Department of Veterans Affairs Northern California Health Care System

COOPERATION OF RADIOLOGY SERVICE, RESEARCH SERVICE,

MRI SAFETY SUBCOMMITTEE, AND RESEARCHERS IN PERFORMANCE

OF MRI SCANS FOR RESEARCH PURPOSES

Standard Operating Procedures (SOP)

R&D Approval Date:

2 /28/2018

Effective Date:

2/28/2018

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Contents

1. PURPOSE .................................................................................................. 3

2. SCOPE ...................................................................................................... 3

3. ABBREVIATIONS/DEFINITIONS.................................................................... 3

4. RESPONSIBILITY........................................................................................ 4

5. PROCEDURES ........................................................................................... 9

6. POINTS OF CONTACT................................................................................. 9

7. REFERENCES ...........................................................................................11

8. SIGNATURE BLOCK...................................................................................11

APPENDIX A, MRI/FMRI APPLICATION..............................................................12

APPENDIX B, RADIOLOGY SERVICE STANDARD OPPERATING PROCEDURE MAGNETIC RESONANCE IMAGING SAFETY .....................................................13

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1. PURPOSE

The purpose of this SOP is to describe the cooperation of Radiology Service, Research Service, the facility MRI Safety Subcommittee, and researchers for the performance of magnetic resonance imaging (MRI) scans or functional MRI (fMRI) scans for research purposes. This SOP does not address the conduct of standard clinical MRI scans for patient care purposes when included in a research protocol as part of standard-of-care procedures.

2. SCOPE

All Veterans Affairs Northern California Health Care System (VANCHCS) research must be approved in accordance with established guidelines and must be directed by a principal investigator (PI). Implementation of MRI/fMRI scans for research purposes for approved research protocols will require interaction between VANCHCS Research Service and Radiology Service under the guidance of VANCHCS MRI safety guidelines and the direction of the PI.

3. ABBREVIATIONS/DEFINITIONS BDMS: Benefit and Data Management Service CPRS: Computerized Patient Record System DICOM: Digital Imaging and Communications in Medicine, a standard for

handling, storing, printing, and transferring information from medical imaging. It includes definition of file format and a network communications protocol.

fMRI: Functional magnetic resonance imaging, a magnetic resonance

imaging technique that measures brain activity. HIMS: Health Information Management System HRPP: Human Research Protection Program, a program that enforces

compliance with Veterans Affairs and federal regulations that protect the safety and rights of participants in research studies.

IRB: Institutional Review Board, an independent committee that has

responsibility for reviewing research involving human subjects and ensuring that such research is performed in such a way that maximizes

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benefits and minimizes risks to research subjects and is compliant with all applicable Veterans Affairs and federal regulations. The IRB reports to the Research & Development Committee.

IRBManager: A web-based system for research protocol submission, administrative

review, research protocol tracking, and research committee and oversight.

MR: Magnetic resonance, a medical imaging technique. MRI: Magnetic resonance imaging, a type of medical imaging that uses the

response of nuclei within molecules of body tissues to high-frequency radio waves when placed in a strong magnetic field to produce images of the internal organs.

PACS: Picture archiving and communication system. The Phillips Intellispace

PACS System is the electronic system in which Veterans Affairs Northern California Health Care System stores clinical magnetic resonance images.

PI: Principal investigator, the researcher with overall responsibility for a

given research study. R&DC: Research & Development Committee, the facility committee that

provides independent oversight of all research occurring at Veterans Affairs Northern California Health Care System.

SOP: Standard Operating Procedures VA: Veterans Affairs VANCHCS: Veterans Affairs Northern California Health Care System. VHA: Veterans Health Administration VISTA: Veterans Information Systems and Technology Architecture

4. RESPONSIBILITY

A. The PI desiring to participate in the performance of MRI/fMRI scans for research

purposes as part of a Veterans Affairs (VA) research protocol is responsible for a. securing approval from the individual who serves as his/her

supervisor for his/her research activities for participating in the performance of MRI/fMRI scans and documenting this approval on the Scope of Research Practice;

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b. ensuring that all members of the research team proposed to participate in the performance of research MRI/fMRI scans have completed training in the operation of the facility MRI scanner to ensure their safe participation in research MRI scanning as specified by Radiology Service and provide evidence of this training to the Research Service;

c. ensuring that they and members of their research team that participate in research MRI scanning review and follow the Radiology Service Standard Operating Procedures (SOP) for Magnetic Resonance Imaging Safety (attached as appendix B);

d. including with the protocol submission information describing the MRI/fMRI portion of the research including description of the characteristics of the subjects to be scanned to include their physical, mental, and cognitive condition, total number of scans to be performed for each subject and interval over which these scans will be performed, exposure associated with a single scan and all scans to be completed, and personnel to participate in the performance of the research MRI/fMRI scans. This information to be supplied as a completed form (“MRI/fMRI Application”, attached as Appendix A). After full implementation of research protocol submission and review through IRBManager, researchers will be required to supply the same information elicited on the current MRI/fMRI application through the corresponding questions presented through the IRBManager web-portal;

