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N A T I O N A L

R A D I O L O G Y

S E R V I C E S

O P E R A T I O N A L

P O L I C Y

NATIONAL RADIOLOGY SERVICESOPERATIONAL POLICY

MINISTRY OF HEALTH MALAYSIA


Clinical Support Services UnitMedical Development Divison

Minitry of Health Malaysia


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


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

LIST OF ABBREVIATIONS 12CONTENT:1.0 ORGANISATION & MANAGEMENT

1.1 Vision 1.2 Mission 1.3 Objectives 1.4 Scope of Service1.5 Organisational Structure

13-15

2.0 OPERATIONAL POLICY 2.1 General Statement2.2 Scheduling an examination2.3 Special Examinations 2.4 Mammography 2.5 Interventional Radiology2.6 Peripheral Radiology Services2.7 Forensic Radiology

16-21

3.0 PATIENT CARE 22-23

4.0 REPORTING, CONSULTATION & IMAGE MANAGEMENT

23

5.0 SAFETY IN IMAGING 5.1 Radiation Safety5.2 Examination on Females of Child Bearing Age 5.3 MRI Safety 5.4 Contrast Media Safety 5.5 Infection Control 5.6 Occupational Safety5.7 Chemical Waste Management 5.8 Incidents in the Radiology Department

24-33


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6.0 PATIENT’S RIGHTS

34

7.0 TRAINING / CONTINUOUS PROFESSIONAL DEVELOPMENT (CPD)

34

8.0 FACILITIES AND EQUIPMENT 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

35-39

9.0 APPENDIX 40-63


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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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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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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 IngNational Advisor on Radiology Services 2018– present


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Definition

Special Examination

Peripheral Radiology Services

Satellite Services

Interventional Radiology

Forensic Radiology

Radiology Consultation

Refers to all other forms of imaging other than general radiography (X-ray)

Refers to the provision of trained radiology personnel to handle imaging modalities in other departments.

Refers to the provision of radiology servicesin areas other than the main department.

Refers to the utilization of minimally invasive image guided procedures to diagnose and treat diseases.

Refers to the application of imaging on a deceased person and / or body parts to questions of law.

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 RadiologyAKI Acute kidney injuryCD Compact DiscCIN Contrast Induced NephropathyCME Continuous Medical EducationCPD Continuous Professional DevelopmentCT Computed TomographyeGFR Estimated Glomerular Filtration RateFIFO first-in-first-outGBCA Gadolinium Based Contrast AgentHSIP Hospital Specific Implementation PlanICRP International Commission on Radiological ProtectionICT Information and Communication TechnologyIT Information TechnologyIVU Intravenous UrographyKPI Key Performance IndicatorMOH Ministry of HealthMOA Memorandum of AgreementMR Magnetic ResonanceMRI Magnetic Resonance ImagingNPPV Noninvasive Positive Pressure VentilationNSF Nephrogenic Systemic FibrosisOSH Occupational Safety and HealthOSHA Occupational Safety and Health AdministrationPMCT Post Mortem CTQAP Quality Assurance ProgramRPC Radiation Protection CommitteeRPO Radiation Protection OfficerSOP 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 Angiography1.4.9 Interventional Radiology 1.4.10 Forensic Radiology1.4.11 Bone Densitometry 1.4.12 Radiology Consultation1.4.13 Peripheral Radiology Services1.4.14 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 InterventionalNeuroradiology 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 outpatients 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 REPORTING, CONSULTATION & IMAGE 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 Kual i t i (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 Hospitals

Major Specialist Hospitals

MinorSpecialist Hospitals

Non Specialist Hospital (No in-house Radiologist)

Hospital Tuanku Fauziah (Kangar)Hospital Sultanah Bahiyah (Alor Setar)Hospital Pulau Pinang (Pulau Pinang)Hospital Raja Permaisuri Bainun (Ipoh)Hospital Kuala Lumpur (KL)Hospital Tengku Ampuan Rahimah (Klang)Hospital Tuanku Ja’afar (Seremban)

Hospital Kulim Hospital Sg Petani Hospital Seberang Jaya Hospital Taiping Hospital Teluk Intan Hospital Ampang Hospital Kajang Hospital Serdang Hospital Selayang Hospital Sg Buloh Hospital Shah Alam Hospital Putrajaya Hospital Tuanku Ampuan Najihah(Kuala Pilah)

