MRI Local Rules & Procedures

Quality Manual Version: 1.1, October 2014

CRICBristol Quality Manual, version 1.1 Page 2 of 126

Contents

Contents ................................................................................................................................. 2

Document version notes ............................................................................................... 8

Abbreviations ................................................................................................................ 8

Introduction .......................................................................................................................... 10

Purpose of this Quality System ................................................................................... 10

Statutory and professional standards and frameworks ................................................ 11

Section A: Main Quality Manual for use of CRICBristol .................................................... 12

1. CRICBristol staff, premises and safety ........................................................................ 12

1.1 Staff and site information ...................................................................................... 12

1.1.1. Site addresses and contact details ..................................................................................... 12

1.1.2. Site description .................................................................................................................. 12

1.1.3. Employing authority........................................................................................................... 12

1.1.4. Responsible persons .......................................................................................................... 12

1.1.5. Organisation chart ............................................................................................................. 13

1.1.6. CRICBristol governance structure ...................................................................................... 13

CRICBristol Board: Terms of reference .................................................................................... 13

CRICBristol Management Advisory Group (MAG): Terms of reference .................................. 14

CRICBristol Governance Advisory Group (GAG): Terms of reference ...................................... 14

CRICBristol Scientific Advisory Group (SAG) ............................................................................ 14

1.1.7. Qualifications, training, and training records for CRICBristol staff .................................... 15

1.2. Office hours ......................................................................................................... 16

1.2.1. Out of hours research working policy ................................................................................ 16

1.2.2. Securing CRICBristol out of hours and on weekends. ........................................................ 17

1.3. Lone working policy ............................................................................................. 18

1.3.1. Actions to be taken by lone workers ................................................................................. 18

1.4. Fire and major emergency ................................................................................... 19

1.4.1. Introduction to fire and major emergency policy .............................................................. 19

1.4.2. Purpose .............................................................................................................................. 20

1.4.3. Duties and responsibilities ................................................................................................. 20

1.4.4. Evacuation procedures ...................................................................................................... 20

1.4.5. Hazardous materials .......................................................................................................... 23

1.4.6. Training .............................................................................................................................. 23

1.4.7. Action in event of fire ........................................................................................................ 23

1.4.8. Implementation ................................................................................................................. 23


1.4.9. Summary ............................................................................................................................ 23

Appendix A.1: Escape from fire or similar emergency within the clinical research & imaging

centre ....................................................................................................................................... 24

Appendix A.2: Action in event of fire ....................................................................................... 25

1.5. Procedure for the management of cardio-respiratory arrest (or other medical

emergency) ................................................................................................................ 26

1.6. Oxygen policy ...................................................................................................... 27

1.6.1. Administration of oxygen in research ................................................................................ 27

1.6.2. Administration of oxygen in emergency ............................................................................ 27

2. Research access to CRICBristol ................................................................................. 28

Figure A.1: CRICBristol process for approval of a study .......................................................... 29

2.1. Pathways to approval........................................................................................... 30

Figure A.2: Pathways to approval, University of Bristol Chief Investigators ........................... 31

Figure A.3: Pathways to approval, all other Chief Investigators .............................................. 32

Figure A.4: Pathways to approval, studies on non-human objects or materials ..................... 33

2.2. Compliance with CRICBristol rules and procedures ............................................. 33

Annexes to Section A of this Quality Manual ................................................................... 34

Annex A.1: Floor plan to CRICBristol ............................................................................................ 34

Annex A.2: Initial project request form ....................................................................................... 35

Annex A.3: Full project specification form ................................................................................... 36

Annex A.4: Terms and conditions of use ..................................................................................... 41

Annex A.5: Checklist for management ........................................................................................ 47

Annex A.6: Calpendo registration email template ...................................................................... 48

Annex A.7. General risk assessment ............................................................................................ 49

Annex A.8: Incident report form .................................................................................................. 51

Annex A.9: Fire emergency procedure risk assessment – working hours ................................... 52

Annex A.10: Stock management .................................................................................................. 54

Section B: MRI local rules and procedures ........................................................................ 55

3. MR Authorised personnel ............................................................................................ 55

3.1. Authorised General User (AGU) .......................................................................... 56

3.2. Authorised Staff User (ASU) & Authorised Postgraduate User (APU) [operators] 56

3.3. Non-living objects Authorised User (NAP) ............................................................ 57

4. Project initiation and booking policy ............................................................................. 58

4.1. Booking system ................................................................................................... 58

4.2. Cancellations ....................................................................................................... 58


4.3. Advance booking limit .......................................................................................... 58

4.4. Regular bookings ................................................................................................. 58

4.5. Operator cover ..................................................................................................... 59

4.6. Scan timing .......................................................................................................... 59

4.7. Other equipment .................................................................................................. 59

5. CRICBristol MRI data handling policy .......................................................................... 60

5.1. Confidentiality ...................................................................................................... 60

5.2. Data transfer ........................................................................................................ 60

Figure B.1: Data transfer diagram ............................................................................................ 60

5.3. Data security ........................................................................................................ 61

5.4. Data analysis ....................................................................................................... 61

6. Designated controlled area .......................................................................................... 61

7. Health and safety regulations ...................................................................................... 62

8. Access to the MRI suite ............................................................................................... 63

8.1 Rules for Authorised Personnel ............................................................................ 64

8.2. Rules for Unauthorised Personnel requiring access to the controlled area ........... 64

9. Emergencies in the MRI suite ...................................................................................... 66

9.1. Quenching the Magnet using the emergency stop button .................................... 66

9.2. Medical emergencies ........................................................................................... 67

9.3. Fire ...................................................................................................................... 67

10. Examination procedures ............................................................................................ 69

10.1. Examination procedures for research participants ............................................. 69

10.2. Examination procedures for clinical research participants .............................. 70

11. Use of external equipment within the Magnet Room .................................................. 71

12. Description of the MRI suite ...................................................................................... 72

Figure B.2: Plan of the MRI suite ................................................................................................. 72

13. Procedure for administration of screening forms ....................................................... 73

13.1. General .............................................................................................................. 73

13.2. Initial screening form procedure ......................................................................... 73

13.3. Second screening form procedure ..................................................................... 74

13.4. Implants and devices ......................................................................................... 74

13.5. Visitor screening form procedure ....................................................................... 75

Appendix B.1: Initial screening form ............................................................................................ 76

Appendix B.2: Second screening form ......................................................................................... 78

Appendix B.3: Visitor screening form .......................................................................................... 79


14. General MRI safety precautions, procedures and incident reporting .......................... 80

14.1. Static magnetic field ........................................................................................... 81

14.2. Time-varying fields ............................................................................................. 82

14.3. Radio-frequency (RF) fields ............................................................................... 83

14.4. Liquefied helium ................................................................................................. 84

14.5. Acoustic noise .................................................................................................... 85

14.6. Contraindications ............................................................................................... 85

15. Emergency contacts .................................................................................................. 86

15.1. MRI scanner emergency contact cascade ......................................................... 86

15.2. Incident specific list of emergency contacts ....................................................... 86

16. Technical contacts..................................................................................................... 87

16.1. MRI support group ............................................................................................. 87

16.2. Estates & facilities .............................................................................................. 87

16.3. CRICBristol internal numbers ............................................................................. 87

17. Training protocol for MR examinations ...................................................................... 88

17.1. Screening and scanning procedure for research participants ............................. 88

17.1.1. At recruitment ................................................................................................................. 88

17.1.2. In CRICBristol.................................................................................................................... 88

17.1.3. In the MRI suite: ........................................................................................................... 89

18. Guidelines for clinical research scans with a diagnostic component .......................... 90

Annexes to Section B of this Quality Manual ................................................................... 91

Annex B.1: Procedure for cardio-respiratory arrest / medical emergency in MRI scanner ........ 91

Annex B.2: MRI scanning outside core hours policy .................................................................... 91

Annex B.3: Authorised MRI scanner operators declaration ........................................................ 93

Annex B.4: Templates for MR studies (x3)................................................................................... 94

Template 1: MRI information form for research participants – fMRI ..................................... 94

Template 2: MRI information form for research participants – Anatomical Imaging ............ 96

Template 3: Clothing in the MRI scanner ................................................................................ 98

Annex B.5: Administration of intravenous gadolinium contrast agents policy ........................... 99

Annex B.6: Working in MRI during pregnancy ........................................................................... 100

Annex B.7: Procedure for safe MRI shut down in an emergency .............................................. 101

Annex B.8: Fire emergency procedure risk assessment - MRI scanning out of hours ............... 102

Annex B.9: Agreement for the use of CRICBristol for clinical purposes .................................... 104

Section C: Sleep Studies Suite local rules and procedures ............................................ 110

19. Sleep study suite booking procedures ..................................................................... 110


20. Responsibilities ....................................................................................................... 111

20.1. Responsibilities of the Responsible Authorised User (RAU) ............................. 111

20.2. Responsibility of CRICBristol ........................................................................... 111

21. Access and exit ....................................................................................................... 112

22. Emergency procedure ............................................................................................. 113

22.1. Fire emergency ................................................................................................ 113

22.2. Fire evacuation procedure ............................................................................... 113

22.3. Medical emergency .......................................................................................... 113

Annexes to Section C of this Quality Manual ................................................................. 114

Annex C.1: General floor plan to the Sleep Study Suite in CRICBristol ...................................... 114

Annex C.2: Floor plan of the Sleep Study Suite location, showing medical gases cut-off ......... 115

Annex C.3 Sleep study booking policy SOP ................................................................................ 116

Section D: Clinical Investigation Suite local rules and procedures ............................... 117

23. Clinical rooms .......................................................................................................... 117

23.1 Contents of each room ...................................................................................... 117

23.2 Study specific equipment .................................................................................. 117

23.3 Booking and access .......................................................................................... 117

23.3.1. Clinical rooms booking policy ........................................................................................ 117

23.3.2. Regular bookings............................................................................................................ 117

23.3.3. Booking other equipment .............................................................................................. 118

24. Wet Lab ................................................................................................................... 118

24.1. Projector in wet room ....................................................................................... 118

24.2. Centrifuge ........................................................................................................ 118

24.2.1. Procedure....................................................................................................................... 119

24.2.2. Breakages ....................................................................................................................... 119

25. Clean and dirty utility ............................................................................................... 120

25.1. Definition of clean and dirty utility rooms: ......................................................... 120

25.2. Store and handle linen ..................................................................................... 120

25.3. Store and handle equipment and supplies ....................................................... 120

26. Disposal of waste materials ..................................................................................... 121

26.1. Non-clinical (domestic) waste .......................................................................... 121

26.2. Clinical waste ................................................................................................... 121

26.3. Disposal guidelines .......................................................................................... 122

27. Storage ................................................................................................................... 123

27.1. Refrigerators & freezers ................................................................................... 123


27.2. Drug cabinet .................................................................................................... 123

27.3. Storing sample ................................................................................................. 123

27.4. Other considerations ........................................................................................ 123

Annexes to Section D of this Quality Manual ................................................................. 124

Annex D.1: Sample storage log .................................................................................................. 124

Annex D.2: Drug cabinet log ...................................................................................................... 125

Annex D.3: Colour coding for laundry bags ............................................................................... 126

CRICBristol Quality Manual Version draft Page 8 of 126

Document version notes

This quality manual has been prepared with reference to the following documents:

Guidelines for Magnetic Resonance Diagnostic Equipment in Clinical Use, With Particular Reference to Safety. UK Medicines and Healthcare products Regulatory Agency (MHRA), issued December 2007

American College of Radiology White Paper on MR Safety. AJR 188. 2007

The Aston Brain Centre MRI Local Rules and Procedure document previously prepared by Aston University

CUBRIC MRI-Suite Safety Notes Rules and Procedures University of Cardiff, Version 12, 06/2007

Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices. US Food and Drug Administration (FDA). July 14, 2003

CRICBristol MRI Local Rules Version 1.1, November 2011

This quality manual is version 1.1, Dated 22 October 2014

Version 1 reviewed by the CRICBristol Governance Advisory Group and approved for use by

the CRICBristol Directors on Oct 22nd 2014.

Document review

This document has been reviewed by the CRICBristol Governance Advisory Group. It is recommended that a review of this quality manual should be undertaken every two years. However, should there be significant changes to the working procedures, changes in legislation (or introduction of new legislation), or changes in best practice, an earlier review should commence.

Date of next document review

October 2016

Abbreviations

ADR Alternative Dispute Resolution AGU Authorised General User AP Authorised Personnel APU Authorised Postgraduate User ARSAC Administration of Radioactive Substances Advisory Committee ASU Authorised Staff User BAMRR British Association of MR Radiographers BLS Basic Life Support CE (mark): CE marking is the manufacturer's declaration that the product meets the

requirements of the applicable EC directives CEDR Centre for Dispute Resolution CI Chief Investigator CIS Clinical Investigation Suite CM Centre Manager CRICBristol Clinical Research and Imaging Centre Bristol CTA Clinical Trial Authorisation


CTIMP Clinical Trial of an Investigational Medicinal Product ECG Electrocardiogram eGFR Estimated Glomerular Filtration Rate GAG Governance Advisory Group GCP Good Clinical Practice H&S Health and Safety HPA Health Protection Agency ICH The International Conference on Harmonisation of Technical Requirements

for Registration of Pharmaceuticals for Human Use ICNIRP International Commission on Non-Ionizing Radiation Protection IEC International Electrotechnical Commission IPR Intellectual Property Rights IUD Intrauterine Device IV Intravenous Therapy LRR Lead Research Radiographer MAG Management Group MHRA Medicines and Healthcare products Regulatory Agency MR Magnetic Resonance MRI Magnetic Resonance Imaging MRISA Magnetic Resonance Imaging Scientific Advisor MRSO Magnetic Resonance Safety Officer NAP Non-Living objects Authorised Person NHS National Health Service NRPB National Radiological Protection Board NSF Nephrogenic Systemic Fibrosis PACS Picture Archiving and Communication System PI Principal Investigator PIS Patient Information Sheet PNS Peripheral Nervous System RA Risk Assessment RAU Responsible Authorised User RCUK Research Councils UK REC Research Ethics Committee RF Radio-Frequency SAG Scientific Advisory Group SAR Specific Absorption Rate SLA Service Level Agreement SOP Standard Operating Procedure TOR Terms of Reference SSI Site Specific Information SSS Sleep Study Suite UHBristol University Hospitals Bristol NHS Foundation Trust (also sometimes referred to

as the “Trust”) UoB University of Bristol UPARC University Planning and Resources Committee


Introduction

CRICBristol is a University of Bristol Facility based in St Michael’s Hospital. It is primarily a research facility with the capability to undertake some clinical work where capacity and financial circumstances allow. Clinical MRI in CRICBristol is governed by the Service Level Agreement in Annex B.9.

CRICBristol facilities include a Siemens 3Tesla Magnetom Skyra MRI scanner, a two bedroom Sleep Study suite and four clinical investigation rooms alongside a wet laboratory, clean utility, dirty utility, meeting rooms and access to high performance computing facilities.

All persons whose work involves the use of CRICBristol facilities (including scanner operators, MRI support and technical staff, researchers conducting experiments) must familiarise themselves and comply with this Quality Manual.

The Health and Safety at Work Act 1974 clearly defines the mandatory responsibilities and the statutory requirements under the Act, of the employer, of the employee, and all who have access including visitors, to the site of work.

The Facility is governed in its set up and management by an agreement between the University of Bristol and University Hospitals Bristol NHS Foundation Trust (UHBristol). “The Agreement for the establishment, letting and operation of Clinical Research and Imaging Centre” signed on 23rd July 2010 states that the parties will work together to establish and operate a clinical research and imaging centre on the terms of this Agreement which is intended to have the capability to deliver world-leading research in patient imaging and translational medicine, fostering 'bench to bed' integration. In addition the “Framework Research Collaboration Agreement” signed 31st March 2009 is an agreement that sets out the framework for advance MR research between University of Bristol and Siemens plc using the CRICBristol MR scanner.

Purpose of this Quality System

This Quality Manual sets out the policies and procedures for work undertaken in CRICBristol. It aims to ensure the quality and integrity of the work undertaken at CRICBristol, as well as the safety of CRICBristol staff, users and research participants.

This document is presented in four sections. Section A is the main quality manual for the CRICBristol facility and includes generic policies and procedures for using and working in CRICBristol; it includes the annexes that are referred to in the main section. Sections B, C and D provide additional policies that are specific to the facilities of the MRI Scanner, the Sleep Study Suite and the Clinical Investigation Rooms. These sections are in addition to the main section.

CRICBristol will also make available the facilities for clinical NHS diagnostics and treatment to UHBristol under the UHBristol Care Quality Commission registration. All such activity and services must be governed by a Service Level Agreement (SLA) between both parties for each NHS service.

The UHBristol NHS MRI clinical service SLA can be found in Annex B.9

Full copies of this Quality Manual are kept in the administrative area of CRICBristol and the MRI suite Control Room.


Statutory and professional standards and frameworks

Guidelines for Magnetic Resonance Diagnostic Equipment in Clinical use, With Particular Reference to Safety. UK Medicines and Healthcare products Regulatory Agency (MHRA), issued December 2007 http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBulletins/CON2033018

Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices. US Food and Drug Administration (FDA). July 14, 2003.

The Human Rights Act 1998

The Data Protection Act 1998

The Human Tissue Act 2004

The Mental Capacity Act 2005

The Safeguarding Vulnerable Groups Act 2006

The Medicines for Human Use (Clinical Trials) Regulations 2004

BAMRR: British Association of MR Radiographers

MRIsafety.com

The NHS Research Governance Framework for Health and Social Care (2005)

University of Bristol Ethics of Research Policy and Procedure

University of Bristol Research Governance and Integrity Policy

http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBulletins/CON2033018


Section A: Main Quality Manual for use of CRICBristol

1. CRICBristol staff, premises and safety

1.1 Staff and site information

1.1.1. Site addresses and contact details

The address is: Clinical Research and Imaging Centre (CRICBristol), University of Bristol, 60 St Michael´s Hill, Bristol, BS2 8DX

Telephone: +44 (0)117 342 1500 and email: [email protected]

1.1.2. Site description

CRICBristol facilities include a Siemens 3Tesla Magnetom Skyra MRI scanner, a two-bedroom sleep suite and four clinical investigation rooms alongside a laboratory, meeting rooms and access to high performance computing facilities. A site map is provided at Annex A.1.

