QUALITY ASSURANCE

AND
PROFICIENCY TESTING

DR.C.C.CHEMONGES
 Objectives
· To present the requirements necessary
for acceptable level of good laboratory
practice and to be reassured that this level
is constantly maintained (i.e. quality
assurance).
 Learning points and goals
· To know programmes of quality management as
• Internal quality control,
• External quality assessment,
• Pre-analytic and post-analytic control
• Standardization.

· At the end of the presentation, we should be

able to
– Understand the principles of Quality control
– Understand the importance for internal and external
quality control schemes
 Quality is....
· invisible when GOOD

· impossible to ignore when BAD

 The flow chart in the main laboratory considerations
- Standard conditions
- Posture Specimen collection QUALITY MANAGEMENT
- Tourniquet
- Anticoagulant
Specimen transit PRE-ANALYTIC CONTROL
Intra laboratory

- Test request recorded

Selected methods IQC
- Instrumental calibration EQA
- Equipment check Standardization
Analytic process

Data processing

POST ANALYTIC CONTROL

Records

- Technical
Significance Usually in-built in automated
- Doctors/specialists Reporting
Reference values methods

Reports transit to clinic areas

 The patient Test selection Sample collection

Laboratory
analysis
Report creation Sample transport
Examination
phase

Report transport
 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
 Quality ?
·Consistency

– Accuracy
– Precision
·Right result
– First time
– Every time
 Variables that affect the quality of
results
1. The educational background and training of
the laboratory personnel
2.The condition of the specimens

3.The controls used in the test runs

4.Reagents

5.Equipment

6.The interpretation of the results

7.The transcription of results

8.The reporting of results

 Errors in measurement
· True value - this is an ideal concept which cannot
be achieved.
· Accepted true value - the value approximating
the true value, the difference between the two
values is negligible.
· Error - the discrepancy between the result of a
measurement and the true (or accepted true
value).
 True Value vs. Measured Value
True Value Measured Value
The known, accepted The result of an
value of a quantifiable individual’s
property measurement of a
quantifiable property
 Sources of error
1. Input data required - such as standards used,
calibration values, and values of physical constants.
2. Inherent characteristics of the quantity being measured
- e.g. CFT and HAI titre.
3. Instruments used - accuracy, repeatability.
4. Observer fallibility - reading errors, blunders,
equipment selection, analysis and computation errors.
5. Environment - any external influences affecting the
measurement.
6. Theory assumed - validity of mathematical methods
and approximations.
 Systematic vs. Random Errors
Systematic Error Random Errors
Avoidable error due to Unavoidable errors
controllable variables that are always
in a measurement. present in any
measurement.
Impossible to
eliminate
 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
· The terms “quality assurance” and “quality control”
are often used interchangeably to refer to ways of
ensuring the quality of a service or product.
· The terms, however, have different meanings.
· Assurance: The act of giving confidence, the state
of being certain or the act of making certain.
Quality Assurance: The planned and systematic
activities implemented in a quality system so that
quality requirements for a product or service will be
fulfilled.
The Quality Assurance Cycle

Patient/Client Prep
Sample Collection
Personnel Competency
Reporting Test Evaluations
•Data and Lab
Management
•Safety
•Customer
Service Sample Receipt
and Accessioning

Record Keeping

Quality Control Sample Transport

Testing
The Quality System

Organization Personnel Equipment

Process
Purchasing Control Information
(QC & EQA) &
& Inventory Specimen
Management
Management

