory Medical Laboratory Science professionals are Council, which will be registered and licensed responsible regulating, training and practicing of Medical Laboratory Professionals in The Gambia 66 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here]

11.3.2 Develop guidelines on MoH X X X CPD/CME requirements for licensing laboratory professionals

11.3.3 Conduct regional MoH X X X sensitization meetings on the new CPD/CME regulatory guidelines and the importance of registration and licensing for training institutions

11.3.4 Develop guidelines on MoH,partners, X X the process of administering regulatory the laboratory personnel oath bodies at graduation 12. Monitoring and Evaluation . Objective: Create and implement mechanisms to effectively measure Timeline performance of the health laboratory sub-sector to facilitate management, planning, learning and policy formulation in the country Strategies Sub-Objectives Funding Source Y1 Y2 Y3 Y4 Y5

12.1 Establish an 12.1.1 Develop and MoH X X X X X effective program to implement an M&E plan to monitor and evaluate guide the implementation of the implementation of the National Health the National Health Laboratory Strategic Plan and Laboratory Strategic Annual Operational Plan. Plan

12.2 Establish M&E 12.2.1 Establish a system for MOH, GF X X X X X system for laboratory M&E of laboratory logistics activities commodities to inform forecasting and ascertain their quality | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025

12.2.2 Conduct M&E training MOH, GF X X X X X for all laboratories

12.3 Ensure regular 12.3.1 Conduct M&E on MoH X X X X X assessment of the services to assess laboratory overall performance of system performance in line laboratory services with the National Health Sector Strategic Plan 2021- 2025 13. Finance and Accountability Timeline 67 Objective: Establish resource mobilization and accountability mechanisms at national and sub-national levels to ensure availability and accessibility of adequate resources for the provision of sustainable laboratory services Strategies Sub-Objectives Funding Source Y1 Y2 Y3 Y4 Y5

13.1 Ensure a dedicated 13.1.1 Ensure the laboratory MoH X X X X X budget for laboratory services have a dedicated services in the MOH vote in the MOH budget to facilitate timely and consistent implementation of laboratory plan

13.2 Coordinate partner 13.2.1 Establish a finance and MoH X X X X funding activities for accounting unit at the laboratory services DNHLS to mobilize, coordinate and monitor government and partner funding opportunities

13.2.2 Establish a finance MoH X X X X forum among funding partners and the DNHLS to monitor the funding of laboratory activities

13.2.3 Build capacity of MoH X X X X laboratory managers at all levels, in budgeting, finance and accountability, to improve their management skills for proper planning

13.3 Mobilize funds to 13.3.1 Develop and MoH X X X X meet laboratory budget implement a plan of resource needs mobilization for delivery of laboratory services at all levels in accordance with the Public-Private Partnership for Health (PPPH)

13.3.2 Ensure implementation MoH X X X X of a cost recovery programme to facilitate uninterrupted provision of laboratory services 68 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here]

13.4 Establish a 13.4.1 Adopt the established MoH X X X X transparent system to Ministry of Finance ensure programmatic Guidelines on Financial and financial Management and accountability of Accountability to ensure laboratory services effective management of laboratory resources

13.4.2 Build capacity of MoH X X X X laboratory managers at all levels to plan and monitor budgets in line with the Ministry of Finance and PCU guidelines to ensure effective accountability 14. Ethics and Community Objective: Laboratory services shall be an integral part of the health service’s responsiveness to community needs and shall adhere to ethical and environmental standards Strategies Sub-Objectives Funding Source Y1 Y2 Y3 Y4 Y5

14.1 Promote integrity, 14.1.1 Develop and enforce MoH x dignity and appropriate guidelines for laboratory staff conduct in laboratory to comply with ethical practices and responses standards to community needs at all times and at all level

