Laboratory assessment report

Number of tests performed weekly

Name of the laboratory Test Clinical chemistry 0
Telephone 111111111 Haematology & hemostasis 0
Fax 222222222 Parasitology - Mycology 0
E-mail sdd@ffdfdf.com Bacteriology (except serology) 0
Virology (except serology) 1
Date of the assessment 39490 Viral serology 1
Name of the laboratory director Pr CDWDDV Bacterial serology 0
Name of the respondent Dr wdfwdff Toxicology 0
Name of the assessor(s) Dr DSDF Histopathology 0
Visit number 2 Human genetics 1
Food analysis (microbiology) 1
Level of laboratory intermediate Food analysis (chemicals or others) 1
Affiliation/ type of laboratory Hospital Water analysis 1
Veterinary microbiology 1
Veterinary testing (others) 1
General indicator 52% Other environmental testing (air, soil) 1

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
1. Organisation and Management 25%
1. Organisation and Management 25%
2. Personnel 60%
2. Personnel 60%
3. Documents and records 50%
3. Documents and records 50%
4. Purchasing and inventory 77%
4. Purchasing and inventory 77%
5. Equipment 63%
5. Equipment 63%
6. Process control 42%
6. Process control 42%
7. Information management 50%
7. Information management 50%
8. Assessment 100%
8. Assessment 100%
9. Process improvement 0%
0%
9. Process improvement
10. Facility and safety 50% 10. Facility and safety 50%

1
General comments on the assessment Conclusions and recommendations

Insert photographs below

2
Score for each module

1. Organization and Management 25%

2. Personnel 60%
3. Documents and records 50%
4. Purchasing and inventory (of services and supplies) 77%
5. Equipment 63%
6. Process control (quality of pre-, post-, and examination procedures) 42%
7. Information management 50%
8. Assessment 100%
9. Occurrence management, process improvement, & customer service 0%
10. Facility and safety 50%

General indicator 52%

 Tests performed in the laboratory
Laboratory identification (indicate the number of tests
performed weekly):

Name of the laboratory Test Clinical chemistry 0

Telephone 111111111 Haematology & hemostasis 0

Fax 222222222 Parasitology - Mycology 0

E-mail sdd@ffdfdf.com Bacteriology (except serology) 0

Virology (except serology) 1

Date of the assessment 2/12/2008 Viral serology 1

Name of the laboratory director Pr CDWDDV Bacterial serology 0

Name of the respondent Dr wdfwdff Toxicology 0

Name of the assessor(s) Dr DSDF Histopathology 0

Visit number 2 Human genetics 1

Food analysis (microbiology) 1

Level of laboratory intermediate Food analysis (chemicals or others) 1

Affiliation/ type of laboratory Hospital Water analysis 1

Number of managers (post-graduate degree) 2 Veterinary microbiology 1

Number of laboratory technologists 5 Veterinary testing (others) 1

Other environmental testing (air, soil) 1

4
1. Organization and Management

1.1 The organizational and management structure and its relationship with any other organization is documented N

1.2. A quality manual describing the quality management system policy and the procedures is available N

1.3. A quality manager is designated Y

1.4. The management designs, implements, maintains and improves a quality management system N

5
 0% 25%

0%

100%

0%

6
2. Personnel

2.1. Job descriptions defining qualifications and duties are available Y

2.2. The staff having executive responsibility has the appropriate qualifications and competence Y

2.3. There are adequate staff resources to undertake the required work N

2.4. Qualifications, training and experience of staff are recorded Y

2.5. Continuing education (training, workshop, conference…) has been provided to all staff members in the last 12 months N
3. Documents and records

3.1. The operating documents (instructions, operating procedures, bench aids) are written by the laboratory
na
staff to fit the local context

3.2. The document format is standardized (standardized headers, page numbering…) Y

3.3. A document and record control system is in place (i.e. documents listed, numbered, approved & signed,
N
reviewed periodically, archived)
3.4. Records (patients and quality control results, instruments print outs, worksheets…) are retained for at
na
least 2 years and archived in a suitable environment
4. Purchasing and inventory (of services and supplies)

4.1. The services provided by the laboratory to its customers (e.g patients, health care bodies, insurance
Y
companies) are described in up-to-date contracts

4.2. The laboratory refers specimens to other laboratories when testing is not available Y

4.3. A list of referral laboratories is maintained N

4.4. A register of all referred specimens (with duplicates of results) is maintained Y

4.5. The laboratory has appropriate packages for referring samples (triple package if air transport, or any
Y
package in conformity with local regulation)

4.6. The person(s) in charge of shipment by air courier is certified for the transport of infectious substances na

4.7. A list of manufacturers and suppliers, and catalogs of reagents are available Y

4.8. The purchase of supplies, consumables, reagents or services is recorded and the record maintained for a
Y
minimum of 2 years
4.9. The new reagents (new product, new lot, including home-made reagents) that affect the quality of
N
testing are verified against old reagents or reference materials before use
4.10. A supplies and reagents inventory system provides at least the following information: quantities, date of
na
receipt, lot numbers, date the material is placed in service

4.11. The laboratory experiences shortage of reagents and supplies: 1 = regularly, 2 = sometimes, 3 = never 3

4.12. The laboratory uses expired products and reagents: 1 = regularly, 2 = sometimes, 3 = never 3
4.13. Disposables supplies (e.g. tips, plastic pipettes) are reused: 1 = regularly, 2 = sometimes, 3 = never 2
5. Equipment

5.1. The adequate equipment is in place Y

5.2. The up-to-date instructions on the use and maintenance of equipment (manufacturer manual,
N
procedures) are readily available to the laboratory personnel

5.3. A preventive maintenance programme is in place and documented Y

5.4. The following information is recorded for each instrument: identity, serial number, manufacturer
information, date of receipt, location, condition (new, used..), performance records (calibration, checks), N
maintenance (past and planned), damages and repairs

5.5. The defective equipment is taken out of service and labelled appropriately Y

5.6. The laboratory has a list of available external maintenance and repairing services N

5.7. The equipment is maintained in a safe working condition (including electrical safety) Y

5.8. There is a daily monitoring record of the temperature of refrigerators, freezers and incubators (if any) Y
Enter the number of FUNCTIONING equipment

