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REPUBLIC OF SIERRA LEONE

REPUBLIC OF SIERRA LEONE

MINISTRY OF HEALTH AND SANITATION

NATIONAL HEALTH LABORATORY STRATEGIC PLAN

2016 - 2020

DELIVERING QUALITY LABORATORY SERVICES

TABLE OF CONTENT

FOREWORD4

PREFACE5

ACKNOWLEDGEMENTS6

Executive Summary7

ACRONYMS9

SECTION 1: CONTEXT13

CHAPTER 1- Introduction13

CHAPTER 2: SWOT Analysis21

CHAPTER 3: POLICY ENVIRONMENT25

CHAPTER 4: STRATEGIC DIRECTIONS27

SECTION 2: STRATEGIC OBJECTIVES, INTERVENTIONS AND TARGETS30

CHAPTER 1: GOVERNANCE31

CHAPTER 2: HUMAN RESOURCES DEVELOPMENT AND MANAGEMENT35

CHAPTER 3: LABORATORY INFRASTRUCTURE AND EQUIPMENT38

CHAPTER 4: LABORATORY SERVICES & SUPPORT SYSTEMS41

CHAPTER 5: BIORISK MANAGEMENTBIOSAFETY, BIOSECURITY, BIOBANKING)45

CHAPTER 6: INFORMATION MANAGEMENT SYSTEMS47

CHAPTER 7: EMERGENCY PREPAREDNESS AND RESPONSE49

CHAPTER 8: RESEARCH, DEVELOPMENT AND ETHICS51

CHAPTER 9: PARTNERSHIPS AND LINKAGES53

CHAPTER 10: TOTAL QUALITY MANAGEMENT SYSTEMS (QUALITY ASSURANCE)56

SECTION 3: IMPLEMENTATION MECHANISMS58

MONITORING AND EVALUATION71

FRAMEWORK FOR THE MONITORING AND EVALUATION PLAN75

FINANCING THE PLAN76

ANNEXES79

ANNEX 1: IMPLEMENTATION FRAME80

Annex 2: Sample Budget Outline for PHU99

ANNEX 3: Minimum standards107

ANNEX 4: Emergency Response Budget Justifications.109

ANNEX 5: TEAM MEMBERS111

List of Tables and Figures

Table 1: Distribution of health facilities by district July 201518

Table 2: Recommended laboratory staffing..19

Table 3: Strategic Framework .58

Table 4: Strategic time frame .61

Table 5 Indicators and Monitoring Tools ..73

Table 6: Estimated major costs (millions of Leones) to be worked out for 5 years period75

Table 7 Estimated cost for laboratory emergency response per district (US Dollars)..76

Figure 1: Lab tiers.19.

Figure 2: Strategic plan process flow...27

Figure 3: Strategic inputs...31

Figure 4: Critical path of development.49

Figure 5: Actions to address all levels of laboratory network.52

Figure 6:Network of national public health reference laboratory system55

FOREWORD

The 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 ministrys 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 Leone

PREFACE

The 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 its 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 Kargbo

Chief Medical Officer

Ministry of Health and Sanitation

ACKNOWLEDGEMENTS

On 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-Lebby

Director Hospital and Laboratory Services

Ministry of Health and Sanitation

Executive Summary

Laboratory 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:

1. Governance (Coordination, legal framework and ethics).

2. Human Resource planning, development and management.

3. Infrastructure and Equipment.

4. Laboratory Services & Support Systems (Logistics & Management Systems).

5. Bio risk management (Health and Safety, Bio-safety, Bio-security and Bio-banking.

6. Information Management Systems.

7. Emergency Preparedness and Response.

8. Research, Development and Ethics.

9. Partnership & Linkages

10. 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.

1. Capacitating all 14 district laboratories to perform all test menus of the BPEHS.

2. Strengthening all 5 centres of excellence facility laboratories as reference labs supporting district and PHU.

3. Coordinating partners supporting laboratories services as per national priority with geographic equity to produce tangible outcomes.

4. Instituting Public Health Laboratory network supporting IDSR.

5. Establishment of integrated outbreak response.

6. Establish professional regulatory body to structure and monitor laboratory staff.

7. Strengthening commodity security.

8. 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.