14.2 Develop strategies 14.2.1 Develop a plan for MoH X X X X to increase community community awareness and access to equitable feedback to ensure an quality testing services understanding of testing | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 services among the population 69 LIST OF CONTR IBUTORS No Name Designation Institution 1 Sheriffo Jagne Acting Director National Public Health Laboratories MOH Deputy Permanent Secretary- 2 Karamba Keita MoH Technical 3 Momodou Lamin Jaiteh Permanent Secretary MoH 5 Dr Mustapha Bittaye Director of Health Services MoH Dr Juliana Ndasi 6 International Consultant FIND 7 Dr Mamdy Cham Chief Executive 0fficer Bwaim General Hospital 8 Dr Haddy Bah Chief Laboratory Scientist EFSTH Head of Genomic 9 Dr Abdul Karim Ceesay MRCG Laboratories 10 Gibril Jarjue Director DPI-MoH 11 Alieu Faal Senior Laboratory Scientist National Public Health Laboratories Disease Prevention and 12 Dr Sharia Larreff-Jah WHO CO, The Gambia Control (DPC) Officer WHO Consultant (Lab 13 LALI Zira WHO, Uganda country Office expert) 15 Dr Omar Manjang Acting Director DNMS/ MoH 16 Dr Makie Taal Vice Chancellor American International University 17 Dr Fatoumata Jah-Sowe Deputy Executive Director Medicines Control Agency 18 Sana Sambou Programme Coordinator EDC/MoH 19 Dr. Fatoumata Dibba Program Manager- Quality Assurance Unit 20 Sheriffo Badgie Deputy Program Manager NACP 21 Alpha Khan Deputy Director-NAS NAS Laboratory Specialist/Former 22 Ignatius Baldeh NPHL Director Local Consultant/Acting 23 Bakary Sanneh NPHL Deputy Director 24 Balla Jatta NDSO/NTD-FP EDC/MoH 25 Dawda Samateh PHRO MoH 26 Sainey Cham LTBCO Officer NLTP 27 Saikou Jawara Senior Planner DPI/ MoH 28 Lamin Jawla M&E Officer DPI/ MoH 29 Dr Buba Manjang Director Directorate of Public Health and Environment Regional Principal Nursing 30 Basirou Drammeh RHD-W2/ MoH Officer 31 Fatou Samateh Principal Pharmacist NPS/ MoH 70 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] 32 Momodou Lamin Jammeh Head of Laboratory services West Africa Holistic Medical centre Deputy Program Manager- 33 Saffie Abia NPHL NBTS Director of Administration 34 Kenbugal Diko Riders for Health and M & E 35 Alhagie Papa Sey Data Manager NPHL Senior 36 Dr Ousman Leigh Registrar/Pathologist/Head EFSTH Laboratory Clinical services 37 Baboucarr Babou Laboratory Manager-SGH MoH 39 Abdoulie M. Sanyang Laboratory Scientist NPHL 40 Dr Davis Nwakanma Laboratory Manager MRCG 41 Baba K Fofona Principal Laboratory Scientist EFSTH 42 Ramatoulie Secka Principal Laboratory Scientist EFSTH 43 Michael Gomez Biomedical Technician NPHL 44 Musa Ceesay Senior Laboratory Scientist NPHL 45 Alphonse Mendy Senior Laboratory Scientist NPHL 46 Mamadou S. Jallow Laboratory Scientist NPHL 47 Haruna S. Jallow Laboratory Scientist NPHL 48 Biran L. Faye Laboratory Scientist Department of Veterinary Services MoA 49 Mr Mamodou Bah Director General FSQA 50 Dr Ousman Ceesay Deputy Director General Department of Livestock Services, Ministry of A 51 Mariama Drammeh Senior Laboratory Scientist NPHL 52 Momodou Lamin Keita Head of Laboratories Jobot Laboratory 53 Dr. Dave Mills Consultant FIND 54 Kim Lewis Consultant FIND | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 71 72 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] 2021 – 2025 | BANJUL, THE GAMBIA, MARCH 2021 | 73 74 | THE GAMBIA NATIONAL HEALTH LABORATORY SERVICES STRATEGIC PLAN 2021 – 2025 [Type here] 2021 – 2025 | BANJUL, THE GAMBIA, MARCH 2021 | 75