User Manual of the Laboratory Assessment Tool
WHO/CSR/Lyon
23/06/04
WHO
OMS
Table of contents
Table of contents ........................................................................... 1
Table of figures.............................................................................. 2
Acronyms ..................................................................................... 2
1- Introduction .............................................................................. 3
2- Presentation of the tool................................................................. 3
3- The assessment process................................................................ 4
4- National consensus on laboratory equipments ..................................... 7
5- General guidelines in completing each module ..................................... 9
6- Module 1: General facts ............................................................... 10
7- Module 2: Biosafety .................................................................... 12
8- Module 3: Sampling .................................................................... 15
9- Module 4: Equipment .................................................................. 18
10- Module 5: Reagents .................................................................. 19
11- Module 6: tests ........................................................................ 22
12- Module 7: Laboratory staff & working time ....................................... 25
13- Module 8: Total quality ............................................................... 27
14- Module 9: Reporting, analysis and communication .............................. 30
15- Module 10: outbreaks ................................................................ 31
16- Analysis of the results and summary .............................................. 33
17- Un-protecting & Editing LAT......................................................... 37
Appendix 1: indicators calculation ....................................................... 39
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
1/52
Table of figures
Figure 1 : the various worksheets............................................................................. 3
Figure 2 : equipment list based on the level of the laboratory ........................................... 8
Figure 3: revealing additional information hidden in the cells ............................................ 9
Figure 4: limited possibility for answers (here Y, N and na) ............................................ 10
Figure 5 : error message in case of unauthorized value ................................................ 10
Figure 6 : upper part of the module about general facts................................................ 11
Figure 7 : part of sterilization logbook, Plovdiv, Bulgaria, 2003 ........................................ 14
Figure 8 : WHO biosafety guideline ......................................................................... 15
Figure 9 : filing in of the equipment module .............................................................. 19
Figure 10 : screening test for diphtheria not needed .................................................... 23
Figure 11 : screening test for diphtheria not done ....................................................... 23
Figure 12 : screening test for diphtheria done ............................................................ 23
Figure 13 : confirmation test for dysenteria ............................................................... 24
Figure 14 : confirmation test for tuberculosis not done ................................................. 25
Figure 15 : critical thinking toward samples during night and week end ............................. 27
Figure 16 : sheet containing all indicators and their graphic representation ......................... 34
Figure 17: general indicator calculation, including the 10 modules ................................... 34
Figure 18: calculation of the general indicator without the modules 2 and 8 ........................ 35
Figure 19: weighted indicator sheet ........................................................................ 35
Figure 20: list of available coefficients ..................................................................... 36
Figure 21: general un-weighed indicator .................................................................. 36
Figure 22: difference in general un-weighed indicator and general weighed indicator. ............ 36
Figure 23 : active sheet unprotected ....................................................................... 37
Figure 24 : right board un-removed ........................................................................ 38
Figure 25 : right board removed once unprotected, calculations can be seen ...................... 38
Acronyms
AST: Antibiotic Susceptibility Testing
CSR: Communicable disease Surveillance
and Response
CCL: Core Capacities of Laboratories
EQC: External Quality Control
IDSR: Integrated Disease Surveillance and
Response
IHR: International Health Regulation
IQC: Internal Quality Control
LAT: Laboratory Assessment Tool
OEL: Outils d’Evaluation des Laboratoires
PHL: Public Health Laboratory
SOP: Standardized Operating Procedure
CSR/LYO/LAB unit:
Medical staff:

Unit coordinator: Dr Bradford Kay

Training responsible: Dr Philippe Dubois

Quality assurance responsible: Dr Antoine Pierson

Country activity responsible: Dr Mohamed Youssef

Country follow-up responsible: Dr Sébastien Cognat

Lab management responsible: Dr Isabelle Bergeri
Distance learning and tool conception staff:

Ms Anouk Berger
Administrative staff:

Ms Isabelle Battaglia

Ms Anjelika Efimova
Note: Mr. Hojoon Sohn did take active part in reviewing and editing this tool
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
2/52
1- Introduction
The Laboratory Assessment Tool or « LAT », also called « outil d’évaluation des
laboratoires (OEL) » in French, is an evaluation tool designed to:





Assess a microbiological lab in a standardized way
Automatically generate numerical indicators related to laboratory
capacities
In different parts called « modules »
Easily follow the improvement of the same laboratory over time
Perform an evaluation based on the technical and administrative level of
the laboratory (reference, intermediate, periphery)
The current edition of the assessment is an MS Excel file, and is ran only using
calculations (no macros). Absence of macros enables the LAT to be used on any
computer, independent of the operating system language.
This assessment tool has been developed and revised by the WHO/CSR/Lyon
unit in 2003 and 2004 with the comments and input of many contributors. This
current version has been field tested in Bulgaria, Iran, India, and in Burkina
Faso. The principal designers and editors of this assessment tool are Dr. Antoine
Pierson and Dr. Augusto Pinto.
2- Presentation of the tool
The file includes sixteen worksheets, titled in English. Altering or renaming of
these titles may result in calculation error and possibly compromise the
interpretation of the data.
Titles and descriptions of each worksheet
Figure 1 : the various worksheets


Indicator summary: A full summary of evaluation and assessment of
the laboratory with LAT.
All indicators: A visual summary of the evaluation of each indicators. 3
pages when printed.
Specific Modules

1-general: includes questions concerning the details of the laboratory
facility being assessed and the respondent. This section evaluates
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
3/52












laboratory building conditions, water and electricity supply and general
activities of the laboratory.
2-biosafety: includes questions about biosafety practices, waste
management and security of the lab being assessed
3-sampling: includes questions regarding the laboratory’s sampling
procedures, request forms, and specimen recording procedures.
4-equipment: includes questions targeting the equipment status of the
laboratory. Recommended equipments (both quantity and types) are listed
in the « Nat. Consensus on equipment » module.
5-reagents: gathers information concerning reagents and supplies
utilized in the laboratory, their management, and preparation. This
module also includes questions concerning financial resources for
purchasing reagents and supplies.
6-tests: This large module assesses the laboratory’s diagnostic test and
procedures.
7-staff: This module concerns staff and their working conditions at the
laboratory. (E.g. the number of days and hours of opening, procedures in
emergency cases handled outside the opening hours).
8-quality: This module is dedicated to the examination of the overall
quality procedures of the laboratory: quality assurance, internal and
external quality control, analysis procedures, preventive maintenance and
repair of laboratory equipment.
9-reports: Communications capabilities of the laboratory are assessed in
this module, which includes reporting of priority diseases to the public
health authorities, data archives, monthly reports and data backup
procedures and practices.
10-outbreak: This module examines the laboratory’s activities in disease
outbreak investigations.
Nat. Consensus on equipment: This module is a summary of both
essential and optimum level of equipments (both number and type)
recommended in the laboratory classified by the level of the laboratory.
This sheet is used as a reference for interpretation of the results from
module 4 (equipment module).
weighed summary: A full summary of the assessment on which you can
weigh (3 levels) any of the ten modules for the summary indicator
calculation
weighed indicators: A visual summary of the evaluation of each
indicators, that can be weighed (3 levels) to calculate the module
summary
3- The assessment process
IMPORTANT NOTE: It is imperative that the assessment is carried out by a
microbiologist or a person who has in-depth knowledge in laboratory assessment
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
4/52
(includes those who have prior experience in laboratory assessment) and
understands the general laboratory operations.
1) Recommended length of the assessment
A complete assessment of a laboratory should take at least half a day for a
reference laboratory and should take about 2~3 hours for a peripheral
laboratory.
This assessment must be carried out during opening hours, in order to be able to
observe staff at work.
Aside from bringing both electronic and paper version of LAT, it is necessary to
have a notebook and a camera (ideally digital) for documentation purpose.
2) Approach to the assessment and securing cooperation from the
laboratory
Before you begin the assessment of the laboratory, it is recommended to the
assessor explain the main purpose of the assessment. You MUST point out that
this is not a control process that may lead to punitive measures. It should also be
mentioned that there is an agreement with the national authorities that the
assessment will indeed NOT be used for punitive measures. The followings are
recommended to be highlighted at the conclusion of the assessment:
 Strengths of the laboratory, in order to highlight positive aspect of the
laboratory
 Weaknesses of the laboratory in order to highlight future improvements of
the laboratory
IMPORTANT: Furthermore, it is very important to note that assessment results
should follow confidentiality rules, and in establishing such a confidence climate,
a quality assessment will be possible to be carried out
3) Assessment procedures and guidelines
The assessor should first visit the laboratory, following the sample path:
 Sample or patient reception
 Sampling rooms
 Recording
 Microscopy
 Technical rooms (culture, Identification, Antibiotic Susceptibility Testing,
serology, molecular biology …)
 Support rooms (washing room, sterilization, restroom, guard room, stock
room, repair room, secretary room, offices)
Look at the global cleanliness, the global organization, biosafety level while
manipulating
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
5/52
In each room (if applicable), the assessor may be required to perform following
tasks:

Check the condition and organization of refrigerators

Check the condition and organization of incubators

Check the condition and organization of freezers  How is the eventual

Visually evaluate the condition and cleanliness of the laboratory benches
and facilities
Examine the condition and organization of stock shelves, cards, and
expiration dates of the chemicals on the shelves
Check the laboratory logbooks, patient records or information (check if
they correspond to the right patient), and management of the
antibiogramme results
Check the eventual archives
Check the condition of the microscopes (always assess one or two slides
in order to check




1) Are the refrigerators clean?
2) Randomly take 3 or 4 old-looking products and check expiration dates
3) Is there an internal thermometer available? If not, are there any
temperature charts available?
4) etc.
1) Look at the thermostat adjustments and eventual hemoculture bottles
2) Check the organization of Petri dishes  Are there any old Petri
dishes? Do all of Petri dishes have identifications?
3) Maintenance of special environment (CO2, anaerobia, microaerophila…)
4) Check how the temperature of the incubator is recorded (ideally, it is
recommended to have a thermometer inside a water can in the
incubator)
5) Check the overall cleanliness of the incubator
serotheque organized?
1) the quality of the films and stains, 2) the condition of the microscope,
and 3) the Kohler adjustment (centering of optical axes).

Observe and evaluate how laboratory technicians work

Check and evaluate how the laboratory waste is managed inside technical
rooms. This is important information as it will tell us about the laboratory’s
activities within the past 24 hours of the assessment.
1) Do they use lab coats, gloves, glasses, masks?
2) Is the bench clean? Do they disinfect the bench at the end of the
work? Is regular disinfection of the lab bench likely?
1) How full are the waste containers?
2) Are the wastes regularly emptied?
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
6/52
3) Are there separate waste (lid-covered?) containers for non
contaminated and contaminated wastes?
4) Is there any special solvent container (any for acids?)

