Specimen Referral Networks Final

National Guidelines for Laboratory Specimen Referral Networks
A
National Guidelines for Laboratory Specimen Referral
Networks
2012
i
Any part of this document may be freely reviewed, reproduced, translated,

or quoted in full or in part for noncommercial use only, provided the source
is acknowledged.
Suggested Citation:
Ministry of Public Health and Sanitation and Ministry of Medical Services,

Republic of Kenya. National Guidelines for Laboratory Referral Networks.
Nairobi: Republic of Kenya, July 2012.
2012 Ministry of Public Health and Sanitation and Ministry of Medical

Services, Government of Kenya
Enquires and feedback should be addressed to:
Permanent Secretary
Ministry of Public Health and Sanitation
P.O. Box 30016-00100
Nairobi, Kenya
Tel: +254 (0)20 2717077
E-mail: psph@health.go.ke
and Permanent Secretary
Ministry of Medical Services
P.O. Box 30016-00100
Nairobi, Kenya
Tel: +254 (0)20 2717077
E-mail: ps@health.go.ke
This Publication was supported by Cooperative

Agreement Number 1U2GPS001862 from the Centers
for Disease Control and Prevention. Its contents are
solely the responsibilities of the author and do not
necessarily represent the official views of the
Centers for Disease Control and Prevention.
ii
TABLE OF CONTENTS
Foreword ......................................................................................................v
Preface.........................................................................................................vii
Acknowledgements.......................................................................................ix
Abbreviations and Acronyms........................................................................xi
1. Introduction.....................................................................................1
1.1. Background ........ ..............................................................1
1.2. Justification........................................................................4
1.3. Situation Analysis: History of Referral Networks ................5
1.4. Purpose and Target Users of the Guidelines.........................8
1.5. Goal of the National Laboratory Referral Network...............9
1.6. Policy Orientations Supporting the Laboratory Referral
Networks...........................................................................9
2. Structure and Organisation of Laboratory Referral Networks.......11
2.1. Structure of Integrated Laboratory Specimen Referral
Networks........................................................................11
2.2. Facilities in the Integrated Laboratory Referral
Networks.........................................................................12
2.3. Roles and Responsibilities of Facilities in Laboratory
Networks.........................................................................12
2.4. Roles of Nodal Laboratory Sites..........................................17
2.5. Coordination of the Laboratory Referral Network.............19
3. Laboratory Specimens and Tests...................................................21
4. Specimen Handling and Reports....................................................27
4.1. Specimen Collection.........................................................27
4.2. Packaging and Transportation..........................................28
4.3. Means for Sending Laboratory Reports and Results to the
Satellite Laboratory.........................................................30
iii
4.4. Communication within Referral Networks........................31

4.5. Communication Methods................................................34
5. Laboratory Resource Requirements .............................................35
5.1. Physical Infrastructure.....................................................35
5.2. Equipment and Supplies...................................................36
5.3. Human Resources............................................................37
5.4. Finance.............................................................................38
6. Quality Assurance..........................................................................39
6.1. Standard Operating Procedures.......................................39
6.2. Analytical Process Control Measures.................................39
6.3. Mentorship Support.........................................................40
7. Biosafety and Biosecurity...............................................................42
8. Monitoring and Evaluation ............................................................44
9. Establishment of a New Specimen Referral Network.....................46
References...................................................................................................51
Annex 1. Model of Referral Networks..........................................................53
Annex 2. Model of a National Specimen Referral Network..........................54
Annex 3. Directory of IDSR Referral Sites......................................................55
Annex 4. Kenya Laboratory-Based Surveillance List.....................................63
Annex 5. Sample and Specimen Referral Form............................................64
Annex 6. Model and Instructions for Triple Packaging of Specimens...........65
Annex 7. Contents of a Spill Kit....................................................................67
Annex 8. List of Essential Laboratory Equipment for Each Level of Care......68
Annex 9. Integrated Supportive Supervision Tool (MOH 2012)....................70
Annex 10. Referral Audit Tool.....................................................................107
Annex 11.Technical Working Group Members, Technical Reviewers, and List
of Contributors...........................................................................................111
iv
Foreword
The Constitution of Kenya has entrenched the right to health care services
for all. Enjoyment of this right by all will depend on the implementation of
measures to improve access to quality health services.
The Comprehensive Kenya Health Policy 20112030 has the goal of attaining
the highest possible health standards in a manner responsive to the
population needs, which will be achieved through provision of equitable,
affordable, and quality health and related services.1
The Kenya Health Sector Strategic Plan (KHSSP) 20122017, which has as its
goal accelerating attainment of health impact goals, aims to implement a
broad base of health and related services that will impact on the health of
persons in Kenya.2
These national policy and strategic guidance documents recognize the

importance of referral systems in the attainment of these overall health
goals in Kenya, and articulate measures to be taken to strengthen these
systems. Specimen transfer is a key component of the national referral
system which increases all Kenyans access to the highest level of laboratory
services, regardless of the point where they seek health care.
The Comprehensive Kenya Health Policy has operationalized the two-

tier health management system, corresponding with national and county
governments.1 Providing standard guidance documents to ensure quality
health service delivery to all Kenyans is one of the roles of the national
ministry responsible for health.
To achieve the referral strategys maximum intended benefits, the Ministries

of Health have developed the National Guidelines for Laboratory Specimen
Referral Networks; these guidelines are designed to strengthen and reinforce
coordination and efficiency of integrated laboratory specimen referral,
thereby improving access to laboratory services.
v
Country-wide implementation of these guidelines will ensure that patients

can access all relevant laboratory services available to address their medical
needs; ensure accurate disease surveillance; and provide information to
direct healthcare policies.
Dr. S. K. Sharif MBS,MBChB, MMed, MSc Dr. Francis M. Kimani

Director, Public Health and Sanitation Director, Medical Services
Ministry of Pubic Health And Sanitation Ministry of Medical Services
vi
Preface
Both the Ministries of Health have established programmes, policies, and
strategies to ensure the realization of the Health Laboratory Sub-sector
Vision of an efficient and high-quality care system that is accessible,
equitable, and affordable.
To improve access and equity in health services delivery, the National

Referral Strategy and Investment Plan for Health Services,3 covering multi-
disease laboratory tests, was prepared. The implementation of this strategic
plan will provide laboratories with the structure and essential requirements
for effective specimen referral.
The National Guidelines for Laboratory Specimen Referral Networks present

recommendations that can be applied to multi-disease laboratory networks.
These guidelines define the structure and organization of the referral
networks as well as the responsibilities of the facilities in the networks. The
guidelines describe the recommended laboratory service delivery for each
level of care and the mix of resources required for effective and efficient
service delivery. The guidelines also detail standard measures to be taken
in specimen management to guarantee their integrity as well as the safety
of health workers. Finally, the guidelines offer a monitoring and evaluation
(M&E) framework to facilitate M&E activities to establish and maintain
network efficiency and effectiveness.
The National Guidelines for Laboratory Specimen Referral Networks is a

crucial reference document for implementing a new referral network, as the
guidelines define the requirements for establishing new laboratory nodal
sites, which will allow increased access to new services.
vii
Establishment of laboratory specimen referral networks, in accordance

with these standard guidelines, will enhance the effectiveness of laboratory
services in support of patient management as well as surveillance for priority
diseases.
Dr. Jane W. Siminyu Dr. Margaret Oduor

Head, National Public Health Laboratory Services Head,Department of Diagnostics and
Ministry of Public Health and Sanitation ForensicServicesNationalBlood Transfusion Services
Ministry of Medical Services
viii
Acknowledgements
The development of the National Guidelines for Laboratory Specimen
Referral Networks was led by a technical working group. The Ministries of
Health wish to extend special thanks to the technical working group (annex
11) for their leadership and teamwork throughout the development process
of these guidelines. These members were drawn from:
The National Public Health Laboratory Services, with

representation from Central Reference Laboratories, District
Medical Laboratory Technologists, and a Health Centre Laboratory
Technologist
The Department of Diagnostic and Forensic Services and National

Blood Transfusion Services, with representation from the Office
of the Chief Medical Laboratory Technologist, Provincial Medical
Laboratory Scientific Officers, and Provincial Pathologists
Management Sciences for Health (MSH)
The ministries acknowledge the invaluable contributions made by

participants of the laboratory stakeholders meetings on referral networks
held in February 2011 and November 2011, as well as other consultative
forums. We would like to thank the facilities that participated in the
piloting of the guidelines for their support and cooperation in assessing the
guidelines applicability.
We would particularly like to thank the reviewers (annex 11) for their detailed
reviews and willingness to make contributions to improve the guidelines
content.
ix
We are grateful for the concerted efforts of all the individuals and institutions
that participated in the development of these guidelines.
Both ministries particularly appreciate the technical support from the
US Presidents Emergency Plan for AIDS Relief (PEPFAR), through the
Management Sciences for Health Strengthening Public Health Laboratories
Project in Kenya.
Mr. Abdulatiff Ali

Chief Medical Laboratory Technologist
x
Abbreviations and Acronyms

AFB acid-fast bacilli
AIDS acquired immunodeficiency syndrome
ART antiretroviral therapy
ASOT anti-streptolysin O test
CDC US Centers for Disease Control and Prevention
CME continuing medical education
CRL county referral laboratory
CSF cerebrospinal fluid
DNA deoxyribonucleic acid
EID early infant diagnosis
ELISA enzyme-linked immunosorbent assay
EQA external quality assurance
FIF Facility Improvement Fund
Hb haemoglobin
H&E haematoxylin and eosin
HIV human immunodeficiency virus
IDSR integrated disease surveillance and response; also refers
to the Draft Technical Guidelines for the Integrated Disease
Surveillance and Response
IQC internal quality control
KEPH Kenya Essential Package for Health
Lab ICC Laboratory Interagency Coordinating Committee
LFT liver function test
M&E monitoring and evaluation
MOH Ministry of Health
MTB/RIF Mycobacterium tuberculosis/resistance to rifampicin (test)
OJT on-the-job training
PAS periodic acid-Schiff (test)
PCR polymerase chain reaction
PPB Perls Prussian blue
xi
QA quality assurance
RNA ribonucleic acid
RPR rapid plasma reagin
SOP standard operating procedure
STI sexually transmitted infection
TB tuberculosis
TCBS thiosulfate citrate bile sucrose
TPHA treponema pallidum haemaglutination assay
U/E/C urea, electrolytes, creatinine
VDRL venereal disease research laboratory
WBC white blood count
WHO World Health Organization
ZN Ziehl-Neelsen stain
xii
1.Introduction
1.1. Background
The global commitment to achieve disease reduction targets set by the
Millennium Development Goals 2000 has led to increased demands for
countries to improve their healthcare systems. Countries with limited
resources have had to identify opportunities for optimising resources to
achieve functional health systems that meet national priorities and support
global disease control objectives.
As a signatory to the Millennium Declaration, the Government of Kenya has

stated its duty to provide its citizens with the highest attainable standard
of health. The goal of the Comprehensive Kenya Health Policy 20112030
is better health in a responsive manner. The strategic objectives of the
policy include increasing equitable access to affordable health services and
improving the quality and responsiveness of services in the sector, as well as
the efficiency and effectiveness of service delivery.1
The vision for the laboratory sub-sector is to have an efficient and high-
quality health care system that is accessible, equitable, and affordable for
all. The mission statement of the sub-sector is to provide effective, efficient,
accessible, equitable, and affordable laboratory services that support the
diagnosis and management of patients, public health disease surveillance,
and the regulation and monitoring of standards of laboratory practice in
Kenya.
Health services in Kenya are structured in a hierarchal manner, with four

levels of care: community services, primary care services, county referral
services, and national referral services.1 The categorization ensures efficiency
in the use of existing resources. It means, however, that clients may not be
able to receive all the services they require at the health service delivery unit
they visit, particularly if they are only able to visit the community service.
The Ministries of Health (MOH) have developed the National Referral
3
Strategy to address this shortcoming.
A referral system is defined as a mechanism to enable clients health needs
1
to be comprehensively managed using resources beyond those available

where they access care.National Referral Strategy and Investment Plan
for Health Services: 201020153
Effective referral networks provide linkages across the different levels of the
health system from the community to the national level, which ensure
that the client can receive the full scope of care the health system is able
to provide in the country irrespective of the health system level where
the client physically accesses care. The framework for the national referral
system recognizes specimen movement as an indirect referral mechanism.
Laboratory specimen referral consists of the movement of a laboratory

specimen from one laboratory to another for investigative purposes or
quality assurance (QA), and back movement of results/reports. It is a system
of sharing vital laboratory services among various laboratory units where
such services are not available due to logistical or other challenges, with
the aim of improving their clients access to such services. The system
aims at maximizing the clients visit and offering a standard laboratory
package throughout the health system. This strategic approach ensures
the laboratory services execute the mandate as stipulated in the National
Referral Strategy.3
A laboratory network can be defined as a collection of laboratories that use

standard operating procedures (SOPs), carry out quality assessments, and
report information which is used for clinical and public health action in a
systematic manner.
The key elements needed for a functional laboratory referral network

