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 SERVICES OPERATIONAL POLICY
MINISTRY OF HEALTH MALAYSIA
NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
Clinical Support Services Unit Medical Development Divison Minitry of Health Malaysia NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
First Edition 2019
Efforts were coordinated by Clinical Support Unit, Medical Services Development Section Medical Development Division Ministry of Health, Malaysia.
A catalogue record of this document is available from the Library and Resource Unit of Institute of Medical Research, Ministry of Health;
MOH/P/PAK/427.19 (BP)
And also available from National Library of Malaysia;
ISBN 978-967-2173-78-6
© Ministry of Health Malaysia 2019
All rights reserved: no part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise without the prior permission of the Ministry of Health Malaysia.
Published by : Medical Development Division Ministry of Health, Blok E1,Parcel E, Federal Government Administrative Center, 62590 Putrajaya, Malaysia. Tel : 603-88831489 Fax : 603-88831155 http://www.moh.gov.my
Page 2 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
This policy was developed by the Medical Development Division and the Drafting Committee of Operational Policy on Radiology Services Ministry of Health Malaysia.
Page 3 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
ACKNOWLEDGEMENT
The completion of this National Operational Policy on Radiology Services could not have been possible without the participation and assistance of the Drafting Committee of Operational Policy on Radiology Services. Their contributions are sincerely appreciated and gratefully acknowledged.
Page 4 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
Page 5 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
FOREWORD Director General of Health Malaysia 8 Former National Advisor on Radiology Services . 9 National Head of Radiology Services 10
LIST OF ABBREVIATIONS 12 CONTENT: 1.0 ORGANISATION & MANAGEMENT 13-15 1.1 Vision 1.2 Mission 1.3 Objectives 1.4 Scope of Service 1.5 Organisational Structure
2.0 OPERATIONAL POLICY 16-21 2.1 General Statement 2.2 Scheduling an examination 2.3 Special Examinations 2.4 Mammography 2.5 Interventional Radiology 2.6 Peripheral Radiology Services 2.7 Forensic Radiology
3.0 PATIENT CARE 22-23
4.0 REPORTING, CONSULTATION & 23 IMAGE MANAGEMENT
5.0 SAFETY IN IMAGING 24-33 5.1 Radiation Safety 5.2 Examination on Females of Child Bearing Age 5.3 MRI Safety 5.4 Contrast Media Safety 5.5 Infection Control 5.6 Occupational Safety 5.7 Chemical Waste Management 5.8 Incidents in the Radiology Department
Page 6 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
6.0 PATIENT’S RIGHTS 34
7.0 TRAINING / CONTINUOUS 34 PROFESSIONAL DEVELOPMENT (CPD)
8.0 FACILITIES AND EQUIPMENT 35-39 8.1 General 8.2 Facilities 8.3 Equipment 8.3.1 Safety and Performance 8.3.2 Storage / Security and Maintenance of Mobile X-ray Equipment 8.3.3 Contingency Plan for Equipment / System Failure 8.3.4 Decommissioning
9.0 APPENDIX 40-63
Page 7 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
In the wake of the Fourth Industrial Revolution, healthcare services all around the globe will not be spared of the Internet ripple, and radiology will be at the forefront of the wave of Artifical Intelligence and the Internet of Things. As one of the earliest adopters of X-ray technology in 1873, Malaysian healthcare system will once again be tested.
Tremendous development of imaging modalities that utilises ionizing radiation such as CT and X-ray, magnetic resonance imaging and ultrasound in recent years provides clinicians with even more information with precise accuracy. Our physicians are now able to expedite clinical decisions, hence enable us to yield an improved quality of care to our patients.
Malaysian healthcare system is often antagonised with economic inflations and constrains of limited resources. Routinely, high degree of co-ordination for advanced imaging are required in assisting clinicians’ diagnosis as well as radiological therapeutic interventions. Henceforth, the birth of this policy is hoped to provide guidance to relevant parties on a development of a system that is financially viable, coordinated and efficient.
