This document provides technical support to Member States in the South-East Asia and Western Pacific Regions on the steps required to develop and effectively implement a national laboratory policy and national laboratory plan in accordance with the Asia Pacific Strategy for Strengthening Health Laboratory Services (2010-2015). The document provides a structure for developing a comprehensive policy and regulatory framework for establishing, operating and monitoring the health laboratory services, and promoting better coordination of activities among health programmes and institutions for efficient support to both clinical and public health services.
9 7 8 9 2 9 0 2 2 3 9 6 2 ISBN 978 92 9022 396 2
South-East Asia Region Western Pacific Region South-East Asia Region Western Pacific Region
Development of
Development of
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Printed in India WHO Library Cataloguing-in-Publicaion data
Development of naional health laboratory policy and plan. 1. Laboratory Techniques and Procedures – manpower – standards. 2. Clinical Laboratory Informaion Systems. 3. Equipment and Supplies. 4. Guidelines. I. World Health Organizaion, Regional Oice for South-East Asia. II. World Health Organizaion, Regional Oice for the Western Paciic.
iii
Development of Nai onal Health Laboratory Policy and Plan
Contents
Acknowledgements v
Preface vii
Introduci on ix
Nai onal policy and planfor health laboratories
1. 1
1.1 Role of laboratory services in the health system 1
1.2 Developing policy guidelines and sei ng priorii es 1
1.3 Monitoring and evaluai on 6
Esseni al elements of the nai onal health laboratory 2.
policy and nai onal health laboratory plan 7
2.1 Laboratory organizai onal and management structure ... 7
2.2 Nai onal standards for infrastructure, tests, techniques and equipment ... 10
2.3 Human resource management ... 11
2.4 Quality management systems ... 13
2.5 Procurement and supplies management ... 14
2.6 Laboratory equipment management ... 15
2.7 Laboratory informai on management system ... 16
2.8 Safety and waste management ... 16
2.9 Laboratory fi nancing ... 17
Annexes 1. Examples 19 1.a Template for developing a nai onal health laboratory plan ... 19
1.b Template for developing a fi nancial plan ... 20
We gratefully acknowledge the contribuions of Dr Jane Carter, Technical Director, Clinical and Diagnosics, African Medical and Research Foundaion, Nairobi, Kenya for preparing the irst drat of this document.
The contribuions made by several experts (Annex 2) in inalizaion of this document are also acknowledged.
Laboratory services are an essenial and fundamental part of all health systems. Their purpose is to improve the health status of the populaion by providing the evidence base for detecion, management and prevenion of diseases. The Asia Paciic Strategy for Strengthening Health Laboratory Services (2010–2015) was developed to guide and encourage all Member States in the South-East Asia and Western Paciic Regions of the World Health Organizaion (WHO) to develop appropriate, scieniically sound, evidence-based, pracical and sustainable naional strategies for strengthening health laboratory services within their naional health systems. Since it is acknowledged that “one size does not it all”, each country’s strategy for developing and strengthening laboratory services should be planned according to that country’s unique health system, ensuring integraion with other health system components and existing national health policies, strategies and resources.
Recognizing that strong health systems are the foundaion for health programmes to improve performance, and that laboratory services are a criical component of health systems, the Sixieth session of the WHO Regional Commitee of the Western Paciic (2009) endorsed strengthening of health laboratory services and through resoluion WPR/RC60.R6, urged Member States:
to guide the development of coherent national
frameworks for health laboratory services;
to provide adequate human, material and financial
resources to strengthen local and naional capaciies for the implementaion of naional plans or equivalents; to establish country-speciic minimum standards for
health laboratories at diferent levels.
viii
The key challenge for countries is to ensure that the recommendaions are implemented and monitored so that individuals and communiies will beneit from improved laboratory services at all levels of care. This requires ownership by all relevant stakeholders and a irm commitment by ministries of health, and may require the establishment of appropriate regulatory and legal support structures.
Establishing a naional laboratory policy and naional laboratory strategic plan provides the framework for the coordinated development and delivery of quality and accessible naional laboratory services. The policy and plan should systemaically outline the major issues that need to be addressed, including organizational and management structure, human resources, laboratory infrastructure, care and maintenance of equipment, provision of laboratory supplies, a funcional informaion management system, a quality management system and adequate inancial support.
