National Health Laboratory Strategic Plan - Ministry of Health & Child Care 2017 - 2021 - UNICEF
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Ministry of Health
& Child Care Government of Zimbabwe
National Health Laboratory
Strategic Plan
2017 - 2021National Health Laboratory Strategic Plan 2017-2021 FOREWORD Accurate and reliable diagnosis is the cornerstone of disease management and prevention. As such, medical laboratories are indispensable as they provide the diagnostic services that are critical to individual case management but also to disease surveillance, control and education. This Strategic Plan (2017 - 2021) is a major milestone in the journey towards quality, accessible and reliable laboratory services. The value of laboratory services is often overlooked despite its vital contribution to the provision of cost effective quality health care. Laboratory results provide the only scientific approach to patient management allowing the clinician to make accurate diagnosis and rationalize drug use. It is estimated that 70% of all diagnosis depend on the laboratory. In addition, laboratories play a vital role in epidemiological surveillance, control of infectious diseases such as cholera, TB, diarrheal diseases and other communicable diseases. With the launch of the 90-90-90 UNAIDS HIV Global targets, the role of the laboratory has even been more heightened for diagnosis of people with HIV and monitoring viral suppression for people receiving antiretroviral therapy. In addition, other emerging public health threats such as MDR and XDR TB, Ebola virus have demonstrated the weaknesses and the need to revitalise the Laboratory services. The Ministry of Health and Child Care is committed to strengthening the coordination and quality of laboratory services to support the implementation of the National Health Strategy. Furthermore, maintaining a functional and effective national health laboratory services requires guidance, support and regulation through well laid down policies and strategies. The overall objective of this strategic plan is to provide a shared vision, goals and targets for the laboratory services for the period 2017 – 2021. I wish to thank all who contributed to the development of this strategic plan and call upon all the stakeholders and partners to align their present and future activities with the guidelines laid out in this strategic plan. The successful implementation of this strategic plan will contribute significantly to improved health service delivery in general. Bregadier General Dr G. Gwinji Permanent Secretary Ministry of Health and Child Care ii
National Health Laboratory Strategic Plan 2017-2021
ACKNOWLEDGEMENTS
The development of the Zimbabwe Health Laboratory Strategic Plan (NHLSP) involved the participation of
stakeholders at different stages of the consultative process. In particular, the consultative process included
planning meetings and review of key documents.
The contributions of the following institutions and organizations are acknowledged for the development of
this strategic plan
•• inistry of Health and Child Care for the leadership and guidance provided through the Laboratory
M
Directorate
•• UNICEF and CHAI for the financial and technical support throughout the development, drafting,
finalization and printing of the plan
•• The members of the Laboratory Community for their commitment and dedication in developing the
strategic plan
•• Partners such as EGPAF, JSI, MSF, and others for the dedicated participation and contributions to
the creation of this strategic plans
I would like to acknowledge the consultants and all participants from the National Reference laboratories,
Central and District hospital laboratories, other organizations and individuals for their significant contributions
in revising the Zimbabwe Health Laboratory Strategic Plan.
Mr D. Mangwana
Director Laboratory Services
Ministry of Health and Child Care
iiiNational Health Laboratory Strategic Plan 2017-2021
TABLE OF CONTENTS
FOREWORD...............................................................................................................................................ii
ACKNOWLEDGEMENTS..........................................................................................................................iii
TABLE OF CONTENTS.............................................................................................................................iv
ABBREVIATIONS AND ACRONYMS........................................................................................................vi
INTRODUCTION.........................................................................................................................................1
1. EXISTING LABORATORY SERVICES...................................................................................................2
1.1 Public facilities.......................................................................................................................................2
1.1.1 National Reference laboratories/Central/Province/District/Rural health centres................................2
1.1.2 The National Blood Services Zimbabwe (NBSZ)...........................................................................2
1.1.3 Government Analyst’s Laboratory...................................................................................................3
1.1.4 National Institute of Health Research.............................................................................................3
1.1.5 Central Veterinary Laboratory.........................................................................................................3
1.1.6 Zimbabwe National Quality Assurance Programme (ZINQAP)......................................................3
1.2 Private sector and other research institutions ..................................................................................4
2. SITUATION ANALYSIS...........................................................................................................................5
2.1 Laboratory organization and structure...............................................................................................5
2.2 Laboratory tiered network and referral..............................................................................................5
2.3 Legal and Regulatory Frameworks...................................................................................................6
2.4 Human Resources............................................................................................................................6
2.5 Laboratory Equipment and Commodities..........................................................................................6
2.6 Infrastructure.....................................................................................................................................7
2.7 Quality Management System (including Biosafety)............................................................................7
2.8 Laboratory Information System.........................................................................................................7
2.9 Research, development and Collaboration.......................................................................................8
2.10 Monitoring and Evaluation...............................................................................................................8
2.11 Financing Laboratory Services........................................................................................................8
2.12 SWOT ANALYSIS...........................................................................................................................9
3. THE STRATEGIC PLAN.................................................................................................................... 9
3.1 STRATEGIES..................................................................................................................................11
3.1.1 Laboratory organization and structure..........................................................................................11
ivNational Health Laboratory Strategic Plan 2017-2021
