Quality Control

Quality assurance
in laboratories

May 2007

Laboratory Training for Field Epidemiologists

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 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

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 Quality is....

• invisible when GOOD

• impossible to ignore when BAD

Laboratory Training for Field Epidemiologists

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 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

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 Quality ?

•Consistency

– Accuracy
– Precision

•Right result

– First time
– Every time

Laboratory Training for Field Epidemiologists

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 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

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 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

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 Quality assurance =
Internal quality control + External
quality assessment

Continuously and
Retrospectif and
concurrently assessing
periodic
lab work

Laboratory Training for Field Epidemiologists

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 Assessment of Quality System

Man-driven Material-driven

• Audit, On-site inspection • Quality Assessment

• Internal • Internal

• External • External

• Schematic way: Extern

• Accreditation
al Quality Assessment
Scheme (EQAS)

Laboratory Training for Field Epidemiologists

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 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

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 Quality in labs is mutual responsibility of…..

• Laboratory specialists

• Clinicians

• Public health physicians

Laboratory Training for Field Epidemiologists

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 Factors influencing internal quality

Sample Sample
Transport Sample
handling
Sample receiving
Collection
Analysis
Patient Outside
Outsidelaboratory
laboratory
preparation
Within
Withinlaboratory
laboratory

Requisition
Results

Patient
Doctor Reports

Laboratory Training for Field Epidemiologists

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 1.1 - Factors influencing quality:
Pre-analytical
• Investigation

– Ex: blood culture in the first week of enteric fever and not Widal

• Specimen

Right
– Ex: No stool in SARS

• Collection technique

– Ex: Stool from bedpan→ collect stool in a clean container

• Storage and transportation

– Ex: Not kept in cold chain- overgrowth of other bacteria

• Quantity

– Ex: Not enough serum for serology

• Labeling

– Ex: Mismatch of sample

• Laboratory

– Ex: Not necessary test capacity

Laboratory Training for Field Epidemiologists

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 1.2 - Factors influencing quality:
Analytical
PROFICIENCY OF
PERSONNEL:
Education, Training, Aptitude, REAGENTS STABILITY, INTEGRITY EQUIPMENT RELIABILITY:
Competence, Commitment, AND EFFICIENCY: Meet technical needs, Compatible, User &
Adequate number, CME, Stable, Efficient, Desired quality, maintenance friendly, Cost effective,
Supervision, Motivation Continuously available, Validated Validated

SPECIFICITY & SENSITIVITY OF

USE OF APPROPRIATE SELECTED TEST:
CONTROLS: ANALYTICAL Adequate ST, Sufficient SP, cost
• Internal: Labs, Calibrated effective, compatible with, available
against national FACTORS infrastructure and expertise,
• External: Supplied by interpretable, meets the needs/
manufacturer, National, objectives, validated
International
Procedural
DOCUMENTATION: reliability using
Assessment All the written policies, plans, procedures, Standard
instructions and records, quality control Operating
procedures and recorded test results Procedures
involved in providing a service or the
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manufacture of a product N S E
 Documentation

• If you have not documented it,

• you have NOT done it …

• If you have not documented,

• it is a RUMOUR !!!

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 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

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 Standard Operating Procedures (SOP)

• = comprehensively written document that describes

the laboratory procedure and all other related issues
• Essential for ensuring uniformity in laboratory
SOP for Gram Staining
procedures

Laboratory Training for Field Epidemiologists

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 Validation

• = is about determining whether something does what it is supposed to do

Laboratory Training for Field Epidemiologists

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 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

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 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 ! (Keep it short and simple)

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 Bottom-line

€
•Quality costs ,

•but poor quality costs more …

Laboratory Training for Field Epidemiologists

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 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

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 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.

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 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

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 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 inter-laboratory) 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;

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 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)

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 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 …)

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 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

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 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

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 To summarize
•The determinants that ensure the quality of the laboratory & therefore the specimen results
are:

Pre-analytical Analytical Post-analytical

INTERNAL QUALITY CONTROL: Investigation Proficiency of personnel Recording and
Specimen reporting
Set of procedures undertaken by the staff to Reagents stability, integrity and efficiency
Collection Interpretation
ensure quality of reports technique Equipment reliability
Turnaround time
Storage and Specificity & sensitivity of selected test
transportation
Procedural reliability using standard operating procedures
Quantity
Labeling Use of appropriate controls
Laboratory Documentation
Assessment

EXTERNAL QUALITY ASSESSMENT: External quality assessment scheme

Rechecking
a system of objectively checking laboratory
results by means of an external agency On-site visits
Combination of any two or more of the above

ACCREDITATION: Process of inspection of Laboratory license

laboratories and their licensing by a third party
to ensure conformity to pre-defined criteria

Laboratory Training for Field Epidemiologists

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 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

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