HUSM/HEMA-UPT/QP-05

PROCESS OF HANDLING EXTERNAL QUALITY CONTROL SAMPLES

HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY HOSPITAL UNIVERSITI SAINS MALAYSIA

Prepared by: Checked by: Approved by: Effective date:

Saw Teik Hock Lim Seng Hock Assoc Prof Dr Rosline Hassan 01.11.2009

15.08.2009 01.10.2009 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 PROCESS OF HANDLING Page EXTERNAL QUALITY CONTROL TITLE: TABLE OF CONTENT Version SAMPLES (HUSM/HEMA-UPT/QP-05)

2 of 8 2

PAGE

TABLE OF CONTENT

Title of Quality Procedure

Table of Content

Record of Amendment and Record of Review

Objective, Scope and Abbreviation

Definition and References

Procedure and Responsibility

Record

Flow Chart Appendices Appendix 1: Name of EQC programmes Appendix 2: (a) Worksheet for Corrective Action for External Quality Control Exercise (b) External Quality Control Summary Report (c) Assessment of External Quality Control Programme

Prepared by Checked by Approved by

Saw Teik Hock Lim Seng Hock 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 PROCESS OF HANDLING Page EXTERNAL QUALITY TITLE: RECORD OF AMENDMENT Version CONTROL SAMPLES AND RECORD OF REVIEW (HUSM/HEMA-UPT/QP-05)

3 of 8 2

RECORD OF AMMENDMENT VERSION NO 2 DATE DESCRIPTION OF AMMENDMENT Amendment 1: Page 8 flowchart Amendment 2: Inclusion of Appendix 2a, 2b, 2c from QP04 Transform to online documentation in http://www.medic.usm.my/hematology/index.php/qp05 Amendment 3: Appendix 1 Regarding some minor changes in the list of hematology and transfusion medicine tests for EQC Amendment 4. Appendix 1 Regarding the frequency of the EQC exercise and new tests. Regarding Item No.3 on abbreviation and item no.8 on flow chart BY

20.07.2010

2 2

01.08.2010 21.03.2011

19.03.2012

RECORD OF REVIEW DATE OF REVIEW 05.07.2010 21.03.2011 19.03.2012 NAME OF REVIEWER Lim Seng Hock Lim Seng Hock Saw Teik Hock Selamah Ghazali SIGNATURE OF REVIEWER BY

Prepared by Checked by Approved by

Saw Teik Hock Lim Seng Hock 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 PROCESS OF HANDLING Page EXTERNAL QUALITY TITLE: OBJECTIVE, SCOPE AND Version CONTROL SAMPLES ABBREVIATION (HUSM/HEMA-UPT/QP-05) 1.

4 of 8 2

OBJECTIVE To ensure that samples for external quality control programmed are properly assigned, handled and performed in the department. SCOPE All types of external quality control samples for laboratory tests performed either manually or by automation in both the Haematology and Transfusion Medicine Laboratories ABBREVIATION Ab Identification Ab Screening DAT EQAP EQC FBC HbE HBV HCV HIV LH HOD IMR MLT MRM NEQAS NRL PDN SO QA QC QM RCPA

2.

3.

: Antibody Identification : Antibody Screening : Direct Antiglobulin Test : External Quality Assurance Programme : External Quality Control : Full Blood Count : Haemoglobin Electrophoresis : Hepatitis B Virus : Hepatitis C Virus : Human Immunodeficiency Virus : Lecturer of Haematology : Head of Department : Institute of Medical Research, Kuala Lumpur : Medical Laboratory Technologist : Management Review Meeting : National External Quality Assurance Survey : National Serology Reference Laboratory, Australia : National Blood Centre, Kuala Lumpur : Scientific Officer : Quality Assurance : Quality Control : Quality Manager : Royal College of Pathologists of Australasia

Prepared by Checked by Approved by

Saw Teik Hock Lim Seng Hock 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 PROCESS OF HANDLING Page EXTERNAL QUALITY TITLE: DEFINITION AND Version CONTROL SAMPLES REFERENCES (HUSM/HEMA-UPT/QP-05)

5 of 8 2

4.

