Laboratory
Quality Management System
Assessment Tool
User Manual
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a - Introduction
The Laboratory Quality Management System Assessment Tool (LQMSAT) is available
on the Excel file “Laboratory QMS Assessment Tool.xls”. This document is the user
manual of the Excel file.
The Laboratory Quality Management System Assessment Tool is an evaluation tool
designed to:
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assess any individual laboratory in a standardized way with regards to the
implementation of a Quality Management System
automatically generate numerical indicators related to the laboratory
capacities and quality in different parts called «modules»
follow the improvement of the same laboratory over time
perform an evaluation based on the technical and management requirements
expected according to the level of the laboratory (reference, intermediate,
periphery)
The tool is an all-purpose assessment tool that can be used to assess laboratories
with different specialties and from different levels of the health system (from basic
peripheral level to specialized central level). Recommended tests and instruments
may vary from one country to another. It is the assessor’s responsibility to compare
the practice in the assessed laboratory with the national recommended practices or
regulations. In case such regulations do not exist, the assessor needs to compare the
observed practices with the state of art in similar settings or with the international
recommendations (WHO, scientific societies, and literature). The tool can also be
adapted to include some specific questions according to the purpose or scope of the
assessment (refer to the section “editing the tool”).
The current edition of the assessment tool is a Microsoft Excel® file, and is run only
using calculations (no macros). Absence of macros enables the LQMSAT to be used
on any computer, independent of the operating system language.
b - Presentation of the tool
The file includes fourteen worksheets, titled in English. Altering or renaming of these
titles may result in calculation error and possibly compromise the interpretation
of the data.
A laboratory offers adequate services only if its results are delivered in a safe,
reliable, and timely manner. Therefore, the main objectives of the tool are to
describe and assess objective elements that contribute to the capacity, performance,
and quality of the laboratory. Quality requirements have been described widely these
last years, by various organizations. Some of the most popular and used documents
are the ISO standard 15189:20071 and the CLSI GP26-A3 guidelines2. These
documents describe the essential technical and management requirements that
ensure that the laboratory is functioning well and delivers quality results. These
documents are very comprehensive and used widely by inspection teams or
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ISO 15189:2007. Medical laboratories- Particular requirements for quality and competence
GP26-A3 Vol. 24 No.36. Application of a Quality Management System Model for Laboratory
Services; Approved Guideline – Third Edition. Clinical and Laboratory Standards Institute.
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accreditation bodies to design assessment checklists34. Some countries have adapted
these comprehensive documents, extracting the most relevant items for their local
purpose5.
The proposed assessment tool is based on the 12 quality essentials described by the
CLSI. These essentials are very similar to the elements described in the ISO 15189
standard, even if organized in a different manner. These essentials apply to simple
and complex laboratory operations. Therefore, the assessment tool can be used to
assess a wide spectrum of laboratories, such as multi-disciplinary or specialized in
one discipline or even one disease.
Figure 1: The various worksheets
Titles and descriptions of each worksheet:
 Assessment results modules
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Summary: A full summary of evaluation and assessment of the laboratory
with LQMSAT. Two pages when printed.
All indicators: A summary of the evaluation of each indicator. One page
when printed.
 Specific Modules
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1-Lab identification: this module gathers information concerning the
laboratory being assessed and the respondent. The tests (type and number)
must also be indicated.
2-Personnel: this module includes questions related to staff management.
3-Documents and records: this module deals with the management of all
the documents handled by the laboratory: procedures, forms, reports etc.
4-Purchasing and inventory (of services and supplies): this module
gathers information on the reagents and supplies purchased or prepared by
the laboratory (e.g., stock management). The module also includes questions
concerning other services contracted by the laboratory, such as the referral of
samples to other laboratories.
5-Equipment: this module assesses and lists the laboratory equipment and
its maintenance.
6-Process control (quality of pre-, post- and examination
procedures): this module reviews most of the operations and quality
requirements during the preexamination phase (sample collection), the
examination phase (internal quality control, written procedures) and the
postexamination phase (release of results, storage of samples).
7-Information management: this module examines the laboratory results
and data management and reporting.
Check-list standard pour l’accréditation de laboratoires médicaux selon ISO/CEI 17025
(1999) respectivement ISO 15189 (2003). Swiss Accreditation Service.
http://www.seco.admin.ch/sas
4 A Guidance Document for the Application of ISO 15189:2003 to Medical Laboratories.
Caribbean Laboratory Accreditation Service. 2004.
http://www.carec.org/pdf/accreditation_guidelines_april_2004.pdf
5 Quality Standards in Health Laboratories. Implementation in Thailand: A Novel Approach.
SEA-HLM-386. World Health Organization. 2005.