Centrifuge, refrigerated
Centrifuge, simple
Fluorimeter
Freezer -18°
Freezer -70°
Refrigerator
Incubator
CO2 incubator
pHmeter
UV/visible spectrophotometer
Colorimeter
Turbidimeter
Coagulometer
Flame photometer
Immunoassays automated analyser
Chemistry analyser
Haematology automated analyser
Flow cytometer
Automated Blood culture incubator
Automated microbial identification and susceptibility testing systems
Semi-automated microbial identification or susceptibility testing systems (strips reader)
Hematocrit centrifuge
Autoclave
Binocular microscope
Candle jar
Electrophoresis equipment
ELISA equipment (Washer/Incubator/Reader)
Fluorescence microscope
 Pulsed Field Gel Electrophoresis
Glassware kit
Heated magnetic agitator
Internet connection
Laminar flow cabinet
McFarland photometer
Media dispenser
Oven
Automatic pipettes
Plexiglass screen
Basic scale
Precision scale
Biosafety cabinet class I
Biosafety cabinet class II
Biosafety cabinet class III
Thermal cycler (Thermocycler, PCR Machine or DNA Amplifier)
DNA automated extractor
Vortex
Water distiller
Waterbath
Gas Chromatography with any detection system (e.g. Mass Spectrometry, Nitrogen Phosphorous Detection…)
High Performance Liquid Chromatography with any detection system (e.g. fluorescence, UV…)
Mass Spectrometry- Mass Spectrometry (with or without Liquid Chromatography)
Thin Layer Chromatography (with/without scanning device)
beta and gamma (scintillation) counters
Atomic Absorption Spectrometry
Lyophilizer
SpeedVac concentrator
Gel electrophoresis for nucleic acids and peptides
UV light table
Computers
Printers
6. Process control (quality of pre-, post-, and examination procedures)

Pre-examination process

6.1. Specific instructions for the proper collection and handling of primary sample are documented, made
N
available to the responsible staff, and implemented

6.2. A standardized request form is available to the prescribers and includes: name, gender and date of birth
of the patient, identification and address of the requesting person, type of sample, examinations requested, Y
clinical information, date and time of collection

6.3. All primary samples are recorded in a book, worksheet, computer or other comparable system, with a
Y
unique identification system, date and time of receipt of samples

6.4. Criteria are developed and documented for acceptance or rejection of primary samples (including
Y
potential caution if non-conforming samples are accepted)

6.5. There is a procedure for the storage of primary sample, if it is not immediately examined N

6.6. The laboratory can monitor the transportation of samples to ensure they are transported within the
na
appropriate time frame, temperature, preservatives and safety

6.7. There is a documented procedure for the receipt, processing and reporting of urgent samples Y
Examination process

6.8. The laboratory uses examination procedures that have been published in established/authoritative
N
textbooks, peer-reviewed texts or journals or in international, national or regional guidelines.

6.9. Any in-house procedures are appropriately validated and documented Y

6.10. The procedures are documented and available at the workstation, in a language commonly understood
by the relevant staff (any summary bench aid is acceptable provided that it is part of the complete quality Y
manual)

6.11. Review of procedures is undertaken at least annually and documented Y

6.12. Internal quality control procedures are in place, as required by the manufacturer or the regulatory
Y
requirements

Post-examination process

6.13. The authorized personnel (with the adequate competences) systematically and critically reviews the
N
results of examination before releasing the results
6.14. Samples are stored for a specific time under appropriate conditions to enable repeating the examination
na
or for additional examinations, after reporting
7. Information management

7.1. Results are reported in a standardized format including: laboratory identification, patient identification,
prescriber identification, examination identification (with the measurement procedure), date and time of
sample collection, sample type, time of receipt by the laboratory, date and time of release of report, results N
reported in SI units where applicable, biological reference intervals (where applicable), interpretation (where
appropriate), identification and signature of the person authorizing the release of the report.

7.2. Copies of reported results are retained as long as medically relevant or as required by any regulations Y

7.3. Policies and procedures define those authorized to access patient data and those authorized to enter
Y
patient results or change results

7.4. Efficient back-up is in place to prevent loss of patient result data in case of hardware or software (in any)
N
failure or theft
7.5. The person in charge of the release of results has at their disposal telephone, fax, regular mail service,
computer with Internet access: 0- none ;1- 1 out of the 4 items; 2 - 2 out of 4 items; 3-out of 4 items; 4-4 4
out of 4 items
7.6. Data storage media (tapes, disks, papers) are properly labelled, stored and protected from damage or
Y
unauthorized use

7.7. Computers (if any) are protected with an uninterruptible power supply N

7.8. There is a procedure for immediate notification of a physician when results are critical for patient care Y

7.9. There are surveillance system forms available and reporting procedures to follow when results are of
N
public health interest (i.e. notifiable diseases, outbreak investigation…)
7.10. The laboratory can provide basic statistical data (e.g. number of tests ordered, aggregated
N
quantitative/qualitative data…)
8. Assessment

8.1. The laboratory management organizes an internal audit (even partial) at least once a year Y

8.2. The laboratory participates at least semi-annually in External Quality Assessment (EQA) programmes for
Y
each discipline (proficiency-testing or systematic rechecking)
8.3. The laboratory exchanges samples with other laboratories for confirmation especially when formal EQA
Y
programmes are not available
8.4. The laboratory has been licensed/authorized to operate by the health authorities after a preliminary on-
Y
site visit

8.5. The laboratory has been inspected by the health authorities at least once in the past year Y

8.6. The laboratory is certified or accreditated to an internationally recognized standard (ISO 9001, ISO
Y
17025, ISO 15189, WHO polio or measles…)
9. Occurrence management, process improvement, & customer service

9.1. The laboratory monitors quality indicators that measure some performance at the pre-, post- or
examination steps (e.g. number of inappropriate request forms received, disparities between Gram staining N
and the culture result, number of injuries of laboratory personnel...)