WHO has prepared this guidance document to provide technical support to Member States in the South-East Asia and Western Paciic Regions on the steps required to develop and efecively implement a naional laboratory policy and naional laboratory strategic plan. The document provides a structure for developing a comprehensive policy and regulatory framework for establishing, operaing and monitoring the health laboratory services, and promoing beter coordinaion of aciviies among health programmes and insituions.
Reliable and imely results from laboratory invesigaions are criical elements for decision-making in almost all aspects of health care, and are essenial for the surveillance and control of diseases of public health importance. Improved disease recogniion also improves the accuracy of health informaion and promotes effective national health planning. However, laboratory services are oten fragmented and accorded low priority, compounded by inadequate allocaion of resources. There is oten no naional laboratory policy or strategic plan to deliver comprehensive and integrated quality laboratory services to those who need them.
The health laboratory services include all those laboratories that provide support to prevenive, promoive, rehabilitaive and curaive health services. The efecive implementaion of the Asia Paciic Strategy for Strengthening Health Laboratory Services requires a systemaic approach to establishing a coherent naional framework for laboratory services. This includes developing a naional laboratory policy and strategic plan; deining managerial, oversight and regulatory mechanisms; and establishing the required support services within the context of each country.
x
existence of a naional health laboratory policy and naional health laboratory plan are an indicaion of the commitment of a government to provide quality health services to its people by ensuring that systems are established for the management and operaion of laboratory services, and adequate and sustainable inancing is available.
This document is divided into two main secions: naional health laboratory policy and plan; and essenial elements of the naional health laboratory policy and naional health laboratory plan. The irst secion outlines the role and responsibiliies of the laboratory services within the naional health system, and the principles, processes and steps involved in developing a naional health laboratory policy and naional health laboratory plan. This secion also provides an approach to monitoring and evaluaing the implementaion and impact of the naional health laboratory policy and naional health laboratory plan.
1.1 Role of laboratory services in the health
system
Laboratory services are an essenial component of a comprehensive health-care system. They provide the required diagnosic support to curaive and prevenive health services, health promoion aciviies and research. These are essenial to guide appropriate treatment and raional use of essenial drugs, and for surveillance and control of diseases of public health concern. Laboratory services may be uilized efecively at every level of health care including the primary level, where many common diseases and diseases with outbreak potenial may be diagnosed using basic laboratory tests.
Laboratory services need to be considered as an integrated programme, and not fragmented with only parts of the system strengthened to support speciic disease control iniiaives. A verical approach may lead to disorganizaion of the laboratory and neglect of other components of the laboratory services.
Laboratory services should be recognized as a vital and integral part of a quality health service at all levels of the health system. This requires all stakeholders to undertake operaional planning and allocate adequate and sustainable resources.
1.2 Developing policy guidelines and seing
prioriies
The approach to establishing an effective national health laboratory service requires addressing essential services at each level, including clinical and public health needs, required resources, staing, equipment and supplies. The following steps are required:
1
Naional policy and plan
2
A detailed countrywide
situaional analysis to determine the current
status of the health laboratory services and requirements based on clinical and public health aciviies;
Establishment of a
naional health laboratory policy outlining the
structure and funcion of the laboratory services, including the structure of laboratory management and support systems;
Development of a long-term (5–10 years)
naional health laboratory
plan outlining prioriies, imelines and indicaive budgets; Development of
annual operaional plans detailing clear imelines, costs
and responsibiliies of implemening partners, including the contribuion of the private sector.
The responsibility and leadership for conducing the countrywide situaional analysis, developing the naional health laboratory policy, the naional health laboratory plan, and annual operaional plans lie with the naional laboratory focal point. The naional laboratory focal point works through a consensus-building process involving a wide range of stakeholders, including government and nongovernmental decision-makers, service providers, health development partners, professional users, paients, training insituions and inancers. A diverse group of technical experts, including laboratory scienists, clinicians, pathologists, public health experts, health economists and biomedical engineers, should be involved in the process.
The situaional analysis should be conducted using a structured checklist that includes all the elements to be addressed in the naional health laboratory policy and naional health laboratory plan. These essenial elements are outlined in Secion 2 of this document. Based on the indings of the situaional analysis, the naional health laboratory policy and naional health laboratory plan are drated through a consensus-building process.
3
Development of Naional Health Laboratory Policy and Plan Review of the key indings of the situaional analysis.
↓
Drating of the naional health laboratory policy and plan by a selected technical working group based on the essenial elements adapted to the
country's needs.