1.1.3. Employing authority

Staff employed as CRICBristol staff are University of Bristol (UoB) employees. University of Bristol, Senate House, Tyndall Avenue, Bristol, BS8 1TH. Tel: 0117 928 9000

1.1.4. Responsible persons

UoB must be satisfied that organisational arrangements exist for the safe installation and use of MRI equipment within its authority. The CRICBristol Directors are ultimately responsible for all internal controls including policies and procedures regarding safety and security. The Directors delegate responsibility for internal control to the CRICBristol Centre Manager. Standards and systems of internal control are designed, implemented and reviewed by the Directors to adequately safeguard all users (staff and participants) of the CRICBristol facilities. Appropriate policies supported by evidence from regulatory bodies will be applied on a consistent and ongoing basis but will be subject to review. As with all Health and Safety directives, all personnel have a personal responsibility to behave sensibly and ensure the well-being of themselves, their colleagues, participants in research and MRI examinations and any other visitors. The CRICBristol Management Group (MAG) is responsible for writing the rules and procedures outlined in this document. However the Lead Research Radiographer carries responsibility for keeping informed of any new legislation or external guidelines for MRI that may be relevant to internal procedures, advised by the MR Advisor in the UHBristol Medical Physics and Governance Advisory Committee. The Centre Manager has operational responsibility for what may occur in CRICBristol facility, and is a member of the CRICBristol management Group, which collectively decides and reviews the working operational and safety strategy for the facility. On all substantive issues relating to operation of the CRICBristol facility the Directors must be consulted and retain the right to suspend any activity. The Centre Manager is responsible for ensuring that the rules and procedures set out in this document are adhered to at all times. The current MR Safety Officer (MRSO) will be the LRR. This person will spend most of their working day in the MR suite. Note that the MRSO does not have to be physically present for scanning or screening of participants to occur but either

mailto:[email protected]


they, or the scanner operator must be on site and within easy contact when such scanning is being carried out.

1.1.5. Organisation chart

1.1.6. CRICBristol governance structure

CRICBristol Board: Terms of reference

This is the key supervisory body with responsibility for ensuring the success of the CRICBristol

project and agreeing strategic direction and policy. It comprises representation at a high level

from both key partners, UoB and UHBristol.

The Board has responsibility for the management of CRICBristol; approval of policy and operating procedures for the Centre; management arrangements; governance arrangements; external advice on setting up CRIC; ensuring the correct processes are in place to allow joint decision making and conflict resolution; ensuring the communication and approval routes through both organisations are clear and agreed; oversight of funding flows. Quoracy: at least two members of each organisation to be present when decisions are being made.

The Board will itself report to high level committees within the administrative structure of the

partner institutions: the University Planning and Resources Committee (UPARC) or the

University Research Committee and UHBristol Trust Executive Group. All users and

researchers of CRICBristol can, where necessary, raise any concerns with the Chair of the

CRICBristol Board.


CRICBristol Management Advisory Group (MAG): Terms of reference

The operational, day-to-day management of the facility will be overseen by the MAG, who will

report to the CRICBristol Board. The MAG will be responsible for development and effective

utilisation of the facilities within CRICBristol including the day-to-day running of CRICBristol,

ensuring that it is run efficiently, securely, complies with all safety and research standards,

meets the needs of researchers and operates within its budget and encourages use of the

facilities to support world class clinical and imaging research. This group will oversee the

development and periodic review of policies and standard operational procedures (SOPs) for

all aspects and activities undertaken within the CRICBristol. The Management Group will

formally approve these documents. The MAG will have responsibility for approving research

projects for use of the CRICBristol facility and allocating resources to projects from

CRICBristol (staff and equipment/space) as required.

CRICBristol Governance Advisory Group (GAG): Terms of reference

Representation on GAG will include members of the UoB and UHBristol research governance teams and clinical academics. The responsibility of the GAG is to advise on the development of research and clinical governance policy as well as standard operating procedures. In particular, it will review any clinical incidents or complaints to determine if any changes in policy or procedures are required and ensure that all procedures are compliant with UoB and UHBristol polices. The GAG will also review research governance, approval and monitoring arrangements for projects conducted within CRICBristol and ensure consistency and compliance with UoB and UHBristol polices.

CRICBristol Scientific Advisory Group (SAG)

SAG has representatives from the major research groups using the facility as well as members

of CRICBristol academic staff and will be chaired by the Professor of Imaging.

The Scientific Advisory Group will report to MAG on:

feedback received from CRICBristol users

proposed changes to operational procedures to improve effective use of the facility.

scientific issues relating to state-of-the-art use and functioning of CRICBristol

technical developments and suggest proposals for new equipment purchases or changes to the facility.

In exceptional circumstances, SAG members can express their concerns directly to the

CRICBristol Board.


1.1.7. Qualifications, training, and training records for CRICBristol staff

CRICBristol staff training log is kept in the administrative area of CRICBristol

Job Title Training activity required for role

Lead Research Radiographer HPC Registration

Hospital Life Support

Venepuncture training

Fire safety

Good Clinical Practice

Academic Staff (Professor of Imaging

and Research Fellows)

Basic Life Support

Fire Safety


Centre Manager Basic Life Support

Fire Safety


Support staff (with the exception of

the Lead Research Radiographer)

Basic Life Support

Fire Safety



1.2. Office hours

1.2.1. Out of hours research working policy

This policy outlines the out of hours working policy at CRICBristol. Note: An MRI scanning outside core hours policy can be found in Annex B.2.

i) Out of hours is defined as 5.00pm-9.00am and includes weekends (all hours of Saturday and Sunday).

ii) No out of hours access to CRICBristol is available to staff or researchers who do not have a CRICBristol activated UHBristol staff swipe card, or access to a temporary CRICBristol swipe card.

iii) No research studies are to take place in CRICBristol out of hours without prior

arrangement and approval from the CRICBristol Management Group.

iv) No research users are permitted to work alone in CRICBristol out of normal working hours when conducting research with patients/participants.

v) There must always be at least two researchers or a researcher and a member of

CRICBristol staff present in the centre.

vi) One researcher will be identified as the Responsible Authorised User (RAU). All booking of CRICBristol facilities will be the responsibility of the RAU.

vii) The RAU must read and adhere to this CRICBristol Quality Manual, paying particular

attention to the policies relating to the facility they have booked at CRICBristol.

viii) The RAU must attend a building induction provided by CRICBristol staff before they can work in the centre outside of working hours without a member of CRICBristol staff present.

ix) The RAU with securing CRICBristol responsibilities will be trained on the securing

CRICBristol procedure (section 1.2.2) by CRICBristol staff and follow the procedures set out in this policy.

x) No MRI scanning of human volunteers outside of working hours can take place without

a member of MR authorised CRICBristol staff present.


1.2.2. Securing CRICBristol out of hours and on weekends.

The procedure is for out of hours working after 5pm, or working on weekends.

To be carried out by the Responsible Authorised User (RAU).

1. Ensure all doors are closed and secure in your area of work

2. Ensure the following doors are closed: a. Fire exit in corridor B-162 (next to the academic research room) b. Fire exit in Simulation Scanner room (B-174) c. Door leading from CRICBristol to St Michael’s Hospital (at end of corridor B-

168) d. Centre Manager’s office door (behind reception)

The above doors should be closed at all times, and the alarm will not set properly if any of

these doors remain open.

3. Ensure the doors along the 2 main corridors are closed (4 doors in total). Some of these doors are held open by a magnet. To release these doors, press the

small button underneath the magnet.

These doors are fire-doors and must be closed overnight.

Once actions 1-3 are completed ensure you and all personnel and research

participants are ready to leave the unit (have all personal belongings, etc) before

continuing.

4. Set the alarm (on the wall next to reception).

a. Enter the alarm code onto the key pad. b. The display will read ‘welcome back’ c. The display will read ‘would you like to arm system?’ Press YES d. The exit tone will sound. Once the exit tone is sounding, you should leave the

building.

e. Leave the unit. Walk towards the main front doors of CRICBristol. The two sets of doors (internal doors, and main front door) will automatically open and you should leave CRICBristol.

f. In the event that the second set of doors (the main front door) do not open automatically leave through the back door of CRICBristol into St Michaels hospital (this is a swipe access door). You may need to reset the alarm to give yourself enough time to exit through these doors.

Please note: once the alarm is set and the exit tone is sounding you have 45 seconds from

the opening of the main doors (either the doors that lead to the street or the doors that lead

into Level B of St Michaels hospital) to leave the unit.

g. Before moving away from the front doors, please ensure that they have closed securely behind you - to prevent anyone from gaining access to the unit.


1.3. Lone working policy

This policy is intended as guidance to members of staff working alone at CRICBristol. It

contains information regarding the risk of working alone at CRICBristol. It should be read

together with the UHBristol lone working policy. A copy of this can be found in the Quality

manual folder in the administrative area of CRICBristol.

Researchers must never see participants alone in CRICBristol. There must always be at least

two researchers or a researcher and a member of CRICBristol staff present in the centre whilst

a participant is on site.

The MRI scanner must not be operated by lone workers unless prior approval has been given

by the Directors and this will only be granted for the scanning of non living objects.

Definition of terms

Members of staff are those persons who are CRICBristol core staff and UoB or UHBristol

staff who have their office based in CRICBristol e.g. Bristol Health Partners and CardioNomics

research team.

Researchers include users of CRICBristol facilities who are not based at CRICBristol.

Lone workers Those who work by themselves without close or direct supervision, e.g. staff

working outside core hours in offices at CRICBristol.

Risk

There is a potential risk to lone workers due to the fact that CRICBristol is separated from St

Michaels Hospital by restricted access swipe.

Lone working is sometimes unavoidable and risks of safety to Staff need to be minimised.

1.3.1. Actions to be taken by lone workers

When working alone staff should take responsibility for informing security of their presence. To

inform UHBristol security that you are working alone by emailing Paul Wood

([email protected]) Head of UHBristol security and Martin Reid

([email protected]) with the date, time, and the names of those who will be present.

They will then inform the operations team.

a) Inform your line manager or colleague of the time you will be working alone.

b) Ensure you are aware of how to raise an alarm if necessary and be aware of relevant

health and safety policies and procedures.

c) Do not allow anyone access to the building unless you know they do not present a risk.

d) Report all incidents or risks raised by lone working to the centre manager.

If a staff member feels their personal safety is in danger they should call the

police via 999




1.4. Fire and major emergency

Fire and major emergency evacuation policy

Version: 1

Ratified by: Derek Pearce – Fire Safety Advisor for UHBristol

Date Ratified: Name of Originator/Author: N. Jade Thai Role: Centre Manager Division: School of Clinical Sciences Name of Responsible Committee/Individual: Date Issued: 06.12.2013 Review Date: December 2015 Target Audience: Staff working in the CRICBristol

Contents of fire and major emergency evacuation policy

1.4.1. Introduction 1.4.2. Purpose 1.4.3. Duties and responsibilities 1.4.4. Evacuation procedures 1.4.5. Hazardous materials 1.4.6. Training 1.4.7. Action in event of fire 1.4.8. Implementation 1.4.9. Summary

Appendices

Appendix 1: Escape from fire or similar emergency from the Clinical Research & Imaging Centre (CRICBristol). Appendix 2: Action in event of fire or equivalent emergency

References: University Hospitals, Bristol Ward Evacuation Training Document (2008) Consultation: University Hospitals Bristol Fire Safety Adviser. Scope: The provisions of this document, albeit focused on fire, may be applied to any generally threatening emergency, such as natural hazard, explosion or terrorism, subject to common-sense adaptation for the particular circumstances of an incident.

1.4.1. Introduction to fire and major emergency policy

i) This Policy addresses the needs of research participants, patients, visitors and staff in event of a fire or other emergency requiring evacuation from CRICBristol, which is situated at 60 St Michael’s Hill.

ii) CRICBristol is made up of: a) Main Reception area b) 1 Administration area (2 offices & reception desk) c) 4 consulting rooms d) Research equipment store room e) 1 clinical research office f) 1 Academic computing room g) 1 MR research office h) 1 Clean Utility


i) 1 Dirty Utility j) 1 Wet lab k) 1 baby changing room l) Domestic store room m) 2 en-suite bedrooms (Sleep Study Suite) with central control room n) 1 MRI reception area o) 1 MRI anaesthetic preparation room p) 1 MRI control room q) 1 MRI magnet room r) 1 Server room s) 1 Meeting room t) 1 Laundry room u) 1 Staff locker room v) 2 Staff shower/toilet w) 1 office (no window) x) 1 refuge store room y) 5 Toilets

1.4.2. Purpose

i) The aim of this document is to set out the emergency evacuation policy and emergency actions for CRICBristol Centre.

1.4.3. Duties and responsibilities

The CRICBristol Centre – General Advice

i) ‘Fire doors’ are normally only fire-resistant, with specific and limited fire resistance capability that is measured in minutes. They are not fire-proof unless they are stated to be so on the door itself, are obviously large and/or constructed of steel or similar material. They do not protect against smoke and fumes unless provided with smoke seals. They are normally to be kept shut and a notice is to be displayed on them to this effect. This retards the spread of fire.

ii) Glass panels in doors are not fire-proof. They are usually resistant only to a degree comparable to the door itself and are emplaced primarily to permit observation for search and rescue purposes. Such panels are commonly found in normal doors as well as in fire doors.

iii) Hand-held fire extinguishers are called ‘First Aid’ extinguishers because like Medical

First Aid, they can alleviate and perhaps rectify a problem, but they cannot cure a serious outbreak. They must only be used on an initial outbreak or to cut through flame or knock it back to support rescue or escape.

iv) Once on the scene, the senior Emergency Services Officer assumes command of the

incident, but will always aim to work to this Policy.

1.4.4. Evacuation procedures

i) Preparedness for evacuation: CRICBristol is to have requisite preparations in place to anticipate fire or similar emergencies. These are to accord with this Policy document and they cover:


ii) Assigned responsibilities for action in the event of fire a. Agreed and approved assembly points for evacuees with a pre-appointed ‘fire-

marshal’ for each, to supervise evacuees and to check a post-evacuation nominal roll of all evacuees. A nominal roll is to be maintained in each department/ward, with a record of those present each day.

b. Any special equipment as may be required to effect evacuation of each category of

research participant (see par.v. below).

c. Whether or not a ‘Delayed Evacuation’ (sub-par.viii/c. below) is decided upon, full preparation must be made from the first knowledge of the threatening emergency for evacuation to be carried out at very short notice. Under these circumstances, maximum use is to be made of refuges protected by fire/smoke-resisting doors or offering respiratory protection. Such refuges must always offer means of further onward retreat and are to be clearly marked as refuges.

d. At the commencement of any duty period, staff are personally responsible for informing their Manager or other Supervisor of any matter that could impinge upon their ability to assist during an evacuation. Researchers must give notice to the Centre Manager who will make the CRICBristol support staff aware and a written record kept in the researcher’s project file.

iii) Immediate response.

The immediate response to an incident is to sound the alarm, call for the Emergency Services, determine the location of the incident and only tackle it with ‘First Aid’ fire appliances (see par.1.4.3 above) if you have had full training on equipment and it is safe to do so. The location of the hazard must be made known to others involved so that evacuation is effected in the right direction and the Emergency Services may be directed to it. Thereafter, prepare to assist with evacuation in an orderly and calm fashion. All management and staff are to be familiar with and practised in the evacuation procedures relevant to their areas of responsibility and with the order of priorities as laid down at par.v.

iv) Lifts/Elevators. Lift-shafts on fire or in the vicinity of fire act as powerful draught creators, attracting and conducting smoke and fire, in the process generating ferocious heat. Lifts are also liable to failure in event of power-loss or other system-damage created by fire that may be remote from the lift-shaft itself. They are therefore potentially lethal and are never to be used in any building subject to evacuation during a fire or comparable emergency which may result in fire (e.g. a suspected, threatened, or other incipient risk of explosion).

v) Priorities. In event of a fire or other emergency requiring evacuation, the order of priorities is:

To save life.

To save equipment essential to sustaining the life of any immediately-dependant person during the evacuation and its immediate aftermath until an alternative becomes available.

To save the premises and other important equipment.


vi) Patient research participant categories. For Fire and Rescue purposes, patients are categorised as follows:

Category 1: ambulant patients / research participants (may need some assistance).

Category 2: semi ambulant patients research participants (wheelchair patients; may be able to transfer).

vii) Evacuee classification.

Everyone, whether they are research participant, patient, staff or visitor and regardless of their mobility or health, in any area threatened during a fire or similar emergency, is at risk and may require evacuation. Depending upon the health, mobility, clinical condition or treatment of anyone to be evacuated (see par.vi. above for patient categories), there are two classifications:

a. Independent. Adult’s only, with unimpaired mobility and/or mental health or who

have slight physical impairment but are able to leave the affected area either without assistance or with minimal assistance. Includes all Category 1 patients (see par.vi. above). Some assistance and guidance will however usually be necessary even to the most able-bodied and mentally capable in a strange environment.

b. Dependent. All persons not classified as ‘Independent’ as at sub-par.vii/a. above

including all children and all persons of any age with mental health conditions (including persons suffering temporary panic or other stress attacks in consequence of the emergency), regardless of their mobility. Most category 2 patients will be in this classification. All dependent people will require staff supervision and in some cases physical assistance to effect evacuation, as well as close supervision of all children involved.

viii) Evacuation procedures.

There are three defined evacuation procedures tailored to the classification of evacuee as defined at par.vi. These are:

a. Single Stage: Applicable to all persons classified under sub-par.vii/a. above as

‘Independent’ and to ambulant children (sub-par.vii/b. above), under the close supervision of responsible staff members. This is also applicable to ‘dependent’ people with mental health conditions but with sufficient physical capability to negotiate stairs with the ambulant. Single stage evacuation entails the swiftest (but orderly) evacuation of these people from the affected area to a place of permanent safety and is the preferred evacuation procedure wherever possible (also see sub-par.viii/b. below).

b. Progressive Horizontal Evacuation. Defined as evacuation where possible to a

different, safer location on the same floor-level as the place evacuated, with eventual transfer to other floors if necessary. Some protection will be afforded by fire doors (see sub-par.1.4.3/iii above) along pre-determined routes to pre-determined temporary sanctuaries. However, the sanctuaries themselves may need to be evacuated progressively if the threat develops. Progressive horizontal evacuation applies to persons classified as ‘dependent’ at sub-par.vii/b. above, except those ambulant ‘dependents’ such as children and physically able persons with mental health conditions, who may be able to take advantage of ‘single stage’ evacuation. This is the most likely (if not the preferred) initial evacuation procedure (see par.viii. above).

c. Delayed Evacuation. Fire can erupt at any moment to catastrophic proportions.

