BASICS AND QUALITY

CONTROL IN CLINICAL
LABORATORY
CLINICAL BIOCHEMISTRY-
BMB1303

LECTURE 1
Quality Control
Quality Assurance
Quality Assessment
 Clinical biochemistry Definition

 Clinical Biochemistry : division of laboratory medicine that

deals with the measurement of chemicals in blood, urine
and other body fluids.

 These test results are useful for detecting health

problems, determining prognosis and guiding the therapy
of a patient.
 Mainly deals with the biochemical aspects that are
involved in several conditions.
 Qualitative and quantitative analysis results of body
fluids assist the clinicians in the diagnosis, treatment
and prevention of the disease and drug monitoring,
tissue and organ transplantation and forensic
investigations.
Clinical Biochemistry
 Various biological fluids subjected to
chemical tests and assays include blood,
plasma, serum, urine, cerebrospinal fluid
(CSF), ascetic fluid, pleural fluid, faeces,
calculi and tissues.

Note:- Modern day medical practice is highly

dependent on the laboratory analysis of body
fluids, especially the blood. The disease
manifestations are reflected in the composition
of blood and other tissues.
Hence, the demarcation of abnormal from
normal constituents of the body is another aim
of the study of clinical biochemistry.
Clinical Biochemistry Laboratory:
 In the era of modern technology, health
care delivery system involves so many
different personnel and specialties that the
caregiver must have an understanding and
working knowledge of other professional
endeavors, including the role of diagnostic
evaluation.

 Basically, laboratory and diagnostic tests

are tools by and of themselves, they are
not therapeutic.
Clinical Biochemistry Laboratory:

 In conjunction with a pertinent history and

physical examination, these tests can
confirm a diagnosis or provide valuable
information about a patient status and
response to therapy.

 In addition to these, laboratory findings are

essential for epidemiological surveillance and
research purposes.
Scopes Of Clinical Biochemistry:
 Deals with the chemical nature, structure and
functions of the chemicals of life so is
involved in various research related works.

 Used in clinical diagnosis, manufacture of

various biological products, treatment of
diseases ,in nutrition, agriculture.
Scopes Of Clinical Biochemistry:

 Has revealed the abnormalities in

biomolecules metabolism and their
relationship to various diseases.

 Has helped to correct these disorders

with dietary modifications or genetic
manipulations.

 Has ramified into many branches of

science like Medicine, pharmacy,
Microbiology, Agriculture etc.
Role of medical/Clinical laboratory
science in Health Care:
 The medical laboratory services play a
pivotal role in the promotion, curative and
preventive aspects of a nation’s health
delivery system.

 The service gives a scientific foundation by

providing accurate information to those with
the responsibility for:
Role of medical/Clinical laboratory science in
Health Care:
1. Treating patients and monitoring their
response to treatment.

2. Monitoring the development and spread of

infectious and dangerous pathogens
(disease causing organisms).

3. Deciding effective control measures against

major prevalent disease.

4. Deciding health priorities and allocating

resources.
Contd…
Without reliable laboratory services:
 The source of a disease may not be
identified correctly.
 Patients are less likely to receive the
best possible health care.
 Resistance to essential drugs may
develop and continue to spread.
 Epidemic diseases may not be identified on
time and with confidence.
 Quality control in themedical laboratory is a
statistical process used to monitor and evaluate the
analytical process that produces patient results.

 Quality control refers to the measures that

must be included during each assay run to verify that
the test is working properly

 QUALITY CONTROL: set of operations carried out in the

laboratory aimed at ensuring the adequate likelihood of
measurement of results.
 Quality Assurance :overall program that ensures that
the final results reported by the
laboratory are correct.
i. Quality assurance means quality enhancement

ii. Quality assurance aims at ensuring that the data

provided are reliable and relevant

iii. Quality assurance involves all measures that can be

taken to improve laboratory efficiency and
effectiveness.

iv. It ensures laboratory performance with minimum risk

for laboratory workers and gives maximum benefit to
the individual and community
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
 Quality Assurance vs. Quality
Control
Quality Assurance Quality
Control
Overall management Series of analytical
plan to guarantee the measurements used
integrity of data (The to assess the
“system”) quality of the
analytical data (The
“tools”)
Quality Assurance vs. Quality Control

 The aim of quality control is simply to ensure

that the results generated by the test are
correct.