Hospital Langkawi Hospital Bukit Mertajam Hospital Kepala Batas Hospital Seri Manjung Hospital Slim River Hospital Gerik Hospital Kuala Kangsar Hospital Banting Hospital Labuan Hospital Port Dickson Hospital Tampin Hospital Enche’ Besar Hajjah Kalsom (Kluang)Hospital Kota Tinggi

All Hospitals - Offering general radiology / ultrasound (with visiting Radiologist only)

Hospital Kuala Lipis Hospital BentongHospital Pekan Hospital BesutHospital DungunHospital Gua MusangHospital Lahad DatuHospital KeningauHospital BeaufortHospital Kota MaruduHospital Kapit Hospital LimbangHospital SarikeiHospital Sri Aman Hospital Mukah

Hospital Melaka (Melaka)Hospital Sultanah Aminah (Johor Bahru)Hospital Tengku Ampuan Afzan (Kuantan)Hospital Sultanah Nur Zahirah (Kuala Terengganu)Hospital Raja Perempuan Zainab II (Kota Bharu)Hospital Queen Elizabeth (Kota Kinabalu)Hospital Umum Sarawak (Kuching)

Hospital Pakar Sultanah Fatimah (Muar) Hospital Sultanah Nora Ismail (Batu Pahat) Hospital Sultan Ismail (Johor Bahru) Hospital Segamat Hospital Temerloh Hospital Kemaman Hospital Kuala Krai Hospital Tanah Merah Hospital Sandakan Hospital Tawau Hospital HQE II Hospital Miri Hospital Sibu Hospital Bintulu

1 to 4


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Health Clinics (No in-house Radiologist) Offering General Radiography

Perlis Klinik Kesihatan Kangar

Kedah Klinik Kesihatan Changloon Klinik Kesihatan Tunjang Klinik Kesihatan Pokok Sena Klinik Kesihatan Naka Klinik Kesihatan Bandar Alor Setar Klinik Kesihatan Jalan Putra Klinik Kesihatan Datuk Kumbar

Pulau Pinang Klinik Kesihatan Penaga Klinik Kesihatan Kepala Batas Klinik Kesihatan Tasek Gelugor Klinik Kesihatan Butterworth Klinik Kesihatan Seberang Jaya Klinik Kesihatan Bukit Minyak Klinik Kesihatan Jalan Perak Klinik Kesihatan Bandar Baru Air Itam Klinik Kesihatan Sungai Dua Klinik Kesihatan Bayan Baru

Perak Klinik Kesihatan Pengkalan Hulu Klinik Kesihatan Lenggong Klinik Kesihatan Kuala Kurau Klinik Kesihatan Bagan Serai Klinik Kesihatan Kamunting Klinik Kesihatan Taiping Klinik Kesihatan Pokok Assam Klinik Kesihatan Simpang Klinik Kesihatan Changkat Jering Klinik Kesihatan Padang Rengas Klinik Kesihatan Kampung Simee Klinik Kesihatan Jelapang Klinik Kesihatan Greentown Klinik Kesihatan Buntung Klinik Kesihatan Gunung Rapat Klinik Kesihatan Bruas Klinik Kesihatan Pantai Remis Klinik Kesihatan Tronoh Klinik Kesihatan Sitiawan Klinik Kesihatan Pulau Pangkor Klinik Kesihatan Kampar Klinik Kesihatan Tapah Klinik Kesihatan Teluk IntanKlinik Kesihatan Tanjung Malim

Klinik Kesihatan Simpang KualaKlinik Kesihatan Pendang Klinik Kesihatan Bandar Sg.PetaniKlinik Kesihatan Bakar Arang Klinik Kesihatan Kulim Klinik Kesihatan Padang Serai Klinik Kesihatan Serdang Klinik Kesihatan Kuah Klinik Kesihatan Air Hangat Klinik Kesihatan Padang Matsirat

Wilayah Persekutuan Klinik Kesihatan Kuala Lumpur Klinik Kesihatan CherasKlinik Kesihatan JinjangKlinik Kesihatan Tanglin Klinik Kesihatan Putrajaya Presint 9Klinik Kesihatan Putrajaya Presint 18Klinik Kesihatan WP Labuan

