QP05

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HUSM/HEMA-UPT/QP-05

PROCESS OF HANDLING EXTERNAL QUALITY CONTROL SAMPLES

HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY HOSPITAL UNIVERSITI SAINS MALAYSIA

Prepared by: Saw Teik Hock

15.08.2009

Checked by: Lim Seng Hock

01.10.2009

Approved by: Assoc Prof Dr Rosline Hassan

01.11.2009

Effective date: 01.11.2009

HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSM

Prepared by Checked by Approved by

Saw Teik Hock Lim Seng Hock

Assoc. Prof. Dr Rosline Hassan Effective Date 01.11.2009


PROCESS OF HANDLING EXTERNAL QUALITY CONTROL

SAMPLES (HUSM/HEMA-UPT/QP-05)

TITLE: TABLE OF CONTENT of 8 Version 2

PAGE TABLE OF CONTENT

1 Title of Quality Procedure

2 Table of Content

3 Record of Amendment and Record of Review

4 Objective, Scope and Abbreviation

5 Definition and References

6 Procedure and Responsibility

7 Record

8 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







(HUSM/HEMA-UPT/QP-05)

TITLE: RECORD OF AMENDMENT AND RECORD OF REVIEW

of 8 Version 2

RECORD OF AMMENDMENT VERSION

NO DATE DESCRIPTION OF AMMENDMENT BY

2 20.07.2010

Amendment 1: Page 8 flowchart

Amendment 2: Inclusion of Appendix 2a, 2b, 2c from QP04

2 01.08.2010 Transform to online documentation in http://www.medic.usm.my/hematology/index.php/qp05

2 21.03.2011 Amendment 3: Appendix 1 Regarding some minor changes in the list of hematology and transfusion medicine tests for EQC

2 19.03.2012

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

RECORD OF REVIEW

DATE OF REVIEW NAME OF REVIEWER SIGNATURE OF REVIEWER BY

05.07.2010 Lim Seng Hock

21.03.2011 Lim Seng Hock

19.03.2012 Saw Teik Hock Selamah Ghazali








TITLE: OBJECTIVE, SCOPE AND ABBREVIATION

of 8 Version 2

1. OBJECTIVE

To ensure that samples for external quality control programmed are properly assigned, handled and performed in the department.

2. 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

3. ABBREVIATION Ab Identification : Antibody Identification Ab Screening : Antibody Screening DAT : Direct Antiglobulin Test EQAP : External Quality Assurance Programme EQC : External Quality Control FBC : Full Blood Count HbE : Haemoglobin Electrophoresis HBV : Hepatitis B Virus HCV : Hepatitis C Virus HIV : Human Immunodeficiency Virus LH : Lecturer of Haematology HOD : Head of Department IMR : Institute of Medical Research, Kuala Lumpur MLT : Medical Laboratory Technologist MRM : Management Review Meeting NEQAS : National External Quality Assurance Survey NRL : National Serology Reference Laboratory, Australia PDN : National Blood Centre, Kuala Lumpur SO : Scientific Officer QA : Quality Assurance QC : Quality Control QM : Quality Manager RCPA : Royal College of Pathologists of Australasia








TITLE: DEFINITION AND

REFERENCES

of 8 Version 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.

Quality Control : 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.

External Quality Control : External quality control programmes enrolled by Haematology and

Transfusion Medicine Laboratories to fulfill the requirements of quality assurance.