Etc.
Advice and recommendations should be made following the observation and
examination. It is important to note that these assessments are only made to
improve the condition of the laboratory and understand that keeping good
relations between the assessor and the laboratory personnel is vital. Hence, all
recommendations and advice should be made in friendly manner. Furthermore,
some comments that may be quite embarrassing or upsetting for the laboratory
should only be mentioned to the respondent of the laboratory (or the person in
charge).
During the visit, document the facility by taking pictures of the rooms, working
staff, equipments, packaging delivery procedures, etc. These pictures can aid
you to illustrate and explain the conditions of the laboratory for the final report.
A detail visit, normally lasting around 90 minutes for a reference laboratory, is a
must as it will allow the assessor to save time and be more efficient during the
utilization of the tool. It also gives the assessor an opportunity to demonstrate
several key improvements to be made for the laboratory and their staff on site.
Once the initial visual evaluation of the laboratory facility is completed,
immediate assessment of the laboratory, using LAT is recommended. The
assessor can initially use the paper version of the tool for his/her convenience,
but it is recommended him/her to directly utilize and fill-in the electronic version.
Utilization of the electronic version of this tool (LAT) enables immediate
discussions with the respondent from the laboratory following the questions and
make recommendations for future improvements of the laboratory, suggested
from the indicators of LAT.
4- National consensus on laboratory equipments
LAT worksheet 13 is a list of recommended equipments and their quantity based
on the level of the laboratory. The current list has been carefully prepared after
extensive discussions between WHO collaborators and the developer of this tool
and is based on our previous laboratory assessment experiences, mostly in
Africa, Middle-East and Eastern Europe. The list of equipment by level can be
kept as provided in LAT
However, it is highly recommended to health authorities to refine this list when
assessing a certain number of laboratories in their specific country. This can
provide a unique opportunity for health authorities to organize a workshop on
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
7/52
equipment that should be available for each level of public laboratories and then
issue National recommendations about this important topic1.
Based on the assessment information on equipments and the National consensus
on laboratory equipments, LAT can automatically generate a list of recommended
equipment and its quantities required or needed as well as financial parameters
in purchasing these equipments for the assessed laboratory. Thus, it is
IMPORTANT for the assessor to review this table before the assessment as the
calculation of the indicator for the equipment module is linked to this table and
depends on the level of the laboratory being assessed2.
This table is listed with both ‘minimum’ and ‘optimum’ equipment quantities for
each laboratory level. ‘Minimum’ is defined by the number of equipments
absolutely necessary for laboratory operations and ‘Optimum’ concerns the
quantity of equipments for ideal laboratory operations (figure 2). For some
‘minimum’ and ‘optimum,’ “0” signifies the following:
1) the equipment is not needed for the purpose of the laboratory (ex.
disease specific or specialized laboratories)
2) the equipment is not needed for the particular laboratory level (ex. culture
and serology analysis)3
Figure 2 : equipment list based on the level of the laboratory
In addition to this list of equipment by level, it is also very important to get the list of staff
required and the list of analysis that should be performed at each level of the laboratories
2
« 1 » is the peripheral level (1~2 laboratory staffs), « 2 » is the intermediate level (5~10), and
« 3 » is the reference laboratory (11~40).
1
3
Analysis
Microscopy
Serology (ex.
etc.)
Culture
ELISA,
Level 1 (district)
Required
If needed, but not required
(only for HIV analysis or other
relevant disease analysis)
Not recommended (outside
any specific and/or special
programs)
Level 2 (interm.)
Required
Recommended (depending
on
the
operational
capabilities)
Recommended
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
Level 3 (ref.)
Required
Required
Required
8/52
5- General guidelines in completing each module
To help you with assessment process and completion of LAT, additional
information will be available for some selected questions and indicators in LAT.
This information is hidden in the cells, but can be viewed by dragging the cursor
to the cells with corners highlighted with red (Figure 2).
Figure 3: revealing additional information hidden in the cells
Besides the consensus about equipment, all gray cells of the modules 1 to 10
must be filled in.
For each question, and for the entire tool, you have a limited number of possible
answers:
 « Y » for yes
 « N » for no
 « na » for « non applicable », should be entered if the question isn’t
applicable to the laboratory.
 For example,
« do you diagnose tuberculosis using bacilloscopy »;
if the laboratory doesn’t perform this analysis (availability of another TB
specialized centre), you reply « na » and the question goes out of the
indicator calculation.


« 1, 2, 3, 4 or 5 » for open question with different possible answers
Different values other than those above can entered when asking:
o Quantity of equipment
o Number of tests performed annually
o Percentage of equipment coming from outside
o Number of samples handled daily
o etc.
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
9/52
Figure 4: limited possibility for answers (here Y, N and na)
Clicking the small arrow at the right side of the cell opens a listbox with
authorized values. Error message will appear as below, when trying to enter
values other than the ones listed in the listbox:
Figure 5 : error message in case of unauthorized value
Hence, YOU CAN ONLY ENTER AN AUTHORIZED VALUE IN THE LISTBOX.
At the end of each question, next to the gray cell, you can find a code similar to
epi-info 6 or epi-data codes:
 <Y> signifies a yes/non answer, sometimes « na »
 # signifies that a one digit number must be entered (1, 2, 3…)
 ## signifies that a one or two digits number must be entered
 ### signifies that a one, two or three digit number must be entered
IMPORTANT NOTE:
If you think the answer to the question applies to both Y and N, you must
SYSTEMATICALLY choose the most severe answer of the two.
Examples:
1) If the answer is « yes » in few cases but « no », for most cases, you have to
choose « no ».
2) For question « did somebody from the staff attend a training on biosafety
before working? », if a new staff member at the laboratory attended a refresher
course on biosafety, and not a full training course with handouts, you must
choose « no » for the question
This systematical « severity » will allow a calibration between the different
assessors and may allow their respective assessments to be more comparable.
6- Module 1: General facts
The upper part of this module has to be filled in carefully as these will be the
header of the printable reports.
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
10/52
Figure 6 : upper part of the module about general facts
Please pay careful attention when entering the level of the laboratory being
assessed as this number is used in the calculation of several indicators in LAT
(circled in figure 5).
Note: « 1 » is the peripheral level, « 2 » is the intermediate level, and « 3 » is
the reference laboratory
 Building conditions
There are three questions in this section concerning the building conditions
including questions regarding roof/ceiling, wall, and the ground of the laboratory:
o Answer « 3 » if the state of the building is very good (new or close
to new or well maintained)
o Answer « 2 » if problems exist (water infiltration, walls spoiled or
attacked by termites) but won’t cause major problems
o Answer « 1 » if major infiltrations are present: walls showing major
structural defect or breakdown, the ground is damaged,
compromising the working quality inside the laboratory
 Fluids supply
Enter the % of water and electricity availability, practically:
o 100% if you don’t have any shortage
o 90% if shortages are rare (1 to 2 time monthly)
o 70% if shortages are regular (once a week)
o 50% if shortages are systematic (more than once a week)
o 30% if shortages are occurring daily
For the generator, answer « Y » if the electric generator is present and functions
properly, AND if its supply in gasoline is done regularly. Otherwise, answer « N »
For the safe sewage disposal method, verify whether or not the laboratory
implements a system for separating or disinfecting hazardous and non hazardous
liquid waste before draining out to the common sewage

Laboratory rooms
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
11/52
1) Enter the total number of rooms inside the laboratory, including technical
rooms, reception, sampling, offices, stock, rest room, guard room. Do not count
toilets.
2) Enter after the number of benched rooms, and the number of used benched
rooms. For example, enter 3, if the laboratory has a total of 10 benched rooms,
but with only 3 functional or being used.
NOTE: If an office is equipped with laboratory benches that are not used for
laboratory purposes, you have to count the room as “non used benched rooms”
and exclude them from the total number of “number of rooms in current usage.”

Communication possibilities
Answer « Y » or « N » for each question concerning the communication means in
the laboratory facility.
NOTE: In order to answer « Y » for certain questions, the laboratory must meet
the following:




Telephone and fax are present inside the laboratory
The computer(s) (At least MS Windows 98 operated or Apple OS
9.01 version is good enough) is (are) present inside the
laboratory
Internet connection/access is available throughout the facility for
regular access for the laboratory personnel (connections can be
localized at another location).
Functional national postal services are available at the facility.
 Coverage of infectious diseases
Fill « Y » or « N » for each question.
1) The part « virology » concerns the « real » virology with cell culture and
virological diagnosis. You should select answers for serology separately.
2) Answer « na » for tuberculosis, parasitology and mycology, ONLY if these
specialties are covered by another reference centre, otherwise, answer
« Y » or « N ».
For molecular biology analysis, answer « na » for level 1 and 2
laboratories. For reference laboratory, answer « Y » if the unit is
functional, and « N » if the unit is non functional or not present.
NOTE: Reference laboratories are recommended to have a molecular biology
analysis unit.
7- Module 2: Biosafety
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
12/52
 Use of protective gears
For these questions, your answers should be based on your observations of the
laboratory and their staff.
For each protective gear (labcoat, glove, mask and glasses), you should respond
« 1 » if the laboratory staff never uses them, « 2 » if rarely uses them, and « 3 »
if always uses them.
During the visit, pay close attention to the use of the gloves.
 Availability of safety procedures
Questions in this section concern WRITTEN or PRINTED procedures regarding
biosafety in the laboratory. Ask the staff member to show you these procedures.
Visual verification of these procedures is recommended.
 Training in biosafety
Questions in this section concern the training procedures in biosafety at the
laboratory being assessed. Each question addresses safety training in following
recommended categories:
o Security while manipulating laboratory samples
o Classification of different classes of micro-organisms
o Security while sampling
o Methods in Packaging and triple-packaging of a sample
o Using disinfectants and procedures in disinfections
o Waste management
Note: Each training session should be done with proper handouts, containing
necessary information about each training subject. The biosafety training
sessions can be carried out by either in-lab professionals or professionals from
outside the laboratory
 Safety conditions
For answering any biosafety conditions of the laboratory, following observations
should be made:
o Availability of hypo chlorite or similar liquid disinfectants at the laboratory
benches and at the washing room4.
* Cresols (liquid or solid) or Lysol (50% cresol in aqueous solution).
* Hypochlorite (household bleach)
* Calcium hypochlorite
* Chloramine-T
* Calcium hydroxide solution (not suitable for disinfecting stools from patients with
TB)
* Quaternary ammonium compounds (QUATS)
* Alcohols (ethanol, isopropanol) or other alcohol based disinfectants
4
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
13/52
o Availability of separate sink for washing hands (please check if there are
any biological staining traces!).
o Check the condition of the laboratory benches and its materials (wood or
plastic benches?).
Note: Benches made of resin, glass, ceramic or stone are recommended as they
are resistant of chemicals and other biological solvents and are easily washable.

