Documente Academic
Documente Profesional
Documente Cultură
Quality assurance
in laboratories
May 2007
Learning objectives
Understand the importance for internal and external quality control schemes
Quality is....
invisible when
GOOD
BAD
Quality ?
= sum-total of
Quality ?
Consistency
Accuracy
Precision
Right result
First time
Every time
Inappropriate action
Over-investigation
Over-treatment
Mistreatment
Inappropriate inaction
Lack of investigation
No treatment
Delayed action
Legal action
Quality assurance =
Internal quality control +
External quality assessment
Continuously and
concurrently assessing
lab work
Retrospectif and
periodic
inspection
Internal
External
Accreditation
Material-driven
Quality Assessment
Internal
External
Schematic way:
External Quality Assess
ment Scheme (EQAS)
Sample
handling
Sample
Collection
Sample
receiving
Analysis
Patient
preparation
Outside
Outsidelaboratory
laboratory
Within
Withinlaboratory
laboratory
Requisition
Results
Patient
Doctor
Reports
Right
Ex: blood culture in the first week of enteric fever and not Widal
Specimen
Collection technique
Quantity
Labeling
Laboratory
PROFICIENCY OF
PERSONNEL:
Education, Training, Aptitude,
Competence, Commitment,
Adequate number, CME,
Supervision, Motivation
USE OF APPROPRIATE
CONTROLS:
Internal: Labs, Calibrated
against national
External: Supplied by
manufacturer, National,
International
ANALYTICAL
FACTORS
DOCUMENTATION:
Assessment
All the written policies, plans,
procedures, instructions and records,
quality control procedures and recorded
test results involved in providing a
Laboratory Training for Field Epidemiologists
service or the manufacture of a product
EQUIPMENT RELIABILITY:
Meet technical needs, Compatible, User
& maintenance friendly, Cost effective,
Validated
Documentation
it is a RUMOUR !!!
Value of Documentation
= comprehensively written
laboratory procedures
Validation
Importance of validation
Re-validation
after you have changed/modified
periodic
Reporting
Unequivocal message
KISS !
Laboratory Training for Field Epidemiologists
Bottom-line
Quality costs ,
but poor quality costs more
Training
3 types, mainly 2:
EQA
Laboratory assessment
On-site visits:
Expensive, heavy
Only for one laboratory
Very much time consuming
Very effective if motivated staff
Very complementary to all other schemes especially rechecking
3- Accreditation
Very very long task (As example, around 20% of French laboratories are accredited by
COFRAC, it takes around 2-3 years to follow the roadmap)
To summarize
The determinants that ensure the quality of the laboratory & therefore the specimen
results are:
Pre-analytical
Analytical
Post-analytical
Investigation
Specimen
Collection
technique
Storage and
transportation
Quantity
Labeling
Laboratory
Proficiency of personnel
Recording and
reporting
Interpretation
Turnaround time
Quality Control
Developed by:
The Department of Epidemic and Pandemic Alert and
Response of the World Health Organization with the
assistance of:
European Program for Field Epidemiology
Training
Canadian Field Epidemiology Programme
Thailand Ministry of Health
Institut
Pasteur
Laboratory Training for
Field Epidemiologists