National Radiology Services Operational Policy 1st Edition

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NATIONAL

RADIOLOGY
SERVICES
OPERATIONAL
POLICY
NATIONAL RADIOLOGY SERVICES
OPERATIONAL POLICY

MINISTRY OF HEALTH MALAYSIA

NATIONAL RADIOLOGY SERVICES


OPERATIONAL POLICY

Clinical Support Services Unit


Medical Development Divison
Minitry of Health Malaysia
NATIONAL RADIOLOGY SERVICES
OPERATIONAL POLICY

First Edition 2019

Efforts were coordinated by


Clinical Support Unit,
Medical Services Development Section
Medical Development Division
Ministry of Health, Malaysia.

A catalogue record of this document is available from the Library and


Resource Unit of Institute of Medical Research, Ministry of Health;

MOH/P/PAK/427.19 (BP)

And also available from National Library of Malaysia;

ISBN 978-967-2173-78-6

© Ministry of Health Malaysia 2019

All rights reserved: no part of this publication may be


reproduced, stored in a retrieval system, or transmitted
in any form or by any means, electronic, mechanical,
photocopying, recording or otherwise without the prior
permission of the Ministry of Health Malaysia.

Published by :
Medical Development Division
Ministry of Health, Blok E1,Parcel E,
Federal Government Administrative Center,
62590 Putrajaya, Malaysia.
Tel : 603-88831489
Fax : 603-88831155
http://www.moh.gov.my

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NATIONAL RADIOLOGY SERVICES
OPERATIONAL POLICY

This policy was developed by the Medical Development Division


and the Drafting Committee of Operational Policy on Radiology Services
Ministry of Health Malaysia.

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NATIONAL RADIOLOGY SERVICES
OPERATIONAL POLICY

ACKNOWLEDGEMENT

The completion of this National Operational Policy on Radiology Services


could not have been possible without the participation and assistance of the
Drafting Committee of Operational Policy on Radiology Services. Their
contributions are sincerely appreciated and gratefully acknowledged.

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NATIONAL RADIOLOGY SERVICES
OPERATIONAL POLICY

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NATIONAL RADIOLOGY SERVICES
OPERATIONAL POLICY

FOREWORD
Director General of Health Malaysia 8
Former National Advisor on Radiology Services . 9
National Head of Radiology Services 10

LIST OF ABBREVIATIONS 12
CONTENT:
1.0 ORGANISATION & MANAGEMENT 13-15
1.1 Vision
1.2 Mission
1.3 Objectives
1.4 Scope of Service
1.5 Organisational Structure

2.0 OPERATIONAL POLICY 16-21


2.1 General Statement
2.2 Scheduling an examination
2.3 Special Examinations
2.4 Mammography
2.5 Interventional Radiology
2.6 Peripheral Radiology Services
2.7 Forensic Radiology

3.0 PATIENT CARE 22-23

4.0 REPORTING, CONSULTATION & 23


IMAGE MANAGEMENT

5.0 SAFETY IN IMAGING 24-33


5.1 Radiation Safety
5.2 Examination on Females of Child Bearing Age
5.3 MRI Safety
5.4 Contrast Media Safety
5.5 Infection Control
5.6 Occupational Safety
5.7 Chemical Waste Management
5.8 Incidents in the Radiology Department

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OPERATIONAL POLICY

6.0 PATIENT’S RIGHTS 34

7.0 TRAINING / CONTINUOUS 34


PROFESSIONAL DEVELOPMENT (CPD)

8.0 FACILITIES AND EQUIPMENT 35-39


8.1 General
8.2 Facilities
8.3 Equipment
8.3.1 Safety and Performance
8.3.2 Storage / Security and Maintenance of
Mobile X-ray Equipment
8.3.3 Contingency Plan for Equipment / System
Failure
8.3.4 Decommissioning

9.0 APPENDIX 40-63

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OPERATIONAL POLICY

In the wake of the Fourth Industrial Revolution,


healthcare services all around the globe will
not be spared of the Internet ripple, and
radiology will be at the forefront of the wave of
Artifical Intelligence and the Internet of Things.
As one of the earliest adopters of X-ray
technology in 1873, Malaysian healthcare
system will once again be tested.

Tremendous development of imaging


modalities that utilises ionizing radiation
such as CT and X-ray, magnetic resonance
imaging and ultrasound in recent years provides
clinicians with even more information with
precise accuracy. Our physicians are now
able to expedite clinical decisions, hence
enable us to yield an improved quality of care to our patients.

Malaysian healthcare system is often antagonised with economic inflations


and constrains of limited resources. Routinely, high degree of co-ordination
for advanced imaging are required in assisting clinicians’ diagnosis as well
as radiological therapeutic interventions. Henceforth, the birth of this policy is
hoped to provide guidance to relevant parties on a development of a system that
is financially viable, coordinated and efficient.

The use of radiation is governed by complex regulations and license condition


therefore it is impartial that the management and healthcare providers to
continue to embrace initiative designed to response and complement to these
challenges and abide to the policy promulgated. Therefore, it is our professional
responsibility to carry out the delivery of safe and effective practice.

Finally, I would like to congratulate the Medical Development Division for


amalgamating this effort and commendation must belong to the drafting
committee led by Datin Dr Zaharah Musa for their continuing dedication and
commitment. I believe that this commitment will continue safeguarding Ministry
of Health’s mission to provide the country with an unsurpassable healthcare
system into the 21st century.

Datuk Dr. Noor Hisham Abdullah


Director General of Health, Malaysia

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OPERATIONAL POLICY

Radiology has become an integral component


of modern medical patient care. a has grown in
leaps and bounds since the discovery of X-rays
in 1895 and Malaysia was at the forefront of the
medical radiology when the first x-ray machine
in Malaysia was installed in Taiping Hospital in
1896.

The scope of service today has expanded from


basic radiography to include modern sophisticated
radiological equipment and applications. The
service now has progressed into therapeutic
realm with the evolution of interventional
radiology. Modern medicine in the 21st century has recognized the value of
radiology and its use is now extended into forensic radiology where vigorous
research is ongoing worldwide to assess its role in converting open autopsy to
virtual autopsy.

As radiology continues to progress in this era of disruptive technology, our


focus must pivot on patient care. Precedence of quality patient care in our
service also means, every member of the radiological department must work
effectively together to provide high-quality and time-efficient patient imaging
whilst ensuring the safety of the medical personnel and patients alike during
the radiological procedure.

The publication of this policy is timely, and it is aimed at setting out the
principles and arrangements which we believe are appropriate for high-quality
patient care. It is hoped that this document will assist and guide radiological
and non-radiological staff alike to understand our work processes better and
hence able to optimize its usage in patient care.

The Medical Development Division, Medical Radiation Surveillance Division,


Family Health Development Division as well as Engineering Division has provided
enormous support in the preparation of this document and I am grateful for
their guidance and assistance. I would also like to thank my seniors and
colleagues in the drafting committee who developed this document and all
those who have also helped one way or another.

Datin Dr. Zaharah Musa


Former National Advisor on Radiology Services .

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NATIONAL RADIOLOGY SERVICES
OPERATIONAL POLICY

This National Radiology Services


Operational Policy document was initiated
by my predecessor, Datin Dr Zaharah Musa.
The aims of this policy document are to
establish guidelines and best practices in
our organisation. It is hope that this policy
document will serve as a reference standard
among the radiology service providers and
the end users in order to provide quality and
safe practice.

As the radiological fraternity is on the verge


of a major revolution in medicine with the
advent of artificial intelligence (AI) we should
be actively involved in shaping our own future
and warrant that we will be the fittest to survive natural selection. Radiologists
need to expand their role and show value in order to remain relevant in clinical
practice in the era of AI.

Radiologists must go beyond detecting lesions and interpreting images


because machines already perform these tasks better than humans. The
radiologists role will rather be to answer clinical questions by integrating the
imaging information together with clinical information and putting it all in context.
Radiologists must include more information in their reports from genomics and
fields other than imaging, and not just give recommendations This document
will not be complete without the contribution and commitment from the drafting
committee and for that I would like to express my gratitude. I hope that this
document can be put to good use to raise the bar of radiology service in the
Ministry of Health Malaysia.

Dr. Yun Sii Ing


National Advisor on Radiology Services
2018– present

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Definition

Special Examination Refers to all other forms of imaging


other than general radiography
(X-ray)

Peripheral Radiology Services Refers to the provision of trained


radiology personnel to handle
imaging modalities in other
departments.

Satellite Services Refers to the provision of radiology


servicesin areas other than the
main department.

Interventional Radiology Refers to the utilization of


minimally invasive image guided
procedures to diagnose and treat
diseases.

Forensic Radiology Refers to the application of imaging


on a deceased person and / or
body parts to questions of law.

Radiology Consultation Refers to the provision of expert


opinion on image and patient
management as well as direct
patient consultation.

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LIST OF ABBREVIATIONS

ACR American College of Radiology


AKI Acute kidney injury
CD Compact Disc
CIN Contrast Induced Nephropathy
CME Continuous Medical Education
CPD Continuous Professional Development
CT Computed Tomography
eGFR Estimated Glomerular Filtration Rate
FIFO first-in-first-out
GBCA Gadolinium Based Contrast Agent
HSIP Hospital Specific Implementation Plan
ICRP International Commission on Radiological Protection
ICT Information and Communication Technology
IT Information Technology
IVU Intravenous Urography
KPI Key Performance Indicator
MOH Ministry of Health
MOA Memorandum of Agreement
MR Magnetic Resonance
MRI Magnetic Resonance Imaging
NPPV Noninvasive Positive Pressure Ventilation
NSF Nephrogenic Systemic Fibrosis
OSH Occupational Safety and Health
OSHA Occupational Safety and Health Administration
PMCT Post Mortem CT
QAP Quality Assurance Program
RPC Radiation Protection Committee
RPO Radiation Protection Officer
SOP Standard Operating Procedures

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1.0 ORGANISATION AND MANAGEMENT

Radiology Services provide diagnostic imaging and / or interventional /


therapeutic services to inpatients and outpatients in state, major and minor
specialist hospitals, non-specialist hospitals, selected special institutions
and health clinics.

1.1 Vision

Safe, efficient and quality radiology services.

1.2 Mission

To provide quality and excellent radiological services through


a team of caring professional and dedicated staff utilising the
current available technology emphasising patient comfort
and safety.

1.3 Objectives

1.3.1 To provide appropriate, effective and efficient


diagnostic and interventional services, utilising
up-to-date technology, by a dedicated team of trained
personnel.

1.3.2 To adhere to relevant laws, regulations, standards


and guidelines to ensure safety of patients, public,
staff and the facility.

1.3.3 To promote continuous professional development,


quality improvement activities and research.

1.4 Scope of Service

Services provided depend on the type of facilities, essentially


divided into the State, Major Specialist, Minor Specialist,
Non-Specialist Hospital, Special Institution and Health Clinic
(Appendix 1). The department provides diagnostic and
interventional services for patients of all age groups and
disciplines. The types of services provided are:

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1.4.1 General Radiography


1.4.2 Intravenous Urography (IVU)
1.4.3 Fluoroscopy
1.4.4 Ultrasonography
1.4.5 Computed Tomography (CT)
1.4.6 Mammography
1.4.7 Magnetic Resonance Imaging (MRI)
1.4.8 Angiography
1.4.9 Interventional Radiology
1.4.10 Forensic Radiology
1.4.11 Bone Densitometry
1.4.12 Radiology Consultation
1.4.13 Peripheral Radiology Services
1.4.14 Mobile Services
i. General Radiography
ii. Ultrasonography
iii. C-Arm Fluoroscopy
iv. Mobile CT

Mobile services are bedside services provided for the critically


ill and non-ambulatory patients.

Emergency radiology services are provided 24 hours a day.


The type of services shall depend on the local availability of
resources.