↓
Wider consultaion and discussion in a stakeholders’ forum that includes senior members of the Ministry of Health.
↓
A second drat of the naional health laboratory policy and naional health laboratory plan developed by the technical working group based on
amendments suggested at the stakeholders’ meeing.
↓
Wider review of the drat document by naional and internaional experts.
↓
Discussion and incorporaion of suggesions by the technical working group.
↓
Review of the third drat by senior Ministry of Health oicials including legal experts.
↓
Approval of the naional health laboratory policy and naional health laboratory plan by the appropriate naional authority.
↓
4
Developing a naional health laboratory policy
A naional health laboratory policy is a document that provides the overall direcion for establishing and strengthening the naional laboratory services. It should include the following:
A vision statement
, for example: afordable, accessible, sustainable,
equitable, quality health laboratory services for the people of a country;
A mission statement
, for example: provide accessible and equitable
quality health laboratory services that contribute to improved health outcomes for the people of the country;
Objecives
of the naional health laboratory policy:
To airm government commitment and support for the organizaion (1)
and management of eicient, cost-efecive and sustainable health laboratory services;
To strengthen laboratory services for supporting diagnosis, (2)
treatment, surveillance, prevenion and control of diseases; To establish naional standards for laboratory quality systems; (3)
To ensure the quality of the health laboratory through an established (4)
quality system;
To empower the establishment, implementaion and monitoring (5)
of the naional health laboratory plan;
To ensure adequate inancial and human resources to meet the (6)
requirements of the health laboratory services;
To commit to ethical values in laboratory pracice, including paient (7)
conideniality, adherence to professional codes of conduct and ethical research pracices;
To encourage research and collaboraion to inform and improve (8)
the quality of health laboratory services.
Developing a naional health laboratory plan
5
Development of Naional Health Laboratory Policy and Plan developing the strategies and aciviies required to achieve the components deined in the naional health laboratory policy. Each key component of the naional health laboratory policy becomes a strategic objecive and a number of planned aciviies are developed for its implementaion.
The naional health laboratory plan should be carefully designed, realisic and pracical, and include a ime frame for implementaion with the necessary indicators, budgetary allocaions and designated partners. A step-wise approach to development is more likely to be sustainable and capable of contribuing to the achievement of health system goals.
The process of developing a naional health laboratory plan should include the following steps:
Specify the strategic objecives that align with the objecives of the naional health laboratory policy.
↓
Specify the aciviies that will be undertaken to implement each of the strategic objecives.
↓
Allocate responsibiliies and accountability for each strategic objecive including the roles of implemening partners.
↓
Set priority areas for implemening the naional health laboratory plan. ↓
Deine ime frames for the compleion of each strategic objecive. ↓
Outline budgetary requirements and sources for each strategic objecive and complete a inancial plan.
↓
6
Once the naional health laboratory plan is developed, annual operaional plans need to be drawn up, detailing aciviies, ime frames, implemening partners, budgetary allocations and annual funding sources, taking into consideraion the contribuion of the private sector.
A template for developing a naional health laboratory plan and a inancial plan are given in Annex 1.
1.3 Monitoring and evaluaion
Implementaion of the naional health laboratory plan and annual operaional plans requires regular, careful monitoring to ensure that agreed aciviies are properly implemented and inancial expenditures are accounted for. The following should be considered:
Establish mechanisms for monitoring the implementaion of aciviies, (1)
including idenifying responsible persons, establishing regular reporing mechanisms, and holding regular review meeings with stakeholders to assess progress.
Review progress through the measurement of indicators, as follows: (2)
Acivity indicators: measurement of aciviies conducted (a)
Outcome indicators: measurement of outcomes and (b)
performances.
Prepare imely reports addressing the review of indicators as well as (3)
challenges and constraints.
Adjust aciviies, objecives and imelines according to the results of (4)
the review.
Conduct periodic audits, both internal and external, to evaluate (5)
The essential elements of the national health laboratory policy and naional health laboratory plan should include the following:
Laboratory organizaional and management structure (1)
Naional standards for infrastructure, tests, techniques (2)
and equipment
Human resource management (3)
Quality management systems (4)
Procurement and supplies management (5)
Laboratory equipment management (6)
Laboratory informaion management system (7)
Safety and waste management (8)
Laboratory inancing. (9)
2.1 Laboratory organizaional and management
structure
A coherent naional framework for health laboratory services includes a well-organized and managed structure, the important components of which are as follows:
Naional laboratory focal point and naional laboratory (a)
coordinaing commitee Naional regulatory mechanism (b)
Laboratory structure and network. (c)
2
Essenial elements of the
8
(a)
Naional laboratory focal point and naional laboratory
coordinaing commitee
A national laboratory focal point or department and national laboratory coordinaing commitee should be established. The terms of reference for the naional laboratory focal point, and the composiion and terms of reference for the naional laboratory coordinaing commitee should include responsibility and accountability for steering and monitoring the health laboratory services.
