HUSM/HEMA-UPT/QP-06

REFERRAL LABORATORY TEST

HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY HOSPITAL UNIVERSITI SAINS MALAYSIA

Prepared by:

Dr Wan Haslindawani Wan Mahmood Assoc. Prof. Dr. Rapiaah Mustaffa Assoc. Prof. Dr. Rosline Hassan 01.11.2009

15.08.2009

Checked by: Approved by:

01.10.2009 01.11.2009

Effective date:

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

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HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSM REFERRAL Page LABORATORY TEST TITLE : TABLE OF CONTENT Version (HUSM/HEMA-UPT/QP-06)

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

Flow chart Appendices: i. ii. Appendix 1 : List of Tests Referred Appendix 2 : Worksheet Borang Ujian Saringan Kedua HIV (Particle Agglutination Test) untuk Penderma Darah yang Reaktif dari Pilot dan Segmen Appendix 3 : Worksheet Borang Ujian Pengesahan HIV (Western Blot) untuk Penderma Darah yang Reaktif dari Pilot dan Segmen Appendix 4 : Worksheet Borang Ujian Pengesahan HCV untuk Penderma Darah yang Reaktif dari Pilot dan Segmen Appendix 5 : Worksheet Keputusan Ujian Saringan Penderma Darah (VDRL/TPHA dan MP) Appendix 6: Urgent Request for VDRL test during blood shortage

iii. iv. v. vi.

Prepared by Checked by Approved by

Dr Wan Haslindawani Wan Mahmood Assoc. Prof. Dr Rapiaah Mustaffa Assoc. Prof. Dr Rosline Hassan

Effective Date

01.11.2009

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

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HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSM Page REFERRAL LABORATORY TEST (HUSM/HEMA-UPT/QP-06) TITLE: RECORD OF AMENDMENT AND RECORD OF REVIEW Version 3 of 8 2

RECORD OF AMMENDMENT VERSION NO 2 2 2 2 2 DATE 01.08.2010 04.08.2010 20.03.2011

2.5.2012 2.5.2012

DESCRIPTION OF AMMENDMENT Transform to online documentation in http://www.medic.usm.my/hematology/index.php/qp06 Amendment 1: merge LEVEL 4 STM with level 3 QP Amendment 2: Delete confirmatory test for HIV (Particle Agglutination Test) and Appendix 2 Amendment 3: Change of procedure 6.3, 6.5, 6.8e, 6.11, 6.12, Amendment 4: Change of appendix 1, appendix 4

BY

RECORD OF REVIEW DATE OF REVIEW 05.07.2010 NAME OF REVIEWER Dr. Wan Haslindawani Wan Mahmood Dr. Wan Haslindawani Wan Mahmood Ang Cheng Yong Rohana Yusoff SIGNATURE OF REVIEWER SIGNATURE OF APPROVAL

21.03.2011

2.5.2012

Prepared by Checked by Approved by

Dr Wan Haslindawani Wan Mahmood Assoc. Prof. Dr Rapiaah Mustaffa Assoc. Prof. Dr Rosline Hassan

Effective Date

01.11.2009

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

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HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSM Page REFERRAL LABORATORY TEST (HUSM/HEMA-UPT/QP-06) TITLE: OBJECTIVE, SCOPE, ABBREVIATION, DEFINITION AND REFERENCES Version 4 of 8 2

1.

OBJECTIVE This quality procedure provides guideline on Referral laboratory tests to other laboratory whether due to unforeseen reasons (e.g.: workload, need further expertise or temporary incapacity) or on a continuing basis. SCOPE Apply to all types of laboratory tests required by Department of Haematology/UPT, HUSM. ABBREVIATION HOD : Head of Department LH : Lecturer of Haematology MO : Medical Officer MLT : Medical Laboratory Technologist PAP : Pembantu Am Pejabat SO : Scientific Officer SN : Staff Nurse TML : Transfusion Medicine Laboratory AK : Atendan Kesihatan

2.

3.

4.

DEFINITION Referral Lab.Tests Temporary incapacity Competent Referral

: Sending out specimen for the test to be performed by other testing laboratory or to be interpreted for second opinion : Temporary withholding performance of laboratory test due to default of equipment, insufficient reagents etc. : Referral is referred to laboratory that complies with national standard or equivalent.

5.