include the following:
Definition of the laboratory tests available in the referral network
Organisation, coordination, and financing of health systems to

allow effective functioning of the referral network
Definition of the human resource requirements for facilities in the

network
2
Essential equipment and its maintenance for continuous service

delivery
Definition of the required logistics, including documentation,

supplies, transportation, and communication systems
A QA programme to guarantee accuracy and reliability
Applicable standard SOPs for all procedures, including specimen

handling
M&E for effective implementation and continuous improvement
The Kenya Essential Package for Health (2005; KEPH)4 defines the scope of
services to be provided at each level of the health system, including on-site
laboratory testing capacity. The National Referral Strategy has defined an
investment plan to equip the laboratories to provide the stated minimum
packages.3
The laboratory strengthening efforts of development partners in support of

diagnosis and management of HIV and AIDS, tuberculosis (TB), and malaria
have provided several laboratories with the capacity to provide more tests
than those prescribed under the KEPH schedules.4 The infrastructure, staff
capacity, and quality systems built into these laboratories can also be utilized
to support the management of other communicable and non-communicable
diseases, including diabetes mellitus, hypertension, and cancer, which are
emerging as public health threats in developing countries.
The important role of public health laboratories has been emphasized by the
World Health Organization (WHO), which, through the Maputo Declaration,
in 2008, urged member states to develop well-staffed and properly
equipped laboratories and formulate guidelines for national integrated
specimen referral networks.5 Although the emphasis of this resolution
was on disease surveillance and response, the benefits apply equally for
patient management. Such benefits include supporting the management
of communicable and non-communicable diseases which are among the
leading causes of illness, disability, and death in African communities. The
3
laboratory referral network functions go beyond analysis of specimens. They

include provision of equipment, supplies, QA, and training so that tests can
be performed accurately and reports made available in a timely manner. The
data obtained through the networks can be used in patient care and linked
to disease surveillance activities and the planning of health services.
1.2. Justification
Access to reliable diagnostic facilities is a major challenge contributing to
the delay or lack of appropriate, timely patient management and response
to disease outbreaks in Africa. An effective laboratory referral system will
lead to accessible and affordable services, ensuring timely diagnosis,
enabling appropriate clinical management, and supporting public health
interventions.
Specimen referrals have previously been operational in public health

facilities; for example, referral of TB, microbiology and histology, and
forensic specimens. These referral networks, however, are uncoordinated,
not integrated, and in many cases involve the patient moving with the
specimen. The efforts to increase access to laboratory services in support of
HIV and AIDS care and treatment have emphasized the need for functional
laboratory referral networks as an effective, sustainable approach.
Experiences from countries in the region have shown that establishment

of laboratory referral networks, using standard guidelines, enhances the
effectiveness of laboratories in support of patient management as well as
surveillance for priority diseases. Standardization of referral systems will
improve the scope of laboratory services.
The benefits of implementing these guidelines include the following:

1. Improving the quality of tests offered through networks will lead
to improved laboratory services and thus increased access and
utilization of services, with attendant reduction in morbidity.
2. Effective specimen referral systems will reduce the direct costs

of accessing and delivering health services, as patients will be
managed at the appropriate level of care.
4
3. The quality and delivery of specialized services to users will be

strengthened.
4. Improved quality of health data collection and management will

inform better decision making.
5. Tracking of specimens (e.g., histology specimens) will be

enhanced.
1.3. Situation Analysis: History of Referral Networks

1.3.1. Referral Networks in Support of HIV Services
In 2003, WHO and UNAIDS launched the 3 by 5 Global Initiative, targeting
treatment for 3 million HIV patients by 2005. The Kenya National AIDS
Strategic Plan6 provided a framework for antiretroviral therapy (ART)
scale-up based on this initiative. Laboratories did not have the capacity to
manage the CD4 testing requirements in support of ART that followed the
huge patient inflow at the public hospitals. A strategic approach was devised
where 12 high-volume laboratories were identified and equipped with
standardized equipment. Procurement of reagents and other consumables
was standardized, and network systems were devised for these laboratories
to provide tests for remotely located ART satellite sites. The approach
improved service uptake and access, which was essential in the ART scale-
up strategy. Other tests were added to the network over time, including HIV
viral load and early infant diagnosis (EID) (polymerase chain reaction [PCR]),
haematology, biochemistry, and opportunistic infection detection.
The laboratory network approach (see annexes 1 and 2) employed these

steps:
Specimens were collected and shipped to the nearest processing

laboratory.
Standardized protocols and trainings were adopted for specimen

collection, initial processing, packaging, and transportation.
Common QA schemes, including external quality assurance (EQA),

were instituted for the network laboratories.
5
Patients and clients were cushioned against transport costs and

other incidental costs.
Lessons learnt from four ART pilot sites in Coast Province (2003
2005) were shared, and the approaches were expanded to Nyanza
in 20052006.
Expansion in the use of the laboratory network approach for ART

monitoring was implemented in all provinces from 2007.
1.3.2. Referral Networks for Tuberculosis

A laboratory network approach has been partially developed for TB testing,
following these steps:
Initially, the TB county referral laboratories (TB-CRLs) were the

only level of public laboratory performing routine TB culture/drug
sensitivity testing.
Plans were put in place to decentralize TB culture services to

improve service delivery.
Currently, some county referral hospital laboratories also act as

referral centres. The network involves peripheral laboratories
sending specimens for microscopy, GeneXpert MTB/RIF, line
probe assay, or mycobacterial culture to these referral centres.
The TB-CRL supports the EQA networks for acid-fast bacilli (AFB)
microscopy for regional and high-volume laboratories (annex 2).
1.3.3. Referral Networks for Surveillance of and Response to

Epidemic-Prone Diseases
A laboratory network is partially in place for surveillance and management
of epidemic-prone diseases, with the following components:
Laboratory diagnosis of diseases under surveillance is coordinated

by the Department of Disease Surveillance and Response.
Specimens from suspected cases are transported to designated
6
analytical laboratories by staff from the district surveillance

offices.
The analytical laboratories include Provincial General Hospital

laboratories, the Central Microbiology Reference Laboratory,
the African Medical Research Foundation laboratory, and Kenya
Medical Research Institute viral laboratories.
The Analytical Laboratories plays a role in collection of blood

specimens (e.g. for measles antibodies), providing transport
media for stool samples, and packaging of the specimens in
readiness for transfer to nodal laboratories.
1.3.4. Referral Networks for Non-communicable Diseases

The status of referral networks in managing non-communicable diseases is
not optimal, with the following capacities and gaps:
Laboratories which are unable to process histology and forensic

specimens send them to the National Public Health Laboratory
Services.
Referral of microbiology specimens to the Central Microbiology

Reference Laboratory has also been operationalized.
There is no formal system for referral of laboratory specimens for
other diseases. Most referrals have involved patient movement
with the sample.
1.3.5. Ministries of Health Response: Efforts to Address

Referral Systems
The MOH have taken these steps to address the gaps in the existing
patchwork of laboratory referral systems:
In 2010, the MOH prepared a National Referral Strategy,3 including

specimen referral as a strategy to improve access and equity in
health services delivery.
7
The strategy covers multi-disease laboratory tests. It also

recognizes faith-based and private institutions as well as
international institutions as part of the referral system. The
implementation of the strategic plan will provide laboratories with
the structure and essential requirements needed for effective
specimen referral systems.
1.4. Purpose and Target Users of the Guidelines

These National Guidelines for Laboratory Specimen Referral Networks are
designed to guide the implementation of the laboratory element of the
National Referral Strategy,3 with the following applications, target users,
goals, and policy support.
1.4.1. Application to Multi-disease Laboratory Networks

These guidelines will be applied to multi-disease laboratory networks
through the following:
Defining the purpose, components, and coordination of a public

health laboratory network
Providing general guidance for establishing and strengthening a

national laboratory network
Providing guidance on communication within and among county

laboratories, national referral laboratories, private laboratories,
and development partners
1.4.2. Target Users of the Guidelines

The guidelines target a scope of laboratory users, consumers, and
stakeholders who are involved in supporting the referral system. These
target users include the following:
Laboratory personnel to guide in specimen referral processes
Laboratory management to aid in planning, budgeting, and

quality management
8
Clinicians as key consumers of laboratory information for

collaboration and creating demand for laboratory services
Policy makers and administrators of health facilities for planning

and coordination, and to ensure funding and other support is
provided to maintain and sustain an effective referral system
Development partners to guide them in their support of the

referral systems
Training institutions to help in the development and reviewing of

training curricula
1.5. Goal of the National Laboratory Referral Network

The goal of a national public health laboratory network is to provide high-
quality, accurate, and timely laboratory-based information. This information
should be used for clinical management of patients, forensic diagnosis, and
for public health decisions to direct effective disease control and prevention
programmes.
1.6. Policy Orientations Supporting the Laboratory Referral

Networks
Policies provide directions for planning and resource allocation. The National
Referral Strategy3 has defined the policy framework which will support and
strengthen integrated laboratory referral networks. The National Referral
Strategy3 states that:
The service standards and SOPs for different levels shall be
defined, prepared, and customized at all levels to guide them in
appropriate referral of specimens.
Both public and non-public laboratories shall be a part of the

overall laboratory network.
National Public Health Laboratory Services will be strengthened

to function as reference laboratories for disease control and
surveillance.
9
National referral hospital laboratories will be strengthened to act

as reference laboratories for clinical diagnosis and management
of patients.
Higher-level laboratories will be strengthened to support and

build capacity of the lower ones in their zones of referral.
All laboratories shall have the necessary capacity to facilitate

specimen referral to higher-level laboratories.
10
2.Structure and Organisation of Laboratory Referral

Networks
2.1. Structure of Integrated Laboratory Specimen Referral
Networks
The organizational structure of laboratory specimen referral networks will
follow the national health delivery structure based on the KEPH,4 which is
supported by the Norms and Standards for Health Services Delivery.7 This
approach enables the laboratory referral system to be entrenched into the
national health delivery model and the ministrys health funding structure,
thus ensuring sustainability of the networks.
As shown in figure 1, the national health laboratory network shall have a

hierarchal pyramidal structure with the national reference laboratories
at the top of the pyramid, followed by CRL, and the primary healthcare
laboratories at the base.
National
reference labs

County referral labs
Primary care labs
Figure 1. Tiered national laboratory structure

Laboratories at lower levels will send specimens to the next level,
where the required analysis will be provided.
Laboratories may bypass the next level in the hierarchy and send
the specimen to the higher level, where the required analysis will
be provided.
11
Longitudinal referral networks, where a laboratory sends a

specimen to another laboratory at the same KEPH level,4 should
also be effectively in place at each tier of the healthcare system.
Such longitudinal networks should provide alternate testing sites
in case of machine breakdown or reagent stock-out, and function
effectively as inter-laboratory QA schemes.
The minimum laboratory activities shall be defined for each level

of care in accordance with the laboratory policy and National
Referral Strategy.3
2.2. Facilities in the Integrated Laboratory Referral Networks

The facilities in the integrated specimen referral network will include the
following:
Primary care laboratories, county hospital laboratories, teaching

or tertiary-level hospital laboratories, and disease-specific
national reference laboratories
Faith-based and private medical laboratories are also included

in the referral networks as provided by the National Referral
Strategy.3
2.3. Roles and Responsibilities of Facilities in Laboratory

Networks
In any laboratory referral network, there is the referring facility which
collects and refers the specimen; it is sometimes called the satellite site. The
facility to which the specimen is sent for analysis is the receiving facility, also
called the nodal site. A laboratory may function as both a nodal and satellite
site depending on the services that it provides. A laboratory may also use
several referral laboratories for different tests; for example, a health centre
laboratory may send blood specimens to the district hospital for CD4 testing
and sputum samples to the TB-CRL for TB culture. The established health
care system management structures will be used to manage and coordinate
laboratory referral networks, especially for tests used in support of diseases
12
of public health importance. For the referral system to function effectively

and efficiently, the roles and responsibilities of each facility must be clearly
defined.
2.3.1. National-Level Roles and Responsibilities

The national level includes the MOH laboratory sector heads as well as
the national clinical referral laboratories, central public health reference
laboratories, and research laboratories. Heads at each facility should provide
leadership and management oversight for all laboratory services, including
the referral systems. National reference laboratories will, in addition,
provide specialized diagnostic services. They shall, therefore, have both
management and service roles, as described below.
Leadership and Management Roles

The leadership and management roles of national-level laboratories include:
Planning for laboratory referral networks in support of priority

diseases such as HIV and TB, and as part of laboratory service
delivery strategy.
Advocacy for budgetary provisions to support national specimen

referral networks and putting in place systems to ensure allocated
finances are utilized for the intended purpose. This will include
budgetary provisions for courier and logistics systems for
specimen transfer.
Guiding the integration of laboratory specimen referral within

vertical programmes.
Guiding policy formulation and implementation in respect to

specimen referral networks.
Forecasting and quantification of national commodity

requirements for specimen transfer.
Establishing a coordination structure for national and county
13
laboratory specimen referral networks and creating linkages with

national offices, including human resources management, the
commodity unit, and the QA unit.
Developing the framework and tools for monitoring the

performance of referral networks.
Maintaining and regularly updating a national directory of referral

networks, particularly those for highly specialized tests.
Coordination of national development partner activities in

support of specimen referral networks.
National Reference Laboratory Services Roles

