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REPUB3619531813500LIC OF SIERRA LEONEMINISTRY OF HEALTH AND SANITATIONNATIONAL HEALTH LABORATORY STRATEGIC PLAN2016 - 2020DELIVERING QUALITY LABORATORY SERVICESTABLE OF CONTENT TOC \t "Heading 1,3,TOC Heading,1,Title,2" FOREWORD PAGEREF _Toc332036755 \h 4PREFACE PAGEREF _Toc332036756 \h 5ACKNOWLEDGEMENTS PAGEREF _Toc332036757 \h 6Executive Summary PAGEREF _Toc332036758 \h 7ACRONYMS PAGEREF _Toc332036759 \h 9SECTION 1: CONTEXT PAGEREF _Toc332036760 \h 13CHAPTER 1- Introduction PAGEREF _Toc332036761 \h 13CHAPTER 2: SWOT Analysis PAGEREF _Toc332036762 \h 21CHAPTER 3: POLICY ENVIRONMENT PAGEREF _Toc332036763 \h 25CHAPTER 4: STRATEGIC DIRECTIONS PAGEREF _Toc332036764 \h 27SECTION 2: STRATEGIC OBJECTIVES, INTERVENTIONS AND TARGETS PAGEREF _Toc332036765 \h 30CHAPTER 1: GOVERNANCE PAGEREF _Toc332036766 \h 31CHAPTER 2: HUMAN RESOURCES DEVELOPMENT AND MANAGEMENT PAGEREF _Toc332036767 \h 35CHAPTER 3: LABORATORY INFRASTRUCTURE AND EQUIPMENT PAGEREF _Toc332036768 \h 38CHAPTER 4: LABORATORY SERVICES & SUPPORT SYSTEMS PAGEREF _Toc332036769 \h 41CHAPTER 5: BIORISK MANAGEMENTBIOSAFETY, BIOSECURITY, BIOBANKING) PAGEREF _Toc332036770 \h 45CHAPTER 6: INFORMATION MANAGEMENT SYSTEMS PAGEREF _Toc332036771 \h 47CHAPTER 7: EMERGENCY PREPAREDNESS AND RESPONSE PAGEREF _Toc332036772 \h 49CHAPTER 8: RESEARCH, DEVELOPMENT AND ETHICS PAGEREF _Toc332036773 \h 51CHAPTER 9: PARTNERSHIPS AND LINKAGES PAGEREF _Toc332036774 \h 53CHAPTER 10: TOTAL QUALITY MANAGEMENT SYSTEMS (QUALITY ASSURANCE) PAGEREF _Toc332036775 \h 56SECTION 3: IMPLEMENTATION MECHANISMS PAGEREF _Toc332036776 \h 58MONITORING AND EVALUATION PAGEREF _Toc332036777 \h 71FRAMEWORK FOR THE MONITORING AND EVALUATION PLAN PAGEREF _Toc332036778 \h 75FINANCING THE PLAN PAGEREF _Toc332036779 \h 76ANNEXES PAGEREF _Toc332036780 \h 79ANNEX 1: IMPLEMENTATION FRAME PAGEREF _Toc332036781 \h 80Annex 2: Sample Budget Outline for PHU PAGEREF _Toc332036782 \h 99ANNEX 3: Minimum standards PAGEREF _Toc332036783 \h 107ANNEX 4: Emergency Response Budget Justifications. PAGEREF _Toc332036784 \h 109ANNEX 5: TEAM MEMBERS PAGEREF _Toc332036785 \h 111List of Tables and FiguresTable 1: Distribution of health facilities by district – July 2015…………………………………………18Table 2: Recommended laboratory staffing……………………………………………………………………..19Table 3: Strategic Framework ………………………………………………………………………………………….58Table 4: Strategic time frame ………………………………………………………………………………………….61 Table 5 Indicators and Monitoring Tools ………………………………………………………………………..73Table 6: Estimated major costs (millions of Leones) to be worked out for 5 years period…75 Table 7 Estimated cost for laboratory emergency response per district (US Dollars)………..76Figure 1: Lab tiers………………………………………………………………………………………………………….…19.Figure 2: Strategic plan process flow………………………………………………………………….…………..27Figure 3: Strategic inputs………………………………………………………………………………….……………..31Figure 4: Critical path of development……………………………………………………………….……………49Figure 5: Actions to address all levels of laboratory network………………………………………….52Figure 6:Network of national public health reference laboratory system………………………55FOREWORDThe Ministry of Health and Sanitation (MOHS) is moving forward with its vision to improve services and instituting systems to deliver and increase access to high quality health care to reduce national mortality. The ministry’s current focus is to put these systems and supporting structures to meet the demand and supply in working towards reduced mortality. The laboratory network system in Sierra Leone now has an approved policy and this document forms the platform for the development of the national laboratory strategic plan. The plan contains the strategic activities that ensure quality and equitable laboratory services to support disease diagnosis, treatment monitoring, disease prevention and control, and laboratory support of national surveillance and rapid response to disease outbreaks. Activities have been phased over a five year period taking cognizance of the National Health Sector priority program such as the Free Health Care Initiative and prevention of Communicable and Non-communicable infections. The document was prepared by an expanded National Laboratory Technical Working Group, constituting of selected laboratory specialists and related health sector personnel including senior staff members from Blood Transfusion program, Disease Prevention Unit, health information, finance, statistics and surveillance units. The final draft was validated by stakeholders, which included all related health units at central and local government health leads and key partners. The validated draft was reviewed and edited by the Laboratory and Surveillance and Epidemiology Technical working group as well as development partners prior to submission, review, and approval by the Ministry of Health and Sanitation. On behalf of my ministry, I wish to extend appreciation for the support of the Association of Public Health Laboratories (APHL), Sierra Leone for providing technical and financial support from Centers for Disease Control (CDC), Atlanta. I also commend the commitment of the National Technical Working group and the leadership of the Laboratory directorate. My ministry looks forward to strengthening quality health care delivery and accessible health care systems that will contribute to improving the health and well-being of the people of Sierra Leone.Dr. Abubakarr Fofanah Honorable Minister Ministry of Health and Sanitation, Sierra LeonePREFACEThe National Health Laboratory Services plays a pivotal role in the response to an effective health care delivery.The laboratory services serves as a key component to achieving both quality clinical care and meaningful public health interventions. The Ministry of Health and Sanitation (MOHS) has generated its 2015-2020 directional maps through the national health sector strategic plan (NHSSP) translated in the Basic Package of Essential Health Services (BPEHS) to drive improved access to affordable quality laboratory services and ultimately better health total care delivery. Recognising the impact of outbreaks (Cholera-2012 and Ebola 2014-2015) on the implementation of the 2010-2015, this plan expanded the national priority themes from 7 to 10 each aligned by an integrated health sector team, to the national indices towards equitable and sustainable health sector performance The Laboratory services have gained it’s recognition as critical to the advancement of national and global health security. In view of this, the interventions outlined in this plan puts premium on the minimum standards package of operations such as adequate water supply and energy , appropriate infrastructure, skilled human resource and infections control and outbreak preparedness to ensure functionality of laboratory services.The MOHS hope that this plan will serve as the directory for laboratory support and implementation by stakeholders and partners coordinated by the Directorate of Hospital and Laboratory Services towards quality and sustainable laboratory services. I commend the leadership of the directorate of hospital and laboratory services and appreciate the collective efforts of all directorates in the development of this road map. Dr. Brima KargboChief Medical Officer Ministry of Health and Sanitation ACKNOWLEDGEMENTSOn behalf of the Ministry of Health and Sanitation, I wish to acknowledge the immense contributions of the national core team and National Laboratory Technical working Group (LTWG) for a dedicated work done in generating this document amidst multiple tasks. Their efforts in reviewing and analysing the many documents amidst a myriad of activities that led them to work out of call of duty is highly appreciated. Key to note are the institution and key partners support to formulate the supporting tools used such as the comprehensive laboratory service assessment by DFID through Options Consultancy; Public Health Laboratory Assessment by US-CDC, China-CDC, WHO, and APHL; IDSR assessments by the Disease Prevention Directorate Surveillance officers; and the untiring efforts by the Laboratory Services and Surveillance managers and team on site verifications throughout the processes. Our invaluable thanks to the technical support lead provided by CDC through APHL Senior Laboratory Specialists, who played an important background role to define processes and direct collations as per MOHS focus for a coordinated output. I appreciate the efforts of the national, regional and districts health teams and the Public Health Rapid Response Team who participated in the validation of the document. A special thanks goes to key partners – WHO, US –CDC, Options Consultancy, e-Health Africa, Public health England and China-CDC, who contributed to the validation of the implementation frame. I do hope partners and stake holders will use this document to guide objectives as we drive towards sustainable and quality services. Dr Victor Matt-LebbyDirector Hospital and Laboratory Services Ministry of Health and Sanitation Executive SummaryLaboratory support has a pivotal role in diagnosis and patient management, disease surveillance and outbreak investigation. At present, the laboratories of Sierra Leone are not able to provide adequate support to the clinical care services to meet the government defined basic health package.The Ministry of Health and Sanitation subscribe to International Charters such as the GHSA, IHR and ECOWAS regulations and seek “To develop, strengthen and maintain capacities of laboratories to detect, assess, notify, and report events”. This is in line with the requirement of the ASLM declaration done in Freetown recently regarding the need to strengthen laboratory services and to:Develop national laboratory policies within the National Health Development Plan that will guide the implementation of a national integrated laboratory strategic plan Develop and implement a 5-year national laboratory strategic plan that addresses quality diagnosis, monitoring and surveillance of diseases of public health importance at all levels of the tiered laboratory system.The above items require Sierra Leone to establish reliable, high quality laboratory services that can provide trusted information to guide decision making for quality health care. In order to meet these requirements, action is needed in 10 key fields:Governance (Coordination, legal framework and ethics).Human Resource planning, development and management.Infrastructure and Equipment.Laboratory Services & Support Systems (Logistics & Management Systems).Bio risk management (Health and Safety, Bio-safety, Bio-security and Bio-rmation Management Systems.Emergency Preparedness and Response. Research, Development and Ethics. Partnership & Linkages Total Quality Management Systems.This document sets out the policies and actions required to meet these needs in three sections covering the context, the strategic objectives, interventions and targets and the implementation mechanisms. FOCUS: is to meet the National Basic Package of Essential health services toward increased access to quality service and ultimately improved health systems within the next 5 years. Capacitating all 14 district laboratories to perform all test menus of the BPEHS.Strengthening all 5 centres of excellence facility laboratories as reference labs supporting district and PHU.Coordinating partners supporting laboratories services as per national priority with geographic equity to produce tangible outcomes.Instituting Public Health Laboratory network supporting IDSR.Establishment of integrated outbreak response.Establish professional regulatory body to structure and monitor laboratory staff.Strengthening commodity security.Support researches of national interest with defined outcomes. An estimated costing plan was generated based on the national 2010-2015 investment plan updated within current financial context. Given that this is a living document, it is hoped that flexibility is employed to implement to meet the priorities with sustainable input. An effective M and E plan to monitor laboratory service delivery using quality indicator to monitor the 10 quality elements. ACRONYMSAFBAcid Fast BacilliAFR/RC WHO/AFRO Regional CommitteeAIDSAcquired Immuno-Deficiency SyndromeAPHLAssociation of Public Health Laboratories ASLMAfrica Society for Laboratory MedicineBPEHSBasic Package of Essential Health ServicesCD4Cluster of Differentiation CDCCentre for Disease Control and PreventionCHCCommunity Health CentreCOMAHSCollege of Medicine and Allied Health SciencesCPHRLCentral Public Health Reference LaboratoryDHLSDirectorate of Hospitals and Laboratory ServicesDHSS Demographic Health Systems SurveyDOTDirectly observed treatmentDSTDrug Susceptibility TestingDPIDirectorate of Planning and InformationDPCDisease Prevention ControlEIDEarly Infant DiagnosisELISAEnzyme Linked Immunosorbent AssayEPKEastern Polytechnic, KenemaEQAExternal Quality AssuranceEQASExternal Quality Assessment SchemeFBCFourah Bay College FBOFaith Based OrganisationFHCIFree Health Care InitiativeGFATMGlobal Fund for AIDS, Tuberculosis and MalariaGHSAGlobal Health Security AgendaGLRAGerman Leprosy and TB Relief AssociationHAPSAT HIV/AIDS Program Sustainability Analysis Tool HCT HIV Counseling and Testing HPAHealth Protection Agency (UK)HIVHuman Immuno-deficiency VirusHPAHealth Protection Agency of the United KingdomHRHuman ResourcesIATAInternational Air Transport AssociationIDSRIntegrated Disease Surveillance and ResponseIHRInternational Health RegulationsIQCInternal Quality ControlLFTLiver Function TestsLISLaboratory information systemLIMSLaboratory Information Management SystemsLTWGLaboratory Technical Working GroupLSETWGLaboratory, Surveillance and Epidemiology Technical Working groupM&EMonitoring and EvaluationMDCSLMedical and Dental Council of Sierra LeoneMDGMillennium Development GoalsMMCET Milton Margai College of Education and TechnologyMOHSMinistry of Health and SanitationMScMaster of ScienceNEQASNational External Quality Assessment SchemeNGONon-Governmental OrganisationNHSSPNational Health Sector Strategic PlanNLRCNational Laboratory Regulatory CouncilNLSNational Laboratory ServicesNPHLSNational Public Health Laboratories Systems NPHRLNetwork Public Health Reference LaboratoriesNQAPNational Quality Assurance ProgrammeNTBRLNational TB Reference Laboratory NTDNeglected Tropical DiseasesPCMH Princess Christian Maternity Hospital (Freetown)PEPFAR President’s Emergency Plan for AIDS ReliefPHUPeripheral Health -UnitPMTCTPrevention of Mother to Child TransmissionPPEPersonal Protective EquipmentPRSPPoverty Reduction Strategy PaperPHLRTPublic Health Laboratory Response Team QAQuality AssuranceQCQuality ControlRRTRapid Response Team TQMSTotal Quality Management SystemRCHReproductive and Child HealthRHReproductive HealthRT-PCR Reverse Transcriptase Polymerase Chain ReactionSOPStandard Operating ProcedureTBTuberculosisTORTerms of ReferenceU/EUrea/ElectrolytesUSAIDUnited States Agency for International DevelopmentWBCWhite Blood Cell CountWHOWorld Health OrganisationSECTION 1: CONTEXTCHAPTER 1- IntroductionThe first National Laboratory Strategic Plan (2011-2015) was generated to establish a framework for laboratory operations in Sierra Leone and to provide the much-needed direction in the areas of governance, human resource, infrastructure and equipment, stocks management, health and safety and quality systems. This was to support the government’s drive to provide a basic essential package of health services, mainly focused on primary and secondary care. The significance of a functional laboratory system and its impact on the treatment outcomes of patients and quality of public health services cannot be over-emphasised. Laboratory support in diagnosis and patient management, disease surveillance, outbreak investigation and response is pivotal, with an increasing demand for providing scientific evidence as part of the total quality management cycle. Evidence based decision making in the diagnosis and management of illnesses is a key component of quality health care however, laboratories have not grown in tandem with health care delivery services to enable them adequately meet this demand. The 2010-2015 plan was to address all core areas of the laboratory system, with specific emphasis on six priorities at the time that needed urgent attention, which were:Weak coordination and regulation of laboratory practice at all levels of the laboratory system (Governance).Infrastructural inadequacies (Infrastructure and equipment).Supply bottle-necks leading to interruption of services (Reagents and supplies).Bio-risk management (Bio-safety and Bio-security and emergency response).Inadequate numbers of skilled workers (Human Resource).Inequities in laboratory service delivery.Poor quality systems limiting access to quality assured laboratory services (Quality systems).There have been achievements in some of these areas, such as, higher level of training of laboratory staff (both locally and internationally), establishment of a public health hub, the Central Public Health Reference Laboratory, which serves for some epidemic prone diseases such as Measles, Enteric bacteria diseases and Rota Viruses; Establishment of molecular unit. There are still areas in the plans which were not addressed due to the challenges experienced in the implementation, one of which was the unexpected and unprecedented Cholera Outbreak in 2012 and Ebola outbreak in 2014-2015, which also exposed the lack of outbreak and emergency preparedness within the health system.In spite of the above achievements, Sierra Leone still continues to experience problems with the management and delivery of quality assured laboratory services to support national treatment and prevention programmes, primarily due to weak leadership at all levels of the tiered laboratory system. Other reasons for this are the lack of participation of laboratory professionals at policy and decision-making levels, inadequate number of qualified personnel, scant and unstructured investment in laboratories and weak quality control systems.Background The 2010 -2015 strategic plan interventions was interrupted with two major outbreaks thus the total implementation timeframe was 3 years instead of 5 years. The plan used as part of its building block the revised International Health Regulations (IHR 2005) which requires countries “To develop, strengthen and maintain capacities of laboratories to detect, assess, notify, and report events”. In addition to the IHR requirement, WHO/AFRO has urged member countries to commit to strengthening laboratory services, in line with the following declarations and resolutions:The