1.5 Organisational Structure

The organisational chart (Appendix 2-4)

1.5.1 The National Head of Radiology shall serve as


the advisor to the Ministry of Health on all matters
pertaining to the services.

1.5.2 The State Radiologist shall be appointed by the State


Health Director and assist the National Advisor in all
state radiology matters including health clinics.

1.5.3 The radiology department shall be headed by a


Radiologist appointed by the Hospital Director. He /

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She shall be responsible for the following:

i. The authority on matters pertaining to the clinical


radiological service management of the hospital

ii. Supervisory position on administrative matters


of the department.

iii. Manpower planning and facilitating to the most


optimal usage of the radiology department
personnel, and ensure that radiology department
activities aredelegated appropriately according
to staff’s position, skills and abilities.

iv. Ensuring CPD, quality and research activities


are carried out.

v. Plan and implement the budget resources for


the radiology department.

1.5.4 He / She shall be assisted by senior radiologists,


medical officers, senior radiographers, medical
physicists and nurses.

1.5.5 The department personnel shall be involved in the


process of procurement, pertaining to the Radiological
Services and imaging equipment procurement for
the hospital.

1.5.6 The department shall conduct periodic appropriate


meetings and special ad-hoc meetings, when
necessary.

1.5.7 The department shall be represented in the Radiation


Protection Committee as well as various committees
at hospital level as deemed necessary by the Hospital
Director.

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2.0 OPERATIONAL POLICY

2.1 General

2.1.1 All radiology procedures shall be performed by


qualified and credentialed personnel. Notwithstanding
the above, medical personnel who have undergone
appropriate training in specific procedures can be
privileged to perform the procedures.

2.1.2 A radiological investigation or procedure shall be


performed upon request from a registered medical
/ dental practitioner and when deemed appropriate
by a radiologist. Such request shall contain clinical
information to justify the examination.

2.1.3 All requests for radiology examinations shall be


accompanied by duly completed radiology request
forms / order entries. (Including consent and checklist
if relevant) (Appendix 5)

2.1.4 The department shall be fully operational for all types
of examination during office hours.

2.1.5 Outside office hours, urgent radiological examinations


shall be performed according to timeliness.

2.1.6 Examinations on a patient shall be carried out in the


presence of an appropriate chaperone.

2.1.7 For all radiological examinations involving ionizing


radiation, the dose / exposure factors / fluoroscopy
time shall be recorded.

2.2 Scheduling of Examinations

2.2.1 General radiography examinations shall be done on


the same day unless otherwise specified.

2.2.2 Special examinations / procedures shall be scheduled

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according to priority and availability.

2.2.3 The request for special examinations or procedures


shall be made by a specialist. However, medical
officers may make request upon consultation with
the specialists. 

2.2.4 Requests for early or urgent appointments shall be


given priority upon discussion between the requesting
doctor and the radiologist.

2.2.5 Radiology department shall coordinate with the


various department personnel if their services are
required.

2.2.6 Rescheduling may be done in the following situations:

i. Patients not adequately prepared or not


fulfilling certain conditions where patient
safety and quality of diagnosticexamination
are compromised.

ii. Patient presenting late on the appointment day


or on the wrong date.

iii. Equipment breakdown, malfunction and or


unavoidable circumstances.

iv. Patient’s request.

2.2.7 The requesting doctor / clinic shall be informed about


the rescheduled examinations. Reasons for rescheduling
shall be indicated. 

2.2.8 For urgent referrals to Radiology Department in another


hospital, such requests shall be coordinated by the
Radiology department of the hospital concerned.

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2.3 Special Examinations

2.3.1 Examination shall be performed according to the


specific imaging protocols.

2.3.2 For examination requiring contrast media, serum


creatinine shall be required for all patients above
50 years old and those suspected with renal
impairment. In a patient with abnormal renal function,
consultation with nephrologists / referring doctor may
be necessary.

2.3.3 Review of checklist shall be done before performing


the examination. If there is non-compliance, the
radiologist shall discuss the appropriate alternative
examinations with the requesting doctor. (Appendix
6, 7)

2.3.4 Special precautions shall be taken for high risk cases.

2.3.5 A fully equipped Resuscitation / Emergency Trolley


shall be readily accessible.

2.3.6 All clinical specimens collected from the procedure


shall be:

i. Labelled correctly

ii. Dispatched either to the pathology department


or the relevant ward and documented accordingly.

2.4 Mammography examinations

2.4.1 Mammography examinations shall be performed by


female radiographers trained in mammography.

(Refer to Pekeliling Mengenai Keperluan Tambahan
Perlesenan Di Bawah Akta Perlesenan Tenaga Atom
1984 (Akta 304) (19)dlm.KKM-153(13/172) Bhg2 – 29
Februari 2000).

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2.5 Interventional Radiology

2.5.1 Interventional Radiology is divided into Interventional


Neuroradiology and Interventional Peripheral
radiology.  Interventional Neuroradiology involves
procedures from the neck above and the spine.

2.5.2 The radiologist performing interventional


procedures must hold qualifications and maintain
competency   specific to the range of interventional
procedures he/she is performing.

2.5.3 Interventional radiology   procedures are to be


performed in a well-equipped  room with appropriate
facilities and qualified procedures  performed at the
mentioned site, and for the treatment of possible
complications.

2.5.4 Equipment for physiological monitoring of patients


undergoing interventional procedures shall be
appropriate to the procedure being performed.
These include ECG, blood pressure and pulse
oximetry. Where warranted, additional equipment
like pressure monitoring for pulmonary arteriography
and intravascular pressure  gradients in peripheral
and visceral diagnostic angiograpghy shall be made
available.

2.5.5 Interventional radiologist is to be involved in a


multidiscipline discussion related to their case in
order to achieve a high level of care.

2.5.6 All interventional radiology doctors ( consultant, fellow


and registrar ) shall personally attend their patients
in order to perform pre-operative and post operative
assessment of their patients, including obtaining
consent for the respective procedure.

2.5.7 All interventional procedures (peripheral and


neurointervention) receive their patients from their

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respective primary team as the main referrer. This


is to be followed until revision to allow interventional
radiology unit to be privileged as primary team is
achieved in the future.

2.6 Peripheral Radiological Service

2.6.1 Relevant radiology personnel shall provide radiological


services in designated areas outside the radiology
department when required.

2.6.2 Requests shall be made by specialists using the


standard radiology request forms. However, medical
officers may make requests upon consultation with
the specialist. 

2.6.3 The requesting doctor shall screen and prepare patient


adequately for the procedure. Relevant checklist and
consent forms shall be completed by the requesting
clinician.

2.6.4 The examinations shall be performed in designated


rooms in compliance to MOH regulations and
international safety standards.

2.7 Forensic Radiology Service

2.7.1 All radiological procedures shall conform to the


relevant standards to preserve the “chain of custody”.

2.7.2 General radiography of the deceased person / body


parts shall be performed in the mortuary or designated
area.

2.7.3 Request for general radiography examination on the


deceased person / body parts shal be made by the
General Pathologist / Forensic Pathologist or Forensic
Medical Officer.

2.7.4 The department personnel shall not take / move items

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belonging to the deceased. Any movement of items


/ parts shall be done in the presence of forensic
pathology staff.

2.7.5 In centers where dedicated Post Mortem CT (PMCT)


is available, examination shall be performed as pre-
autopsy procedure (all police cases).

2.7.6 For PMCT / radiological procedures request, other than


the above mentioned cases, the General Pathologist,
Forensic Pathologist or Forensic Medical Officer
shall discuss the case with the attending Forensic
Radiologist prior to performing the procedure.

2.7.7 There shall be no request for PMCT in centers without


dedicated PMCT services.

2.7.8 All post mortem digital images shall be immediately


deleted after soft and hard copies have been securely
archived.

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3.0 PATIENT CARE

3.1 The requesting doctor shall screen and prepare patient


adequately for the radiological procedure. Relevant checklist
and consent forms shall be completed by the requesting
doctor.

3.2 Sedation / pain relief of patients, if required, shall be the


responsibility of the requesting doctor. If the procedure is
unable to be carried out under sedation, the patient shall be
rescheduled and referred to the Anesthesiologist for general
anesthesia.

3.3 For services that require general anesthesia / sedation, the


requesting doctor shall coordinate with the relevant department
(example anesthesia or paediatric department) depending
on local policy.

3.4 In cases where the attending radiologist provides sedation, he


/ she shall adhere to the Recommendations for Sedation and
Analgesia by Non-Anesthesiologists (Refer to Recommendations
for Sedation and Analgesia by Non-Anaesthesiologist)

3.5 Ill patients and those requiring special attention:

i. Shall be accompanied by medical personnel competent


to deal with the medical condition of the patient through
out the transport and shall remain with the patient for
the duration of the examination.

ii. Shall be identified and given priority

3.6 Paediatric cases requiring sedation shall be attended by the


paediatric team / requesting department at designated location. 

3.7 For emergencies occurring in the department (including contrast


media reactions), the radiology department personnel shall
commence initial resuscitation immediately and activate Code
Blue or any Medical Response alerts if deemed necessary.
Following that, all in-patients shall be sent to the respective

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wards while out- patients shall be sent to the emergency


department for further management. Should a death occur
within the department, the same pathway will follow.

3.8 All procedures performed and drugs administered (including
contrast media) shall be documented.

4.0 R E P O R T I N G , C O N S U LTAT I O N & I M A G E


MANAGEMENT

4.1 All special examinations shall be reported by radiologists


/ medical officer privileged to do so within turnaround time
specified in the national KPI.

i. In-patient turnaround time is within 2 working days.

ii. Out-patient turnaround time is within 14 days.

4.2 The radiologist shall communicate the radiological findings


to the respective specialist in a timely manner and document
in the following situations:

i. All findings that may need immediate / urgent intervention


where failure to act may adversely affect patient’s health.

ii. All findings that the interpreting radiologist reasonably


believes may be seriously adverse to the patient’s health
and may not require immediate attention but, if not
acted on, may worsen over time and possibly result in
an adverse outcome.

4.3 Collection of film / radiology report shall be done by the primary


team and thereafter, the films and reports will be sent to the
medical records office by the primary team for archiving and
future retrieval.

4.4 Images of patient referred from other health facilities shall


be digitised and uploaded into the hospital archiving system.

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4.5 The collected / received information on film / radiology report


/ CD shall be documented.

4.6 All staff with access rights to patients’ radiological reports /


images shall follow the policies and laws that govern the use
of disclosure of patients’ medical records / images.

4.7 For IT hospitals, all requests for hardcopies of patient’s


radiological reports or images for referrals shall be requested
by the attending specialist according to local hospital standard
operating procedures.

4.8 Requests for films or images by patients for their own use
must be through the medical record office.

4.9 For formal interpretations of radiological examination /


procedure done elsewhere (public or private health care
facilities), a request for reporting shall be made by the specialist
on a duly completed request form.

5.0 SAFETY IN IMAGING

5.1 Radiation Safety

(Refer to: Atomic Energy Licensing Act 1984 and subsidiary


regulations under the Act)

5.1.1 All examinations utilising ionizing radiation shall be


performed in accordance with the basic principles of
radiation protection.

5.1.2 Adequate protective and safety measures shall be


in accordance with existing laws, regulations and
guidelines.

5.1.3 There shall be scheduled monitoring of radiation dose


received by the staff handling irradiating apparatus
as well as those performing the procedures

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5.1.4 Thorough investigation shall be conducted in the event


of a staff is exposed to radiation above the dose limit.

5.1.5 Radiation protection program shall be established


and maintained. Radiation Protection Officer (RPO)
shall be appointed and is responsible for co-ordinating
and overseeing the radiation protection activities for
patient, staff and public on behalf of the Radiation
Protection Committee (RPC).

5.1.6 Radiation warning signs shall be posted on the


entrance door of examination rooms with irradiating
apparatus.

