QP 04

HUSM/HEMA-UPT/QP-04
ASSURING QUALITY OF TEST RESULTS
HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY HOSPITAL UNIVERSITI SAINS MALAYSIA
Prepared by: Checked by: Approved by:
Rohana Yusof Assoc. Prof. Dr. Wan Zaidah Abdullah Assoc Prof Dr Rosline Hassan
15.08.2009 01.10.2009 01.11.2009
Effective date:
01.11.2009
HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSM ASSURING QUALITY OF TEST RESULTS (HUSM/HEMA-UPT/QP-04) TITLE: TABLE OF CONTENT Page Version 2 of 8 2
PAGE
TABLE OF CONTENT
Title of Quality Procedure
Table of Content
Record of Amendment and Record of Review
Objective, Scope, Abbreviation, Definition and References
Procedure and Responsibility
Record
Other Related Document
Flow Chart Appendices i. ii. iii. iv. v. vi. Appendix 1 (a) : Internal Quality Control Schedule Appendix 1 (b) : Establishing Own QC Established Own QC Mean, Standard Deviation Ranges Appendix 2: Indications of repeat calibration and QC test Appendix 3: Corrective actions for unacceptable calibration and QC results Appendix 4: Validation of test calibration and QC results Appendix 5: Internal Quality Control Summary Report
Prepared by Checked by Approved by
Rohana Yusof Assoc. Prof. Dr. Wan Zaidah Abdullah Assoc. Prof. Dr Rosline Hassan
Effective Date
01.11.2009
Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

Sebarang cetakan dan penggunaan semula mana-mana bahagian dalam dokumen ini tidak dibenarkan
HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSM ASSURING QUALITY OF TEST RESULTS (HUSM/HEMA-UPT/QP-04) RECORD OF AMENDMENT VERSION NO 1 DATE 01.11.2009 DESCRIPTION OF AMENDMENT Addition appendix 6 Amendment 1: page 8/8 Revise of flowchart Amendment 2: exclusion of Appendix 6 and 7 2 20.07.2010 Amendment 3: page 3/8 6.7 amend procedure. 6.10 excluded from procedure. Amendment 4: page 6/8 Removed External QC File in QP04 Record. Amendment 5: appendix 5 Changed the appendix 5 accordingly Transform to online documentation in http://www.medic.usm.my/hematology/index.php/qp04 Amendment 1: page 7/8 merge LEVEL 4 STM with level 3 QP Amendment 2; Appendix 4 Update new test in validation of QC Amendment 3 Update on Establishing own QC ranges Update list of references (9&10) Amend Procedure 6.1 & Appendix 1 a&b SIGNATURE OF APPROVAL TITLE: RECORD OF AMENDMENT AND RECORD OF REVIEW Page Version 3 of 8 3
2 3 3
01.08.2010 04.08.2010 04.08.2010
5.12.11
RECORD OF REVIEW DATE OF REVIEW 05.07.2010 21.03.2011 21.03.2011 NAME OF REVIEWER Assoc. Prof. Dr. Wan Zaidah Abdullah Assoc. Prof. Dr. Wan Zaidah Abdullah Pn. Salamah Pn. W. Soriany SIGNATURE OF REVIEWER SIGNATURE OF APPROVAL
Effective Date
01.11.2009

HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSM Page ASSURING QUALITY OF TEST RESULTS (HUSM/HEMA-UPT/QP-04) 1. 2. TITLE: OBJECTIVE, SCOPE, ABBREVIATION, DEFINITION AND REFERENCES Version 4 of 8 3
OBJECTIVE To closely monitor the validity of test undertaken in order to ensure the quality of test results SCOPE All types of laboratory tests performed either manually or by automation in both Haematology laboratory and Transfusion Medicine Unit ABBREVIATION EQC HOD LD LH MLT SO STM UKP QA QC DEFINITION Quality Assurance : External Quality Control : Head of Department : Lab Director : Lecturer of Haematology : Medical Laboratory Technologist : Scientific Officer : Standard Technical Manual : Unit Kejuruteraan dan Penyelenggaraan : Quality Assurance : Quality Control : Planned and systematic activities implemented within the quality system and demonstrated as needed, to provide adequate confidence that an entity will fulfill requirements for quality. : A test between intended used reagent and known value sample (Normal/ abnormal) in order to counter check the validity of the subsequent test on patients sample. : A test between intended used reagent and calibrator (with known value) in order to obtain standard curve of the test. : Receipt of Sample : Sample Processing : Process of Handling External QC Samples : Corrective action for non-conformance : Preventive Action for non-conformance : Calibration and maintenance of equipment : Management of consumable reagents : Practical Quality Control Guide For Quantitative Analysis In the Clinical Laboratory : Validation, Verification and Quality Assurance of Automated Hematology Analysers; Approved Standard Second Edition. H26-A2. Vol. 30 No.14 : Streck Establishing Quality Control Means and Standard Deviation for Hematology Instrumentation.
3.
4.
Quality Control
Test calibration 5.
REFERENCES 1) HUSM/HEMA-UPT/QP01 2) HUSM/HEMA-UPT/QP02 3) HUSM/HEMA-UPT/QP03 4) HUSM/LCD/QP-05 5) HUSM/LCD/QP-06 6) HUSM/LCD/QP-16 7) HUSM/LCD/QP-18 8) MHT/DL T47 9) MHT/DL 252 10) MHT/DL 258
Effective Date
01.11.2009

HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSM ASSURING QUALITY OF TEST RESULTS (HUSM/HEMA-UPT/QP-04) 6. NO TITLE: PROCEDURE Page Version 5 of 8 3
PROCEDURE AND RESPONSIBILITY ACTIVITY RESPONSIBILITY MLT/SO REFERENCE STM each test Appendix 1 (a) Appendix 1 (b) STM each test / Appendix 1 (a) Appendix 2 Appendix 3
Internal/External QA activity: 6.1 Prepare schedule for regular test calibration and related QC activities; e.g.: establishing QC mean, SD ranges 6.2 Perform calibration tests (accordingly) and QC prior to the testing of test samples or simultaneously during testing of sample Repeat calibration and QC when necessary Record any Corrective Action taken in worksheet Notes: If repeatedly unsatisfactory calibration and internal QC to call vendor Validate the result of Test Calibration & QC Record the Calibration in calibration file and Internal QC Test Result in internal QC File Run test samples
MLT/SO
6.3 6.4
MLT/SO MLT/SO
6.5 6.6 6.7
MLT/SO MLT/SO MLT/SO
Appendix 4
6.8 6.9
Plot daily, review frequently (as recommended in Appendix 4) and generate monthly Internal QC Charts/ Results Perform remedial action if necessary and record in the Internal QC File
MLT/SO /LH MLT/SO /LH
HUSM/HEMAUPT/QP-02, QP-05 STM each test STM each test QC file Appendix 5
Effective Date
01.11.2009

HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSM ASSURING QUALITY OF TEST RESULTS (HUSM/HEMA-UPT/QP-04) 7. RECORD NO. 7.1 7.2 TYPE OF RECORD Calibration Record & Internal QC File or in the respective instrument (analyzer)* External QC File LOCATION All section in the department Cabinet RETENTION PERIOD 3 years 5 years TITLE: RECORD Page Version 6 of 8 3
* The retention period for Calibration and QC result in the instrument (analyzer) varies from one analyzer to the other. Once the capacity is reached, the admission of the subsequent result will cause deletion of the first entered result/data. Each section is advised to keep hard copies on their QC data. 8. OTHER RELATED DOCUMENT List of Standard Technical Manual (STM) refer to Masterfile: a. Makmal Hematologi (HUSM/Hema/PK/001) b. Makmal UPT (HUSM/HEMA-UPT/ RK-001T )
Effective Date
01.11.2009

HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSM ASSURING QUALITY OF TEST RESULTS (HUSM/HEMA-UPT/QP-04) 8. FLOWCHART TITLE: FLOW CHART Page Version 8 of 8 3
ASSURING THE QUALITY OF TEST RESULTS INTERNAL QA
Prepare schedule for test calibration & related QC activities
Repeat Perform test calibration & QC
Unsatisfactory Validate Internal QC Satisfactory Document in Internal QC file
Troubleshooting and Record Corrective Action
Plot daily internal QC charts/results
Review Internal/External QC performance
Unsatisfactory
Record the trend and take appropriate action ** if repeatedly unsatisfactory call vendor
Effective Date
01.11.2009