e. ensuring that a member of the research team works with a representative designated by Radiology Service to schedule research subjects for research MRI/fMRI scans into the MTZ RAD RESEARCH clinic;

f. ensuring that a member of the research team notifies a representative designated by the Radiology Service at least 24 hours in advance of a scheduled research MRI/fMRI scan and confirms availability of a certified VA MR technologist;

g. reviewing the safety of MRI with research subjects using the standard clinical MRI safety checklists used by VA MR technologists, documenting this review on a paper checklist and ensuring that the completed and signed safety checklist is scanned and uploaded into PACS within two business days of completion of this safety screening;

h. participating with the VA MR technologist in any modifications of the MRI scanner needed to accomplish the research MRI/fMRI scan;

i. under the direct supervision of the VA MR technologist, returning the MRI scanner/scanner room to the configuration expected for clinical MRI scans;

j. creating VHA health records/CPRS charts for research subjects who do

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not have such charts previously following processes/protocols negotiated by Research Service, HIMS, Eligibility, and BDMS or others as appropriate.

B. The VANCHCS Research Service is responsible for

a. administrative processing (review for completeness, consistency, and clarity, availability of funding for research MRI/fMRI scans) of documents/information received from researchers seeking approval for research protocols involving MRI/fMRI scans for research purposes;

b. providing the representative from the facility MRI Safety Subcommittee with access to the researcher’s description of the MRI/fMRI portion of the research protocol as well as the informed consent form. This description will include a description of the characteristics of the subjects to be scanned to include their physical, mental, and cognitive condition, number of scans to be performed and duration over which these scans will be completed, exposure associated with a single scan and all scans to be completed, and personnel to be involved in the performance of the research MRI/fMRI scans. This access will be provided by forwarding to the representative of the facility MRI Safety Subcommittee, as defined by that subcommittee, a completed request to perform MRI/fMRI for research purposes (“MRI/fMRI Application”, attached as Appendix A) and the informed consent form submitted by the researcher. After full implementation of IRBManager, this access will be given by providing the representative of the facility MRI Safety Subcommittee with access to the corresponding information through the IRBManager web portal associated with the research protocol;

c. providing the facility MRI Safety Officer with evidence of completion and continued compliance with level 1 and level 2 MRI Safety training for all researchers proposed to participate in MRI/fMRI research scans;

d. serving as the liaison between the representative of the facility MRI Safety Subcommittee and the researcher to resolve any concerns with the research MRI/fMRI protocol identified by the point of contact of the facility MRI Safety Subcommittee;

e. receiving the results of the facility MRI Safety Subcommittee review of research protocols including MRI/fMRI and providing the IRB with access to this information;

f. providing at least annually and within two business days of request to a representative of the Radiology Service a list of current Research & Development Committee (R&DC) approved research protocols approved to perform MRI/fMRI scans for research purposes;

g. providing the point of contact designated by the Radiology Service with copies of the R&DC approval letter, IRB approved research

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protocol and a blank copy of the IRB approved consent form within five business days of approval of a research protocol by the R&DC. After full implementation of IRBManager, this requirement will be satisfied by providing the point of contact designated by Radiology Service with access to copies of these documents through IRBManager;

h. providing researchers with information for Radiology Service points of contact i) for scheduling research MRI/fMRI scans; ii) for notifying Radiology Service of research MRI/fMRI scans that have been scheduled;

i. working with a representative from Radiology Service and Fiscal Service as needed to ensure that the facility is reimbursed for the cost of MRI/fMRI scans performed for research purposes to include MR technologist time/overtime;

j. ensure that appropriate PACS codes are used such that research MRI/fMRI images and/or data stored in PACS do not trigger the requirement for reading by a radiologist.

C. The VANCHCS MRI Safety Subcommittee is responsible for

a. notifying the Research Service of the documentation/forms/information that they require to review for the use of MRI/fMRI for research purposes (currently the “MRI/fMRI Application”, attached as Appendix A and the research consent form);

b. notifying the Research Service of a point of contact to be sent documentation/forms/information for review of requests for performance of MRI/fMRI for research purposes. After full implementation of IRBManager, this requirement will be met by providing the MRI Safety Subcommittee point of contact access to documentation/forms/information through IRB-Manager;

c. communicating with the Research Service HRPP Program Manager to resolve any concerns with research use of MRI/fMRI scans proposed by researchers;

d. notifying the Research Service HRPP Program Manager of the results of the review of requests for performance of MRI/fMRI for research purposes;

D. The VANCHCS Radiology Service is responsible for

a. defining the training that is required of researchers desiring to participate in the performance of MRI/fMRI scans for research purposes and notifying the Research Service of these requirements [currently this training includes level 1 training in TMS (course #9696)