5.1.7 Only personnel who are required to assist shall


be present during the performance of an X-ray
examination. No person shall hold the patient or
film cassette during exposure unless it is absolutely
necessary (MS838:2007. Malaysian Standard code
of practice for radiation protection - Medical X-ray
Diagnosis)

5.1.8 When a patient or image receptor must be held by


an individual:

i. the holder shall be selected from individuals


who may be rotated through the assignment

ii. the holder shall be in order of preference;

a. next of kin

b. relative or friend accompanying the


patient

c. medical staff accompanying the patient

iii. the holder shall not be a radiation worker at


the facility unless in an emergency, where no
other persons are available.

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5.2 Examination on Females of Childbearing Age.

(Refer to Surat Pekeliling Ketua Pengarah Kesihatan Malaysia


Bil 4 Tahun 1998. Garispanduan Bagi Menjalankan Prosedur
Diagnosis Perubatan Menggunakan X-ray Bagi Wanita Yang Disyaki
Mengandung)

5.2.1 For women of child bearing age, the guidelines laid


down by the MOH based on international guidelines
shall be adhered to. (Refer to ICRP 1984 & NRPB
1985)

5.2.2 Requests for examinations utilizing ionizing radiation


for pregnant patients shall be made by requesting
specialists or medical officers (after consultation with
respective specialists) (Appendix 9,10)

5.2.3 Consent shall be obtained for all examinations using
ionizing radiation on pregnant and possibly pregnant
patients. (Refer to Consent form). Where possible,
a spousal consent shall be obtained, especially for
elective case.

5.2.4 All female patients of menstrual age (typically aged
between 12 to 55 years) must be directly questioned
about pregnancy status by the radiographer.

5.2.5 For non-urgent examinations involving high doses


to uterus in patients who are possibly pregnant, the
examination shall be done within 10 days of their
menstrual cycle (10 Day Rule).

5.2.6 For most of the routine examinations, except those


falling into high dose category, which will result in
irradiation to the uterus, the 28 Day Rule shall apply.

5.2.7 For patients with irregular menses, a urine pregnancy
test may be required.

5.2.8 Radiation exposure to the lower abdomen and

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pelvis of women of child-bearing potential shall be


kept to a minimum. During pregnancy, radiological
examination shall be performed only when there is
absolute indication.

5.2.9 Multilingual warning signage for pregnancy shall be


posted in the proximity / entrance door of examination
rooms.

5.3 MRI Safety

5.3.1 All MRI facilities shall comply with the 4 zone-safety


principles and ensure that the workflow is compliant
to the safety structure. All areas within the MRI facility
shall be clearly marked, and separated, by appropriate
barriers. Clear signage in local languages shall be
displayed on the magnet room door.

(Please refer to document on Magnetic Resonance


Imaging Safety & Quality by College of Radiology,
Academy of Medicine Malaysia)

5.3.2 Movement in the control room and magnet room shall


be limited and strictly supervised.

5.3.3 No unauthorised individual shall be allowed into


the magnet room without the clearance of the MR
radiographer on duty

5.3.4 Only radiographers who have undergone specific


training shall be privileged to operate MR equipment
and shall undergo refresher courses on a regular
basis on equipment familiarisation and safety.

5.3.5 Healthcare staff from other department or relative


accompanying patient shall be briefed and screened
by the MR radiographer on MR safety before being
allowed into the magnet room.
5.3.6 Personnel in and outside of department, including
maintenance staff from concession company, shall

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undergo MR safety training before he / she shall be


allowed to access the magnet room.

5.3.7 In the event of an emergency occurring during


scanning where a patient requires medical attention,
the MR radiographer at the time of the incident shall
observe the following Emergency Procedures:

i. In a situation where emergency quenching of the


magnet or shutdown of the MRI system is required,
strict adherence to SOP on Emergency Shutdown
and Quench Procedures shall be complied.

ii. In an emergency situation whereby a patient is


required to exit the magnet room immediately, the
MR radiographer shall follow SOP on Exiting the
Magnet room in an Emergency.

5.3.8 Pregnant personnel may be allowed to enter the


magnet room for patient set up, but shall not remain
inside it during scanning in line with International
Practice Guidelines and Standards.

5.3.9 Pregnant Patient and MRI

i. The MRI examination shall be delayed till after


the first trimester whenever possible.

ii. Gadolinium based contrast agents shall be


administered only when there is a potential
significant benefit to the patient and / or foetus.
The benefit must also outweighs the possible
but unknown risks of foetal exposure to free
gadolinium ions.

iii. Requests for MRI and use of contrast involving


pregnant patients shall be made by attending
specialists after discussion with the radiologist; the
following points shall be taken into consideration
and documented in the patient record or radiology

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report.

a. That information requested from the MRI


study cannot be acquired without the use of IV
contrast or by using other imaging modalities.

b. That the information needed affects the


care of the patient and / or foetus during the
pregnancy.

c. That the requesting doctor is of the opinion
that it is not prudent to wait to obtain this
information until after the patient is no longer
pregnant.

iv. Informed consent shall be obtained from the
patient and whenever possible, from the spouse.

5.4 Contrast Media Safety

5.4.1 Examinations with intravenous contrast medium shall


be performed if deemed indicated after considering
risk versus benefit.

5.4.2 Steps shall be taken to minimise likelihood of contrast


reaction and to be fully prepared to treat a reaction
should one occur.

5.4.3 Patients at risk of developing an acute allergic-like


reaction shall be given steroid premedication.

5.4.4 Premedication may be omitted under emergency


situation (Refer ACR Guidelines 10.2)

5.4.5 Informed consent shall be taken from all patients


requiring use of intravascular contrast media

(Ruj:Arahan Menggunakan Borang Kebenaran


Menjalani Prosedur Radiologi di semua Fasiliti
Kementerian Kesihatan Malaysia. KKM87/P1/32/1Jld.2

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(76) Bertarikh 20bh Nov 2015)

5.4.6 Administration of contrast medium shall be performed


by doctors or other privileged medical personnel.

5.4.7 Steps shall be taken to prevent risk of contrast


extravasation and air embolism.

5.4.8 Protocol on prevention, evaluation and management


of extravasation shall be in place. (ACR Guidelines
for Contrast Media Safety)

5.4.9 There shall be a protocol on evaluation and


management of allergic reactions due to contrast
medium. (Refer ACR Guidelines).

5.4.10 The personnel shall be adequately trained to handle


such an event.

5.4.11 Adequately equipped emergency resuscitation trolley


shall be on site or readily available.

5.4.12 There shall be proper documentation in the request


form or patient’s record, of the type and dose of
contrast media used as well as occurrence of any
adverse event.

5.4.13 Contrast Induced Nephropathy (CIN)

i. A baseline serum creatinine (with or without eGFR)


shall be available before the injection of contrast
medium in all patients considered at risk of CIN.
(Refer ACR Guidelines)

ii. Known risk factors including but not limited to:


a. Age above 50 years;
b. History of renal disease;
c. Hypertension
d. Diabetes Mellitus.

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iii. Volume expansion and / or oral hydration shall be


given to reduce risk of CIN. Oral N-Acetylcystine
may also be considered on a case-by-case basis.

5.4.14 Diabetic Patients on Metformin

i. Patients on Metformin and require injection of


contrast medium shall have their renal function
assessed and be classified into one of the two
categories based on the patient’s renal function
(as measured by eGFR). (Refer ACR Guidelines
Version 10.2, 2016)

a. Category I

For patients with no evidence of AKI and / or


eGFR ≥30 mL / min/1.73m2, Metformin may
be continued either prior to or following the
intravenous contrast media.

b. Category II

For patients taking Metformin with AKI or


severe chronic kidney disease (stage IV or
stage V; i.e., eGFR< 30), or are undergoing
arterial catheter studies that might result in
emboli to the renal arteries, metformin should
be temporarily discontinued at the time of or
prior to the procedure, and withheld for 48
hours following the procedure and reinstituted
only after renal function has returned to normal
value.

ii. There is no necessity to discontinue metformin


for patients requiring gadolinium based contrast
medium injection.

5.4.15 Gadolinium Based Contrast Agent (GBCA)

i. Patients requiring GBCA shall be screened for

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conditions and other factors associated with renal


function impairment.

ii. Known risk factors include but not limited to:


a. Age above 50 years;
b. History of renal disease;
c. Hypertension
d. Diabetes Mellitus.

iii. Patients with above risk factors shall have their


renal function assessed by laboratory testing and
eGFR calculated.

iv. GBCA shall be avoided and other alternative


sought in patients at risk for Nephrogenic Systemic
Fibrosis (NSF).

v. If GBCA is still deemed necessary, the indication


shall be clearly documented and informed consent
taken before giving injection.

vi. GBCA least likely to cause NSF shall be used

vii. The lowest possible dose required to obtain the


necessary clinical information shall be used.

5.5 Infection Control

5.5.1 The staff of radiology department shall apply standard


precaution for control of infection at all times.

5.5.2 The appropriate disinfectants, antiseptics, germicides


shall be appropriately used for the cleaning and
disinfecting of all radiology equipments and devices.

5.5.3 Personnel shall use appropriate personal protective


equipment (gowns, goggles, gloves, mask) when
in contact with patients with known or suspected
infection.

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5.5.4 “Biological hazard” status of the patient shall be


communicated to the radiology department personnel
when making a request.

5.5.5 Staff shall adhere to hospital infection control policy


for infection control and prevention including needle
stick and sharp injuries. Staff shall adhere to existing
Policies and Procedures of Infection Control at all
times.

5.6 Occupational Safety

5.6.1 Occupational Safety and Health (OSH) committee


shall be established in hospitals to facilitate safety
regulations and minimize risks to patients, staff,
visitors and contractors. Refer to OSHA guidelines
for details.

5.6.2 All radiation workers shall undergo periodic medical


surveillance according to the regulations. (As specified
in the Atomic Energy Lic. Act 304)

5.7 Chemical Waste Management

5.7.1 Proper arrangements shall be made for the labelling,


storage and disposal of chemical waste as defined in
the Environment Quality Act 1974 (127 and subsequent
amendments and subsidiary legislations referring to
scheduled waste)

5.8 Incidents in Radiology Department

5.8.1 All incidents occurring in a radiology department shall


be promptly reported, investigated, discussed by
staff and root cause analysis done with actions taken
within the agreed time frame to prevent recurrence.

5.8.2 The incident reporting form shall be completed and


submitted to the Hospital Quality Unit / Department.

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6.0 PATIENTS’ RIGHTS & RESPONSIBILITIES

6.1 Privacy, confidentiality safety and comfort of the patients shall


be ensured throughout.

6.2 There shall be adequate security with regards to access of


patients’ data from within and outside the radiology department.

6.3 Patients shall respect and comply with the rules and regulations
of the department / hospital.

7.0 TRAINING / CME ACTIVITIES

7.1 The radiology department shall contribute to the educational


programmes of doctors, radiographers, science officers,
allied health professionals and other related fields from
collaborating institutions with established MOA (Memorandum
of Agreement).

7.2 There shall be committees at national level to handle matters


pertaining to training related matters for postgraduate /
advance diploma and sub-specialty training.

7.3 Radiology centres that comply with necessary training


requirements shall be identified to participate in the
educational programmes by the relevant training committees.

(Refer to Garis Panduan Penggunaan Fasiliti KKM bagi Tujuan


Latih amal Pelajar Institusi Pengajian Tinggi 2015)

7.4 All elective postings to the department shall comply with the
Surat Pekeliling Pengarah KKM87/A/6-6 and trainees shall
present the training objectives on arrival / registration. The
training shall abide by the specific structured curriculum.

7.5 The department shall facilitate staff to attend relevant


educational programmes organized by MOH, professional
groups, agencies / societies and educational institutes to
enhance continuous professional development (CPD).

