Basics of QC & Westgard rules

By: ARUN SHARMA

APPLICATION SPECIALIST (QC)-
North India
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 Regulations Tell Us We Should!

Worldwide
ISO (International Organization for Standardization)
Recommends use of internal quality control systems to
ensure reliability of patient test results

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 More Regulations…

United States
CLIA (Clinical Laboratory Improvement Amendments)
“Laboratories must test controls at prescribed intervals… at
least two different concentrations should be used”

CLSI (Clinical and Laboratory Standards Institute)

“Control materials need to be different from calibrator
materials”

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 And Yet More Regulations...

Australia
NATA (National Association of Testing Authorities)
“The laboratory must have a system of long term monitoring of
internal quality control results to assess the method
performance”

India
NABL (National Accreditation Board for testing &
calibration laboratories, India)
“The laboratory should include a minimum of one level of QC at
least once a day” (more if >25 patient samples per day)

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  But It More About Patient care………

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 But It’s Really Is About Patient Care

Patient test results provided by your laboratory allow health

care providers to make critical, and potentially life-saving,
diagnostic and therapeutic decisions

These decisions are only as good as the results that you

provide

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 To Summarize... Why Use QC?
 It’s About Regulations
Tell us we should run QC

 It’s About Patient Care

Making informed decisions

 It’s About Cost

Consider the cost of not using QC (or not using it right)

 It’s About Laboratory Credibility

Confidence in results

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 What Is Quality Control ?

Quality Control in a Medical Laboratory is the statistical

process used to monitor and evaluate the analytical
process that produces patient results.

Statistical quality control (SQC) is the term used to

describe the set of statistical tools used by quality
professionals.

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 Types of Quality Control
Laboratory with good Quality Control Program will
generally adopt two separate , but complimentary to each
other , assuring quality of service.

Quality Control

External QC Internal QC

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 Precision & Accuracy

Precision ✔ Precision ✔ Precision ✘

Accuracy ✔ Accuracy ✘ Accuracy ✘✘

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 Internal Vs External Quality control

Internal Quality Control: IQC specimens comprises either

1. In-house patient sera (single or pooled clinical samples), or

2. International serum standards with values within each clinically
significant ranges.
3. Use to check the precision of testing system.

External Quality control (EQA/ILC/PT):

1. Is a mechanism to ensure standardized testing across clinical
laboratories and evaluate your lab’s performance in comparison to peer
groups performance.
2. Uses commercially available materials & evaluations
3. Use to check Accuracy.

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 What is a Control?

 A control is a “Patient-Like” sample composed of one or

many constituents whose concentrations are known. The
constituent or analyte concentrations are represented by a
range of acceptable values with upper and lower limits.
Controls are used to monitor the precision and accuracy of
the diagnostic testing system.

 When the observed control values fall within the acceptable

range, the laboratories can confirm the test system is
working properly and the patient results can be reported
with confidence.

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 Purpose of Quality Control

 It gives the confidence to report patient samples.

 Minimization of Error.
 Precision check.
 Accuracy check.

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 What Is calibration ?

 Calibration is “setting” the analyzer to give correct

results using calibrating materials

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 Difference in QC and Calibrator

Quality Control Calibrator

QC is checking to see if the analyzer is Calibration is “setting” the analyzer to

producing correct results. give correct results using calibrating
Checking the instrument’s calibration materials, not QC materials.
and other analytical processes

QC goes for value assignment Calibrator is made by traceability

process
QC has a range Calibrator has a specified value

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 How dose the basic QC works ?

 Step 1: Run a control sample

 Step 2: Compare result with expected range of values derived from

previous testing

 Sept 3: Check to see if the result is right

 yes -- system is working : report good patient results

 no -- system is not working :do not report any bad data

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 QC Statistics

 Mean

 Standard Deviation

 Coefficient of Variation

 The Standard Deviation Index / Z - Score

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 Mean

•The mean is defined as the

arithmetic average of a set of data
points. In other words it is the sum
divided by the count (N).

•The mean describes the “central

tendency” of the data set. In the
clinical laboratory, the mean identifies
the “target value” of a set of data
points

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 Establishing Mean
 According to CLSI (C24-Statistical Quality Control for Quantitative
Measurement Procedures: Principles and Definitions) recommends
that at least 20 data points collected from 20 or more “separate” runs
be used to establish laboratory target values for control materials.

 The mean provides a good estimate of the true value or accuracy for a
specific level of control. May also be used to indicate the presence of
systematic error.

 External Quality Assessment (EQA) and Peer Group

Comparison programs will provide useful information on the means and SDs
observed in other laboratories.

 Peer group comparison programs can also be used to automatically

calculate the mean and cumulative means.
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 SD-Standard Deviation

 Standard Deviation (SD): Degree of dispersion of data point about the

mean.
 Used to set limits (Range) upon which control result acceptability is
determined
 A method/instrument --low standard deviation– good precision
 A method/instrument -high standard deviation- poor precision, greater
variability

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 SD-Establish Decision Limit

Both the mean and SD are used to  Result: 101, 102, 103, 104,
establish decision limits. A 2SD 105
range is adopted by most  Mean: 103
laboratories.  1SD: 1.6
 Once the mean and SD have  2SD: 1.6x2= 3.2
been established calculate 2SD
 Calculation:
by multiplying the SD by 2
Low= 103-3.2= 99.8
 To establish the lower decision
limits subtract 2SD from the High= 103+3.2=106.2
mean  +/-2SD Range= 99.8 to 106.2
 To establish the upper decision
limits add 2SD to the mean.

