Ministry of NHSR &C

National Laboratory Policy

Islamic Republic of Pakistan

December 2017
National Institute of Health/National Public Health Institute
Ministry of National Health Services Regulations & Coordination
Government of Pakistan NIH Publication No.
PHLD/NLWG-001-2018
National Laboratory Strategic Framework
Islamic Republic of Pakistan
 Message
Federal Minister
The implementation of International Health Regulations (IHR) (2005) is an important concern for
the Government of Pakistan. We are well aware of health security issues and cognizant to
strengthen the core capacities under IHR (2005) and Global Health Security Agenda (GHSA).
Laboratory services are also included in the IHR (2005) framework as a core public health capacity.
Therefore, a comprehensive approach to strengthening laboratories across Pakistan is required to
harmonize efforts to implement communicable disease prevention and control strategies in the
country.
Realizing the importance of the laboratory services, the Ministry is focused on One Health
methodology towards strengthening the laboratory system in Pakistan through a systematic
approach. We consider cross-sectoral collaboration for system strengthening as vital and thus a
National Laboratory Working Group (NLWG) was established to spearhead the policy, strategic
and operational planning for the laboratory system in Pakistan. The NLWG, comprising relevant
experts and stakeholders from different Ministries and sectors of health and provincial authorities,
provided valuable input through a series of consultations for the nalization of the National
Laboratory Strategic Framework in Pakistan. The consultative process ensured national
ownership for the Strategic Framework as well as the commitment of all relevant stakeholders.
I believe that this important framework document will lay the foundation for building a sound
laboratory system in the country. It is the responsibility of the Ministry of National Health Services,
Regulations & Coordination to provide leadership through regulation, policy and collaboration as
well as direct service provision to assure that within resource limitations the most appropriate mix
of laboratory services - diagnostic, surveillance and outbreak response - is developed to achieve
the best outcomes in health for all.

Saira Afzal Tarar

Federal Minister
National Health Services, Regulations & Coordination
Government of Pakistan

i
 Message
Federal Secretary
Health laboratory systems can be strengthened by developing national policies, strategies and
standards, supported by sustainable pre-service and in-service training programs for laboratory
staff at the managerial and technical level. Ministry of National Health Services, Regulations and
Coordination truly understands the responsibility in this regard and has always been striving hard
to provide the best medical facilities to the masses. The present policy has been accomplished
through a sternuous process and is meant for providing better and quality assured laboratory
diagnostic services to the people of Pakistan
We would like to commend the hard work and commitment of the National Laboratory Working
Group in preparing this policy. We also appreciate the assistance extended by technical advisors
from WHO and the support of the European Union.
The Ministry of National Health Services, Regulations & Coordination shall remain committed to
implement the GHSA, provide technical assistance, advocacy and resource mobilization for the
building IHR 2005 core capacities in the country.

Naveed Kamran Baloch

Federal Secretary
National Health Services, Regulations & Coordination
Government of Pakistan

ii
 Preface
Accurate and reliable diagnosis is the cornerstone of disease management and prevention. Well-
functioning, sustainable laboratory services, operating according to international principles of
quality and safety, are an essential part of strong health systems and are crucial to improving
health care. The analyses that laboratories provide offer a reliable foundation for evidence-based
control of disease outbreaks, robust surveillance of adverse events associated with
pharmaceutical or vaccine use and early and correct treatment of both acute and chronic
diseases. Furthermore, laboratory services should operate according to the core capacity
requirements of the International Health Regulations (IHR) (2005), a legally-binding agreement
which provides a framework for the coordination of the management of events that may constitute
a public health emergency of international concern. It intends to improve the capacity of all
countries to detect, assess, notify and respond to public health threats. Furthermore we also have
to strengthen our capabilities under One Health and Global Health Security Agenda.
The development of greater laboratory capacity in resource constrained countries is an urgent
need, as dened in the Maputo Declaration on Strengthening of Laboratory Systems of 2008 and
the Freetown Declaration of 2015. Pakistan, with its population of over 200 million people, is the
sixth populous country in the world, and, as many countries, is constrained in resources. Where
the unmet needs for health services are most prominent, the application of the cost effective
interventions should be of the highest priority.
Well-functioning health laboratory services require coordination and supervision of laboratory
services at the national and provincial levels, as well as the implementation of and adherence to
laboratory quality standards.
The development of a National Laboratory Policy covering all laboratories is a step towards
strengthening the laboratory services. The Pakistan National Laboratory Policy is designed to
guide best choices in achieving health.

Prof Brigadier Aamer Ikram, SI(M)

Executive Director
National Institute of Health

iii
 Acknowledgement
The development of this document was supported by the European Union (European
Commission's Directorate-General for Development and Cooperation) as part of the project for
"Strengthening Health Laboratories to minimize potential biological risks" (Contract
IFS/2013/332312). However, the views expressed herein can in no way be taken to reect the
ofcial opinion of the European Union.
Recognition also goes to the World Health Organization's technical support.
We are extremely grateful to Dr Linda Oskam for her dedication and commitment in completion of
this policy.
We extend our gratitude to all the experts and stakeholder for their persistence in initial analyses
and compilation of draft document.

iv
 Contents
Contents
Foreword 1
Acronyms 3
Background 5
Vision 2025 6
Policy objective 7
Denitions 8
Policy Statements 9
Component 1: Regulatory and legal framework 9
Component 2: Coordination and networking 10
Component 3: Equitable accessibility 12
Component 4: Infrastructure 12
Component 5: Finance 13
Component 6: Human Resource Management 14
Component 7: Equipment and consumables 16
Component 8: Information and data management 17
Component 9: Quality management systems 18
Component 10: Occupational health 19
Component 11: Biorisk management and waste management 19
Component 12: Research 20
Policy Implementation 22
Annex I - The process of Policy development 23
Annex II - Outcomes of the LAT system assessment 24
Limitations 24
Analysis of the assessment outcomes 24
Gap analysis 27
Annex III – Reviewed SWOT analyses for the 11 Policytopics, sub-topics and
evidence 28

v
 Contents
Topic 1: Regulatory and legal framework 28
Topic 2: Coordination and networking 30
Topic 3: Equitable accessibility 32
Topic 4: Infrastructure 33
Topic 5: Finance 34
Topic 6: Human Resource Management 36
Topic 7: Equipment and consumables 38
Topic 8: Information and data management 39
Topic 9: Quality management systems 40
Topic 10: Biorisk management and waste management 42
Topic 11: Research – SWOT analysis 43
ANNEX IV - List of laboratory and Public Health Professional participated in the
consultative workshops on Development on the National Laboratory Policy in
Pakistan 44

vi
 Foreword
Laboratories play an essential role under the International Health Regulations (2005) and are a key
building block of a properly functioning health system. Accurate and reliable diagnosis is the
cornerstone of disease management and prevention. Poor laboratory services are costly in terms
of high wastage of scarce public resources and private out-of-pocket expenditures on ineffective
treatments, loss of economic productivity of the population due to (chronic) illness and loss of life
of humans and animals alike.
Recent independent assessments by WHO have shown that our laboratory sector needs
improvement. The development of a National Laboratory Policy covering all laboratories involved
in health under the One Health concept is a crucial rst step in addressing the needs of the
laboratory system as a whole. It provides direction to laboratory strengthening efforts and ensures
efcient use of public funds and donor investments as well as the development of a sustainable
system of laboratory services.
This document reects the strong commitment of the Ministry of National Health Services
Regulations & Coordination and other ministries for improvement of the laboratory sector in the
country. It is the rst essential step towards strategic and operational plans to drive actions that are
carried out in an integrated manner at a pace that is in-line with the country's managerial and
nancial resources.
This Policy is the result of an established methodology, as described in the facilitators' guide of
WHO for National Laboratory Policy development. The implementation of these policy
recommendations aims to overcome the current challenges to improve the laboratory
performance in the country. Therefore, all actors are strongly encouraged to contribute to
realization of these policy statements.