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8-Assessment: this module deals with the internal on-site assessments
(audit), external on-site assessment visits, and other interlaboratory
comparisons through the participation to external quality assessment
schemes (e.g. proficiency-testing schemes) or rechecking systems.
9-Occurrence management, process improvement, and customer
service: this module reviews how the errors are detected and monitored, and
how corrective actions are implemented for a continuous improvement of the
laboratory performance.
10-Facility and safety: this module assesses the infrastructure conditions
and the biosafety measures.
 Language
The LQMSAT can be used either in English or in other languages. Its initial language
is English. Prior to switching languages, other fonts may need to be installed on your
computer.
To switch from English to another language, do the following:
1) Select worksheet names “language”
2) Translate the English words in the other language in column D (just as the French
example)
3) Toggle the cell number B3 from “1” (English) to “2” (other language).
Any modification to the wording in the modules worksheets should be done
ONLY in this sheet as the cells of the other modules reports to the
“Language” sheet.
c- The assessment process
IMPORTANT NOTE: It is necessary that the assessment is carried out by a
laboratory specialist or a person who has in-depth knowledge 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.
In addition to using the electronic and paper version of LQMSAT, it is pertinent to
have a notebook and a camera (ideally digital) for documentation.
2) Approach to the assessment and securing cooperation from
the laboratory
Before you begin the assessment of the laboratory, it is recommended that the
assessor explains the main purpose of the assessment. He/she must point out that
this is not a control process that may lead to punitive measures.
3) Assessment procedures and guidelines
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The assessment should begin with a short meeting with the laboratory manager or
whoever is in charge in order to describe why the assessment will be conducted,
what the process will be and what the expected outcome might be. This meeting
could be useful to get some information about the laboratory organization and many
management items (staff, procurement of equipment, financing, etc…).
After the preliminary meeting, the assessor should visit the laboratory, following the
“sample path”:
 sample or patient reception
 sampling rooms
 recording
 technical rooms (microscopy, chemistry, hematology, culture, bacteriology,
serology, molecular biology)
 support rooms (glassware washing room, sterilization, restroom, guard room,
stock room, repair room, secretary room, offices)
The assessor should look at the global cleanliness, the global organization, biosafety
level while manipulating samples.
In each room (if applicable), the assessor may be required to perform the following
tasks:
 Inspect the condition and use of refrigerators
1) Are the refrigerators clean?
2) Randomly take 3 or 4 old-looking products and inspect their expiration
dates.
3) Is there an internal thermometer available? If not, are there any
temperature charts?
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Inspect the condition and organization of incubators
1) Look at the thermostat adjustments and daily temperature chart records
of each incubator (ideally, it is recommended to have a thermometer
inside a water can in the incubator)
2) Inspect the overall cleanliness of the incubator
3) Inspect the maintenance of special atmospheres (e.g., 5% CO 2, anaerobic,
micro-aerophilic conditions)
4) Inspect blood culture bottles Are there any old bottles? Do all the bottles
have identifications?
5) Inspect the organization of Petri dishes  Are there any old Petri dishes?
Do all of Petri dishes have identifications?
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Inspect the condition and organization of freezers  How is the sera collection
organized?
Check the conditions of all the other equipment (use, maintenance…)
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 reagents on the shelves
Inspect the laboratory logbooks, patient records or information (inspect if
they correspond to the right patient), and management of the results
Inspect the archives
Inspect the condition of the microscopes: always assess one or two slides in
order to check: 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 technologists work
1) Do they use personal protective equipment, e.g., lab coats, gloves,
glasses, masks? (Is Personal Protective Equipment available?)
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2) Is the bench clean? Do technologists disinfect the bench at the end of
their work? Is regular disinfection of the laboratory bench likely?
Inspect and evaluate how the laboratory waste is managed inside technical
rooms. This is important information as it will tell about the laboratory’s
activities within the past 24 hours of the assessment.
1) Is the waste regularly emptied?
2) Are there separate waste (lid-covered?) containers for noncontaminated
and contaminated wastes?
3) Is there a special solvent container (any for acids?)
Recommendations should be made following the observation and inspection. It is
important to note that assessments are performed 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. Comments that may be quite embarrassing or upsetting for the
laboratory should only be mentioned to the manager of the laboratory (or the person
in charge).
During the visit, document the assessment by taking pictures of the rooms, working
staff, equipment, packaging delivery procedures, etc. These pictures will help to
illustrate and explain the conditions of the laboratory for the final report. Always ask
for permission to take photographs.
Once the initial visual evaluation of the laboratory is completed, immediate
assessment of the laboratory using LQMSAT is recommended. The assessor can
initially use the paper version of the tool for his convenience, but it is recommended
to directly use the electronic version. Using the electronic version enables immediate
discussions with the manager about the indicators of LQMSAT questions.