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 Normal or Gaussian distribution

The figure here is a representation of the frequency distribution of a large

set of laboratory values obtained by measuring a single control material.

This distribution shows the shape of a normal bell curve.

In a normalized distribution it is estimated that

68% of data points will be within +/- 1SD
95% of data points will be within +/-2SD
99.7% of data points will be within +/-3SD

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 Coefficient of variation ( CV)

 The CV is essentially the SD expressed

as a percentage of the mean

 The coefficient of variation (CV) is a

measure of variability.

 CVs of 5% or less generally give us a

feeling of good method performance,
whereas CVs of 10% and higher sound
bad. However, we should look
carefully at the mean value before
judging a CV.

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 Why CV is useful?

 The SD of a method is dependent on concentration i.e. the

higher the concentration the larger the SD.

 The CV can therefore be used to assess performance over a

range of concentrations

 CV reflects a ratio of the standard deviation to the concentration,

it is often provides a better estimate of method performance
over a range of concentrations.

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 Standard Deviation Index ( SDI)
The standard deviation index [SDI]
is a peer-based estimate of
reliability.
The target SDI is 0, which indicates
the Lab Mean is same as Peer’s
Mean.

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 Coefficient of Variation Ratio (CVR)

 The coefficient of variation ratio compares your laboratory

precision for a specific test to the CV of other laboratories
performing the same test.

 Ratio less than 1.0 indicates that precision is better than the peer
group.
 Ratio greater than 1.0 indicates that imprecision is larger.
 Ratio greater than 1.5 indicate a need to investigate the cause of
imprecision.
 Ratio of 2.0 or greater usually indicates need for troubleshooting
and corrective action.
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 WESTGARD RULES

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 Westgard Rules

Random Error Systematic Error

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Random Error:
 Sudden unexpected change in the testing system or Measuring unit
 Which leads one control value out side the acceptable limits
 Random errors can be eliminated

Systematic Error:
 Unexpected change and continued will leads more than one QC
values out side the acceptable limits
 Systematic Errors can’t be eliminated but can be minimized by a
systematic approach

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The following are the Important Westgard rules which a lab can follow
to monitor there QC.

1-2s: Warning Rule

2-2s: Rejection Rule
1-3s: Rejection Rule
R4s: Rejection Rule
10X: Rejection Rule
41S: Rejection Rule

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 12s
12s : refers to the control rule that is commonly used with a Levey-
Jennings chart when the control limits are set as the mean plus/minus
2s. In the original Westgard multirule QC procedure, this rule is used as a
warning rule to trigger careful inspection of the control data by the
following rejection rules.

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 2 2s
22s : reject when 2 consecutive control measurements exceed the same
mean plus 2s or the same mean minus 2s control limit.

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 13s
13s : refers to a control rule that is commonly used with a Levey-
Jennings chart when the control limits are set as the mean plus 3s and
the mean minus 3s. A run is rejected when a single control measurement
exceeds the mean plus 3s or the mean minus 3s control limit.

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 R 4s
R4s : reject when 1 control measurement in a group exceeds the mean
plus 2s and another exceeds the mean minus 2s.

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 10 X
10x : reject when 10 consecutive control measurements fall on one side
of the mean.

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 4 1s
41s : reject when 4 consecutive control measurements exceed the same
mean plus 1s or the same mean minus 1s control limit.

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 Conclusion

Problem identified by Westgard rule violated

Systematic Error (bias) 1 3s, 2 2s, 4 1s, 10x

Shifts, drifts, or trends Calibration failure

OR

Random Error (imprecision) 1 3s, R4s

Poor reproducibility / Outliers

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 Example 1

12s
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 Example 2
13s

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 Example 3

22s

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 Example 4

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 Example 5

R4s

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 Thank You
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Using Unity™ as a Complete QC System
 Unity Real Time LT

 Facilitates regulatory compliance under CLIA and

ISO 15189
 Provides high-quality run validation with
comprehensive audit trails
 Provides advanced data analysis charts and
reports
 Enables consolidation of QC management into one
advanced platform
 Enables participation in the Unity™ Interlaboratory
Program for external feedback on laboratory
performance

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 Lab Setup

 Only basic configuration

 Sort lab numbers (NEW)
47  Duplicate lab with selected lot numbers
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 Lot Setup

 Only basic configuration

 Copy function to copy lots
across lab numbers

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48 |
 Test Setup

 Only basic configuration

 Sort tests alphabetically
 Search and filter function

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 Unity Real Time LT
Westgard Rule Configuration screen

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 Unity Real Time LT

Data Entry Screen Layout

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 Levey-Jennings

 Delta f indicates changed fixed mean or SD

 And codified actions are displayed on demand
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 Bar Chart

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 Point Data Report

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 Dr. Westgard’s recommendations

Emphasizes Doing Right QC Right

•Don’t use 2 SD control limits

•Don’t just repeat controls
•Don’t use the same control rules for all tests
•Don’t use bottle values to establish control limits
•Don’t rely on electronic checks alone
•Don’t eliminate statistical QC in POC applications

•Do standardize QC operations

•Do establish control limits from your own laboratory data
•Do select QC procedures that minimize false rejections
•Do define the quality required for each test
•Do select QC procedures that detect medically important errors
•Do adopt modern QC planning tools & techniques

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