REFERENCES 1) HUSM/LCD/QM : Laboratory Quality Manual

Prepared by Checked by Approved by

Dr Wan Haslindawani Wan Mahmood Assoc. Prof. Dr Rapiaah Mustaffa Assoc. Prof. Dr Rosline Hassan

Effective Date

01.11.2009

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

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HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSM REFERRAL LABORATORY TEST (HUSM/HEMA-UPT/QP-06) 6. NO 6.1 6.2 TITLE: PROCEDURE AND RESPONSIBILITY Page Version 5 of 8 2

PROCEDURE AND RESPONSIBILITY ACTIVITY Maintain a register of all certified laboratories that are used for Referral the tests Record the evidence of compliance of all Referral. e.g.: A copy of Accreditation certificate Updating list of tests to be permanently subcontracted of the year. a) Name of tests b) Type and amount of specimen required to be send Acquire the requirement of the test from the Referral lab Receive sample Prepare the serum or any related pre-analytical requirement and keep at proper storage Packed the sample appropriately Record the sample that is going to be subcontracted. This includes: a) Name of patient / donor registration no/ donor blood bag b) I.C number / Lab ID c) Name of test d) Date of sending specimen e) Ward/Clinic/Lab Send the packed sample and request form / worksheet Transport the specimen accordingly in recommended transport media/storage Make sure the referral lab staff verify the receipt of specimen in the dispatch book/worksheet RESPONSIBILITY HOD SO REFERENCE Appendix 1 -

6.3

SO/LH/HOD

Appendix 1

6.4

MLT/SO

STM of the test (Other related documents) Worksheet Appendix 2, 3, 4, &5

6.5 6.6 6.7 6.8

MLT MLT MLT MLT/SO

6.9 6.10 6.11

MLT MLT AK

Prepared by Checked by Approved by

Dr Wan Haslindawani Wan Mahmood Assoc. Prof. Dr Rapiaah Mustaffa Assoc. Prof. Dr Rosline Hassan

Effective Date

01.11.2009

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

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HEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSM REFERRAL LABORATORY TEST (HUSM/HEMA-UPT/QP-6) Page TITLE: RECORD Version Amendment 6 of 8 2 1

NO 6.12

ACTIVITY Receive test report from Referral a) Record date of receive and receiver b) Review and verify the result Keep a copy of result a) The report b) Date of receive Dispatch the laboratory test report accordingly

RESPONSIBILITY MLT/SO/MO/LH

REFERENCE N/A

6.13

MLT/SN/SO

N/A

6.14

MLT/SO

N/A

7. NO. 7.1 7.2

RECORD TYPE OF RECORD File book of Referred Subcontracted Lab. to Microbiology Lab Record book of Referred Test to Referral lab LOCATION TML TML / Hematology Lab RETENTION TIME 20 years 3 years

8.

OTHER RELATED DOCUMENTS - List of Standard Technical Manual (STM) refer to Masterfile: o Makmal Hematologi (HUSM/Hema/PK/001) o Makmal UPT (HUSM/HEMA-UPT/ RK-001T )

Prepared by Checked by Approved by

Dr Wan Haslindawani Wan Mahmood Assoc. Prof. Dr Rapiaah Mustaffa Assoc. Prof. Dr Rosline Hassan

Effective Date

01.11.2009

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

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HEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSM Page REFERRAL LABORATORY TEST (HUSM/HEMA-UPT/QP-06) 8. FLOWCHART TITLE: FLOW CHART Version 8 of 8 2

Receive specimen

Sample preparation

Record

Send to Referral Lab as scheduled

Receive report from Referral

Record/Dispatch

Prepared by Checked by Approved by

Dr Wan Haslindawani Wan Mahmood Assoc. Prof. Dr Rapiaah Mustaffa Assoc. Prof. Dr Rosline Hassan

Effective Date

01.11.2009

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

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Appendix 1

LIST OF TESTS REFERRED 1. Transfusion Medicine Laboratory Lab Referred Makmal Mikrobiologi & Parasitologi Perubatan (MMPP), USM Kelantan Type of Test Screening test for VDRL/TPHA and MP Confirmatory test for HIV (Western Blot) Confirmatory test for HCV (InnoLIA) Blood culture and sensitivity Type of Sample/Volume Serum/ 1-2 ml Serum/ 2-3 ml Serum/ 2-3 ml Blood/Plasma / 1-3 ml in aerobic/anaerobic Bactec bottle

HUSM/HEMA-UPT/QP-06/A1

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

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Appendix 2

UNIT PERUBATAN TRANSFUSI HUSM BORANG UJIAN PENGESAHAN HIV UNTUK PENDERMA DARAH YANG REAKTIF DARI PILOT DAN SEGMEN
No. Penderma No. Beg Darah No. Kad Pengenalan JTMP Yang Menjalankan Ujian Saringan Keputusan Ujian Pengesahan HIV

Bil.

