HUSM/LCD/QP-22

MEDICAL LABORATORIES

HOSPITAL UNIVERSITI SAINS

MALAYSIA

REVIEW OF CONTRACTS

Prepared by: Assoc. Prof. Dr Rosline Hassan

Approved by: Dr Zaidun Kamari

Effective

date: 01.11.2009

MEDICAL LABORATORIES HOSPITAL UNIVERSITI SAINS MALAYSIA

Page 1 of 8

Version 1

REVIEW OF CONTRACTS

HUSM/LCD/QP-22

Title: TABLE OF CONTENT

Amendment 1

PAGE TABLE OF CONTENT

1 Table of content

2 Record of Amendment

3 Record of Review

4 Objective , Scope References, Definition & Abbreviation

5 Responsibility

6 Procedure

7 Records

8 Flow Chart

Appendices

Appendix 1 : Agreement document

Appendix 2 : Registration form for laboratory services

Appendix 3 : Checklist

Appendix 4a : Carta Aliran Makmal (diuruskan oleh USAINS tech services) Appendix 4b : Carta Bayaran Perkhidmatan USAINS

Appendix 5 : Borang ujian Makmal (Unit Kewangan) Appendix 6 : Borang tuntutan melalui USAINS

Prepared by

Approved by

Assoc. Prof. Dr Rosline Hassan

Dr Zaidun Kamari

Effective Date 01.11.2009

MEDICAL LABORATORIES HOSPITAL UNIVERSITI SAINS MALAYSIA

Page 2 of 8

Version 1

REVIEW OF CONTRACTS

HUSM/LCD/QP-22

Title: RECORD OF AMENDMENT

Amendment 3

RECORD OF AMENDMENT

VERSION

NO.

VERSION

DATE

DESCRIPTION OF AMENDMENT 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

29/04/2010)

Ammendment 1:

Page 5 of 7, 7.5 Change to:

Dispatch results to:

i. doctor who request the test or/and

ii. laboratory physician

1 1.11.2009

(Effective

date

29/04/2010)

Ammendment 2:

Appendix 3: New form

VERSION

NO.

AMENDMENT

DATE

DESCRIPTION OF AMENDMENT SIGNATURE OF APPROVAL

1 1.08.2010 Document was reviewed on the 14.7.2010

Amendment 3: pg 2 of 8

Version Date was replaced by Date of

Amendment. Added record of review.

Amendment 4: pg 3 of 8

Revised thoroughly at page 5 and add i.

appendix 4a: Carta alir makmal (diuruskan oleh Usains). ii. Appendix 4b : Carta alir cara bayaran perkhidmatan Usains.

Prepared by

Approved by

Assoc. Prof. Dr Rosline Hassan

Dr Zaidun Kamari

Effective Date 01.11.2009

MEDICAL LABORATORIES HOSPITAL UNIVERSITI SAINS MALAYSIA

Page 3 of 8

Version 1

REVIEW OF CONTRACTS

HUSM/LCD/QP-22

Title: RECORD OF REVIEW

Amendment 3,4

DATE OF REVIEW NAME OF REVIEWER APPROVED BY

14 Jul 2010

Dr. Rapiaah Mustaffa

Pn. Norizah Tumin

Prepared by

Approved by

Assoc. Prof. Dr Rosline Hassan

Dr Zaidun Kamari

Effective Date 01.11.2009

MEDICAL LABORATORIES HOSPITAL UNIVERSITI SAINS MALAYSIA

Page 4 of 8

REVIEW OF CONTRACTS

HUSM/LCD/QP-22

Title: OBJECTIVE, SCOPE,

REFERENCES, DEFINITION AND

ABBREVIATION

Version 1

1. OBJECTIVE

To describe the procedures for review contracts to customer requiring medical laboratory

services.

2. SCOPE

This procedure is to be applied to all customers requiring medical laboratory services from

Medical Laboratories in Hospital Universiti Sains Malaysia.

3. REFERENCES

3.1 Laboratory Quality Manual: HUSM/LCD/QM

3.2 MS ISO 15189 Standards

4. DEFINITION

Routine test : Series of tests that are done during office hours and do not require

appointment

Special Test : Series of tests that are done in batches and do/do not require

appointment

STAT Test : Series of tests that are done during or after office hours and do not

require appointment but results are needed urgently

External Customer :Customers who are medical officer, clinicians working in other health

care institutions, health insurance companies, pharmaceutical

companies requesting for medical laboratory services

Internal Customer :Customers working in HUSM who are medical officer and/or clinicians,

requesting for medical laboratory services

Batches : Test run in group within the specific time

5. ABBREVIATION

LD : Laboratory Director

TM : Technical Manager

SO : Scientific Officer

QM : Quality Manager

MLT : Medical Laboratory Technologist

Prepared by

Approved by

Assoc. Prof. Dr Rosline Hassan

Dr Zaidun Kamari

Effective Date 01.11.2009

MEDICAL LABORATORIES HOSPITAL UNIVERSITI SAINS MALAYSIA

Page 5 of 8

REVIEW OF CONTRACTS

HUSM/LCD/QP-22

Title: RESPONSIBILITY

Version 1

6. RESPONSIBILITY

6.1 Laboratory Director

- Responsible for the contract made between customers and laboratory services

6.2 Quality Manager

- Responsible in the implementation of the contract procedure

6.3 Scientific Officer / Technical manager

- Responsible in the maintenance of laboratory procedures in accordance to Quality