Maputo Declaration on strengthening of laboratory systems: Maputo January 2008. Resolution AFR/RC58/R2: Strengthening public health laboratories in the WHO African region: Yaoundé, Cameroon September 2008.5th Meeting of the Regional HIV/AIDS Public Health Laboratory Network, Dakar, Senegal, September 2008.Resolution AFR/RC59/WP/3: Policy orientations on the establishment of centres of excellence for Disease Surveillance, Public Health laboratories, Food and Medicines regulation. Kigali, Rwanda September 2009.Resolution AFR/RC59/R2 – Drug Resistance related to AIDS, Tuberculosis and Malaria: Issues, Challenges and the Way Forward. Kigali, Rwanda September 2009.This 2016-2020 plan is developed with global health security in view and thus add to the above; new concepts and strategies that recognises the pivotal role of laboratory actions in disease detection, treatment monitoring, and prevention control for a sustainable health through:Global Health Security Agenda (GHSA) 2015 –: Promote an integrated IHR accelerated plan towards world safety against infectious disease threat through innovative, multi-sectorial, local and international partnership response.African Society for Laboratory Medicine (ASLM) Freetown Declaration 2015 ASLM—: Recognising the critical role of public health laboratory systems in supporting GHSA by requesting countries to establish?functional public health laboratory networks for early detection and responses to emerging disease threats.There is now an increased emphasis in strengthening laboratory systems including leadership and management structures. Over the years, the Sierra Leone Ministry of Health and Sanitation (MOHS) has gradually restructured, with the aim of improving its capacity to respond in an adequate and timely manner to the health care needs of the country within a resource constrained environment. This is in accordance with the Millennium Development Goals (MDG), World Health Organisation (WHO) and Global Health Initiative (GHI) support for governments to show leadership and to commit to strengthening health systems, including laboratory services. As part of the efforts of the government, several documents and strategic guidelines were developed, including the Health Sector COMPACT Guide which provided the coordination platform of partners in the implementation of National Health Sector Strategic Plan (NHSSP 2010-2015) and more recently, the Health Sector Recovery plan 2015-2020, to address the challenging issues especially during the post-Ebola period. It was therefore necessary to review the first National Health Laboratory Strategic Plan, to align it with these documents, revised and new, such as the revised Basic Essential Package of Health Services 2015, the Sierra Leone Health Sector Recovery Plan 2015-2020, of the Ministry of Health and Sanitation and the Emergency Response Manual 2015.National Laboratory Services Directorate of Hospital and Laboratory ServicesThe National Laboratory Services (NLS) program operates under the Directorate of Hospitals and Laboratory Services (DHLS) of the Ministry of Health and Sanitation (MOHS) that provides overarching policy leadership. This includes setting national norms and standards, building capacity, and monitoring of service quality. The NLS systems comprises of clinical-community and hospital diagnostics laboratories; Regional Reference laboratories, and Public Health Laboratories. Given the crosscutting support of laboratory services, the DHLS work closely with Directorate of Disease Prevention and Control surveillance program and Health Systems Strengthening (HSS) unit.The DHLS at central level is inter-connected with the semi-autonomous District Health Management Team (DHMT) that provides the localised leadership and implementations through the District Medical Officer under the District Council. The DHLS is led by a Director, National Manager, a Deputy Manager that doubles as the In-Charge of the Central Public Health Reference Laboratories (CPHRL) and Laboratory Technical Working Group comprising of a team of Laboratory Technical and Systems experts. Basic Packages of Essential Health Services (BPEHS) and National Health Laboratory SystemsThe MOHS has as its priority five themes that will build a resilient health system. The themes listed below take into consideration recovery efforts from the recent outbreak and services that are realistic, achievable and thus sustainable through the leadership of the government:Patient and health workers biosafety and biosecurity.Human Resource strengthening.Essential Health munity rmation and surveillance.The BPEHS (2015-2020) serves as the platform for delivering vision of MOHS outlined in the National Health Sector Strategic Plan (NHSSP) - 2015-2020 for quality health care. The function of the package is to direct interventions and monitor progress for the effective delivery of the themes.The BPEHS defines the level of services at each strata of care inclusive of the minimum systems standards such as infrastructures, HR, Biosafety and support services. Recognizing the critical role of laboratory services to support comprehensive health care delivery; the BPEHs 2015-2020 is extended to include public health laboratory services in line with GHSA to strengthen prompt diagnosis, outbreak detection and action to prevent and contain biological threats. Levels of Laboratory services Tier Systems There are 4 tiers in the network of laboratories with defined functions and test menu as per BPEHs criteria based on population needs, geopolitical zones and systems practicality as follows: Primary Level: Laboratory service at chiefdom level is mainly provided at the Community Health Centre (CHC), which is one of the three primary levels of the Peripheral Health Units (PHUs). The test menu is limited to microscopic detection of parasites, basic clinical chemistry and serology using point of care and rapid testing device.Secondary Level: Laboratory services at district hospitals of over 100-bed capacity provided extensive range of tests including blood service screening for safe blood transfusion. The service is more comprehensive to support secondary medical care with a higher staff caliber and also support primary level diagnosis. Tertiary Level Laboratory services at Regional hospitals at district headquarter towns (Kenema for the East, Bo for the South, and Makeni for the North). This level is an expansion of district hospital services with additional systems capacity such as graduate level staff, infrastructures and utilities to support complex equipment and can handle complex infectious diseases and emergency services.Public Health Laboratory Services The public health laboratories serve at national and regional level to provide overarching support and instituting quality systems. Key functions include establishing of norms and standards, emergency and outbreak response, high-end technology testing that are not cost effective at other levels, targeted training to improve and strengthen human resource; surveillance and operational research. Following the recent Ebola outbreak, the MOHS has established three Regional Hubs as centers for excellence at regional hospitals. These systems will form part of the Network of Public health Laboratories (NPHL) linked to the central hub at the Central Public Health Reference Laboratory, the Jui P3 Lab and TB Reference Laboratories.Laboratory Mapping:Table 1: Distribution of Health Facilities by District, July 2015In accordance with the BPEH, functional laboratory services are available in 257 out of 1208 health facilities. These are 233 PHUs and 24 Government hospitals. The Government laboratories include district (15) and Regional (5); Forces (2) and Public health laboratories (3) in various combinations with some sites active in 2 capacities. The community level diagnosis made up of MCHP and CHP accounts for 632 and 319 facilities respectively with the capacity of performing community Rapid Diagnostic Tests for pregnancy, malaria and STI screening for antenatal care.Following various analyses of field assessments, there are currently 179 functional laboratories with staff complements of the MOHS based on the minimum service requirement of the BPEHS. Most of the primary laboratories are operating as an offshoot of DOT centers with the capacity of testing the three Global fund supported diseases: Malaria, TB and HIV. Figure 1: Laboratory tiersHuman Resource Laboratory staffing is one of the most acute Human Resource shortages in the country. The staffing profile per facility as defined by the BEHP (not inclusive of 24 hour service at district level) is as follows: Table 2: Recommended laboratory staffingSTAFF LEVELPHUDISTRICTREGIONALPUBLIC HEALTH LABORATORY INCLUDING SURVEILLANCE RESPONSE,SENIOR LAB SPECIALIST5LABORATORY SPECIALIST55LABORATORY SCIENTIFIC OFFICER155LABORATORY TECHNICIAN1355LABORATORY ASSISTANT1455HOUSEKEEPING STAFF55Source: BPEHS 2016Based on the BPEH requirement and the number of functional laboratories at all level, there should be 329 Laboratory Assistants, 275 Laboratory Technicians and 14 graduate laboratory scientific officers. Currently only less than 30% of the skilled staffing capacity is met. The 2015 survey showed 208 junior level cadre of laboratory personnel in all laboratories in the country including private and Faith- Based and Non-Governmental Organizations. Due to shortage, the laboratory services inherited 151 persons without formal training; working as laboratory assistants.There are 8 mid-level scientific officers with science degree qualification but without specialized laboratory medicine curriculum training. Recently added to the pool; are 12 of 24 trained graduates bonded to the MOHS to support laboratory strengthening including outbreak and emergency response. Medical graduates are also been encouraged and supported in the field of laboratory medicine specialization.In terms of laboratory specialists, all disciplines (Haematologist, Clinical Chemistry, Parasitologist, Virologist, Microbiologist) have at least one senior scientist but most of them are close to retirement. Justification of a revised plan The laboratory services form a major component of the health systems pillar which has over the years operated with the national laboratory strategic plan (2011-2015) to assist in implementing the NHSSP. This plan provided guidance to all stakeholders for the efficient operations of the public laboratories nationwide. The laboratory provides direct cross-crossing support to many programmes in the ministry that contribute to the attainment of Millennium Development Goals. Data generated from laboratory analyses contribute to programme management and decision making. However, programmes have in the past produced individual laboratory plans addressing their specific needs without regarding the entire system, leading to duplication and sometimes skewed service delivery. The first edition of the National Health Laboratory Strategic Plan was created in 2010 to last for five years.The 2010-2015 National Health Laboratory Strategic Plan identified that laboratories in Sierra Leone were ‘not able to provide adequate support to the clinical care services and as a result, laboratory results are not trusted and laboratory diagnostic services are underutilised. The implementation of the strategic plan was faced with funding constraints due to competing demand on government. However the following activities were achieved: Activating the national laboratory, surveillance and epidemiology technical working group which worked with partners to develop the listed key tools : National Laboratory investment plan.Integrated Disease surveillance Strategic Plan review.Health and Safety policy draft.National Norms Standards for the 4 tier level laboratories.Development of Laboratory Basic package for essential health.Generating the national health systems strengthening laboratory plan.Human Resource development : Activation of B.Sc. Honors in Laboratory Medicine.Increase the pool of post graduate laboratory scientists.Support the establishment of short course FELTP program.Support intensive short courses.Public Health Response Activation of a Central Public Health Reference Laboratory Hub.Establish diagnosis of epidemic prone diseases- Measles; yellow fever; Influenza, Cholera.Establishment of Molecular testing for Early Infant diagnosis.Support the national testing for the Demographic Health Survey DHSS 2012 (16000) Sample.Quality Assurance:Establishment of National Quality OfficersIntroduction to accreditations using the SLMTA process and SLIPTA tool.Establish national HIV EQA to 35 sites.Laboratory Services Increased functioning laboratories,Increased test menu.However key thematic areas such as regulatory, supplies and logistics, infrastructures activities were not undertaken. These limitations together with the burden of infectious epidemic prone diseases immensely weakened the laboratory services. The Government has therefore prioritised the need to improve laboratories taking into consideration new and re-emerging challenges posed by our National health system and also align with the IDSR. CHAPTER 2: SWOT AnalysisThe Strategic plan of 2010 - 2015 was to articulate the National Laboratory policy with a focus to improve health care delivery and also monitor quality implementation towards an interrupted service delivery especially with the novel Free Health Care Initiate (FHCI).In 2010-2015, an Environmental SWOT analysis to assess laboratory situation was based on field experiences and consultative meetings with all district lead clinicians, district laboratory supervisors, laboratory related programs such as TB, Malaria and HIV; Forces, private and faith based organization. Given the weak laboratory response as per health indices, especially the limitation to meet the needs of the recent outbreaks, the MOHS in collaboration with partners has conducted a series of field assessments that inform the development of the NHSSP, National Health Recovery Plan, BPEHS and the recent Health Systems Strengthening plan. A more recent assessment with specific focus on laboratory systems are:A joint partner health systems assessment conducted in 2014, revealed that only 5% of the NHSSP target, was implemented. Post Ebola laboratory assessment was the most comprehensive as it addressed all laboratory systems indicators - July 2015Disease Surveillance Laboratory Inventory of stool analysis for polio containment program – November 2015.Public health laboratories quality audit towards transition and recovery plan – February and May 2015Western Area Laboratories site assessment (Horizontal Audit)- 2016 The focus of these assessments was to identify gaps, challenges and best practices to serve as the platform for the development of an integrated National Laboratory Strategic Plan for effective and sustainable service. The elements audited as aligned in the SLMTA/SLIPTA quality indicators systems management are as follows: Laboratory Profile.Human Resource.Infrastructure.Transport and Referral.Management of Consumables and Stock.Maintenance of Equipment.Testing Performance.Specimen Management.Bio-safety.Public Health anization and Management.Data Management.Supplies of Consumables & Equipment.Basic Testing Capability5ReportStrengthsThe availability of a National Health Policy 2009, National Laboratory Policy 2010 and sound National Laboratory Strategic Plan (2011-2015) which provide a framework for effective implementation.The availability of public and private laboratory structures at district level including the majority of Community Health Centres providing laboratory services nationwide.Diagnostic testing services available across the country. Basic laboratory services closer to communities through the Global Fund and other supported programs of Malaria, TB and HIV. There is the existence of a management structure for hospital and laboratory services by the Directorate of Hospitals and Laboratory Services, under the Ministry of Health Services and Sanitation (MOHS). The availability of a Laboratory Service Manager and a functional Laboratory Technical Working Group (LTWG) provides Laboratory technical assistance and advice.Institutions are in place that provides basic laboratory education the existence of the B.Sc. honors medical laboratory course.Existing laboratory policy documents recognize the need to establish efficient LIS.Other Ministries and programmes require laboratory support and can be expected to contribute to LIS strengthening.WeaknessesPoor human resource system for laboratory personnel.Poor remuneration policy and working environment.Lack of succession policy.Inadequate funding to support implementation of policy and strategic plan.Acute shortage of qualified laboratory personnel including laboratory scientists and technicians.Lack of scheme of service for laboratory personnel which does not reflect educational level and skills.No system for Continuing Education of laboratory personnel.Poor laboratory infrastructure, power and water supplies which often leads to poor infection prevention practices, organization and service delivery.Poor waste disposal systems, which includes lack of incineration equipment and absence of proper drainage for wastewater.Weak laboratory registration and licensing system which includes a regulatory body, service and equipment standards and SOPs.Weak laboratories services to enable effective management of outbreak and other diseases.Partial implementation of laboratory services as per Basic Package of Essential Health Services. Mostly seen is TB, Malaria and HIV (Global Fund Supported Programmes).Weak quality monitoring systems and inadequate supportive supervision.Limited Assurance Program.Weak transport and referral of specimen. Weak supply chain management of reagents and equipment.Opportunities The development of the scheme of service for laboratory personnel.Directorate of Training collaborating with the Tertiary institution for Laboratory Medicine courses.Upgrading and restructuring of existing training institutions to produce more and better skilled laboratory graduates. Existing procurement systems at the NPPU in place.Graduates from affiliated sciences, such as Biology or Chemistry who, if given additional opportunities for professional development, could be trained to become laboratory staff. Health systems strengthening through the national resilient plan post Ebola which includes laboratory support.Existence of the Laboratory technical working group.Existence of the National Laboratory Policy.Increased international technical and financial support for Post –Ebola Recovery and