The National Reference Laboratory Service Roles shall include:
Providing specialized laboratory tests. (See National Nodal Site

Roles, below.)
Providing mentorship and support to county referral facilities

when necessary, to strengthen and improve specimen referral
networks.
2.3.2. County-Level Roles and Responsibilities

This level includes the county laboratory leadership and CRLs. Their
responsibilities will include management as well as diagnostic services, as
described below.
Management Roles
The National Reference Laboratory Management Roles shall include:
Planning for and coordinating implementation of county

laboratory specimen referral networks
Coordination of county supply of laboratory commodities in

respect to specimen transfer
14
Advocating for budgetary provisions to support county specimen

referral networks
Monitoring performance of county referral networks and

ensuring timely delivery of reports to clinicians, as well as
accurate and timely reporting of network function data to county
health management teams and national laboratory offices where
required
Continuously assess and respond to the laboratory testing needs

at the county
Coordination of regional implementing partner activities in

support of the referral networks
Diagnostic Services Roles

Acting as nodal sites for primary care facilities (county nodal sites).
Mentoring, coaching, and providing other support to staff in

lower-level facilities as the need arises.
Compiling and regularly updating a directory of tests and networks

in the region(annex3). The directory should include tests available
in private and faith-based organization laboratories, and it should
map out where surveillance tests (annex 4) are being done. It
should be updated quarterly and circulated to all laboratories in
the county and to the national coordinating office.
2.3.3. Responsibilities for Referring Facilities (Satellite Sites)

The responsibilities for referring facilities include the following:
Developing and regularly updating a list of tests done on-site and

for referral (test menu). A standard tool should be used for this
purpose. The list should contain the following information:
Test name
Specimen requirements for the test
15
Name of the testing laboratory

Turnaround time for results
Schedule for testing (daily, weekly, etc.)
Charges for the test
Alternate testing laboratory
Circulating the list to laboratory users and other stakeholders,

including the coordinating facilities for regional and national test
mapping.
Creating demand for laboratory tests by informing laboratory

users of available tests in the networks and their clinical utility.
This should be done through clinical-laboratory interactions in
ward rounds, mortality meetings, continuing medical education
(CME) forums, or laboratory newsletters.
Requesting and effectively managing commodities for specimen

collection and packaging, and documentation tools. These will
include the following materials:
Phlebotomy materials, specimen containers, and personal

protective equipment
Laboratory requisition forms (for example, annex 5), laboratory
registers, and logs
Delivery books and packaging materials as required
Ensuring proper specimen collection, initial processing, and

packaging for safe transportation. A designated dispatch area
should be created in the laboratory with standard tools to improve
safety and ensure quality of specimens. The tools should include
a dispatch checklist, SOPs, and job aids for specimen packaging
and dispatch.
Shipping specimens to the referral laboratory as scheduled and

ensuring the necessary documentation is done for specimen
collection and transfer.
16
Where applicable, ensuring necessary payments for referral tests

are made, including the cost of specimen transfer, and transfer of
the appropriate funds made to the nodal site.
Monitoring the function of the network using the agreed list of

indicators.
Utilizing specimen referral networks data to inform the need

for initiation of on-site testing, and planning for the same. The
planning for on-site testing should include arrangements for on-
the-job training (OJT) of satellite staff at the nodal facility.
2.4. Roles of Nodal Laboratory Sites

The National Referral Strategy3 recommends referral from lower-level
facilities to the next higher level in the tiered health structure. Specialised
tests such as viral tests, EID, TB culture, and histology may, however, only be
available at the national referral laboratories. Peripheral laboratories would,
therefore, bypass the CRLs and send specimens for such tests directly to
the national referral laboratories. This arrangement takes cognizance of two
levels of nodal laboratories, the county and national nodal sites, each with
different roles.
2.4.1. County Nodal Sites

Laboratory management at the CRL shall be responsible for organizing
and coordinating the referral network it serves. Coordination can be done
by a designated focal point person, whose contact information should be
circulated to all the satellite facilities in the referral network. The county
laboratory will refer tests it is not able to perform to the appropriate national
referral laboratory.
The county nodal sites will perform all the roles of the satellite
laboratories and, in addition, they will support the satellite
primary care laboratories through the following activities:
Preparing the laboratory tests menu, with specimen requirements,

costs, and turnaround times, and distributing the same to the
17
satellite laboratories in the network.
Receiving referred specimens and performing the required tests,

assuring quality of analysis and reporting results.
Ensuring proper management of commodities used in specimen

transfer.
Maintaining an effective equipment management programme,

to include establishment of a backup plan in case of equipment
malfunction.
Confirming payments for tests provided under the Facility

Improvement Fund (FIF).
Ensuring proper documentation of all processes at the nodal site

to provide data that can be used to monitor quality as well as the
efficiency and effectiveness of the network.
Maintaining a separate register for referral tests to be used

for tracking the activity. In respect to programme-supported
tests, each satellite should have its own separate register at the
nodal site to allow for satellite-specific data analysis. Standard
information should be captured in the register, including date,
number of specimens brought, whether acceptable or rejected,
name and designation of person bringing the specimens, and
mode of transport used.
Regular data analysis should be done to provide information

that will guide supportive supervision of satellite sites on pre-
analytical processes if the specimen rejection rate is high. The
report findings should be communicated to the satellite facility.
Providing reports of network functions to relevant authorities in

a timely manner.
18
2.4.2. National Nodal Sites

The laboratories at the apex of the hierarchal structure have multiple roles
in the referral networks, especially those for priority disease programmes.
These include the following:
Providing specialized analytical services, such as TB culture and resistance

testing, HIV viral load tests, mycology cultures, and tumour marker tests
Supporting QA for laboratory referral networks for priority diseases through

provision of proficiency testing and other EQA programmes for specific tests
and validation reagent kits
2.4.3. Development Partners Roles and Responsibilities

Development partners help provide the resources required to establish and
maintain functional laboratory referral networks.
2.5. Coordination of the Laboratory Referral Network

Specimen referral networks are strategic for achievement of programme
and health service goals. A coordination mechanism is required to provide
oversight for the networks and monitor their performance. Levels of
coordination include national, county, and health facility levels, as detailed
below.
2.5.1. National Level

A technical subcommittee should be set up under the Laboratory Interagency
Coordinating Committee (Lab ICC) to coordinate the management of referral
networks and make recommendations to the Lab ICC. The subcommittee
will carry out the following functions:
Provide and regularly review and update the national laboratory

test menu and referral mapping directory.
Promote knowledge exchange within the network. This can

be through stakeholders meetings to share experiences and
preparation of newsletters.
19
Promote best practices in network operations.
Work collaboratively with referral laboratories to ensure optimal

use of referral systems.
Promote community and non-public (private) participation in

referral networks growth and maintenance.
Develop indicators to be used to monitor networks progress and

use M&E data to inform measures to improve specimen referral
networks and enhance their sustainability.
2.5.2. County Level

A subcommittee of the County Lab ICC should be formed to coordinate the
referral networks in each of the counties. The subcommittee will advise
and make recommendations to the County Lab ICC on matters related to
laboratory specimen referral networks.
2.5.3. Health Facility Level

Each laboratory facility should have a designated person for coordinating the
management of specimen referral services at the facility.
20
3. Laboratory Specimens and Tests

The Kenya Health Sector Strategic Plan2 has adopted the KEPH, based on
health services required by the six age cohorts derived from the human
life cycle, as the approach for comprehensive health service delivery in
the country. To provide these KEPH services, norms and standards have
been defined in the Draft Technical Guidelines for the Integrated Disease
Surveillance and Response in Kenya 2011(IDSR)8 which indicate the minimum
laboratory services to be offered at each level. The position paper on the
implementation of the Kenya Constitution in the health sector defines
four levels of health services delivery: community level (I), primary care
level (level II), county referral level (level III) and national referral (level IV).
Laboratory services are offered from level 2 upwards.
The IDSR8 guidelines for integrated disease surveillance and response also
define the laboratory tests to be performed at each healthcare service level
in support of disease surveillance and outbreak response based on these
norms and standards (table 4). The National Referral Strategy3 specifies
logistics, essential laboratory staffing, and equipment to be provided at
each health care service level to support the implementation of the national
referral networks, including laboratory specimen referral networks.
Laboratories should be supported to provide all recommended

on-site tests.

Nodal sites should put equipment bought to support laboratory
tests for priority diseases to maximum use by purchasing
additional reagents using FIF; for example, purchasing reagents
for performing additional tests available on a biochemistry auto-
analyser.

Higher-level laboratories will provide all tests and services
performed at the lower laboratories. In addition, they will provide
those specified for their level.
Laboratory testing capability for priority notifiable diseases will

also follow the levels of healthcare service delivery linked to the
infectious disease surveillance.
21
The recommended on-site laboratory services for each level are in tables
14.
Table 1. Recommended Minimum Package of Tests for Primary Care

Laboratories
Rapid tests Other tests
HIV rapid tests AFB smear by light microscopy
Hemoglobin Malaria smear
Whole blood glucose by glucose Dipstick urinalysis, wet mounts

meter
Stool microscopy
Rapid urine pregnancy test
ABO blood grouping, including
Malaria rapid test sickling test
Rapid syphilis test Pap smear collection
Brucella test High-vaginal swab for

microscopy(wet prep and Gram
stain)
Rheumatoid factor test
Venereal disease research labo-

ratory (VDRL) test
22
Table 2. Recommended Minimum Package of Tests for CRLs

Microbiology and Haematology Chemistry tests
serology
Syphilis serology test CBC (complete blood Liver function tests
count) with WBC (LFTs; alanine ami-
Cryptococcus antigen (white blood cell) dif- notransferase, bili-
ferential rubin)
India ink
Peripheral film evalu- Serum electrolytes
Gram stain ation
Renal function
Urine dipstick with mi- CD4 counts (absolute tests (creatinine,
croscopy required; percentage urea, nitrogen)
is preferred)
Cerebrospinal fluid Lipid profile
(CSF)/body fluid cell ABO group and cross-
counts match Serum amylase
Hepatitis B Blood transfusion and Glucose

reaction investiga-
Hepatitis C tions Whole-blood lac-
tate
Microbiology cultures Haemoglobin (Hb)
and susceptibility tests electrophoresis Semen analysis
Sexually transmitted in- Coagulation tests Hormonal profile

fection (STI) diagnosis:
high-vaginal swab for Thyroid functional
tests
o Chlamydia
Tumour markers
o ASOT (anti-streptoly- (prostate-specific
sin O test) antigen)
o Brucella tests
o H. pylori antigen
o Water microbiology
Other services
o Bone marrow aspi-

rates collection
o Pap smear collection
23
Table 3. Recommended Minimum Package of Tests for National Referral

Laboratories
EID Hormonal Microbiology HIV resistance
tests culture, iden- testing
Viral load tification and
Tumour susceptibilities AFB suscepti-
Opportunis- markers bility (for first-
tic infection Blood cultures and second-
screening TB culture line drugs)
and micros- Complete
LFTs copy chemistry Ultrasensitive
panel p24 antigen
U/E/C (urea, Other
electrolytes, cultures AFB smear (by Quantitative
creatinine) fluorescence nucleic acid
Biopsy technique) testing for
CSF sugar/ antiretroviral
protein Autopsy AFB culture, monitoring
identification (HIV RNA)
Full haemo- Pap smear and suscepti-
gram bility (first-line Qualitative
Aspirates drugs) nucleic acid
Sickling tests testing (HIV
Hb electro- Quantita- RNA)
phoresis tive nucleic
acid test for Variety of diag-
Fungal antiretroviral nostic testing
culture monitoring
(PCR, bDNA) Other esoteric
Water mi- reference lab
crobiology Qualitative testing as
nucleic acid needed
Food safety testing for
Laboratory diagnosis of
tests infants (DNA
PCR)
24
Table 4. Recommended Package of Tests for Disease Surveillance and

Response at Each Level
National refer-
Primary care labora- ence labora-
Disease tory CRL tory
Cholera Macroscopic examina- V. cholerae Isolation of V.
tion isolation cholerae O1 from
from stool stool specimens
Microscopic exami- specimens and antimicrobial
nation for shooting and anti- resistance testing
star pattern for Vibrio microbial
cholerae resistance
testing
Inoculation of transport
media (Cary Blair, alka-
line peptone water)
Rapid test if available