3.1.2 Laboratory tiered network and referral.........................................................................................12
3.1.3 Legal and Regulatory Frameworks...............................................................................................13
3.1.4 Human Resources........................................................................................................................13
3.1.5 Laboratory Equipment and Commodities.....................................................................................14
3.1.6 Infrastructure ................................................................................................................................15
3.1.7 Quality Management System.......................................................................................................16
3.1.8 Biosafety......................................................................................................................................17
3.1.9 Monitoring and Evaluation............................................................................................................17
3.1.10 Laboratory Information System..................................................................................................18
3.1.11 Research, development and Collaboration.................................................................................18
3.1.12 Financing Laboratory Services...................................................................................................19
4.STRATEGIC PLAN MATRIX (2017 – 2021)......................................................................................20
4.1 LABORATORY ORGANIZATION AND STRUCTURE.....................................................................20
4.2 LABORATORY TIERED NETWORK AND REFERRAL..................................................................21
4.3 LEGAL AND REGULATORY FRAMEWORKS................................................................................23
4.4 HUMAN RESOURCES....................................................................................................................24
4.5 LABORATORY EQUIPMENT..........................................................................................................25
4.6 COMMODITIES..............................................................................................................................27
4.7 QUALITY MANAGEMENT SYSTEM...............................................................................................30
4.8 BIOSAFETY.....................................................................................................................................32
4.9 LABORATORY INFORMATION SYSTEM......................................................................................33
4.10. RESEARCH, DEVELOPMENT AND COLLABORATION.............................................................35
4.11 MONITORING and Evaluation......................................................................................................36
4.11 FINANCING Laboratory Services..................................................................................................37
5.PRIORITY STRATEGIC ACTIVITIES................................................................................................38
vNational Health Laboratory Strategic Plan 2017-2021 ABBREVIATIONS AND ACRONYMS BRTI Biomedical Research and Training Institute DLS Department of Laboratory Services GOZ Government of Zimbabwe HIV Human Immunodeficiency virus M&E Monitoring and Evaluation MLCSCZ Medical Laboratory and Clinical Scientists Council of Zimbabwe MOHCC Ministry of Health and Child Care NBSZ National Blood Services Zimbabwe NMRL National Microbiology Reference Laboratory NTRL National TB Reference Laboratory PT Proficiency Testing EQA External Quality Assessment QC/IQC Quality Control/ Internal Quality Control UZ University of Zimbabwe WHO World Health Organisation ZINQAP Zimbabwe National Quality Assurance Program vi
National Health Laboratory Strategic Plan 2017-2021
INTRODUCTION
Zimbabwe is a landlocked country situated in the being of the public in the following service areas;
southern part of Africa, with a total land area of public health and epidemiological needs, clinical
390,757 square kilometres. It shares borders with health and the provision of safe blood and blood
Zambia, Mozambique, South Africa, Botswana, and products, national reference laboratory function,
Namibia. The country has a population estimated quality assurance, teaching and research. These
at 12 million. It is divided into 10 administrative laboratories operate with minimum standard
provinces, two of which are urban (i.e. Harare and requirements for equipment, reagents and supplies,
Bulawayo). The provinces are in turn divided into staffing levels and qualifications, repertoire of
62 districts. available tests at each level of the tiered system
from Rural Health Centre right up to the National
Zimbabwe is one of the countries within the Sub- Reference Laboratories.
Saharan region that are seriously affected by the
HIV and AIDS pandemic. The HIV and AIDS in In Zimbabwe, the role of health laboratory services,
Zimbabwe is generalised and mature. The adult as integral and important to both clinical and
HIV prevalence is estimated at 15% and about public health functions, is increasingly recognized.
1.4 million are people living with HIV. Other priority For years, public sector laboratory services and
diseases and conditions to be addressed are systems have been severely neglected. Despite
malaria and TB. this central role, strengthening laboratory services
has, until recently received inadequate attention
The Government of Zimbabwe desires to have the in the country. Unfortunately, these recent efforts
highest possible level of health and quality of life have gone into improving disease specific control
for all its citizens, attained through the combined programs such as HIV/AIDS, TB, and malaria,
efforts of individuals, communities, organizations where the funding has been available through
and the government, which will allow them to global health initiatives.
participate fully in the socioeconomic development
of the country. This vision will be attained through There has been significant effort to improve and
guaranteeing every Zimbabwean access to strengthen the quality of health laboratory services
comprehensive and effective health services. in Zimbabwe. However, there are still many
challenges to be addressed such as operating with
The country’s health care delivery is guided by a limited budget, inadequately staffed laboratory
the National Health Strategy. One of the National facilities, inadequately maintained equipment,
Health Strategy’ main objectives is to seek equity and inadequate supplies. This National Health
in health by targeting resources and programs to Laboratory Strategic Plan aims at improving
the most vulnerable and needy in the population. and strengthening the quality and management
The public health system is built on primary health of health laboratory services at all levels of the
care services which are provided through rural healthcare delivery system. This will be achieved
health centres and rural hospitals in each of the through complemented efforts involving the
rural districts. Ministry of Health and its partners.
The laboratory services in Zimbabwe has the
responsibility to fulfil the needs of all patients
and clients, and promote the health and well-
1National Health Laboratory Strategic Plan 2017-2021
1 EXISTING LABORATORY SERVICES
Health laboratories refer to government institutions, A menu of tests for each level of services has
private institutions, research and teaching been defined with reference laboratories offering
institutions. The MOHCC laboratories are organized reference services. Central hospital laboratories
under the Laboratory Services Directorate covering offer a greater range of more complex tests than
the disciplines of Medical Microbiology, Chemical provincial and district laboratories. At the lowest
Pathology, Haematology, Histopathology and level the health centres offer low complexity testing
Blood Bank/ Blood Transfusion. (e.g. rapid HIV tests, malaria, malaria and TB
smear microscopy and other point of care tests).