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as well as level 2 training available by viewing video training in MRI Safety by Siemens available in three parts:

https://www.youtube.com/watch?v=zUXzqValm1U https://www.youtube.com/watch?v=g15WaLZTBkQ https://www.youtube.com/watch?v=C721AzAoNA0

b. notifying the Research Service of clinical requirements for

documentation of safety checks and completion of MRI scans; c. notifying the Research Service of the Radiology Service point of contact

to receive a copy of the R&DC approval letter, IRB approved research protocol and a blank copy of the IRB approved consent form for research protocols involving MRI/fMRI scans for research purposes. After full implementation of IRBManager, this requirement will be met by providing the Radiology Service point of contact access to the aforementioned documents through IRBManager;

d. notifying the Research Service of the Radiology Service point of contact to schedule or assist with scheduling of research subjects into the MTZ RAD RESEARCH clinic for research MRI/fMRI scans;

e. notifying the Research Service of the Radiology Service point of contact to be notified by researchers of the dates and times that research subjects are scheduled for MRI/fMRI scans;

f. querying VISTA to obtain the list of research subjects scheduled into the MTZ RAD RESEARCH Clinic;

g. providing a certified MR technologist to ensure that the provision of MRI/fMRI scans for research purposes is consistent with VANCHCS MRI Safety Policy.

h. arranging for overtime for MR technologists if needed to accommodate needs of researchers requiring MRI/fMRI scans for research purposes.

i. ensure that research MRI/fMRI images and/or data are uploaded and stored into in PACS with codes that do not trigger the requirement for reading by a radiologist.

E. The VANCHCS IRB is responsible for

a. receiving from the Research Service research protocols for review; b. ensuring that all research protocols requesting performance of

MRI/fMRI for research purposes include notification of the results of the review of the MRI/fMRI component of the research by the facility MRI Safety Subcommittee;

c. only approving research protocols requesting research performance of MRI/fMRI scans if the MRI/fMRI component of the research has received approval from the facility MRI Safety Subcommittee;

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5. PROCEDURESResearch protocols that request to perform MRI/fMRI scans for research are expected to include the following procedures/specifications:A. Two independent evaluations of the safety of MRI for the research subject

will be completed and documented using the standard MRI safety checklist used clinically, with the final safety evaluation to be performed by a certified VA MR technologist before the research subject enters the magnet room.

B. A certified MR technologist will have responsibility for ensuring the safe execution of all MRI/fMRI scans performed for research purposes.

C. Listing of qualifications of researchers proposed to participate in the performance of the MRI/fMRI scanning protocol will meet the requirements of Radiology Service.

D. Researchers requesting performance of MRI/fMRI scans for research purposes will reimburse the facility for the costs of these scans including MR technologist time (or overtime if applicable) either from grant funds orthrough other arrangements with the Research Service.

E. VHA health records/CPRS charts will be created for all research subjects not currently having such VHA health records. To limit concerns of these individuals for the security of their personal information, these CPRS charts will be created using the minimum information required for creation of CPRS charts and access to these research CPRS charts will be restricted torelevant Research, Radiology, and MRI Safety Subcommittee personnel tothe maximum extent possible.

F. Forms for MRI safety screening of research subjects will be uploaded into PACS, just as for clinical MRI scans.

G. Images and/or data for research MRI/fMRI scans will be stored in PACS with the assignment of appropriate codes that do not trigger the requirement for reading by a radiologist.

H. Whenever possible, research MRI/fMRI scans will be performed during regularly scheduled research hours.

6. POINTS OF CONTACT

A. For Radiology Service:a. Review of MRI/fMRI Applications:

i. Drs. Lien Che (lien.kuei.che@va.gov, 916-843-7375) and Matthew Falk (matthew.falk@va.gov, 925-372-2622);

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b. Receiving from the Research Service copies of (or electronic access to)documents indicating Research & Development Committee (R&DC)approval of research protocols as follows: the R&DC approval letter, theIRB approved research protocol, and a blank copy of the IRB-approvedconsent form within 5 days of R&DC approval of research studiesinvolving MRI/fMRI scanning:

i. Dr. Matthew Falk (matthew.falk@va.gov, 925-372-2622) and CherylPonce (cheryl.ponce@va.gov, 916-709-3694);

c. Scheduling MRI/fMRI scans and notification of dates and times ofresearch MRI/fMRI scans as well as names of research subjects to bescanned:

i. Cheryl Ponce (cheryl.ponce@va.gov, 916-709-3694);d. Receiving records of level 1 and level 2 MRI Safety training for

researchersi. MR Safety Officer Nancy Darden (nancy.darden@va.gov, 916-843-

7199);e. Liaison with Researchers for questions and all other issues:

i. Dr. Matthew Falk (matthew.falk@va.gov, 925-372-2622); Dr. Falkwill refer researchers to other Radiology staff as appropriate;

B. For facility MRI Safety Subcommittee:a. Drs. Lien Che (lien.kuei.che@va.gov, 916-843-7375).

C. For Research Servicea. Review of MRI/fMRI Applications, resolution of issues raised by facility

MRI Safety Subcommittee, liaising with researchers concerning any human subjects issues related to research MRI/fMRI scans:i. HRPP Program Manager, Mr. Jefferson Lee