HIS.Increased International focus on HIS and interoperability of HIS systems.ThreatsInsufficient allocation of resources to facilitate a functional laboratory system.Internal and external brain drain.Donor dependency and foreseen donor fatigue.Uncoordinated partner donor support.Laboratory specialist professionals almost at retirement age.Laboratory decentralization.Lack of National Laboratory Professional Act.Emergency Preparedness Laboratory Audit Despite recurring disease outbreaks, the laboratory service has not been able to fully support disease outbreak detection. For both Cholera and Ebola outbreaks, laboratory service has been a secondary service rather than be part of the primary pillar from notification through investigations to response and control. Recognising the acute limitations, the MOHS and key partners has led a series of consultations and site visits to formulate National Public Health Laboratory (PHL) systems as part of a National public health institute. The recent Ebola outbreak has seen international partners donating high-end technology laboratories and also providing technical support to strengthen the network of PHL. Using the IDSR approach the MOHS has instituted an integrated approach by tailoring the response team to include laboratory as part of the core team members. The report of an audit based on site visits and consultation as below:StrengthsLaboratory Response ManualNational Rapid Response Manual aligned to IDSR and GHSATraining tools generated Laboratory Response team in training. WeaknessCoordinationLack of clear or transparent objectivesHuman resource limitation: no clear training plans for national staffFunding OpportunitiesGHSA laboratories prioritizationDonor commitment Donated laboratoriesUniversity training course ThreatsLimited Government funding allocationDonor dependencyCHAPTER 3: POLICY ENVIRONMENTThe 2010-2015 Laboratory Strategic plan translated 2010 National laboratory policy under the umbrella 2009 Health Sector Policy. This plan (2016-2020) is generated following review of the past plan within the same policy environment but with the addition of key strategic document to support a resilient health sector delivery. However this plan has the opportunity of a clearer defined NHSSP goal and performance markers for effective monitoring.24822151812290NHSSP Performance MarkersAccessQualityEquityEfficiency00NHSSP Performance MarkersAccessQualityEquityEfficiencyRecognizing the role of laboratory services within the national health and social security network, the MOHS has prioritized laboratory services as key input in the health sector performance index towards the Presidential Agenda for Prosperity. This all-encompassing framework includes the implementation of the NHSSP 2015-2020 through the BPEHS (2015-2020) and response to emergency and outbreak whilst remaining compliant to international charters such as IHR, GHSA and ECOWAS-WAHO.8001004686300Agenda for Prosperity 2013-2015“To strengthening of health program through introducing innovative strategies, new policies that will improve health outcome for Sierra Leoneans”00Agenda for Prosperity 2013-2015“To strengthening of health program through introducing innovative strategies, new policies that will improve health outcome for Sierra Leoneans”This plan applies inter-program policies and strategic plan towards IDSR as follows: National health and Safety Policy and ManualNational TB program TB diagnosis and treatment integrated guidelines National AIDS Control ProgramHIV Strategic Plan 2015-2020HIV Viral Load Implementation planNational Malaria Control ProgramNational Malaria Strategic PlanNational Malaria Quality Assurance Strategic PlanIDSR:National Emergency and Outbreak Manual Polio Containment Protocol (2015)REVIEW PROCESSThe review and development of the 2016-2020 strategic plan was done by a core team under the leadership of the Directorate of Hospital and Laboratory Services in collaboration with the Directorate of Disease Prevention and Control, Directorate of Health Systems Strengthening, Planning and Research and Directorate of Training and National Laboratory, Surveillance and Epidemiology Technical Working group. The figure below outlines the process stage approved by the team.Figure 2: Strategic plan process flowNational Priority Themes- 2016-2020: The 2010 -2015 NLSP identified seven priority themes and was expanded to 10 themes in the 2016-2020 plan as the focus moves to tangible indicators in order to respond to national health needs. Governance (Coordination, legal framework and ethics).Human Resource planning, development and management.Infrastructure and Equipment.Laboratory Services & Support Systems (Logistics & Management Systems).Bio risk management (Health and Safety, Bio-safety, Bio-security and Bio-rmation Management Systems.Emergency Preparedness and Response.Research, Development and Ethics.Partnership &Linkages Total Quality Management Systems.Total Quality Management System (Quality Assurance).CHAPTER 4: STRATEGIC DIRECTIONSThere are key strategic imperatives driving this plan;LEADERSHIP- national direction of key roles and responsibilities HEALTH FINANCE – Coordinated; focused, accountability and transparencyOPERATIONAL show plan activity and related expenditure and status of annual implementation. MONITORING – high level monitoring grid for equitable support INTEGRATION Global health – one health- Human and animal health linkage 7835903429000VisionTo provide Sierra Leone with a quality and appropriate laboratory service that is accessible and affordable to all using a systems approach. MissionTo establish an integrated functional laboratory system that will provide quality service delivery and support accurate diagnoses, treatment, prevention, surveillance, research and forensic services.00VisionTo provide Sierra Leone with a quality and appropriate laboratory service that is accessible and affordable to all using a systems approach. MissionTo establish an integrated functional laboratory system that will provide quality service delivery and support accurate diagnoses, treatment, prevention, surveillance, research and forensic services.Vision, Mission and Core Values (derived from the National Laboratory Policy and NHSSP 2015-2020)Equity: Laboratory resources and services are distributed equitably throughout the country.Accessibility: Services are affordable and within reach.Relevance: Laboratory services are apt for the purpose and address the needs of the community.Partnership: Promote teamwork and team spirit among all laboratory personnel, and networking and collaboration with stakeholders.Confidentiality: Promote professionalism and ethical practice among all staff and their relationships with patients.Timeliness: Ensure laboratory results reach the patient on time and contribute to appropriate patient management.Customer focus: Always bear in mind who we are serving. The customer may be the community, patient, clinician, individual or the public good. Integration: Promote team spirit and integration of service delivery among all laboratory personnel and also within and between programmes.Sub Mission/Core ValuesTo establish an integrated functional laboratory system at each level of care based on the Basic Package of Essential Services.To upgrade the PHL, CRL and have a functional laboratory network to enhance service delivery and respond to emerging public health concerns and emergencies.To support surveillance and research to inform policies and actions.To build capacity of Human resource laboratory needs of the country using a systems approach. Core Functions This five-year strategic plan projects that the laboratory system will oversee and implement the core functions outlined below, with the expansion of regional reference laboratories linked to public health laboratories to form the network of clinical and public health Laboratory. The core functions will provide a basis for the assessment of laboratory performance against defined national norms and standards as set in the BPEHS and capability to respond to outbreaks in the following areas: Clinical Diagnosis:More emphasis on clinical diagnostics to supplement quality of care from at all levels. The clinical services will be offered through the network of clinical facilities (PHU, districts and hospitals) throughout the country.Disease Prevention and Control In response to the revised IHR (2005) requirements and in contributing to disease prevention programmes, the approach will be a combination of community and health facility laboratory -based surveillance linking to public health laboratories for timely microbial identification and confirmation to support prevention. SurveillanceWith the Central Public Health Laboratory as the hub, the NPHRLS will be linked to the national programmes and national surveillance activities of the DPC and DPI units to ensure national capacity to detect at least 10 of the priority epidemic prone diseases.Integrated Laboratory Data Management The NPHRL Systems network will serve as the national focal point for capturing the laboratory data and linking it with the Health information management Systems (HMIS) for planning and decision-making.Reference and Specialized Testing The NPHRLS will serve to coordinate IDSR support including other specialised testing.Food, Water and Environmental Health and Protection Working towards the ONE-Health strategy, to support inter-sector collaboration linking environment, zoonosis and human health with the MAFFS, MWR; National Standards Bureau and the Pharmacy Board. Total Quality Systems Management (TQSM)Develop and coordinate all the elements of quality indicators, with the aim of promoting quality assurance programs for clinical and public health laboratories through training; proficiency testing, quality audit and customer survey. Laboratory Management and Coordination Provide scientific and managerial leadership in developing monitoring grid to ensure compliance with promoting, and integrating clinical and public health laboratory science into practice including developing standards for all health-related laboratories. Public Health-Related Research Evaluate and validate new technologies for in-country use.HR Development and Management Through tertiary institutions support laboratory workers. Support fast track targeted training to build the critical mass at all levels. Institute laboratory management and leadership training. Networking, Partnerships and Communication Develop and strengthen partnerships among the countrywide network of laboratories. Develop a national map of laboratory resources to assist partnership, communication and training. SECTION 2: STRATEGIC OBJECTIVES, INTERVENTIONS AND TARGETS Figure 3: Systemic InputsCHAPTER 1: GOVERNANCE (Coordination, legal framework and ethics)Organisation, Management and CoordinationStrong organizational and management systems provide a mechanism for effective delivery of services. This is especially important when there are many facilities offering services at different levels.Sierra Leone operates a four-tier laboratory system (primary, secondary, tertiary and a combined function of public health and reference services with a central apex hub). Apart from the existing public health reference laboratories, all the other public sector laboratories are attached to health facilities. MOHS provides oversight centrally through the directorate and by the district health management team. Given that laboratory and hospital services are combined, the laboratory lead-in-charge reports to the medical superintendent of the hospital and the laboratory technician in charge of a PHU reports to the district superintendent, who will in turn pass information to the directorate. At present, there is no intermediate organizational structure to provide linkage between the districts and the Directorate. Coordination and supervisory activities are therefore undertaken from the headquarters. At district level, the laboratory manager reports directly to and is accountable to the medical superintendent. At this level the laboratory has to compete for resources with other priority hospital departments. This state is reflected all along the laboratory tiers up to national level.Laboratory management and coordination is being strengthened by the creation of a Laboratory Directorate with regional and district management structures and strong coordination structure provided through the National Laboratory, Epidemiology and Surveillance Technical Working Group (LSeTWG) with redefined roles inclusive of advisory, advocacy and technical.Challenges:Low priority status given to the laboratory at all levels in resource allocation.Limited technical and management capacity of the laboratory managers at all levels to provide effective support and supervision to the peripheral laboratories.Weak management structures and skills at all levels.Lack of an effective coordination mechanism for laboratory service providers and funding agencies.Limited resources at central level to provide overarching coordination and monitoring. Policy:To establish an effective laboratory management structure in the MOHS that can provide stewardship and coordination of laboratory services at central, regional, and district levels.Objective 1: To strengthen the laboratory organizational and management structures to provide oversight and coordination of laboratory services throughout all the levels of health care by end 2020.InterventionsEstablish a directorate for the National laboratory Service at the MOHS by end 2020.Engagement of MOHS and administrative units to determine the implications of setting up the directorate by end 2020Appoint a Medical Laboratory Services Director by end 2018.Appoint Senior Laboratory Specialist Scientists to provide technical oversight by end 2018.Post an administrator, accountant, personnel officer, data officer and support staff to the directorate by end 2018.Procure three vehicles for the directorate in 2020.Establish clearly defined laboratory tiers with management functions and reporting structures by end 2017.Classify laboratories and define functions for each laboratory tier by end 2016.Appoint five (5) Senior Laboratory Scientists to manage the different sections of the National Reference Laboratories by end 2018.Appoint four (4) Provincial Laboratory Scientists to manage the regions and the regional laboratories by end 2018.Appoint nine (9) District Laboratory Scientists to manage district laboratories by end 2019.Initiate and coordinate Bi-Monthly National Laboratory activity updates and experiences sharing meeting for all 14 districts and National LaboratoryStrengthen the management capacity of all laboratory managers by end 2020.Equip all district laboratory managers with management skills by end 2017.Provide ongoing mentorship to national and regional laboratory managers by end 2020.Establish laboratory coordination mechanism by end 2018.Redefine the role of the LTWG (Laboratory Technical Working Group) in collaboration with Surveillance and Epidemiology Technical working Group (SETWG) by end 2016Establish a secretariat for the LTWG by end 2017.Activate LTWG monthly central meetings by end 2016.Expand quarterly Laboratory TTM to include all districts by 2017.Institute quality audit improvement project monitoring by 2018. Legal and Regulatory Framework and EthicsThe NLP has now been adopted by the MOHS and will be used as the basis for developing and strengthening the laboratory system in the country. Regulatory/legal frameworks are important to ensure consistent delivery of quality laboratory services at all tiers. Professional laboratory staff are guided by codes of ethics that would ensure compliance to set standards that meet international best practices. Ethical considerations are important in service delivery to protect the rights and privacy of users of health services in the handling of information and test results. A regulatory framework specific to the laboratory system has yet to be developed.Currently the MDCSL licenses premises for delivery of health services including laboratory services. There is no mechanism for the licensing and registration of laboratory personnel and the practice of laboratory medicine. This has led to the mushrooming of unlicensed laboratories and the entry into practice of unqualified staff. A National Laboratory Regulatory Council (NLRC) will be established to regulate practice, and to prescribe and enforce professional ethics.Challenges:Limited mandate and technical expertise of the National Medical Council of Sierra Leone NMCSL in addressing the full range of laboratory matters that require regulationLack of a professional regulatory body to address issues specific to the laboratoryLack of a written code of practice/ethics protocol on laboratory practiceLimited monitoring of laboratories by the current assigned agency (MDCSL).Policy:To provide a framework for regulation of training, laboratory practice and observance of professional ethics in laboratory practice in Sierra Leone.Objective 2:To provide a policy and legal framework for proper regulation, training, laboratory practice and observance of professional ethics in laboratory practice by end 2020.Interventions:Development of an Act for the establishment of the National Laboratory Regulatory Council (NLRC) by end 2017 Appoint a technical committee at the MOHS to start drafting of the Bill by end 2016. Liaise with Solicitor General’s Office to draft the Bill for the establishment of the NLRC by end 2016Present the Bill to parliament for debate and enactment by end 2017Establish and operationalize the NLRC by 2017.Appoint members of the Council by end 2017Hire technical and administrative staff for performing tasks related to licensing and registration by end 2016Draw up rules related to laboratory code of practice, professional ethics and subsidiary legislation by end 2016Develop a minimum standard of requirements for setting up of laboratories by tier; review and harmonize the curriculum for laboratory training programmes.Develop laboratory-monitoring tools to incorporate indicators for ethics compliance monitoring.Institute in-service training programes on mence licensing of all (as defined by the Act) laboratories and registration of laboratory personnel in 2018Identify and start licensing all laboratories appropriatelyCommence registration of laboratory practitioners who meet requirementsDevelop a transition mechanism for personnel who are practicing but would not qualify for employment or practice under the new legislationObjective 3:To strengthen community awareness of ethics for laboratory professionals and increase demand by service users and providers at all levels by 2017Interventions:Create community awareness through use of mass media on laboratory ethics, the rights of users and methods of seeking redress.Ensure visible display of codes of ethics in all laboratories as part of standard practice by 2017Create appropriate channels for complaints management in at least 30% of all public and private laboratories.CHAPTER 2: HUMAN RESOURCES DEVELOPMENT AND MANAGEMENT?The most recent survey of laboratories was undertaken in 2015. This identified 208 junior cadre laboratory personnel trained at the Ordinary National and Higher Diploma levels .They are employed by both the public and private sectors as laboratory assistants and Technicians respectively.In addition, there are 141 persons working as laboratory assistants without formal training. Most of these have education at secondary or BECE levels only. Currently, there are three Senior Medical Laboratory Scientists in the MOHS (1Biochemist, 1 Microbiologist and 1 Parasitologist who doubles as Laboratory Manager, and three Laboratory Physicians (Consultant Microbiology, Histopathologist and Haematologist) and eight mid-level scientific officers at first degree level in Public Service. The laboratories are therefore understaffed in terms of trained personnel to provide technical managerial leadership at secondary and tertiary levels. The MOHS is currently supporting the formal training of all unskilled laboratory workers in public service and with respect to laboratory a competency assessment program is planned to enable deployment of staff to their right scale. Following the recent Ebola outbreak, a team of 28 Bachelor’s degree graduates in Biological Sciences and Diploma in Medical Laboratory graduate were trained in an intensive viral molecular course for the transition of the Ebola laboratory and towards building a Public Health Laboratory Response (PLHRT). 