The Health Laboratory System has two major Stand-alone VCT for HIV are also offered by
arms; first the public health laboratories that serve NGO’s. Services are offered nationwide with an
the department of epidemiology and disease equitable distribution of health facilities.
control in the Ministry of Health and Child Care
(MOHCC). These include institutions such as the
Government Analyst and the (National Institute of 1.1.2 T
he National Blood Services
Health Research) NIHR. These laboratories are Zimbabwe (NBSZ)
community focused as opposed to clinical care of
individual patients. The NBSZ is registered as a non-profit making
The second arm of the laboratory system is the company under section 26 of the Companies
diagnostic laboratory service based in hospital Act, Chapter 24:03 and is also registered as a
institutions, independent private laboratory private voluntary organization (WO/54/68) as
facilities and the National Blood Service of required by the Private Voluntary Organizations
Zimbabwe (NBSZ), which is an independent body. Act, Chapter 17:05. The Service has managed
The diagnostic laboratory services focus on patient to provide a nationally and internationally
clinical quality care. These laboratories include recognised and renowned blood service. The
public health laboratories, mission laboratories, Service attained the WHO Collaborating Status
uniformed forces laboratories, local authorities, city and it was requested by WHO to be a Regional
council laboratories, national reference laboratories Quality Training centre. A Quality Management
[National Microbiology Reference Laboratory System based on ISO9001:2000 was introduced
( NMRL), National Tuberculosis Reference in 2004. The transfusion of blood and blood
Laboratory (NTBRL) & National Virology Reference products is recognized as one of the essential
Laboratory, (NVRL)], private clinical laboratories, therapeutic interventions in modern health care,
veterinary laboratories, research laboratories, hence, the service is commitment to provision of
training institutions laboratories and Zimbabwe effective blood service. The donation of blood is
National Quality Assurance Programme,( ZINQAP). governed by the Anatomical Donations and Post-
Mortem Examinations Act, Chapter 15:01. The
administration of the Act falls under the Ministry of
1.1 Public facilities Health and Child Care (MOHCC).
Consequently, those operations of the NBSZ
1.1.1 N
ational Reference laboratories/ relating to the collection and use of donated blood
Central/Province/District/Rural are regulated by the Act. However, this does not
health centres make all the operations of the NBSZ accountable
to the MOHCC. The National Committee is the
2National Health Laboratory Strategic Plan 2017-2021
highest decision making body of NBSZ with combat the most prevalent diseases. It is organized
responsibility to provide an enabling environment into 3 sectional departments namely Vector
for management to implement agreed policies. Borne Diseases, Communicable & Infectious
The National Committee is made up of elected Diseases, Health Systems & Technologies and two
blood donors and co-opted members representing support units. The Support units are divided into
the MOHCC, the Secretary General of Zimbabwe administration and technical support services; the
Red Cross Society (ZRCS), National AIDS Council laboratory is one of these support units that provide
(NAC) and the Executive Secretary of National services to the research activities. The laboratories
Association of Medical Aid Societies (NAMAS) are in microbiology, immunology, molecular biology,
and the Pledge 25Club Chairperson. From NBSZ, schistosomiasis, serology and malaria and mainly
the Chief Executive Officer, Medical Director, support research activities.
Bulawayo Branch Manager are ex-officio members
of the National Committee.
1.1.5 Central Veterinary Laboratory
The NBSZ provides safe blood and blood products
to all hospitals in Zimbabwe and is the sole provider It belongs to the Department of Veterinary
of this service. Its main customers are MOHCC, Services, Ministry of Lands and Agriculture. It is
mission and private hospitals. MOHCC by virtue the referral laboratory and part of a network of
of it being the largest provider of healthcare veterinary laboratories with services decentralized
in Zimbabwe is also its largest customer. It is to the provincial laboratories. It plays a key role in
internationally accredited and recognized as a zoonosis control. Its main services are disease
centre of excellence. diagnosis, outbreak investigations and disease
preparedness, specialist referral and advisory
service, and research. It collaborates with a
1.1.3 Government Analyst’s Laboratory number of overseas research institutes in research
projects and with the University of Zimbabwe
The Government Analyst’s Laboratory is funded (UZ) and National Institute of Health Research. It
directly by MOHCC and is situated in Harare. It is receives specimens from National Public Health
the reference laboratory for all chemical analysis in Laboratories for specialist tests, Environmental
public health and organizationally it is divided into Health Department and private veterinarians. It
units namely: Customs and Industrial, Clinical and participates in reporting notifiable diseases to
Toxicology; Food Unit, Waters Division, Urine and the Health Information System, Department of
Iodine Laboratory. Epidemiology &Disease Control. It provides also
attachment training for students from the UZ.
1.1.4 N
ational Institute of Health
Research 1.1.6 Z
imbabwe National Quality
Assurance Programme (ZINQAP)
The National Institute of Research formerly Blair
Research Institute of the Ministry of Health & Child The Zimbabwe National Quality Assurance
Care is situated in Harare and its core business Program (ZINQAP) was established in 1995 with
is research in biomedical sciences, communicable a mandate to assist all laboratories in Zimbabwe
and vectors borne diseases, health systems attain and maintain a high standard of performance
policies and technologies. It has well qualified staff and to improve the quality of testing services.
and has an active research program that provides It is the only laboratory quality assurance body
useful information to support government health in Zimbabwe conducting a proficiency-testing
policies and information to program managers to
3National Health Laboratory Strategic Plan 2017-2021
program. It attained international accreditation to to the citizens is complimented by private providers.
