Malaysian Hospital Accreditation Standards 4th Edition January 2013

SERVICE STANDARD 14 Radiology / Diagnostic Imaging Services

TOPIC 14.1: ORGANISATION AND MANAGEMENT

STANDARD 14.1.1

The Radiology/Diagnostic Imaging Services shall be organised to provide safe efficient radiological services.
The services shall be coordinated with other departments and services of the Facility.

CRITERIA FOR COMPLIANCE:

14.1.1.1 There are documented purposes which may be termed Vision and Mission statements, goals,
objectives and values that suit the scope of the Radiology/Diagnostic Imaging Services. When
compiling the purposes, consideration shall be given to the following:

a) They are what the services want to achieve.

b) The goals of the service are achieved by the objectives as stated.

c) The goals and objectives are consistent with professional standards, guidelines and
relevant legislation.

d) Statements are monitored, reviewed and revised as required accordingly.

14.1.1.2 There is an organisation chart which:

a) provides a clear representation of the structure, function and reporting relationships

between the Head and the staff of the Radiology/Diagnostic Imaging Services;

b) is accessible to all staff;

c) includes off-site services if applicable;

d) is revised when there is a major change in any one of the following:

 organisation;
 functions;
 reporting relationships;
 goals and objectives;
 staffing patterns.

14.1.1.3 There are written and dated specific job descriptions for all categories of staff that include:

a) qualifications, training, experience and certification required for the position;

b) lines of authority;

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c) accountability, functions, and responsibilities;

d) review when required and when there is a major change in any one of the following:

 nature and scope of work;

 duties and responsibilities;
 general and specific accountabilities;
 qualifications required and privileges granted;
 staffing patterns;
 Statutory Regulations.

14.1.1.4 Regular staff meetings which include medical practitioners are held to discuss issues and matters
pertaining to the operations of the Radiology/Diagnostic Imaging Services. Minutes are kept and
accessible to relevant staff.

14.1.1.5 The Radiology/Diagnostic Imaging Services staff participate in the following:

a) where applicable, the clinical aspects of patient care and other radiological matters in the
Facility;

b) communications with the relevant services and participation in education programmes

organised by the Facility, interdepartmental meetings/committees, and education
programmes organised by external bodies.

14.1.1.6 Personnel records on training, staff development, leave and others are maintained for every staff.

14.1.1.7 The Head of Radiology/Diagnostic Imaging Services is involved in the planning, management,
and justification of budget and resource utilisation of the services.

Notes /Explanations

The Head of the service could be the Person In Charge (PIC) of the Facility in the event where
there is no resident radiologist in the Facility.

Where there is no resident radiologist, the following shall be applicable:

i. In the case of government facilities, the services shall be overseen and supervised by the
state radiologist or his assignee.

ii. In the case of private facilities, the services shall have access and suitable arrangement
with an off-site radiologist who shall provide interpretation of the findings of procedures,
guidance and support with regards to the safety, standardisation of procedures and
equipment in addition to providing supervision for staff competency and privileges.

14.1.1.8 The Head of Radiology/Diagnostic Imaging Services is involved in the appointment and/OR
assignment of staff.
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14.1.1.9 The Head of the Radiology/Diagnostic Imaging Services shall ensure that the staff of
Radiology/Diagnostic Imaging Services complete incident reports and these are discussed by the
department and forwarded to the Person In Charge (PIC) of the Facility. Reporting, investigation
and implementation of remedial measures shall be made in the prescribed form.

14.1.1.10 Incidents reported have had Root Cause Analysis done and action taken to prevent recurrence.

14.1.1.11 Appropriate statistics and records shall be maintained in relation to the provision of
Radiology/Diagnostic Imaging Services and used for managing the services and patient care
purposes.

14.1.1.12 Specific radiological and diagnostic imaging services provided shall depend on the size and
scope of the Facility.

14.1.1.13 The radiological reports of investigations for inpatients shall be available to the requesting doctor
within 24 hours. A copy is to be kept in the patient’s medical record.

Notes/Explanations

Reports are made on radiological/imaging examinations by a radiologist. In the absence of a

radiologist, the interpretation of the examination must be made by a competent medical
practitioner. Competent medical practitioner is an officer who has undergone attachment/training
in Radiology/Diagnostic Imaging Department supervised by a radiologist.