(jefferson.lee2@va.gov, phone (916) 843-2769, FAX (916) 364-0306);

b. Concerns regarding reimbursement of the facility for research MRI/fMRI scans; provision of administrative information concerning researchMRI/fMRI scans including research protocols approved by the VANCHCS R&DC to perform research MRI/fMRI scans, communication with researchers concerning points of contact within Radiology Service, concerns about compliance of researchers with facility or Radiology Service requirements for research MRI/fMRI scansi. Administrative Officer, Research Service, Miguel (“Michael”)

Sanchez, Ph.D., (Miguel.sanchez@va.gov, (916) 843-2893, mobile(925) 270-5141);

c. Any other purposes not listed above:i. Associate Chief of Staff/Research, Dawn Schwenke, Ph.D.

(dawn.schwenke@va.gov, (916) 843-2776, mobile (916) 540-0045).

7. REFERENCES

38 CFR 16 (VA) "Protection of Human Subjects"45 CFR 46 (HSS) "Protection of Human Subjects"21 CRFVHA Handbook 1200.5 "Requirements for the Protection of Human Subjects"VHA Handbook 1105. 05 "M�netic Resonance Imaging Safety"

8. SIGNATURE BLOCK

Dawn Schwenke, Ph.D., FAHA Assoc iate Chief of Staff for Research

;L_L Lien Che, M.D. Chair, MRI Safety Subcommittee

Ch�t, Assoc iate Chief of Staff for Radiology

Paramita Ghosh, Ph.D. Chair, Research & Development Committee

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APPENDIX A, MRI/FMRI APPLICATION

APPENDIX A

V. 1/25/2018 Page 1 of 3

Northern California Health Care System

MR/fMRI APPLICATION

Principal Investigator:

Title of Study: VA File Number:

PRINCIPAL INVESTIGATOR PREFERS APPROVAL NOTIFICATION DOCUMENT SENT BY: VA NCHCS Inter-Office Mail United States Postal Service

Principal Investigator:

Contact Person (if different from PI):

Phone: Phone: Pager or Cell Phone: Pager or Cell

Phone:

Email: Email: Fax: Fax: US Mailing Address: US Mailing

Address:

VANCHCS site and VA Inter-Office Mail Code:

VANCHCS site and VA Inter-Office Mail Code:

Subjects (check all that apply):

Non-patient volunteers Outpatients Inpatients Young control subjects Older control subjects (above 60 years of age) TBI patients Stroke patients Dementia patients Patients with other neurological diseases (e.g., Parkinson’s, MS, etc.) Patients that require sedation Non-ambulatory patients Patients over 80 yrs of age Patients with shunts, stents, implants, or prostheses

Department of Veterans Affairs

APPENDIX A

V. 1/25/2018 Page 2 of 3

Will you use any contrast agents such as gadolinium?

Yes No Will subjects undergo repeated scans?

Yes No If Yes: What is the maximal number of scanning sessions anticipated for a subject? ___________ Over what interval will these scans occur? ______________________________________ Will subjects with significant medical conditions (e.g., limited mobility, significant cognitive or psychiatric impairments, etc.) be scanned for research purposes?

Yes No If Yes, explain the provisions for the comfort, safety and welfare of these participants: ________________________________________________________________________ ________________________________________________________________________ Pulse sequences: Do you plan to use the Siemens Verio scanner?

Yes No • If Yes, will you exclusively use standard MR imaging protocols that have already

been programmed? __________________________________________________ Yes No • If No, will you use new research protocols that will require pulse sequence

programming? _________________________________________________ Yes No

• If Yes, please specify who will be doing the pulse sequence programming: _____________________________________________

Devices: Will any devices be used in the scanner room that have not been designed explicitly for use in an MR environment?

Yes No • If Yes, describe the devices:

____________________________________________________________________________________________________________________________________________________________

• Describe the safety precautions being used: ____________________________________________________________________________________________________________________________________________________________

APPENDIX A

V. 1/25/2018 Page 3 of 3

Implementation of Research MRI/Fmri Scans: Who will participate with the responsible certified VA MR technologist to perform the research MR scans?

Names of Researchers (Include degree, i.e., MD, PhD, etc.)*: 1. 2.

* Attach documentation of completion of training to demonstrate familiarity with operation of the MRI scanner as required by the Radiology Service.

MR Research Support: The project has been

Funded Funding is pending Source: ______________________________________________ No funding is anticipated

Have funds been allocated in the proposal budget for hourly costs associated with MRI and fMRI scanning?