ACRONYMS

AFBAcid Fast Bacilli

AFR/RC WHO/AFRO Regional Committee

AIDSAcquired Immuno-Deficiency Syndrome

APHLAssociation of Public Health Laboratories

ASLMAfrica Society for Laboratory Medicine

BPEHSBasic Package of Essential Health Services

CD4Cluster of Differentiation

CDCCentre for Disease Control and Prevention

CHCCommunity Health Centre

COMAHSCollege of Medicine and Allied Health Sciences

CPHRLCentral Public Health Reference Laboratory

DHLSDirectorate of Hospitals and Laboratory Services

DHSS Demographic Health Systems Survey

DOTDirectly observed treatment

DSTDrug Susceptibility Testing

DPIDirectorate of Planning and Information

DPCDisease Prevention Control

EIDEarly Infant Diagnosis

ELISAEnzyme Linked Immunosorbent Assay

EPKEastern Polytechnic, Kenema

EQAExternal Quality Assurance

EQASExternal Quality Assessment Scheme

FBCFourah Bay College

FBOFaith Based Organisation

FHCIFree Health Care Initiative

GFATMGlobal Fund for AIDS, Tuberculosis and Malaria

GHSAGlobal Health Security Agenda

GLRAGerman Leprosy and TB Relief Association

HAPSAT HIV/AIDS Program Sustainability Analysis Tool

HCT HIV Counseling and Testing

HPAHealth Protection Agency (UK)

HIVHuman Immuno-deficiency Virus

HPAHealth Protection Agency of the United Kingdom

HRHuman Resources

IATAInternational Air Transport Association

IDSRIntegrated Disease Surveillance and Response

IHRInternational Health Regulations

IQCInternal Quality Control

LFTLiver Function Tests

LISLaboratory information system

LIMSLaboratory Information Management Systems

LTWGLaboratory Technical Working Group

LSETWGLaboratory, Surveillance and Epidemiology Technical Working group

M&EMonitoring and Evaluation

MDCSLMedical and Dental Council of Sierra Leone

MDGMillennium Development Goals

MMCET Milton Margai College of Education and Technology

MOHSMinistry of Health and Sanitation

MScMaster of Science

NEQASNational External Quality Assessment Scheme

NGONon-Governmental Organisation

NHSSPNational Health Sector Strategic Plan

NLRCNational Laboratory Regulatory Council

NLSNational Laboratory Services

NPHLSNational Public Health Laboratories Systems

NPHRLNetwork Public Health Reference Laboratories

NQAPNational Quality Assurance Programme

NTBRLNational TB Reference Laboratory

NTDNeglected Tropical Diseases

PCMH Princess Christian Maternity Hospital (Freetown)

PEPFAR Presidents Emergency Plan for AIDS Relief

PHUPeripheral Health -Unit

PMTCTPrevention of Mother to Child Transmission

PPEPersonal Protective Equipment

PRSPPoverty Reduction Strategy Paper

PHLRTPublic Health Laboratory Response Team

QAQuality Assurance

QCQuality Control

RRTRapid Response Team

TQMSTotal Quality Management System

RCHReproductive and Child Health

RHReproductive Health

RT-PCR Reverse Transcriptase Polymerase Chain Reaction

SOPStandard Operating Procedure

TBTuberculosis

TORTerms of Reference

U/EUrea/Electrolytes

USAIDUnited States Agency for International Development

WBCWhite Blood Cell Count

WHOWorld Health Organisation

SECTION 1: CONTEXTCHAPTER 1- Introduction

The 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 governments 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:

1. Weak coordination and regulation of laboratory practice at all levels of the laboratory system (Governance).

2. Infrastructural inadequacies (Infrastructure and equipment).

3. Supply bottle-necks leading to interruption of services (Reagents and supplies).

4. Bio-risk management (Bio-safety and Bio-security and emergency response).

5. Inadequate numbers of skilled workers (Human Resource).

6. Inequities in laboratory service delivery.

7. 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: Yaound, 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 establishfunctional 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 Services

The 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 Systems

The 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:

1. Patient and health workers biosafety and biosecurity.

2. Human Resource strengthening.

3. Essential Health Services.

4. Community ownership.

5. Information 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 2015

In 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 tiers

Human 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 staffing

STAFF LEVEL

PHU

DISTRICT

REGIONAL

PUBLIC HEALTH LABORATORY INCLUDING SURVEILLANCE RESPONSE,

SENIOR LAB SPECIALIST

5

LABORATORY SPECIALIST

5

5

LABORATORY SCIENTIFIC OFFICER

1

5

5

LABORATORY TECHNICIAN

1

3

5

5

LABORATORY ASSISTANT

1

4

5

5

HOUSEKEEPING STAFF

5

5

Source: BPEHS 2016

Based 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 Officers

Introduction 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 Analysis

The 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 2015

Disease 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 2015

Western 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.