‘Delayed Evacuation’ is therefore a very high-risk procedure, only to be a decision


of last resort in individual cases, as when clinical circumstances, such as serious instability and dependence upon specific ventilation modes, mitigate against immediate evacuation. A decision to delay must be made by the Intensive Care Doctor, where possible in consultation with the Nurse in Charge and the Senior Emergency Services Officer. Should the situation suddenly deteriorate, such as by explosive force or a rush of noxious gases, such consultation may be impossible. The senior Staff member in the immediate vicinity of the affected patients is therefore authorised to make a decision at such a time and occurrence and to act as appropriate to the crisis.

1.4.5. Hazardous materials

Hazardous materials, such as flammable, explosive or combustion-supporting gases (e.g. oxygen), volatile liquids and certain electrical equipment are subject to special precautionary provisions. They are normally stored and used under specialised conditions, subject to strict supervision by trained Staff.

1.4.6. Training

Training for action in event of fire (and similar emergencies) is to be incorporated in induction training and is to be a standing component of continuation training, in particular drawing attention to new preventive or other provisions such as may be published from time-to-time.

1.4.7. Action in event of fire

Effective action in event of fire is dependent upon anticipation of the event. Apart from observance of standing Fire Orders throughout the establishment, all Management and Staff, Medical and Lay, are to be familiar with the University Hospital’s Bristol NHS Foundation Trust Fire Policy. A copy of the Hospital’s fire policy can be found in the Quality Manual folder in the administrative area of CRICBristol.

1.4.8. Implementation

Implementation of this Policy requires considerable planning, such as to determine, map and physically sign appropriate routes and sanctuary areas; to ensure that induction and continuation-training syllabi for all personnel are continually updated (par.1.4.6. above). This will become part of staff induction when commencing work in the CRICBristol. Up-dates will be managed via the Trust fire and safety training department and within timescales according to the direction from the Trust. Liaison with/between all Departments is to be sustained to ensure its provisions are and remain relevant to the needs of the CRICBristol and that they accord with the University Hospitals Bristol NHS Foundation Trust Policies. CRICBristol needs to take ownership by selecting a Fire-Prevention Manager working in the CRICBristol who will maintain responsibility for familiarisation with all aspects of this Policy, including escape provision, fire-prevention and protection awareness and for liaison with Internal Departments, the local Fire, Rescue and Emergency Services (see sub-par.1.4.3/iv above) and with the Trust’s appointed Fire Adviser.

1.4.9. Summary

This document provides the guidance to support staff in event of a fire/major emergency occurring in CRICBristol that would result in an evacuation of research participants, patients and staff from CRICBristol. This policy will be used in the induction of staff to the CRICBristol.


Appendix A.1: Escape from fire or similar emergency within the clinical research &

imaging centre

1. Responsibilities

1.1. CRICBristol trained Fire Officers:

Instruct Staff, researchers, visitors, research participants to leave the building via nearest exit.

Instruct staff/researcher to evacuate research participants/patients out of the MRI scanner.

Ensure all windows and external doors are closed.

Check all rooms, incl. lavatories and wash-rooms, for isolated individuals.

Ask non-clinical Staff not required for evacuation support to evacuate themselves by the nearest safe exit and to report to their appropriate Emergency Assembly point

1.2. Staff:

In event of an alarm, all staff to evacuate the building.

Be prepared to assist in any way requested. Evacuate if instructed to do so.


Appendix A.2: Action in event of fire

NB. The Senior CRICBristol staff in charge of the department will decide when the evacuation

of research patients is to begin, the order of priorities for evacuation, to where the evacuation

is to be made and what equipment must accompany them. Be prepared to put affected

research patients into blankets or wheelchairs.

At all times maintain a calm demeanour; do not panic, shout or fluster. Lives can

depend upon good order.

On detecting fire or equivalent emergency:

1. Activate the nearest Fire Alarm

2. Dial 2222

3. Tell operator clearly and coherently:

A. The nature of the emergency

B. The location of the occurrence

C. The number of patients in the vicinity

D. Any dangerous substances in the vicinity

E. Do not hang up until the operator tells you to do so, unless your life or that of

others could be jeopardised by the delay.

4. Evacuate research patients and handicapped visitors/children as follows:

A. On receiving instruction to do so unless it is clear that awaiting instructions could

jeopardise life.

B. By any means possible (using techniques as taught)

C. Having established where the fire is, to the nearest safe sanctuary away from it,

through fire doors. Stay with them until you can hand them over to a suitable

person.

5. Require all able-bodied visitors to leave the building(s) affected, offering advice on

safe routes and exits and physical guidance if needed

6. Maintain a count of the number of evacuees from your area, to tally with the final roll-

call. The emergency Services will need this kind of support to avoid unnecessary

search and rescue.


1.5. Procedure for the management of cardio-respiratory arrest (or other medical

emergency)

There will always be at least two people present when conducting research studies at CRICBristol. In the event of a cardio-respiratory arrest (or other medical emergency):

Person 1 Person 2

1 Commence Basic Life Support

immediately

Dial 2222 to call the Resuscitation Team

2 Clearly state which team you need, i.e.

adult, paediatric or neonatal

3 State that access to CRICBristol is via the

corridor on Level B, St Michael’s Hospital

4 Take the resuscitation trolley to the scene

5 Wait at entry to CRICBristol on the Level B

corridor to direct the Resuscitation Team

6 Assist with resuscitation as appropriate

Following the resuscitation, the leader of the resuscitation team will be responsible for the post-resuscitation care & safe transport of the patient.

An MRI scanner specific cardio-respiratory policy is in Annex B.1


1.6. Oxygen policy

Oxygen is classified as a drug which requires a prescription in medical and research settings.

1.6.1. Administration of oxygen in research

a. An appropriately qualified person will be responsible for the oxygen management

b. All staff and research users should be aware of and comply with the relevant

University Hospital Bristol NHS foundation Trust policy for the Prescription and

Administration of Oxygen. A copy of the Trust’s oxygen policy can be found in the

Quality Manual folder in the administrative area of CRICBristol.

1.6.2. Administration of oxygen in emergency

a. A prescription is not required and oxygen can be given by an appropriately qualified

healthcare professional e.g. nurse, doctor, paramedic.

b. The person who administers the oxygen should document that oxygen was given in

the person’s source records e.g. medical records and or record log sheet located in

folder on resuscitation trolley

c. If cylinders have been used, inform CRICBristol staff so that they can ensure

cylinders which are low or empty are replaced.


2. Research access to CRICBristol

2.1. The following process is provided as a flowchart in Figure A.1.

A researcher may contact CRICBristol to access the facilities, access may come through the website or through general queries email/phone number ([email protected]) Tel: 0117 342 1500).

The researcher will be asked to complete as much as possible of the initial project request form (Annex A.2) and email it to the CRICBristol Centre Manager (CM). The CRICBristol CM will arrange a meeting/telephone call with the researcher, and if the proposed study involves MRI scanning will invite a CRICBristol magnetic resonance imaging scientific advisor (MRISA1) who will be assigned to the project. This meeting will help the researcher to scope the CRICBristol aspects of their research, including costs (according to UoB FEC2 costing tool or funder rules), feasibility, safety, resource implications, technical input, timetables etc and to determine the suitability of the facilities.

The CRICBristol CM will inform the researcher of the study approval pathway they will need to use for full project approval and provide a template study risk assessment (Annex A.7). It depends on what stage their proposed project is at in the approval pathway as to whether further dialogue will be needed to complete the full project specification form.

Once the full project specification form (Annex A.3), all pathway to approval documents and a risk assessment are completed, the project will be submitted to the CRICBristol Management Group (MAG) or Directors for their conditional approval of the proposed use of the facilities. The CRICBristol CM will provide the MAG/Directors with a checklist (Annex A.5) listing the approvals required for the research according to the pathways to approval given in section 2.1 below. MAG or Directors conditional approval of the research will be annotated on the full/initial project request form which will become an agreement to provide services when signed by the researcher (chief investigator), subject to all the required pathway approvals being in place. For chief investigators (CI) who are not UoB employees a Terms and Conditions of Use agreement (Annex A.4) will also need to be signed by the chief investigator and the CRICBristol CM, including the full project specification form as its appendix.

Once all the pathway approvals are in place and the MAG or Directors have signed the full project specification form, the CRICBristol CM notifies the CI that the study can commence. This notification will include details for logging onto the booking system Calpendo3 as a user and a unique project code. The Calpendo registration email template can be found in Annex A.6. All bookings under the project code will be monitored/restricted to ensure that they are in accordance with the facilities and usage agreed in the Full Project Specification.

1 Where the contribution of the MRISA merits substantial involvement in many or all aspects of the study

(i.e. Conception, design, analysis and interpretation of data, drafting and critically revising the final article) co-authorship may be appropriate in accordance with normal academic practice. 2 http://www.bristol.ac.uk/fec/

3 https://cric-bristol.calpendo.com/


http://www.bristol.ac.uk/fec/

http://www.bristol.ac.uk/fec/

https://cric-bristol.calpendo.com/


Figure A.1: CRICBristol process for approval of a study

Yes No

Chief Investigator/researcher -

Initial contact with CRICBristol staff

If you have close to complete project design

then CI to complete ‘Full Project

Specification‘

Is it an MRI study?

If you are at the early stages of project

conception then CI to complete ‘Initial

Project Specification‘

CI meet/discuss with CRICBristol staff – costs, feasibility,

safety/risk, resources, bid preparation etc.

Complete full project specification form

Agree correct approval pathway and approval documents

to be submitted to CRICBristol Executive Assistant to file

in projects folder on CRICBristol shared drive

MRI Scientific Advisor (MRISA)

assigned by CRICBristol to support

MRI aspects of study design/approvals

if required

CI to complete Risk Assessment

CRICBristol CM submits paperwork to MAG or CRIC Directors for review and conditional approval

MAG/CRICBristol Directors

approve study CONDITIONAL

on the study approval pathway

(section 2.1) being met

On receipt of all approvals, CM recommends CRICBristol Directors approve study by

signing Full Project Specification form (scanned and saved into project folder)

CRICBristol CM/Executive Assistant saves all into shared projects folder under CI name

and onto database

MAG/CRIC Directors reject study

and, if appropriate, reasons given to

CI and any recommendations

CRICBristol CM/Executive Assistant notifies CI and provides CI with unique project

number and details for CI to become a user in the booking system allowing CI to book

agreed facilities


2.1. Pathways to approval

i) All studies performed using CRICBristol equipment or resources must obtain all the

necessary approvals before they can start. For UoB Chief Investigators, the UoB

chief investigators pathways to approval (Figure A.2) should be followed.

ii) The approval procedures for Chief Investigators who are not University of Bristol

employees are detailed in the pathways to approval for all other Chief Investigators

(Figure A.3). The procedure for these researchers includes the requirement to:

provide additional information on insurance and professional liability cover,

especially in cases where these users have been permitted to use their own

hardware solutions or add-ons

provide their full approved ethics application and study procedures and protocol

for CRICBristol MAG to review before approval to use can be granted

sign a CRICBristol Terms and Conditions of Use Agreement (Annex A.4). iii) The pathway for studies on non-human objects or materials provides details of the

approvals needed to ensure correct governance of these studies.


Figure A.2: Pathways to approval, University of Bristol Chief Investigators


Figure A.3: Pathways to approval, all other Chief Investigators


Figure A.4: Pathways to approval, studies on non-human objects or materials

2.2. Compliance with CRICBristol rules and procedures

All applicants will be required to read and understand the CRICBristol quality manual, and any

relevant risk assessments, and sign a sheet to confirm this, which will be retained in the

project file.

Procedure for non-compliance issues on research projects

Any general incidents of non-compliance on a research project will be dealt with as follows:

The CRICBristol Centre Manager or Directors will complete an Adverse Incident report

(template provided at Annex A.8) detailing the incident and any corrective and preventative

actions that can be undertaken to mitigate the effect of the incident and help prevent future

occurrences. This report shall be sent to the UoB Head of Research Governance for

information. If the Directors or the Head of Research Governance wish to report the incident

as potential research misconduct under the UoB Regulations on Research Misconduct using

the Policy on Public Interest Disclosure4 they are free to do so and it will be formally assessed

and investigated according to those policies. General advice on non-compliance issues within

CRICBristol can be provided by the UoB Head of Research Governance.

4 http://www.bristol.ac.uk/secretary/studentrulesregs/

http://www.bristol.ac.uk/secretary/studentrulesregs/


Annexes to Section A of this Quality Manual

Annex A.1: Floor plan to CRICBristol


Annex A.2: Initial project request form

Chief/ Principle Investigator

Name:

Email:

Tel :

Co Investigator(s)/researcher collaborators

Title of project

Sponsor

Funding

Study start Date and length of study

CRICBristol facilities

MRI Scanner

Clinical investigations/Testing Room

Sleep study suite


Annex A.3: Full project specification form

Full Project Specification Form

Principal Investigator

Name:

Address:

Email:

Telephone:

Co Investigators/Research Collaborators

Name /s:

Email:

Title of Project

Sponsor

Funding

Study Start Date & length of Study

Approval Pathway

CRICBristol MRI Scanner

Type of MR scan required

Number of scans

Total scan time


Number of research patients/participants

MR specialist Equipment required

Other requests

MR Personnel Support required

Clinical Investigation Suite

Number of rooms

Days/Hours required

Number of subjects/patients

Procedure/Testing

Equipment

Personnel support

Sleep Study labs

Number of rooms

Number of subjects/Patients

Equipment


Procedure/Testing

Detail of personnel working on project in the night (5.00pm-9.00am)

N.B. Bookings

All bookings are provisional until approved by a member of the CRICBristol staff

Operator Cover

For studies requiring an MR operator you must book slots during the hours where there is MR cover available.

For studies requiring operator cover outside the designated hours you should arrange this with the operators directly.

Bookings for more than 4 weeks in advance are considered provisional, to allow the operators to plan leave. Scan Timing

It is the responsibility of the researcher to ensure that the experiment can be completed within the booked scanner time. Over-running is likely to result in the experiment being cut short.

The researcher shall ensure that the participant is ready to enter the MR scanner at least 5 minutes before the start of the exam. This includes:

Initial and second screening forms have been completed. The participant has removed all metal from their pockets, clothes, hair etc. Consent form has been completed. The experiment and MR procedure has been fully discussed with the participant.

Advance booking limit

3 months for patient groups, 2 months for other studies.

Regular bookings

For studies that require a regular timeslot each week (e.g. clinical populations, or large cohorts) you can request this from the CRICBristol Centre Manager.

The timing of the regular slot will be accommodated as far as reasonably practicable, subject to the limitations of radiographer provision.

Regular bookings may have to be changed in future to accommodate changes in radiographer provision or scanner demand.

A maximum of four hours per study per week during Core Hours (as defined below) may be allocated in regular bookings to any one study.

Core Hours are :

Mon 9-5*, Tues 9- 5*, Wed 9 – 5*, Thurs 9 – 5*, Friday 9 – 5*

*If the research overruns and this can be accommodated without compromising other CRICBristol research, then the use of the

facilities will be charged in addition to this agreement per session (or part thereof).

Out of core hours bookings are available on request and must be approved by the Centre Manager or Lead Research

Radiographer

Other Equipment

If your study requires additional equipment – e.g. Physiological monitoring, MR compatible specialist equipment e.g. eye tracker, paediatric entertain box - please ensure that this equipment is booked as well. This equipment is often used in other parts of the building, so a booking of the MR scanner does not imply these components are included. Consumables please list consumables you wish for CRICBristol to provide. Please be aware that these will be invoiced according to the cost of the items required


Invoicing

Study total £

Payment schedule:

Amount for invoicing £……………………………… monthly/ in total (delete as appropriate)

UoB: Account Code

EL1: EL2:

Non-UoB: Invoice contact details and purchase order number:

Purchase order number:

Contact Name:

Address:

Email:

Telephone:

Applicant Signature

By signing, agreeing to the total and dates given in this form and the conditions of

study approval

Signature:

Name: Date:


CRICBristol OFFICE USE ONLY:

CRICBristol Project Code

Study costs

(delete as appropriate)

MRI

Clinical room

Sleep Study Suite

Staff allocation

Study approval pathway documents

User Agreement

Dated:

Risk assessment

Dated:

GCP Training Certificate or UoB ethics and governance training

Dated:

CRICBristol Authorisation

Signature:

Title:

Name: Date:


Annex A.4: Terms and conditions of use

(version 2, dated 30/01/2013)

Clinical Research and Imaging Centre (CRICBristol) Terms & Conditions of Use

Parties:

UNIVERSITY OF BRISTOL whose address is Senate House, Tyndall Avenue, Bristol, BS8

1TH “UoB” and

........................................ whose address is ................................... “Research Organisation”

This agreement is to confirm the indemnity, financial and other management processes that are needed to enable the Research Organisation to use CRICBristol facilities to carry out the study detailed in appendix 1 (the “Study”).

The parties hereby agree as follows:

1. Description of Service

Provision of such CRICBristol facilities as are confirmed in the completed ‘project specification’ form (attached as appendix 1) at St Michael’s Hospital, Southwell Street, Bristol (the “Premises”). CRICBristol facilities include a Magnetic Resonance Imaging scanner (the “Scanner”), a Sleep Studies Suite (“SSS”), a wet room, clinical research rooms, hot desks and meeting rooms (“CRICBristol Facilities”).

2. Agreement Term and Basis of Contract

2.1 This agreement will commence upon signature by UoB and will terminate either when the services to be provided by UoB as set out in the ‘project specification’ form have been completed and the Research Organisation has paid all invoices or in accordance with clause 11.

2.2 These conditions will apply to the exclusion of any other terms that the Research Organisation seeks to impose or incorporate, or which are implied by trade, custom, practice or course of dealing.

