Download Independent Health Facilities - College of Physicians and Surgeons

Independent Health Facilities
Clinical Practice Parameters
and Facility Standards
Magnetic Resonance Imaging & Computed Tomography
3rdth Edition – October 2015
The College of Physicians and Surgeons of Ontario
Vision Statement
Quality Professionals, Healthy System, Public Trust
Our Mandate
Build and maintain an effective system of self-governance.
The profession, through and with the College, has a duty to serve and protect the public interest by
regulating the practice of the profession and governing in accordance with the Regulated Health
Professions Act.
Our Vision Defined
Quality Professionals, Healthy System, Public Trust.
Our new vision is the framework by which we organize ourselves.
It guides our thinking and actions into the future. It defines not only who we are, but what we stand for,
the role we see for ourselves, our critical relationships, in what system we work, and the outcomes we
seek.
Each component of our vision is defined below:
Quality Professionals – as a profession and as professionals, we recognize and acknowledge our role
and responsibility in attaining at a personal, professional, and at a system-level, the best possible
patient outcomes.
We are committed to developing and maintaining professional competencies, taking a leadership
position on critical issues that impact the performance of the system, and actively partner to provide
tools, resources, measurement, to ensure the optimal performance at all levels of the system.
Healthy System – the trust and confidence of the public and our effectiveness as professionals is
influenced by the system within which we operate. Therefore, we, as caring professionals, are actively
involved in the design and function of an effective system including:
•
•
•
•
accessibility
the interdependence of all involved
measurements and outcomes
continued sustainability
Public Trust – as individual doctors garner the trust of their patients, as a profession we must aim to
have the trust of the public by:
•
•
•
building positive relationships with individuals
acting in the interests of patients and communities
advocating for our patients and a quality system
Our Guiding Principles
Integrity, accountability, leadership and cooperation.
The public, through legislation, has empowered the profession to regulate itself through the College.
Central to the practice of medicine is the physician-patient relationship and the support of healthy
communities. As the physician has responsibility to the patient, the profession has the responsibility to
serve the public through the health-care system.
To fulfill our vision of quality professionals, healthy system, public trust we will work to enhance the
health of the public guided by professional competence and the following principles:
Integrity – in what we do and how we go about fulfilling our core mandate:
• Coherent alignment of goals, behaviours and outcomes;
•
Steadfast adherence to a high ethical standard.
Accountability to the public and profession – we will achieve this through:
• An attitude of service;
•
Accepting responsibility;
•
Transparency of process;
•
Dedicated to improvement.
Leadership – leading by proactively regulating our profession, managing risk and serving the public.
Cooperation – seeking out and working with our partners – other health-care institutions, associations
and medical schools, etc. – to ensure collaborative commitment, focus and shared resources for the
common good of the profession and public.
Independent Health Facilities
Clinical Practice Parameters
and Facility Standards
Magnetic Resonance Imaging & Computed Tomography
3rd Edition –October 2015
First Edition, January 2003: Members of the MRI & CT Task Force:
Dr. George Lougheed, Chair
Barrie
Dr. Ian Cunningham
London
Dr. Richard Drost
London
Dr. Michael Fung
Peterborough
Dr. Pat Garces
Timmins
Dr. Barry Hobbs
London
Dr. Amit Mehta
St. Catharines
Dr. Mitesh Mehta
Toronto
Dr. Mark Prieditis
Scarborough
Dr. Lisa Thain
London
Ms Joy Craighead
Toronto
Mr. Mark Lepp
Brampton
Ms Marlene McCarthy
Collingwood
Second Edition, May 2009 Members of the MRI & CT Task Force:
Dr. Paul Voorheis, Chair
Barrie
Dr. Pat Garces
Oakville
Dr. Alex Hartman
Toronto
Ms Joan Hatcher
Niagara Falls
Dr. Erik Jurriaans
Jersyville
Ms Marlene McCarthy
Collingwood
Dr. Mark Prieditis
Toronto
Dr. Lalitha Shankar
Toronto
Third Edition, October 2015
Members of the MRI & CT Task Force:
Dr. Paul Voorheis, Chair
Barrie
Mr. Jeff Frimeth
Toronto
Dr. Anish Kirpalani
Toronto
Dr. Martin O’Malley
Toronto
Dr. Mark Prieditis
Toronto
Dr. Lalitha Shankar
Toronto
Ms Elizabeth Staten
St. Catharines
Published and distributed by the College of Physicians and Surgeons of Ontario. For more information about the
Independent Health Facilities program, contact:
Wade Hillier
Director, Quality Management Division
The College of Physicians and Surgeons of Ontario
80 College Street
Toronto, Ontario M5G 2E2
Toll free (800) 268-7096
(416) 967-2600 ext. 636
Email: [email protected]
Table of Contents
Preface
i
Purpose of Clinical Practice Parameters ......................................................................................i
Role of the College of Physicians and Surgeons ..........................................................................i
Responsibilities of the College ....................................................................................................ii
Updating this Document .............................................................................................................ii
Radiology Guiding Principles...................................................................................................... iii
VOLUME 1 FACILITY STANDARDS ................................................................................... 1
Chapter 1
Staffing a Facility...................................................................................... 1
Overview .................................................................................................................................... 1
Qualifications of Physicians MRI & CT ....................................................................................... 1
Qualifications for Radiologists who have not been in active practice in either MRI and/or CT 2
Continuing Professional Development ...................................................................................... 3
MRI/CT Director ......................................................................................................................... 3
Quality Advisor ........................................................................................................................... 4
Medical Physicist – CT and/or MRI ............................................................................................ 5
Radiation Protection Officer (RPO) for CT ................................................................................. 6
Medical Radiation Technologists (MR) ...................................................................................... 6
Medical Radiation Technologists CT .......................................................................................... 7
Injection Certification ................................................................................................................ 8
Chapter 2
Facilities, Equipment and Supplies......................................................... 11
Overview .................................................................................................................................. 11
Facilities, Equipment and Supplies .......................................................................................... 11
Imaging Equipment for CT/MRI ............................................................................................... 11
Quality Control for CT .............................................................................................................. 12
Quality Control for MRI ............................................................................................................ 14
Safety Concerns and Resuscitation Equipment ....................................................................... 15
Administration of Medications in Imaging Department.......................................................... 16
Emergency Procedures ............................................................................................................ 18
Chapter 3
Developing Policies and Procedures ....................................................... 19
Overview .................................................................................................................................. 19
Developing Policies and Procedures ........................................................................................ 19
Infection Control ...................................................................................................................... 21
Respiratory Infections .............................................................................................................. 21
PHIPA........................................................................................................................................ 21
Radiation Safety and Dose Reduction (ALARA Principles) ....................................................... 21
Chapter 4
Requesting and Reporting Mechanisms .................................................. 23
Overview .................................................................................................................................. 23
Requesting Procedures ............................................................................................................ 23
The Diagnostic Imaging Final Written Report .......................................................................... 24
Charges for Copying Patient Records (As Per MOHLTC Fact Sheet) ........................................ 29
Retrieval of Films from another IHF/Institution ...................................................................... 29
Chapter 5
Providing Quality Care ........................................................................... 31
Overview .................................................................................................................................. 31
Quality Management Program Goals ...................................................................................... 31
Providing Quality Care ............................................................................................................. 31
Components of a Quality Management Program.................................................................... 32
Monitoring the Program .......................................................................................................... 33
VOLUME 2 CLINICAL PRACTICE PARAMETERS................................................................ 35
CAR Practice Guidelines for Magnetic Resonance Imaging ..................................................... 37
CAR Standards for Computed Tomography............................................................................. 37
CAR Guidelines for Test Appropriateness ................................................................................ 37
Ministry of Health and Long-Term Care, Wait Time Targets for MRI/CT Scans ...................... 37
VOLUME 3 TELERADIOLOGY (PACS) .............................................................................. 39
CPSO Telemedicine Policy ........................................................................................................ 40
CAR Standards for Teleradiology ............................................................................................. 40
OAR Teleradiology Practice Standard ...................................................................................... 40
APPENDICES FOR MRI/CT AND GENERAL GUIDANCE
Appendix I
ACR Guidance Document on MR Safe Practices: 2013 ............................ 49
Appendix II
MR Safety ............................................................................................. 80
Appendix V
Sample Emergency Safety Policy .......................................................... 110
Appendix VI
Requirement for MRI/CT Priority Protocol............................................ 112
Appendix VII Prevention of IV Contrast Reaction Protocol ............................................ 113
Appendix VIII Independent Health Facilities Act - Ontario Regulation 57/92 ............... 115
Quality Advisor and Advisory Committee .............................................................................. 115
Standards ............................................................................................................................... 116
Records of Employees ............................................................................................................ 116
Patient Records ...................................................................................................................... 117
Books and Accounts ............................................................................................................... 118
Notices ................................................................................................................................... 119
Miscellaneous ........................................................................................................................ 119
Appendix IX Sample Patient Survey: Quality of Care ....................................... 121
Appendix X Sample Referring Physician Survey-Independent Health Facilities
Program............................................................................................. 123
Preface
The Independent Health Facilities Act (IHFA), proclaimed in April 1990, and amended in 1996 and 1998,
gives the College of Physicians and Surgeons of Ontario the primary responsibility for carrying out
quality assessments in Independent Health Facilities. These non-hospital facilities may provide some of
the following insured services:
• in diagnostic facilities: radiology, ultrasound, magnetic resonance imaging, computed
tomography, positron emission tomography (PET), nuclear medicine, pulmonary function, and
sleep studies
• in treatment or surgical facilities: one or more of a variety of procedures in peripheral vascular
disease, plastic surgery, obstetrics and gynaecology, dermatology, nephrology, ophthalmology,
and their related anaesthetic services and perhaps other specialties.
The College of Physicians and Surgeons of Ontario has a legislative mandate under the Act to perform
quality assessment and inspection functions. This responsibility, and others set out by agreement with
the Ministry of Health and Long-Term Care, contribute to the College achieving its goals as stated in the
College’s Mission Statement. An important goal of the College is to promote activities which will
improve the level of quality of care by the majority of physicians. The Independent Health Facilities
program helps reach this goal by developing and implementing explicit clinical practice parameters and
facility standards for the delivery of medical services in Ontario, assessing the quality of care provided
to patients, and as a result, promotes continuous quality improvement.
Purpose of Clinical Practice Parameters
The Independent Health Facilities clinical practice parameters and facility standards are designed to
assist physicians in their clinical decision-making by providing a framework for assessing and treating
clinical conditions commonly cared for by a variety of specialties. The primary purpose of this document
is to assist physicians in developing their own quality management program and act as a guide for
assessing the quality of patient care provided in the facilities.
Note: The parameters and standards are not intended to either replace a physician’s clinical judgment
or to establish a protocol for all patients with a particular condition. It is understood that some patients
will not fit the clinical conditions contemplated by certain parameters and that a particular parameter
will rarely be the only appropriate approach to a patient’s condition.
In developing these clinical practice parameters, the objective is to create a range of appropriate
options for given clinical situations, based on the available research data and the best professional
consensus. The product, therefore, should not be thought of as being “cast in stone”, but rather subject
to individual, clinically significant patient differences.
Role of the College of Physicians and Surgeons
The College adopted the role of a facilitator for the development of clinical practice parameters and
facility standards. Representatives of national specialty societies and sections of the Ontario Medical
Association, and individuals with acknowledged skill, experience and expertise formed specialty-specific
Task Forces.
All Clinical Practice Parameters and Facility Standards undergo an external review process.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
i
External Reviewers Include: Registrars of other regulatory colleges, department heads at relevant
academic institutions, relevant national and provincial organizations, independent health facilities, IHF
assessors and other stakeholders as determined by the relevant Task Force.
Task Force members ensure that:
• clinical practice parameters must be based on the appropriate mix of current, scientificallyreliable information from research literature, clinical experience and professional consensus.
• any parameter-setting exercise must be done exclusively from the quality perspective. That
may well mean that some of the conclusions reached could add to medical care costs.
• parameters have to be flexible enough to allow for a range of appropriate options and need to
take into account the variations in practice realities from urban to rural areas.
• parameters need to be developed by consensus and consultation with the profession at large.
• parameters should provide support and assistance to physicians without boxing them in with
“cookbook formulas.”
• parameters will need to be regularly updated based on appropriate research studies.
• parameters should reduce uncertainty for physicians and improve their clinical decisionmaking.
• information on practice parameters must be widely distributed to ensure that all physicians
benefit from this knowledge.
Responsibilities of the College
Responsibilities of the College include:
• assessing the quality of care when requested by the Ministry. The College will maintain a roster
of physicians, nurses, technologists and others to serve as inspectors and assessors as required.
• inspecting the illegal charging of facility fees by unlicensed facilities when requested by the
Ministry.
• monitoring service results in facilities. The College’s information system will monitor individual
and facility outcome performance. This is a unique feature of the legislation, which for the first
time in North America, requires facility operators to establish and maintain a system to ensure
the monitoring of the results of the service or services provided in a facility.
• providing education and assisting facilities so that they may continually improve the services
they provide to patients. The College will work with and assist physicians in these facilities so
that they can develop their own quality management programs based on the parameters and
standards, monitor facility performance by conducting quality assessments, work with facilities
to continually improve patient services, assist in resolving issues and conducting reassessments
as necessary.
Updating this Document
These parameters and standards are subject to periodic review, and amendments in the form of
replacement pages may be issued from time to time. Such pages will be mailed automatically to all
relevant independent health facilities. It is planned to issue new editions of the parameters and
standards at intervals not greater than five years. The external review process will be repeated to
validate the new parameters as they are developed.
ii
The College of Physicians and Surgeons of Ontario
Radiology Guiding Principles
Extracted from the first edition (February 1995) of Clinical Practice Parameters and Facility Standards
for Diagnostic Imaging,
A diagnostic imaging practice is a consultative physician service rendered by qualified specialists who
have completed an accredited residency program in diagnostic radiology which includes using all
modalities in the imaging portrayal of human morphology and physiological principles in medical
diagnosis.
The elements of radiologic consultation include:
•
•
•
pre-examination evaluation by a referring physician.
a request for radiologic consultation. The requisition includes pertinent clinical findings, a
working diagnosis, and signature of referring physician or other qualified professional.
a safe patient environment in which the radiologist supervises a qualified staff whose efforts
are directed at producing a radiologic examination yielding maximum diagnostic information
and consistent with the least possible exposure to radiation.
Diagnostic imaging is a patient care specialty and it is an important function of the radiologist to advise
referring physicians about the best sequence of examinations for resolving a clinical problem
expeditiously and with the least risk and cost.
It is not possible to establish a “minimum” or “optimum” standard of care. Guiding principles and
attributes for appropriate care in diagnostic imaging can be summarized as follows:
•
•
•
•
•
•
•
examinations and procedures are performed with the greatest benefit and least risk to the
patient.
examinations and procedures are interpreted with the highest degree of competence using all
available information including comparison with previous examinations and procedures.
examination/procedure findings and conclusions are communicated promptly and expeditiously
to the referring physician.
referring physicians are consulted in order to select and perform only the most useful
examinations/procedures.
flow of data including storage, retrieval, and general handling of images, diagnostic data, and
reports are managed efficiently.
patient services provided are considerate of the human side of care as well as the purely
technical component of care.
patient services are managed so that productivity is maintained and optimal use of available
resources is assured.
These principles should constitute the basis for the evaluation of desirable and undesirable practice
patterns.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
iii
Independent Health Facilities Clinical
Practice Parameters and Facility
Standards:
Magnetic Resonance Imaging & Computed
Tomography
VOLUME 1
FACILITY STANDARDS
Chapter 1
Staffing a Facility
Overview
Each licensee in consultation with the Quality Advisor (QA) ensures:
•
Diagnostic imaging services are provided by qualified imaging physicians and technologists.
•
There is a current written plan describing the organization of the facility and its services.
•
There are sufficient numbers of qualified physicians, technologists, and clerical personnel
available to meet the stated goals and objectives.
•
That the duties and responsibilities of all diagnostic imaging service staff are specified in job
descriptions. They are kept up to date and on site.
•
Quality Advisors, Physicians, Technologists and Licensees review their legal obligations and may
consider obtaining professional liability insurance as there is potential for liability issues in IHFs.
•
Staff obtains education in Workplace Hazardous Materials Information System (WHMIS) which
is documented and maintained on site for future review at the time of Ministry of Labour (MOL)
inspections.
•
A radiologist or designated physician with current Advanced Cardiac Life Support (ACLS)
certification is personally and immediately available. Documentation regarding ACLS
certification is maintained on site.
•
At least one staff member with current Basic Cardiac Life Support (BCLS) certification is on site
at all times during hours of scanner operation. Documentation regarding BCLS certification is
maintained on site. It is expected that the training includes being certified in both theory and
hands-on components. To identify training courses contact the Heart and Stroke Foundation of
Ontario and/or St. John Ambulance.
Qualifications of Physicians MRI & CT
Physicians performing or interpreting Magnetic Resonance Imaging (MRI) and Computed Tomography
examinations are:
•
Certified in Diagnostic Radiology with the Royal College of Physicians and Surgeons of Canada
and have a certificate of registration to practice in Ontario.
•
Have a restricted certificate of Registration to practice independently. Documentation must be
available to demonstrate full compliance with any terms, condition or limitations of their
registration with the CPSO, including any supervision requirement or scope of practice
definition.
OR
And for MRI
•
Have demonstrated competence (6 months of MRI training, 1500 reported cases) in an
appropriate facility and under the full-time supervision of a radiologist fully trained in MRI as
per the description of an MRI Director.
rd
Clinical Practice Parameters and Facility Standards for MRI and CT – 3 Edition
1
Appropriate training centres for radiologists seeking to obtain the required MRI credentials are:
•
•
An academic centre with a diagnostic radiology residency program OR
A hospital MRI facility in Canada under the supervision of the MRI Director.
Note: Where training occurs at a hospital MRI centre not associated with a University centre, the
training should also include at least 160 hours of training through ACCME, RCPSC-recognized CME
courses or equivalent (a full range of MRI clinical applications as well as MRI physics, instrumentation,
QA and safety) within 2 years prior to start of practice.
A letter signed by the MRI Director attesting to the training outlining what specific anatomy they are
trained to interpret for all MRI Radiologists, including the Director, will be required. This letter should
be kept on file at the facility.
Note: For the following, “MRI Radiologist” means a radiologist satisfying the above criteria.
And for CT
•
Have demonstrated competence (6 months of CT training with 1500 reported cases) in an
appropriate facility and under the full-time supervision of a radiologist fully trained in CT as per
the description of a CT Director.
Appropriate training centres for radiologists seeking to obtain the required CT credentials are:
•
•
An academic centre with a diagnostic radiology residency program OR
A hospital CT facility in Canada under the supervision of the CT Director.
Note: Where training occurs at a hospital CT center not associated with a university center, the training
should also include at least 160 hours of training through ACCME, RCPSC – recognized CME courses or
equivalent (a full range of clinical applications of CT as well as CT physics, instrumentation, QA and
radiation safety) within 2 years prior to start of practice.
A letter signed by the CT Director Attesting to the training outlining what specific anatomy they are
trained to interpret for all CT Radiologists, including the CT Director, will be required. This letter should
be kept on file at the facility.
Note: For the following, “CT Radiologist” means a radiologist satisfying the above criteria.
Qualifications for Radiologists who have not been in active practice in
either MRI and/or CT
MRI and/or CT Radiologists who have not been in active practice of MRI and/or CT (i.e. performing less
than 100 patient cases/year) or who have not actively provided MRI and/or CT services for two years or
more but were fully trained in the past will require re-training at an appropriate MRI and/or CT facility
as described earlier in this section. A minimum of one month of re-training at an appropriate MRI
and/or CT facility will include reporting a minimum 300 patient cases, with an appropriate case mix,
under the direct supervision of a qualified MRI and/or CT Director-level radiologist. A letter from the
preceptor, attesting to competence, must be presented to the MRI and/or CT Director and kept on file
by the licensed facility.
2
The College of Physicians and Surgeons of Ontario
Under certain very specific situations, it may be appropriate for a highly specialized organ system based
radiologist to interpret MRI (CT) studies limited to their sub-specialty despite not obtaining the
minimum number of cases described above. Examples of this include Breast MRI or Abdominal/Body
imaging. In this situation, training and limitations should be documented and approved by the MRI (CT)
director and the MRI (CT) cases interpreted should be limited to the area of expertise.
Continuing Professional Development
All physicians attend Continuing Professional Development (CPD) programs relevant to their practice,
which comply with their Royal College requirements for maintenance of certification. Documentation of
annual CPD in MRI/CT-related courses taken by every radiologist providing MRI/CT medical services
must be submitted to the MRI Director no later than the end of each calendar year.
MRI/CT Director
Each licensed facility has an MRI/CT Radiologist who is appointed as the MRI/CT Director (note: This
position can be individual physicians or a dual role). The MRI/CT Director shall have demonstrated
competence (one year of MRI/CT training) and would be qualified to provide additional on-site training
to the other MRI/CT radiologists in the licensed facility.
Every MRI/CT Director shall:
•
Be physically present at the IHF on a regular basis, on average at least 8 hours per week. The
MRI/CT Director or a designated MRI/CT Radiologist should be available by phone for
consultation at any time when services are provided and documented.
•
Ensure that safe MRI/CT practice guidelines are established and maintained as current and
appropriate for the facility.
•
Consult with the facility staff after any serious MRI/CT safety incidents and, as a minimum,
update the MRI/CT safety guidelines on a yearly basis.
•
Approve and review all MRI protocols performed by the licensed facility at least annually, or as
often as may be deemed necessary by the MRI Director. All requisitions will be assigned a
specific protocol by an MRI radiologist associated with the facility prior to the study being
performed. Changes to the assigned protocol can only be modified by the MRI Director or
another designated MRI Radiologist.
•
Approve and annually review all CT imaging protocols performed by the licensed facility
including use of contrast, CT safety and radiation exposure as outlined in the Report of the
Diagnostic Imaging Safety Committee for Computed Tomography (CT) – February 2007 by the
Ministry of Health and Long-Term Care (see Appendix III). All requisitions will be assigned a
specific protocol by a CT radiologist associated with the facility prior to the study being
performed. Changes to the assigned protocol can only be modified by the CT Director or
another designated CT Radiologist.
Note: MRI/CT Director can also be the Quality Advisor.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
3
Quality Advisor
The Quality Advisor (QA) must be a physician licensed to practice in Ontario by the College of Physicians
and Surgeons of Ontario and meet the qualifications as outlined above.
The Quality Advisor must submit the Notice of Appointment of Quality Advisor and Quality Advisor
Acknowledgement forms to the Director, IHF. These forms are available at
http://www.health.gov.on.ca/en/public/programs/ihf/forms.aspx
Role of the Quality Advisor
The role of the Quality Advisor is an important one. Quality Advisors play a vital role in the overall
operation of the IHF to ensure that the services provided to patients are being conducted appropriately
and safely.
Each IHF licensee is responsible for operating the facility and providing services in accordance with the
requirements of the IHFA. Pursuant to O. Reg. 57/92 under the Independent Health Facilities Act (see
Appendix VII), “every licensee is required to appoint a Quality Advisor to advise the licensee with
respect to the quality and standards of services provided in the IHF. The Quality Advisor must be a
health professional who ordinarily provides insured services in or in connection with the facility and
whose training enables him or her to advise the licensee with respect to the quality and standards of
services provided in the facility.”
Note: The term “Health Professional” as referenced in the IHFA, refers to a physician.
Responsibilities of the Quality Advisor
The Quality Advisor is responsible for advising the licensee with respect to the quality and standards of
services provided. In order to fulfill this duty the Quality Advisor:
•
•
•
•
•
•
•
4
Shall personally attend the facility at least twice each year, and may attend more frequently,
where in the opinion of the Quality Advisor it is necessary based on the volume and types of
services provided in the facility. The visits may be coordinated as part of the Quality Advisory
Committee (QA Committee) meetings.
Shall document all visits to the facility made in connection with the Quality Advisor’s role.
Shall ensure that a qualified physician be available for consultation during the facility’s hours of
operation.
Shall seek advice from other health professionals where in the opinion of the Quality Advisor it
is necessary to ensure that all aspects of the services provided in the facility are provided in
accordance with generally accepted professional standards and provide such advice to the
licensee.
Shall chair the QA Committee. The QA Committee shall meet at least twice a year if the facility
employs more than six full-time staff equivalents including the Quality Advisor; otherwise the
QA Committee shall meet at least once a year. Regular agenda items should include: review of
cases; policies and procedures; quality control matters on equipment; incidents; medical and
technical issues.
Shall ensure all QA Committee meetings are documented.
Obtain copies of assessment reports from the licensee/owner/operator. If deficiencies were
identified in the assessment, the Quality Advisor shall review same with the QA Committee and
document such review. The Quality Advisor’s signature is required on any written plan
submitted by the licensee to the College.
The College of Physicians and Surgeons of Ontario
The Quality Advisor shall advise the licensee on the implementation of an ongoing Quality Management
(QM) Program, which should include but not be limited to, the following:
•
•
•
•
•
•
•
Ensuring ongoing and preventive equipment maintenance
Follow-up of interesting cases
Follow-up patient and/or medical and technical staff incidents
Continuing education for medical and technical staff
Ensuring certificates of registration, BCLS, etc. are current
Regular medical and technical staff performance appraisals
Patient and referring physician satisfaction surveys.
The Quality Advisor will advise the licensee, and document the provision of such advice, in connection
with the following:
•
•
•
•
•
•
•
•
•
•
•
Health professional staff hiring decisions, in order to ensure that potential candidates have the
appropriate knowledge, skill and competency required to provide the types of services
provided in the facility.
Continuing education for all health professional staff members employed in the facility, as may
be required by their respective regulatory Colleges or associations.
Appropriate certification for all health professional staff members employed in the facility with
the respective regulatory College or associations.
Leadership, as may be required to address and resolve any care-related disputes that may arise
between patients and health professional staff.
Appropriate resources for health professional staff members employed in the facility.
Formal performance appraisals for all health professional staff.
Technology used in the facility, in order to ensure it meets the current standard(s) and is
maintained through a service program to deliver optimal performance.
Establishment and/or updating of medical policies and procedures for the facility, e.g.
consultation requests, performance protocols, infection control, and standardized reports, and
other issues as may be appropriate.
Equipment and other purchases as may be related to patient care.
Issues or concerns identified by any staff member, if related to conditions within the facility
that may affect the quality of any aspect of patient care.
Establishing and/or updating system(s) for monitoring the results of the service(s) provided in
the facility.
If the Quality Advisor has reasonable grounds to believe the licensee is not complying with the
licensee’s obligation to ensure that services are being provided in accordance with the generally
accepted standards and to ensure that the persons who provide services in the facility are qualified to
provide those services, the Quality Advisor must inform the Director of Independent Health Facilities
forthwith in accordance with the provisions and Regulations under the IHFA.
Medical Physicist – CT and/or MRI
The medical physicist must have appropriate training in CT and/or MRI. A medical physicist has the
responsibility for the initial acceptance testing of equipment and related systems/components and for
implementing and overseeing routine quality control testing of the MRI and/or CT scanner. The medical
physicist may repeat the acceptance test after any major hardware upgrades or major service incidents
and failures (see Chapter 2, Quality Control).
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
5
The medical physicist must either be:
•
•
•
•
•
Board certified in Diagnostic Radiology by the Canadian College of Physicists in Medicine (for CT
or MRI testing)
Board certified in Magnetic Resonance Imaging by the Canadian College of Physicists in
Medicine (for MRI testing only)
Board certified in Diagnostic Medical Physics by the American Board of Radiology
Board certified in Magnetic Resonance Imaging by the American Board of Medical Physics, or
If the medical physicist does not have board certification, the following qualifications must be
met:
o Graduate degree in medical physics, radiologic physics, physics, or other relevant
physical science or engineering discipline from an accredited institution
o Formal coursework in the biological sciences with at least one course in
biology/radiation biology, one course in anatomy and physiology, and three years of
documented clinical experience in a CT and/or MR environment
A copy of the physicist’s credentials should be kept on file at the facility.
Radiation Protection Officer (RPO) for CT
According to the HARP Act, a Radiation Protection Officer (RPO) must be designated for the facility.
This role may be assumed or designated by the Quality Advisor.
http://www.ontario.ca/laws/statute/90h02
The OAR has recently published a paper outlining the roles and responsibilities of the RPO.
http://www.oar.info/pdf/OAR_RPO_DUTIES_2011.pdf
Medical Radiation Technologists (MR)
In Ontario, Medical Radiation Technologists (MRTs) are self-regulated professionals. They must practice
in accordance with the applicable provincial legislation, the Medical Radiation Technology Act (MRTA)
and the College of Medical Radiation Technologists of Ontario (CMRTO) standards of practice.
Medical Radiation Technologists have a current and valid certificate of registration with the College of
Medical Radiation Technologists of Ontario in the specialty of magnetic resonance imaging. Certification
in MRI must be documented, and be of the designation MRT(MR).
All technologists must maintain and document current Basic Cardiac Life Support (BCLS) certification.
Continuing Medical Education
Medical Radiation Technologists attend and document their attendance at relevant continuing medical
education programs, as mandated by the CMRTO, or as identified by the MRI Director. This
documentation must be provided to the MRI Director annually no later than at the end of the calendar
year.
Charge Technologist Qualifications
The designation of a Charge Technologist is mandatory. Their qualifications must include:
•
6
Current and valid certificate of registration with the College of Medical Radiation Technologists
The College of Physicians and Surgeons of Ontario
•
•
of Ontario (CMRTO) in the specialty of magnetic resonance imaging.
Should have 4 years full-time MRI experience.
Certificate in BCLS with recertification yearly.
Charge Technologist Responsibilities
The Charge Technologist is current with changing technical trends in MRI by attending conferences,
meetings, or other CME, and reading current relevant literature.
Documentation of CME is maintained.
Charge Technologists are responsible for the day-to-day operation of the MRI suite, including:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Training of all technologists to include Quality Control, MRI safety, injections, policies and
procedures
Reporting to/advising the MRI Director/Quality Advisor
Advising the Quality Advisor that all technologists are current with all qualifications and CME
requirements
Ensuring that all support staff receive and implement MRI safety guidelines
Inputting site-specific protocols into the MRI unit
Writing and updating MRI policy and procedure manual on at least an annual basis
Ensuring implementation of policies and procedures
Maintaining records of equipment calibration, maintenance, and repair procedures
Maintaining copies of test observations and reports
Ensuring that safety policies and the equipment and facilities necessary for their
implementation are in place and in working order
Implementing infection control measures
Maintaining all necessary facility supplies
Performing and documenting Quality Control procedures
Responsible for supervising the technologists for injection certification. The MRI/Quality
Advisor certifies the technologist.
Medical Radiation Technologists CT
In Ontario, Medical Radiation Technologists (MRTs) are self-regulated professionals. They must practice
in accordance with the applicable provincial legislation, the Medical Radiation Technology Act (MRTA)
and the College of Medical Radiation Technologists of Ontario (CMRTO) standards of practice.
Medical Radiation Technologists have a current and valid certificate of registration with the College of
Medical Radiation Technologists of Ontario (CMRTO).
Technologists have completed cross sectional anatomy of the brain, neck and body similar to the CT
Certification Course at Michener or equivalent.
All technologists must maintain and document current Basic Cardiac Life Support (BCLS) certification.
Continuing Medical Education
CT Technologists attend and document their attendance at relevant continuing medical education
programs, as mandated by the CMRTO, or as identified by the CT Director. This documentation must be
provided to the CT Director annually no later than at the end of the calendar year.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
7
Charge Technologist Qualifications
The designation of a Charge Technologist is mandatory. Their qualifications must include:
•
•
•
Current and valid certificate of registration with the College of Medical Radiation Technologists
of Ontario (CMRTO).
Should have 4 years full-time CT experience
Certificate in BCLS with recertification yearly.
Charge Technologists have completed an injection course and are certified by a Radiologist as per
facility policy. Their qualifications should also include 4 years of full-time CT experience consistent with
the scope of practice at the facility.
Charge Technologist Responsibilities
The Charge Technologist is current with changing technical trends in CT by attending conferences,
meetings, or other CME, and reading current relevant literature.
Documentation of CME is maintained.
Charge Technologists are responsible for the day-to-day operation of the CT suite, including:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Training of all technologists to include Quality Control, radiation safety, injections, policies and
procedures
Reporting to/advising the CT Director/Quality Advisor
Advising the Quality Advisor that all technologists are current with all qualifications and CME
requirements
Ensuring that all support staff receive and implement CT safety guidelines
Inputting site-specific protocols into the CT unit
Writing and updating CT policy and procedure manual on at least an annual basis
Ensuring implementation of policies and procedures
Maintaining records of equipment calibration, maintenance, and repair procedures
Maintaining copies of test observations and reports
Ensuring that safety policies and the equipment and facilities necessary for their
implementation are in place and in working order
Implementing infection control measures
Maintaining all necessary facility supplies
Performing and documenting Quality Control procedures
Responsible for supervising the technologists for injection certification. The CT Quality Advisor
certifies the technologist.
Injection Certification
The Charge Technologist is responsible for supervising the technologist/regulated health care
professional at the facility who performs injections. The Quality Advisor or the Director of CT/MRI
certifies the technologist to be competent for the IHF.
8
The College of Physicians and Surgeons of Ontario
For IV contrast injection at a CT/MRI facility, the licensee is responsible for the following:
•
All technologists/regulated health care professionals are responsible for completion of the
venipuncture/injection certification course from an accredited program, which include but are
not limited to the following:
http://michener.ca/ce_course/venipuncture-techniques
https://www.humber.ca
http://www.cvaa.info/
•
The technologist should provide the certificate to the IHF facility.
•
The charge technologist is responsible for supervising the technologist following completion of
IV injection training course.
•
The CT/MR director or Quality advisor of the IHF facility will approve and document the
competence of the technologist for IV injection.
•
Observation of the technologist and recommendation where necessary by CT/MRI director.
•
Review of all policies with the CT/MRI technologist regarding the contrast injection (patient
consent, contraindication, contrast reaction, premedication, sterile techniques and needle
disposal and facility standards)
•
Annual refresher for contrast injections at the discretion of the QA and CT/MRI director.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
9
10
The College of Physicians and Surgeons of Ontario
Chapter 2
Facilities, Equipment and Supplies
Overview
The facility has adequate space, equipment and supplies for the safe and efficient performance of
diagnostic imaging services.
Facilities, Equipment and Supplies
Facilities have sufficient space to meet workload requirements and ensure the effective care and
privacy of patients.
Appropriate safety precautions are maintained and documented against electrical, mechanical and
radiation hazards as well as against fire and explosion, so that personnel and patients are not
endangered.
The thermoluminescent dosimeter (TLD) monitoring service of the Personnel Dosimetry Services of
Health Canada, Bureau of Radiation and Medical Devices, is used and documented to ensure the safety
of personnel. Records are posted in the facility for staff information.
For CT, pregnancy warning signs are posted in the waiting area, change rooms and examination rooms.
Basic supplies for infection prevention and control is on site and used appropriately as per current
provincial guidelines/policies. Resources are available through the Provincial Infectious Diseases
Advisory Committee of Public Health Ontario at
http://www.publichealthontario.ca/en/BrowseByTopic/InfectiousDiseases/PIDAC/Pages/InfectionPrevention-and-Control-for-Clinical-Office-Practice.aspx
If headphones are available to MRI patients, they must be disinfected after each use, otherwise
disposable ear plugs should be offered.
An area must be provided for patients’ valuables/personal belongings to be secured/locked during
procedures.
Facility monitoring equipment and procedures are appropriate to the documented patient mix and
procedures.
Imaging Equipment for CT/MRI
Computed Tomography
For patient imaging, the CT scanner meets or exceeds the following specifications:
•
•
•
New when installed in the facility and manufactured within 6 months prior to installation and
has at least a 64-row detector array
Use of software and hardware to manage patient doses, in line with the ALARA principle,
including, but not limited to automatic tube current modulation
Power injector: the injector shall be pressure limited and have adjustable rate and volume
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
11
•
Must pass all quality control tests at the time of installation as outlined by organizations such as
the American Association of Physicists in Medicine (AAPM), the American College of Radiology
(ACR), or Health Canada Safety Code 35.
Note: The lifespan of CT equipment is no longer than 8-12 years, depending on utilization, and is
normally expected to be 10 years based on expected mid-range utilization as defined in the CAR
guidelines referenced below. Replacement equipment should be purchased as brand new equipment
under the same conditions as new equipment
•
•
•
Reference: Lifecycle Guidance for Medical Imaging Equipment in Canada 2013, Canadian
Association of Radiologists (http://www.car.ca/en/standards-guidelines.aspx)
Additional software upgrades are in accordance with the scope of practice being provided
within the facility.
A clear upgrade pathway, defined to keep the software and hardware technology current, will
be implemented by the facility.
A vendor approved Original Equipment Manufacturer (OEM) service contract which includes hardware
and software will exist for its lifespan.
Note: The Ministry of Health and Long-Term Care must give approval to install and operate a CT
scanner under the Healing Arts Radiation Protection Act (HARP Act) R.S.O. 1990, c.H.2 clauses 23(2)(a)
and (b). Under section 3 of the HARP Act, the written approval of the Director of X-ray Safety is required
for CT equipment to be installed.