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7.6 All radiology clinical staff shall be trained and certified in


Basic Life Support.

7.7 A written orientation programme shall be used to introduce


new staff and trainees to the relevant aspects of the facilities.

8.0 FACILITIES AND EQUIPMENT

8.1 General

8.1.1 The radiology department is equipped with a full range


of appropriate imaging equipment. There shall be a
mechanism to monitor functionalities and maintenance
of all rooms and equipment.

8.1.2 All imaging equipments and associated facilities shall


pass the Testing, Commissioning and Acceptance Test
to comply with the performance and safety standards
prior to clinical use.

(Refer Pekeliling Keperluan Tambahan Perlesenan


Di bawah Akta Perlesenan Tenaga Atom 1984).

8.2 Facilities

8.2.1 Store

i. Storage rooms / areas dedicated for specific


purpose i.e linen, x-ray films, stationery and
surgical items / general store rooms shall be
made available.
ii. The movement of consumable items from the store
shall comply with “first-in-first-out (FIFO) policy”.
All stock movements shall be documented.

iii. Monthly statistics shall be kept to verify expiry
status, usage and balance.

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8.2.2 Staff Facilities

i. Prayer rooms shall be provided for male and


female Muslim staff.

ii. Pantry shall be provided for staff use

iii. Lockers shall be provided for staff.

iv. On-call rooms shall be provided.

v. Staff shall be allowed to use ICT facilities for


service related purposes.

8.3 Equipment

8.3.1 Operations

i. All imaging equipment shall be operated by


qualified, trained and privileged personnel.

ii. Facilities and imaging personnel shall adhere to


regulations and guidelines regarding the use of
ionizing radiation / irradiating apparatus (Refer
to the Atomic Energy Licensing Act 304 and
subsidiary regulations).

8.3.2 Safety & Performance

i. All radiology equipment and related accessories


shall be regularly inspected (Quality Control),
maintained and calibrated on scheduled and as
required basis . Appropriate records shall be
maintained. (Refer to: Manual Perlaksanaan
Program Jaminan Kualiti (QAP) dalam
Perkhidmatan Radiologi)

ii. Regular equipment performance-checklist shall


be performed and documented according to
manufacturers’ recommendations.

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iii. All medical and non-medical equipments shall


be recorded in departmental asset and inventory
cards respectively, in accordance with 1 Pekeliling
Perbendaharaan (1PP).

iv. The radiology department personnel shall ensure


that facilities and equipments are assessed
yearly or when necessary by an independent
and licensed medical physics consultants (Class
H licensed) for safety.

v. All equipment and facilities in the radiology


department shall be maintained and serviced by
the concession company on scheduled basis and
when required.

vi. The care, maintenance and repair of the


department infrastructure and assets shall follow
standard procedural guidelines of government
facility and assets.

vii. Any physical expansion or additional asset


procurement shall be in compliance with
established guidelines.

viii. All departmental personnel shall be responsible


in safeguarding and ensuring that all the assets
are in good working order so as not to cause
untoward effects on the delivery of medical care.

ix. Maintenance and changes of inventory shall be


updated and the Head of Department shall be
informed.

x. Staff-in-charge of facilities and equipment shall


monitor the down time after report has been made
to the concession company and to document it in
the equipment breakdown record book.

xi. Staff-in-charge shall:

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a. Monitor all activities pertaining to equipment’s


maintenance and repair.

b. Shall ensure that all consumable supplies are


adequate for daily use.

8.4 Storage / Security & Maintenance of Mobile Radiology


Equipment

8.4.1 Unused mobile X-ray machines shall be locked and


placed in designated areas.

8.4.2 Care shall be taken to ensure that the keys to the


mobile X-ray machines are kept safely and not within
reach of non-designated personnel.

8.4.3 Only radiology department personnel are authorised to


use the X-ray machines (including mobile fluoroscopy
and mobile CT scanners) from the designated areas
as and when the need arises.

8.4.4 Location of mobile X-ray machines will be designated


and monitored.

(Refer to the Guidelines on the use of mobile x-ray


machines 2005)

8.5 Contingency Plan for equipment / system failure

8.5.1 In case of equipment failure, radiological examinations


shall be done in external facilities as per Master
Agreed Plan and Hospital Specific Implementation
Plan (HSIP).

8.5.2 Arrangement for transport of patient shall be under


the responsibility of the concession company as
stipulated in the HSIP.

8.5.3 The radiology department shall coordinate the

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scheduling of cases referred to external facilities.

8.5.4 The retrieval of films and reports shall follow the


local policy.

8.6 Decommissioning

8.6.1 Faulty and obsolete assets shall be considered for


decommissioning.

8.6.2 Disposal of X-ray machines shall follow the guidelines


of Decommissioning of Radiation Apparatus by
Bahagian Kawalselia Radiasi Perubatan (BKRP),
Ministry of Health.

8.6.3 Refer to Appendix 5: Acceptable Method of


Decommissioning of X-ray Machine.

8.6.4 Approval from BKRP, Ministry of Health shall be


obtained before any disposal of radiation apparatus.

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Appendix

1. Ministry of Health Facilities with Radiology Services

2. Organisational Structure of National Radiology Services

3. Organisational Structure of Radiology Department (Specialist Hospital)

4. Organisational Structure of Radiology Department (Non Specialist Hospital)

5. Borang Permohonan Pemeriksaan Radiologi PER.SS-RA301 (Pind. 1/2018)


6. Consent for Radiological procedure that may require contrast medium

injection

7. Borang keizinan bagi prosedur Radiologi yang memerlukan suntikan media

kontras

8. Consent for Radiological procedure for pregnant or possibly pregnant lady

9. Borang keizinan bagi prosedur Radiologi bagi wanita mengandung atau

kemungkinan hamil

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APPENDIX 1

MINISTRY OF HEALTH FACILITIES WITH RADIOLOGY SERVICES

State Hospital Tuanku Fauziah (Kangar) Hospital Melaka (Melaka)


Hospitals Hospital Sultanah Bahiyah (Alor Setar) Hospital Sultanah Aminah (Johor Bahru)
Hospital Pulau Pinang (Pulau Pinang) Hospital Tengku Ampuan Afzan (Kuantan)
Hospital Raja Permaisuri Bainun (Ipoh) Hospital Sultanah Nur Zahirah (Kuala
Hospital Kuala Lumpur (KL) Terengganu)
Hospital Tengku Ampuan Rahimah Hospital Raja Perempuan Zainab II (Kota
(Klang) Bharu)
Hospital Tuanku Ja’afar (Seremban) Hospital Queen Elizabeth (Kota Kinabalu)
Hospital Umum Sarawak (Kuching)

Major Hospital Kulim Hospital Pakar Sultanah Fatimah (Muar)


Specialist Hospital Sg Petani Hospital Sultanah Nora Ismail (Batu Pahat)
Hospitals Hospital Seberang Jaya Hospital Sultan Ismail (Johor Bahru)
Hospital Taiping Hospital Segamat
Hospital Teluk Intan Hospital Temerloh
Hospital Ampang Hospital Kemaman
Hospital Kajang Hospital Kuala Krai
Hospital Serdang Hospital Tanah Merah
Hospital Selayang Hospital Sandakan
Hospital Sg Buloh Hospital Tawau
Hospital Shah Alam Hospital HQE II
Hospital Putrajaya Hospital Miri
Hospital Tuanku Ampuan Najihah Hospital Sibu
(Kuala Pilah) Hospital Bintulu

Minor Hospital Langkawi Hospital Kuala Lipis


Specialist Hospital Bukit Mertajam Hospital Bentong
Hospitals Hospital Kepala Batas Hospital Pekan
Hospital Seri Manjung Hospital Besut
Hospital Slim River Hospital Dungun
Hospital Gerik Hospital Gua Musang
Hospital Kuala Kangsar Hospital Lahad Datu
Hospital Banting Hospital Keningau
Hospital Labuan Hospital Beaufort
Hospital Port Dickson Hospital Kota Marudu
Hospital Tampin Hospital Kapit
Hospital Enche’ Besar Hajjah Kalsom Hospital Limbang
(Kluang) Hospital Sarikei
Hospital Kota Tinggi Hospital Sri Aman
Hospital Mukah

Non All Hospitals - Offering general radiology / ultrasound (with visiting Radiologist only)
Specialist
Hospital
(No
in-house
Radiologist)

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Health Perlis Klinik Kesihatan Simpang Kuala


Clinics (No Klinik Kesihatan Kangar Klinik Kesihatan Pendang
in-house Klinik Kesihatan Bandar Sg.Petani
Radiologist) Kedah Klinik Kesihatan Bakar Arang
Offering Klinik Kesihatan Changloon Klinik Kesihatan Kulim
General Klinik Kesihatan Tunjang Klinik Kesihatan Padang Serai
Radiography Klinik Kesihatan Pokok Sena Klinik Kesihatan Serdang
Klinik Kesihatan Naka Klinik Kesihatan Kuah
Klinik Kesihatan Bandar Alor Setar Klinik Kesihatan Air Hangat
Klinik Kesihatan Jalan Putra Klinik Kesihatan Padang Matsirat
Klinik Kesihatan Datuk Kumbar
Wilayah Persekutuan
Pulau Pinang Klinik Kesihatan Kuala Lumpur
Klinik Kesihatan Penaga Klinik Kesihatan Cheras
Klinik Kesihatan Kepala Batas Klinik Kesihatan Jinjang
Klinik Kesihatan Tasek Gelugor Klinik Kesihatan Tanglin
Klinik Kesihatan Butterworth Klinik Kesihatan Putrajaya Presint 9
Klinik Kesihatan Seberang Jaya Klinik Kesihatan Putrajaya Presint 18
Klinik Kesihatan Bukit Minyak Klinik Kesihatan WP Labuan
Klinik Kesihatan Jalan Perak
Klinik Kesihatan Bandar Baru Air Itam Negeri Sembilan
Klinik Kesihatan Sungai Dua Klinik Kesihatan Simpang Durian
Klinik Kesihatan Bayan Baru Klinik Kesihatan Jelebu
Klinik Kesihatan Bandar Seri Jempol
Perak Klinik Kesihatan Bahau
Klinik Kesihatan Pengkalan Hulu Klinik Kesihatan Kuala Pilah
Klinik Kesihatan Lenggong Klinik Kesihatan Sikamat
Klinik Kesihatan Kuala Kurau Klinik Kesihatan Ampangan
Klinik Kesihatan Bagan Serai Klinik Kesihatan Seremban
Klinik Kesihatan Kamunting Klinik Kesihatan Seremban 2
Klinik Kesihatan Taiping Klinik Kesihatan Senawang
Klinik Kesihatan Pokok Assam Klinik kesihatan Lukut
Klinik Kesihatan Simpang Klinik Kesihatan Port Dickson
Klinik Kesihatan Changkat Jering Klinik Kesihatan Rembau
Klinik Kesihatan Padang Rengas Klinik Kesihatan Johol
Klinik Kesihatan Kampung Simee Klinik Kesihatan Gemencheh
Klinik Kesihatan Jelapang Klinik Kesihatan Gemas
Klinik Kesihatan Greentown
Klinik Kesihatan Buntung Melaka
Klinik Kesihatan Gunung Rapat Klinik Kesihatan Masjid Tanah
Klinik Kesihatan Bruas Klinik Kesihatan Selandar
Klinik Kesihatan Pantai Remis Klinik Kesihatan Durian Tunggal
Klinik Kesihatan Tronoh Klinik Kesihatan Ayer Keroh
Klinik Kesihatan Sitiawan Klinik Kesihatan Tanjung Kling
Klinik Kesihatan Pulau Pangkor Klinik Kesihatan Peringgit
Klinik Kesihatan Kampar Klinik Kesihatan Tengkera
Klinik Kesihatan Tapah Klinik Kesihatan Ujong Pasir
Klinik Kesihatan Teluk Intan Klinik Kesihatan Umbai
Klinik Kesihatan Tanjung Malim Klinik Kesihatan Merlimau