1
 Acronyms
AFIP Armed Forces Institute of Pathology
AJK Azad Jammu & Kashmir
ASM American Society for Microbiology
BCLRA Baluchistan Clinical Laboratory Registration Authority
BSC Biosafety Cabinet
BSL Biosafety Level
CAP College of American Pathologists
CCHF Congo-Crimean Hemorrhagic Fever
CDC Centers for Disease Control (Atlanta, GA)
CME Continuous Medical Education
CPSP College of Physicians and Surgeons Pakistan
EPA Environmental Protection Agency
EQA(S) External Quality Assurance (Services)
FAO Food & Agriculture Organization
FDA Food & Drug Administration
FELTP Field Epidemiology & Laboratory Training Program
GB Gilgit Baltistan
GF Global Fund
GHSA Global Health Security Agenda
GLI Global Laboratory Initiative
HIV Human Immunodeciency Virus
IATA International Air Transport Association
IHR International Health Regulations 2005
ISO International Organization for Standardization
IT Information Technology
JICA Japan International Cooperation Agency
JCI Joint Commission International
KfW German Development Bank (Kreditanstalt für Wiederaufbau)
KIT Royal Tropical Institute (Koninklijk Instituut voor de Tropen), Netherlands

3
 Acronyms
KP Khyber-Pakhtunkhwa
LAT Laboratory Assessment Tool
LIMS Laboratory Information Management System
LIS Laboratory Information System
LQMS Laboratory Quality Management System
LQSI Laboratory Quality Stepwise Implementation (tool)
MNHSR&C Ministry of National Health Services Regulation & Coordination
NIH National Institute of Health, Pakistan
NLWG National Laboratory Working Group
OIE World Organization for Animal Health
PNAC Pakistan National Accreditation Council
PPM Public-Private Mix
PPP Public-Private Partnership
PT Prociency testing
QC Quality Control
RIQAS Randox International Quality Assessment Scheme
SOP Standard Operating Procedure
SWOT Strengths, Weaknesses, Opportunities & Threats
TB Tuberculosis
WHO World Health Organization
WHO EMRO World Health Organization Eastern Mediterranean Regional Ofce

4
 Background
The Government of the Islamic Republic of Pakistan recognizes the signicance imparted to
diagnostic laboratories under the IHR (2005) and One Health agenda. Laboratories remain a key
building block of an appropriately functioning health system. Recent independent assessments in
the country denoted improvement in the laboratory sector.
Realizing the importance, the Ministry of National Health Services, Regulations & Coordination
(MNHSR&C) notied a National Laboratory Working Group (NLWG) to guide and develop a draft
laboratory policy and strategic plan. The National Laboratory Policy was developed in a series of
interactive, facilitated workshops involving primary stakeholders (Annex IV - list of members) and
two external facilitators from WHO Country Ofce and the WHO Collaborating Centre for
Laboratory Strengthening at the Royal Tropical Institute (KIT) in Amsterdam, The Netherlands.
The process of policy development and the methodology followed is detailed in Annex I. There was
a consensus from all laboratory stakeholders to have a clear vision for a national policy as a crucial
activity for laboratory strengthening. Primarily, the National Laboratory Policy needed to be
integrated with already existing health policies and strategies and at the same time incorporate
current international best practice in laboratory systems strengthening. In order to ensure wider
national ownership as well as the commitment of all relevant parties, a post-workshop policy
dialogue phase and consultations with all stakeholders was performed.

5
 Vision 2025
Pakistan shall have well-organized, sustainable system of quality laboratory services under
the One Health concept that are accessible and affordable to all. This system is governed and
monitored through implemented and regularly updated policies, plans, rules and regulations.
Laboratories are organized in networks and use paperless information and communication
systems according to international standards and a state-of-the-art referral and sample
transportation system, thus ensuring optimal patient care and robust surveillance for public health
events.
Up to date pre-service and in-service training programs generate well-trained, qualied staff that is
dedicated and well-paid. Trained laboratory managers are competent to manage and lead
processes in the laboratory. At all levels of the laboratory networks, technical staff performs
evidence based quality assured laboratory tests using quality equipment and consumables,
standardized methodologies and ethical practices. Where appropriate, procedures are
automated to allow for high volume testing.
All laboratories are registered and licensed based on dened minimum standards and EQA
programs are widely established. Laboratories are encouraged to pursue accreditation. Proper
biorisk management, infection control and waste disposal systems are implemented in all
laboratories.

6
 Policy Objective
The objective of the National Laboratory Policy is to give direction to laboratory strengthening
efforts for all laboratories involved in human, animal, agricultural, food safety and environmental
care under the concept of “One Health” and to ensure the development of a sustainable system of
laboratory services in-line with international standards and able to meet the need of the population,
while safeguarding efcient use of Government funds and donor investments.

7
 Denitions
Biorisk management: overarching term that includes both biosafety and biosecurity management.
Biosafety management: Coordinated activities to prevent accidental or unintentional personal,
laboratory and environmental exposure to potentially infectious agents.
Biosecurity management: Coordinated activities to prevent malicious or intentional personal,
laboratory and environmental exposure to potentially infectious agents.
Continuing education: All training and retraining received after a person has started working. This
can be on the job training as well as formal courses.
Inter-sectoral: referring to overarching activities that involve multiple sectors of the laboratory
services under the One Health concept, such as human health, veterinary, agricultural, food safety
and environmental laboratory services.
LIMS: software-based laboratory information management system with features that support a
modern laboratory's operations and management.
LIS: software-based information management system with features that support data exchange and
management as a part of Laboratories network.
Metrology: measurement, embracing both experimental and theoretical determinations at any level
of uncertainty in any eld of science and technology
One Health: the One Health concepts aims to improve health and well-being through the prevention
of risks and the mitigation of effects of crises that originate at the interface between humans, animals,
agricultural, food safety and the environment (www.onehealthglobal.net).
Policy: a deliberate system of principles to guide decisions and achieve rational outcomes. A policy
applies to a certain eld (in this case Laboratory Services) and guides the future activities in this
particular eld. It describes the direction in which the country wants to proceed (concentrating on
“what” and “why”).
Pre-service training: all training performed at universities, colleges and similar that aim to develop
competencies that are relevant for the eld of work in which a person will start his/her career.
Provincial/provinces/interprovincial: pertaining to all provinces and Federal Administered
Territories
Quality assurance: activities aimed at the prevention of nonconformities in laboratory testing as per
international standards.
Quality control: activities aimed at the detection of nonconformities during and after laboratory
testing.
Quality management: a coordinated set of activities needed to control, assure and manage the
quality of the laboratory's processes with the aim to provide consistent and reliable results in an
efcient way.
Sustainable: Ability to maintain certain capacities or use a resource so that the resource is not
depleted or permanently damaged
Tiered Laboratories System: A system of laboratories arranged at different levels
(National/Regional or Provincial, District/Tehsil and Community)
8
 Policy Statements
Component 1: Regulatory and legal framework
Legislation
Outcome: Continuous, consistent laboratory policies, laws, rules and regulations that are fully
implemented, monitored and enforced.
1. Federal and Provincial legislation on laboratory services shall be harmonized with the
National Laboratory Policy and Strategic Plan and be in line with international
recommendations.
2. All laboratory policies shall take the One Health concept into account.
3. Trained and competent laboratory experts from all relevant sectors shall be involved in the
development of laboratory-related policies, laws and regulations.
4. Legislation shall specically include biosafety and biosecurity requirements including safe
standard transport/shipment of specimens.
5. There shall be a mechanism to regularly review and update all laboratory-related policies,
plans, laws, and regulations to ensure that they are in line with the latest developments in
the eld of laboratory services.
6. There shall be a mechanism to enforce implementation of policies and legislation.
7. Implementation of laws and regulations shall be monitored and evaluated to ensure
compliance and identify points for improvement.
8. The list of notiable diseases as well as the notication mechanism(s) shall be regularly
updated in line with national and international requirements.

Licensing
Outcome: All laboratories and laboratory workers in Pakistan are registered and licensed.
9. There shall be a licensing body at federal and/or provincial level for licensing laboratories
as well as laboratory workers.
10. All laboratories and laboratory workers (public and private) shall be licensed according to
the national standards to ensure quality of services.
11. The laboratory license shall be periodically renewed after re-inspection to ensure
continued compliance with the standard.
12. The laboratory worker's license shall be periodically renewed based on a dened set of
criteria.

9
 Policy Statements
Component 2: Coordination and networking
Structured networks
Outcome: Functional laboratory network system(s) with a dened harmonized package of services
and effective communication, collaboration and coordination.
1. There shall be a Federal coordinating and advisory mechanism, whereas the Provinces
shall have the implementing arm for the Laboratory strategic framework.
2. Sustainable, accessible and rationally designed tiered laboratory networks under the One
Health concept shall support disease management, surveillance, prevention and control.
3. Vertical program laboratory networks shall as far as possible be integrated into the general
laboratory network.
4. The best practices of the vertical program laboratory networks shall be taken into account
in the design of the tiered laboratory networks.
5. Standardized Terms of Reference with clear and distinct roles and responsibilities shall be
prepared for each tier of the laboratory network to ensure harmonized laboratory activities.
6. There shall be a robust laboratory-based surveillance system for diseases of public or
animal health importance.
7. All public and private laboratories shall be part of or report to relevant human and animal
health surveillance networks.
8. There shall be a national laboratory database for all laboratories indicating the scope of
service delivery.

