Standard Operating Procedure. General Procedures for Bio Imaging suite Access at PERFORM

Transcription

1 Standard Operating Procedure General Procedures for Bio Imaging suite Access at PERFORM PC-SOP-IM-001-v02 Revision History Version Reason for Revision Date 01 New SOP Revised from PC-SOP-IM-006-v01 02 Change document to reflect current status Change definition of Responsible user Moved safety screening forms to specific safety SOP January/30/2015 March/24/2017 Summary The content of this standard operating procedure (SOP) provides guidelines for obtaining access to the Bio Imaging suite at the PERFORM Centre. The suite provides a variety of services and imaging capabilities for research into the anatomy and physiology of human participants. This SOP provides standards and requirements for using the Bio Imaging suite including access to the area, responsibilities and mandatory training for all users and practices for safe operation within the area. PC-SOP-IM-001-v02 Printed copies are not controlled. Page 1 of 8

2 Table of Contents 1. Definition of Terms Introduction Background Purpose Scope Responsibilities Relevant Documents Procedure Access Visitor, Participant and Auxiliary Staff Access Participant Safety Medical Supervision... 8 APPENDIX 1: INCIDENT REPORT FORM APPENDIX II: SOP TRAINING RECORD PC-SOP-IM-001-v02 Printed copies are not controlled. Page 2 of 8

3 1. Definition of Terms and Abbreviations Adverse event AED CAMRT CCER CNSC Collège des médecins du Québec DEXA EHS MRI OTIMROEPMQ PERFORM PET-CT Principal Investigator (PI) Responsible User Bio Imaging RSO SPECT-CT Standard Operating Procedure (SOP) T Imaging Technologist UHREC Ultrasound Imaging An untoward medical occurrence in a research participant that occurs during a research activity, which does not necessarily have a causal relationship with the activity. Automated External Defibrillator Canadian Association of Medical Radiation Technologists Comité central d éthique de la recherche Canadian Nuclear Safety Commission Organization overseeing medical practice in the Province of Quebec Dual Energy X-ray Absorptiometry Concordia University Environmental Health & Safety Magnetic Resonance Imaging Ordre des technologues en imagerie médicale, en radiooncologie et en électrophysiologie médicale du Québec The PERFORM Centre at Concordia University Positron Emission Tomography - Computed Tomography Head researcher who is responsible for all aspects of a given research project or program at PERFORM. A designated user authorized by the Bio Imaging Platform Supervisor to operate the Ultrasound or DEXA equipment. Radiation Safety Officer, responsible for the safe use of radiation and radioactive materials as well as regulatory compliance Single-Photon Emission Computed Tomography - Computed Tomography SOP s at PERFORM are any operating document that require a full review process and approval by the SD. Tesla is the SI-derived unit of magnetic field strength. An imaging technologist is a person trained in the technology of Radiology or Nuclear Medicine and is a member in good standing of CAMRT/OTIMROEPMQ. University Human Research Ethics Committee An imaging method that uses high-frequency sound waves to produce images of structures within the body PC-SOP-IM-001-v02 Printed copies are not controlled. Page 3 of 8

4 User Person using space or equipment at the PERFORM Centre that has received adequate technical and safety training PC-SOP-IM-001-v02 Printed copies are not controlled. Page 4 of 8

5 2. Introduction 2.1. Background The imaging facility at PERFORM consists of specialized equipment including a 3T MRI, a PET-CT, a SPECT-CT, DEXA and Ultrasound imaging equipment. Working with such equipment could entail a risk of exposure to ionizing radiation, electromagnetic environment and other risks associated with the use of these equipment and hence there is a need for procedures to ensure safety of all users and research participants Purpose This SOP provides a set of minimum standards and practices for the safe access and use of the Bio Imaging suite at the PERFORM Centre of Concordia University. It outlines the minimum training requirements and general rules to be adhered to in the different areas of the Bio Imaging suite based on the users expected role Scope This SOP applies to all persons requesting access to the Bio Imaging platform, including but not limited to University faculty, staff, students, research participants and authorized visitors Responsibilities All Users All users of the Bio Imaging suite are responsible for: Following all applicable regulations, safety rules and practices outlined in this SOP, applicable Concordia policies and obligations of any professional bodies/orders to which they belong Reporting any deviation from normal operations, injuries, damage to equipment or property to the platform supervisor and/or the RSO Using and wearing all relevant personal protective equipment (lead aprons, lab coats, gloves etc.) as required by study protocols and postings in the Bio Imaging suite Attending all training courses as directed by the platform supervisor and/or RSO Booking the platform for the time required using PERFORM s online booking system Accessing the platform only during booked times so as to respect other users and minimize potential safety hazards. PC-SOP-IM-001-v02 Printed copies are not controlled. Page 5 of 8