Yes No • If No, please explain: _________________________________________________

By signing below, the Principal Investigator confirms that the research team will perform a MRI safety check of research subjects using the standard MRI safety checklist used clinically at VANCHCS before scheduling the research subjects and will retain a copy of this document in the research subject’s file. ________________________________________ __________________ Signature of Principal Investigator Date By signing below, the Chair/Designee of the VANCHCS MRI Safety Subcommittee affirms that the MRI scanning procedures described in this application appropriately protect the safety of research subjects. ________________________________________ __________________ Chair/Designee, MRI Safety Subcommittee Date

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APPENDIX B, RADIOLOGY SERVICE STANDARD OPPERATING PROCEDURE MAGNETIC RESONANCE IMAGING SAFETY

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VA Northern California Health Care System Radiology Department 01/23/2018

Radiology Service Standard Operating Procedure MAGNETIC RESONANCE IMAGING SAFETY

1) PURPOSE

To outline and address MRI safety concern’s and ensures a safe environment for all our patients, visitors and staff.

2) POLICY

The Diagnostic Imaging Service minimizes the risk of MRI studies to the greatest degree possible. This is done by providing barriers to unauthorized entry into the magnet room, by screening patients, employees, and objects for potential risk before they enter the magnet room, by using MRI-safe conveyances and monitoring equipment, requiring MRI safety training for appropriate personnel and by promoting risk awareness.

3) Zones: There are four zones that relate to the MRI environment.

1. Zone 1: Hallways and public areas. 2. Zone 2: Can include MRI reception, waiting, holding and screening areas. 3. Zone 3: MRI control room. 4. Zone 4: MRI scanner room

4. RISK OF INJURY MRI may present a significant risk of injury to patients and employees. Risks include: (a) Static Magnetic Field Risk. The magnetic field of a MRI machine is exceptionally strong. The field attracts certain metals and draws them to the magnet with uncontrollable force. This may damage the magnet or strike and injure a patient or employee near the magnet. Ferromagnetic metals (most commonly iron and some forms of steel) are most strongly attracted to magnets. Some other metals, such as cobalt, nickel, titanium, chromium, platinum and certain alloys, may be attracted to a much lesser degree. Examples of objects that may become lodged in the magnet include gurneys and beds, IV poles, oxygen tanks, and floor buffers. Implanted spring steel, such as early generation intracranial aneurysm clips, may become dislodged or twist in the magnetic field causing an intracranial hemorrhage. Steel fragments near the orbit may injure the optic nerve. Pacemakers and other medical devices may be damaged, reprogrammed, or turned off. (b) Radio-frequency (RF) Electromagnetic Field Risk. Prolonged imaging may cause the patient’s core body temperature to rise by deposition of energy from RF fields. The RF field may induce currents in electrically-conductive materials, such as wires that are lying on the patient, causing skin burns. It may also induce currents in intracardiac leads, resulting in inadvertent cardiac pacing. (c) Gradient Magnetic Field Risk. While changes in magnetic fields do not cause harm under normal imaging conditions, extreme gradients may cause biological effects, such as contraction of

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peripheral muscles or perceived flashes of light from the retina. Potentially, extreme gradients could induce seizures or arrhythmias. (d) Cryogen Risk. During an unplanned loss of magnetic field, helium in the magnet may evaporate suddenly. This gas is normally directed to the exterior of the building by large pipes. In the event that helium leaks into the magnet room, it may displace oxygen in the room which could result in suffocation. (e) Gadolinium Risk. Gadolinium contrast agents are sometimes given intravenously to improve the visibility of structures during MRI studies. Administration of gadolinium contrast agents to patients may cause nausea and headache. Less common effects are severe allergic reactions. If gadolinium remains in the body for a prolonged time, as in a patient with chronic kidney disease, it may dissociate from the chelate. Free gadolinium may induce Nephrogenic Systemic Fibrosis (NSF), an often fatal disease in which skin and internal organs become fibrotic.

Patients with altered renal function: All patients requiring gadolinium injection must

have a eGFR done within 30 days of the MRI. 1. eGFR >45 - approved for contrast without restrictions

2. eGFR 31-44 - needs radiologist approval, no informed consent needed- radiologist may

request we use Multihance

3. eGFR <30 - needs radiologist and ordering physician or nephrologist approval, informed

consent needed. (Omniscan and Magnevist are NEVER to be used with an eGFR below 30).

4. If a patient has a prior history of gadolinium contrast reaction, such as nausea, urticaria, or anaphylactoid reaction, the radiologist must be consulted and approve the administration of gadolinium. An informed consent must be done. A reliable intravenous line must be placed before the injection is given. The study may be deferred until the patient has been pre-medicated.

4) SAFETY PROCEDURES AND SCREENING

a. All approaches to the magnet control room will be conspicuously marked to indicate the presence of a magnetic field hazard. The doorway to the magnet room will be conspicuously marked to indicate that each entry by patients or staff requires authorization by MRI personnel.

b. All doors to the MRI suite will remain locked when unattended. c. When unlocked, the door to the magnet room will remain closed and access to the

magnet room will be guarded by MRI personnel. d. All persons who enter the magnet room must be screened using a Patient Safety form

approved by the service chief. Forms must be signed by the person who is performing the screening and by the individual requesting entry. Safety Forms of patients must be retained in their electronic health record.

e. Persons who enter the magnet room frequently, including Level-2 trained personnel, need not be screened on each entry. These persons can be screened once and the screening safety form retained in the MRI department for a period of at least 2 years