14.1.1.14 The radiologist shall consult with the referring practitioner immediately when there are critical or
unexpected findings. There is evidence of documentation of this consultation.

14.1.1.15 Films or other hard or soft copy images shall be made available when required. Where these
hard copies need to be stored in the Facility, these shall be stored vertically in an air conditioned
room with suitable environmental conditions to prevent fungus and in a manner for easy retrieval.

Notes/Explanations

If the policy of the Facility allows patients to take their films home, they shall be advised to take
proper care of the films and make them available whenever necessary. In Facilities where the
films are not returned to patients, films may be given on loan for the purpose of obtaining a
second opinion to ensure that patients do not undergo additional radiation exposure.

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Malaysian Hospital Accreditation Standards 4th Edition January 2013

TOPIC 14.2: HUMAN RESOURCE DEVELOPMENT AND MANAGEMENT

STANDARD 14.2.1

The Radiology/Diagnostic Imaging Services shall be directed by a qualified radiologist and assisted by
qualified support staff to achieve the services’ aims and objectives; and there is a continuing education
programme to enhance human resource development.

CRITERIA FOR COMPLIANCE:

14.2.1.1 The direction by the Head and staffing of the services are provided by personnel qualified by
education, training, experience and certification to meet the demands of the various positions and
to achieve the objectives of the services.

14.2.1.2 The Head of the Radiology/Diagnostic Imaging Services may be full-time or part-time depending
on the size and complexity of the department.

14.2.1.3 The authority, responsibilities and accountabilities of the Head of Radiology/Diagnostic Imaging
Services are clearly delineated and documented in a letter of appointment.

14.2.1.4 Sufficient numbers of personnel and support staff with appropriate qualifications are employed to
enable the services to meet its documented purposes.

14.2.1.5 All radiographic procedures shall be carried out by appropriately qualified, privileged and
competent personnel.

14.2.1.6 A radiologist and radiographer shall be on duty or be available on call after normal working
hours.

14.2.1.7 There is a structured orientation programme where new staff including medical practitioners are
briefed on their services, operational policies and relevant aspects of the Facility to prepare them
for their roles and responsibilities.

14.2.1.8 There is evidence of a staff development plan which provides the knowledge and skills required
for staff to maintain competency in their current positions as the demands of the positions evolve.
There is evidence of competency assessment.

14.2.1.9 There are continuing education activities for staff including medical practitioners to pursue
professional interests and to prepare for current and future changes in practice. There is
evidence that staff education and development needs have been appraised and identified.

14.2.1.10 Staff including medical practitioners receive written evaluation of their performance at the
completion of the probationary period and annually thereafter, or as defined by the Facility.

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14.2.1.11 Proper documented instructions are available and safety precautions are implemented for the
protection of patients and staff who are exposed to hazardous equipment. References are based
on the following statutory regulations:

a) Atomic Energy Licensing Act 1984 (Act 304).

b) Atomic Energy Licensing Act 1984 (Act 304): Radiation Protection (Licensing) Regulations
1986.

c) Atomic Energy Licensing Act 1984 (Act 304): Atomic Energy Licensing (Basic Safety
Radiation Protection) Regulations 2010.

14.2.1.12 In a teaching hospital, the Radiology/Diagnostic Imaging Services shall provide educational
needs and teaching for undergraduates and postgraduates without compromising patient safety
and comfort.

14.2.1.13 In Facilities which have teaching and research responsibilities, the staff of the
Radiology/Diagnostic Imaging Services give their cooperation or participate in the teaching and
research programmes.

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TOPIC 14.3: POLICIES AND PROCEDURES

STANDARD 14.3.1

There are written and dated policies and procedures for all activities of the Radiology/Diagnostic Imaging
Services. These policies and procedures reflect current standards of radiology/diagnostic imaging practices,
relevant regulations, statutory requirements, and the purposes of the services.

There should be available throughout the Facility a list of procedures requiring informed consent specific to
radiology/diagnostic imaging. Possible risks and complications arising from procedures should be documented
either in specific consent forms or in patient’s medical record.

CRITERIA FOR COMPLIANCE:

14.3.1.1 There are written policies and procedures for the Radiology/Diagnostic Imaging Services and
they are consistent with the overall policies of the Facility.