Meningitis Macroscopic and mi- Culture, PCR (if possible)
croscopic examination identifica-
(direct and after Gram tion, and
staining on sediment antimicrobial
from centrifugation) resistance
testing, if
Latex agglutination test possible
for Neisseria menin-
gitis, Staphylococcus
pneumoniae and Hae-
mophilus influenza type
b (Hib) (if possible)
Inoculation of media
transport (trans-isolate
bottle)
25
National refer-
Primary care labora- ence labora-
Disease tory CRL tory
Plague Microscopic examina- Yersinia pestis isola-
tion after Gram staining tion from bubo or
bubo aspiration or sputum and antimi-
sputum crobial resistance
testing
Dipstick testing on
bubo aspiration or
sputum
Inoculation of transport
media (Cary Blair)
Collection and ship-

ment of blood sample
to the reference
laboratory for serology
testing
Diarrhea with Macroscopic exami- Isolation of
blood nation Staphylococ-
cus dysen-
Inoculation of trans- teriae type
port media (Cary 1 from stool
Blair) specimens
and
antimicrobial
resistance
testing
QA
TB AFB staining AFB staining Culture, identifica-
tion, and antimi-
crobial resistance
testing
Gonococcus Microscopic examination Microscopic Isolation of Neis-
for Gram stain on urethral examination seria gonorrhoeae
pus for Gram from urethral pus
stain on ure- and antimicrobial
thral pus resistance testing
Source: IDSR8
26
4. Specimen Handling and Reports

Most laboratory errors occur in the pre-analytical phase. QA in the laboratory
begins with obtaining a good specimen. Rejection of poor-quality referred
specimens leads to significant delays in obtaining laboratory results, with
attendant delay in patient care. On the other hand, laboratory specimens
usually contain infectious agents and pose a risk to all who handle them
within the laboratory and during transfer to the nodal site. Standard
measures must be taken to ensure that the specimens collected are of good
quality and that appropriate bio-safety measures are used in handling them.
SOPs and job aids for all the processes involved should be provided and used.
Laboratory specimens should be collected and handled according to

disease specification. They must be transported to the referral laboratory
for examination as quickly as is reasonably possible. Specimens should be
maintained at the correct temperature and under conditions suitable for
examination at all times to ensure that reliable results are obtained.
4.1. Specimen Collection

The following conditions should be followed during laboratory specimen
collection:
The laboratory specimens shall be collected and handled

appropriately according to the tests requested.
All staff collecting specimens from patients shall receive training

in the proper procedures for collecting specimens.
Instructions for proper specimen collection shall be given to

patients.
Appropriate specimen containers should be provided.
For bacteriological analysis, specimens should be inoculated onto

an appropriate transport medium at the point of collection, for
safe shipment to the referral laboratory.
27
4.2. Packaging and Transportation

The packaging and transportation of laboratory specimen should be done
as follows:
Referral specimens should be properly packaged and labeled

for transfer to the nodal site for examination. Packaging aims
to maintain integrity of specimens and ensure personnel safety
during transportation.
Packaging and shipping must follow the International Air Transport

Association (IATA) Instruction 650-Diagnostic Specimens.9 Triple
packaging shall be used, as shown in figure 2and annex 6.10
Appropriate packaging materials and bio-hazard labels should be

provided. Plastic vials should be used for specimens whenever
possible to prevent breakage during transportation. If glass
tubes are used, they should be well padded. Cool boxes should
be provided to maintain required temperatures during specimen
transfer.
Laboratory staff should be trained and certified in the proper

procedures for packaging and shipping dangerous goods. If a
contracted courier service is used, the courier staff should also be
trained on bio-safety and quality measures, including how to deal
with spillages during transportation, as well as documentation
requirements for the referral chain. Job aids should be developed
to reinforce the training. Training should also be provided to clinic
clients or facility staff who transport specimens to nodal sites. A
spill kit with the recommended contents should be provided to
manage spillages (annex7).
The documentation requirements of the referring laboratory,

the courier, and the receiving laboratory should be defined and
applied. The sample and specimen referral form should be duly
filled in (annex5).
28
The transportation mechanisms for the tests in the referral

network should be clearly defined and should be a part of a
centralized system for referral transport. The transport may not
necessarily belong to only one facility; several sites in a region
may share the transport mechanism as recommended in these
guidelines.
Where possible, specimens being referred to the same nodal site

should be transported together to minimize transport costs. All
specimens should be packed according to their SOPs with due
attention to temperature requirements.
The shipment days may be specified in each facility for tests

that can be batched. In such cases, the shipment day(s) shall be
documented and communicated to the clinical teams. The batched
specimens should be stored at the appropriate temperature and
conditions that maintain specimen integrity.
Tests supported through programmes and those with short

turnaround times should not be batched unless specified (e.g.,
dried blood spot).
Modes of transportation of specimens that are safe, effective, and

sustainable should be used. These include:
MOH/Government of Kenya transport
Courier services (motor vehicles, motorbikes, motorboats)
Public service vehicles
When selecting the mode of transport, consideration should be

given to distance to the nodal site and the terrain, to maintain
specimen integrity and particularly to avoid haemolysis of whole
blood specimens.
Incidents during specimen transportation which may affect quality

of the specimen or safety of personnel should be documented
and action taken by the quality officer and/or bio-safety officer.
29
Packing &&
Packing shipping infectious
shipping material
infectious
material
Primary
Primary Absorbent
Absorbent packaging material
packaging material
container
container
Specimen
Specimen
Cap
Cap
Secondaery
Secondary container
container Study # Specimen record
Specimen record
Date
Screw-on cap
Screw-on cap Sample
Biohazard label
Biohazard label
OuterOuter
(tertiary) container
(tertiary) container
Address to
Address from
Address
Address labellabel
Source: WHO/AFRO/CDC 200811

Figure 2.Single-specimen triple-packaging model
4.3. Means for Sending Laboratory Reports and Results to the

Satellite Laboratory
The process for sending reports and feedback to referring facilities should
be clearly defined and documented. Logistical support should be provided
to maintain the agreed process for regional and national referral networks.
Patient confidentiality should be maintained at all times. Effective means for
sending reports and results include the following:
Providing hard copy of reports. The reports should be collected

when specimens are delivered to the nodal site.
Using smartphones and the Short Message Service system to

alert the satellite site when reports for urgent tests are ready for
collection, and to provide preliminary reports of the same. The
message should go to the designated facility focal point person
who will scan the report and send it to the satellite laboratory
by e-mail. A specific e-mail which is secure for confidentiality of
30
patient results should be used.
Using electronic communication system for laboratories with

established laboratory information management systems.
4.4. Communication within Referral Networks

Laboratory tests provided through referral networks form part of the services
offered by the laboratory. The facility management team needs to receive
regular information on the performance of the networks, especially those
supporting management of diseases of public health importance. Timely
sharing of information in referral systems is also necessary for disease
surveillance and for effective management and coordination of the referral
networks.
There should be effective communication within referral networks and

therefore:
All facilities within the network should have effective means

of communication with each other and with their respective
health services management. A reporting framework should be
adopted across the referral chain for activities related to clinical
management of patients, surveillance activities, and referral
network management.
Frequency of reporting from facilities to the regional and national

levels should be established.
Data obtained from the referral chain should be analyzed at all

levels of the referral chain.
The data should be used to inform on the performance of the

networks, identify opportunities for improvement and advocate
for support for recommended improvement measures to
implementing ministries and supporting partners.
31
4.4.1. Information for the Facility Health Management Team

The facility health management team should be provided with information
on laboratory and referral networks performance for decision making.
Information should be provided monthly to the health management team
in the form of a laboratory management report and should include the
following:
Revenue generated in the laboratory from referral tests.
Information on the indicators for quality delivery of laboratory

services, including the referral services. These include internal
laboratory processes information, including status of equipment,
commodities, and communication systems; and information on
analytical service interruptions during the review period and the
causes, whether equipment failure or reagent stock-outs, and
plans for internal process improvements.
Information on staff continuing education and growth, including

CME sessions and trainings attended by laboratory staff as well as
OJT and supportive visits to the laboratory.
4.2.2. Communication between Satellite and Nodal Sites

Apart from the reports of laboratory tests done, nodal sites should provide
information to satellite facilities in their region on the following:
Rejected specimens and corrective measures to prevent

recurrences.
Analytical service interruptions or delays (breakdowns of service)

and resumption.
Alteration in the analytical schedules for specific tests, changes of

analytical method, or changes to reference values.
New tests added to menu at the nodal site. This will include
indications for performing the test, specimen requirements, and
the testing schedule if batch analysis is applied.
32
4.4.3. Communication with Regional Disease Surveillance

Teams
Regular reports should be provided on laboratory diagnosis of priority
diseases as required. The format and tools for reporting should be provided
to the laboratory.
4.4.4. Communication with Regional and National Reference

Laboratories
Primary care and CRL should provide regular reports on the following:
The positivity rate of priority diseases and other laboratory

specimen referral indicators as required for the national health
management information system
The growth of specimen referral service in terms of overall total

test volume, as well as number of tests from individual sites
Specimen referralrelated commodity consumption rates to

assess the effectiveness of the supply chain and the efficiency of
commodity utilization and equipment performance
QA indicators, including sample rejection rates, internal quality

control (IQC), and EQA performance, and staff training in respect
to referral services
The information provided should be used to plan for resource requirements

(staff, equipment, and commodities) in the referral networks, as well as in
identifying needs for establishing new nodal sites for priority tests.
33
4.5. Communication Methods

Reliable and effective methods should be used for referral networks
communication and should include the following;
Surface mail, telephone, fax, and e-mail. Telephone devices

should be fixed (for the facility), and hand-held (for the designated
persons for referral management).
National referral laboratories should have computers with e-mail

services. A paper-based laboratory information system should be
used to facilitate compilation of summary reports.
34
5. Laboratory Resource Requirements

Laboratory specimen referral networks are created to improve access to
quality laboratory tests needed for the care, treatment, prevention, and
surveillance of diseases. Adequate resources should be provided to enable
the network laboratories to provide quality results.
Successful implementation of new diagnostic tests will also require

functional networks of laboratories with trained and motivated staff, quality
management systems, and safe working environments.
5.1. Physical Infrastructure

In relation to laboratory physical infrastructure, the following
should be taken into consideration;
Laboratory facilities should be constructed using standard designs

that facilitate function, protect laboratory workers, and provide
barriers to ensure the safety of people outside the laboratory.
A designated specimen dispatch and receiving area should be
provided.
Laboratory management should ensure that facilities meet

the standards required for the laboratorys function and
the recommended bio-safety measures. There should be an
uninterruptible power supply to equipment and running water, as
well as distilled water.
Regular review of the physical infrastructure should be done to

identify infrastructure requirements as the referral networks
grow. A standard assessment tool should be developed and
utilized for this purpose.
Laboratory evaluation for establishment of new nodal sites

supporting care and treatment of priority diseases must include
infrastructural assessment for both equipment placing and
specimen handling for the referral service.
35
5.2. Equipment and Supplies

The management of equipment and supplies should ensure that:
The list of minimum laboratory equipment and related supplies

for the different care levels should be provided as recommended
in the National Referral Strategy3 (annex8).
Equipment should be standardized across the referral chain to

enable facilities to benefit from economies of scale (including cost
reduction through bulk procurement) and ease of service and staff
training (due to limited variety of equipment, standardization of
reference values, and reporting units).
An equipment management programme should be developed

and used at all levels to ensure proper documentation and
maintenance of equipment. Laboratory management should
prepare the schedule for preventive maintenance in collaboration
with the biomedical team.
An equipment backup plan should be in place to ensure continuity

of referral service in case of equipment malfunction.
Commodities required for specimen transfer should be budgeted

for and procured either centrally or from the FIF. Reagents shall
be validated before use.
Laboratory management staff at all levels should have commodity

management skills to be able to forecast, quantify, order, and
report on time. Laboratory staff should be proficient in inventory
management.
Tools for inventory management should be provided and used

appropriately.
Communication regarding equipment failure and reagents stock-

outs should be done promptly and documented.
36
5.3. Human Resources
The human resources required for effective referral networks encompass

more than just the laboratory professional. A nodal site may require health
records information officers and messengers to function efficiently. The
need for these additional cadres has been captured in the National Referral
Strategy3 as follows:
The minimum laboratory staffing norms for each care level,

also as specified in the National Referral Strategy,3 should be
implemented.
Regular assessment of the staff in each laboratory in the network

should be done to ensure they are adequate in number and have
the required competencies for the workload.
Assessment of staff training needs shall be done relevant to

referral network expansion, and appropriate training approaches
implemented.
Staff should be trained on new techniques and technologies

introduced into the referral chain. The emphasis of training
activities shall be on demonstrable skills and measurable
competencies in these skills. Innovative training methods such as
OJT and bench training shall be used.
An attachment programme should be developed and supported,

enabling laboratory personnel from the referring laboratories to
undergo apprenticeship training in new techniques or retraining
in basic techniques as required at the County or National
Reference Laboratories. Staff trained should undergo competency
assessment after the training. Such staff may be used to analyze
specimens from their facility in programme-supported tests as
part of human resources sharing. Formal assignment of these
analytical tasks at the nodal laboratories should be done in
37
compliance with accreditation standards.
Regular facility-based and county-level CME events on topical

subjects should be provided and documented. Laboratory staff
should be encouraged to provide CME sessions on referral tests
to aid in creation of demand for laboratory tests done in referral
networks.
5.4. Finance
Most laboratory tests are provided under the Facility Improvement Fund
(FIF) programme. Sustainability of test provision for satellite sites requires
a cost-recovery approach. Revenue collection structures are in place in
all health facilities. Formal systems are needed for the transfer of funds
between public health facilities. For sustainability of the specimen referral
system, the following should be adopted:
The annual and quarterly laboratory budgets should include

budgetary provisions for specimen referral systems. The cost
of each test provided should be determined, including those
supported through programmes. A standard tool for test costing
should be developed and applied across the referral chain.
A cost-recovery plan should be developed for referred tests if

these are not supported fully. The referring facility should retain
the cost of commodities used for specimen collection, handling,
and transfer if these are procured through the FIF.
The facility health management team should adopt the test

stipulated under the FIF.
Formal agreements on payments should be made when

specimens are referred to nodal laboratories. The agreements
should indicate the amounts, mode, and schedules of revenue
remittance to the testing laboratory. Such agreements should also
be done if specimens are referred to faith-based organization or
private laboratories.
38
6. Quality Assurance
For the laboratory referral system to be useful for patient care and disease
surveillance, results have to be accurate and available in a timely manner.
Laboratories in the network should adhere to good laboratory practices.
A QA system consisting of IQC, EQA, and continuous quality improvement
should be in place in all the laboratories in the network. Establishing a
QA system reduces the chances of variability in the laboratory processes.
The QA system should be supported by budgetary provisions at both the
central and health facility levels. Satellite sites should look for evidence of
QA measures when selecting laboratories as reference testing sites for non-
programmesupported tests.
6.1. Standard Operating Procedures