The use of radiation is governed by complex regulations and license condition therefore it is impartial that the management and healthcare providers to continue to embrace initiative designed to response and complement to these challenges and abide to the policy promulgated. Therefore, it is our professional responsibility to carry out the delivery of safe and effective practice.
Finally, I would like to congratulate the Medical Development Division for amalgamating this effort and commendation must belong to the drafting committee led by Datin Dr Zaharah Musa for their continuing dedication and commitment. I believe that this commitment will continue safeguarding Ministry of Health’s mission to provide the country with an unsurpassable healthcare system into the 21st century.
Datuk Dr. Noor Hisham Abdullah Director General of Health, Malaysia
Page 8 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
Radiology has become an integral component of modern medical patient care. a has grown in leaps and bounds since the discovery of X-rays in 1895 and Malaysia was at the forefront of the medical radiology when the first x-ray machine in Malaysia was installed in Taiping Hospital in 1896.
The scope of service today has expanded from basic radiography to include modern sophisticated radiological equipment and applications. The service now has progressed into therapeutic realm with the evolution of interventional radiology. Modern medicine in the 21st century has recognized the value of radiology and its use is now extended into forensic radiology where vigorous research is ongoing worldwide to assess its role in converting open autopsy to virtual autopsy.
As radiology continues to progress in this era of disruptive technology, our focus must pivot on patient care. Precedence of quality patient care in our service also means, every member of the radiological department must work effectively together to provide high-quality and time-efficient patient imaging whilst ensuring the safety of the medical personnel and patients alike during the radiological procedure.
The publication of this policy is timely, and it is aimed at setting out the principles and arrangements which we believe are appropriate for high-quality patient care. It is hoped that this document will assist and guide radiological and non-radiological staff alike to understand our work processes better and hence able to optimize its usage in patient care.
The Medical Development Division, Medical Radiation Surveillance Division, Family Health Development Division as well as Engineering Division has provided enormous support in the preparation of this document and I am grateful for their guidance and assistance. I would also like to thank my seniors and colleagues in the drafting committee who developed this document and all those who have also helped one way or another.
Datin Dr. Zaharah Musa Former National Advisor on Radiology Services .
Page 9 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
This National Radiology Services Operational Policy document was initiated by my predecessor, Datin Dr Zaharah Musa. The aims of this policy document are to establish guidelines and best practices in our organisation. It is hope that this policy document will serve as a reference standard among the radiology service providers and the end users in order to provide quality and safe practice.
As the radiological fraternity is on the verge of a major revolution in medicine with the advent of artificial intelligence (AI) we should be actively involved in shaping our own future and warrant that we will be the fittest to survive natural selection. Radiologists need to expand their role and show value in order to remain relevant in clinical practice in the era of AI.
Radiologists must go beyond detecting lesions and interpreting images because machines already perform these tasks better than humans. The radiologists role will rather be to answer clinical questions by integrating the imaging information together with clinical information and putting it all in context. Radiologists must include more information in their reports from genomics and fields other than imaging, and not just give recommendations This document will not be complete without the contribution and commitment from the drafting committee and for that I would like to express my gratitude. I hope that this document can be put to good use to raise the bar of radiology service in the Ministry of Health Malaysia.
Dr. Yun Sii Ing National Advisor on Radiology Services 2018– present
Page 10 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
Definition
Special Examination Refers to all other forms of imaging other than general radiography (X-ray)
Peripheral Radiology Services Refers to the provision of trained radiology personnel to handle imaging modalities in other departments.
Satellite Services Refers to the provision of radiology servicesin areas other than the main department.
Interventional Radiology Refers to the utilization of minimally invasive image guided procedures to diagnose and treat diseases.
Forensic Radiology Refers to the application of imaging on a deceased person and / or body parts to questions of law.
Radiology Consultation Refers to the provision of expert opinion on image and patient management as well as direct patient consultation.
