Brigham and Women s Hospital Advanced MRI Center Research Policy

Transcription

1 Brigham and Women s Hospital Advanced MRI Center Research Policy Research on BWH Advanced MRI Center scanners may be conducted only by certified users. Either scanner operation and/or ongoing participation in a research study constitute research. This document outlines the procedure for gaining user certification and the policy for research. Table of Contents User Certification 2 General Research Guidelines 3 Broken Equipment 5 Human Subject Research 6 Emergency Response 7 Incident Reporting 9 Animal Research 11 Clean Up Self Check List 14 Scheduling 15 Practical Training/Competency Test 16 Contact List 17 1 of 17

2 User Certification To gain certification: User must take Department of Radiology MRI Safety course o o MRI Safety Officer for user name and password (see Contact List) User must undergo Practical Training/Competency Test o Research Training Officer (see Contact List) to schedule test New users must have mentor (an experienced user), preferably from within his/her group. User must be trained in HIPAA policy even if he/she will not be scanning human subjects. Patient specific data is available on the scanner. o BWH employees must be cleared by Occupational Health BWH employees must be current with OSHA and Fire safety training 2 of 17

3 General Research Guidelines Always be aware of MRI safety. The magnet is always on. No food/drinks in console area or scanner room Sign logbook (available at each scanner) every imaging session o Time in o Time out o Indicate you cleaned the room o Indicate quality assurance scan was performed o Records problems Document mess that was there when you arrived Body fluids Syringes/sharps Lab equipment left behind Report problem to MRI tech on duty Ask MRI tech on duty to co-sign book o Problems with scanner o Lights in room burned out o Etc. If scanner is found in a down (non-functioning) state or in a limited use state, and this was not documented in the logbook and reported o Document in logbook the fact that the scanner was found in down state o Follow procedure in Broken Equipment section of this policy If scanner or other equipment goes down during use o Follow procedure in Broken Equipment section (below) A user or research group will be held accountable if they did not document an equipment problem or mess, even if they to did not cause the problem or mess. Violations by a user or research group will result in a penalty o First offense verbal warning o o Second offense suspension of scan time Third offense suspension of scan time and other measures to be decided on an individual bases by the Director and MRI Operations Manager User must demetal (remove watch, keys, wallet, hairpins, pager, cell phone, metal pen, etc.) prior to entering scanner room. No item should be brought into the scanner room unless it is known to be MRI safe o A handheld magnet is available at each scanner area Don't use paper clips or other small metal objects (staples, etc.) around scanner room door/console area. They tend to land on the floor and find their way into the scanner room and into the magnet. Clean up o Return all equipment to its labeled place on the shelves or in the drawers. 3 of 17

4 o Place soiled linens in the laundry hamper in the scanner room. Empty and replace the linen bag if it is full. (See further detail under Animal Research in this policy) o Contaminated materials (excluding sharps) must be placed in biohazard disposal bin (red or orange bag). Contaminated materials are never to be placed in the wastebasket. o All sharps are to be placed in the plastic sharps container located in the magnet room. Sharps are never to be placed in any wastebasket. o If trash is full, call housekeeping to empty (see Contact List). Quality assurance o Run the QA protocol (under Other, protocol 1) at the end of your session using the GE quadrature head coil and the head loader phantom (green spherical phantom inside white plastic cylinder) o Record in log book Bring concerns about 221 Longwood Ave location to the Research Facilitator/Scheduler (see Contact list) If you cannot use your scanner time, send to the BWH MRI research community signa@bwh.harvard.edu 4 of 17

5 Broken Equipment If breakage results from usage of the equipment under normal circumstances, you will not be held responsible, but we cannot fix items unless we know they are broken. Damage to the scanner resulting from non-standard equipment or pulse sequences is not covered by our GE service contract. The group involved may be held financially responsible for the cost of service. Report ALL broken equipment and equipment failures (e.g., scanner, coils, contrast injection pump, ECG leads) immediately to the MRI technologist on duty. He/she will notify the appropriate parties (e.g., GE Cares, the GE field engineer, chief MRI technologist) o After hours, call tech at Bay 1 (75 Francis St) (see Contact List) Note the breakage in the logbook. Notify other groups this will affect. This may be done through signa@bwh.harvard.edu 5 of 17