SANAS ISO Guide 43 in February 2005 and later The largest of these are CIMAS Laboratories,
to the SANAS ISO 17043:2010, making it the first Premier Laboratories and Clinical Laboratories.
internationally recognized PT body in Zimbabwe Public-private partnerships have existed at
and the second in Africa to attain this standard. various levels for many years with cross referral
It provides a comprehensive PT service to 130 of specimens and joint training and technical
medical laboratories both public and private and committees.
testing sites in Zimbabwe. These laboratories Other non-governmental research institution
perform at different levels of participation and exists and includes Biomedical Research and
complexity in the major laboratory disciplines which Training Institute (BRTI) and the African Institute of
include Immunology, Microbiology, Haematology/ Biomedical Science & Technology (AIBST).
Blood Transfusion Medicine and Clinical Chemistry.
ZINQAP’S organizational structure is made up of a
Board of Trustees which oversees the work of the
organization.
1.2 P
rivate sector and other research
institutions
In Zimbabwe, the capacity of the public sector to
provide quality and accessible health care services
4National Health Laboratory Strategic Plan 2017-2021
2 SITUATION ANALYSIS
2.1 L
aboratory organization and between the laboratories at different levels remain
structure weak because of lack of focal persons at Provincial
and District level. The DLS sometimes has an
Zimbabwe has a well-developed heath care delivery overwhelming task of directly interfacing with the
system. The laboratory services are coordinated by more than 170 labs in the country which severely
the Laboratory Directorate, a department under the limits top supervision and technical support to these
Ministry of Health and Child Care. The Laboratory lower facilities. This also overwhelms the limited
Directorate operates an integrated tiered network staffing at Directorate that currently consists of the
consisting of over 170 Registered diagnostic Laboratory Director, Deputy Laboratory Director,
centres/ Laboratories operating at five main levels TB Focal person and the Logistics Coordinator.
organized along the referral chain of health service
delivery as indicated below:
2.2 L
aboratory tiered network and
referral
National Reference Laboratories Except for private laboratories, most laboratories
in Zimbabwe are essentially based in health care
facilities with their complexity increasing with the
Central Hospital Laboratories level of the facility. There is one district hospital in
each district. District hospitals in turn refer to the
provincial or central hospitals. Most the laboratories
Provincial Hospital Laboratories
are at district level including mission hospitals.
There are five central hospitals that provide tertiary
District / Mission Hospital and quaternary health care services in the country.
Local authority or municipal clinics provide much
of the primary health care in both rural and urban
Rural Health Centres
areas. Faith based organisations are a major
provider of the health services in most rural areas.
The current laboratory services are organised to There has been a general deterioration of laboratory
serve both clinical and public health needs. As services where the tiered system has failed to
a result, the national laboratory services, as part provide the standard package of laboratory tests in
of the national health system, support curative, support of the health delivery system at each level
preventative and public health components of the of healthcare. Although test menu is defined at each
health system. level of the tiered system, many laboratories are not
able to consistently fulfill the testing requirements
The health laboratory services are geared towards due to lack of personnel, frequent stock out of
clinical care and are based in health facilities which supplies and lack of or frequent breakdown of
falls under the department of clinical services. This equipment. This has resulted in patients seeking
has raised complications in reporting, significantly services from the private sector where the costs are
compromising DLS ability to manage and unaffordable and continue to increase beyond the
coordinate the services in the country. Linkages reach the average Zimbabwean. In some cases,
5National Health Laboratory Strategic Plan 2017-2021
complex tests or functions are being performed in of the bulk of the Medical Laboratory Scientists who
even lower tiers which previously would not. are involved in carrying out laboratory diagnosis
of various diseases. However, human resources
The laboratory services are intended to function remain a major challenge as experienced Medical
as a network with a system that allows for referral Laboratory Scientists and those graduating from
of specimens or patients to the next level. This the Department of Medical Laboratory Sciences
type of referral system is currently not functional at the University of Zimbabwe College of Health
largely due to resources needed at each level. Sciences continue to leave the country into the
Only donor supported services such T.B, and early region and overseas. This has affected the capacity
infant diagnosis of HIV, have clearly defined and to provide laboratory services in most part of the
functional referral systems that run from the lowest countries especially in the peripheral areas. For
level to the central or national level. However, there those who have stayed, they are poorly motivated
have been recent efforts to build an integrated e.g. due to low remuneration.
sample referral system to address this gap.
Different strategies have been rolled out to ensure
at least laboratory facilities are manned by trained
2.3 L
egal and Regulatory cadres. Programs for training lower cadres such as
Frameworks SCMLT and microscopists are ongoing to try and
address the staffing gaps in many laboratories.
The Medical Laboratory and Clinical Scientists
Council of Zimbabwe is a statutory regulatory body The pre-service training curricula need to be
enacted by an Act of Parliament of the Republic revised and standardised to meet the country’s
of Zimbabwe under the Health Professions Act needs in terms of technology changes and new
Chapter 27:19 of 2001, which is responsible for the concepts. Laboratory associations are not yet
licensing of medical laboratory personnel, medical visible in Zimbabwe and therefore there are no
laboratories/test sites and setting of standards opportunities to train, motivate and improve ethical
of training for medical laboratory personnel. The standards of their members.
Council also oversees the regular monitoring of
laboratories during regular supervisory visits.
