MEDICAL LABORATORY HOSPITAL UNIVERSITI SAINS MALAYSIA

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HUSM/LCD/QP-21 MEDICAL HOSPITAL UNIVERSITI SAINS MALAYSIA EXAMINATION BY REFERRAL : : Effective Date: 01.11.2010

Page 1 of 8 Title: TABLE OF CONTENTS Version 2 TABLE OF CONTENTS No. Index Page 1. Table of content 1 2. Record of Amendments 2 3. Record of Review 3 4. Objective 4 5. Scope 4 6. Reference 5 7. Definition 5 8. Abbreviation 5 9. Responsibility 6 10. Procedure 7 11. Flow Chart 8 Appendix Appendix 1 Appendix 2

RECORD OF AMMENDMENT MEDICAL LABORATORIES HOSPITAL UNIVERSITI SAINS MALAYSIA Title: RECORD OF AMMENDMENT Page 2 of 8 Version 2 Amendment 2 VERSION NO. VERSION DATE: DESCRIPTION OF AMMENDMENT SIGNATURE OF APPROVAL 1 1.11.2009 Changes of version MS ISO 15189:2004 to new version MS ISO 15189:2007 1 1.11.2009 Transforming version 1 MS ISO 15189:2007 into electronic document web address: http://www.quality.kck.usm.my/husm/ms ISO 15189:2007 1 1.11.2009 (Effective date: 1.06.2010) Ammendment 1: New appendix 1,2,3,4 Appendix 1: Selection of the referral laboratory Appendix 2: Acknowledgement Form Appendix 3: Review of Referral Laboratory Appendix 4: List of Referral Laboratory VERSION NO. AMENDMENT DATE: DESCRIPTION OF AMENDMENT SIGNATURE OF APPROVAL 1 01.08.2010 Amendment 2: Page 2,3 of 9 Version Date was replaced by Amendment Date. Added record of review.

Title: Record of REVIEW Page 3 of 8 Version 2 Amendment 2 DATE OF REVIEW NAME OF REVIEWER APPROVED BY En. Chandran Govindasamy 14 Jul 2010 En. Mohd Rafi Mustapha Dato

Page 4 of 8 Title: OBJECTIVE & SCOPE Version 2 1. OBJECTIVE To ensure effective subcontracting process of the clinical laboratory tests to the referral laboratories when required. 2. SCOPE To be applied to all clinical laboratory tests subcontracted to referral laboratories

Title: REFERENCES, DEFINITION & ABBREVIATIONS Page 5 of 8 Version 2 3. REFERENCES 3.1 Hospital Raja Perempuan Zainab II Website (http://hrpz2.moh.gov.my) 3.2 Hospital Kuala Lumpur Website (http://www.hkl.gov.my) 3.3 Institute for Medical Research Website (http://www.imr.gov.my/functions/diagnostic.htm) 3.4 National Blood Centre Website (www.pdn.gov.my) 3.5 Makmal Kesihatan Awam Kebangsaan Website (http://mka.moh.gov.my) 3.6 Molecular Research Laboratory of the Malaysian Liver Foundation (http://www.liver.org.my/molecular.asp) 4. DEFINITION 4.1 Referral Laboratory External laboratory to which a sample is submitted for a supplementary or confirmatory examination procedure and report 5. ABBREVIATION HOD LD DLD SO CMLT SMLT MLT ASO PAP PTR LA Head of Department Lab Director Deputy Lab Director Scientific Officer Chief Medical Lab Technologist Senior Medical Lab Technologist Medical Lab Technologist Assistant Scientific Officer Pembantu Am Pejabat Pembantu Tadbir Rendah Laboratory Assistant

Page 6 of 8 Title: RESPONSIBILITY Version 2 6. RESPONSIBILITY 6.1 HOD - Head of Department Responsible for overall management for subcontracting process of the medical laboratory tests 6.2 LD - Lab Director Responsible for selecting, evaluating and monitoring of referral laboratories 6.3 DLD - Deputy Lab Director Responsible for assisting the lab director for selecting, evaluating and monitoring of referral laboratories 6.4 SO - Scientific Officer Responsible for organising and regular monitoring of the performance of the referral laboratories 6.5 SMLT - Senior Medical Laboratory Technologist Responsible for management of test request, sample handling and despatch to referral laboratories and compilation of results/reports received 6.6 MLT - Medical Laboratory Technologist Responsible for receiving test request, sample handling and despatching to referral laboratories and compilating of results/reports received 6.7 ASO - Responsible for receiving test request, sample handling and despatching to referral laboratories and compilating of results/reports received 6.8 PAP - Pembantu Am Pejabat Responsible for receiving test request, sample handling and despatching to referral l laboratories 6.9 PTR - Pembantu Tadbir Rendah Responsible for receiving test request, sample handling and despatching to referral laboratories 6.10 LA - Laboratory Assistant Responsible for receiving test request, sample handling and dispatching to referral laboratories