Management system

Prepared by

Approved by

Assoc. Prof. Dr Rosline Hassan

Dr Zaidun Kamari

Issued Date

Effective Date

01.11.2009

MEDICAL LABORATORIES HOSPITAL UNIVERSITI SAINS MALAYSIA

Page 6 of 8

REVIEW OF CONTRACTS

HUSM/LCD/QP-22

Title: PROCEDURE

Version 1

7. PROCEDURE

No Activity Responsibility

7.1

7.2

7.3

7.4

7.5

7.6

Identify the customers

7.1.1 Customer requesting for laboratory test will be

identified either as internal or external customer

7.1.2 For both customers, the tests and related information

are made available by medical laboratories.

Prepare contract details

7.2.1 For internal customers

The arrangement may be in the form of memorandum, manual,

circular, letter, minutes of meeting

7.2.2 For external customers

a) Prepare contract documents consisting :

i. List of tests offered and/or cost for each test (note : cost

of test may differ depends on customers either private or

MOH)

ii. Agreement document (Appendix 1)

iii. Registration form for laboratory services (Appendix 2)

b)Send contract review to customer

c)The customer is expected to fill in the documents and send

them back to the respective laboratory

Upon receipt of contract documents from customer proceed

with the approval from lab director

7.3.1 Based on checklist (Appendix 3) send to customer

a) letter of approval with acknowledgement in case of any

deviation in the contract

b) Documents related to the test requested

Proceed to tests as requested

Despatch results accordingly

Acknowledge Unit Kewangan HUSM if customer from

Ministry of Health or USAINS if customers are from private

hospital/clinic

7.6.1 Follow the flowchart as in Appendix : 4a and 4b

7.6.2 Send the borang ujian makmal to Unit Kewangan

(Appendix 5 : Husm/Kew/BUM/06) or USAINS Holding BHD

(Appendix 6) if application is from private hospital

LD

LD/QM

QM/TM

LD

TM/SO/MLT

TM/SO/MLT

TM/SO/MLT

Prepared by

Approved by

Assoc. Prof. Dr Rosline Hassan

Dr Zaidun Kamari

Effective Date 01.11.2009

MEDICAL LABORATORIES HOSPITAL UNIVERSITI SAINS MALAYSIA

Page 7 of 8

REVIEW OF CONTRACTS

HUSM/LCD/QP-22

Title: RECORD

Version 1

8. RECORD

Prepared by

Approved by

Assoc. Prof. Dr Rosline Hassan

Dr Zaidun Kamari

Effective Date 01.11.2009

No.

Record

Retention of Records

1.

Records of contract documents

At least 5 years

2.

Records of contract amendment

At least 5 years

Proceed to tests

MEDICAL LABORATORIES HOSPITAL UNIVERSITI SAINS MALAYSIA

Page 8 of 8

REVIEW OF CONTRACTS

HUSM/LCD/QP-22

Title: FLOWCHART

Version 1

9. FLOWCHART

Prepared by

Approved by

Assoc. Prof. Dr Rosline Hassan

Dr Zaidun Kamari

Effective Date 01.11.2009

Prepare contract details

Agreement between

client and respective

Medical Laboratory

Yes

No

Reject with

explanation

Despatch results to customer

Identify the customer

Acknowledge to

Unit Kewangan HUSM

Appendix 1

AGREEMENT DOCUMENT Ref No:

BETWEEN _________________ LABORATORY SERVICE HOSPITAL USM AND MINISTRY OF HEALTH OR

PRIVATE HOSPITAL DATE :______________________________

Description of Customer

1. Name of Hospital: _____________________________________________________

2. Licence No. : _____________________________________________________

3. Address : _____________________________________________________

4. Office Phone No.: _____________________________________________________

5. Fax No. : _____________________________________________________

6. Name of Customer : ______________________________________________________

Designation : ______________________________________________________ NRIC No. : ________________________________ H/P No. : ________________________________ Signature : ________________________________

7. Name of Lab Director:

NRIC No. : _________________________

Tel. No (O) : _________________________ H/Phone No. : __________

Signature : _________________________

8. Name of Hospital Director : ______________________ Signature : _______________________

HOSPITAL UNIVERSITI SAINS MALAYSIA 16150 KUBANG KERIAN, KELANTAN

Tel: 09-7673000 (General Line) Fax: 09-7648277

HOSPITAL UNIVERSITI SAINS MALAYSIA 16150 KUBANG KERIAN, KELANTAN

Tel: 09-7673000 (General Line) Fax: 09-7648277

REGISTRATION FORM FOR LABORATORY SERVICE Ref No: Hospital: _____________________________ Tel: ________________ Fax: ______________

Address : ___________________________________________________________________________ ____________________________________________________________________________ Name of Medical Laboratory, HUSM: _______________________Date : _____________________ Type of Test Requested :

1. 2.

