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QC Statistical Process Control

QC Statistical Process Control outlines quality control procedures for medical laboratories. Regular quality control testing using normal and abnormal controls monitors the analytical testing process. Control results are plotted on a Levey-Jennings chart, which uses mean and standard deviation calculations to establish decision limits at ±1s, ±2s, and ±3s. Trends or shifts seen on the chart indicate systematic errors like instrument deterioration, while random errors are any deviations from the mean within expected standard deviation limits. The chart is used to evaluate testing runs and ensure reliable patient results.

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Wulan Nureva
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66 views

QC Statistical Process Control

QC Statistical Process Control outlines quality control procedures for medical laboratories. Regular quality control testing using normal and abnormal controls monitors the analytical testing process. Control results are plotted on a Levey-Jennings chart, which uses mean and standard deviation calculations to establish decision limits at ±1s, ±2s, and ±3s. Trends or shifts seen on the chart indicate systematic errors like instrument deterioration, while random errors are any deviations from the mean within expected standard deviation limits. The chart is used to evaluate testing runs and ensure reliable patient results.

Uploaded by

Wulan Nureva
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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QC Statistical Process Control

Wimba Widagdho Dinutanayo


Jurusan Analis Kesehatan – Poltekkes Tanjungkarang
TABLE OF CONTENTS

01 Recap QC 03 Levey Jennings


Chart

02 Calculations
Recap :
01 Quality Control
What is Quality Control?
● Quality control in the medical laboratory is a statistical process used to
monitorand evaluate the analytical process that produces patient results

● QC results are used to validate whether the instrument is operating


within pre-defined specifications, inferring that patient test results are
reliable.
How does the person performing the test
know that this result is truly reliable?

Regular use of quality Statistical process


control materials control
Quality Control Products

● A quality control product is a patient-like material ideally made from


human serum, urine or spinal fluid
● Control products should be tested in the same manner as patient samples
● A quality control product usually contains many different analytes and
has different range : low, normal, high
Regular Testing

● Good laboratory practice requires testing normal and abnormal controls


for each test at least daily to monitor the analytical process.

● Regular testing of quality control products creates a QC database that


the laboratory uses to validate the test system.

● Validation occurs by comparing daily QC results to a laboratory-defined


range of QC values.

● The lab-defined range is calculated from QC data collected from testing


of normal and abnormal controls.
Regular Testing
02 Calculations
Calculating a Mean [x]
The mean (or average) is the laboratory’s best
estimate of the analyte’s true value for a specific
level of control
Calculating a Standard Deviation [s]
 Standard deviation is a statistic that quantifies how close numerical values (i.e., QC values) are in
relation to each other.

 Standard deviation is calculated for control products from the same data used to calculate the mean.
It provides thelaboratory an estimate of test consistency at specific concentrations.
Calculating a Standard Deviation [s]
To calculate the standard deviation for the normal level of control (Level I)
in Table 1, begin by calculating the mean [ x ]:

x = 4.0 + 4.1 + 4.0 + 4.2 + 4.1 + 4.1 + 4.2 mmol/L ÷ 7


x = 28.7 mmol/L ÷ 7
x = 4.1 mmol/L
03 Levey-Jennings 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.
 When an analytical process is within control,
approximately 68% of all QC values fall within
±1 standard deviation (1s).

 Likewise 95.5% of all QC values fall within ±2


standard deviations (2s) of the mean.

 About 4.5% of all data will be outside


the ±2s limits when the analytical process is in
control.

 Approximately 99.7% of all QC values


are found to be within ±3 standard deviations

 As only 0.3%, or 3 out of 1000 points,


will fall outside the ±3s limits

 Any value outside of ±3s is considered to be


associated with a significant error condition and
patient results shouldnot be reported.
Using a Levey-Jennings Chart
to Evaluate Run Quality
Systematic Error

Systematic error is evidenced by a change in the mean of the


control values. The change in the mean may be gradual and
demonstrated as a trend in control values or it may be abrupt
and demonstrated as a shift in control values.
Trend

A trend indicates a gradual loss of reliability in the test system. Trends


are usually subtle. Causes of trending may include:

•• Deterioration of the instrument light source


•• Gradual accumulation of debris in
sample/reagent tubing
•• Gradual accumulation of debris on
electrode surfaces
•• Aging of reagents
•• Gradual deterioration of control materials
•• Gradual deterioration of incubation chamber
temperature (enzymes only)
•• Gradual deterioration of light filter integrity
•• Gradual deterioration of calibration
Shift

Abrupt changes in the control mean are defined as shifts. Shifts in QC


data represent a sudden and dramatic positive or negative change in
test system performance. Shifts may be caused by:

•• Sudden failure or change in the light source


•• Change in reagent formulation
•• Change of reagent lot
•• Major instrument maintenance
•• Sudden change in incubation temperature
(enzymes only)
•• Change in room temperature or humidity
•• Failure in the sampling system
•• Failure in reagent dispense system
•• Inaccurate calibration/recalibration
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).
THANKS

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