5. REFERENCES

1) HUSM/HEMA-UPT/QP-01 : Receipt of sample 2) HUSM/HEMA-UPT/QP-02 : Sample Processing 3) HUSM/HEMA-UPT/QP-04 : Assuring quality of tests results 4) HUSM/LCD/QP-02 : Control of quality records 5) HUSM/LCD/QP-05 : ‘Tindakan Pembetulan Bagi Ketidakpatuhan’ 6) HUSM/LCD/QP-06 : ‘Tindakan Pencegahan Bagi Ketidakpatuhan’ 7) HUSM/LCD/QP-16 : Calibration and maintenance of equipment 8) HUSM/LCD/QP-18 : Management of consumables and reagents 9) MHT/DL T47 : Practical Quality Control Guide – For Quantitative

Analysis In the Clinical Laboratory








TITLE: PROCEDURE AND RESPONSIBILITY

of 8 Version 2

6. PROCEDURE

NO

ACTIVITY

RESPONSIBILITY

REFERENCE

External QA activity: 6.1 Subscribe the various external quality control

(EQC) programmes

HOD Appendix 1

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.

MLT/SO Refer each external QC files

6.3 Assign and record in the respective EQC files, the MLT(s) who will perform the respective testing activities required on the EQC materials.

MLT U32/U36/U38/SO -

6.4 Perform the tests required. MLT of respective sections

-

6.5 Analyze and review the results before sending MLT/SO/LH -

6.6 Recheck and send the report before the due time

MLT/SO/LH/HOD -

6.7 i) Analyze the returned EQC results and take remedial actions immediately

ii) Document remedial action(s) in EQC file

HOD/LH/SO MLT U38/U36/U32/U29

Appendix 2a,2b

6.8 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

MLT/SO/LH SO/LH

Appendix 2b,2c

6.9 Compile all reports of the EQC activities annually

MLT U32/U36/U38/SO -

6.10 Present the reports during departmental Management Review Meeting (MRM)

MLT/SO/QM/LD -






PROCESS OF HANDLING EXTERNAL QUALITY CONTROL SAMPLES (HUSM/HEMA-UPT/QP-05)

TITLE: RECORD

of 8 Version 2

7. RECORD

NO TYPE OF RECORD LOCATION RETENTION PERIOD

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

EQC File Cabinet in respective sections EQC File Cabinet in respective sections

5 years






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

PROCESS OF HANDLING EXTERNAL QUALITY CONTROL SAMPLES (HUSM/HEMA-UPT/QP-05)

TITLE: FLOW CHART

of 8 Version 2 Amendment 1

8. FLOWCHART i) FLOWCHART OF MANAGING THE EXTERNAL QUALITY CONTROL PROGRAMME

Submit report

Receive, check and record the EQC materials

Review by SO/MLT in-charge of the section

Compile reports and present at departmental MRM

Evaluate EQC report received by HOD/LH

Perform, Analyze, Report & Comment

Subscribe the EQC programs


Appendix 1

NAME OF EQC PROGRAMMES

LABORATORY EQAP TESTS FREQUENCY Haematology RCPA 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

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

Transfusion Medicine

RCPA General Compatibility Module comprising: Blood Group, DAT, Ab Screening, RBC Phenotype, Elution Studies, Antibody Identification & Compatibility Testing Phenotyping Module

3-6x/year 2-4x/year

NRL HIV HBV HCV

1-3x/year 1-3x/year 1-3x/year

IMR HIV

1-2x/year

PDN HBV HCV

1-2x/year 1-2x/year

Stem cell RCPA CD 34 1-3x/year

HUSM/HEMA-UPT/QP-05/A1

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) Prepared by: Wan Soriany Wan Md Zain Date of review: 01/07/09 Name of reviewer: 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: …………………………… Date: …………………..

Supervisor (Senior MLT, Scientific officer/Lecturer) : Date: ………………….. ……………………………………….. No.1-‐3: To be filled-‐up by scientific officer in-‐charge No4. : To be filled-‐up by operator Supervisor to verify

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


HUSM/HEMA-UPT/QP-05/A2b

Section: 1. Test Performances [State the

problem(s) identified]:

2. Reagent Problem:

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:

Appendix 2c

HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY

HOSPITAL UNIVERSITI SAINS MALAYSIA Assessment Form

c. Assessment of External Quality Control Programme


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

QP05

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