Appendix 1(a) INTERNAL QUALITY CONTROL SCHEDULE Unit/ Division Haematology Laboratory Frequency of Internal QC Test and QC review Daily QC: for routine tests - FBC - ESR - G6PD - PT/APTT - D-dimer - Fibrinogen Weekly QC: Drift to monitor for routine test - FBC - PT/APTT/Fib/D-Dimer In batches (Specialized Test) - Lupus Anticoagulant - Anti-thrombin - Protein C assay - Protein S assay - vWF antigen - Immunophenotyping (monoclonal antibodies) - Fibrinogen (calibration) - Hb Analysis - Serum Ferritin Simultaneously with the test - Bone Marrow Aspiration for MGG, PERL and Cytochemistry - G6PD Screening Test - Hb Electrophoresis - Hams Test - OFT - Factor assays (calibration) - Molecular tests - Immunophenotyping Daily (Immunohematology, rujuk Rekod Kawalan Mutu Dalaman) - ABO Rhesus grouping - Antibody screening - Hemoglobin Estimation (Finger Prick) Daily/In Batches: (internal QC) - anti HIV - anti HCV (8 hourly) - HBsAg Monthly QC - Packed Cells - Platelet Concentrate (Random & Apheresis) - Fresh Frozen Plasma - Cryoprecipitate Simultaneously with the test - Direct Antiglobilin Test - RBC Phenotyping - Antibody Identification - Rhesus Genotyping
Transfusion Medicine Laboratory
* Recalibration must be done every time change lot/batches except QC for blood components
HUSM/HEMA-UPT/QP-04/A1(b)

Appendix 1(b) ESTABLISH OWN QC MEAN, STANDARD DEVIATION RANGES Each laboratory is required to establish its own mean and acceptable ranges and use the value obtained as own guides, and CLIA (Chemical Laboratory International Association) also deems it as a good laboratory practices. Procedure for establishing own mean and Standard Deviation (SD): 1. Analyze the control a minimum of 20 times. 2. Take the average of these runs. 3. This average should be within the range stated on the assay sheet. 4. If the average is within range, it will be considered as the new mean. 5. Calculate a two Standard Deviation range from the results. 6. Incorporate this SD range around the new mean and monitor throughout the dating of the product. 7. The mean and SD values should be periodically recalculated during the life of the new lot. If the instrument is working properly, your SD should not change significantly from lot to lot. Here is a procedure that may be used to set a preliminary mean until 20 runs have completed as in the previous procedure: 1. Analyze the control ten times. 2. Take the average of these runs. 3. This average should be within the range stated on the assay sheet. 4. If the average is within range, it will be considered as the temporary mean. 5. Use your established laboratory SD or your SD from your latest STATS report (from the same level of control) as your Temporary SD. 6. When you have run the control 20 times, utilize the above procedure to establish your new mean for this lot of control. The laboratorys calculated mean should fall within the range listed on the published assay. All QC results for an individual laboratory do not need to fall within the published assay range. It is advised to recalculate the mean and ranges periodically or every new LOT changes.
HUSM/HEMA-UPT/QP-04/A1(b)

Appendix 2 INDICATIONS OF REPEAT CALIBRATION AND QC TEST Repeat calibration and QC test are indicated when: 1) Calibration & QC are out of range (Appendix 4). 2) When using a new lot of reagent (may require revision of QC chart if present of significant batch changes) 3) Short stability of reagent 4) After an equipments underwent service, maintenance and following repairment (may require revision of QC chart if presence of significant changes in test results) 5) When skewing of QC results from Levy-Jennings Chart or other QC monitoring methods/charts (Appendix 4) Note: Examples of skewing of QC results or QC are out of range a) b) c) d) One widely deviant result outside 3SD = a gross error or blunder Two or more results on or outside the +2SD or -2SD limits = random errors Several consecutive values on one side of the mean = calibration fault (to exclude) Consecutive values constantly rising (or falling) = continuing bias error
HUSM/HEMA-UPT/QP-04/A2