The national laboratory coordinating committee should comprise key individuals in the Ministry of Health and other relevant government departments, the naional laboratory focal point, naional regulatory authoriies and other key stakeholders, including representaives of donors and partner agencies such as WHO, professional bodies, clinical and public health physicians, disease programme managers, representatives of relevant professional societies, research and training insituions, legal advisers, health administrators and representaives from the laboratory network, including nongovernmental and private laboratories.
The principal funcions are as follows:
Naional laboratory focal point or department
To develop the naional health laboratory policy and naional health (1)
laboratory plan, including cosing, and ideniicaion and allocaion of inancial resources for implementaion of the plan;
To take overall responsibility for the coordinaion and guidance of the (2)
laboratory services in accordance with the plan;
To coordinate the establishment of national standards for health (3)
laboratory quality systems;
To ensure that the quality of laboratory services is maintained. (4)
Naional laboratory coordinaing commitee
To advise the Ministry of Health on naional health policies, and relevant (1)
9
Development of Naional Health Laboratory Policy and Plan To coordinate various iniiaives or proposals in which the health (2)
laboratory services can contribute to the overall health systems strategy;
To contribute to the development of legislaion and regulaions, as (3)
required;
To regularly review and, where necessary, propose revision of the (4)
national health laboratory plan with respect to communicable diseases including emerging infecions, and noncommunicable disease control;
To evaluate new laboratory iniiaives and technologies; (5)
To provide a forum for discussion on naional issues relaing to the (6)
laboratory services;
To provide technical inputs through expert groups on various issues (7)
concerning the health laboratory services.
(b) Naional regulatory mechanism
Regulaion is the legal means of governing or controlling health service provision, including laboratories, laboratory staf, equipment, test kits and reagents, and reporing of essenial informaion to meet the required standards. Regulaion is a tool for ensuring competent performance as well as conidence in the laboratory services. It is important for the country to idenify or establish a regulatory authority and mechanism, and to formulate appropriate laws or regulaions to govern its health laboratory services, addressing both the public and private sectors. Regulaions incorporate a code of ethics that deines appropriate and proper conduct.. They are also responsible for licensing providers, seing naional standards, monitoring performance and compliance with those standards, and intervening, including taking disciplinary acion for non-compliance.
Key components
The responsibility of a naional regulatory mechanism may include:
Drawing up appropriate legislation governing health laboratory (1)
pracices;
Establishing mechanisms to strengthen training of staf to carry out (2)
10
Licensing of laboratory service providers; (3)
Monitoring compliance with standards for human resources and (4)
competence;
Seing requirements for pre-service training and coninuing professional (5)
development for health laboratory personnel.
(c)
Laboratory structure and network
A well-deined laboratory structure must be established, which ideniies key management and technical roles and responsibiliies at each level, and establishes a funcional laboratory network and referral system. The laboratory network should include a disease monitoring and response system.
Key components These may include:
Identification of the roles and responsibilities, including both (1)
management and technical responsibilities, at each level of the laboratory;
Establishment of systems for coordinaion and communicaion, such as (2)
referral of specimens to reference laboratories and within the network. The necessary guidelines and resources for specimen referral and return of results should be provided;
Ideniicaion of and support to naional reference laboratories for (3)
speciic diseases, and surveillance and response mechanisms; Establishment of mechanisms for procurement and distribuion of (4)
laboratory equipment and supplies to all laboratories in the health-care system.
2.2 Naional standards for infrastructure, tests, techniques
and equipment
11
Development of Naional Health Laboratory Policy and Plan Key components
These may include:
Establishment of a physical laboratory infrastructure of appropriate size, (1)
locaion, and with essenial uiliies, to provide a safe environment for workers, paients and visitors;
Establishment of essenial tests and techniques required at each health (2)
facility level;
Establishment of the required competency of staf for each level of (3)
laboratory throughout the network;
Selecion of standardized equipment appropriate for the tests performed (4)
at diferent levels of laboratories, with clear technical speciicaions; Availability of standard operaing procedures (SOPs) in every laboratory (5)
for transportaion of specimens, use of equipment, test procedures, reporting formats and guides to interpretation, including normal reference ranges for quanitaive results;
Provision of up-to-date inventories to all laboratory users of the (6)
available tests, their indicaions and limitaions, costs and types of specimens required;.