CT Layout
When seated at the console, CT technologist should have a direct view of the patient. If this is not the
case, then a closed television camera/monitor is installed to provide this view of the patient.
Requirements of the HARP Act and Regulations must be fulfilled.
Quality Control for CT
All safety measures are in compliance with federal and provincial laws/regulations (HARP Act or
equivalent). All equipment is properly maintained and calibrated during scheduled preventive
maintenance sessions in accordance with manufacturer specifications. Written records of preventive
maintenance, repairs, and unscheduled down time are maintained. The following Quality Control
schedule is recommended:
Daily: The site is asked to perform the following tests which follow the ACR CT Accreditation program
requirements
a) Water CT Number and Standard Deviation
b) Artifact Evaluation
Monthly: The site is asked to perform the following tests which follow the ACR CT Accreditation
program requirements
a) Visual Checklist
b) Display Monitor QC
12
The College of Physicians and Surgeons of Ontario
Annually: The site is asked to perform the following tests which follow the ACR CT Accreditation
program requirements
a)
b)
c)
d)
e)
f)
g)
h)
i)
j)
k)
l)
Review of Clinical Protocols
Scout Prescription and Alignment Light Accuracy
Image Thickness
Table Travel Accuracy
Radiation Beam Width
Low-Contrast Performance
Spatial Resolution
CT Number Accuracy
Artifact Evaluation
CT Number Uniformity
Dosimetry
Gray Level Performance of CT Acquisition Display Monitors
A CT “protocol” refers to the settings and parameters that are used to acquire images for a specific
examination (e.g. Abdominal/Pelvic CT) based on the clinical information provided. The CT
protocols will determine image quality and dose. Each IHF must maintain a copy of CT protocols
based on common clinical indications. Guidance on the development of CT scan protocols should
be provided by the vendor, the CT Director and a medical physicist, as appropriate. Suggested CT
scan protocols have been published by the AAPM (American Association of Physicists in Medicine).
Reference: American Association of Physicists in Medicine; CT Protocols (http://www.aapm.org)
In the event of major hardware upgrades or service repairs being performed (e.g. tube replacement or
detector module replacement), it is not required, but it is recommended to have the medical physicist
repeat the acceptance tests.
Magnetic Resonance Imaging
The minimum strength of the primary magnet must be 1.5 Tesla. The MRI system should be equipped
with the appropriate gradient hardware, radio frequency hardware (receiver channels), phased array
coils, and software packages for the case mix. A power injector is required.
For patient imaging, the MRI system meets or exceeds the following specifications:
•
New when installed in the facility and manufactured within 12 months prior to installation with
current technology.
Note: The lifespan of MRI equipment is no longer than 8-12 years, depending on utilization, and is
normally expected to be 10 years based on expected mid-range utilization as defined in the CAR
guidelines referenced below. Replacement equipment should be purchased as brand new equipment
under the same conditions as new equipment
•
•
Reference: Lifecycle Guidance for Medical Imaging Equipment in Canada 2013, Canadian
Association of Radiologists (http://www.car.ca/en/standards-guidelines.aspx
A clear upgrade pathway, defined to keep the technology current, will be implemented by the
facility.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
13
Note: A vendor approved OEM service contract which includes hardware and software will exist for its
lifespan
In recognition of changing technology standards, machines need to be upgradeable to future state-ofthe-art requirements.
•
The MRI scanner must pass all quality assurance tests at the time of installation as outlined by
organizations such as the American Association of Physicists in Medicine (AAPM) or the
American College of Radiology (ACR).
Quality Control for MRI
All equipment is properly maintained and calibrated during scheduled preventive maintenance sessions
in accordance with manufacturer specifications. Written records of preventive maintenance, repairs,
and unscheduled down time are maintained. A daily record of both the MRI magnet room and
equipment room temperature, humidity, primary chilled water temperature, secondary water
temperature, and the magnet helium level (where appropriate) are documented. While documentation
by the technologist of the facility’s Quality Control program is required, the following Quality Control
schedule is recommended:
Weekly: The site is asked to perform the following tests, which follow the ACR MRI Accreditation
Program Requirements
a)
b)
c)
d)
e)
f)
g)
h)
i)
j)
k)
Table positioning, setup and scanning, laser alignment
Centre frequency
Transmitter gain or attenuation
Geometric accuracy
High contrast spatial resolution
Low contrast detectability
Artifact evaluation
Visual checklist
Slice thickness accuracy
Magnetic field uniformity
Slice position accuracy
Annually: The medical physicist performs the complete system acceptance test with the ACR Test
Phantom (or equivalent). The required tests are:
a)
b)
c)
d)
e)
f)
g)
h)
i)
j)
k)
l)
m)
n)
14
Table positioning, setup and scanning, laser alignment
Centre frequency
Transmitter gain or attenuation
Geometric accuracy
High contrast spatial resolution
Low contrast detectability
Artifact evaluation
Visual checklist
Percent signal ghosting (PSG)
Image intensity uniformity (PIU)
Magnetic field homogeneity
Slice position accuracy
Slice thickness accuracy
RF coil checks
The College of Physicians and Surgeons of Ontario
o) Soft copy (monitor) QC
In addition, the medical physicist must perform an assessment of the site’s own MR Safety
Program.
After any service work/repairs the service engineer runs the calibrations/ service tests as appropriate
for the specific hardware serviced.
Safety Concerns and Resuscitation Equipment
The licensee shall reference the ACR Guidance Document on MR Safe Practices: 2013 (J Magnetic
Resonance Imaging 2013, 37:501–530) for all MRI safety practice guidelines (see Appendix I).
Patient monitoring equipment and facilities for cardiopulmonary resuscitation including vital signs
monitoring, support equipment and an emergency crash cart are immediately available. Radiologists,
technologists, and staff members are able to assist with procedures, patient monitoring and support. A
written policy is in place for dealing with emergency procedures such as cardiopulmonary arrest.
The facility has alternate materials available for patients with known or suspected latex allergies.
Contrast-enhanced studies require the presence of a physician who is trained and experienced in the
recognition and management of adverse effects of these agents and other life threatening events. If
this physician is not the CT/MRI Radiologist, then he/she must also have appropriate training and
experience in CT/MRI safety. Technologists are trained in resuscitation (BCLS). IHFs must have an
emergency protocol in place to deal with these types of emergencies.
Reference: ACR Manual on Contrast Media, Version 9
(http://www.acr.org/quality-safety/resources/contrast-manual) – see Appendix VI)
As pediatric patients receive contrast, specific paediatric doses/drugs and paediatric resuscitation
equipment are clearly labeled and colour coded for age groups.
Facilities provide a means of moving patients in difficulty to an adjacent area, which is equipped to
handle any adverse reactions up to and including respiratory and cardiac arrest.
MRI Layout
The MRI facility layout must give the MRI technologist an unimpeded view of the magnet room
entrance door when seated at the operating console. Access is restricted to all areas within the 5 gauss
magnetic field line of the MRI magnet. The magnet room itself usually encompasses this area.
Ideally the MRI technologist has a direct view of the patient down the bore of the magnet when seated
at the operating console. If this is not the case then a closed television camera/monitor is installed to
provide this view of the patient to the MRI technologist.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
15
MRI Safety Zones
All MRI facility layouts in Ontario must comply with and incorporate the four (4) recognized MRI Safety
Zones as outlined in Appendix I.
The purpose of establishing MRI Safety Zones is to minimize potential risks to patients and staff within
the MRI environment. There are four zones in total and each one is defined as follows:
a) Zone I: areas freely accessible to the general public; typically is outside the MRI environment
and is the area where individuals can access the MRI environment.
b) Zone II: area where patients are greeted/screened and not allowed to move freely (only under
MRI personnel supervision).
c) Zone III: access is strictly restricted and regions within it (e.g. Zone IV) are controlled/supervised
by MR personnel.
d) Zone IV: the MRI scanner room (within Zone III) and the magnet’s associated magnetic fringe
fields.
All zones must be labelled in the facility.
The MRI Director should designate individuals in the MRI environment as either MRI personnel or nonMR personnel. MR personnel are broken down into Level 1 and Level 2 personnel. Level 1 personnel are
individuals who have passed minimal safety educational efforts to ensure their own safety within Zone
III. Level 2 personnel are individuals who have received more extensive training in MR safety (e.g.
issues in thermal burns). Non-MRI personnel constitute everyone else in the MRI environment.
Non-MRI personnel must be screened prior to entering Zone III.
It is recommended to use ferromagnetic detection systems as a supplement to screening of persons
and devices approaching Zone IV.
Patients must remove all readily removable metallic personal belongings and devices as well as fill out a
safety screening questionnaire.
If patients/non-MRI personnel have a history of potential ferromagnetic foreign object penetration,
they must undergo further investigation (e.g. CT, radiograph).
All ferrous objects should be Zone III restricted (whenever practical). A handheld magnet can help to
determine if there is significant ferromagnetism in objects. All objects/devices to be taken into Zone IV
are either MR Safe or not MR Safe. MR Safe is defined as objects which present no attractive forces
present and its composition is known to be non-magnetic. Non-MR safe objects present grossly
detectable attractive forces. They may be taken into Zone III if they are deemed necessary and
appropriate for patient care (under MR personnel supervision).
Administration of Medications in Imaging Department
•
•
16
It is reasonable to assume some medications may be given to maximize the information
obtained from CT and MR images (e.g. anxiolytics, beta blockers, nitroglycerin, antiperistaltic
agents). In order to safely administer drugs in an IHF, there must be medical directives in place
which include, but are not limited to: drug dosage, route of administration, and management of
adverse events related to the various medications.
Patients under the age of 18 requiring sedation are not to be examined in an IHF
The College of Physicians and Surgeons of Ontario
Resuscitative and Monitoring Equipment Required for Both CT and MRI
Appropriate emergency equipment and medications must be immediately available to treat adverse
reactions associated with the administration of contrast media. It is recommended that for each site a
plan of action and formulary be developed in consultation with local anaesthetists and internal
medicine specialists responsible for their hospital arrest teams. Appropriate emergency equipment and
medications, as noted below, must be immediately available to treat adverse reactions associated with
the administration of contrast media. Protocols for the contact of Emergency Medical Services (EMS)
and patient transfer to a hospital should be published, posted and regularly reviewed.
Emergency equipment and Formulary as per ACLS standards, includes but is not limited to:
•
•
•
•
•
•
•
•
•
•
•
•
•
ECG monitor
Defibrillator
Oxygen source with mask and suction
Oxygen saturation monitor
Resuscitation drugs
Stethoscope
Sphygmomanometer
IV pole
Wheelchair
Stretcher
Laryngoscope and endotracheal tubes (sized for adults and children)
Oropharyngeal airways (sized for adults and children)
Ambu bag or equivalent (sized for adults and children)
The contents of the resuscitation tray are checked monthly for expiry dates on all drugs and sterile
equipment. These activities are documented and kept with the resuscitation equipment.
MRI Safe Equipment
The following MRI safe equipment is available:
•
•
•
•
•
•
Stretcher (if scanner table is not detachable)
Wheelchair
IV poles
Laundry hamper
Step stool
All oxygen tanks must be MRI safe
If a parent is expected to accompany and stay inside the magnet room with their child, then a MR
safe chair is provided for inside the magnet room.
All facility fire extinguishers that may be brought into the magnet room during a fire emergency are MR
safe. The fire alarm must be audible inside the magnet room.
There should be a small, portable, strong (usually rare earth) magnet available to the MRI technologist
to test whether objects are ferromagnetic. [For example, Lee Valley, product number 50K02.01]
A MR safe step ladder (usually aluminum) should be provided for changing light bulbs inside the MRI
magnet room. This task should be performed by an individual trained in MR safety.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
17
Emergency Procedures
All resuscitations are performed outside the scanner room.
For MRI the biggest danger is the introduction of ferromagnetic objects into the magnet room by the
responding staff and the resulting projectile motion of the ferromagnetic objects toward the centre of
the magnet causing injury/death to anyone intersecting the projectile trajectory.
Although it is possible to set up a complete emergency response trolley and equipment which is MR
safe, it is almost impossible to ensure that all staff who may respond to the emergency will not carry
any ferromagnetic objects into the magnet room.
Ambulance, fire or police crews who respond to an emergency call will be carrying ferromagnetic
objects. For these reasons, it is imperative that the first response to a patient code inside the magnet is
for the MRI technologist(s) to remove the patient from the magnet room.
CT/MRI Facilities provide a means of moving patients in difficulty outside the magnet room to an area
equipped to handle any adverse reactions up to and including respiratory and cardiac arrest.
Any interventions and resuscitative procedures MUST take place outside the magnet room. No
additional personnel or equipment will enter the magnet room.
18
The College of Physicians and Surgeons of Ontario
Chapter 3
Developing Policies and Procedures
Overview
Current written policies and procedures are required to provide staff with clear direction on the scope
and limitations of their functions and responsibilities to patient care.
Developing Policies and Procedures
The procedure manual is available for consultation by all facility staff. The manual is reviewed
annually, revised as necessary, and dated to indicate the time of the last review or revision.
There is documentation to indicate who makes the policies, sets the standards, and who supervises
physicians, technologists, and other staff.
Procedures in the manual include, but are not limited to, the following:
Facility
•
•
•
Scope and limitations of diagnostic imaging services provided by the facility.
Patient-booking systems.
Documentation of and method for receiving written referrals for consultation.
Facility Staff
•
•
•
Delegated acts and medical directives. Refer to CPSO policy on Delegation of Controlled Act:
http://www.cpso.on.ca/Policies-Publications/Policy/Delegation-of-Controlled-Acts.
Safety training for medical and non-medical staff.
Certification for administration of contrast injections.
Records and Communication/Reporting & Privacy Principles
•
•
•
•
Methods for preliminary interpretations and/or telephone calls of reports, and for the
subsequent written interpretation of images by qualified diagnostic imaging physicians.
Maintenance of requisitions, imaging media and interpretation reports (See Appendix VII,
Independent Health Facilities Act-Ontario Regulation 57/92 -Amended to O.Reg. 14/95).
Confidentiality.
Patient consent, written or verbal, based on the scope of practice in the facility and in
accordance with the Health Care Consent Act.
Diagnostic Services
•
•
Instructions regarding routine preparation of patients.
Imaging protocols detailing the sequences involved in examining a target organ for both adult
and pediatric patients. For CT these include but are not limited to:
o Oral contrast –volume and type
o IV contrast –volume and rate and type of administration
o Scanning region and length
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
19
o
o
o
o
o
o
o
o
o
o
o
•
•
•
•
•
•
•
Patient Position
Detector Configuration
Reconstructed Slice thickness
Reconstruction Algorithm
Scan type
Rotation time
mAs and kVp
Pitch
Displayed CTDIvol
Pediatric/small adult protocols preprogrammed in scanner with reduced specific organ
patient dose.
Contraindications for performing tests.
Screening just prior to patient entering the magnet room.
Adult sedation.
Family member/ support person in the room.
Performance of additional views and examinations- any additional views or examinations are
identified in the imaging report with reasons.
Use of protective devices.
Pre-medication for known contrast allergy.
Assessment of renal function where appropriate prior to contrast injection.
Equipment Maintenance
•
•
Maintenance work inside the magnet room.
Routine maintenance and calibration of equipment.
Emergency Procedures and Safety Policies
• Ensuring patients who have taken oral or sublingual anxiolytics/antihistamines are provided
discharge instructions and are accompanied by a person prior to departing the facility.
• Techniques for managing patients with claustrophobia, anxiety and emotional distress.
• Managing patients with possible or definite ferrous/metallic foreign bodies (particularly
intracranial and intraocular locations).
• Response to fire alarm and fire within the magnet room.
o When personnel are present in the facility
o When personnel are not present in the facility.
o Inadvertent magnet quenches.
• Pregnancy of patients or facility staff.
• Infection control.
• Specific first aid measures to be followed and documented in the event of an adverse health
effect, including a description of the arrangements for transferring patients to an acute care
facility when required.
• Emergency resuscitation for MR only to occur outside the magnet room.
Quality Management Program
Refer to Chapter #5
20
The College of Physicians and Surgeons of Ontario
Infection Control
Routine practices to prevent infection are in keeping with provincial guidelines. Resources are available
through the Provincial Infectious Diseases Advisory Committee of Public Health Ontario at
http://www.publichealthontario.ca/en/BrowseByTopic/InfectiousDiseases/PIDAC/Pages/InfectionPrevention-and-Control-for-Clinical-Office-Practice.aspx
At Risk Patients
The facility must identify patients who have any possibility of transmission of infection at the front
desk.
Hand Hygiene
It is recommended to post the Ministry of Health “Hand-washing Techniques” document for IHF staff
and patients in designated areas.
Personal Protective Equipment
Gloves, masks, gowns and eye- protection equipment must be used where and when necessary to
protect both patient and personnel.
Needle Safety
Under the Occupational Health and Safety Act, the Needle Safety section states, “when a worker is to
do work requiring use of a hollow-bore needle, the employer shall provide the worker with a safetyengineered needle that is appropriate for the work. O.Reg. 474/07, s.3(1)”. Therefore IHFs shall provide
appropriate access to safety-engineered needles as required.
Respiratory Infections
Each facility should implement a written protocol to manage all patients with potentially infectious
respiratory conditions.
PHIPA
The independent health facility is expected to implement the various privacy procedures and policies to
maintain patient information confidentiality within the organization. The organization must respect all
laws that apply to it, including laws relating to privacy, confidentiality, security of records and access to
records, including the Personal Health Information Protection Act, 2004.
Information and Privacy Commissioner/Ontario, Suite 1400, 2 Bloor Street East, Toronto, ON M4W 1A8
https://www.ipc.on.ca
Radiation Safety and Dose Reduction (ALARA Principles)
The ALARA principle (As Low As Reasonably Achievable) must be considered for all examinations using
ionizing radiation to minimize radiation exposure to the patient and staff.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
21
Pre-programmed protocols should be available for infant, child and youth (small, medium and large by
weight for each) and also organ specific.
Low dose CT protocols should be designed to minimize the dose based on the clinical indication (e.g.
low dose CT protocol for renal colic), without sacrificing the image quality necessary to make a
diagnosis.
Note: Refer to the Report of the Diagnostic Imaging Safety Committee for Computed Tomography (CT) –
February 2007 by the Ministry of Health and Long-Term Care (see Appendix III).
Policies and procedures should be developed under the direction of the radiation protection officer
(RPO) to ensure compliance with the HARP Act and other applicable legislation.
22
The College of Physicians and Surgeons of Ontario
Chapter 4
Requesting and Reporting Mechanisms
Overview
The content of this overview has been extracted from the CAR Standard for Communication of
Diagnostic Imaging Findings (2010) (www.car.ca)
Communication is a critical component of the art and science of medicine and is especially important in
Diagnostic Imaging. It is incumbent upon radiologists and the facilities in which they work to ensure
that the results of diagnostic studies are communicated promptly and accurately in order to optimize
patient care.
The final product of any consultation is the submission of a report on the results of the consultation. In
addition, the radiologist and the ordering physician have many opportunities to communicate directly
with each other during the course of a patient’s case management. Such communication should be
encouraged because it leads to more effective and appropriate utilization of Diagnostic Imaging services
and it can enhance the diagnostic yield of the study in question. From a utilization standpoint,
discussions with the referring team will help to focus attention on such concerns as radiation exposure,
appropriate imaging studies, clinical efficacy and cost-effective examinations. The provision of a welldefined clinical question and the overall clinical context can improve interpretation of complete cases
and may enable the radiologist to streamline the diagnostic impression into a few likely and relevant
differential considerations rather than providing a textbook list of possible differential diagnoses that
may be of less utility and of less impact.
These principles apply to all radiology consultations irrespective of the technology used including
teleradiology, Picture Archiving & Communication Systems (PACS) or an equivalent electronic work
station with an archival system refer to Volume # Teleradiology (PACS).
In order to afford optimal care to the patient and enhance the cost-effectiveness of each diagnostic
examination, radiological consultations should be provided and images interpreted within a known
clinical setting. No screening radiological examination should be performed unless evidence-based or
part of an organized population-based screening program.
The Canadian Association of Radiologists (CAR) supports radiologists who insist on clinical data with
each consultation request and the IHF Task Force supports this same principle.
All communication should be performed in a manner that respects patient confidentiality. Medical
images and reports constitute confidential patient information and must be treated accordingly. It is
incumbent upon IHF staff and all imaging personnel including radiologists to ensure patient privacy.
This includes institution of appropriate privacy procedures, and appropriate policies and procedures for
release of images or reports from medical images to third parties.
Requesting Procedures
Written requisitions and forms to screen the patient for CT/MRI compatibility must be completed by
the referring physician. All CT/MRI requests must be approved and prioritized by a radiologist prior to
booking the test.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
23
The technologist rescreens just prior to the patient entering the magnet room. (for sample screening
forms, see Appendix II)
Overview
An appropriate request for all radiological consultations is the responsibility of the referring physician
and specifies:
•
•
The basic demographic information of the patient such as name, health number, date of birth,
and sex.
The name of the ordering physician/healthcare provider and the names of any other physicians
who are to receive copies of the report.
Note: If patient information is entered electronically, clinic staff must ensure that the patient
demographic information including the requesting physician noted on the requisition is current and
correct. Any changes to update the information must be made prior to the performance of the study.
•
•
The type of procedure requested for the patient including any special instructions where
applicable.
Pertinent clinical information including indications, pertinent history, and provisional diagnosis.
Note: This is the responsibility of the ordering physician/healthcare provider. If a patient arrives with a
requisition containing incomplete information, the diagnostic imaging physician or designated staff
member should attempt to contact the ordering physician/healthcare provider or interview the patient
to obtain the necessary information prior to conducting the procedure.
•
Whether a “stat report” is required.
It is recommended that patients be provided written information about computed
tomography/magnetic resonance imaging procedures prior to an appointment.
Technologist Identification
Technologists must be identified at the time of the examination in order for the interpreting physician
to identify the technologist performing the examination.
The Diagnostic Imaging Final Written Report
The final report is considered to be the definitive means of communicating to the ordering physician or
other healthcare professionals the results of an imaging examination or procedure. Additional methods
of communication of results are necessary in certain situations.
The final report should be transmitted to the ordering physician or healthcare professional who is
responsible for the clinical follow-up. The ordering physician or other healthcare professional also
shares in the responsibility of obtaining the results of imaging studies he or she has ordered.
The timelines of reporting any imaging examination varies with the nature and urgency of the clinical
problem. The written final report should be made available to the ordering physician/healthcare
provider within 24 hours if possible.
24
The College of Physicians and Surgeons of Ontario
The final report should be proofread carefully to avoid typographical errors, accidentally deleted words,
and confusing or conflicting statements, and should be authenticated by the reporting radiologist,
whenever possible.
Note: Given the complexity of CT and MRI studies in general, compared to other modalities, it is strongly
recommended that the final report should be proofread and verified by the reporting radiologist
Electronic and rubber-stamp signature devices, instead of a written signature, are acceptable if access
to them is secure. In any case, the name of the dictating radiologist must appear as such on the report.
A copy of the diagnostic image is retained as the permanent record for the appropriate length of time
as prescribed by regulations.
If there was a significant discrepancy between the preliminary report and the final report, this should
be documented and the referring physician notified of the change in cases where they change may alter
immediate patient management.
Voice recognition systems are widely employed to facilitate timely reporting. These systems are not
foolproof and methods should be in place to allow detection and correction of program generated
errors.
Final reports may be transmitted by paper, fax, and email, provided appropriate security measures are
in place. Facilities should seriously consider instituting “read receipt” mechanisms to identify any
report that has not been picked up by the ordering physician/healthcare provider.
A copy of the final report should be archived by the imaging facility as part of the patient’s medical
record (paper or electronic) and be retrievable for future reference. It is of sufficient quality to record
permanent findings, to be used for comparison with subsequent examinations, and enable third party
radiologists to confirm the diagnosis.
The IHF must have the ability to retrieve and/or produce a copy of the image(s) stored within one
working day of the request as required.
The imaging media and reports are filed using an accepted coding system which allows films and
reports to be retrieved by patient identification information.
Unusual and interesting examinations are maintained for educational purposes in accordance with the
IHF Regulations.
Previous stored diagnostic images are available for the interpreting physician.
Report Attributes
Reports of the interpretation of imaging procedures include the following:
•
•
•
•
Name of the patient and another identifier such as birth date, pertinent identification number
or office identification number.
The facility or location where the study was conducted.
Name of the ordering physician.
Name of most responsible physician for patients cared for by multiple clinical services.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
25
Rationale: To provide more accurate routing of the report to one or more locations specified by the
ordering physician. Each facility has a policy to ensure proper distribution of the written report to the
most responsible physician and/or other physicians/healthcare professionals.
•
•
Name or type of examination.
Dates of examination.
Whenever possible, the month should be spelled rather than risking the ambiguity of American and
international formats (e.g. 03 July 2010 rather than 03/07/10 or 07/03/10.
•
Dates of dictation.
Rationale: Quality Control
Body of the Report
The effective transmission of imaging information from the radiologists to the ordering
physician/healthcare provider constitutes the main purpose of the report.
The report should be clear and concise. Normal or unequivocally positive reports can be short and
precise. Whenever indicated the report includes:
Procedures and Materials
A description of the examinations and/or procedures performed and any contrast media (including
agent, concentration, volume and route of administration, where applicable), medications, catheters, or
devices if not reported elsewhere. Any known significant patient reaction or complication should be
recorded.
Rationale: To ensure accurate communication and availability of the information for future reference.
Findings
Use precise anatomical, radiological and pathological terminology to describe the findings accurately.
Abbreviations should be avoided to avoid ambiguity and risk of miscommunication, unless initially
spelled out.
Limitations
Where appropriate, identify factors that can limit the sensitivity and specificity of the examination.
Such factors might include technical factors, patient anatomy (e.g. dense breast pattern,) and
limitations of the technique (e.g. the low sensitivity of a chest x-ray for pulmonary embolism).
Clinical Issues
The clinical history, indication or clinical question may be inserted at the beginning of the report. While
not mandatory this practice is encouraged.
Note: It is strongly recommended that clinical history, indication or clinical question be included in the
final report under a separate heading.
26
The College of Physicians and Surgeons of Ontario
The report should address or answer any pertinent clinical issues raised in the request for the imaging
examination. If there are factors that prevent answering the clinical question, these should be stated.
For example, to rule out pneumothorax, state “there is no evidence of pneumothorax” or to rule out
fracture, state “there is no evidence of fracture”. It is not appropriate to use universal disclaimers such
as “the mammography examination does not exclude the possibility of cancer” as it is expected that the
ordering physician understands that even a well performed diagnostic exam does not necessarily have a
100% sensitivity. Descriptive reporting that offers no opinion, or guidance for resolution of the clinical
question should be avoided.
Comparative Data
Comparisons with previous examinations and reports, when possible, are part of an imaging
consultation and report, and should be included in the body of the report and/or conclusion section
when appropriate.
Note: It is strongly recommended that comparative data be included in the final report under a
separate heading.
Assessment and Recommendations
The report should conclude with an interpretive commentary on the data described. The proper
terminology for ending the report may include the following terms: conclusion, impression,
interpretation, opinion, diagnosis or reading.
Each examination should contain such an interpretive commentary. Exceptions can be made when the
study is being compared with other recent studies and no changes have occurred during the interval or
the body of the report is very brief and a separate conclusion would be a redundant repetition of the
body of the report.
•
•
•
•
Give a precise diagnosis whenever possible.
Give a differential diagnosis when appropriate.
Recommend follow-up and/or additional diagnostic imaging studies to clarify to confirm the
conclusion, only when appropriate.
Any significant patient reaction should be reported.
Standardized computer-generated template reports (or other structured report formats) that satisfy
the above criteria are considered acceptable.
Note: It is strongly recommended that conclusion, impression, interpretation, or opinion be included in
the final report under a separate heading.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
27
Preliminary Report
A preliminary report may precede the final report in certain circumstances and contains limited
information relevant to immediate patient management. It may be time sensitive and should not be
expected to contain all the imaging findings. It should be generated when a timely communication is
necessary in unexpected elective cases where clinical urgency mandates immediate communication of
the results. It is acknowledged that not all serious findings require a preliminary report if they are
already known or could have been reasonably expected by the referring physician (e.g. bowel cancer on
a barium enema) as long as the final report is generated within 24-48 hours.
A preliminary report may not have the benefit of prior imaging studies and/or reports and may be
based upon incomplete information due to evolving clinical circumstances which may compromise its
accuracy. Preliminary reports may be communicated verbally, in writing or electronically and this
communication should be documented. Preliminary communications should be reproduced into a
permanent format as soon as practical and appropriately labeled as a preliminary report, distinct from
the final report.
Note: Technologists are not permitted to provide preliminary findings of any examination either directly
to the patient and/or the ordering physician without first consulting the radiologist. The radiologist
must then decide, based on the preliminary findings who will convey the information to the ordering
physician.
Verbal or Other Direct Communication
Radiologists should attempt to co-ordinate their efforts with those of the ordering physician in order to
best serve the patient’s well-being. In some circumstances, such co-ordination may require direct
communication of unusual, unexpected or urgent findings to the ordering physician in advance of the
formal written report. These include:
•
•
•
•
The detection of conditions carrying the risk of acute morbidity and/or mortality which may
require immediate case management decisions.
The detection of disease sufficiently serious that it may require prompt notification of the
patient, clinical evaluation or initiation of treatment.
Detection of life or limb threatening abnormalities which might not have been anticipated by
the referring physician.
Any clinically significant discrepancy between an emergency or preliminary report and the final
written report should be promptly reconciled by direct communication to the ordering
physician or his/her representative.
In these circumstances, the radiologist or his/her representative, should attempt to communicate
directly (in person or by telephone) with the ordering physician or his/her representative. Alternative
methods including fax, text messaging or email could be used for these purposes if there is a way of
verifying receipt of the reports. The timeliness of direct communication should be based upon the
immediacy of the clinical situation.
Documentation of the actual or attempted direct communication may be a desirable facility policy.
•
28
It is incumbent upon ordering physicians/healthcare professionals to make available a way of
communicating results to an alternative provider in circumstances such as holiday, sickness or
restricted office hours.
The College of Physicians and Surgeons of Ontario
Charges for Copying Patient Records (As Per MOHLTC Fact Sheet)
http://www.health.gov.on.ca/en/public/programs/ihf/fact_sheets.aspx
If an individual requires a copy of all or any part of his/her patient record, which may include imaging
media, for the provision of ongoing care by another health care provider, the IHF must provide a copy
of the record(s) at no cost/charge to the patient or health care provider.
When the patient attends an IHF to obtain a copy of their images and reports for their ongoing
care/treatment the acceptable turnaround time for requests that are received by the IHF for the images
and reports to be made available for courier or pick-up is within 3 working days of receiving the
request.
Retrieval of Films from another IHF/Institution
When previous images and reports are required from another IHF in order to make a comparison, the
acceptable turnaround time for requests that are received by the IHF would be for the images and
reports to be made available for courier or pickup within 3 working days of receiving the request.
Based on the above turnaround time couriered images and reports must be received by the requesting
party within a maximum of 5 working days of the IHF receiving the original request.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
29
30
The College of Physicians and Surgeons of Ontario
Chapter 5
Providing Quality Care
Overview
A Quality Advisory Committee is established as per the IHF Act (See Appendix VIII). The QA Committee
shall consist of health professionals who provide health services in or in connection with the
independent health facility and must be chaired by the Quality Advisor. Regular meetings are held and
minutes maintained (IHF Act Regulation 57/92).
The requirements for and responsibilities of the Quality Advisor (QA) are detailed in Chapter 1, Staffing
a Facility.
The QA Committee shall meet at least twice a year if the facility employs more than six full time staff
equivalents including the Quality Advisor, otherwise the QA Committee shall meet at least once a year.
Regular agenda items may include but not be limited to: review of cases; policies and procedures; QC
matters on equipment, incidents, staffing issues.
All QA Committee meetings shall be documented.
Records are to be kept of the:
o
o
Minutes of the quality advisory committee.
Minutes of general staff meetings.
The Committee is to supervise creation and maintenance of a quality management program adequate
to reach the goals detailed below.
The goals, procedures and protocols for the quality management program of the facility are written and
included in the policy and procedure manual.
Quality Management Program Goals
The goals of the program include but are not limited to ensuring that:
•
•
•
•
The services planned and provided are consistent with the patient’s needs and assure
diagnostic reliability and patient safety.
Services conducted in the facility are safe.
Services conducted are appropriate to the problem(s) being investigated.
The performance of diagnostic radiological examinations comply with current Canadian
Association Radiologists (CAR) Guidelines accepted by the College of Physician and Surgeons of
Ontario and in the absence of current standards and guidelines generally accepted medical
standards of practice.
Providing Quality Care
The performance of CT/ MRI examinations complies with standards accepted by the College of
Physicians and Surgeons of Ontario as described in the Clinical Practice Parameters section.
A designated CT/MRI Radiologist is available for consultation with the technologist on a case-by-case
basis. For cases requiring monitoring, ideally, the CT/MRI Radiologist is on-site and available to
participate in the examination when required.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
31
Although optimally a designated CT/ MRI Radiologist is present for all cases, this is not always possible.
For cases that do not require monitoring a designated CT/MRI Radiologist should always be available by
phone to consult with the technologist and referring physician.
Whenever contrast is administered, a designated physician must be personally and immediately
available. There must be adequate equipment/medications available to treat an adverse reaction.
A CT/MRI-trained radiologist should visit the facility on a regular basis to review imaging procedures
and provide technologist supervision. Ideally there should be a CT/MRI radiologist present at the facility
on a daily basis. Even in remote sites, a CT/MRI-trained radiologist should be on site at least one day per
week. A daily log of visits to the facility by the radiologist should be maintained.
Diagnostic imaging procedures are carried out in a manner in which patient privacy is respected.
Components of a Quality Management Program
The facility establishes and maintains a system to monitor the results of the services provided.
The facility establishes a quality management program appropriate for its size, volume and types of
services provided. It is recognized that quality management programs will vary depending on the facility
size, scope of practice, and geographical considerations.
Quality Management Program activities are documented and maintained on-site.
To ensure that the goals of the Quality Management Program are met the Committee’s tasks include
but are not limited to:
•
•
•
•
•
•
•
•
•
•
•
•
•
32
Review quality management goals and objectives annually.
Supervise and document a systematic ongoing review of the facility policy and procedures
manual.
Review safety data on any equipment new to the facility since the last meeting, and ensure that
all equipment in the facility meets safety standards.
Review any incident or accident report since the last meeting and document any such actions to
prevent similar incidents or accidents. Provide a report of all such proceedings to the facility’s
Quality Advisor.
Recommendations from other assessing bodies such as the Ministry of Health X-ray Inspection
Services and HARP.
Supervise and document a program of annual performance reviews for all staff who have
patient contact, including documentation of action taken to correct any significant deficiencies
in performance.
Ensure registration certificates, BCLS certificates, etc. are current.
Review the CPD activities of the technical and medical staff.
Promote the discussion of interesting/challenging cases seen at the facility and disseminate any
teaching points to the staff for educational purposes.
Review results of regular surveys of patient, referring physician and staff satisfaction,
documenting actions to address any suggestions, problems, or issues raised.
Compliance with quality assurance protocols as appropriate.
Assessing the accuracy of interpretations and the appropriateness of procedures process.
The IHF will have established a physician peer review program and provide a description of the
process of how this is done.
http://www.car.ca/uploads/standards%20guidelines/20120831_EN_Peer-Review.pdf
The College of Physicians and Surgeons of Ontario
•
Staff participation in planning strategies to overcome any deficiencies and to continually
improve the services provided to patients.
Monitoring the Program
To monitor the program the QA committee shall be comprised of a minimum of 2 health professionals
who provide health services in or in connection with the IHF, including at least one physician and at
least one technologist.
Recommendations from the QA Committee shall be circulated to all staff as minutes of the meeting
once they are finalized. These recommendations shall be reviewed at a general staff meeting including
all healthcare professionals who provide services in or in connection with the IHF. Quorum for such
meetings shall be 2 or 50% of the staff whichever is greater. Staff members who cannot attend are to
review and sign off on the minutes of that meeting.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
33
34
The College of Physicians and Surgeons of Ontario
Independent Health Facilities Clinical
Practice Parameters and Facility
Standards:
Magnetic Resonance Imaging & Computed
Tomography
VOLUME 2 CLINICAL PRACTICE PARAMETERS
rd
Clinical Practice Parameters and Facility Standards for MRI and CT – 3 Edition
35
Position Statement from the IHF Diagnostic Imaging Task
Force
It is the position of the IHF Diagnostic Imaging Task Force that the
revised (2015) Clinical Practice Parameters and Facility Standards will
contain a list of CAR/ACR standards that are applicable to the services
provided in Independent Health Facilities.
To ensure that Radiologists and Facilities are in compliance with
current CAR/ACR Standards, the radiologist and facility staff are
responsible for, at least annually, reviewing the Canadian Association
of Radiologists website www.car.ca to ensure that they have obtained
and are in compliance with the most current standards of practice for
the profession.