To ensure consistency in performing laboratory activities, SOPs should be
developed for all activities in the referral networks, including specimen
collection, storage, and transportation to the referral laboratory. For these
to be achieved:
Staff should be trained on how to prepare SOPs and supported to

develop SOPs in their respective areas.
Nodal site staff should provide satellite sites with the SOPs for
collection and handling of specimens for referred tests. The
appropriate SOPs should be made available to staff for the satellite
laboratories and utilized at all times.
6.2. Analytical Process Control Measures

The laboratories in the referral chain should have QA procedures to ensure
quality of all steps in the workflow. To ensure quality;
All diagnostic tests should be performed by a qualified laboratory

staff member.
Quality control checks should be employed for both quantitative

and qualitative tests to detect and minimize errors.
39
Nodal laboratories should participate in EQA programmes to

monitor the accuracy and precision of results for tests in the
network.
IQC and EQA results should be reviewed and inter-laboratory

assessment schemes should be established between nodal
laboratories in a geographical region. There should be a formal
agreement for such schemes, which should be coordinated by the
focal point persons in both laboratories.
The referral network should be used to support rechecking and

on-site evaluation EQA programmes, including those for TB smear
and malaria microscopy. The National Reference Laboratories
should assess the County Referral Laboratories, which in turn,
would assess the Primary Care Laboratories in their region.
6.3. Mentorship Support

The routine functioning of the referral system can be improved only
through the mentorship support of the network health facilities. Supportive
mentorship visits are essential components of continual follow-up of trained
personnel and on-the-job performance training of the staff. It is aimed at
ensuring that the SOPs for documentation and analysis are followed in all
facilities. Skill gaps should be identified for targeted capacity building of the
staff. Mentorship support should include the following provisions:
Higher-level laboratories should provide adequate support to staff

at lower levels. Such OJT and updates will enable higher levels to
pass on new information and changes in laboratory techniques on
a regular basis to the lower levels.
CRLs should be in charge of supervision of primary care

laboratories in their catchment areas and they in turn will be
supported by the national referral laboratories.
A documented mentorship support framework should be

implemented across all facilities in the referral chain. This
40
framework should include an integrated tool and the plan for

mentorship visits (annex9). The lower levels should receive at
least one supportive visit each quarter. Logistics support, including
transport and other necessary tools, should be made available to
facilitate regular supervision at all levels.
Laboratories being established as new testing sites should receive

more frequent mentorship support during the establishment and
capacity development phase.
There should be regular feedback on the effectiveness of the

supportive visits and follow-up of agreed improvements.
41
7. Biosafety and Biosecurity

A key element of bio-safety and bio-security practices is to ensure that the
laboratory worker and the environment are protected from potentially
hazardous microorganisms. In addition, these practices ensure that
laboratory microorganisms are not used as bio-weapons. The process of
laboratory specimen referral involves transportation of specimens, which
poses a risk to the specimen handlers and the environment. Bio-safety
measures in referral networks will include application of universal safety
precautions, waste segregation, and disposal protocols. Each laboratory
should have a safety officer who ensures the following:
Laboratory personnel are aware of potential hazards and the

risk of laboratory-acquired infections when handling infectious
materials.
Staff are trained and proficient in the practices and techniques of

handling such materials.
Bio-safety guidelines, laboratory safety handbooks, material

safety data sheets, and SOPs relevant to safety are developed and
made available to staff.
Laboratory personnel safety practices and techniques are

supplemented by recommended immunizations, including
hepatitis B vaccination.
Procedures and policies are in place covering occupational

exposure and first aid, and the required materials for these are
available.
Primary and secondary containment measures are put in place

to protect the laboratory personnel, the products, and the
environment from contamination and infection.
Bio-security measures are put in place to prevent the intended

use of bio-hazard materials to cause harm.
42
Laboratories at all levels have SOPs and spill kits for dealing with
biological, chemical, and radiological spills. The spill kit should be
kept in an easily accessible place. (See annex7 for recommended
contents of a spill kit.)
Staff should know how to use firefighting equipment. Fire exits

must be unobstructed and lead to an open space.
Bio-hazardous waste in the laboratory should be segregated at

the point of generation and category, and later disposed of as per
the recommended bio-safety guidelines and facility requirements.
Laboratories should carry out bio-risk assessments to identify

risk factors and implement mitigation actions to prevent their
occurrence or possible elimination. The bio-risk assessment
should include risks associated with specimen transportation to
nodal laboratories.
Regular safety audits, using a standard safety checklist, should be

carried out and identified gaps addressed to ensure laboratory
workers and the environment are protected from potentially
hazardous agents.
43
8.MONITORING AND EVALUATION

Laboratory specimen referral, as an integral part of the health care system,
must be part of the laboratory performance M&E system, which must meet
the following criteria:
Monitoring is the routine collection and tracking of key data

on performance of the specimen referral networks over time.
It is a process that helps to identify network problems early so
that they can be quickly corrected. It requires identification of
the key network performance indicators and routine collection,
compilation, analysis, and utilization of data. A system of
maintaining records and information at all levels is mandatory
for this function. The operation of the specimen referral system
should be monitored to ensure the planned activities are being
implemented effectively.
A set of indicators will be tracked to assess specimen referral

network function and determine nodal site saturation in terms
of the following:
o Network effectiveness (number of specimens sent from
satellite sites, number of new nodal or satellite sites
established in support of care and treatment for priority
diseases, number of new tests added to the test menu)
o Network efficiencyreferral costs and turnaround time
for results
o QAspecimen rejection rate, IQC and EQA performance,
accuracy of data collection and reporting
o Nodal site saturationworkload analysis
A referral network audit tool shall be developed and applied
regularly (annex 10).
Other necessary tools for data collection and reporting shall be
developed and communicated to all laboratories in the referral
network.
Mechanisms should be established to ensure the quality of the
44
data collected and protect the confidentiality of the client as

data moves up and down the networks. The documentation and
monitoring systems used should, however, not overburden the
service providers.
Results from the audits and supportive supervision should be
analyzed and shared with all facilities in the referral chain in a
stakeholders forum. The forum should also be used to share best
practices for the various activities in the referral chain, particularly
for programme-supported tests.
Mechanisms should be in place to facilitate the use of the
collected information for improvement of the network and its
referral system.
The laboratory staff and managers should be trained on core
referral system indicators and the methods of documentation,
data retrieval, analysis and presentation for decision making.
Operational research should be encouraged and supported, using
the indicators to provide the evidence base to guide improvement
of the specimen referral networks.
45
9. Establishment of a New Specimen Referral

Network
Whenever a laboratory begins offering a new diagnostic test or service,
an opportunity is created for a new referral network to be developed to
increase access to the new service.
The need to establish new diagnostic services in public laboratories may
arise from three main areas:
1. National strategies. The National Referral Strategy specifies

diagnostic services to be provided at various health care levels.3
Provision of the required equipment and staff will lead to the
initiation of new tests. There is a long-term national plan to
progressively increase the number of sites for key laboratory
services such as histology, cytology, and other specialized tests.
2. Programme-specific strategies. Specimen referral systems for

tests supporting the management of priority public health
diseases, including HIV and AIDS and TB, are usually well defined.
The laboratories selected to act as nodal sites handle high
volumes of these programme-specific tests. As patient numbers
increase, the laboratories may be overstretched and inefficiencies
may ensue. In addition, new treatment sites may be opened up
with laboratory requirements that cannot be adequately served
by the existing nodal site because of geographical inaccessibility
or other reasons. There will therefore be need, from time to time,
to initiate a new nodal site for a referral system.
3. Health facility strategies. The demand for new diagnostic services

at the facility level may result from establishing specialized clinical
services that require special laboratory support, such as critical
care or dialysis units. Such tests are planned for and initiated at
the facility level in consultation with the clinicians. Consideration
should be given to the cost of performing the new test on-site as
opposed to referring specimens. The cost-benefit analysis should
include the turnaround time for results and the implications for
46
patient care.
The steps for setting up a new laboratory nodal site for tests in support
of priority disease management are similar to those for establishing a
new test in a laboratory. There is, however, involvement of a wider range
of stakeholders, including supporting partners, in the selection and
establishment of new nodal sites, as discussed below.
Steps for Establishment of a New Laboratory Nodal Site

The following process (figure 3) should be followed in determining whether
to establish a new nodal site:
Identify the possible need for a new nodal site and hold a
stakeholders meeting.
Conduct regular review of performance indicators in existing

nodal site(s) to help determine if a new site is needed.
Use indicators of network efficiency and effectiveness, including

the volume of tests referred to the existing nodal site, turnaround
time for results, costs of specimen transportation, and the quality
of specimens on arrival at the nodal site.
Assess clinicians demand for laboratory services during the

establishment of specialized clinical services that require specific
laboratory support.
Laboratory management, the health facility management team,

clinicians, supporting partners, community representatives, and
other important stakeholders should be brought together in a
meeting once the need for a new nodal site has been rationalized.
The stakeholders meeting should be used to identify the location
of the new nodal site, the satellites it would serve (catchment
area), the requirements for setting up the nodal site, the process
for establishing it, and the timeline.
Next, the proposed new nodal site should undergo assessment, following
these steps:
47
Evaluate the level of preparedness of the laboratory for its role as

a new nodal site.
Constitute a team comprised of the key stakeholders to conduct

the assessment using a standard assessment checklist.
Assess all the key elements required for a functional referral

network.
Next, it is necessary to establish the required systems and processes for

initiating and supporting the new network. The site assessment exercise
discussed above will identify the issues that need to be addressed before
the new network can be initiated. The laboratory management team should
also take the following steps:
Identify the contact persons in all the laboratories in the network

(nodal and satellites).
Hold sensitization meetings with laboratory staff in both nodal

and satellite laboratories to discuss and agree on the operations
of the referral network. For example, set days for each satellite to
take its specimens to the nodal laboratory can be agreed.
Clearly state the roles and responsibilities of each of the

laboratories, including maintenance of confidentiality of patient
information in the network.
Develop and distribute the required documentation tools and train

all staff in the network on their use. Establish the communication
system to be used in the network.
Identify and train the technical staff that will perform analysis.
The training should be done before the analytical equipment is
installed at the nodal site. Competency assessment of trained
staff should be done.
Determine and budget for the commodities required for the

network.
48
Install and validate the new equipment. Parallel testing at the new
nodal and the previous testing site should be done as part of the
validation process.
Provide SOPs and job aids for the processes involved in the
network.
Provide the standard format for the laboratory report. Add the
new test to the facility test menu.
Inform the regional and national referral network coordinators to

update the regional directory of diagnostic services.
Develop a plan for monitoring the network and use findings for
continual improvement.
Create awareness of the new specimen referral network in the

community.
49
Convene meeting of key stakeholders
Assess the selected new nodal site (mapping)
Establish required systems to initiate and support new

network
Monitor performance of new nodal site
Identify need for new nodal site
Create awareness of new specimen referral network in the

community
Figure 3. Summary of establishment of a new laboratory nodal site
50
References
1. Ministry of Medical Services and Ministry of Public Health and
Sanitation. Comprehensive Kenya Health Policy 20112030. Nairobi:
Government of Kenya; 2011
2. Ministry of Medical Services and Ministry of Public Health and

Sanitation. Kenya Health Sector Strategic Plan (KHSSP) 2012-2017.
Nairobi: Government of Kenya; 2012.
3. Government of Kenya (GOK). National Referral Strategy and Investment

Plan for Health Services: July 2010June 2015. Nairobi: GOK; 2010.
4. Government of Kenya (GOK). Kenya Essential Package for Health in

National Health Sector Strategic Plan II 2005-2010: GOK; 2005.
5. World Health Organization Regional Office for Africa (WHO/AFRO).

Consultation on Technical and Operational Recommendations for
Clinical Laboratory Testing Harmonization and Standardization, Maputo,
Mozambique, 2224 January 2008: Meeting Report. Brazzaville,
Republic of Congo: WHO/AFRO; 2008.
6. Government of Kenya (GOK). Kenya National AIDS Strategic Plan

(KNASP). Nairobi: GOK; 2005
7. Ministry of Health. Norms and Standards for Health Services Delivery,

June 2006. Nairobi: Kenya Ministry of Health; 2006.
8. Ministry of Public Health and Sanitation. Draft Technical Guidelines for

Integrated Disease Surveillance and Response in Kenya, March 2011.
Nairobi: Kenya Ministry of Public Health and Sanitation; 2011.
9. International Air Transport Association (IATA). International Air Transport

Association Instruction 650-Diagnostic Specimens, January 1999
10. World Health Organization (WHO). Laboratory Biosafety Manual. 3rd

ed. Geneva: WHO; 2004.
11. World Health Organization Regional Office for Africa (WHO/AFRO),
51
and U.S. Centers for Disease Control and Prevention (CDC). Guide for
National Public Health Laboratory Networking to Strengthen Integrated
Disease Surveillance and Response (IDSR), September 2008. Brazzaville,
Republic of Congo: WHO/AFRO and CDC; 2008.
52
Annex 1. Model of Referral Networks
Satellite
labs
Satellite County nodal Satellite

labs lab labs
Satellite
labs
CD4 Testing Referral Networks
53
Annex 2. Model of a National Specimen Referral

Network
National
reference labs
County labs County labs County labs
Primary care Primary care

County labs
lab lab
Primary care
lab
TB Culture/DTS Referral Networks
54
Annex 3. Directory of IDSR Referral Sites

Contents of National and County Directory of Laboratory Services
Name of laboratory
Address
Telephone number
Name of key contact people
Services and tests offered by the laboratory
Hours of operations
Priority disease, Focal person, name of laboratory, address,

conditions, and events and phone number
Polio Kenya Medical Research Institute
Centre for Viral Research
Polio Laboratory
Mbagathi Roadnear Kenyatta Market
Phone: +254 (0) 022722541
Contact person: Mr. Kingori
55

Cholera National Public Health Laboratory
Centre for Microbiology
Microbiology Laboratory
Kenyatta National Hospital Grounds
Phone: +254 (0) 022722541
Contact person: Ms. J. Tonui
HIV Kenya Medical Research Institute
HIV Laboratory
Mbagathi Roadnear Kenyatta Market
Phone: +254 (0) 022722541
Contact person: J. Mwangi
National Public Health Laboratory
HIV Reference Laboratory
Phone: +254 (0) 02729549
Contact: Mr. Mamo
56

Tuberculosis National Public Health Laboratories
Tuberculosis Laboratory
Phone: +254 (0) 022722541
Contact person: Mr. Jeremiah Ogoro
Measles Kenya Medical Research Institute
Measles Laboratory
Mbagathi RoadNear Kenyatta Market
Phone: +254 (0) 02 2722541
Contact person: Dr. Sang
Plague National Public Health Laboratories
Regional Plague Centre
Phone: .+254 (0) 022722541
Contact person: Mr. .J. Rotich
57

Human influenza caused Kenya Medical Research Institute

by a new subtype
National Influenza research Laboratory
National Public Health Laboratories
Phone: +254 (0) 022722541
Contact person: Mr. Samuel
Rift Valley disease Kenya Medical Research Institute
Arborviruses Laboratory
Phone: +254 (0) 022722541
Dengue fever Kenya Medical Research Institute
Phone: +254 (0) 022722541
58

Public health events of Kenya Medical Research Institute

national or international
concern Mbagathi RoadKenyatta Market
Phone: +254 (0) 022722541
Kenya Radiation Board
Radiation Laboratory
Kenyatta National Hospital
Phone:+254 (0)0202714558
Department of Veterinary Services
Kabete
+254 (0) 202718870
Government Chemist
Kenyatta National HospitalGrounds
Adjacent to National Public Health Laboratories
59

Anthrax For human samples
Kenya Medical Research Institute
Centre for Microbiology Research
Microbiology Laboratory
Mbagathi Road
Phone: +254 (0) 022722541
Contact : Dr. Njega
For animal samples
Department of Veterinary Services
Veterinary Laboratories
Kabete
Phone: +254 (0) 202608354
Contact person: Dr. Macharia
60

Chikungunya Kenya Medical Research Institute
Phone: +254 (0) 2022722541
Typhoid fever National Public Health Laboratories
Central Microbiology
Reference Laboratory
Phone: +254 (0) 202710518
Schistosomiasis National Public Health Laboratories
Division of Vector Borne and Neglected Diseases
Schistosomiasis Laboratory
Phone: +254 (0) 202710518
Contact person: Dr. Muchiri
61

Leishmaniasis National Public Health Laboratories
Division of Vector Borne and Neglected Diseases
Leishmaniasis Laboratory
Phone: +254 (0) 202710518
Contact person: Dr. Muchiri
8
Source: Ministry of Public Health and Sanitation 2011
62
Annex 4. Kenya Laboratory-Based Surveillance List
Priority diseases for laboratory-based surveillance

MDR-TB
Shigella dysenteriae type 1
Typhoid fever
Brucellosis
Influenza
Schistosomiasis
8
Source: Ministry of Public Health and Sanitation 2011
63
Annex 5. Sample and Specimen Referral Form
MOH 240H
MINISTRY OF HEALTH
Specimen Ref No.............................
SAMPLE AND SPECIMEN REFERRAL FORM

Note: incompetely filled forms will not be processed
I. Patients and Specimen details
IP/OP No............................
Patients Name........................................................................ Age(yrs/months)....................Sex M F
Residence..........................................................Postal address........................................................................
Sample / specimen and description................................................................. Source.....................................
Collection date (d/ mm/ yyyy) ___/___/_____ Time (24hrs).......................
Date of preservation.........................................Method of preservation..........................................
II. Referring Lab (name and address)...............................................................................................

Reasons for Referral........................................................................................................................
III. Details of person Referring sample

Name...................................................................Designation.....................................Modile..........................
Email................................................................................ Signature....................................................
IV. Investigations Requested.............................................................................................................................
V. Lab referred to(name and address)...............................................................................................................
VI. Details of the person receiving sample
Name...........................................................Designation...................................Mobile No. .............................

Email....................................................................Signature..............................
VII. Condition of sample:
Accepted Rejected (specify reason)_____________
64
Annex 6. Model and Instructions for Triple Packaging

of Specimens
Triple Packaging Requirements
Source:WHO 200410
Primary container: The primary packaging that contains the specimen must
be watertight. Example: Vacutainer with adhesive tape around the screw
cap. Use screw-cap conical test tubes or cryo-vials. Do not use Eppendorf
tubes, with tape or parafilm around the cap.
Secondary container: The secondary packaging may contain several primary

containers. The secondary packaging must also be watertight. Examples
of watertight secondary containers include Ziploc plastic bags, a conical
50ml test tube and screw-cap containers. Absorbent material must be
placed between the primary and secondary container. The quantity should
be sufficient to absorb all liquid in the shipment. Examples include paper
65
towels, cotton balls, filter paper, etc.
If dry ice is needed to keep samples frozen, it should be put between the
secondary and tertiary packaging. Styrofoam and cardboard both allow dry
ice vapor to escape, so dry ice must be placed only OUTSIDE the secondary
packaging. Packaging dry ice inside impermeable, screw-cap containers may
cause the shipment to explode.
Outer shipping container: The tertiary packaging (outside) must protect

the inside packaging to prevent breakage or perforation under normal
transport conditions. Corrugated cardboard is the usual choice. Styrofoam
boxes, plastic bags, or paper envelopes are unacceptable outer containers
for shipping biological materials.
66
Annex 7. Contents of a Spill Kit

Personal Protective Equipment
Safety glasses.
Chemical-resistant gloves
Heavy-duty gloves
Dust mask
Lab coat
Spill equipment
Sand/paper towels or other adsorbent
Dustpan, brush/broom forceps, tongs
Bio-hazard bags, sharps containers
Appropriate disinfectant solution (e.g. a 1/10 dilution of household
bleach, prepared freshdaily is effective in most situations)
NB: All personnel must know of the location of the spill kit and the spill
cleanup procedure
67
Annex 8. List of Essential Laboratory Equipment for

Each Level of Care
Equipment Dispensaries Health County County Regional National

(4129) centres district referral referral referral
(509) hospitals hospitals hospitals hospitals
(366) (47) (12) (4)
Binocular + + + + + +
microscope
Glucometer + +
Haemo- + +
globinometer
Hot air oven + + + +
Water baths + + + +
Centrifuges + _ + +
(bench top)
Centrifuges + + + +
(haemotocrit)
Autoclave + + + +
Safety hood + + + +
Fridges (for + + + +
reagents)
Blood bank + + + +
fridge
68
Platelets + + +
incubator
Blood bank + + +
freezer
Haematology + +
analyser (812
parameters)
Haematology + +
analyser (18
parameters)
Clinical + +
chemistry
analyser
(semi-
automated)
Clinical + +
chemistry
analyser (fully
automated)
Blood GXM + + + +
machine
(semi-
automated)
Tissue + +
processor
Microtome + +
Blood gas + +
analyser
Source: GOK 20103
69
Annex 9. Integrated Supportive Supervision Tool

(MOH 2012)
General Administrative Information
Name of health
facility
Level of health II III IV V VI
facility Others (Specify)_____________________
Facility affiliation GOK Faith-based Private
Other(Specify)______________________
Province
County
District
Hospital
telephone
number
Number of
outpatients per
month
Bed capacity in
hospital
Hospital Name______________________
superintendent/
administrator Signature__________________
Date of visit
Supervisor Name______________________
Signature__________________
General Laboratory Information
Laboratory in-charge Name__________________
Signature__________
70
Designation/position of
person interviewed
Telephone contact of
laboratory in-charge
Workload (average tests
done per month)
Total number of laboratory

personnel
Normal working days per 5 6 7

week
Normal working hours per 8 24

day
If no 24-hour service, is Yes No

out-of-hours or emergency
service available?
If 24-hour service, number ____________

of staff on night duty
Does the lab have a service Yes No
delivery charter? (Confirm
its availability and that
it is specifically for lab)
71
Human Resources | Current Working Staff

Cadre (qualification) Number
Laboratory technologist (degree)
Laboratory technologist (higher national
diploma)
Laboratory technologist (ordinary diploma)
Laboratory technician (certificate)
Trainees
Health records information officer
Support staffs
Others (Specify)
Technical staff GOK

affiliation Partners (Specify)
(employer)
Community
Others (Specify)
Are all laboratory technicians and Yes No

technologists in the laboratory registered by
the Kenya Medical Laboratory Technicians
and Technologists Board?
72
Refresher Training
Have any of the staff attended refresher training in the last three months?
Yes No
(If yes, specify type of training in table below.)
Area of training Number Duration On-site/off-site
trained
1
2
3
4
5
6
Has all laboratory Yes No
support staff been
trained on general N/A
lab safety and
precautions?
73
Number of staff in each lab section and area of specialization

Number of staff working Number of staff
in section specialized in area
Sample collection (phle-
botomy)
Sample reception
Biochemistry
Haematology
Serology
Parasitology
Bacteriology
Blood transfusion
Histopathology
Others (specify)
Laboratory Infrastructure | Building Facilities and Utility Services

What % of the working day do you have the following services available?
Electricity <50% 50100%

Running water <50% 50100%
Gas <50% 50100%
Is there a backup power source in Yes No
case of power failure (e.g. emer-
gency generator, solar)?
If there is a backup power source, Refrigerators/freezers
what systems are protected? Ventilation/AC
Computers CD4 Machines
Chemistry machine
Haematology machine
Other (Specify)______________
74
What ventilation is provided? Natural (doors, windows, air

spaces)
Electrically powered ventilation

(exhaust, fans) system
Air-conditioning: AC or exhaust?
Laboratory Space and Window Area

Type of room Floor area (in square me- Window(in square me-
tres) tres)
Sample collection
Sample reception
Haematology
Bacteriology
Chemistry
Parasitology
Serology
Blood donation rooms
Histology
Special rooms CD4
PCR
Total working area
Sluice/utility room
Store
Office for head of labo-
ratory
Media preparation
room
75
Staff room(library/tea
Yes No
room)
Patients waiting bay Yes No
Data office Yes No
Are the following Changing room with
rooms/facilities avail- locker/night duty rest Yes No
able? room)
Staff toilets Yes No
Patients toilet (also used
for urine/stool collec- Yes No
tion)
76
Inspection of Laboratory Area

If the answer for any of the questions is no, describe the status of the area
in the comments box.
Identify any areas in need of improvement and the type of improvement

needed and note in the comments box.
Laboratory area Yes No Comments

1. Laboratory area is maintained in good
condition (e.g. clean, all trash removed,
shelves are sturdy).
2. Laboratory is secured with a lock and
key but is accessible during normal
working hours.
3. Laboratory has shelves and lockable
cupboards; access is limited to autho-
rized personnel.
4. Laboratory has sufficient space to ad-
equately store existing supplies.
5. Laboratory has running water.
6. Laboratory has an adequate number of
power points (sockets).
7. Laboratory has separate sinks for
washing hands after being exposed to
infected materials.
8. Laboratory has separate sinks for wash-
ing laboratory ware and staining.
9. Laboratory has drainage from labora-
tory sinks that are closed and that lead
to either a septic tank or a deep pit.
77
Laboratory area Yes No Comments

10. Laboratory has a functioning incinera-
tor or other nationally acceptable waste
management. (Note that the incinera-
tor should be functioning and used to
destroy all hazardous waste.
11. Laboratory floors are in good condition.
12. Roof is maintained in good condition to
avoid sunlight and water penetration.
13. Internal walls are in good condition.
14. External walls are in good condition.
15. Laboratory is well lit.
16. Windows and doors are in good condi-
tion.
17. Laboratory has firm in-built benches
with level and easy to clean surfaces.
18. Laboratory has firm shelves to store
supplies and reagents.
19. There is adequate glassware and/or
plastic ware.
20. Windows have security bars.
21. There are adequate numbers of labora-
tory stools.
22. Laboratory has working firefighting
equipment.
23. Laboratory has an emergency fire exit
(open at all times).
General comments:
78
Equipment and Reagent Supply

Equipment
Number Number Comments* (PM, O,
available functional OP, SOP)
Haematology
analyser
Microscope
Neuber chamber
Tally counter
Differential counter
Refrigerator
Centrifuge
Blood bank
refrigerator
Freezer -20 C
Bio-safety cabinet
CO2 incubator
Autoclave
37 C incubator
Glucometer
Chemistry analyser
ELISA machine and
washer
Flow cytometer for
CD4
Hot air oven
Weighing balance
Computer and
printer
Distillation unit
Is there laboratory equipment inventory in place? YES NO
79
If equipment inventory available, is it regularly YES NO

updated?
Do some equipment have service contract? YES NO
If yes list the equipment with service contracts
* KEY comments
PM Preventive maintenance (available)
O Obsolete
OP Operational manual (available)
SOP Standard operating procedure (available)
80
Reagents
Has there been a recent stock-out of the following?

Sample reagents Stock-out Period of Expired Comment
(YES/NO) stock-out YES/NO
Haematology autoanaly-
ser reagent kit
Sickling test reagents
Haematological stains
Haemoglobin test re-
agents
Liver function test
Kidney function test
Lipid profile
Blood glucose
CSF sugar
CSF protein
Uric acid
Hormonal studies (thy-
roid function test)
Gram stain
ZN stain
Indian ink
Blood agar
CLED (cystine, lactose,
electroly te-deficient
test)
MacConkey agar
TCBS
Other media
Typing sera(list)
Widal
Brucella
81
Sample reagents Stock-out Period of Expired Comment

(YES/NO) stock-out YES/NO
HIV rapid test kit
Uristix
HIV ELISA kit
PCR reagents
CD4 reagents
RPR/VDRL
Hepatitis screening kit
ASOT RF
Parasitological stains (Gi-
emsa)Field stain (A&B)
Pregnancy test kit
ABO and RH grouping
sera
Compatibility testing
sera (albumin and anti-
globulin)
Cytological stains/pre-
servatives
Histological stains/pre-
servatives
Vacutainer tubes
Stool polypots
Sputum mugs
Slides
List 5 reagents with frequent stock-outs
1.
2.
3.
4.
5.
82
Laboratory Tests (Level IVVI Facilities)

(See appendix for level II and III.)
Does the laboratory have the capacity to carry out the following tests?
Key
Why tests not done (A = lack of reagents, B = lack of kits, C = lack of
equipment, D = staff shortage, E = no request
Bacteriology
Test Yes No A v e r a g e If test not
m o n t h l y done, state
workload reason (see
key below).
Prepare media
Carry out culture and con- Stool
firm isolates from
Blood
Sputum
Others(specify)
Capacity to confirm isolates using
biochemical tests and sera typing
Identification of drugs through sensi-
tivity testing
Identification Gram
of organisms stain
through
India ink
Ziehl-
Neelsen
stain
83
TB culture
Are bacteriology SOPs available?
Are bacteriology manuals available?
All SOPs for bacteriology QA and job
aids available
Parasitology
Direct/concentration methods for
ova/cyst
Zinc sulphate flotation method
Confirm malaria parasites by Giemsa
stain
Identify and report malaria species
& stages
Urine microscopy for parasites
Are SOPs available?
Haematology
Full haemogram
Differential white blood cell count
Erythrocyte sedimentation rate
CD4/CD3
Blood transfusion
ABO grouping and RH typing (tube/
slide method
Du test
Blood donor service
Blood storage
Incompatibility testing
Coombs test (direct/indirect)
Antibody screening test
Total haematological tests
84
Are SOPs available?

Serology
RPR, TPHA, VDRL (test for syphilis)
ASOT
HIV long ELISA
HIV rapid tests
Widal test
Rheumatoid factor
Cryptococcal antigen
Helicobacter pylori
Hepatitis A test
Hepatitis B test
Hepatitis C test
PCR viral load
Prostate-specific antigen
Brucella agglutination test
Are SOPs available?
Clinical Chemistry Tests
Technique Yes No Monthly If test not

workload done, state
reason (See
key)
Urine chem- 10 parameters glu-
istry cometer
85
Blood glu-
cose
Oral glucose
tolerance
Photometer/ chem-
test
istry analyser
Liver func-
tion tests
Renal func-
tion tests
Lipid profile
Thyroid func-
tion
Are SOPs available?
Histopathology/Cytology
Collection and preservation of cervi-
cal smear
Cytological examination of fluids
Cytological examination of aspirates
Histological examination of tissues
Frozen sections
Biopsies/bone marrows with special
stain(PAS, PPBH&E, ZN)
Bone decalcification
Are SOPs available?
86
Quality Assurance
When did this Within the last 3 months
laboratory receive
Within the last 6 months
the last supervisory/
support visit from a More than 6 months ago
higher-level lab?
> 1 yr ago
Never
Verify documentation Available
of last support
Not available
supervision
Did the supervision One
focus on one
Multiple
programme or
multiple integrated
programmes?
What programmes Malaria
were covered during
STI
the supervision?
(Check all that apply) HIV and AIDS
TB
IDSR
Other (Specify)___________________
87
What was done during Infrastructure inspected

the supervisory visit?
Equipment inspected
Reinforcement of universal safety

precautions
Record keeping for performed

tests checked
Inventory of supplies checked
Maintenance records checked
Cold-chain records checked
Stock cards, stock ledgers, and/or

reports checked
Quality control
On-the-job training/coaching
Feedback to/from staff
None of the above
Other (Specify)________________
Does the lab have a Yes No

designated quality
assurance officer?
Does the quality Yes No
assurance officer have
defined duties and
responsibilities?
88
Is there sample Yes No

testing protocol and
turnaround time in
place?
Does the laboratory use Yes No
any system for internal
quality control?
Are internal controls Yes No
included in each test
run?
If Yes, is the Yes No
performance of these
internal controls
recorded and
monitored over time?
(Check for proof)
Does the laboratory Yes No
participate in any
external quality
assurance or proficiency
schemes?
Are EQA samples being Yes No
handled as routine
samples?(Confirm by
physically checking the
records documentation
registers, personnel)
What programmes have
EQA samples run?
List programmes
where lab is enrolled
in proficiency-testing
schemes
89
Is the functioning Yes No

of ALL electrical or
mechanical equipment
routinely monitored
and recorded (e.g.
microscope calibration,
checking temperatures
of refrigerators or
incubators, calibration
of pipettes or handling
devices, autoclave
function)?
Are calibration,
maintenance and
service records
kept? (Check for
proof)
Operational
manuals
Are SOPs for all
benches easily
accessible?
Are the SOPs
authorized and
reviewed
When were they 1year ago 2years 5years
last reviewed Never
Are job aids
available to tests
Are they displayed
in relevant
places?(Check for
proof)
90
Are audits routinely Yes No

conducted?
Frequency of audit Internal audit__________External au-
dit___________
Quality Assurance
When did this laboratory Within the last 3 months
receive the last supervisory/
Within the last 6 months
support visit from a higher-level
lab? More than 6 months ago
> 1 yr ago
Never
Verify documentation of last Available
support supervision
Not available
Did the supervision focus on One
one programme or multiple
Multiple
integrated programmes?
What programmes were cov- Malaria
ered during the supervision?
STI
(Check all that apply)
HIV and AIDS
TB
IDSR
Other (Speci-
fy)___________________
91
What was done during the Infrastructure inspected

supervisory visit?
Equipment inspected
Reinforcement of univer-
sal safety precautions
Record keeping for per-

formed tests checked
Inventory of supplies
checked
Maintenance records
checked
Cold-chain records
checked
Stock cards, stock ledgers,

and/or reports checked
Quality control
On-the-job training/
coaching
Feedback to/from staff
None of the above
Other (Speci-
fy)________________
Does the lab have a designated Yes No
quality assurance officer?
Does the quality assurance Yes No
officer have defined duties and
responsibilities?
92
Is there sample testing protocol Yes No

and turnaround time in place?
Does the laboratory use any sys- Yes No
tem for internal quality control?
Are internal controls included in Yes No
each test run?
If Yes, is the performance of Yes No
these internal controls recorded
and monitored over time?
(Check for proof)
Does the laboratory participate Yes No
in any external quality assurance
or proficiency schemes?
Are EQA samples being handled Yes No
as routine samples?(Confirm by
physically checking the records
documentation registers, per-
sonnel)
What programmes have EQA
samples run?
List programmes where lab is
enrolled in proficiency-testing
schemes
Is the functioning of ALL electri- Yes No
cal or mechanical equipment
routinely monitored and record-
ed (e.g. microscope calibration,
checking temperatures of refrig-
erators or incubators, calibration
of pipettes or handling devices,
autoclave function)?
93
Are calibration, maintenance

and service records kept?
(Check for proof)
Operational manuals
Are SOPs for all benches easily
accessible?
Are the SOPs authorized and
reviewed
When were they last reviewed 1year ago 2years 5years
Never
Are job aids available to tests
Are they displayed in relevant
places?(Check for proof)
Are audits routinely conducted? Yes No
Frequency of audit Internal audit__________
External audit___________
94
Laboratory Information Management System
Are the following standardized laboratory registers/tools available in lab,

and correctly and completely filled in? (Confirm availability)
Tool Available Complete Correctly

filled
Lab request and report forms
Reception register
Clinical chemistry registers
Parasitology
Bacteriology
Haematology
Serology
Histology/cytology
Referral register
Lab tests data summary report
form (MOH 706)
DAR
Do you record your specimen/clients information in the autho- Yes No
rized lab register upon receipt? (Check the reception register for
completeness and accuracy)
Are the specimens received accompanied by the recommended
lab request forms?
Do the requests contain relevant data?
Are the request forms complete and accurately filled?
Are unique laboratory numbers assigned
for every specimen received?
Does the lab retain and file duplicate cop-
ies of the original results?
Does the lab have an officer assigned to
compile the laboratory reports?
Does the lab send reports to higher levels according
to the recommended reporting period?
95
Are there copies of recent laboratory data reports

sent?(Verify)
Does the lab receive feedback after sending re-
ports?
Does the lab have a designated mode of sending
reports?
Does the lab have a computer where you log in the
lab information?
Does the lab have measures to ensure data secu-
rity?
Number of staff computer-literate
Is collected information utilized at facility for plan-
ning?
96
Laboratory Safety
Is there a safety officer? Yes No
Has the laboratory personnel received training in
laboratory safety?
Is there safety manual easily accessible to laboratory
staff?
Do you segregate your waste?(Check if done)
What mode of solid-waste disposal is used in this Autoclaving
laboratory?(Verify) Incineration
Burial with no
treatment
What mode of liquid disposal is used in this Autoclaving
laboratory?(Verify) Incineration
Burial with no
treatment
Are there SOPs on laboratory safety?
Are staff offered immunization?
Are the following protective clothing/equipment Latex gloves
available for laboratory staff: Safety glasses
Lab coats
Masks
Percentage of staff observed to be using gloves while
working
Are bio-hazard labels in place?
Are there records on accidents/incident occurrence?
Are staff trained on injection safety?
Is the PEP start pack available and accessible 24 hours
a day?
Is there an eye wash station in place?
Are there hand-washing facilities in place?
97
Are there functioning fire extinguishers in place?

