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EDITORIAL

Quality Assurance (QA) in Laboratory Testing


Md. Tahminur Rahman

Prof. Dr. Md. Tahminur Rahman, Professor & Head, Pathology


Anwer Khan Modern Medical College, Dhanmondi, Dhaka
email: tahminurrahman@yahoo.com

Government of Bangladesh has recently approved a Quality control (QC) or the other hand covers the
draft on National Health Policy with an aim to reach part of quality assurance which primarily concerns
the minimum Health care facility (MDG) by 20151. the control of errors in the performance of tests
and verification of test results. Quality control
The purpose of the health care system in a country
must be practical, achievable and affordable. The
is to correctly diagnose the disease, identify the
primary aim of quality control is to do the test
factors responsible for the disease and take
reliably. The broad aim of quality control is that
appropriate preventive and curative measures to
results from one lab should be comparable with
control the disease. The pathologists and
that from any lab in the world provided the same
laboratory people are very much involved in the
method is followed2.
correct diagnosis, effective treatment and follow
up of the patients. For correct diagnosis quality Quality control can be implemented in two ways:
assurance and quality control are very important.
a. Internal or intra laboratory QC-performed by
A test wrongly done is worst than a test not done.
individual labs at their own levels. It forms the
Quality control is the process to ensure prevent a
day to day basis working quality assurance.
test from being done wrongly. Laboratory quality
control is designed to detect, reduce and correct b. External or inter laboratory QC-performed by
deficiencies in laboratories analytical process to many labs at the same time, monitored by one.
release patient results and improve the quality of It is costly.
test result2. Many international agencies supervise quality
Quality assurance (QA) is aimed at ensuring assurance namely ISO, ioQA, intertek and Quality
quality test results. The purpose of quality assurance program run by different reputed laborites
assurance is to give relevant, reliable, timely test aboard. Proper QA dramatically improve the
results which is interpreted correctly. Quality effectiveness of QC program of a laboratory4,5,6.
assurance involves activities both inside and For histo and cytopathology quality control
outside laboratory, good laboratory practice and involves intra departmental consultation, random
proper management skilll. The WHO definition of case review, intra departmental and inter
quality assurance is a total process whereby the departmental conference, inter institutional
quality of lab reports can be quaranteed3. review, specimen adequacy record, lost specimen
It has been summarised as the record, turn about times, techniques i.e staining,
proper sectioning, embedding, fixation, re and de
• right result, at the
hydration of samples, clearing, mounting,
• right time, on the labelling etc7,8,9.
• right specimen, from the For biochemistry quality control involves optimum
condition variance (OCV), routine condition
• right patient, with result/interpreatation based on
variance known value (RCVK), composite and
• correct reference date, and at the logn term assay, computer aided check, accuracy
• right place and precision tests. Accuracy is defined as

AKMMC J 2011; 2(2): 03-05


04 █ AKMMC J 2011; 2(2) Md. Tahminur Rahman
closeness of the test result and accepted true value, Faults may also be with the specimen. A faulty
whereas precision is a measure of reproducibility. specimen is one which is inadequate, collected at
Daily QC chart preparation is mandatory. Control incorrect time in dirty and contaminated container,
value within ± 2SD is good sign and patient’s in a container without proper anticoagulant and
results obtained are reliable and can be reported. If stored incorrectly or in hemolysed status. These
control value is beyond ± 2SD the result must not are known as pre analytical faults.
be reported and fresh control serum should be
In the analytical stage the faults resulting in wrong
measured together with few patients sample. If the
findings if the principle and procedure of the test is
result is now within ± 2SD, the result can be
not strictly followed; reagents, standards, QC
reported. The type of material used for QC are
materials are not prepared, mixed, processed
frozen, pooled serum; commercially available
properly and performance standards are not
lyophilized freeze dried pool serum; commercially
followed strictly.
available low temperature liquid serum pools7.
In the post analytical stage the faults may occur if
For microbiology quality control involves use of
reporting, checking and verifications are not done
ATTCC strains of organisms for standardization,
properly, interpretation of test results are not
measuring the disc potency, MIC, media
considered seriously, and abnormally/unexpected
contamination, standardization of staining
result is not taken seriously and not reviewed and
procedures, autoclaving and sterilizaiton of media,
or performed again.
Safe disposal of infected materials is also an
important procedure to maintain standard lab It is very important to maintain QA and QC for
proactice. reliable, quick and dependable results in shortest
possible time. This will help the clinicians to come
For hematology standardization of staining
to a correct diagnosis and treat the patient early.
procedures, preparation of proper blood film, bone
This will lead to early recovery and save working
marrow smear, special staining techniques flow
time, money for the patient and the nation. But to
cytometry, chromosome analysis are the mainstay
achieve this all the relevant parties involved ie the
of quality conrol.
clinicians, pathologists, patients all have equal
Wrong test results are caused by faults on the part responsibilities.
of the clinicians like sending samle without
To monitor QA and QC, minimize errors
identificaiton number and name of the test,
establishment of a Central Reference Laboratory
collection date, appropriate container, sending
and Institute of Pathology is a must and need of
specimens divided in several parts to different
the hour. The sooner the Government, peoples
labs; without clinical history, provisional
representatives, Medical professionals, Social
diagnosis, other relevant test results,
workers, Journalists, Patients and their relative
radiology/imaginf reports/etec.
understand this, the better is the out come.
Wrong results are also caused by the faults of Bangladesh Society of Pathologists should come
laboratory and the pathologists which can be up with concrete proposals for this and talk to the
divided into preanalytical stage faults, analytical Government and other appropriate agencies for its
stage faults and post analytical stage faults. In the early implementation. The good news is that
preanalytical stage the faults are misidentification Government has accepted in principle the concept
of patients due to incomplete ID, incorrectly of a Central reference laboratory, allocated budget
labelled specimen container, partly erased or for this project and preliminary baseline work has
illegible label and disparity between request form been done. Now the society of Pathologists should
and specimen. work shoulder to shoulder with Ministry of Health
for quick implementation of the project.
Quality Assurance (QA) in Laboratory Testing █ 05
Reference 5. Quality assurance ioglobal. net www. ioglabal.net.
1. National Health Policy January 2010, Final Draft 6. Quality Control Testing labortory www. interetck-
Prepared by Ministry & Health & Family Welfare Govt. cb.com/analytical/gelab. shtml.
of Bangladesh. 7. Talib VH, A hand book of medical laboratory
2. Kumar V, Abbas AK, Fausto N Robbins & Cotran technology. 2nd ed2002, CBS publishers and distributors,
pathologic Basis of Disease.ed. 7th 2004 Saunders USA. India: 227-32.
3. Rosai. J. Rosai and Ackerman’s Surgical Pathology ed. 8. Internet search on quality control and quality assurance.
9th ed. Mosby USA; 2004: 2790-2799. 9. Gowenlock AH, McMurry JR and McLauchian DM.
4. Laboratory Quality Control wikipedia, Varley’s clinical biochemistry; 1st Indian edition, CBS
www eu. wikipedia. org/wiki/Lab. quality control. publishers and distributors India; reprint 2002: 285-300.

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