6 Ensuring the use of CCER approved protocols only for research participants and providing a signed copy of the approved consent form to the platform supervisor for each study participant Principal Investigator/Project Lead The principal investigator/project lead is responsible for ensuring all their team members (students and staff) and any other users in their protocols/projects have completed the proper trainings and adhere to all Bio Imaging suite requirements, as directed by the Supervisors of Nuclear Medicine and Magnetic Resonance Imaging Responsible Users DEXA and Ultrasound Responsible Users will obtain Platform Supervisor approval to use either the DEXA or Ultrasound equipment (see section 3.1: Access). The Responsible User must: Provide signed copies of the CCER approved consent form for all human participants to the platform supervisor Save, store and transfer the acquired data as appropriate Ensure to properly clean the equipment and room prior to leaving the area Signal any broken equipment or missing stock to the Platform Supervisor as soon as possible Be able to identify all evacuation routes and understand procedures for emergency response Relevant Documents VPS-40 Environmental Health and Safety Policy VPS-42 Policy on Injury/Incident Reporting and Investigation VPS-45 Policy on First Aid and Medical Emergencies VPS-46 Radiation Safety Policy VPS-54 Magnetic Field Safety Policy PC-SOP-GA-002 Handling of Biological Materials at PERFORM PC-SOP-GA-009: Emergency Response Procedures at the PERFORM Centre PC-SOP-GA-007: General Access to PERFORM Centre PC-SOP-GA-011: Guidelines for Management of Incidental Finding at PERFORM PC-SOP-IM-001-v02 Printed copies are not controlled. Page 6 of 8

7 PC-SOP-IM-003: Magnetic Resonance Imaging Safety Procedures at PERFORM PC-SOP-IM-004: Nuclear Medicine Imaging Safety Procedures at PERFORM PC-SOP-IM-005: Handling of Radioisotopes Material PC-SOP-IM-007: Radiation Emitting Devices Note: This SOP defers to Concordia policies at all times 3. Procedure 3.1. User Access Access to the DEXA suite and equipment will be provided to those who have completed Concordia s EHS Radiation Emitting Device Safety Training and the DEXA user training provided by the Supervisor Nuclear Medicine Access to the MRI suite will be granted upon completion of the Bio Imaging Safety Orientation. It is expected that you remain outside the Nuclear Medicine limits unless an emergency situation arises (i.e. require AED or evacuation) Access to the Nuclear Medicine suite - without radiation source manipulation will be granted upon completion of the Bio Imaging Safety Orientation. A review of project participation will be required to determine the risk of radiation exposure Access to the Nuclear Medicine suite with open radiation source manipulation will be granted upon completion of Concordia s EHS Radiation Safety Training and the Bio Imaging Safety Orientation. Those who plan to receive or ship radiation will also require Transport of Dangerous Goods training (TDG7) Access to the Ultrasound suite and equipment will be provided to those with prior knowledge of the safe use or to those who will be supervised by someone knowledgeable in ultrasound technology Visitor, Participant and Auxiliary Staff Access Participants and visitors must always be accompanied by an authorized user of the Bio Imaging suite All auxiliary (maintenance, custodial, service, etc.) staff requiring access to the Bio Imaging suite must be accompanied by an authorized user at all times, and/or obtain prior approval from the RSO or MRI Supervisor before undertaking any cleaning or maintenance work in the Bio Imaging suite. PC-SOP-IM-001-v02 Printed copies are not controlled. Page 7 of 8

8 4. Participant Safety 4.1. Medical Supervision PERFORM is equipped to host a variety of research protocols and activities which will vary in degree of risk depending on the invasiveness of the procedures and health status of the participant. As a shared research platform with multiple users of varied institutional affiliations, the following guidelines are used by PERFORM to establish consistent levels of supervision which the principal investigator/study lead must ensure: Only OTIMROEPMQ (or recognized equivalent)-certified technologists from PERFORM will operate the MRI, SPECT-CT & PET-CT equipment whenever a human participant is involved Non technologists will be allowed to operate the DEXA scanner or Ultrasound equipment once approved, please see section for access requirements A nurse must be present to directly monitor participants condition during intervention protocols or injection of certain medications and to administer first responder aid in the case of adverse events A responsible physician must be present on-site in the event any medication may need to be administered to a participant, unless administration of that medication has been determined by a physician to be possible and safe under the supervision of a nurse A responsible physician must be present on-site during any contrast studies and must directly supervise preparation of the subject and contrast administration For nuclear cardiac stress imaging, a physician must be on-site to initiate and supervise the intervention. PC-SOP-IM-001-v02 Printed copies are not controlled. Page 8 of 8

9 APPENDIX 1: INCIDENT REPORT FORM Can be completed and submitted at: PC-SOP-IM-001-v02 Printed copies are not controlled. Appendix I

10 APPENDIX II: SOP TRAINING RECORD PC-SOP-IM-001-v02 Printed copies are not controlled. Appendix II

11 SOP Title General Procedures for Bio Imaging suite Access at PERFORM SOP Code Ownership Document type Area SOP Number Version PC SOP IM Training Record Full Name Institution/PI Contact ( or phone number) Signature Sign here and return to SOP custodian Date SOP Training Record