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

Laboratory Training for Field Epidemiologists

Retrospectif and
periodic

Assessment of Quality System

Man-driven
Audit, On-site

inspection
Internal
External

Accreditation

Laboratory Training for Field Epidemiologists

Material-driven
Quality Assessment
Internal
External
Schematic way:
External Quality Assess
ment Scheme (EQAS)

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

Sample
receiving
Analysis

Patient
preparation

Outside
Outsidelaboratory
laboratory
Within
Withinlaboratory
laboratory

Requisition

Results
Patient

Laboratory Training for Field Epidemiologists

Doctor

Reports

1.1 - Factors influencing quality:

Pre-analytical
Investigation

Right

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

Specimen

Ex: No stool in SARS

Collection technique

Ex: Stool from bedpancollect 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

Laboratory Training for Field Epidemiologists

Ex: Not necessary test capacity

1.2 - Factors influencing quality:

Analytical

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

REAGENTS STABILITY, INTEGRITY

AND EFFICIENCY:
Stable, Efficient, Desired quality,
Continuously available, Validated

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

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

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

laboratory procedures

Laboratory Training for Field Epidemiologists

SOP for Gram

Staining

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)

Laboratory Training for Field Epidemiologists

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 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)

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

Laboratory Training for Field Epidemiologists

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:

INTERNAL QUALITY CONTROL:

Set of procedures undertaken by the staff
to ensure quality of reports

Pre-analytical

Analytical

Post-analytical

Investigation
Specimen
Collection
technique
Storage and
transportation
Quantity
Labeling
Laboratory

Proficiency of personnel

Recording and
reporting

Reagents stability, integrity and efficiency

Equipment reliability
Specificity & sensitivity of selected test
Procedural reliability using standard operating procedures
Use of appropriate controls
Documentation
Assessment

EXTERNAL QUALITY ASSESSMENT:

a system of objectively checking laboratory
results by means of an external agency

ACCREDITATION: Process of inspection of

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

External quality assessment scheme

Rechecking
On-site visits
Combination of any two or more of the above
Laboratory license

Laboratory Training for Field Epidemiologists

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