Referral systems
Outcome: Standardized safe and secure handling, packaging, storage and transport of sample and
data including appropriate communication within the facility, across the country and abroad.
9. A national system for efcient, reliable, timely and safe sample referral and reporting
system shall be designed and implemented to ensure standardized and traceable sample
referral.
10. National sample/patient referral guidelines shall be based on international guidelines.
11. Institutes shall implement and familiarize the staff for safe handling storage, packaging
and transport including accidents such as leakage and spills of biological materials.
12. Local courier services should be authorized by National Biosafety Committee and guided
for proper and safe transport of such specimens.

10
 Policy Statements
13. A system of international sample referral shall be in place and regularly tested to ensure
safe and secure transportation of samples in compliance with international regulations,
including IATA rules.
14. The laboratory budget shall have a separate earmarked allocation for sample referral.

Coordination
Outcome: Efcient and effective coordination between all stakeholders in the laboratory sector.
15. Relevant Federal and Provincial Ministries shall have a dedicated laboratory policy and
planning unit to ensure the availability of relevant expertise at Government level.
16. Expertise, knowledge and capacities exchange mechanisms among different laboratory
sectors shall be in place to ensure efcient use of resources, information and data sharing.
17. There shall be a coordination mechanism for laboratory based surveillance for notiable
diseases.
18. The Federal Government shall promote and strengthen effective communication,
collaboration and coordination between Federal and Provincial authorities to ensure
harmonization of activities.
19. Expertise, knowledge and capacities exchange mechanisms between professional
organizations shall be in place to ensure efcient use of resources, information and data
sharing.
20. There shall be appropriate and effective linkages among public laboratories and between
public and private laboratories to ensure coordination of activities.
21. Communication and information technology developments shall be harnessed to facilitate
transmission among laboratories and laboratory networks.
22. There shall be an intersectoral body of national representatives comprising of laboratory-,
quality and biosafety- and biosecurity experts endorsed at Federal and Provincial levels.

11
 Policy Statements
Component 3: Equitable accessibility
Outcome: Equitable and accessible laboratory services for all.
1. Network design criteria shall include geographical distribution and operating hours to
ensure equitable accessibility of laboratory services.
2. In places where laboratory services are not available, a system of sample collection and
referral stations shall be set up to ensure equitable access.
3. Advocacy activities shall be undertaken to raise the awareness and augment the trust of
the general population and the professional community in existing laboratory services.
4. A Code of Ethical Conduct shall be developed that will guide all laboratory personnel and
services.
5. Laboratory staff shall treat all clients with respect and shall safeguard condentiality and
privacy.

Component 4: Infrastructure
Outcome: Well-maintained, standardized, functional, safe and secure laboratory facilities.
1. National minimum standards and guidelines for laboratory construction and design
according to function and tier requirements shall be developed. These shall include safety
guidelines based on assessed risks of biological hazard and threat and uninterrupted
supply of basic utilities.
2. A mechanism and approved budget shall be in place for skilled construction and
continuous maintenance of laboratory premises.
3. Licensing requirements shall include compliance of laboratories to these national
standards and guidelines to ensure continuous and high quality laboratories services.

12
 Policy Statements
Component 5: Finance
Outcome: Adequate and sustainable funding and nancing mechanisms for laboratory services at
all levels.

Budget and budgeting

1. Each province shall have a secure-targeted budget for laboratory services as a whole
based on need assessments. Consequently, each public laboratory shall receive a
dedicated budget to cover actual expenditures.
2. The laboratory budget shall cover laboratory operating, management, maintenance and
capital costs.
3. A transparent and regular independent auditing system shall be in place to ensure
programmatic and nancial accountability of the laboratory services.
4. There shall be a secure-targeted budget for emergency testing in case of public health
emergencies.
5. Laboratory activities related to disease surveillance shall receive sustainable public
funding.
6. There shall be dedicated training programs for laboratory managers and auditors in
laboratory budgeting to ensure transparent and correct handling of budgets.

Income generation
7. There shall be a rationalized costing formula including direct as well as indirect costs for
establishing and regularly updating the justiable prices of testing.
8. There shall be a regularly updated list of laboratory services that are provided free of
charge through public funding by public and public-private partnerships laboratories.
9. All public laboratories shall be allowed to charge for their services and a xed percentage
of the funds thus generated will be earmarked for that laboratory.
10. Appropriate nancial support shall be extended to private laboratory facilities for
laboratory services provided as part of Public Private Partnerships.
11. There shall be public-private partnerships for outsourcing of auxiliary services to ensure
high quality and cost-efcient services.
12. Laboratory tests that are included into health insurance schemes shall be reimbursed for
both outpatient and inpatient testing.
13. There shall be a coordination mechanism between the Government and donors to ensure
efcient and effective use of nancial resources in line with the National Laboratory Policy
and its implementation plans.

13
 Policy Statements
Component 6: Human Resource Management
Outcome: Availability of well-trained, competent and motivated staff in adequate numbers capable
of providing quality laboratory services.

Organizational structure
1. The staff/workload ratio for each laboratory shall be determined and regularly reviewed in
an evidence-based way to ensure an appropriate workload.
2. The laboratory at each tier of the network shall be staffed by the recommended number of
competent and appropriately trained personnel to ensure quality laboratory services in
line with its dened terms.
3. All laboratories shall have an organizational chart clearly indicating the lines of authority.
4. All laboratories shall have an adequately trained laboratory manager to ensure both
technical and managerial leadership.

HRM
5. Job descriptions with dened tasks and responsibilities as well as requisite qualications,
competencies, skills and attitudes shall be developed for each position in the laboratory.
6. A transparent service regulatory policy regarding hiring, career development and service
termination shall be implemented. Background checks shall be performed before hiring
staff where applicable like sensitive tasks, working in BSL3 or BSL4. Laboratories, etc.
7. All laboratory staff shall adhere to the Code of Conduct to protect patients/clients against
exploitation and harm.
8. A mandatory orientation program shall be in place for all newly hired staff regarding
laboratory environment and their tasks before commencement of work to ensure the
quality of their work.
9. Personnel les in accordance with international requirements shall be available for each
laboratory worker.
10. There shall be an intersectoral national database of laboratory personnel working in both
in both the private and the public sector.
11. A system of career development and nancial and non-nancial incentives for high-
performing staff shall be designed to increase staff motivation and retention.
12. The salary structure of the different levels of laboratory workers in all sectors shall be
regularly reviewed to ensure that they are competitive with similar professional categories
to ensure retention of staff.
13. All laboratory staff shall have a regularly renewed license to practice.

14
 Policy Statements
Pre-service training
14. Minimum relevant educational qualications shall be dened for each staff level to ensure
adequately qualied staff.
15. Laboratory training curricula shall be competency-based and include theoretical
knowledge and practical skills development as well as mandatory internship.
16. Existing laboratory training curricula shall be reviewed and, where necessary, updated
and harmonized to ensure that they are in line with the requirements of modern day
laboratories.
17. All training Institution/training programs shall be accredited.
18. Sustained funding support to both pre-service and continuing education trainings as well
as Training of Trainers shall be identied to ensure sustainable in-country capacity.

Continuing education
19. There shall be a system of continuing education and training for laboratory personnel to
improve their working skills, knowledge and ethics to ensure staff motivation and quality
laboratory services.
20. There shall be an effective continuing education program for laboratory professionals in
coordination with universities, vocational training institutes and other relevant
stakeholders.
21. Continuing education and/or re-training shall be part of the laboratory workers' licensing
requirements.
22. A dedicated budget for continuing education activities shall be available at institutional
level.
23. It shall be the responsibility of the employer to provide opportunities for all laboratory
personnel to participate in appropriate continuing education activities.
24. There shall be periodic trainings including competency assessment for biosafety and
security.
25. There shall be specialized education programs for laboratory quality management
systems.
26. There shall be a specialized education programs for laboratory managers on laboratory
leadership and management.
27. Participation in national and international training programs shall be encouraged to ensure
experience and expertise exchange.