Coninual review of the cost-efeciveness and appropriateness of (7)
recommended standards.
2.3 Human resource management
12
Key components These may include:
Laboratory services to be provided only by staff with recognized (1)
qualiicaions or relevant training;
Development of job descripions for all laboratory personnel working (2)
at diferent levels of the health system;
Establishment of a scheme of service for laboratory workers with clear (3)
structures and opportuniies for career advancement;
A system of incenives to encourage staf to work in remote and (4)
underserved areas;
Periodic competency assessments of staf to verify individual demonstraion (5)
of necessary skills, knowledge and correct work pracices;
Establishment of a staf record for each laboratory worker, including (6)
personal and employment details, resumé (CV), posts held and dates, authorized areas of tesing, terms and condiions of employment, job descripion, coninuing professional development, competency assessments, disciplinary acions and work injury records;
Performance of annual appraisals by the immediate supervisor, using a (7)
standard appraisal tool to provide feedback to individual staf on work performance and guide career development;
Organizaion of appropriate in-service training programmes for all (8)
categories of staf. In-service training programmes may be linked to the annual registraion process, to speciic disease iniiaives or/and address overall staf competency in areas including quality processes, safety, procurement and supply management, and reporing of results. Training programmes may include distance learning and intra- and intercountry exchanges;
Development of effective supervisory systems to monitor work (9)
13
Development of Naional Health Laboratory Policy and Plan Involvement in naional and/or regional professional associaions to (10)
promote professional development and ethical pracices.
2.4 Quality management systems
Quality laboratory services are achieved by establishing and maintaining a quality management system for all aspects of the laboratory services. Monitoring quality and its coninuous improvement is an essenial component of a well-managed laboratory service.
Key components These may include:
Developing a naional laboratory quality statement. The laboratory (1)
quality statement should relect the intenion and commitment of the naional authoriies to ensure that quality laboratory services are provided at all levels of health faciliies;
Provision of adequate and sustainable inancial resources for establishing (2)
and maintaining quality laboratory systems;
Creaion of a network of quality managers among various insituional (3)
laboratories under the oice of the naional laboratory focal point to coordinate all aciviies relaing to the quality system;
Development, implementaion and monitoring of quality standards in (4)
all laboratories;
Training of all laboratory staf on all aspects of the quality system; (5)
Development, maintenance and updaing of SOPs; (6)
Ensuring that internal quality control (IQC) is pracised in all laboratory (7)
procedures;
Organizaion of appropriate external quality assessment schemes (EQAS) (8)
for each level of laboratory, and ensuring mandatory paricipaion; Assessment of laboratory performance through audits (internal or (9)
external);
Development of relevant quality indicators to consistently monitor and (10)
14
Development of a naional system of step-wise accreditaion and support (11)
laboratories to achieve accreditaion (naional or internaional); Ensuring efecive communicaion between laboratory staf, professional (12)
laboratory users, health administrators, technical support services, health development partners, government and nongovernmental decision-makers, paients, training insituions and donors.
2.5 Procurement and supplies management
The selecion and standardizaion of laboratory supplies and reagents must be based on the types of tests performed and equipment used at every level of laboratory across the health system. Standardizaion promotes eiciency in inventory control, storage and distribuion, quaniicaion and procurement procedures; and increases economies of scale and reduces procurement costs. The naional laboratory procurement and supplies management system should be in line with the naional medical supply and distribuion system.