Negeri Sembilan Klinik Kesihatan Simpang Durian Klinik Kesihatan Jelebu Klinik Kesihatan Bandar Seri Jempol Klinik Kesihatan Bahau Klinik Kesihatan Kuala Pilah Klinik Kesihatan Sikamat Klinik Kesihatan Ampangan Klinik Kesihatan Seremban Klinik Kesihatan Seremban 2 Klinik Kesihatan Senawang Klinik kesihatan Lukut Klinik Kesihatan Port Dickson Klinik Kesihatan Rembau Klinik Kesihatan Johol Klinik Kesihatan GemenchehKlinik Kesihatan Gemas

Melaka Klinik Kesihatan Masjid Tanah Klinik Kesihatan Selandar 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

2 to 4


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Selangor Klinik Kesihatan Bestari Jaya, Batang Berjuntai Klinik Kesihatan Serendah Klinik Kesihatan Rawang Klinik Kesihatan Taman Ehsan, Kepong Klinik Kesihatan Sungai Buloh Klinik Kesihatan Seksyen 7, Shah Alam Klinik Kesihatan Seksyen 19 Klinik Kesihatan Bukit Kuda Klinik Kesihatan Bandar Botanik Klinik Kesihatan PandamaranKlinik Kesihatan Pelabuhan Klang Klinik Kesihatan Kelana Jaya Klinik Kesihatan Medan Maju Jaya Klinik Kesihatan Batu 9 Klinik Kesihatan Seri Kembangan Klinik Kesihatan Sungai Chua Klinik Kesihatan Kajang Klinik Kesihatan Bandar Baru Bangi Klinik Kesihatan Bandar Seri Putra Klinik Kesihatan Salak

Pahang Klinik Kesihatan Karak Klinik Kesihatan Simpang Pelangai Klinik Kesihatan Sungai Koyan Klinik Kesihatan Bandar Jerantut (KKIA NT KK) Klinik Kesihatan Bandar Mentakab Klinik Kesihatan Tanjung Lalang (Simpang Songsang) Klinik Kesihatan Bandar Jengka Klinik Kesihatan Jengka 22 Klinik Kesihatan Pekan Tajau Klinik Kesihatan Purun Klinik Kesihatan Maran Klinik Kesihatan Paya Besar Klinik Kesihatan Kurnia Klinik Kesihatan Bandar Pekan Klinik Kesihatan Bandar Kuantan Klinik Kesihatan Indera Mahkota Klinik Kesihatan Beserah

Klinik Kesihatan Simpang KualaKlinik Kesihatan Pendang Klinik Kesihatan Bandar Sg.Petani Klinik Kesihatan Bakar Arang Klinik Kesihatan Kulim Klinik Kesihatan Padang Serai Klinik Kesihatan Serdang Klinik Kesihatan Kuah Klinik Kesihatan Air Hangat Klinik Kesihatan Padang Matsirat

Wilayah Persekutuan Klinik Kesihatan Kuala Lumpur Klinik Kesihatan CherasKlinik Kesihatan JinjangKlinik Kesihatan Tanglin Klinik Kesihatan Putrajaya Presint 9Klinik Kesihatan Putrajaya Presint 18Klinik Kesihatan WP Labuan

Negeri Sembilan Klinik Kesihatan Simpang DurianKlinik Kesihatan Jelebu Klinik Kesihatan Bandar Seri JempolKlinik Kesihatan Bahau Klinik Kesihatan Kuala Pilah Klinik Kesihatan Sikamat Klinik Kesihatan Ampangan Klinik Kesihatan Seremban Klinik Kesihatan Seremban 2Klinik Kesihatan Senawang Klinik kesihatan Lukut Klinik Kesihatan Port DicksonKlinik Kesihatan Rembau Klinik Kesihatan Johol Klinik Kesihatan GemenchehKlinik Kesihatan Gemas

Melaka Klinik Kesihatan Masjid Tanah Klinik Kesihatan Selandar 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

3 to 4


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Terengganu Klinik Kesihatan Sri Bandi Klinik Kesihatan Batu 2 1/2Klinik Kesihatan Ketengah Jaya Klinik Kesihatan Kuala DungunKlinik Kesihatan Kuala Berang Klinik Kesihatan Merchang Klinik Kesihatan Bukit Payong Klinik Kesihatan Hiliran Klinik Kesihatan Kampung Rahmat Klinik Kesihatan Permaisuri Klinik Kesihatan Padang Luas