Over the years, the capacity of the Council has
2.5 L
aboratory Equipment and
been limited largely due to underfunding and
Commodities
understaffing. The lack of funding has restricted
the council’s capacity to implement its regulatory
The Laboratory Directorate together with its
role and this has led to many laboratories operating
partners have developed a Harmonisation and
without proper registration of staff or the facilities
standardisation guideline for procurement and
themselves. With the advent of Point of Care
placement of equipment. This is a document
testing, classification, registration and licensing
that will be guiding the equipment selection,
of non-laboratory personnel has remained loosely
procurement and deployment to the different tiers
defined.
of laboratory services. However, many laboratory
stakeholders have not been sensitized on the
Harmonisation and standardisation guidelines.
As such, many partners purchase equipment with
2.4 Human Resources varying specifications leading to difficulties in their
servicing and maintenance. Currently old and
The Department of Medical Laboratory Sciences at existing have no service and maintenance plans.
the University of Zimbabwe is involved in the training
6National Health Laboratory Strategic Plan 2017-2021
Mechanisms for disposal of obsolete equipment 2.7 Q
uality Management System
are not effective in most facilities leading to space (including Biosafety)
challenges within the laboratories. Introduction of
technology has been hampered by lack of clarity Since 2010, several Quality Management System
on the process of equipment evaluation and the training programs have been initiated in Zimbabwe
institutions coordinating these evaluations. to support laboratories improve their quality of
The establishment of a laboratory Logistician testing and results. One of the training program
working with the logistics sub unit (LSU), has was the Strengthening Laboratory Management
substantially improved coordination, procurement Towards Accreditation (SLMTA) program and the
and supply management of laboratory commodities. WHO AFRO Stepwise Laboratory Improvement
This unit is responsible for forecasting, Process Towards Accreditation (SLIPTA) program.
quantification, procurement and distribution of Although these programs were well received,
all commodities (Laboratory Equipment and they have had limited coverage in reaching to
Reagents/ Consumables). While the Logistic unit all laboratories. There has also been continuing
has greatly improved the supplies situation in the challenges in the roll out of the Quality training
country, the list of supplies is usually HIV related programs resulting in declining culture of quality.
and as a result other tests have stock outs. At the This decline has caused loss of trust in the
facilities, personnel are often not knowledgeable laboratory services by both clinicians and patients.
about logistics management and as a result there is Most laboratories are not verifiably compliant
overstocking in a bid to make sure their laboratories with basic quality standards. There is also lack
have adequate supplies. This has contributed of a national certification program to oversee the
to reagents expiring in many laboratories and in implementation of minimum standards for quality
turn reducing the storage space. The process for in Zimbabwe for all laboratories.
disposal of expired reagent is not efficient. An external quality assessment (EQA) scheme
exist in the country and is overseen by the
Zimbabwe National Quality Assurance Program
(ZINQAP). However, the scheme is limited in scope
2.6 Infrastructure and coverage. Participation of laboratories in the
EQA programs is still left to the laboratories to
Most of the hospitals and health facilities in decide and as such many laboratories participate
Zimbabwe benefited from the DANIDA project irregularly and inconsistently.
that built hospital laboratories. These laboratories
were built following the standard laboratory Biosafety programs still need to be developed and
infrastructural guidelines. However, there are rolled out to the laboratories.
some hospital that still are having infrastructural
challenges where the laboratory space was not
originally designed for laboratory testing. The
majority of these health laboratory facilities in 2.8 L
aboratory Information
the country have not undergone regular routine System
maintenance since they were constructed years
ago. Renovations are needed for some as scope of Paper based laboratory information system
testing has been changing over time. The greatest remains the main tool for the collection and storing
challenge has been space that is being taken up by of results of patients. In many laboratories, this
obsolete equipment and expired reagents.
7National Health Laboratory Strategic Plan 2017-2021
information is still kept in files and logbooks. collaborations with the public health laboratories.
However, there is no mechanism to ensure a flow This is also compounded by the inadequate capacity
of this information in a collated way to the next among the majority of laboratory professionals to
level up to the national level. There is a need for exploit these data, develop proposals and conduct
a National Laboratory Information System that operational research.
manages and disseminates data.
2.10 Monitoring and Evaluation
There are electronic LIS platforms that have been
developed and are in use to support delivery and Currently there is no effective system or measurable
management of laboratory results. However, these indicators to assess the laboratory system’s
LIS are currently disease or program specific performance on whether it is effectively supporting
such as EID and TB program. An integrated LIS the service delivery. There is lack of clearly defined
approach will address the disparities in managing laboratory indicators and M & E tools. Where M&E
and disseminating laboratory data. The currently is happening,
laboratory paper based information is not linked It is vertical and related to specific funded programs.
to the MOHCCDHIS for effective integration of There is a need to develop M&E tools and indicators
laboratory data. that support the delivery of laboratory services.
2.9 R
esearch, development and 2.11 F
inancing Laboratory Services
Collaboration
The health laboratory services are grossly under-
Currently, there are no coordinated mechanisms funded. This urgently needs to be addressed. This
for conducting operational research geared at has been compounded by inadequate systems and
improving laboratory service delivery. While skills for planning the utilization and for accounting
research institutions and Universities exists within for the limited resources invested in laboratory
the country, and have the capacity to conduct service delivery.
