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

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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

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

Laboratory Training for Field Epidemiologists

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

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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 !!!

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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

SOP for Gram Staining

laboratory procedures

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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 !
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(Keep it short and simple)

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, 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;

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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 )

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

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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

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

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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

Laboratory Training for Field Epidemiologists