1. Human Resource.

2. Infrastructure.

3. Transport and Referral.

4. Management of Consumables and Stock.

5. Maintenance of Equipment.

6. Testing Performance.

7. Specimen Management.

8. Bio-safety.

9. Public Health Functions.

10. Organization and Management.

11. Data Management.

12. Supplies of Consumables & Equipment.

13. Basic Testing Capability5

Report

Strengths

The 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.

Weaknesses

Poor 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.

Threats

Insufficient 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:

Strengths

Laboratory Response Manual

National Rapid Response Manual aligned to IDSR and GHSA

Training tools generated

Laboratory Response team in training.

Weakness

Coordination

Lack of clear or transparent objectives

Human resource limitation: no clear training plans for national staff

Funding

Opportunities

GHSA laboratories prioritization

Donor commitment

Donated laboratories

University training course

Threats

Limited Government funding allocation

Donor dependency

CHAPTER 3: POLICY ENVIRONMENT

The 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.

NHSSP Performance Markers

Access

Quality

Equity

Efficiency

Recognizing 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.

This plan applies inter-program policies and strategic plan towards IDSR as follows:

Agenda for Prosperity 2013-2015

To strengthening of health program through introducing innovative strategies, new policies that will improve health outcome for Sierra Leoneans

National health and Safety Policy and Manual

National TB program

TB diagnosis and treatment integrated guidelines

National AIDS Control Program

HIV Strategic Plan 2015-2020

HIV Viral Load Implementation plan

National Malaria Control Program

National Malaria Strategic Plan

National Malaria Quality Assurance Strategic Plan

IDSR:

National Emergency and Outbreak Manual

Polio Containment Protocol (2015)

REVIEW PROCESS

The 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 flow

National 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.

1. Governance (Coordination, legal framework and ethics).

2. Human Resource planning, development and management.

3. Infrastructure and Equipment.

4. Laboratory Services & Support Systems (Logistics & Management Systems).

5. Bio risk management (Health and Safety, Bio-safety, Bio-security and Bio-banking.

6. Information Management Systems.

7. Emergency Preparedness and Response.

8. Research, Development and Ethics.

9. Partnership &Linkages Total Quality Management Systems.

10. Total Quality Management System (Quality Assurance).

CHAPTER 4: STRATEGIC DIRECTIONS

There are key strategic imperatives driving this plan;

LEADERSHIP- national direction of key roles and responsibilities

HEALTH FINANCE Coordinated; focused, accountability and transparency

OPERATIONAL 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

Vision, Mission and Core Values (derived from the National Laboratory Policy and NHSSP 2015-2020)

Vision

To provide Sierra Leone with a quality and appropriate laboratory service that is accessible and affordable to all using a systems approach.

Mission

To establish an integrated functional laboratory system that will provide quality service delivery and support accurate diagnoses, treatment, prevention, surveillance, research and forensic services.

1. Equity: Laboratory resources and services are distributed equitably throughout the country.

2. Accessibility: Services are affordable and within reach.

3. Relevance: Laboratory services are apt for the purpose and address the needs of the community.

4. Partnership: Promote teamwork and team spirit among all laboratory personnel, and networking and collaboration with stakeholders.

5. Confidentiality: Promote professionalism and ethical practice among all staff and their relationships with patients.

6. Timeliness: Ensure laboratory results reach the patient on time and contribute to appropriate patient management.

7. Customer focus: Always bear in mind who we are serving. The customer may be the community, patient, clinician, individual or the public good.

8. Integration: Promote team spirit and integration of service delivery among all laboratory personnel and also within and between programmes.

Sub Mission/Core Values

To 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.