36
The College of Physicians and Surgeons of Ontario
CAR Practice Guidelines for Magnetic Resonance Imaging
CAR Practice Guidelines for Magnetic Resonance Imaging
http://www.car.ca/uploads/standards%20guidelines/20110428_en_standard_magnetic_resonance.pdf
CAR Practice Guidelines for Breast Imaging & Intervention
http://www.car.ca/uploads/standards%20guidelines/20131024_en_breast_imaging_practice_guidelines.pdf
CAR Standards for Computed Tomography
CAR Practice Guidelines for Cardiac Computed Tomography
http://www.car.ca/uploads/standards%20guidelines/GSCCT_Guidelines_Standards_Cardiac_CT_EN.pdf
CAR Practice Guidelines for Consensus Training Standards for Cardiac CT
http://www.car.ca/uploads/standards%20guidelines/standard_car_ccs_train_cardiacct_en.pdf
CAR Practice Guidelines for CT Colonoscopy
http://www.car.ca/uploads/standards%20guidelines/201001_CAR_CTC_Standards_EN.pdf
CAR Practice Guidelines for Prevention of Contrast Induced Nephropathy
http://www.car.ca/uploads/standards%20guidelines/20110617_en_prevention_cin.pdf
CAR Guidelines for Test Appropriateness
http://www.car.ca/en/standards-guidelines/guidelines.aspx
Ministry of Health and Long-Term Care, Wait Time Targets for MRI/CT
Scans
http://www.health.gov.on.ca/en/pro/programs/waittimes/surgery/target.aspx
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
37
38
The College of Physicians and Surgeons of Ontario
Independent Health Facilities Clinical
Practice Parameters and Facility
Standards:
Magnetic Resonance Imaging & Computed
Tomography
VOLUME 3 TELERADIOLOGY (PACS)
rd
Clinical Practice Parameters and Facility Standards for MRI and CT – 3 Edition
39
CPSO Telemedicine Policy
http://www.cpso.on.ca/CPSO/media/documents/Policies/Policy-Items/Telemedicine.pdf?ext=.pdf
CAR Standards for Teleradiology
http://www.car.ca/uploads/standards%20guidelines/Standard_Teleradiology_EN.pdf
OAR Teleradiology Practice Standard
May 2015
OAR TELERADIOLOGY PRACTICE STANDARD
Amended May 2013
Originally Approved June 2007
Definition
Teleradiology in Ontario is the electronic transmission of radiographic images from one geographical
location to another for the purposes of interpretation and consultation by diagnostic imaging physicians
accredited by the Royal College of Physicians and Surgeons of Canada (or recognized equivalent) and
licensed by the College of Physicians and Surgeons of Ontario.
These guidelines and standards have been developed to protect patients and ensure their data is kept
confidential. Teleradiology services are to facilitate patient care and are not intended to be a costcutting measure, which may jeopardize patient safety and the standards of health care.
Preface
The transmission of images between centres has been going on for a number of years and has proved
to be valuable for centres seeking expert opinions on emergency and problem cases. The most common
such connections have been with radiologists who work at a site and are now able to offer image
interpretations online from other sites within an institution, from their offices, home or elsewhere.
More recently radiological images have been transmitted to main centres from smaller community
hospitals in areas of low population density where small radiology departments have proven
unsustainable. The vastly improved capacity of the internet and the speed of transmission have
permitted a much wider use of teleradiology.
Teleradiology has advantages but it must be done properly to ensure that a high quality of care is
provided to patients and to maintain the radiologist interaction with their clinical colleagues. It is also
important that those radiologists providing the service are properly trained, are registered with the
appropriate authorities, and undergo continuing update through Continuing Medical Education (CME).
40
The College of Physicians and Surgeons of Ontario
The services provided must be open to audit and the ability to discuss cases with those reporting the
studies must be available. This standard has been developed to provide guidance to radiologists,
managers of health care facilities, patient’s representatives and governments on appropriate standards
for teleradiology services.
Teleradiology has undergone a number of health-technology assessments in different countries with
regard to the context of its use, but a great deal of thought and study is still required. Teleradiology
clearly has a number of advantages, but it also has the potential to create considerable difficulties for
the delivery of a high quality radiological service to patients, unless its role and the legal responsibilities
involved are clearly defined.
Role of a Diagnostic Radiologist
The role of a radiologist providing medical services in a diagnostic imaging service is considerably wider
than simply issuing a diagnostic interpretation and report. It includes:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Evaluating the clinical information produced by referring physician clinicians.
Deciding which test is appropriate.
Establishing and assuming responsibility for the imaging protocols, quality parameters and a
host of other technical factors that are integral to the creation of the diagnostic image and
report.
Being responsible for the technical staff/standards involved in the diagnostic imaging facility.
Optimizing the study and assisting the referring physician colleague.
Evaluating the study and relating it to the clinical findings.
Having knowledge of the practice of referring physicians.
Reviewing previous examinations and their interpretations to compare them with the current
study.
Identifying further appropriate management including diagnostic investigations essential to
obtain a comprehensive diagnosis and treatment, and reviewing.
Those recommendations with referring physicians.
Reviewing all clinical data in a multi-disciplinary environment.
Performing interventional therapeutic and diagnostic procedures
Assuming responsibility for the appropriate management of the patient during the diagnostic
imaging procedure.
Contributing radiological expertise to the management of the diagnostic imaging service to
ensure the highest possible quality assurance and quality control.
Being responsible for patient safety by ensuring minimal exposure to radiation dose and other
matters that could compromise patient care.
Adhering to all provincial and federal regulations, statutes relating to the delivery of medical
services generally and diagnostic imaging services provincially.
Meeting and exceeding the standard of care in the delivery of diagnostic imaging services in the
province; maintaining membership in all of the licensing bodies and fulfilling the requirements
of that licensure regime.
Ensuring the selection and use of appropriate and modern equipment, properly trained staff
and other elements in the high quality delivery of diagnostic imaging.
Where relevant, teaching radiology residents and fellows according to national training
program requirements.
Where relevant, participating in radiology research.
Auditing the delivery of radiology services in the sites where the radiologist works
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
41
•
•
Ensuring timely communication of urgent findings.
Maintaining appropriate records/confidentiality as mandated by legislation.
In essence, appropriate teleradiology in this era is the same as the whole practice of radiology. The fact
that patient data can be moved over a broadband connection does not alter the role or responsibilities
of the supervising and interpreting radiologist.
The importance of interaction between the referring clinicians and the radiologist cannot be overemphasized. There are considerable quality patient care and medical-legal implications when
teleradiology services are provided by a radiologist outside the patient’s jurisdiction. Regulatory bodies,
licensing and credentialing (including the College of Physicians and Surgeons of Ontario, the Royal
College of Physicians and Surgeons of Canada, Health Protection Branch, the Ministry of Health’s
Independent Health Facility branch, OHIP, X-ray Inspection branch, and other provincial and federal
bodies), are unable to enforce regulations outside their jurisdiction yet have a responsibility to patients
with respect to the enforcement of a wide spectrum of regulations and statutes inter-linked to the high
quality delivery of radiologists’ services in the province. The requirements of these and other related
bodies are constantly subject to change requiring the radiologist to comply with a new and more
stringent degree of responsibility with respect to the delivery of patient care.
Key Principles
1. Diagnostic radiology is an integrated medical service required in every modern health care system.
2. Referring physicians are dependent upon the local availability of diagnostic imaging physicians to
assist them to manage the health of their patients.
3. Only fully qualified diagnostic radiologists should provide the teleradiology service. They must be
properly accredited, registered, and licenced in Ontario. The radiologist should be subject to
licensing and quality assurance requirements of the provincial health authority; legislative and
professional requirements of the facility providing the service; the provincial College of Physicians
and Surgeons, accreditation and be in good standing with the Royal College of Physicians and
Surgeons of Canada.
4. A definitive report is mandatory with the signature of the reporting radiologist. Electronic signatures
are acceptable as long as they can be authenticated.
5. In a public hospital the members of the radiology department must be credentialed and be part of
the recognized medical staff.
6. The department head via the Medical Advisory Committee (MAC) and Board is responsible for the
medical service.
7. In an Independent Health Facility (IHF), the off-site radiologist must be approved by the radiologist
Quality Advisor who is legislatively responsible for Quality Control/Quality Assurance (QC/QA) at the
IHF.
8. All radiologists providing teleradiology services must be covered by the Canadian Medical Protective
Association (CMPA) for medical liability issues and ensure they are compliant with current CMPA
guidelines and policies covering diagnostic imaging physicians to safeguard patient interests.
9. Ensure that all radiologists and their staff involved in the delivery of teleradiology services are in full
compliance with relevant privacy legislation and facility policies to protect patient confidentiality.
10.Ensure that the information received for a primary read is the full data set and that the reading
radiologist should have all of the functionality of the PACS at his/her disposal to do an interpretation.
42
The College of Physicians and Surgeons of Ontario
Key Management Issues
1. Teleradiology services must be organized between the source radiologists and the off-site radiologist
provider to guarantee the proper management of the patient. This will ensure that:
a. The clinical evaluation and data is provided with the request for the examination.
b. The requirements of the Healing Arts Radiation Protection Act (HARP) (including justification,
appropriate techniques, optimization, and good procedure) are fulfilled.
c. The report of the teleradiology service can be reviewed with clinicians and where applicable,
in multi-disciplinary meetings and integrated with patients’ notes and previous studies.
d. The reporting radiologist of the teleradiology service is able to communicate directly with the
referring radiology department and clinicians in order to discuss the clinical background and
unexpected diagnosis, which may be relevant to the timely management of the patient.
e. Teleradiology services that are developed to meet the needs of rural, remote and small
community areas must be linked to the nearest substantive radiology department and the
service is managed by that department. The radiologists involved in providing the service
must have a close connection and knowledge of referring clinicians, and technologists, and
should understand any particular local disease and cultural factors.
2. Equipment used for teleradiology should provide a similar level of resolution and functionality as is
available in the radiology department/facility.
3. The American College of Radiology’s (ACR) Technical Standard for Teleradiology for equipment and
other supporting technologies used in the delivery of teleradiology is the acknowledged current
technical standard. Radiologists delivering teleradiology standards are expected to comply or exceed
the ACR Technical Standard for Teleradiology.
Real and Potential Problems
Clinico-Radiological Communication
If reporting of radiographs is taken away from close proximity with the patient, the clinical contact
between the referring clinicians and radiologists is substantially reduced.
It is imperative that teleradiology facilities have phone links with the hospitals and/or clinics from which
images are obtained, and have the ability for direct discussion between a referring clinician and the
reporting radiologist on individual cases. Without this, the bond between the patient and the
radiologist becomes unclear. If urgent or significant unexpected features are found, the teleradiology
service must transmit them directly to the referring clinician. This will be impossible unless there is a
clear point of contact for the teleradiology service.
Team Working
The ability to hold multi-disciplinary meetings is much more difficult with teleradiology, even with
teleconference links. It is now widely accepted that multi-disciplinary meetings, which are often led by
the radiology department, are essential in the management of problematic cases, i.e., cancer care. They
maximize the understanding of the clinical problems by radiologists.
External reviews of health care disasters have emphasized the importance of teamwork especially in
medicine and the need for enhanced teamwork, involving radiology has been highlighted. Interaction
between different members of the hospital team with radiology may be impaired, if radiology is
undertaken at the long distance by a teleradiology link.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
43
Communication
It is necessary that there be good communication between referring physicians, radiologists and
technologists.
Wording of Report and Clinical Impact
Even if radiologists and referring clinicians have a common first language, it has to be recognized that
radiological reporting may be subject to regional variation. Radiological reports often rely on verbal
expressions of probability and may contain some regionally used expressions.
Modern imaging commonly demonstrates an abundance of reportable findings, some of which are
clinically relevant and some of which are incidental findings/pseudo-disease. Multiple pathologies can
exist in the same patient. The clarity and certainty conveyed in the text is particularly important in
converting a report that is merely ‘diagnostically accurate’ into one that has a diagnostic outcome and
potentially a therapeutic outcome for the patient. Clinicians are more likely to act on the nuances
intended in a report generated by a radiologist with whom they regularly liaise compared with a report
generated by a third party teleradiology service from someone they never met. Specific wording of
reports for general family doctors may be necessary, which is different from the reports to specialists
within their sphere of interest. Familiarity with the referring doctors can make specific reports more
appropriate and useful. Health care delivery varies between different jurisdictions. Recommendations
for further imaging/specialist referral, which might be appropriate in the locale where a teleradiology
service is provided, may be inappropriate in the area where the patient is located.
Access to Previous Examinations/Interpretations
The failure to review previous examinations and interpretations has been shown to be a significant
cause of errors in both perception and cognition. It is therefore important that previous studies and
reports are available to the reporting radiologist where these are relevant. This should be possible if the
teleradiology service has access to the referrer’s PACS system. There also has to be access to the
hospital information system, so relevant lab data and clinical notes can be reviewed.
Downstream Costs
Teleradiology may generate significant downstream costs. There is potentially increased cost from
recommendations by the teleradiology service (which may actually be unnecessary) are required due to
the inexperience or insecurity of the reader of the initial study or from clinicians responding to reports
describing clinically insignificant radiological findings. There may be variations in the style of practice in
different jurisdictions that impact the kind or volume of studies ordered. This problem will be
compounded by a potential lack of background clinical knowledge of the case and the clinical
expectations of the referring clinician by the teleradiology service. Clinicians who are not confident in a
report from a teleradiology service may ask radiologists with whom they work to re-report the images
and to advise on case management, thus leading to duplication and poor use of financial resources. For
all of these reasons, the importance of close communication between the radiologist and the clinician
to minimize inappropriate clinical referrals for imaging cannot be over emphasized.
Quality Control and Quality Assurance
Quality control is paramount with teleradiology in order to prevent errors in radiology. Learning from
mistakes through participation in radiological discrepancy/error meetings is established practice. Much
informal feedback occurs at clinico-radiological meetings and corridor encounters. Audit is another
potent form of radiological quality assurance. All these activities are much more difficult for a
44
The College of Physicians and Surgeons of Ontario
teleradiology service which would need a very close link between the radiologists and clinicians at the
source hospital/facility. It is difficult for teleradiology services to have a proper feedback of the
outcome and undertake satisfactory audit of their reports.
Radiologists providing services may provide advice relating to radiation exposure, image quality, patient
positioning, and several other quality assurance and quality control (QA/QC) issues based on images
they have received for interpretation. They must communicate directly with technologists, often real
time, so as to be able to intervene directly to ensure optimal QA and QC. The Radiation Protection
Officer, an on-site radiologist, remains responsible for the overall QA and QC and ensuring safe
operation of a facility.
Legal Issues
There are a number of potential legal issues.
a. The registration of the reporting doctors must be accredited by the regulatory body of the local
jurisdiction of a hospital/facility or the health authority purchasing the service. This is an
essential requirement in order to maintain proper standards of practice. The reporting
radiologists must demonstrate that they undergo appropriate CME and are properly trained in
the tasks to be undertaken.
b. The providers of the service must abide by the jurisdiction’s health and safety legislation.
c. The use of radiology also creates difficulties in terms of the medico-legal issues and the medicolegal responsibilities of the referring hospital/facility and that of the reporting teleradiology
services must be identified. Any radiologist that reviews images has a responsibility. Liability
may also reside with the purchasers of the radiology service and/or the employers of the
“radiologist”. It must be clear who maintains responsibility for the patient. It is clear that the
“radiologist” has a direct responsibility for the patients whose study they interpret.
Teleradiology providers would have to comply with any statutory duty of candor to inform the
hospital/facility and patient(s) when they become aware of a negligent act or omission. At
present, the legal status of teleradiology remains to be clearly established.
d. Consent. It is not clear whether the patients will be required to give explicit consent for their
images to be transferred to another country or different provincial jurisdiction for reporting.
e. Jurisdiction. An individual has the right to sue a company providing electronic services within
another country and the suit would be heard in the patient’s own country or provincial
jurisdiction.
f.
Patient confidentiality. The teleradiology service must ensure patient confidentiality and be of
adequate technical specification. It must comply with the data protection legislation in the
transmitting and receiving provincial jurisdiction.
g. There is increasing awareness of the need to reduce the radiation dose that many patients
receive, particularly CT scanning. When creating teleradiology contracts, it must be made clear
who has responsibility for defining the protocol of an individual imaging study, e.g. high or low
dose depending on clinical indication. Teleradiology providers need to comply with pertinent
directives mandated in the provincial jurisdiction.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
45
OHIP Billing Rule Affecting Teleradiology in Ontario
OHIP added the following rule interpretation commentary to the October 2010 Schedule
of Benefits (refer to page D1 of the Diagnostic Radiology section of the Schedule)
where the additional note was added and remains in effect:
Commentary: As described in Regulation 552 of the Health Insurance Act, for a
service to be insured, the interpreting physician must physically be present in
Ontario when the interpretation service is rendered.
Legal Interpretation
The specific legal reference is found in Subsection 37.1(1) of R.R.O. 1990,
Regulation 552 made under the Health Insurance Act, R.S.O., c. H. 6. Section
37.1(1) of the Regulation provides:
A service rendered by a physician in Ontario is an insured service if it is
referred to in the schedule of benefits and rendered in such circumstances or
under such conditions as my be specified in the Schedule of Benefits. [emphasis
added]
Guidelines for the Development and Appropriate Use of Teleradiology
1. The principle that the patient is best served by a close liaison between the patient, the clinicians and
the clinical radiology department should be paramount.
2. The radiologist’s expected duty of care to the patient must not be compromised, lowered, or altered
in any way by the use of teleradiology.
3. Teleradiology referrals should, be in the majority of cases, organized between clinical radiologists and
the teleradiology provider. It is important that the radiologists act as practitioners under the
statutes, regulations, directives, policies, bulletins, bylaws issued by provincial and local
hospital/clinic authorities in order to ensure that appropriate investigations are performed and to
justify any further investigations suggested by the reporting radiologist.
4. The full agreement of radiologists should be obtained in order for the development of teleradiology
services to be implemented.
5. Teleradiology services developed for rural, remote and/or under-serviced areas should be linked to
other facilities in the province of Ontario and the service should be managed by the receiving
department/clinic unless there is a radiologist at the originating centre who may elect to assume
that responsibility or share it with the receiving centre radiologist. The radiologists involved in
providing the service should have close communication with the referring clinicians and patients and
should understand any particular local disease and cultural factors.
6. The radiologists providing the service must be properly accredited and registered within the
provincial jurisdiction where the patient receives the service. They should also be registered and
subject to quality and revalidation requirements, where applicable.
7. Under no circumstances should teleradiology reports be made by radiologists in training without
supervision and the implementation of teleradiology should not be to the detriment of the training
in the originating centre.
46
The College of Physicians and Surgeons of Ontario
8. The use of subspecialty services should be for the benefit of a second opinion or for the immediate
transfer of patients to specialist centres and not for the centralization of subspecialty reporting away
from general hospitals/clinics.
9. The reporting radiologist of the teleradiology service must be able to communicate directly with the
referring radiology department and clinicians in order to discuss the clinical background and
unexpected diagnosis which may be relevant to the timely management of the patient. The
equipment used to undertake the whole process of teleradiology must be of a quality and standard
that provides diagnostic quality images at all times.
10. Proper audit procedures should be in place in order to check the quality of the teleradiology service,
the accuracy of the radiological reports and the overall therapeutic and clinical impact of the service.
This must include user/clinician feedback.
11. The teleradiology service must comply with all national and provincial data protection standards.
Transfer of images outside the province could pose significant problems of data protection. It is
essential that the privacy and the integrity of patient information must be preserved at all times.
12. There needs to be clearly defined agreement with the teleradiology service with regard to
confidentiality of the images which should allow retention for comparison, proper defense against
litigation or other clinically appropriate reason.
13. The legal arrangements must be clearly defined between the user and the provider so that proper
restitution may be made to patients, if errors are made. If the service is less than optimal, patients
should not be required to litigate in the foreign country in the event of a complaint unless they have
consented formally to the transfer of their rights for local litigation in addition to initial image
transfer.
14. At all times the provision of teleradiology must be primarily developed in the best interest of the
patient care and not as a cost cutting measure which may jeopardize patient safety and standards of
health care.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
47
APPENDICES FOR MRI/CT AND
GENERAL GUIDANCE
48
The College of Physicians and Surgeons of Ontario
Appendix I
ACR Guidance Document on MR Safe Practices:
2013
Citation for published article: J Magnetic Resonance Imaging 2013, 37:501–530
Paper provided in cooperation with the publisher, the American College of Radiology (www.acr.org).
May, 2015.
http://onlinelibrary.wiley.com/doi/10.1002/jmri.24011/pdf
(Full text version on next page)
rd
Clinical Practice Parameters and Facility Standards for MRI and CT – 3 Edition
49
CME
JOURNAL OF MAGNETIC RESONANCE IMAGING 37:501–530 (2013)
Special Communication
ACR Guidance Document on MR Safe Practices: 2013
Expert Panel on MR Safety: Emanuel Kanal, MD,1* A. James Barkovich, MD,2
Charlotte Bell, MD,3 James P. Borgstede, MD,4 William G. Bradley Jr, MD, PhD,5
Jerry W. Froelich, MD,6 J. Rod Gimbel, MD,7 John W. Gosbee, MD,8
Ellisa Kuhni-Kaminski, RT,1 Paul A. Larson, MD,9 James W. Lester Jr, MD,10
John Nyenhuis, PhD,11 Daniel Joe Schaefer, PhD,12 Elizabeth A. Sebek, RN, BSN,1
Jeffrey Weinreb, MD,13 Bruce L. Wilkoff, MD,14 Terry O. Woods, PhD,15
Leonard Lucey, JD,16 and Dina Hernandez, BSRT16
Because there are many potential risks in the MR environment and reports of adverse incidents involving
patients, equipment and personnel, the need for a guidance document on MR safe practices emerged. Initially
published in 2002, the ACR MR Safe Practices Guidelines
established de facto industry standards for safe and
responsible practices in clinical and research MR environments. As the MR industry changes the document is
reviewed, modified and updated. The most recent version
will reflect these changes.
Key Words: MR safety; MR; MR safe practices
J. Magn. Reson. Imaging 2013;37:501–530.
C 2013 Wiley Periodicals, Inc.
V
1
Department of Radiology, University of Pittsburgh Medical Center,
Pittsburgh, Pennsylvania, USA.
2
Department of Radiology and Biomedical Imaging, University of
California, San Francisco, California, USA.
3
Milford Anesthesia Associates, Milford, Connecticut, USA.
4
University of Colorado, Denver, Colorado, USA.
5
Department of Radiology, University of California San Diego Medical
Center, San Diego, California, USA.
6
Department of Radiology, University of Minnesota, Minneapolis,
Minnesota, USA.
7
Cardiology Associates of E. Tennessee, Knoxville, Tennessee, USA.
8
University of Michigan Health System and Red Forest Consulting LLC,
Ann Arbor, Michigan, USA.
9
Radiology Associates of the Fox Valley, Neenah, Wisconsin, USA.
10
Durham Radiology Associates, Raleigh, North Carolina, USA.
11
Department of Electrical and Computer Engineering, Purdue
University, West Lafayette, Indiana, USA.
12
MR Systems Engineering, GE Healthcare, Waukesha, Wisconsin, USA.
13
Yale School of Medicine, New Haven, Connecticut, USA.
14
Cleveland Clinic, Cleveland, Ohio, USA.
15
FDA Center for Devices & Radiological Health, Silver Spring,
Maryland, USA.
16
American College of Radiology, Reston, Virginia, USA.
Reprint requests to: Department of Quality & Safety, American College of Radiology, 1891 Preston White Drive, Reston, VA 20191-4397.
*Address reprint requests to: E.K., University of Pittsburgh Medical
Center, Presbyterian University Hospital\Presbyterian South Tower,
Room 4776, Pittsburgh, PA 15213. E-mail: [email protected]
Received October 3, 2012; Accepted December 4, 2012.
DOI 10.1002/jmri.24011
View this article online at wileyonlinelibrary.com.
C 2013 Wiley Periodicals, Inc.
V
THERE ARE POTENTIAL risks in the MR environment, not only for the patient (1,2) but also for the
accompanying family members, attending health care
professionals, and others who find themselves only
occasionally or rarely in the magnetic fields of MR
scanners, such as security or housekeeping personnel, firefighters, police, etc. (3–6). There have been
reports in the medical literature and print-media
detailing Magnetic Resonance Imaging (MRI) adverse
incidents involving patients, equipment and personnel
that spotlighted the need for a safety review by an
expert panel. To this end, the American College of
Radiology originally formed the Blue Ribbon Panel on
MR Safety. First constituted in 2001, the panel was
charged with reviewing existing MR safe practices and
guidelines (5–8) and issuing new ones as appropriate
for MR examinations. Published initially in 2002 (4),
the ACR MR Safe Practice Guidelines established de
facto industry standards for safe and responsible
practices in clinical and research MR environments.
These were subsequently reviewed and updated in
May of 2004 (3). After reviewing substantial feedback
from the field and installed base, as well as changes
that had transpired throughout the MR industry since
the publication of the 2004 version of this document,
the panel extensively reviewed, modified, and updated
the entire document in 2006–2007.
The present panel consists of the following
members: A. James Barkovich, MD, Charlotte Bell,
MD, (American Society of Anesthesiologists), James P.
Borgstede, MD, FACR, William G. Bradley, MD, PhD,
FACR, Jerry W. Froelich, MD, FACR, J. Rod Gimbel,
MD, FACC, Cardiologist, John Gosbee, MD, MS, Ellisa
Kuhni-Kaminski, RT (R)(MR), Emanuel Kanal, MD,
FACR, FISMRM (chair), James W. Lester Jr., MD,
John Nyenhuis, PhD, Daniel Joe Schaefer, PhD Engineer, Elizabeth A. Sebek, RN, BSN, CRN, Jeffrey
Weinreb, MD, Terry Woods, PhD, FDA, Pamela Wilcox,
RN, MBA (ACR Staff), Leonard Lucey, JD, LLM (ACR
Staff), and Dina Hernandez, RT (R) (CT) (QM) (ACR
Staff). The following represents the most recently
501
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
68
502
modified and updated version of the combined prior
three reports (3,4,9) issued by the American College of
Radiology Blue Ribbon Panel on MR Safety, chaired by
Emanuel Kanal, MD, FACR. It is important to note that
nothing that appears herein is the result of a ‘‘majority
vote’’ of the member of this panel. As with each prior
publication of these ACR MR Safe Practice Guidelines,
the entire document, from introduction to the markedly expanded appendices, represents the unanimous
consensus of each and every member of this Safety
Committee and the various areas of expertise that they
represent. This includes representation from fields and
backgrounds as diverse as MR physicists, research/
academic radiologists, private practice radiologists, MR
safety experts, patient safety experts/researchers, MR
technologists, MR nursing, National Electrical Manufacturers Association, the Food and Drug Administration, the American Society of Anesthesiologists, legal
counsel, and others. Lay personnel, physicians,
Ph.D.s, department chairs and house-staff/residents,
government employees and private practitioners,
doctors, nurses, technologists, radiologists, anesthesiologists, cardiologists, attorneys—these are all
represented on this Committee. It was believed that
achieving unanimity for these Guidelines was critical
to demonstrate to all that these Guidelines are not
only appropriate from a scientific point of view, but
reasonably applicable in the real world in which we all
must live, with all its patient care, financial, and
throughput pressures and considerations. The views
expressed in this study are solely those of the authors
and in no way suggest a policy or position of any of the
organizations represented by the authors.
The following MR safe practice guidelines document
is intended to be used as a template for MR facilities to
follow in the development of an MR safety program.
These guidelines were developed to help guide MR practitioners regarding these issues and to provide a basis
for them to develop and implement their own MR policies and practices. It is intended that these MR safe
practice guidelines (and the policies and procedures to
which they give rise) be reviewed and updated on a regular basis as the field of MR safety continues to evolve.
The principles behind these MR Safe Practice
Guidelines are specifically intended to apply not only
to diagnostic settings but also to patient, research
subject, and health care personnel safety for all MRI
settings, including those designed for clinical diagnostic imaging, research, interventional, and intraoperative MR applications.
With the increasing advent and use of 3.0-Tesla and
higher strength magnets, users need to recognize that
one should never assume MR compatibility or safety
information about a device if it is not clearly documented in writing. Decisions based on published MR
safety and compatibility claims should recognize that
all such claims apply only to specifically tested conditions, such as static magnetic field strengths, static
gradient magnetic field strengths and spatial distributions, and the strengths and rates of change of gradient and radiofrequency (RF) magnetic fields.
Finally, there are many issues that impact MR
safety which should be considered during site
Kanal et al.
planning for a given MR installation. We include in
this manuscript, as separate appendices, sections
that address such issues as well, including cryogen
emergency vent locations and pathways, 5-Gauss
line, siting considerations, patient access pathways,
etc. Yet despite their appearance herein, these issues,
and many others, should be reviewed with those experienced with MR site planning and familiar with the
patient safety and patient flow considerations before
committing construction to a specific site design. In
this regard, enlisting the assistance of an architectural firm experienced in this area, and doing so early
in the design stages of the planning process, may
prove most valuable.
It remains the intent of the ACR that these MR Safe
Practice Guidelines will prove helpful as the field of
MRI continues to evolve and mature, providing MR
services that are among the most powerful, yet safest,
of all diagnostic procedures to be developed in the
history of modern medicine.
ACR GUIDANCE DOCUMENT ON MR SAFE
PRACTICES: 2013
A. Establish, Implement, and Maintain Current
MR Safety Policies and Procedures
1. All clinical and research MR sites, irrespective of
magnet format or field strength, including installations for diagnostic, research, interventional,
and/or surgical applications, should maintain
MR safety policies.
2. These policies and procedures should also be
reviewed concurrently with the introduction of
any significant changes in safety parameters of
the MR environment of the site (e.g., adding
faster or stronger gradient capabilities or higher
RF duty cycle studies) and updated as needed. In
this review process, national and international
standards and recommendations should be
taken into consideration before establishing local
guidelines, policies, and procedures
3. Each site will name a MR medical director whose
responsibilities will include ensuring that MR
safe practice guidelines are established and
maintained as current and appropriate for the
site. It is the responsibility of the site’s administration to ensure that the policies and procedures
that result from these MR safe practice guidelines are implemented and adhered to at all times
by all of the site’s personnel.
4. Procedures should be in place to ensure that any
and all adverse events, MR safety incidents, or
‘‘near incidents’’ that occur in the MR site are to
be reported to the medical director in a timely
manner (e.g., within 24 hours or 1 business day
of their occurrence) and used in continuous quality improvement efforts. It should be stressed
that the Food and Drug Administration states
that it is incumbent upon the sites to also report
adverse events and incidents to them by means
of their Medwatch program. The ACR supports
this requirement and believes that it is in the
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
69
ACR Guidance on MR Safe Practices
503
Figure 1. Idealized sample floor
plan illustrates site access restriction considerations. Other MR
potential safety issues, such as
magnet site planning related to
fringe magnetic field considerations,
are not meant to be include herein.
See Appendix 1 for personnel and
zone definitions. Note—In any zone
of the facility, there should be compliance with Health Insurance Portability
and
Accountability
Act
(HIPAA) regulations in regard to privacy of patient information. However, in Zone III, there should be a
privacy barrier so that unauthorized
persons cannot view control panels.
Note: In any zone of the facility,
there should be compliance with
HIPAA regulations in regard to privacy of patient information. However, in Zone III, there should be a
privacy barrier so that unauthorized
persons cannot view the control
panels. Please note that this diagram is an example intended for
educational, illustration purposes
only. The MR Functional Diagram
was obtained from and modified
with the permission of the ‘‘Department of Veterans Affairs Office of
Construction & Facilities Management, Strategic Management Office’’.
ultimate best interest of all MR practitioners to
create and maintain this consolidated database
of such events to help us all learn about them
and how to better avoid them in the future (10).
B. Static Magnetic Field Issues: Site Access
Restriction
1. Zoning
The MR site is conceptually divided into four Zones
[see Fig. 1 and Appendices 1 and 3]:
a. Zone I: This region includes all areas that are
freely accessible to the general public. This area
is typically outside the MR environment itself
and is the area through which patients, health
care personnel, and other employees of the MR
site access the MR environment.
b. Zone II: This area is the interface between the
publicly accessible, uncontrolled. Zone I and the
strictly controlled Zones III and IV. Typically,
patients are greeted in Zone II and are not free to
move throughout Zone II at will, but are rather
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
70
504
under the supervision of MR personnel (see
section B.2.b, below). It is in Zone II that the
answers to MR screening questions, patient
histories, medical insurance questions, etc. are
typically obtained.
c. Zone III: This area is the region in which free
access by unscreened non-MR personnel or
ferromagnetic objects or equipment can result in
serious injury or death as a result of interactions
between the individuals or equipment and the
MR scanner’s particular environment. These
interactions include, but are not limited to, those
involving the MR scanner’s static and time-varying magnetic fields. All access to Zone III is to be
strictly restricted, with access to regions within it
(including Zone IV see below) controlled by, and
entirely under the supervision of, MR personnel
(see Section B.2.b, below). Specifically identified
MR personnel (typically, but not necessarily only,
the MR technologists) are to be charged with
ensuring that this MR safe practice guideline is
strictly adhered to for the safety of the patients
and other non-MR personnel, the health care personnel, and the equipment itself. This function of
the MR personnel is directly under the authority
and responsibility of the MR medical director or
the level 2-designated (see section B.2.b, below)
physician of the day for the MR site.
Zone III regions should be physically restricted
from general public access by, for example, key
locks, passkey locking systems, or any other reliable, physically restricting method that can differentiate between MR personnel and non-MR
personnel. The use of combination locks is discouraged as combinations often become more
widely distributed than initially intended, resulting in site restriction violations being more likely
with these devices. Only MR personnel shall be
provided free access, such as the access keys or
passkeys, to Zone III.
There should be no exceptions to this guideline.
Specifically, this includes hospital or site administration, physician, security, and other non-MR personnel (see section B.2.c, below). Non-MR
personnel are not to be provided with independent
Zone III access until such time as they undergo the
proper education and training to become MR personnel themselves. Zone III, or at the very least the
area within it wherein the static magnetic field’s
strength exceeds 5-Gauss should be demarcated
and clearly marked as being potentially hazardous.
Because magnetic fields are three-dimensional
volumes, Zone III controlled access areas may
project through floors and ceilings of MRI suites,
imposing magnetic field hazards on persons on
floors other than that of the MR scanner. Zones
of magnetic field hazard should be clearly
delineated, even in typically nonoccupied areas
such as rooftops or storage rooms, and access to
these Zone III areas should be similarly restricted
from non-MR personnel as they would be inside
any other Zone III region associated with the MRI
suite. For this reason, magnetic field strength
Kanal et al.
plots for all MRI systems should be analyzed in
vertical section as well as in horizontal plan,
identifying areas above or below, in addition to
areas on the same level, where persons may be
at risk of interactions with the magnetic field.
d. Zone IV: This area is synonymous with the MR
scanner magnet room itself, i.e., the physical
confines of the room within which the MR
scanner is located (see Appendix 3). Zone IV, by
definition, will always be located within Zone III,
as it is the MR magnet and its associated magnetic field that generates the existence of Zone
III. Zone IV should also be demarcated and
clearly marked as being potentially hazardous
due to the presence of very strong magnetic
fields. As part of the Zone IV site restriction, all
MR installations should provide for direct visual
observation by level 2 personnel to access pathways into Zone IV. By means of illustration only,
the MR technologists would be able to directly
observe and control, by means of line of site or
by means of video monitors, the entrances or
access corridors to Zone IV from their normal
positions when stationed at their desks in the
scan control room.
Zone IV should be clearly marked with a red light
and lighted sign stating, ‘‘The Magnet is On’’.
Ideally, signage should inform the public that the
magnetic field is active even when power to the
facility is deactivated. Except for resistive systems, this light and sign should be illuminated at
all times and should be provided with a battery
backup energy source to continue to remain
illuminated in the event of a loss of power to
the site.
In case of cardiac or respiratory arrest or other
medical emergency within Zone IV for which
emergent medical intervention or resuscitation is
required, appropriately trained and certified MR
personnel should immediately initiate basic life
support or CPR as required by the situation
while the patient is being emergently removed
from Zone IV to a predetermined, magnetically
safe location. All priorities should be focused on
stabilizing (e.g., basic life support with cardiac
compressions and manual ventilation) and then
evacuating the patient as rapidly and safely as
possible from the magnetic environment that
might restrict safe resuscitative efforts.
Furthermore, for logistical safety reasons, the
patient should always be moved from Zone IV to the
prospectively identified location where full resuscitative efforts are to continue (see Appendix 3).
Quenching the magnet (for superconducting systems only) is not routinely advised for cardiac or
respiratory arrest or other medical emergency,
because quenching the magnet and having the
magnetic field dissipate could easily take more
than a minute. Furthermore, as quenching a
magnet can theoretically be hazardous, ideally
one should evacuate the magnet room, when
possible, for an intentional quench. One should
rather use that time wisely to initiate life support
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
71
ACR Guidance on MR Safe Practices
measures while removing the patient from Zone
IV to a location where the strength of the magnetic field is insufficient to be a medical concern.
Zones III and IV site access restriction must be
maintained during resuscitation and other emergent situations for the protection of all involved.