Tarikh Hantar :

___________________

Dipohon Oleh Tandatangan

: ____________________ : ____________________

Untuk Kegunaan Makmal Mikrobiologi & Parasitologi Perubatan, USM Tarikh Ujian Dijalankan Ujian Dijalankan Oleh Jenis Ujian Nama Reagen No. Lot Tarikh Luput : ____________________ : ____________________ Tandatangan : _______________

: ____________________________ : : : ____________________________ ____________________________ ____________________________

Disemak dan Disahkan oleh : _________________________________________ Catitan : ________________________________________________________________

Tarikh Keputusan Diterima : ____________________ Keputusan Diterima Oleh : ____________________ Tandatangan : ____________ HUSM/HEMA-UPT/QP-06/A2

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

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Appendix 3

UNIT PERUBATAN TRANSFUSI HUSM BORANG UJIAN PENGESAHAN HCV UNTUK PENDERMA DARAH YANG REAKTIF DARI PILOT DAN SEGMEN
No. Penderma No. Beg Darah No. Kad Pengenalan JTMP Yang Menjalankan Ujian Saringan Keputusan Ujian Pengesahan HCV

Bil.

Tarikh Hantar :

___________________

Dipohon Oleh Tandatangan

: ____________________ : ____________________

Untuk Kegunaan Makmal Mikrobiologi & Parasitologi Perubatan, USM Tarikh Ujian Dijalankan Ujian Dijalankan Oleh Jenis Ujian Nama Reagen No. Lot Tarikh Luput : ____________________ : ____________________ Tandatangan : _______________

: __________________________ : : : __________________________ __________________________ __________________________

Disemak dan Disahkan oleh : _________________________________________ Catitan : ________________________________________________________________

Tarikh Keputusan Diterima : ____________________ Keputusan Diterima Oleh : ____________________ Tandatangan : ____________ HUSM/HEMA-UPT/QP-06/A3

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

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Appendix 4 Unit Perubatan Transfusi, Hospital Universiti Sains Malaysia

Keputusan Ujian Saringan Penderma Darah (VDRL/TPHA dan MP)

Tarikh Cetak:

No. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

No. Beg Darah

VDRL

TPHA

MP

Catatan

Nama Disediakan dan disemak oleh: Dihantar oleh: Sampel diterima oleh: Ujian dijalankan oleh: Keputusan disahkan oleh: Keputusan diterima oleh:

Tarikh & Masa

Keputusan Ujian Saringan Penderma Darah (VDRL/TPHA dan MP)

HUSM/HEMA-UPT/QP-06/A4

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

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Appendix 5

URGENT REQUEST FOR VDRL TEST DURING BLOOD SHORTAGE

After office hour/public holidays Responsibility: MLT On Call/Standby at UPT Lab 1. Receive urgent request from ward for blood/blood component 2. If the VDRL need to be done urgently, call UPT Medical Officer On Call to inform Microbiology Specialist On Call 3. Verify VDRL samples and form 4. Inform the ward concerned for their attendant to send the VDRL samples to Microbiology Lab 5. When the VDRL results are ready, call the respective ward to get the results and send to UPT lab. For any reactive cases, send for repeat segment. 6. Check the results and record in Borang Keputusan Ujian Saringan (BKUS) 7. File the VDRL results in File Keputusan Ujian Saringan Penderma Darah (VDRL) (HUSM/58/PK/65T) 8. Release blood to the ward after complete verification on screened blood for all TTI markers by Senior Technologists Oncall. Office hour Responsibility: MLT Transfusion Microbiology/Component Section 1. During office hour, UPT attendants are responsible for sending all donor specimens for VDRL test to the Microbiology Lab as well as getting back the complete VDRL results

HUSM/HEMA-UPT/QP-06/A5

Hakcipta Makmal Hematologi & Unit Perubatan Transfusi 2012

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