Kelantan Klinik Kesihatan Bachok Klinik Kesihatan Pengkalan Chepa Klinik Kesihatan Bandar Klinik Kesihatan Wakaf Bharu Naiktaraf KK Pasir Pekan ke (Klinik 1 Malaysia (K1M) Pasir Pekan Klinik Kesihatan Meranti Klinik Kesihatan Mahligai Klinik Kesihatan Ketereh Klinik Kesihatan Pulai Chondong Klinik Kesihatan Jeli Klinik Kesihatan Manik Urai Klinik Kesihatan Gua Musang

Sabah Klinik Kesihatan Tawau Klinik Kesihatan Semporna Klinik Kesihatan Lahad Datu Klinik Kesihatan Sandakan Klinik Kesihatan Luyang Klinik Kesihatan Telupid Klinik Kesihatan Putatan

Sarawak Klinik Kesihatan Tudan Klinik Kesihatan Bandar Miri Klinik Kesihatan Sungai Asap Klinik Kesihatan Belaga Klinik Kesihatan Bintulu Klinik Kesihatan Tatau Klinik Kesihatan Sibu Jaya Klinik Kesihatan Jalan Oya Klinik Kesihatan Kapit Klinik Kesihatan Song Klinik Kesihatan Jalan Lanang Klinik Kesihatan Bintangor Klinik Kesihatan Sarikei Klinik Kesihatan Debak Klinik Kesihatan Sri AmanKlinik Kesihatan Tanah Puteh Klinik Kesihatan Kota Samarahan Klinik Kesihatan Kota SentosaKlinik Kesihatan Batu KawaKlinik Kesihatan Jalan MasjidKlinik Kesihatan Petra JayaKlinik Kesihatan Sematan

4 to 4


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APPENDIX 2

ORGANIZATION STRUCTURE OF NATIONAL RADIOLOGY SERVICES APPENDIX 2

ORGANIZATION STRUCTURE OF NATIONAL RADIOLOGY SERVICES

Director General of Health

Deputy Director General (Medical)

Director Medical Development Division

National Radiology Advisor

HOD of Radiology Department

Committee Chairman of Subcommittees

State Radiologist


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APPENDIX 3

RADIOLOGY DEPARTMENT ORGANIZATION STRUCTURE (SPECIALIST HOSPITAL)

Hospital Director

Nurses

Sister

Chief Matron

Chief Radiographer

Head of Department

Radiologist

Medical Officer

Matron

Senior Radiographer

Radiographer

Physicist

Healthcare Assistant

Administrative Assistant

Secretary

APPENDIX 3

RADIOLOGY DEPARTMENT ORGANIZATION STRUCTURE (SPECIALIST HOSPITAL)


Page 47

APPENDIX 4

RADIOLOGY DEPARTMENT ORGANIZATION STRUCTURE(NON-SPECIALIST HOSPITAL)

Hospital Director

Medical Officer (Incharge)

Head Radiographer

Radiographer Healthcare Assistant

APPENDIX 4

RADIOLOGY DEPARTMENT ORGANIZATION STRUCTURE (NON-SPECIALIST HOSPITAL)


Page 48

1/2

KEMENTERIAN KESIHATAN MALAYSIABORANG PERMOHONAN PEMERIKSAAN RADIOLOGI

HOSPITAL / KLINIK : ……………………………………

PER.SS-RA301(Pind1/2018)

Bulatkan pada pilihan yang berkenaan.

MAKLUMAT PESAKIT KEGUNAAN PEJABAT

1. Nama Penuh (Huruf Besar)

2. No. Kad Pengenalan/ Pasport Waktu Terima Waktu Selesai Juru X-Ray

3. Alamat Kediaman

4. Tarikh Lahir

/ /Hari Bulan Tahun

Tarikh Pemeriksaan

No.Pemeriksaan

5. Jantina L / P 19. PAPARAN IMEJ

6. No. Telefon 7. Etnik 8. Umur Bilangan Filem

9. No. Daftar Pesakit10. Wad / Klinik / A&E / RH

11. Disiplin Bilangan CD / DVD

12. LMP(Jika berkaitan) *13. Mengandung Ya / Tidak 20. FAKTOR DEDAHAN

14. Asma / Alahan / Reaksi MediaKontras (Nyatakan)

15. Mobile Ya / TidakkVp mAs Dos Radiasi

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

X-Ray Am CT MRI US Fluoro Angio IR *MMG BMD *Media

Imej*Digitize Image *Pelaporan

(Nyatakan Jika Berkaitan)