research, there not efforts to create linkages and
8National Health Laboratory Strategic Plan 2017-2021
2.12 SWOT ANALYSIS
Strengths Weaknesses
•• Laboratory Directorate in place •• on-standardized equipment and
N
reagents
•• MLCSCZ in Place
•• Stock-outs especially for non-HIV tests
•• Logistic Unit in place
•• ack of registering and monitoring of all
L
•• aboratory infrastructure in most hospital
L
laboratories
facilities
•• Inadequate servicing and maintenance
•• Documented laboratory tiered system
plans
•• INQAP supporting the national EQA
Z
•• Frequent breakdown of equipment
program
•• Inefficient obsolete equipment and
•• vailability of research institutions and
A
expired reagents disposal mechanisms
universities involved in research
•• Weak specimen referral system
•• raining Universities for the Laboratory
T
personnel •• Declining culture of quality
•• Existence of laboratory budget line •• eak collaboration between the existing
W
research institutions and the general
health laboratories
•• ack of clearly defined laboratory
L
indicators and M&E tools
•• o National Laboratory Information
N
System that manages and disseminates
data
•• Inadequate budgetary allocation for
laboratory services
9National Health Laboratory Strategic Plan 2017-2021
Opportunities Threats
••
H armonisation and Standardisation •• Limited staffing at Directorate level
guidelines in place
•• ack of the National certification program
L
•• xisting program specific sample referral
E and Quality Assurance department
systems and piloted integrated sample
•• Lack of accredited NRLs
referral system
•• Staffing challenges
•• Technical working groups
•• Newly formed Laboratory association
•• Existing program specific electronic LIS
•• ole of laboratory recognized and elevated
R
by programs such as UNAIDS 90-90-90
targets
•• Funding support from laboratory partners
•• Institutionalization of the SLIPTA program
for certification of laboratories
10National Health Laboratory Strategic Plan 2017-2021
3 THE STRATEGIC PLAN
This National Health Laboratory Strategic Plan Mission Statement
(NHLSP) is developed to implement the Zimbabwe
National Health Laboratory Policy - 2015. The To timeously provide the best quality laboratory
NHLSP is an important document to articulate the services and results to clients, in order to fulfil
shared vision, goals and targets for the laboratory the laboratory services role in the health delivery
services for the period 2016 – 2020. It will serve system.
as a basis for advocacy, resource mobilisation
and programming during this period. The five year
Good governance
NHLSP will provide a clear road map in the form
of strategies and a plan of action. In the next five
The following principles will guide the
years, the NHLSP will execute the listed activities
implementation of this policy:
with the Director of Laboratory services providing
leadership.
a. Efficient and effective utilisation of resources
The NHLSP gives strategic direction in 11 strategic b. Integrity and honesty
areas namely:
c. transparent system shall be in place
A
1. Laboratory organization and structure to ensure programmatic and financial
accountability of the laboratory services
2. Laboratory tiered network and referral
d. Ethic
3. Legal and Regulatory Frameworks
4. Human Resources
5. Laboratory Equipment and Commodities
3.1 STRATEGIES
6. Infrastructure
7. uality Management System (including
Q 3.1.1 Laboratory organization and structure
Biosafety)
8. Laboratory Information System Policy Objective
9. Research, development and Collaboration
To have a clear organizational structure with
10. Monitoring and Evaluation appropriate authority to coordinate and manage
11. Financing Laboratory Services the provision of comprehensive health laboratory
services at all levels in the country.
Vision
Specific objective
To provide the best, high quality evidence based
laboratory services, which are accessible and 1. To strengthen the Directorate in order
affordable to the population of Zimbabwe.
11National Health Laboratory Strategic Plan 2017-2021
to provide adequate administrative and Specific objective
technical oversight over laboratory services
across all agencies and the private sector. 1. To ensure equitable coverage and access to
2. o facilitate and enhance service provision
T high quality laboratory services
across all tiers of the laboratory systems. 2. To strengthen the specimen referral system
Strategic activities Strategic activities
1. reate and recruit focal persons for the
C 1. isseminate approved guidelines for the test
D
following areas: Quality Assurance, M&E/ menus for all tiers to all laboratories
Research and Development, ICT & LIMS. 2. ist commodity requirements for the test
L
2. upport the national laboratory logistician to
S menus to assist with annual budget planning
continue to have oversight on procurement 3. pprove and disseminate the harmonization
A
of laboratory commodities and equipment standardization
3. trengthen the role of Laboratory Technical
S requirements for each level of health care
Working Group (TWG). There shall be one 4. rocure conventional equipment and
P
TWG with Terms of Reference (TORs) distribute according to testing complexity at
defined by DLS with members co-opted each level
according to specific needs defined by DLS
5. evelop and implement a plan to enhance
D
4. reate posts for Provincial and district
C the capacity for standardized laboratory
laboratory managers testing
5. rovide resources and technical capacity to
P 6. Increase access to laboratory services
the appointed focal personnel at all tiers through appropriate POC diagnostics
6. onduct quarterly feedback meetings with
C 7. nsure appropriate deployment of skilled
E
all laboratory staff and key stakeholders laboratory personnel to all levels
7. Conduct annual review of laboratory plans 8. romote rational and appropriate use
P
of laboratory services among clinicians,
laboratory practitioners, and the general
public
3.1.2 Laboratory tiered network and
referral 9. upport and expand the NMRL into a multi-
S
disciplinary referral laboratory
Policy Objective 10. trengthen the NRL’s to provide laboratory
S
support necessary for disease surveillance,
To provide laboratory services appropriate to each investigations and management of
level and that meets the needs for the delivery of outbreaks
health services at that level.
12National Health Laboratory Strategic Plan 2017-2021
11. esign an integrated specimen and results
D To ensure adequate availability of laboratory
transportation system personnel with the appropriate skills and
competencies to support the delivery of a
12. evelop effective guidelines for specimen
D comprehensive laboratory services at each level of
referral and result reporting health care
13. ilot the integrated specimen and results
P
transportation system Specific objectives
14. Implement the integrated specimen and
results transportation system in all the 1. o improve laboratory personnel recruitment
T
laboratories and motivation to achieve the retention
2. o develop a career path for Laboratory
T
professionals
3. o strengthen and standardize pre- service
T
3.1.3 Legal and Regulatory Frameworks
training programs for laboratory personnel.