Recommendations for improvement of the laboratory can be made following the
discussions. The assessor does not have to ask all the questions and can enter
directly some answers according to the observations made during the visit. The
assessor should ask only the questions to be highlighted (for instance for an
educational purpose) or the questions for which the visit cannot give clear answers.
The following aspects are recommended to be noted at the conclusion of the
assessment:
 Strengths of the laboratory, in order to highlight positive aspects of the
laboratory
 Weaknesses of the laboratory in order to highlight future actions for
improvement of the laboratory
IMPORTANT: the observations are kept confidential. Establishing a confidential
climate will make the assessment flow easier.
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d- General recommendations for completing each
module
General rule: all gray cells of the sheets “Lab ID” to sheet #10 must be filled in.
For each question, and for the entire tool, the assessor has a limited number of
possible answers:
 « Y » for yes
 « N » for no
 « na » for « non applicable », should be entered if the question doesn’t apply
to the laboratory.
 « 1, 2, 3, 4 or 5 » for questions with different possible answers
 Different values other than those above can entered when asking:
o Number of equipment
o Number of tests performed weekly
o etc.
Figure 2: Limited possibility for answers (here Y, N and na)
Clicking the small arrow at the right side of the cell opens a box with authorized
values. Error message will appear as below, when trying to enter values other than
the ones listed in the drop down list:
Figure 3 : Error message in case of unauthorized value
Hence, THE ASSESSOR CAN ONLY ENTER AN AUTHORIZED VALUE IN THE
LISTBOX.
IMPORTANT NOTE:
If the assessor thinks that the answer to the question applies to both Y and N,
he/she must SYSTEMATICALLY choose the most accurate answer of the two.
Examples:
1) If the answer is « yes » in few cases but « no », for most cases, the assessor has
to choose « no ». This systematic « rigorousness » will allow the observations made
by different assessors more comparable.
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e- Calculations of the indicators
Calculations of modules indicators are automatically performed when answering to
each question.
The calculations are based on the following principles:
- answering Yes (“Y”) gives 1 point (or “100%”)to the question
- answering No (“No”) gives 0 (or “0%”) point to the question
- answering Not applicable “na” excludes the question from the calculation
- for some questions, the respondent can choose between other options
such as “regularly”, “sometimes” or “never”, “bad”, “medium” or “good”.
In that case, answering each answer can give the following scores:
Regularly
Sometimes
Never
Bad
Medium
Good
0 point = 0%
0.5 point = 50%
1 point = 100%
0 point = 0%
0.5 point = 50%
1 point = 100%
The indicator is calculated from the average of all the questions and appears usually
at the top in the cell D2 (or E2). Calculations can be seen on the right hand of the
questions columns. They are hidden by a white panel that should moved away after
the sheet is unprotected (see below section g-editing the tool).
Figure 4 shows the calculations for module 1.
Figure 4 : Calculations
f- Analysis of the results and summary
 General overview in analyzing indicator summary
The analysis of the results of the indicators should be done with the manager of the
laboratory who has been collaborating in this assessment. This should be done at the
end of the assessment and after entering all the data in the LQMSAT.
NOTE: the assessor should discuss not only the weaknesses, but also the strengths
of the laboratory on which an improvement plan can be built.
After analysis, the assessor should highlight only the three most important indicators
that need to be implemented for the laboratory’s improvement in the future.
Figure 5 shows an example of the graphic representation of indicators in the LQMSAT
with background color ranging from red to green. This allows the assessor to easily
assess conditions of each indicator:
 Red: Below 50%, requires significant improvement
 Yellow: Between 50 and 80%, some improvement is necessary
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Green: Above 80%, the laboratory is in good standing
Figure 5 : “All indicators” worksheet.
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General indicator summary
This calculation is an average of all modules. It is reported both in the “all indicators
sheet” and the “summary” sheet.
g- editing the tool
Each worksheet in the LQMSAT is protected against any modification. This is to avoid
performing incorrect manipulations that may compromise calculation. Some white
« panels » have been placed in certain locations to hide cells that are used for
calculations, particularly on the right hand of the grey cells.
NOTE: To unprotect these worksheets in LQMSAT, click on “tools” in the menu bar in
Excel to find “protection.” Then click “unprotect sheet” as shown in the diagram
below (Figure 6).
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Figure 6: active sheet unprotected.
This will unprotect each worksheet in the LQMSAT and the assessor may be able to
move the white panels to reveal calculation section, add or delete questions, change
indicator calculations, or add/delete indicators.
CAUTION: In doing this task, the assessor must first save his/her work in a different
name so that he/she may go back to the original file.
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