Key components These may include:
Establishment of an efecive naional laboratory procurement and (1)
supplies management system, with appropriate storage faciliies and imely distribuion systems;
Evaluaion and validaion of laboratory consumables and reagents (2)
to be conducted by qualiied, competent laboratories using standard guidelines or reference to reliable evaluaions and validaions such as peer-reviewed publicaions, WHO, etc. Consumables and reagents should be subject to regular checks. Those that do not meet required standards will not be procured;
Ideniicaion of a naional centre for independent quality assurance (3)
and pre-qualiicaion of consumables and reagents;
Development of clear guidelines for acceping and receiving donated (4)
supplies to ensure that they meet the required speciicaions and are appropriate for the laboratory;
Establishment of a standardized system for inventory and stock control (5)
15
Development of Naional Health Laboratory Policy and Plan Development of appropriate systems for receipt, quality checking and (6)
storage of consumables and supplies by the laboratory;
Training of laboratory managers in procurement and supply management (7)
and logisics, including planning, quaniicaion, cosing, budgeing, storage, stock-keeping, inventory control and raional use of supplies; Establishment of standard procedures to idenify laboratory chemicals (8)
and supplies for safe disposal.
2.6 Laboratory equipment management
A naional equipment management policy must be in place. Major items of laboratory equipment are expensive to purchase, operate and maintain, and constitute the largest capital expenditure of the laboratory. The national laboratory equipment management system should be in line with the naional medical equipment management system.
Key components These may include:
Evaluaion and validaion of new/donated equipment by authorized (1)
tesing centres, using standard guidelines;
Establishment of a national database of equipment including (2)
informaion on instrument type, operaional status and service contract providers;
Establishment of standard procedures for equipment purchase, using (3)
a structured checklist as required;
Development of clear guidelines for acceping and receiving donated (4)
equipment to ensure that the equipment meets the required specifications, can be supported by local service agents, and is appropriate for the laboratory;
Ensuring that all equipment is supplied with appropriate service and (5)
16
Ensuring that all major equipment is installed by suppliers, and training (6)
on equipment use, maintenance and trouble-shooing is provided to relevant personnel at the ime of installaion or when put into use; Development of SOPs for equipment use, care and maintenance, and (7)
disposal of obsolete or unserviceable equipment.
2.7 Laboratory informaion management system
The naional laboratory informaion management system (LIMS) database is used to generate relevant informaion, and provide data for evaluaing and planning quality health laboratory services. The naional LIMS must be in line with the naional health informaion management system (HIMS), and may be electronic or paper-based.
Key components These may include:
Establishment of standard record-keeping systems, and recording and (1)
reporing tools. Reporing formats should include paient demographics, type and source of specimen, tests performed, posiive and negaive results;
Establishment of reporing procedures from across the laboratory (2)
network from the peripheral to the central laboratories on a weekly, monthly or quarterly basis;
Analysis of data at district, provincial/regional and central levels to (3)
guide support to clinical services, including planning of procurement and supplies, and human resource distribuion;
Provision of appropriate data to relevant disease control programmes (4)
and naional centres as part of naional programmes for surveillance and disease control;
Use of national data for health services planning and resource (5)
17
Development of Naional Health Laboratory Policy and Plan
2.8 Safety and waste management
Laboratory managers need to ensure that appropriate safety measures are applied in all laboratory pracices. Laboratory safety procedures should be developed in line with naional health and safety guidelines, and in collaboraion with health facility infecion control teams.
Key components These may include:
Designaion of a laboratory safety oicer; (1)
Establishment of naional safety policies and guidelines; (2)
Provision of adequate protecion to laboratory personnel to prevent (3)
occupationally acquired diseases, and management in cases of exposure, including post-exposure prophylaxis (PEP);
Establishment of appropriate cleaning, disinfecion and sterilizaion (4)
procedures in all laboratories;
Establishment of a biological waste management programme including (5)
cleaning, disinfection, sterilization, and disposal of sharps and contaminated material;
Establishment of standard procedures for the safe disposal of chemicals (6)
and supplies;
Disposal of laboratory waste in accordance with naional environmental (7)
protecion regulaions.