15
 Policy Statements
Component 7: Equipment and consumables
Outcome: A steady supply of quality reagents and consumables and well maintained, high quality
equipment are available at all laboratories.

Procurement
1. Procurement shall be based on the specications provided by the end users with guidance
of a laboratory procurement specialist if required.
2. A transparent system of tendering shall be followed taking both quality and price into
consideration.
3. The public procurement procedure shall be uniform, streamlined, monitored and regularly
reviewed to ensure the continued timely procurement of quality materials for all tiers of the
laboratory network.
4. There shall be procedures in place for emergency procurements.
5. Laboratory supplies and equipment shall only be purchased from qualied and certied
companies taking the recommendations of end-users into account.
6. Each laboratory budget shall have an approved budget line for procurement of laboratory
equipment and supplies.
7. Training in supply management shall be promoted at all tiers of the laboratory network to
ensure steady supplies.
8. There shall be a proper documentation system to support supply management (electronic
and/or paper based).
9. All donations of equipment and supplies shall be accounted for on mutually agreed terms
and conditions and shall be needs-based.

Equipment maintenance
10. Equipment contracts shall include installation, initial validation, training and after-sales
services including maintenance.
11. Each laboratory shall have an annual maintenance plan and an approved budget line for
equipment maintenance, calibration and validation to ensure optimal functioning of its
equipment.
12. Each laboratory shall have access to biomedical engineering services for equipment
maintenance and metrology.
13. There shall be a body to license agencies to certify biosafety cabinets in accordance with
accepted international standards.
14. There shall be a system for safe de-commissioning and disposal of obsolete laboratory
equipment.

16
 Policy Statements
Component 8: Information and data
management
Information and communication technology
Outcome: An efcient and effective information and communication system with adequately trained
staff structured to the needs of the users and beneciaries.
1. All laboratories shall have access to information technology with proper data storage and
backup facilities for communication and staff trained in the use of these facilities.
2. All databases and data exchange mechanisms shall be designed to ensure data security
and patient/client data condentiality.
3. A system shall be set up to ensure direct communication and data exchange within the
laboratory network, including remote areas. Direct communication for consultation shall
be made available 24/7.
4. A system shall be set up to inform and advise professionals about the available tests and
the interpretation of test results to ensure informed decision making.

Data management
Outcome: Adequate and efcient data management contributing to evidence-based decision
making.
5. All laboratories shall have access to (electronic) databases relevant to their Terms of
Reference and staff trained in the use of these databases.

LIMS
6. There shall be dedicated LIMS units at national and provincial levels.
7. There shall be a mechanism in place for regular compilation, exchange and analysis of
laboratory management data to improve planning and decision making at Federal and
Provincial levels.

LIS
8. There shall be a laboratory sample and data management program to ensure efcient
sample and data handling.
9. There shall be a uniform national coding system for national and provincial laboratory
databases.
10. There shall be effective and efcient, standardized and harmonized reporting systems at
different tiers of the laboratory networks.

17
 Policy Statements
11. There shall be unied guidelines for laboratory-based disease surveillance and data
analysis to ensure timely decision making for disease control and outbreak response.
12. There shall be a systematic inter-sectoral data and information exchange mechanism in
place to allow coordinated and rapid responses when needed.

Component 9: Quality management systems

Outcome: Efcient, high quality laboratory services providing accurate, reliable and timely results.

Quality assurance
1. All laboratory testing shall include appropriate controls and quality assurance to ensure
reliable results.
2. There shall be a regularly updated list of approved tests and testing algorithms for each tier
of the public laboratory network.
3. There shall be designated entities that provide EQA services for all laboratories within the
country.
4. Approved external quality assurance schemes shall be expanded to all critical tests to
ensure quality results.
5. There shall be sets of quality indicators for the different tiers of the laboratory network to
objectively assess the quality of the services provided by the laboratory.
6. Laboratory licensing criteria shall include use of quality indicators and participation in
selected EQA programs.
7. Reference laboratories shall be encouraged to participate in international quality
assurance programs.

Quality management
8. Regularly reviewed and updated national quality standards for each laboratory tier shall be
developed on the basis of international standards to improve quality of laboratory services.
9. Each laboratory shall conform to the national quality standards as part of its licensing
requirements to ensure quality of services.
10. A trained quality focal person shall be available at each laboratory to ensure sufcient
attention to quality aspects of the work.
11. Awareness and sensitization programs on the importance of quality shall be developed for
laboratory staff, managers and other stakeholders..

18
 Policy Statements
Certication and accreditation
12. All reference laboratories shall be encouraged to obtain accreditation according to
international standards.
13. There shall be auditing systems for licensing of laboratories and laboratory workers to
ensure compliance to national quality standards.
14. There shall be incentives to ensure motivation of laboratories to reach certication or
accreditation.

Component 10: Occupational health

Outcome: Laboratory staff is well protected from occupational health hazards.

Occupational health
1. There shall be a comprehensive occupational health program for all laboratory workers
including medical check-ups, vaccinations, accident management, ergonomics and risk-
group management (for example pregnant women, immune compromised or disabled
persons).
2. Sufcient and appropriate personal protective equipment shall be available at all
laboratory facilities.
3. There shall be a system in place for incident reporting and corrective and preventive
measures.

Component 11: Biorisk management and waste

management
Outcome: Laboratory services that are safe to staff, clients, the community and the environment.

Waste management
1. All institutions dealing with biological materials shall have an effective waste management
program that incorporates waste segregation at the time of waste generation, waste
minimization, waste disposal and documented traceability of the disposed material.
2. All institutes/laboratories shall provide proper training of staff in waste handling.
3. In case of third party involvement for the waste disposal, the institute shall assess this third
party's capacity and capability (EPA approved or similar).

19
 Policy Statements
Biorisk management
4. Each laboratory shall have a laboratory safety focal person.
5. There shall be a National Biosafety Committee comprising of experts in laboratory
biosafety and biosecurity from all sectors and endorsed at Federal and Provincial levels.
This Committee shall be responsible for overall implementation and monitoring of
biosafety and biosecurity legislation and guidelines.
6. All safety guidelines will be regularly reviewed, updated and communicated to laboratory
personnel and administration.
7. Each laboratory dealing with biological materials shall have an institutional
biosafety/biosecurity committee.
8. All laboratories shall have emergency management plans in place.
9. Each laboratory dealing with biological materials shall have an approved annual budget to
implement its biosafety and biosecurity program.

Component 12: Research

Outcome: A research culture is fostered in the country that is compatible with international
standards.
1. The existing Codes of Conduct for Researchers shall be reviewed, harmonized and
universally implemented. Review shall include concerns related to dual-use of research
(biosecurity).
2. All research proposals involving living organisms shall be approved by the institutional
ethical review board.
3. The Government shall mobilize resources for research activities from public funds, private
sector alliance, donors and external universities and institutes.
4. A mechanism for inter-institutional infrastructure and knowledge sharing shall be set up to
ensure efcient use of resources for high quality research.
5. A dedicated budget shall be available for research to strengthen infrastructure, personnel,
equipment and training.
6. There shall be a system of continuing education for research personnel to improve their
research skills including research methodology, proposal writing and ethics.
7. An approval mechanism shall be designed to use research outcomes for routine testing
after validation, trials and standardization.

20
 Policy Statements
8. Research forums shall be established to ensure communication of research results with
stakeholders.
9. Research activities shall be promoted at all levels and shall conform to national goals and
priorities, while reecting local needs.

21
 Policy Implementation
The development and approval of a National Laboratory Policy needs to be followed by the
development of Federal and Provincial Laboratory Strategic and Operational Plans that ensure
that the Policy statements are translated into actions that are carried out in an integrated manner at
a pace that is in-line with the country's and provinces' managerial and nancial resources.
Development of strategic and operational plans again requires the support of many sectors of
society and government. It will be of utmost importance that all actors involved in the planning
process have realistic and accurate expectations and will operate in an effective, coordinated and
timely way. The strategic plans must be living documents, implemented through continual annual
operational plans that are linked back to the plans' goals and objectives and updated as needed to
reect successes and lessons learned. The operational plans focus on specic technical and
managerial areas, should have clear objectives, indicators identied and activities spelled out.
An intersectoral core leadership team including representatives from the provincial governments
as well as laboratory experts, guided by the Ministry of National Health Services Regulation &
Coordination, should move forward at an administrative and political level; it will act as the driver of
the overall process, will give management oversight and vision to the entire program, including
specialist task groups, as required. Relevant Ministries and departments will be responsible for
implementation of the National Laboratory Policy.