Documents Occurrence
Assessment
& Records Management

Process Customer Facilities &

Improvement Service Safety
 QAP ensures;
 Personnel with  Detection of errors
adequate training and  Prompt and corrective
experience. measures
 Proper specimen  Preventive maintenance
collection.  Continuous training of
 Proper performance staff
of tests.  Documentation
 Coordination
 Efficient processing
 Timely feedback
of results.
 Reagents and
equipment are of good
quality
 Quality Control
· Control: An evaluation to indicate needed
corrective responses; the act of guiding a process in
which variability is attributable to a constant
system of chance causes.
Quality Control: The observation techniques and
activities used to fulfill requirements for quality.
 It’s a process of effective & systematic
monitoring of laboratory performance
 Ensures that the laboratory results are accurate,
reliable and reproducible
 Ensures the competency of diagnostic services
 Quality Control applied to:
· Lab. arrangement & administration
 Equipment
 Collection & transport of specimens
 Handling of specimens
 Stains & reagents
 Analytical procedures
 Reporting of results
 Quality Assurance vs. Quality Control
Quality Assurance Quality Control
· · A series of
An overall
management plan to analytical
guarantee the measurements used
integrity of data to assess the quality
(The “system”) of the analytical
· A system designed to data (The “tools”)
continuously improve the
reliability and efficiency
of laboratory service
 4 components of QA programme
1 ) Internal Quality Control ( IQC )
2 ) External Quality Control ( EQC )
3 ) Standardization
4 ) Proficiency surveillance

QA = IQC + EQA

Continuously and Retrospective

concurrently and periodic
assessing lab
work
 The objective of QA is to achieve precision & accuracy
· Accuracy
- the closeness of the estimated value to the true
mean
- can be checked by the use of reference materials
which have been assayed by independent methods
of known precision
· Precision
- reproducibility of a results, whether accurate or
inaccurate within a define frame time ( eg: within
the same day, from week to week etc )
- can be controlled by replicate tests, check tests on
previously measured specimens and statistical
evaluation of results
 Accuracy vs. Precision
Accuracy Precision
· How well a · How well a series of
measurement agrees measurements agree
with an accepted with each other
value
Accuracy vs. Precision
 Assessment of Quality System
Man-driven Material-driven

· Audit, On-site • Quality Assessment

inspection
• Internal
> Internal
• External
> External • Schematic way:
External Quality
· Accreditation Assessment Scheme
(EQAS)
 1 - Internal quality control in laboratory
· Set of procedures undertaken by the staff to ensure
quality of reports
· Based on monitoring the tests procedures that are
performed in the lab
· Total process beginning with sample collection up
to final reporting
 IQC…..
· Includes measurements on specially prepared
materials, and repeated measurements on routine
specimens, statistical analysis and day by day data
obtained from the tests which have been routinely
carried out
· Is intended to ensure that there is continual
evaluation of the reliability of the work of the lab
and that control is exercised over the release of the
results
· It is primarily a check of precision but not
necessarily accuracy
 Quality in labs is mainly a mutual
responsibility of…..
· Laboratory specialists
· Clinicians
· Public health physicians
 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
 Factors influencing quality:
Pre-analytical
· 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
 Factors influencing quality:
Analytical
PROFICIENCY OF EQUIPMENT RELIABILITY:
PERSONNEL: REAGENTS STABILITY, INTEGRITY Meet technical needs,
Education, Training, Aptitude, AND EFFICIENCY: Compatible, User & maintenance
Competence, Commitment, Stable, Efficient, Desired quality, friendly, Cost effective, Validated
Adequate number, CME, Continuously available, Validated
Supervision, Motivation SPECIFICITY &
SENSITIVITY OF
SELECTED TEST:
USE OF APPROPRIATE Adequate ST, Sufficient SP,
CONTROLS: cost effective, compatible
• Internal: Labs, Calibrated ANALYTICAL with, available
against national infrastructure and
• External: Supplied by FACTORS expertise, interpretable,
manufacturer, National, meets the needs/
International objectives, validated

DOCUMENTATION: Procedural
Assessment
All the written policies, plans, reliability using
procedures, instructions and records, Standard
quality control procedures and recorded Operating
test results involved in providing a Procedures
service or the manufacture of a product
 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
 Standard Operating Procedures
(SOP)
·Comprehensively written
document that describes the
SOP for
laboratory procedure and all Gram
Staining
other related issues
·Essential for ensuring
uniformity in laboratory
procedures
 Validation
· It’s about determining whether something does what
it is supposed to do
· Importance of validation;
– Validation - before you introduce something
– Re-validation
> after you have changed/modified
> periodic
– Validation is applied to:
> SOP
> reagents
> equipment
> software
 Factors influencing quality:
Post-analytical
·Right recording and reporting
· Right interpretation
– Range of normal values