6 Human Subject Research Follow all procedures in General Research Guidelines Certified user must be listed on a Investigation Review Board (IRB) protocol approved for the purpose of data collection o Human subject recruited for study are screened by phone to rule out contraindications for MRI o Telephone Confirmation Checklist (back of MRI Procedure Screening Form) o Weight must be < 400 lbs due to weight limit of scanner table Human subject must be consented for IRB protocol by appropriate agent prior to imaging. Human subject must sign MRI Procedure Screening Form prior to entering scanner room. These forms are available at each MRI location. o File form with your IRB consent form. If there is uncertainty regarding contraindication for MRI with a Human subject o Consult MRI technologist o Refer to Kanal text for list of MRI compatible implants Available at 1.5T and 3T o Err on the side of caution do not scan the patient if there is doubt Human subject must demetal (remove watch, keys, wallet, hairpins, jewelry, cell phone, brazier with underwire, etc) prior to entering scanner room. Human subject must change clothes into patient gown (jonnie) prior to entering scanner room. o Patient gowns are provided in gowning area o User may provide scrubs in place of gown (not provide by site) An MRI technologist or BWH employed physician must oversee studies involving patients. Lower patient table using foot pedal for Human subjects who cannot otherwise get onto the table (note: table weight limit 400 lbs) o Scale is available in patient gowning area Human subject must wear ear protection o Ear plugs and or headphones o Available in each scanner room Human subject must be given patient alarm squeeze ball o The Human subject may use to this to alert scanner operator to problems (e.g., claustrophobia, discomfort, etc). Ensure RF coil cables do not make contact with patient or form loop to prevent burns Ensure ECG cables do not make contact with patient or form loop to prevent burns 6 of 17

7 Emergency Response Refer to BWH Emergency Response Guide: 221 Longwood Ave Complex Emergency phone numbers are listed in the Contact List section of this policy o Dial for a medical emergency (this is different from policy for main hospital) In the case of a fire, chemical spill, or biological spill, or human subject code o During patient clinical hours, the clinical MRI technologist will assume control of the scene and will interact with emergency responders. o During non-clinical hours, when no MRI technologist is on site, the most senior investigator will interact with emergency responders. o Remove human subject from scanner and scanner room if necessary o If rapid human subject removal is necessary, Stop the Scanner Press stop scan button on console keyboard or front of the scanner Roll the handle of the patient cradle towards you to disengage the cradle from the motors of the table. Pull cradle completely out of the scanner. Depress Undock pedal at the foot of the patient table bed. Remove table and patient from scanner room o Lock scanner room door to prevent unauthorized entry If emergency is inside the scanner room (e.g., small fire or limited spill) before admitting entry to responders o o Inform them of the presence of the magnetic field Screen them for contraindications for entering magnetic field (pace maker, neuro stimulator, metal in eye, aneurysm clips) Ask them to demetal (remove air cylinders, fire axes, keys, etc.) Emergency off button (E-off) Red button on scanner keyboard, front shroud of scanner, and gradient cabinet in computer room Turns off all cabinets in computer room, turns off console, turns off all power to magnet Will not run down (eliminate magnetic field) of the magnet Push if Fluid gets into magnet Electrical current is entering human subject or animal Smoke is coming from scanner, etc. Run-down button 7 of 17

8 Eliminates magnetic field Sometimes misnamed the quench button Located on wall of magnet room Push if A person is pinned against the magnet by a large metal object Advanced fire fighting equipment must be brought into the scanner room The human subject can not be removed from the magnet during a code situation and life saving equipment must be brought into the scanner room There are other life threatening reasons o The cost to get the magnet back on line may be in the tens of thousands of dollars. o If time allows, contact the clinical technologist on duty (see Contact List) at the main hospital to help in this decision process Treat animal bite like a needle stick from a procedural perspective 8 of 17

9 Incident Reporting Report and adverse event, medical error, or sentinel event. Definitions o Adverse Patient Event: An unexpected, unintended occurrence that results in injury to the patient or has the potential for causing injury. This event may or may not be due to medical error (an adverse event that is caused by an unintended action or mistake). o Medical Error: Failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. o Sentinel Event: As defined by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), an event that results in unanticipated death or serious injury to a patient and is not related to the natural course of a patient s illness or underlying condition, or the risk thereof. Examples o Events that require additional treatment or increased monitoring, that cause delay in discharge or transfer to an intensive care unit, or cause death or emotional or physical suffering: Medication error in dose that reaches the patient and results in increased monitoring Rare complication from surgical procedure that requires additional treatment Process Disclosure to the patient and/or family member should generally be made when any adverse patient event has occurred. In some situations, consideration should be given to discussing adverse events or medical error that have not resulted in patient injury. The decision to disclose will depend on the specific circumstances of the event. The Risk Management Department should be consulted when there is any uncertainty with regard to the need to disclose an event to a patient and/or family. Disclosure should take place at the appropriate time, i.e., when the patient is medically stable enough to absorb the information, and in the right setting. In situations where the patient has suffered permanent injury or death, information should be provided to the patient s family or legal representative in a timely and considerate manner. Typically, disclosure should take place within 24 hours after the event has occurred or is discovered. In most cases, the clinician with overall responsibility for the patient s care, i.e., the attending physician, should handle the decision to disclose, as well as the actual disclosure of information and any subsequent discussions with the patient and/or family. In some situations, however, other healthcare professionals may be more appropriate to disclose the event, such as a senior administrator or other healthcare professional who 9 of 17