2. MR Personnel and non-MR personnel
a. All individuals working within at least Zone III of the
MR environment should be documented as having
successfully completed at least one of the MR safety
live lectures or prerecorded presentations approved
by the MR medical director. Attendance should be
repeated at least annually, and appropriate documentation should be provided to confirm these
ongoing educational efforts. These individuals shall
be referred to henceforth as MR personnel.
b. There are two levels of MR personnel:
1. Level 1 MR personnel: Those who have passed
minimal safety educational efforts to ensure their
own safety as they work within Zone III will be
referred to henceforth as level 1 MR personnel.
2. Level 2 MR personnel: Those who have been
more extensively trained and educated in the
broader aspects of MR safety issues, including,
for example, issues related to the potential for
thermal loading or burns and direct neuromuscular excitation from rapidly changing gradients,
will be referred to henceforth as level 2 MR personnel. It is the responsibility of the MR medical
director not only to identify the necessary training, but also to identify those individuals who
qualify as level 2 MR personnel. It is understood
that the medical director will have the necessary
education and experience in MR safety to qualify
as level 2 MR personnel. (See Appendix 1.)
c. All those not having successfully complied with
these MR safety instruction guidelines shall be
referred to henceforth as non-MR personnel. Specifically, non-MR personnel will be the terminology
used to refer to any individual or group who has not
within the previous 12 months undergone the designated formal training in MR safety issues defined by
the MR safety director of that installation.
3. Patient and non-MR personnel screening
a. All non-MR personnel wishing to enter Zone III
must first pass an MR safety screening process.
Only MR personnel are authorized to perform an
MR safety screen before permitting non-MR personnel into Zone III.
b. The screening process and screening forms for
patients, non-MR personnel, and MR personnel
should be essentially identical. Specifically, one
should assume that screened non-MR personnel,
health care practitioners, or MR personnel may
enter the bore of the MR imager during the MR
imaging process.
Examples of this might include if a pediatric
patient cries for his mother, who then leans into
505
the bore, or if the anesthetist leans into the bore
to manually ventilate a patient in the event of a
problem.
c. Metal detectors
The usage in MR environments of conventional
metal detectors which do not differentiate between
ferrous and nonferromagnetic materials is not recommended. Reasons for this recommendation
against conventional metal detector usage include,
among others:
1. They have varied—and variable—sensitivity
settings.
2. The skills of the operators can vary.
3. Today’s conventional metal detectors cannot
detect, for example, a 2 3 mm, potentially
dangerous ferromagnetic metal fragment in the
orbit or near the spinal cord or heart.
4. Today’s conventional metal detectors do not differentiate between ferromagnetic and nonferromagnetic metallic objects, implants, or foreign
bodies.
5. Metal detectors should not be necessary for the
detection of large metallic objects, such as oxygen tanks on the gurney with the patients.
These objects are fully expected to be detected –
and physically excluded – during the routine
patient screening process.
However, ferromagnetic detection systems are currently available that are simple to operate, capable
of detecting even very small ferromagnetic objects
external to the patient, and differentiating between
ferromagnetic and non-ferromagnetic materials.
While the use of conventional metal detectors is
not recommended, the use of ferromagnetic detection systems is recommended as an adjunct to
thorough and conscientious screening of persons
and devices approaching Zone IV. It should be reiterated that their use is in no way meant to replace
a thorough screening practice, which rather
should be supplemented by their usage.
d. Non-MR personnel should be accompanied by, or
under the immediate supervision of and in visual
or verbal contact with, one specifically identified
level 2 MR person for the entirety of their duration
within Zone III or IV restricted regions. However, it
is acceptable to have them in a changing room or
restroom in Zone III without visual contact as long
as the personnel and the patient can communicate
verbally with each other.
Level 1 MR personnel are permitted unaccompanied access throughout Zones III and IV. Level 1
MR personnel are also explicitly permitted to be
responsible for accompanying non-MR personnel
into and throughout Zone III, excluding Zone IV.
However, level 1 MR personnel are not permitted
to directly admit, or be designated responsible for,
non-MR personnel in Zone IV.
In the event of a shift change, lunch break, etc.,
no level 2 MR personnel shall relinquish their
responsibility to supervise non-MR personnel still
within Zone III or IV until such supervision has
been formally transferred to another of the site’s
level 2 MR personnel.
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
72
506
e. Nonemergent patients should be MR safety screened
on site by a minimum of 2 separate individuals. At
least one of these individuals should be level 2 MR
personnel. At least one of these 2 screens should be
performed verbally or interactively.
Emergent patients and their accompanying nonMR personnel may be screened only once, providing the screening individual is level 2 MR personnel. There should be no exceptions to this.
f. Any individual undergoing an MR procedure must
remove all readily removable metallic personal
belongings and devices on or in them (e.g.,
watches, jewelry, pagers, cell phones, body piercings (if removable), contraceptive diaphragms, metallic drug delivery patches (see Section I, below),
cosmetics containing metallic particles (such as
eye make-up), and clothing items which may
contain metallic fasteners, hooks, zippers, loose
metallic components or metallic threads). It is
therefore advisable to require that the patients or
research subjects wear a site-supplied gown with
no metal fasteners when feasible.
g. All patients and non-MR personnel with a history
of potential ferromagnetic foreign object penetration must undergo further investigation before
being permitted entrance to Zone III. Examples of
acceptable methods of screening include patient
history, plain X-ray films, prior CT or MR studies
of the questioned anatomic area, or access to written documentation as to the type of implant or foreign object that might be present. Once positive
identification has been made as to the type of
implant or foreign object that is within a patient,
best effort assessments should be made to identify
the MR compatibility or MR safety of the implant
or object. Efforts at identification might include
written records of the results of formal testing of
the implant before implantation (preferred), product labeling regarding the implant or object, and
peer-reviewed publications regarding MR compatibility and MR safety testing of the specific make,
model, and type of the object. MR safety testing
would be of value only if the object or device had
not been altered since such testing had been
published and only if it can be confirmed that the
testing was performed on an object of precisely the
same make, model, and type.
All patients who have a history of orbit trauma by
a potential ferromagnetic foreign body for which
they sought medical attention are to have their
orbits cleared by either plain X-ray orbit films
(2 views) (11,12) or by a radiologist’s review and
assessment of contiguous cut prior CT or MR
images (obtained since the suspected traumatic
event) if available.
h. Conscious, nonemergent patients and research
and volunteer subjects are to complete written MR
safety screening questionnaires before their introduction to Zone III. Family or guardians of nonresponsive patients or of patients who cannot reliably
provide their own medical histories are to complete
a written MR safety screening questionnaire before
their introduction to Zone III. These completed
Kanal et al.
questionnaires are then to be reviewed orally with
the patient, guardian, or research subject in their
entirety before permitting the patient or research
subject to be cleared into Zone III.
The patient, guardian, or research subject as well
as the screening MR staff member must both sign
the completed form. This form should then become
part of the patient’s medical record. No empty
responses will be accepted—each question must be
answered with a ‘‘yes’’ or ‘‘no’’ or specific further information must be provided as requested. A sample pre-MR screening form is provided (see
Appendix 2). This is the minimum information to
be obtained; more may be added if the site so
desires.
i. Screening of the patient or non-MR personnel
with, or suspected of having, an intracranial aneurysm clip should be performed as per the separate
MR safe practice guideline addressing this particular topic (see section M, below).
j. Screening of patients for whom an MR examination is deemed clinically indicated or necessary,
but who are unconscious or unresponsive, who
cannot provide their own reliable histories regarding prior possible exposures to surgery, trauma, or
metallic foreign objects, and for whom such histories cannot be reliably obtained from others:
1. If no reliable patient metal exposure history can
be obtained, and if the requested MR examination cannot reasonably wait until a reliable history might be obtained, it is recommended that
such patients be physically examined by level 2
MR personnel. All areas of scars or deformities
that might be anatomically indicative of an
implant, such as on the chest or spine region,
and whose origins are unknown and which may
have been caused by ferromagnetic foreign
bodies, implants, etc., should be subject to
plain-film radiography (if recently obtained
plain films or CT or MR studies of such areas
are not already available). The investigation
described above should be made to ensure
there are no potentially harmful embedded or
implanted metallic foreign objects or devices. All
such patients should also undergo plain film
imaging of the skull or orbits and chest to
exclude metallic foreign objects (if recently
obtained such radiographic or MR information
not already available).
2. Monitoring of patients in the MR scanner is
sometimes necessary. However, monitoring
methods should be chosen carefully due to the
risk of thermal injury associated with monitoring equipment in the MR environment. Sedated,
anesthetized, or unconscious patients may not
be able to express symptoms of such injury.
This potential for injury is greater on especially
higher field whole body scanners (e.g., 1 Tesla
and above), but exists at least theoretically at
all MR imaging field strengths. MR Conditional
EKG electrodes should be used and leads
should be kept from touching the patients during the scan. Patients who require EKG
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
73
ACR Guidance on MR Safe Practices
monitoring and who are unconscious, sedated,
or anesthetized should be examined after each
imaging sequence with potential repositioning
of the EKG leads and any other electrically conductive material with which the patient is in
contact. Alternatively, cold compresses or ice
packs could be placed upon all necessary electrically conductive material that touches the
patient during scanning.
Distortion of the electrocardiogram within the
magnetic field can make interpretation of the ECG
complex unreliable, even with filtering used by
contemporary monitoring systems. Routine monitoring of heart rate and rhythm may also be
accomplished using pulse oximetry, which would
eliminate the risks of thermal injury from
electrocardiography.
k. Final determination of whether or not to scan any
given patient with any given implant, foreign body,
etc. is to be made by the level 2 designated attending MR radiologist, the MR medical director, or
specifically designated level 2 MR personnel following criteria for acceptability predetermined by the
medical director. These risks include, among
others, consideration of mechanical and thermal
risks associated with MR imaging of implants, as
well as assessments of the safety of exposure of
the device to the electromagnetic forces used in
the MR imaging process.
For implants that are strongly ferromagnetic, an
obvious concern is that of magnetic translational
and rotational forces upon the implant which
might move or dislodge the device from its
implanted position If an implant has demonstrated
weak ferromagnetic forces on formal testing, it
might be prudent to wait several weeks for fibrous
scarring to set in, as this may help anchor the
implant in position and help it resist such weakly
attractive magnetic forces that might arise in MR
environments.
For all implants that have been demonstrated to
be nonferrous in nature, however, the risk of
implant motion is essentially reduced to those
resulting from Lenz’s forces alone. These tend to
be quite trivial for typical metallic implant sizes of
a few centimeters or less. Thus, a waiting period
for fibrous scarring to set in is far less important,
and the advisability for such a waiting period may
well be easily outweighed by the potential clinical
benefits of undergoing an MR examination at that
time. As always, clinical assessment of the risk
benefit ratio for the particular clinical situation
and patient at hand are paramount for appropriate
medical decision making in these scenarios.
It is possible that during the course of a magnetic
resonance imaging examination an unanticipated
ferromagnetic implant or foreign body is discovered within a patient or research subject undergoing the examination. This is typically suspected
or detected by means of a sizable field-distorting
artifact seen on spin echo imaging techniques that
grows more obvious on longer TE studies and
expands markedly on typical moderate or long TE
507
gradient echo imaging sequences. In such cases, it
is imperative that the medical director, safety officer, and/or physician in charge be immediately
notified of the suspected findings. This individual
should then assess the situation, review the imaging information obtained, and decide what the
best course of action might be.
It should be noted that there are numerous potentially acceptable courses that might be recommended which in turn are dependent upon many
factors, including the status of the patient, the location of the suspected ferromagnetic implant/foreign
body relative to local anatomic structures, the mass
of the implant, etc. Appropriate course of actions
might include proceeding with the scan under way,
immobilizing the patient and the immediate removal from the scanner, or other intermediate
steps. Regardless of the course of action selected, it
is important to note that the forces on the implant
will change, and may actually increase, during the
attempt to remove the patient from the scanner
bore. Furthermore, the greater the rate of motion of
the patient/device through the magnetic fields of
the scanner bore the greater the forces acting upon
that device will likely be. Thus it is prudent to
ensure that if at all possible, immobilization of the
device during patient extraction from the bore, and
slow, cautious, deliberate rate of extricating the
patient from the bore, will likely result in weaker
and potentially less harmful forces on the device as
it traverses the various static magnetic field gradients associated with the MR imager.
It is also worthy of note that the magnetic fields
associated with the MR scanner are three dimensional. Thus, especially for superconducting systems, one should avoid the temptation to have the
patient sit up as soon as they are physically out of
the bore. Doing so may expose the ferrous object
to still significant torque- and translation-related
forces despite their being physically outside the
scanner bore. It is therefore advisable to continue
to extract the patient along a straight line course
parallel to the center of the magnet while the
patient remains immobilized until they are as far
as physically possible from the MR imager itself,
before any other patient/object motion vector is
attempted or permitted.
l. All non-MR personnel (e.g., patients, volunteers,
varied site employees and professionals) with
implanted cardiac pacemakers, implantable cardioverter defibrillators (ICDs), diaphragmatic pacemakers, electromechanically activated devices, or
other electrically conductive devices upon which
the non-MR personnel is dependent should be precluded from Zone IV and physically restrained
from the 5-Gauss line unless specifically cleared
in writing by a level 2 designated attending radiologist or the medical director of the MR site. In
such circumstances, specific defending risk-benefit rationale should be provided in writing and
signed by the authorizing radiologist.
Should it be determined that non-MR personnel
wishing to accompany a patient into an MR scan
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
74
508
room require their orbits to be cleared by plain-film
radiography, a radiologist must first discuss with
the non-MR personnel that plain X-ray films of their
orbits are required before permitting them access to
the MR scan room. Should they still wish to proceed
with access to Zone IV or within the 5-G line, and
should the attending radiologist deem it medically
advisable that they do so (e.g., for the care of their
child about to undergo an MR study), written
informed consent should be provided by these
accompanying non-MR personnel before their
undergoing X-ray examination of their orbits.
m. MR scanning of patients, prisoners, or parolees
with metallic prisoner-restraining devices or RF ID
or tracking bracelets could lead to theoretical
adverse events, including: (i) ferromagnetic attractive effects and resultant patient injury, (ii) possible ferromagnetic attractive effects and potential
damage to the device or its battery pack, (iii) RF
interference with the MRI study and secondary
image artifact, (iv) RF interference with the functionality of the device, (v) RF power deposition and
heating of the bracelet or tagging device or its circuitry and secondary patient injury (if the bracelet
would be in the anatomic volume of the RF transmitter coil being used for imaging). Therefore, in
cases where requested to scan a patient, prisoner,
or parolee wearing RF bracelets or metallic handcuffs or anklecuffs, request that the patient be
accompanied by the appropriate authorities who
can and will remove the restraining device before
the MR study and be charged with its replacement
following the examination.
n. Firefighter, police, and security safety considerations: For the safety of firefighters and other emergent services responding to an emergent call at the
MR site, it is recommended that all fire alarms,
cardiac arrests, or other emergent service response
calls originating from or located in the MR site
should be forwarded simultaneously to a specifically designated individual from amongst the site’s
MR personnel. This individual should, if possible,
be on site before the arrival of the firefighters or
emergent responders to ensure that they do not
have free access to Zone III or IV. The site might
consider assigning appropriately trained security
personnel, who have been trained and designated
as MR personnel, to respond to such calls.
In any case, all MR sites should arrange to prospectively educate their local fire marshals, firefighters associations, and police or security
personnel about the potential hazards of responding to emergencies in the MR suite.
It should be stressed that even in the presence of a
true fire (or other emergency) in Zone III or IV, the
magnetic fields may be present and fully operational.
Therefore, free access to Zone III or IV by firefighters
or other non-MR personnel with air tanks, axes,
crowbars, other firefighting equipment, guns, etc
might prove catastrophic or even lethal to those
responding or others in the vicinity.
As part of the Zone III and IV restrictions, all MR
sites must have clearly marked, readily accessible
Kanal et al.
MR Conditional or MR Safe fire extinguishing equipment physically stored within Zone III or IV.
All conventional fire extinguishers and other firefighting equipment not tested and verified safe in
the MR environment should be restricted from
Zone III.
For superconducting magnets, the helium (and the
nitrogen as well, in older MR magnets) is not flammable and does not pose a fire hazard directly.
However, the liquid oxygen that can result from
the supercooled air in the vicinity of the released
gases might well increase the fire hazard in this
area. If there are appropriately trained and knowledgeable MR personnel available during an emergency to ensure that emergency response
personnel are kept out of the MR scanner or magnet room and 5-Gauss line, quenching the magnet
during a response to an emergency or fire should
not be a requirement.
However, if the fire is in such a location where
Zone III or IV needs to be entered for whatever reason by firefighting or emergency response personnel and their firefighting and emergent equipment,
such as air tanks, crowbars, axes, defibrillators, a
decision to quench a superconducting magnet
should be very seriously considered to protect the
health and lives of the emergent responding personnel. Should a quench be performed, appropriately designated MR personnel still need to ensure
that all non-MR personnel (including and especially emergently response personnel) continue to
be restricted from Zones III and IV until the designated MR personnel has personally verified that
the static field is either no longer detectable or at
least sufficiently attenuated as to no longer present a potential hazard to one moving by it with, for
example, large ferromagnetic objects such as air
tanks or axes.
For resistive systems, the magnetic field of the MR
scanner should be shut down as completely as
possible and verified as such before permitting the
emergency response personnel access to Zone IV.
For permanent, resistive, or hybrid systems whose
magnetic fields cannot be completely shut down,
MR personnel should ideally be available to warn
the emergency response personnel that a very
powerful magnetic field is still operational in the
magnet room.
4. MR Personnel Screening
All MR personnel are to undergo an MR-screening
process as part of their employment interview process
to ensure their safety in the MR environment. For
their own protection and for the protection of the nonMR personnel under their supervision, all MR personnel must immediately report to the MR medical director any trauma, procedure, or surgery they experience
or undergo where a ferromagnetic object or device
may have become introduced within or on them. This
will permit appropriate screening to be performed on
the employee to determine the safety of permitting
that employee into Zone III.
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
75
ACR Guidance on MR Safe Practices
509
5. Device and Object Screening
Ferrous objects, including those brought by patients,
visitors, contractors, etc., should be restricted from
entering Zone III, whenever practical.
As part of the Zone III site restriction and equipment testing and clearing responsibilities, all sites
should have ready access to a strong handheld magnet (1000-Gauss) and/or a handheld ferromagnetic
detection device. This will enable the site to test external, and even some superficial internal devices or
implants for the presence of grossly detectable ferromagnetic attractive forces.
a. All portable metallic or partially metallic devices
that are on or external to the patient (e.g., oxygen cylinders) are to be positively identified in
writing as MR Unsafe or, alternatively, MR Safe
or MR Conditional in the MR environment before
permitting them into Zone III Figure 2. For all
device or object screening, verification and positive identification should be in writing. Examples of devices that need to be positively
identified include fire extinguishers, oxygen
tanks and aneurysm clips.
b. External devices or objects demonstrated to be
ferromagnetic and MR Unsafe or incompatible in
the MR environment may still, under specific circumstances, be brought into Zone III if for example, they are deemed by MR personnel to be
necessary and appropriate for patient care. They
should only be brought into Zone III if they are
under the direct supervision of specifically designated level 1 or level 2 MR personnel who are
thoroughly familiar with the device, its function,
and the reason supporting its introduction to
Zone III. The safe usage of these devices while
they are present in Zone III will be the responsibility of specifically named level 1 or 2 MR personnel. These devices must be appropriately
physically secured or restricted at all times during which they are in Zone III to ensure that they
do not inadvertently come too close to the MR
scanner and accidentally become exposed to
static magnetic fields or gradients that might
result in their becoming either hazardous projectiles or no longer accurately functional.
c. Never assume MR compatibility or safety information about the device if it is not clearly documented in writing. All unknown external objects
or devices being considered for introduction
beyond Zone II should be tested with a strong
handheld magnet (1000-Gauss) and/or a handheld ferromagnetic detection device for ferromagnetic properties before permitting them entry to
Zone III. The results of such testing, as well
as the date, time, and name of the tester, and
methodology used for that particular device,
should be documented in writing. If a device has
not been tested, or if its MR compatibility or
safety status is unknown, it should not be permitted unrestricted access to Zone III.
d. All portable metallic or partially metallic objects
that are to be brought into Zone IV must be prop-
Figure 2. U.S. Food and Drug Administration labeling criteria (developed by ASTM [American Society for Testing and
Materials] International) for portable objects taken into Zone
IV. Square green ‘‘MR safe’’ label is for wholly nonmetallic
objects, triangular yellow label is for objects with ‘‘MR conditional’’ rating, and round red label is for ‘‘MR unsafe’’ objects.
erly identified and appropriately labeled using
the current FDA labeling criteria developed by
ASTM International in standard ASTM F2503
(http://www.astm.org). Those items which are
wholly, nonmetallic should be identified with a
square green ‘‘MR Safe’’ label. Items which are
clearly ferromagnetic should be identified as ‘‘MR
Unsafe’’ and labeled appropriately with the corresponding round red label. Objects with an MR
Conditional rating should be affixed with a triangular yellow MR Conditional label before being
brought into the scan room/Zone IV.
As noted in the introduction to this section B.5,
above, if MR safety data is not prospectively
available for a piece of equipment or object that
requires electricity (or battery power) to operate,
it should not be brought into Zone IV without
being subjected to the testing outlined in ASTM
F2503. If MR safety data is not prospectively
available for a given object that is not electrically
activated (e.g., wash basins, scrub brushes, step
stools), initial testing for the purpose of this
labeling is to be accomplished by the site’s MR
personnel exposing the object to a handheld
magnet (1000-Gauss). If grossly detectable
attractive forces are observed between the object
being tested or any of its components and the
handheld magnet, it is to be labeled with a
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
76
510
circular red ‘‘MR Unsafe’’ label. If no attractive
forces are observed, a triangular yellow ‘‘MR Conditional’’ label is to be attached to the object. It is
only when the composition of an object and its
components are known to be nonmetallic and
not electrically conductive that the green ‘‘MR
Safe’’ label is to be affixed to a device or object.
Particularly with regard to nonclinical and incidental equipment, current products marketed
with ill-defined terminology such as ‘‘nonmagnetic’’, or outdated classifications such as ‘‘MR
compatible’’, should not be presumed to conform
to a particular current ASTM classification. Similarly, any product marketed as ‘‘MR safe’’ but
with metallic construction or components should
be treated with suspicion. Objects intended for
use in Zone IV, including nonclinical incidental
products such as stepping stools or ladders,
which are not accompanied by manufacturer or
third-party MR safety test results under the
ASTM F2503 criteria, should be site tested as
described above.
e. Decisions based on published MR compatibility
or safety claims should recognize that all such
claims apply to specifically tested static field and
static gradient field, strengths and only to the
precise model, make, and identification of the
tested object. For example, ‘‘MR Conditional having been tested to be safe at 3.0 Tesla at gradient
strengths of 400-G/cm or less and normal operating mode.’’,
f. It should be noted that alterations performed by
the site on MR Safe, MR Unsafe, and MR Conditional equipment or devices may alter the MR
safety or compatibility properties of the device.
For example, tying a ferromagnetic metallic twisting binder onto a sign labeling the device as MR
Conditional or MR Safe might result in artifact
induction – or worse – if introduced into the MR
scanner.
Lenz’s Forces:
Faraday’s Law states that a moving or changing magnetic field will induce a voltage in a perpendicularly
oriented electrical conductor. Lenz’s Law builds upon
this and states that the induced voltage will itself be
such that it will secondarily generate its own magnetic
field whose orientation and magnitude will oppose
that of the initial time varying magnetic field that created it in the first place. For example, if an electrical
conductor is moved perpendicularly toward the magnetic field B0 of an MR scanner, even if this conductor
is not grossly ferromagnetic, the motion itself will
result in the generation of voltages within this conductor whose magnitude is directly proportional to
the rate of motion as well as the spatial gradient of
magnetic field B0 through which it is being moved.
Conducting objects turning in the static field will also
experience a torque due to the induced eddy currents.
Lenz’s law states that this induced current will in
turn create a magnetic field whose orientation will
Kanal et al.
oppose the B0 magnetic field that created this
current.
Thus, moving a large metallic but nonferromagnetic
electrical conductor toward the magnet bore will
result in the induction of a voltage and associated
magnetic field which will orient in such a manner and
at such a strength to oppose the motion of the metallic object into the bore of the MR scanner. If, for example, one tries to move a nonferrous oxygen tank into
the bore of an MR scanner, as the scanner bore is
approached Lenz’s forces will be sufficiently strong to
virtually stop forward progress of the tank. Furthermore, the faster one moves the tank into the bore, the
greater the opposing force that is created to stop this
motion.
This also has potential consequence for large
implanted metallic devices such as certain metallic
nonferrous infusion pumps. Although they may not
pose a projectile hazard, rapid motion of the patient/
implant perpendicular to the magnetic field of the MR
imager can be expected to result in forces on the
implant that would oppose this motion and may likely
be detected by the patient. If the patient were to complain of experiencing forces tugging or pulling on the
implant, this might bring the patient or health care
personnel to erroneously conclude that there were
ferrous components to the device, and possible cancellation of the examination. Slowly moving such large
metallic devices into and out of the bore is a key
factor in decreasing any Lenz’s forces that might be
induced, and decrease the likelihood of a misunderstanding or unnecessary study cancellation.
C. MR Technologist
1. MR technologists should be in compliance with
the technologist qualifications listed in the MR
Accreditation Program Requirements.
2. Except for emergent coverage, there will be a
minimum of 2 MR technologists or one MR technologist and one other individual with the designation of MR personnel in the immediate Zone II
through Zone IV MR environment. For emergent
coverage, the MR technologist can scan with no
other individuals in their Zone II through Zone IV
environment as long as there is in-house, ready
emergent coverage by designated department of
radiology MR personnel (e.g., radiology house
staff or radiology attending).
D. Pregnancy Related Issues
1. Health Care Practitioner Pregnancies:
Pregnant health care practitioners are permitted to
work in and around the MR environment throughout
all stages of their pregnancy (13). Acceptable activities
include, but are not limited to, positioning patients,
scanning, archiving, injecting contrast, and entering
the MR scan room in response to an emergency.
Although permitted to work in and around the MR
environment, pregnant health care practitioners are
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
77
ACR Guidance on MR Safe Practices
requested not to remain within the MR scanner
bore or Zone IV during actual data acquisition or
scanning.
2. Patient Pregnancies
Present data have not conclusively documented any
deleterious effects of MR imaging exposure on the
developing fetus. Therefore no special consideration is
recommended for the first, versus any other, trimester
in pregnancy. Nevertheless, as with all interventions
during pregnancy, it is prudent to screen females of
reproductive age for pregnancy before permitting
them access to MR imaging environments. If pregnancy is established consideration should be given to
reassessing the potential risks versus benefits of the
pending study in determining whether the requested
MR examination could safely wait to the end of the
pregnancy before being performed.
a. Pregnant patients can be accepted to undergo MR
scans at any stage of pregnancy if, in the determination of a level 2 MR personnel-designated attending radiologist, the risk–benefit ratio to the patient
warrants that the study be performed. The radiologist should confer with the referring physician
and document the following in the radiology report
or the patient’s medical record:
1. The information requested from the MR study
cannot be acquired by means of nonionizing
means (e.g., ultrasonography).
2. The data is needed to potentially affect the care
of the patient or fetus during the pregnancy.
3. The referring physician believes that it is not
prudent to wait until the patient is no longer
pregnant to obtain this data.
b. MR contrast agents should not be routinely provided to pregnant patients. This decision too, is on
that must be made on a case-by-case basis by the
covering level 2 MR personnel-designated attending
radiologist who will assess the risk–benefit ratio for
that particular patient.
The decision to administer a gadolinium-based MR
contrast agent to pregnant patients should be
accompanied by a well-documented and thoughtful
risk–benefit analysis. This analysis should be able
to defend a decision to administer the contrast
agent based on overwhelming potential benefit to
the patient or fetus outweighing the theoretical but
potentially real risks of long-term exposure of the
developing fetus to free gadolinium ions.
Studies have demonstrated that at least some of
the gadolinium-based MR contrast agents readily
pass through the placental barrier and enter the fetal circulation. From here, they are filtered in the
fetal kidneys and then excreted into the amniotic
fluid. In this location the gadolinium-chelate molecules are in a relatively protected space and may
remain in this amniotic fluid for an indeterminate
amount of time before finally being reabsorbed and
eliminated. As with any equilibrium situation
involving any dissociation constant, the longer the
chelated molecule remains in this space, the
greater the potential for dissociation of the poten-
511
tially toxic gadolinium ion from its ligand. It is
unclear what impact such free gadolinium ions
might have if they were to be released in any quantity in the amniotic fluid. Certainly, deposition into
the developing fetus would raise concerns of possible secondary adverse effects.
The risk to the fetus of gadolinium based MR contrast agent administration remains unknown and
may be harmful.
E. Pediatric MR Safety Concerns
1. Sedation and Monitoring Issues
Children form the largest group requiring sedation for
MRI, largely because of their inability to remain
motionless during scans. Sedation protocols may vary
from institution to institution according to procedures
performed (diagnostic vs. interventional), the complexity of the patient population (healthy preschoolers vs.
premature infants), the method of sedation (mild
sedation vs. general anesthesia) and the qualifications
of the sedation provider.
Adherence to standards of care mandates following
the sedation guidelines developed by the American
Academy of Pediatrics (14,15), the American Society
of Anesthesiologists (16), and the Joint Commission
on Accreditation of Healthcare Organizations (17). In
addition, sedation providers must comply with
protocols established by the individual state and the
practicing institution. These guidelines require the following provisions:
a. Preprocedural medical history and examination
for each patient
b. Fasting guidelines appropriate for age
c. Uniform training and credentialing for sedation
providers
d. Intraprocedural and post procedural monitors
with adaptors appropriately sized for children
(MR Conditional equipment)
e. Method of patient observation (window, camera)
f. Resuscitation equipment, including oxygen delivery and suction
g. Uniform system of record keeping and charting
(with continuous assessment and recording of
vital signs)
h. Location and protocol for recovery and discharge
i. Quality assurance program that tracks complications and morbidity.
For the neonatal and the young pediatric population,
special attention is needed in monitoring body temperature for both hypo- and hyperthermia in addition to
other vital signs (18). Temperature monitoring equipment that is approved for use in the MR suite is readily
available. Commercially available, MR-approved neonatal isolation transport units and other warming devices are also available for use during MR scans.
2. Pediatric Screening Issues
Children may not be reliable historians and, especially for older children and teenagers, should be
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
78
512
questioned both in the presence of parents or guardians and separately to maximize the possibility that all
potential dangers are disclosed. Therefore, it is recommended that they be gowned before entering Zone IV
to help ensure that no metallic objects, toys, etc. inadvertently find their way into Zone IV. Pillows, stuffed
animals, and other comfort items brought from home
represent real risks and should be discouraged from
entering Zone IV. If unavoidable, each should be carefully checked with a powerful handheld magnet and/
or ferromagnetic detector and perhaps again in the
MR scanner before permitting the patient to enter
Zone IV with them to ensure that they do not contain
any objectionable metallic components.
3. MR Safety of Accompanying Family or Personnel:
Although any age patient might request that others
accompany them for their MR examination, this is far
more common in the pediatric population. Those
accompanying or remaining with the patient should
be screened using the same criteria as anyone else
entering Zone IV.
In general, it would be prudent to limit accompanying adults to a single individual. Only a qualified,
responsible MR physician should make screening
criteria exceptions.
Hearing protection and MR safe/MR conditional
seating are recommended for accompanying family
members within the MR scan room.
F. Time Varying Gradient Magnetic Field Related
Issues: Induced Voltages
Types of patients needing extra caution:
Patients with implanted or retained wires in anatomically or functionally sensitive areas (e.g., myocardium
or epicardium, implanted electrodes in the brain)
should be considered at higher risk, especially from
faster MRI sequences, such as echo planar imaging
(which may be used in such sequences as diffusionweighted imaging, functional imaging, perfusion
weighted imaging, MR angiographic imaging, etc.).
The decision to limit the dB/dt (rate of magnetic field
change) and maximum strength of the magnetic field
of the gradient subsystems during imaging of such
patients should be reviewed by the level 2 MR personnel-designated attending radiologist supervising the
case or patient.
G. Time Varying Gradient Magnetic Field Related
Issues: Auditory Considerations
1. All patients and volunteers should be offered and
encouraged to use hearing protection before
undergoing any imaging in any MR scanners.
FDA’s current MR Guidance Document (Attachment B entitled, ‘‘Recommended User Instructions for a Magnetic Resonance Diagnostic
Device’’) states that instructions from manufacturers of MR equipment should state that hearing protection is required for all patients studied
on MR imaging systems capable of producing
Kanal et al.
sound pressures that exceed 99 dB(A). The International standard on this issue (IEC 60601-2-33:
‘‘Particular requirements for the basic safety and
essential performance of magnetic resonance
equipment for medical diagnosis’’), also states
that, for all equipment capable of producing
more than an A-weighted rms sound pressure
level of 99dB(A), hearing protection shall be used
for the safety of the patient and that this hearing
protection shall be sufficient to reduce the Aweighted r.m.s. sound pressure level to below 99
dB(A).
2. All patients or volunteers in whom research
sequences are to be performed (i.e., MR scan
sequences that have not yet been approved by
the Food and Drug Administration) are to have
hearing protective devices in place before initiating any MR sequences. Without hearing protection in place, MRI sequences that are not FDA
approved should not be performed on patients or
volunteers.
H. Time Varying Radiofrequency Magnetic Field
Related Issues: Thermal
1. All unnecessary or unused electrically conductive
materials external to the patient should be
removed from the MR system before the onset of
imaging. It is not sufficient to merely to ‘‘unplug’’
or disconnect unused, unnecessary electrically
conductive material and leave it within the MR
scanner with the patient during imaging. All electrical connections, such as on surface coil leads
or monitoring devices must be visually checked
by the scanning MR technologist before each
usage to ensure the integrity of the thermal and
electrical insulation.
2. Electrical voltages and currents can be induced
within electrically conductive materials that are
within the bore of the MR imager during the MR
imaging process. This might result in the heating
of this material by resistive losses. This heat
might be of a caliber sufficient to cause injury to
human tissue. As noted in section H.9, among the
variables that determine the amount of induced
voltage or current is the consideration that the
larger the diameter of the conductive loops the
greater the potential induced voltages or currents
and, thus the greater the potential for resultant
thermal injury to adjacent or contiguous patient
tissue.
Therefore, when electrically conductive material
(wires, leads, implants, etc.), are required to
remain within the bore of the MR scanner with
the patient during imaging, care should be taken
to ensure that no large-caliber electrically conducting loops (including patient tissue; see section H. 5, below) are formed within the MR
scanner during imaging. Furthermore, it is possible, with the appropriate configuration, lead
length, static magnetic field strength, and other
settings, to introduce resonant circuitry between
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
79
ACR Guidance on MR Safe Practices
the transmitted RF power and the lead. This could
result in very rapid and clinically significant lead
heating, especially at the lead tips, in a matter of
seconds to a magnitude sufficient to result in tissue thermal injury or burns. This can also theoretically occur with implanted leads or wires even
when they are not connected to any other device
at either end. For illustration, the FDA has noted
several reports of serious injury including coma
and permanent neurological impairment in
patients with implanted neurological stimulators
who underwent MR imaging examinations. The
injuries in these instances resulted from heating
of the electrode tips (19,20).
Furthermore, it is entirely possible for a lead or
wire to demonstrate no significant heating while
undergoing MR imaging examinations at 1.5 Tesla
yet demonstrate clinically significant and potentially harmful degrees of heating within seconds
at, for example, 3 Tesla. It has also been demonstrated that leads may demonstrate no significant
heating at 3 Tesla yet may rapidly heat to hazardous levels when undergoing MR imaging at, for
example, 1.5 Tesla. (Personal Observation, MR
Safety testing, E. Kanal, MD, University of Pittsburgh Medical Center MR Research Center, 8/28/
05) Thus at no time should a label of MR Conditional for thermal issues at a given field strength
be applied to any field strength, higher or lower,
other than the specific one at which safety was
demonstrated.
Thus, exposure of electrically conductive leads or
wires to the RF transmitted power during MR
scanning should only be performed with caution
and with appropriate steps taken to ensure significant lead or tissue heating does not result (see
section H.9, below).
3. When electrically conductive materials external to
the patient are required to be within the bore of
the MR scanner with the patient during imaging,
care should be taken to place thermal insulation
(including air, pads, etc.) between the patient and
the electrically conductive material, while simultaneously attempting to (as much as feasible) keep
the electrical conductor from directly contacting
the patient during imaging. It is also appropriate
to try to position the leads or wires as far as possible from the inner walls of the MR scanner if the
body coil is being used for RF transmission. When
it is necessary that electrically conductive leads
directly contact the patient during imaging, consideration should be given to prophylactic application of cold compresses or ice packs to such
areas.
4. There have been rare reports of thermal injuries/
burns associated with clothing that contained
electrically conductive materials, such as metallic
threads, electrically conductive designs, and silver
impregnated clothing. As such, consideration
should be given to having all patients remove
their own clothing and instead change into provided gowns to cover at the very least the region/
volume of the patient that is scheduled to undergo
513
MR imaging and, therefore, RF irradiation.