Disinfection/sterilization of laboratory equipments
1) Centrifuges
It is imperative that disinfection of the centrifuge is done when the centrifuge is
contaminated with samples from a tube break or other cause. It is recommended
that the centrifuges are cleaned and disinfected regularly, at least once a month.
If these two conditions are met, answer « Y », otherwise, answer « N ».
2) Incubators
Likewise, disinfection of the incubators in the laboratory must be done when the
incubator is contaminated (or contamination is suspected). It is also
recommended that incubators are disinfected and cleaned every 60 days
regardless of contamination. In LAT, answer « Y » if these two criteria are met.
Otherwise, answer « N ».
3) Sterilization indicators
Sterilization indicators should be used for EACH sterilization. You should ask the
laboratory respondent to see the strips being used at the laboratory for
inspection. If the laboratory does not use such strips, you should recommend the
use of a sterilization strips and a sterilization logbook for to document each
sterilization (ex. Plateau temperature).
3
2
4
5
6
1
Figure 7 : part of sterilization logbook, Plovdiv, Bulgaria, 2003
The logbook should contain the following categories:
1. Date and list of the sterilized items
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
14/52
2.
3.
4.
5.
6.
Time of beginning and ending of sterilization
Plateau temperature
Number of baskets (being sterilized)
Strip glued, verifying sterilization.
Signature of the officer
 Waste disposal
Check the following for waste disposals in the facility:
1) Availability of two separate waste containers for infectious and noninfectious wastes. For infectious waste container, please check if the
waste container has a lid.
2) Availability of broken glass/sharp object waste containers in the sampling
rooms.
3) Check if there are any unsecured ‘waste’ bowls or small static bench cans
(static meaning not emptied regularly) in the laboratory. Also check if the
waste containers are made in materials other than rigid plastic (wood,
iron, etc.).
NOTE: Some African laboratories may use large jerrican as solvent containers.
 Documents in biosafety
Relevant and updated biosafety guide must be present in order to be able to
check « Y » to this question. For the WHO security manual, the lab must possess
one of the following three manuals (shown in the picture below – please show
the picture of these books to the respondent).
Figure 8 : WHO biosafety guideline
8- Module 3: Sampling
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
15/52

Laboratory capacity in sample processing AND Quality of samples
received
Answering questions in these two sections enable the LAT to assess the main
problems concerning sample received by the laboratory:
o Wrong package means that a regular safe package (triple package
for example) wasn't use for the transport. This can also mean that
some leakage happens regularly or any other package failure
o Wrong conservation means that samples are not delivered at the
right temperature (frozen, cold or at 37°C)
o Wrong transport media: for example CSF in Cary Blair transport
media, or no transport media when needed
o Wrong identification: samples for HIV labeled as TB, etc., incorrect
or wrong identification of the patient…
o Delay in sample delivery: samples delivered with a delay prohibiting
a correct further analysis

Availability of sampling procedures
o First four questions in this section concerns written sampling procedures
used by the laboratory. The respondent from the laboratory must be
able to show you these documents in order to check « Y » to these
four questions.
o Next question only refers to the countries that have more than one
official language (ex. India, Cameroon, Namibia, China, etc.). In these
countries, it is common to have procedures written in a language that
may be different from the language used by the technicians or
laboratory personnel. If this is the case, answer « N ». For countries
with one official language, such as francophone countries in Africa
(where medical training and teaching is done in French), answer
« na ».

Staff Access to the sampling procedures: Staff access to these
procedures is critical and should be permanently accessible. Answer « N »
if these procedures are kept in a closed office or not available.

Review of Sampling Procedures by Clinician: Sometimes lab samples
are collected by non-laboratory personnel or clinician. Hence, if the
laboratory has standardized written or printed procedures for sampling,
availability of these sampling procedures to the clinician can significantly
improve the quality of the samples. This is the same in case of
biologists/physicians collecting the sample. If the sampling procedures are
NOT available to these people, answer « N ».

Quality of the request form
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
16/52
The best way to answer these questions is to have a sample request form
in hand. Please ask the respondent a copy of the sample request form
being used in the laboratory. Specifically look whether or not the form has
sampling time and date section.
NOTE: If the form is meningitis and/or hemoculture specific, temperature
column must be present. If this is not the case, answer « N » for the
temperature question. Answer « na » if the form is not specific for meningitis or
hemoculture specimen.
5

Critical thinking about the samples
This question is to assess laboratory’s logistical procedure in handling
samples with limited information. LAT has three possible responses
labeled 1 to 3. Expected answer from the respondent is the 3 rd one (‘TRY
TO CONSULT THE SENDER OR THE PATIENT’). When asking the question,
give the respondent an opportunity to answer independently (without
knowing the response choices). If the answer significantly differs from one
of three answer choices or the respondent has trouble answering, then,
ask the respondent to choose from the three possible responses.

Identification of Specimens
To answer questions regarding identification of specimens, you should
first refer to the logbook of the laboratory being assessed. Answer « Y »,
« N », or « na » for each question based on your examination of the
logbook.

Macroscopic examination
For the first question, ask the staff member or respondent if macroscopic
examination is done on all samples received and analyzed5. If so, verify
this in the logbook and answer « Y » to both questions. If macroscopic
examination is not recorded in the logbook, answer « N » for the second
question.

Sample destruction
This question is to assess laboratory’s sample management after testing
(ex. to verify if the results from the samples are obtained and verified
before being discarded and to check how long the samples are kept if retesting may be necessary). When asking the question, give the
respondent an opportunity to answer independently (without knowing the
response choices). If the answer significantly differs from one of three
answer choices or the respondent has trouble answering, then, ask the
respondent to choose from the three possible responses.
Stool, CSF, serum, urine, etc.
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
17/52

Specimen tracking
Answering first two questions in this section in « Y » will require you to
examine the laboratory logbook. The logbook should be organized so that
one may be able to find records of specimen by the following:
o Patient’s name (Can you find the specimen or test results
by a patient’s name?)  This is possible only if the laboratory
keeps a separate book with alphabetical list of patient names.
Answer « N » if this book is not present.
o Sampling Date (Can you find the specimen or test results
by sampling date?)  This method is may be the best way to find
samples, if the logbook is well organized. To answer this question,
ask the respondent to find a sample by giving a random date.
Answer accordingly based on the result the respondent’s
performance.
o Results of the test (Can you find the specimen record from a test
result?)  Search by the result of the test is possible only if the
laboratory keeps a separate book containing alphabetic listing of
patients with positive test results. Answer « N » if this book is not
present.
9- Module 4: Equipment
This module is linked to the national consensus about equipment by level (see
page 7). When filling in this module, count the number of FUNCTIONING6
equipment, easily ACCESSIBLES7 for the microbiology laboratory.
This module is directly linked to the national database on recommended
laboratory equipments based on the level of the laboratory.8 When completing
this module, only count the number of FUNCTIONING equipments in the
laboratory and ACCESSIBLES in the microbiology laboratory. Automated
comparison with the national database for the laboratory equipments, done by
the program, will generate recommended list and amount of equipments needed
to meet the National standards. Financial requirements in obtaining
recommended laboratory equipment can also be calculated in this module. In
order to do this, you must enter the price of EACH equipment (in USD) in the
« Functioning » means the equipment is in working condition on the day of the
assessment.
7
Only count hematology or parasitology equipment only if
 Located in the same premises
 The equipment can be used without constraints by the microbiology
laboratory, meaning no official request is necessary to use the equipment.
8
refer to page 7 of this manual and the Nat. Consensus of equipment module in LAT
6
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
18/52
column labeled « average price ». The result will appear at the bottom of the
page.
NOTE 1: All equipment prices are listed as average prices in US dollars and it
takes account of the costs for shipping and handling and 10% of total equipment
price for purchasing spare parts at the time of initial order (spare parts for the
equipment can be best purchased when bundled with the initial order of the
equipment as it (may) allow additional discounts).
NOTE 2: There are two parts to this calculation: TOTAL and BASIC. Total refers
to the entire equipment recommended while BASIC refers to the equipments
essential for microbiology laboratory. Following are the list of equipments that
are included in the BASIC group:
 autoclave
 fridge
 scale
 freezer –20°
 microscope
 incubator (large and small)
 Candle jar
 water distiller
 ELISA chain
 water bath
NOTE 3: Please note the following when entering information about glassware:
0- Don’t have any laboratory glassware
1- Shortage (laboratory glassware is available, but not enough to cope with the
capacity of the laboratory).
2- Minimum (the laboratory has just enough glassware for normal operation).
3- Optimal (the laboratory has more than enough glassware for its capacity).
Figure 9 : filing in of the equipment module
10- Module 5: Reagents

In-lab preparation of reagents
This section concerns any media or reagents that are prepared in the laboratory
oppose to pre-made products from companies. If the laboratory prepares (some
of) its own reagents/media, then check the preparation of following three
examples:
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
19/52
o « Gram »: Ask if the laboratory receives the stains ready-made
(costly, but convenient and quality assured) or in powder form
(quality may depend on the preparation procedure and conditions).
Answer « N » if lab purchases ready-made stains.
o « Blood agar »: While chocolate agar (cooked blood) is easy to
prepare by mixing hemoglobin in powder, blood agar requires use
of fresh blood. Hence, it requires easy access to fresh blood supply
(e.g. blood from a sheep). Human blood is not recommended in
preparation for blood agar. Answer « Y » if sheep blood is easily
available to the lab (e.g. a large number of African laboratories own
2 or 3 sheep at or near the facility for this purpose).
o BCP agar (Bromo Crésol Pourpre) or McConkey agar both are basic
media and can be easily prepared at the laboratory. Answer « Y » if
the laboratory prepares its own BCP agar or McConkey agar.
The part about QC of the home made media has to be strictly marked:
o Gram : stain has to be controlled
 Visually (no sediment, precipitate or silt)
 Using known Gram + and – strains (ATCC for example) and
adjusting if relevant, the times for the staining and
decolorizing steps.
o Home-made media
 Visual tests: aspect, color and smelling
 Sterility tests: for EACH batch, during 48 hours, written on a
media preparation logbook
 Growing tests: to be performed at least for selective media
(TCBS, SS, HEK, chromogenic media…)
If one part of these controls is lacking, answer « N »
It is important to be thorough in checking the quality of the media/reagents
made in the laboratory. Please check the following:
o Gram
 Visually check if there are sediments, precipitates, or silts.
 Comparing with the standard Gram positive and negative
strains samples (ex. ATTC or Pasteur Institute standards),
examine staining and decolorizing steps.
o Lab made media
 Visual tests: aspect, color, and smell
 Check if the media is sterile: For EACH batch of media (a
sample of each batch incubated for 48 hours), please check
if the media preparation is documented in the relevant
laboratory logbook and verify the date labeled on the bottle.
 Perform growing test: It is recommended to perform
growing for at least the following list of selective media:
TCBS, SS, HEK, chromogenic media, etc.
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
20/52

Reagent management
1) It is required for each laboratory to have AT LEAST stock cards for the
laboratory’s stock management. Answer « Y » to the first question if the
laboratory has stock cards (you need to verify this) or a system similar to
stock cards. Answer « na » for the first question if the laboratory manages
the stock of its reagents electronically, for central level laboratories, it is
highly recommended to have an electronical reagent stock management
system.9
2) A simple UP-TO-DATE MS EXCEL worksheet version of stock management
system is good enough to count as an electronic management of the
reagents in the laboratory. If this applies to the laboratory (ex. MS Excel
file), you can answer « Y » for the second question in this section.
3) It is highly recommended that laboratories keep some sort of logbook for
expired reagents. If any expired reagents or media is found in the
laboratory, answer « N ».
NOTE: Some laboratories keep expired reagents for teaching purposes and
keep them in a separate location with clear labels. If the laboratory does not
keep a logbook for expired reagents or have a separate location for stocking
expired reagents, do recommend the respondent or other laboratory
personnel to keep a logbook. A monthly inventory or check-up of the expired
reagent is recommended.
4) Check if the opening date is recorded on the reagent bottles or containers.
Answer « N » if there is reagent containers without opening date recorded
on the container as this process should be universal for all reagents used
in the laboratory.
5) For this question, the laboratory should perform at least 2 major
inventories of their reagents and media kept in the laboratory. If this is
the case, answer « Y », otherwise, answer « N ».