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or until no longer needed. An important difference between Level-1 and Level-2 trained personnel is that Level-1 trained personnel must be safety screened before entering the magnet room and authorized to enter by a Level-2 trained individual. Level-2 trained personnel may enter the magnet room without permission or screening. Untrained personnel may enter the room only under escort of a Level-2 trained individual and must be continuously observed while in the room.

f. Personnel who enter the magnet room infrequently, but are not placed in the bore of the magnet, must be screened once per imaging session. These forms will be kept for at least 1 year or until no longer needed. Screening forms for persons accompanying patients (ie: family needed for comfort purposes) will be scanned into PACS with the patient’s form.

g. Persons who are placed in the bore of the magnet (i.e., patients and research subjects) must be screened twice. This must be done for every imaging session. The first screening will be done by the ordering physician in CPRS at the time of order. MRI orders made without the first level screening will be cancelled. The second screening is more complete and must be performed by level 2 MRI personnel shortly before the patient enters the magnet room.

h. If patients cannot give a history, and if the patient has not recently undergone an MRI without complications, the radiologist or referring physician must be consulted. If there is no history available, the procedure must be cancelled, or the requesting physician must certify in an electronic medical record that the study is urgently needed and a risk benefit assessment has been done. The screening form must be signed by either a family member with proper authority and one who is intimately familiar with the patient’s medical history or if there is no such person, two physicians. The form must also be co-signed by the approving radiologist. All previous imaging will be reviewed to look for metallic implants and devices and x-rays will be performed if necessary.

i. Police Officers will not be allowed to enter Zones 3 or 4 without the removal of all equipment/weapons, and authorization from MRI personnel. **Under no circumstances will a Police Officer be allowed to enter either of these areas without removal of all weapons**. In addition, all police officers are required to take the level 1 TMS course 9696 annually and to attend the live MRI Safety in Emergencies training annually.

j. Patients, employees and visitors with the following devices will not be allowed in the magnet room and will not undergo MRI examination:

1. Cardiac Pacemakers and external pacemaker wires. 2. Implantable cardioverter defibrillator (ICD). 3. Intracardiac leads, such as those in PA lines. 4. Intracranial aneurysm clips listed as unsafe. 5. Neurostimulators, some Cochlear Implants, and other implanted electronic

devices. 6. Conductive Halos and head frames. 7. Intravascular stents without documentation or radiologist approval. 8. Patients with traction bars in place. 9. Patients with non-removable dentures or braces containing magnetic parts and

other devices containing magnets.

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k. Other metal implants, devices and/or foreign bodies determined to be in the patient will be identified by name and compared to the published lists of magnetic safety tested implants and devices. Devices or implants listed as conditional may be scanned following manufacturer guidelines. The location and type of foreign body should be determined if possible before scanning. Consultation with an MRI radiologist may be necessary if the foreign body is located near critical tissue, or is identified as being ferrous (ex: steel shot, BBs). A history of metal fragment(s) to the eye requires a water’s view x-ray or CT of the orbits prior to scanning unless the patient has been previously screened clear or had an MRI since without complications.

l. If a potential contraindication is found on screening, resolution of this finding must be documented on the Patient MRI screening form and retained in the health record. In cases of implanted devices, a “device warning” note must be entered into the patient’s chart. If the safety of a device is unknown, the manufacturer must be contacted to provide a letter or written safety statement. If identification or safety of an implant is unable to be obtained, proceeding with the MRI can only be authorized by an MRI radiologist after a risk/benefit assessment. If a medical device is investigated and it is determined the patient must not be imaged while the device is in place, the contraindication must be documented via a “device warning” note in CPRS. Likewise, complications resulting from MRI of a device must also be documented.

m. The MRI department must keep a file of all manufacturer safety documents, web pages, and correspondence that are used to determine the safety of a device.

5) PATIENT PREPARATION

a. Patients must be changed into a hospital provided scrubs/gowns and booties and are to be examined for hazardous objects and devices. No personal clothing items are allowed INCLUDING underwear, bras or socks. If the patient’s legs are bare, scrub pants are recommended OR care must be taken to make sure bare skin does not touch by providing padding between the legs. Patients, staff and visitors should not be allowed to take any of the following into zone 4:

(1) Wallets; (2) Money clips; (3) Credit cards and other cards with magnetic strips; (4) Electronic devices such as, beepers or cell phones; (5) Hearing aids; (6) Metal jewelry or watches; (7) Pens; (8) Paper clips or safety pins; (9) Keys; (10) Coins; (11) Hair barrettes and hairpins; (12) Shoes (patients only) (13) Belt buckles (patients only) (14) Any article of personal clothing (patients only).