Appendix 3 CORRECTIVE ACTION FOR UNACCEPTABLE CALIBRATION AND QC RESULTS The fault for unacceptable QC results maybe in the reagent or the laboratory ware or caused by incorrect adjustment/calibration of the instrument, technical error or even to clerical error in transcribing the results. Before an intensive investigation, the test should be repeated with another QC sample and the possibility must also be considered that the inconsistency may be due to deterioration or infection of the batch material. Checklist for reagent checking: 1) Expiry date not exceeded 2) No turbidity or physical damage 3) Proper storage (temperature, humidity, etc.) 4) Follow the preparation recommended by manufacturer Checklist for equipment checking: 1) Previous component replacement 2) Instrument maintenance and calibration (recent changes) 3) Instrument move 4) Follow the technical manual (instruction) Contact UKP/manufacturer for further troubleshooting if problem persist. The corrective actions taken are jotted in the worksheet displayed below in appendix 5.

Appendix 4 VALIDATION OF TEST CALIBRATION AND QC RESULTS A test cannot be performed if the QC results are not acceptable. Hence, all the QC results relevant to the test should be validated before a particular test is done. If the QC test are run together with the test samples, the QC result should be validated first before the result of tests samples are accepted. Test Calibration and QC results are acceptable and validated when: 1) QC results are within recommended range 2) The control results (positive and negative) are in accordance to their expected finding 3) All consumables reagents and instrument dealing with the test are satisfactory following their respective Quality Procedures and manual. 4) QC charts are satisfactory. The graphs for QC monitoring, e.g., Levy-Jennings Chart, shows no drift or bias, etc. QC chart review by responsible personnel for different section is elaborated below: Haematology Routine: QC materials for 2-3 levels are performed once daily in the morning. Results of daily QC should be ideally within 1 SD (for all levels). The review of QC results should be done once/ week (5 working days) to see for the trend and bias. The results above/below 1SD but within 2SD is acceptable, however results above 2SD are not acceptable for all control materials. If the results during review are violated as in Westgard rule 4(1s) noted consecutively, troubleshooting should be considered as recommended before. (41s The rule is violated within the control materials when the last 4 controls values of the same control level exceed the same mean +1s or the same mean 1s limit.) This may not require to rejecting samples, but it can be an indicator to perform instrument maintenance and/or calibration. The review should also look at the trend and graph bias. Should the last 10 consecutive results are on the same side of the mean within same control material (although within 2 SD), trouble shooting should also be considered pending on the tests performance. Similarly, this may not require to rejecting samples, but it can be an indicator to perform instrument maintenance and/or recalibrate. ESR: QC materials for 2 levels are performed once daily in the morning. Results of daily QC should be ideally within 1 SD (for all levels). The review of QC results should be done once/ week (5 working days) to see for the trend and bias. The results above/below 1SD but within 2SD is acceptable, however results above 2SD are not acceptable for all control materials. G6PD: QC materials: Deficient and Normal control are run parallel with test samples.
Coagulation: QC materials for 2 levels are performed once daily for routine test. Results of daily QC should be ideally within 1 SD (for all levels). The review of QC results should be done once/ week (5 working days). The results above/below 1SD but within 2SD are acceptable, however results above 2SD are not acceptable for all control materials. If the results during review are violated as in Westgard rule 4(1s) noted consecutively, troubleshooting should be considered as recommended before. (41s The rule is violated within the control materials when the last 4 controls values of the same control level exceed the same mean +1s or the same mean 1s limit.) This may not required to rejecting the samples, but it can be an indicator to perform instrument maintenance and/or calibration. For INR calibration and APTT sensitivity to factors / Heparin, details procedure is explained in the STM of coagulation section.
The review should also look at the trend and graph bias. Should the last 10 consecutive results are on the same side of the mean within same control material (although within 2 SD), trouble shooting should also be considered pending on the tests performance. Similarly, this may not require to rejecting samples, but it can be an indicator to perform instrument maintenance and/or recalibrate. For persistence problem, further comparison with External Quality Control results and a vendor aid, to exclude bias.
Hb Analysis: QC materials for 2 levels are performed for Hb A2 and Hb F for every batch of HPLC test. Results of each QC should be ideally within 1 SD (for all levels). The review of QC results should be done once/ month (4 weeks).The results above/below 1SD but within 2SD are acceptable, however results above 2SD are not acceptable for all control materials. If the results during review are violated as in Westgard rule 4(1s) noted consecutively, troubleshooting should be performed as recommended before. (41s The rule is violated within the control materials when the last 4 controls values of the same control level exceed the same mean +1s or the same mean 1s limit.) This may not required to rejecting samples, but it can be an indicator to perform instrument maintenance and/or calibration. The review should also look at the trend and graph bias. Should the last 10 consecutive results are on the same side of the mean within same control material (although within 2 SD), trouble shooting should also be considered pending on the test performance. Other acceptance criteria from calibrator report review: -Total area: 1.0-3.0 million -Retention time of A2 and Fin range -A2 and F within established linearity (A2 < 10 and F up to 40) -Response factor is within 0.8-1.2 -Proper baseline -Peak shape is sharp and symmetrical -No unknown peaks - Values of calibrator is within +/- 0.2 of calibrator value Transfusion Microbiology: Internal QC materials for 2 levels (HBsAg and HCV assays) and 3 levels (HIV assay) are performed daily. Results of daily QC should be ideally within 1 SD (for all levels). The QC results should be checked daily and reviewed based on Westgard rule. The results above/below 1SD but within 2SD are acceptable; however results above 2SD (2SD) are not acceptable for all control materials. If the results during review are violated as in Westgard rule 4(1s) noted consecutively, troubleshooting should be considered as recommended before. (41s The rule is violated within the control materials when the last 4 controls values of the same control level exceed the same mean +1s or the same mean 1s limit.) This may not require to rejecting samples, but it can be an indicator to perform instrument maintenance and/or calibration. The review should also look at the trend and graph bias. Should the last 10 consecutive results are on the same side of the mean within same control material (although within 2 SD), troubleshooting should also be considered. Similarly, this may not require to rejecting samples, but it can be an indicator to perform instrument maintenance and/or recalibrate. For persistence problem, further comparison with External Quality Control and a vendor aid, to exclude bias. Molecular Test