Funding for purchase of reagents used in the laboratory
‘Dedicated funds’ means that a specific line inside the budget of the institution,
line managed by the director of the lab. If you have to make your orders through
administration, this is not a dedicated line and you will have to answer « N »
The 3 other questions can be interpreted as well for funds or for reagents
donation, if these donations are regular. If one of these 2 conditions is met,
answer « Y »
Softlab® is a software specifically designed for laboratory stock management, for
any details, contact Dr. Antoine Pierson (piersona@lyon.who.int), WHO/CSR/Lyon
Office
9
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
21/52
These set of questions are useful in determining the sources of fund used for
purchasing reagents at the laboratory. “Dedicated funds” means a specific line of
funds included in the budget of the laboratory or the institution managed by the
director of the laboratory.
o For ONLY THE FIRST QUESTION, answer « Y » if the funding for reagent
is part of the institution’s budget.
o For the rest of the questions in this section, answer « Y » if the donations
or funding is permanent or regular for relevant organization.

Use of expired reagents
This is simple to answer. Be cautious in choosing the « 3–never » answer. If the
laboratory uses ANY TYPES of expired reagents (even if it is very rarely used),
DO NOT select this answer.

Availability of various reagents
There are 8 sections (a total of 42 questions) specifically designed to assess the
availability of reagents/antisera/media at laboratory for specific purpose. Only
answer according to what the laboratory has available ON THE DAY OF THE
ASSESSMENT. Following are choices available:
o 1: Always available in the laboratory
o 2: Available for part of the time (>6 months/year)
o 3: Not Available (regular shortage or never available)
o 4: Not Applicable (reagents not necessary for the laboratory)
If the laboratory regularly stocks a reagent, but does not have it stocked on the
day of the assessment, your choice of answer should be « 2 ». Choice « 4 »
should be used when the laboratory does not stock certain reagents and the
laboratory does not perform tests requiring those reagents. Feel free to use
« 4 » in answering questions in this section in order to have proper
representation of the indicator (choosing « 3 » instead of « 4 » will have direct
impact on the calculation of the indicator)
11- Module 6: tests
This is the longest and most important module in LAT. Hence it is recommended
to be performed at the last part of assessment. It is imperative to recognize the
difference between the two types of « no, I am not able to perform this
analysis » for each question in this section. Following are two possible cases:

The laboratory does not perform the test because it is irrelevant for the
purpose of the laboratory (or the laboratory is not responsible in
performing such test).
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
22/52

The laboratory does not perform the test because of the lack of reagents,
equipments, or skilled personnel.
Overall, the module is categorized in two separate parts:
 Screening Tests
 Confirmation Tests
Examples in distinguishing two different cases of « no, I am not able to perform
this analysis » answer is given below.
NOTE: All the questions should be answered based on the availability of the test
on the DAY OF THE ASSESSMENT.
1. Screening tests:
Example: Diphtheria Screen Test:
1- If screening tests are not necessary for the laboratory or are not part
of the laboratory duties
Figure 10 : screening test for diphtheria not needed
Answer « Y » on the first raw
2- If screening tests are necessary but not performed due to a lack of
reagents/stock/equipment
Figure 11 : screening test for diphtheria not done
o Answer « N » on the first and last row, and « Y » on the second one in
order to reflect this condition in LAT.
3- If screening tests are performed
Figure 12 : screening test for diphtheria done
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
23/52
o Answer « N » for the first two rows and « Y » on the last row (which
indicates specific screening test(s) that is being performed at the
laboratory).
Note: For other tests, several screening tests may be available. Answer « Y » for
each relevant screen tests being performed in the laboratory.
Once this section is finished, count the total number of diseases screened at the
laboratory and enters this number in the cell « B5 ».
Confirmation tests:
Answering these questions should be similar to the previous section. However,
note the following differences:
 It is not necessary to count the number of diseases screened in this
section.
 For each test, you must enter the number of tests performed in the past
year preceding the assessment.
Example 1: Bacillary Dysentery:
Figure 13 : confirmation test for dysenteria




If confirmation is performed answer « N » for the first two rows.
For the rest of the question, answer « Y » or « N » accordingly based on
the laboratory to identify specific tasks being performed for the test at the
laboratory (ex. culture, tube and gallery (API type), serotyping by
agglutination (sd1, flexneri, sonnei …)
If the laboratory performs antibiogramme (« AST »), answer « Y » as in
the Figure 12.
For #### section, fill in the number of bacillary dysentery tests
performed at the laboratory in the past year preceding the assessment.
Example 2: Tuberculosis (TB)
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
24/52
Figure 14 : confirmation test for tuberculosis not done
1. If the laboratory does not perform any TB tests it may be because of following
reasons:
1) The laboratory is too small (intermediate/periphery).
2) TB testing is not the main duty of the laboratory (reference laboratory
specializing in diseases other than TB).
For these two cases, answer « Y » for the first question and select « N » for the
rest of the questions.
2. If lack/shortage of reagents or equipment prevents the laboratory to perform
TB test, you should answer « Y » for the second question and « N » for the first
and rest of the questions in the section. Otherwise, answer « Y » or « N » based
on the laboratory.
12- Module 7: Laboratory staff & working time

Laboratory Staff
For this section, record the number of staff members in each category (specialty)
listed in LAT. Following are the relevant categories:
o Senior staff (doctor, biologists, pharmacist biologist, PhD., or
other high level scientists)
o Full time laboratory technicians
o Custodians and janitors or staff in charge of cleaning and
sterilizing
o Total number of staff including the number counted in the
previous three categories, as well as secretaries and stock
managers)

Staff Training
Use following parameters when answering questions in this section. For relevant
questions, if the laboratory meets these conditions, answer « Y ».
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
25/52
1) Formal on-site training: A training performed by professionals from
outside the laboratory. Official training certificates must be issued
following the training.
2) Training at a national laboratory level: a formal training should be carried
out by the laboratory responsible or by an external professional group.
Again, official training certificates must be issued following the training.
3) International training: Access to a relevant training for one or more staff
members at a location outside of the country.
4) Informal on-site training: Continuous internal review and training of the
technicians (ex. coproculture, malaria diagnosis, microscopy, etc.).

Test Selection
For this section, do not give the list of possible answer choices to the
respondent. Only provide these choices when the response is significantly
different from the three answer choices.

Opening days and hours
For this section, answer following questions accordingly:
o
Number of days the laboratory is operates in a week (for a
laboratory opened 5 days ½ per week, count as 5 days)
o
Number of hours the laboratory operates per day (this should be an
average)
o
Number of staff working overtime or outside the normal working
hours (usually relevant for laboratories associated with a hospital
that has a permanent nightshift positions)
o
Samples received after hours
NOTE: When entering the number of staff working overtime or working outside
the normal working hours consider the following:
1) Number of staff members present in the laboratory during the night shifts
at a hospital.
Or
2) In case of PHL (all the staff members work during normal operating
hours), enter only “1” if one laboratory personnel resides in a location less
than 30 minutes from the laboratory (to come to the lab in case of
emergency).

Procedures in handling specimen and samples received outside
the office hours)
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
26/52
Figure 15 : critical thinking toward samples during night and week end
These questions should only be answered if «The laboratory accepts specimens
after working hours? » question is answered « Y ». Again, this is to assess the
laboratory’s general procedure and the personnel’s critical thinking when
receiving the samples or specimen (CSF, blood, urine, and stool) after laboratory
operational hours. Do not give out the possible answer choices unless the answer
given by the respondent is significantly different from the choices available. Only
choose one answer in « Y » and rest in « N » for the relevant sample/specimen
being handled after operational hours of the laboratory. Answer « na » if the
sample/specimen is not handled after the operational hours of the laboratory
(figure 14.)
13- Module 8: Total quality
 Analysis procedures
Written procedures (printed or handwritten) have to be present in order to
answer « Y » at the first question
For the two other questions about language and accessibility of the procedure,
see page 16Error! Bookmark not defined.
For the first question in this section, you must verify whether or not the
laboratory being assessed has written analysis procedures (printed or
handwritten). If the laboratory is able to show you this document, answer « Y ».
Otherwise, answer « N ».
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
27/52
In answering next two questions in this section regarding the language and
accessibility, please refer to page 16.

Internal quality control (IQC)
Question numbers:
1. This question concerns availability of any WRITTEN or PRINTED list of
different IQC implemented by the laboratory. In order to answer « Y » for this
question, the laboratory must have at least two from the following set:
1) AST control with standardized strains
2) Culture media control
3) IQC for serology (both positive and negative control)
4) IQC for staining methods (Gram and other tests)
2. This question concerns availability of ATTC or other standardized strains. If
the laboratory possesses AT LEAST 3 ATCC strains (E. coli, S. aureus & P.
aeruginosa) or 3 other standardized strains (Pasteur, CDC, etc.), answer « Y »
for this question.
3. This question concerns assessment of the quality of AST at the laboratory. If
the laboratory performs WEEKLY assessment of the quality of AST with at least 3
strains, answer « Y ». If with 2 strains and/or monthly, answer « N ».
4. This question concerns the quality of any in-lab made culture media. If the
laboratory has an adequate system or procedure of testing sterility for any in-lab
made culture media, answer « Y »10.
5. For this question, if the laboratory uses BOTH negative and positive controls
for ANY serologic tests (including HIV tests and doctor tests), answer « Y ». If
this is not done in one of serologic tests, answer « N ».

External Quality control (EQC)
For this section, only answer « Y » for both questions (serology and bacteriology)
if the laboratory have participated in any EQC program for both serology and
bacteriology IN THE PAST 12 MONTHS. You must be able to verify this (by
asking for a certification or form). Answer « na » if each question is not relevant to the
laboratory (ex. Viral EQC in a bacteriological laboratory ( not applicable).