9.2. Policy and procedures are in place to resolve incidents or complaints: complaints or incidents recording
N
system, investigations and corrective actions to be undertaken

9.3. The review of incidents, non-conformances, failures identified through internal or external
assessment/controls leads to documented actions plans to reduce the likelihood of the occurrence of errors N
(including preventive actions)
10. Facility and safety

10.1. What are the general conditions of the laboratory building and the infrastructure? For the next
questions, choose one of the following answers: 1-poor/non existing; 2-medium; 3-good

Condition of walls and floors 3

Condition of the windows and doors 3

Condition of the benches 2

Condition of the heating/AC 2

Condition of the lighting 1

Condition of the waste disposal 2

10.2. The laboratory faces shortage of electricity or running water: 1 = regularly, 2 = sometimes, 3 = never 3

10.3. Space allocated is sufficient to perform the work without compromising the quality and safety of
Y
patients and personnel
10.4. Storage space (for samples, equipment, spare parts, supplies, reagents, manuals, documents and
Y
records) is adequate

10.5. Access to technical areas is controlled N

10.6. Sample collection is carried out in room(s) separated from the laboratory examination room(s) N

10.7. Offices, library, kitchen, cloakrooms or any non technical areas are clearly separated from examination
Y
rooms
10.8. There is an effective separation between adjacent laboratory sections in which there are incompatible
Y
activities (e.g. nucleic acid extraction vs amplification)

10.9. The "clean" and "dirty" sites are clearly designated and labelled (e.g. biohazard stickers etc…) na

10.10. Written biosafety procedures are available N

10.11. Employees wear gloves and laboratory coats at appropriate times Y

10.12. Employees wear protective masks and glasses at appropriate times N

10.13. Disinfectants are freshly prepared Y

10.14. Material Safety Data Sheets are available for review in the immediate laboratory area na

10.15. Sharps are discarded in specific containers Y

10.16. Bio-hazardous wastes are discarded in specific containers (appropriately labelled or colored) N

10.17. Bio-hazardous wastes containers are incinerated (on site or through a contract with a specialized
N
company)
10.18. The work areas are clean and well maintained N

10.19. Separate sinks for handwashing are available Y

10.20. Biological/chemical temperature indicators are included during sterilization N

10.21. The new staff benefits from a biosafety introductory course before working alone N

10.22. Refresher biosafety training is organized at least every 3 years N

10.23. The laboratory staff have access to occupational/worker health services N

10.24. The laboratory staff is vaccinated against Hepatitis B and other relevant diseases as appropriate Y

1
2
3
ENTER IN THE CELL A3 THE CODE OF THE LANGUAGE

1 1- English
1 Laboratory idenLaboratory identification
1 Name of the la Name of the laboratory
1 Telephone Telephone
1 Fax Fax
1 E-mail E-mail
1 Date of the as Date of the assessment
1 Name of the labName of the laboratory director
1 Name of the r Name of the respondent
1 Name of the asName of the assessor(s)
1 Visit number Visit number
1 Level of labora Level of laboratory
1 Affiliation/ typ Affiliation/ type of laboratory
1 Number of manNumber of managers (post-graduate degree)
1 Number of laboNumber of laboratory technologists
Tests performed in the laboratory (indicate the number of
1 Tests performetests performed weekly):
1 Clinical chemis Clinical chemistry
1 Haematology &Haematology & hemostasis
1 Parasitology - Parasitology - Mycology
1 Bacteriology (eBacteriology (except serology)
1 Virology (excepVirology (except serology)
1 Viral serology Viral serology
1 Bacterial serol Bacterial serology
1 Toxicology Toxicology
1 HistopathologyHistopathology
1 Human geneticHuman genetics
1 Food analysis Food analysis (microbiology)
1 Food analysis (Food analysis (chemicals or others)
1 Water analysis Water analysis
1 Veterinary mic Veterinary microbiology
1 Veterinary test Veterinary testing (others)
1 Other environme Other environmental testing (air, soil)
1 1. Organizati 1. Organization and Management

1.1 The organizational and management structure and its

1 1.1 The organi relationship with any other organization is documented

1.2. A quality manual describing the quality management

1 1.2. A quality system policy and the procedures is available
1 1.3. A quality 1.3. A quality manager is designated
1.4. The management designs, implements, maintains
1 1.4. The managand improves a quality management system
1 2. Personnel 2. Personnel
2.1. Job descriptions defining qualifications and duties
1 2.1. Job descri are available
 2.2. The staff having executive responsibility has the
1 2.2. The staff appropriate qualifications and competence
2.3. There are adequate staff resources to undertake the
1 2.3. There are required work
2.4. Qualifications, training and experience of staff are
1 2.4. Qualificat recorded
2.5. Continuing education (training, workshop,
conference…) has been provided to all staff members in
1 2.5. Continuin the last 12 months
1 3. Documents a3. Documents and records

3.1. The operating documents (instructions, operating

procedures, bench aids) are written by the laboratory
1 3.1. The operatstaff to fit the local context
3.2. The document format is standardized (standardized
1 3.2. The documheaders, page numbering…)

3.3. A document and record control system is in place

(i.e. documents listed, numbered, approved & signed,
1 3.3. A document
reviewed periodically, archived)

3.4. Records (patients and quality control results,

instruments print outs, worksheets…) are retained for at
1 3.4. Records (pleast 2 years and archived in a suitable environment
1 4. Purchasing a4. Purchasing and inventory (of services and supplies)

4.1. The services provided by the laboratory to its

customers (e.g patients, health care bodies, insurance
1 4.1. The servic companies) are described in up-to-date contracts
4.2. The laboratory refers specimens to other laboratories
1 4.2. The laborawhen testing is not available
1 4.3. A list of r 4.3. A list of referral laboratories is maintained
4.4. A register of all referred specimens (with duplicates
1 4.4. A register of results) is maintained

4.5. The laboratory has appropriate packages for

referring samples (triple package if air transport, or any
1 4.5. The laborapackage in conformity with local regulation)