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b. Transport devices must be removed or replaced with MRI safe devices, and non-ambulatory patients transported from zone 2 into the magnet room using a MRI safe wheelchair, walker or gurney as needed.

c. All ambulatory patients must pass through the ferromagnetic detectors (where available) before entering zone 4.

d. Dermal patches at risk for heating will be removed. Refer to dermal patch policy. e. Infusion pumps will be removed and converted to safe devices under the

supervision of a nurse or physician. Non-MRI safe sand bags will be replaced with MRI safe sandbags.

f. If physiologic monitoring equipment is present, it will be removed and replaced by MRI-safe monitoring equipment under the supervision of a nurse or physician. MRI-safe equipment will have high impedance or fiber optic leads to minimize the possibility of skin burns. Leads will be directed straight out of the magnet without forming a loop so as not to induce currents.

g. The technologist may exchange oxygen cylinders with wall oxygen regulators, taking care that the flow rate is unchanged.

h. Hearing protection in the form of earplugs and/or headphones must be used. Patients cannot be scanned without at least one form of hearing protection. Both earplugs and headphones are required when scanning on the 3T magnets unless the patient is extremely hard of hearing.

i. The patient needs to be positioned to not form a loop by touching limbs distally. An example would be the knees held apart but the feet touching each other. At no time, can the patient touch the inside bore of the scanner. Sponges can be used to hold limbs apart and away from the bore.

j. Patients who are claustrophobic or have survived traumatic events may require extra time and encouragement before being placed in the magnet. It is recommended that these individuals be allowed to inspect the magnet, be told how far in they will be placed in the bore, and be reassured that they will be removed immediately upon pressing the emergency call button. It is helpful to speak to them between each series. When possible the MRI procedure needs to be discussed with patients when appointments are scheduled. Those patients with concerns need to contact their referring provider for possible prescription for oral sedation.

k. Patients must be offered an emergency call button that allows them to signal the technologist that they require immediate attention or wish to be removed from the magnet. The call ball should be checked for proper function before each patient’s scan is started. The use of this button is not possible for patients who are paralyzed, sedated, or obtunded. Those patients must be checked between each imaging series.

l. Patients in the magnet room will be under the direct observation of the technologist at all times.

m. Prolonged imaging with strong RF fields is prevented by software, and can only be over-ridden beyond FDA levels by order of the radiologist. High SAR imaging requires pauses or cool down periods and regular communication with the patient.

n. If a patient attempts to remove an imaging coil during the course of a study, the study will be terminated and the radiologist notified. Such patients may be shocked by high voltages, or may cause expensive damage to the coil.

o. If a patient suffers respiratory or cardio-respiratory arrest, the technologist will press the code blue buttons located in the control rooms (Mather only) OR call

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3333, state “code blue (and the location)”. They will then immediately remove the patient from the magnet room before the Code Team arrives and shut access doors to zone 3 and 4. All emergency code responses will take place outside of the magnet room in zone 1 or 2.

p. Patients who are insensate, sedated, or obtunded may not know that they are being burned by currents induced in a cable, pulse oximeter, or other device. Patients who are unable to speak may not be able to communicate the fact that they feel pain. These patients must be examined between imaging sequences in order to detect skin burns early before they progress. Extra care must be taken that any leads, wires or other devices are MRI conditional, positioned appropriately (ie: not coiled) and padding must be placed between the patient and these devices.

q. Pregnancy related issues: 1. Health care practitioner pregnancies- pregnant workers are allowed to

work in and around MRI throughout their pregnancy. It is requested that the employee not remain in the scanner bore or zone 4 during image acquisition.

2. Patient pregnancies- there have been no risks associated with scanning a pregnant patient and fetus in any trimester, however, it is recommended that the MRI radiologist and ordering physician perform a risk/benefit assessment prior to authorizing an MRI during the pregnancy and get informed consent. If the decision is made to do the MRI, documentation in the patient’s chart should include:

a. The information requested from the MR study cannot be acquired by means of nonionizing means (e.g., ultrasonography).

b. The data is needed to potentially affect the care of the patient or fetus during the pregnancy.

c. The referring physician believes that it is not prudent to wait until the patient is no longer pregnant to obtain this data

3. Gadolinium administration in pregnancy is not recommended.

6) EMERGENCIES

a. Mock drills will be completed annually. These drills are to include, code blue,

quench/trapped patient, contrast reaction and fire. Each MRI technologist will be required to attend. Technologist(s) present at each drill, as well as a summary of the drill, will be documented and maintained in the MRI section.

b. In the event of a fire emergency, only MRI compatible fire extinguishers may be used

in the MRI area. Level 2 personnel need to be available during regular business hours to control access to zone 4 by untrained personnel.

c. Emergency quench procedures- If a patient is pinned within the magnet by a

ferromagnetic object that cannot be removed, or there is fire present within Zone 4 then the magnetic field may be quenched.

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d. After hours emergencies- For fire/natural disaster emergencies, engineering and the

police will have contact numbers for level 2 personnel who can assist with the decision to quench. During the quench, the magnet room door must be kept open to promote circulation of air, and to avoid ambient air from being displaced by helium. Only necessary personnel should be in zone 3 during a quench. All others should be removed to zone 1.