Availability of temperature charts
For questions in this section, answer based on what you observed ON THE DAY
OF THE ASSESSMENT. Temperature charts must be present in relevant
equipment in order to answer « Y » for each question.

Preventive maintenance of laboratory equipments
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
28/52
These set of questions are designed to assess how laboratory equipments are
maintained.
o Answer « Y » for the first question if the laboratory conducts
regular preventive maintenance on all of their equipments.
o Answer « Y » for the second question if there are written or printed
preventive maintenance procedures for each equipment available to
the laboratory staff.
o Answer « Y » for the third question if the laboratory has a
permanent staff member assigned for laboratory equipment
maintenance.
o Answer « Y » for the fourth question if the laboratory has various
contracts with private companies for regular maintenance of their
equipments.
o Answer « Y » only if each laboratory equipment has a maintenance
logbook. The maintenance logbook should be visible and located
near or at the equipment.

Regular Equipment Adjustments/Calibration
Following parameters should be met to answer « Y » for relevant question in this
section:
o Automatic pipette must be check and calibrated AT LEAST once a
year (for accuracy, precision, and lubrication)
o Kohler adjustment for microscopes must be performed every three
months.
o Spectrophotometers and ELISA readers must be checked and
calibrated AT LEASE once a year (for parasitic light, linearity, and
wavelength).
Note: these adjustments can be done by an external company for equipments
such as spectrophotometers and ELISA readers.

User manuals and spare parts
Following must be met in order to answer « Y » for relevant questions:
o AT LEAST 75% of all laboratory equipments must have a user
manual and these manuals should be in the common language of
the country
o A basic set of spare parts for each equipment must be available
inside the laboratory. Examples for this include:
 Microscope bulbs
 Incubator, distillatory or autoclaves resistors (?)
 A small stock of various fuse
 A basic tool box
 Etc.
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
29/52
14- Module 9: Reporting, analysis and communication
NOTE: for all yellow celled questions, please refer to section 6 (page 8) before
answering. Answer all the relevant questions in Y, N, or na.

General reporting
Please consider following when answering « Y » to each question in this section:
o
Efficient communication between disease surveillance services
and the laboratory (ex. Minimum weekly update of the list of
disease under surveillance diagnosed in the laboratory)
o
Presence of an updated list of priority disease and/or disease
under surveillance (this list should be available to all staff
members working in the laboratory and clearly displayed).
Guidelines regarding IDSR should also be available INSIDE the
laboratory.
o
Availability of a procedure clearly specifying how disease under
surveillance are reported
o
Availability of a standardized form for disease reporting (a simple
duplicable form which can be filled by hand is sufficient enough).
o
Availability of a standardized form for disease reporting in the
document archives.

Documentation of general laboratory activities
Please consider following when answering « Y » for questions in this section:
o A systemic use of laboratory logbook
o Documentation of basic analysis performed at the laboratory (ex. Number
of samples, number of positively identified samples, distribution of microorganisms, AMR sensitivity profiles, etc.)
o Availability of archived monthly summary of the laboratory activities (sent
on a monthly basis to the laboratory officials, including the laboratory
director and other relevant authorities of the laboratory).

Electronic recording of the data
NOTE: This section only concerns reference/level 3 laboratories. For other
laboratories (intermediate and peripheral level laboratories), answer « na » for
each question.
Please consider following when answering « Y » for questions in this section:
o Availability of electronic archive (in MS Word or MS Excel format) of
monthly summary of all laboratory activities.
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
30/52
o Availability of electronic archive (in MS Word, MS Excel, or PDF format) of
monthly summary of all laboratory activities to the laboratory officials.
o Regular back-up of the laboratory data (on floppy disk, CD, or USB data
storage). It is recommended to perform data back-up daily.

Sample referrals
NOTE: Questions in this section mainly concerned with smaller laboratories
(intermediate and peripheral level). However, in some cases, reference
laboratories may also refer samples to WHO CC or other international
laboratories. Answer « na » in this section if referral of the sample is not relevant
for the laboratory.
In answering questions in this section, ask the respondent if any samples,
including bacteriology samples, are sent to a reference laboratory for analysis. If
so, ask if they have special methods (or boxes) for this purpose. Answer
accordingly.

Supervision of the laboratory
In order to answer « Y » to these questions, relevant laboratories must be
supervised annually:
o By an intermediate or higher level laboratories for a peripheral laboratory
o By a reference laboratory for an intermediate laboratory
o By an international specialists (WHO, WHO CC labs, or other international
laboratories) or collaborative centers for a reference laboratory

Laboratory collaborations
Please consider following when answering « Y » for questions in this section:
o The laboratory has some sort of agreement with laboratories in the region
to share necessary reagents/media in case of emergency
o The laboratory has a correspondent for communication with supervising
party in case of emergency or question: (intermediate and peripheral
laboratories) for national level laboratories and (international laboratories
and WHO Collaborative Centers) for reference laboratories
o The laboratory accepts and manages samples/specimens from other
laboratories, if needed.
o The laboratory supervises lower level laboratories.
15- Module 10: outbreaks

General involvement during an outbreak
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
31/52
Please consider following parameters before answering « Y » for questions in this
section:
o The laboratory has at least one representative or correspondent for
organizing meetings/crisis committee during the epidemic control or in
case of an outbreak
o The laboratory have analyzed samples from AT LEAST two out breaks or 2
suspicion outbreaks (depends on the laboratory’s capacity level)

Sources of supplies during an outbreak
Answer in all applicable part in this section. If the question does not apply to the
lab (meaning the laboratory did not receive any supply during past 12 months
before the assessment from a specific organization) answer « N ». Answer « Y »
only if the laboratory received free reagents and other laboratory supplies AT
LEASE ONCE from relevant partners or organizations during the past 12 months
before today’s assessment.

Outbreak participation and investigation
Please consider the following guidelines before answering « Y » for questions in
this section:
o Has one or more laboratory staff (microbiologist or laboratory technician)
traveled to an outbreak location or participated in a field study for a
purpose of (possible) outbreak investigation in the past 2 years? If so,
answer « Y » for the first question.
o Has the laboratory been consulted for preparation/shipment/handling of
samples by other laboratories? IF so, answer « Y » for the second
question.
o Did the laboratory ever handle samples referred from other laboratories
located in an outbreak region during an outbreak? If so, answer « Y » for
the third question.
o In case of an outbreak in the region in which the laboratory is responsible,
has the laboratory referred its samples/specimens to a reference or other
laboratories for further analysis? If so, answer « Y » for the fourth
question.

Availability of specific guidelines for outbreaks
For this section, answer « Y » or « N » for only relevant questions. Feel free to
respond « na » if the question does not apply to the laboratory (ex. Plague in
Western Africa).
If answering « Y », you need to make sure that the laboratory has a specific
guideline for each relevant disease (Hemorrhagic fever, Plague, Cholera,
Meningitis) OR an IDSR guideline in INSIDE the laboratory.
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
32/52

Specific outbreak procedures
Please consider following parameters when answering questions in this section:
o Does the laboratory have specific procedures during an outbreak? (This
includes procedures for transporting media, organizing intervention teams,
and handling other emergencies during an outbreak). If so, answer « Y »
first question.
o Does the laboratory keep or document all samples received and tested
that are linked to an outbreak in a special logbook or in a mark them on a
regular logbook? If so, answer « Y » for second question.
o Do the laboratory personnel have an easy access to a contact person
other relevant staff members in case of an outbreak?
IF so, answer « Y » for the third question.

Critical thinking with samples in case of outbreak
Often, reagents are limiting factor in most laboratories when analyzing a large
number of samples. Because these samples may have similar result, this
question is designed to show whether or not the laboratory can save precious
resources if large number of samples arrive at the laboratory during an outbreak.
Similar to previous questions, assessing critical thinking of a laboratory
personnel, ask this question to the responding person WITHOUT giving him/her
the list of possible answers. If the respondent does not answer or does not
know the answer, answer « 1 ».
16- Analysis of the results and summary
 General overview in analyzing indicator summary
When analyzing results of the indicators, it is imperative to do this with the
respondent from the laboratory who has been working on this assessment with
you. This should be done at the end of the assessment and after entering all the
data in LAT.
NOTE: Discuss not only the weaknesses, but also the strengths of the laboratory
on which an improvement plan can be built
After analysis, highlight only the three most important indicators that need to be
implemented for the laboratory’s improvement in the future.
Figure 16 shows an example of the graphic representation of indicators in LAT
with background color ranging from red to green. This allows for you to easily
assess conditions of each indicator:
 Red: Below 50%, requires significant improvement
 Yellow: Between 50 and 85%, some improvement is necessary
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
33/52

