QP06

HUSM/HEMA-UPT/QP-06

REFERRAL LABORATORY TEST

HAEMATOLOGY ANDTRANSFUSION MEDICINE LABORATORY HOSPITAL UNIVERSITI SAINS MALAYSIA

Prepared by: Dr Wan Haslindawani Wan Mahmood

15.08.2009

Checked by: Dr Rapiaah Mustaffa 01.10.2009

Approved by: Assoc. Prof. Dr. Rosline Hassan 01.11.2009

Effective date: 01.11.2009

HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSMREFERRAL LABORATORY TEST(HUSM/HEMA-UPT/QP-06)

TITLE : TABLE OF CONTENTPage 2 of 7Version 1Amendment 1

PAGE TABLE OF CONTENT

1 Title of Quality Procedure

2 Table of Content

3 Record of Amendment and Record of Review

4 Objective, Scope, Abbreviation, Definition and References

5 Procedure and Responsibility

6 Record

7 Flow chart

Appendices:

i. Appendix 1 : List of Referral laboratories and testsii. Appendix 2 : Worksheet Borang Ujian Saringan Kedua HIV (Particle

Agglutination Test) untuk Penderma Darah yang Reaktif dari Pilot dan Segmen

iii. Appendix 3 : Worksheet Borang Ujian Pengesahan HIV (Western Blot) untuk Penderma Darah yang Reaktif dari Pilot dan Segmen

iv. Appendix 4 : Worksheet Borang Ujian Pengesahan HCV untuk Penderma Darah yang Reaktif dari Pilot dan Segmen

v. Appendix 5 : Worksheet Keputusan Ujian Saringan Penderma Darah (VDRL/TPHA dan MP)

vi. Appendix 6: Urgent Request for VDRL test during blood shortage

Prepared byChecked byApproved by

Dr Wan Haslindawani Wan MahmoodDr Rapiaah Mustaffa

Assoc. Prof. Dr Rosline Hassan

Issued Date Effective Date

01.10.200901.11.2009

HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSM


(HUSM/HEMA-UPT/QP-06)

TITLE: RECORD OF AMENDMENT AND RECORD OF REVIEW

Page 3 of 7Version 1Amendment 1

RECORD OF AMMENDMENT

VERSION NO DATE DESCRIPTION OF AMMENDMENT BY

RECORD OF REVIEW

DATE OF REVIEW NAME OF REVIEWER SIGNATURE OF REVIEWER

SIGNATURE OF APPROVAL





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HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSM



TITLE: OBJECTIVE, SCOPE, ABBREVIATION, DEFINITION AND

REFERENCES


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.

2. SCOPE

Apply to all types of laboratory tests required by Department of Haematology/UPT, HUSM.

3. ABBREVIATION

HOD : Head of DepartmentLH : Lecturer of HaematologyMO : Medical OfficerMLT : Medical Laboratory TechnologistPAP : ‘Pembantu Am Pejabat’SO : Scientific OfficerSN : Staff NurseTML : Transfusion Medicine Laboratory

4. DEFINITION

Referral Lab.Tests : Sending out specimen for the test to be performed by other testing laboratory or to be interpreted for second opinion

Temporary incapacity : Temporary withholding performance of laboratory test due to default of equipment, insufficient reagents etc.

Competent Referral : Referral is referred to laboratory that complies with national standard or equivalent.

5. REFERENCES

1) HUSM/LCD/QM : Laboratory Quality Manual





15.08.200901.11.2009

HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSMREFERRAL LABORATORY TEST(HUSM/HEMA-UPT/QP-06)

TITLE: PROCEDURE AND RESPONSIBILITY


6. PROCEDURE AND RESPONSIBILITY

NO ACTIVITY RESPONSIBILITY REFERENCE

6.1 Maintain a register of all certified laboratories that are used for Referral the tests

HOD Appendix 1

6.2 Record the evidence of compliance of all Referral.e.g A copy of Accreditation certificate

SO

6.3 Updating list of tests to be permanently subcontracted of the year.

a) Name of testsb) Type and amount of specimen required

to be sendc) Schedule of sending the specimen out

to the subcontracted laboratory.

SO/LH/HOD Appendix 1

6.4 Acquire the requirement of the test from the Referral lab.

MLT/SO STM of the test

6.5 Received sample as scheduled MLT6.6 Prepare the serum or any related pre-analytical

requirement and keep at proper storageMLT

6.7 Packed the sample appropriately MLT6.8 Record the sample that is going to be

subcontracted. This includes:a) Name of patient / donor registration nob) I.C number / Lab IDc) Name of testd) Date of sending specimene) Ward/Clinic

MLT/SO WorksheetAppendix 2, 3, 4, & 5

6.9 Send the packed sample and request form / worksheet

MLT

6.10 Transport the specimen accordingly in recommended transport media/storage

MLT

6.11 Verify the receipt of specimen in the dispatch book/sheet

Referral

6.12 Receive test report from Referrala) Stamp date of receiveb) Review and verify the result

MLT/SO/MO/LH

6.13 Keep a copy of result a) The reportb) Date of receive

MLT/SN/SO

6.14 Dispatch the laboratory test report accordingly MLT/SO





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HEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSM



TITLE: RECORDPage 6 of 7Version 1Amendment 1

7. RECORD

NO. TYPE OF RECORD LOCATION RETENTION TIME

7.1 File book of Referred Subcontracted Lab. To Microbiology Lab

TML 20 years

7.2 Record book of Referred Test to Referral lab

TML / Hematology Lab 3 years





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HEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY, HUSM



TITLE: FLOW CHARTPage 7 of 7Version 1Amendment 1

8. FLOWCHART





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Appendix 1

UNIT PERUBATAN TRANSFUSIHUSM KELANTAN

Send to ReferralLab as scheduled

Sample preparation

Record

Receive report from Referral

Record/Dispatch

Received specimen

Lists of Referral laboratory

1. Microbiology laboratory, HUSM Kelantan2. National Blood Centre. Kuala Lumpur

Lists of Referral tests

1. Screening test for VDRL/TPHA and MP2. Confirmatory test for HIV (Western Blot)3. Confirmatory test for HIV (Particle Agglutination Test)4. Confirmatory test for HCV (Inno-LIA)5. Blood culture and sensitivity

HUSM/HEMA-UPT/QP-06/A1Appendix 2

UNIT PERUBATAN TRANSFUSI HUSM KELANTAN

BORANG UJIAN SARINGAN KEDUA HIV (PARTICLE AGGLUTINATION TEST)

UNTUK PENDERMA DARAH YANG REAKTIF DARI PILOT DAN SEGMEN

BIL NO.PENDERMA

NO.BAG NO. I/C

JTMP Yang Menjalankan

Ujian Saringan

Keputusan Ujian

Pengesahan HIV

Tarikh Hantar : ___________________ Dipohon Oleh : ______________________

Tandatangan : ______________________

Untuk Kegunaan Makmal Serologi, Jabatan Mikrobiologi

Tarikh Jalankan Ujian : ____________________

Ujian Dijalankan Oleh : ____________________ T/Tangan : ________________

Nama Reagen : __________________________

No. Lot : __________________________

Tarikh Luput : __________________________

Disemak dan Disahkan oleh : _________________________________________

Catitan : ________________________________________________________________

Tarikh Keputusan Diterima : ____________________

Diterima Oleh JTMP : _________________________ T/Tangan : ____________________



BORANG UJIAN PENGESAHAN HIV (WESTERN BLOT)UNTUK PENDERMA DARAH YANG REAKTIF DARI PILOT DAN SEGMEN

BIL NO.PENDERMA

NO.BAG NO. I/C


Ujian Saringan

Keputusan Ujian

Pengesahan HIV


Tandatangan : ______________________




Nama Reagen : __________________________

No. Lot : __________________________

Tarikh Luput : __________________________


Catitan : ________________________________________________________________


Diterima Oleh JTMP : _________________________ T/Tangan : ____________HUSM/HEMA-UPT/QP-06/A3

Appendix 4


BORANG UJIAN PENGESAHAN HCV UNTUK PENDERMA DARAH YANG REAKTIF DARI PILOT DAN SEGMEN

BIL NO.PENDERMA

NO.BAG NO. I/C


Ujian Saringan

Keputusan Ujian

Pengesahan HCV


Tandatangan : ______________________




Nama Reagen : __________________________

No. Lot : __________________________

Tarikh Luput : __________________________


Catitan : ________________________________________________________________


Diterima Oleh JTMP : _________________________ T/Tangan : ____________HUSM/HEMA-UPT/QP-06/A4

Appendix 5

Unit Perubatan Transfusi, Hospital Universiti Sains MalaysiaKeputusan Ujian Saringan Penderma Darah (VDRL/TPHA dan MP)

Tarikh Cetak:

No.

Makmal

No. Bag

VDRL TPHA MP

Komen

1234567

89

1011121314151617

Nama MasaDirekod dan dihantar oleh:

Diterima oleh:Ujian dijalankan oleh JTMP:

Keputusan disahkan oleh:

Keputusan Ujian Saringan Penderma Darah(VDRL/TPHA dan MP) / TMSIS-Version 3.0


URGENT REQUEST FOR VDRL TEST DURING BLOOD SHORTAGE

After office hour/public holidaysResponsibility: 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 form4. Inform the ward concerned for their attendant to send the VDRL samples to

Microbiology Lab1. When the VDRL results are ready, call the respective ward to get the results and

send to UPT lab2. Check the results and record in Borang Keputusan Ujian Saringan (BKUS) 3. For any reactive cases, inform the Senior Technologist on call and send for repeat

segment. Record the repeated VDRL results in BKUS 4. File the VDRL results in File ‘Keputusan Ujian Saringan Penderma Darah (VDRL)’

(HUSM/58/PK/65T)

5. Release blood to the ward after complete verification on screened blood for all TTI markers.

Office hourResponsibility: 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/A6

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QP06