4.6. The person(s) in charge of shipment by air courier is

1 4.6. The personcertified for the transport of infectious substances
4.7. A list of manufacturers and suppliers, and catalogs of
1 4.7. A list of reagents are available
4.8. The purchase of supplies, consumables, reagents or
services is recorded and the record maintained for a
1 4.8. The purch minimum of 2 years
 4.9. The new reagents (new product, new lot, including
home-made reagents) that affect the quality of testing
are verified against old reagents or reference materials
1 4.9. The new rebefore use
4.10. A supplies and reagents inventory system provides
at least the following information: quantities, date of
receipt, lot numbers, date the material is placed in
1 4.10. A supplieservice
4.11. The laboratory experiences shortage of reagents
1 4.11. The labo and supplies: 1 = regularly, 2 = sometimes, 3 = never
4.12. The laboratory uses expired products and reagents:
1 4.12. The labo 1 = regularly, 2 = sometimes, 3 = never

4.13. Disposables supplies (e.g. tips, plastic pipettes) are

1 4.13. Disposablreused: 1 = regularly, 2 = sometimes, 3 = never
1 5. Equipment 5. Equipment
1 5.1. The adequ5.1. The adequate equipment is in place
5.2. The up-to-date instructions on the use and
maintenance of equipment (manufacturer manual,
procedures) are readily available to the laboratory
1 5.2. The up-to personnel
5.3. A preventive maintenance programme is in place
1 5.3. A prevent and documented

5.4. The following information is recorded for each

instrument: identity, serial number, manufacturer
information, date of receipt, location, condition (new,
used..), performance records (calibration, checks),
1 5.4. The follow maintenance (past and planned), damages and repairs
5.5. The defective equipment is taken out of service and
1 5.5. The defectlabelled appropriately
5.6. The laboratory has a list of available external
1 5.6. The laboramaintenance and repairing services
5.7. The equipment is maintained in a safe working
1 5.7. The equipm condition (including electrical safety)
5.8. There is a daily monitoring record of the
temperature of refrigerators, freezers and incubators (if
1 5.8. There is a any)
1 Enter the num Enter the number of FUNCTIONING equipment
1 Centrifuge, ref Centrifuge, refrigerated
1 Centrifuge, simCentrifuge, simple
1 Fluorimeter Fluorimeter
1 Freezer -18° Freezer -18°
1 Freezer -70° Freezer -70°
1 Refrigerator Refrigerator
1 Incubator Incubator
1 CO2 incubator CO2 incubator
1 pHmeter pHmeter
1 UV/visible spe UV/visible spectrophotometer
1 Colorimeter Colorimeter
1 Turbidimeter Turbidimeter
1 Coagulometer Coagulometer
1 Flame photomeFlame photometer
1 ImmunoassaysImmunoassays automated analyser
1 Chemistry analChemistry analyser
1 Haematology aHaematology automated analyser
1 Flow cytometerFlow cytometer
1 Automated BlooAutomated Blood culture incubator
Automated microbial identification and susceptibility
1 Automated micro testing systems
Semi-automated microbial identification or susceptibility
1 Semi-automated testing systems (strips reader)
1 Hematocrit cenHematocrit centrifuge
1 Autoclave Autoclave
1 Binocular microBinocular microscope
1 Candle jar Candle jar
1 Electrophoresi Electrophoresis equipment
1 ELISA equipment ELISA
(Washer/Incubator/Reader)
equipment (Washer/Incubator/Reader)
1 Fluorescence mFluorescence microscope
1 Pulsed Field GePulsed Field Gel Electrophoresis
1 Glassware kit Glassware kit
1 Heated magnetic Heated magnetic agitator
1 Internet conne Internet connection
1 Laminar flow c Laminar flow cabinet
1 McFarland photo McFarland photometer
1 Media dispenser Media dispenser
1 Oven Oven
1 Automatic pipeAutomatic pipettes
1 Plexiglass screen
Plexiglass screen
1 Basic scale Basic scale
1 Precision scale Precision scale
1 Biosafety cabineBiosafety cabinet class I
1 Biosafety cabineBiosafety cabinet class II
1 Biosafety cabineBiosafety cabinet class III
Thermal cycler (Thermocycler, PCR Machine or DNA
1 Thermal cycler Amplifier)
1 DNA automatedDNA automated extractor
1 Vortex Vortex
1 Water distiller Water distiller
1 Waterbath Waterbath

Gas Chromatography with any detection system (e.g.

1 Gas ChromatogrMass Spectrometry, Nitrogen Phosphorous Detection…)
High Performance Liquid Chromatography with any
1 High Performandetection system (e.g. fluorescence, UV…)
Mass Spectrometry- Mass Spectrometry (with or without
1 Mass SpectromeLiquid Chromatography)
 Thin Layer Chromatography (with/without scanning
1 Thin Layer Chr device)
1 beta and gamma beta and gamma (scintillation) counters
1 Atomic AbsorptAtomic Absorption Spectrometry
1 Lyophilizer Lyophilizer
1 SpeedVac conce SpeedVac concentrator
1 Gel electrophorGel electrophoresis for nucleic acids and peptides
1 UV light table UV light table
1 Computers Computers
1 Printers Printers
6. Process control (quality of pre-, post-, and
1 6. Process contexamination procedures)
1 Pre-examinatioPre-examination process

6.1. Specific instructions for the proper collection and

handling of primary sample are documented, made
1 6.1. Specific i available to the responsible staff, and implemented
6.2. A standardized request form is available to the
prescribers and includes: name, gender and date of birth
of the patient, identification and address of the
requesting person, type of sample, examinations
requested, clinical information, date and time of
1 6.2. A standardcollection

6.3. All primary samples are recorded in a book,

worksheet, computer or other comparable system, with a
unique identification system, date and time of receipt of
1 6.3. All primar samples
6.4. Criteria are developed and documented for
acceptance or rejection of primary samples (including
potential caution if non-conforming samples are
1 6.4. Criteria a accepted)

6.5. There is a procedure for the storage of primary

1 6.5. There is a sample, if it is not immediately examined
6.6. The laboratory can monitor the transportation of
samples to ensure they are transported within the
appropriate time frame, temperature, preservatives and
1 6.6. The laborasafety

6.7. There is a documented procedure for the receipt,

1 6.7. There is processing and reporting of urgent samples
1 Examination prExamination process