14.3.1.2 The policies and procedures shall be developed by the Radiology/Diagnostic Imaging Services
staff and the Radiation Safety Committee in consultation with representatives from other related
services.

14.3.1.3 Policies and procedures are dated, authorised, signed and reviewed at least once every three
years and revised as required.

14.3.1.4 New and revised policies and procedures are communicated to all staff.

14.3.1.5 There is evidence of compliance with policies and procedures.

14.3.1.6 Copies of policies and procedures, relevant Acts, Regulations, By-Laws and statutory
requirements are accessible to staff.

14.3.1.7 A diagnostic radiological/imaging investigation or procedure will be performed upon written

request by a medical practitioner or when deemed as indicated by a radiologist. Such requests
will be made in writing and contain sufficient clinical information to justify the examination.

14.3.1.8 The Head of Radiology/Diagnostic Imaging Services shall be accountable for all procedures.

14.3.1.9 Reports are made on procedures/radiological/imaging examinations by a radiologist. In the

absence of a radiologist, the interpretation of the examination must be made by a competent
medical practitioner.

14.3.1.10 Written policies and procedures shall include the following:

a) scheduling of patients and staff;

b) informed consent;
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c) identification of patients, correct procedure, correct site before performing the

investigation;

d) radiological examinations in areas other than the Radiology/Diagnostic Imaging Services;

e) administering diagnostic agents;

f) extravasation and management of complications of contrast media;

g) roles of paramedical personnel;

h) care of patients having special needs including those who are critically ill and those
needing isolation precautions;

i) response times for interpretations, viewing and reporting as required;

j) handling of special patients, e.g. infants and small children, physically or mentally
challenged patients, the elderly, detainees, etc;

k) the routine checking of last menstrual period (LMP) in women of child bearing age prior to
radiological examinations;

l) precautions in pregnant patients undergoing radiological examinations;

m) duplication and issue of films or images.

14.3.1.11 Staff shall ensure that patient exposure is kept as low as reasonably achievable using time,
distance, shielding as well as collimation during radiological examination whilst providing images
of diagnostic quality for radiological interpretation.

Notes/Explanations

This is a mandate to protect patients from unnecessary radiation exposure.

14.3.1.12 There are written procedures for treatment of anaphylactic response and complication of
administration of radiological agents which include but not limited to contrast media reaction and
extravasation. There is access to emergency and resuscitation equipment and medical supplies.

14.3.1.13 A manual of guidelines for patient preparations for radiological/imaging examinations shall be
available and distributed to all relevant staff.

14.3.1.14 A technical manual for equipment shall be available within the Services.

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14.3.1.15 A manual/guidelines/charts for radiographic procedures shall be made available to all relevant
staff.

Notes/Explanations

The Radiology/Diagnostic Imaging Services must have documented protocols on the required
projections and or manoeuvres required for the acquisition of quality diagnostic images.

14.3.1.16 There is a policy to ensure safety and confidentiality of images acquired digitally.

Notes/Explanations

There is a user control and access policy in the Ministry of Health.

14.3.1.17 There is a Radiation Safety Committee comprising a designated Radiation Protection Officer and
representatives from other services using ionising equipment.

a) Minutes or issues raised at the Radiation Safety Committee meetings must be brought to the
attention of the Head of clinical services and other users of radiology services.

b) In smaller facilities, where the Radiation Safety Committee is not established, radiation issues
should be an agenda in the Hospital Safety Committee meeting.

14.3.1.18 Staff involved in the operating of ionising equipment shall undergo medical examinations in
accordance with Atomic Energy Licensing Act 1984 (Act 304) and Regulations on Basic Safety
Radiation Protection 2010. Full medical examination and a full blood examination to be
conducted by a registered medical practitioner:

a) pre-employment medical examination;

b) regular medical examination (at least once in three years and more frequent for those
exposed to higher ionizing radiation);

c) termination/completion of services.

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TOPIC 14.4: FACILITIES AND EQUIPMENT

STANDARD 14.4.1

The Radiology/Diagnostic Imaging Services shall be provided with sufficient space, suitable equipment and
adequate supplies for the safe performance of all services provided.