22
 Annex I
The process of Policy development
The development of the National Laboratory Policy followed WHO guidelines and was divided into
three phases:

Phase 1: Preparatory activities

The NLWG was ofcially established and essential information on the country's laboratory system
was collected. For the collection of this information the system questionnaire of the Laboratory
Assessment Tool (LAT) developed by World Health Organization (WHO) was used
(http://www.who.int/ihr/publications/laboratory_tool/en/). Information on the laboratory system
was gathered and analyzed before and during the rst workshop (see Annex II).

Phase 2: Workshops and activities for the development of a National

Laboratory Policy
This phase involved 3 facilitated workshops of 3 days each, the rst of which was conducted during
a broader assessment visit. During these workshops participants of the NLWG worked together on
the development of the National Laboratory Policy using an established methodology, as
described in the facilitators guide of WHO for Policy development. The rst Policy development
workshop was held in Islamabad on 4-6 February 2015, the second workshop on 6-8 October 2015
and the nal workshop on 9-11 November 2015 under the guidance of the Ministry of National
Health Services Regulation & Coordination and WHO Regional and Country Ofce. Dr. Linda
Oskam of the WHO Collaborating Centre for Laboratory Strengthening at KIT (Royal Tropical
Institute), Amsterdam, the Netherlands and Dr. Musa Rahim of the WHO Country Ofce in Pakistan
served as facilitators for these workshops.
During these workshops the foundation for a National Laboratory Policy was build, through
development of Vision 2025, performance of SWOT analysis (Annex III) and formulation of Policy
components and their sub components.

Phase 3: Policy dialogue and nal draft preparation

After the third workshop a Policy dialogue process was set in motion to discuss the draft National
Laboratory Policy before endorsement. This ensured national ownership as well as the
commitment of all the relevant stakeholders.

23
 Annex II
Outcomes of the LAT system assessment
The summary outcomes of the assessment and the gap analysis are given in Figures 1 and 2. The
outcomes were veried and discussed during the meeting on 4-6 February and formed the basis
for subsequent discussions.

Limitations
Because of the short time frame in which the LAT tool had to be completed, it was not possible to
collect all the documentation or perform extensive interviews with a large group of experts.
However, the questionnaires were lled in by a group of three experts and the overall outcomes
were veried by and discussed during a meeting with a large group of experts on 4-6 February
2015.
Due to the devolved laboratory system, with the responsibility essentially at provincial level, it is
difcult to give an overarching picture of the laboratory system situation in Pakistan. From the
discussions it became clear that the situation is quite heterogeneous, leading to many “partial” (2)
scores in the LAT tool. The system in Punjab is in many aspects further developed than the rest of
the country. It would be good to do LAT system assessments at provincial level to get a better
insight into this heterogeneity and design locally relevant interventions.

Analysis of the assessment outcomes

0% 20% 40% 60% 80% 100%

Coordination and management

Structure and organization

Regulations

Quality of laboratory system

Laboratory information management

Infrastructure

Human resources

Biorisk management

Figure 1: Summary outcome of the laboratory system assessment

Figure 1 shows a typical picture for a system that is at the building up stage. Many activities are
being undertaken in Pakistan and many ideas, plans and draft documents are present, but
adoption, implementation and enforcement are mostly still in its infancy. This is reected in the
overall score of 36%.
Two topics had medium scores (50-75%): biorisk management and structure and organization.
Biorisk management (55%)

24 
 Annex II
There is a high awareness among the experts of biorisk issues, but they felt that the score for this
topic was too high. The high score was mainly due to the existence of in-country and international
sample transportation systems, even though it was indicated that the compliance of the in-country
courier services with biosafety regulations was variable, even though it was improving. Dedicated
transportation materials for national sample transportation are available at NIH, but not at all
locations. Where it is not available laboratory staff uses alternatives to comply with the rules as
good as possible.
The international shipments are carried out according to the IATA regulations and materials and
couriers for this are available.
National legislation regarding biosafety measures and requirements has been developed, but this
is still in draft.
The absence of national certication bodies for biosafety cabinets (BSCs) was perceived as a large
problem: BSCs now have to be certied by international experts (often the manufacturers) and this
is costly and it is not always clear to the laboratory managers whether this is done to international
standards.
Safety measures for laboratory staff (vaccinations etc.) is only partly in place.
Structure and organization (53%)
The relatively high score of structure and organization is mainly due to the presence of some
reference laboratories. However, there are still many shortcomings, the main being that there is no
comprehensive list of laboratories in Pakistan. Especially in rural areas there are many very small
private laboratories that are run by technicians and the quality of services is unclear. A system of
mandatory registration and licensing could give a better insight in the laboratory sector and would
assist the design of tiered networks and referral mechanisms.
The remainder of the categories scored low (below 50%).
Quality of laboratory system (36%)
There are no national laboratory quality standards. With the absence of national laboratory
registration and licensing system (see above) it would be difcult to implement these, even when
they would be present.
The TB program participates in the international prociency testing organized by the
Supranational Laboratory in Antwerp, Belgium. Armed Forces Institute of Pathology (AFIP) has a
quarterly prociency testing EQA program in which civilian laboratories can participate against a
nominal fee, but participation from the civilian sector is low. The AFIP EQA program is currently for
chemistry, microbiology and haematology and can provide an excellent basis for setting up an all-
encompassing EQA system that should include as many laboratories and laboratory topics as
possible.
There are few accredited laboratories in Pakistan (8 are ISO-15189 accredited and 24 are ISO-
17025 accredited, there are also some laboratories that are JCI and CAP accredited or are in the
process of obtaining this accreditation). However, Pakistan National Accreditation Council (PNAC)
exists that can perform accreditation services for both ISO-15189 and ISO-17025.

25
 Annex II
Coordination and management (33%)
The low score for this topic is mainly due to the devolved system, with only limited opportunities for
the Federal Government to provide overall coordination. There is a central public health laboratory
and compliance with IHR regulations is a Federal responsibility. There is no national laboratory
policy, but a rst step to develop this was set during the current mission.
Funding of services is a mix of government funding, client fees, donor contributions and private
insurance payments. A national health insurance for low income groups (living below the poverty
line) is envisaged for 2015, but this only covers inpatient services, including laboratory services.
This platform provides a basis for future expansion to universal coverage.
Coordination with donors is partial at best.
Infrastructure (33%)
The situation in the country is heterogeneous. A huge concern at the moment is the frequent load
shedding throughout the country, which requires the universal presence of generators for the
laboratories to ensure uninterrupted electrical supply. Unfortunately, the LAT tool only has 3
questions in this section, making it difcult to interpret the score.
Laboratory information management (30%)
There is a unit at the NIH that collects and analyses data and also provides a seasonal newsletter
regarding notiable and epidemic-prone diseases. However, most laboratories still use paper-
based systems that are not standardized and data are provided at the aggregated level.
Human resources (30%)
The quality and number of staff seems to be inadequate, even though pre-service training is
improving. However, there are private educational institutes that provide curricula that do not cover
the basic needs of the laboratories. So pre-service training seems to be variable. There is no
dedicated system of in-service training and as there is also no register or licensing system for
laboratory workers, it is difcult to ensure the competencies of the laboratory workers.
Regulations (17%)
There is no regulatory system for public or private laboratories in Pakistan. In the absence of a
comprehensive register of laboratories (see above) this would also be difcult to enforce, even
though this can be a chicken and egg question which can be solved by only registering
laboratories that have a license to operate. This would only work if there are also enforcement
mechanisms (nancial or punitive) in place.
Legislation is mostly absent. Some document have been developed, but these are mostly still at
the draft stage and need to be implemented.

26
 Annex II
Gap analysis

Gap analysis, from 0 (no gap) to 5 (high gap)

0 1 2 3 4 5
Financial resources for laboratory activities
Human resources qualications and availability of suitable
Equipment adequacy
Reagent and consumable quality
National guidelines on specic laboratory practices
Collection of specimens
Transportation of specimens
Laboratory organization, service delivery structure, and networking
Regulatory framework
Laboratory safety or security
Quality assurance
Recognition of importance of laboratory services
Political commitment (national laboratory policies, budget, etc.)
Database of laboratory workers and organized information systems

Figure 2: Outcome of the gap analysis

The analysis identied gap in all areas. The main gaps (scores 4 and 5) are due to the weak
legislative and regulatory structure that is currently in place in Pakistan and to insufcient advocacy
for the importance of laboratory services to clients (patients and doctors) and policy makers.
Additional weaknesses
Two topics were added (both score 4):
Ÿ A database of laboratory workers
Ÿ Organized information systems
A more detailed identication of weaknesses is given as part of the SWOT analysis (Annex III).