1. Mather and Martinez- if no level 2 staff are present in the facility, the VA Police

will be responsible for directing first responders to MRI and preventing all access to zone 4 until it can be determined if access to zone 4 is required. The police may contact level 2 staff by phone if needed to make this determination. However, if first responders or the VA police feel it is essential to access zone 4 to manage the emergency and there is no time to contact level 2 staff, the VA police have permission to quench the magnet. Under NO circumstances may first responders or VA police staff enter zone 4 when the magnetic field is active.

2. Redding- if no level 2 staff are present in the facility, the VA Police will be responsible for directing first responders to the MRI trailer and preventing all access to zone 4. First responders need only prevent fire from spreading to the main VA facility. They do not need access to zone 4 in the MRI trailer. The VA police should cordon off the area immediately around the MRI trailer to prevent all access until level 2 staff can arrive to assess whether a quench is required or has already occurred.

7) LEVEL 1 AND 2- DEFINITION AND TRAINING

a. Level 1- These are individuals who have completed course 9696 in TMS. Level-1 Personnel can enter Zone 4 of a MRI suite, but only with approval of Level-2 Personnel. They do not have free access to Zone 4. Personnel requiring this training include radiology technical staff, clerical staff with access to zone 3, nurses, monitor techs, biomedical engineers, engineering, site safety officers and housekeeping. Level 1 training must be completed yearly. b. Level 2- these are individuals who have completed an advanced course in MRI safety (i.e., Level-2 training) and have been designated by the Radiology Service Chief. Level-2 personnel can enter the magnet room freely without the need for prior approval, and can admit others into the magnet room by following established screening and monitoring procedures. These are to include MRI technologists and radiologists, the Service Chief, radiology chief tech and lead tech. Level 2 training must be completed yearly.

8. RESPONSIBLITIES a. MRI Medical Director

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1. Appointed by the Chief of Diagnostic Imaging and is the chair of the MRI Safety Committee. 2. Assess the risk of MRI injuries and makes written recommendations to minimize

that risk. 3. Works with the Chief of Diagnostic Imaging to write MRI safety policies and

procedures. 4. Works with the MRI Radiologists to ensure that imaging protocols are safe.

5. Delegates responsibility for executing duties

b. MRI Safety Officer 1. Has expertise in MRI safety issues and how to access such information

(excluding contrast) 2. Plans for the physical security of the MRI imaging suite; this may include locks,

barriers, and signs. 3. Ensures that monitoring equipment and conveyances for purchase are MRI safe. 4. Provides safety instruction and reference materials to MRI personnel as needed. c. MRI Safety Committee: 1. Constituted by the MRI Medical Director. Membership includes an MRI

Radiologist and MRI technologist representative from Mather and Martinez, site safety officers and administrative representatives from both sites.

2. Provides advice and input to the MRI Medical Director and MRI Safety Officer. 3. Meets quarterly to review incidents and assess risks of MRI injuries.

4. Conducts a risk assessment yearly of the MRI facilities, ensuring that the recommendations of the ACR Guidance Document for Safe MRI Practices are met. If recommendations are not met, a remediation plan or alternative measure that meets the intent of the recommendation must be devised.

5. Ensures security of the facility, including use of physical barriers and signs. 6. Ensures MRI-safe monitoring and transport devices have been provided. 7. Conducts emergency drills yearly to simulate emergencies, including a patient who

has suffered an allergic contrast reaction while in the magnet, a cardiac arrest in the magnet, a patient who is trapped in the magnet by a ferromagnetic object, and a fire in the magnet room.

8. Ensures that panic buttons, call systems and intercoms between patients and technologists are tested regularly.

9. Discusses adverse events and close calls with the Patient Safety Manager, and with the Patient Safety Manager coordinator devising means to eliminate or mitigate risk.

10. Developing and testing lasting remedies, which may include erection of barriers or architectural changes to imaging area.

d. MRI Technologists: 1. Maintains physical security of the magnet room to prevent access by

unauthorized or unscreened personnel or patients. 2. Screens all patients, employees and visitors before they enter zone 3. 3. Ensures that only MRI compatible safe devices and monitoring equipment enter

the magnet room.

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4. Removes dangerous objects from the vicinity of the magnet room.5. Refers questions and concerns to the MRI Safety Officer and/or the MRI Medical

Director

6. BIANNUAL REVIEW, RESCISSION OR REISSUE DATERadiological Services will review this SOP for recession/reissue within two years ofissuance.

7. REFERENCESa. VHA handbook 1105.05 Magnetic Resonance Imaging Safety-2012b. www.mrisafety.com Provides a list of safe and unsafe medical devices.c. www.fda.gov/cdrh/ode/perimerf6.html FDA’s MRI Working Group report.d. www.acr.org American College of Radiology accreditation standards and white paper

on MR safety.e. The Reference Manual for Magnetic Resonance Safety, Implants and Devices: 2014

editionf. Dr. Kanal’s MRI Medical Director/MRI Safety Officer training course

___________________________________________ Lien Che, MD, MD MRI Medical Director, VA Northern California Health Care System