· Right turnaround time

· Report to right user
 Reporting
· Unequivocal message
· Numerical value with units as and when required
· KISS ! (Keep it short & simple)
· Bottom-line
–Quality costs ,
–but poor quality costs more …
 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
 External Quality Assessment (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
· Includes comparison of a laboratory's result at
intervals with those of other laboratories
· The main objective is the establishment of
trueness as it;
1. helps identify potential areas of error within the laboratory that Internal QC
may fail to highlight.
2. is a valuable on-going teaching resource
 EQA How?
· Participating clinical laboratories are sent samples on a
regular basis which they test as if they had come from
patients.
· Results are returned to EQA centres which provide a
report that compares the participant's performance with
that of all laboratories and/or groups of laboratories using
the same test method(s).
· Aim;
1. To establish inter-laboratory comparability (accuracy).
2. To influence the reliability of future testing.
3. To ensure credibility of the laboratory.
4. In stimulating performance improvements.
 EQA………
· 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
 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
 Objectives of EQA schemes……..
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- & inter-lab) to alert
professionals &/or govt. bodies about problems
related to traceability & 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;
 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)
 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 …)
 The ideal situation: 2 types together
and very targeted on-site visits
· On-site visits:
– Expensive, heavy
– Only for one laboratory
– 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
 Quality Control Measures
· Standards and Calibration
· Blanks
· Recovery Studies
· Precision and Accuracy Studies
· Method Detection Limits
· NJQLs
 Standardization
· Refers to both materials and methods
· A material standard or reference preparation is used
to calibrate analytic instruments and to assign a
quantitative value to calibrators
· A reference method is an exactly defined technique
which provides sufficiently accurate and precise
data for it to be used to assess the validity of other
methods
· International reference preparations are not freely
available for routine use but are intended to act as
standards for assigning values to commercial ( or
lab produced ) ‘secondary standard’ or calibrators
 Proficiency surveillance
· Implies critical supervision of all aspects of
laboratory tests ( collection, labelling, delivery,
storage of specimens before the tests are preformed
and of reading and reporting of results )
· Also includes maintenance and control of
equipment and apparatus
· It is necessary for correct interpretation of test
results, for the lab to establish normal reference
values that are valid for their test methods and their
local population
 Control materials
· A reference standard is a substance ( e.g.; Hb std ) that has
been characterized by chemical or physical means and has
specific values.
· International reference standard are manufactured by or on
behalf an international organization (e.g.; WHO, Clinical
& Laboratory Standards Institute -CLSI)
· A reference material is a substance (e.g.; plasma) or device
(e.g.; reference beads ) that conform to national or
international reference std. This material is used to ensure
accuracy of the test procedure
· A calibrator is a substance or device that conforms to a
reference std or specification. It is used to calibrate an
apparatus or to adjust a measurement to obtain accurate
results
 Statistics of QC
· Mean ( x ) the total score of all the measurements divided
by the number of measurements

· Standard deviation ( SD ) – variation in measurement

obtained in lab tests
formula: SD = Σ ( x – x )2
n–1
n : number of measurement

· Coefficient of variation ( CV ) – relation of SD to the

actual measurement
formula : CV = SD X 100%
x
 Analysis of data
· Standard deviation of control specimens
- if value assigned to a specimen a number of times,
dispersion of results around the mean will indicate
the error of reproducibility
- 95% of results on the same specimen should be
within ± 2 SD and 99.7% within ± 3 SD
- by chance, 1 in 20 of measurement might expected
to fall outside 2 SD and only 1 in 333 outside 3
SD
- If measurement more widely dispersed, this
indicates an error in the test
 Control Charts & Rules
1. Shewhart Control Chart
2. Westgard rules
3. Warning rules
4. Mandatory rules
 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
 Summary
· Carry home messages……..
– Quality assurance measures what a lab can do to
improve reliability
– The determinants that ensure the quality of the
laboratory & therefore the specimen results are IQC &
EQA
– EQA complements the IQC procedures that
laboratories use to monitor within- & between-
analytical run variability.
· Quality ensures right result at right time on the
right specimen from right patient using right
technique to test it!
 Right

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