27
 Annex III
Reviewed SWOT analyses for the 11 Policy
topics, sub-topics and evidence
Key: F: Fact; O: Opportunity

Topic 1: Regulatory and legal framework

Strengths Weaknesses
1. Licensing and regulatory mechanisms are in 1. No legal framework for laboratories to
place for blood transfusion laboratories (F) address One Health issues at regular basis,
2. Health care commission regula ons in only ad hoc (F)
Punjab, KP and Baluchistan for laboratory- 2. One Health concept is not universally
related issues (F for human health; understood at various levels (O)
Baluchistan Clinical Laboratory Authority Act 3. Lack of laboratory policies (F, Punjab and KP
since 2005; Punjab veterinary health have policies)
regula ons as well) 4. Absence of laboratory regula ons in Sindh,
3. Many universi es and ins tutes have AJK, GB, and at Federal level (F)
bioethical commi ees (F) 5. Lack of con nuity, consistency,
4. Na onal Biosafety Act (2005) by implementa on, monitoring and
Environmental Department (F; also enforcement of policies, rules and
important for topic 10) regula ons between provinces (EO/F,
5. Regula ons for No fiable Diseases (F; list example pre-marital tes ng for thalassemia)
varies per province) 6. Absence of na onal regulatory agency for
6. Mechanism of no fica on and list of licensing of labs in Pakistan (F)
no fiable diseases (human and zoono c) is 7. Licensing and registra on only for human
in process (F; expected coming months) labs and only has recently started in KP and
Punjab (F; Baluchistan has licensing log of
BCLRA)
8. Unregulated and unregistered private
laboratories, o en run by unauthorized staff
(F)
9. Unsupervised side laboratories in some
public facili es (F)

28
 Annex III
Opportuni es Threats
1. Devolu on of responsibility for laboratories
1. IHR and GHSA force strengthening of the
to the provinces may create local
laboratory system (F)
opportuni es or threats depending on
2. Devolu on of responsibility for laboratories
provincial government (EO)
to the provinces may create local
2. Lack of interest regarding One Health
opportuni es or threats depending on
concept and laboratory services in general
provincial government (EO)
(O)
3. Interest of interna onal organiza ons (WHO)
3. Lack of priority for health issues among
in policy and legisla on development (F)
poli cians (F; based on GDP% spent on
4. One Health concept recognized for some
health)
diseases (F; avian flu, CCHF, dengue, polio in
4. Weak implementa on of legisla on in
environment)
general (F)
5. Availability of health legisla on other than
5. Weak human resources for health policy
specific laboratory legisla on (F)
making and management (O)
6. Unnecessary poli cal interference in daily
management of laboratories (F)
7. Lack of con nuity among policy
makers/health managers due to frequent
turnovers (F)

Subtopics
Ÿ Legislation
Ÿ Licensing

29 
 Annex III
Topic 2: Coordination and networking
Strengths Weaknesses
1. (Successful) ver cal programs and laboratory 1. Lack of coordina on between laboratories;
networks for TB, malaria and HIV (F) network structure is not well defined (EO)
2. TB program has private and public mix of 2. Lack of coordina on between human and
laboratories (F) veterinary public health sectors (F; for most
3. Some lab-based surveillance systems present diseases).
and data are shared (F; e.g. TB, dengue, 3. Lack of ered laboratory networks (F; a er
CCHF, Naegleria, Influenza) devolu on this disappeared except for
4. Formula on and no fica on of NLWG by the ver cal programs)
Federal government having representa ves 4. Lack of standardiza on of lab services across
from various sectors (F) the country (F)
5. Professional associa ons represen ng 5. Lack of integra on of the laboratory
medical, veterinarian, and agriculture component of ver cal programs in the
professionals exist (F) general laboratory system (F; parallel tes ng
6. There is collabora on under the One Health facili es)
concept for some zoonoses.(F; see above) 6. Lack of referral mechanisms for most of the
7. There is repor ng for some diseases from diseases (F)
districts to higher levels (F; e.g. dengue) 7. In-country sample transporta on system is
8. Na onal IHR focal point (F; at NIH) weak for most diseases due to lack of
9. Successful program under FELTP funded funding and transport infrastructure (F)
through interna onal agency (F) 8. Interna onal sample referral system is not
10. Interprovincial coordina on mechanism for clear for all situa ons (F)
some ver cal programs (F; TB, HIV, polio) 9. Lack of integrated diseases surveillance
programme backed with a network of Public
Health Laboratories (F)
10. Lack of integrated disease surveillance
program for emerging infec ons (F)
11. Weak traveller surveillance at ports of entry
(O)
12. Lack of updated list of no fiable diseases at
na onal level (see topic 1)
13. Lack of coordina on between different
professional associa ons (F)
14. Lack of linking research labs with rou ne
labs for use of research data for evidence
based rou ne tes ng (F)

30
 Annex III
Opportuni es Threats
1. Successful ver cal programs for TB, malaria, 1. Devolu on of health system makes
avian influenza and HIV can serve as models coordina on and networking more
for QA ered lab networks (O) challenging (O)
2. Availability of mobile technologies to 2. Due to security threats access to certain
strengthen networking and coordina on (F) areas is limited (F)
3. Successful program under FELTP funded 3. Embargo on interna onal travel in case of
through interna onal agency can provide emergence of communicable disease
example of intersector coordina on (O) (outcome of lack of lab services; reason to
4. Professional associa ons can be brought improve your lab system)
together under the roof of One Health to 4. Impact of diseases to Pakistan that may
increase communica on and networking (O) become uncontrollable due to lack of
surveillance at ports of entry (as previous
one)

Subtopics
Ÿ Structured networks
Ÿ Referral systems
Ÿ Coordination

31
 Annex III
Topic 3: Equitable accessibility
Strengths Weaknesses
1. Basic package of tests available for free in 1. Unequal distribu on of laboratory services
many public health and veterinary labs (F) especially in rural areas (F)
2. Specimen transport mechanism in some 2. Limited trust in laboratory services (O), but
programs increases accessibility (F) it is improving
3. Private health insurance schemes (F) 3. Services not available 24/7 everywhere (F)
4. Limited opening hours for outpa ents (F)
5. Majority of insurance schemes only for
inpa ent care (F)

Opportuni es Threats
1. Government health insurance system (F) 1. Low literacy rate (F)
2. Government interest in equitable access to 2. Lack of knowledge and awareness among
quality labs (idem) the general public as health is not a
3. Interna onal interest in health care systems separate topic in school/college educa on
strengthening (F) (F)
4. Vibrant mass media sector (F) 3. Social norms leads to decreased access for
5. Media awareness (O) some (F)
6. Sensi za on of young popula on on health 4. No trained health journalists (F)
issues (F; blood dona on day, hepa s day,
school programs, etc.)

32
 Annex III
Topic 4: Infrastructure
Strengths Weaknesses
1. There are a few high level public and private 1. Majority of private laboratories are not
laboratories (F) located in designated laboratory buildings (F;
2. Basic laboratory infrastructure is present in many in residen al or commercial buildings)
most hospitals, research ins tutes and 2. Laboratory design and construc on for
universi es (F) majority of laboratories not at par with
3. Well-organized infrastructure in ver cal interna onal standards (F)
programs (F) 3. Lack of specialized design specialists,
architects and engineers for laboratory
designing, construction and maintenance (F)
4. Certain specialized construc on materials
have to be imported (F)
5. Inadequate engineering and financial support
for infrastructure maintenance (F)
6. Bidding process for building facili es in public
sector is so complicated that good
companies do not tender (F)
7. Lack of water storage tanks for regular water
supply (F)
8. Lack of generators, gas and petroleum at
most facili es (F)

Opportuni es Threats
1. Funding sources are available from donors 1. Lack of water supply (F)
for laboratory renova on and improving 2. Repeated power failures (F)
infrastructure (F; graduates, alumni, JICA, 3. Poor general infrastructure for
KfW, GF) commodi es such as electricity,
2. Construc on consulta on on issues such as water, sewage, etc. (F)
lab design, BSL3 design and ven la on 4. Natural disasters such as like floods,
systems can be taken via electronic earthquakes, etc. (F)
communica on means (F)
3. Laboratory infrastructure of ver cal
programs can be used as role model and for
integra on to support other diagnos c
programs (O)

