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Quality assurance in laboratories. Quality Control. May 2007. 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. Quality is.

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Quality assurance in laboratories l.jpg

Quality assurance in 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


Quality l.jpg
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


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Quality ?

  • Consistency

    • Accuracy

    • Precision

  • Right result

    • First time

    • Every time


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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


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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


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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

Audit, On-site inspection

Internal

External

Accreditation

Man-driven

Material-driven

  • Quality Assessment

    • Internal

    • External

    • Schematic way: External Quality Assessment 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

Sample

Transport

Sample

handling

Sample

receiving

Sample

Collection

Analysis

Patient

preparation

Outside laboratory

Within laboratory

Requisition

Results

Patient

Reports

Doctor


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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: Analytical

PROFICIENCY OF PERSONNEL:

Education, Training, Aptitude, Competence, Commitment, Adequate number, CME, Supervision, Motivation

EQUIPMENT RELIABILITY:

Meet technical needs, Compatible, User & maintenance friendly, Cost effective, Validated

REAGENTS STABILITY, INTEGRITY AND 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 the needs/ objectives, validated

  • USE OF APPROPRIATE CONTROLS:

  • Internal: Labs, Calibrated against national

  • External: Supplied by manufacturer, National, International

ANALYTICAL FACTORS

Procedural reliability using Standard Operating Procedures

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


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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, 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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2-2 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 togetherand 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

    • Quality assurance (procedures, way of working)

    • IQC

    • EQC

    • Networking of the laboratories

    • … 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 andtactfully 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


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To summarize

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


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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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