6.8. The laboratory uses examination procedures that

have been published in established/authoritative
textbooks, peer-reviewed texts or journals or in
1 6.8. The laborainternational, national or regional guidelines.
 6.9. Any in-house procedures are appropriately validated
1 6.9. Any in-ho and documented
6.10. The procedures are documented and available at
the workstation, in a language commonly understood by
the relevant staff (any summary bench aid is acceptable
1 6.10. The proc provided that it is part of the complete quality manual)
6.11. Review of procedures is undertaken at least
1 6.11. Review o annually and documented
6.12. Internal quality control procedures are in place, as
required by the manufacturer or the regulatory
1 6.12. Internal requirements
1 Post-examinatiPost-examination process
6.13. The authorized personnel (with the adequate
competences) systematically and critically reviews the
1 6.13. The authoresults of examination before releasing the results

6.14. Samples are stored for a specific time under

appropriate conditions to enable repeating the
examination or for additional examinations, after
1 6.14. Samples reporting
a
1 7. Informatio 7. Information management
7.1. Results are reported in a standardized format
including: laboratory identification, patient identification,
prescriber identification, examination identification (with
the measurement procedure), date and time of sample
collection, sample type, time of receipt by the laboratory,
date and time of release of report, results reported in SI
units where applicable, biological reference intervals
(where applicable), interpretation (where appropriate),
identification and signature of the person authorizing the
1 7.1. Results ar release of the report.

7.2. Copies of reported results are retained as long as

1 7.2. Copies of medically relevant or as required by any regulations
7.3. Policies and procedures define those authorized to
access patient data and those authorized to enter patient
1 7.3. Policies a results or change results
7.4. Efficient back-up is in place to prevent loss of patient
result data in case of hardware or software (in any)
1 7.4. Efficient failure or theft
7.5. The person in charge of the release of results has at
their disposal telephone, fax, regular mail service,
computer with Internet access: 0- none ;1- 1 out of the 4
items; 2 - 2 out of 4 items; 3-out of 4 items; 4-4 out of 4
1 7.5. The personitems
7.6. Data storage media (tapes, disks, papers) are
properly labelled, stored and protected from damage or
1 7.6. Data stor unauthorized use
 7.7. Computers (if any) are protected with an
1 7.7. Computersuninterruptible power supply

7.8. There is a procedure for immediate notification of a

1 7.8. There is a physician when results are critical for patient care

7.9. There are surveillance system forms available and

reporting procedures to follow when results are of public
health interest (i.e. notifiable diseases, outbreak
1 7.9. There are investigation…)
7.10. The laboratory can provide basic statistical data
(e.g. number of tests ordered, aggregated
1 7.10. The laborquantitative/qualitative data…)
1 8. Assessment 8. Assessment
8.1. The laboratory management organizes an internal
1 8.1. The laboraaudit (even partial) at least once a year

8.2. The laboratory participates at least semi-annually in

External Quality Assessment (EQA) programmes for each
1 8.2. The laboradiscipline (proficiency-testing or systematic rechecking)
8.3. The laboratory exchanges samples with other
laboratories for confirmation especially when formal EQA
1 8.3. The labor programmes are not available
8.4. The laboratory has been licensed/authorized to
operate by the health authorities after a preliminary on-
1 8.4. The laborasite visit
8.5. The laboratory has been inspected by the health
1 8.5. The laboraauthorities at least once in the past year
8.6. The laboratory is certified or accreditated to an
internationally recognized standard (ISO 9001, ISO
1 8.6. The labora17025, ISO 15189, WHO polio or measles…)
9. Occurrence management, process improvement, &
1 9. Occurrence customer service
9.1. The laboratory monitors quality indicators that
measure some performance at the pre-, post- or
examination steps (e.g. number of inappropriate request
forms received, disparities between Gram staining and
the culture result, number of injuries of laboratory
1 9.1. The laborapersonnel...)
9.2. Policy and procedures are in place to resolve
incidents or complaints: complaints or incidents recording
system, investigations and corrective actions to be
1 9.2. Policy and undertaken
9.3. The review of incidents, non-conformances, failures
identified through internal or external
assessment/controls leads to documented actions plans
to reduce the likelihood of the occurrence of errors
1 9.3. The review(including preventive actions)
1 10. Facility an 10. Facility and safety
 10.1. What are the general conditions of the laboratory
building and the infrastructure? For the next questions,
choose one of the following answers: 1-poor/non
1 10.1. What areexisting; 2-medium; 3-good
1 Condition of waCondition of walls and floors
1 Condition of t Condition of the windows and doors
1 Condition of t Condition of the benches
1 Condition of t Condition of the heating/AC
1 Condition of th Condition of the lighting
1 Condition of th Condition of the waste disposal

10.2. The laboratory faces shortage of electricity or

1 10.2. The laborrunning water: 1 = regularly, 2 = sometimes, 3 = never
10.3. Space allocated is sufficient to perform the work
without compromising the quality and safety of patients
1 10.3. Space all and personnel

10.4. Storage space (for samples, equipment, spare

parts, supplies, reagents, manuals, documents and
1 10.4. Storage records) is adequate
1 10.5. Access to10.5. Access to technical areas is controlled
10.6. Sample collection is carried out in room(s)
1 10.6. Sample coseparated from the laboratory examination room(s)
10.7. Offices, library, kitchen, cloakrooms or any non
technical areas are clearly separated from examination
1 10.7. Offices, rooms
10.8. There is an effective separation between adjacent
laboratory sections in which there are incompatible
1 10.8. There is activities (e.g. nucleic acid extraction vs amplification)

10.9. The "clean" and "dirty" sites are clearly designated

1 10.9. The "cleaand labelled (e.g. biohazard stickers etc…)

1 10.10. Written 10.10. Written biosafety procedures are available

10.11. Employees wear gloves and laboratory coats at
1 10.11. Employeappropriate times
10.12. Employees wear protective masks and glasses at
1 10.12. Employeappropriate times
1 10.13. Disinfec10.13. Disinfectants are freshly prepared

10.14. Material Safety Data Sheets are available for

1 10.14. Materialreview in the immediate laboratory area

1 10.15. Sharps a10.15. Sharps are discarded in specific containers

10.16. Bio-hazardous wastes are discarded in specific

1 10.16. Bio-hazacontainers (appropriately labelled or colored)
 10.17. Bio-hazardous wastes containers are incinerated
(on site or through a contract with a specialized
1 10.17. Bio-hazacompany)

