QUALITY CONTROL

Achieving quality in the medical laboratory

requires the use of many tools. These
include procedure manuals, maintenance
schedules, calibrations, a quality assurance
program, training and quality control.
What is Quality Control?
Quality control in the medical laboratory is a
statistical process used to monitor and evaluate the
analytical process that produces patient results.
A quality control product is a patient-like material
ideally made from human serum, urine or spinal
fluid. A control product can be a liquid or
freezedried (lyophilized) material and is composed
of one or more constituents (analytes) of known
concentration. They are certified, hence reliable.
Control products should be tested in the same
manner as patient samples.
control can contain any number of
chemistry analytes including
potassium, glucose, albumin and
calcium.
A normal control product contains
normal levels for the analyte being
tested. An abnormal control product
contains the analyte at a
concentration above or below the
normal range for the analyte. For
example, the normal range for a
potassium level is about 3.5 – 5.0
mmol/L. A normal control would
contain potassium at a level within
 INTERNAL QUALITY CONTROL (IQC)

IQC procedure involves:

 Regular testing of quality control products along with

patient samples.
 Comparison of quality control results to specific

statistical limits (ranges).

Calculation and Use of QC Statistics
The most fundamental statistics used by
the laboratory are the mean and standard
deviation
Mean: The mean (or average) is the
laboratory’s best estimate of the analyte’s
true value for a specific level of control.
To calculate a mean for a specific level of
control, first, add all the values collected
for that control. Then divide the sum of
these values by the total number of values.

Standard Deviation : Standard deviation

is a statistic that quantifies how close
numerical values (i.e., QC values) are in
relation to each other.
Coefficient of
Variation [CV]
The Coefficient of Variation [CV] is
the ratio of the standard deviation to
the mean and is expressed as a
percentage.
The CV allows the technologist to
make easier comparisons of the
overall precision. Since standard
deviation typically increases as the
concentration of the analyte
increases, the CV can be regarded
as a statistical equalizer.
 Levey-Jennings Chart (L-J chart)
Standard deviation is commonly used for preparing Levey-
Jennings (L-J or LJ) charts. The Levey-Jennings chart is used to
graph successive (run-to-run or day-to-day) quality control
values.
A chart is created for each test and level of control. The first step
is to calculate decision limits. These limits are ±1s, ±2s and ±3s
from the mean.
 Precision: Refers to the reproducibility of the result
when the same sample is analyzed on different
occasions by the same person.
 Accuracy: Closeness of the estimated result to the

true value.
 When the results are plotted on the Levey-Jennings

chart, an assessment can be made about the quality of

run. “Errors” in an analysis refers to the difference
between the value obtained for a sample and the
actual value of the analyte in it. Errors may be either
systematic error or random error.
 Using a Levey-Jennings Chart to Evaluate Run Quality
SYSTEMATIC ERROR