Policy Objective
Strategic activities
To ensure registration, licensing, education and
discipline in the medical laboratory professions and 1. onduct human resources audits
C
maintenance of quality standards for laboratories periodically to determine and fill staffing
gaps within laboratories
Specific objectives 2. eview the staff establishments in line with
R
new technologies and disease trends
1. o strengthen professionalism among
T
3. efine and provide incentives for staff in
D
laboratory professionals
peripheral areas
2. o ensure practising laboratory premises
T
4. vail training opportunities for laboratory
A
comply with applicable regulations
personnel to improve skills in management
and leadership
Strategic activities 5. upport training of lower cadres (e.g.
S
SCMLT and microscopists) for deployment
1. o enforce registration of practicing
T to lower levels
laboratory professionals and premises.
6. upport the establishment of a laboratory
S
professional association to conduct
Continuous Professional Development
(CPD) point system
3.1.4 Human Resources
7. esign and develop a career path for
D
Policy Objectives laboratory staff including an agreed
13National Health Laboratory Strategic Plan 2017-2021
internship period in lower level laboratories 3. eploy all approved conventional equipment
D
according to national guidelines
8. Implement and evaluate CPD program and
continually implement improvements 4. Develop an equipment replacement plan
9. upport review and implementation of
S 5. obilize resources for procurement of
M
standardized curricula by training institutions equipment, servicing and maintenance of
to match the evolving laboratory testing new and existing equipment
6. ispose obsolete equipment according to
D
the National guidelines
3.1.5 L
aboratory Equipment and
Commodities 7. eview guidelines to ensure that every
R
equipment that is procured has a service
and maintenance plan
A – Equipment
8. trengthen coordination between DLS,
S
Policy objective partners and other MOH programs on
laboratory equipment procurement
To ensure that laboratories are adequately 9. oordinate the evaluation of all POC
C
and appropriately equipped in order to meet devices
requirements of the service delivery system
10. isseminate and operationalize the POC
D
testing guidelines
Specific objectives
11. eploy POCs according to the POC
D
guidelines
1. o harmonize and standardize equipment by
T
level of testing
2. o ensure there is appropriate technology
T B – Commodities
and equipment in place at all levels
3. o ensure all equipment have service and
T Policy objective
maintenance plan
To ensure uninterrupted supply of laboratory
4. o deploy all POC devices according to
T
reagents and consumables at all levels of health
national guidelines
care
Strategic activities
Specific objectives
1. aunch the harmonization and
L
1. o strengthen management of laboratory
T
standardization guidelines on equipment
commodities at the facility level
and personnel and disseminate them to all
facilities and stakeholders 2. o harmonize procurement and distribution
T
for integrated laboratory services
2. perationalize harmonization and
O
standardization of equipment guidelines 3. o provide pre-service supply chain
T
(redistribute equipment if necessary) management training for laboratory
14National Health Laboratory Strategic Plan 2017-2021
undergraduates/trainees 13. Implement and maintain the computerized
LMIS
4. o provide in service training in supply chain
T
management 14. evelop laboratory guidelines and standard
D
operating procedures for disposal of
5. To computerize the Logistics Management
commodities
Information System (LMIS).
15. acilitate disposal of expired laboratory
F
6. o facilitate and implement laboratory
T
commodities using government approved
guidelines for environmentally safe disposal
procedure at least once a year
of laboratory commodities
Strategic activities 3.1.6 Infrastructure
1. Evaluate the laboratory logistics system Policy objective
2. eview annually standard operating
R
To ensure all laboratories meet minimum
procedures and training curriculums for the infrastructural requirements as defined by National
laboratory logistics system Guidelines for Medical Laboratories
3. rain new and existing staff (refresher) on
T
the laboratory logistics system Specific objectives
4.
Maintain the existing laboratory logistics unit
1. o ensure infrastructure is available to
T
which integrates existing programs
match scope of testing at every health
5. onitor and support the new laboratory
M institution.
logistics system with quarterly reviews
2. o ensure that all laboratory infrastructures
T
6. rovide product specifications as and when
P are routinely inspected for compliance
required by procurement agencies to National Guidelines for Medical
7. trengthen the technical working group on
S Laboratories.
supply chain management
Strategic activities
8. onduct a forecasting and quantification of
C
laboratory reagents and supplies at least
1. onduct National Assessment on the
C
twice a year
state of laboratory infrastructure using the
9. aintain and monitor a national pipeline
M minimum set guidelines
database including timeliness
2. evelop a work-plan with a list of prioritized
D
10. onitor the supplier performance and
M labs for the upgrading of infrastructure
quality of deliveries
3. ource funding for the upgrading of the
S
11. evelop supply chain curriculum for
D laboratory facilities
laboratory training institutions
4. ork with Ministry of Public Works
W
12. Design and develop a computerized LMIS department to review specifications
15National Health Laboratory Strategic Plan 2017-2021
for renovation/construction of public 1. Define TOR for Quality Assurance Unit
health laboratories to address identified
2. ecruit the Quality Assurance Coordinator
R
infrastructural gaps
and team for the Laboratory Directorate to
5. evelop a schedule for inspection to ensure
D oversee quality management programs.
that all the laboratories are inspected within
3. stablish a TWG to spearhead the
E
the 5 years using a standardized checklist.
establishment of a national laboratory
6. onduct assessments according to
C certification program
schedule, develop and implement
4. et up the national laboratory certification
S
recommendations for improvement
program for laboratories and Point of Care
testing sites
3.1.7 Quality Management System 5. dopt guidelines to use as minimum
A
standards in certifying laboratories and
Policy objective enhancing quality.