1 10.18. The wor10.18. The work areas are clean and well maintained

1 10.19. Separat10.19. Separate sinks for handwashing are available

10.20. Biological/chemical temperature indicators are
1 10.20. Biologic included during sterilization
10.21. The new staff benefits from a biosafety
1 10.21. The newintroductory course before working alone
10.22. Refresher biosafety training is organized at least
1 10.22. Refresheevery 3 years
10.23. The laboratory staff have access to
1 10.23. The labooccupational/worker health services
10.24. The laboratory staff is vaccinated against Hepatitis
1 10.24. The laboB and other relevant diseases as appropriate
1 General indicatGeneral indicator
1 central central
1 intermediate intermediate
1 peripheral peripheral
1 Not applicable Not applicable
1 Yes Yes
1 No No
1 Not applicable Not applicable
1 Score for each Score for each module
1 Disciplines an Disciplines and number of tests performed every week
1 Other disciplin Other discipline
1 Laboratory ass Laboratory assessment report
1 Number of testNumber of tests performed weekly
1 1. Organisati 1. Organisation and Management
1 2. Personnel 2. Personnel
1 3. Documents a3. Documents and records
1 4. Purchasing 4. Purchasing and inventory
1 5. Equipment 5. Equipment
1 6. Process cont6. Process control
1 7. Informatio 7. Information management
1 8. Assessment 8. Assessment
1 9. Process imp 9. Process improvement
1 10. Facility an 10. Facility and safety
1 General commeGeneral comments on the assessment
1 Conclusions a Conclusions and recommendations
1 Insert photogr Insert photographs below
2- Français
Identification du laboratoire
Nom du laboratoire
Telephone
Fax
E-mail
Date de l'évaluation
Nom du directeur du laboratoire
Nom du répondant
Nom de(s) l'évaluateur(s)
Numéro de la visite
Niveau de laboratoire
Appartenance / type de laboratoire
Nombre de managers (diplôme de 3ème cycle)
Nombre de techniciens de laboratoire

Tests réalisés au laboratoire (indiquez le nombre de tests réalisés par semaine):

Biochimie clinique
Hématologie et hémostase
Parasitologie-Mycologie
Bactériologie (sauf sérologie)
Virologie (sauf sérologie)
Sérologie virale
Sérologie bactérienne
Toxicologie
Histopathologie
Génétique humaine
Analyse alimentaire (microbiologie)
Analyse alimentaire (chimique ou autres)
Analyse de l'eau
Microbiologie vétérinaire
Analyses vétérinaires (autres)
Analyses environnementales
1. Organisation et Management
1.1. La structure organisationnelle et de management
ainsi que ses relations avec d'autres organisations est
documentée
1.2. Un manuel qualité décrivant les principes et
procédures du système de gestion de la qualité est
disponible
1.3. Un responsable qualité est désigné
1.4. La direction conçoit, mets en œuvre, maintient et
améliore un système de gestion de la qualité
2. Personnel
2.1. Les déscriptions de poste définissant les
qualifications et les devoirs sont disponibles
2.2. Le personnel ayant des responsabilités éxécutives a
les qualifications et les compétences adéquates
2.3. Il y a des ressources humaines adéquates pour
assumer le travail requis
2.4. Les qualifications, formations et expériences du
personnel sont enregistrées
2.5. Une formation continue (cours, atelier, conférence) a
été offerte à tout le personnel au cours des 12 derniers
mois
3. Documents et enregistrements
3.1. Les documents opératoires (instructions, procédures
opératoires, aide-mémoires de paillasse) sont écrits par le
personnel du laboratoire de façon à s'adapter au contexte
local
3.2. Le format des documents est standardisé (en-têtes
standardisés, numéros de page…)
3.3. un système de contrôle des documents et des
enregistrements est en place (i.e. documents listés,
numérotés, approuvés et signés, revus périodiquement,
archivés)
3.4. Les enregistrements (résultats des patients et du
contrôle de qualité, impressions des équipements, feuilles
de paillasse…) sont conservées au moins 2 ans dans un
environnement adéquat.
4. Achats et inventaires (des services et fournitures)
4.1. Les services fournis par le laboratoire à ses
consommateurs (ex: patients, centres de soins,
compagnies d'assurance) sont décrits dans des contrats à
jour
4.2. Le laboratoire réfère des échantillons à d'autres
laboratoires lorsque le test n'est pas disponible
4.3. Une liste des laboratoires référents est conservée
4.4. Un registre des échantillons référés (avec copie des
résultats) est conservé
4.5. Le laboratoire dispose d'emballages appropriés pour
référer des échantillons (triple emballage en cas de
transport aérien, ou emballage conforme au régulations
locales)
4.6. La(les) personne(s) en charge des envois par voie
aérienne est certifiée pour le transport des substances
infectieuses
4.7. Une liste des fabricants et distributeurs, et des
catalogues de réactifs sont disponibles
4.8. L'achat de fournitures, consommables, réactifs ou
services est enregistré et l'enregistrement conservé
pendant au moins 2 ans
4.9. Les nouveaux réactifs (nouveau produit, nouveau lot,
réactifs maison inclus) pouvant altérer la qualité des
analyses, sont vérifés contre d'anciens réactifs ou des
matériels de référence avant usage
4.10. Un système d'inventaire des fournitures et réactifs
fournit au minimum les informations suivantes: quantités,
date de réception, numéros de lot, date de mise en
service
4.11. Le laboratoire a des ruptures de réactifs et
fournitures: 1 = régulièrement, 2 = parfois, 3 = jamais
4.12. Le laboratoire utilise des produits et des réactifs
expirés: 1 = régulièrement, 2 = parfois, 3 = jamais
4.13. Les consommables à usage unique (ex: cônes,
pipettes en plastique) sont réutilisés:1 = régulièrement, 2
= parfois, 3 = jamais
5. Equipement
5.1. L'équipement adéquat est en place

