Quality Assurance in

Hematology Laboratories

Clinical Correlations 449

Dr. A. Al-Awadhi
• The terms quality control and quality
assurance are used to refer to the control of
the testing process to ensure test results meet
quality requirements.

• Nevertheless, quality assurance is more

expansive and entails monitoring of numerous
parameters.

• Quality control is an important part of the

quality assurance program.
 Quality Assurance
• It is the coordinated effort to organize all
the various activities in the laboratories in
order to provide the best possible service
to the patient and the physician.

• It is divided to two major components:

➢Non-analytical factors
➢Analytical factors (analysis of quantitative
data)
 Non-analytical Factors
• Non analytical factors that support quality
testing include the following:

1) Laboratory space and equipment

➢ Always keep clean
➢ Provide adequate space and ventilation
➢ Proper voltage stability, temperature, humidity
➢ Check water supply, waste outlets
➢ Maintenance
➢ Daily and weekly checks of accuracy
➢ Daily calibrations using known controls
2) Reagents
• Must verify: Name of reagent, purpose of use,
concentration, date of preparation,
date of expiry, storage temperature, initials of
preparer.

3) Appropriate methodology
• When new methods are introduced, it is
important to check for accuracy and variability.
• Replicate analyses using control specimens are
recommended to check for accuracy and
eliminate factors such as day to day variability,
reagent variability and differences between
technicians.
• New methods must provide speed, ease of
performance and reliable outcome.
4) Qualified personnel

➢ Validation of degree obtained

➢ Full identification of personnel
➢ Job description
➢ Responsibilities and duties to be
performed
➢ Years of experience
➢ Participation in continuing education
activities to maintain competence
5) Established laboratory manual and standard
operating procedures (SOPs)

• Laboratory policies should be included in a

laboratory reference manual that is available to
all hospital personnel.

• SOPs are written instructions that detail the

steps to be performed during a given
experimental procedure and include information
about potential hazards and how these hazards
will be delt with.
6) Patient sample

➢ Complete request form (name, age, gender,

patient number, ward, doctor, type of specimen,
test requested)
➢ Correct method of sample collection
➢ Correct transport and storage of samples
➢ Sample rejection policy
• SOPs documents must include the following:

➢ Type, quantity, and nature of the chemical used. Note that the
Safety Data Sheet (SDS) lists important information regarding
potential hazards that will need to be considered, such as toxicity,
flammability, reactivity, warning properties, and symptoms of
exposure.
➢ Location of use, including fume hood or other containment devices.
➢ Experimental procedures that include safety measures to reduce
exposure.
➢ Available safety equipment, including personal protective
equipment.
➢ Waste collection, storage, and disposal requirements.
➢ Decontamination procedures.

• SOPs should be written by laboratory personnel who are most

knowledgeable and involved with the experimental process.

https://ipo.rutgers.edu/rehs/sop
7) Accuracy in reporting results

• Patient results must be recorded correctly using correct

figures and units.
• Appropriate labeling must be rechecked - correct result
sent to the right patient.
• When extremely abnormal results (panic or critical value)
or differences from previous results are found, the
laboratory protocol should establish the method of
rechecking and reporting the results to the attending
physician.
• Appropriate communication (verbal or written) is critical
to high quality patient care.
Mubarak Hospital

Maternity Hospital
 Analysis of Quantitative Data
• It is important for Hematology technologist
to understand basic statistical concepts
and terms used for quality assurance.

• Terms used in clinical quality assurance

include:

➢Accuracy: describes how close the test

result is to the true value.
➢ Precision: describes how close the test results
are to one another when repeated analyses of
the same material are performed
(reproducibility)
➢ Control: represents a specimen that is similar in
composition to the patient’s whole blood or plasma.

• The value of the control specimen is known.

• Control specimens are tested in exactly the same way as

the patient specimen.

• Control samples are usually run:

➢ At the beginning of each shift
➢ After an instrument is serviced
➢ When reagent lots are changed
➢ After calibration
➢ Whenever patient results seem inappropriate
➢ Standards:
• Are highly purified substances of known
composition.
• A standard may differ from control in the overall
composition and in the way it is handled in the
test.
• Standards are used to calibrate instruments or to
define a standard curve for analysis.
• Standards are the best way to measure
accuracy.

➢ Calibration:
• Is the comparison of an instrument
measurement or reading to a known standard.
 Internal Quality Control

• Internal quality control involves the analysis of

control samples along with patients’ specimens
and evaluation of the results statistically to
determine the acceptability of the test run.

• Results of internal quality control assessment

can be displayed on statistical charts for ease of
monitoring.
 Quality Control Chart
The Levey-Jennings Chart
• Quality control charts are used in the clinical
laboratory to graphically display the assay
values of controls versus time.

• The Levy-Jennings chart is the traditional

approach to monitoring quality control.

• The control results are plotted on the y axis

versus time on the x axis.

• The chart shows the expected mean value by

the solid line in the center and indicates the
confidence limits of acceptable values by the two
lines above and below the mean.
• Confidence limits are calculated from the mean
and SD.

• The confidence limits represent a set of

mathematically established limits into which the
majority of the results will fall.

• Within the confidence limits, the results are

assumed to be accurate.

• It is common practice to use ± 2SD as the limit

for confidence - (the area in which 95% of values
fall).

• If the control value falls outside the confidence

limits, the control and patients’ results can not be
reported and are considered incorrect.
 Types of Change in the Levey-
Jennings Chart

• The classification of changes in quality

control system is important because
different kinds of changes suggest
different sources of problem.

• Three types of changes are commonly

observed in the Levey-Jennings chart:
1) Systematic drift or trend:

• This type of change is displayed when the

control value direction moves progressively in
one direction from the mean for at least 3 days.

• This problem may be because of the

deterioration of a reagent or control.

• Diluents' contamination affects RBC and WBC

controls with an upward trend as bacterial
growth increases.
2) Increased dispersion of results:

• This change is observed when random

errors (values beyond the ±2SD limits)
increase.

• This type of pattern indicate

inconsistency in technique or a stability
problem (e.g. fluctuating electrical
voltage or poor mixing of a cellular
control specimen).
+2SD

Mean

-2SD
3) Shift or abrupt change in results:

• This change is seen when values of

control shift suddenly from one level to
another.

• This problem is associated with the

malfunction of an instrument or an error
in the technique.
 External Quality Control
• In internal quality control programs, the precision of the
test method, not the accuracy, is usually monitored.

• The accuracy of a test method can be evaluated by

comparing the performance of the analysis with an
external quality control program.

• The external quality control program provide a means

whereby the performance of each laboratory of an
identical specimen can be evaluated and compared
against the performance of laboratories with the same
method across the country.

• A laboratory performance is evaluated by how close its

results compare with those of the accurate value.
 Identifying source of error
• While all control procedures can highlight an
analytical problem, they do not identify the
source of error or solve the problem.

• One way of identifying errors is physical

inspection of analytical method, equipment,
reagents and specimen.

• The inspection should include reviews of logs

and records that document changes occurring in
the instrument or reagent.
• Knowing type of error is key in identifying source of error.
For example:

➢ Systematic errors (within test system of method) are

often related to calibration problems such as impure
calibration materials, improper preparation of standards,
unstable or contaminated standards, inadequate
calibration techniques, etc.

➢ Random errors (mistakes without prediction or regularity)

are due to lack of reproducibility in pipetting samples and
reagents, dissolving of reagents, mixing of samples and
reagents, lack of stability in temperature baths, timing
regulation and photometric or other sensors.

External quality control procedures may provide information about

systematic errors
https://www.scribbr.com/methodology/random-vs-systematic-error/