UBC MRI Research Centre

Transcription

1 THE UNIVERSITY OF BRITISH COLUMBIA UBC MRI Research Centre 3T Facility SAFETY POLICY July 2, 2008

2 The following document contains important safety information with respect to the 3T Facility at the UBC MRI Research Centre. Please read this entire document thoroughly and retain a copy for your records. Outline 1. Introduction No Scent Policy 2 3. The UBC MRI Research Centre Protocol Review Committee Overview of Safety Policy for Researchers and Visitors Screening and Approval of Researchers and Visitors MRI Safety Training 6 7. Human Research Subjects 7 8. Gadolinium Injection Policy 7 9. Incidental Findings Philips 3T MRI Scanner Operators Emergency Procedures Access and Training for Custodial Staff Access and Training for Emergency Personnel Safety Officer Incidents Introduction This manual outlines the specific safety policies to mitigate the risks and safety hazards unique to the 3 Tesla MRI environment within the UBC MRI Research Centre, located in the UBC Hospital, Purdy Pavilion. The safety procedures outlined are intended to supplement safety regulations and policies already established for the UBC Hospital MRI Department, Vancouver Coastal Health Authority. The 3T facility is installed with a Philips Achieva 3.0T Quasar Dual MRI System. The 3T MR system will be operated in strict adherence to existing Canada Health and Welfare safety guidelines regarding acoustic noise, static magnetic field, pulsed gradient magnetic fields, and radiofrequency electromagnetic absorption (SAR). 2. No Scent Policy The UBC 3T MRI Research Centre is a scent free environment. All staff, researchers, patients, normal volunteers, and visitors MUST refrain from wearing scented products. (Perfume, aftershave, scented shampoos etc.) Any persons wearing scented products will be asked to remove scent (wash) or leave the MRI Department immediately. 7/2/2008 2

3 3. The UBC MRI Research Centre Protocol Review Committee This Committee is comprised of individuals knowledgeable of research procedures in MR, medicine, and physics. The Protocol Review Committee is responsible for review and approval (or disapproval) of protocol proposals for all research uses of the 3T Philips MR scanner. Research Protocols should first be submitted to the UBC Ethics Board for review. Research studies will not be conducted without the approval of both the UBC MRI Research Centre Protocol Review Committee and the UBC Ethics Board. 4. Overview of the Safety Policy for Researchers and Visitors The facility is divided into a number of Safety Zones, each with a different degree of stringency in the rules and regulations that apply to that area (summarized in Figure 1 and Table 1). Access to these zones is restricted according to a person s Safety Level, which is determined by his or her degree of safety training and screening approval (summarized in Table 2). 3T MRI Area Access and Safety Zones Waiting Area Main Entrance Green no restrictions Yellow restricted access Red restricted access, strong magnetic field Wash Room Security Door Reception 3T Technical Room Scan Room MRI Preparation Area 3T Operator / Control Area Radiology Reading Room Fire/Emergency Exit only Figure 1 3T MRI area access and safety zones. 7/2/2008 3

4 Table 1 UBC MRI Research Centre 3T Facility Safety Zones Zone Location Rules Green Yellow Reception area and waiting room. Area beyond key padded security door. Includes hallways, patient stretcher bay, 3T console area, Director s office, and scanner equipment room. No special restrictions All persons must check in at reception. Entry restricted to persons supervised by MR technologist or Centre scientist. Security door must be kept closed. Area in front of magnet room door and 3T console area must be kept clear of unnecessary articles. Persons may be asked to leave the Yellow Zone immediately in consideration of patient confidentiality and privacy. Prolonged access requires MRI User Safety Training Professional conduct expected at all times. Red Magnet room (within 5 Gauss line) Entry is denied if unscreened or having contraindications to magnetic field exposure (e.g. pacemaker, pregnancy) No loose metallic objects/equipment allowed in the magnet room Magnet room door must remain closed unless otherwise authorized Prolonged access requires MRI User Safety Training 7/2/2008 4

5 Table 2 UBC MRI Research Centre 3T Facility Safety Levels for Visitors and Users Safety Level Access Desired Requirements Responsibilities Unscreened Visitor Entry to Green Zone and Yellow Zone. No screening required for access to Green Zone and Yellow Zone. Yellow Zone with supervision only. Must NOT enter MRI scan room (Red Zone) Screened Visitor Entry to Yellow Zone and Red Zone (with supervision) for short-term visit Complete a Screening Form Pass a screening consultation by the MR technologist Allowed entry to magnet room ONLY if accompanied by MR Technologist or Centre scientist. Follow safety instructions from MR Technologist or Centre Scientist MRI User Access to Yellow Zone /Red Zone to support execution of MRI experiment Attend safety orientation given by Safety Officer Watch MRI Safety Movie Complete a Screening Form Screened by MRI technologist Sign Safety Log and User Training Checklist Follow safety rules outlined by MR Technologist or Centre Scientist and video Must be familiar with safety procedures, including quench and emergency procedures Notify MR Technologist if screening status changes 7/2/2008 5