2 to 4

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Selangor Klinik Kesihatan Simpang Kuala


Klinik Kesihatan Bestari Jaya, Batang Klinik Kesihatan Pendang
Berjuntai Klinik Kesihatan Serendah Klinik Kesihatan Bandar Sg.Petani
Klinik Kesihatan Rawang Klinik Kesihatan Bakar Arang
Klinik Kesihatan Taman Ehsan, Kepong Klinik Kesihatan Kulim
Klinik Kesihatan Sungai Buloh Klinik Kesihatan Padang Serai
Klinik Kesihatan Seksyen 7, Shah Alam Klinik Kesihatan Serdang
Klinik Kesihatan Seksyen 19 Klinik Kesihatan Kuah
Klinik Kesihatan Bukit Kuda Klinik Kesihatan Air Hangat
Klinik Kesihatan Bandar Botanik Klinik Kesihatan Padang Matsirat
Klinik Kesihatan Pandamaran
Klinik Kesihatan Pelabuhan Klang Wilayah Persekutuan
Klinik Kesihatan Kelana Jaya Klinik Kesihatan Kuala Lumpur
Klinik Kesihatan Medan Maju Jaya Klinik Kesihatan Cheras
Klinik Kesihatan Batu 9 Klinik Kesihatan Jinjang
Klinik Kesihatan Seri Kembangan Klinik Kesihatan Tanglin
Klinik Kesihatan Sungai Chua Klinik Kesihatan Putrajaya Presint 9
Klinik Kesihatan Kajang Klinik Kesihatan Putrajaya Presint 18
Klinik Kesihatan Bandar Baru Bangi Klinik Kesihatan WP Labuan
Klinik Kesihatan Bandar Seri Putra
Klinik Kesihatan Salak Negeri Sembilan
Klinik Kesihatan Simpang Durian
Pahang Klinik Kesihatan Jelebu
Klinik Kesihatan Karak Klinik Kesihatan Bandar Seri Jempol
Klinik Kesihatan Simpang Pelangai Klinik Kesihatan Bahau
Klinik Kesihatan Sungai Koyan Klinik Kesihatan Kuala Pilah
Klinik Kesihatan Bandar Jerantut (KKIA Klinik Kesihatan Sikamat
NT KK) Klinik Kesihatan Ampangan
Klinik Kesihatan Bandar Mentakab Klinik Kesihatan Seremban
Klinik Kesihatan Tanjung Lalang Klinik Kesihatan Seremban 2
(Simpang Songsang) Klinik Kesihatan Senawang
Klinik Kesihatan Bandar Jengka Klinik kesihatan Lukut
Klinik Kesihatan Jengka 22 Klinik Kesihatan Port Dickson
Klinik Kesihatan Pekan Tajau Klinik Kesihatan Rembau
Klinik Kesihatan Purun Klinik Kesihatan Johol
Klinik Kesihatan Maran Klinik Kesihatan Gemencheh
Klinik Kesihatan Paya Besar Klinik Kesihatan Gemas
Klinik Kesihatan Kurnia
Klinik Kesihatan Bandar Pekan Melaka
Klinik Kesihatan Bandar Kuantan Klinik Kesihatan Masjid Tanah
Klinik Kesihatan Indera Mahkota Klinik Kesihatan Selandar
Klinik Kesihatan Beserah Klinik Kesihatan Durian Tunggal
Klinik Kesihatan Ayer Keroh
Klinik Kesihatan Tanjung Kling
Klinik Kesihatan Peringgit
Klinik Kesihatan Tengkera
Klinik Kesihatan Ujong Pasir
Klinik Kesihatan Umbai
Klinik Kesihatan Merlimau

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Terengganu Sabah
Klinik Kesihatan Sri Bandi Klinik Kesihatan Tawau
Klinik Kesihatan Batu 2 1/2 Klinik Kesihatan Semporna
Klinik Kesihatan Ketengah Jaya Klinik Kesihatan Lahad Datu
Klinik Kesihatan Kuala Dungun Klinik Kesihatan Sandakan
Klinik Kesihatan Kuala Berang Klinik Kesihatan Luyang
Klinik Kesihatan Merchang Klinik Kesihatan Telupid
Klinik Kesihatan Bukit Payong Klinik Kesihatan Putatan
Klinik Kesihatan Hiliran
Klinik Kesihatan Kampung Rahmat Sarawak
Klinik Kesihatan Permaisuri Klinik Kesihatan Tudan
Klinik Kesihatan Padang Luas Klinik Kesihatan Bandar Miri
Klinik Kesihatan Sungai Asap
Kelantan Klinik Kesihatan Belaga
Klinik Kesihatan Bachok Klinik Kesihatan Bintulu
Klinik Kesihatan Pengkalan Chepa Klinik Kesihatan Tatau
Klinik Kesihatan Bandar Klinik Kesihatan Sibu Jaya
Klinik Kesihatan Wakaf Bharu Klinik Kesihatan Jalan Oya
Naiktaraf KK Pasir Pekan ke (Klinik 1 Klinik Kesihatan Kapit
Malaysia (K1M) Pasir Pekan Klinik Kesihatan Song
Klinik Kesihatan Meranti Klinik Kesihatan Jalan Lanang
Klinik Kesihatan Mahligai Klinik Kesihatan Bintangor
Klinik Kesihatan Ketereh Klinik Kesihatan Sarikei
Klinik Kesihatan Pulai Chondong Klinik Kesihatan Debak
Klinik Kesihatan Jeli Klinik Kesihatan Sri Aman
Klinik Kesihatan Manik Urai Klinik Kesihatan Tanah Puteh
Klinik Kesihatan Gua Musang Klinik Kesihatan Kota Samarahan
Klinik Kesihatan Kota Sentosa
Klinik Kesihatan Batu Kawa
Klinik Kesihatan Jalan Masjid
Klinik Kesihatan Petra Jaya
Klinik Kesihatan Sematan

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APPENDIX 2

APPENDIX 2
ORGANIZATION STRUCTURE
ORGANIZATION OF
STRUCTURE OF NATIONAL RADIOLOGY
NATIONAL RADIOLOGY SERVICES SERVICES

Director General of Health

Deputy Director General


(Medical)

Director
Medical Development Division

National Radiology Advisor

Committee Chairman of
State Radiologist
Subcommittees

HOD of Radiology Department

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APPENDIX 3

APPENDIX 3
RADIOLOGY DEPARTMENT ORGANIZATION STRUCTURE
RADIOLOGY DEPARTMENT ORGANIZATION STRUCTURE (SPECIALIST HOSPITAL)
(SPECIALIST HOSPITAL)

Hospital Director

Head of Department Secretary


Chief Matron

Radiologist
Matron

Medical Officer

Sister Chief Radiographer Physicist

Nurses Senior Radiographer

Radiographer

Administrative Healthcare
Assistant Assistant

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APPENDIX 4
APPENDIX

RADIOLOGY DEPARTMENT ORGANIZATION STRUCTURE (NON-SPECIALIST HOSPITAL)


RADIOLOGY DEPARTMENT ORGANIZATION STRUCTURE
(NON-SPECIALIST HOSPITAL)

Hospital Director

Medical Officer
(Incharge)

Head
Radiographer

Healthcare
Radiographer
Assistant

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APPENDIX 5

Borang Permohonan Pemeriksaan Radiologi


PER.SS-RA301 (Pind. 1/2018)

KEMENTERIAN KESIHATAN MALAYSIA PER.SS-RA301


BORANG PERMOHONAN PEMERIKSAAN RADIOLOGI (Pind1/2018)

HOSPITAL / KLINIK : ……………………………………

Bulatkan pada pilihan yang berkenaan.

MAKLUMAT PESAKIT KEGUNAAN PEJABAT


Waktu
2. No. Kad Pengenalan/ Pasport Waktu Terima Juru X-Ray
1. Nama Penuh Selesai
(Huruf Besar)

4. Tarikh Lahir Tarikh


Pemeriksaan

3. Alamat Kediaman
/ / No.
Hari Bulan Tahun Pemeriksaan

5. Jantina L / P 19. PAPARAN IMEJ


Bilangan
6. No. Telefon 7. Etnik 8. Umur
Filem
10. Wad /
Bilangan CD /
9. No. Daftar Pesakit Klinik / 11. Disiplin
DVD
A&E / RH
12. LMP
(Jika berkaitan)
*13. Mengandung Ya / Tidak 20. FAKTOR DEDAHAN
14. Asma / Alahan / kVp mAs Dos Radiasi
Reaksi Media 15. Mobile Ya / Tidak
Kontras (Nyatakan)

16. Status Bayaran Warganegara Ya / Tidak Penjawat Awam Ya / Tidak FPP Ya / Tidak 21. TEMUJANJI PEMERIKSAAN

17. Renal Function Tarikh Creatinine eGFR Tarikh Masa

18. PERKHIDMATAN *22. MEDIA KONTRAS


(Nyatakan Jika Berkaitan)
X-Ray *Media *Digitize
CT MRI US Fluoro Angio IR *MMG BMD *Pelaporan Jenama :
Am Imej Image
Isipadu Media Kontras : ……………… ml
Bahagian Pemeriksaan: KOMEN

RINGKASAN KLINIKAL

..............……....……………………………………………
Tandatangan dan Cop Pakar / Pegawai Perubatan
Tarikh / Masa : ..........................................................

SENARAI DOS BERKESAN UNTUK PEMERIKSAAN RADIOLOGI


Sumber: Health Physics Society Fact Sheet 2010, UNSCEAR 2008 Report Vol.1 dan FA Mettler et al., Radiology
2008;248:254-63
Pemeriksaan Dos Bersamaan Pemeriksaan Dos (mSv) Bersamaan Pemeriksaan Dos (mSv) Bersamaan Pemeriksaan Dos (mSv) Bersamaan Pemeriksaan Dos (mSv) Bersamaan
(mSv)
Chest(AP) Chest(AP) Chest(AP) Chest(AP) Chest(AP)

Chest (AP) 0.02 1 Lumbar Spine (AP) 0.7 35 Mammogram (4views) 0.7 35 CT Thoracic Spine 6 300 CT Angio
(Brain/Thorax/
16.4 820
Abdomen/
Extremities (2 views) 0.01 0.5 IVU / IVP (6 films) 2.5 125 Barium Swallow 1.5 75 CT Chest 8 400 Extremities)
Coronary
Chest (LAT) 0.04 2 Dental (LAT) 0.02 1 Barium Enema 7 350 CT Lumbar Spine 3.3 165 4.60 – 15.80 230 – 790
Angiogram
Angioplasty
Skull (2 views) 0.04 2 Dental (panaromic) 0.09 4.5 HSG 1.2 60 CT Abdomen 10 500 7.50 – 57.00 375 – 2850
(heart study)

Pelvis (AP) 0.7 35 DEXA (whole body) 0.0004 0.02 ERCP 4 200 CT Pelvis 10 500 Nota : Dos berkesan dalam jadual
ini adalah nilai tipikal untuk pesakit
dewasa bersaiz sederhana. Dos
Cervical Spine 0.1 5 Hip 0.8 40 CT Head / Brain 2 100 CT Pulmonary Angio 18.2 – 19.5 910 – 975 sebenar mungkin berbeza
bergantung kepada saiz pesakit dan
juga perbezaan dalam teknik
Thoracic Spine (AP) 0.4 20 Abdomen 1.2 60 CT Cervical Spine 1.5 75 CT Urography 4.5 225 pengimejan.