3. Obligations of the Parties

3.1 The Research Organisation shall and shall ensure that its employees and agents use the CRICBristol facilities:

- in a proper, professional and workmanlike manner;

- in accordance with any operating instructions or operating manual;

- in accordance with UoB’s instructions which may include without limitation undertaking any training requirements from time to time;

- within the manufacturer's rated capacities as notified by UoB.

3.2 The Research Organisation shall ensure that its employees and agents shall not make or allow any alteration to the CRICBristol facilities.

3.3 The Parties agree that the Scanner will be used for the research purposes set out in the completed ‘project specification’ form attached at appendix 1 only. For the avoidance of any doubt under no circumstances, will the Research Organisation or its employees or agents use the Scanner for any diagnostic or treatment purposes.


3.4 The Research Organisation agrees:-

- Following approval, the Study will be conducted in accordance with the protocol and all other details described in the ‘project specification’ form at appendix 1.

- The Study will only commence when relevant ethical approval from the appropriate ethics committee has been obtained.

- That appropriate funding has been arranged and is in place for this Study. 4. Indemnity and Liability Arrangements

4.1 Nothing in this clause 4 shall operate so as to restrict or exclude the liability of any party in relation to death or personal injury caused by the negligence of that party or its agents or employees or to restrict or exclude any other liability of any party which cannot be so restricted in law.

4.2 The Research Organisation indemnifies and shall keep indemnified UoB from and against all claims, proceedings, demands, damages and other liabilities and costs and expenses (including legal and other professional advisers’ fees and sums in settlement) in respect of:

a) personal injury (including death) made or brought against UoB by any research participant arising out of or relating to the products or therapies under investigation or any clinical intervention or procedure provided for or required by the Study to which the research participant would not have been exposed but for their participation in the Study;

b) any claim arising out of the misuse (whether negligent or wilful) of the Scanner or other

facilities by the Research Organisation or its employees or agents

(each a “Relevant Claim”).

4.3 In relation to the indemnity provided under Clause 4.2 above:

a) UoB shall inform the Research Organisation in writing as soon as reasonably practicable following receipt of notice of a Relevant Claim;

b) upon the Research Organisation’s request and subject to the Research Organisation providing reasonable security for UoB’s costs and expenses, UoB shall give the Research Organisation full control of the Relevant Claim and provide all reasonable assistance in relation to such Relevant Claim;

c) UoB shall make no admission in respect of a Relevant Claim other than with the prior written consent of the Research Organisation;

d) the Research Organisation shall have no liability to the extent that a Relevant Claim arises out of personal injury (including death) caused by the negligent or wrongful acts or omissions or breach of statutory duty of UoB, its employees or agents or the failure to properly maintain the CRICBristol facilities by UoB.

4.4 The Research Organisation will maintain appropriate insurance cover in respect of its potential liability under clause 4.2 above. Such cover shall be in the sum of at least £10,000,000 (ten million pounds Sterling) and the Research Organisation shall provide written evidence that such insurance is in place and is maintained as required by UoB. However, where the Research Organisation is an NHS Trust it is acknowledged that it is covered by the NHS Clinical Negligence Scheme and the NHS Litigation Risk Pooling Schemes (which includes the Liability to Third Parties Scheme) and this will be acceptable in lieu of insurance cover.

4.5 UoB shall have in place insurance to cover the CRICBristol facilities and shall be responsible for ensuring that a maintenance agreement is in place to ensure the quality and safety of the CRICBristol facilities.

4.6 The Research Organisation shall indemnify and keep indemnified UOB from and against all

claims, proceedings liabilities and costs and expenses (including legal and other professional advisors’ fees) in respect of any claim by a third party relating to the Study including (without limitation) the use of any results obtained from the Scanner.

4.7 Other than as provided in clauses 4.2 or 4.6 no party shall be liable to the other in contract, tort,


breach of statutory duty or otherwise for any loss of profits, revenue, reputation, business opportunity, contracts, or any other indirect, consequential, financial or economic loss arising directly or indirectly out of or in connection with this agreement.

4.8 The Research Organisation shall ensure that research participants are fully informed of all risks associated with the Study and that prior to participating in the Study each research participant has signed an ethically approved consent form acknowledging such risks.

4.9 UoB shall not be liable and the Research Organisation shall not be entitled to any reduction in the fee if the Research Organisation’s employees or agents fail to arrive or arrive late at the

Premises, or if participants do not pass MR screening (contra-indications must be checked by the research Organisation prior to the participant arriving for a scan), or if participants fail to meet any criteria for the Study

5. Regulatory Requirements

5.1 The Research Organisation shall comply with all laws and statutes applicable to the performance of the Study including, but not limited to, the Data Protection Act 1998, the Medicines for Human Use (Clinical Trials) Regulations 2004, and the Human Rights Act 1998, and with guidance on the conduct of a Study, such as ICH GCP and the Research Governance Framework, all as amended from time to time.

5.2 Whilst on the Premises, the Research Organisation shall and shall procure that its employees,

agents and invitees comply with all relevant health and safety, security and reporting requirements, systems and operating procedures put in place for the Premises and/or the safe use of the CRICBristol facilities. This includes providing documentary evidence to UoB of the relevant approvals and sponsorship for the Study as detailed on the CRICBristol website (http://www.cricbristol.ac.uk/ ).

6. CRICBristol Obligations

UoB shall use all reasonable endeavours to ensure that the Premises and CRICBristol facilities and services meet appropriate controls assurance standards and regulations, including but not limited to the Health and Safety at Work Act 1974, relevant guidelines from the Department of Health, the Medicines and Healthcare products Regulatory Agency and the Health Protection Agency.

7. Intellectual Property

The parties agree that as between them, the intellectual property rights (“IPR”) arising out of the use of the CRICBristol facilities for the purposes of the Study shall belong to the Research Organisation provided that UoB shall be permitted to copy and store all data obtained from the CRICBristol facilities to the extent that such data relates to the functionality or performance of the CRICBristol facilities.

8. Confidentiality

8.1 Each party shall keep confidential, and shall procure that its employees and agents shall keep confidential the other party’s Confidential Information. For these purposes “Confidential Information” includes information in whatever form:

a) in relation to both parties’ staff, agents, products, affairs and finances;

b) in relation to the Research Organisation technical data and know-how relating to the Study and any medical records or personal data relating to any participant in the Study

c) in relation to UoB technical data and know-how relating to the Scanner.

8.2 The obligations in clause 8.1 shall not apply to information which is:

a) made public at any time by the disclosing party to whom that information is confidential, or by others with the permission of that party;

http://www.cricbristol.ac.uk/


b) lawfully in the possession of the receiving party before the date of receipt from the other party without any obligation to maintain the confidentiality thereof;

c) lawfully in the possession of the receiving party before the date of receipt from the other party without any obligation to maintain the confidentiality thereof;

d) in the public domain;

e) independently received from a third party who is free to disclose it;

f) demonstrably conceived by the recipient independently of the confidential information supplied hereunder

g) subject to disclosure being required by law (including for the avoidance of doubt pursuant to the Freedom of Information Act 2000), provided that the party required to make such disclosure notifies the owner of the confidential information and uses its reasonable endeavours to minimise the scope of such disclosure.

9. Publicity and Publications

9.1 Save as provided in clause 9.2 the parties shall keep the terms of this agreement confidential and shall not disclose them to any third party without the consent of the other party.

9.2 The Research Organisation shall use the following wording in any research publications: “We would like to thank the Clinical Research and Imaging Centre (Bristol) for the use of its facilities in undertaking this research.”

10. Services and Invoicing Arrangements

10.1 The CRICBristol facilities and services of UoB are set out in the completed ‘project specification’ form at appendix 1

10.2 The price for the use by the Research Organisation of the CRICBristol facilities is set out in the completed ‘project specification’ form.

10.3 UoB will raise invoices for the instalment frequency and amounts agreed in the ‘project specification’ form (attached) on signature of this agreement. VAT shall be charged in addition where appropriate.

10.4 Invoices shall be sent to the Research Organisation at its address set out in the ‘project specification’ form

10.5 The Research Organisation shall pay UoB’s invoice in full in cleared funds without deduction or set off within 30 days of the date of the invoice.

11. Breach

11.1 UoB may terminate this agreement immediately by written notice (or orally if the Research Organisation’s employees or agents are on the Premises) to the Research Organisation if the Research Organisation commits a material breach of this agreement which (in the case of a breach capable of a remedy) it does not remedy within 14 days (or such shorter period as is reasonable in the context of the breach) of receiving written notice of the breach.

11.2 The Research Organisation may terminate this agreement immediately by written notice to UoB if UoB commits a material breach of this agreement which (in the case of a breach capable of a remedy) it does not remedy within 7 days of receiving written notice of the breach.

11.3 On termination of this agreement the Research Organisation will immediately cease to exercise its rights under this agreement and if the Research Organisation has already entered upon the Premises it shall immediately vacate the Premises.

11.4 Termination shall be without prejudice to the accrued rights of any party at the termination date. The obligations set out in clauses 4, 8 and 9 and any other provisions which are either expressed to survive termination or, from their nature or context are intended to survive termination, shall survive termination of this agreement, however arising.


12. Cancellation

12.1 If the Research Organisation cancels its use of the facilities less than 7 days but more than 24 hours before the start date as set out in the ‘project specification’ form the Research Organisation shall be liable to pay 50% of the fee. If the Research Organisation has already paid the fee in full in accordance with clause 10, UoB shall refund 50% of the fee to the Research Organisation. If the Research Organisation has not yet paid the fee it will pay 50% of the same to UoB forthwith.

12.2 If the Research Organisation cancels its use of the facilities less 24 hours before the start date as set out in the ‘project specification’ form the Research Organisation shall be liable for the full fee and if the Research Organisation has not already paid the fee in full in accordance with clause 10 the Research Organisation shall pay the full fee to UoB forthwith.

12.3 If the Research Organisation cancels its use of the facilities it will advise the CRICBristol Centre Manager by e-mail forthwith.

13 Force Majeure

Neither of the parties shall be under any liability to the other to the extent to which it may be hindered or obstructed in performing its obligations hereunder by reasons of war, invasion, act of foreign enemy hostilities (whether war has been declared or not), civil war, revolution, insurrection, martial law, riot or civil commotion, strikes, labour disputes or accident, fire,

explosion or plant breakdown (for reasons other than wilful neglect of maintenance), materially adverse weather conditions lasting more than five days, action of any governmental or local authority or any other circumstances beyond its reasonable control.

14. Amendments

This agreement may only be amended by written agreement of both parties.

15. Notices

15.1 All notices, statements and other matters concerning this agreement shall be addressed to the signatories to this agreement for each party at the address set out at the head of this agreement

15.2 Notices shall be validly given if delivered by hand, sent by fax (provided that the fax is confirmed by sending the same notice by first class post on the same day) or recorded delivery post to the addresses specified above or any subsequent notified address.

16. Alternative Dispute Resolution

16.1 If any dispute arises out of this agreement the parties will attempt to settle it by negotiation and such dispute shall be referred to an appropriate senior representative of each party if it is not otherwise resolved.

16.2 If the parties are unable to settle any dispute by negotiation within 21 days the parties will attempt to settle it by mediation in accordance with the Centre for Dispute Resolution (CEDR) Model Mediation Procedure.

16.3 To initiate mediation a party must give notice in writing ("ADR Notice") to the other party to the dispute requesting mediation in accordance with this Clause.

16.4 A party may not serve an ADR notice or commence court proceedings until 21 days after it has made a written offer to the other party to negotiate a settlement to the dispute.

16.5 Nothing in this clause shall prevent either party from having recourse to a court of competent jurisdiction to resolve the dispute in question including inter alia for the purpose of seeking a preliminary injunction or such other provisional judicial or equitable relief as it considers


necessary to avoid irreparable damage.

17. Severability

If any term of this agreement is invalid or unenforceable under any statute, regulation, ordinance, executive order or other rule of law, such term shall be considered deleted, but only to the extent necessary to comply with such statute, regulation, ordinance, order or rule, and the remaining provisions of this agreement shall remain in full force and effect.

18. Entire Agreement

18.1 Subject to clause 18.2 this agreement together with the appendix specifically referenced in this writing, constitutes the final and entire agreement between the parties with respect to the matters contained in it and supersedes all prior oral or written representations and agreements. Any modification, alteration or amendment to this agreement must be in writing and signed by all parties.

18.2 Where the Research Organisation is University Hospitals Bristol NHS Foundation Trust (the “Trust”) (or any permitted assignee of the MRI Agreement as hereafter defined) this agreement is subject to the terms between the Trust and the UoB relating to the Clinical Research and Imaging Centre dated 23 July 2010 (“MRI Agreement”) to the extent of any conflict between this agreement and the MRI Agreement.

19. Assignment

Neither party may assign or subcontract any obligation, benefit or interest herein without the prior written consent of the other party.

20. Governing Law

This agreement shall be governed by the laws of England and Wales and both parties agree to submit to the exclusive jurisdiction of the courts of England and Wales.

On behalf of Research Organisation On behalf of UoB

Signed ......................................................... Signed .........................................................

Position......................................................... Position.........................................................

Date .......................................................... Date ..........................................................

Appendix 1 – Full Project Specification Form

Project Chief Investigator: .............................................................

Project title: ............................................................................


Annex A.5: Checklist for management

Study Title:

Chief Investigator: CRICBristol ref:

Essential Document Version

Number

Date of

document

CRICBristol

CM

signature

or N/A*

Date Filed

Protocol

Ethics Approval

Research Governance

registration

Risk Assessment

SSI

Research Governance

Sponsorship

MHRA CTA (IMP)

MHRA letter no objection

NHS Permission

Insurance/indemnity

arrangements

ARSAC

Terms and Conditions of Use

Agreement signed

Home Office licence holder

approval/acknowledgement

For MRI: Protocol and PIS

includes an appropriate

incidental findings policy

*CRICBristol CM to identify which documents are required depending on the pathway for

research – see Section 2.1 of the CRICBristol Quality Manual - Pathways to approval.


Annex A.6: Calpendo registration email template

Please register yourself on the CRICBristol booking system ‘Calpendo’ at this link: https://cric-bristol.calpendo.com/ You will be sent an email when you have been approved as a user. At this point please login to Calpendo and register your project (using your CRICBristol project code), by selecting 'project / create project' from the tab along the top. Please fill in as much information as possible. Once you have submitted your project and it has been authorised, you can use Calpendo to book the appropriate CRICBristol resources. Please note, all bookings are considered provisional until they have been approved by a CRICBristol member of staff. Your project code is: ___________________________ Please don’t hesitate to contact us if you need any further information.



Annex A.7. General risk assessment

ASSESSMENT REF NO:

STUDY NAME PRINCIPAL INVESTIGATOR

GENERAL RISK ASSESSMENT

1. PROCEDURE BEING ASSESSED

2. HAZARD

3. THOSE WHO MIGHT BE HARMED

4. EXISTING CONTROL MEASURES

5. A: Severity of Injury (1-3) B: Likely Occurrence (1-3) Risk = (AxB)

6a. DATE ASSESSMENT UNDERTAKEN:

6c. ASSESSED BY:

6d. CHECKED BY:

6b. REVIEW DATE:


Risk = Hazard Severity (A) x Likelihood of Occurrence (B)

Risk Score Response Times

9

6

3&4

<3

Immediate remedy or cessation of activity

Immediate remedy

3 months

12 months (date of next audit)

It must be recognised that some risks cannot be eliminated and it may be acceptable to

implement control measures which downgrade risks from a high score to less than 3.

ASSESSMENT REF NO:

ACTION PLAN

FURTHER ACTION REQUIRED

BY WHOM

BY WHEN

COMPLETED

Score 3 2 1

Column A: Severity of Injury:

Major injury or death Injury requiring medical treatment

Minor or no injury

Column B: Likely Occurrence:

Regular exposure of several employees to hazard

Occasional exposure of few employees

Exposure to hazard very rare


Annex A.8: Incident report form

CRICBristol Incident Report Form [DATE]

Date of adverse event:

Reported by: Date:

Reported to: Date

Nature of event

Actions Completed by: Date

1

2

3

Summary of Corrective and preventive action

Document created by:

Name: Signed: Date:

Countersigned by:

Name: Signed: Date:

CRICBristol Director to confirm if no further action necessary:

__________________________ ________________________ _________

SIGNATURE PRINT NAME DATE


Annex A.9: Fire emergency procedure risk assessment – working hours



Annex A.10: Stock management Details as to who is responsible for the general CRICBristol (non study-specific) stock

monitoring are below.

CRICBristol area Responsible person

MRI suite Lead Research Radiographer

Sleep study suite Sleep Research Associate

Clinical rooms Executive Assistant

Administrative area Executive Assistant


Section B: MRI local rules and procedures

The Health Protection Agency and the Department of Health have published the following documents relating to the use of Clinical Magnetic Resonance equipment:

“Safety Guidelines for Magnetic Resonance Imaging Equipment in Clinical Use”, Medicines and Healthcare products Regulatory Agency (MHRA), Department of Health, DB2007(03), December 20075; and

“Protection of Research participant and Research participants undergoing MRI Procedures”, Document of the Health Protection Agency, August 2008.

Copies of these documents are available for reference in the CRICBristol Academic Suite and MRI Control Room.

The ultimate responsibility for the implementation and the maintenance of procedures to ensure the health and safety of all persons entering the MRI suite lies with the employer.

The day-to-day responsibility for aspects of safety, the research participants scanned and all personnel who have access to the MRI suite is delegated to a “MR Responsible Person” as referred to in the referenced Department of Health document. At CRICBristol, this will be the Lead Research Radiographer (LRR).

3. MR Authorised personnel

As Authorised Staff Users the Centre Manger and Lead Research Radiographer (LRR) must undergo the standard screening procedures. The Centre Manager and Lead Research Radiographer can be the sole occupant of the MR suite, so long as another member of staff is present in CRICBristol and knows that they are in the MRI suite. The Centre Manager and LRR have the right to review the classification of any person and, if appropriate, can re-classify that person, suspend their rights and access privileges if appropriate. This must be immediately reported to the Directors for review and approval. Any such activity must be reported to the Line Manager/ Project PI for that person for information and follow up with the CRICBristol Directors. The Centre Manager, and or LRR must be informed before any previously unclassified person is admitted to the MR Controlled Area. The Centre Manager and or LRR must be consulted before any new piece of equipment can be admitted to the MR Controlled Area. The LRR is the key operational person for managing and ensuring compliance in the MRI suite and has the same access privileges as the Centre Manager. As the MR Safety Officer the LRR has the day-to-day responsibilities for administering access privileges to other users and is responsible for ensuring that Authorised Users have been properly screened and trained.