Page 7 of 8 Title: PROCEDURE Version 2 7. PROCEDURE No Activity Responsibility 7.1 Selection and Agreement for Referral Laboratory 7.1.1. Identify the services or tests to be sent to referral laboratory LD / DLD / SO 7.1.2. Identify the laboratory offering the services and obtain relevant information (Refer to Appendix 1) LD / DLD / SO 7.1.3. Obtain approval from the Hospital Director HOD/LD 7.1.4. Obtain approval from the Referral Lab HOD/LD 7.2 7.2.1. Receive request and specimen as in related procedures 7.2.2. Pack, record and send specimen to the referral laboratory Note: Obtain acknowledgement of sample received by referral lab (Refer to Appendix 2) SMLT / MLT / ASO/ PAP / PTR / LA SMLT / MLT / ASO/PAP / PTR / LA 7.2.3. Upon receiving the result from the referral laboratory (i) Check the patient information (ii) Enter results into LIS if available (iii) Photocopy and retain the photocopy results in the file in laboratory 7.2.4. Dispatch the result to the requester 7.2.5 Review the referral lab yearly (Refer to Appendix 3) SMLT / MLT / ASO SMLT / MLT/ASO SMLT / MLT/ASO SMLT / MLT / ASO/PTR / PAP LD/DLD/SO

Page 8 of 8 Title: FLOW CHART Version 2 FLOW CHART Identify the services or tests to be sent to referral laboratory Identify the laboratory offering the services and obtain relevant information Obtain approval from the Hospital Director Obtain approval from the referral Lab Request and specimen received Pack, record and send specimen to the referral laboratory Results received from the referral laboratory Dispatch result to requester

Appendix 1 HOSPITAL UNIVERSITI SAINS MALAYSIA Selection of the Referral Laboratory 1 Name of the Laboratory: 2 Address: 3 Laboratory Certification: Yes No MS ISO 15189 MS ISO 9001:2004 ISO 17025 Others Please Specify: 4 Tests offered (Refer to References) Participation in EQA programme: Yes/ No 5 Laboratory Consultant: Yes/ No Particulars of consultant Name: Qualification and year: MMC registration: : Date: A HUSM/LCD/QP-21/R1

Appendix 2 HOSPITAL UNIVERSITI SAINS MALAYSIA Acknowledgement Form The following Specimens / Samples have been sent to the referral laboratory No. Name of patient Registration No. Type of Specimen Type of Tests Total of Specimen / Sample --------------------------- This is to acknowledge that I/we have received No. of specimen / sample received --------------------------- No. of specimen / sample missing / damaged --------------- from the Medical Laboratory, Hospital USM. { (Name of Specific) laboratory} Comments (if any) Received by: Signature: Name: Laboratory / stamp: HUSM/LCD/QP-21/R2

Appendix 3 HOSPITAL UNIVERSITI SAINS MALAYSIA Review of Referral Laboratory 1 Name of the Laboratory: 2 Address: 3 Any changes in the requirement Yes No Pre-examination Examination procedure Post-examination If yes, please specify: 4 Turn-around-time Meet the TAT Yes / No If no, please state the reasons: HUSM/LCD/QP-21/R3

Appendix 4 Hospital Raja Perempuan Zainab II Kota Bharu 15586 Kelantan Tel: 09-7452000, Fax: 09-7486951 Department of Pathology Hospital Kuala Lumpur Jalan Pahang 50586 Kuala Lumpur Tel: 03-26155594, Fax: 03-03-26970417 List of Referral Laboratory Universiti Kebangsaan Malaysia Medical Centre Jalan Yaacob Latif Bandar Tun Razak 56000 Cheras, Kuala Lumpur Tel: 03-91455555, Fax: 03-91724530 Jabatan Patologi Pusat Perubatan Universiti Malaya, Lembah Pantai, 59100, Kuala Lumpur, Malaysia Tel:03-7949 4422 Fax: 03-7956 2253 Institute for Medical Research Jalan Pahang 50588 Kuala Lumpur Tel: 03-40402402, Fax:03-26938210 National Blood Centre Jalan Tun Razak 50400 Kuala Lumpur Tel: 03-2693 3888, Fax: 03-2698 0362 Makmal Kesihatan Awam Kebangsaan Lot 1853, Kg Melayu Sungai Buloh Sungai Buloh 47000 Selangor Tel: 03-61565109, Fax: 03-61402249 Molecular Research Laboratory of the Malaysian Liver Foundation No.10-3, Jalan 25/70A Desa Sri Hartamas 50480 Kuala Lumpur Tel: 03-23003455, Fax: 03-23003458 Institute of Health & Community Medicine of the Universiti Malaysia Sarawak (UNIMAS) Kota Samarahan 94300 Sarawak Tel: 082-671730, Fax: 082-671785