6 5. Screening and Approval of Researchers and Visitors All visitors entering the Red Zone must be screened for contraindications before entering the magnet room. Personnel will be asked to complete and sign an MRI Screening Form and undergo a screening interview with an MR technologist, after which a decision will be made regarding the individual s suitability to safely enter a 3T magnetic field environment. If any contraindications are revealed during the screening process, the individual will be restricted from the Red Zone (scan room), but may still be allowed access to the Yellow Zone with supervision. Although screening interview and access decisions are the responsibility of the MR technologists, when there is uncertainty regarding a person s screening status, the UBC radiologists will be consulted and their decision will be final. Individuals are only required to fill out the screening form once; however, they must inform the MR technologist if their screening status changes (e.g. possibility of pregnancy, recent surgery). MR technologists may review an individual s screening status from time to time and update their screening form on file, especially if the applicant is returning from a long absence (over 6 months) away from the facility. Individuals entering the Red Zone (scan room) are required to remove all loose metallic objects outlined in Safety training. All additional apparatus (such as positioning devices) related to the experiment must be approved during protocol review (by the 3T Protocol Review Committee). ALL individuals must check with the MR technologist or Centre scientist before entering the scan room each day to ensure safety procedures are strictly enforced. 6. MRI Safety Training Short-term visitors wishing to enter the Yellow or Red Zone will undergo some basic safety training and a brief orientation by Centre MR technologist or scientists. All users wishing prolonged access to the Yellow or Red Zone are required to complete the User Safety Orientation. Compliance is documented by a signed MRI User Training Checklist and MR Safety Log An MRI User Safety Orientation and Training Session must be organized through the MR Technologist. This session, presented by the Safety Officer, will cover the following topics: Viewing of MRI Safety Video. Precautions when entering the magnet room. Emergency quench procedure. Reviewing of document Training, Communication Blamed on MRI Accident. Medical emergency procedures. Instructions for recruiting volunteers and patients, and their safety. 7/2/2008 6

7 7. Human Research Subjects All normal healthy volunteers and patients will be required to: Sign an approved UBC Ethics Board consent form. Complete a standard MR screening form for contraindications to MRI. Review MR screening form with MR Technologist. Those subjects with contraindications to MRI will not be scanned. Change into hospital pajamas. Special exceptions will be given to patients with disabilities; all clothing will be carefully examined by MR Technologist for metallic snaps, zippers, metallic threads on labels, and pockets searched for potential projectiles. Remove ALL jewelry and piercings, metallic objects, dentures, medication patches. Refrain from wearing eye makeup, or scented products. Patients and volunteers MUST remain in the Green Zone (waiting area) until permission to enter the Yellow or Red Zone is given by the MR Technologist or Centre Staff. Normal Volunteers with implants will not be scanned. Patients with implants will be scanned according to safety guidelines and UBC Ethics approval. Researchers may be required to forward operative reports for certain implants in patients to the MR Technologist for radiologist s review. Normal volunteers with possible metal in the eye will not be scanned. Patients with possible metallic foreign body in the eye will be required to have an orbital x-ray reported by a radiologist before proceeding with study. The patient s referring physician is responsible for ordering orbital x-rays. The UBC MRI Research Centre will NOT refer patients for orbital x-rays. All subjects will be closely monitored during the MR procedure. An emergency call bell will be given to the subject and he/she will be instructed to notify MR Technologist of discomfort of any kind. Should this occur, the scan will immediately be terminated and the subject removed from the magnetic field. 8. Gadolinium Injection Policy All contrast injections must be approved by the UBC Ethics Board and the UBC MRI Research Centre Protocol Proposal Committee. The UBC Hospital (UBCH) on-duty MR Fellow will oversee all contrast injections. When the MR fellow is unavailable, the attending UBCH MR Radiologist for that day will be contacted to oversee the contrast injection. All contrast (Gadolinium) injections will be administered by Vancouver Coastal Health MR Technologists who will strictly follow standard Vancouver Coastal Health guidelines. Contrast studies will be scheduled Monday to Friday. Contrast studies will not be scheduled from 12:00-13:00 or after 16:00. 7/2/2008 7