5 http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBulletins/CON2033018



MR Authorised Personnel (AP) with subcategories:

There are three categories of Authorised Personnel: Authorised General User (AGU) Authorised Staff User (ASU) Authorised Postgraduate User (APU). The key difference is in their rights and responsibilities. Training records for all categories of Authorised Personnel are held in the CRICBristol shared folder, and in the control room. Booking access for the scanner is dependent on the CRICBristol Centre Manager having copies of current relevant training records as described below. All MR relevant training is expected to be refreshed every twelve months.

3.1. Authorised General User (AGU)

To obtain status as an AGU, the appropriate training needs to be received from the Lead Research Radiographer or other appointed person. Before Authorised Person status as AGU is conferred, a person must undergo the following training and testing:

1. They must know how to follow emergency procedures.

2. Training in removing an unconscious participant from the Magnet Room.

3. Viewing the current Siemens safety video.

4. Signed to say they have read and understood this Quality Manual

5. Successfully completing a written test on Section B of this Quality Manual titled MR Local Rules and Procedures overseen by either the LRR or Centre Manager.

The required General User competencies are given above. These need to be completed and signed off by the LRR before any individual can work within the MRI suite. An AGU cannot operate the scanner but can screen research participants and work in the MRI suite with another ASU present.

3.2. Authorised Staff User (ASU) & Authorised Postgraduate User (APU) [operators]

These are staff who are conversant with, and who agree and are able to put into practice, all the rules and emergency practices outlined in this document. They are responsible for screening participants and other visitors to ensure that it is safe for them to enter the Controlled Area, and they must supervise all non-authorised people at all times when in the Controlled Area. Records of screening are kept by the LRR and held in the Control Room. Authorised User status is granted by the CM or the LRR. A list of current authorised users will be kept on the CRICBristol shared drive and any additions/deletions will be reported to the CRICBristol management committee. Before Authorised User status can be confirmed, a person must undergo the following training and testing: 1. Authorised General User Status 2. Training in the operation of the scanner. 3. Training in the administration of screening questionnaires. 4. Training in First Aid (to the level of ‘appointed persons’) 5. Basic fire training (internal programme; content to be determined by the UHBristol Safety

Officer)


6. Training in removing an unconscious participant from the controlled area. 7. Viewing the current Siemens safety video. (Attendance at a safety lecture given by a

suitably qualified person approved by the Management Committee (or viewing a video recording of such a lecture).

8. Reading the Guidelines for Magnetic Resonance Equipment in Clinical Use (December. 2007) published by the (MHRA).

9. Studying all relevant risk assessment forms (provided by the MRSO). 10. Thoroughly reading the local Rules of Operation and successfully completing a written test,

to be administered by the LRR, covering the rules and procedures covered in this document.

11. These requirements apply to all persons, including members of the Management Committee.

Persons who satisfy all the above requirements but have little or no practical experience will initially be given Probationary Authorised User Status. Such persons will become full Authorised Users when they have been present at 10 scans and have operated the scanner on at least 5 of those occasions. This will be supervised and authorized by the Lead Research Radiographer or Centre Manager. Authorised Persons must be screened at least yearly. They must also be trained in the use of any new equipment, software or procedures that may be introduced from time to time. The current list of authorised personnel, together with their qualifications, training and experience, will be made available on request to all relevant university ethics committees. Note that: Only Authorised Personnel (AP) may: • Perform screening of MR participants, their helpers, other staff members and members of the general public, so that they may be admitted to the Outer Controlled Area. • Perform screening of MR participants such that they may be scanned using the MR system within the Inner Controlled Area. An AP may only scan participants if another AP is in attendance. An AP may only enter the Controlled Area in accordance with the rules outlined in Section 3 An AP must notify changes in their health status (surgery, pregnancy etc.) to the Centre Manager or LRR who will re-screen them and makes changes to their classification (if appropriate).

3.3. Non-living objects Authorised User (NAP)

Another class of MR operator Non-living objects Authorised Person (NAP) can be granted to

those persons who have completed the MR safety training listed in section 3.2 by the LRR.

Persons with NAP status will be permitted to operate the scanner unsupervised only when

scanning non-living objects and materials.


4. Project initiation and booking policy

For MRI projects the MRISA and Lead Research Radiographer are responsible for the day-to-

day scheduling of scanner time and other resources. Researchers with booked scanner slots

are required to confirm with the MRISA or LRR by email or phone at least 24 hours ahead of

the booked time that the participant has:

committed to the booked slot.

been screened for contra-indications for scanning.

In the absence of this confirmation, the booking will be cancelled and charged as detailed

below and the slot made available to other researchers.

4.1. Booking system

All bookings must be made through the CRICBristol booking system via https://cric-bristol.calpendo.com/

All projects are assigned a CRICBristol project number and bookings must be made against the project number.

Bookings are only taken when a research user has registered themselves and their project on the booking system.

The user and project will be approved by CRICBristol staff on the booking system. For MRI projects the CRICBristol scanner operator will approve bookings.

4.2. Cancellations

Cancelled bookings are chargeable. For any project, the first ‘chargeable’ cancellation will be overlooked, but subsequent cancellations will be charged at the following rate:

Bookings cancelled less than 7 days before the scan will be charged at 50% of the scan fee (excepting bookings made less than 7 days before the scan).

Bookings cancelled less than 24 hours before the scan will be charged at 100% of the scan fee (excepting bookings made less than 24 hours before the scan)

The researcher should inform the operator and/or the CRICBristol Lead Research radiographer that the slot has been vacated.

The following are also chargeable cancellations:

Researcher failing to arrive, or arriving late for the scanning session.

Participants not passing MR screening (contra-indications should be checked prior to the participant arriving for a scan).

Participants failing to meet any criteria for the experiment (e.g. failing a performance limit for a task).

4.3. Advance booking limit

3 months for patient groups, 2 months for other studies.

4.4. Regular bookings

Projects that require a regular timeslot each week (e.g. clinical populations, or large cohorts) can request this from the CRICBristol Centre Manager.




The timing of the regular slot will be accommodated as far as practical, subject to the limitations of staff and radiographer (for MRI) provision.

Regular bookings may have to be changed in future to accommodate changes in staff and radiographer (for MRI) provision or scanner demand.

A maximum of six hours per project per week during core hours may be allocated in regular bookings to any one MRI project.

Core Hours are defined as:

Mon 9-5*, Tues 9- 5*, Wed 9 – 5*, Thurs 9 – 5*, Friday 9 –5*

* Requests for Out of core hours, including Saturday MRI scanning slots should be

made to Lead Research Radiographer or Centre Manager.

4.5. Operator cover

Studies requiring operator cover outside the designated hours should arrange this with the operators directly.

Bookings for more than 4 weeks in advance are considered provisional, to allow the operators to plan leave.

4.6. Scan timing

It is the responsibility of the researcher to ensure that the experiment can be completed within the booked scanner time. Over-running is likely to result in the experiment being cut short.

The researcher should ensure that the participant is ready to enter the MR scanner at least 5 minutes before the start of the exam. This includes;

Initial and second screening forms have been completed. The participant has removed all metal from their pockets, clothes, hair etc. Consent form has been completed. The experiment and MR procedure has been fully discussed with the

participant.

4.7. Other equipment

If your study requires additional equipment – e.g. physiological monitoring, MR compatible specialist equipment e.g. eye tracker, paediatric entertain box - please ensure that this equipment is booked as well. This equipment is often used in other parts of the building, so a booking of the MR scanner does not imply these components are included.


5. CRICBristol MRI data handling policy

This data handling policy is in accordance with RCUK6 and NIHR7 guidelines

5.1. Confidentiality

Subject to the requirements of legislation, including the Data Protection Act 1998, all information obtained about participants during an investigation is confidential unless otherwise agreed in advance. All MRI research imaging data is anonymised before scanning in order to protect an

individual’s identity. Anonymisation is done by using coded information as the participant ID.

The key to this code is only accessible to members of the research team using that

information.

This process should be detailed in the ethically approved research protocol and participant

information sheet/consent form, which must be adhered to.

5.2. Data transfer

At the end of each scan session, the operator will transfer all anonymised research data onto a University file server. Access to this is via UoB IT account, User ID and Password. Images needing to be reviewed by a clinician will be sent to the secure Trust PACS8 system. The console will be cleared of all scans monthly. Users must check that their data has arrived on the relevant file server within this time.

Figure B.1: Data transfer diagram

6 Research Councils UK

7 National Institute for Health Research

8 Picture Archiving and Communication System

MRI scanner local database

Cleared of data monthly after checking data has

arrived at relevant destination.

RESEARCH PARTICIPANT healthy volunteer scanned for

research purposes

Anonymised data sent to University file server

CLINICAL RESEARCH Identifiable patients scanned for research

purposes

Anonymised research data sent to University file server

Identifiable clinical images sent to hospital PACS system directly from

scanner

NON RESEARCH CLINICAL images sent to Hospital PACS system.


5.3. Data security

All image data is only accessible to authorised users who have a UoB IT account user ID and

password for a firewall protected server.

5.4. Data analysis

Data analysis will use a variety of methods. These will include Siemens programmes on the MRI console and computer based programs such as MATLAB, SPM, AFNI, DTIstudio, DTIslicer, LC Modelling and programs created/modified by the researchers.

6. Designated controlled area

6.1. The MRI equipment generates three types of electro-magnetic field: (i) a static

magnetic field, (ii) a low frequency time-varying magnetic field and (iii) a radiofrequency electromagnetic field. Individuals undergoing an MRI examination will be exposed to all three types of field simultaneously, whilst others in the immediate vicinity will be exposed to a reduced level of static magnetic field only.

6.2. Access to the MRI suite is via doors, which are interlocked using swipe card

access. A plan of the MRI suite is reproduced in Figure B.2 and a detailed description of the Controlled Area is provided in section 12.

6.3. The MRI magnet is located within the Magnet Room. Essential hardware for the MRI scanner including the gradient and RF amplifiers are located inside the MRI Equipment Room. Both the Magnet Room and the MRI Equipment Room are sited inside a designated Controlled Area. The 5 Gauss (0.5mT) line of the magnetic field is within the Magnet Room. Only Authorised Personnel with the appropriate level of training may have free access to the Controlled Area.

6.4. All personnel who are not designated as Authorised Personnel, including staff and

visitors, must complete the relevant MRI Safety Screening Form (reproduced in Section 13) and should be accompanied and supervised by an Authorised Person at all times whilst they remain within the Controlled Area. Screening for MRI safety should be performed in the MR Preparation Area before entering the MRI controlled area.

6.5. No individual may enter the Controlled Area until they have completed the MRI

Safety Screening Form to confirm that none of the contraindications to entry apply to them. Notices at the point of entry into the Controlled Area must be visible to remind individuals to check that they carry no ferromagnetic objects. This is particularly important for individuals who intend to work close to the MRI scanner, where such objects can behave as missiles, injuring people and damaging the equipment.

6.6. Currently, there is no conclusive evidence that electromagnetic fields used for MRI

and spectroscopy can cause any detrimental effect to the well-being of the embryo or foetus during pregnancy. However, to reduce the potential risks to the foetus from acoustic noise it is advisable for Authorised Personnel to avoid entrance to the Magnet Room during the first trimester of pregnancy, while the scanner is being operated.


7. Health and safety regulations

7.1 The Health and Safety at Work etc Act 1974 clearly defines the mandatory responsibilities and the statutory requirements under the Act, of the employer, of the employee and all who have access, including visitors, to the site of work. A number of aspects of the Act are particularly relevant to the MRI safety.

7.2 The specific implications of the Act and of Guidelines issued by the Department of Health for Magnetic Resonance Diagnostic equipment in clinical use are as follows: 7.2.1. Only Authorised Personnel may have free access to the MRI suite. These are

personnel who have satisfactorily completed training in their responsibilities and have gained an appropriate appreciation of the MRI diagnostic equipment and its safety requirements. Copies of the current list of Authorised Personnel are kept in the administrative area of CRICBristol.

7.2.2. All unauthorised personnel, including staff, research participants and visitors,

may only enter the MRI suite under the direct supervision of an Authorised Person.

7.2.3. All persons who are contraindicated by the MRI safety screening form are

prohibited from entering the controlled area.

7.2.4. Ferromagnetic objects must not be taken into the Controlled Area. For example, standard hospital trolleys, wheelchairs, drip stands, tools, keys, and jewellery, as they present a projectile risk. These objects should remain outside the Controlled Area.

7.2.5. During the first trimester of pregnancy you are advised against entering the

Magnet Room during scanning.

7.2.6. Personal belongings such as bank and credit cards, analogue watches and cameras should not be taken into the Controlled Area as they may be permanently damaged by the magnetic field. For logistical reasons such personal belongings should be deposited in the lockers outside the MR Preparation Area.

7.2.7. The doors to the Magnet Room and MRI Equipment Room should be kept

closed at all times other than when Authorised Personnel need access to those areas. It is the responsibility of the scanner operator to ensure that, upon finishing a session, the Magnet and Equipment room doors are locked.


8. Access to the MRI suite

It is extremely important to control the access of personnel and equipment into the MRI Controlled Area (see Figure B.2). The restriction and control of personnel and equipment into the Controlled Area forms the principal defence against MR related injury. The only means of access to the Controlled Area should be via the security doors, which can be opened by means of a swipe card. Figure B.2 shows a plan of the MRI suite and the extent of the Controlled Area.

Members of the public and staff should be excluded from the Controlled Area unless accompanied and supervised by an MR Authorised Person after satisfactorily completing the relevant MRI safety screening form.

No person should work in the Controlled Area on their own when scanning research participants. No person may be placed in the scanner unless at least Two Authorised Persons are present and at least one of whom is an ASU.

No person, other than CRICBristol MR authorised staff (i.e. Centre Manger, Imaging Professor and Lead Research Radiographer), or the Siemens MRI engineers, UHBristol Medical Physics staff approved by Centre Manager or LRR may enter the Magnet Room when alone in the MRI suite.

The boundaries of the MRI suite are clearly defined on the plan in Figure B.2. The outer door to the MRI suite must be kept closed at all times – even when the area is being supervised by an Authorised Person. Admission is by swipe card only. Only Authorised Persons will have swipe card access. Swipe card access is granted by the LRR or CM.

UHBristol staff, or University of Bristol staff with an UHBristol honorary contract who are MR authorised will be granted swipe card access through their UHBristol staff card by the Centre Manager. They will be required to give their staff card number to the Centre Manager who will request security to activate the card for access to the MRI suite. Their staff card number will be kept in the MR authorised Persons record book held in the administrative area of CRICBristol.

All other MR authorised Personnel will be given a CRICBristol MRI zoned swipe card while they are working in the MRI suite. This swipe card must be signed in and out at reception.

When the MRI suite is not in use, the following doors must be kept locked:

Magnet Room door

Equipment/Cabinet Room door

Control Room door

Control and Magnet room doors are accessed by keys only. These doors are clearly identified on the plan of the MRI suite provided in Figure B.2. Keys are kept in the CRICBristol administrative area in a locked cabinet. Only an Authorised Person will be issued with the keys, which must be signed for in the accompanying log book. Upon return of the keys to reception, the Authorised Person must sign the log book to acknowledge the keys have been returned.

An additional set of keys are kept by the MRSO and Centre Manager.


8.1 Rules for Authorised Personnel

8.1.1. All Authorised Personnel should be conversant with, and be able to put into practice, the general rules and emergency procedures contained within this document. In addition, they should be conversant with the specific rules relevant to their work area.

8.1.2. Authorised Personnel are further classified as to their Level of Training, which determines their competency to use the MRI equipment. The competencies of each Level of Training are summarised in Section 3. Following training and assessment by two of the Operator Assessors listed in the contacts list in Section 15, Authorised Personnel should complete and sign the form appropriate to their Level of Training. The operation, if any, of the MRI equipment by Authorised Personnel must be strictly confined according to these competencies.

8.1.3. Authorised Personnel should not undertake tasks/jobs that are beyond their level of training.

8.1.4. All Authorised Personnel have the responsibility to ensure that all visitors, research participants and other members of staff who enter the MRI suite are only allowed to do so subject to the general rules stated in Section 3. In particular, Authorised Personnel must ensure that persons fitted with a cardiac pacemaker, or who are otherwise contraindicated, do not enter the Controlled Area. The Authorised Person shall take full responsibility for an unauthorised person who enters the Controlled Area for the duration of their stay.

8.1.5. All Authorised Personnel have the responsibility to ensure that all visitors and other members of staff do not enter the Magnet Room unless they are under the continuous supervision of an Authorised Person and are subject to the general rules stated in Section 3.

8.1.6. During the normal working day (Monday to Friday, 09.00-17.00 hours) the responsibility for checking that it is safe for an individual to enter the MRI suite is taken by one or more of the relevant Authorised Personnel working in the MRI suite. See Section 3 for guidelines on levels of access to the MRI suite afforded to personnel of different levels of training.

8.1.7. Authorised Personnel who are pregnant must inform the MRSO. During the first trimester of pregnancy, they should be given the choice whether or not to enter the Magnet Room, but may enter the Controlled Area including the MRI Control Room without detrimental effect. However, they may not remain in the Magnet Room during scanning.

8.1.8. Action in breach of Quality Manual will result in an investigation and incident reporting. Appropriate measures after the investigation will be taken and this could result in MR authorised status being revoked.

8.2. Rules for Unauthorised Personnel requiring access to the controlled area

8.2.1 All Unauthorised Persons e.g. porters, cleaners, Estates & Facilities staff, university staff and relatives accompanying research participants, and


visitors requiring access to the Controlled Area must gain authorisation from, and be under direct supervision of, an Authorised Person before entry is permitted.

8.2.2 Before entry into the Controlled Area they should complete the MRI Visitor Safety

Screening Form (Appendix B.3) and must place ferromagnetic objects and personal belongings in the lockers provided. For certain members of staff, it may be appropriate to complete the screening form on a monthly basis if repeated, periodic visits are necessary.