Green: Above 85%, the laboratory is in good standing
Figure 16 : sheet containing all indicators and their graphic representation
 General indicator summary
For the summary of general indicator (located in the « Indicator Summary »
Sheet), it is possible to choose different modules in calculating the general
indicator of the laboratory. To choose specific modules, select « Y » or « N » in
the left corner (Figures 17-18). The default value is « Y ». Choosing « N » will
exclude that specific module for the final calculation (a simple average).
Figure 17: general indicator calculation, including the 10 modules
This calculation is an average of all modules or any combination of selected
modules. This allows you (the assessor) to figure out which indicator contributes
the most to the final summary this assessment. In other words, you can
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
34/52
graphically interpret which modules and how much of the particular module
needs to be improved in order to reach recommended overall level.
Figure 18: calculation of the general indicator without the modules 2 and 8
For an example, refer to the difference between Figure 18 and 19. In this
example assessment, we can find that biosafety and total quality (modules 2 and
8) contribute about 8% decrease in the general indicator
 Weighed indicators
When calculating the overall indicator for each module, LAT is also capable of
emphasizing and de-emphasizing the importance of specific indicator and its
contribution in the calculation of the overall indicator by means of weight
categories. LAT incorporates three weight categories (1: less important, 2:
important, 3: very important) which can be selected individually in a special
indicator summary page called “weighed indicator” sheet in LAT (Figure 17).
Default value is « 2 » (important).
3
2
4
1
Figure 19: weighted indicator sheet
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
35/52
This sheet summarizes the following:
 un-weighed indicators (1)
 both un-weighed (2) and weighed (3) module score
 weighing coefficients (4), « 2 » by default (important)
NOTE: in this worksheet, enter ONLY the coefficient value (1, 2 or 3). When
clicking on the arrow close to the cell, a list of the 3 coefficients is revealed
(figure 20). After entering all the coefficients, the new module summary (3) is
automatically calculated.
Figure 20: list of available coefficients
 Weighed general indicator summary
It is also possible to configure general indicator summary page to reflect the
relative importance of each module in the calculation of the general indicator.
Like the previous, there are also three choices (1: less important, 2: important,
3: very important) to reflect the relevant importance of each module in the
overall calculation of the general indicator. Hence, the result of general indicator
will change according to the weight adjustments for each module (Figure 22).
The default value is « 2 ». Please note that the reason for implementing this
system is to evaluate the overall indicator more accurately by prioritizing and
reflecting the most important modules in analyzing the assessment result.
Figure 21: general un-weighed indicator
Figure 22: difference in general un-weighed indicator and general weighed indicator.
Choosing same weight, for instance « 2 », will produce a result that is no
different from the un-weighed module summary (if no coefficient was attributed
to each indicator). Similar to the general summary page, you can also choose to
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
36/52
include or exclude specific module in the overall calculation of the general
indicator by choosing « Y » or « N » in the left corner. The default value is « Y ».
NOTE 1:
There is two weighing processes one after the other:
 For each indicator  module summary
 For each module summary  global indicator
NOTE 2: Upon the final review of LAT, each indicator will have specific weight
contribution to the overall calculation of the general indicator based on its
relevant importance. Once these parameters are set, weights for each indicator
and module will be locked and protected against changes, especially for the
version to be used in the actual laboratory assessment. However, an unlocked
version will be available for assessed laboratories and assessor for review and
perform additional analysis of the assessment results.
17- Un-protecting & Editing LAT
Each worksheet in LAT is protected against any modification. This is to avoid
performing wrong manipulation that may compromise calculation. Some
« boards » have been placed in certain locations to hid cells that are used for
calculations.
NOTE: To unprotect these worksheets in LAT, click on “tools” in the menu bar in
Excel to find “protection.” Then click “unprotect sheet” as shown in the diagram
below (Figure 18).
Figure 23 : active sheet unprotected
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
37/52
This will unprotect each worksheet in LAT and you may be able to move the
boards to reveal calculation section, add or delete questions, change indicator
calculations, or add/delete indicators.
CAUTION: In doing this task, first save your work in a different name so that
you may go back to the original file.
NOTE: your changes and improvements may be an interest to us as this is still a
developing project. We kindly ask you to send us your new version or revised
version to the following email addresses if possible:
 piersona@lyon.who.int
Figure 24 : right board un-removed
Figure 25 : right board removed once unprotected, calculations can be seen
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
38/52
Appendix 1: indicators calculation
1- Building facilities and utility service
*** BUIDLING CONDITIONS***
* for the next 3 questions, choose from following: 3-good,
2-medium, 1-bad
Condition of the roof
Condition of floors
Condition of walls
#
#
#
Indicator calculation:
Good  100%
Medium  50%
Bad  0%
Final indicator = average
*** FLUIDS CONDITIONS ***
What percentage of working hours are the following available?
ELECTRICITY
###
RUNNING WATER
###
Do you have an emergency electric generator or other back up power
source?
<Y>
Do you have a safe sewage disposal method?
<Y>
*** % OF BENCHED ROOM UTILIZED***
Rooms in the building
###
Number of laboratory rooms in current usage ###
Indicator calculation:
2 first questions  %
last one, yes = 100%,
no = 0%
Final indicator = average
Indicator calculation:
% of room utilized  first indicator =
# of benched rooms utilized/ # of
benched rooms available.
*** NUMBER OF BENCHED ROOMS
(LEVEL DPT.)***
Number of rooms with laboratory benches
###
Number of laboratory rooms in current
usage
###
Indicator calculation:
Level
100%
50%
>9
>6
>6
>4
>3
>2
* Final indicator = Average
1
2
3
*** COMMUNICATION (ACCESS TO INTERNET)***
Telephone
<Y>
Fax
<Y>
E-mail
<Y>
Regular mail service
<Y>
Computer (inside the laboratory)
<Y>
*** COMMUNICABLE DIEASE COVERAGE ***
Does the Laboratory perform following:
Bacteriology microscopy?
<Y>
0%
<6
<4
<2
Indicator calculation:
Final indicator = average
Indicator calculation
Calculation of normal workload, based
on the level of the laboratory
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
39/52
Bacteriology culture?
<Y>
Serological analysis?
<Y>
Virology culture?
<Y>
Parasitology analysis?
<Y>
Mycology microscopy and/or culture?
<Y>
Molecular biology analysis?
<Y>
Tuberculosis microscopy
<Y>
Tuberculosis culture
<Y>
level 3: all (total 9)
level 2: all except virology, molecular
biology (total 6)
level 1: bacteriology microscopy,
parasitology, mycology, and TB
bacilloscopy (total 4)
2- Biosafety, hygiene and security
*** USE OF SAFETY EQUIPMENT ***
Does the laboratory personnel/staff use following while working in the
laboratory? *choose from following: 1 never, 2 sometimes, 3 always
Labcoat?
Gloves?
Protective masks?
Protective glasses?
*Where are labcoats and laboratory linens washed?
1 home, 2 central lab, 3 outside laundry service
#
#
#
#
#
*** AVAILABILITY OF SAFETY PROCEDURES ***
For hand washing?
<Y>
For disinfection of contaminated materials? <Y>
For sterilization?
<Y>
For glassware and equipment washing?
<Y>
For waste disposal?
<Y>
For laboratory cleaning?
<Y>
For laboratory related injury?
<Y>
For fire emergency?
<Y>
For protection against specific infectious agents? <Y>
Indicator calculation
always  100%
sometimes  50%
never  0%
for clothes washing:
home  0%
other  100%
Final indicator =
average
Indicator calculation
Final indicator = average
*** LEVEL OF SAFETY TRAININGS ***
Security while manipulating laboratory samples
<Y>
Classification of different classes of micro-organisms
<Y>
Security while sampling
<Y>
Methods in packaging and triple-packaging of a sample <Y>
Using disinfectants and procedures in disinfections
<Y>
Proper waste management (handling hazardous and non hazardous
wastes)
<Y>
Indicator calculation:
Final indicator 
Average
*** SAFETY CONDITIONS ***
Indicator calculation
Do you regularly use liquid disinfectant (incl. HYPOCHLORITE) when
disinfecting the laboratory? <Y>
Do you have a sink for washing hands only?
<Y>
Are the benches solvents and chemicals resistant?
<Y>
Are the benches easily washable?
<Y>
Final indicator =
average
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
40/52
*** DISINFECTION/STERILIZATION OF EQUIPMENTS ***
Do you regularly disinfect your centrifuge?
<Y>
Do you regularly disinfect your incubators?
<Y>
Do you always use temperature strips for sterilization?
<Y>
Indicator calculation
Final indicator =
average
*** WASTE DISPOSALS ***
Do you have separate disposals for infectious and non-infectious wastes?
<Y>
Do you have covered waste disposal containers?
<Y>
Do you have safe waste containers
<Y>
Do you have special sharps containers
<Y>
Do you have dedicated waste for used solvents
<Y>
Indicator calculation
Final indicator =
average
*** AVAILABILITY OF BIOSAFETY DOCUMENTATION ***
Do you follow specific biosafety guideline?
<Y>
Do you have the WHO laboratory biosafety manual (3rd edition)? <Y>
Indicator calculation
Final indicator =
average
3-Specimen collection, handling and transportation
*** QUALITY OF SAMPLES RECEIVED ***
Do you encounter following problems when receiving samples?
Answer by: (3) never, (2) sometimes or (1) always?
WRONG PACKAGE
<A>
WRONG CONSERVATION
<A>
SAMPLES IN INADEQUATE MEDIA
<A>
WRONG IDENTIFICATION
<A>
DELAY IN SAMPLE DELIVERY
<A>
*** SAMPLING PROCEDURES ***
Stool sampling?
<Y>
Standard procedures for blood sampling?
<Y>
CSF sampling?
<Y>
Throat sampling?
<Y>
Are the procedures written in the most appropriate language? <Y>
Does the staff have an easy access to these procedures
<Y>
Are these procedures available to clinicians and non-laboratory staff
collecting the samples?<Y>
*** QUALITY OF SAMPLING REQUEST FORM ***
Does the lab provide standard request forms to order lab test?
<Y>
* If yes, does the form contain the following:
DATE of sample?
<Y>
TIME of sample?
<Y>
NAME of the patient?
<Y>
AGE of the patient?
<Y>
SEX of the patient?
<Y>
ADDRESS of the patient?
<Y>
TYPE OF SPECIMEN of the patient?
<Y>
TEMPERATURE of the patient?
<Y>
CLINICAL DETAILS of the patient?
<Y>
NAME OF THE SUBMITTING CLINICIAN?
<Y>
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
Indicator calculation
always  0%
sometimes  50%
never  100%
Final indicator = average
Indicator calculation
Final indicator = average
Indicator calculation:
If response to first question
= no  indicator = 0