5. To help safeguard against thermal injuries or
burns, depending on specific magnet designs,
care may be needed to ensure that the patient’s
tissue(s) do not directly come into contact with
the inner bore of the MR imager during the MRI
process. This is especially important for several
higher field MR scanners. The manufacturers of
these devices provide pads and other such insulating devices for this purpose, and manufacturer
guidelines should be strictly adhered to for these
units.
6. It is important to ensure the patient’s tissues do
not form large conductive loops. Therefore, care
should be taken to ensure that the patient’s arms
or legs are not positioned in such a way as to
form a large caliber loop within the bore of the
MR imager during the imaging process. For this
reason, it is preferable that patients be instructed
not to cross their arms or legs in the MR scanner.
We are also aware of unpublished reports of thermal injury that seem to have been associated with
skin-to-skin contact such as in the region of the
inner thighs. It might be prudent to consider
ensuring that skin-to-skin contact instances are
minimized or eliminated in or near the regions
undergoing radiofrequency energy irradiation.
7. Skin staples and superficial metallic sutures:
Patients requested to undergo MR studies in
whom there are skin staples or superficial metallic sutures (SMS) may be permitted to undergo
the MR examination if the skin staples or SMS
are not ferromagnetic and are not in or near the
anatomic volume of RF power deposition for the
study to be performed. If the nonferromagnetic
skin staples or SMS are within the volume to be
RF irradiated for the requested MR study, several
precautions are recommended.
a. Warn the patient and make sure that they are
especially aware of the possibility that they
may experience warmth or even burning along
the skin staple or SMS distribution. The
patient should be instructed to report immediately if they experience warmth or burning
sensations during the study (and not, for
example, wait until the ‘‘end of the knocking
noise’’).
b. It is recommended that a cold compress or ice
pack be placed along the skin staples or SMS if
this can be safely clinically accomplished during the MRI examination. This will help to serve
as a heat sink for any focal power deposition
that may occur, thus decreasing the likelihood
of a clinically significant thermal injury or burn
to adjacent tissue.
8. For patients with extensive or dark tattoos,
including tattooed eyeliner, to decrease the potential for RF heating of the tattooed tissue, it is recommended that cold compresses or ice packs be
placed on the tattooed areas and kept in place
throughout the MRI process if these tattoos are
within the volume in which the body coil is being
used for RF transmission. This approach is
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
80
514
especially appropriate if fast spin echo (or other
high RF duty cycle) MRI sequences are anticipated in the study. If another coil is being used
for RF transmission, a decision must be made if
high RF transmitted power is to be anticipated by
the study protocol design. If so, then the above
precautions should be followed. Additionally,
patients with tattoos that had been placed within
48 h before the pending MR examination should
be advised of the potential for smearing or smudging of the edges of the freshly placed tattoo.
9. The unconscious or unresponsive patient should
have all attached leads covered with a cold compress or ice pack at the lead attachment site for
the duration of the MR study.
10. As noted above, it has been demonstrated that
resonant circuitry can be established during MRI
between the RF energies being transmitted and
specific lengths of long electrically conductive
wires or leads, which can thus act as efficient
antennae. This can result in heating of the tips of
these wires or leads to temperatures in excess of
90 C in a few seconds. Therefore, patients in
whom there are long electrically conductive leads,
such as Swan-Ganz thermodilution cardiac output capable catheters or Foley catheters with electrically conductive leads as well as electrically
active implants containing leads such as pacemakers, ICDs, neurostimulators, and cochlear
implants, let alone electrically active implant such
as pacemakers,, should be considered at risk for
MR studies if the body coil is to be used for RF
transmission over the region of the electrically
conductive lead, even if only part of the lead pathway is within the volume to undergo RF irradiation. This is especially true for higher-field
systems (e.g., greater than 0.5 T) and for imaging
protocols using fast spin echo or other high-RF
duty cycle MRI sequences. Each such patient
should be reviewed and cleared by an attending
level 2 radiologist and a risk benefit ratio assessment performed before permitting them access to
the MR scanner.
11. The potential to establish substantial heating is
itself dependent upon multiple factors, including,
among others, the static magnetic field strength of
the MR scanner (as this determines the transmitted radiofrequencies (RF) at which the device operates) and the length, orientation, and inductance
of the electrical conductor in the RF irradiated
volume being studied. Virtually any lead lengths
can produce substantial heating. Innumerable factors can affect the potential for tissue heating for
any given lead. It is therefore critical to recognize
that of all electrically conductive implants, it is
specifically wires, or leads, that pose the greatest
potential hazard for establishing substantial
power deposition/heating considerations.
Another important consideration is that as a direct
result of the above, it has already been demonstrated in vitro that heating of certain implants or
wires may be clinically insignificant at, for example,
1.5 Tesla but quite significant at 3.0 Tesla. How-
Kanal et al.
ever, it has also been demonstrated that specific
implants might demonstrate no significant thermal
issues or heating at 3.0 Tesla, but may heat to clinically significant or very significant levels in seconds
at, for example, 1.5 Tesla. Thus, it is important to
follow established product MR Conditional labeling
and safety guidelines carefully and precisely, applying them to and only to the static magnetic field
strengths at which they had been tested. MR scanning at either stronger and/or weaker magnetic
field strengths than those tested may result in significant heating where none had been observed at
the tested field strength(s).
I. Drug Delivery Patches and Pads
Some drug delivery patches contain metallic foil.
Scanning the region of the metallic foil may result in
thermal injury (21). Because removal or repositioning
can result in altering of patient dose, consultation
with the patient’s prescribing physician would be indicated in assessing how to best manage the patient. If
the metallic foil of the patch delivery system is
positioned on the patient so that it is in the volume of
excitation of the transmitting RF coil, the case should
be specifically reviewed with the radiologist or physician covering the case. Alternative options may
include placing an ice pack directly on the patch. This
solution may still substantially alter the rate of
delivery or absorption of the medication to the patient
(and be less comfortable to the patient, as well). This
ramification should therefore not be treated lightly,
and a decision to proceed in this manner should be
made by a knowledgeable radiologist attending
the patient and with the concurrence of the referring
physician as well.
If the patch is removed, a specific staff member
should be given responsibility for ensuring that it is
replaced or repositioned at the conclusion of the MR
examination.
J. Cryogen-Related Issues
1. For superconducting systems, in the event of a
system quench, it is imperative that all personnel
and patients be evacuated from the MR scan
room as quickly as safely feasible and the site
access be immediately restricted to all individuals until the arrival of MR equipment service
personnel. This is especially so if cryogenic gases
are observed to have vented partially or completely into the scan room, as evidenced in part
by the sudden appearance of white ‘‘clouds’’ or
‘‘fog’’ around or above the MR scanner. As noted
in section B.3.n above, it is especially important
to ensure that all police and fire response
personnel are restricted from entering the MR
scan room with their equipment (axes, air tanks,
guns, etc.) until it can be confirmed that the
magnetic field has been successfully dissipated,
as there may still be considerable static magnetic
field present despite a quench or partial quench
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
81
ACR Guidance on MR Safe Practices
of the magnet (22).
2. It should be pointed out that room oxygen monitoring was discussed by the MR Blue Ribbon
Panel and rejected at this time because the present oxygen monitoring technology was considered
by industry experts not to be sufficiently reliable
to allow for continued operation during situations of power outages, etc.
K. Claustrophobia, Anxiety, Sedation, Analgesia
and Anesthesia
Adult and pediatric patient anxiolysis, sedation, analgesia, and anesthesia for any reason should follow
established ACR (23), American Society of Anesthesiologists (ASA) (15,24–26), and TJC standards (17).
L. Contrast Agent Safety
1. Contrast agent administration issues:
No patient is to be administered prescription MR
contrast agents without orders from a duly licensed
physician. Intravenous injection-qualified MR technologists may start and attend to peripheral IV access
lines if they have undergone the requisite site-specified training in peripheral IV access and have demonstrated and documented appropriate proficiency in
this area. IV-qualified MR technologists may administer FDA-approved gadolinium-based MR contrast
agents by means of peripheral IV routes as a bolus or
slow or continuous injection as directed by the orders
of a duly licensed site physician.
Administration of these agents is to be performed as
per the ACR policy. The ACR approves of the injection
of contrast material and diagnostic levels of radiopharmaceuticals by certified and/or licensed radiologic technologists and radiologic nurses under the
direction of a radiologist or his or her physician designee who is personally and immediately available, if
the practice is in compliance with institutional and
state regulations. There must also be prior written
approval by the medical director of the radiology
department/service of such individuals. Such approval process must follow established policies and
procedures, and the radiologic technologists and
nurses who have been so approved must maintain
documentation of continuing medical education
related to materials injected and to the procedures
being performed (27).
The name of the administered contrast agent, the
administered dose, and the route (and, if applicable,
rate) of administration as well as any adverse reactions, if any, should be recorded for all contrast
agents administered as part of the executed MR
examination.
2. Prior Contrast Agent Reaction Issues:
a. According to the ACR Manual on Contrast Media
(28) adverse events after intravenous injection of
gadolinium seem to be more common in patients
who had previous reactions to an MR contrast
515
agent. In one study, 16 (21%) of 75 patients who
had previous adverse reactions to MR contrast
agents reacted to subsequent injections of gadolinium. Patients with asthma also seem to be
more likely to have an adverse reaction to administration of a gadolinium-based MR contrast
agent. Patients with allergies also seemed to be at
increased risk (2.0–3.7 times, compared with
patients without allergies). Patients who have had
adverse reactions to iodinated contrast media are
more than twice as likely to have an adverse reaction to gadolinium (6.3% of 857 patients).
b. At present, there are no well-defined policies
for patients who are considered to be at
increased risk for having adverse reaction to
MR contrast agents. However, the following
recommendations are suggested: patients who
have previously reacted to one MR contrast
agent can be injected with another agent if they
are restudied, and at-risk patients can be premedicated with corticosteroids and, occasionally, antihistamines.
c. All patients with asthma, allergic respiratory
histories, prior iodinated or gadolinium-based
contrast reactions, etc. should be followed more
closely as they are at a demonstrably higher risk
of adverse reaction.
3. Severe Renal Disease, Gadolinium-Based MR
Contrast Agents, and Nephrogenic Fibrosing
Dermopathy/Nephrogenic Systemic Fibrosis
(NFD/NSF)
Since the prior version of this document the ACR
decided that MR safety issues related to gadolinium
based contrast agents (GBCA) and NSF would be the
purview of the ACR Committee on Drugs and Contrast
Media. For the recommendations of the ACR Committee on Drugs and Contrast Media regarding GBCA
and NSF, the reader is referred to the most recent
publication of that committee in this regard which
appears in the ACR Manual on Contrast Media, Version 8, Chapter 13, Nephrogenic Systemic Fibrosis.
The most recent version of the ACR Manual on Contrast Media may be downloaded from the American
College of Radiology website at http://www.acr.org/
Quality-Safety/Resources.
M. Patients in Whom There Are or May Be
Intracranial Aneurysm Clips
1. In the event that it is unclear whether a patient
does or does not have an aneurysm clip in place,
plain films should be obtained. Alternatively, if
available, any cranial plain films, CT or MR
examination that may have taken in the recent
past (i.e., subsequent to the suspected surgical
date) should be reviewed to assess for a possible
intracranial aneurysm clip.
2. In the event that a patient is identified to have an
intracranial aneurysm clip in place, the MR examination should not be performed until it can
be documented that the specific manufacturer,
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
82
516
3.
4.
5.
6.
Kanal et al.
model, and type of aneurysm clip within that
patient is MR Safe or MR Conditional. All
documentation of types of implanted clips, dates,
etc. must be in writing and signed by a licensed
physician. Phone or verbal histories and histories
provided by a nonphysician are not acceptable.
Fax copies of operative reports, physician statements, etc. are acceptable as long as a legible
physician signature accompanies the requisite
documentation. A written history of the clip itself
having been appropriately tested for ferromagnetic properties (and description of the testing
methodology used) before implantation by the
operating surgeon is also considered acceptable
if the testing follows the standard test methods
established by ASTM International.
All intracranial aneurysm clips manufactured
1995 or later for which the manufacturer’s product labeling continues to claim MR Conditional
labeling may be accepted for MR scanning without further testing.
Clips manufactured before 1995 require either
pretesting (as per the ASTM F2503 standard
practice guidelines) before implantation or individual review of previous MRI of the clip or brain
in that particular case, if available. By assessing
the size of the artifact associated with the clip
relative to the static field strength on which it
was studied, the sequence type, and the MRI
parameters selected, an opinion may be issued
by one of the site’s level 2 MR attending radiologists as to whether the clip demonstrates significant ferromagnetic properties or not. Access to
the MR scanner would then be based on that
opinion.
A patient with an aneurysm clip (or other
implant) may have safely undergone a prior MR
examination at any given static magnetic field
strength. This fact in and of itself is not sufficient
evidence of the implant’s MR safety and should
not solely be relied upon to determine the MR
safety or compatibility status of that aneurysm
clip (or other implant).
Variations in static magnetic field strength, static
magnetic field spatial gradient, orientation of the
aneurysm clip (or other implant) to the static
magnetic field or static field gradient, rate of
motion through the spatial static field gradient,
etc. are all variables that are virtually impossible
to control or reproduce. These variables may not
have resulted in adverse event in one circumstance but may result in significant injury or
death on a subsequent exposure. For example, a
patient who went blind from interactions between
the metallic foreign body in his retina and the
spatial static fields of the MR scanner entered
the magnet and underwent the entire MR examination without difficulty; he only went blind
upon exiting the MR scanner at the completion of
the examination.
Barring availability of either pretesting or prior
MRI data of the clip in question, a risk–benefit
assessment and review must be performed in
each case individually. Furthermore, for
patients with intracranial clips with no available
ferromagnetic or imaging data, should the risk–
benefit ratio favor the performance of the MR
study, the patient or guardian should provide
written informed consent that includes death as
a potential risk of the MRI procedure before permitting that patient to undergo an MR
examination.
N. Patients in Whom There are or May Be
Cardiac Pacemakers or Implantable
Cardioverter Defibrillators
MRI of Cardiac Implantable Devices
Background: Cardiac implantable electronic devices
(CIEDs) have expanded in number and complexity
since their introduction in 1958 and now include cardiac pacemakers, implantable cardioverter-defibrillators (ICD), implantable cardiovascular monitors (ICM)
and implantable loop recorders (ILR). Pacemakers
(pulse generators) and leads that are FDA labeled MR
conditional became available in the U.S., February of
2011 and both commercially available ILRs are
labeled also ‘‘MR Conditional’’ The vast majority of
CIEDs, however, are not labeled as MR Conditional.
No ICDs are currently labeled ‘‘MR Conditional’’ and
none are expected to be clinically available for several
years. Patient product wallet identification cards,
industry maintained databases, plain film lead and
pulse generator X-ray identifiers, and operative notes
may assist in identification of MR Conditional patient
hardware.
Radiologists and cardiovascular specialists must be
familiar with restrictions for each device, recognizing
that because each MR conditional device is unique,
there are no ‘‘universal’’ labeling guidelines that are
applicable for all. Failure to follow the product labeling for a particular device is ‘‘off-label’’ and could
result in an adverse event.
Potential Complications: Unexpected programming
changes, inhibition of pacemaker output, failure to
pace, transient asynchronous pacing, rapid cardiac
pacing, the induction of ventricular fibrillation, heating of the tissue adjacent to the pacing or ICD system
and especially cardiac tissue near the lead tip, early
battery depletion, and outright device failure requiring
replacement may occur during MRI of patients with
pacemakers or ICDs (18,29–31). Multiple deaths have
been documented to occur under poorly and incompletely characterized circumstances when CIED
patients underwent MRI (32–34). These deaths may
have occurred as a result of pacemaker inhibition,
failure to capture or device failure (resulting in prolonged asystole) and or rapid cardiac pacing or asynchronous pacing (resulting in the initiation of ventricular tachycardia or fibrillation).
Patient Assessment: Most CIEDs can be viewed as
having a pacing or defibrillator ‘‘system’’ comprised of
a pulse generator and one or more leads. Current
insertable loop recorders are leadless and are for
monitoring
(not
therapeutic)
purposes
alone.
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
83
ACR Guidance on MR Safe Practices
Importantly, leads and occasionally pulse generators
may have been ‘‘abandoned’’ in the patient from previous implants. As such, each patient may have a ‘‘system’’ that includes both active and inactive (abandoned)
hardware.
While
electrically
and
therapeutically inactive with regard to pacing functionality outside the MR suite, abandoned hardware
may pose a substantial risk if exposed to MRI energies
irrespective of the MR compatibility of the active pacing hardware (35). Indeed, abandoned leads may well
pose a greater relative risk of lead tip heating if
exposed to the MR imaging process than leads that
are part of an actively implanted system.
The experience with MR imaging in patients who
have retained metallic materials after cardiac surgery
such as epicardial pacing leads is perhaps helpful
(36). While some have produced survey data suggesting that in the case of postoperatively retained cardiac
pacing wires, ‘‘the absence of reported complications
in thousands of exposed patients suggests that the
risk is low (37), others have voiced appropriate concern as to the general relevance of this data to the
overall population (38).’’
Patient Assessment for MRI
All device hardware should be included in the practitioner’s assessment of the patient’s suitability for MR
scanning. Coordination with the physician managing
the device (cardiologist/electrophysiologist) and a
representative from the device manufacturer is of
paramount importance to determine whether the
system (pulse generator and leads) is MR Conditional. Practitioners and their staff should note that
the entire system (pulse generator and leads) must
be labeled ‘‘MR Conditional’’ for a system to in fact
be considered MR conditionally safe. Furthermore,
an MR Conditional system is only considered safe if
all of the MR conditions for safe use are followed.
The presence of abandoned leads from previous nonlabeled systems or ‘‘mix-and-match’’ systems (combined MR Conditional labeled and nonlabeled hardware) renders the system as a whole MR Unsafe or
at best ‘‘MR unknown’’. Importantly, because of the
potential for heating, an abandoned (unattached to a
pulse generator) MR Conditional lead should be considered, and from a risk assessment point of view,
treated as, MR Unsafe.
The patient’s attestations as to their device MR compatibility is not sufficient to establish MR safety. To
provide for the safest scanning experience, to minimize confusion and disappointment, to prevent delays
in diagnosis due to rescheduling, and to limit the
potential for throughput disruption in an already
busy MR schedule, we recommend the development of
institutional policies, protocols and care pathways for
all patients with implantable rhythm devices irrespective of their labeling. Careful, thoughtful advance
planning and close collaboration between the radiology and cardiology staffs and the industry representatives of the device manufacturers will provide the
greatest likelihood for a consistent, safe experience.
517
Unlabeled Cardiac Devices: Amongst the patients
with MR unsafe CIEDs, many have conditions that
would ordinarily be assessed with MRI. While many
can have their medical conditions managed without
MRI, in some instances, specific clinical circumstances may present compelling reasons for undergoing
an MR examination (39). Should MRI be considered, it
should be evaluated on a case-by-case and site-bysite basis and only if the site is manned with individuals with the appropriate radiology and cardiology
knowledge and expertise on hand.
The committee eschews the term ‘‘modern’’ when
referring to a particular device, recognizing that all
devices not labeled for use in the MRI contain legacy
components and designs that may not be resistant to
the forces and electromagnetic interference present in
the MRI suite. All devices, unless appropriately tested
and labeled, should never be regarded as safe for
MRI simply because they are ‘‘modern’’ or recently
manufactured.
Consent: The patient with a pacemaker or ICD that
is not labeled as MR Conditional should be apprised
of the risks associated with MRI and should provide
informed consent. While the majority of reported
deliberate scans of device patients have proceeded
without adverse effects when appropriate precautions were undertaken, several have not, and there
is under-reporting of adverse events, including
deaths. Thus, assignment of a risk benefit ratio to
the performance of MRI in any given device patient
is difficult. While the risk may be low, patients with
devices that are not labeled as MR Conditional
should be advised that life-threatening arrhythmias
might occur during MRI and serious device malfunction might occur requiring replacement of the device.
Precautions during MRI with CIEDs: Should any MRI
examination be contemplated for a patient with an
implanted pacemaker or ICD, it is recommended that
radiology and cardiology personnel and a fully stocked
crash cart be readily available throughout the procedure in case a significant arrhythmia develops during
the examination that does not terminate with the
cessation of the MR study. The cardiologist should be
familiar with the patient’s arrhythmia history and the
implanted device. A programmer that can be used to
adjust the device should be readily available. The goal
of pre-MRI programming should be to mitigate the
risk to the patient and the device while undergoing
MRI (40,41). All such patients should be actively
monitored throughout the examination. A central
monitoring facility located in the hospital with appropriately trained staff may be sufficient to monitor
appropriately selected low risk device patients undergoing MR scanning.
At a minimum, EKG and pulse oximetry should be
used for monitoring these patients. At the conclusion
of the examination, the device should be interrogated
to confirm that the function is consistent with
the pre-examination state. In the absence of detected
post MR anomalies, the value of repeating device
re-evaluation is controversial. However, the clinician
may recommend a post-scan follow-up check of the
patient’s device (1–6 weeks) following the scan to
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
84
518
confirm appropriate function. For appropriately
selected patients who have no post-MRI device abnormalities demonstrated, remote follow-up through
home monitoring seems appropriate. There is no compelling evidence that post MRI defibrillation threshold
testing is required if the MR-exposed ICD shows no
post MRI anomalies (42).
Should an MRI (or entry into the magnet area) be
performed inadvertently on a patient with a pacemaker or ICD, the patient’s cardiologist should be
contacted before the patient’s discharge from the MRI
suite. Exposure to the static magnetic field alone may
adversely affect device function or alter its programming (43–45). The importance of interrogation of the
device before the patient’s leaving the MRI suite cannot be overstated.
APPENDIX 1
Kanal et al.
ZONE DEFINITIONS
Zone I
This region includes all areas that are freely accessible to the general public. This area is typically outside
the MR environment itself and is the area through
which patients, health care personnel, and other
employees of the MR site access the MR environment.
Zone II
This area is the interface between the publicly accessible uncontrolled Zone I and the strictly controlled
Zone III (see below). Typically, the patients are greeted
in Zone II and are not free to move throughout Zone II
at will, but rather are under the supervision of MR
personnel. It is in Zone II that the answers to MR
screening questions, patient histories, medical insurance questions, etc. are typically obtained.
Personnel Definitions
Non-MR Personnel
Patients, visitors or facility staff who do not meet the
criteria of level 1 or level 2 MR personnel will be
referred to as non-MR personnel. Specifically, non-MR
personnel will be the terminology used to refer to any
individual or group who has not within the previous
12 months undergone the designated formal training
in MR safety issues defined by the MR safety director
of that installation.
Level 1 MR Personnel
Individuals who have passed minimal safety educational efforts to ensure their own safety as they work
within Zone III will be referred to as level 1 MR personnel (e.g., MRI department office staff, and patient
aides.)
Level 2 MR Personnel
Individuals who have been more extensively trained
and educated in the broader aspects of MR safety
issues, including, issues related to the potential for
thermal loading or burns and direct neuromuscular
excitation from rapidly changing gradients, will be
referred to as level 2 MR personnel (e.g., MRI technologists, radiologists, radiology department nursing
staff.)
Zone III
This area is the region in which free access by
unscreened non-MR personnel or ferromagnetic
objects or equipment can result in serious injury or
death as a result of interactions between the individuals or equipment and the MR scanner’s particular environment. These interactions include, but are not
limited to, those with the MR scanner’s static and time
varying magnetic fields. All access to Zone III is to be
strictly physically restricted, with access to regions
within it (including Zone IV; see below) controlled by,
and entirely under the supervision of, MR personnel.
Zone IV
This area is synonymous with the MR scanner magnet
room itself. Zone IV, by definition, will always be
located within Zone III as it is the MR magnet and its
associated magnetic field which generates the existence of Zone III.
Non-MR Personnel should be accompanied by, or
under the immediate supervision of and visual contact with, one specifically identified level 2 MR person
for the entirety of their duration within Zone III or IV
restricted regions.
Level 1 and 2 MR personnel may move freely about
all zones.
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
85
ACR Guidance on MR Safe Practices
519
APPENDIX 2
Safety Screening Form for Magnetic Resonance (MR) Procedures
Date________ Name (first middle last)_________________________________________________________________________
Female [ ] Male [ ]
Age_____
Date of Birth________
Height_______
Weight______
Why are you having this examination (medical problem)?___________________________________________________
_____________________________________________________________________________________________________________
YES
NO
Have you ever had an MRI examination before and had a problem?
_____
_____
If yes, please describe_____________________________________________________________________________________
Have you ever had a surgical operation or procedure of any kind?
_____
_____
If yes, list all prior surgeries and approximate dates: _______________________________________________________
Have you ever been injured by a metal object or foreign body (e.g., bullet, BB shrapnel)?
_____
_____
If yes, please describe_____________________________________________________________________________________
Have you ever had an injury from a metal object in your eye (metal slivers,
metal shavings, other metal object)?
If yes, did you seek medical attention?
If yes, describe what was found__________________________________________________________
_____
_____
_____
_____
Do you have a history of kidney disease, asthma, or other allergic respiratory disease?
_____
_____
Do you have any drug allergies?
_____
_____
If yes, please list drugs____________________________________________________________________________________
___________________________________________________________________________________________________________
Have you ever received a contrast agent or X-ray dye used for MRI, CT,
or other X-ray or study?
_____
_____
Have you ever had an X-ray dye or magnetic resonance imaging (MRI)
contrast agent allergic reaction?
_____ _____
If yes, please describe_____________________________________________________________________________________
___________________________________________________________________________________________________________
Are you pregnant or suspect you may be pregnant?
_____
_____
Are you breast feeding?
_____
_____
Date of last menstrual period______ Post-menopausal?
_____
_____
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
86
520
Kanal et al.
MR Hazard Checklist
Please mark on the drawings provided the location of any metal inside your body or site of surgical
operation.
The following items may be harmful to you during your MR scan or may interfere with the MR examination.
You must provide a ‘‘yes’’ or ‘‘no’’ for every item. Please indicate if you have or have had any of the following:
YES
NO
____
____ Any type of electronic, mechanical, or magnetic implant
Type_________________
____
____ Cardiac pacemaker
____
____ Aneurysm clip
____
____ Implanted cardiac defibrillator
____
____ Neurostimulator
____
____ Biostimulator
Type__________________
____
____ Any type of internal electrodes or wires
____
____ Cochlear implant
____
____ Hearing aid
____
____ Implanted drug pump (e.g., insulin, Baclofen, chemotherapy, pain medicine)
____
____ Halo vest
____
____ Spinal fixation device
____
____ Spinal fusion procedure
____
____ Any type of coil, filter, or stent
Type__________________
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
87
ACR Guidance on MR Safe Practices
____
____ Any type of metal object (e.g., shrapnel, bullet, BB)
____
____ Artificial heart valve
____
____ Any type of ear implant
____
____ Penile implant
____
____ Artificial eye
____
____ Eyelid spring
____
____ Any type of implant held in place by a magnet
521
Type___________________
____
____ Any type of surgical clip or staple
____
____ Any IV access port (e.g., Broviac, Port-a-Cath, Hickman, Picc line)
____
____ Medication patch (e.g., Nitroglycerine, nicotine)
____
____ Shunt
____
____ Artificial limb or joint
What and where______________
____
____ Tissue Expander (e.g., breast)
____
____ Removable dentures, false teeth or partial plate
____
____
Diaphragm, IUD, Pessary
Type________________________
____
____ Surgical mesh
Location_____________________
____
____ Body piercing
Location_____________________
____
____ Wig, hair implants
____
____ Tattoos or tattooed eyeliner
____
____ Radiation seeds (e.g., cancer treatment)
____
____ Any implanted items (e.g., pins, rods, screws, nails, plates, wires)
____
____ Any hair accessories (e.g., bobby pins, barrettes, clips)
____
____ Jewelry
____
____ Any other type of implanted item
Type_____________________
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
88
522
Kanal et al.
Instructions for the Patients
1. You are urged to use the ear plugs or headphones that we supply for use during your MRI examination
because some patients may find the noise levels unacceptable, and the noise levels may affect your
hearing.
2. Remove all jewelry (e.g., necklaces, pins, rings).
3. Remove all hair pins, bobby pins, barrettes, clips, etc.
4. Remove all dentures, false teeth, partial dental plates.
5. Remove hearing aids.
6. Remove eyeglasses.
7. Remove your watch, pager, cell phone, credit and bank cards and all other cards with a magnetic strip.
8. Remove body piercing objects.
9. Use gown, if provided, or remove all clothing with metal fasteners, zippers, etc.
I attest that the above information is correct to the best of my knowledge. I have read and understand the
entire contents of this form, and I have had the opportunity to ask questions regarding the information on this
form.
Patient signature___________________________________
MD/RN/RT signature______________________________
Date___________
Print name of MD, RN, RT__________________________
_____________________________________________________________________________________________________________
For MRI Office Use Only
Patient Name________________________________________
Patient ID Number__________________________________
Referring Physician_______________________
Procedure__________________________________________
Diagnosis_______________________
Clinical History_____________________________________
Hazard Checklist for MRI Personnel
YES
NO
____
____ Endotracheal tube
____
____ Swan-Ganz catheter
____
____ Extra ventricular device
____
____ Arterial line transducer
____
____ Foley catheter with temperature sensor and/or metal clamp
____
____ Rectal probe
____
____ Esophageal Probe
____
____ Tracheotomy tube
____
____ Guidewires
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
89
ACR Guidance on MR Safe Practices
APPENDIX 3
MR Facility Safety Design Guidelines
The goal of MR safety is to prevent harm to patients,
though a MR facility cannot simply adopt one or two
interventions and hope to successfully attain this
objective. According to safety and human factors engineering principles, multiple safety strategies must be
adopted to be effective. This approach is sometimes
termed ‘‘defense in depth.’’ The safety strategies outlined in the main body of this MR Safe Practice Guidelines document include, for instance, policies that
restrict personnel access, specialized training and
drills for MR personnel, and warning labels for devices to be brought into Zone IV regions.
Along with these people-oriented strategies of policies and training, organizations need also to adopt the
strategies of safety-oriented architectural and interior
design. These design elements can support the other
safety strategies, by making them easier or more
obvious to follow. The architectural enhancements
described herein add one or more strong barriers to
enhance ‘‘defense in depth’’.
This appendix includes descriptions of architectural
and interior design recommendations organized
around the many MR suite functional areas. Note that
a facility’s design can encourage safety and best practices by improving the flow of patients, various healthcare personnel, and equipment and devices, and not
just by to preventing MR unsafe items from becoming
missiles, or screening out patients with hazardous
implanted devices.
Placing design elements strategically in a suite layout such that the element supports best practice
workflow patterns will increase compliance with safer
practices. For example, having a private area for
patient screening interviews will make it more likely
the patients will disclose sensitive types of implants.
Another example of designing for safety is to include
dedicated space and temporary storage for MR Unsafe
equipment (e.g., ferromagnetic IV poles, transport
stretchers) out of direct sight and away from people
flow patterns.
Effective and safe MRI suites must balance the
technical demands of the MR equipment with local
and state building codes, standards of accrediting
bodies, clinical and patient population needs, payor
requirements and a collage of civil requirements from
Health Insurance Portability and Accountability Act
(HIPAA) to the Americans with Disabilities Act (ADA).
In an effort to better match appropriate facility
design guidelines with levels of patient acuity and
care, the ACR MR Safety Committee is currently
developing level designations for MRI facilities in conjunction with the efforts of Committees from other
Societies and Organizations. These will address customization of requirements for sites with varying
anticipated patient care sedation, anesthesia, and/or
interventional activities.
While it would be desirable to provide a universal
MRI suite safety design, the variables are too numerous to adequately address in a single template. The
following MRI Facility Safety Design Guidelines are
523
provided to provide information in support of planning, design and construction of MR facilities, including updates to existing MR facilities, which enhance
the safety of patients, visitors and staff. This information is intended to supplement and expand upon
patient safety guidance provided throughout the ACR
MR Safe Practice Guidelines document.
1. MR Equipment Vendor Templates
Design templates provided by MR equipment manufacturers are invaluable in developing suites that
meet the minimum technical siting requirements for
the specific equipment. Vendor design templates,
however, typically depict only the control and equipment rooms, in addition to the magnet room, Zone IV.
Patient/family waiting, interview areas, physical
screening/changing areas, access controls, storage,
crash carts, induction, medical gas services,
postscreened patient holding areas, infection control
provisions, and interventional applications, among
many other issues, are not addressed in typical vendor provided drawings. These issues are left to facility
owners, operators and their design professionals to
resolve. The guidance which follows is designed to
address many of these issues which directly impact
safety within the MR suite.
2. Patient interview/clinical screening areas (Zone II)
Reviewing the patient Safety Screening Form and MR
Hazard Checklist requires discussing confidential personal information. To facilitate full and complete
patient disclosure of their medical history, this clinical screening should be conducted in an area which
provides auditory and visual privacy for the patient.
Facilities should prospectively plan for electronic
patient medical records, which are useful in clinical
screening, and should provide for access to records in
the MR suite in support of clinical patient screening.
Clinical screening of inpatients may be completed in
the patient room for hospital-based MR facilities.
However, all screenings are to be double-checked and
verified by appropriately trained MR Personnel before
MR examination.
3. Physical screening and patient changing/gowning
rooms (Zone II)
All persons and objects entering Zone III should be
physically screened for the presence of ferromagnetic
materials which, irrespective of size, can become
threats in proximity to the MR. A location should be
provided for patients in which they may change out of
their street clothes and into a facility provided gown
or scrubs, if/as deemed appropriate. For those facilities which either do not provide space for, or do not
require, patient changing, the facility must provide alternative means of identifying and removing items
which the patient may have brought with them that
might pose threats in the MR environment.
A high-strength hand-held magnet is a recommended tool to evaluate the gross magnetic characteristics of objects of unknown composition. Magnetic
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
90
524
strength for these permanent magnets fall off quickly
as one moves away from the face of the magnet. Thus,
these may not demonstrate attraction for ferromagnetic components which are not superficially located
or cannot for whatever reason be brought into close
proximity with the surface of this hand-held magnet.
Ferromagnetic detection systems have been demonstrated to be highly effective as a quality assurance
tool, verifying the successful screen and identifying
ferromagnetic objects which were not discovered by
conventional screening methods. It is recommended
that new facility construction anticipate the use of
ferromagnetic detection screening in Zone II and provide for installation of the devices in a location which
facilitates use and throughput. Many current ferromagnetic detection devices are capable of being positioned within Zone III, even at the door to the magnet
room, however a recommended use of ferromagnetic
detection is to verify the screening of patients before
passing through the controlled point of access into
Zone III.
Physical screening of patients should consist of removal of all jewelry, metallic/ferromagnetic objects,
onplants and prostheses (as indicated by manufacturer’s conditional use requirements and physician
instructions), and either having patients change out
of their street clothes into facility provided gowns/
scrubs or thorough screening of street clothes, including identifying the contents of pockets and composition of metallic fibers, fasteners, and reinforcing.
While gowning maybe helpful, it is certainly not fool
proof in precluding a patient from entering with ferromagnetic material on them.
4. Transfer Area/Ferrous Quarantine Storage (Zone II)
Patients arriving with wheelchairs, walkers, portable
oxygen and other appliances that may be unsafe in
the MR environment should be provided by the facility
with appropriate MR safe or MR conditional appliances. An area should be provided to transfer the
patient from unsafe appliances to ones appropriate to
the MR environment. Unsafe appliances brought by
the patient should be secured in a ‘ferrous quarantine’ storage area, distinct from storage areas for MR
safe and MR conditional equipment and ideally locked
out of sight. Patient belongings should be retrieved
from the ‘ferrous quarantine’ only when discharging
the patient to whom the objects belong from the MR
suite.
5. Access control (Zone III/Zone IV)
Means of physically securing and restricting access to
Zone III from all adjacent areas must be provided. Independent access into Zone III must be limited to only
appropriately trained MR personnel.
6. Patient Holding (Zone III)
Depending upon facility capacity and patient volume,
it may be advisable to provide a postscreened patient
holding area. Zone III holding areas should be
equipped and appointed to prevent patient exit and
Kanal et al.
subsequent re-entry. This will help prevent the inadvertent—or even intentional—introduction of unscreened objects and personnel.
Many multi-modal radiology facilities combine
patient holding and/or induction areas for patients of
different modalities. This presents safety challenges
when, for example, patients scheduled to receive a CT
are held in a patient holding area shared by
postscreened MR patients. As CT patients would not
typically be screened for MR contraindications or ferrous materials, this poses risks to both the CT patient
with a contraindicated implant and to those in the
MRI zone IV should an unscreened individual inadvertently enter with a ferrous object or implant.
Unless all persons in patient holding areas used for
postscreened MR patients are screened for MRI, the
practice of shared patient holding areas between MR
and other modalities is discouraged. Ultimately it is
the responsibility of trained MR staff to verify the
screening of any co-mingled patient before permitting
them access to Zone III and Zone IV.
In all MR facilities, Zone III is required to be physically secured and access limited to only MR personnel
and successfully MR prescreened non-MR personnel
accompanied by MR personnel. Ideally, facilities
should be designed such that patients for other
modalities are not co-mingled with postscreened MR
patients.