12 of this team are now undergoing orientation and supported until absorbed by the MOHS to increase h pool of skilled professionals.A recent increase in remuneration of health workers has helped significantly to improve staff morale and will hopefully translate to retention of personnel in public service for a much longer period than at present. A draft scheme of service for laboratory personnel has been proposed that clearly defines a career path with job descriptions to rationalize deployment and improve staff management and efficiency. Opportunities should be created for the laboratory scientific officers to specialize in different laboratory fields of study – haematology and blood banking, microbiology, and chemical pathology, since the secondary and tertiary level services require these specialties. Medical and Science Laboratory Technicians are trained at all the five tertiary institutions in the country (FBC, COMAHS, Njala University, MMCET and EPK). However, the curriculum is being revisited and the facilities provided at these establishments (e.g. training laboratories, equipment) needs to be greatly improved. A curriculum for the Bachelors’ Degree in Medical Laboratory Sciences has been developed and approved by the academic structures of the University of Sierra Leone. First year classes in basic sciences have commenced but are awaiting the completion of a training laboratory for the continued running of the course. With full support COMHAS should hopefully produce the first set of graduates in three years’ time.Training for medical specialists in laboratory medicine is currently not available in country. Efforts are being made by the Ministry of Health for medical graduates to undergo specialty training in the West African sub-region under the auspices of the West African College of Physicians.During the period over which this plan operates, the MOHS should recruit the full complement of laboratory scientists with appropriate qualifications, skills and competences to meet the needs of the nation.Challenges:Inadequate numbers of skilled laboratory professionals. Poor personnel attraction and retention programs.? Limited opportunities for both postgraduate training and continuous professional development. Lack of an enabling working environment.Delayed employment of trained and qualified staff.Poor staff workload ratio across all laboratories. Policy:To ensure the availability of adequate numbers of laboratory personnel with the appropriate knowledge, competencies and skills to support the delivery of a comprehensive laboratory package at each level of health care.Objective 4: To meet the minimum qualified laboratory personnel levels to support the delivery of a comprehensive laboratory package at each level of health care by end 2020.Interventions:Deploy adequate numbers of skilled laboratory staff to all laboratory facilities by end 2020.Conduct competency assessment of current staff and develop deployment plan. By end 2016-2017Recruit 10 technicians yearly from 2016 – 2020 to provide services at Community Health Clinics (CHC) and district laboratories. Recruit annually, over three years starting 2016 - 2018 five senior laboratory scientists including laboratory physicians to work at regional and reference laboratories.Establish an Emergency laboratory response team at national and district level by end 2017Improve the output and quality of laboratory personnel from training colleges by end 2020.Develop a training plan by end plete the harmonization and standardization of the curriculum for the training of technicians at diploma level by end 2016.Improve on the training facilities of the training institutions by end 2017.Train a core group of scientists and laboratory physicians in specific laboratory specialties by end 2020.Train two scientists locally in microbiology by end 2018.Train five scientists in molecular biology by end 2018.Train two scientists in virology and immunology in mence specialist training of 4 medical doctors one each in Hematology, Microbiology, Histopathology and Chemical Pathology by end 2018.Train 46 staff in QMS from 2017 - 2020 through on -the- job training.Develop a structure for the upgrade of community and untrained laboratory support workers.Develop and operationalize retention and post-training policy by 2017.Develop and implement a scheme of service for all cadre of lab personnel.Conduct consultative and consensus workshop in collaboration with the Human Resource Directorate. CHAPTER 3: LABORATORY INFRASTRUCTURE AND EQUIPMENTInfrastructureThe design of a laboratory is essential to ensure proper workflow and safety of laboratory staff, other health professionals and patients. The designation of separate work areas for reception, specimen collection, sample processing, assays and relaxation is a major consideration for laboratory infrastructure. Furthermore, ensuring that there is appropriate lighting, ventilation, and bench space is essential for efficient laboratory operations. Equally important is ensuring restricted access to specialized areas. Despite the importance of appropriate laboratory infrastructure, a huge gap exists in the various levels of laboratory infrastructure in Sierra Leone. According to the Rapid Response Assessment that was conducted in 2015 only three laboratories met the required internal standards.The government plans to improve significantly on the standard of laboratories infrastructure taking into cognisance the lessons learnt from the Ebola outbreak. It is anticipated that the laboratories will meet the required international standards for quality and safety taking into consideration Infection Prevention and Control (IPC).Challenges:Absence of a national standard for laboratory infrastructure.Inappropriately designed and poorly ventilated laboratory space. Irregular maintenance of laboratory premises. Inconsistent power supply. Inconsistent water supplies, low water pressure and poor water quality Lack of safe disposal facilities for water/ liquid waste from laboratories Lack of proper incineration facilities for solid hazardous wasteLack of proper storage facilityLack of Appropriate archived roomLack of common and dressing roomLack of easy accessibility to laboratory by the disabled (Ramp) Lack of detached laboratory from hospital buildingLack of emergency exit in the laboratoriesPolicy: To provide at each level of health care delivery, laboratory facilities appropriately designed to ensure a correct, safe, functional and operational environment for effective performance and service delivery. Objective 5: To provide adequate laboratory space appropriate for each level for effective service delivery by end 2020Interventions:Ensure that targeted laboratories meet minimum required standards for infrastructure and environment by end 2020 Reviewed laboratory design to meet international standards (by the end of 2016) Renovate /upgrade 193 laboratories that do not meet required quality and safety standards as appropriate for their level (To include water and power supply) by end 2020. Construct 9 new laboratories, 3 in each of the three regions (east, north and south) by end 2019Inspect and carry out annual maintenance of laboratories infrastructure 2019Equipment:Most laboratory analyses in the country are still being done using manual methods without validation of results. There are very few automated haematology and chemistry analysers in the country. Equipment procurement is done with little involvement of laboratory personnel, sometimes resulting in purchase of inappropriate equipment. There are no policies for procurement of laboratory equipment and procedures for installation, and for training personnel on the use, care, and regular maintenance of such equipment. Challenges:Inadequate involvement of laboratory personnel in the planning and procurement process resulting in the purchase of obsolete and inappropriate equipment.Bottlenecks in the distribution of laboratory reagents and supplies. Limited storage capacity for laboratory reagents and supplies at facility level. Lack of knowledge of the appropriate conditions for the storage and distribution of reagents and supplies. Poorly maintained cold chain. Inadequate stock control systems (to ensure supplies are maintained and time expired materials are disposed of properly). Lack of capacity at district level for procurement of specialized equipment. Lack of involvement of suppliers in equipment installation, training and commissioning. Lack of an equipment service contract system.Lack of appropriate temperature for storage of equipment PolicyTo provide the necessary procurement directions and stock management systems for an efficient quality laboratory service at all levels Objective 6To provide technical expertise that will align international (regional) tools and documents of equipment requirements appropriate to support the BPEHS.Interventions:Ensure the procurement of appropriate and adequate laboratory equipment and commodities for all levels of service delivery nationwide.Develop a national equipment and supplies management plan by 2016. Equip each laboratory with equipment and supplies including stock management and waste disposal to support approved testing platform according to the Basic Essential Package (BEP) by 2016. Develop and ensure compliance of the policy for service contracts on all procured equipment and supplies by end of 2016.LTWG to provide central oversight for the procurement, installation, distribution and maintenance of all laboratory equipment.CHAPTER 4: LABORATORY SERVICES & SUPPORT SYSTEMS (Logistics & Management Systems)Laboratory ServicesMost district laboratories do not have the capacity fully to support the delivery of the minimum health package and other programme activities. Haematology services in almost all hospital laboratories are limited to haemoglobin estimation and occasional manual WBC counts. Microbiology services at both PHU and hospital level are limited to microscopy for TB, Malaria and parasitological examinations of faecal samples, although a limited number use rapid diagnostic tests (RDTs) for malaria, HIV, syphilis and Hepatitis B testing. Biochemistry tests are limited to urinalysis by dipsticks and occasional blood sugar estimation. Very few laboratories provide Urea and Electrolyte or Liver Function Tests (LFT), and key items in patient management. Limited histology services are offered through the histopathology unit at central level. There are no cytology or toxicology services. The Kenema hospital laboratory is the most advanced laboratory in the country and has an adjoining Lassa Fever BSL3 Containment laboratory that has the capacity for molecular and Enzyme immuno-assay. This service is of international standard and provides support to neighbouring countries. The services for Malaria, HIV, TB, and Lassa Fever provide an opportunity for the public health laboratory to build on and expand the referral system to encompass other diseases and a much wider range of specimens. Challenges:Limited testing capability at all levels due to inadequacies in skills, equipment and reagents.Limited infrastructure and utilities to support laboratory service. Weak specimen referral system.Policy:To provide laboratory services appropriate to each level of the health care system that respond to the defined national health care package.Objective 7: To provide laboratory services appropriate to each level of the health care system within the defined laboratory package by end 2020.Interventions:Define the laboratory tests and techniques to be offered at each level by end 2016.Strengthen and expand the specimen referral system to include diseases and specimens other than those currently covered by end 2018.Define a national stock management systems protocol by end 2018.Revise referral and feedback tools by end 2017.Develop and distribute guidelines and provide training on specimen packaging by end 2017.Establish a specimen referral courier system by end 2018.Establish a stock management protocol for all equipment, supplies and consumables at all levels by end 2018.Laboratory Logistics and Management SystemDuring the EVD outbreak, the laboratory services were challenged by the scarcity of skilled human resources and management supply chain in support of laboratory services. This led to a major hindrance in the delivery of quality laboratory services. The MoHs should ensure that critical testing supplies are available when needed to prevent delays in providing pertinent testing results to patients. A robust equipment maintenance and calibration programme is thus necessary for proper and consistent functioning of all laboratory equipment and reliable test results. Adequate attention should be given to inventory and stock management including maintenance of infrastructure and equipment for a laboratory to run efficiently.A good storage system is essential to the guaranteed integrity of laboratory commodities at all levels of distribution in accordance with the manufacturer’s instruction. The delivery of commodities to the lab facilities should be based on logistics report which should be sent to the central warehouse through the state procurement and supply chain management team. Reagents and supplies:Weak capacity for quantification and specification coupled with procurement and distribution bottlenecks often result in stock-outs of reagents and essential laboratory supplies. Districts attempt to fill the gaps by sourcing equipment and reagents at district level from the few local suppliers, posing challenges of availability, problems of standardisation of reagents and a lack of the benefits of economies of scale. Challenges:Weak inventory management. Lack of established preventative maintenance programmes.Lack of equipment management systems. Lack of vendor (equipment and supplies) service contracts.Limited systems for validation of laboratory testing results. Limited storage space for reagents, specimens, and supplies nationwide. Limited involvement of laboratory staff in the acquisition of laboratory equipment and supplies.Only one biomedical engineers to address in-country equipment maintenance needs.Service interruption due to Non-usable equipment.Inadequate documented procedures to address notification of physicians of critical values, delayed results and to prevent loss of laboratory data.Lack of guidelines on disposal of obsolete equipment and expired reagent.Unreliable forecasting, quantification and specifications of supplies.Policy:To provide the necessary procurement directions and stock management systems for an efficient quality laboratory service at all levels.Objective 8: To provide all government medical laboratories with appropriate equipment, and assure availability of commodities (media, sera, reagents etc.) for efficient service delivery by end 2020.Interventions:Strengthen national testing norms and standards definitions Update the national standard equipment list and specification for procurement at the different levels of healthcare by end 2016. Provide a common and appropriate laboratory equipment platform for test assays by end 2016. Develop essential supply list based on the test requirements for the various levels of healthcare delivery by end 2016.Institute diagnostic and public health commodity systems Train 36 laboratory personnel on logistics and supply chain management by 2017. Ensure representation of laboratory personnel on local and national procurement committees by 2017.To develop policy for disposal of obsolete equipment and expired reagent by 2017.Objective 9: To provide all government medical laboratories with complimentary supplies and consumables for efficient service delivery by end 2020.Intervention: Strengthen the storage and distribution mechanism for equipment, supplies and reagents at all levels.Establish minimum and maximum stock levels for each laboratory by 2016.Provide adequate reagent storage facilities at each laboratory according to the National Basic Essential Health Package (2016- 2020). Provide cold storage facilities for all laboratories by end of 2016.CPHRL to validate all laboratory reagents procured in country.Provide periodic in-service training in stock management of equipment, reagents and various supplies (2016). CHAPTER 5: BIORISK MANAGEMENTBIOSAFETY, BIOSECURITY, BIOBANKING)Medical laboratories handle infectious waste materials and generate biological waste. It is important that the staff, the public and the environment are protected from injury or contamination by these materials.The last Ebola outbreak led to the infection and death of several medical and laboratory staff. The lessons learned from this should ensure that all health care providers consider health and