5.2. Les instructions sur l'utilisation et la maintenance des

équipements (manuel du fabricant, procédures) sont
immédiatement disponibles pour le personnel
5.3. Un programme de maintenance préventive est en
place et documenté
5.4. Les informations suivantes sont enregistrées pour
chaque instrument: identité, numéro de série, information
sur le fabricant, date de réception, emplacement, état
(neuf usagé...), enregistrement des tests liés à la
performance (calibration, contrôles), maintenance
(passée et planifiée), dégâts et réparations
5.5. L'équipement défectueux est enlevé du laboratoire et
étiquetté correctement
5.6. Le laboratoire dispose d'une liste des services
extérieurs de réparation et de maintenance
5.7. L'équipement est conservé dans des conditions de
sécurité suffisantes (incluant la sécurité électrique)
5.8. Il y a un enregistrement quotidien de la température
des réfrigérateurs, congélateurs et incubateurs (le cas
échéant)
Entrez le nombre d'équipement EN FONCTION
Centrifugeuse, réfrigérée
Centrifugeuse, simple
Fluorimètre
Congélateur -18°
Congélateur -70°
Réfrigérateur
Incubateur
Incubateur CO2
pHmètre
Spectrophotomètre UV/visible
Colorimètre
Turbidimètre
Coagulomètre
Photomètre de flamme
Automate d'immunoanalyse
Automate de chimie
Automate d'hématologie
Cytomètre de flux
Incubateur automatisé pour hémoculture
Système automatisé d'identification bactérienne et
d'antibiogramme
Système semi-automatisé d'identification bactérienne et
d'antibiogramme (lecture de galeries)
Centrifugeuse à hématocrite
Autoclave
Microscope binoculaire
Jarre à bougie
Equipement d'électrophorèse
Equipement ELISA (Laveur/Incubateur/Lecteur)
Microscope à fluorescence
Electrophorèse en champ pulsé
Kit de verrerie
Agitateur magnétique chauffé
Connexion Internet
Hotte à flux laminaire
Photomètre de McFarland
Dispensateur de milieu
Four
Pipettes automatiques
Ecran plexiglass
Balance basique
Balance de précision
Poste de sécurité microbiologique de classe I
Poste de sécurité microbiologique de classe II
Poste de sécurité microbiologique de classe III

Thermocycler
Extracteur automatisé d'ADN
Vortex
Distillateur d'eau
Bain-marie
Chromatographie en Phase Gaseuze avec système de
détection (ex. Spectromètre de masse, Nitrogen
Phosphorous Detection…)
Chromatographie Liquide Haute Performance avec
système de détection (ex. fluorescence, UV…)
Spectromètre de Masse - Spectromètre de Masse avec ou
sans chromatographie en phase liquide)
Chromatographie couche mince (avec/sans scanner)
Compteurs à scintillation beta et gamma
Spectromètre d'Absorption Atomique
Lyophilisateur
Concentrateur Speed Vac
Electrophorèse en gel pour acides nucléiques et peptides
Table de lumière UV
Ordinateurs
Imprimantes
6. Contrôle du processus (qualité des procédures pré-,
post- et analytiques
Etapes pré-analytiques
6.1. Des instructions spécifiques pour le prélèvement et la
manipulation des échantillons primaires sont
documentées, disponibles pour le staff, et mises en
œuvre

6.2. Un formulaire standardisé est disponible pour les

prescripteurs et inclut: nom, sexe et date de naissance du
patient, identification et adresse du prescripteur, type
d'échantillon, analyses demandées, information clinique,
date et heure de prélèvement
6.3. Tous les échantillons primaires sont enregistrés dans
un cahier, une feuille de travail, un ordinateur ou tout
autre système comparable, avec un numéro
d'identification unique, la date et l'heure de réception des
échantillons
6.4. Des critères sont développés et documentés pour
l'acceptation ou le rejet d'échantillons primaires (incluant
une réserve potentielle si des échantillons non conformes
sont acceptés)
6.5. Il y a une procédure pour la conservation des
échantillons primaires, si ils ne sont pas examinés
immédiatement

6.6. Le laboratoire peut monitorer le transport des

échantillons de façon à s'assurer des bonnes conditions
de délai, température, conservation et sécurité
6.7. Il y a une procédure documentée pour la réception,
l'analyse et le rendu des résultats pour les échantillons
urgents
Etape analytique
6.8. Le laboratoire utilise des procédures analytiques
ayant été publiées dans des livres, des textes ou des
journaux à comité de revue renommés/reconnus ou dans
des lignes directrices nationales, régionales ou
internationales
6.9. Les éventuelles procédures uniques au laboratoire
sont validées et documentées de façon appropriées
6.10. Les procédures sont documentées et disponibles au
niveau du poste de travail, dans une langue comprise par
le personnel (un aide-mémoire résumé est acceptable
pourvu qu'il fasse partie du manuel qualité)
6.11. Une revue des procédures est réalisée et
documentée au moins une fois par an
6.12. Des procédures de contrôle de qualité interne sont
en place, selon les exigences du fabricant ou d'éventuels
régulations
Etape post-analytique
6.13. Le personnel autorisé (avec les compétences
adéquates) vise systématiquement et de façon critique les
résultats avant le rendu des résultats