 However, quality assurance is concerned

with much more that the right test is carried
out on the right specimen, and the right
result and right interpretation is delivered to
the right person at the right time
  Also known as proficiency testing

 Quality Assessment is a means to determine

the quality of
the results generated by the laboratory
 Quality Assessment may be external or internal
 Quality Assessment is a challenge to the QA
and QC programs
 Support provision of high
quality health-care

 Reduce
morbidity

 Reduce
mortality

 Reduce
economic loss
 Generate confidence in
 Ensure credibility of lab
lab results
 How to implement a QC program?
– Establish written policies and procedures

– Assign responsibility for monitoring and reviewing

– Train staff

– Obtain control materials

– Collect data

– Set target values (mean, SD)

– Establish control charts.

– Routinely plot control data

– Establish and implement troubleshooting and corrective
action
protocols

– Establish and maintain system for documentation

→
Specimen
→
Collection technique
→
Storage and
→ transportation
→ Quantity
Labeling
→ Mismatch of sample
→ Laboratory : No
necessary test capacity
 Control of Preanalytical
Variables
Preanalytical variability is defined as errors which occur
when non-analytical factors change the conc. of analytes
• Test conducted- appropriate test should be requested &
performed
• Patient identification- labeling of specimen may be
improper; corrected by bar coding
• Turnaround time (TAT)-should be kept minimum
• Laboratory logs- entry of patient & test details in lab
registers & computers
• Transcription errors- a substantial risk of transcription
error exists from manual entry of data, even when results
are double checked; computerization reduces this error
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 Control of Preanalytical
• Variables
Patient preparation- proper patient preparation is essential
to obtain meaningful test result
• Specimen collection- container, anticoagulant, time
taken to send specimen to lab, corrected by using
vacutainer tubes & collection of samples by lab personnel
• Specimen Transport- critical for some tests
• Specimen Separation, aliquoting- monitoring of the
performance of the centrifuge, container used for storage
• Personnel- variation fr person to person. Safety precautions
for all specimens. Throughput time to be monitored on a
weekly or monthly basis
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 Factors influencing analytical variables
PROFICIENCY OFPERSONNEL:
REAGENTS STABILITY, INTEGRITY AND EFFICIENCY: EQUIPMENT RELIABILITY:
Education, Training, Competence, Stable, Efficient, Desired quality Meet technical needs, Compatible, User &
Commitment,Supervision, maintenance friendly, Cost effective, Validate

SPECIFICITY & SENSITIVITY OF SELECTED

TEST:
Adequate ST, Sufficient
SP, cost effective, compatible with, available
infrastructure and
USE OF APPROPRIATE CONTROLS:
expertise, interpretable, meets
• Internal: Labs, Calibrated
the needs/objectives, validated
• External: Supplied by manufacturer,
National, International

Procedural reliability
using Standard
DOCUMENTATION: Operating Procedures
All the written
Assessment policies, plans, procedures, instructions and records,
quality control procedures and recorded test results
involved in providing a service or the manufacture of
a product
 Control of Analytical
• Analytical variables must be controlled carefully to
Variables
ensure accurate measurements by analytical methods
• Reliable analytical methods are obtained through
careful process of :
(1) Selection
(2) Evaluation
(3) Implementation
(4) Maintenance
(5) Control
• Clear concepts in relation to Analytical methods-
Calibration, trueness, accuracy and precision.
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 Sample Sample
Transpor Sample
handling
Sample t receiving
Collection
Analysis
Patient Outside laboratory
preparation
Within laboratory

Requisition
Results

Patient
Doctor Reports
 If you have not documented it,
you have NOT done it …
 If you have not documented,
it is a RUMOUR !!!
 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
 Key Documents
• Results archive
– File results in an organised and easily accessible manner
• Laboratory monitoring
– Documentation of temperature monitoring, reagent
control, accuracy/precision assays, corrective
actions, audit reports
• Instrumentation
– Standard operating procedures(SOPs)
– Equipment files + Manuals
– Service history records of the instrument.
– Records of daily, weekly and monthly calibrations and
maintenance
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 It is a comprehensively written
document that describes the laboratory
procedure and all other related issues

 Essential for ensuring uniformity in

laboratory procedures
 The SOP should define test performance,
tolerance limits, reagent preparation,
required quality control, result reporting
and references
 Right recording and reporting
 Right interpretation(Range of
normal values)
Right turnaround time(time from
when a test is ordered until the
result is reported)
Report to right user
 Reporting results
• Proper procedure includes:
– All data entry results should be verified by a section
head or supervisor (when available) and reviewed
by management for final interpretation and release
of results
– In the event that a report has already been sent out
and needs correction, a new report is issued with
updated report written on it
• The old report remains in the patient file
– Verbal result reports should be documented, listing
the time of the receipt of the report
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