10 has the most information about the event and/or has an existing relationship with the patient and family. At least one other hospital staff member (either clinical or administrative) should be present at the initial disclosure discussion or at subsequent planned discussions with the patient and/or family. Risk Management Department (or Partners attorney on call through the hospital paging system if after regular business hours) is available as a resource if the clinician has questions about appropriateness of discussion, timing of discussion, involved parties, consideration of financial reimbursement, etc. The clinician is encouraged to discuss the event with a colleague. Other resources available to the clinician include the Ethics Service, Administrator-On-Call and Nursing Administrator. In addition, the Department of Psychiatry and Employee Assistance Program are also available for debriefing and processing of the event. A copy of all Adverse Events reports are submitted to the MRI Safety Officer (see Contact List). The Partners Healthcare incident report can be filled out on-line. o On Partners PC, click Start, click Partners Applications, Click Safety Reporting o Ask for help from the MRI Safety Officer or MRI Operations Manager in filing the report if necessary Related documents Guidelines Related to Disclosure of Adverse Patient Events o ministrativepolicymanual/v-18a.doc BWH Principles of Patient Safety o ety/bwh%20principles%20of%20patient%20safety.doc Adverse Event Reporting o gement/rm-adverse%20event%20reporting.doc If the study is done under a Partners IRB, also file and Adverse Events report with the Human Research Committee. o 10 of 17

11 Animal Research Follow all General Research Guidelines of this policy (above). Follow all BWH Advanced MRI Center -221 Longwood Ave. Infection Control Policies Personnel must be listed on animal protocol approved by the Harvard Medical School Standing Committee on Animals. o Animal research scheduling o Animal research may begin after clinical operation hours (7pm) o The area should not be utilized for human patients/subjects until at least four (4) hours have passed from the time the animal leaves the MRI suite. The first patient typically is at 6:30am, therefore, animal research must stop by 2:30am. Animal must have been released from any prior quarantine after review by the designated facility veterinarian Animal must be free of common zoonotic diseases (e.g., salmonellosis). o Non-human primates must be serologically negative for Herpesvirus simiae. o Animals displaying clinical signs of disease (skin lesions, respiratory infections, etc.) will not be allowed to enter the MRI suite. Animal Transportation o All animals must be accompanied at all times by research staff from the institution of origin or a BWH designee. o Animal must be transported in recommended carrier that limits exposure between the animal and humans. o Animal transported to and from BWH and within BWH buildings must be in vehicles and enclosures that comply with federal laws and regulations and must be pre-approved by ARCM veterinary staff. o Animals must be covered and out of sight of patients at all times. o When animals are placed in the scanner room, shades and doors must remain closed. o Do not prepare animals in plain sight of patients or in scanner rooms. Preparations must be done before the animal is brought into the MRI suite- 221 Longwood Area Care of the Environment o Equipment not required for the study must be removed or covered with non-pervious drapes before the animal is brought into the examination room (e.g., cover power injector with blue linen bag). It is ideal to build an MR-compatible surface where the animal can be placed during the examination, over the regular table. o Place absorptive padding under animals (e.g., chucks, diaper). 11 of 17

12 o Areas that may come in contact with animal blood, body fluids and dander must also be draped. o The MR control area doors must be kept closed while animals are in the room; no one other than personnel actively involved in the research project will be allowed in the room. User Requirements o If user must handle the animal at any time, protective clothing (gowns or scrubs, gloves, masks, and shoe covers) will be worn as required. Gloves must be changed before touching control panels, video equipment, telephones, doorknobs, or other devices. o User handling the animals or sample material must wash their hands prior to leaving the MRI suite. Clean up o Post-study cleaning should take place immediately after the study session has ended. o If more than one animal will be scanned, clean up may wait until after the final animal o Refer to Advanced MRI Center 221 Longwood Ave. Infection Control Policies o Follow clean up policy under General Research Guidelines (in this policy) o Wear gloves Apply Purell before gloving and after degloving Before touching console or interface on scanner, remove one glove and apply Purrell Apply Purell after removing gloves o Cleaning of surfaces and MRI coil Wipe up fluids, visible hair, visible dander with damp wash clothe or damp paper towels Decontaminate with Ecolabs Aseptiwipes (available in suite) If fluid has leaked into bore or patient table Clean as well as you are able Log in book Report to MRI Technologist GE must be called to remove table top to access fluids Wipe patient table, MRI coil, any nearby surface that may be contaminated by dander, and anything a gloved hand touched o Cleaning of bore Wipe walls of bore with Ecolabs Aseptiwipes Lay on table Ask second person to advance you to isocenter Or advance table to far end of bore Roll back handle to disengage table from motor 12 of 17