6.14. Les échantillons sont stockés dans des conditions et

pour une période appropriées de façon à répéter l'analyse
ou pour des analyses supplémentaires, après le rendu
des résultats
7. Gestion de l'information
7.1. Les résultats sont rendus selon un format
standardisé incluant: identification du laboratoire,
identification du patient, identification du prescripteur,
identification de l'analyse (avec le système de mesure),
date et heure du prélèvement, type d'échantillon, date de
réception au laboratoire, date et heure de rendu du
résultat, résultats rendu si possible en unités S.I.,
intervalles biologiques de référence (si possible),
interprétation (si appropriée), identification et signature
de la personne autorisée à rendre le rapport
7.2. Des copies des résultats rendus sont gardés aussi
longtemps que nécessaire (pour des raisons médicales ou
règlementaires
7.3. Des principes et procédures sont en place pour
définir l'accès aux données des patients et l'autorisation
de rentrer des données ou de les modifier
7.4. Un système de sauvegarde est en place pour
prévenir la perte des résultats des patients en case de
panne matérielle ou logicielle
7.5. La personne en charge du rendu des résultats a à sa
disposition le téléphone, le fax, un service postal, un
ordinateur avec accès internet: 0- aucun de ces moyens ;
1- 1 moyen parmi les 4; 2 - 2 moyens parmi les 4; 3- 3
moyens parmi les 4; 4-4 moyens parmi les 4
7.6. Le matériel de stockage des données (disques,
cassettes, papiers) est étiqueté correctement, conservé et
protégé des dégradations ou d'un usage non autorisé
7.7. Les ordinateurs éventuellement présents sont
protégés par des systèmes de type onduleur
7.8. Il existe une procédure pour la notification immédiate
du médecin lorsque les résultats sont critiques pour les
soins du patient
7.9. Des formulaires des systèmes de surveillance ainsi
que des procédures de remise de ces formulaires sont
disponibles pour les résultats d'intérêt en santé publique
(ex: maladies à déclaration obligatoire, investigation
d'épidémie…)
7.10. Le laboratoire peut fournir des données statistiques
de base (ex: nombre de tests prescrits, données
qualitatives ou quantitatives agrégées
8. Evaluation
8.1. La direction du laboratoire organise un audit interne
(même partiel) au moins une fois par an
8.2. Le laboratoire participe au moins semi-annuellement
à des programmes d'Evaluation Externe de la Qualité
(EEQ) pour chaque discipline ("proficiency-testing" ou
tests d'aptitude, ou re-contrôle systématique)
8.3. Le laboratoire échange des échantillons avec d'autres
laboratoires spécialement lorsque des programmes d'EEQ
ne sont pas disponibles
8.4. Le laboratoire a obtenu une license/autorisation
d'exercice délivrée par les autorités de santé après une
visite préliminaire
8.5. Le laboratoire a été inspecté par les autorités de
santé au moins une fois au cours de l'année écoulée
8.6. Le laboratoire est certifié ou accrédité selon une
norme reconnue internationalement (ISO 9001, ISO
17025, ISO 15189, OMS polio ou rougeole…)
9. Gestion des erreurs, amélioration des procédures et
service clientèle
9.1. Le laboratoire surveille la qualité à travers des
indicateurs mesurant la performance des étapes pré-,
post- et analytiques (ex: nombre de prescriptions
inappropriées, disparité entre la coloration de Gram et le
résultat de la culture, nombre d'accidents du personnel au
laboratoire...)
9.2. Des principes et des procédures sont en place pour
résoudre les incidents ou les plaintes: système
d'enregistrement des plaintes ou des incidents,
investigations et actions correctives devant être menées
9.3. La revue des incidents, non-conformités, ou
problèmes identifiés à travers les contrôles de qualité
internes ou externes, conduit à des plans d'action
documentés pour réduire la probabilité de survenue des
erreurs (incluant les actions préventives)
10. Installations et sécurité
10.1. Quel est l'état général du bâtiment et des
infrastructures? Pour les questions suivantes, choisissez
une des réponses suivantes: 1-mauvaise/inexistante; 2-
moyenne; 3-bonne
Etat des murs et sols
Etat des fenêtres et portes
Etat des paillasses
Etat du chauffage/air conditionné
Etat des lumières
Etat du système d'élimination des déchets
10.2. Le laboratoire est confronté parfois à des coupures
d'electricité ou d'eau courante: 1 = régulièrement, 2 =
quelquefois, 3 = jamais
10.3. L'espace alloué est suffisant pour travailler sans
compromettre la qualité et la sécurité des patients et du
personnel
10.4. L'espace dédié au stockage (des échantillons,
colorants, equipement, pièces détachées, fournitures,
réactifs, manuels, documents et enregistrements) est
adéquat
10.5. L'accès au zones techniques est contrôlée
10.6. Les prélèvements sont réalisés dans des pièces
séparées des pièces techniques d'analyse
10.7. Les bureaux, la librairie, la cuisine, les vestiaires et
autres zones non techniques sont clairement séparées
des pièces techniques d'analyse
10.8. Il y a une séparation effective entre des sections
adjacentes du laboratoire dans lesquelles des activités
incompatibles sont menées
10.9. Les zones "propres" et "sales" sont clairement
désignées et étiquetées (ex: autocollants de risque
biologique…)
10.10. Des procédures écrites de biosécurité sont
disponibles
10.11. Les employés portent des gants et des blouses de
laboratoire lorsque c'est approprié
10.12. Les employés portent des masques et des lunettes
lorsque c'est approprié
10.13. Les désinfectants sont fraîchement préparés
10.14. Des Fiches Techniques Santé/Sécurité (FTSS) sont
disponibles pour consultation immédiate dans le
laboratoire
10.15. Les objets coupants sont éliminés dans des
récipients spécifiques
10.16. Les déchets à risque biologique sont éliminés dans
des récipients spécifiques (couleur ou étiquette
appropriée)
10.17. Les déchets à risque biologique sont incinérés (sur
place ou grâce à un contrat avec une société spécialisée)
10.18. Les zones de travail sont propres et bien
entretenues
10.19. Il existe des lavabos séparés pour le lavage des
mains
10.20. Des indicateurs de température biologiques ou
chimiques sont utilisés lors de la stérilisation
10.21. Les nouvelles personnes reçoivent une formation
de sensibilisation à la biosécurité avant de travailler seuls
10.22. Des formations continues en biosécurité sont
organisées au moins tous les 3 ans
10.23. Le personnel du laboratoire a accès à un service
de médecine du travail
10.24. Le personnel du laboratoire est vacciné contre
l'hépatite B et autres maladies (si approprié)
Indicateur général
central
intermediaire
périphérique
Non applicable
Oui
Non
Non applicable
Score pour chaque module
Disciplines et nombre de tests réalisés chaque semaine
Autre discipline
Rapport d'évaluation du laboratoire
Nombre de tests réalisés chaque semaine
1. Organisation et Management
2. Personnel
3. Documents et enregistrements
4. Achat et inventaire
5. Equipement
6. Contrôle du processus
7. Gestion de l'information
8. Evaluation
9. Amélioration des procédures
10. Installations et sécurité
Commentaires généraux sur l'évaluation
Conclusions et recommandations
Insérer les photographies ci-dessous
semaine):