Trend: A trend indicates a gradual loss of reliability in the

test system. Causes of trending may include:
• Deterioration of the instrument light source
• Gradual accumulation of debris in sample/reagent tubing/electrode surfaces
• Aging of reagents
• Gradual deterioration of control materials
Shift: Abrupt changes in the control mean are defined as shifts. Shifts may be caused by:
• Sudden failure or change in the light source
• Change of reagent lot/Change in reagent formulation
• Major instrument maintenance
• Inaccurate calibration
Random Error
Technically, random error is any deviation away from an
expected result. For QC results, any positive or negative
deviation away from the calculated mean is defined as
random error. There is acceptable (or expected) random
error as defined and quantified by standard deviation.
There is unacceptable (unexpected) random error that is
any data point outside the expected population of data
(e.g., a data point outside the ±3s limits).
 MULTIRULE QC ("WESTGARD RULES“)
Multirule QC uses a combination of decision
criteria, or control rules, to decide whether an
analytical run is in-control or out-of-control. The
well-known Westgard multirule QC procedure
uses 5 different control rules to judge the
acceptability of an analytical run. By
comparison, . "Westgard rules" are generally used
with 2 or 4 control measurements per run, which
means they are appropriate when two different
control materials are measured 1 or 2 times per
material.
Some alternative control rules are more suitable
when three control materials are analyzed, which
is common for applications in hematology,
coagulation, and immunoassays.
Random error is usually indicated by the 13s or R4srules, whereas
systematic error is more likely indicated by the 2 2s,41s, or 10x rules.
Trouble shooting involves inspecting the testing process & identifying the cause of
the problem, Correcting the problem, followed by re-analysis of control samples
again to assess control status.
Proficiency Testing/External
Quality Assessment (EQAS)
A program in which multiple blind
specimens are periodically evaluated by a
group of laboratories for interlaboratory
analysis and/or identification. Each
laboratory’s results are compared with
those of the other laboratories in the
group and/or with an assigned value and
reported to the participating laboratory
and others.
Evaluation of unacceptable PT/EQAS results can lead to quality
improvements. A root cause analysis follows every unacceptable
PT/EQAS result. Quality assurance issues related to daily QC
measurements, QC-data comparison, training of personnel,
standard operating procedures, and maintenance of equipment
are examined with suitable changes instituted, as necessary. This
will generally improve the quality of the testing process.
AGENCIES ORGANIZING EQAS:
a) ACBI /CMC EQA programme
b) College of American Pathologists(CAP)
c) Bio-Rad
d) Randox
OSPE
OSPE
REFERENCE INTERVAL
{
Physicians need a reference measure that they can compare to in order
to make the correct clinical decisions. These reference measures,
obtained from a sample group in the healthy population are termed
“reference interval”.
STEPS INVOLVED IN ESTABLISHING A REFERENCE INTERVAL
According to the CLSI/IFCC:
 Reference Individual is a selected person who meets the defined criteria for

reference individuals for establishing a reference interval for a specific

analyte.
 Reference population refers to all reference individuals in the general

population.
 Reference sample groups are individuals within the reference population

pool.
 Reference values are obtained from the test results of reference sample

group (at least 120 reference individuals).

 Reference distribution is evaluated from reference values.

 Reference limits are calculated from reference values. The reference interval

principle is usually to take the central 95% of a reference population.

 Finally reference intervals are those values that lie between the lower and

upper of the reference limits

 If a literature or manufacturer’s range is to be used in your laboratory a local

validation (for example, using 20 “normal” samples) is required.

Sl.no List of the tests Reference Interval
.
1 Fasting plasma glucose 70 – 100 mg/dl
2. Postprandial plasma
100 to 140 mg/dl
glucose
3. Random plasma glucose 70 – 140 mg/dl
4 Serum Urea 20 – 50 mg/dl
5 Serum Creatinine Male : 0.9-1.3 mg/dl

Female : 0.6 – 1.1

mg/dl
6 Serum Uric acid Male : 3.5 – 7.2 mg/dl

Female : 2.6 – 6.0

mg/dl
7 Triglycerides Up to 150 mg/dl
8 Total Cholesterol Up to 200 mg/dl
9 HDL Cholesterol 40 – 80 mg/dl
Adult Males >40
Adult Females >50
10 LDL Cholesterol Up to 100 mg/dl
11 VLDL 5-40 mg/dl
12
Bilirubin Total: 0.3 - 1.2 mg/dl

13
Bilirubin Direct 0.0 - 0.3 mg/dl
14
Bilirubin indirect 0-0.9 mg/dl
15
Aspartate transaminase Male 10 - 35 U/L
Female 10 - 31 U/L
16
Alanine transaminase Male 10 - 45 U/L
Female 10 - 34 U/L
17
Alkaline Phosphatase 45 - 129 U/L
18
Total Protein 6.4 - 8.3 g/dl
19
Albumin 3.5 – 5.2 g/dl
20
Globulin 2.5-3.4 g/dl
21
A/G ratio 0.9-2
22
Serum Calcium 8.6 -10.2 mg/dl
23
Serum Amylase 28-100 U/L
24
Sodium 136-145 mEq/L
25
Potassium 3.5-4.5 mEq/L
26
Glycated Hemoglobin Below 5.6% :
(HbA1c) Normal
5.7%- 6.4% :
Prediabetic
>=6.5% : Diabetic
 Test Reference Interval
Total 0.72-2.02 ng/ml
Triiodothyronine
(T3)
Total Thyroxine (T4) 4.3-12.5 µg/dl

Thyroid Stimulating 0.4-4.2 µIU/ml

Hormone (TSH)
Free 2.60-5.40 pg/ml
Triiodothyronine
(fT3)
Free Thyroxine 0.93-2.50 ng/dl
(fT4)