CRITERIA FOR COMPLIANCE:

14.4.1.1 There is adequate and proper utilisation of space and equipment to enable staff to carry out their
professional and administrative functions.

14.4.1.2 There is documented evidence that the equipment complies with relevant standards, e.g. those
set by the Atomic Energy Licensing Board and Licensing Authority.

14.4.1.3 There is evidence that the facility has a comprehensive maintenance programme such as
predictive maintenance, planned preventive maintenance and calibration activities, to ensure the
facilities and equipment are in good working order.

14.4.1.4 Facilities and equipment shall be assessed for safety at yearly intervals by independent radiation
experts (Class H license holders certified by Engineering Services Division Ministry of Health).
Records of such assessment shall be kept.

14.4.1.5 Where specialised equipment is used, there is evidence that only staff who are qualified and
privileged by the Facility operate such equipment.

14.4.1.6 Radiation safety measures shall be developed and supervised by the Head of the
Radiology/Diagnostic Imaging Services.

14.4.1.7 Staff working with ionising equipment shall wear appropriate monitoring devices to be assessed
periodically. Where film badge is used for monitoring, the exposure readings shall be sent to and
reported by an appropriate laboratory. The radiation exposure results of every staff shall be
monitored by the Radiation Safety Officer.

14.4.1.8 For staff having exceeded the maximum permissible dose, there is a protocol for reporting,
investigation, and immediate and long term remedial actions.

14.4.1.9 Multilingual signs warning women of childbearing age with regards to radiation exposure and
pregnancy shall be prominently displayed.

14.4.1.10 There is evidence of a current equipment inventory providing information on all equipment used
to acquire or print images for diagnostic imaging procedures, i.e. name of equipment, serial
number or other identifier, date of purchase, date of planned preventive maintenance (PPM)
completed and next scheduled date for PPM.

14.4.1.11 There shall be suitable change rooms for patients and facilities to keep their personal valuables.

14.4.1.12 There is adequate space or area for patient preparation and observation pre and post
interventional procedure.

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TOPIC 14.5: SAFETY AND QUALITY IMPROVEMENT ACTIVITIES

STANDARD 14.5.1

There are safety and quality improvement programmes to improve staff performance, the clinical practice and
ethical standards of the Radiology/Diagnostic Imaging Services. There is evidence that the statistical data
collected are analysed and utilised for the ongoing improvement of the services.

CRITERIA FOR COMPLIANCE:

14.5.1.1 There is evidence that the Head of the Service has in a written document assigned
responsibilities to appropriate individuals/committees for safety and quality improvement activities
within the services.

14.5.1.2 The Head of the Radiology/Diagnostic Imaging Services shall ensure the provision of high quality
performance with its ongoing involvement in the patient safety and quality improvement
programme of the Facility and the overall quality care.

14.5.1.3 There are planned and systematic safety and quality improvement activities that monitor and
evaluate the performance of the services including a plan for action and follow up to ensure that
the action taken is effective in continually improving the quality of care. Innovation is advocated.

14.5.1.4 There are safety and quality improvement activities in place which support the Facility’s safety
and quality improvement activities including tracking and trending of specific performance
indicators not limited to but at least two (2) of the following:

a) For Facility with Radiologist

i) percentage of plain films/images reported by radiologists

ii) percentage of abnormal Magnetic Resonance Imaging (MRI) and Computed Axial
Tomography (CT) scans

iii) percentage of radiological examination errors, i.e. wrong marker, use of primary markers,
wrong site x-rayed, wrong patient x-rayed

iv) complication rate for post-interventional procedures

b) For Facility without resident radiologist

i) rate of accuracy of x-rays reported by medical officers of the hospital audited by a

radiologist

ii) percentage of radiological examination errors, i.e. wrong marker, use of primary markers,
wrong site x-rayed, wrong patient x-rayed

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Notes/Explanations

Reports are available on indicators include tracking and trending for specific
performance indicators carried out.

14.5.1.5 Feedback on results of safety and quality improvement activities are regularly communicated to
the staff.

14.5.1.6 Appropriate documentation of safety and quality improvement activities is kept and confidentiality
of staff and patients is preserved.

14.5.1.7 There are safety and quality improvement activities that address staff safety.

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14.6. SPECIAL REQUIREMENTS

STANDARD 14.6.1: Viewing Boxes

The Facility shall use appropriate viewing boxes and conduct the reporting of radiographs by radiologists in
satisfactory conditions.