safety paramount in the operations of health facilities nationwide.The issue of specimen repository of left over biological samples from investigations conducted in our laboratories has become more important than ever before. There had been no policy to guide specimen archiving, storage, retrieval and destruction. Vital samples from endemic and epidemic prone diseases in this country are not stored properly and their destruction is haphazard. Well-structured and resourced bio repositories could serve as a vital resource to promote research and training of our future scientists. . Laboratory workers are also exposed to dangerous chemicals and fire incidents and should be taught how to protect themselves from such ugly incidents. Challenges: Lack of laboratory bio-security policyInadequate supply and hence insufficient use of PPEPoor waste management systems including a lack of waste disposal equipmentInadequate skilled personnel to safely package and transport infectious substancesLack of training in fire safety and containmentPolicy:To promote and sustain laboratory safety and safe laboratory practices in all laboratories in order to protect staff, products, community, and environment.Objective 10To support all laboratories to implement the laboratory bio-safety policy and adhere to safety guidelines by end 2018InterventionsImplement the national laboratory safety policy and guidelines by end 2018Establish a laboratory waste management protocol by end of 2018Procure and distribute adequate quantities of waste disposal systems by end 2018Procure and distribute appropriate PPE and continue to train staff in its use till 2020Build capacity of laboratory personnel on fire safety to address chemical spills and contamination by end 2016Establish national repositories for the safe storage and security of biological specimen for use in the development of an effective public health system by end 2020. Develop functional inventory and a system for specimen management (collection, transportation, archiving and retrieval of stored specimens-Laboratory Information Management System) by end of 2020.Develop policies for destruction, accessing retrieval and utilization, disposal of stored specimens by end of 2016.Establish a National Governing body for overseeing bio banking by end of 2016.Establish and strengthen capacity for management, coordination, operation and maintaining of the bio banking by end of 2018.CHAPTER 6: INFORMATION MANAGEMENT SYSTEMSLaboratory Information System is a paper, electronic or web based system that processes, stores and manages data from all stages of medical procedures and tests, with the sharing of data on patient’s care, disease surveillance, and monitoring and evaluation of laboratory performance.Proper implementation of LIS ensures high quality actionable data is available to users in a timely manner, it assures security and confidentiality of laboratory data by the administrator and eligible users. This plan continues to recognise the weakness of the laboratory information systems and highlighted LIS as one of the strategic focus areas in the plan. Policy Environment of LIS The 2009 Health Policy affirmed goal to establish and strengthen laboratory systems. The National Laboratory Policy highlights the need for national Laboratory Information Systems (LIS).The 2011-2015 Laboratory Strategic Plan sets out mechanisms to establish and strengthen the LIS. The strategic plan identifies Integrated Laboratory Data Management as a core function of the laboratory system. Strengths Existing laboratory policy documents recognize the need to establish efficient LIS. Other ministries and programmes require lab support and can be expected to contribute to LIS strengthening.Main challenges Weak lab management and coordination structures. Lack of infrastructure for data management.No standardised system for management of laboratory data.Inadequate supervision and monitoring of service delivery. Poor data collection, compilation, analysis, utilization and reporting.Limited capacity in data management. Inadequate data collection tools at laboratory level. Vertical programmes running parallel data collection systems. No harmonisation of vertical programmes data with national laboratory data. No link with DHSPPI.Opportunities: Increased international technical and financial support for Post-Ebola Recovery and HSS.Increased interest and focus on HIS and interoperability of HIS systems. There are existing programmes to support LIS – DHIS. Increased demand for data use in decision making. Overall laboratory investments for more cohesive service delivery. LIS modules in pre-service lab training and continuing professional development. Threats: Continued dependency on donor support threatens sustainability.Power supply and telecommunications inadequacies limit the functionality of LIS.Inadequate skilled human resources and staff retention challenges.Task overload.Policy: To establish an efficient and integrated LIMS at all levels Objective 11: To establish a laboratory information and management system that is integrated into the national health management information system Interventions: Establish an integrated system for data capturing, analysis and use at all levelsEstablish a data unit at the laboratory directorate by 2017Establish laboratory LIS TWG with defined terms of reference by end 2016 Train district laboratory in-charges on the use of the tools and relevant software by end 2018Provide network and information communication technology equipment at all levels by end 2019Establish an electronic LIMS throughout NPHRL network by end 2017 Train specified personnel at the district laboratories in the use of the tools by end 2018Link laboratory data unit to national data warehouse by end 2020Establish effective data management and sharing systems by 2018Generate Protocol for LIS integration into HIS by 2019 Establish an electronic LIMS at NPHRLIdentify the software to be used by end of 2nd quarter in 2017Install software and train staff by end 2017CHAPTER 7: EMERGENCY PREPAREDNESS AND RESPONSE Public Health Functions Sierra Leone has experienced two major epidemic-prone disease outbreaks within the past 5years; these are Cholera and the Ebola Virus Disease (EVD). Given that there had been previous Cholera epidemics, it would have been assumed that lessons learnt in handling such would have influenced the country’s preparedness in response to the 2014 EVD outbreak however, this was not so. During this outbreak, many lives were lost, including 202 frontline health service providers, further depleting the already low number of this cadre; there was exposure of the lack of capacity and preparedness within an already weak health infrastructure, in responding to other outbreaks.This section will provide direction in preparedness and response for future outbreaks, in accordance with the Integrated Disease Surveillance and Response (IDSR) strategy adopted by WHO AFRO member states for improving public health surveillance and response. The focus areas will be on Disease Prevention and Control, Surveillance and the identification of disease outbreaks, facilitation of an appropriate response and the implementation of prevention and control measures.Integrated Disease Surveillance and Response (IDSR)The technical guidelines for IDSR in African Regions 2010 clearly highlighted the Laboratory confirmation of a disease to allow for timely intervention to limit the impact of the health of affected communities. Although the current drive takes into account (one world- one health) perspective that integrates human, animal and ecosystem health, the plan only addresses the human health with the flexibility to link with animal and environmental effects. With the commitment of MOH to implement IDSR, key critical development paths are considered as per figure below.Figure 4: Critical path of developmentChallenges:Implementation of the IDSR strategy in Sierra Leone is not optimal at this point in timeA lack of emergency/rapid response teams (RRTs) at all levels that is, National, District and CommunityLimited training in emergency preparedness at all levels that is, national, district and communityPolicy To improve laboratory capacity for surveillance and responseObjective 12:To fully implement the IDSR strategy in Sierra Leone by 2020Interventions:Create a Laboratory coordinating office at the Emergency Operations Centre (EOC).Develop a Laboratory Rapid Response Operational manual, with a costed implementation plan.Integrate the laboratory emergency response into the overall national response.Train relevant national and district level personnel as part of the rapid response teams (RRTs) for disease outbreaks.Train 2 Laboratory scientists as part of the national level RRTTrain 14 Laboratory Scientists as part of the district level RRTs (one per district)Establish RRTs at all levels, national, district and community.Train laboratory staff in outbreak emergency preparedness, including laboratory activation simulations.CHAPTER 8: RESEARCH, DEVELOPMENT AND ETHICSThe capacity of laboratories to conduct research in the country is limited. In collaboration with the Health and Biomedical Research Group a symposium has been organised to build technical capacity in proposal writing and research methodology for simple operational research that addresses the needs of the country and various ministry programmes. Members of staff are being encouraged to publish their work in both local and international peer review journals. We can now leverage on the experience and expertizes available during the EVD outbreak and create/maintain a network of laboratories and researchers at all tiers within the country and internationally in other to strengthen the laboratories capacity to conduct research.Challenges:Low technical capacity in proposal writing and research methodologyLaboratories poorly equipped to conduct researchLack of a national laboratory research policyInadequate funding and resources to support research and development activities.No National research database.Laboratory data management (reporting format) not integrated.Policy:To promote and strengthen research that will contribute to improving the quality of health and health care delivery in Sierra LeoneObjective 13: To strengthen operational research technical capacity to enhance laboratory services in Sierra Leone by 2020InterventionsDefine research priorities relevant to laboratory services by end 2016Establish strategic partnerships and linkages with internal and external academic centres to collaborate and strengthen the national public health research agenda by end 2017Collaborate with the Health and Biomedical Research group to train laboratory personnel in proposal writing and research methodology by end 2016Advocate for funding/ Mobilize resources for operational research aligned with the Directorate of Planning, policing and information by end 2017.Develop a national research data base by 2018Develop an integrated data management system by the end of 2018.CHAPTER 9: PARTNERSHIPS AND LINKAGESSierra Leone operates a countrywide network of 179 functioning laboratories, operating in a four- tiered, system, with increasing degrees of competence and capacity as you go up the tiers. The preceding consists of the following:Four public health laboratories. Two research laboratories—Kenema Viral Haemorrhagic Fever (VHF) laboratory in Kenema and Mercy Laboratory in Makeni.24 public clinical laboratories comprising of :- 12 district clinical laboratories of which 5 are regional laboratories (MOHS); 4 laboratories run by the forces (Military, Police and Prisons); 4 laboratories run by the current universities, 4 private clinical laboratories countrywide— 3 in Western Area, 1 in the South.Figure 5: Areas of actions to address all levels of laboratory networkDue to the weak laboratory infrastructure, inadequate numbers of skilled personnel and lack of equipment, many laboratories, in all the tiers, are neither performing to capacity nor meeting the needs of the BEPHS, the Free Health Care initiative, FHCI and the Global Health Security agenda. At the district level, there is minimal supervision and coordination of the primary health unit (PHU) laboratories. There is no intermediate technical supervisory, coordinating and monitoring unit between the districts and the central levels; all laboratories, down to PHU level, are therefore supervised from the central level. The Central Public Health Reference Laboratory (CPHRL) serves as the hub for the network of public health labs, which include the Jui Public Health laboratory, the VHF Kenema, the Makeni Reference lab, the National TB Reference laboratory Lakka, the Neglected Tropical Disease (NTD) laboratory in Makeni, and the existing tertiary laboratories at regional level. The network of public health laboratories is moving toward integrated disease surveillance and also linking with clinical diagnostic and reference laboratories at the tertiary level. Challenges:Weak inter-laboratory collaboration Weak referral systems among all tiers of laboratoriesWeak collaboration between Surveillance and LaboratoriesWeak linkages and partnerships, both local and internationalPolicy:To establish effective and efficient mechanisms for national and international networking and collaboration for quality laboratory services, improving access to laboratory services by the population and maximising resource mobilisation and utilisation. Objective 14: To establish an effective laboratory network at national and international level for quality laboratory services and resource mobilization by mid-2020.InterventionsTo strengthen the national laboratory network for clinical diagnostic and reference, and public health laboratories.Develop a national map of laboratories and laboratory resources by 2016.Establish an integrated national laboratory network of both public health and clinical laboratories, with defined roles and responsibilities for each tier by end work PHU laboratories with the district laboratories by mid-work district laboratories with the regional laboratories by end work the regional laboratories with NPHRL by end 2017.Strengthen collaborative and communication linkages among all laboratories across all tiers countrywide by end 2020.Establish a referral system among all tertiary clinical and reference laboratories, (Connaught, Makeni, Kenema, PCMH, Ola During and Bo) by end 2017.Strengthen the referral system of the National Public Health Reference Laboratory (NPHRL) by end 2020.Strengthen partnerships among the existing network of laboratories countrywide.Strengthen international partnerships with both laboratory and non-laboratory technical partners, for the purpose of training, research and development, efficiency and innovation and quality assurance by end 2020.Strengthen inter-programme linkages by 2016.Strengthen linkage with international laboratories by 2017.Strengthen the linkages and reporting of the Central Directorate and the national technical working groups to the Emergency Operating Centre (EOC) by 2016.Strengthen Central Directorate and the national technical working groups to provide oversight to all laboratories, coordinate laboratory services within the regions and to support districts in disease surveillance and outbreak investigation, linking with the NPHRLS by 2020.Provide linkages to food/water bacteriological testing at NPHRL and clinical laboratory systems in collaboration with the National Standards Bureau by end 2018.Provide linkages to basic water testing for microbial and element contaminations to district laboratories by mid-2018.Linkage with the Office of the National Security, ONS for emergency respoFigure 6: Network of National Public Health Reference Laboratory SystemCHAPTER 10: TOTAL QUALITY MANAGEMENT SYSTEMS (QUALITY ASSURANCE)Laboratory quality can be defined as accuracy, reliability and timeliness of reported test results. These results must be as accurate as possible, all aspects of the laboratory operations must be reliable, and reporting must be timely in order to be useful in a clinical or public health setting. However, achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories in Sierra Leone. The LQMS is for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians.Present Situation:The country does not currently have a national quality assurance program to enable it to develop and implement a laboratory quality system with the exception of the TB and HIV programmes. There is no standardization of equipment and techniques, making it difficult to develop national SOPs and External Quality Assurance (EQA) programmes with the exception of the TB and HIV programmesMany laboratories do not have internal Quality Control (QC) systems in place. Only Lassa fever, Central Public Health Reference Laboratory, TB reference laboratories and the Microbiology laboratory at the Connaught hospital participate in international EQA programmes.The TB and Central Public Health reference labs are the only labs that manage national EQA for TB and HIV diagnosis.The EVD Labs participate in EQA facilitated by WHO/CDC and coordinated by the LTWG and the goal was to improve the quality of laboratory services in accordance with the International Organization for Standardization (ISO)Challenges:Lack of National QA PolicyLack of National Lab Quality Management System (LQMS) Manual/HandbookInsufficient number of trained staffInadequate supporting infrastructure and equipmentLack of standardization of equipment and testsQuality and performance of most labs cannot be evaluatedPoorly motivated staffInadequate top management supportive supervision to labsPolicy:To provide and maintain standards of operation of laboratory services to levels acceptable for assured provision of quality health care delivery through effective monitoring, evaluation and intervention.Objective 15 To establish a Quality Management System (QMS) for quality assured laboratory test results by end 2020Intervention:Establish a National External Quality Assurance Programme (NQAP) by end 2016 Develop a National QA Policy- 2016Develop a National Lab Quality Management System (LQMS) Manual/Handbook. By end 2017Train and assign 14 District QA Managers by end 2017Standardise equipment and tests for each level by end 2016Facilitate /Develop SOPs for equipment and lab procedures by end 2017Train laboratory staff in the use of the lab quality manual and SOPs by end 2017.Expand the National External Quality Assurance Scheme (NEQAS) in accordance with the National QA Policy by end 2020Strengthen NPHRLs and Clinical Laboratory to prepare proficiency panels for the most