Jenama :

Isipadu Media Kontras : ……………… mlBahagian Pemeriksaan: KOMEN

RINGKASAN KLINIKAL

..............……....……………………………………………Tandatangan dan Cop Pakar / Pegawai PerubatanTarikh / Masa : ..........................................................

SENARAI DOS BERKESAN UNTUK PEMERIKSAAN RADIOLOGISumber: Health Physics Society Fact Sheet 2010, UNSCEAR 2008 Report Vol.1 dan FA Mettler et al., Radiology

2008;248:254-63Pemeriksaan Dos

(mSv)BersamaanChest(AP)

Pemeriksaan Dos (mSv) BersamaanChest(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/

Abdomen/ Extremities)

16.4 820Extremities (2 views) 0.01 0.5 IVU / IVP (6 films) 2.5 125 Barium Swallow 1.5 75 CT Chest 8 400

Chest (LAT) 0.04 2 Dental (LAT) 0.02 1 Barium Enema 7 350 CT Lumbar Spine 3.3 165 Coronary Angiogram 4.60 – 15.80 230 – 790

Skull (2 views) 0.04 2 Dental (panaromic) 0.09 4.5 HSG 1.2 60 CT Abdomen 10 500 Angioplasty (heart study) 7.50 – 57.00 375 – 2850

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

sebenar mungkin berbeza bergantung kepada saiz pesakit dan

juga perbezaan dalam teknik pengimejan.

Cervical Spine 0.1 5 Hip 0.8 40 CT Head / Brain 2 100 CT Pulmonary Angio 18.2 – 19.5 910 – 975

Thoracic Spine (AP) 0.4 20 Abdomen 1.2 60 CT Cervical Spine 1.5 75 CT Urography 4.5 225

*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.

Borang Permohonan Pemeriksaan RadiologiPER.SS-RA301 (Pind. 1/2018)

APPENDIX 5


Page 492/2

LAPORAN RADIOLOGI

Nama Pesakit No. Pemeriksaan

Jenis Pemeriksaan Tarikh Pemeriksaan

……………………………………………………...............Tandatangan dan Cop Pakar / Pegawai PerubatanTarikh: …………………………………………


Page 50

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

Perkara / Ruangan

Butiran

Hospital/ Klinik Pihak hospital atau klinik perlu mengisi nama fasiliti yang berkaitan.

1 Nama pesakit perlu diisi dengan huruf besar.

2 Nombor kad pengenalan bagi warganegara dan nombor pasport 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.

10Pemohon perlu menyatakan lokasi pesakit tersebut dengan terperinciseperti 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.

13

Pemohon perlu membulatkan pilihan sama ada pesakit mengandung atau tidak. Sekiranya pesakit mengandung atau kemungkinan hamil, pemohon perlu melengkapkan borang Keizinan - Prosedur BagiWanita Mengandung Atau Kemungkinan Hamil. (Lampiran 1)

14 Pemohon perlu menyatakan sekiranya pesakit mempunyai sebarangalahan, penyakit Asma ataupun sejarah reaksi terhadap media kontras.

15Pemohon perlu membulatkan pilihan sama ada permohonanpemeriksaan Radiologi adalah secara mobile atau statik di JabatanRadiologi.

16Pemohon perlu membulatkan pilihan yang berkaitan warganegara, penjawat awam dan sama ada pesakit adalah pesakit bayaran penuh (Full Paying Patient - FPP).

17

Pemohon perlu melengkapkan maklumat tarikh dan keputusan ujian creatinine serta eGFR terkini pesakit. Maklumat ini diperlukan sekiranyapemeriksaan mendapati keperluan penggunaan kontras ketika prosedurberlangsung.


