Quality Control
Quality assurance in laboratories
May 2007
Laboratory Training for Field Epidemiologists
Learning objectives
At the end of the presentation, participants should
Understand the principles of Quality control Understand the importance for internal and external quality control schemes
Laboratory Training for Field Epidemiologists
Quality is....
invisible when
GOOD
impossible to ignore when
BAD
Laboratory Training for Field Epidemiologists
Quality ?
= sum-total of all the characteristics
of a product/service that has a bearing upon the utilization of the product/service to the entire satisfaction of the consumer
Laboratory Training for Field Epidemiologists
Quality ?
Consistency
Accuracy Precision
Right result
First time Every time
Laboratory Training for Field Epidemiologists
Objectives of quality in lab
Support provision of high quality health-care
Reduce morbidity
Reduce mortality Reduce economic loss
Ensure credibility of lab Generate confidence in lab results
Laboratory Training for Field Epidemiologists
Consequences of poor quality
Inappropriate action
Over-investigation
Over-treatment Mistreatment
Inappropriate inaction
Lack of investigation No treatment
Delayed action
Loss of credibility of laboratory
Legal action
Laboratory Training for Field Epidemiologists
Quality assurance = Internal quality control + External quality assessment
Continuously and concurrently assessing lab work
Retrospectif and periodic
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Assessment of Quality System
Man-driven
Audit, On-site
Material-driven
Quality Assessment
Internal
inspection
Internal External
External
Schematic way: External Quality Assessment Scheme (EQAS)
Accreditation
Laboratory Training for Field Epidemiologists
1 - Internal quality control in laboratory
= set of procedures undertaken by the staff to ensure quality of
reports
Total process beginning with sample collection up to final
reporting
Laboratory Training for Field Epidemiologists
Quality in labs is mutual responsibility of..
Laboratory specialists Clinicians
Public health physicians
Laboratory Training for Field Epidemiologists
Factors influencing internal quality
Sample Transport
Sample handling
Sample Collection Patient preparation Outside laboratory
Sample receiving
Analysis
Within laboratory
Requisition
Results
Patient
Doctor
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Reports
1.1 - Factors influencing quality: Pre-analytical
Investigation
Ex: blood culture in the first week of enteric fever and not Widal
Right
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Specimen
Ex: No stool in SARS
Collection technique
Ex: Stool from bedpan collect stool in a clean container
Storage and transportation
Quantity
Ex: Not kept in cold chain- overgrowth of other bacteria
Labeling
Ex: Not enough serum for serology
Ex: Mismatch of sample
Laboratory
Ex: Not necessary test capacity
PROFICIENCY OF PERSONNEL: Education, Training, Aptitude, Competence, Commitment, Adequate number, CME, Supervision, Motivation
1.2 - Factors influencing quality: Analytical
REAGENTS STABILITY, INTEGRITY AND EFFICIENCY: Stable, Efficient, Desired quality, Continuously available, Validated EQUIPMENT RELIABILITY: Meet technical needs, Compatible, User & maintenance friendly, Cost effective, Validated
USE OF APPROPRIATE CONTROLS: Internal: Labs, Calibrated against national External: Supplied by manufacturer, National, International
ANALYTICAL FACTORS
SPECIFICITY & SENSITIVITY OF SELECTED TEST: Adequate ST, Sufficient SP, cost effective, compatible with, available infrastructure and expertise, interpretable, meets the needs/ objectives, validated
Procedural reliability using Standard Operating Procedures
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 manufacture of a product service or the
Documentation
If you have not documented it,
you have NOT done it
If you have not documented,
it is a RUMOUR !!!
Laboratory Training for Field Epidemiologists
Value of Documentation
Ensures processes and outcomes are traceable Processes can be audited, thus external assessments can take place
Tool for training Reminds you what to do next
Laboratory Training for Field Epidemiologists
Standard Operating Procedures (SOP)
= comprehensively written
document that describes the laboratory procedure and all other related issues
Essential for ensuring uniformity in
SOP for Gram Staining
laboratory procedures
Laboratory Training for Field Epidemiologists
Validation
= is about determining whether
something does what it is supposed to do
Laboratory Training for Field Epidemiologists
Importance of validation
Validation - before you introduce something Re-validation
after you have changed/modified
periodic
Validation is applied to:
SOP reagents equipment software
Laboratory Training for Field Epidemiologists
1.3 - Factors influencing quality: Post-analytical
Right recording and reporting Right interpretation
Range of normal values
Right turnaround time
Report to right user
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Reporting
Unequivocal message
Numerical value with units as and when required
KISS !