commonly performed lab tests for ten diseases that meet IDSR by end 2019 Train laboratory staff on Quality Assurance by end 2018Enrol regional and district laboratories in NEQAS by end 2018Work with Laboratory Technical Working Group (LTWG) to establish a National Quality Assurance Programme (NQAP)Support LTWG to establish a National Quality Assurance (NQA) CommitteeDevelop SOPs for QASECTION 3: IMPLEMENTATION MECHANISMSTable 3: Strategic FrameworkObjective numberObjectiveOutputIndicator1To strengthen the laboratory organizational and management structures to provide oversight and coordination of laboratory services throughout all the levels of health care by end 2020.National Laboratory Service Directorate established. Senior laboratory managers attend at least one management-training programme.LTWG role expanded to include coordination in advisory capacityNo. of senior laboratory managers with management training.Number of LTWG meetings held and accompanying report2To provide a policy and legal framework for the regulation, training, laboratory practice and observance of professional ethics by end 2020.NRLC established and operationalNo. of personnel registeredNo. of laboratories licensed3To strengthen community awareness of ethic for laboratory professionals and increase demand by service users and providers at all levels from 201770% of laboratories staffing adhere to laboratory code of ethics 70% of laboratories staff aware of laboratory ethics and with 70% compliancy scored at lab customer service audit4To meet the minimum qualified laboratory personnel levels to support the delivery of a comprehensive laboratory package at each level of health care by end 202050% of laboratories meet staffing normsNumber of laboratories meeting staffing norms5To provide adequate laboratory space appropriate for each level for effective service delivery by end 2020193 Laboratory upgraded (reorganised, renovate or constructed) for logical operational flowLaboratory designed approved and disseminated6To provide technical expertise that will align international (regional) tools and documents of equipment requirements appropriate to support the BPEH by end 2016Approved Equipment package database National equipment and accessories - Original Manufacturer or vendor lists with specifications generated 7To provide laboratory services appropriate to each level within the defined laboratory package by end 2020.80% of laboratories provide full packageReport on training on applications of systems tools and reporting audit 8To provide all laboratories with appropriate equipment and assure availability of commodities for efficient service delivery by end 2020. Update national specification for procurement of laboratory equipment list at different level.Provide the national standardized list of equipment and specification.9To provide all government medical laboratories with complimentary supplies and consumables for efficient service delivery by end 2020.Laboratories report less than two stock outs of reagents and supplies per year.No. of laboratories reporting >2 stock outs of tracer reagents and supplies.8.To establish an effective network at national and international level for quality laboratory services and resource mobilization by mid 2020.Strengthened national laboratory network for clinical diagnostic and reference, and public health laboratories. Linkage between Regional and Public health laboratories Coordinated network of national and international laboratories.9.To provide adequate laboratory space appropriate for each level for effective service delivery by end 2020.50% of laboratories renovated to meet minimum standards for infrastructure.50% of laboratories meeting standards for infrastructure.10To support all laboratories to implement the laboratory safety policy and adhere to safety guidelines by end 2018100% of laboratories implementing safety guidelines% of laboratories implementing safety guidelines11To establish a laboratory information and management system that is integrated into the national health management information system Over 90% of laboratories providing timely reportNo. and % of labs submitting timely and accurate report12.To fully implement the IDSR strategy in Sierra Leone by end 2020.Functional laboratory coordinating office at EOC.Laboratory Rapid Response Operational manual.80% of Regional District Laboratory and surveillance IDRS implementation Laboratory coordinating office at EOC.National Integrated laboratory Rapid Response Operational manual activated 13To strengthen operational research technical capacity to enhance laboratory services in Sierra Leone by 2020.At least 2 papers published or presented at national or international conferences per Reference laboratory per yearNo. of research conducted and papers published or presented at conferences. Evidence of operational research impact on health service activities14To establish an effective laboratory network at national and international level for quality laboratory services and resource mobilization by mid-2020.Established tier laboratory network within a regions Functional referral systems Laboratory twining for technical interchange. Laboratory maaping and linkage map and training report.Number of laboratories twined with international accredited laboratories 15To establish a QMS for quality assured laboratory test results by end 2020.100% of regional/reference laboratories enrolled in NEQAS 50% of PHCs (193) laboratories enrolled in NEQASReference and Regional Laboratories with >3 stars in WHO accreditation schemeNo. and % of regional/reference laboratories scoring 100% in NEQASNo. and % of PHCs enrolled in NEQAS scoring >50%No. of laboratories with WHO Stepwise Accreditation rating higher than 3 starsTable 4: Strategic time frame (working frame)Objective 1: To strengthen the laboratory organizational and management structures to provide oversight and coordination of laboratory services throughout all the levels of health care by 2018OutputInterventionsTimeframe (by end of relevant year)Responsible LeadCollaboration 20162017201820192020Laboratory Directorate establishedEstablish a laboratory directorate at the Ministry of Health and sanitation MOHS - Policy and AdministrationHRMOEstablish clearly defined laboratory tiersDirectorate of Hospital and Laboratory Services (DHLS) All Senior laboratory managers attend at least one management trainingStrengthen management capacity of laboratory managersMOHS, DHLSDirectorate of Training USLWAHOLTWG role expanded to include coordinationEstablish a laboratory coordination mechanismOFFICE of CMOObjective 2: To provide a policy and legal framework for proper regulation, training, laboratory practice and observance of professional ethics by 2020National Medical Laboratory Regulatory Council (NMLRC) Develop an Act for the establishment of NMLRCOffice of the Minister of Health and SanitationCabinet Office; Law Officers Establish and operationalize NMRLCNMLRCSLMDA and Phamacy Board Commence licensing and registration of facilities and personnelObjective 3: To strengthen community awareness of ethics for laboratory professionals and increase demand by service users and providers at all levels.Strengthen Community Awareness of ethics for laboratory professionals Create community awareness through the use of mass mediaNMLRC Ethics Board USLObjective 4: To meet the minimum qualified laboratory personnel levels to support the delivery of a comprehensive laboratory package at each level of health care by end 202050% of laboratories meet staffing normsDeploy adequate no. of skilled personnel to all laboratories DHLSHRMOImprove output & quality of laboratory personnel from training collegesDHLSDirectorate of TRAINING USLMESTTrain core group of scientists & laboratory physicians/CliniciansDevelop and operationalize retention and post training policyMOHS Policy and AdmistrationDHLSNMLRCHRMOObjective 5: To provide adequate laboratory space appropriate for each level for effective service delivery by end 202050% of laboratories renovated to meet minimum standards for infrastructureEnsure laboratories meet minimum standards for infrastructureDHLSPLANNING HSSLTWGObjective 7: Provide laboratory services appropriate to each level within the defined laboratory package by 202080% of laboratories provide full packageDefine laboratory tests and techniques by levelMOHSLTWGStrengthen and expand specimen referral systemDHLSDefine a national stock management systems protocolDHLSPlanning, NPPUObjective 8: To provide all Government laboratories with appropriate equipment and assure availability of commodities for efficient service delivery by 2020.Laboratories report less than 2 stock-outs of tracer reagents and supplies per yearUpdate the national standard equipment list & specification for procurement at all levelsDHLSLTWGProvide a common & appropriate laboratory equipment platform for test assays DHLSNMLRCDevelop essential supply list base on the test requirement at all levelsDHLSTrain laboratory personnel on logistic and supply chain managementMOHSUSLRepresentation of laboratory personnel on local & national procurement committeesMOHSNPPUDevelop policy for disposal of obsolete equipment & expired reagentMOHSONSObjective 7: To provide all government medical laboratories with complimentary supplies and consumables for efficient service delivery by end 2020.Objective 10: To support all laboratories to implement the laboratory safety policy and adhere to safety guidelines by 2018100% of laboratories implementing safety guidelinesDevelop national laboratory safety policy and guidelinesMOHSDHLSLTWGEstablish laboratory waste management protocolsMOHSDHLSLTWGProvide adequate PPE and train staff on use.MOHSBuild capacity of laboratory personnel on fire safety to address chemical spills and contaminationMOHSEPAFIRE FORCEEnforce safety guidelinesMOHSLTWGONSEstablish national repositories for the safe storage & security of biological specimen DHLSONSDevelop functional inventory & system for specimen management DHLSONSEstablished National Specimen Archiving coordination centre Develop policies for destruction, accessing retrieval & utilization, & disposal of stored specimensMOHSDHLSONSEstablish National Governing body to oversee bio bankingMOHSLTWGONSEstablish and strengthen capacity for Management, Coordination, operation and Maintaining of the bio bankingMOHSONSObjective 12: To fully implement the IDSR strategy in Sierra Leone by 202080% IDSR implementation strategyCreate a laboratory coordinating office at the EOCMOHSDHLSDPCEOCONSLTWGDevelop a laboratory Rapid Response Operational manual with a costed implementation planIntegrate the laboratory emergency response into the overall national response.Train national & district level personnel as part of the rapid response teams for disease outbreaksDHLSDIRECTORATE OF TRAINING HSSLTWGUSLEstablish RRTs at all levels, national and district MOHSDHLSDPCONSFunctional regional Centres of Excellence laboratory and Surveillance network Train laboratory staff in outbreak emergency preparedness, including laboratory activation simulationsDHLSCPHRLObjective 13: To strengthen research capacity to enhance laboratory services in Sierra Leone by end 2020At least 2 publications (local and or international) presented per year from each of the public health laboratory NetworkDefine research priorities relevant to laboratory services from 2016MOHSEHTICLTWGEstablish internal and external and linkages with academic institutions to collaborate and strengthen the national public health research agendaMOHSMOHS- DIRECTORATE OF TRAINING AND RESEARCH MESTUSLDevelop and implement short courses on research methodology for practicing medical professionalsHSSUSLCollaborate with the Health and Biomedical Research group to train laboratory personnel in proposal writing and research methodologyDHLSHBIOMEDLTWGMobilize resources for operational researchMOHSHSSEstablish an integrated data management systemDHLSPLANNING USLObjective 11: To establish a laboratory information and management system that is integrated into the national health management information system80% of laboratories providing timely reportsEstablish an integrated system for data capturing, analysis and use at all levelsMOHSDHLSDirectorate of PlanningHSSDPCEstablish effective data management and sharing systems by 2018Establish an electronic LIMS at NPHRLObjective 14: Establish an effective laboratory network at national and international levels for quality laboratory services and resource mobilization by mid-2020.Strengthen the national laboratory network for clinical diagnostic & reference, & public health laboratoryDevelop a national map of laboratories and laboratory resources DHLSLTWGEstablish an integrated national laboratory network for both public health and clinical laboratories for each tier DHLSDPCDHMTStrengthen collaborative & communication linkages among all laboratories across all tiers countrywideDHLSDPCDHMTStrengthen international partnerships with both laboratory & non-laboratory technical partners, for training, research & development MOHSDHLSHSSDPCStrengthen the linkages & reporting of the central Directorate& the national technical working groups to the EOCMOHSDHLSHSSEOCDPCStrengthen Central Directorate & the National Technical Working Groups to provide oversight to all laboratoriesMOHSLTWGProvide linkages to food/water bacteriological testing at NPHRL & clinical laboratory systems in collaboration with the national Standard BureauMOHSSTANDARDS BUREAUCPHRLLinkage with the office of the National Security, ONS for emergency responseMOHSONSDPCObjective 15: To establish a QMS for quality assured laboratory test results by 202080% laboratories enrolled in NEQASEstablish the NQAP.CPHRLNMLRCLTWGExpand NEQAS in accordance with the National QA PolicyCPHRLMONITORING AND EVALUATIONINTRODUCTIONIn the NMLStP 2010 – 2015, monitoring and evaluation (M&E) of medical laboratory services was not given sufficient attention therefore it is deemed necessary that it forms an essential element of the National Medical Laboratory Strategic Plan NMLStP for Sierra Leone 2016-2020.This Monitoring and Evaluation (M&E) Plan describes the approach and system developed to assess progress and impact of the overall strategic objectives of the NMLStP. Information from the M&E system will measure the extent to which activities contribute to achievement of the results described in the M&E framework. The M&E framework presents the results that the NMLStP expects to achieve in the specific priority areas. The M&E plan will provide the platform for routine tracking of implementation of laboratory activities. It will serve to guide laboratory services management, allowing partners to adjust targets and approaches if necessary in order to meet the intended objectives and also detail the data flows required at each level and the key studies to be conducted to measure impact. PURPOSE To guide, the core M&E activities to be implemented as a part of the NMLStP, providing strategic information on the progress of implementation of laboratory services and accomplishments, measuring the impact of interventions taken, and enabling the timely and opportune identification of problems for decision making and planning. OBJECTIVES 1. Create an easy to use and interpret standardized National M&E system; that also meets the needs of government and partners, to monitor and evaluate the implementation of the NMLStP.2. Identify the core indicators that will allow key stakeholders evaluate and measure the impact of the NMLStP, also providing data to compare the national accomplishments with other countries. 3. Generate strategic information for decision making in order to constantly improve medical laboratory services and management.CRITERIA FOR SELECTION OF INDICATORSFor selection of the indicators, the guiding tools are the laboratory quality indicators that ensure practicality and quality output. In view of this the following listed below are used to build the milestones monitoring plan. Coherence with the policy objectives of the NMLStP and all its priority themes.Feasibility to collect the required data taking into account indicators for which data is already available in the country but where flow needs to be improved. Sensitivity to detect changes and impact of improvement monitoring through quality improvement activitiesAbility to compare indicators with other countries.Measureable output to impact on national priority health indices, PROPOSED M&E UNIT/ SUB-COMMITTEE An M&E Unit is proposed and should be located physically and organizationally within the MOHS headed by the M&E Officer with knowledge of laboratory quality audit and its interpretation to national health impact. The team members should have representation at Provincial and or District levels. This M&E Sub-committee should be a technical multi-sectoral body responsible of coordinating and implementing the NMLStP M&E plan. PURPOSE OF THE M&E SUB-COMMITTEETo ensure that policy and decision makers and the public have access to timely and reliable strategic information on the implementation and achievements of the NMLStP for policy making, planning, research and general use. OBJECTIVES OF THE M&E SUB-COMMITTEETo coordinate and facilitate the implementation of the M&E plan including: To finalize the proposed framework, plan and system for the M&E of the NMLStPTo facilitate/provide technical assistance to DHMTs and partners in the development of their provincial and district M&E plans To agree on the terms of reference for any consultant hired to conduct operational or evaluation research relevant to the NMLStP and the aims and objectives of such research To safeguard the quality of M&E activities that are part of the national laboratory services and management reports, including: To provide technical assistance to the development of studies and/or surveys required to provide data for the national indicators. To critically review M&E reports from the provinces, districts and any other source.To critically review research findings, situation analysis and other relevant reports on laboratory services and management in the country. Submit strategic information and recommendations for decision making to the Planning division or the relevant body for policy making, planning, research and general use. COMPOSITION OF THE M&E SUB-COMMITTEE The Chair of the Sub-committee will be selected by the MOHS technical lead and will be part of the LTWG mandate and the appointment will be for the life of the NMLStP. The lead will work with direct support of the M&E Unit Officer responsible for Laboratory service . Full time members: Representative from the DPC - Surveillance Unit of the MOHS. Representative from the GFTAM of the MOHS. Representative from Statistics Sierra Leone. Representatives from MOHS Planning and Health Systems Strengthening unit Key Health development partners such as WHO and health stakeholders.Representative from University of Sierra Leone. Associate members Representatives from Ministries of Education/Agriculture/Planning & Development.Representative from any other relevant Unit of MOHSM&E Focal Point from the Medical and Dental CouncilADMINISTRATIVE FUNCTIONS OF THE M&E SUB-COMMITTEE The M&E Sub-committee will meet every quarter. Its key function is to provide continuity between overall implementation and tracking progress toward goals/objectives established in the NMLStP and to supervise the implementation of the national M&E plan. Other functions can include but not limited to: Liaison between the MOHS Planning Division and the M&E Sub-committee Collaboration with the communications officer in the design and implementation of a communication plan of strategic information to key stakeholders and the publicCoordination with and provision of TA to National & Regional M&E mission & Oversee special studies and or surveys. Convene and facilitation of quarterly and other meetings of the M&E Sub-committee. Specifically:Collection and organization of all information and data on topics or issues required or addressed during the M&E Sub-committee meetings Collection of information from institutions and organizations in order to update the performance of national indicators and prepare a quarterly report to be presented to the MOHS Planning division. ? IMPLEMENTATION?OF THE M&E PLAN?? ?In order to fulfill the commitments in the M&E Plan, MOHS and its partners need to strengthen the M&E capacity at all levels, specifically, training and capacity building should be provided for the M&E Sub- Committee in the following areas: ? Research methodology ? Advanced data analysis skills ? Technical writing ? Proposal and report writing/project management FRAMEWORK FOR THE MONITORING AND EVALUATION PLAN Table 5: Indicators and Monitoring ToolsIndicatorsMonitoring toolsNo. of senior laboratory managers with management trainingNo. of monthly LTWG coordination meetings % increase of qualified personnel in labs% of laboratories meeting equitable staff versus workload ratio% of laboratories providing full BPEHS package% of Stock outs of tracer reagents and supplies by laboratory and length of stock out% of laboratories meeting standards for infrastructure% of laboratories participating in at least one of EQA and scoring >80% in NEQASNo. of laboratories participating in WHO Stepwise Accreditation and annual % increase rating% Laboratories providing timely reports (TAT)% of laboratories implementing safety guidelinesNo. of research papers published or presented at conferencesNo. of supervision or Quality Audit visits% of equipment down time Supervision Checklist /Quality Audit tool Data collection and collation formsLaboratory request and results formsTechnical worksheets and chartsMonthly and quarterly reporting formsMOHS Activity Grid ReportsMonthlyAll laboratories at different levels will generate weekly summaries of work done and undertake monthly monitoring of outputs. QuarterlyQuarterly reports will be submitted to relevant management at district, regional and national levels for results monitoring and support supervision. EvaluationA mid-term and end-term evaluation will be undertaken. The mid-term evaluation will assess progress towards achievement of outcomes and make any necessary strategic changes where necessary. The findings and recommendations of the end-term evaluation results will inform the development of the next plan.FINANCING THE PLAN3284220122555The successful implementation of this plan will require the leadership of the MOHS to coordinate national priorities 00The successful implementation of this plan will require the leadership of the MOHS to coordinate national priorities The plan will be financed through;Government budgetary allocationsWorld BankFunding from GFATMGlobal Health Security Agenda DFIDUSGChina CDCItalian CooperationDevelopment PartnersCost recoveryThe regular budgetary allocation by the MOHS for laboratory services for purchase of equipment had been disaggregated to the districts. However, current plan to support this plan is to return to pool-procurement at central level coordinated from the Directorate level. Other costs such as personnel emoluments, procurement of reagents and supplies, supervision, coordination and monitoring are implemented and monitored centrally. The laboratory directorate will be required to play a greater advisory and overarching coordinating role to ensure that procurement of especially of equipment, is coordinated to benefit from economies of scale and promote standardisation. The approved national testing algorithm and test menu package will be the guide for procurement of all laboratory supplies and consumables. GFATM and other Ministry programmes that utilise laboratory services will work towards harmonised budgets equivalent to the support they require. A significant part of the budget, represented by the gap in funding, will be met through technical and logistic assistance from development partners.Already a significant proportion of the costs for the establishment of NPHRL Systems are being met by Development Partners, while the government will continue to meet the personnel emoluments, donor support will be required for the advanced training of senior scientists at the NPHRL. Costing formulae: The following systems and structures should be taken into consideration in estimating the bidget requirement to support the interventions 2016-2020:Profile and Test Capability 3 Public health Laboratories 5 Centre of Excellence / Regional Hospital facility 14 district laboratories 155 PHU Infrastructural upgrade needs of facilities Utility such as energy and water Human Resource Training and Recruitment Laboratory Housekeeping and Maintenance Central and Regional coordination Table 6: Estimated Major costs (millions of Leones) to be worked-out for 5 years period) CATEGORYPHUDistrictRegionalNPHRLManagementTOTALLeCoordinationReagentsEquipmentHRInfrastructureQMS & SafetyResearch & DevelopmentHealth & safetyInformation ManagementTotalsTable 8: Estimated Cost for Laboratory Emergency Response per districts (US Dollars) EMMERGENCY PREPAREDNESSACTVITY UNIT COST /DISTRICT /MONTH (US Dollars )Facility readiness audit 5000Maximum of 2 audit /year to ensure compliancy Establishment of screening and confirmatory testing in outbreak 25000Laboratory Rapid deployment and response within outbreak zone and specimen management for referral Preparedness Audit 2000Facility based readiness to set up testing and IPC set up Human Resource 13000 ( see justification annex 3)Laboratory coordination and analysis through the report dissemination for prompt action Stocks 25000Specimen men management supplies and accessories for a 25 bed capacity Transportation TBDLeveraging of vehicle and bikes with Rapid response team manual ANNEXESANNEX 1: IMPLEMENTATION FRAME IMPLEMENTATION FRAME (BIANNUAL) inclusive of the national 10-24 month plan NA= not applicable as these have policy implicationsNone= no partner has been identifiedNote: Partners identified to support activities maybe for part of the stated objective and not be all inclusive InterventionActivitiesTimeframeIDENTIFIED PARTNER/S SUPPORT 2016-2017 Remark20162017201820192020Objective 1: To strengthen the laboratory organizational and management structures to provide oversight and coordination of laboratory services throughout all the levels of health care by end 2020Establish a directorate for the national laboratory service at the MOHS Engagement of MOHS policy and administrative leads to determine implications of setting up the directorateNAPolicy level input Appoint a Medical Laboratory Services Director NAAppoint a Senior Laboratory Specialist Scientists to provide technical oversight supporting DHLSCDC-APHL World BankPartners can support the MOHS in filling in these positions until absorbed Post an administrator, accountant, personnel officer, data officer and support staff to the directorateNAMOHSProcure three vehicles for the directoratenoneEstablish clearly defined laboratory tiers with management functions and reporting structuresClassify laboratories and define functions for each laboratory tierAligned to support BPEHS 2015-2020Completed Appoint five (5) Senior Laboratory Scientists to manage the different sections of the National Reference LaboratoriesWorld BankSupport to temporarily filled until absorbed by the MOHS Appoint four (4) Provincial Laboratory Scientists to manage the regions and the regional laboratoriesNAPart of staff competency and deployment by MOHSAppoint nine (9) District Laboratory Scientists to manage district laboratoriesNAMOHS Initiate and coordinate Bi-Monthly National Laboratory activity updates and experiences sharing meeting for all 14 districts and National LaboratoryCDC-APHLWestern area covered, gap is the regional meetings Strengthen the management capacity of all laboratory managersEquip all district laboratory managers with management skillsCDC-APHLQMS and Laboratory Leadership training Provide mentorship to national and regional laboratory managersCDC-APHL PHEWestern Area covered. Reference laboratory partners to provide additional regional support- ongoing Establish laboratory coordination mechanismRedefine the role of the LTWG (Laboratory Technical Working Group) in collaboration with Surveillance and Epidemiology Technical working Group (SETWG) CDC-APHLStructured meeting with defined outputs to monitor laboratory service delivery progress – ongoing Establish a secretariat for the LTWGNAPolicy level decision. Current support at DHLSActivate LTWG monthly central meetingsCDC-APHLOngoing Expand quarterly Laboratory TTM to include all districtCDC-APHLPHEProposal made to partners supporting PHLS to collaborateInstitute quality audit improvement project monitoringCDC-APHL; CDC-WHOSLMTA TEAM TQI initiated Objective 2: To provide a policy and legal framework for proper regulation, training, laboratory practice and observance of professional ethics by 2020Development of an Act for the establishment of the National Medical Laboratory Regulatory Council (NMLRC)Appoint a technical committee at the MOHS to start drafting of the BillNADraft initiated Liaise with Solicitor General’s Office to draft the Bill for the establishment of the NLRCNAMOHSPresent the Bill to parliament for debate and enactmentNAEstablish and operationalize the NLRCAppoint members of the CouncilNLRC MOHSHire technical and administrative staff for performing tasks related to licensing and registrationNADraw up rules related to laboratory code of practice, professional ethics and subsidiary legislationnoneTo be supported through LTWGDevelop a minimum standard of requirements for setting up of laboratories by tier.NACOMPLETED Review and harmonise the curriculum for laboratory training programmes.NACOMPLETED Develop laboratory-monitoring tools to incorporate indicators for ethics compliance monitoring.noneTo be supported through LTWGInstitute in-service training programmes on ethicsWHOTo be supported through LTWGCommence licensing of all (as defined by the Act) laboratories and registration of laboratory personnel Ifrom 2016 Identify and start the licensing all laboratories appropriatelynoneTo be supported through LTWGCommence registration of laboratory practitioners who meet the requirementsnoneTo be supported through LTWGDevelop a transition mechanism for personnel who are practicing but would not qualify for employment or practice under the new legislationnoneObjective 3: To strengthen community awareness of ethics for laboratory professionals and increase demand by service users and providers at all levels.Create community awareness through use of mass media on laboratory ethics, the rights of users and methods of seeking redressEnsure visible display of codes of ethics in all laboratories as part of standard practicenoneTo be supported through LTWGCreate appropriate channels for complaints management in at least 30% of all public and private laboratoriesnoneTo be supported through LTWGObjective 4: To meet the minimum qualified laboratory personnel levels to support the delivery of a comprehensive laboratory package at each level of health care by end 2020Deploy adequate numbers of skilled laboratory staff to all laboratory facilities by end 2020Conduct competency assessment of current staff and develop deployment planCDC-APHLWHODFID-OPTIONSAssessment tools generated.Partner to support for a defined period until MOHS can absorbRecruit 10 technicians yearly from 2016 - 2020 to provide services at Community Health Clinics (CHC) and district laboratoriesNARecruit annually, over three years starting 2016 - 2018 five senior laboratory scientists including laboratory physicians to work at regional and reference laboratoriesNAMOHSEstablish an Emergency laboratory response team at national and district levelCDC--APHLWHONational level ongoingImprove the output and quality of laboratory personnel from training colleges by end 2020Develop a training plan by end 2016noneLTWGComplete the, harmonization and standardization of the curriculum for the training of technicians at diploma level by end 2016CDC-APHLDFID- OptionsOngoing Improve on the training facilities of the Tertairy training institutions by end 2017CDC-APHL Training lab upgradingTrain a core group of scientists and laboratory physicians in specific laboratory specialties by end 2020Train two scientists locally and internationally in microbiologynoneTrain five scientist in molecular biology and related laboratory areas noneTrain two scientist in virology and immunologyChina CDCCommence specialist training of 4 medical doctors one each in Haematology, Microbiology, Histopathology and Chemical PathologyChina CDCTrain 46 staff in QMS from 2017 - 2020 through on -the- job trainingCDC/APHL; CDC-WHO; OPTIONS, PHEAdapted SLMTA/SLIPTA TOOLS Develop a structure for the upgrade of community and untrained laboratory support workersnoneDevelop and operationalize retention and post-training policy by 2016Develop, validate and implement a curriculum for training at certificate level for laboratory assistants in and out of government service by end 2017Options/APHLOngoing Develop and implement a scheme of service for all cadre of lab personnelNAMOHS; HRMOConduct consultative and consensus workshop in collaboration with the Human Resource Directorate LTWGCDC-APHLSupport through HRMOObjective 5: Provide laboratory services appropriate to each level within the defined laboratory package by 2020Define the laboratory tests and techniques to be offered at each level by end 2016Strengthen and expand the specimen referral system to include diseases and specimens other than those currently coveredCDC-APHL, BPEHS Laboratory test Menu generated Define a national stock management systems protocol by end 2018Revise referral and feedback toolsCDC-eHealth, CDC-WHODevelop and distribute guidelines and provide training on specimen packagingCDC-WHOEstablish a specimen referral courier systemCDC-e-Health OptionsEstablish a stock management protocol for all equipment, supplies and consumables at all levelsCDC-APHLAt CPHRL- ongoing Gap is regional reference laboratories Objective 6: To provide all Government Medical Laboratories with appropriate equipment and assure availability of commodities (media, sera, reagents etc.) for efficient service delivery by 2020.Strengthen national testing norms and standards definitions Update the national standard equipment list and specification for procurement at the different levels of healthcareCDC-APHLNational Norms and standards for each level of test menu – completed Provide a common and appropriate laboratory equipment platform for test assaysCDC-APHLRecommended vendor of equipment platform with service contract for maintenance protocolDevelop essential supply list based on the test requirements for the various levels of healthcare deliveryLTWGInstitute diagnostic and public health commodity systems Train 36 laboratory personnel on logistics and supply chain management by 2017. CDC-eHealth Ensure representation of laboratory personnel on local and national procurement committeesNAMOHSTo develop policy for disposal of obsolete equipment and expired reagentWHOStrengthen the storage and distribution mechanism for equipment, supplies and reagents at all levelsProvide adequate storage facilities at each laboratoryCDC-APHLStorage at CPHRL completed Gap is other regional inventory management Establish minimum and maximum stock levels for each laboratory CDC-APHLComponent of QMS in SLMTA /SLIPTAObjective 7: To provide all government medical laboratories with complimentary supplies and consumables for efficient service delivery by end 2020.Objective 8: Establish an effective laboratory network at national and international levels for quality laboratory services and resource mobilization by mid-2020.To strengthen the national laboratory network for clinical diagnostic and reference, and public health laboratoriesDevelop a national map of laboratories and laboratory resourcesCDC-APHLTo be supported through LTWGEstablish an integrated national laboratory network of both public health and clinical laboratories, with defined roles and responsibilities for each tiernoneLTWGNetwork PHU laboratories to the district laboratoriesCDC-APHLPHELinkage of NPHL in all regions Network district laboratories to the regional laboratoriesnoneNetwork the regional laboratories to NPHRLLTWG Strengthen collaborative and communication linkages among all laboratories across all tiers countrywide by end 2020Establish a referral system among all tertiary clinical and reference laboratories, (Connaught, CHINA P3; Makeni, Kenema, PCMH, Ola During and Bo)CDC-APHLTo be supported through LTWGStrengthen the referral system of the National Public Health Reference Laboratory (NPHRL)CDC-APHLTo be supported through LTWGStrengthen partnerships among the existing network of laboratories countrywideLTWGStrengthen international partnerships with both laboratory and non-laboratory technical partners, for the purpose of training, research and development, efficiency and innovation and quality assuranceStrengthen inter-programme linkagesDHLSLaboratory Twinning Strengthen linkage with international laboratoriesDHLSCDC-APHLRegional and International twinning Strengthen the linkages and reporting of the Central Directorate and the national technical