8 Because of the possible relationship between the use of gadolinium contrast agents and the subsequent development of nephrogenic systemic fibrosis (NSF), the following process will be strictly enforced. 1. All subjects must be screened for the possibility of renal impairment or family history of such, dialysis, type I or II diabetes, liver transplant, stroke, peripheral vascular or ischemic cardiac disease, or if they are over the age of 60 years. 2. All subjects who indicate that they have or may have any of the above risk factors, are required to have a recent (within 3months) laboratory test indicating the subject s serum creatinine and estimated glomerular filtration rate (egfr). 3. The medical collaborators for the study are responsible for ordering the laboratory test, if this is not current or available. 4. Laboratory results must be faxed to the 3T MR technologists at least one day prior to scan booking. 5. Gadolinium contrast will NOT be given to subjects with egfr less than 60ml/min/1.73 m Incidental Findings All scanning protocols are designed to answer research questions for studies approved by the Protocol Proposal Committee and UBC ethics. Research scans are typically not designed for clinical diagnosis. Study and protocol development scans will NOT be routinely reviewed by the Centre Radiologist. If a finding is incidentally identified (by the MR technologists or investigators) in healthy normal volunteers or patient subjects, the Centre Radiologist will review the scans and take the following actions if the finding may be of potential clinical significance and follow up is needed. Contact the Principal Investigator if he/she is a physician. Or Explain to the research participant that an incidental finding has been identified, and with their permission, contact his/her family physician. Directly refer subjects with central nervous system related incidental findings to the designated UBC Neurologist, subject to the approval of the subject and his/her family physician. Notify the Principal Investigator Clinical MR scans will NOT be performed at the Centre for follow up of incidental findings. A clinical radiology report of research scans will NOT be issued routinely. All potential incidental findings identified by investigators, including students, research assistants, scientists, and principal investigators must be reported to the 3T MR technologists in order to facilitate review by the Centre Radiologist. In the event that the Centre Radiologist is unavailable to review the scans and the incidental finding is felt to be of potential clinical 7/2/2008 8

9 concern, one of the UBC Hospital MRI Radiologists will be contacted for a preliminary consultation. All incidental findings, actions, and follow up will be recorded in the Incidental Finding Log and reported biannually to the UBC Research Centre Core Group. The incidental findings policy will be reviewed biannually to ensure commitment to scientific research integrity and ethical responsibility of subject welfare and privacy. 10. Philips 3T MRI Scanner Operators Qualified scanner operators will be limited to one of the following: Registered MR technologist (RTMR) with current membership CAMRT Philips Clinical Scientist UBC MRI Research Centre Scientist Graduate students and scientists with strong MR Physics backgrounds who require privileged access to the scanner in order to carry out research projects involving MR technique development. These individuals will have restricted scanning privileges. All patients will be scanned by a qualified MR technologist. 11. Emergency Procedures a) Procedure in the Event of a Quench: The Philips MR system design is set up that in the event of a quench, the helium gas is guided through a vent to the outside. A quench can be unexpected or can be initiated by pushing the quench button when a staff or subject is pinned to the scanner by a metal object due to the magnetic field. In the event of a quench: 1. Clear the scan room of all persons. 2. Close and secure the scan room door. 3. Call security and fire department. 4. Notify the Philips MR Service engineer and Clinical Scientist. 5. Notify the UBC Radiologists and Centre Director. b) Procedure in the Event of an incident or medical emergency requiring medical attention: When possible, the operator will remove the subject from the scan room, so the emergency response team will not be required to enter the scan room. 7/2/2008 9

10 In the event of an incident or medical emergency, depending on severity, the following emergency responses are available: Initiate Code Blue emergency response. (UBC Hospital Code Blue Team) Initiate Mr. Strong emergency response. (Security, First Aid, and Porter) Call the UBC Radiologists, Radiology Residents, or MR Fellow Transport to Urgent Care c) Procedure in the Event of a Fire: 1. Remove people from immediate danger (close all doors, shut off equipment) 2. Activate fire alarm pull station. 3. Telephone 0000, State Code Red and location 4. Evacuate/extinguish, move all persons out of fire zone 12. Access and Training for Custodial Staff Custodial staff will have access to the Green Zone and Yellow Zone, but will be required to complete a Safety Orientation before entering the Red Zone. Custodial staff performing weekly cleaning in Red Zone must do so under direct supervision of MR technologist or Centre scientist. 13. Access and Training for Emergency Personnel It may be necessary for UBC security, paramedics, and fire department personnel to enter the facility in response to an emergency situation. In the case of an emergency, Centre staff or MR technologists will immediately remove patient or volunteer from scan room. Centre staff will assist and inform emergency responders, with regard to potential hazards in responding to situations inside the magnet room, and initiate a magnet quench if required. All emergency personnel that may potentially respond to an emergency within the 3T facility must undergo a safety orientation and consultation with Centre staff or UBC Hospital MR technologists. 14. Safety Officer The Centre s MR Technologist, 3T Supervisor is appointed as the Safety Officer to oversee all elements of the Safety Policy. The Safety Officer is responsible for coordinating all safety training, monitoring safety compliance, liaising with emergency personnel and custodial staff, and maintaining records of screening activities and safety incidents. The Safety Officer will report periodically to the MRI Centre Core Group and will propose any changes to the Safety Policy as needed. 7/2/

11 The Safety Officer will ideally conduct the safety training and record keeping procedures. However, all other 3T MR technologists will, at their own discretion, conduct training procedures if the Safety Officer is unavailable. Safety forms, Incident Reports, training material and records will be kept in the 3T console area. 15. Incidents All operators will report all violations of safety procedures and protocols, all accidents, incidents involving damage to equipment, emergency quench, and any incidents requiring medical attention to the Safety Officer, Centre Director, and Centre Radiologist. All incidents and corrective actions to prevent a recurrence of such an incident will be recorded in the Incident Report permanent record and reported to the UBC MRI Research Centre Core Group. 7/2/