13 Pull table out Lay on table and manually move in to bore Cleaning agents are available in utility closet o Cleaning of large spills Lock MRI scanner room Go to utility closet at end of hallway (room 077c) Key to closet is at reception desk Fill MRI compatible mop bucket with 2 gallons of water Wear gloves and eye protection Add one pump (0.5 oz) of Ecolabs A456N Fill plastic liter container on mop bucket with mixture from mop bucket Mop floor Wipe up large spills with clothe or paper towels wet with A456N solution Return mop bucket to utility closet (housekeeping will empty water) If solution gets in eyes or on skin, flush with cold water. If burning persists, report to Occupation Health (or ER if after hours). o Take sharps, soiled linens, drapes, chux, medical supplies, etc. with you for disposal at the animal facility Inspect scanner room and console area before you leave using the Self-Checklist in the policy. 13 of 17

14 Clean Up Self Check List Animal removed Animal hair and body fluids cleaned Wipe table top, MRI coil, bore and other surfaces potentially in contact with animal using a cleaning solution House keeping called to empty trash (if necessary) All equipment used in research removed from area Uncover clinical equipment Pull shade back up Sign logbook (room cleaned, QA scan performed) Take with you when you leave o Medical waste in biohazard container o Sharps in sharps container o Linens in linen bag 14 of 17

15 Scheduling To subscribe to the scheduling mailing list: Patient research o Schedule through the Chief MRI Technologist (see Contact List) o Scheduled only during clinical hours o Must have F-number for billing purposes Phantom, animal, or human subject research o Schedule through the Research Facilitator (see Contact List) o Animal studies Scheduled during non-clinical hours. Must end four (4) hours before the first patient If you will not be using your research time, please report the opening to the list-server: signa@bwh.harvard.edu and inform the Research Facilitator. Priority for Assignment of Scanner Time Funded human research from within the department Funded human research from outside the department Funded animal research from within the department Funded animal research from outside the department Funded phantom research from within the department Funded phantom research from outside the department Unfunded research from within the department Unfunded research from outside the department 15 of 17

16 Practical Training/Competency Test This process is intended to reinforce the on-line safety course, educate the user on safety specifics on the particular scanner where he/she will do research, serve as an in-service on how to use the MRI scanner. At the end of this training session, the user is expected to be competent on the points on the New Scanner Operator Checklist in this policy. Contact Research Training Officer (see Contact List) to make an appointment for this test. New Scanner Operator Check List How to fill out logbook How to screen subjects (if applicable) Review animal policy (if applicable) How to start an exam How to load a protocol How to turn off auto transfer How to turn on research mode How to attach the head coil and any coils used in study Where are ear plugs, squeeze ball, linen, and fans How to land mark phantom How to advance phantom to iso-center How to use intercom system How to acquire localizer set of images How to acquire second set of images How to end exam How to archive exam and send over network How to run quality assurance (QA) protocol How and why to reset TPS How and why to reboot scanner Remove phantom How to transfer and remove P-files ( if applicable) Where are emergency off buttons and when to use Where is run down (quench) button and when to use Demonstrate knowledge of equipment specific to study Where to empty linen How to clean up after animal study (if applicable) How to respond to emergency How to notify house keeping to empty trash (if necessary) 16 of 17

17 Contact List (as of 12/2005) Medical Emergency Security (Security emergency, Fire, Bomb Threat, Biological Spill, Radiation Spill, Chemical Spill) Ferenc Jolesz Director Patty Devine Chief MRI Technologist , BB John Shirosky MRI Safety Officer , BB Yanping Sun Research Training Officer Nan-kuei Chen Research Facilitator Clare Tempany Clinical Liason , BB GE Cares (system I.D. on front of scanner) 800-GE-Cares Clinical MRI technologist (after 7pm) , BB User community House keeping To page someone, dial then enter page number. 17 of 17