7. Lines of Sight/Situational Awareness (Zone III)
Trained MR personnel are arguably the single greatest
safety resource of MR facilities. These individuals
should be afforded visual control over all persons
entering or exiting Zones III or IV. The technologist
seated at the MR operator console should therefore be
able to view not only the patient in the MR scanner
but also the approach and entrance into Zone IV. Line
of sight between the MR system operator console and
both the Zone IV entrance(s) and the patient within
the MR scanner are requirements of the 2010 edition
of Guidelines for Design and Construction of Health
Care Facilities (46). When practical, suites should
also be prospectively designed to provide a view from
the MR operator’s console to patient holding areas. If
this cannot be satisfactorily achieved by direct line of
sight, remote video viewing devices are an acceptable
substitute toward accomplishing this objective.
The technologist at the console should also be provided with a view to induction/recovery areas within
the MR suite, as applicable.
8. Emergency Resuscitation Equipment
(Zone II or Zone III)
Because of risks associated with contrast agents,
sedation, anesthesia, and even the frail health of
patients undergoing MR examinations, it is advised
that each facility have appropriate provisions for stabilization and resuscitation of patients.
It is recommended that crash carts and emergency
resuscitation equipment be stored in a readily accessible area within either Zone II or Zone III. This emergency resuscitation equipment is to be appropriately
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
91
ACR Guidance on MR Safe Practices
labeled and also tested and verified as safe for usage
in the MR environment for the anticipated conditions
of usage.
MR facilities should maintain a supply of emergency
medications to treat adverse reactions to administered
contrast agents.
MR facilities providing care to patients who require
clinical support during the MR examination should
have emergency response equipment and personnel,
trained in MR safety issues as well as trained to
respond to anticipatable adverse events, readily available to respond to patient adverse events or distress
in the MR arena.
9. Fringe Magnetic Field Hazards (Zone III)
For many MR system installations, magnetic fringe
fields which project beyond the confines of the magnet
room superimpose potential hazards on spaces which
may be outside the MR suite, potentially on levels
above or below the MR site and perhaps even outside
the building. Facilities must identify all occupy-able
areas, including those outside the MR suite (including
rooftops, storage areas, mechanical closets, etc.)
which are exposed to potentially hazardous magnetic
fringe field strengths. Areas of potential hazard must
be clearly identified and access to these areas
restricted, just as they would be within the MR suite.
10. Cryogen Safety (Zone IV)
Liquid helium and liquid nitrogen represent the most
commonly used cryogens in MR environments. The
physical properties of these cryogenic liquids present
significant potential safety hazards. If exposed to
room air these cryogenic liquids will rapidly boil off
and expand into a gaseous state. This produces several potential safety concerns, including:
• Asphyxiation potential as cryogenic gases replace
oxygenated air.
• Frostbite considerations at the exceedingly low
temperatures of these cryogenic liquids.
• Fire hazards can exist in the unlikely event of a
quench, especially if some of the cryogenic gases
escape into the magnet room/Zone IV
• Pressure considerations within Zone IV can rarely
exist in the unlikely event of a quench in which
some of the cryogenic gases escape into the magnet room/Zone IV.
a. Cryogen Fills. Though contemporary superconducting magnets require cryogen re-fills only infrequently, there is still almost always the need to
periodically bring hundreds of liters of liquid cryogen
to the magnet. It is because of the risks to persons
near the magnet and storage/transport dewars that
trans-fill operations should be undertaken with great
care and only by appropriately trained personnel.
• Dewars containing cryogenic liquids should never
be stored inside an MRI facility or indeed in any
enclosed facility unless it is in a facility specifically designed to obviate the associated pressure,
temperature, and asphyxiation risks.
525
• A cryogen transfill should never be attempted by
untrained personnel or even with any unnecessary personnel in attendance, including MR personnel staff and patients, within Zone IV.
• Cryogen transfills should only be performed with
appropriate precautions in place to prevent
against pressure entrapment and asphyxiation.
b. Magnet Room Cryogen Safety. For most MRI systems if the magnet quenches, the escaping cryogenic
gases are ducted outside the building to an unoccupied discharge area. However, there have been documented failures of cryogen vent/quench pipe
assemblies which have led to considerable quantities
of cryogenic gases being inadvertently discharged into
the magnet room/Zone IV. The thermal expansion of
the cryogens, if released into the magnet room, can
positively pressurize the magnet room and entrap persons inside until such time that the pressure is
equalized.
The following recommended MRI suite design and
construction elements reduce patient and staff risks
in the unlikely event of a quench in which the cryogen
vent pathway (quench pipe) ruptures or leaks into
Zone IV:
• All magnet rooms/Zone IV regions for superconducting magnets should be provided with an
emergency exhaust pathway. The emergency
exhaust grille is to be located in the ceiling opposite the entrance to the magnet room (Zone IV)
door. At this location, when activated in the
unlikely event of a quench breach, the exhaust
fan is positioned to draw the vaporous cloud of
cryogenic gas away from the door exiting from the
magnet room.
• Many MR manufacturers are now requiring that
magnet rooms for superconducting magnets also
be provided with an additional form of passive
pressure relief/pressure equalization to minimize
the risks of positive-pressure entrapment. Designs
for passive pressure relief mechanisms should follow design criteria similar to that of cryogen vent
pathway and active exhaust, including discharge
to a protected area as described in section 10.c
below.
Some MR facilities are constructed without open
waveguides or glass observation windows to Zone IV
regions. In these facilities the potential risks of
entrapment are even greater and may warrant an
additional degree of attention in this regard.
While it can provide a degree of redundancy, it
should be noted that, even with an exhaust fan,
designing the door to Zone IV to swing outward is not,
by itself, an appropriate means of pressure relief. In a
severe positive pressure situation unlatching an outward-swinging door might permit the door to burst
open with tremendous pressure, potentially injuring
person(s) opening the door. If used as the only means
of pressure equalization, an outward-swinging door
may actually introduce new hazards to any staff person attempting to open the door to a pressurized magnet room from the outside.
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
92
526
Kanal et al.
Similarly, though it has proven effective in lifethreatening situations, breaking a control window
should not be advocated as a primary means of relieving/equalizing Zone IV pressure in a quench situation. It should be noted that the current construction
of many RF shielded observation windows is such
that it would make breaking the window very difficult,
further diminishing it as a viable means of timely
pressure relief.
Once provided with appropriate pressure equalization and emergency exhaust, magnet room door swing
direction and design should be left to the discretion of
a facility and their design professionals.
c. Cryogen Vent Pathway. Obstructions, inappropriate pipe materials, insufficient pipe caliber and/or
length, or faulty connections in the length of the cryogen vent pathway can cause failure between the magnet and point of discharge. An evaluation of the
current cryogen vent piping/ducting assembly is recommended to help identify and correct potential
weaknesses that could potentially fail in a quench.
Facilities are advised to evaluate the design and
inspect the construction of their cryogen vent system.
Because minimum design requirements for some
cryogen vent systems have been revised by magnet
system vendors, facilities should obtain current
standards from the original equipment manufacturers
to use in evaluating their cryogen vent assembly and
not rely on original siting requirements.
Beyond the assessment of the current construction of
the cryogen vent system, it is prudent for MRI facilities:
• To inspect cryogen vent systems at least annually,
•
•
•
•
identifying stress/wear of pipe sections and
couplings, loose fittings and supports or signs of
condensation/water within the cryogen vent pathway which may indicate a blockage.
Following any quench of a superconducting magnet, to conduct a thorough inspection of cryogen
vent system, including pipe sections, fittings,
couplings, hangers and clamps, before returning
the magnet to service.
Because obstructions/occlusions of the cryogen
vent can increase the likelihood of rupture in a
quench event, facilities should ensure that:
The discharge point has an appropriate weatherhead which prevents horizontal, wind-driven precipitation from entering, collecting, or freezing in
the quench exhaust pipe.
The discharge point is high enough off of the roof
or ground surface that snow or debris cannot
enter or occlude the pipe.
The discharge is covered by a material of sufficiently small openings to prevent birds or other
animals from entering the quench pipe, while not
occluding cryogenic gaseous egress in a quench
situation.
Facilities that discover failings in any of these basic
protections of the cryogen discharge point should immediately take additional steps to verify the patency
of the cryogen vent and provide the minimum current
discharge protections recommended by the original
equipment manufacturer.
To protect persons from cryogen exposure at the
point of discharge:
• At the point of cryogen discharge, a quench safety
exclusion zone with a minimum clear radius of 25
feet (8 meters) should be established and clearly
marked with surface warnings and signage.
• The quench safety exclusion zone should be
devoid of serviceable equipment, air intakes, operable windows or unsecured doors that either
require servicing or offer a pathway for cryogenic
gasses to re-enter the building.
• Persons who must enter this quench safety exclusion zone, including incidental maintenance personnel and contractors, should be permitted to do
so only after receiving specific instruction on
quench risks and response.
11. MR Conditional Devices (Zone IV)
The normal or safe operation of many medical devices
designed for use in the MR environment may be disrupted by exposure to conditions exceeding the device’s
conditional rating threshold. It is advisable for MR facilities to identify the allowable conditional rating for static
field and spatial gradient exposure for each MR Conditional device which may be brought into Zones III and
IV. MR Conditional devices may be conditionally safe for
one specific field strength, but unsafe at higher or lower
field strength. For prospective installations it is recommended that the location of critical isogauss line(s) be
identified for MR Conditional equipment and devices
used within the MR suite and delineated on the floor
and walls of the magnet room to aid in the positioning
and safe and effective operation of said equipment.
All MR facilities should evaluate all MR Conditional
patient monitoring, ventilators, medication pumps,
anesthesia machines, monitoring devices, biopsy and
other devices and equipment which may be brought
into the magnet room for magnetic field tolerances.
Facilities should consider providing physical indications of critical gauss lines in the construction of the
magnet room to promote the safe and effective use of
MR Conditional equipment, as appropriate.
12. Infection control (Zone IV)
Because of safety concerns regarding incidental personnel within the MR suite, restricting housekeeping
and cleaning personnel from Zone III and/or IV
regions may give rise to concerns regarding the cleanliness of the MR suite. Magnet room finishes and construction details should be designed to facilitate
cleaning by appropriately trained staff with nonmotorized equipment. Additionally, as the numbers of MRguided procedures and interventional applications
grow, basic infection control protocols, such as seamless floorings, scrub-able surfaces and hand washing
stations should be considered.
13. Limits of applicability/recommended design
assistance
The facility design issues identified in this document
address only general safety design issues for MRI
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
93
ACR Guidance on MR Safe Practices
suites. There are a multitude of site-specific and magnet-specific operational and technical design considerations relevant to MR facility design and construction
that are not addressed in these Guidelines. These
issues include, but are not limited to, patient acuity,
staff access, modality conflicts, vibration sensitivity,
throughput/efficiency, HIPAA considerations, magnetic
contamination, sound transmission, magnet shim tolerances, shielding design, moving metal interferences,
MR equipment upgrades, electromagnetic interference,
and many others.
In addition to incorporating the guidance from this
document, a facility would be well advised to seek
expert assistance in the planning and design of MRI
and multi-modal radiology suites.
APPENDIX 4
MR Facility Emergency Preparedness Guidelines
Healthcare facilities have a unique obligation to minimize the disruption from disasters and hasten their
ability to restore critical patient care services when
interrupted.
Those charged with the operation of MRI facilities
have the added complexities of protecting not only the
staff and structure, but also the equipment which
may be extraordinarily sensitive to changes in its
environment, including vibration, power supply, and
water damage.
In the fall of 2005, many watched as hurricanes
Katrina and Rita devastated vast swathes of the
United States’ Gulf Coast. Those facilities which were
well prepared for the damage, loss of power, and other
failures of infrastructure fared far better than those
that that were not.
Even those not in the likely path of future Gulf hurricanes may have to contend with earthquakes, tornadoes, fires, ice storms, snowstorms, or blackouts, at
some point. Particularly those involved in providing
patient care should look to how we will provide care
at the times when it is most widely and desperately
needed. We may find that the facilities, equipment
and infrastructure required to provide clinical care
have not been adequately protected.
1. Water Damage:
Whether from roof-failure, burst pipes, storm surge or
rising rivers, every facility has the potential for water
damage to equipment and facilities. Damages can
range from inconveniences cured by a couple of hours
with a wet-dry vacuum, to flooding of equipment electronics. It takes only a small quantity of water in contact with an MRI scanner to incapacitate or destroy
the equipment.
To keep leaking roofs, burst pipes or other overhead
damage from dousing MRI equipment, it is recommended that facilities prepare by covering gantries
and equipment with sturdy plastic, taped in place,
when water damage is an anticipated possibility. To
keep processors and gradient cabinets from becoming
swamped in a flood situation, electronics that can be
lifted up off the ground should be moved as far up off
527
of the floor as possible. RF shields, particularly the
floor assembly, may be significantly damaged and
need to be replaced in a flood situation if not designed
to protect against water damage.
During the 2005 hurricanes, many hospitals and
imaging facilities that had emergency generators to
help restore power discovered that their sites had generators, or other critical supplies, in basements or
other low-lying areas that were flooded. Facilities
should evaluate risks from water damage and assess
their preparations for failure of the building enclosure
as well as the potential for a flood situation.
2. Structural damage:
MRI presents a particular challenge with structural
failure. Though unlikely with current magnet systems,
vibrations from seismic events do have the potential
to initiate a quench of the magnet system. Structural
damage or motion may also damage the RF shield enclosure, potentially degrading image quality until the
shield is repaired.
3. Power Outage:
Without electrical power to the vacuum pump / cold
head to keep the cryogen within a superconducting
MRI liquefied, the cryogen will begin to boil off at an
accelerated rate. Depending upon cryogen vent design
and boil off rate, the additional cryogenic gas discharge may freeze solid any accumulated water in the
cryogen vent, occluding the pipe and increasing the
possibility for a cryogen vent breach in the event of a
quench.
At some point if power to the vacuum pump is not
restored, likely a couple days to perhaps a week after
power is lost, the magnet will spontaneously quench,
discharging most or all of its remaining cryogenic gasses. This poses a safety risk to anyone near the discharge and runs a small but finite risk of potentially
permanently damaging the magnet coils.
However, if power to the vacuum pump/cold head
and cryogen levels is restored before a quench, there
should be no long-term consequences to the magnet’s
operation from a power interruption.
Temporary electrical power may be provided either
through on-site or portable generators. Co-generation,
or generating one’s own electricity all the time, may
not be economically feasible for smaller or standalone sites, but is increasingly appealing to hospitals
for several reasons, with emergency capacity being
only one.
4. Quench:
During the 2005 hurricanes, facilities, fearing extensive damage to their MRI systems from water or protracted power outages, manually initiated pre-emptive
quenches. Under the best circumstances, a quench
subjects a magnet to a change of 500 F thermal shock
within a few dozen seconds, which can cause major
physical damage. Rarely, it is possible for the venting
cryogenic gases to breach the quench tube and cause
significant damage to the magnet room and/or
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
94
528
jeopardize the safety of those in the vicinity. At one
New Orleans area facility that elected to preemptively
quench its magnets, the quench tube reportedly failed
and the pressure from the expanding cryogen blew
out the control room radiofrequency window (personal
communication, Tobias Gilk, October 2005).
Because of the risks to personnel, equipment and
physical facilities, manual magnet quenches are to be
initiated only after careful consideration and preparation. In addition to following those specific recommendations provided by the MRI manufacturer, a facility
should initiate a pre-emptive quench in nonemergent
situations only after verifying the function of emergency exhaust systems, verifying or providing means
of pressure relief and a preliminary visual inspection
of the cryogen vent pipe as it leaves the MR unit to
check for signs of water or ice inside the pipe (including water leaking from fittings or condensation forming on vent pipe sections). If/when feasible, a
discussion with the device manufacturer regarding an
intentional controlled static magnetic field ramp-down
may be advisable.
5. Fire/Police:
Though very infrequent, MR suites have been the
scene of emergencies requiring fire and/or police
response. While it is highly likely that this will be the
first time many of the responders have been to an MR
suite, this should not be the first time that responding
organizations have been introduced to the safety
issues for MR. Sites are encouraged to invite police
and fire representatives to presentations on MR safety
and to provide them with facility tours.
6. Code:
In the event that a person within the MR suite should
require emergency medical attention, it is imperative
that those responding to a call for assistance are
aware of, and comply with, MR safety protocols. This
includes nurses, physicians, respiratory technicians,
paramedics, security, and others.
The impulse to respond immediately must be tempered by an orderly and efficient process to minimize
risks to patients, staff and equipment. This requires
specialized training for code teams and, as with Fire/
Police responses, clear lines of authority for screening, access restrictions and quench authority. Full
resuscitation of patients within Zone IV is complicated
by the inability to accurately interpret electrocardiographic data. Furthermore, this may place at risk of
injury all within the Zone IV from ferromagnetic
objects which may be on, within, or brought into Zone
IV by emergency response personnel responding to a
code if one is called in that area. Therefore, after initiating basic cardiopulmonary resuscitation (airway,
breathing, chest compressions), the patient should be
immediately moved out of Zone IV to a prospectively
designated location where the code can be run or
where the patient will remain until the arrival of
emergent response personnel.
It is strongly advised that all MR facilities perform
regular drills to rehearse and refine emergency
Kanal et al.
response protocols to protect patients, MR staff and
responders.
7. Prevention:
While it is the nature of emergencies to be surprises,
we can anticipate the types of incidents that have
higher likelihoods given our facilities, practices and
locations. Every facility can anticipate the potential
for flooding, fire and code situations. In addition to
these, many areas (California and coastal Alaska, for
example) can expect earthquakes. The central and
southern plains states of the U.S. can anticipate tornados. Colder climates can expect massive snows or
ice storms.
State and federal offices of emergency preparedness
are dedicated to anticipating and preparing for the
specific threats to your region. These can serve as an
excellent resource regarding risks and strategies for
preparation.
Once a disaster has struck, it is important to assess
what the immediate needs of the community are and
to restore those critical patient care services first.
Damage to MRI equipment and facilities may not be
repaired as quickly. For gravely incapacitated facilities, semi-trailer based MRI units may be the only
means of quickly restoring radiology capacity.
All healthcare facilities should have emergency preparedness plans. The healthcare plans for MRI facilities should specifically address the unique aspects of
MRI equipment. These plans should define who has
the authority to authorize nonemergent quenches,
procedures for emergency or backup power for vacuum pump/cold head, as well as instructions on how
to protect gantries and sensitive electronics. Facilities
should have the necessary supplies prepositioned and
checklists for preparatory and responsive actions.
Emergency preparedness plans should also include
information necessary for restoring clinical services,
including contacts for MRI system vendor, RF shield
vendor, cryogen contractor, MR suite architect and
construction contractor, local and state officials, and
affiliated hospital and professional organizations.
Below are a few questions that may facilitate the development of an emergency preparedness plan specific
to the needs of a facility.
• What are the likely/possible natural disasters to
affect the area?
• What are the likely/possible man-made disasters
to affect the area?
• Is electrical power likely to be interrupted?
• Would other utilities (natural gas, telecommunications, etc.) likely be interrupted?
• What equipment would be inoperative during the
emergency?
• What equipment could be damaged by the
emergency?
• What equipment should be provided with critical
or backup power?
• If the utility service is not quickly restored, what
other risks may arise?
• Would patients and staff be able to get to the
facility?
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
95
ACR Guidance on MR Safe Practices
529
• Would patients or staff be trapped at the facility?
• How critical is each patient care service provided
at the facility?
• How does the facility protect the equipment
19.
needed to support each service?
• How does the facility protect the patient data
(including such options as off site storage) from
each service?
• If the facility does not have the resources on site,
who can provide them?
20.
21.
REFERENCES
1. Patient death illustrates the importance of adhering to safety precautions in magnetic resonance environments. Health Devices
2001;30:311–314.
2. Chaljub G, Kramer LA, Johnson RF III, Johnson RF Jr, Singh H,
Crow WN. Projectile cylinder accidents resulting from the presence of ferromagnetic nitrous oxide or oxygen tanks in the MR
suite. AJR Am J Roentgenol 2001;177:27–30.
3. Kanal E, Borgstede JP, Barkovich AJ, et al. American College of
Radiology White Paper on MR Safety: 2004 update and revisions.
AJR Am J Roentgenol 2004;182:1111–1114.
4. Kanal E, Borgstede JP, Barkovich AJ, et al. American College of
Radiology White Paper on MR Safety. AJR Am J Roentgenol
2002;178:1335–1347.
5. Kanal E, Shellock FG. Policies, guidelines, and recommendations
for MR imaging safety and patient management. SMRI Safety
Committee. J Magn Reson Imaging 1992;2:247–248.
6. Shellock FG, Kanal E. Policies, guidelines, and recommendations
for MR imaging safety and patient management. SMRI Safety
Committee. J Magn Reson Imaging 1991;1:97–101.
7. ACR practice guideline for performing and interpreting magnetic
resonance imaging (MRI). Available at: http://www.acr.org/
SecondaryMainMenuCategories/quality_safety/guidelines/dx/mri_
performing_interpreting.aspx. Accessed September 13, 2011.
8. Shellock FG, Kanal E. Guidelines and recommendations for MR
imaging safety and patient management. III. Questionnaire for
screening patients before MR procedures. The SMRI Safety Committee. J Magn Reson Imaging 1994;4:749–751.
9. Kanal E, Barkovich AJ, Bell C, et al. ACR guidance document for
safe MR practices: 2007. AJR Am J Roentgenol 2007;188:
1447–1474.
10. Device Advice: Comprehensive regulatory assistance. Available at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
default.htm. Accessed September 19, 2011.
11. Jarvik JG, Ramsey S. Radiographic screening for orbital foreign
bodies prior to MR imaging: is it worth it? AJNR Am J Neuroradiol 2000;21:245–247.
12. Seidenwurm DJ, McDonnell CH III, Raghavan N, Breslau J. Cost
utility analysis of radiographic screening for an orbital foreign
body before MR imaging. AJNR Am J Neuroradiol 2000;21:
426–433.
13. Kanal E, Gillen J, Evans JA, Savitz DA, Shellock FG. Survey of
reproductive health among female MR workers. Radiology 1993;
187:395–399.
14. American Academy of Pediatrics Committee on Drugs: Guidelines
for monitoring and management of pediatric patients during and
after sedation for diagnostic and therapeutic procedures. Pediatrics 1992;89:1110–1115.
15. Guidelines for monitoring and management of pediatric patients
during and after sedation for diagnostic and therapeutic procedures: addendum. Pediatrics 2002;110:836–838.
16. Practice guidelines for sedation and analgesia by non-anesthesiologists: An updated report by the American Society of Anesthesiologists Task Force on Sedation and Analgesia by NonAnesthesiologists. Anesthesiology 2002;96:1004–1017.
17. Standards and intents for sedation and anesthesia care. Comprehensive Accreditation Manual for Hospitals. Chicago, IL: Joint
Commission on Accreditation of Healthcare Organizations; 2002:
Report no. TX 2–2.
18. US Food and Drug Administration Manufacturer and User Facility
Device Experience (MAUDE) Data Base (MDR Report Key 434259,
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
489264, 410913). Available at: http://www.accessdata.fda.gov/
scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm. Accessed September 8, 2011.
Gandhi OP, Chen XB. Specific absorption rates and induced
current densities for an anatomy-based model of the human for
exposure to time-varying magnetic fields of MRI. Magn Reson
Med 1999;41:816–823.
Konings MK, Bartels LW, Smits HF, Bakker CJ. Heating around
intravascular guidewires by resonating RF waves. J Magn Reson
Imaging 2000;12:79–85.
Food and Drug Administration Public Health Advisory: Risk of
Burns during MRI Scans from Transdermal Drug Patches
with Metallic Backings, March 5, 2009, Updated March 9, 2009.
Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInforma
tionforHeathcareProfessionals/PublicHealthAdvisories/ucm111313.
htm. Accessed May 15, 2012.
IEC 60601–2-33, Ed. 2.0 Medical Electrical Equipment-Part 2:
Particular requirements for the safety of magnetic resonance
equipment for medical diagnosis. Geneva, Switzerland: International Electrotechnical Commission (IEC); 2002.
ACR-SIR practice guideline for adult sedation/analgesia.
Available at: http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/iv/adult_sedation.aspx. Accessed
September 13, 2011.
Standards for basic anesthesic monitoring. (Approved by the ASA
House of Delegates on October 21, 1986, and last amended on
October 20, 2010 with an effective date of July 1, 2011.) Park
Ridge, IL: American Society of Anesthesiologists.
Standards for postanesthesia care. (Approved by the ASA House
of Delegates on October 27, 2004, and last amended on October
21, 2009.) Park Ridge, IL: American Society of Anesthesiologists.
Statement on non-operating room anesthetizing locations.
(Approved by the ASA House of Delegates on October 19, 1994
and last amended on October 22, 2008.) Park Ridge, IL: American Society of Anesthesiologists.
American College of Radiology. ACR digest of council actions.
Reston, VA: ACR, 1999:126 (Res 1-H 1987, 1997).
American College of Radiology. ACR Manual on Contrast Media,
Version 8, 2012. Available at: http://www.acr.org/SecondaryMain
MenuCategories/quality_safety/contrast_manual.aspx.
Accessed
September 13, 2011.
Al-Sabagh KH, Christensen BE, Thogersen AM, et al. [Safety of
magnetic resonance imaging in patients with pacemaker and
implantable defibrillator]. Ugeskr Laeger 2010;172:1740–1744.
Gimbel JR. Unexpected asystole during 3T magnetic resonance
imaging of a pacemaker-dependent patient with a ’modern’ pacemaker. Europace 2009;11:1241–1242.
Gotte MJ, Russel IK, de Roest GJ, et al. Magnetic resonance
imaging, pacemakers and implantable cardioverter-defibrillators:
current situation and clinical perspective. Neth Heart J 2010;18:
31–37.
Avery JK. Loss Prevention case of the month. Not my responsibility! J Tenn Med Assoc 1988;81:523.
Ferris NJ, Kavnoudias H, Thiel C, Stuckey S. The 2005 Australian MRI safety survey. AJR Am J Roentgenol 2007;188:
1388–1394.
Irnich W, Irnich B, Bartsch C, Stertmann WA, Gufler H, Weiler G.
Do we need pacemakers resistant to magnetic resonance imaging? Europace 2005;7:353–365.
Langman DA, Goldberg IB, Finn JP, Ennis DB. Pacemaker lead
tip heating in abandoned and pacemaker-attached leads at 1.5
Tesla MRI. J Magn Reson Imaging 2011;33:426–431.
Hartnell GG, Spence L, Hughes LA, Cohen MC, Saouaf R, Buff B.
Safety of MR imaging in patients who have retained metallic
materials after cardiac surgery. AJR Am J Roentgenol 1997;168:
1157–1159.
Murphy KJ, Cohan RH, Ellis JH. MR imaging in patients with
epicardial pacemaker wires. AJR Am J Roentgenol 1999;172:
727–728.
Kanal E. Safety of MR imaging in patients with retained epicardial pacer wires. AJR Am J Roentgenol 1998;170:213–214.
Faris OP, Shein M. Food and Drug Administration perspective:
Magnetic resonance imaging of pacemaker and implantable cardioverter-defibrillator patients. Circulation 2006;114:1232–1233.
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
96
530
40. Gimbel JR. Magnetic resonance imaging of implantable cardiac
rhythm devices at 3.0 tesla. Pacing Clin Electrophysiol 2008;31:
795–801.
41. Nazarian S, Halperin HR. How to perform magnetic resonance
imaging on patients with implantable cardiac arrhythmia devices.
Heart Rhythm 2009;6:138–143.
42. Gimbel JR. Guidelines and the growing service burden. J Interv
Card Electrophysiol 2010;28:83–85.
43. Hauser RG, Kallinen L. Deaths associated with implantable cardioverter defibrillator failure and deactivation reported in the
United States Food and Drug Administration Manufacturer and
Kanal et al.
User Facility Device Experience Database. Heart Rhythm 2004;1:
399–405.
44. Jilek C, Tzeis S, Reents T, et al. Safety of implantable pacemakers and cardioverter defibrillators in the magnetic field of a
novel remote magnetic navigation system. J Cardiovasc Electrophysiol 2010;21:1136–1141.
45. Gimbel JR. Unexpected pacing inhibition upon exposure to the
3T static magnetic field prior to imaging acquisition: what is the
mechanism? Heart Rhythm 2011;8:944–945.
46. The Facility Guidelines Institute. Guidelines for the Design and
Construction of Health Care Facilities, 2010 edition. Chicago:
American Society for Healthcare Engineering; 2010.
IHF Clinical Practice Parameters and Facility Standards for MRI and CT - 3rd Edition
97
Appendix II
MR Safety
The following is a sample screening form from St. Michael’s Hospital. For additional examples of basic
screening tools, refer to the ACR Guidance Document on MR Safe Practices: 2013 (Appendix I).
rd
Clinical Practice Parameters and Facility Standards for MRI and CT – 3 Edition
80
Appendix III Report of the Diagnostic Imaging Safety
Committee for Computed Tomography (CT) – February 2007
Executive Summary
Computed tomography (CT) has revolutionized the investigation of patients who have a wide variety of
medical conditions and has led to more efficient patient care. The technology for this imaging modality
has advanced rapidly over the past decade and as a result, there has been a significant increase in the
use of CT in Ontario and around the world.
Ionizing radiation, as used for CT, can increase an individual’s lifetime risk of developing cancer. This risk
increases as the dose increases, is greater for children than for adults, and is greater for females than
for males. As with all medical procedures, the small potential risk from a CT examination must be
weighed against the potential benefits.
As with all medical imaging technology involving ionizing radiation, the principle of ALARA (As Low As
Reasonably Achievable) should be applied in CT. In other words, CT examinations should be performed
using sufficient dose to achieve acceptable image quality given the clinical context, but without
exposing patients to unnecessary amounts of ionizing radiation. It is recognized that this is often a
complex balancing act. Much effort needs to be focused now and in the future on dose management
and optimization so that CT technology continues to be used appropriately in Ontario.
The recommendations in this report are intended to be applicable to any diagnostic CT scanner in
Ontario that is used for the purpose of medical imaging of humans, and include a section focusing on
the pediatric population. Because of the rapid changes in CT technology, the emphasis in this report is
on the newer multidetector CT (MDCT) scanners. In the future, newer imaging technologies that use
ionizing radiation will need to be assessed in light of existing regulations, and safety standards will need
to be developed for their use.
The Healing Arts and Radiation Protection (HARP) Act, Revised Statutes of Ontario, 1990, and the X-ray
Safety Code (Regulation 543) cover the use of x-rays for the irradiation of human beings in the province
of Ontario. Under the X-ray Safety Code, a “computed transaxial tomography x-ray machine” is
specifically excluded from the definition of a “diagnostic x-ray machine.” At the same time, a
“computed axial tomography (CT) scanner or machine” is not defined in the HARP Act. Due to the rapid
technological developments and increase in CT use, any future revisions to the HARP Act should define
what a CT scanner is and should recognize that the radiation doses associated with CT examinations are
generally higher than those associated with conventional x-ray examinations.
Recommendations
The Committee recommends that the province of Ontario put in place regulations and/or legislation as
follows:
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
81
HARP Act
1. The HARP Act should be revised to include a definition of a “computed axial tomography (CT) scanner
or machine.” Future revisions to the HARP Act should also recognize that the radiation doses associated
with CT examinations are generally higher than those associated with conventional x-ray examinations.
Dose Reduction Strategies
This section focuses on strategies and recommendations that can be used to manage and reduce the
radiation dose related to CT scanning.
Alternative Imaging Methods
The decision to perform a CT examination must be justified based on the clinical setting and is a shared
responsibility between the referring clinician and the radiologist. Alternative imaging methods that do
not use ionizing radiation — such as ultrasound (US) or magnetic resonance imaging (MRI) — should be
considered if appropriate.
Prescribing or Requesting a CT Scan
CT examinations should specifically be excluded from Medical Directives. The larger radiation doses
generally associated with CT compared to those associated with conventional x-rays pose patient safety
concerns in the use of Medical Directives for CT examinations.
4. The HARP Act should be revised to ensure that only individuals who have the appropriate clinical
knowledge and training in radiation safety are permitted to prescribe or request CT examinations.
Pregnancy
5. Each CT facility shall have a policy for screening women of childbearing age for pregnancy before
performing a CT examination. If the patient is pregnant or possibly pregnant, the benefits of performing
the CT must be weighed against any potential risk to the fetus.
Patient Shielding
6. The Radiation Protection Officer (RPO) at each facility shall develop a policy for patient shielding
specifically for CT. The policy should be appropriate for the facility’s CT equipment and patient
population, and comprise protocols for in-beam and out-of-beam shielding accessories. The policy
should be reviewed on a regular basis, taking into consideration changes in practice and technological
innovations.
7. The Committee recommends that in-beam shielding not be used under the following conditions:
a) when real-time dose modulation is used and the presence of the shield will cause the CT
scanner to compensate by increasing dose; or
b) where there is proof that in-beam shielding will interfere with the imaging objectives.
Anatomic Coverage
8. The anatomic coverage of a CT examination should be limited to the area of clinical interest.
82
The College of Physicians and Surgeons of Ontario
CT Protocols
9. CT protocols should be designed to obtain the necessary diagnostic information based on the clinical
indication of each situation. CT protocols should be reviewed periodically by radiologists and CT
technologists to ensure dose optimization.
CT Scanning Parameters
10. CT technologists and radiologists must be knowledgeable about how the manipulation of various
scanning parameters may influence dose and image quality in their CT scanners.
Multiphase Image Acquisition
11. The acquisition of more than one set of images from the same anatomic region must be justified
based on detailed medical and radiological knowledge.
Repeat CT Examinations
12. When a follow-up or repeat CT examination is requested, the referring clinician and the radiologist
must first consider other imaging modalities that do not use ionizing radiation, such as US or MRI.
Repeat CT examinations must be justified based on the clinical indication. If a follow-up CT examination
is justified, the examination may be modified to reduce the dose, as long as clinical care is not
compromised.
CT Manufacturers/Vendors
13. Upon installation of a new CT scanner, a facility’s Radiation Protection Officer (RPO) shall provide
the X-ray Inspection Service (XRIS) of MOHLTC proof that the technologists and physicians operating
that specific make and model of CT scanner have received training on dose reduction strategies
appropriate to the planned clinical operation of the scanner. This proof would be in the form of a
certificate of training provided by the vendor. In addition, the RPO must keep a permanent record of
authorized operators and their training status on installed CT scanners for review by MOHLTC and its
enforcement agents for at least six years.
Diagnostic Reference Levels
14. Ontario should establish Diagnostic Reference Levels for the following CT examinations: head CT,
chest CT, and abdominal/pelvic CT. A team consisting of members from professional medical bodies
should be established to review the methods for establishing DRLs, administer the survey, collect the
data, determine the DRLs, and disseminate the information to all stakeholders. Once established, DRLs
should be reviewed periodically. Funding that is appropriate to the scope of the project will be
required.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
83
15. Manufacturers of CT scanners (including Positron Emission Tomography/CT units) must display the
dose for each CT examination on the control console.
16. The dose for each CT examination must be recorded. This record must be kept and be available for
periodic audit.
17. In pediatric cases, the size of the CT phantom used in calculating dose information must be
displayed.
Pediatric CT
18. All requests for CT examinations for children must be reviewed by a radiologist prior to booking to
ensure that the referral is appropriate and that possible alternative imaging modalities have been
considered.
19. Each CT facility must establish local protocols for use in pediatric scanning. The Radiation Protection
Officer must demonstrate to MOHLTC that technologists and radiologists operating the CT scanner have
received instruction on the appropriate use of pediatric protocols.
20. All CT manufacturers must have suggested protocols specific to children of varying ages available on
all models of scanner, for all commonly performed examinations.
21. As an additional safeguard to promote the use of weight-adjusted protocols in children, it is
recommended that all manufacturers adapt CT software to promote protocol adjustments based on
patient weight.
CT Technologist Training
22. MOHLTC should continue to provide support for a standardized CT curriculum for all
undergraduate/college Medical Radiation Technologist (MRT) programs and for access to the same
curriculum for MRT graduates in Ontario.
23. The CT curriculum shall include training in radiation safety and dose management.
CT Personnel and the Work Environment
24. In addition to existing legislation and policies, CT facilities shall adopt the following safety
guidelines:
a) Doors accessible to the general public that enter into a CT scan room must be locked during
scanner operation.
b) CT operators must be within arm’s length of the scan abort button during image acquisition.
c) CT operators must be in visual contact with the patient during image acquisition.
CT Scanner Testing and Inspection
84
The College of Physicians and Surgeons of Ontario
25. The testing and inspection of CT scanners should be specifically incorporated into the HARP Act. This
may require a major revision to the HARP Act and the X-ray Safety Code. The role and duties of the Xray Inspection Service may also need to be modified so that XRIS is able to perform and audit the
inspection and maintenance of CT scanners, including dental cone beam CT, in Ontario. The appropriate
resources to expand this service will be necessary.
Education Materials
Health Care Workers
26. The province should designate an organization to develop and disseminate information for
physicians and other health care workers that helps them to better weigh the benefits and risks of CT
studies for their patients. The topic of benefits and risks of procedures that use ionizing radiation such
as CT should be included in the training programs of health care providers who are involved in the
prescribing or performing of such procedures.
Patients
27. The province should designate an organization to develop and disseminate information concerning
the benefits and risks of imaging studies involving ionizing radiation, specifically CT, to patients and the
general public.