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(Keep it short and simple)
Bottom-line
Quality costs , but poor quality costs more
Laboratory Training for Field Epidemiologists
Training
The quality system is only as good as the staff who actually work with it No matter how good the quality system is on paper, quality cannot be achieved if the theory cannot be translated into practice Training policy and plan Training must include an understanding of why quality is important Training should be need based, for all staff and reviewed
Laboratory Training for Field Epidemiologists
2 - External Quality Assessment
3 types, mainly 2:
An EQA organizer provides surveys in which identical material will be tested by all participating laboratories
ex: WHO/NHLS programme in Africa
Participating laboratories send specimens to EQA organizer for Rechecking
ex: Tuberculosis bacilloscopy quality control in Morocco
On-site visits with physical assessment)
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EQA
According to the ISO definition, EQA (also known as proficiency testing (PT) or EQ Control = EQC) refers to: a system of objectively checking laboratory results by means of an external agency
including comparison of a laboratory's result at intervals with those of other laboratories
the main objective being the establishment of trueness
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What makes microbiology different to other EQA schemes?
Microbiology samples are fundamentally non-uniform. Microbiological taxonomy is fundamentally imprecise.
Microbiological samples are changing.
Traditional microbiological analysis depends upon behavior, not constitution. Microbiology has many right answers.
Laboratory Training for Field Epidemiologists
Objectives of EQA schemes for laboratories
Laboratory oriented objectives:
1. Identifying possible deficiencies in laboratory practice, and guiding participants in any corrective actions to be taken for improvement;
2. Identifying the reliability characteristics of particular methods, materials and equipment under routine conditions and suggest corrective actions as appropriate; 3. Assessing and monitoring the impact of training; help for the preparation of future trainings
Laboratory Training for Field Epidemiologists
Objectives of EQA schemes for laboratories
Public health oriented objectives:
4. Providing the basis for the comparability of results during epidemiological surveillance and disease control 5. Collecting information on laboratory measurements ( intra- and interlaboratory) to alert professionals and/or government bodies about problems related to traceability and harmonization of results, and establish limits of acceptability of results as appropriate for a given purpose;
6. Collecting information for the purpose of licensing or accreditation of laboratories;
Laboratory Training for Field Epidemiologists
2.1 Example of EQA organizer:
CMPT, Canada
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2-2 Rechecking (RC)
Participating laboratories send specimen to be rechecked on a regular basis to the EQA body Targeted specimens and/or randomized specimens Usually blind, can be single or multiple
Example of tuberculosis bacilloscopy in Morocco:
180 centres in the country All positives smears (targeted) 10% of all negative smears (randomized)
Laboratory Training for Field Epidemiologists
2.3 On-site visits
Laboratory assessment
Laboratory licensing and/or accreditation
Combined with the other types of EQA
After repeated problems (corrective action)
During on-site supervision (routine checking)
After training session (practical implementation of the training )
In addition to the assessment of the existing conditions, QC material can also be provided (slides, strain, sera, specimen for rapid tests )
Laboratory Training for Field Epidemiologists
The ideal situation: 2 types together and very targeted on-site visits
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
On-site visits should be used with extreme situations
Initial situation: laboratory assessment, licensing
Bad situation: repeated problems, failures in training Good situation: accreditation
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3- Accreditation
= process of inspection of laboratories and their licensing by a third party to ensure conformity to pre-defined criteria 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)
Last step of the entire process
1. Quality assurance (procedures, way of working)
2. IQC 3. EQC 4. Networking of the laboratories 5. and then only accreditation if 1-4 completed
Laboratory Training for Field Epidemiologists
Carry home messages..
Quality assurance measures what a lab can do to improve reliability
As an epidemiologist, you may engage the laboratory in a dialogue and tactfully ask about QA measures in place
BE CAREFUL ! An epidemiologist is NOT in a position to assess the reliability of the lab or to evaluate its QA procedures as this requires a specific expertise
Laboratory Training for Field Epidemiologists
To summarize The determinants that ensure the quality of the laboratory & therefore the specimen results are:
Pre-analytical
INTERNAL QUALITY CONTROL: Set of procedures undertaken by the staff to ensure quality of reports Investigation Specimen Collection technique Storage and transportation Quantity Labeling Laboratory
Analytical
Proficiency of personnel Reagents stability, integrity and efficiency Equipment reliability Specificity & sensitivity of selected test Procedural reliability using standard operating procedures
Post-analytical
Recording and reporting Interpretation Turnaround time
Use of appropriate controls
Documentation Assessment
EXTERNAL QUALITY ASSESSMENT: a system of objectively checking laboratory results by means of an external agency
External quality assessment scheme Rechecking On-site visits Combination of any two or more of the above Laboratory license
ACCREDITATION: Process of inspection of laboratories and their licensing by a third party to ensure conformity to pre-defined criteria
Laboratory Training for Field Epidemiologists
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