8.2.3 All unauthorised persons should not enter the Magnet Room unless requested to

do so and only when accompanied by an Authorised Person.

8.2.4 Members of staff may accompany a research participant into the Magnet Room throughout the period of the examination provided they are subject to the general rules given in Section 3.

8.2.5 Persons fitted with a cardiac pacemaker or any other electronically, magnetically or mechanically operated life saving device, or otherwise contraindicated by the MRI Safety Screening Questionnaire, should not be admitted into any part of the MRI suite.

8.2.6 Staff, including Estates & Facilities staff and other engineers who are not on the Authorised Personnel list but require access to the MRI suite for maintenance purposes, should first notify the MRSO, LRR or CM before commencing any inspection or work.

8.2.7 All University staff requiring access into the Controlled Area will be required to complete the MRI Safety Screening Form (Appendix B.1).

8.2.8 Persons in this category may gain access during normal working hours on admittance by an Authorised Person and subject to the general rules stated in section 3.

8.2.9 Persons in this category wishing to gain access to the Controlled Area outside normal working hours should notify the MRSO. In addition, they should be conversant with the general rules in section 3 and the emergency procedures in section 9.

8.2.10 Cleaning Staff who do not have AP status must be supervised by the MRSO when cleaning the Controlled Area and be subject to the general rules given in section 3. Only clearly labelled CRICBristol MR safe cleaning equipment can be used in the Controlled Area.


9. Emergencies in the MRI suite

9.1. Quenching the Magnet using the emergency stop button

Please see Figure B.2 for the location of the Quench Buttons in the MRI suite.

Please also see Annex B.7 (procedure for safe MRI shut down in an emergency) for further

information.

9.1.1 This action may be required in the event that a ferromagnetic object is brought into the vicinity of the magnet within the Magnet Room. The very strong magnetic field gradients will cause the object to be pulled very rapidly into the magnet with considerable force. Under certain circumstances severe injury may result if persons are struck by such objects.

9.1.2 In the event of needing to ‘ramp down’ the magnet quickly, the Emergency Quench Buttons are located in the Magnet Room and the Control Room.

9.1.3 The Emergency Quench Button should only be activated by an authorised person in circumstances where persons are in immediate danger and the presence of the magnetic field is still endangering the injured person.

9.1.4 When the magnet has been quenched by activating the Emergency Quench Button, cryogenic gases are very rapidly released and vented out of the building. The Magnet takes approximately 30 seconds to collapse to a safe, negligible field.

9.1.5 In addition to a quench being initiated by activating the Emergency Quench Button, there is a potential for a quench to occur spontaneously, however this is uncommon. This spontaneous quench is normally accompanied by a loud bang and sometimes the rapid release of large quantities of cold cryogenic gases into the Magnet Room. The cryogenic helium gas will liquefy oxygen out of the air and asphyxia becomes a threat because the oxygen levels in the Magnet Room may become dangerously low. The presence of the cold gases could cause cold burns, frostbite or hypothermia. It is important to evacuate everybody out of the MRI Controlled Area and particularly out of the Magnet Room as quickly as possible and restrict access to the Magnet Room until the arrival of the scanner service engineers. In the unlikely event that someone is trapped in the Magnet Room and the oxygen level is dangerously low keep the door of the Magnet Room completely open until the trapped person can be rescued.

9.1.6 Do not press the Emergency Quench Button unless the situation is life-threatening – a quench involves several weeks of down-time and is expensive. Persons initiating unnecessary quenches may be liable for these costs.


9.2. Medical emergencies

9.2.1. In the event of a medical emergency, the research participants must be taken out

of the scanner immediately using the un-dockable table and brought into MR Lobby or the anaesthetic preparation room. The standard operating procedure for a medical emergency is described in Annex B.1.

9.2.2. Under no circumstances must the resuscitation trolley or defibrillator be taken into the Magnet Room. Procedures such as defibrillation must be performed in the MR Lobby. Such a procedure must not be performed before the person is removed from the Magnet Room. Resuscitation equipment must never be taken into the Magnet Room.

9.3. Fire

9.3.1. In the event of a fire within CRICBristol, the alarm should be raised and all staff,

research participants and visitors should be evacuated in accordance with the fire and major emergency procedure in section 1.4 of the main section of this quality manual. There are some additional safety procedures required for the MRI suite, the Fire Service has been made aware of the MRI suite and the presence of the magnetic field; this information is held in a central database and available to local fire stations/crews. However, it cannot be guaranteed that in the event of a fire the attending Fire Officers will be aware of the special safety precautions necessary. In the event of a fire or fire alarm, the current scanner operator should await (in a safe location outside the building) the arrival of the Fire Service to ensure safety procedures are followed. In particular, the Fire Officers need to be informed of the dangers of entering the Magnet Room.

9.3.2. If the fire is in the MRI suite, an authorised person should push the electrical

cut off button, the electrical cut off button is found in the control room and the magnet room.

9.3.3. Do not take any fire extinguishers into the Controlled Area unless you are sure

they are MR Safe. The MR safe fire extinguishers are clearly labelled and located in the MR Lobby next to the magnet room door.

9.3.4. These may be used within the Magnet Room. Fire fighting equipment from

outside MRI Controlled area must not be taken into the Magnet Room whilst the magnet is energised.

9.3.5. Only Authorised Personnel who have received appropriate fire training should

attempt to use the MR safe fire extinguishers and only if it is safe to do so.

9.3.6. Smoke detectors are fitted in all rooms of the MRI suite. If a fire occurs outside of normal working hours, the Fire Service should be met by a Designated Person at the Main Entrance to the CRICBristol to provide any necessary keys etc to allow entry to the MRI suite. The Designated Person must not enter the Controlled Area under any circumstances unless an Authorised person is also present to supervise entry and only then, if instructed to do so by the Fire Service.

9.3.7. Members of the Fire Service may only enter the Controlled Area under the

instruction and supervision of a Senior Fire Service Officer who has been instructed in the relevant safety procedures required for access to the Controlled Area.


9.3.8. All the Fire Service’s fire fighting and auxiliary equipment may be used throughout the CRICBristol but NOT in the Magnet Room.

9.3.9. In the event of a fire in the Magnet Room which requires additional fire fighting

equipment and/or the entry of personnel wearing breathing apparatus or carrying metallic objects, the magnet must be ramped down and stopped using the Emergency Magnet Quench Button. See Section 9.1 and Annex B.7.

9.3.10. The Emergency Magnet Quench Button should only be activated in the event of a

severe fire within the Magnet Room.

9.3.11. When the magnet has been quenched using the Emergency Magnet Quench Button, cryogenic gases are released very rapidly and vented out of the building. The Magnet takes approximately 30 seconds to collapse to a safe, negligible field, at which point it is safe to enter with any metallic objects.

9.3.12. During the quenching procedure, small amounts of air may condense around the

pipe-work venting the cryogenic gases. Because of a small risk of explosion from naked flames or sparks during this period, the Magnet Room door should be closed until 30 seconds have elapsed after activating the Emergency Magnet Quench Button.


10. Examination procedures

10.1. Examination procedures for research participants

10.1.1 Imaging of research participants should only be carried out by persons trained in

the safe use of the MRI equipment and who have obtained at least Authorised

Staff User status as set out in Section 4.

10.1.2 Research participants may only undergo an MR examination under protocols

approved by either the appropriate NHS Ethics Committee or the University Ethics

Committee, as required by the pathways in Section 2.1.

10.1.3 Research participants undergoing an MR examination should only enter the MRI

suite after the initial screening form has been completed (see Appendix B.1) and

when instructed to do so by an Authorised Person.

10.1.4 It is the responsibility of the project Principle Investigator to ensure that their

research participant has been able to demonstrate good comprehension and to be

able to express informed consent. Normally, the research participant should sign to

indicate written informed consent. In circumstances where the research participant

is unable to sign but can indicate consent (e.g. verbally), then the form should be

signed by a friend or family member.

10.1.5 It is the responsibility of the project Principle Investigator to ensure that their

research participants who are children (under the age of 16) only undergo an MR

examination once parental consent has been obtained. Parental consent must be

given before the child research participant comes to CRICBristol. The Principle

Investigator must consider the child capable of complying with the rigours of the

scan and that they understand appropriate safety instructions (such as the use of

the alarm-call button). A parent or guardian must accompany the child to the MRI

suite if the child is under 12 years of age. The child and parent/guardian must give

written informed consent for all research investigations. Children can only be

scanned by Authorised Staff User or above.

10.1.6 Any personal effects or ferromagnetic objects belonging to the research participant

should be placed in the lockers provided before the research participant enters the

MRI controlled area. On no account must a person fitted with a cardiac

pacemaker or otherwise contraindicated by the MRI Safety Screening Form be

allowed to enter the Controlled Area.

10.1.7 Research participants should only enter the MRI Suite and Magnet Room when

accompanied by an Authorised Person. The MRI scanner should only be operated

by an Authorised Person with ASU or APU status. There should be at least one

other Authorised Person in the MRI suite with a minimum of level of MR safety

training (i.e. a General User); while the research participant is in the MRI magnet

bore.


10.1.8 For MRI scan operators, who are also University postgraduate students (APU),

there should be at least one other Authorised person Staff User in the MRI suite

while the research participant is in the MRI magnet bore. At least one of the

scanner operators present must be a full, rather than student operator. In general,

and within normal working hours, it is expected that this role will be fulfilled by the

Lead Research Radiographer.

10.1.9 Before proceeding with the study, the operator performing the scan should ensure

that the MRI Safety Screening has been satisfactorily completed and that there are

no contraindications which would prevent the MR examination from continuing.

Guidelines for these contraindications are given in Section 14.6.

10.1.10 Two-way communication between the research participant and the operator should

be possible at all times. In particular, the research participant should be within view

of an operator at all times and the research participant should be able to attract the

attention of the operator at all times using the "panic button" or by some other pre-

arranged visual signal.

10.1.11 The operator should make all efforts to keep within the Specific Absorption Rate

(SAR) limits set by the Health Protection Agency (see Section 14).

10.1.12 The operator should ensure that when the research participant enters the magnet

bore, any cabling associated with monitoring equipment and RF coils are kept well

away from each other and from the research participant and that there are no

loops in any of these cables, which may give rise to burns.

10.1.13 Research participants requiring a wheelchair should be transferred onto the MRI

compatible wheelchair (which is kept in the Lobby) before entering the Controlled

Area. On no account should any other trolley or wheelchair be taken into the

Controlled Area.

10.1.14 The time spent in the magnet bore by any one person must not exceed 90 minutes

in any 24 hour period. Other than this, there is no restriction on the frequency with

which a screened person may be scanned.

10.2. Examination procedures for clinical research participants

10.2.1 The definition of clinical research participants here may include individuals who

are currently in hospital, research participants who have a greater than normal risk

of having a further medical incident (e.g. prior cardiac failure). Such individuals

may only undergo MR examination under protocols approved by the appropriate

NHS Ethics Committee. A research participant protocol for MR examinations is

reproduced in section 17.1 this must be modified to include any additional

precautions and procedures approved by the NHS ethics committee.


10.2.2 MR studies with clinical research participants who have increased risk should only

be carried out when there is a medically trained person available in the MRI suite.

Imaging of clinical research participants should only be carried out by persons

extensively trained and experienced in the safe use of the MRI equipment, i.e.

Radiographer.

10.2.3 Clinical Research participants who are undergoing an MR study should complete a

MRI safety form prior to the examination in the presence of an Authorised Staff

User (see Appendix B.1). The clinical research participant must be able to

demonstrate good comprehension and to be able to express informed consent.

Normally, the research participant should sign to indicate written informed consent.

In circumstances where the research participant is unable to sign but can indicate

consent (e.g., verbally), then the form will be signed by a friend or family member.

10.2.4 Before proceeding with the study, the Authorised Staff User performing the scan

should ensure that the MRI safety form has been satisfactorily completed and that

there are no contraindications for the MR examination to continue (see section 13).

10.2.5 Two-way communication between the clinical research participant and operator

should be possible at all times. In particular, the research participant should be in

view of the operator at all times and the research participant should be able to

attract the attention of the operator at all times using the "alarm-call button" or

some other pre-arranged visual signal.

10.2.6 The scanner operator should make all efforts to keep within the lower SAR limits

set by HPA9, IEC10 and ICNIRP11 (see section 14). The SAR values will be

recorded for each scan.

10.2.7 In the clinical environment, pregnant patients are only scanned in emergency

situations. With this in mind, and realising that research is not done on an

emergency basis, pregnant women cannot undergo an MRI scan at CRICBristol

without full ethical approval.

11. Use of external equipment within the Magnet Room

11.1 Before the use of any peripheral equipment within the Magnet Room, prior documentation must be provided to the Centre Manager and or MRSO to confirm that it is MR compatible/safe at 3Tesla

11.2 The equipment must not enter the Magnet Room until the Centre Manager or MRSO, after consultation with the MR Physicist, Manufacturer or other expert body, has approved its use.

11.3 If the equipment has any likelihood of increasing the risk of harm to research participants, then studies requiring that equipment must gain specific approval from the appropriate Ethics Committee.

9 Health Protection Agency

10 International Electrotechnical Commission

11 International Commission on Non-Ionizing Radiation Protection


12. Description of the MRI suite

The MRI suite within CRICBristol contains the MR system which is a 3Tesla Magnetom Skyra system from Siemens Medical Solutions of Erlangen, Germany. The Magnet Room completely encloses the 5 Gauss (0.5 mT) line produced by the MRI scanner. The Controlled Area is further classified as being the “Magnet Room”, the “Control Room and the “Equipment Room”. The Magnet Room contains the strongest magnetic fields and hence is the most hazardous area of the MRI suite. The restrictions governing who may enter the Magnet Room and under what circumstances, are therefore more stringent than those for the Control Room. Within the Controlled Area, at certain points, the field strength is greater than the general safety limit of 5 gauss (0.5mT). Members of the public and staff should be excluded from the Controlled Area unless accompanied and supervised by an authorised member of staff after carrying out MRI safety screening. Clear visible warning signs are displayed at the entrance to the MRI suite with the following wording, “Warning, Strong Magnetic Fields; Restricted Area; No Unauthorised Entrance; Persons Fitted with Heart Pace-Maker Must Not Enter.”

Figure B.2: Plan of the MRI suite


13. Procedure for administration of screening forms

13.1. General

All participants must complete both the initial and second screening forms before entering the Controlled Area. In cases where the research participant cannot complete the screening form or cannot understand the questions, a member of staff should go through the questions with the research participant and with an interpreter if necessary.

Completion of the screening forms must be supervised by an Authorised Person who must be satisfied that the participant has read the questions carefully and understands their importance.

The first screening may take place at another site before the participant travels to the MRI suite. This is designed to exclude people who may be at risk from being sent for a scan.

The second screening form must be countersigned by an Authorised Person before the person enters the Controlled Area. The form should only be signed if all questions have been answered satisfactorily (see below). This is designed to exclude people who may be at risk from entering the controlled area.

If the person satisfactorily answers all questions on both screening forms and the Authorised Person is satisfied that the person has given the questions due consideration, the person may be permitted to enter the Controlled Area.

Completed screening forms are filed in the relevant study folder in the MRI control room.

13.2. Initial screening form procedure

See appendix B.1

If a person answers ‘yes’ to any of the questions this should be discussed with the MRSO before the participant arrives for the scan.

Persons with a cardiac pacemaker cannot be scanned and must not enter the MRI controlled area.

If a person answers ‘yes’ to any question referring to metal in the body this should be discussed with the MRSO before the participant arrives at CRIC. The participant must not be allowed into the controlled area until the implants have been checked for MRI safety and cleared by the MRSO.

Pregnant participants must not be scanned at CRIC unless they are part of an ethically approved project to scan the foetus.

Participants with removable implants such as hearing aids, dentures, prosthesis, or skin patches should remove these items before entering the controlled area.

If a person answers ‘yes’ to question 9, they may enter the Controlled Area, but can only be scanned if they state that the tattoo was a standard one (not containing any metallic inks) performed in the UK. If scanning proceeds they must be told to press the alarm-call button if any heating or discomfort is detected at the tattoo site. Should this occur, scanning should be stopped and a cold compress placed over the tattoo. The person must consent to the procedure and be aware of the risks.

If there is any doubt as to whether it is safe to proceed, the participant must not be allowed to enter the Controlled Area.


Note: if someone is prevented from being scanned because of an answer on their screening forms, the person supervising the screening should explain the situation clearly, making clear that there is no cause for alarm, and cancel any MRI examination that has been arranged. They should also point out that rejection as a research participant does not necessarily mean that a future MRI scan for medical purposes would be unsafe and that they should be guided by the medical personnel concerned if such a need should arise.

13.3. Second screening form procedure

See appendix B.2

A. If the participant answers ‘yes’ to question 1 then he/she should be asked to remove

the item(s) in question, if that is practical, and then amend the answer and initial the change, or complete a fresh second screening form.

B. If the participant answers ‘yes’ to question 2, the initial screening form must be completed afresh and any affirmative answers acted upon in accordance with the rules above.

C. If the participant answers 'yes' to question 3, they must not be allowed into the Controlled Area.

D. A person answering ‘yes’ to question 4 they must not be scanned, unless part of an ethically approved study.

13.4. Implants and devices

All of the implants and devices should be checked as defined below:

1. Clarification of make and model from the research participant notes.

2. Use the manufacturer’s website.

3. Also cross-reference with Shellock website (information resource for magnetic resonance safety):

mrisafety.com

Go to “THE LIST” (left hand side, blue box)

“CLICK HERE to search the list”

Put name of the device in “Object Name”

Under “Result Status” enter “All”

Enter “Manufacturer Name” if known

Click the device in question in the “Object Category”

“search the database”

“The LIST” will then search the database for the implantable devices and will state if safe or unsafe and also give reference information

http://www.mrisafety.com/


13.5. Visitor screening form procedure

See appendix B.3

For people wishing to access the control room but not the MRI room, such as observers, a

visitor screening form should be completed and filed in the visitor screening folder in the MRI

control room. These visitors must be supervised at all times and are not allowed entry into the

MRI scan room.