33
 Annex III
Topic 5: Finance
Strengths Weaknesses
1. Government is recently inves ng in some 1. Donor dependency (F; but only for ver cal
laboratories (F, KP, Sindh, Punjab) programs)
2. Some commi ed funds from the 2. Insufficient funds for daily opera on of the
government for public laboratory staffing, lab due to lack of propor onate increase
some supplies, some equipment, including (infla on, increased workload) in alloca on
universi es (F) of funds/resources for most public
3. Some public laboratories are genera ng part laboratories (F)
of their own budget (F) 3. Some public laboratories are genera ng
4. Availability of Global Fund Grant (F; un l some of their own budget (F)
December 2017) 4. Inadequate budget; and laboratory experts
5. Alloca on of funds in light of IHR and GHSA not involved in comprehensive budget
(F; CDC grant for public health lab network, planning (F).
WHO) 5. Laboratory manager not integrally involved
6. Funds available for (interna onal) zoonosis and not trained in budget planning (F).
diagnosis and surveillance (One Health) (F; 6. Insufficient in-house financial audi ng
CDC coopera ve agreement, Ministry of capacity by medical technical auditors (F)
Food Security and Research) 7. Unnecessary or wrong tes ng by
7. Introduc on of PPMs and PPPs in exis ng laboratories due to financial perverse
public labs (F) incen ves (commissions) and/or over-
reques ng by health workers (F)
8. Unregulated prices in private sector (F)

34
 Annex III
Opportuni es Threats
1. People are prepared to spend for quality 1. Economic and geopoli cal instability (O)
services (O) 2. Inappropriate use of funding (O)
2. Demand for lab tests for which the client has 3. Lack of sustainability of resources, including
to pay is increasing (O) donor dependence
3. Funds genera on through charity and 4. Large and rapidly growing popula on (F)
donors 5. Demand for lab tests which have to be
4. Geopoli cal situa on leads to Pakistan being provided for free is increasing (O)
on the interna onal radar for health
investments (O)
5. General donor interest in improving the
laboratory sector
6. High incidence of zoonosis can a ract
interna onal funding (O)
7. Social franchising expansion (F)
8. Public and private health insurance systems

Subtopics
Ÿ Budget and budgeting
Ÿ Income generation

35
 Annex III
Topic 6: Human Resource Management
Strengths Weaknesses
1. Staff levels are improving because of be er 1. Organograms are missing in many
training programs (F) laboratories (F)
2. Ins tutes are available that offer laboratory 2. In government system mostly no specific
technologist courses and higher specialized posi on for phlebotomist in the organogram
degrees (F) (F)
3. Good and structured training for 3. No job descrip ons with defined
pathologists (F; CPSP, and PhD/M.Phil from qualifica ons, competencies, skills, a tudes
universi es) (F)
4. Higher Educa on Commission approves 4. Posi on of laboratory manager does not
curricula for more than 1 year diplomas and formally exist in most of the public labs (F;
degrees (F) senior most person func ons as such)
5. Government and private ins tutes are 5. Lack of qualified experienced laboratory
offering courses (F) managers (F; no training program available)
6. CMEs and training workshops by 6. Implementa on of hiring, promo on and
governmental and non-governmental firing policies is not universally transparent
ins tutes are increasingly available (F) (EO)
7. Service structure (i.e. career structure) for 7. Lack of trained and duly qualified staff in
lab technologists and paramedical staff is most public and private laboratories (F)
present, but only in public sector (F). 8. Formal con nuing training programs are
8. Benefits to working in public sector (F; has weak and only mandatory for doctors (F)
to do with work package) 9. Scarcity of dedicated laboratory courses for
technical staff (F)
10. Staff/workload ra o is not always
ra onalized, leading to inappropriate
workload in most laboratories (F)
11. High turnover rates in private sector (O; want
to set up own labs due to lack of regula ons
or go abroad)
12. Lack of implemented accountability in the
public sector (F)
13. Lack of sa sfac on due to absence of career
structure and work condi on and lab
environment (O)
14. No compe ve remunera on package to
improve performance (O)

36
 Annex III
Strengths Weaknesses
15. Scarcity of biomedical engineers in Pakistan
laboratories due to lack of training
opportuni es and posi ons
16. University MSc and BSc curricula lack hands-
on experience due to lack of training
laboratories and weak internship programs
(F)
17. Insufficient capacity in recognized
standardized training centres (F)

Opportuni es Threats
1. Especially young staff is eager to learn and 1. Brain drain of qualified and trained staff
mo vated to look for opportuni es (EO) (F)
2. Opportuni es for jobs for trained lab
professionals (F)
3. Interna onal vendors in Pakistan can be used
for addi onal training opportuni es in
techniques and equipment (F; Roche, Abbo ,
Siemens etc)
4. Ver cal programs organize trainings which can
be opened to other staff (O)
5. Addi onal/external organiza ons (e.g. WHO,
CDC, FAO, ASM, etc) can be approached for
addi onal training opportuni es (F)
6. Interna onal online courses (F)
7. Telemedicine can be used to explore further
training between the centers (F)

Subtopics
Ÿ Organizational structure
Ÿ HRM
Ÿ Pre-service training
Ÿ Continuing education

37
 Annex III
Topic 7: Equipment and consumables
Strengths Weaknesses
1. Presence of interna onal companies in 1. Weak equipment maintenance and service
Pakistan (F) contracts (F)
2. Some equipment and consumables 2. Inadequate biomedical engineering support (F; see
manufactured locally (F) topic 6)
3. Rapid diagnos cs available for some 3. Inadequate system for standardiza on, calibra on
diseases (F) and cer fica on of equipment (F; not suitable for
4. Some reagents and kits are tax accredita on)
exempted (F) 4. Standardiza on of locally produced goods is weak
5. Rental basis procurement of (F; not all companies are ISO9001 cer fied)
equipment possible (F) 5. Insufficient exper se in wri ng specifica ons
resul ng in procurement of low quality goods (F)
6. Requirements of end users in lower level
laboratories are not always taken into account in
procurement procedures (O)
7. No laboratory regulatory authority for authorizing
quality equipment and consumables (F)
8. Public procurement procedure is me-consuming
and lengthy (F; at least 3 months)
9. Low budget for equipment procurement,
consumables and maintenance (F)
10. Time lag in receipt of goods due to shipment and
customs clearing delays
Opportuni es Threats
1. Introduc on of new technologies (O) 1. Fast technological developments leading to
2. No importa on restric ons on the established techniques becoming obsolete
majority of (new) technologies rapidly asking for new investments (O)
3. Demand for laboratory technology 2. New technologies are o en expensive (F)
training programs (topic 6) 3. Withdrawal of services/vendor from the country
(F; due to safety, market, regulatory issues)

Subtopics
Ÿ Procurement
Ÿ Equipment maintenance

38
 Annex III
Topic 8: Information and data management
Strengths Weaknesses
1. Par al availability of computerized LIS (F; 1. Many laboratories do not have computers
private, ver cal and some public [ter ary, and/or internet access (F)
academic] laboratories) 2. Lack of computer proficiency in many
2. Availability of internet services in many laboratories (F)
higher level laboratories (F) 3. Lack of LIS/LIMS in most laboratories (F)
3. Mobile phone communica on used for 4. Lack of integra on of laboratory data into
data exchange and repor ng (F) centralized databases (F)
4. Par al online data exchange system (F; 5. Insufficient data security and confiden ality (F)
only in private sector and ver cal 6. Lab data are insufficiently used for surveillance
programs) and epidemiology (F)
5. Trained bio-informa cs specialists 7. Mechanisms for fast data analysis for outbreak
available (F) detec on and control are not fully
6. Government is using IT for informa on implemented (F)
sharing (F) 8. Hardly inter-sectoral data exchange for One
7. Landlines accessible for almost all Health (F)
laboratories (F) 9. Weak data compila on management for
8. So ware available (F) paper-based system (F; laborious and not
always supervised)
10. No feedback a er data analysis (F)
11. Secure data backup facili es are not
available (F)
Opportuni es Threats
1. Almost universal coverage of mobile 1. Online data hacking/data security (i.e.
networks and internet (F) privacy issues) (F)
2. IT experts and informa on systems exist 2. Computer or so ware crashes (F)
throughout the country (F)
3. Local so ware developers for health
management so ware are available locally (F)
4. Interna onal so ware for health care
system and laboratory specific so ware
available (F; for free or for purchase)