Page 51

Perkara / Ruangan

Butiran

18 Pemohon perlu membulatkan pilihan perkhidmatan yang dipohon dan menyatakan dengan jelas bahagian badan yang memerlukanpemeriksaan diruangan yang disediakan (Bahagian Pemeriksaan). Bagi permohonan MMG (mammogram), pemohon juga perlumelengkapkan Borang Soal Selidik MMG. (Lampiran 2)Manakala permohonan media imej, digitize image ataupun pelaporanperlu dinyatakan sebab permohonan di ruangan Ringkasan Klinikal.

- Permohonan media imej (hard copy) adalah ketika permohonanpencetakan filem atau CD, tambahan daripada media imej yang telah diberikan ketika pemeriksaan asal dilakukan. Begitu jugadengan Pelaporan.

- Digitize image adalah ketika permohonan untuk memuat naik media imej (hard copy) ke dalam sistem untuk disimpan sebagaisoft copy.

Sekiranya permohonan pemeriksaan adalah dengan menggunakan media kontras, pemohon perlu melengkapkan Borang Keizinan BagiPesakit Menjalani Prosedur Radiologi Yang Memerlukan Suntikan Media Kontras. (Lampiran 3)

19 Pegawai Jabatan Radiologi perlu menyatakan bilangan filem atau CD/DVD yang dicetak.

20 Pegawai Jabatan Radiologi perlu menyatakan faktor dedahan yang berkaitan.

21 Pegawai Jabatan Radiologi perlu menyatakan tarikh dan masa temujanji pemeriksaan yang akan datang.

22

Pegawai Jabatan Radiologi perlu menyatakan jenama dan isipadu media kontras yang digunakan sekiranya berkenaan.Pegawai juga perlu memastikan Borang Keizinan Bagi PesakitMenjalani Prosedur Radiologi Yang Memerlukan Suntikan Media Kontras dilengkapkan oleh pemohon. (Lampiran 3)

RingkasanKlinikal

Perlu diisi oleh pemohon dilengkapi dengan tandatangan dan cop sertatarikh/ masa borang permohonan di isi.

LaporanRadiologi

Perlu diisi oleh Pakar atau Pegawai Perubatan Radiologi dilengkapidengan tandatangan dan cop serta tarikh laporan disediakan.

Kegunaan Pejabat

Pegawai Jabatan Radiologi perlu mengisi maklumat waktu terima, waktu selesai, nama Juru X-Ray, tarikh pemeriksaan dan nombor pemeriksaan.


Page 52

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.

APPENDIX 6


Page 53

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

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 med ia. 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

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

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

Address …………………………………………….............................. Radiological Procedure ………………………………….................

…………………………………………………………....…......... ………………………...................................................................


Page 54

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

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 ……………………….…………....…….....

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

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 ………………………………,,....………….


Page 55

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.

Borang keizinan bagi prosedur Radiologi yang memerlukan suntikan media kontras

APPENDIX 7


Page 56

Keizinan - Prosedur Radiologi Yang Memerlukan Suntikan Media Kontras 1/2

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.

KEIZINAN – PROSEDUR RADIOLOGI YANG MEMERLUKAN SUNTIKAN MEDIA KONTRAS

MAKLUMAT PESAKIT

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

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

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

............................................................................. .............................................................................................

..............................................................................................


Page 57

Keizinan – Prosedur Radiologi Yang Memerlukan Suntikan Media Kontras 2/2

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 ………………………....………………..

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

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 …………………………………………...


Page 58

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.

APPENDIX 8


Page 59

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 ………………..........................……........………

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

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 ……………………...........……………............…


Page 60

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

Menstrual or Gestational age

(weeks)

< 50 mGy 50-100 mGy > 100 mGy

0 - 2 None None None

3 - 4 None Probably none Possible spontaneous abortion

5 - 10 None Potential effects are scientifically uncertain

and probably too subtle to be clinically

detectable

Possible malformations increasing in likelihood as

dose increases



detectable

Increased risk of deficits in IQ or mental retardation that increase in frequency and

severity with increasing dose

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

Chest Intravenous Urogram

Lumbar Spine Pelvis Skull

Thoracic spine

1.4

<0.01 1.7 1.7 1.1

<0.01 <0.01

4.2

<0.01 10 10 4

<0.01 <0.01

Fluoroscopic examination: Barium meal (upper GI)

Barium enema

1.1 6.8

5.8 24

Computed Tomography: Abdomen

Chest including CTPA Head

Lumbar Spine Pelvis

8.0 0.06

<0.005 2.4 25

49

0.96 <0.005

8.6 79

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


Page 61

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.