2.9 Laboratory inancing
18
Key components These may include:
Provision of adequate inancial resources to sustain all costs associated (1)
with quality and reliable laboratory services;
Development of budgets for the naional laboratory services taking into (2)
consideraion all sources of funding, including the government, global health iniiaives, and mulilateral and bilateral donors, in consultaion with the naional laboratory focal point;
Development of naional health budgets keeping in mind laboratory (3)
needs;
Training of laboratory managers in developing annual operaional (4)
plans;
Coninuous monitoring and regular updates of inancial expenditure, (5)
and making these available to laboratory managers;
Establishment of an eicient, efecive, user-friendly and transparent (6)
19
Development of Naional Health Laboratory Policy and Plan
Annex 1
Examples
1.a Template for developing a naional health laboratory plan
Strategic objecive
Planned aciviies
Time frame (year) Responsible partners
Outcomes and planned
results 2011 2012 2013 2014 2015
Strengthen point and naional QA commitee
4 Disseminate documents X X X MOH
Documents
available in all laboratories
5
20
1.b Template for developing a inancial plan
Secion 1 (costs in US $ 1000)
Planned
aciviies
Time frame (year) Comments 2011 2012 2013 2014 2015
1 2
3 0.3
4 10.0 2.0 2.0
Use exising distribuion systems, where possible
5 20.0 20.0 20.0 20.0 20.0 Use exising grant for EQA
6 1.0 1.0 1.0 1.0 1.0
7 10.0 10.0 10.0 10.0 10.0
Sub-total
21
Development of Naional Health Laboratory Policy and Plan
Annex 2
Contributors
Dr Susan Best Director
Naional Serology Reference Laboratory (NRL)
4th Floor, Healy Building 41 Victoria Parade
Fitzroy, Victoria 3065, Australia
Dr Sau Sokunna Deputy Director in
Hospital Services Department Head, Bureau of Medical Laboratory Services Ministry of Health
#151-153 Avenue Kampuchea Krom Phnom Penh, Cambodia
Mr Douglas Ngaeikura-Tou Laboratory Manager Ministry of Health P.O. Box 109
Rarotonga, Cook Islands
Ms Lisa Barrow
Naional Laboratory Coordinator
FSM Department of Health & Social Afairs P.O. Box PS-70
Palikir, Pohnpei
Federated States of Micronesia
Dr Liia Tudravu
Chief Medical Oicer in Pathology
Labasa Hospital
P.O. Box 577 Labasa, Fiji
Mr Uraia Rabuatoka Senior Laboratory Technician Fiji Centre for Communicable Disease Control (FCCDC) Mataika House, Tamavua, Fiji
Dr James Kalougivaki Pathology Department CWM Hospital Ministry of Health, Fiji
Dr Eka Buadromo Chief Pathologist Pathology Department CWM Hospital Ministry of Health Suva, Fiji
Ms Salanieta Elbourne Duituturaga Laboratory Specialist
Public Health Surveillance & Communicable Disease Control Level 2, Lotus Building, Ratu Mara Rd, Nabua
Secretary of the Paciic Community Private Mail Bag, Suva, Fiji
Dr Wilina Lim
Consultant Microbiologist Virus Unit
Department of Health
Public Health Laboratory Centre 9/F, 382 Nam Cheong Street Shek Kip Mei
Kowloon, Hong Kong
Dr Prety Muliharina, PhD
Coordinator, Laboratory for Infecious Diseases
Naional Insitute of Health Research and Development
22
Ms Tiero Tetabea Deputy Director Laboratory Services
Ministry of Health & Medical Services P.O. Box 268, Nawerewere
Tarawa, Kiribai
Dr Jane Carter
Technical Director, Clinical and Diagnosics African Medical and Research Foundaion P O Box 30125, 00100 GPO, Nairobi
Kenya
Dr Phengta Vongphrachanh Director-General
Naional Centre for Laboratory and Epidemiology
Ministry of Health Km 3, Thadeua Road Vieniane Capital,
Lao People’s Democraic Republic
Dr Chanphomma Vongsamphanh
Lao People’s Democraic Republic
Mr Paul Lalita
Majuro Hospital Laboratory P.O. Box 16
Majuro 96960, Marshall Islands
Dr Shahnaz Murad Director
Insitute for Medical Research Ministry of Health Malaysia Jalan Pahang
50588 Kuala Lumpur, Malaysia
Professor Lai-Meng Looi Department of Pathology Faculty of Medicine University of Malaya
50603 Kuala Lumpur, Malaysia
Ms Amarjargal Yadam
Central Scieniic Research Laboratory Research Insitute of Medicine P.O. Box 48/47,
Ulaanbaatar-210648, Mongolia
Professor Dr Ne Win
Director (Laboratory and Blood Service) Naional Health Laboratory (NHL) Ministry of Health Union of Myanmar No. 35, Maw Kun Tailk ST.,