Surveillance

With 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 Inputs

CHAPTER 1: GOVERNANCE

(Coordination, legal framework and ethics)

Organisation, Management and Coordination

Strong 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.

Interventions

Establish 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 2020

Appoint 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 Laboratory

Strengthen 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 2016

Establish 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 Ethics

The 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 regulation

Lack of a professional regulatory body to address issues specific to the laboratory

Lack of a written code of practice/ethics protocol on laboratory practice

Limited 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 Generals Office to draft the Bill for the establishment of the NLRC by end 2016

Present the Bill to parliament for debate and enactment by end 2017

Establish and operationalize the NLRC by 2017.

Appoint members of the Council by end 2017

Hire technical and administrative staff for performing tasks related to licensing and registration by end 2016

Draw up rules related to laboratory code of practice, professional ethics and subsidiary legislation by end 2016

Develop 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 ethics.

Commence licensing of all (as defined by the Act) laboratories and registration of laboratory personnel in 2018

Identify and start licensing all laboratories appropriately

Commence registration of laboratory practitioners who meet requirements

Develop a transition mechanism for personnel who are practicing but would not qualify for employment or practice under the new legislation

Objective 3:

To strengthen community awareness of ethics for laboratory professionals and increase demand by service users and providers at all levels by 2017

Interventions:

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 2017

Create 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 Bachelors 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 2016-2017

Recruit 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 2017

Improve the output and quality of laboratory personnel from training colleges by end 2020.

Develop a training plan by end 2016.

Complete 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 2018.

Commence 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 EQUIPMENTInfrastructure

The 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 waste

Lack of proper storage facility

Lack of Appropriate archived room

Lack of common and dressing room

Lack of easy accessibility to laboratory by the disabled (Ramp)

Lack of detached laboratory from hospital building

Lack of emergency exit in the laboratories

Policy:

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 2020

Interventions:

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 2019

Inspect and carry out annual maintenance of laboratories infrastructure 2019

Equipment:

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

Policy

To provide the necessary procurement directions and stock management systems for an efficient quality laboratory service at all levels

Objective 6

To 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 Services

Most 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 System

During 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 manufacturers 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 policy

Inadequate supply and hence insufficient use of PPE

Poor waste management systems including a lack of waste disposal equipment

Inadequate skilled personnel to safely package and transport infectious substances

Lack of training in fire safety and containment

Policy:

To promote and sustain laboratory safety and safe laboratory practices in all laboratories in order to protect staff, products, community, and environment.

Objective 10

To support all laboratories to implement the laboratory bio-safety policy and adhere to safety guidelines by end 2018

Interventions

Implement the national laboratory safety policy and guidelines by end 2018

Establish a laboratory waste management protocol by end of 2018

Procure and distribute adequate quantities of waste disposal systems by end 2018

Procure and distribute appropriate PPE and continue to train staff in its use till 2020

Build capacity of laboratory personnel on fire safety to address chemical spills and contamination by end 2016

Establish 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 SYSTEMS

Laboratory 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 patients 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 levels

Establish a data unit at the laboratory directorate by 2017

Establish 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 2018

Provide network and information communication technology equipment at all levels by end 2019

Establish an electronic LIMS throughout NPHRL network by end 2017

Train specified personnel at the district laboratories in the use of the tools by end 2018

Link laboratory data unit to national data warehouse by end 2020

Establish effective data management and sharing systems by 2018

Generate Protocol for LIS integration into HIS by 2019

Establish an electronic LIMS at NPHRL

Identify the software to be used by end of 2nd quarter in 2017

Install software and train staff by end 2017

CHAPTER 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 countrys 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 development

Challenges:

Implementation of the IDSR strategy in Sierra Leone is not optimal at this point in time

A lack of emergency/rapid response teams (RRTs) at all levels that is, National, District and Community

Limited training in emergency preparedness at all levels that is, national, district and community

Policy

To improve laboratory capacity for surveillance and response

Objective 12:

To fully implement the IDSR strategy in Sierra Leone by 2020

Interventions:

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 RRT

Train 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 ETHICS

The 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 methodology

Laboratories poorly equipped to conduct research

Lack of a national laboratory research policy

Inadequate funding and resources to support research and development activities.

No National research database.

Laboratory data management (reporting format) not integrated.

Policy: