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National Guidelines for Laboratory Specimen Referral Networks
Networks
2012
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National Guidelines for Laboratory Specimen Referral Networks
Suggested Citation:
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
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National Guidelines for Laboratory Specimen Referral Networks
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
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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
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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.
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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:
We would particularly like to thank the reviewers (annex 11) for their detailed
reviews and willingness to make contributions to improve the guidelines
content.
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National Guidelines for Laboratory Specimen Referral Networks
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.
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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
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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.
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.
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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.
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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 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
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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.
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Lessons learnt from four ART pilot sites in Coast Province (2003
2005) were shared, and the approaches were expanded to Nyanza
in 20052006.
The TB-CRL supports the EQA networks for acid-fast bacilli (AFB)
microscopy for regional and high-volume laboratories (annex 2).
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National
reference labs
County referral labs
Laboratories may bypass the next level in the hierarchy and send
the specimen to the higher level, where the required analysis will
be provided.
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Management Roles
The National Reference Laboratory Management Roles shall include:
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Test name
Specimen requirements for the test
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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:
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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.
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The recommended on-site laboratory services for each level are in tables
14.
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o Brucella tests
o H. pylori antigen
o Water microbiology
Other services
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Inoculation of media
transport (trans-isolate
bottle)
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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)
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
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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
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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.
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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:
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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.
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.
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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.)
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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.
Identify the possible need for a new nodal site and hold a
stakeholders meeting.
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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.
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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.
Develop a plan for monitoring the network and use findings for
continual improvement.
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References
1. Ministry of Medical Services and Ministry of Public Health and
Sanitation. Comprehensive Kenya Health Policy 20112030. Nairobi:
Government of Kenya; 2011
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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.
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Satellite
labs
Satellite
labs
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National
reference labs
Primary care
lab
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Name of laboratory
Address
Telephone number
Name of key contact people
Services and tests offered by the laboratory
Hours of operations
Polio Laboratory
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Microbiology Laboratory
HIV Laboratory
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Tuberculosis Laboratory
Measles Laboratory
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Arborviruses Laboratory
Arborviruses Laboratory
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Radiation Laboratory
Phone:+254 (0)0202714558
Kabete
Government Chemist
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Microbiology Laboratory
Mbagathi Road
Veterinary Laboratories
Kabete
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Arborviruses Laboratory
Central Microbiology
Reference Laboratory
Schistosomiasis Laboratory
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Leishmaniasis Laboratory
8
Source: Ministry of Public Health and Sanitation 2011
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Typhoid fever
Brucellosis
Influenza
Schistosomiasis
8
Source: Ministry of Public Health and Sanitation 2011
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MOH 240H
MINISTRY OF HEALTH
Specimen Ref No.............................
Email................................................................................ Signature....................................................
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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.
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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.
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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
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Glucometer + +
Haemo- + +
globinometer
Water baths + + + +
Centrifuges + _ + +
(bench top)
Centrifuges + + + +
(haemotocrit)
Autoclave + + + +
Safety hood + + + +
Fridges (for + + + +
reagents)
Blood bank + + + +
fridge
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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
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Date of visit
Supervisor Name______________________
Signature__________________
General Laboratory Information
Laboratory in-charge Name__________________
Signature__________
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Designation/position of
person interviewed
Telephone contact of
laboratory in-charge
Workload (average tests
done per month)
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Others (Specify)
Others (Specify)
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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?
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Chemistry machine
Haematology machine
Other (Specify)______________
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Air-conditioning: AC or exhaust?
PCR
Total working area
Sluice/utility room
Store
Office for head of labo-
ratory
Media preparation
room
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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)
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General comments:
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* KEY comments
PM Preventive maintenance (available)
O Obsolete
OP Operational manual (available)
SOP Standard operating procedure (available)
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Reagents
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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
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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
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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?
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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)___________________
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Quality control
On-the-job training/coaching
Other (Specify)________________
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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)___________________
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Reinforcement of univer-
sal safety precautions
Inventory of supplies
checked
Maintenance records
checked
Cold-chain records
checked
Quality control
On-the-job training/
coaching
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?
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External audit___________
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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?
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Laboratory Referrals
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IDSR
Has any specimens been received in the last 3 months for outbreak
investigation?
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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: *..............................................................................................
................
* .....................................................................................................................
* .....................................................................................................................
* .....................................................................................................................
* .....................................................................................................................
* .....................................................................................................................
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3. List in the first column of the table each of the problems from Item 2
above. Then complete the rest of the table.
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Laboratory Tests for Level III and II (Health Centres and Dispensaries)
Is the laboratory able to carry out the following tests/procedures?
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
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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
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National
Result Performance Means of Frequency referral Primary
area indicator verification of collection labs CRLs care labs
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
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National
Result Performance Means of Frequency referral Primary
area indicator verification of collection labs CRLs care labs
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
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National Guidelines for Laboratory Specimen Referral Networks
National
Result Performance Means of Frequency referral Primary
area indicator verification of collection labs CRLs care labs
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
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National Guidelines for Laboratory Specimen Referral Networks
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
National Guidelines for Laboratory Specimen Referral Networks
112
National Guidelines for Laboratory Specimen Referral Networks
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
National Guidelines for Laboratory Specimen Referral Networks
114
National Guidelines for Laboratory Specimen Referral Networks
115
National Guidelines for Laboratory Specimen Referral Networks
116
National Guidelines for Laboratory Specimen Referral Networks
118