Dagon Tsp, Yangon, Myanmar
Dr Alani Tangitau
Director of Medical Services RON Hospital
Denig District, Nauru
Dr Geeta Shakya Director
Naional Public Health Laboratory (NPHL) Teku,
Kathmandu, Nepal
Mr Philip Wakem
Paciic Paramedical Training Centre (PPTC) P.O. Box 7013
Wellington 6242, New Zealand
Ms Chrisine Briasco
Health Advisor
New Zealand Aid Programme (NZAID) Ministry of Foreign Afairs and Trade
New Zealand
Mr John Elliot Director
Paciic Paramedical Training Centre P.O. Box 7013
23
Development of Naional Health Laboratory Policy and Plan
Ms Lily Ulitech Laboratory Supervisor Ministry of Health P.O. Box 6027 Koror 96940, Palau
Dr Evelyn Lavu Director
Central Public Health Laboratory Port Moresby General Hospital Boroko NCD, Papua New Guinea
Dr Jianwei Wang
Deputy Director and Professor Insitute of Pathogen Biology Chinese Academy of Medical Sciences 9# Dong Dan San Tiao
Dongcheng District
Beijing 100730, People’s Republic of China
Beijing 100044, People’s Republic of China
Ms Myrna T. Reyes Bacteriologist IV
Naional Centre for Health Facility Development
Department of Health Sta. Cruz
Manila, Philippines
Mr Vaomalo Michael Kini Manager, Laboratory Services Laboratory Division
Naional Health Services Private Mail Bag, Apia, Samoa
Dr Nguyen Khac Tien Medical Oicer
Department of Medical Service Administraion
Ministry of Health 38, Giang Vo Street Ba Dinh District
Ha Noi, Socialist Republic of Viet Nam
Dr Vu Sinh Nam,
Deputy Director General & Prof. General Department of Prevenive
Medi-cine
Ministry of Health Lane 135 Nutruc Ba Dinh District
Ha Noi, Socialist Republic of Viet Nam
Mr Alfred Dofai
Head of Medical Laboratory Medical Laboratory Department Ministry of Health
P.O. Box 349, Honiara, Solomon Islands
Dr Ajith Mendis
Director General Health Services Ministry of Health
Government of the Democraic Socialist Republic of Sri Lanka
Suwasiripaya P.O. Box 513 Colombo 10, Sri Lanka
Ms Surang Dejsirilert
WHO CC for Animicrobial Resistance &
Training
Naional Insitute of Health Dept. of Medical Sciences Ministry of Public Health Nonthaburi 11000, Thailand
Mrs Suwanna Charunut Director
WHO CC on Lab Quality
24
Mrs Latu’uta Soakai Senior Medical Scienist Central Public Health Laboratory Vaiola Hospital
Vaiaku, Funafui , Tuvalu
Ms Carol Fridlund
Centers for Disease Control (CDC) 12 Execuive Park Drive, NE Mailstop G-25
Atlanta, Georgia
United States of America
Ms Vasii Uluivii
Regional Laboratory Coordinator Paciic Islands Health Oicers Associaion (PIHOA)
c/o Guam Public Health Laboratory Mangilao, Guam 96923,
United States of America
Mr George Junior Pakoa
Naional Laboratory Manager (PLO) Senior Medical Laboratory Technologist Naional Laboratory
Vila Central Hospital
PMB 9013, Port Vila, Vanuatu
Dr Zamberi Sekawi Technical Oicer
Health Technology and Laboratory Oice of the WHO Representaive in the South Paciic
P.O. Box 113 Suva, Fiji
Dr Sébasien Cognat
Laboratory Quality and Management Strengthening
Internaional Health Regulaions Coordinaion
Health Security and Environment WHO Lyon Oice
58 Avenue Debourg 69007 Lyon, France
Dr Rajesh Bhaia
Regional Adviser
Blood Safety and Laboratory Technology
WHO House
Indraprastha Estate
Ring Road
New Delhi 110002, India
Dr Gayatri Ghadiok Technical Oicer
Essenial Health Technologies Adviser World Health Organizaion
Regional Oice for the Western Paciic P.O. Box 2932
This document provides technical support to Member States in the South-East Asia and Western Pacific Regions on the steps required to develop and effectively implement a national laboratory policy and national laboratory plan in accordance with the Asia Pacific Strategy for Strengthening Health Laboratory Services (2010-2015). The document provides a structure for developing a comprehensive policy and regulatory framework for establishing, operating and monitoring the health laboratory services, and promoting better coordination of activities among health programmes and institutions for efficient support to both clinical and public health services.
9 7 8 9 2 9 0 2 2 3 9 6 2 ISBN 978 92 9022 396 2
South-East Asia Region Western Pacific Region South-East Asia Region Western Pacific Region