Monitoring Patient Dose
28. At this time, the Committee does not recommend attempting to establish a permanent, portable
record of the cumulative dose that each patient in Ontario receives.
Dental Cone Beam CT
29. The HARP Act should be revised to reflect the newer technology of dental CBCT.
30. MOHLTC should lift the current moratorium on approval of dental CBCT scanners, but approval
should be restricted to Oral and Maxillofacial Radiologists and graduate Oral Radiology academic
centres.
31. Dental CBCT scanners must be operated under the supervision of an Oral and Maxillofacial
Radiologist.
32. All requests for dental CBCT examinations must be reviewed and approved according to protocol by
an Oral and Maxillofacial Radiologist prior to performing the examination.
Research
33. Close collaboration among CT manufacturers, imaging scientists, and radiologists is encouraged to
further explore and promote methods of dose management for CT.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
85
Full Report
BACKGROUND
The Ontario Health Technology Advisory Committee (OHTAC) recommended that a study of the safety
aspects of computed tomography (CT) and magnetic resonance imaging (MRI) be conducted. The
Ministry of Health and Long-Term Care (MOHLTC) provided a research grant to the Healthcare Human
Factors Group at the University Health Network to investigate and provide safety recommendations on
CT and MRI for OHTAC’s consideration. Recommendations from the two reports, covering CT and MRI
safety, were endorsed by OHTAC [1,2]. One of the recommendations was to create a Diagnostic Imaging
Safety Committee for CT and MRI. The CT Safety Committee would be responsible for the development
of recommendations concerning standards and best practices for CT, including methods of dose
reduction to patients and medical imaging staff, as well as the testing and inspection of CT scanners in
Ontario.
INTRODUCTION
The use of CT imaging has revolutionized the investigation of patients who have a wide variety of
medical conditions, including cancer, trauma, and cardiovascular, neurological, respiratory,
gastrointestinal, urological, and musculoskeletal illnesses. CT technology has advanced rapidly in the
past decade, creating an even wider application of this imaging modality and enabling more efficient
patient care. As a result, there has been a significant increase in the use of CT for medical imaging in the
province of Ontario and around the world [3,4].
Although there will always be some debate in an issue involving risk estimates, it is accepted from the
consensus of scientific literature that there is no level of ionizing radiation that can be considered
completely safe. Ionizing radiation, as used for diagnostic CT imaging, carries the potential of increasing
an individual’s lifetime risk of developing cancer. The Biological Effects of Ionizing Radiation (BEIR) VII
report estimates that “approximately one individual per thousand would develop cancer from an
exposure of 0.01Sv,” which is the dose estimate from an abdominal CT scan. To put the risk in
perspective, in the United States, the overall lifetime risk of cancer in the general population is 42 out
of 100 people. In other words, a person’s risk of developing cancer related to the radiation from an
abdominal CT scan would increase to 42.1% from 42.0%. It is also recognized that the risk increases as
the dose increases, that the risk is greater for children than for adults, and that the risk is slightly
greater for girls than for boys [5]. The relative risk from exposure to low levels of radiation should be
weighed against the potential clinical benefits of a CT examination by a qualified health care
practitioner. The recommendations of this report should not be a substitute for clinical judgment and it
is recognized that each patient and clinical scenario is unique.
As with all medical imaging technology involving ionizing radiation, the principle of ALARA (As Low As
Reasonably Achievable) should be applied. In other words, CT imaging studies should be performed
using sufficient dose to achieve acceptable image quality given the clinical context, but without
exposing patients to unnecessary amounts of ionizing radiation. It is recognized that this is often a
complex balancing act and that a great deal of effort needs to be focused now and in the future on dose
management and optimization, so that CT technology continues to be used appropriately in Ontario.
The recommendations contained in this report are intended to be applicable to any diagnostic CT
scanner in Ontario that is used for the purpose of medical imaging of humans for routine clinical
practice. The recommendations apply to all patients and include a section focusing on the pediatric
86
The College of Physicians and Surgeons of Ontario
population. Because of the rapid changes in CT technology, the emphasis in this report is on the newer
multidetector CT (MDCT)scanners.
Generally, a CT scanner is considered an x-ray device that uses a rotating fan-beam and detector system
to acquire data that can be reconstructed into a three-dimensional (3D)image. The 2006 Annual Report
of the Office of the Auditor General of Ontario considered safety issues relevant to fan-beam devices
[3]. There is a wider class of specialty device that is able to acquire images that can be reconstructed
into 3D images, but these devices are not considered CT scanners for billing purposes under the Ontario
Health Insurance Plan (OHIP). However, they meet the functional definition of CT in the eyes of
MOHLTC. Primarily, these devices are described as cone-beam imagers, volume imagers, or cone-beam
CT. Presently, any x-ray device that has the ability to take precisely positioned angled views and that is
fitted with a digital receptor is potentially able to produce 3D images with the addition of appropriate
reconstruction software. Therefore, x-ray devices being produced now and in the future that meet
these specifications may potentially be considered CT scanners. In the future, specific
recommendations for the use of cone-beam devices and other imaging devices that use ionizing
radiation will be needed.
It is the responsibility of the Radiation Protection Officer (RPO) of a CT facility to assess new technology
in light of existing regulations and to develop safety standards for its use. Facilities owning and
operating cone-beam technology should have policies in place that address issues of dose monitoring,
dose reduction, and quality control, consistent with the Healing Arts Radiation Protection (HARP) Act.
Patient dose monitoring is a particularly important issue because cone-beam devices do not estimate
dose in the same manner that fan-beam CT scanners estimate and display dose.
The HARP Act, Revised Statutes of Ontario, 1990, and the X-ray Safety Code (Regulation 543) cover the
use of x-rays for the irradiation of human beings in the province of Ontario. Under the X-ray Safety
Code, a “computed transaxial tomography xray machine” is specifically excluded from the definition of
a “diagnostic x-ray machine.” At the same time, a “computed axial tomography (CT) scanner or
machine” is not defined in the HARP Act. Due to the rapid technological developments and increase in
CT use, any future revisions to the HARP Act should define what a CT scanner is and should recognize
that the radiation doses associated with CT examinations are generally higher than those associated
with conventional x-ray examinations.
At the national level, a Safety Code for Radiation Protection in Radiology for Large Facilities is currently
being prepared by Health Canada. It is anticipated that this Safety Code will contain recommended
safety procedures for the installation, use, and control of x-ray equipment, including CT scanners, in
large radiological facilities. There are a number of other national and international bodies also currently
working on guidelines for managing patient dose with MDCT scanners, including the International
Commission on Radiological Protection (ICRP) [6]. These reports and guidelines will need to be taken
into consideration as they become available.
RECOMMENDATIONS
For the purposes of this report, it is intended that recommendations made to “Ontario” or to “the
province of Ontario” be understood as being made to Ontario’s Ministry of Health and Long-Term Care
(MOHLTC) or any other provincial body responsible for governing CT facilities.
The Committee recommends that the province of Ontario put in place regulations and/or legislation as
follows:
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
87
HARP ACT
1. The HARP Act should be revised to include a definition of a “computed axial tomography (CT) scanner
or machine.” Future revisions to the HARP Act should also recognize that the radiation doses associated
with CT examinations are generally higher than those associated with conventional x-ray examinations.
DOSE REDUCTION STRATEGIES
This section focuses on strategies that can be used to manage and reduce the radiation dose related to
CT scanning. The discussion includes specific recommendations to pursue the goal of dose reduction.
Alternative Imaging Methods
Radiation protection includes justification for medical imaging studies that use ionizing radiation [6].
When a CT scan is requested, the referring clinician and the radiologist should consider the clinical
question and determine whether an alternative imaging method that does not use ionizing radiation —
such as ultrasound or MRI — might be more appropriate. This is particularly important for the pediatric
population. The clinical setting, patient age and gender, local expertise, and available resources will
influence the determination. There are national published guidelines that may help referring clinicians
and radiologists to determine the appropriateness of imaging studies for a variety of clinical scenarios.
These publications include:
• Diagnostic Imaging Referral Guidelines (Canadian Association of Radiologists) [7]
• American College of Radiology Appropriateness Criteria, 2000 (American College of Radiology)
[8]
• Royal College of Radiologists, 2003 – Making the Best Use of a Department of Clinical
Radiology: Guidelines for Doctors (Royal College of Radiologists, United Kingdom) [9]
• European Guidelines for Multislice Computed Tomography, 2004 – CT Quality Criteria
(European Commission) [10]
2. The decision to perform a CT examination must be justified based on the clinical setting and is a
shared responsibility between the referring clinician and the radiologist. Alternative imaging methods
that do not use ionizing radiation — such as ultrasound or magnetic resonance imaging (MRI) — should
be considered if appropriate.
Prescribing or Requesting a CT Scan
The draft of the Safety Code being prepared by Health Canada outlines the responsibility of the
referring physician with regards to prescribing or requesting x-ray procedures and states: “The main
responsibility of the referring physician is to ensure that the use of xrays is justified.” In Ontario, the
HARP Act indicates who can prescribe or request the operation of an x-ray machine for the irradiation
of a human being. At some institutions, a member of the College of Nurses of Ontario who holds an
extended certificate of registration may request an x-ray examination. Currently, where a local Medical
Directive is in place, some nurses or other authorized health care professionals may be requesting x-ray
examinations, including CT scans.
88
The College of Physicians and Surgeons of Ontario
3. CT examinations should specifically be excluded from Medical Directives. The larger radiation doses
generally associated with CT compared to those associated with conventional x-rays pose patient safety
concerns in the use of Medical Directives for CT examinations.
4. The HARP Act should be revised to ensure that only individuals who have the appropriate clinical
knowledge and training in radiation safety are permitted to prescribe or request CT examinations.
Pregnancy
Ionizing radiation is recognized to be potentially harmful to the developing fetus and is dose-dependent
[5].
5. Each CT facility shall have a policy for screening women of childbearing age for pregnancy before
performing a CT examination. If the patient is pregnant or possibly pregnant, the benefits of performing
the CT must be weighed against any potential risk to the fetus.
Patient Shielding
Patient shielding devices are designed to reduce the amount of radiation absorbed by a particular body
part. Shielding devices can be used to cover anatomic structures outside the area of irradiation that
may receive scatter radiation (out-of-beam) or within the area of irradiation (in-beam). With state-ofthe-art MDCT scanners, the x-ray beam is narrowly collimated. As a result, the majority of the radiation
exposure that organs receive outside of the primary beam comes from internal scatter. The exception
to this principle is when contiguous anatomy is significantly higher or lower than the area being
scanned. Therefore, with MDCT scanners, the use of “out-of-beam” shielding is often of little or no
practical benefit with regards to patient dose reduction. The Health Physics Society, an American
scientific and professional organization whose members specialize in radiation safety, currently is of the
opinion that the practice of out-of-beam shielding is of limited or no benefit but its use may provide
psychological reassurance to the patient [11].
In-beam shields, however, are believed to provide a benefit in terms of dose reduction. Studies have
shown that in-beam shielding can significantly reduce the dose to the breasts, thyroid gland, and eyes
[12, 13]. However, in-beam shielding devices may interfere with image quality [14]. In addition, one of
the features of MDCT scanners is automatic tube current modulation (also known as automatic
exposure control or AEC), which aims to optimize the dose according to patient size and desired image
quality. The technology for dose optimization with MDCT scanners, including AEC, is rapidly evolving
and there is variation among vendors in the methods used for automatic tube current modulation [15].
Currently, there is a paucity of literature on the subject of inbeam shielding for state-of-the-art MDCT
scanners, including a discussion of the interaction between such shields and AEC, and the resulting
impact on dose and image quality.
Some in-beam shielding devices, such as eye shields, are intended for single use, while others, such as
breast shields, are designed for multiple uses. When considering the use of patient shielding devices,
the cost and disposability of these devices, the impact on workflow, and any infection control issues
should be taken into consideration.
All facilities with CT scanners should consider maintaining an inventory of the following protective
accessories:
o In-beam protection:
• eye shields;
• breast shields (in sizes appropriate to the patient population — small, medium, large);
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
89
• thyroid shields;
• gonadal shields;
o Out-of-beam protection:
• wrap-around skirts or lead sheets that meet provincial standards.
6. The Radiation Protection Officer (RPO) at each facility shall develop a policy for patient shielding
specifically for CT. The policy should be appropriate for the facility’s CT equipment and patient
population, and include protocols for in-beam and out-of-beam shielding accessories. The policy should
be reviewed on a regular basis, taking into consideration changes in practice and technological
innovations. The analysis leading to the facility’s shielding policy should be documented and explained
to front-line staff so that they may answer patients’ questions. The policy should cite each available
shielding option and why it is, or is not, appropriate for the stated use.
If in-beam shielding is observed to increase repeat examinations, the facility’s shielding policy should be
re-evaluated.
7. The Committee recommends that in-beam shielding not be used under the following conditions:
a) when real-time dose modulation is used and the presence of the shield will cause the CT
scanner to compensate by increasing dose; or
b) where there is proof that in-beam shielding will interfere with the imaging objectives.
Anatomic Coverage
The unnecessary irradiation of organs outside the area of clinical interest can be minimized by limiting
scanning to the anatomic area in question. For example, in most patients with renal colic, it would be
appropriate to limit anatomic coverage from the top of the kidneys to the bladder base. On the other
hand, for a patient with a suspected or proven intra-abdominal malignancy, for example, larger
anatomic coverage, extending from the top of the diaphragm to the bottom of the bony pelvis, would
be more appropriate.
8. The anatomic coverage of a CT examination should be limited to the area of clinical interest.
CT Protocols
CT protocols should be designed to obtain the necessary diagnostic information based on the clinical
indication of each situation. In keeping with the ALARA principle, the dose should be optimized
according to the clinical indication. For example, “low dose” protocols have been successfully used in
scenarios with inherent high contrast such as evaluating urinary tract stones or screening for lung or
colon cancer (CT colonography) [16-18]. Other clinical indications may require a higher dose with “low
noise” to ensure optimum image quality. These situations occur when there is inherent low contrast
between tumors and background structures. For example, when performing a preoperative CT for liver
tumors or when evaluating a possible pancreatic tumor, the benefits of optimum image quality clearly
justify any risks from irradiation. Finally, the majority of other protocols will fall into a “standard dose”
category. Thus, CT protocols can be generally grouped into three categories: low dose, standard dose,
and low noise.
Weight- and age-adjusted protocols should be developed and used for pediatric patients (see Pediatric
CT) and small adults.
90
The College of Physicians and Surgeons of Ontario
9. CT protocols should be designed to obtain the necessary diagnostic information based on the clinical
indication of each situation. CT protocols should be reviewed periodically by radiologists and CT
technologists to ensure dose optimization.
CT Scanning Parameters
CT technologists and radiologists should be knowledgeable about how the manipulation of various
scanning parameters may influence dose and image quality. With the rapid changes in CT technology,
technologists, radiologists, and medical physicists need to work closely with CT vendors because there
will be parameters unique to each make and model of CT scanner that will influence dose and image
quality. Parameters that can influence dose and image quality include, but are not limited to: tube
current (milliamperes or mA), tube rotation time, tube potential (peak kilovoltage or kVp), collimation,
table speed, pitch, scanner geometry, x-ray filters, and reconstruction kernel or algorithm [19]. A
common and effective method of reducing dose while maintaining diagnostic image quality with MDCT
scanners is the use of automatic tube current modulation, also known as automatic exposure control
(AEC). Each make and model of CT scanner may construct and apply AEC differently. Therefore, it is
imperative that technologists and radiologists understand how this feature influences dose and image
quality in their specific equipment. In newer MDCT scanners that can be adjusted to reduce dose, the
ability to select a user-defined noise level that will influence image quality is an important parameter
that is closely related to the AEC feature [15].
10. CT technologists and radiologists must be knowledgeable about how the manipulation of various
scanning parameters may influence dose and image quality in their CT scanner.
Multiphase Image Acquisition
The acquisition of more than one set of images from the same anatomic region should be justified
based on detailed medical and radiological knowledge. For example, multiple phases are often needed
to detect and characterize liver nodules in patients with cirrhosis [20]. As another example, when
performing CT urography for evaluating the urinary tract, some published protocols have used up to
four acquisitions through the kidneys [21], while others have used only two [22]. This reduction in
phases of image acquisition has been accomplished by altering the sequence of intravenous (IV)
contrast injection and image acquisition, thereby reducing the total potential dose to the patient
without significantly diminishing the goals of the examination.
11. The acquisition of more than one set of images from the same anatomic region should be justified
based on detailed medical and radiological knowledge.
Repeat CT Studies
12. When a follow-up or repeat CT examination is requested, the referring clinician and the radiologist
must first consider other imaging modalities that do not use ionizing radiation, such as ultrasound or
MRI. Repeat CT examinations must be justified based on the clinical indication. If a follow-up CT
examination is justified, the examination may be modified to reduce the dose, as long as clinical care is
not compromised.
CT Manufacturers/Vendors
In Ontario and elsewhere, when a new CT scanner is installed, CT technologists are trained in the
operation of that specific CT scanner by the vendor. Like most sophisticated machinery that
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
91
incorporates powerful computers and state-of-the-art engineering, CT scanners have manufacturerspecific features. In recent years, manufacturers of MDCT scanners have focused more attention on
dose optimization and have introduced new features to reduce dose while maintaining diagnostic
image quality.
CT technologists and radiologists need to work closely with the vendor when a new make or model of
CT scanner is installed in order to properly understand the features that determine dose and image
quality in the new CT scanner.
Although MOHLTC approves the installation of CT scanners, the vendor typically conducts training and
equipment maintenance.
13. Upon installation of a new CT scanner, a facility’s Radiation Protection Officer (RPO) shall provide
the X-ray Inspection Service (XRIS) of MOHLTC proof that the technologists and physicians operating
that specific make and model of CT scanner have received training on dose reduction strategies
appropriate to the planned clinical operation of that scanner. This proof would be in the form of a
certificate of training provided by the vendor. In addition, the RPO must keep a permanent record of
authorized operators and their training status on installed CT scanners for review by MOHLTC and its
enforcement agents for at least six years, in keeping with Section 8(7) of Regulation 543 of the HARP
Act.
Diagnostic Reference Levels
There is tremendous variation in CT protocols and in the engineering of CT machines. Thus, the dose
related to a given CT protocol can vary greatly among CT scanners and health care facilities. A number
of factors will influence the protocols used at each facility, including, but not limited to: the make and
model of CT scanner, the range of clinical indications and their complexity, local expertise, efficient
patient throughput, and the spectrum of patients (including their age, gender, and body habitus).
The implementation of Diagnostic Reference Levels (DRLs) is one tool for radiation dose management
[23, 24]. DRLs are determined by means of a survey of current practice to establish typical dose levels in
a given geographic region. They are used to provide guidance for dose management rather than to set
limits. A survey of patients of a standardized size is conducted, often with further measurements
performed using phantoms designed for the procedure. Common CT studies such as for the head,
chest, and abdomen/pelvis are chosen and a survey is conducted of the doses associated with these
studies, at multiple hospitals. A threshold, such as the 80th percentile of recorded radiation doses, or
more than twice the standard error of the mean, is then selected as the Diagnostic Reference Level.
Institutions are then able to compare their standard doses to the DRL for each of the standard studies.
If doses routinely exceed the suggested DRL, an investigation can be conducted to determine if the
doses are justified or if the CT protocols can be further optimized. Thus, the purpose of DRLs is to
reduce the overall radiation burden to the population over time. Diagnostic Reference Levels have been
established in the United Kingdom, the European Union, and the province of British Colombia [25]. In
the United States, the American Association of Physicians in Medicine recommends reference values for
CT [26] and the American College of Radiology currently incorporates reference values into their
accreditation program for CT [27]. The Phase II Report of the MRI and CT Expert Panel submitted to
MOHLTC in December 2006 recommended that all existing CT facilities obtain American College of
Radiology (ACR) accreditation within a three-year timeframe and that all future CT facilities obtain ACR
accreditation within two years of CT installation.
92
The College of Physicians and Surgeons of Ontario
Diagnostic Reference Levels can be expressed in various units, including CTDIvol (CT dose index volume)
and DLP (dose length product). The CTDIvol and DLP values can then be converted to estimate the
effective dose. The International Commission on Radiation Protection (ICRP) draft emphasizes that
“effective dose is intended for use as a protection quantity on the basis of reference values and
therefore should not be used for epidemiological evaluations, nor should it be used for any specific
investigations of human exposure. ...The use of effective dose for assessing the exposure of patients
has severe limitations”[28].
The ICRP states that it is inappropriate to use DRLs for regulatory or commercial purposes. Moreover,
the values should be selected by professional medical bodies and be reviewed periodically [28].
14. Ontario should establish Diagnostic Reference Levels for the following CT examinations: head CT,
chest CT, and abdominal/pelvic CT. A team consisting of members from professional medical bodies
should be established to review the methods for establishing DRLs, administer the survey, collect the
data, determine the DRLs, and disseminate the information to all stakeholders. Once established, DRLs
should be reviewed periodically. Funding that is appropriate to the scope of the project will be
required.
15. Manufacturers of CT scanners (including Positron Emission Tomography/CT units) must display the
dose, which follows a currently accepted standard, for each CT examination on the control console.
16. The dose for each CT examination must be recorded. This record must be kept and be available for
periodic audit for a minimum period of time, such as six years, in accordance with the HARP Act.
17. In pediatric cases, the size of the CT phantom used in calculating dose information must be
displayed.
PEDIATRIC CT
The use of CT in children is increasing throughout the world, probably even more rapidly than in adults,
with an estimated 2.7 million pediatric CT examinations per year in the U.S., with 30% of these patients
undergoing at least three scans [29]. This increase in practice is seen in pediatric hospitals as well as in
general community hospitals. Children undergoing repeated CT scans in the follow-up of chronic
illnesses are of particular concern with regards to cumulative dose.
Multidetector CT technology enables much faster scanning than previous single slice technology, with a
significant reduction in the need for sedation or anesthesia in children. This has made the CT scanning
of children more accessible and user-friendly compared to a decade ago. The ever-increasing
capabilities and diagnostic quality of CT have also broadened its applications in pediatric care. For
example, CT angiography, high resolution chest CT, trauma care, and oncology (cancer) follow-up scans
are all significantly easier to perform and are of higher diagnostic quality now than in the past.
However, the concerns related to the use of ionizing radiation are of particular importance in children
because their sensitivity to its effects is greater than that of adults.
There is an exponential increase in lifetime cancer risk with decreasing age [30, 31]. This means that a
child is more likely to develop a malignancy later in life than an adult exposed to the same amount of
radiation, and the younger the child, the greater the risk he/she would have. Multiple factors contribute
to this increased sensitivity in children, including the patients’ size, their organ development, and their
greater life expectancy, over which any resultant malignancies can manifest. As a result, children are
between two and ten times more vulnerable than adults to the effects of ionizing radiation.
Many imaging needs in children can be achieved using modalities that do not use ionizing radiation,
namely, ultrasound and MRI. The applications of ultrasound in children are often wider than in adults
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
93
due to smaller patient size and thinner body habitus. MRI also has a significant role, although there is
an ongoing need for greater availability and expertise. Pediatric patients frequently require sedation or
anesthesia for MRI examinations due to the longer time required for image acquisition. This carries its
own risks, and requires resources for the administration of sedation or anesthesia and for patient
monitoring.
In 2001, several scientific articles highlighted the risks associated with the levels of ionizing radiation
involved in pediatric CT and the importance of reducing radiation dose when scanning children [32-34].
There is now increased awareness internationally among radiologists of the need to adjust CT settings
for pediatric patients rather than using standard adult protocols, which results in unnecessarily high
radiation doses to children.
However, there remains considerable variation among institutions in the technical parameters used in
pediatric scanning. This has been demonstrated in many countries, including the U.K., the E. U., and the
U.S. [10,24,33], and was also recently highlighted in the 2006 Annual Report of the Office of the Auditor
General of Ontario [3]. This variability in technical parameters and patient dose is not confined to
pediatric patients but is of particular concern in children, given their increased vulnerability to ionizing
radiation.
CT manufacturers are making progress in developing specific pediatric protocols with dose-saving
features, and new approaches continue to evolve. Such development, along with ongoing, collaborative
research with clinical users, should be actively encouraged.
The variability in performance characteristics among CT manufacturers and scanner types means that
one particular set of pediatric protocols will not optimize the performance characteristics of all
scanners. Scanner performance and dose implications are affected by multiple factors, including type
and number of detectors, scanner geometry, and filtration. It is therefore necessary for CT users to
work in conjunction with their vendor to establish appropriately optimized pediatric protocols for their
scanner.
General guidelines on the principles of achieving dose reductions in pediatric CT are available from
sources in Canada, the U.S., and Europe [34-39]. These include using weight-adjusted tube current
(mAs); reducing kVp, pitch, and slice width selection; using AEC (automatic exposure control)
technology; avoiding pre-contrast scans and multiphase imaging when possible; limiting region of
anatomic coverage; and establishing further dose-reducing protocols for specific clinical indications or
follow-up examinations. Examples of institution-specific pediatric protocols are also available [3440].
Pediatric CT dosimetry is a developing area of scientific research. The variability in the size of pediatric
patients — from premature babies to teenagers — increases the complexity of establishing dose
measures and risk estimates. Commonly displayed dose measures such as CTDIvol and DLP are often
based on phantoms intended for adult patients. Further work on the validity of dose measures, on the
most appropriate phantoms and dose measures for use in pediatric CT, and on a uniform method of
dose display among manufacturers, is needed.
Diagnostic Reference Levels for two pediatric studies (CT head and thorax) have been suggested
recently in the U.K [24]. These are not yet in widespread use, partly due to the complexities given
above. This is, however, an area of ongoing international development, and institutions in Ontario and
across Canada should be encouraged tocontribute to these advances.
94
The College of Physicians and Surgeons of Ontario
18. All requests for CT examinations for children must be reviewed by a radiologist prior to booking to
ensure that the referral is appropriate and that possible alternative imaging modalities have been
considered. It is the joint responsibility of the referring physician and the radiologist to ensure that the
optimal imaging management occurs for each patient, taking into account both benefits and risks.
19. Each CT facility must establish local protocols for use in pediatric scanning. These protocols may be
suggested by the manufacturer or be developed based on local expertise. The establishment of further
dose-reducing protocols for specific clinical indications should be encouraged. The RPO must
demonstrate to MOHLTC that technologists and radiologists operating the CT scanner have received
instruction on the appropriate use of pediatric protocols.
20. All CT manufacturers must have suggested protocols specific to children of varying ages available on
all models of scanner, for all commonly performed examinations.
21. As an additional safeguard to promote the use of weight-adjusted protocols in children, it is
recommended that all manufacturers adapt CT software to promote protocol adjustments based on
patient weight.
CT TECHNOLOGIST TRAINING
Medical Radiation Technologists (MRTs) working in CT in Ontario are primarily Radiological (x-ray)
Technologists with enhanced CT knowledge, skill, and judgment.
MRTs, including those who perform CT, are governed by national standards developed by the national
professional association, the Canadian Association of Medical Radiation Technologists (CAMRT). These
standards are identified in the competency profile provided by CAMRT. In some provinces, including
Ontario, MRTs are also regulated by provincial standards. The College of Medical Radiation
Technologists of Ontario (CMRTO) is the regulatory body for MRTs in Ontario. In order to practice
medical radiation technology in Ontario, an MRT must possess a CMRTO certificate of registration.
There are four specialties within CMRTO: Radiography, Nuclear Medicine, Radiation Therapy, and
Magnetic Resonance Imaging. CT is not a specialty within the College. MRTs in any specialty registered
with CMRTO can perform CT, assuming they have the knowledge, skill, and judgment to perform CT.
The educational requirements for MRTs are covered by the registration regulations. For a CT
technologist, basic CT knowledge is acquired in their initial undergraduate/college program in one of
the specialties. Most CT training is presently acquired “on the job,”during employment as an MRT.
Employers/hospitals usually set minimum requirements for knowledge, skill, and judgment, but there
are no standards. CAMRT offers a specialty certificate in computed tomography imaging (CTIC). The
specialty certificate demonstrates that a higher level of CT knowledge has been achieved. CAMRT has
recently revised all MRT competency profiles to reflect current and future MRT practice, including the
practice of CT by MRTs in all specialties. These new profiles will be effective for the 2011 certification
examinations. The level of CT expertise within each discipline’s competency profile differs depending on
the CT practice within that specialty. For example, the Radiological Technology profile includes in-depth
CT competencies related to diagnostic CT, whereas the Nuclear Medicine profile includes competencies
related to the performance of PET/CT (positron emission tomography/CT), and the Radiation Therapy
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
95
profile includes CT competencies related to radiation therapy planning. With the advent of hybrid
imaging such as PET/CT, all specialties will be performing CT to some degree and level.
In October 2004, MOHLTC established an MRI and CT Expert Panel. A Phase I Report, submitted in April
2005, provided recommendations on the education of CT technologists. This report included a
recommendation (Recommendation 10) for Ontario MRT programs to expand their curricula to include
CT competencies and to provide training to current technologists to upgrade their skills. The report is
posted on the MOHLTC website:
http://www.health.gov.on.ca/renouvellement/wait_timesf/wt_reportsf/mri_ct.pdf.
In response to this recommendation, MOHLTC has provided funding to The Michener Institute in
Toronto to develop a CT curriculum. The curriculum will provide a standard level of education for CT
technologists across Ontario by offering CT courses as part of full-time undergraduate imaging
programs and by providing graduate MRTs access to the same CT educational opportunities. Course
development has begun, with input from a variety of stakeholders.
The following are key elements of the curriculum development:
a) the curriculum receives funding and support from MOHLTC for its development;
b) the curriculum establishes a standard level of education for CT technologists in Ontario;
c) the curriculum recognizes the increased complexity of knowledge and skill required of CT
technologists;
d) the curriculum’s CT theory component includes optimization of image quality and dose
management;
e) the curriculum includes management of quality control for CT equipment;
f) the curriculum recognizes the recent significant advances in CT technology;
g) the curriculum includes a hands-on laboratory component (most CT courses presently
available focus on theory only); and
h) the curriculum is offered in distance format to ensure accessibility for all MRTs in Ontario.
The first course of the CT program will begin in May 2007. The curriculum will be available for inclusion
in undergraduate MRT programs in Ontario.
The MRI and CT Expert Panel Phase II Report, submitted in December 2006, recommended that MRT
programs continue to incorporate full CT competency into their curriculum.
22. MOHLTC should continue to provide support for a standardized CT curriculum for all
undergraduate/college MRT programs and for access to the same curriculum for MRT graduates in
Ontario.
23. The CT curriculum shall include training in radiation safety and dose management.
96
The College of Physicians and Surgeons of Ontario
CT PERSONNEL AND THE WORK ENVIRONMENT
The safety of personnel in the CT environment is governed by provincial legislation. Federal guidelines
and internal policy and procedures may be used as complementary measures and best practice
standards. The current status of safety for CT personnel is attached in Appendix A, “Worker Radiation
Protection in CT Applications.”
24. In addition to existing legislation and policies, CT facilities shall adopt the following safety
guidelines:
a) Doors accessible to the general public that enter into a CT scan room must be locked during
scanner operation. This will diminish the potential for unnecessary exposure to personnel
working in the CT environment or to the general public. Locked doors also prevent
interruption of a scan in progress.
b) CT operators must be within arm’s length of the scan abort button during image acquisition.
c) CT operators must be in visual contact with the patient during image acquisition.
CT SCANNER TESTING AND INSPECTION
The X-ray Inspection Service (XRIS) is a unit within MOHLTC and is the enforcement body for the HARP
Act. XRIS works at arm’s length from the HARP Commission.
Currently, CT scanners are not inspected by XRIS and are excluded from the HARP Act in this regard.
25. The testing and inspection of CT scanners should be specifically incorporated into the HARP Act. This
may require a major revision to the HARP Act and the X-ray Safety Code. The role and duties of X-ray
Inspection Service may also need to be modified so that XRIS is able to perform and audit the inspection
and maintenance of CT scanners, including dental cone beam CT, in Ontario. The appropriate resources
to expand this service will be necessary.
EDUCATION MATERIALS
Health Care Workers
Recent studies have shown that there is a lack of awareness among patients and physicians regarding
the magnitude of radiation doses involved in CT and its associated risks [41, 42]. An increased
awareness of the risks and benefits of procedures using ionizing radiation would help health care
workers make appropriate decisions for their patients and would reduce the risk of unnecessary patient
exposure to radiation. The draft of the Safety Code currently being prepared by Health Canada states
that the referring physician, who is the individual authorized to prescribe or request x-ray procedures,
should “be aware of the risks associated with x-ray procedures.”
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
97
26. The province should designate an organization to develop and disseminate information to
physicians and other health care workers that helps them to better weigh the benefits and risks of CT
studies for their patients. The topic of benefits and risks of procedures that use ionizing radiation such
as CT should be included in the training programs of health care providers who are involved in the
prescribing or performing of such procedures.
Patients
Health care is a shared responsibility between health care providers and patients. In order to
participate in the decision-making process, patients should be aware of the basic benefits and risks of a
CT scan and, indeed, of any test for diagnostic or therapeutic purposes. Any material provided for
patients should be presented in a way that does not provoke anxiety in patients, but rather provides an
appropriate perspective for making decisions.
27. The province should designate an organization to develop and disseminate information concerning
the benefits and risks of imaging studies involving ionizing radiation, specifically CT, to patients and the
general public.
Using a website to provide the above information would be an effective way to disseminate educational
materials to patients and health care workers. The educational material for patients would be
accessible to the general public, whereas the educational material for health care workers would be
available through professional organizations such as the College of Physicians and Surgeons of Ontario
(CPSO) and CMRTO. The content of these educational materials would require input from several
groups, including, but not necessarily limited to: Ontario Association of Radiologists (OAR), CPSO, and
CMRTO. Such a website would require funding for its development and maintenance.
MONITORING PATIENT DOSE
Increased awareness among patients and health care workers that any amount of ionizing radiation is
potentially harmful is, in and of itself, likely to help promote the safe and appropriate use of CT
scanners and other devices that use ionizing radiation. It is recognized that there is a cumulative risk
from multiple examinations or procedures that use ionizing radiation. If it were possible to collect the
data and monitor the cumulative dose from all radiation emitting devices that patients were exposed
to, patients may be more likely to avoid investigations and procedures that use ionizing radiation. One
potential method of monitoring patient dose is the concept of a “dose card” that could document
cumulative dose.
The concept of a “dose card” for each patient was reviewed by the Committee. A “dose card” would be
part of a patient’s permanent medical record. Each time an investigation or procedure using ionizing
radiation was performed, the dose would be recorded. The advantage of such a system would be that a
patient’s cumulative dose could be monitored. However, there are a number of important issues and
limitations to such a proposal. Currently, dose information is captured in different units by different
radiation emitting devices. The dose information from a CT examination can be expressed in various
units, the two most common being CTDIvol (CT dose index volume) and DLP (dose length product).
Typically, both these measurements are displayed on the CT console for each CT examination. It must
be noted, however, that these measurements are an indirect estimate of dose. More work on the
validity of DLP estimates, especially in children, is needed.
Exact measurements of dose in a given patient for a given CT study would be difficult to determine and
could involve time-consuming and complex measurements and calculations. In addition, new methods
and standards to quantify dose for MDCT may be introduced in the future. The current lack of
98
The College of Physicians and Surgeons of Ontario
measurement standardization across the range of radiation emitting devices and the fact that doses are
typically indirectly estimated are major obstacles to implementing a system for monitoring patient
dose. Other issues include: who would be responsible for monitoring dose information; who would be
responsible for calculating the risks for patients before they undergo an investigation or procedure
using ionizing radiation; and how useful would this information be if patients forget to bring their dose
card to an examination/procedure. Furthermore, setting an absolute dose limit would not be
appropriate because the benefits and risks of each procedure must be assessed on an individual basis in
the context of the patient’s overall care.
28. At this time, given the above limitations, the Committee does not recommend attempting to
establish a permanent, portable record of the cumulative dose that each patient in Ontario receives.
Once a comprehensive, electronic record-keeping system is in place for the citizens of Ontario, it would
allow for at least a record to be kept of the type and frequency of x-ray examinations. This information
may influence a physician’s decision when considering a request for imaging tests.
DENTAL CONE-BEAM CT (CBCT)
Currently, panoramic radiology is used for many conventional diagnostic dental examinations and is
associated with a significantly lower radiation dose compared to dental cone-beam (CBCT) scanners,
which use cone-beam CT technology [43]. Dental CBCT scanners are specifically designed for advanced
dental applications and are used primarily for dental implant and orthognathic surgical planning. Other
applications include 3D localization of impacted teeth and diagnosis of pathology related to the maxilla
and mandible. Compared to CT scanners used for “body” imaging, dental CBCT scanners are relatively
simple and use significantly lower radiation doses to produce high-resolution images. Image acquisition
is almost completely automated, with a limited number of parameters that can be adjusted.
However, if dental CBCT scanners become readily available for use by general dentistry practices, it is
possible that this technology will replace panoramic radiology for conventional diagnostic dental
examinations. This raises concerns about a potential increase in patient and population exposure to
radiation. Also of concern is the current lack of training for general dentists in the interpretation of
images generated by dental CBCT scanners. Within the dental profession, the specialty of Oral and
Maxillofacial Radiology has training in both the application and the interpretation of images produced
by dental CBCT scanners.