Otherwise, final indicator =
average
41/52
*** CRITICAL THINKING ABOUT SAMPLES ***
What do you do if the requested information is not complete?
<A>
* 1 (TEST SAMPLE ANYWAY WITHOUT CONTACTING ANYBODY)
* 2 (NO ANALYSIS IS PERFORMED AND SAMPLE IS REJECTED)
* 3 (TRY TO CONTACT THE SENDER OR THE PATIENT)
Indicator calculation
1 and 3  0%
2  100%
*** QUALITY OF THE LOGBOOK ***
Do you have an unique identification number or system for locating
specimen?
<Y>
If YES, do you record by the NAME of the patient?
<Y>
by the AGE of the patient?
<Y>
by the SEX of the patient?
<Y>
by the ADDRESS of the patient?
<Y>
by the TEMPERATURE and/or the CLINICAL DETAILS of the patient? <Y>
by the NAME OF THE PRESCRIBER of the patient?
<Y>
by the TYPE of specimen?
<Y>
by the DATE of sampling?
<Y>
Indicator calculation
Final indicator =
average
*** MACROSCOPIC EXAMINATION ***
Do you perform macroscopic examination of the samples?
<Y>
Are the macroscopic examination results of the sample recorded?
<Y>
Indicator calculation
Final indicator =
average
*** SPECIMEN STORAGE ***
What do you usually do with the specimen after testing
<A>
* 1 (IMMEDIATE DESTRUCTION)
* 2 (KEEP 3-5 DAYS AND DESTRUCTION)
* 3 (OTHER)
Indicator calculation
1 = 0%
2 = 100%
3 = 100%
*** QUALITY OF SPECIMEN TRACKING ***
Do you keep track of the specimen or samples (specimen)
received?
<Y>
Are you able to easily find a previous result?
<Y>
* if yes, can you find the records of a specimen by:
Can you find it using the patient name?
<Y>
Can you find it using the sampling date?
<Y>
Can you find it using the results?
<Y>
Indicator calculation
Final indicator = average
4-Equipment
*** 1) MINIMAL FUNCT. EQUIP. 2)
OPTIMAL FUNCT. EQUIP. 3) BASIC
MINIMAL FUNCT. EQUIP.T 4) BASIC
OPTIMAL FUNCT EQUIP. ***
autoclave
basic scale
Indicator calculation: (level dpt.) in %
available
At the beginning of the assessment, a national
consensus on equipment by level has to be reached
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
42/52
binocular microscope
candle jar
CO2 incubator
computer + printer
centrifuge
electrophoresis equipment
ELISA equipment (W/I/R)
fluorescence microscope
freezer-20°
freezer-70°
fridge
gel pulse electrophoresis
glassware kit *
heated magnetic agitator
incubator, large
incubator, small
Internet connection (year)
manipulation box
McFarland photometer
media dispenser
oven
pH meter
automatic pipettes
Plexiglas screen
precision scale (electronic)
rotative agitator
safety cabinet class II
safety cabinet class III
thermocycler
vortex
distiller
waterbath
first.
The indicators will be then calculated depending on
this list
The basic equipment indicators will be calculated in
the same way but only these equipments will be
included in the calculation:
autoclave
basic scale
binocular microscope
candle jar
ELISA equipment (W/I/R)
freezer-20°
fridge
incubator (any types)
water distiller
waterbath
Glassware will be calculated based on following
ratings:
0- Don’t have any laboratory glassware
1- Shortage (laboratory glassware is available, but
not enough to cope
with the capacity of the laboratory).
2- Minimum (the laboratory has just enough
glassware for normal
operation).
3- Optimal (the laboratory has more than enough
glassware for its
capacity).
5-Reagents and supply
*** REAGENT PREPARATION FROM POWDER ***
Do you prepare reagents in the laboratory?
<Y>
Indicator calculation
Final indicator = average
of answers from Gram,
blood agar, Mc Conkey or
BCP media, and ‘quality
control’ questions.
*if YES, are the following media or reagents prepared from row
material or ready-to-use powders?
Gram staining
<Y>
Blood agar
<Y>
Mc Conkey or BCP media
<Y>
*if YES, do you quality control these home made reagents? <Y>
*** QUALITY OF REAGENT MANAGEMENT ***
Do you have stock cards for your reagents
<Y>
Do you manage your stock electronically
<Y>
Do you check regularly expiration dates of your reagents
Do you write the date of opening written on the reagents
Do you perform at least 2 yearly inventories of your stock
Indicator calculation
Final indicator = average
<Y>
<Y>
<Y>
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
43/52
*** AVAILABILITY OF FUNDS FOR REAGENTS ***
Do you have dedicated funds for your laboratory
Do you receive funds from MOH?
Do you receive funds from Public Health Authorities
Do you receive funds from cost-recovering
Do you receive funds from international cooperation?
*** USE OF EXPIRED REAGENTS ***
Do you use expired products and reagents?
(0 = regularly, 1 = sometimes, 2 = never)
<Y>
<Y>
<Y>
<Y>
<Y>
Indicator calculation
Final indicator =
average
Indicator calculation
0  0%
1  50%
2  100%
#
For all the next set of questions, following are calculation parameters:
*1:
*2:
*3:
*4:
always  100 %
sometimes (AT LEAST 6 MONTHS PER YEAR)  50% enteric
never, 0%
not applicable (not needed)  does not enter in the calculation
*** AVAILABILITY OF BASIC STAINING REAGENTS
***
Gram staining
#
Methylen blue staining
#
Giemsa staining
#
May Grünewald Giemsa or field staining
#
Ziehl staining
#
Lugol staining (iodine/iodure)
#
Indicator calculation
*** AVAILABILITY OF SPECIAL STAINING
REAGENTS ***
Trichrome staining
Lactophenol blue staining
Weber staining
China ink contrast (CSF)
Gomori Grocott staining
Indicator calculation
#
#
#
#
#
Final indicator = average
Final indicator = average
*** AVAILABILITY OF ENTERIC TRANSPORT AND
CULTURE MEDIA ***
Cary-Blair transport media
#
Alkaline peptone water transport media
#
Hektoen or other Salmonella-Shigella culture media
#
Mc Conkey culture media
#
TCBS culture media
#
*** MENINGITIS TRANSPORT AND CULTURE MEDIA ***
TransIsolate transport media
#
Blood agar culture media
#
Chocolate culture media
#
*** AVAILABILITY OF OTHER TRANSPORT AND
CULTURE MEDIA ***
Indicator calculation
Final indicator = average
Indicator calculation
Final indicator = average
Indicator calculation
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
44/52
Sabouraud culture media
Chapman culture media
Hemoculture bottle
Löwenstein-Jensen culture media
Brain heart broth or equivalent broth
#
#
#
#
#
Final indicator = average
*** AST REAGENTS AND CULTURE MEDIA ***
Muller Hinton 2 culture media
#
Plastic Petri dish for AST
#
Antibiotic disks for AST
#
Indicator calculation
Final indicator = average
*** AVAILABILITY OF SPECIFIC ANTISERA ***
Neisseria meningitidis
#
Salmonella spp.
#
Shigella spp.
#
Vibrio spp.
#
Staphylococcus spp.
#
Streptococcus spp.
#
Escherichia coli O157
#
Indicator calculation
Final indicator = average
*** AVAILABILITY OF SEROLOGY REAGENTS ***
Hepatitis A
#
Hepatitis B
#
Hepatitis C
#
HIV
#
Measles
#
Yellow fever
#
Viral hemorrhagic fever
#
Rubella
#
Indicator calculation
Note: not done for level 1
Final Indicator = average
6-Analysis and Test performed
*** AVAILABILITY OF SCREENING FOR TARGETED
DISEASES
AVAILABILITY OF REAGENTS FOR SCREENING
TESTS ***
*Screening tests for diphtheria
Non applicable
<Y>
Possible to do, but not done
<Y>
Sampling and Gram-staining
<Y>
Indicator calculation
*Screening tests for hepatitis B
Non applicable
Possible to do, but not done
Transaminasis
Other liver enzymes
For each disease:
 if the answer of ANY of the
screening test is “yes”, then the result
for the disease is 100%
 if NO screening test is available, the
result for the disease is 0%
 If the answer to any of the
screening tests (disease is not
screened by the laboratory) is “na”,
the answer will not be part of the
Indicator calculation.
*Screening tests for tuberculosis
Non applicable
Possible to do, but not done
Bacilloscopy on sputum (ZN)
Bacilloscopy on sputum (Auramin)
Bacilloscopy on gastric fluids
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
FIRST INDICATOR
This indicator will check the availability
of laboratories to perform screening
tests.
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
45/52
Bacilloscopy on urine
<Y>
*Screening tests for dysentery
Non applicable
Possible to do, but not done
Sampling and Gram-staining
Blood in stool checking
<Y>
<Y>
<Y>
<Y>
*Screening tests for w. diarrhoea
Non applicable
Possible to do, but not done
Sampling and Gram-staining
<Y>
<Y>
<Y>
*Screening tests for meningitis
Non applicable
Possible to do, but not done
Sampling and Gram-staining
Proteins & glucose dosage
WBC counting & differentiation
<Y>
<Y>
<Y>
<Y>
<Y>
*Screening tests for malaria
Non applicable
Possible to do, but not done
Sampling & Giemsa staining
<Y>
<Y>
<Y>
*Screening tests for leishmaniosis
Non applicable
Possible to do, but not done
Sampling the lesion and Giemsa Staining
Sampling bone narrow and Giemsa staining
*Screening tests for VHF
Non applicable
Basic coagulation tests (thromb, Quick ...)
*Screening tests for brucella
Non applicable
Sampling and Gram-staining
*Screening tests for plague
Non applicable
Sampling and Gram-staining
<Y>
<Y>
<Y>
<Y>
Final indicator = average of all “Y” or
“N” answered questions.
Targeted diseases:
Diphtheria
hepatitis B
tuberculosis
dysentery
w. diarrhea
meningitis
malaria
leishmaniosis
VHF
plague
If the disease is not a common disease
in the assessed country, it will not
count towards the calculation of the
indicator (ex: malaria in Belarus)
 If the answer to any of the
screening tests (disease is not
screened by the laboratory) is “na”,
the answer will not be part of the
Indicator calculation.
SECOND INDICATOR
% of responses “Possible to do, but
not done” that will give an idea of the
availabilities of reagents (for both
screening AND confirmation tests) on
THE DAY OF THE ASSESSMENT
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
*** AST AVAILABILITY
AVAILABILITY OF IDENTIFICATION
AVAILABILITY OF HIGH LEVEL IDENTIFICATION
AVAILABILITY OF VERY SPECIFIC TESTS ***
Indicator calculation
*Confirmation tests for diphtheria
Non applicable
Possible to do, but not done
Culture and tube identification
Culture and gallery identification
AST for diphtheria
Note: if N/A, it doesn’t count for
the indicator (so, lowest level will
not be penalized)
<Y>
<Y>
<Y>
<Y>
<Y>
 AST availability
diphtheria, dysentery, watery
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
46/52
Toxin checking
*Confirmation tests for measles
Non applicable
Possible to do, but not done
IgM serology on microplates
IgM automated immunoenzymatic serology
IgM radioimmunology serology
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
*Confirmation tests for hepatitis B
Non applicable
<Y>
Possible to do, but not done
<Y>
HbS Ag serology on microplates
<Y>
HbS Ag automated immunoenzymatic serology <Y>
HbS Ag radioimmunology serology
<Y>
Other Ag are checked
<Y>
*Confirmation tests for rubella
Non applicable
Possible to do, but not done
IgM serology on microplates
IgM automated immunoenzymatic serology
IgM radioimmunology serology
*Confirmation tests for tuberculosis
Non applicable
Possible to do, but not done
Culture on Löwenstein-Jensen media
Culture on Coletsos media
Culture on other media
Diagnosis by PCR
Direct AST on solid media
Indirect AST on solid media
AST on liquid media
*Confirmation tests for dysentery
Non applicable
Possible to do, but not done
Culture and tube identification
Culture and gallery identification
Immunotyping by agglutination
AST
*Confirmation tests for w. diarrhoea
Non applicable
Possible to do, but not done
Culture and tube identification
Culture and gallery identification
Immunotyping by agglutination
AST
*Confirmation tests for meningitis
Non applicable
Possible to do, but not done
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
diarrhea, plague, meningitis,