Page 11 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
LIST OF ABBREVIATIONS
ACR American College of Radiology AKI Acute kidney injury CD Compact Disc CIN Contrast Induced Nephropathy CME Continuous Medical Education CPD Continuous Professional Development CT Computed Tomography eGFR Estimated Glomerular Filtration Rate FIFO first-in-first-out GBCA Gadolinium Based Contrast Agent HSIP Hospital Specific Implementation Plan ICRP International Commission on Radiological Protection ICT Information and Communication Technology IT Information Technology IVU Intravenous Urography KPI Key Performance Indicator MOH Ministry of Health MOA Memorandum of Agreement MR Magnetic Resonance MRI Magnetic Resonance Imaging NPPV Noninvasive Positive Pressure Ventilation NSF Nephrogenic Systemic Fibrosis OSH Occupational Safety and Health OSHA Occupational Safety and Health Administration PMCT Post Mortem CT QAP Quality Assurance Program RPC Radiation Protection Committee RPO Radiation Protection Officer SOP Standard Operating Procedures
Page 12 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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:
Page 13 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
1.4.1 General Radiography 1.4.2 Intravenous Urography (IVU) 1.4.3 Fluoroscopy 1.4.4 Ultrasonography 1.4.5 Computed Tomography (CT) 1.4.6 Mammography 1.4.7 Magnetic Resonance Imaging (MRI) 1.4.8 Angiography 1.4.9 Interventional Radiology 1.4.10 Forensic Radiology 1.4.11 Bone Densitometry 1.4.12 Radiology Consultation 1.4.13 Peripheral Radiology Services 1.4.14 Mobile Services i. General Radiography ii. Ultrasonography iii. C-Arm Fluoroscopy iv. Mobile CT
Mobile services are bedside services provided for the critically ill and non-ambulatory patients.
Emergency radiology services are provided 24 hours a day. The type of services shall depend on the local availability of resources.
1.5 Organisational Structure
The organisational chart (Appendix 2-4)
1.5.1 The National Head of Radiology shall serve as the advisor to the Ministry of Health on all matters pertaining to the services.
1.5.2 The State Radiologist shall be appointed by the State Health Director and assist the National Advisor in all state radiology matters including health clinics.
1.5.3 The radiology department shall be headed by a Radiologist appointed by the Hospital Director. He /
Page 14 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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.
Page 15 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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
Page 16 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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.
Page 17 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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).
Page 18 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
2.5 Interventional Radiology
2.5.1 Interventional Radiology is divided into Interventional Neuroradiology and Interventional Peripheral radiology. Interventional Neuroradiology involves procedures from the neck above and the spine.
2.5.2 The radiologist performing interventional procedures must hold qualifications and maintain competency specific to the range of interventional procedures he/she is performing.
2.5.3 Interventional radiology procedures are to be performed in a well-equipped room with appropriate facilities and qualified procedures performed at the mentioned site, and for the treatment of possible complications.
2.5.4 Equipment for physiological monitoring of patients undergoing interventional procedures shall be appropriate to the procedure being performed. These include ECG, blood pressure and pulse oximetry. Where warranted, additional equipment like pressure monitoring for pulmonary arteriography and intravascular pressure gradients in peripheral and visceral diagnostic angiograpghy shall be made available.
2.5.5 Interventional radiologist is to be involved in a multidiscipline discussion related to their case in order to achieve a high level of care.
2.5.6 All interventional radiology doctors ( consultant, fellow and registrar ) shall personally attend their patients in order to perform pre-operative and post operative assessment of their patients, including obtaining consent for the respective procedure.
2.5.7 All interventional procedures (peripheral and neurointervention) receive their patients from their
Page 19 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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
Page 20 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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.
Page 21 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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
Page 22 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
wards while out- patients shall be sent to the emergency department for further management. Should a death occur within the department, the same pathway will follow.
3.8 All procedures performed and drugs administered (including contrast media) shall be documented.
4.0 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.
Page 23 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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
Page 24 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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.
Page 25 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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
Page 26 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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
Page 27 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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
Page 28 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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
Page 29 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
(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.