Subtopics
Ÿ Information and communication technology
Ÿ Data management
39
 Annex III
Topic 9: Quality management systems
Strengths Weaknesses
1. Quality and accredita on/cer fica on 1. Lack of implemented LQMS in most
awareness among laboratory staff (O) laboratories (F)
2. QC standards and SOPs introduced par ally 2. Lack of trained QA/LQMS manpower (F)
(F) 3. Scarce trainings on aspects of quality
3. Presence of PNAC for accredita on according management, both pre-service and in-
to interna onal standards (F) service (F)
4. Some laboratories are ISO/JCI accredited (F: 4. Quality assurance tes ng not universally
public and private; veterinary and human) implemented throughout the country
5. Good quality private laboratories leading to because there is no obliga on to par cipate
increased compe on (O) in QA programs (F)
6. System for EQA program available in country 5. Lack of na onal body for EQA program for
through AFIP and ver cal programs (F, One Health (F)
NEQAPP) 6. No system in place for the local production
7. Availability of interna onal cer fied kits (F; of QC and standardiza on materials (F)
CE, FDA) 7. No dedicated budget available to sustain
internal and external QA programs (F)
8. No dedicated budget available to
implement and sustain LQMS (F)
9. Lack of accountability for implemen ng
quality measures (F)
10. Reluctance to read and follow SOPs and
documents (F)
11. Unnecessary or inappropriate tes ng
because of lack of tes ng algorithms (F)

40
 Annex III
Opportuni es Threats
1. Interna onal EQAS, systems available, but 1. Wrong repor ng leading to
expensive (F; RIQAS NEQAS, CAP) mismanagement of pa ents (outcome
2. Public demand for quality laboratory services threat)
(O) 2. Low budgets for QA may lead to shortcuts
3. Good quality laboratories can act as role – wrong repor ng – undue morbidity
models (O) (outcome threat)
4. Certain EQA and PT programs are available and
can be used as models to expand (F)
5. Internet availability makes access to
interna onal agency informa on regarding
standards possible (F; WHO LQMS, LQSI, GLI
tools, FAO and OIE guidance documents)

Subtopics
Ÿ Quality assurance
Ÿ Quality management
Ÿ Certication and accreditation

41
 Annex III
Topic 10: Biorisk management and waste
management
Strengths Weaknesses
1. Biorisk management Policy is under 1. Absence of personal protec on equipment
development with input from NLWG (F) in most public and private laboratories (F)
2. Pakistan Biological Safety Associa on and 2. No occupa onal health program for
other associations (F) laboratory workers (F)
3. Private companies are available for collec on 3. No no fica on of lab acquired infec on (F)
and disposal of biological waste in some ci es 4. Proper waste management systems absent
(F) in most medical, veterinarian and
4. There is growing biosafety awareness among agricultural laboratories (F)
lab staff (O) 5. No implementa on of governmental
5. Biosafety and waste management trainings regula ons for safe disposal of medical
increasingly available (F) waste across the country (F)
6. There is no monitoring of the waste disposal
by the private waste disposal companies (F)
7. Incinerators either absent or some mes
installed in non-appropriate loca ons;
majority are non-func onal (O/F)
8. Non-existence of biorisk management
programs (F)
9. No in-country BSC cer fica on capacity (F)

Opportuni es Threats
1. Existence of Environmental Protec on Agency 1. Outcome threats:
at Federal level and in Punjab and KPK, Punjab - Pollu on of the environment
Healthcare Commission which is governed by a - Fire and chemical hazards
specific act and environmental protec on - Leakage of pathogens to environment
tribunal for safe disposal of waste in Punjab (F) - Reuse of materials such as syringes
2. Government is under pressure to take more
ac ve ini a ves under IHR and GHSA (F)
3. Environmental awareness, fuelled by media (O)

Subtopics
Ÿ Occupational health
Ÿ Waste management
Ÿ Biorisk management 42
 Annex III
Topic 11: Research – SWOT analysis
Strengths Weaknesses
1. Research labs throughout country in 1. Limited na onal research grant
universi es and research centers (F) opportuni es (F)
2. Interna onal connec ons with research 2. Limited experience and training
ins tutes overseas (F) opportuni es in grant proposal wri ng (F)
3. Researchers are proficient in English (F) 3. Lack of mechanism for implementa on of
4. Na onal Bioethics Commi ee in place (F) research finding in rou ne laboratory
5. Na onal and interna onal funding are services (F)
available for new projects (F) 4. Limited sharing of resources between
6. Availability of trained and qualified research ins tutes due to lack of insight into
personnel opportuni es available (F)
7. Courses are taught on Biosafety and security, 5. Insufficient core funding for lab research and
bioethics and lab management lab maintenance (F)
8. Researchers have access to modern 6. Ins tu onal bioethics commi ees not at all
technology (F) research ins tutes (F)
9. Pakistan Health Research Council and other 7. No na onal oversight mechanism in place (F)
similar ins tu ons in place (F) 8. Lack of trained mentors (F)
10. Researchers are capable of innova ve 9. Few incen ves for researchers (O)
thinking (O) 10. Limited integra on of academia and industry
11. Regular publica ons in (inter)na onal, peer- (O)
reviewed journals (F) 11. Lack of awareness and implementa on of
the Code of Conduct for Researchers (F)

Opportuni es Threats
1. Na onal and interna onal collabora on 1. Lack of encouragement (O)
opportuni es (F) 2. Brain drain due to migra on (F)
2. Interna onal funding available (F; research 3. Inappropriate use of research findings
grant opportuni es) and funds (O)
3. Interna onal exchange programs (F)

43
 Annex IV
List of laboratory and Public Health Professional
participated in the consultative workshops on
Development on the National Laboratory Policy in Pakistan
S.No. Name DESIGNATION ORGANIZATION
1. Aamer Ikram Professor & Consultant Armed Forces Ins tute of Pathology
Head of Pathology
2. Aamir Ali Khan Nishtar Medical College, Multan
Department
Chief Public Health Lab Na onal Ins tute of Health,
3. Arshad Mumtaz
Division Islamabad
4. Ashok Kumar Tanwani Professor & Pathologist PIMS Hospital Islamabad
Na onal University of Science &
5. A ya Bha Associate Professor ASAB
Technology, Islamabad
Aga Khan University Hospital,
6. Erum Khan Associate Professor
Karachi
Head of Pathology Allama Iqbal Medical College,
7. Fauzia Ashraf
Department Lahore
8. Ghulam Fa ma Senior Pathologist Civil Hospital, Karachi
9. Ghulam Sarwar Pirkani Professor Microbiology Bolan Medical College, Que a
Shifa Interna onal Hospital,
10. Imran Ahmad Chief Pathologist
Islamabad
Chief Scien fic Officer Na onal Agriculture Research
11. Khalid Naeem Khawaja
Animal Science Ins tute Center, Islamabad
12. Lubna Naseem Consultant Pathologist PIMS, Islamabad
13. Muhammad Kaleem Khan Pathologist Ayub Medical College, Abbo abad
Senior Scien fic Officer, Na onal Ins tute of Health,
14. Muhammad Salman
Public Health Laboratories Division Islamabad
Shifa Interna onal Hospital,
15. Muhammad Usman Consultant Pathologist
Islamabad
Abass Ins tute of Medical Science,
16. Mumtaz Ahmad Khan Head Pathology Department
Muzaffarabad
17. Muhammad Athar Senior Scien fic Officer Na onal Agriculture Research
Abbas NRLPD Center, Islamabad
18. Musa Rahim Na onal Professional Officer WHO Country Office, Islamabad
Na onal Agriculture Research
19. Naila Siddique Program Leader
Center Islamabad
20. Obaidullah Qazi Microbiologist Ins tute of Public Health, Lahore
21. Rani Faryal Associate Professor Quaid-e-Azam University , Islamabad
Professor of Pathology & Aga Khan University Hospital ,
22. Rumina Hassan
Microbiology Karachi
23. Sabira Tahseen Na onal Advisor TB Na onal TB Program
Head of Pathology Hya abad Medical Complex,
24. Shahtaj Khan
Department Peshawar
Na onal Ins tute of Health,
25. Uzma Bashir Amir Senior Virologist
Islamabad

44
 Ministry of NHSR &C

Pubic Health Laboratories Division,

National Institute of Health, Islamabad