Quality Control Training for Labs: Ensuring Reagent and Consumable Quality
LOT VERIFICATION
Labs for Life Project
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What Standards say….
ISO 15189:
5.3.2.3 (Reagents
and consumables
)
Acceptance testing
Each new formulation of examination
kits with changes in reagents or
procedure, or a new lot or shipment,
shall be verified for performance
before use in examinations.
Consumables that can affect the
quality of examinations shall be
verified for performance before use in
examinations.
NABL 112 :
The laboratory shall check each lot of
control and reagent against an earlier
tested in-use control / reagent lot. The
laboratory can follow guidelines
mentioned in Annexure III. Records of
comparative data shall be maintained.
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Transportation
Factors which affect the Quality
of Reagents
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Temperature control during
transport
Temperature Control in your
store before issue
NABL 112
Lot verification is needed for all reagents, Quantitative, Semi
quantitative and qualitative analysis
In this video we will discuss only quantitative lot verifications
Please check details for other details
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Specify acceptance testing for Qualitative
and Quantitative tests
For SQCs
•
Decide the acceptance limits
•
The MDP of each analyte where verification
is needed
•
The material you will use for Lot Verification
•
Quality Specifications eg..TE< TEa/ Sigma> 4
Do you have a QSP?
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Using Sample
Using QCs
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TE/ Sigma
•
Samples to be done in triplicate
with the old and new lots (CLSI EP
26 A)
•
Understand the MDPs
•
Understand acceptable percent
differences
If You are using sample for lot
verification
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If You are using QCs for lot
Verification
Can set better quality specifications like TE and
Sigma
However,
Matrix Effect may be an issue especially in tests like
immunoassays
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Method: Using Samples
Run the same sample (individual or pooled) in
triplicate using old and new lot reagents
Find the percent difference between each run using
the formula
% Difference= (
I
new lot value- old lot value
I
)/ Old lot
value *100
Set acceptance limits ( eg; 1SD at that level / < 10 %)
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Method: Using QC
Using the new lot reagent run the QCs, at all levels, 8 times each
Find the mean and SD
Using the 4 key numbers, Mean, Target, SD and TEa calculate TE and
Sigma
Target value ( is the Mean from old reagent/calibrator lot)
Calculate Sigma performance
Judge Acceptability as per Quality Specifications
Thanks
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This project focuses on maintaining quality control in laboratories by verifying reagents and consumables, adhering to ISO and NABL standards. It includes checking and verifying each lot of control and reagent, assessing transportation factors, monitoring temperature control, and performing lot-to-lot verification using samples and QCs. The project emphasizes the importance of adherence to acceptance limits, material specifications, and using new lot reagents and calibrators.
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Presentation Transcript
LOT VERIFICATION Labs for Life Project QUALITY CONTROL TRAINING QUALITY CONTROL TRAINING
What Standards say. ISO 15189: 5.3.2.3 (Reagents and consumables ) NABL 112 : The laboratory shall check each lot of control and reagent against an earlier tested in-use control / reagent lot. The laboratory can follow guidelines mentioned in Annexure III. Records of comparative data shall be maintained. Acceptance testing Each new formulation of examination kits with changes in reagents or procedure, or a new lot or shipment, shall be verified for performance before use in Consumables that can affect the quality of examinations verified for performance before use in examinations. examinations. shall be 2 10/5/2024 QC TRAINING- LABS FOR LIFE PROJECT
Factors which affect the Quality of Reagents Transportation 3 10/5/2024 QC TRAINING- LABS FOR LIFE PROJECT
Transportation Temperature and Storage temperature Transportation Temperature and Storage temperature Temperature Control in your store before issue Temperature control during transport 4 10/5/2024
NABL 112 Lot verification is needed for all reagents, Quantitative, Semi quantitative and qualitative analysis In this video we will discuss only quantitative lot verifications Please check details for other details 5 10/5/2024 QC TRAINING- LABS FOR LIFE PROJECT
Do you have a QSP? Specify acceptance testing for Qualitative and Quantitative tests For SQCs Decide the acceptance limits The MDP of each analyte where verification is needed The material you will use for Lot Verification Quality Specifications eg..TE< TEa/ Sigma> 4 6 10/5/2024 QC TRAINING- LABS FOR LIFE PROJECT
(CLSI EP 26 A) (CLSI EP 26 A) Lot to lot Verification can be done by: Using Sample Using QCs 7 10/5/2024 QC TRAINING- LABS FOR LIFE PROJECT
New lot Reagent/ Calibrator QC Sample Estimate difference and difference % TE/ Sigma Acceptable limits Not OK OK Use for reporting of samples Repeat/Root Cause/Reject 8 10/5/2024 QC TRAINING- LABS FOR LIFE PROJECT
If You are using sample for lot verification Samples to be done in triplicate with the old and new lots (CLSI EP 26 A) Understand the MDPs Understand acceptable percent differences 9 10/5/2024 QC TRAINING- LABS FOR LIFE PROJECT
If You are using QCs for lot Verification Can set better quality specifications like TE and Sigma However, Matrix Effect may be an issue especially in tests like immunoassays 10 10/5/2024 QC TRAINING- LABS FOR LIFE PROJECT
Method: Using Samples Run the same sample (individual or pooled) in triplicate using old and new lot reagents Find the percent difference between each run using the formula % Difference= (I new lot value- old lot value I)/ Old lot value *100 Set acceptance limits ( eg; 1SD at that level / < 10 %) 11 10/5/2024 QC TRAINING- LABS FOR LIFE PROJECT
Method: Using QC Using the new lot reagent run the QCs, at all levels, 8 times each Find the mean and SD Using the 4 key numbers, Mean, Target, SD and TEa calculate TE and Sigma Target value ( is the Mean from old reagent/calibrator lot) Calculate Sigma performance Judge Acceptability as per Quality Specifications 12 10/5/2024 QC TRAINING- LABS FOR LIFE PROJECT
Thanks 13 10/5/2024 QC TRAINING- LABS FOR LIFE PROJECT