working groups to the Emergency Operating Centre (EOC)NAMOHSStrengthen Central Directorate and the national technical working groups to provide oversight to all laboratories, coordinate laboratory services within the regions and to support districts in disease surveillance and outbreak investigation, linking with the NPHRLSCDC-APHLDHLS LEDERSHIPProvide linkages to food/water bacteriological testing at NPHRL and clinical laboratory systems in collaboration with the National Standards Bureau by end 2018Provide linkages to basic water testing for microbial and element contaminations to district laboratoriesNAMOHS and MoWRLinkage with the office of the National Security, ONS for emergency response NAmohsObjective 9: To provide adequate laboratory space appropriate for each level for effective service delivery by end 2020Ensure that targeted laboratories meet minimum required standards for infrastructure and environment by end 2020 Review laboratory design to meet international standards NAMOHSRenovate /upgrade 193 labs that do not meet required quality and safety standards as appropriate for their level. (To include water and power supply) WORLD-BANKCDC-APHL; PHE; Global Fund;Italian Cooperation 177 labs able to function and support BPEHS. This includes 3 -Public health Reference Hub5 – Centers of excellence and regional Laboratories14 District laboratories 155 PHU Construct 9 new labs, 3 in each of the three regions (east, north and south)Global fund World Bank Inspect and carry out annual maintenance of lab infrastructureNAMOHSEnsure the procurement of appropriate and adequate laboratory equipment and commodities for all levels of service delivery nationwide.Develop a national equipment and supplies management plan NONETo be supported through LTWGEquip each laboratory with equipment and supplies including stock management and waste disposal to support approved testing platform according to the Basic Essential Package (BPEHs) CDC-APHL; PHE; Italian CooperationEach partner should ensure BPEHS is implemented in supported lab Develop and ensure compliance of the policy for service contracts on all procured equipment and supplies noneTo be supported through LTWG; Supportive Supervision LTWG to provide central oversight for the procurement, installation, distribution and maintenance of all laboratory equipmentnoneTo be supported through LTWGStrengthen the storage and distribution mechanism for equipment, supplies and reagents at all levelsEstablish minimum and maximum stock levels for each laboratoryCDC-APHLImplement SLMTA and or QMS stocks management trainings Provide adequate reagent storage facilities at each laboratory according to the National Basic Essential Health PackageCDC-APHL; PHE; Italian CooperationAll to ensure reagent for 12 months is available for to support MOHS as top-up Provide cold storage facilities for all laboratoriesnoneCPHRL to validate all laboratory reagents procured in-countryCDC-APHLInstitute Post-market validation.Activation of national Quality officers Provide periodic in-service training in stock management of equipment, reagents and various suppliesWHOObjective 10: To establish a QMS for quality assured laboratory test results by 2020Establish a National External Quality Assurance Programme (NQAP) by end 2016 Develop a National QA Policy and Quality ManualCDC-APHLWHODevelop a National Lab Quality Management System (LQMS) Manual/HandbookCDC-APHLWHOActivation of National adapted SLAMTA and SLIPTA Trained and Assign 14 District QA ManagernonemohsStandardise equipment and tests by levelCDC-APHLLTWGInventory list generated Facilitate /Develop SOPs for equipment and lab procedures OPTIONS To be supported through LTWGTrain laboratory staff in the use of the lab quality manual and SOPsCDC-APHLWHOExpand the National External Quality Assurance Scheme (NEQAS) in accordance with the National QA Policy by end 2020Strengthen NPHRLs and Clinical Laboratory to prepare proficiency panels for the most commonly performed lab tests for ten diseases that meet IDSRCDC-APHLWHOTrain laboratory staff on Quality Assurance CDC-APHLWHOEnroll regional and district laboratories in NEQASCDC-APHLWHOPHEWork with Laboratory Technical Working Group (LTWG) to establish a National Quality Assurance Programme (NQAP)CDC-APHLSupport LTWG to establish a National Quality Assurance (NQA) CommitteeCDC-APHLWHOOptions Develop SOPs for QACDC-APHLWHOObjective 11 To support all laboratories to implement the laboratory bio-safety policy and adhere to safety guidelines by 2018To support all laboratories to implement the laboratory bio-safety policy and adhere to safety guidelines by end 2018Implement the national laboratory safety policy and guidelinesWHOPolicy and manual generated Establish a laboratory waste management protocolWHOProcure and distribute adequate quantities of waste disposal systemsnoneProcure and distribute appropriate PPE and continue to train staff in its use tillnoneBuild capacity of laboratory personnel on fire safety to address chemical spills and contaminationWHOThrough LTWG and National Fire Force Establish national repositories for the safe storage and security of biological specimen for use in the development of an effective public health systemCDC-APHL Support specimen archiving at CPHRL Develop functional inventory and a system for specimen management (collection, transportation, archiving and retrieval of stored specimens (Laboratory Information Management System)noneDevelop policies for destruction, accessing retrieval and utilization, disposal of stored specimensnoneThrough LTWGEstablish a National Governing body for overseeing bio bankingnoneThrough DHLSEstablish and strengthen capacity for Management, Coordination, operation and Maintaining of the bio bankingNone Through DHLSObjective 12: To fully implement the IDSR strategy in Sierra Leone by 2020Train relevant national and district level personnel as part of the rapid response teams (RRTs) for disease outbreaksCreate a Laboratory coordinating office at the Emergency Operations Centre, EOCNACOMPLETED Develop a Laboratory Rapid Response Operational manual, with a costed implementation planCDC-APHLOngoing Integrate the laboratory emergency response into the overall national responseCDC-APHLOngoing Train 2 Laboratory scientists as part of the national level RRTCDC-APHLOngoing Train 14 Laboratory Scientists as part of the district level RRTs, one per districtCDC-APHLOngoing Establish RRTs at all levels, national, and districtCDC-APHLCDC-WHOTrain laboratory staff in outbreak emergency preparedness, including laboratory activation simulationsCDC-APHL; DTRA;- MRI GlobalOngoing Objective 13: To strengthen research capacity to enhance laboratory services in Sierra Leone by end 2020Define research priorities relevant to laboratory services from 2016Develop a national research database noneWith Directorate of HSSEstablish internal and external and linkages with academic institutions to collaborate and strengthen the national public health research agendaCDC-APHL; Twinning program and linkage to regional training institutions. Develop and implement short courses on research methodology for practicing medical professionalsWHOCollaborate with the Health and Biomedical Research group to train laboratory personnel in proposal writing and research methodologyCOMHASHBIOMEDMobilize resources for operational researchNAMOHSEstablish an integrated data management systemWHOThrough HMISObjective 14: To establish a laboratory information and management system that is integrated into the national health management information systemEstablish an integrated system for data capturing, analysis and use at all levelsEstablish a data unit at the laboratory directorateCDC-WHOOptionsE-Health Establish laboratory LIS TWG with defined terms of referenceNATrain district laboratory in-charges on the use of the tools and relevant softwareCDC-WHOCDC-e-Health DFID-OptionsProvide network and information communication technology equipment at all levelsWHOProvide network and ICT equipment at all laboratory levelsCDC-WHOEstablish an electronic LIMS throughout NPHRL networkCDC-WHOTrain specified personnel at the district laboratories in the use of the toolsCDC-WHOLink laboratory data unit to national data warehouseDFID-OptionsWHOCDC-E-health Establish effective data management and sharing systems by 2018Generate Protocol for LIS integration into HISDFID-OptionsWHOCDC-E-healthEstablish an electronic LIMS at NPHRLIdentify the software to be usednoneInstall software and train staffDFID-OptionsWHOCDC-E-healthAnnex 2: Sample Budget Outline for PHU Detail COST for a FULLY FUNCTIONAL PHUREAGENT AND KITS ????????DESCRIPTIONMETHODOLOGYDESCRIPTION KEYSHELF LIFE UNIT PRICE USD QTYTotal COSTJUSTIFICATION?????????VDRLVDRL Antigen & Buffered Saline Diluent1x5ml VDRL, 1x60ml Buffer (100 tests)?24 Months $40.00 1$40.00These tests are to be offered at the PHU unit according to the Basic package from the National Norms and standards for the lab tier. The quantification is based on the 1 functional peripheral health units, per 25 test per day per 20 days per month giving an estimated 500 tests per month for each PHU. The equipment’s are one off purchases excluding maintenance costs. The minimum standard systems to support lab operations such as energy, water supply, infrastructural design and human resource are included in this costing. The consumable costed on a quarterly basis following which replacement should have been made.??Syphilis control ??? ?$35.00Syphilis Control Positive & Negative Controls 5 x1.0ml vials of each2x5x1ml?18 Months $35.00 1?Monoclonal Grouping Kit3x10ml of Anti-A, Anti-B, and Anti-D 3x10ml?21 Months $24.00 1$24.00HBsAg Test StripsSerum/Plasma/Whole Blood - Cut off 1 ng/ml100T?24 Months $124.00 5$620.00Syphilis Test StripsSerum/Plasma/Whole Blood100T?24 Months $120.00 5$600.00Urine Strips Glucose/Protein/Ketone100T?24 Months $16.00 5$80.00Malaria Rapid test kitRDT Global Fund/MCP30T? Malaria Program 15$0.00HIV RDT RDT Global Fund –NACP 30TNAS/NACP 15$0.00Normal salinetablet10L?NA $30.00 10$300.00ZN stainStain Kit/Global Fund /GLRA-TB1L?NA $- 0$0.00Sodium metabisulfite500g500g?36months $40.00 1$40.00Field stains A and B2 x 100g10L?36months $40.00 1$40.00Giemsa stain25g1L?36months $50.00 4$200.00May-Grundwald stain25g1L?36months $50.00 4$200.00NH3 solution1 x 1Lconcentrate10L?12months $70.00 2$140.00Cholera crystal VC rapid test kitRDT WHO25T?24months $- 1$0.00Immersion oil100ml100ml?36months $50.00 2$100.00xylene(slide cleaner)1L1L?36months $20.00 1$20.00????????SUB TOTAL??????$2,439.00EQUIPMENTS???????HaemocuePOCT301 model?? $1,000.00 1$1,000.00NH3 Solution colorimeter colorimetricvisible range??15001$1,500.00 Microscope TB/ Malaria/Blood film/ microbiologyolympus light microscope?? $1,500.00 1$1,500.00Manual centrifugespecimen processinghand centrifuge/portable?? $150.00 1$150.00Glucometerglucose analysishand held POCT?? $100.00 1$100.00????????SUB TOTAL??????$4,250.00CONSUMABLES???????Hemocue cuvette 301 pak of 200Pack of 200??? $155.00 3$465.00Labware (conical flask, beaker, 100ml, 1000ml measuring cylinder)Basic kit setPolypropylene?? $100.00 1$100.00Microscopic slides (clear glass unground edges-25.4 X76.2mm, 0.8mm-1mm thick)50 slides per packFrosted slides?? $30.00 4$120.00Cover slips50 per pack plastic50x50cm?? $20.00 4$80.00Staining Tank MetalDouble rod 12x 6 tank?? $50.00 1$50.00Fisher brand transfer Pasteur pipetsPack of 50 (plastic)Graduated to1ml?? $20.00 2$40.00Specimen collection kitSee sheet on specimen management??????Test tube rack and tubes setPlastic coated rack and borosilicate tubesSet of 12 tubes per rack?? $25.00 5$125.00 Timer?Non digital?? $10.00 2$20.00Slide rack?Metal rods drying rack?? $50.00 1$50.00Slide boxes?Plastic 2 slides container?? $5.00 20$100.00Concave mixing tiles and stirrer8 well ceramic mixing tileCeramic mixing tile for latex reaction?? $30.00 2$60.00Sterile lancet?capped sterile/auto let?? $100.00 2$200.00Urine containers30ml labelled containerPlastic conical base, pack of 10?? $20.00 10$200.00Disposable scalpel setStainless steel handle and disposablePack of 10?? $40.00 2$80.00SUB TOTAL??????$1,690.00????????SYSTEMS SUPPORT????????Infrastucture upgrade 1RenovationBench space upgrade ?1 $20,000.00 1$20,000.00One-off cost Infrastructure upgrade 2 Building Purpose built ?1 $50,000.00 1$50,000.00Infeastructural upgrade 3reorganisation Basic maintenance ?1 $5,000.00 ?$5,000.00EnergyGenerator maintenance and fuelRepairs and fuel support ??????Inverter batteryTo support backup for 24 hour power ?2 $15,000.00 1$15,000.00Duration of operations depend on monitoring and reapirs as needed. Should coven minimum of 2 years Solar option to support backup for 24 hour power ?2 $10,000.00 1$10,000.00WaterMainsif pipe borne exist ?1???BoreholeWell or borehole ?1 $20,000.00 1$20,000.00filteration unit deioniser or water still?1 $5,000.00 1$5,000.00Human resourceTrainingModular targeted training including management training 2000 ?? $2,000.00 4$8,000.00Supported through the BSC honours course Technical support and mentoring Until absorbed by the MOHS?? $20,000.00 1$20,000.002 year support to ensure functionality and linkage to district labFacility based surveillance personnelsupported by partners until critical mass is possible support priority diseases response Annual amount ? $6,000.00 1$6,000.00Part of public health response team Health and safety Waste management Incineration-customised Demontfort ?1 $5,000.00 1$5,000.00One-of building of facility incineration or support up to 2 years leveraging form existing waste management systemsLIMSPaper basePaper reporting linked to SMS or WIFI tablet with support fund for communications ?1 $2,500.00 1$2,500.00Support for stationery and Wi-Fi linkage to district electronic based LIMS. Specimen Management Collection kitvacutainer set, swab, tape ?1500sets $2,000.00 1$2,000.00Monthly specimen management support Processing Centrifuge, tubes ?1 $2,500.00 1$2,500.00PackagingTriple packaging ?10perbox $700.00 2$1,400.00ReferalReferral Transportation Vehicle and annual fuel and maintenance ?1 $50,000.00 1$50,000.00Supporting specimen transportation for clinical referral and public health specimen management ??Bike ?1 $55,200.00 1$55,200.00ANNEX 3: Minimum standards Laboratory Hidden Operational Costs:Laboratory operational cost is part of the minimum required standards for the basic daily operations of the laboratory. These cost are often hidden running cost vital for the sustenance of the service: House keeping and maintenance SecurityCleaning and care taking Building maintenance and utility billsCommunicationInformation technologyStationeryHealth and safety Waste disposalPPEEquipment and supplies and Quality Service contractSafety compliant and CertificationInstallation or disposal Quality control suppliesSubscription to EQA program Quality Assurance improvement plan support Human ResourceContinuous professional developmentWorkload ratioANNEX 4: Emergency Response Budget Justifications. snDESIGNATIONQUANTITY PER DISTRICT RESPONSIBILITY allowance or stipend per month Logistics support1LABORATORY RESPONSE COORDINATOR1COORDINATE all laboratory activities including partner support and link with surveillance and field epidemiology to support action. Ensure criteria are met to support establishment of Laboratory. Implement quality assurance response ; Assess and implement training needs$30001 Vehicle, Fuel, maintenance, Driver, Phone, Mobile computer or tablet with internet capacity. Stationery2LABORATORY MANAGER1Operationalized district EVD testing laboratory through technical input and ensure activation of testing at all levels. Implement national algorithm and Monitor quality of testing. Implement quality audit and supportive supervision $25001 Vehicle, Fuel, maintenance, Driver, Phone, Mobile computer or tablet with internet capacity. Stationery3SPECIMEN MANAGER 2Ensure supplies are available at all times at the facility for collection; coordinate specimen distribution to laboratory, ensure specimen integrity through cold chain maintenance. Monitor timely transportation of specimen to lab $15004 Vehicles, 8 motor bikes Fuel, maintenance, Driver, Phone, Mobile computer or tablet with internet capacity and UPS facility. Stationery4COURIER MANAGER 2Worth with the specimen manager for logical travel plan to transport specimen to laboratory. Maintain integrity of specimen, $10005Laboratory Rapid Response lab scientist 6Perform quality assured analysis at laboratory and report result within the shortest TAT$25006LABORATORY DATA LEAD2Generate database frame at activated site in collaboration with Surveillance counterpart, Clean raw data and analyse for error and duplication; Collate and distribute result to EOC/DERC in coordinated and timely manner. $15007LABORATORY LIASON OFFICER 2Clean and transmit a Real time accurate result from Lab runs to health facility or clinician for immediate action $10008LABORATORY LOGISITICS LEAD 1Order and stock health facility courier vehicle and provide health and safety material in transport vehicle at all time. Maintain minimum stock levels at the facility for collection and community level. Link with donor partners on supply chain to monitor national stocks. $20002 Vehicles with capacity to transport large stocks, No.ThemesResponsible person(s)MOH Directorate 1GovernanceDr Lebbie & Dr SAS KargboDirectorate of Hospital and Laboratory Services and Directorate of HSS and Planning EthicsDr Samai & Dr KennehDirectorate of Training and Directorate of DPC 2Laboratory Services & Support Systems: Logistics & Management SystemsMiss Doris Harding, Mr Massaly, Dr Z. Koroma, Mr Osman KargboNational laboratory Services, and Blood Services, National Malaria , TB and HIV program 3Health and Safety, Bio-Risk ManagementProf Gevao and Dr Kamara National laboratory Services and LTWG 4Information Management SystemsDr SAS KargboDirectorate of HSS and Planning 5Research & DevelopmentDr Samai, Dr SAS Kargbo Directorate of HSS and Planning and Research and Training 6Partnership & LinkagesDr Y HardingLTWG/ GLRA7Human Resource ManagementProf Gevao & Dr KamaraNational Laboratory Services and LTWG 8Total Quality Management SystemsDr Kamara & Mr Abu GeorgeNational Laboratory Services and GLRA 9Infrastructure and EquipmentDr Kamara & Mr Abu George10Emergency Preparedness and Response Dr Amara Jambai and Dr F. DafaeDCMO and Directorate Disease Prevention and Control Technical Support APHL SIERRA LEONE COLLATION TEAM Dr Victor Matt Lebby, Ms Doris Harding, Dr. Zikan Koroma, Mr Osman Kargbo, Dr. Isatta Wurie (Technical lead)ANNEX 5: TEAM MEMBERS ................
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