Repeat test is required if control positive is not working or when control negative is contaminated. Request for new sample is also indicated when faulty RNA quality or quantity is inadequate. Bone Marrow Aspiration for PERL and Cytochemistry Repeat test is required if control positive is not working Serum Ferritin: QC materials for 3 levels are performed simultaneously with the test samples. Results of QC should be ideally within 2 SD (for all levels). The review of QC results should be done every month to see for the trend and bias. Flowcytometry: Cells stained with CD45 PercpCy5.5 should be run with each sample as a negative control.

Appendix 5
HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY HOSPITAL UNIVERSITI SAINS MALAYSIA WORK SHEET Internal Quality Control Summary Report WSH (QP-04/005) Date of review: 01/07/09 Prepared by: Name of reviewer: Wan Soriany bt Wan Md Zain AP Dr Wan Zaidah Abdullah
Section: 1. Test Performances (State the problem/s identified) 2. Reagents Problem Action: 3. Machine/Equipments Problem Action: 4. Staff Performances Action: 5. Other related problems (state) Action 6. OUTCOMES (Please tick) Problem/s successfully corrected Future review/further action required
7. QA committee - comments


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HUSM/HEMA-UPT/QP-04

ASSURING QUALITY OF TEST RESULTS

HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY HOSPITAL UNIVERSITI SAINS MALAYSIA

Prepared by: Checked by: Approved by:

15.08.2009 01.10.2009 01.11.2009

Title of Quality Procedure

Record of Amendment and Record of Review

Objective, Scope, Abbreviation, Definition and References

Procedure and Responsibility

Other Related Document

Prepared by Checked by Approved by

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

01.08.2010 04.08.2010 04.08.2010

Prepared by Checked by Approved by

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

Prepared by Checked by Approved by

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

6.5 6.6 6.7

MLT/SO MLT/SO MLT/SO

MLT/SO /LH MLT/SO /LH

Prepared by Checked by Approved by

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

Prepared by Checked by Approved by

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

ASSURING THE QUALITY OF TEST RESULTS INTERNAL QA

Prepare schedule for test calibration & related QC activities

Repeat Perform test calibration & QC

Unsatisfactory Validate Internal QC Satisfactory Document in Internal QC file

Troubleshooting and Record Corrective Action

Plot daily internal QC charts/results

Review Internal/External QC performance

Prepared by Checked by Approved by

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

Transfusion Medicine Laboratory

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

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