3. 4.

5. 6.

7. 8.

9. 10.

Choice of payment ( please underline) : Subsidized from Own Hospital / Individual payment ( FOR MINISTRY OF HEALTH HOSPITAL ONLY)

Name of customer :__________________________

Designation :___________________________

Signature :___________________________

Laboratory results despatch to:

Name:___________________________

Department/Unit:___________________

Address:

______________________________

For Lab Used Only Request : Approved Reject : (Reason) ______________________

Approval Number : __________________________________

Name Lab Director : ___________________________________

Date : __________________________________

Appendix 2

Appendix 3

CHECK LIST FOR REVIEW OF CONTRACT

Name of Medical Laboratory

.

Requesting officer:

Date of request: Institution:

Please tick (√) at relevant section:

Verbal:

Type of tests requested :

Written:

STEPS AFFECTED

DETAILS

A) Pre analytical

1 Type of sample

Blood/ Bone marrow

Serum/plasma

DNA/RNA

2 Transportation

3 Receiving sample

B) Analytical

1 Test method

C) Post analytical

1 Turn around time

2 Costing

D) Quality assurance program

Other documentations relevant to

review of contract if any eg : flowchart

Approved by Lab Director :

Appendix 4a

CARTA ALIRAN MAKMAL (DIURUSKAN OLEH USAINS TECH SERVICES SDN. BHD.)

Organisasi/Hospital/Individu

Pendaftaran di Kaunter Klinik Usains - Perlu dicop oleh staf Usains untuk

pengesahan

Borang Lengkap

Individu membuat bayaran terus - Bayar secara Tunai/Cek - Resit dikeluarkan oleh

Usains

SAMPEL dihantar ke makmal berkenaan

Keputusan dari makmal

Makmal perlu mengisi borang BPM Usains

Keputusan hantar ke klinik Usains

POS keputusan kepada pihak berkenaan dan disertakan

bil/inbois

AMBIL KEPUTUSAN SENDIRI di Klinik Usains bayaran terus

secara Tunai/Cek atau bil/inbois

Borang yang tidak lengkap

TAMAT

Appendix 4b

CARTA BAYARAN PERKHIDMATAN USAINS

Organisasi / Hospital / Individu

Terima keputusan dari makmal berkenaan

beserta inbois dari Usains

Buat bayaran kepada

‘USAINS TECH SERVICES SDN BHD’

Cara bayaran : Tunai/Bank in/Cek

Alamat Pos : Usains Tech Services Sdn. Bhd.

Kampus Kesihatan

Universiti Sains Malaysia

16150 Kubang Kerian Kelantan

Account No. : CIMB Bank 0305-0011151-05-2

Pengesahan bayaran oleh pihak Usains

Pihak Usains akan mengeluarkan resit rasmi dan

akan dipos atau difax kepada pihak berkenaan

TAMAT

Sekiranya pembayaran secara

Bank in, EFT atau IBG, sila

hantar pos/fax butiran yang

berkenaan

Tel : 09 – 767 3801 / 6958

Fax : 09 – 765 1724

Tindakan susulan:

Penyata Akaun,

Panggilan Telefon

Tindakan Undang-

Undang

Tidak membuat

pembayaran

UNIT KEWANGAN

HOSPITAL UNIVERSITI SAINS MALAYSIA

16150 KUBANG KERIAN, KELANTAN

BORANG UJIAN MAKMAL

RUJUKAN DARIPADA / KEPADA : _______________________________________________

NAMA PESAKIT : WAD/UNIT :

NO. R/N : MAKMAL RUJUKAN :

I/C : TARIKH :

* Sila tandakan ( √ ) di mana kotak yang berkaitan.

DARIPADA PIHAK LUAR KE HOSPITAL USM

DARIPADA HOSPITAL USM KE PIHAK LUAR

Tujuan:

Sebab-sebab perlu dihantar keluar :

Jenis-jenis Ujian :

Anggaran setiap sampel :

Tandatangan Pemohon : (Ketua Unit/Jabatan/Penyelaras)

Kelulusan Pengarah :

Tandatangan :

Tarikh :

Tujuan:

Sebab-sebab perlu dihantar keluar :

Jenis-jenis Ujian :

Anggaran setiap sampel :

Tandatangan Pemohon :

(Ketua Unit/Jabatan/Penyelaras)

Kelulusan Pengarah :

Tandatangan :

Tarikh :

* Setiap borang yang telah lengkap diisi berserta lain-lain dokumen berkaitan hendaklah dihantar ke Kaunter Taksiran dan

Hasil, HUSM untuk tindakan selanjutnya.

* Sila guna lampiran sekiranya ruangan tidak mencukupi.

Appendix 5:

Husm/Kew/BUM/06

Appendix 6

Borang Tuntutan melalui USAINS

Makmal Perubatan :

Bulan :

Tarikh Nama

Pesakit

No

Pendaftaran

Pesakit

Wad/Klinik Jenis

Ujian

Kos

pakai

habis

Kos

sumber

manusia

Jumlah

Kos (RM)

Nama Pegawai :

Tandatangan :