CRITERIA FOR COMPLIANCE:

14.6.1.1 Viewing requirements for reporting radiographs by radiologists are as follows:

a) RADIOGRAPHIC VIEWING (non-mammographic)

i) Radiographic illuminators:

 Luminance preferably between 1500-3000 cd/m2

 Uniformity of illuminator (maximum deviation < 15%)
 Uniformity of colour bulbs within the department (white or moderate white–
blue with flicker-free illumination)
 Sufficient size for at least 2 radiographs (>40 x 80 cm)
 Possibility of collimation on the size of the radiographs
 Viewing box mounting shall be at an appropriate level for reviewing.

ii) Special viewing possibilities:

 To evaluate details in film areas of high densities (D=2-3), optimum

brightness shall be of 4000-6000 cd/m2

iii) Magnifying glass or lens:

 magnifying factor 2-3

iv) Illumination conditions in the room:

 50 – 100 lux at the place of the viewer (with the viewer 'off')
 Room lighting shall have 'dimmer switch' control
(Reference: Quality Control of Radiographic Illuminators and associated
viewing equipment by E Hartmann and F E Stieve, BIR Report 18, 135-7)

b) MAMMOGRAPHIC VIEWING

i) Luminance of viewing boxes: > 3500 cd/m2 (nit) for mammography with variable
illumination capability.

ii) Room ambient illumination level: 50 lux or less (with viewer 'off').

iii) Collimation to size of radiograph (Reference: ACR Guidelines).

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c) FREQUENCY OF TESTING FOR VIEWING BOXES

i) At commissioning.

ii) After replacement of bulb or front panel of viewing box.

iii) Once yearly.

STANDARD 14.6.2: Teleradiology

CRITERIA FOR COMPLIANCE:

14.6.2.1 The Facility that has this service shall ensure that guidelines on telemedicine from the Ministry of
Health (TELERADIOLOGY Unit) and the Ministry of Energy, Green Technology and Water are
complied with.

STANDARD 14.6.3: Ultrasound

CRITERIA FOR COMPLIANCE:

14.6.3.1 Only appropriately qualified and experienced personnel shall perform the ultrasound
examination. The operator must have adequate training and competency and
credentialed/privileged to perform the ultrasound examinations.

14.6.3.2 All ultrasound examinations shall be interpreted and reported by a radiologist or the specialists in
their area of expertise.

STANDARD 14.6.4: Darkroom and Film Processors

CRITERIA FOR COMPLIANCE:

14.6.4.1 The room or area/equipment shall be equipped with an effective exhaust system and adequate
ventilation.

14.6.4.2 The Services shall ensure safety precautions are taken to avoid accidental light exposure to
films.

STANDARD 14.6.5: Mobile X-rays and Mobile C-Arm

CRITERIA FOR COMPLIANCE:

14.6.5.1 Where these machines are used as static units, the facilities must meet the requirements as per
regulations for X-ray room/fluoroscopy room.

14.6.5.2 C-arm in the operating theatre shall be operated by a qualified radiographer.

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14.6.5.3 The operating theatre where fluoroscopy is constantly used shall have radiation shielding. In the
other rooms where there is no radiation shielding, the radiation scatter outside the room should
be monitored.

14.6.5.4 When mobile x-rays are performed in the wards, efforts should be made to ensure that the
neighbouring patients are protected adequately from scatter radiation.

14.6.5.5 The requirements on shielding and monitoring shall be applicable in other locations where
fluoroscopy and mobile machines are routinely used, e.g. Intensive Care Unit (ICU), Coronary
Care Unit (CCU), Coronary Rehabilitation Ward (CRW) and Emergency Services.

14.6.5.6 There are guidelines on the handling, transport and storage of mobile x-ray machines and their
accessories.

STANDARD 14.6.6: Bone Densitometer

CRITERIA FOR COMPLIANCE:

14.6.6.1 The room shall meet the required specifications for such facilities in accordance with the
requirements of the Ministry of Health and Atomic Energy Licensing Act (304).

14.6.6.2 Bone densitometry examination shall be performed by a qualified radiographer. The radiographer
shall be adequately trained, credentialed and privileged.