Appendix B.1: Initial screening form

MAGNETIC RESONANCE IMAGING INITIAL SCREENING FORM

NAME OF PARTICIPANT.............................................................................. Sex: M / F

Date of birth……………………… Weight ………............ Height .……………

Please read the questions on this screening form CAREFULLY. Your safety in the magnetic environment is our primary

concern. THIS IS VERY IMPORTANT. For a very small number of individuals, being scanned can be uncomfortable, or

endanger health or even life. The purpose of these questions is to make sure that you are not such a person. The

information you provide will be treated as strictly confidential and will be held in secure conditions. If you are unsure of

the answer to any of the questions, please ASK the person who gave you this form or the person who will be performing

the scan.

I wish to be screened by the same gender YES/NO*

Please answer all questions Circle answer

1. Have you been fitted with a pacemaker, artificial heart valve, cochlear implant or any other implanted device?

YES/NO

2. Have you any surgical clips, aneurysm clips, shunts or stents in your body? YES/NO

3. Have you any surgically implanted metal in any part of your body (e.g. joint replacement ) YES/NO

4. Have you ever had any metal fragments in your eyes? YES/NO

5. Have you ever had any metal fragments, eg shrapnel, in any other part of your body? YES/NO

6. Have you ever had any surgery that might have involved metal implants of which you are not aware? YES/NO

7. Do you have any dental work (including dentures, crowns, bridgework, braces) in your mouth, other than simple fillings?

YES/NO

8. Have you ever suffered from any of: Heart disease, epilepsy, diabetes or thermoregulatory problems? YES/NO

9. Do you have any tattoos? Do you have any permanent eye makeup? YES/NO

10. Are you wearing any skin patches? (eg. Nicotine ) YES/NO

11. Do you wear a hearing aid? YES/NO

For female participants only

12. Is there any possibility that you might be pregnant? YES/NO

13. Do you have a contraceptive coil (IUD) installed? YES/NO

14. Are you breast feeding? YES/NO

I have read and understood the questions above and have answered them correctly. SIGNED………………………………....................................... DATE………………………… In the presence of ………………………………….. (Name) ………………………………….. (Signature)


Definitions of Technical Terms

PACEMAKER: An electronic device that is surgically implanted in the research participant's body and connected to the heart to regulate the heartbeat. The safe operation of a pacemaker can be temporarily or permanently disrupted if a research participant goes near an MRI scanner.

COCHLEAR IMPLANT: An electronic medical device that bypasses damaged structures in the inner ear and directly stimulates the auditory nerve, allowing some deaf individuals to learn to hear and interpret sounds and speech.

ANEURYSM CLIP: A surgically implanted metal clip used to cut off blood flow through the neck of an aneurysm. An aneurysm is a deformity of a blood vessel in the body, which can swell and burst causing a haemorrhage.

SHUNT: A surgically implanted connector, which allows passage of fluid between two parts of the body. A common use of a shunt is to allow fluid to drain away from the brain, thus reducing pressure in the brain. May also describe a tube which allows blood to be moved from one part of the body to another.

STENT: A surgical implanted device that is inserted into a blood vessel to provide support, keep the vessel open and promote unblocked and enhanced blood flow. Sometimes used in other fluid carrying vessels in the body such as bile ducts etc.

THERMOREGULATORY PROBLEMS: Thermoregulation is the body’s in-built ability to keep all parts of your body at their correct temperature. Some illnesses prevent the person from properly controlling the temperature of their body. If you think you may have such an illness, please answer “YES” and discuss it with the person who gave you the form, or the person who is in charge of the scan


Appendix B.2: Second screening form

MAGNETIC RESONANCE IMAGING SECOND SCREENING FORM

This form should be completed and signed immediately before your scan.

NAME OF PARTICIPANT ………………………………..................... Date of birth………………………………. Sex: M / F

Please read the following questions CAREFULLY and provide answers. For a very small number of individuals, being scanned can endanger comfort, health or even life. The purpose of these questions is to make sure that you are not such a person.

You have the right to withdraw from the screening and subsequent scanning if you find the questions unacceptably intrusive. The information you provide will be treated as strictly confidential and will held in secure conditions.

Before you are taken through for your scan it is essential that you remove all metal objects including: Watches, Pens, Loose Change, Keys, Hair clips, All Jewellery, clothing with metal fasteners, metallic cosmetics, Cash/debit cards.

Remove any metal dentures, hearing aids and medical patches.

Please answer all questions Circle your answer

1. Are you wearing or carrying any metal items such as those listed above? YES/NO

2. Have your answers to any of the questions in the initial screening form changed? (The initial screening form must be shown to you before you answer this question.)

YES/NO

3. Have you been fitted with a pacemaker, artificial heart valve, cochlear implant or any other implanted device?

YES/NO

4. Is there any possibility that you might be pregnant?

YES/NO

I have read and understood the questions above and have answered them correctly.

SIGNATURE………………………………….............................. DATE…………………………

FOR STAFF USE: CRICBristol UNIQUE IDENTIFIER: I certify that the initial screening form and the consent form have been completed by the person named above and I have attached them to this form. The volunteer has been given the standard information sheet about MRI scans, together with any necessary scan-specific information, and has been given an opportunity to ask questions. I am satisfied that the volunteer is adequately informed and understands the content of the consent form. I have taken adequate steps to ensure that the volunteer has no ferro-magnetic metal in or on his/her person and I am satisfied that the scan can proceed.

SIGNATURE………………………………...................................... NAME (print) …………………………………..


Appendix B.3: Visitor screening form

MAGNETIC RESONANCE IMAGING VISITOR SCREENING FORM

FOR ACCESS TO THE OUTER CONTROLLED AREA ONLY. NO ACCESS TO MAGNET ROOM

NAME OF VISITOR: …………………………………………………

Please read the following questions CAREFULLY and provide answers. For a very small number of individuals, entering rooms in close proximity to an MRI can endanger comfort, health or even life. The purpose of these questions is to make sure that you are not such a person. The information you provide will be treated as strictly confidential and will be held in secure conditions. If you are unsure of the answer to any of the questions, please ASK the person who gave you this form. The person signing the form at the bottom will tell you whether you may enter the MRI suite. This can only be under the supervision of the person who signs at the bottom of this form.

Under no circumstance must you enter the magnet room itself.

I have read and understood the question above and have answered them correctly.

SIGNED………………………………… DATE…………………………

Please do not write below this line

The above person is cleared to enter the Outer Controlled area of the CRICBristol MRI Suite CRICBristol AUTHORISED PERSON:..........................................................

SIGNED .............................................................DATE: ....................................................

Please answer the following question Circle/Bold your answer

Have you been fitted with ANY of the following:

Pacemaker

Hearing Aid

Artificial heart valve

Implanted Cardiac Defibrillator

Neurostimulator

Any type of bio-stimulator

Implanted insulin pump

Cochlear implant

Any other electrical, magnetic or mechanical implanted device?

YES/NO

YES/NO

YES/NO

YES/NO

YES/NO

YES/NO

YES/NO

YES/NO

YES/NO


14. General MRI safety precautions, procedures and incident reporting

Note: Participants/patients have died or lost their sight because they were not adequately screened.

Continued vigilance is needed to prevent harm to research participants or volunteers from bringing them inappropriately into the strong magnetic field, or by using scanning equipment carelessly. Accidents involving the missile effect of ferromagnetic objects in a magnetic field, and burns due to RF heat deposition still happen because of careless practice.

All accidents and adverse incidents (including near misses) should be reported to the Centre Manger and/or MRSO (or, in their absence, the Directors) as soon as possible. They will investigate the seriousness of the incident and may wish to decide immediate actions. All accidents and incidents must be logged and reported using the University standard form; copies can be found in the incident reporting folder in the MRI Control Room. Guidelines on completing the form and a flow diagram, can be obtained from the UoB Safety Office webpage at http://www.bristol.ac.uk/safety/guidance/#accident-reporting

ALL faults must be (i) reported to the LRR or Centre Manager (see emergency Contacts) at the earliest opportunity; and (ii) documented in the Faults Book, which is kept in the Control Room.

If faults occur that prevent normal safe operation of the equipment, it must be taken out of service until repaired and passed fit for use by a competent person. Any work that is required to be undertaken in the MRI suite Controlled Areas, by Estates & Facilities staff or external contractors such as Siemens, must be documented.

Should the use of equipment produce an accident, near miss or hazardous situation, operation must cease immediately until the cause is investigated and the hazard is removed.

To minimise inconvenience, faults should also be reported to all other Authorised Persons who may be intending to use the equipment in the following 48 hours.

In the event of a fault that prevents normal safe operation, the following must be observed:

The room must be signed out of use.

A ‘do not use’ sign must be fixed to the equipment.

The equipment must be signed over to the Siemens engineer and then signed back by the engineer once repaired and tested. Only then may it be signed back into use for scanning.

All accidents and other unforeseen incidents in the MRI suite must be reported. This includes, but is not restricted to:

A. Harm to the participant being scanned.

B. Projectile incidents (including minor ones such as coins).

C. Damage to equipment (which must be reported to the LRR or CM. Their details are listed on the technical contacts list (see section 16). This list is also displayed in the MRI Control Room).

D. Any accident in the MRI suite – to staff or visitors.

E. Any problems with temperature/humidity and services such as electricity and water.

http://www.bristol.ac.uk/safety/guidance/#accident-reporting


F. Any technical problems with the scanner, such as a failure to scan.

Any incident/accident/near miss regarded as having an impact on UHBristol requires notification to the health and safety department at UHBristol, using the UoB incident/accident/near miss reporting form, for their information and further investigation if deemed necessary.

Areas of potential safety concern are briefly reviewed below:

During an MRI examination, individuals being scanned and those in the immediate vicinity of the equipment will be exposed to a static magnetic field, a relatively low frequency time varying magnetic field and a radio-frequency (RF) field. Safety issues including biological effects, projectile hazards, compatibility of implanted devices, compatibility of ancillary equipment, peripheral nerve stimulation, muscle stimulation, acoustic noise, thermal heating, heat stress, current burns and contact burns must be taken into consideration before each MRI examination.

Potential safety risks occur if the MRI scanner is functioning incorrectly or has been modified in some way so as to render it unsafe. Installation of the scanner must be performed exclusively by the manufacturer and their contractors. As part of the installation process, the manufacturer will ensure that the scanner is operating within its standard parameters, which meet all regulatory requirements and limits. Once the scanner is operational, the medical physics department should be called to check the scanner and confirm the quality assurance and safety is satisfactory. In addition, regular site visits by the manufacturer service engineers will ensure that the scanner is operating within normal parameters. No modification of any hardware or software in the MRI suite is permitted unless clear instructions are given by the manufacturer’s service engineers or the manufacturer’s clinical support scientists.

14.1. Static magnetic field

To date, no long-term harmful biological effects on human tissues have been demonstrated from the static magnetic fields used in clinical MRI at 3T. However, because of the risk of life-threatening malfunction of implanted devices with electronic components, all persons entering the vicinity of the MRI scanner must be screened. For example, there is a risk of malfunction of cardiac pacemakers at field strengths as low as 0.5mT.

With a shielded 3T system there are extremely steep fringe field gradients. Therefore a very high level of vigilance must be maintained to prevent anything being taken into the Magnet Room that might result in a projectile incident. Particular attention should be paid to the training of Authorised Personnel, as outlined in the MHRA guidelines.

The MHRA guidelines highlight that implantable medical devices, monitoring equipment, leads, etc should be checked for MR compatibility at 3T before use.

The 3T superconducting magnet is Permanently Activated even when the scanner is not being used for an examination. Hence, there is a need for caution and the potential hazards are summarised below:

The static field can interfere with cardiac pacemakers and other electrically, mechanically or magnetically active devices. Any person with a cardiac pacemaker or any other electrically, mechanically or magnetically active device must not be allowed entry into the MRI Controlled Area.

Embedded metal fragments, aneurysm clips or other implanted medical devices can move (be displaced) due to an attractive and/or torque force. This can cause injury to


the research participant and/or damage to the implanted device. If an individual is identified as having a possibility of metallic fragments in the orbits they cannot be scanned unless proven otherwise

Mechanical attraction of metallic, in particular ferromagnetic objects (e.g. scissors, pins, fire extinguishers etc) can become projectiles when accelerating towards the magnet and may hit the body of a person or the gantry of the scanner. This can cause fatal or serious injury to the person and serious damage to the scanner.

The static magnetic field has no known biological effect on humans. As far as is known, the static fields associated with MRI pose no risks to operating staff, so long as the appropriate screening and safety procedures are followed. However, National Radiological Protection Board12 (NRPB) guidelines state, as a precaution, that occupational static field exposure, averaged over an 8 hour period, should not exceed 0.2T to the whole body.

It is prudent to avoid unnecessary or excessive exposure to the static field, particularly in the case of pregnancy. To date, there has not been any study showing evidence of direct harm from the static fields associated with MRI to the mother or foetus during pregnancy. However, the consensus in the MR community is that pregnant women should only be scanned when there is a clear clinical benefit to either the mother or foetus. Pregnant staff can be allowed to work within the Controlled Area. However, pregnant women should not be in the Magnet Room during scanning.

Monitoring equipment that has ferromagnetic components can be affected by the static magnetic field and only devices that have been tested and demonstrated as being MR Conditional in the specified MR environment with specified conditions of use should be allowed entry into the Magnet Room.

The static field can cause damage to personal possessions such as analogue watches and credit cards. All possessions which may either be damaged by the MRI system, or more importantly, may pose a projectile risk, must be secured in lockers external to the Controlled Area before the research participant is admitted entry to the Controlled Area.

Movement in the static magnetic field may cause some research participants acute vertigo-like sensations. This should be reduced by avoiding rapid movement in the Magnet Room. The sensitivity to movement induced sensations in the static field can vary between individuals. Research participants should be moved into and out of the bore of the magnet slowly as possible to avoid movement induced sensory effects.

14.2. Time-varying fields

Time varying fields (from switching of the gradient magnetic fields)

Rapidly switching magnetic field gradients are used to encode spatial position in the image. The hazards associated are summarised below:

The relatively low frequency (compared to RF fields) time-varying magnetic fields used for spatial encoding can potentially induce electric currents that could be sufficiently large in human tissues to interfere with the normal function of nerve cells and muscle fibres. Some research participants are particularly sensitive to peripheral nerve stimulation (PNS) caused by certain MRI pulse sequences, which employ particularly rapid gradient switching. Usually, if PNS occurs it manifests as an uncomfortable

12

http://www.hpa.org.uk/Publications/Radiation/NPRBArchive/

http://www.hpa.org.uk/Publications/Radiation/NPRBArchive/


tingling sensation, particularly in the extremities. In more serious, but extreme cases, the high rates of gradient field switching could lead to ventricular fibrillation. In scanners operating within IEC13 limits, ventricular fibrillation is prevented by restricting exposure to rates of change of magnetic flux density and the scanner is unable to switch gradients at levels higher than maximums set by regulatory bodies. The thresholds for PNS are much lower than for ventricular fibrillation, hence, while scanning particular care should be taken to ensure the feeling of uncomfortable or painful sensations caused by the induced current densities is minimised. An intercom and alarm-call system must be used so that the participant can report any uncomfortable peripheral sensations and stop the scan if necessary.

Heating can also occur in the vicinity of some implanted metal devices or objects, due to the induced electrical currents. The risk of injury caused by heating can be reduced by careful screening of research participants and by ensuring that they do not form any current loops with their bodies, i.e. no hand clasping or feet crossing.

All Research participants must be given an Alarm-Call Device, which when pressed will sound an alarm and scanning must be stopped immediately. Research participants should be instructed to activate this alarm if any discomfort is felt. This means that only communicative and aware research participants who are able to understand these instructions should be scanned, unless there is in place additional MR conditional equipment for monitoring the research participant’s physiology (heart rate, temperature etc) during scanning.

14.3. Radio-frequency (RF) fields

MRI involves the use of Radio-Frequency (RF) energy, which is applied to the body. RF fields are used to excite hydrogen nuclei in the body, in order to generate the MRI signal, which is detected and digitally recorded. The RF signals are applied and detected using coils placed in close proximity to the body-part being scanned. The potential hazards associated with the RF fields used in MRI are summarised below:

Absorption of energy from the RF fields results in the increased oscillation of molecules and the generation of heat. This is compensated by dilatation of blood vessels which results in an increase in blood flow. The main concern is excessive cardiovascular strain resulting from thermoregulatory responses to body temperatures raised over a short period of time by more than 0.5oC. Research participants suffering from hypertension, pregnant women, the elderly and the very young, or research participants on drugs such as diuretics or vaso-dilators are of concern. Research participants exposed to short periods of RF at Specific energy Absorption Rate (SAR) of 1W/kg to 4W/kg will experience a tolerable heat load and rise in temperature of less than 1oC. The less heat tolerant group should be restricted to less than 0.5oC.

The RF pulses, if used improperly and indiscriminately, could cause extensive localised heating (and even tissue damage in extreme cases). The SAR is a term used to estimate the amount of RF dose received by the research participant, and is expressed as watts of power per kilogram of the research participant's body weight. SAR limits have been set for specific areas of the body (e.g. the head) and must not be exceeded. The scanner will limit the SAR so that RF deposition is within guidelines set by regulatory bodies (such as the IEC). For the SAR to be correctly calculated by the scanner software, it is critical to enter the research participant's correct height and weight and date of birth. Failure to do so may result in incorrect SAR limits being calculated, which may result in research participant heating or burns. The actual SAR

13

International Electrotechnical Commission


applied to the body is dependent on temperature and humidity within the magnet bore. Scanning must not proceed if these are outside the manufacturer’s operating limits; hence routine maintenance of the cooling systems and air conditioning in the Magnet Room and around the MRI system is important.

Currents can be induced in metallic leads and electrodes (such as ECG leads) potentially causing burns in adjacent tissues. Electrical conducting elements, such as wires, must never be looped across the participant’s body or contact the participant’s skin. In addition, the research participant’s skin should never be allowed to touch either the sides of the RF coil, or the bore of the scanner. If necessary, padding (supplied by the manufacturer) should be used to prevent this.

Heating can occur from induced currents when a conductive loop is formed within the research participant’s body, e.g. by skin contact between the research participant’s thighs and feet, or arms. Care should also be taken to insulate the research participant from any metal (e.g. jewellery) that cannot be removed and to avoid the formation of potential conductive loops.