*13. Mengandung - Sila lengkapkan Borang Keizinan Pesakit Mengandung Atau Kemungkinan Hamil Menjalani Prosedur Radiologi
*22. Media Kontras - Sila lengkapkan Borang Keizinan Bagi Pesakit Menjalani Prosedur Radiologi Yang Memerlukan Suntikan Media Kontras.
*MMG - Sila lengkapkan Borang Soal Selidik MMG.
*Media Imej / Digitize Image / Pelaporan - Sila nyatakan sebab permohonan Media Imej / Digitize Image / Pelaporan di ruang Ringkasan Klinikal.

1/2

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LAPORAN RADIOLOGI
Nama Pesakit No. Pemeriksaan

Jenis Pemeriksaan Tarikh Pemeriksaan

……………………………………………………...............
Tandatangan dan Cop Pakar / Pegawai Perubatan
Tarikh: …………………………………………

2/2

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Panduan Pengisian
Borang Permohonan Pemeriksaan Radiologi PER.SS-RA301 (Pind1/2018)

Perkara / Butiran
Ruangan
Hospital/
Pihak hospital atau klinik perlu mengisi nama fasiliti yang berkaitan.
Klinik
1 Nama pesakit perlu diisi dengan huruf besar.
Nombor kad pengenalan bagi warganegara dan nombor pasport
2
sekiranya bukan warganegara.
3 Alamat kediaman perlu diisi dengan lengkap dan jelas.
4 Tarikh lahir pesakit diisi dengan lengkap.
5 Pemohon perlu membulatkan pilihan jantina Lelaki atau Perempuan.
6 Nombor telefon pesakit dinyatakan dengan jelas.
7 Nyatakan etnik pesakit.
8 Nyatakan umur pesakit.
9 Nyatakan nombor daftar pesakit.
Pemohon perlu menyatakan lokasi pesakit tersebut dengan terperinci
10 seperti Wad 2A, Klinik Pakar Kanak-Kanak, Green Zone, Red Zone,
Klinik Rawatan Harian Pembedahan dan sebagainya.
11 Nyatakan disiplin yang memohon pemeriksaan radiologi.
12 Nyatakan Last Menstrual Period (LMP) sekiranya berkaitan.
Pemohon perlu membulatkan pilihan sama ada pesakit mengandung
atau tidak. Sekiranya pesakit mengandung atau kemungkinan hamil,
13
pemohon perlu melengkapkan borang Keizinan - Prosedur Bagi
Wanita Mengandung Atau Kemungkinan Hamil. (Lampiran 1)
Pemohon perlu menyatakan sekiranya pesakit mempunyai sebarang
14
alahan, penyakit Asma ataupun sejarah reaksi terhadap media kontras.
Pemohon perlu membulatkan pilihan sama ada permohonan
15 pemeriksaan Radiologi adalah secara mobile atau statik di Jabatan
Radiologi.

Pemohon perlu membulatkan pilihan yang berkaitan warganegara,


16 penjawat awam dan sama ada pesakit adalah pesakit bayaran penuh
(Full Paying Patient - FPP).

Pemohon perlu melengkapkan maklumat tarikh dan keputusan ujian


creatinine serta eGFR terkini pesakit. Maklumat ini diperlukan sekiranya
17
pemeriksaan mendapati keperluan penggunaan kontras ketika prosedur
berlangsung.

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Perkara / Butiran
Ruangan
18 Pemohon perlu membulatkan pilihan perkhidmatan yang dipohon dan
menyatakan dengan jelas bahagian badan yang memerlukan
pemeriksaan diruangan yang disediakan (Bahagian Pemeriksaan).
Bagi permohonan MMG (mammogram), pemohon juga perlu
melengkapkan Borang Soal Selidik MMG. (Lampiran 2)
Manakala permohonan media imej, digitize image ataupun pelaporan
perlu dinyatakan sebab permohonan di ruangan Ringkasan Klinikal.
- Permohonan media imej (hard copy) adalah ketika permohonan
pencetakan filem atau CD, tambahan daripada media imej yang
telah diberikan ketika pemeriksaan asal dilakukan. Begitu juga
dengan Pelaporan.
- Digitize image adalah ketika permohonan untuk memuat naik
media imej (hard copy) ke dalam sistem untuk disimpan sebagai
soft copy.
Sekiranya permohonan pemeriksaan adalah dengan menggunakan
media kontras, pemohon perlu melengkapkan Borang Keizinan Bagi
Pesakit Menjalani Prosedur Radiologi Yang Memerlukan Suntikan
Media Kontras. (Lampiran 3)

Pegawai Jabatan Radiologi perlu menyatakan bilangan filem atau CD/


19
DVD yang dicetak.
Pegawai Jabatan Radiologi perlu menyatakan faktor dedahan yang
20
berkaitan.
Pegawai Jabatan Radiologi perlu menyatakan tarikh dan masa temujanji
21
pemeriksaan yang akan datang.

Pegawai Jabatan Radiologi perlu menyatakan jenama dan isipadu


media kontras yang digunakan sekiranya berkenaan.
22 Pegawai juga perlu memastikan Borang Keizinan Bagi Pesakit
Menjalani Prosedur Radiologi Yang Memerlukan Suntikan Media
Kontras dilengkapkan oleh pemohon. (Lampiran 3)

Ringkasan Perlu diisi oleh pemohon dilengkapi dengan tandatangan dan cop serta
Klinikal tarikh/ masa borang permohonan di isi.
Laporan Perlu diisi oleh Pakar atau Pegawai Perubatan Radiologi dilengkapi
Radiologi dengan tandatangan dan cop serta tarikh laporan disediakan.

Pegawai Jabatan Radiologi perlu mengisi maklumat waktu terima,


Kegunaan
waktu selesai, nama Juru X-Ray, tarikh pemeriksaan dan nombor
Pejabat
pemeriksaan.

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APPENDIX 6

Consent for Radiological procedure that may require


contrast medium injection

GUIDELINES FOR CONSENT TAKING IN PATIENTS GOING FOR RADIOLOGICAL


PROCEDURE THAT MAY REQUIRE CONTRAST MEDIUM INJECTION

A) When to take consent?

For radiological procedure that may require contrast medium (Intravenous urography (IVU), Computed

tomography (CT), Magnetic resonance imaging (MRI), Angiography etc).

B) Who to take consent?

i) The requesting doctor obtained on the day of request.

ii) Radiology doctor on the day of the examination.

iii) A medical officer may obtain the consent from the patient; however the form has to be counter-signed by

the attending specialist.

C) How to take consent?

i) Complete the checklist for high risk (part B) in the consent form.

ii) The requesting doctor shall explain the patient’s condition, the need for the investigation and how it is

going to alter the management.

iii) The radiology doctor shall explain on the procedure itself and the possible complications.

iv) The consent shall be taken from patient himself/herself. In the event he/she is not capable of doing so,

consent can be taken from guardian / relative.

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CONSENT – RADIOLOGICAL PROCEDURE THAT MAY REQUIRE


CONTRAST MEDIUM INJECTION

PATIENT DETAILS

Name …………………………………………………...………….......... Date …………………………………………....................


IC No ………………………………………………………...…….......... Ward / Clinic …………………………………………….................
Address …………………………………………….............................. Radiological Procedure ………………………………….................
…………………………………………………………....…......... ………………………...................................................................

A) The Procedure
Your condition requires this radiological procedure to be performed and may require the injection of a contrast medium. The
contrast medium is usually administered by injection into a vein through a small needle or cannula. This allows your organs to be
seen more clearly and will help the doctor in interpreting the findings and producing an accurate report.

B) Suitability for a Contrast Medium Injection


Please answer the following questions to assist us in deciding if you have a higher risk of adverse reactions to contrast media. Do
you have any of the following conditions (please tick) :

YES NO

a. Previous history of reaction to contrast medium

b. Definite history of allergy to medication / food

c. Asthma / Hay fever / atopy / allergic sinusitis / rhinitis

d. Renal disease

e. Heart disease

Patients in Group a-c will need steroid premedication. Tab Prednisolone 40mg 12 hours and 2 hours before the procedure (Adult
doses quoted, children dose will be adjusted according to ideal body weight).

C) Risks and Complications of the Procedure


There are some risks/complications, with use of intravascular contrast medium and may include:
a) Metallic taste in the mouth, mild nausea and hot flush which should pass within a few minutes.
b) Occasional mild reactions such as itchiness, sneezing, rashes/hives, vomiting and vein/ tissue injury secondary to contrast
medium leaking outside vein. (Chance of occurrence < 5% or 5 in 100 persons).
c) Risk of worsening renal function may occur especially in patient with preexisting condition of renal failure.
d) Rarely, more serious reactions such as difficulty in breathing, shock, convulsions and cardiopulmonary arrest. (chance of
occurrence ~0.01% or 1 in 10,000 persons).
e) Doctors and emergency equipment are always readily available to treat any emergency condition or event that may arise
from the contrast medium use. Despite prompt treatments serious consequences may ensue that may result in death.
However this is extremely rare. (Chance of occurrence about 0.0005% or 1 in 200,000 persons).
f) Nephrogenic systemic fibrosis, a fibrosing disease that affects skin, subcutaneous tissues, muscles and occasionally other
organs that can lead to contracture and joint immobility, may occur in 1-7% of patients who have severe acute or chronic
kidney injury and receives gadolinium based MRI contrast medium.
g) The doctor has considered these risks and believes that the benefits of obtaining the information from the radiological
procedure far outweigh the risks.

Consent - Radiological Procedure That May Require Contrast Medium Injection 1/2

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DECLARATION BY PATIENT / GUARDIAN / RELATIVE

 I acknowledge that my medical condition and the needs to have the procedure have been explained to me.
 I understand / accept the possible risks of the procedure that has been explained to me and hereby consent
for the radiological procedure.

Signature ………………….......……………...……… IC No. ………………………….......…......…

Print Name ……………………….......……....………… Relationship .……………………....………………


(if the person consenting is not the patient)
Date …………………………….......…....………

DECLARATION BY THE ATTENDING / REQUESTING DOCTOR

I confirm that I have explained to the * patient / guardian / relative, the medical condition, needs and risks of the
radiological examination to the patient. In my opinion he/she understood the explanation.

Signature …………………….………..............….....

Date ……………………….…………....…….....
Please STAMP here

DECLARATION BY THE RADIOLOGY DOCTOR

I confirm that I have explained to the * patient / guardian / relative, the effects and risks of the radiological
examination to the patient. In my opinion he/she understood the explanation.

Signature ……………….…………....………….........

Date ……………....…….………………............
Please STAMP here

DECLARATION BY PATIENT / GUARDIAN / RELATIVE

 I acknowledge that my medical condition and the needs to have the procedure have been explained to me.
 I understand / accept the possible risks of the procedure that has been explained to me and hereby consent
for the radiological procedure.

Signature ……………,,,………………,,,,....………… IC No. ………………………….................

Print Name ………………………...………,,,,,,,……… Relationship .……………....………………………


(if the person consenting is not the patient)
Date ………………………………,,....………….

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APPENDIX 7

Borang keizinan bagi prosedur Radiologi yang


memerlukan suntikan media kontras

BORANG KEIZINAN BAGI PESAKIT MENJALANI PROSEDUR RADIOLOGI YANG


MEMERLUKAN SUNTIKAN MEDIA KONTRAS

A) Bila Keizinan Diperlukan ?

Keizinan diperlukan bagi pesakit yang akan menjalani prosedur radiologi yang memerlukan suntikan media

kontras (UrografiIntravena, Imbasan CT dan Imbasan MR, angiografi dan sebagainya).

B) Siapa yang perlu mengambil keizinan ini ?

i) Doktor yang memohon pemeriksaan pada hari permohonan dibuat.

ii) Doktor Radiologi pada hari prosedur dijalankan.