14.6.6.3 There is evidence that the competency of the radiographer performing the examination is
assessed by performing the precision testing.

STANDARD 14.6.7: Mammography

CRITERIA FOR COMPLIANCE:

14.6.7.1 Mammography shall be performed by a qualified female radiographer. The mammographer shall
be adequately trained, credentialed and privileged.

14.6.7.2 There is evidence that the mammographer and the radiologists reporting the mammogram attend
regular relevant continuing medical education (CME).

14.6.7.3 The mammograms produced are audited following the Perfect, Good, Moderate and Inadequate
(PGMI) classifications with evidence of documentation.

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STANDARD 14.6.8: Magnetic Resonance Imaging (MRI)

CRITERIA FOR COMPLIANCE:

14.6.8.1 Only appropriately qualified and experienced personnel shall perform the MRI scan examination.

14.6.8.2 There are policies and procedures addressing the safety, operations and maintenance of the
MRI equipment.

14.6.8.3 Documented indications are available for the use of MRI, e.g. prolong headache, head trauma,
solitary pulmonary nodule, low back pain and other relevant conditions as deemed by the
services.

14.6.8.4 There are guidelines for the handling of patients:

a) ambulatory;
b) on wheelchair and trolley;
c) requiring oxygen support;
d) on ventilator.

14.6.8.5 There shall be provision for handling of emergencies, e.g. fire outbreak, accidents in the magnet
room etc.

STANDARD 14.6.9: Computed Axial Tomography (CT)

CRITERIA FOR COMPLIANCE:

14.6.9.1 Only appropriately qualified and experienced personnel shall perform the CT scan examination.
The operator must have adequate training and competency and credentialed/privileged to
perform the examinations.

14.6.9.2 Imaging personnel and the facilities shall adhere to regulation and guidelines regarding the use
of ionizing radiation, e.g. Atomic Energy Licensing Act 304, Atomic Energy Licensing Board
(AELB), Atomic Energy Licensing (Basic Safety Radiation Protection) Regulation 2010.

14.6.9.3 The CT scan room shall meet the required specifications for such facilities in accordance with
the requirements of the Ministry of Health and Atomic Energy Licensing Act (304).

14.6.9.4 All CT scan examinations shall be interpreted and reported by a radiologist or the specialists in
their areas of expertise.

14.6.9.5 The information on film/report collection shall be documented and be available in the patient’s
medical record.

14.6.9.6 There are policies and procedures addressing the safety, operations and maintenance of the CT
scan equipment.

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14.6.9.7 The safety and standards for Picture Archiving and Communications System (PACS) should be
complied with.

14.6.9.8 Documented indications are available for the use of CT scan, e.g. prolong headache, head
trauma, solitary pulmonary nodule, low back pain, CT colonoscopy, CT coronary and/or other
relevant conditions as deemed by the services.

14.6.9.9 There are guidelines for the handling of patients:

a) on ventilator;
b) infectious cases;
c) Polytrauma patients.

14.6.9.10 The radiologist shall consult with the referring practitioner immediately when there are critical or
unexpected findings. There is evidence of documentation of this consultation.

14.6.9.11 There are emergency and monitoring equipment readily available and accessible for ill patients.

14.6.9.12 The imaging equipment is monitored regularly by a medical physicist to ensure that the
equipment is functioning properly and taking optimal images.

STANDARD 14.6.10: Picture Archiving and Communications System (PACS)

CRITERIA FOR COMPLIANCE:

14.6.10.1 There shall be adequate provisions with regards to the secure use, access and maintenance of
the system, both within and outside the Radiology/Diagnostic Imaging Department.

14.6.10.2 There is a policy to ensure safety and confidentially of images archived.

STANDARD 14.6.11: Disposal of Chemical Waste

CRITERIA FOR COMPLIANCE:

14.6.11.1 There are proper arrangements made for the storage and disposal of chemical waste.

14.6.11.2 The labelling and disposal of chemical waste (as defined in the Environmental Act 1997(Act 127)
and subsequent amendments) are implemented in accordance with the requirements of the
relevant Acts.

Notes/Explanations

These procedures, including the removal of waste from the site, are in accordance with the
requirements of the relevant authorities such as The Environmental Quality Act 1974(Act 127).

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