DOING THE RIGHT THING IN A RIGHT WAY
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PPTC, Wellington, NZ
Mistakes are made in laboratories every day
What is Quality Control (QC)? IQC (Internal QC)
Mean,SD and CV
Westgard Rules
Defination???
refers
to the measures that must be included .
Introduction Laboratory Quality Management System-Module 1
to ensure that the results generated by the test are correct and reliable. the right test is carried out on the right specimen, and the right result and right interpretation is delivered to the right person at the right time
Man
Material Machinery Manuals/Methodology ( SOP) Motivation
The Quality Assurance Cycle
Patient/Client Prep Sample Collection Reporting Data and Lab Management Safety Customer Service Personnel Competency Test Evaluations
Sample Receipt and Accessioning
Record Keeping Quality Control Testing Sample Transport
SET OF PROCEDURES UNDERTAKEN BY THE LABORATORY STAFF FOR THE
MONITORING OF LABORATORY WORK IN ORDER TO DECIDE WHETHER THE RESULTS ARE RELIABLE ENOUGH TO BE RELEASED.
Internal Quality control: IQC
Nature: Concurrent Performed by: lab staff Objective: Reliable results on a daily basis
WHATS THAT??
Values cover medical decision points
Similar to the test specimen
Available in large quantity
Stored in small aliquots
Ideally, should last for at least 1 year
Often use biological material, consider biohazardous
Sufficient material from same lot number or serum pool for one years testing
Note the date of the QC material opened.
May be frozen, freeze-dried, or chemically preserved Requires very accurate reconstitution if this step is necessary Always store as recommended by manufacturer
Need data set of at least 20 points, obtained over a 30 day period Calculate mean, standard deviation, coefficient of variation AND determine target ranges
Develop Levy-Jennings charts and plot results
Select appropriate controls Assay them repeatedly over time at least 20 data points Make sure any procedural variation is represented Determine the degree of variability in the data to establish acceptable range
Consider the following data set: 3.6, 3.1, 2.7, 2.9, 3.4 Mean
The mean, or sample average, provides a measure of centering. Sample Standard Deviation (SD)
SD is a measure of the spread, or variability, in a data set. Most scientific calculators contain a feature for calculating standard deviation.
The coefficient of variation (CV) is the standard deviation (SD) expressed as a percentage of the mean Ideally should be less than 5%
SD CV x 100 mean
Must use Biological Variation (BV) to calculate the SD. BV will provide CV values for all the analytes. From there we must calculate the SD Example: BV value for Albumin is 1.6 CV=SD/Mean x100 1.6 =SD/24 x 100 SD=6.7
Use Levy-Jennings chart. Plot control values of each run, make decision regarding acceptability of run. Monitor over time to evaluate the precision and accuracy of repeated measurements
Review charts at defined intervals and take necessary action
Consider using Westgard Control Rules
Uses premise that 95.5% of control values should
fall within 2SD
Commonly applied when two levels of control are used
Use in a sequential fashion.
JAMES WESTGARD
Multirule Quality Control
Uses a combination of decision criteria or control rules Allows determination of whether an analytical run is in-control or out-ofcontrol
12S
rule 13S rule 22S rule
R4S
rule 41S rule 10X rule
warning rule
One of two control results falls outside 2SD
Alerts MLTs - possible problems
Detects systematic error or random error Not a cause for rejecting a run
+3SD +2SD +1SD Mean -1SD -2SD -3SD
12S rule violation
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Day
If either of the two control results falls outside of 3SD, rule is violated Detects random error
Run must be rejected If 13S not violated, check 22S
+3SD +2SD +1SD Mean -1SD -2SD -3SD
13S rule violation
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Day
2 consecutive control values for the same level fall outside of 2SD in the same direction, or Both controls in the same run exceed 2SD
Detects systematic error Patient results cannot be reported Requires corrective action
+3SD +2SD +1SD Mean -1SD -2SD -3SD
22S rule violation
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Day
Requires control data from previous runs
Four consecutive QC results for one level of control are outside 1SD, or Both levels of control have consecutive results that are outside 1SD Detects systematic error
+3SD
+2SD +1SD
Mean
-1SD -2SD -3SD
1 2 3 4 5 6 7 8 9
R4S rule violation
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Day
Requires control data from previous runs
Ten consecutive QC results for one level of control are on one side of the mean, or Both levels of control have five consecutive results that are on the same side of the mean Detects systematic error
+3SD +2SD +1SD Mean -1SD -2SD -3SD
10x rule violation
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Day
Stop testing Identify and correct the problem Repeat testing on patient samples and controls Do not report patient results until problem is solved and controls indicate proper performance
Do a summary report of the performance of each analytes. Compare the performance with Unity Report (if available).
Accumulate 1 month CV and compare with the Biological Variation.
Establish written policies and procedures Assign responsibility for monitoring and reviewing Train staff Obtain control materials
Collect data
Set target values (mean, SD) Establish Levy-Jennings charts Routinely plot control data Establish and implement troubleshooting and corrective action protocols Establish and maintain system for documentation