Are there any other fire emergency measures put in
place(e.g., marked emergency fire exits)?
Are staff trained on fire drills?
98
Laboratory Referrals
Referrals to this facility

Specimen type Number of labs that Number of samples Number of
referred samples to the referred to this referral specimen
facility last one month facility in last one reported back
month in the last one
month
CD4
TB culture
LFTs
EID
Referrals from this facility to higher level

Specimen type Number of samples Facility referred to Number of
referred to higher levels in specimen results
last one month received
CD4
TB culture
LFTs
EID
99
IDSR
Has any specimens been received in the last 3 months for outbreak
investigation?
Outbreak No. of specimens re- No. positive Turnaround time

ceived
Cholera
Number of disease outbreaks reported during last 3 months___________.

List the outbreaks.
_____________________________________________________________
____________
100
Fill in this form AT THE END of your visit to the health facility:
Date:
District:
Name of health facility:
Name of the in-charge:
1. State the priority issues which were to be dealt with during this visit.
* .....................................................................................................................
* .....................................................................................................................
* .....................................................................................................................
* .....................................................................................................................
* .....................................................................................................................
2. State the strengths and problems observed and discussed during this
visit:
Key strengths: *..............................................................................................
................
* .....................................................................................................................
* .....................................................................................................................
* .....................................................................................................................
* .....................................................................................................................
* .....................................................................................................................
Key problems: *..............................................................................................

................
* .....................................................................................................................
* .....................................................................................................................
* .....................................................................................................................
* .....................................................................................................................
* .....................................................................................................................
101
3. List in the first column of the table each of the problems from Item 2
above. Then complete the rest of the table.
Problem Cause(s) Action(s) to be taken By whom Timeframe

1.
2.
3.
4.
5.
102
Laboratory Tests for Level III and II (Health Centres and Dispensaries)
Is the laboratory able to carry out the following tests/procedures?
Yes No Average monthly Comments

workload
Bacteriology
Identification of organ-
isms through Gram stain/
India ink
Identification of organisms
through Ziehl-Neelsen
stain
Identification of stool
parasites through wet
preparation
Bacteriology SOPs and
manuals available
Urine microscopy
Other rapid tests
2
Parasitology
Direct/concentration
methods for ova/cyst
Identify and report ma-
laria species and stages
Urine microscopy for
parasites
Haematology
Differential cell count, Hb
HB
103

workload
Peripheral blood film
Platelet count
WBC counts
Sickle cell screening test
Blood grouping and RH
grouping
Serology
Rapid plasma reagin
HIV rapid tests
Widal test (titration)
Rheumatoid factor,
Brucella test, H. pylori,
pregnancy test
Immuno-haematology
ABO grouping and RH ty-
ing (tube/slide method
Clinical chemistry
Urine chemistry (10 pa-
rameters)
Blood glucose (glucom-
eter)
Blood chemistry (photom-
eter/chemistry analyser)
Additional tests per-
formed
1
104

workload
2
3
4
5
6
Are SOPs for performed
tests available?
105
Reagents and other items

Item Adequate Inadequate Comments
Gram stain re-
agents
ZN stain
HIV rapid test kits
Others
List 5 important reagents/kits with stock-outs within last 3months.
1.
2.
3.
4.
5.
106
Annex 10. Referral Audit Tool

Indicator application level
National
Result Performance Means of Frequency referral Primary
area indicator verification of collection labs CRLs care labs
Number of
new satellite
sites referring
specimens to
nodal facility Semiannu-
Nodal health ally
Number of facility speci-
new nodal men referral
sites register
Number of
specimens
received from Quarterly
satellite sites
Proportion of County
satellite sites directory of
that received tests and
Net- test menus networks/
work from the nodal health facility
effec- sites test menu
tiveness
Proportion of
health facilities
using stan-
Observation
dardised speci- Semiannu-
men packaging ally
materials
Proportion
of health
Health facil-
facilities with
ity/labora-
recommended
tory registers
documentation
procedures
107
National
Proportion of
HF meeting
the standard
turnaround
time for indica-
tor tests
Laboratory
CD4 count
specimen
(to level 2)
referral
Full blood Quarterly
registers/
count (Hb)
laboratory
Net- (level 2)
scorecard
work EID for HIV
effi- Creatinine
ciency TB culture
and sensitiv-
ity (level 3)
Histology
Proportion of Satellite
facilities with laboratory
standardised specimen
Semiannu-
means of referral regis-
ally
transport for ters/courier/
referral of transport ser-
specimen vice records
108
National
Proportion of
health facilities
Satellite labo-
with central-
ratory speci-
ised referral
men referral
mechanisms
registers
(from the
laboratory)
Proportion of
facilities with Satellite/
Net-
standardised nodal labora-
work Semiannu-
communica- tory speci-
effi- ally
tion mecha- men referral
ciency
nisms (inter- registers
nal/external)
Proportion of
health facilities
with agreed Health facil-
on financing ity records
mechanisms (MOU)
for the speci-
men referral
109
National
Specimen
Specimen
rejection rate
rejection
from satellite
registers
sites
Proportion
of nodal labs
participating in
EQA for CD4, District medi-
chemistry, cal laboratory
and TB smear technolo- (TB mi-
microscopy gist report/ croscopy)
QA
facility EQA
Proportion of reports
labs with ac-

ceptable EQA
Quarterly
reports
Proportion of
labs with docu-
mented IQC Laboratory

system includ- IQC file
ing corrective
actions
Nodal
site
Proportional
satura- Labora-
increase in
tion- tory referral
referral test
work- register
analysis
load
analysis
110
Annex 11.Technical Working Group Members,

Technical Reviewers, and List of Contributors
Technical Working Group Members
Bernard Sande National Public Health Laboratory Services: Co-
chair
Josephat Yundu National Public Health Laboratory Services: Co-
chair
Agnes Kamuru National Public Health Laboratory Services
Mary Okeyo National Public Health Laboratory Services
Peter Maloba National Public Health Laboratory Services
Bedan Kangthe National HIV Reference Laboratory
David Njogu National HIV Reference Laboratory
Benjamin Cherwon Mosoriot Referral Health Training Centre
Okinyi Fredrick Machakos District Hospital
Dixon Mchana Kakamega Provincial General Hospital
David J. Mtunji Provincial Director of Medical Services Office
Coast
Jafaralli S. Ahmed Vihiga District
Joseph A. Lotukoi Ministry of Medical Services
Angela Amayo Management Sciences for Health
Eric Wakaria Management Sciences for Health
Doris Bota Management Sciences for Health
Technical Reviewers
Jane Wasike National Public Health Laboratory Services
Margaret Oduor Department of Diagnostic and Forensic Services
Abdulatif Ali National Public Health Laboratory Services
Umuro Mamo National HIV Reference Laboratory
Ernest Ruttoh Management Sciences for Health
Juliana Tonui National Public Health Laboratory Services
Mwalimu Viterlis Sitati District medical laboratories
Gabriel Manyara Kenya Medical Training CollegeMachakos
111
Albert G. Gachau Kenyatta University

Emily A. Rogena University of Nairobi
Muthoni Junghae US Centers for Disease Control and Prevention
Njau Mungai Department of Diagnostic and Forensic Services
112
Contributors
Stanley Otara Kisii Level V Hospital
Eliud Njau Mbai Provincial Director of Public Health & Sanita-
tion OfficeEastern
Joseph Opondo Homabay District Hospital
John Mbaya Meru District Hospital
Denje Douglas Coast Provincial General Hospital
Humphrey Mundu Provincial Director of Public Health & Sanita-
tion OfficeCoast
Samuel Gachuhi Provincial Director of Medical Services Office
Rift Valley
Anthony Kabugi Provincial Director of Public Health & Sanita-
tion OfficeCentral
John Munyi Kwale District Hospital
Langat Raphael Walter Reed Project, Kericho
Christopher M. Kimaru Kiambu East District
Nancy K. Njine National Public Health Laboratory Services
Fredrick Gichoni Embu Provincial General Hospital
Okinda Meshack Kakamega Provincial General Hospital
Safari Kithi Nyandarua South
Hezron Okoth New Nyanza Provincial General Hospital
Winnie Migwi Nakuru Provincial General Hospital
Mohamed Mwakuzimu Kilindini District
Mathews Odera Provincial Director of Medical Services Office
Nyanza
Alfred Muia Mbagathi District Hospital
Beatrice Kariuki Provincial Director of Public Health & Sanita-
tion OfficeRift Valley
Joseph Karisa Malindi District Hospital
Jonathan Majani Provincial Director of Public Health & Sanita-
tion Office Western
113
Daniel Wekesa Kitale District Hospital

David Maundu Machakos District Hospital
Emelda Nyairo National Spinal Injury Hospital
Joseph Karanja Kasarani District
Caroline Mbogori National Public Health Laboratory Services
Francis Wesiela Provincial Director of Medical Services Office
Western
Thomas Odera Suba District Hospital
Issack Maalim Garissa Provincial General Hospital
Ahmed M. Fidhow, Provincial Director of Public Health & Sanita-
Omar Mahat tion Office NEP
Enock Marita African Medical Research Foundation

Kipkerich Bera National HIV Reference Laboratory
Benard N. Muture, National Public Health Laboratory Services
Ali Abdulatif, National Public Health Laboratory Services
Jeremiah O. Ogoro Central Reference Laboratory for Tuberculosis

(MOH)
James Mudzori American Society for Microbiology
Jedida Wachira, Management Sciences for Health
Catherine Gichimu, Management Sciences for Health
Ernest Ruttoh, Management Sciences for Health
Judy W. Mwangi Management Sciences for Health
Jacob Okello Management Sciences for Health
114
115
116
This publicationwas supported by cooperative

Agreement Number 1U2GPS001826 from the
Centers for Disease Control and Prevention. Itgs
contents are solely the responsibilities of the author
and do not necessarily respresent the ocial views
of the Centers for Disease Control and Prevention.
118

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National Guidelines for Laboratory Specimen Referral Networks

National Guidelines for Laboratory Specimen Referral

Any part of this document may be freely reviewed, reproduced, translated,

Ministry of Public Health and Sanitation and Ministry of Medical Services,

2012 Ministry of Public Health and Sanitation and Ministry of Medical

Enquires and feedback should be addressed to:

This Publication was supported by Cooperative

4.4. Communication within Referral Networks........................31

These national policy and strategic guidance documents recognize the

The Comprehensive Kenya Health Policy has operationalized the two-

To achieve the referral strategys maximum intended benefits, the Ministries

Country-wide implementation of these guidelines will ensure that patients

Dr. S. K. Sharif MBS,MBChB, MMed, MSc Dr. Francis M. Kimani

To improve access and equity in health services delivery, the National

The National Guidelines for Laboratory Specimen Referral Networks present

The National Guidelines for Laboratory Specimen Referral Networks is a

Establishment of laboratory specimen referral networks, in accordance

Dr. Jane W. Siminyu Dr. Margaret Oduor

The National Public Health Laboratory Services, with

The Department of Diagnostic and Forensic Services and National

Management Sciences for Health (MSH)

The ministries acknowledge the invaluable contributions made by

Mr. Abdulatiff Ali

Abbreviations and Acronyms

As a signatory to the Millennium Declaration, the Government of Kenya has

Health services in Kenya are structured in a hierarchal manner, with four

A referral system is defined as a mechanism to enable clients health needs

to be comprehensively managed using resources beyond those available

Laboratory specimen referral consists of the movement of a laboratory

A laboratory network can be defined as a collection of laboratories that use

The key elements needed for a functional laboratory referral network

Definition of the laboratory tests available in the referral network

Organisation, coordination, and financing of health systems to

Definition of the human resource requirements for facilities in the

Essential equipment and its maintenance for continuous service

Definition of the required logistics, including documentation,

A QA programme to guarantee accuracy and reliability

Applicable standard SOPs for all procedures, including specimen

M&E for effective implementation and continuous improvement

The laboratory strengthening efforts of development partners in support of

laboratory referral network functions go beyond analysis of specimens. They

Specimen referrals have previously been operational in public health

Experiences from countries in the region have shown that establishment

The benefits of implementing these guidelines include the following:

2. Effective specimen referral systems will reduce the direct costs

3. The quality and delivery of specialized services to users will be

4. Improved quality of health data collection and management will

5. Tracking of specimens (e.g., histology specimens) will be

1.3. Situation Analysis: History of Referral Networks

The laboratory network approach (see annexes 1 and 2) employed these

Specimens were collected and shipped to the nearest processing

Standardized protocols and trainings were adopted for specimen

Common QA schemes, including external quality assurance (EQA),

Patients and clients were cushioned against transport costs and

Expansion in the use of the laboratory network approach for ART

1.3.2. Referral Networks for Tuberculosis

Initially, the TB county referral laboratories (TB-CRLs) were the

Plans were put in place to decentralize TB culture services to

Currently, some county referral hospital laboratories also act as

1.3.3. Referral Networks for Surveillance of and Response to

Laboratory diagnosis of diseases under surveillance is coordinated

Specimens from suspected cases are transported to designated

analytical laboratories by staff from the district surveillance

The analytical laboratories include Provincial General Hospital