DEFINITION Quality Assurance : All 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. : The set of procedures designed to monitor the test methods and the results to assure test system performance. The QC programme in place will ensure that reagents, equipments and methods function as expected.

Quality Control

External Quality Control : External quality control programmes enrolled by Haematology and Transfusion Medicine Laboratories to fulfill the requirements of quality assurance. 5. REFERENCES 1) 2) 3) 4) 5) 6) 7) 8) 9) HUSM/HEMA-UPT/QP-01 HUSM/HEMA-UPT/QP-02 HUSM/HEMA-UPT/QP-04 HUSM/LCD/QP-02 HUSM/LCD/QP-05 HUSM/LCD/QP-06 HUSM/LCD/QP-16 HUSM/LCD/QP-18 MHT/DL T47 : : : : : : : : : Receipt of sample Sample Processing Assuring quality of tests results Control of quality records Tindakan Pembetulan Bagi Ketidakpatuhan Tindakan Pencegahan Bagi Ketidakpatuhan Calibration and maintenance of equipment Management of consumables and reagents Practical Quality Control Guide For Quantitative Analysis In the Clinical Laboratory

Prepared by Checked by Approved by

Saw Teik Hock Lim Seng Hock 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 PROCESS OF HANDLING Page EXTERNAL QUALITY TITLE: PROCEDURE AND Version CONTROL SAMPLES RESPONSIBILITY (HUSM/HEMA-UPT/QP-05) 6. PROCEDURE NO ACTIVITY RESPONSIBILITY

6 of 8 2

REFERENCE

External QA activity: 6.1 Subscribe the various external quality control (EQC) programmes 6.2 Receive EQC Programme samples. Check the specimens, the exercise forms and records according to EQC file. Note the date, time and name of staff who received them. Assign and record in the respective EQC files, the MLT(s) who will perform the respective testing activities required on the EQC materials. Perform the tests required. Analyze and review the results before sending Recheck and send the report before the due time Analyze the returned EQC results and take remedial actions immediately ii) Document remedial action(s) in EQC file i) Present the EQC results during departmental QC meeting ii) Record the performance of EQC activities and note the outcome of the remedial action(s) taken Compile all reports of the EQC activities annually Present the reports during departmental Management Review Meeting (MRM) i)

HOD MLT/SO

Appendix 1 Refer each external QC files

6.3

MLT U32/U36/U38/SO

6.4 6.5 6.6 6.7

MLT of respective sections MLT/SO/LH MLT/SO/LH/HOD HOD/LH/SO MLT U38/U36/U32/U29

Appendix 2a,2b

6.8

MLT/SO/LH SO/LH MLT U32/U36/U38/SO MLT/SO/QM/LD

Appendix 2b,2c

6.9 6.10

Prepared by Checked by Approved by

Saw Teik Hock Lim Seng Hock 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 PROCESS OF HANDLING Page EXTERNAL QUALITY TITLE: RECORD Version CONTROL SAMPLES (HUSM/HEMA-UPT/QP-05) 7. NO 7.1 EQC File a) Corrective Action For External Quality Control Exercise b) External Quality Control Summary Report c) Assessment of External Quality Control Programme RECORD TYPE OF RECORD LOCATION EQC File Cabinet in respective sections EQC File Cabinet in respective sections

7 of 8 2

RETENTION PERIOD 5 years

Prepared by Checked by Approved by

Saw Teik Hock Lim Seng Hock 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 PROCESS OF HANDLING Page EXTERNAL QUALITY TITLE: FLOW CHART Version CONTROL SAMPLES Amendment (HUSM/HEMA-UPT/QP-05)

8 of 8 2 1

8.