The HARP Act currently states who is qualified to operate an x-ray machine [Section 5 (1) (2)] and who
can prescribe the operation of an x-ray machine (Section 6). The HARP Act does not specifically state
who can operate a dental CBCT scanner or who can prescribe the operation of a dental CBCT scanner.
Currently, MOHLTC does not approve requests for installation and operation of additional dental CBCT
scanners in Ontario.
29. The HARP Act should be revised to reflect the newer technology of dental CBCT.
30. MOHLTC should lift the current moratorium on approval of dental CBCT scanners, but approval
should be restricted to Oral and Maxillofacial Radiologists and graduate Oral Radiology academic
centres.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
99
31. Dental CBCT scanners must be operated under the supervision of an Oral and Maxillofacial
Radiologist.
32. All requests for dental CBCT examinations must be reviewed and approved according to protocol by
an Oral and Maxillofacial Radiologist prior to performing the examination.
RESEARCH
Because CT technology is advancing rapidly, the current research base for clinical guidance is limited.
Close collaboration among CT manufacturers, imaging scientists, and radiologists should be encouraged
to further explore and promote methods of dose management for CT. Therefore, the appropriate
resources will be required to keep pace with these changes.
33. Close collaboration among CT manufacturers, imaging scientists, and radiologists is encouraged to
further explore and promote methods of dose management for CT.
100
The College of Physicians and Surgeons of Ontario
REFERENCES
1. Computed Tomography Radiation Safety Issues in Ontario. Available at: www.health.gov.on.ca
2. Magnetic Resonance Imaging Environment Safety in Ontario. Available at: www.health.gov.on.ca
3. 2006 Annual Report of the Office of the Auditor General of Ontario. Chapter 3, Section 3.06.
Hospitals – Management and Use of Diagnostic Imaging Equipment. Available at: www.auditor.on.ca
4. United Nations Scientific Committee on the Effects of Atomic Radiation to the General Assembly,
2000. Sources and effects of ionizing radiation, Volume 2, Effects. Available at: www.unscear.org
5. Health Risks from Exposure to Low Levels of Ionizing Radiation: BEIR VII – Phase 2 Report. Available
at: www.nap.edu/catalog/11340.html
6. International Commission on Radiological Protection. New draft report for consultation:
multidetector computed tomography. Available at: www.icrp.org
7. Diagnostic Imaging Referral Guidelines (Canadian Association of Radiologists).First Edition, 2005.
8. American College of Radiology Appropriateness Criteria 2000 (AmericanCollege of Radiology).
Available at: www.acr.org
9. Royal College of Radiologists 2003 – Making the Best Use of a Department of Clinical Radiology:
Guidelines for Doctors. 5th Edition. London: The Royal College of Radiologists, United Kingdom.
10. European Guidelines for Multislice Computed Tomography 2004 – CT Quality Criteria (European
Commission).Available at: www.msct.eu
11. Health Physics Society. “Ask the Experts,” Category: Medical and Dental Equipment/Sheilding.
Available at: www.hps.org
12. Hohl C, Wildberger JE, Suss C, Thomas C, Muhlenbruch G, Schmidt T et al. Radiation dose reduction
to breast and thyroid during MDCT: effectiveness of an in-plane bismuth shield. Acta Radiologica 2006
July; 47:562–567
13. Fricke BL, Donnelly LF, Frush DP et al. In-Plane bismuth breast shields for pediatric CT: effects on
radiation dose and image quality using experimental and clinical data. AJR Feb 2003; 180:407–411
14. Geleijns J, Salvado Artells M, Veldkamp WJH, Lopez Tortosa M, Calzado Cantera A. Quantitative
assessment of selective in-plane shielding of tissues in computed tomography through evaluation of
absorbed dose and image quality. European Radiology Oct 2006; 16:2334–2340
15. McCollough CH, Bruesewitz MR, Kofler JM. CT dose reduction and dose management tools:
overview of available options. Radiographics 2006; 26: 503–512
16. Heneghan JP, McGuire KA, Leder RA et al. Helical CT for nephrolithiasis and ureterolithiasis:
comparison of conventional and reduced radiation-dose techniques. Radiology 2003; 229:575–580
17. Kaneko M, Kusumoto M, Kobayashi T et al. Computed tomography screening for lung carcinoma in
Japan. Cancer 2000; 89:2485–2488
18. van Gelder RE, Venema HW, Serlie IW et al. CT colonography at different radiation dose levels:
feasibility of dose reduction. Radiology 2002; 224:25–33
19. Kalra MK, Maher MM, Toth TL et al. Strategies for CT radiation dose optimization. Radiology 2004;
230:619–628
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
101
20. Iannaccone R, Laghi A, Catalano C et al. Hepatocellular carcinoma: role of unenhanced and delayed
phase multi-detector row helical CT in patients with cirrhosis. Radiology 2005; 234:460–467
21. Caoili EM, Cohan RH, Inampudi P et al. MDCT urography of upper tract urothelial neoplasms. AJR
2005; 184:1873–1881
22. Chai RY, Jhaveri K, Saini S, Hahn PF, Nichols S, Mueller PR. Comprehensive evaluation of patients
with haematuria on multi-slice computed tomography scanner: protocol design and preliminary
observations. Australasian Radiology 2001; 45:536–538
23. Gray JE, Archer BR, Butler PF et al. Reference values for diagnostic radiology: application and
impact. Radiology May 2005; 235:354–358
24. Shrimpton PC, Hillier MC, Lewis MA, Dunn M. Doses from computed tomography examinations in
the UK – 2003 review. NRPB – W67, NRPB Publications. Available at: www.hpa.org.uk
25. Aldrich JE, Bilawich AM, Mayo JR. Radiation doses to patients receiving computed tomography
examinations in British Colombia. CARJ 2005; 57:79–85
26. American Association of Physicists in Medicine.Available at: www.aapm.org
27. American College of Radiology. Available at: www.acr.org
28. Radiological Protection and Safety in Medicine. Annals of the ICRP, 1997.
29. Mettler Jr. FA, Wiest PW, Locken JA, Kelsey CA. CT scanning: patterns of use and dose. J Radiol Prot
2000; 20:353–359
30. Khursheed A, Hillier MC, Shrimpton PC et al. Influence of patient age on normalized effective doses
calculated for CT examinations. Br J Radiol 1997; 75: 819–830
31. Huda W, Atherton JV, Ware DE, Cumming WA. An approach for the estimation of effective radiation
dose at CT in pediatric patients. Radiology 1997; 203(2):417–422
32. Brenner DJ, Elliston CD, Hall EJ, Berdon WE. Estimated risks of radiation-induced fatal cancer from
pediatric CT. AJR 2001; 176:289–296
33. Paterson A, Frush DP, Donnelly LF. Helical CT of the body: are settings adjusted for pediatric
patients? AJR 2001; 176:297–301
34. Donnelly LF, Emery KH, Brody AS et al. Minimizing radiation dose for pediatric body applications of
single-detector helical CT: strategies at a large children’s hospital. AJR 2001; 176:303–306
35. Strategies for minimizing radiation dose in pediatric CT. Guidelines from the Hospital for Sick
Children, Toronto.Available at: www.sickkids.ca/diagnosticimaging
36. Frush DP, Soden B, Frush KS, Lowry C. Improved pediatric multidetector CT using a size-based colorcoded format. AJR 2002; 178: 721–726
37. Verdun FR, Lepori D, Monnin P, Valley JF, Schnyder P, Gudinchet F. Management of patient dose
and image noise in pediatric CT abdominal examinations. Eur Radiol 2004; 14:835–841
38. Cody DC, Moxley DM, Krugh KT, O’Daniel JC, Wagner LK, Eftekhari F. Strategies for formulating
appropriate MDCT techniques when imaging the chest, abdomen, and pelvis in pediatric patients. AJR
2004; 182:849–859
39. Voch P. CT dose reduction in children. Eur Radiol 2005; 15:2330–2340
40. Adult and pediatric CT protocols from the Johns Hopkins Hospital. Available at: www.CTisus.com
102
The College of Physicians and Surgeons of Ontario
41. Lee CI, Haims AH, Monico EP, Brink JA, Forman HP. Diagnostic CT scans: assessment of patient,
physician, and radiologist awareness of radiation dose and possible risks. Radiology 2004; 231:393–398
42. Thomas KE, Parnell-Parmley JE, Haidar S, Moineddin R, Charkot E, BenDavid G et al. Assessment of
radiation dose awareness among pediatricians. Pediatric Radiology 2006; 36:823–832
43. Ludlow JB, Davies-Ludlow LE, Brooks SL, Howerton WB. Dosimetry of three CBCT devices for oral
and maxillofacial radiology: CB Mercuray, NewTom 3G, and i-CAT. Dentomaxillofacial Radiology 2006;
35:219–226
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
103
Appendix A - Worker Radiation Protection in CT
Applications
Installation Approval
The MOHLTC’s current policy is that any x-ray machine used to irradiate a human being —
including CT scanners — for any purpose, including research and analysis, is covered
by the HARP Act and must be approved and designated according to the HARP Act prior
to installation and operation. Proposed installations are reviewed by the X-ray Inspection
Service of the MOHLTC and must comply with Regulation 543: X-ray Safety Code
under the HARP Act, as well as with Appendix 2 of Safety Code 20A (federal legislation).
For facilities under Ministry of Labour jurisdiction (e.g., veterinary, forensic, training
exclusively with phantoms, research), CT installations are further required to have locks
or interlocks on all entry doors.
The following radiation protection requirements are subject to Regulation 861/90,
respecting X-ray Safety and Regulation 67/93 for Health Care and Residential Facilities,
made under the Ministry of Labour’s Occupational Health and Safety Act.
Radiation Safety Training
As required under the Occupational Health and Safety Act, Section 25 (2) (a) and (d)
state:
25 (2) Without limiting the strict duty imposed by subsection (1), an employer shall:
(a) provide information, instruction and supervision to a worker to protect the health or
safety of the worker;
(d) acquaint a worker or a person in authority over a worker with any hazard in the work
and in the handling, storage, use, disposal and transport of any article, device, equipment
or biological, chemical or physical agent;
(x-rays are defined as a physical agent)
104
The College of Physicians and Surgeons of Ontario
Further, under the Health Care and Residential Facilities Regulation (Regulation 67/93),
Section 9 (4) states:
The employer, in consultation with and in consideration of the recommendation of the
joint health and safety committee or health and safety representative, if any, shall
develop, establish and provide training and educational programs in health and safety
measures and procedures for workers that are relevant to the workers' work. O. Reg.
67/93, s. 9.
General Duty to Establish Measures and Procedures
In consultation with the joint health and safety committee or representative, an employer
shall develop, establish, and put into effect measures and procedures for the health and
safety of workers.
Under the Health Care and Residential Facilities Regulation (Regulation 67/93), Section
9 (1) states:
The employer shall reduce the measures and procedures for the health and safety
of workers established under section 8 to writing and such measures and procedures
may deal with, but are not limited to, the following:
7. The hazards of biological, chemical and physical agents present in the workplace,
including the hazards of dispensing or administering such agents.
8. Measures to protect workers from exposure to a biological, chemical or physical agent
that is or may be a hazard to the reproductive capacity of a worker, the pregnancy of a
worker or the nursing of a child of a worker.
9. The proper use, maintenance and operation of equipment.
10. The reporting of unsafe or defective devices, equipment or work surfaces.
11. The purchasing of equipment that is properly designed and constructed.
12. The use, wearing and care of personal protective equipment and its limitations.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
105
Personal Radio-Protective Equipment
The Ministry of Labour Radiation Protection Service has a written policy on personal
radio-protective equipment. For workers remaining in the room during a CT examination,
wrap-around aprons, along with thyroid collars having 0.5 mm lead equivalency at the
highest used kVp, are required to be worn.
Under the Health Care and Residential Facilities Regulation (Regulation 67/93), Section
10 states:
(1) A worker who is required by his or her employer or by this Regulation to wear or use
any protective clothing, equipment or device shall be instructed and trained in its care,
use and limitations before wearing or using it for the first time and at regular intervals
thereafter and the worker shall participate in such instruction and training.
(2) Personal protective equipment that is to be provided, worn or used shall:
(a) (a) be properly used and maintained;
(b) be a proper fit;
(c) be inspected for damage or deterioration; and
(d) be stored in a convenient, clean and sanitary location when not in use.
O. Reg. 67/93, s. 10.
Dosimetry
Under the X-ray Safety Regulation 861/90, Section 12 states:
12. (1) An employer shall provide to each x-ray worker a suitable personal dosimeter that
will provide an accurate measure of the dose equivalent received by the x-ray worker.
(2) An x-ray worker shall use the personal dosimeter as instructed by the employer.
(3) An employer shall ensure that the personal dosimeter provided to an x-ray worker is
read accurately to give a measure of the dose equivalent received by the worker and shall furnish to
the worker the record of the worker's radiation exposure.
(4) An employer shall verify that the dose equivalent mentioned in subsection (3) is
reasonable and appropriate in the circumstances, and shall notify an inspector of any dose
106
The College of Physicians and Surgeons of Ontario
equivalent that does not appear reasonable and appropriate.
(5) An employer shall retain an x-ray worker's personal dosimeter records for a period of
at least three years. R.R.O. 1990, Reg. 861, s. 12.
The word "suitable" is defined by the Ministry of Labour as a personal dosimeter that
provides a measure of dose received by the exposed part of the body. All x-ray workers working
with fluoroscopic or other unshielded open-beam x-ray sources (including CT
systems, if remaining in the room) shall be provided with an additional head/collar badge
(worn on the exterior of the thyroid collar) and/or an extremity badge (worn as a ring on a
hand), where deemed appropriate.
Dosimetry is required for all persons who meet the definition of an x-ray worker,
including external workers who may service or test the CT machine.
Reporting of a high exposure or possible overexposure
Under the X-ray Safety Regulation 861/90, Section 13 and 14 state:
13. Where a worker has received a dose equivalent in excess of the annual limits set out
in Column 4 of the Schedule in a period of three months, the employer shall forthwith
investigate the cause of the exposure and shall provide a report in writing of the findings
of the investigation and of the corrective action taken to the Director and to the joint
health and safety committee or health and safety representative, if any. R.R.O. 1990, Reg.
861, s. 13.
14. Where an accident, failure of any equipment or other incident occurs that may have
resulted in a worker receiving a dose equivalent in excess of the annual limits set out in
Column 3 of the Schedule, the employer shall notify immediately by telephone, telegram or other
direct means the Director and the joint health and safety committee or health and
safety representative, if any, of the accident or failure and the employer shall, within
forty-eight hours after the accident or failure, send to the Director a written report of the
circumstances of the accident or failure. R.R.O. 1990, Reg. 861, s. 14.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
107
Warning Signs
Under the Health Care and Residential Facilities Regulation (Regulation 67/93),
Section 16 states:
A warning sign shall be posted on any door, corridor or stairway,
(a) that is not a means of egress but that is located or arranged so that it could be
mistaken for one; or
(b) that leads to a hazardous, restricted or unsafe area. O. Reg. 67/93, s. 16.
Under the X-ray Safety Regulation 861/90, Section 11 (1) and (3) state:
The following measures and procedures shall be carried out in a workplace where an xray
source is used:
1. X-ray warning signs or warning devices shall be posted or installed in
conspicuous locations.
3. Where the air kerma in an area may exceed 100 micrograys in any
one hour, access to the area shall be controlled by,
i. locks or interlocks if the x-ray source is one to which
subsection 6 (1) applies or is described in subsection 6 (2);
and
ii. barriers and x-ray warning signs if the x-ray source is
portable or mobile and is being so used.
108
The College of Physicians and Surgeons of Ontario
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
109
Appendix V
Sample Emergency Safety Policy
Safety Training for all staff should be carried out. In addition, an emergency safety policy should be
included in the policies and procedures manual. This appendix has been provided as a sample of what
the policy may look like and include. Each policy must be site specific to the facility and may include but
is not limited to the following areas:
Employer Responsibilities (in all incident cases):
Provide first aid in accordance with the regulations.
Record first aid attention, adverse effects, incident report.
Assist to provide immediate transportation to the hospital, doctor, worker/patient’s home, when/as
necessary.
Employee Responsibilities:
Acute Care Transfer
Should a patient, visitor, and/or staff become ill while in the clinic the following is carried out:
1. Immediately, the technologist or clerical staff will alert the attending Radiologist of the
problem.
2. In the event that the attending Radiologist is not available, contact a local GP (agreement
should be made prior between facility and physician – contact numbers should be available for
staff).
3. If the physician is not immediately available, call 911, identify yourself and request transfer to
the nearest hospital.
Fire Prevention and Control Plan
1. All staff members employed at the facility is required to know the fire plan. To facilitate this, an
annual review of the plan will be carried out and is mandatory for all staff members.
2. The fire plan is site-specific for the facility. Staff members are required to familiarize themselves
with the plan for this location.
3. Each employee should have the ability to assess the situation quickly and initiate appropriate
measures upon discovering a fire. This may vary from using a fire extinguisher to contain a fire
or alerting others, evacuating the building and calling the fire department.
If you discover a fire in your area:
1.
2.
3.
4.
110
Remove patients from rooms and out of danger.
Turn off lights, any electrical equipment, gases, and close windows and doors.
Pull the alarm located closest to you.
Dial 911 and advise the Fire Department of the Emergency. Give them your name, location of
the fire and type of fire to the communications operator (electrical, gas, other).
The College of Physicians and Surgeons of Ontario
5. If possible (i.e the fire is contained to a specific area) go back to the room and attempt to put
out the fire using a fire extinguisher.
DO NOT ATTEMPT TO USE THE FIRE HOSE. Everyone should be removed from the office. Have a staff
member positioned at the main corridor junction to direct fire fighters.
If you hear a fire alarm:
1. Collect all patients, visitors, and staff members in the facility and guide them to the closest
exits.
2. DO NOT USE THE ELEVATOR. All staff members along with anyone in the office at the time of
the evacuation alarm, must meet at a predetermined assembly point outside of the building.
3. Personnel will be requested to assist with duties such as checking the office before leaving
ensuring that everyone is accounted for, turning off lights in the fire area, turning off gases
(oxygen), turning off all electrical equipment and closing doors and windows.
The First Aid Box
As a minimum the first aid box should contain:
• A current edition of a first aid manual.
• One card of safety pins.
• Dressings, consisting of:
o 12 adhesive dressings, individually wrapped
o 4 sterile gauze pads, 3 inches square
o 2 rolls of gauze bandages, 2 inches wide
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
111
Appendix VI
Protocol
Requirement for MRI/CT Priority
Overview
The levels noted below should be on the requisition for protocol purposes and the CT/MRI facilities
should have a list of conditions identified for each Level. See Table 1 below:
Table 1
Service Area
MRI/CT Scans
112
Ontario's targets (in
weeks)




PI: Immediate
PII: 48 hours
PIII: 2 - 10 days
PIV: 4 weeks
The College of Physicians and Surgeons of Ontario
Appendix VII Prevention of IV Contrast Reaction
Protocol
ACR Manual on Contrast Media, Version 9:
http://www.acr.org/quality-safety/resources/contrast-manual
For reference, below is a list of the Chapters and Tables that can be found in the ACR Manual on
Contrast Media; all Chapters and Tables can be accessed using the above link:
Preface
Introduction
Chapter 1. Patient Selection and Preparation Strategies
Chapter 2. Injection of Contrast Media
Chapter 3. Extravasation of Contrast Media
Chapter 4. Allergic-Like and Physiologic Reactions to Intravascular Iodinated Contrast Media
Chapter 5. Contrast Media Warming
Chapter 6. Contrast-Induced Nephrotoxicity
Chapter 7. Metformin
Chapter 8. Contrast Media in Children
Chapter 9. Gastrointestinal (GI) Contrast Media in Adults: Indications and Guidelines
Chapter 10. Adverse Reactions to Gadolinium-Based Contrast Media
Chapter 11. Nephrogenic Systemic Fibrosis (NSF)
Chapter 12. Treatment of Contrast Reactions
Chapter 13. Administration of Contrast Media to Pregnant or Potentially Pregnant Patients
Chapter 14. Administration of Contrast Media to Women Who are Breast Feeding
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
113
Tables
Table 1: Indications for Use of Iodinated Contrast Media
Table 2: Organ or System-Specific Adverse Effects from the Administration of Iodine-Based or
Gadolinium-Based Contrast Agents
Table 3: Categories of Acute Reactions
Table 4: Treatment of Acute Reactions to Contrast Media in Children
Table 5: Management of Acute Reactions to Contrast Media in Adults
Table 6: Equipment for Contrast Reaction Kits in Radiology
APPENDIX A: Contrast Media Specifications
114
The College of Physicians and Surgeons of Ontario
Appendix VIII
Independent Health Facilities Act Ontario Regulation 57/92
Note: Ontario Regulation 57/92 has previously been amended. Those amendments are listed in the
Table of Regulations - Legislative History Overview which can be found at www.e-laws.gov.on.ca.
Facilities are encouraged to check the Government Website for updates.
Quality Advisor and Advisory Committee
1(1) Every licensee shall appoint a quality advisor to advise the licensee with respect to the quality and
standards of services provided in the independent health facility.
(2)If the quality advisor dies or ceases to be the quality advisor, the licensee shall appoint a new quality
advisor forthwith.
(3)The quality advisor must be a health professional who ordinarily provides insured services in or in
connection with the independent health facility and whose training enables him or her to advise the
licensee with respect to the quality and standards of services provided in the facility.
(4)It is a condition of a licence that the quality advisor be a physician if all the insured services provided
in the independent health facility that support the facility fees that the licensee may charge are
provided by physicians.
(5)In subsection (4), an insured service supports a facility fee if the facility fee is for or in respect of a
service or operating cost that supports, assists or is a necessary adjunct to the insured service.
(6)A licensee who is qualified under subsection (3) may appoint himself or herself as the quality advisor
only if there is no other health professional who is qualified to be the quality advisor who will consent
to be the quality advisor. O. Reg 57/92, s.1.
2(1)Every licencee shall appoint an advisory committee to advise the quality advisor.
(2)The advisory committee shall consist of health professionals who provide health services in or in
connection with the independent health facility.
(3)The quality advisor shall be the chair of the advisory committee.
(4)Every licensee shall use his or her best efforts to ensure that there is a representative on the advisory
committee from the health profession and each specialty and sub-specialty of medicine, practitioners of
which provide health services in or in connection with the independent health facility. O.Reg. 57/92,
s.2.
3(1)Every licensee shall give the Director the name of the quality advisor in writing forthwith after the
quality advisor is appointed.
(2)If the quality advisor dies or ceases to be the quality advisor, the licensee shall inform the Director in
writing forthwith.
(3)Every licensee shall give the Director, on request, the names of the members of the advisory
committee in writing. O. Reg. 57/92, s.3.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
115
Standards
4 (1)Every licensee shall ensure that all aspects of the services provided in the independent health
facility are provided in accordance with generally accepted professional standards.
(2)Every licensee shall ensure that the persons who provide services in the independent health facility
are qualified, according to generally accepted professional standards, to provide those services.
(3)If the quality advisor has reasonable grounds to believe that this section is not being complied with,
he or she shall inform the Director forthwith. O.Reg. 57/92, s.4.
5 Every licensee shall keep a system to monitor the results of the services provided in the independent
health facility. O. Reg. 57/92, s.5.
6(1)Every licensee shall ensure that all tissues removed from a patient during an operation or curettage
performed in an independent health facility are sent to a laboratory for examination and report unless
the physician performing the operation or curettage is of the opinion that it is not necessary according
to generally accepted medical standards.
(2)The licensee shall ensure that a short history of the case and a statement of the findings of the
operation or curettage are sent with the tissues. O. Reg. 57/92, s.6.
Records of Employees
7 (1)Every licensee of an independent health facility shall maintain, for each employee of the facility
who is not a physician, an employment record setting out the employee’s qualifications and
employment history including a record of any registration with or licensing by the governing body of a
health profession.
(2) Every licensee shall retain an employee’s employment record for at least two years after the
employee ceases to be an employee. O.Reg. 57/92, s.7.
8 (1)Every licensee of an independent health facility shall maintain a record of qualifications and work
history for:
(A) each person the licensee contracts with to manage the facility; and
(B) each person who is not a physician who the licensee contracts with to provide patient-related
services in the facility.
(2)The record shall include a record of any registration with or licensing by the governing body of a
health profession.
(3) Every licensee shall retain the record for a person the licensee contracts with for at least two years
after the licensee ceases to contract with the person. O. Reg. 57/92, s.8.
9 (1)Every licensee shall maintain a declaration of professional standing for each physician who
provides professional services in the independent health facility.
(2)A declaration of professional standing must include the following information:
1. The physician’s name
2. The physician’s registration number with the College of Physicians and Surgeons of Ontario
3. The physician’s number registered with the Health Insurance Division of the Ministry of
Health.
116
The College of Physicians and Surgeons of Ontario
4. The class of the physician’s licence issued under Part III of the Health Disciplines Act and any
terms and conditions attached to it.
5. The physician’s specialty.
(3)Every licensee shall give the Director a copy of each declaration of professional standing, forthwith
after the obligation to maintain it begins under subsection (1).
(4)Every licensee shall give the Director a written statement of any change in a declaration of
professional standing forthwith after the change.
(5)Subsections (3) and (4) do not apply with respect to physicians providing services on a temporary
basis for less than twelve weeks. O.Reg. 57/92, s.9.
Patient Records
10 (1) Every licensee of an independent health facility shall keep, for each person who is or was a
patient, a health record relating to the health services provided in the facility.
(2)A patient’s health record must include:
(a) the patient’s name and home address
(b) the patient’s date of birth
(c) the patient’s health number
(d) the name of any attending physician or practitioner and his or her number as registered
with the Health Insurance Division of the Ministry of Health
(e) the name of any referring physician or practitioner and his or her number as registered with
the Health Insurance Division of the Ministry of Health
(f) a history of the patient
(g) a written record of any orders for examinations, tests, consultations or treatments
(h) particulars of any examination of the patient
(i) any reports of examinations, tests or consultations including any imaging media from
examinations and any physicians’ interpretive or operative reports
(j) any reports of treatment including any physicians’ operative reports
(k) any orders for and reports of any discharge of the patient from supervised care
(l) any consents; and
(m) any diagnoses of the patient.
(3)A) patient’s health record need not contain a history of the patient if the patient came to the
independent health facility for diagnostic services only and received on such service.
(4)Every licensee shall ensure that every part of a patient’s record has a reference on it identifying the
patient or the record.
(5)If information in a patient’s record is kept in the form of a chart, each entry in the chart must be
dated and it must be initialled by the person authorizing the entry. O.Reg. 57/92, s.10.
11 (1) Every licensee shall retain a patient’s health record or a copy of it for at least six years following:
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
117
(a) the patient’s last visit; or
(b) if the patient was less than eighteen years old when he or she last visited the facility, the day the
patient became or would have become eighteen years old.
(2)Despite subsection (1), a licensee is not required to retain imaging media from any examination
other than a mammography for more than three years following:
(a) the patient’s last visit; or
(b) if the patient was less than eighteen years old when he or she last visited the facility, the day the
patient became or would have become eighteen years old.
(3)Every licensee shall retain the film from a mammography for at least ten years following the patient’s
last visit. O.Reg. 57/92, s.11.
(4)On the transfer of a licence under section 11 of the Act, the transferor of the licence shall transfer to
the transferee of the licence, in a manner that will protect the privacy of the records, the records
maintained under section 10 of this Regulation, and the transferee of the licence shall retain those
records in accordance with this section.
Section 12 of the Regulation is revoked and the following substituted:
12 (1)No licensee shall allow any person to have access to any information concerning a patient that is
not subject to the Personal Health Information Protection Act, 2004 except in accordance with
subsection (3).
(2)The reference to “information concerning a patient” in subsection (1) includes information or copies
from a health record, even if anything that could identify the patient is removed.
(3)A) licensee may provide information described in subsection (1) to the following persons if anything
that could identify the patient is removed from the information:
1. Any person, if the information is to be used for health administration or planning or health research
or epidemiological studies and the use is in the public interest as determined by the Minister.
2. Cancer Care Ontario. O Reg. 346/04, s.2.
Books and Accounts
12.1(1)This section applies to licensees of independent health facilities that are funded under section
24 of the Act, other than independent health facilities whose funding is based solely on the Ministry of
Health publication titled “Schedule of Facility Fees”.
(2)Every licensee shall keep the following records in relation to the independent health facility:
1. Current financial records showing:
(i) the amounts paid by the Minister to the licensee under section 24 of the Act.
(ii) the revenue earned by the licensee from facility fees charged by the licensee for or in respect of
services or operating costs that support, assist or are a necessary adjunct to the primary insured
services set out in the licensee’s licence, and
(iii) the expenditures, assets and liabilities of the facility that relate to the costs paid by the Minister
under section 24 of the Act.
118
The College of Physicians and Surgeons of Ontario
2. A reporting record listing each service provided in the facility that is a primary insured service set out
in the licensee’s licence and each service provided in the facility that is a funded service under section
24 of the Act and showing how many of each of such services are provided.
3. An annual income and expense statement showing the income received and the expenses incurred
by the licensee in connection with the services mentioned in paragraph 2.
4. An annual inventory of the assets of the facility that have an acquisition cost exceeding $3,500 and
that relate to the costs paid by the Minister under section 24 of the Act.
(3)Every licensee shall ensure that the records required under section (2):
(a) are kept in the independent health facility; and
(b) are kept in a bound or loose-leaf book or are recorded by a system of mechanical or electronic data
processing or any other information storage device.
(4)Every licensee shall ensure that any part of a record required under subsection (2) that relates to a
period of time is retained for at least six years following the end of the period.
(5)Every licensee shall ensure that the accounts of the independent health facility are audited by a
person licensed under the Public Accountancy Act. O.Reg. 283/94, s.1, part.
12.2 Every licensee of an independent health facility shall furnish such information and accounts as the
Director may require. O. Reg. 283/ 94, s.1, part.
Notices
13 Every licensee of an independent health facility,
(a) who decides to cease operating the facility at a future date shall give the Director, as soon as
possible, written notice of the date; and
(b) who ceases to operate the facility shall give the Director, within seven days after the date the
licensee ceases to operate the facility, written notice of the date. O. Reg. 57/92, s.13.
14 Every licensee of an independent health facility shall give the Director:
(a) if the licensee is a corporation, written notice of any change in the location of the licensee’s head
office within ten days after the change; and
(b) written notice of any change in the name under which the licensee carries on business within ten
days after the change. O.Reg. 57/ 92, s.14.
Miscellaneous
15 It is a condition of a licence that the licensee post the first page of the licence in a conspicuous place
in the independent health facility. O. Reg. 57/92, s.15.
16(1)
The fee for a licence is $100.
(2)
The fee for the transfer of a licence is $100.
(3)
The fee for the renewal of a licence is $100. O. Reg. 57/92, s.16.
17 The administrative charge for the purposes of section 36 of the Act is $50. O. Reg. 57/92, s.17.
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
119
120
The College of Physicians and Surgeons of Ontario
Appendix IX
Sample Patient Survey: Quality of Care
Please rate the following things about your visit to this clinic in terms of whether they
were poor, fair, good, very good, or excellent. Circle the number 1 for poor; 2 for fair; 3
for good; 4 for very good, and 5 if you felt it was excellent. If something doesn’t apply to
your visit or you don’t have an opinion, please circle the number 8.
Please rate each item by circling the number
that best describes your opinion
Poor
Fair
Good
1. Waiting time: how long you had to wait to
get an appointment at this clinic
1
2
3
4
5
8
2. Waiting time: how long you had to wait in
the clinic waiting room for your appointment
1
2
3
4
5
8
3. Instructions: how well the clinic staff
(doctors, receptionists, technologists etc.)
told you how to prepare for the test(s) and
what to expect both before and/or during the
test(s)
1
2
3
4
5
8
4. Ease of getting information: willingness of
clinic staff to answer your questions
1
2
3
4
5
8
5. Information you were given: how clear
and complete the explanations were about
any possible risks and complications of the
test(s)
1
2
3
4
5
8
6. Concern and caring by clinic staff:
courtesy and respect you were given,
friendliness and kindness; how well clinic
staff listened to what you had to say; how
well the clinic staff understood what you
thought was important
1
2
3
4
5
8
7. Safety and security: the provisions for
your safety and the security of your
belongings
1
2
3
4
5
8
8. Privacy: how well your privacy was
considered, for example, type of gowns
used, privacy while changing clothes
1
2
3
4
5
8
1
2
3
4
5
8
9. Instructions on leaving: how clearly and
completely you were told what to do and
what to expect when you left the clinic
Very
Good
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
Excellent
Not Applicable
No Opinion
121
Please answer the following questions by circling 1 for Yes or 2 for No .
10. Were you told to leave the clinic before you felt ready to do so?
11. Did you have to visit a physician, walk-in clinic, emergency room, urgent
care centre or hospital in the days following this service because your health got
worse as a result of the service(s) received at the clinic?
12. Would you recommend the clinic to a friend or family member if they needed
services that it provides?
Please rate this item by circling the number
that best decribes your opinion
13. Overall quality fo care: how you
evaluate the services you received and the
way you were treated
Poor
Fair
Good
1
2
3
Very
Good
4
YES
NO
1
2
1
2
1
2
Excellent
Not Applicable
No Opinion
5
8
14. If there were some things you could change about this visit to improve it, what would they be?
Thank you for completing this survey. Please double check that you have answered all questions
and then place the survey in the envelope provided. Your answers will be kept completely
confidential.
Thank you again for your help!
122
The College of Physicians and Surgeons of Ontario
Appendix X
Sample Referring Physician SurveyIndependent Health Facilities Program
name of facility
Please answer the following questions regarding your experience with the above facility by filling in the
blank or circling the number that best describes your answer.
1. How long have you referred patients to this facility? _______years or _______months
Please base your answers on your contact with the facility in the past 6 months.
2. How satisfied are you with how long it generally takes: (Please rate each item by circling the
number that best describes your opinion)
N/A
Very
Dissatisfied
Dissatisfied
Neutral
Satisfied
Very
Satisfied
1
2
3
4
5
1
2
3
4
5
1
2
3
4
5
to get an appointment for a patient at this
facility?
to obtain written results (a written
consultation) from this facility, once your
patient is seen?
to get an oral report from this facility when it
is required because of an urgent or emergency
situation, once your patient is seen?
3. How often do you speak to a physician at the IHF regarding the patient’s clinical condition before
your patient receives a diagnostic work-up?
Never Rarely
1
2
Occasionally
3
Sometimes
4
Often
Almost all the time
5
6
4. Approximately how many patients have you referred to this facility in the past 6 months?
___________(number of patients referred)
5. Do you refer your patients to more than one facility of this type?
No (if you circled No, please skip to Question number 7)
Yes
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
123
6. What are the reasons you refer patients to this particular facility?
(Please circle all that apply.)
1 Nearer Patient’s home
2 Has specialized equipment needed for test requested
3 Turn around time to receive the results is shortest
4 Has staff that speak other languages, and thus can better understand my patients
5 Is able to quickly see patients when feedback is urgently required
6 Has convenient hours of operation
7 Quality of the services provided
8 Other, please describe ___________________
Please skip to Question number 8.
What are the reasons you refer patients only to this facility? (Please circle all that apply.)
1 Only facility of its type in this community
2 Our group has a service contract with this facility
3 Facility is located near this practice and is thus convenient for patients
4 Has staff that speak other languages and thus can better understand my patients
5 Has specialized equipment needed for tests requested
6 Turn-around time to receive results is short
7 Nearest patients’ homes
8 Is able to quickly see patients when feedback is urgently required
9 Quality of the services provided
10 Has convenient hours of operation
11 Other, please describe____________________
124
The College of Physicians and Surgeons of Ontario
9. Please rate each item by circling the number that best describes your experience with the IHF based
on your contacts in the last 6 months.
Never
Seldom
Sometimes
Frequently
Usually
The waiting period for a test to be
done is long.
1
2
3
4
5
Requests for consultation are
handled promptly.
1
2
3
4
5
1
2
3
4
5
1
2
3
4
5
1
2
3
4
5
The recommendations received are
useful in patient management.
1
2
3
4
5
The recommendations are clearly
stated.
1
2
3
4
5
The reports received are too
wordy.
1
2
3
4
5
Reports of results are sent out in a
timely fashion.
1
2
3
4
5
1
2
3
4
5
When tests are added the resulting
recommendations add information
important to patient care
1
2
3
4
5
The interpreting physician’s
findings are generally consistent
with your clinical findings
1
2
3
4
5
The facility accommodates patients
when the test is urgently required
The interpreting physician is
available to you for consultation.
This facility meets the needs of my
patients whose first language is
other than English or French
The consulting physician orders
tests in addition to those you
requested
10. Have you been dissatisfied with a consult you received from this facility in the past six months?
1 No
2 Yes
If 2 (Yes), please explain:
Clinical Practice Parameters and Facility Standards for MRI and CT – 3rd edition
125
11. Overall, how satisfied are you with the contacts you have had with this facility in the past six
months?
Very
1
Dissatisfied
2
Neutral Satisfied
3
Very Satisfied
4
Thank you for participating in this survey. Please return the survey in the envelope provided.
Our address is:
126
The College of Physicians and Surgeons of Ontario