C) Bagaimana untuk mengambil keizinan ?

i) Lengkapkan senarai semak risiko tinggi (Bahagian B) pada borang keizinan.

ii) Doktor yang memohon pemeriksaan akan menerangkan keadaan pesakit, keperluan pemeriksaan dan

bagaimana ia akan membantu dalam perawatan pesakit.

iii) Doktor dari Jabatan Radiologi pula akan menerangkan prosedur tersebut dan kemungkinan komplikasi.

iv) Kedua-dua pihak yang memohon dan pihak radiologi perlu terlibat dalam mengambil keizinan ini dan

disaksikan oleh seorang anggota perubatan yang lain.

v) Borang keizinan perlu ditandatangani oleh pesakit sendiri. Jika beliau tidak dapat berbuat demikian maka

keizinan boleh diambil dari waris pesakit.

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KEIZINAN – PROSEDUR RADIOLOGI YANG MEMERLUKAN SUNTIKAN MEDIA KONTRAS

MAKLUMAT PESAKIT

Nama ……………………………………………............... Tarikh …………………….........................................

No. IC ……………………………………………….......… Wad / Klinik …………….........……..............………………

Alamat ……………………………………………............... Prosedur


Radiologi ………………..............…...……………
............................................................................. .............................................................................................
A) Prosedur ..............................................................................................
Keadaan anda memerlukan prosedur radiologi ini dengan menggunakan suntikan media kontras. Media kontras ini selalunya di
suntik ke vena menggunakan jarum yang kecil. Ini akan membolehkan organ badan anda dilihat dengan lebih jelas untuk
membantu doktor dalam pengurusan rawatan anda.

B) Kesesuaian Untuk Suntikan Media Kontras


Sila jawab soalan-soalan berikut untuk membantu kami membuat keputusan sama ada anda mempunyai risiko reaksi terhadap
media kontras yang tinggi. Adakah anda dalam kategori berikut (sila tandakan) :

Ya Tidak

a. Sejarah reaksi terhadap media kontras

b. Sejarah alahan terhadap ubat-ubatan / makanan

c. Sakit asma / Hay fever / atopy / alahan resdung / rhinitis

d. Penyakit ginjal

e. Penyakit jantung

Pesakit dalam kumpulan a-c memerlukan pra-medikasi steroid. Tab Prednisolone 40mg 12 jam dan 2 jam sebelum prosedur (Dos
dewasa yang dinyatakan, Dos kanak-kanak perlu dikira mengikut berat badan unggul).

C) Risiko dan Komplikasi Prosedur


Terdapat sedikit risiko / komplikasi apabila menggunakan suntikan media kontras termasuklah:
a) Rasa kurang menyenangkan pada lidah, rasa loya dan panas badan yang sepatutnya hilang setelah beberapa minit
suntikan dilakukan.
b) Reaksi sederhana seperti gatal-gatal, bersin, ruam badan, muntah dan kecederaan pada vena / tisu badan yang
disebabkan kontras media bocor keluar dari vena. (Risiko kejadian <5% atau 5 dari 100 pesakit).
c) Risiko kemerosotan buah pinggang boleh terjadi terutama kepada pesakit yang telah mempunyai kegagalan buah
pinggang.
d) Amat jarang sekali reaksi yang lebih serius seperti kesesakan pernafasan, renjatan dan sakit jantung. (Risiko kejadian
~0.01 % atau 1 dalam 10,000 pesakit).
e) Doktor dan peralatan kecemasan sentiasa tersedia untuk memberikan rawatan segera. Walau bagaimanapun kematian
boleh berlaku tetapi amat jarang sekali. (Risiko kejadian 0.0005% atau 1 dalam 200,000 pesakit).
f) Nephrogenic systemic fibrosis, satu keadaan penyakit yang memberi kesan kepada kulit, tisu subcutaneous otot dan
kadang-kadang sebahagian organ boleh menyebabkan kesukaran pergerakan sendi. Ini mungkin berlaku kepada 1-7 %
pesakit yang mempunyai kegagalan buah pinggang akut atau kecederaan buah pinggang apabila menerima suntikan
media kontras MRI yang berasaskan gadolinium.
g) Doktor telah menimbangkan risiko-risiko ini dan berpendapat kebaikan yang akan diperolehi dari prosedur ini melebihi
risiko yang dihadapi.

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PENGAKUAN OLEH PESAKIT / PENJAGA / WARIS

 Saya mengaku bahawasanya, keperluan menjalani prosedur ini telah diterangkan kepada saya dengan
jelas.
 Saya mengaku bahawasanya, kemungkinan risiko prosedur ini telah diterangkan kepada saya dan saya
bersetuju menjalani prosedur ini.

Tandatangan ………………………………………...... No. IC …………………………………….......

Nama ………………………………………...... Hubungan ………………………………………...


(jika kebenaran diberikan oleh penjaga / waris)
Tarikh …………………………………………...

PENGAKUAN OLEH DOKTOR YANG MERAWAT / MEMOHON

Saya sahkan bahawa saya telah menerangkan kepada * pesakit / suami / ibubapa / penjaga tentang keadaan
kesihatan pesakit dan keperluan dan risiko pemeriksaan radiologi ini kepada pesakit. Pada pendapat saya beliau
telah faham dengan penerangan tersebut.

Tandatangan ……………………………....…….........

Tarikh ………………………....………………..
Cop Rasmi

PENGAKUAN OLEH DOKTOR RADIOLOGI

Saya sahkan bahawa saya telah menerangkan kepada * pesakit / suami / ibubapa / penjaga tentang kebaikan,
kesan dan risiko pemeriksaan radiologi ini kepada pesakit. Pada pendapat saya beliau telah faham dengan
penerangan tersebut.

Tandatangan …………………………………….........

Tarikh …………………………….……………..
Cop Rasmi

PENGAKUAN OLEH PESAKIT / PENJAGA / WARIS

 Saya mengaku bahawasanya, keperluan menjalani prosedur ini telah diterangkan kepada saya dengan
jelas.
 Saya mengaku bahawasanya, kemungkinan risiko prosedur ini telah diterangkan kepada saya dan saya
bersetuju menjalani prosedur ini.

Tandatangan ………………………………………...... No. IC …………………………………….......

Nama ………………………………………...... Hubungan ………………………………………...


(jika kebenaran diberikan oleh penjaga / waris)
Tarikh …………………………………………...

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APPENDIX 8

Consent for Radiological procedure for pregnant or


possibly pregnant lady

GUIDELINES FOR CONSENT TAKING IN PREGNANT OR POSSIBLY PREGNANT PATIENTS


GOING FOR RADIOLOGICAL PROCEDURE

A) When to take consent

i) All radiological examinations where ionizing radiation (x-ray) is used such as plain radiography,

fluoroscopic examinations and CT examinations.

ii) Magnetic Resonance Imaging examinations.

B) Who to take consent

i) The requesting doctor to be obtained on the day of request.

ii) The Radiology doctor on the day of the request.

iii) A medical officer may obtain the consent from the patient; however the form has to be counter-signed

by the attending specialist.

C) How to take consent

i) The requesting doctor will explain more on the need and benefits of the procedure, available

alternatives and how it will help in patient’s subsequent management.

ii) The Radiology doctor will explain on the possible risks and complications towards patient and the

fetus.

iii) For plain radiography, requesting medical officer shall take the consent after consulting their

respective specialists.

iv) For special X-ray examinations, CT examinations and MRI examinations, the consent shall be taken

by the requesting doctor and Radiology doctor accepting the case after consultation with the

Specialists.

v) The consent shall be taken from patient herself. In the event she is not capable of doing so, consent

may be taken from guardian / relative.

vi) If the procedure requires the injection of a contrast medium, the consent form for radiological

procedures with contrast medium must be completed along with the checklist.

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CONSENT – RADIOLOGICAL PROCEDURE FOR PREGNANT OR POSSIBLY PREGNANT LADY

PATIENT DETAILS Date ………....…………............………........................

Name …………………………………………………… LMP ………....………………............……….................

IC No. …………………………………………….……... Ward /Clinic ………....……………………….............................

Address ………………………………………...……......... Radiological procedure ……..…………………............…………

This informed consent form applies only to eachradiological examination involving x-ray radiation or MRI.

You are scheduled for a radiological procedure. You and your unborn child will be exposed to radiation / radiofrequency. The risks
associated are very minimal. The X-radiation might slightly increase the possibility of cancer later in your child‘s life, but the actual
potential healthy life is nearly the same as that of other children in circumstances similar to yours. The examination does not add to
risks for birth defect.

There is also a risk of cancer induction in yourself but the risk is much lower than the risk to your baby. To date, there has been no
indication that the use of clinical MR imaging during pregnancy has produced any deleterious effects. However, as noted by the
U.S. Food and Drug Administration (FDA), the safety of MR imaging during pregnancy has not been proven. Your doctor has
considered the risk associated with this examination and believes it is in your and your child’s best interest to proceed. Any doubts
should be directed to the respective radiologist.

DECLARATION BY PATIENT / GUARDIAN / RELATIVE


I understand / agree that my doctor has explained the need this radiological examination and the possible risks of radiation to me
and / or the pregnancy.

Signature ……....……........………......………………….... IC No. ………….……...............……….....................……...

Print name …………………...................…………………… Relationship ……………..............…….....................…………….


(if patient not the person consenting)
Date ……………………...........……………........……

DECLARATION BY ATTENDING / REQUESTING DOCTOR


I confirm that I have explained to the * patient / guardian / relative the benefit, the effects and risks of the radiological examination
to the patient and her pregnancy. In my opinion he/she understood the explanation.

Signature ………………….................................…………

Date ………………..........................……........………
Please STAMP here

DECLARATION BY THE RADIOLOGY DOCTOR / DOCTOR IN-CHARGE


I confirm that I have explained to the * patient / guardian / relative the benefit, the effects and risks of the radiological examination
to the patient and her pregnancy. In my opinion he/she understood the explanation.

Signature ……………………………..............................…

Print name ………………………..............................………


Please STAMP here

DECLARATION BY PATIENT / GUARDIAN / RELATIVE


I understand / agree that my doctor has explained the need this radiological examination and the possible risks of radiation to me
and / or the pregnancy.

Signature ……....……………......……………….......…..... IC No. ………….……...............……….....................……...

Print name …………………............……………….......…… Relationship ……………..............…….....................…………….


(if patient not the person consenting)
Date ……………………...........……………............…

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Table 1: Summary of suspected In-utero Induced Deterministic Radiation effects

Menstrual or < 50 mGy 50-100 mGy > 100 mGy


Gestational age
(weeks)

0-2 None None None

3-4 None Probably none Possible spontaneous abortion

5 - 10 None Potential effects are Possible malformations


scientifically uncertain increasing in likelihood as
and probably too dose increases
subtle to be clinically
detectable

11 - 17 None Potential effects are Increased risk of deficits in IQ


scientifically uncertain or mental retardation that
and probably too increase in frequency and
subtle to be clinically severity with increasing dose
detectable

18 - 27 None None IQ deficits not detectable at


diagnostic doses

>27 None None IQ deficits not detectable at


diagnostic doses

Adapted from ACR Practice Guideline For Imaging Pregnant or Potentially Pregnant Adolescents and Women with Ionizing Radiation; ACR Practice Guideline 2014

Table 2 : Approximate foetal doses from common diagnostic procedures

Examination Mean (mGy) Maximum (mGy)

Conventional X-ray examination:


Abdomen 1.4 4.2
Chest <0.01 <0.01
Intravenous Urogram 1.7 10
Lumbar Spine 1.7 10
Pelvis 1.1 4
Skull <0.01 <0.01
Thoracic spine <0.01 <0.01

Fluoroscopic examination:
Barium meal (upper GI) 1.1 5.8
Barium enema 6.8 24

Computed Tomography:
Abdomen 8.0 49
Chest including CTPA 0.06 0.96
Head <0.005 <0.005
Lumbar Spine 2.4 8.6
Pelvis 25 79

Adapted from Pregnancy and Medical Radiation; ICRP publication 84, Annals of the ICRP Vol 30, No 1 2000

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APPENDIX 9

Borang keizinan bagi prosedur Radiologi bagi wanita


mengandung atau kemungkinan hamil

BORANG KEIZINAN PESAKIT MENGANDUNG ATAU KEMUNGKINAN HAMIL MENJALANI


PROSEDUR RADIOLOGI

A) Bila keizinan pesakit mengandung atau berpotensi untuk mengandung diperlukan

i) Semua pemeriksaan radiologi di mana radiasi mengion (x-ray) digunakan seperti pemeriksaan am,

pemeriksaan floroskopi dan pemeriksaan imbasan CT.

ii) Pemeriksaan imbasan MR.