FLOWCHART

i) FLOWCHART OF MANAGING THE EXTERNAL QUALITY CONTROL PROGRAMME

Subscribe the EQC programs

Receive, check and record the EQC materials

Perform, Analyze, Report & Comment

Submit report

Evaluate EQC report received by HOD/LH

Review by SO/MLT in-charge of the section

Institute corrective / preventive measures outlined in Appendix 2 & present in EQC Meeting

Compile reports and present at departmental MRM

Prepared by Checked by Approved by

Saw Teik Hock Lim Seng Hock 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

Appendix 1 NAME OF EQC PROGRAMMES LABORATORY Haematology EQAP RCPA TESTS FBC Morphology Flowcytometry (Immunophenotyping) Hb Electrophoresis Hemostasis (INR/PT/APTT/Fib/TT) Coagulation factors ( II,IV,VII,VIII,IX,X,XI & XII ) D-dimer Molecular Manual Differential Count Special Haemostasis Reticulocyte Automated ESR Automated Diff G6PD General Compatibility Module comprising: Blood Group, DAT, Ab Screening, RBC Phenotype, Elution Studies, Antibody Identification & Compatibility Testing Phenotyping Module HIV HBV HCV HIV HBV HCV CD 34 FREQUENCY 6-12x/year 2-4x/year 2-4x/year 2-4x/year 4-8x/year 2-6x/year 2-4x/year 1-2x/year 1-2x/year 1-2x/year 1-2x/year 2-4x/year 2-4x/year 2-4x/year 3-6x/year

Transfusion Medicine

RCPA

NRL

2-4x/year 1-3x/year 1-3x/year 1-3x/year 1-2x/year 1-2x/year 1-2x/year 1-3x/year

IMR PDN Stem cell RCPA

HUSM/HEMA-UPT/QP-05/A1

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

Sebarang cetakan dan penggunaan semula mana-mana bahagian dalam dokumen ini tidak dibenarkan

Appendix 2a

HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY HOSPITAL UNIVERSITI SAINS MALAYSIA WORK SHEET a. Corrective Action For External Quality Control Exercise (Lab staff involved in reporting/running the external QC exercise): WSH (QP-05/001) Date of review: 01/07/09 Prepared by: Name of reviewer: Wan Soriany Wan Md Zain Assoc Prof Dr Wan Zaidah Abdullah

1. Name of the operator: _________________________ Kindly review the external quality control report stated below for improvement in the quality of our test results. 2. Exercise number / External QC Programme: 3. Findings/problems: 4. Actions (corrective and future preventive measures) Investigator: Supervisor (Senior MLT, Scientific officer/Lecturer) : ..
No.1-3: To be filled-up by scientific officer in-charge No4. : To be filled-up by operator Supervisor to verify

Date: .. Date: ..

HUSM/HEMA-UPT/QP-05/A2a


Appendix 2b

HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY HOSPITAL UNIVERSITI SAINS MALAYSIA WORK SHEET b. External Quality Control Summary Report WSH (QP-05/002) Date of review: 01/07/09 Section: 1. Test Performances [State the problem(s) identified]: Reagent Problem: Prepared by: Name of reviewer: Wan Soriany Wan Md Zain Assoc Prof Dr Wan Zaidah Abdullah

2.

Action Taken:

3.

Machine/Equipment Problem:

Action Taken: 4. Staff Performances Action: 5. Other related problems: (Please state): Action Taken:

6.

Outcomes(Please tick):

Problem(s) successfully corrected Future review/further action required

7.

QA committee comments:

HUSM/HEMA-UPT/QP-05/A2b

Appendix 2c

HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY HOSPITAL UNIVERSITI SAINS MALAYSIA Assessment Form c. Assessment of External Quality Control Programme WSH (QP-05/03) Date of review: 01/07/09 Prepared by: Name of reviewer: Wan Soriany Wan Md Zain Assoc Prof Dr Wan Zaidah Abdullah

Section: ________________________________ Exercise number / External QC Programme: Comments : (To state whether appropriate corrective and preventive actions have been done or further follow-up is needed to close the problem) (To be filled-up by the QA committee)

Signature of QA Committee:.

Date: .

Signature Head of Department: Date:

HUSM/HEMA-UPT/QP-05/A2c