6. onduct national certification assessments
C
To provide quality laboratory services that meet for all laboratories
international standards of practice.
7. ccredit National Reference laboratories to
A
Specific objectives international standards
8. dopt a WHO recommended QMS Training
A
1. o ensure there is a Quality Assurance Unit
T Program for lab quality improvement and
for the Laboratory Directorate to oversee meet the requirements of Zimbabwe Medical
quality management programs. Laboratory Guidelines.
2. o establish a national laboratory
T 9. stablish and refresh a national pool of
E
certification programme to support trainers.
certification and accreditation of laboratories 10. oll out trainings using the adopted QMS
R
3. o facilitate laboratories to participate in
T training program
Quality Improvement programs 11. evelop national QMS documents (policies,
D
4. trengthen current EQA systems to provide
S SOPs and forms) for adaptation by
full scope of EQA services that cover laboratories
all testing in Zimbabwe and provide for 12. esignate and train staff to be responsible
D
remedial action to poor PT/EQA performers for implementation of quality management in
5. To ensure all laboratories participate in every laboratory (including safety)
PT schemes and/ or inter-laboratory 13. llocate funding for PT participation for all
A
comparison / IQC for all testing done labs & Point-of-Care testing sites.
including Point of Care.
14. rocure IQC panels for all disciplines for all
P
laboratories
Strategic activities
15. Register and ensure participation of
16National Health Laboratory Strategic Plan 2017-2021
laboratories in PT schemes and/ or inter- upgrade labs to meet minimum biosafety
laboratory comparison recognized by the and biosecurity standards
MLCSCZ 4. dopt a WHO recommended Biosafety
A
16. onitor the PT performance (and corrective
M Training Curriculum including IATA
actions taken) of all laboratories annually Specimen transportation regulations
5. stablish a pool of Biosafety and Biosecurity
E
trainers
3.1.8 Biosafety
6. rain and sensitize laboratory personnel in
T
Policy objective biosafety and biosecurity
7. dopt and implement the WHO
A
To promote safe and secure laboratory practices Containment Standards
at all levels.
8. evelop and disseminate a national list of
D
dangerous chemicals, infectious agents and
Specific objectives
other dangerous materials to facilities and
personnel
1. o ensure all facilities have appropriate
T
space and safe environment for lab 9. aintain inventory system to account for
M
personnel, clients, the general public and infectious and dangerous organisms
environmentTo ensure lab workers are
trained in Biosafety and Biosecurity
3.1.9 Monitoring and Evaluation
2. o ensure national reference laboratories
T
have capacity and access control systems
Policy objective
to handle highly infectious organisms and To monitor and evaluate the quality of the laboratory
meet nationally acceptable containment services using clearly defined laboratory indicators
standards.
Specific objectives
Strategic activities
1. o develop and implement M & E system
T
1. isseminate the minimum standards for
D to assess performance of the laboratory
appropriate space and safe environment for services
health personnel, clients, the general public
and environment and framework for disposal
Strategic activities
of biological and bio-hazard material.
2. onduct bio risk assessments in all
C
1. evelop a laboratory M & E framework in
D
laboratories to ensure they meet the
alignment with the National M & E plan
minimum biosafety and biosecurity
(indicators, reporting, sources of data,
standards.
feedback mechanism)
3. Develop and implement a plan to refurbish/
17National Health Laboratory Strategic Plan 2017-2021
2. ppoint/hire an M & E coordinator within
A 3. isseminate and pilot the standardized
D
DLS paper based systems in selected districts
3. stablish and implement detailed M & E
E 4. oll out the standardized paper based
R
procedures systems
4. evelop measurable indicators, tools and
D 5. evelop guidelines and a standardised
D
milestones for quality delivery of laboratory electronic LIS with tools e.g. Registers,
services request forms, monthly reporting tools for all
indicators
5. rain laboratory personnel on the M & E
T
framework & procedures 6. rocure IT Hardware and infrastructure for
P
the operation of the electronic LIS
6. Manage and use M & E data
7. Integrate laboratory electronic LIS with the
MoHCC electronic system which covers
3.1.10 Laboratory Information System other departments e.g. Pharmacy, PMTCT,
EID
Policy objective 8. rain laboratory staff on the Electronic LIS
T
system
To ensure that all levels of laboratory services
have a functional and comprehensive laboratory 9. ilot the standardised Electronic LIS in
P
information system that manages and disseminates selected laboratories.
data for use by all relevant stakeholders
10. oll out the LIS to laboratories based on the
R
work plan
Specific objectives
11. rovide resources to ensure connectivity of
P
1. strengthen paper based laboratory
To LIS
information systems to promote laboratory
performance, quality patient care,
3.1.11 R
esearch, development and
Collaboration
surveillance, evidence-based medicine and
planning, policy formulation
and research Policy objective
2. o implement an electronic Laboratory
T To promote the development of research that is
information systems relevant to the health priorities of the country
Strategic activities Specific objectives
1. evelop guidelines and a standardized
D 1. o promote laboratory based operational
T
paper based system with tools e.g. research in line with priorities of the
Registers, request forms, monthly reporting MOHCC.
tools for all indicators 2. o encourage collaborative research
T
2. rain laboratory staff on the paper based
T nationally, regionally and internationally
system
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