Borang keizinan bagi prosedur Radiologi bagi wanita mengandung atau kemungkinan hamil

APPENDIX 9


Page 62

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 ……………………………….......……....…

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

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 ……………………………….........….................……


Page 63

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

Menstrual or Gestational age

(weeks)

< 50 mGy 50-100 mGy > 100 mGy

0 - 2 None None None

3 - 4 None Probably none Possible spontaneous abortion



detectable

Possible malformations increasing in likelihood as

dose increases



detectable

Increased risk of deficits in IQ or mental retardation that increase in frequency and

severity with increasing dose

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

Chest Intravenous Urogram

Lumbar Spine Pelvis Skull

Thoracic spine

1.4

<0.01 1.7 1.7 1.1

<0.01 <0.01

4.2

<0.01 10 10 4

<0.01 <0.01

Fluoroscopic examination: Barium meal (upper GI)

Barium enema

1.1 6.8

5.8 24

Computed Tomography: Abdomen

Chest including CTPA Head

Lumbar Spine Pelvis

8.0 0.06

<0.005 2.4 25

49

0.96 <0.005

8.6 79

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


Page 64

Technical Committee on Radiology Services Policy

Advisor

Datuk Dr. Noor Hisham AbdullahDirector General of Health Malaysia

Dato’ Dr. Hj Azman Hj Abu BakarDirector of Medical Development Division


Page 65

Chairman

Datin Dr. Hjh Zaharah MusaSenior Consultant Radiologist

Hospital Selayang Former National Advisor on Radiology Services

Dr. Yun Sii IngSenior Consultant Radiologist

Hospital Sungai Buloh National Advisor on Radiology Services


Page 66

External Panel of Reviewers

Dato’ Dr Yusof Hj Abdul WahabSenior 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


Page 67

Dato’ Dr. Ahmad Zalizan ZainulSenior Consultant Radiologist Hospital Tuanku Fauziah

Dato’ Dr. Zainun A. Rahman Consultant Radiologist Hospital Tengku Ampuan Afzan

Dr. K. Vijayalakshmi Senior Consultant Radiologist Hospital Tengku Ampuan Rahimah

Dr. Hjh Zaleha Abd Manaf Senior Consultant Radiologist Hospital Kuala Lumpur

Dr Lim Cheng KooiSenior Consultant RadiologistHospital Queen Elizabeth

Dr. Tan Suzet Senior Consultant Radiologist Hospital Teluk Intan

Dr. Noraini Ab Rahim Senior Consultant Radiologist National Cancer Institute

Dr Chong Aun KeeConsultant Radiologist Hospital Melaka

Dr. Mohd Shaffie Baba Consultant Radiologist Hospital Raja Perempuan Bainun

Dr. Mawaddah GhazaliSenior Principal Assistant Director Medical Development Division, MOH

Daud Ismail Head Radiographer Hospital Kuala Lumpur

Pushpa Thevi Rajendran Head Radiographer Hospital Ampang

Zaidah Maspin Radiographer Hospital Kuala Lumpur

Siti Normasitah Masduki Science Officer (Physics)Hospital Serdang

Mohammad Azwin Abdul Karim Science Officer (Physics)Hospital Ampang

Shahidah Salleh Senior Assistant Director Allied Sciences Division, MOH

Mohd Khairudin Mohamed Samsi Senior Principal Assistant Director Bahagian Kawalselia Radiasi, MOH

Jeffry Mohamad Noor Senior Principal Assistant Director Engineering Division, MOH

Drafting Committee


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Ir. Dr. Syed Mustafa Kamal Syed Aman Deputy Director Engineering Division, Ministry of Health

Dr. Selvamalar Selvarajan Senior Principal Assistant Director Medical Development Division, MOH

Dr. Melvyn Edward Anthony Senior Principal Assistant Director Medical Development Division, MOH

Dr. Mohd Rizal bin Roslan Consultant Radiologist (Interventional) Hospital Selayang

Ali Ngatman Radiographer Family Health Development Division, MOH

Norsiah Abu Hassan Radiographer Family Health Development Division, MOH

Proof Reading Dato’ Harry Isaacs Grammar School Kuala Terengganu


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