B) Siapa yang perlu mengambil keizinan ini

i) Doktor yang memohon pemeriksaan pada hari permohonan.

ii) Doktor Radiologi pada hari permohonan.

iii) Pegawai Perubatan dibenarkan mengambil kebenaran untuk prosedur radiologi tetapi haruslah

ditandatangani (counter signed) oleh Pakar yang merawat.

C) Bagaimana mengambil keizinan

i) Doktor yang memohon akan menerangkan tentang keperluan pemeriksaan tersebut, alternatif lain

sekiranya ada dan bagaimana keputusan pemeriksaan ini akan membantu dalam pengurusan

rawatan pesakit seterusnya.

ii) Doktor Radiologi akan menekankan kepada risiko dan komplikasi terhadap pesakit dan

kandungannya.

iii) Bagi pemeriksaan radiografi am, pegawai perubatan yang memohon boleh mengambil keizinan

selepas merujuk kepada pakar masing-masing.

iv) Bagi pemeriksaan X-ray khas, imbasan CT dan imbasan MR keizinan perlu diambil oleh pegawai

perubatan yang memohon dan pegawai perubatan radiologi yang menerima kes tersebut selepas

perbincangan bersama Pakar Perubatan.

v) Keizinan perlu diambil dari pesakit sendiri. Sekiranya pesakit tidak dapat berbuat demikian,

keizinan boleh diambil dari penjaga / waris.

vi) Sekiranya prosedur memerlukan penggunaan media kontras maka borang kebenaran pesakit

menjalani prosedur radiologi berkontras perlu dilengkapkan.

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KEIZINAN – PROSEDUR RADIOLOGI BAGI WANITA MENGANDUNG ATAU KEMUNGKINAN HAMIL

MAKLUMAT PESAKIT Tarikh ………….…………….........……….......................

Nama …………….........……………................................. LMP ………………...................................……………

No. IC …………………..............................................…… Wad / Klinik …………………........................……………........

Alamat …...........................…….............…................…… Prosedur Radiologi ……….....................................…...…………

Borang keizinan ini diguna pakai bagi pemeriksaan radiografi, Imbasan CT atau Imbasan MR. Anda dan kandungan akan
didedahkan dengan radiasi / frekuensi radio. Risiko pendedahan sinaran ini adalah sangat minimal. Sinaran-X ini berkemungkinan
meningkatkan kebarangkalian untuk mendapatkan penyakit kanser ke atas kandungan anda di masa depan. Pemeriksaan ini tidak
menambahkan risiko kecacatan semasa kelahiran.

Risiko anda mendapat penyakit kanser adalah wujud namun risikonya adalah jauh lebih rendah dari risiko ke atas bayi anda.
Sehingga kini tidak ada sebarang indikasi yang menunjukkan bahawa seseorang yang menjalani Imbasan MR semasa
mengandung akan memberikan kesan yang tidak baik ke atas kandungan. Walau bagaimanapun seperti yang dinyatakan oleh
U.S. Food and Drug Administration (FDA), bahawa kesan penggunaan pengimejan MR ketika mengandung belum terbukti lagi.

Pakar perubatan yang merawat anda telah menimbangkan risiko yang berkaitan dengan pemeriksaan ini dan yakin bahawa
pemeriksaan ini adalah demi kebaikan anda dan anak anda. Memandangkan pemeriksaan ini adalah penting maka prosedur ini
perlu diteruskan. Sebarang pertanyaan boleh dikemukakan kepada pakar radiologi.

PENGAKUAN OLEH PESAKIT / PENJAGA / WARIS


Saya mengaku bahawasanya kebarangkalian risiko prosedur ke atas * saya / isteri / anak / anak jagaan saya dan kandungannya
telah diterangkan kepada saya oleh doktor saya dan saya bersetuju menjalani prosedur radiologi ini.

Tandatangan pesakit …..................................................... No. IC ……………..............……....................................…

Nama …………...............................……........................... Hubungan ……….................................................................…


(jika kebenaran diberikan oleh penjaga / waris)
Tarikh ……………………………….........….................……

PENGAKUAN OLEH DOKTOR YANG MERAWAT / MEMOHON


Saya sahkan bahawa saya telah menerangkan kepada * pesakit / suami / ibubapa / penjaga tentang kebaikan, kesan dan risiko
pemeriksaan radiologi ini ke atas pesakit dan kandungannya. Pada pendapat saya beliau telah faham dengan penerangan
tersebut.

Tandatangan ……………………….......………………....

Tarikh ……………………………….......……....…
Cop Rasmi

PENGAKUAN OLEH DOKTOR RADIOLOGI / DOKTOR YANG MENJAGA


Saya sahkan bahawa saya telah menerangkan kepada * pesakit / suami / ibubapa / penjaga tentang kebaikan, kesan dan risiko
pemeriksaan radiologi ini ke atas pesakit dan kandungannya. Pada pendapat saya beliau telah faham dengan penerangan
tersebut.

Tandatangan ………………………………….......………

Tarikh ………………………………….......………
Cop Rasmi

PENGAKUAN OLEH PESAKIT / PENJAGA / WARIS


Saya mengaku bahawasanya kebarangkalian risiko prosedur ke atas * saya / isteri / anak / anak jagaan saya dan kandungannya
telah diterangkan kepada saya oleh doktor saya dan saya bersetuju menjalani prosedur radiologi ini.

Tandatangan pesakit …..................................................... No. IC …………………...............................................……

Nama …………...............................……........................... Hubungan ……….................................................................…


(jika kebenaran diberikan oleh penjaga / waris)
Tarikh ……………………………….........….................……

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Table 1: Summary of suspected In-utero Induced Deterministic Radiation effects

Menstrual or < 50 mGy 50-100 mGy > 100 mGy


Gestational age
(weeks)

0-2 None None None

3-4 None Probably none Possible spontaneous abortion

5 - 10 None Potential effects are Possible malformations


scientifically uncertain increasing in likelihood as
and probably too dose increases
subtle to be clinically
detectable

11 - 17 None Potential effects are Increased risk of deficits in IQ


scientifically uncertain or mental retardation that
and probably too increase in frequency and
subtle to be clinically severity with increasing dose
detectable

18 - 27 None None IQ deficits not detectable at


diagnostic doses

>27 None None IQ deficits not detectable at


diagnostic doses

Adapted from ACR Practice Guideline For Imaging Pregnant or Potentially Pregnant Adolescents and Women with Ionizing Radiation; ACR Practice Guideline 2014

Table 2 : Approximate foetal doses from common diagnostic procedures

Examination Mean (mGy) Maximum (mGy)

Conventional X-ray examination:


Abdomen 1.4 4.2
Chest <0.01 <0.01
Intravenous Urogram 1.7 10
Lumbar Spine 1.7 10
Pelvis 1.1 4
Skull <0.01 <0.01
Thoracic spine <0.01 <0.01

Fluoroscopic examination:
Barium meal (upper GI) 1.1 5.8
Barium enema 6.8 24

Computed Tomography:
Abdomen 8.0 49
Chest including CTPA 0.06 0.96
Head <0.005 <0.005
Lumbar Spine 2.4 8.6
Pelvis 25 79

Adapted from Pregnancy and Medical Radiation; ICRP publication 84, Annals of the ICRP Vol 30, No 1 2000

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Technical Committee on Radiology Services Policy

Advisor

Datuk Dr. Noor Hisham Abdullah


Director General of Health Malaysia

Dato’ Dr. Hj Azman Hj Abu Bakar


Director of Medical Development Division

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Chairman

Datin Dr. Hjh Zaharah Musa


Senior Consultant Radiologist
Hospital Selayang
Former National Advisor on Radiology Services

Dr. Yun Sii Ing


Senior Consultant Radiologist
Hospital Sungai Buloh
National Advisor on Radiology Services

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External Panel of Reviewers

Dato’ Dr Yusof Hj Abdul Wahab


Senior Consultant General Surgery
Hospital Tengku Ampuan Rahimah
National Advisor on General Surgery Services

Dr. Ravichandran Jeganathan


Senior Consultant Obstetrician & Gynecologist
Hospital Sultanah Aminah, Johor Bahru
National Advisor on Obstetrics & Gynecology Services

Dr. Hishamshah Mohd Ibrahim


Senior Consultant Pediatrician
Pediatric Institute Hospital Kuala Lumpur
National Advisor on Pediatric Services

Datuk Dr. Noel Thomas Ross


Consultant Physician
Hospital Kuala Lumpur

Dr. Melor @ Mohd Yusof Mohd Mansor


Consultant Anesthesiologist
Hospital Ampang

Dr. Ruzaimi Md Yusoff


Consultant Orthopedic Sugeon
Hospital Kajang

Dr. Azlina A.Rahman


Consultant Emergency Physician
Hospital Ampang

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Drafting Committee

Dato’ Dr. Ahmad Zalizan Zainul Dr. Mawaddah Ghazali


Senior Consultant Radiologist Senior Principal Assistant Director
Hospital Tuanku Fauziah Medical Development Division,
MOH
Dato’ Dr. Zainun A. Rahman
Consultant Radiologist Daud Ismail
Hospital Tengku Ampuan Afzan Head Radiographer
Hospital Kuala Lumpur
Dr. K. Vijayalakshmi
Senior Consultant Radiologist Pushpa Thevi Rajendran
Hospital Tengku Ampuan Head Radiographer
Rahimah Hospital Ampang

Dr. Hjh Zaleha Abd Manaf Zaidah Maspin


Senior Consultant Radiologist Radiographer
Hospital Kuala Lumpur Hospital Kuala Lumpur

Dr Lim Cheng Kooi Siti Normasitah Masduki


Senior Consultant Radiologist Science Officer (Physics)
Hospital Queen Elizabeth Hospital Serdang

Dr. Tan Suzet Mohammad Azwin Abdul Karim


Senior Consultant Radiologist Science Officer (Physics)
Hospital Teluk Intan Hospital Ampang

Dr. Noraini Ab Rahim Shahidah Salleh


Senior Consultant Radiologist Senior Assistant Director
National Cancer Institute Allied Sciences Division, MOH

Dr Chong Aun Kee Mohd Khairudin Mohamed Samsi


Consultant Radiologist Senior Principal Assistant Director
Hospital Melaka Bahagian Kawalselia Radiasi,
MOH

Dr. Mohd Shaffie Baba Jeffry Mohamad Noor


Consultant Radiologist Senior Principal Assistant Director
Hospital Raja Perempuan Bainun Engineering Division, MOH

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Ir. Dr. Syed Mustafa Kamal Syed Ali Ngatman


Aman Radiographer
Deputy Director Family Health Development
Engineering Division, Ministry of Division, MOH
Health
Norsiah Abu Hassan
Dr. Selvamalar Selvarajan Radiographer
Senior Principal Assistant Director Family Health Development
Medical Development Division, Division, MOH
MOH
Proof Reading
Dr. Melvyn Edward Anthony Dato’ Harry Isaacs
Senior Principal Assistant Director Grammar School Kuala
Medical Development Division, Terengganu
MOH

Dr. Mohd Rizal bin Roslan


Consultant Radiologist
(Interventional)
Hospital Selayang

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