brucella
yes = 100%, no = 0%, indicator =
average
 indicator on identification:
diphtheria identification is OK if
tube OR gallery is OK
measles identification is OK if any
IgM is OK
B hepatitis identification is OK if
any Ag HbS is OK
Rubella identification is OK if any
IgM is OK
TB culture identification (all media)
Dysentery identification is OK if
tube OK gallery is OK
Watery diarrhea identification is OK
if tube OR gallery is OK
Plague serology (F1)
Meningitis identification is OK if
tube OK gallery is OK
Brucella basic agglutination (ASW
& rose bengale OK)
 indicator on high level
identification :
gallery ID diphtheria
Measles immunoenzymatic
hep B immunoenzymatic or RIA
rubella immunoenzymatic or RIA
Plague culture + ID
Gallery ID meningitis
Gallery ID dysenteriae
Gallery ID watery diarrhoea
Immunological techniques for
malaria
Leishmania serology
VHF serology
Brucella serology
 indicator on “specific tests”
diphtheria toxin
other Ag for B hep
TB PCR
TB AST (whatever could be the
technique)
Dysentery typing
Watery diarrhoea typing
Bacterial meningitis agglutination
Viral meningitis identification
Cell culture in virology
Antimalaria resistance techniques
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
47/52
Culture and tube identification
Culture and gallery identification
Immunotyping by agglutination (incl. W135)
AST
<Y>
Viral meningitis diagnosis by agglutination
Viral meningitis diagnosis by cell culture
<Y>
<Y>
<Y>
<Y>
<Y>
*Confirmation tests for malaria
Non applicable
<Y>
Possible to do, but not done
<Y>
Sampling & immuno. techniques (QBC or other) <Y>
Antimalaric resistance testing
<Y>
*Confirmation tests for leishmaniosis
Non applicable
Possible to do, but not done
Bone narrow culture
IFI serology
*Confirmation tests for VHF
Non applicable
Possible to do, but not done
Serology on microplates
Automated immunoenzymatic serology
Radioimmunology serology
*Confirmation tests for brucella
Non applicable
Possible to do, but not done
Culture and identification
Serology on tube (ASW)
Rose-Bengal serology
IFI serology
ELISA serology
AST
*Confirmation tests for plague
Non applicable
Possible to do, but not done
Serology
Culture and tube identification
Culture and gallery identification
AST
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
7-Laboratory staff & working time
*** PRESENCE OF A SENIOR STAFF
% OF SENIOR STAFF
PRESENCE OF CLEANING STAFF ***
Indicator calculation
For all communicable disease units:
How many high level laboratory staffs do you have working
in your lab?
###
 PRESENCE OF A SENIOR STAFF
nb senior staff >0
 % OF SENIOR STAFF
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
48/52
How many laboratory technician do you have working in
your lab?
###
How many janitors (cleaning staff) do you have working in
your lab?
###
What is the total of your staff
###
*** STAFF TRAINING ***
 AVAILABILITY OF STAFF TRAINING
 AVAILABILITY OF FORMAL TRAINING
*in the past three years has the laboratory conducted the
following:
A formal training on site?
<Y>
A formal training at the national laboratory?
<Y>
A formal training at international lab?
<Y>
Any informal training on site?
<Y>
if > 15 %  100%
if 5-15%  50%
if <5%  0%
 PRESENCE OF CLEANING
STAFF
nb cleaning staff >0
Final indicator = average
Indicator calculation
any “yes”  100%
any “yes” at the 3 first questions
 100 %
other way 0%
Final indicator = average
*** ANALYSIS DECISION ***
Indicator calculation
for the next 3 questions: 1 prescriber, 2 lab responsible (director or
high level staff), 3 technician, 4 other
Who decides which tests to perform for the samples
#
Who makes decisions for further tests
#
Who reviews the results before to sent to the clinicians
#
If the response is
“prescriber” or
“responsible”  100%
Other way  0%
Final indicator = average
*** WORKING HOURS AND DAYS OF WORK ***
How many days per week do the laboratory staff required to
work?
#
How many hours does the laboratory operate per day?
##
On average, how many laboratory staffs work overtime? ##
Does the laboratory accept specimen after regular opening hours?
<Y>
Indicator calculation
>= 6 days  100%, 5 days
 50%
>= 12 hours  100%, 10
hours  50%
>0  100%
“yes” = 100%
Final indicator = average
*** CRITICAL THINKING OUTSIDE WORKING HOURS
***
*Answer the questions below concerning specimen handling
(Answer all based on the type of samples arriving beyond
regular hours). Answer Y or N based on how the sample is
handed.
*** CSF ***
Are CSF samples plated immediately?
or stored at 4C
or maintained at ambient temperature
or stored at 35C
*** BLOOD***
Are BLOOD samples plated immediately?
or stored at 4C
or maintained at ambient temperature
or stored at 35C
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
Indicator calculation
CSF HANDLING
100% if plated, 50% if at 35°
BLOOD HANDLING
100% if plated, 50% if at 35°
URINE HANDLING
100% if plated, 50% if at 4°
STOOL HANDLING
100% if plated, 50% if at 4°
other responses = 0%
Final indicator = average
49/52
*** URINE ***
Are urine samples plated immediately?
or stored at 4C
or maintained at ambient temperature
or stored at 35C
*** STOOL***
Are the stools plated immediately?
or stored at 4C
or maintained at ambient temperature
or stored at 35C
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
<Y>
8-Total quality
*** AVAILABILITY OF TECHNICAL PROCEDURES ***
Do you have any written standard protocols or guidelines for sample
analysis procedures <Y>
Are procedures written in a language everybody at the laboratory can
easily understand? <Y>
Do the staff members have an easy access to these procedures
<Y>
*** AVAILABILITY OF IQC ***
Do you have a clear policy and procedures for performing IQC? <Y>
Do you use registered strain (ex. From ATCC) for IQC?
<Y>
Do you check the quality of AT LEAST 3 AST strains weekly?
<Y>
Do you perform sterility tests for every batch of the lab made culture
media?
<Y>
Do you use positive/negative control for EVERY serology tests?
<Y>
Indicator calculation
Final indicator =
average
Indicator calculation
Final indicator =
average
*** AVILABILITY OF EQC ***
Has the laboratory participated in any EQC program (for at least
two consecutive years)?
in bacteriology?
<Y>
in serology?
<Y>
Indicator calculation
Final indicator = Average of
answers from bacteriology
and serology.
***AVAILABILITY OF TEMPERATURE CHARTS ***
Do you have temperature chart for fridge
<Y>
Do you have temperature chart for freezers
<Y>
Do you have temperature chart for incubators
<Y>
Do you have temperature chart for autoclave
<Y>
Indicator calculation
Final indicator = average
*** PERFORMING OF PREVENTIVE MAINTENANCE ***
Do you perform preventive maintenance of your equipments? <Y>
Do you have written SOP's for each equipment?
<Y>
Do you have a staff in charge to repair equipments?
<Y>
Do you have a contract with a private company for preventive
maintenance?
<Y>
Do you have a maintenance log book for your equipments? <Y>
*** PERFORMING OF EQUIPMENT ADJUSTMENTS ***
* Do you (or an external company) regularly check :
automatic pipettes (accuracy, precision, repeatability)? <Y>
Kohler centering of your microscope?
<Y>
Spectrophotometer / ELISA reader?
<Y>
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
Indicator calculation
Final indicator =
average
Indicator calculation
Final indicator = average
50/52
*** AVAILABILITY OF DOCUMENTATION AND SPARE PARTS
***
Do you have user manual for all of your equipments?
<Y>
Are the manuals available in the common language used at the
laboratory?
<Y>
Do you have a small stock of spare parts (lamps, fuse, filters ...)? <Y>
Indicator calculation
Final indicator =
average
9-Reporting, analysis & communication
*** AVAILABILITY OF DISEASE REPORTING ***
Do you report the infectious diseases you have diagnosed to other
institutions?
<Y>
Is the list of the diseases you must report available in the laboratory for the
staff? <Y>
Is there a document or protocol regulating reporting procedures?
<Y>
Is there a standardized form to report lab results?
<Y>
Do you keep a record of these notification
<Y>
Indicator
calculation
Final indicator =
average
*** AVAILABILITY OF ACTIVITY RECORDING ***
Do you record all the activities of your laboratory in a logbook? <Y>
Do you perform basic analysis of your data?
<Y>
Do you prepare monthly summary report?
<Y>
Do you send/discuss these reports to/with the authorities?
<Y>
Indicator calculation
Final indicator =
average
*** AVAILABILITY OF ELECTRONIC ACTIVITY RECORDING
***
Do you record all the activities of your laboratory electronically? <Y>
Do you prepare reports in an electronic format? (PDF, doc, etc.) <Y>
Do you regularly backup of your electronic data?
<Y>
Indicator calculation
*** AVAILABILITY OF SAMPLE REFERRING ***
Does your laboratory refer bacteriology or other samples to a
reference labs?
<Y>
Do you have special boxes and procedures specifically for referring
samples?
<Y>
When you refer a sample, do you receive the result back?
<Y>
*** LABORATORY SUPERVISION ***
Are you supervised by other labs or other external companies
(at least yearly)?
<Y>
When supervised, do you always receive the report after each
supervision?
<Y>
Indicator calculation
Final indicator = average
Indicator calculation
Final indicator = average
*** AVAILABILITY OF LAB/LAB COLLABORATION ***
Do you exchange reagents with other lab in case of shortage? <Y>
Do you receive some advice or support from an other lab in case of
problems?
<Y>
Does your laboratory receive samples from other laboratories? <Y>
Do you regularly supervise other laboratories?
<Y>
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
ONLY for level 1 and 2
Final indicator =
average
Indicator calculation
Final indicator = average
51/52
10- Outbreak participation
*** INVOLVEMENT DURING OUTBREAKS ***
Is the lab. part of the crisis committee for epidemic preparedness &
resp. <Y>
Did you participate in any outbreak investigations during the past year?
<Y>
Indicator calculation
Final indicator =
average
*** SPECIFIC OUTBREAK SUPPLY ***
Do you receive (specific) emergency supplies in case of outbreak?
<Y>
from your government
<Y>
from NGOs
<Y>
from WHO
<Y>
from other international agencies
<Y>
Indicator calculation
Final indicator =
average
*** OUTBREAK PARTICIPATION ***
Do you participate in field investigation?
<Y>
Do you give advice on how to collect specimens to other labs?<Y>
Do you receive specimens from the field during an outbreak
investigation? <Y>
Do you prepare and send specimens to reference laboratories? <Y>
*** SPECIFIC OUTBREAK GUIDELINES ***
Do you have IDSR guide for HAEMORRAGIC FEVER?<Y>
Do you have IDSR guideline for PLAGUE?
<Y>
Do you have IDSR guideline for CHOLERA?
<Y>
Do you have IDSR guideline for MENINGITIS?
<Y>
Indicator calculation
Note: only relevant for African labs
Final indicator = average
*** SPECIFIC OUTBREAK PROCEDURES ***
Do you have a specific procedure in case of outbreak?
<Y>
Do you have a specific record logbook for outbreak investigation? <Y>
Do you know who you have to informed if you diagnose a specific
disease?<Y>
*** CRITICAL THINKING WITH OUTBREAK
SPECIMENS ***
* If you receive 50 similar stool specimens
from the same area, what do you do?
<A>
*1 Test them all
*2 randomly choose 10 for testing
*3 Test the first 10 specimens
Indicator calculation
Final indicator =
average
Indicator calculation
Final indicator =
average
Indicator calculation
2 = 100%
3 = 50%
1= 0%
User Manual, Laboratory Assessment Tool, WHO/CSR/Lyon, August 2004
52/52