Page 30 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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
Page 31 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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.
Page 32 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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.
Page 33 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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).
Page 34 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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.
Page 35 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
8.2.2 Staff Facilities
i. Prayer rooms shall be provided for male and female Muslim staff.
ii. Pantry shall be provided for staff use
iii. Lockers shall be provided for staff.
iv. On-call rooms shall be provided.
v. Staff shall be allowed to use ICT facilities for service related purposes.
8.3 Equipment
8.3.1 Operations
i. All imaging equipment shall be operated by qualified, trained and privileged personnel.
ii. Facilities and imaging personnel shall adhere to regulations and guidelines regarding the use of ionizing radiation / irradiating apparatus (Refer to the Atomic Energy Licensing Act 304 and subsidiary regulations).
8.3.2 Safety & Performance
i. All radiology equipment and related accessories shall be regularly inspected (Quality Control), maintained and calibrated on scheduled and as required basis . Appropriate records shall be maintained. (Refer to: Manual Perlaksanaan Program Jaminan Kualiti (QAP) dalam Perkhidmatan Radiologi)
ii. Regular equipment performance-checklist shall be performed and documented according to manufacturers’ recommendations.
Page 36 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY 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:
Page 37 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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
Page 38 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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.
Page 39 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
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
Page 40 NATIONAL RADIOLOGY SERVICES OPERATIONAL POLICY
APPENDIX 1
MINISTRY OF HEALTH FACILITIES WITH RADIOLOGY SERVICES
State Hospital Tuanku Fauziah (Kangar) Hospital Melaka (Melaka) Hospitals Hospital Sultanah Bahiyah (Alor Setar) Hospital Sultanah Aminah (Johor Bahru) Hospital Pulau Pinang (Pulau Pinang) Hospital Tengku Ampuan Afzan (Kuantan) Hospital Raja Permaisuri Bainun (Ipoh) Hospital Sultanah Nur ahirah (Kuala Hospital Kuala Lumpur (KL) Terengganu) Hospital Tengku Ampuan Rahimah Hospital Raja Perempuan aina II (Kota (Klang) Bharu) Hospital Tuanku Ja’afar (Serem an) Hospital Queen Eliza eth (Kota Kina alu) Hospital Umum Sara ak (Kuching)
Major Hospital Kulim Hospital Pakar Sultanah Fatimah (Muar) Specialist Hospital Sg Petani Hospital Sultanah Nora Ismail (Batu Pahat) Hospitals Hospital Se erang Jaya Hospital Sultan Ismail (Johor Bahru) Hospital Taiping Hospital Segamat Hospital Teluk Intan Hospital Temerloh Hospital Ampang Hospital Kemaman Hospital Kajang Hospital Kuala Krai Hospital Serdang Hospital Tanah Merah Hospital Selayang Hospital Sandakan Hospital Sg Buloh Hospital Ta au Hospital Shah Alam Hospital HQE II Hospital Putrajaya Hospital Miri Hospital Tuanku Ampuan Najihah Hospital Si u (Kuala Pilah) Hospital Bintulu
Minor Hospital Langka i Hospital Kuala Lipis Specialist Hospital Bukit Mertajam Hospital Bentong Hospitals Hospital Kepala Batas Hospital Pekan Hospital Seri Manjung Hospital Besut Hospital Slim River Hospital Dungun Hospital Gerik Hospital Gua Musang Hospital Kuala Kangsar Hospital Lahad Datu Hospital Banting Hospital Keningau Hospital La uan Hospital Beaufort Hospital Port Dickson Hospital Kota Marudu Hospital Tampin Hospital Kapit Hospital Enche’ Besar Hajjah Kalsom Hospital Lim ang (Kluang) Hospital Sarikei Hospital Kota Tinggi Hospital Sri Aman Hospital Mukah
Non All Hospitals - Offering general radiology / ultrasound ( ith visiting Radiologist only) Specialist Hospital (No in-house Radiologist)