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Laboratory Training for Field Epidemiologists

Quality assurancein laboratories

Quality Control

May 2007


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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


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Quality is....

invisible whenGOOD

impossible to ignore whenBAD


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Quality ?

= sum-total ofall the characteristics

of a product/service that has a

bearing upon the utilization of the

product/service to the entiresatisfaction of the consumer


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Quality ?

Consistency

Accuracy

Precision

Right result

First time

Every time



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



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



Quality assurance =

Internal quality control + External

quality assessment

Continuously andconcurrently assessing

lab work

Retrospectif andperiodic


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Assessment of Quality System

Audit, On-siteinspection

Internal External

Accreditation

Man-driven Material-driven Quality Assessment

Internal External

Schematic way:External QualityAssessment Scheme

(EQAS)


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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


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Quality in labs is mutual responsibility of

Laboratory specialists

Clinicians

Public health physicians


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Factors influencing internal quality

Outside laboratory

Within laboratory

Samplehandling

Patientpreparation

Requisition

SamplereceivingSample

Collection

SampleTransport

PatientDoctor

Analysis

Reports

Results


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1.1 - Factors influencing quality:

Pre-analytical

Right

Investigation

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

Specimen

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


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1.2 - Factors influencing quality:AnalyticalEQUIPMENT RELIABILITY:Meet technical needs, Compatible, Us

& maintenance friendly, Cost effective

Validated

Procedural

reliability usingStandard

Operating

Procedures

REAGENTS STABILITY, INTEGRITYAND EFFICIENCY:

Stable, Efficient, Desired quality,

Continuously available, Validated

SPECIFICITY & SENSITIVITY OF

SELECTED TEST:

Adequate ST, Sufficient SP, cost

effective, compatible with,

available infrastructure and

expertise, interpretable, meets th

needs/ objectives, validated

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

DOCUMENTATION:All the written policies, plans,

procedures, instructions and records,

quality control procedures and recorded

test results involved in providing a

service or the manufacture of a product

Assessment

ANALYTICALFACTORS


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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 procedures

SOP for Gram Staining


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Validation

= is about determining whether

something does what it is supposed to

do


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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


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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


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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, qualitycannot be achieved if the theory cannot be translated intopractice

Training policy and plan

Training must include an understanding of why quality isimportant

Training should be need based, for all staff and reviewed


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2 - External Quality Assessment

3 types, mainly 2:

An EQA organizerprovides surveys in which identical material willbe tested by all participating laboratories

ex: WHO/NHLS programme in Africa

Participating laboratories send specimens to EQA organizer forRechecking

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 proficiencytesting (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 thoseof 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 ofacceptability of results as appropriate for a given purpose;

6. Collecting information for the purpose of licensing or accreditation of

laboratories;

2 1 Example of EQA organizer:


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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 aregular 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 beprovided (slides, strain, sera, specimen for rapid tests )

The ideal situation: 2 types together


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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

3 Accreditation


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3- Accreditation

= process of inspection of laboratories and their licensing by a third party toensure conformity to pre-defined criteria

Very very long task (As example, around 20% of French laboratories are accredited byCOFRAC, 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

C h


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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 aspecific expertise

To summarize

Th d t i t th t th lit f th l b t & th f th i


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The determinants that ensure the quality of the laboratory & therefore the specimen

results are:

Pre-analytical Analytical Post-analytical

INTERNAL QUALITY CONTROL:

Set of procedures undertaken by the staff

to ensure quality of reports

Investigation

Specimen

Collectiontechnique

Storage andtransportation

Quantity

Labeling

Laboratory

Proficiency of personnel

Reagents stability, integrity and efficiency

Equipment reliability

Specificity & sensitivity of selected test

Procedural reliability using standard operating procedures

Use of appropriate controls

Documentation

Assessment

Recording andreporting

Interpretation

Turnaround time

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

ACCREDITATION: Process of inspection of

laboratories and their licensing by a third

party to ensure conformity to pre-defined

criteria

Laboratory license

Quality Control


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Developed by:

The Department of Epidemic and Pandemic Alert andResponse 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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