Certain types of cosmetic makeup contain metallic compounds; being most prevalent in eye makeup. These can potentially cause heating during scanning leading to discomfort or injury through burning. In addition, metallic makeup may significantly degrade the MR image quality. Research participants should be asked to remove all makeup which is metallic in nature, and in particular should be asked to remove all eye makeup.

It has been known, in rare cases, for tattoos to contain metallic inks. Again, these can show potentially damaging heating effects during scanning. If research participants have tattoos and the presence of metallic inks is definitely confirmed then scanning should not proceed. If the tattoo is thought to be non-metallic, then the research participant can be scanned, but must be advised to press the alarm-call button if heating is felt in the region of the tattoo.

14.4. Liquefied helium

The liquefied helium used by the superconducting magnet also poses potential hazards, which are summarised below:

The equipment on top of the magnet, and pipes leading from it, can be extremely cold. Touching these surfaces can result in severe cold burns.

Sudden collapse of the magnetic field (‘quenching’) can occur without warning, causing immediate and violent boil off of very cold Helium gas. Asphyxiation of persons within the Magnet Room could occur during ‘a quench’, if the ventilation system fails to operate properly.

A quench might occur, either because it has been activated by the scanner operator during an emergency, or on a rare occasion it might occur spontaneously. A quench is generally accompanied by a loud bang and, sometimes, the release of large quantities of cold gas into the Magnet Room. The cryogenic helium gas will liquefy oxygen out of the air; hence, both asphyxia and fire are real threats.

During a quench, the oxygen levels in the Magnet Room may become dangerously low. The presence of the cold gases could cause cold burn, frostbite or hypothermia. It is important to evacuate everybody out of the Controlled Area and particularly out of the Magnet Room as quickly as possible and restrict access to the Magnet Room until the arrival of the scanner service engineers. In the unlikely event that someone is


trapped in the Magnet Room and the oxygen level is dangerously low, keep the door of the Magnet Room fully open until the trapped person can be rescued. There is a risk of fire starting if there are naked flames or sparks in the Controlled Area.

In some emergency cases, the MRI operator may deliberately quench the system. Although most of the helium gas should be vented through the purpose built pipe, there is a risk that cold helium gas will remain in the Magnet Room. This can cause cold-related injuries and potentially cause asphyxiation as the helium displaces oxygen within the Magnet Room. Oxygen monitoring systems are installed and maintained to warn of any dangerous reduction of oxygen within the Magnet Room.

To minimise a large positive pressure in the Magnet Room due to Helium leakage it is recommended that the gas escape vents are annually checked by Estates & Facilities and any blockage removed.

14.5. Acoustic noise

During scanning, rapid gradient switching in MRI systems, results in high levels of noise being produced. It is essential, therefore, for all individuals to wear hearing protection while in the Magnet Room during scanning. Hearing protection must be provided to all staff, research participants and accompanying relatives within the Magnet Room while the scanner is operational. This will consist of magnet-compatible ear defenders (headphones) and/or disposable ear canal inserts.

The Control of Noise at Work Regulations 200514 stipulates that personnel exposed to acoustic noise above 80dB should be offered hearing protection.

14.6. Contraindications

The following people must not be scanned:

Individuals fitted with cardiac pacemakers, cochlear implants, neurostimulators or any other device that is electrically, mechanically or magnetically activated.

Individuals with metallic intra-ocular foreign bodies or individuals with ferromagnetic non-MR compatible aneurysm clips.

Individuals who have had a penetrating injury to the eye involving metal even if it is confirmed to have been removed (as advised by the safety web site, mrisafety.com)

Individuals who have a prosthetic cardiac valve.

Advice must be sought from either the MRSO before scanning the following Categories of Subject:

Participants within 6 weeks of surgery where haemostatic clips have been inserted.

Participants with metallic implants (refer to Shellock15 for compatibility of device).

Participants with a low tolerance to temperature change (these subjects must be monitored

during the scan using the pulse oximeter).

14

http://www.hse.gov.uk/noise/regulations.htm 15



http://www.hse.gov.uk/noise/regulations.htm



15. Emergency contacts

15.1. MRI scanner emergency contact cascade

In the event of a serious emergency or fault occurring with the scanner one of the following people should be contacted. Contact should be attempted from the top of the list downwards.

1. Lead Research Radiographer MRSO (MRI Assessor) Work Tel 0117 3421501

2. Centre Manager (MRI Assessor) Work Tel: 0117 3421501

3. CRICBristol Medical Physics Support (phantoms only MRI assessor) Work Tel: 0117 3421512

Note that in the event of a medical emergency involving someone in the MRI suite follow the arrest procedure in Annex B.1.

Ambulance

An ambulance is called directly on 999 and security informed.

Security

Internal extension number within UHBristol x2222 (Emergency); x2995 (Non-Emergency

15.2. Incident specific list of emergency contacts

Type of Incident Name of Contact Telephone Number

Fire MRSO/Centre Manager 0117 34 21501

Quench MRSO /Centre Manager 0117 34 21501

First Aid MRSO 0117 34 21501

Cardiac Arrest St Michael’s Hospital Resuscitation team

x2222

Broken Scanner MRSO 0117 34 21501

Broken Equipment MRSO 0117 34 21501


16. Technical contacts

In event of a technical fault a member of the MRI Support Group should be contacted and the error message from the MRI scanner should be logged.

16.1. MRI support group

Lead Research Radiographer/ MRSO Work Tel: 0117 34 21501 Centre Manager Work Tel: 0117 34 21501 The MRI support group will contact Siemens to report the fault

Siemens UPTIME services

Tel 0845 3002476, quoting system serial number 006-MR00025660

16.2. Estates & facilities

In case of problems with MRI environment (temp/humidity) and/or services such as water and electricity please report the issue to a CRICBristol member of staff, so they can contact Estates using the online reporting tool. If the issue is serious and requires immediate attention a member of CRICBristol staff can also contact Estates & Facilities on x24444.

Note: this is during normal working hours, out of hours, contact MRI Support Group.

16.3. CRICBristol internal numbers MRI Control Room x21519 Lead Research Radiographer/MRSO x21501 Centre Manager’s Office x21501 CRICBristol reception x21500


17. Training protocol for MR examinations

Healthy volunteers may only be accepted for a MR examination under protocols approved by the University or NHS Ethics Committee.

All volunteers should be assessed for contraindication against having the examination.

The purpose and nature of the examination should be explained to the volunteers.

The volunteers must have had the opportunity to ask questions.

The volunteers will be free to withdraw consent at any time.

Records of each volunteer and their examination will be kept in accordance with the Department of Health guidelines for magnetic resonance diagnostic equipment in clinical use.

17.1. Screening and scanning procedure for research participants

17.1.1. At recruitment

Before being recruited to take part in a study, the potential participant should undergo a preliminary screening for absolute contraindications to MRI scanning, i.e. cardiac pacemaker, aneurysm clip, metallic implants etc.

17.1.2. In CRICBristol

For safety and privacy during screening the participant must complete the screening form in the CRICBristol MRI preparation area or reception meeting room.

The researcher should be available to answer questions whilst the Participant completes the screening form.

If the Researcher is unclear about the safety implications of the Participant’s response to the screening form, the Scanner Operator or MRSO should be consulted.

Explain the purpose of the study and provide the participant information of what to expect during the scanning process (noises, tasks etc).

Do not take the participant into the MRI suite until the Scanner Operator is ready. The participant should remain in the MR preparation Area. Give the completed screening form to the Scanner Operator. Highlight any potential risks from the screening form and from discussions with the participant.

Before entering the MRI suite, ensure that the participant’s pockets are empty. Remove hair clips, watches, jewellery, glasses, piercing etc. Leave items in the lockers. The experimenter should take the locker key and keep it safe outside of the magnet room.


Do not leave the participant unattended within the MRI suite. This is the responsibility of the experimenter, not the Scanner Operator.

Do not take the participant into the MRI suite if they have a pacemaker, aneurysm clip or metallic implants. Take the participant back into the reception area after completing the screening procedure and explain to them why it may not be safe for them to undergo a MRI.

17.1.3. In the MRI suite:

The participant should not enter the MRI suite until the Scanner Operator is ready

Do not leave the participant unattended within the MRI suite.

The Scanner Operator will go through the screening form with the participant.

The final decision as to whether the participant may undergo MRI scanning rests with the Scanner Operator.

If the Scanner Operator is in doubt about the safety of scanning a participant the Participant should not enter the Magnet Room.

Responsibility for ensuring that stimulus presentation equipment is working and set up properly rests with the Researcher.

The Scanner Operator will decide when the scanning session is finished. This is based on the time allocated to the study and is independent of whether the study has been completed. It is up to the Researcher to book enough time to complete the study.

After scanning, the participant should be taken back to the reception area and not remain within the MRI suite longer than is necessary.


18. Guidelines for clinical research scans with a diagnostic component

These guidelines have been written to ensure the correct operating procedures for scanning

research participants at CRICBristol, when part of the scan is to be used in clinical diagnosis.

They have been written with reference to the Medical Research Council Guidelines for Good

Clinical Practice in Clinical Trials (1998)16.

A. Clinical trials will all have the correct ethics approval and risk assessment.

B. The rights, safety and well being of the participant (also now known as the patient) is

the most important consideration.

C. The medical care given and decisions made will be of the highest possible standard.

D. Although the diagnostic scan is performed at CRICBristol MRI scanner, the Hospital

will continue to have a duty of care to the patient.

E. A suitably qualified radiologist will protocol and report the diagnostic component of the

trial.

F. The scans will be acquired by a state registered radiographer.

G. A suitably qualified nurse will be present for patients under 16 years of age.

16

http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002416

http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002416


Annexes to Section B of this Quality Manual

Annex B.1: Procedure for cardio-respiratory arrest / medical emergency in MRI scanner

MRI SCANNER

STANDARD OPERATING PROCEDURE

for the management of CARDIO-RESPIRATORY ARREST (or other medical emergency)

There will always be two people present in the MRI suite during scanning.

In the event of a cardio-respiratory arrest (or other medical emergency):

Person 1 Person 2

1 Undock the table Dial 2222 to call the

Resuscitation Team

2 Wheel the patient out of the Magnet

Room

Clearly state which team you

need, i.e. adult, paediatric or

neonatal

3 Commence Basic Life Support

immediately

State that access to CRICBristol

is via the corridor on Level B, St

Michael’s Hospital

4 Lock the Magnet Room door

5 Take the resuscitation trolley to

the scene

6 Wait at entry to CRICBristol on

the Level B corridor to direct the

Resuscitation Team

7 Assist with resuscitation as appropriate Assist with resuscitation as

appropriate

Following the resuscitation, the leader of the resuscitation team will be

responsible for the post-resuscitation care & safe transport of the patient.

Annex B.2: MRI scanning outside core hours policy


Introduction

The purpose of this document is to ensure appropriate operator and security cover can be

provided outside of the normal working hours of 9am to 5pm. The MRI scanner must not be

operated out of hours by lone workers unless prior approval has been given by the Directors

and this will only be granted for the scanning of non living objects.

Procedure for researchers to follow to book out of hours scans

1. Request scan via the usual booking policy giving at least two weeks notice if the project

would require radiographer or other scanner operator. Availability of the room and staff will be

checked and the researcher will be informed if the chosen date is possible.

2. There must always be two authorised users during scanning. The researcher must therefore

ensure that one authorised user associated with that particular project is available for that day

and time. If there is no authorised user it may be possible to use a bank radiographer at an

additional charge.

3. On the scan date the researcher and participant will gain access through the front door once

the scanner operator is present.

Procedure for CRICBristol staff to follow:

1. Check that a scanner operator is available before confirming the booking.

2. Inform UHBristol security that scanning will be taking place by emailing Paul Wood

([email protected]) Head of UHBristol Security, and Martin Reid

([email protected]) with the date, time (hours), and names of those who will be

present. They will then inform the operations team.

3. When the study is completed ensure that everyone has exited the building before setting the

security alarm system by following procedure in section 1.2.2 of the CRICBristol Quality

Manual accordingly.

Procedure for Scanner operator to follow on the day of the scan

1. Arrive at least 30 minutes before the scan time in order to switch on and receive participant

and researcher.

2. Ensure that everyone signs in and out of the building in the log book at reception.




Annex B.3: Authorised MRI scanner operators declaration

MRI Authorised Scanner Operators Training Declaration

Name.............................................................. Job Title:……………………..

Training activity Date

completed

Certificate in

personnel file

Signed to

confirm

training

undertaken

Signature

date

Siemens MRI safety

video

CRICBristol Quality

Manual

MRHA guidelines for

Magnetic Resonance

Equipment in Clinical Use

2007

UHBristol Fire Safety

training

(provided/arranged in-

house)

UHBristol Basic Life

Support training

The above named has taken and passed the MRI safety Exam and has been signed off for

Level .............................MR Authorised Person

Signed ............................................................... MRSO or Centre Manager

Date.............................................


Annex B.4: Templates for MR studies (x3)

Template 1: MRI information form for research participants – fMRI

Functional Magnetic Resonance Imaging (fMRI) Information Sheet

Project title: ___________________________________

Functional Magnetic Resonance Imaging Volunteer Information Sheet

These notes give some information about an MRI scan in which you are invited to take part.

Functional MRI (fMRI) is a method for producing images of the brain. It involves placing the

volunteer inside a large, powerful magnet which forms part of the brain scanner. In addition,

MRI can be used to determine which parts of the brain are active during different tasks – this is

known as functional MRI or fMRI. When particular regions of the brain are active, they require

more oxygen, which comes from red corpuscles in the blood. As a result, the flow of blood

increases. This can be detected as changes in the detected MR signals. These changes can

then be converted by a computer into 3D images. This enables us to locate which parts of the

brain are active during different tasks. As far as we know, this procedure poses no direct

health risks. However, the Department of Health advises that certain people should NOT be

scanned.

Because the scanner magnet is very powerful, it can interfere with heart pacemakers and clips

or other metal items which have been implanted into the body by a surgeon, or with body

piercing items. If you have had surgery which may have involved the use of metal items you

should NOT take part. If you are pregnant or think you might be pregnant you should NOT

take part.

You will be asked to complete a form (the Initial Screening Form) which asks about these and

other matters to determine whether it is safe for you to be scanned. You have the right to

withdraw from the screening and subsequent scanning if you find the questions unacceptably

intrusive (you can also request the screening to be carried out by someone of your

gender). You will also be asked to complete a second, shorter, screening form immediately

before the scan (the Second Screening Form).

Note that only ferromagnetic materials (e.g. steel) are likely to cause significant problems.

Normal dental amalgam fillings do not prohibit you from being scanned, but a dental plate or

braces which contain metal would, and you would be asked to remove it. You will be asked to

remove metal from your pockets (coins, keys). You will also be asked to remove articles of

clothing (in a dedicated changing room) that have metal fasteners (belts, bras, etc), as well as

most jewellery. Please bring suitable clothing with you for the scan. Sweatshirts and jogging

trousers are ideal.

The magnetic field can cause damage to personal possessions such as watches and credit

cards. Such items should not be taken into the scanner and should be placed in the lockers


provided in the lobby of the MR suite. The key will be placed in a secure location by the

scanner operator and returned to you after the MRI scan.

To be scanned you will lie on your back on a bed on runners, on which you will be moved until

your head is inside the magnet. The scanning process itself creates intermittent loud noises,

and you must wear ear-plugs or sound-reducing headphones.

We are able to talk to you while you are in the scanner through an intercom. If you are likely to

become very uneasy in this relatively limited space (suffer from claustrophobia) you should

NOT take part in the scan. If you do take part and this happens, you will be able to alert the

staff by activating an alarm and will then be removed from the scanner quickly.

It is important that you keep your head as still as possible during the scan, and to help you

with this your head will be partially supported with padded headrests. We shall ask you to relax

your head and keep it still for a period of time that depends on the scan but may be more than

one hour. This may require some effort on your part. If this becomes unacceptably difficult or

uncomfortable, you should ask to be removed from the scanner. You may be asked to look at

a screen through a small mirror (or other device) placed just above your eyes and/or be asked

to listen to sounds through headphones. You may be asked to make judgements about what

you see, or asked to perform some other kind of mental task. Details of the specific scan in

which you are invited to participate will either be appended to this sheet or else given to you

verbally. Detailed instructions will be given just before the scan, and from time to time during it.

The whole procedure will typically take about 1 hour, plus another 15 minutes to discuss with

you the purposes of the scan and answer any questions about it which you may raise. You

will be able to say that you wish to stop the testing and leave at any time, without giving

a reason. This would not affect your relationship with the staff or University in any way.

If you agree to participate you will be asked to sign the initial screening form that accompanies

this information sheet, in the presence of an appropriate member of staff. It is perfectly

acceptable for you to take time to consider whether to participate, or discuss the scan with

other people, before signing. After signing, you will still have the right to withdraw at any time

before or during the scan, without giving a reason.

The brain images will be held securely and any identifiable information stripped from the scan.

The information in the two screening forms will also be treated as strictly confidential and the

forms will be held securely until eventually destroyed. Further information about the specific

scan in which you are invited to participate may have been appended overleaf, if the person

performing the scan has felt that this would be helpful. Otherwise, he/she will already have told

you about the scan and will give full instructions prior to the scan. Please feel free to ask any

questions about any aspect of the scan or the scanning procedure before completing the initial

screening form.

The purpose of the scans we have invited you to have is [study specific information to be

inserted here]


Template 2: MRI information form for research participants – Anatomical Imaging

Magnetic Resonance Imaging Information Sheet

Project title:

Magnetic Resonance Imaging Information Sheet

These notes give some information about an MRI scan in which you are invited to take part.

Magnetic Resonance Imaging (MRI) is a method for producing images of the body. It involves

placing the volunteer inside a large, powerful magnet, which forms part of the MRI scanner.

Radiofrequency signals are also used as part of the imaging process.

The MRI procedure poses no known direct health risks. However, the Department of Health

advises that certain people should NOT be scanned. Because the scanner magnet is very

powerful it can interfere with heart pacemakers and clips or other metal items which have been

implanted into the body by a surgeon, or with body piercing items. If you are pregnant or think

you might be pregnant you should NOT take part. If you have had surgery which may have

involved the use of metal items you should NOT take part.

You will be asked to complete a form (the Initial Screening Form) which asks about these and

other matters to determine whether it is safe for you to be scanned. You have the right to

withdraw from the screening and subsequent scanning if you find the questions unacceptably

intrusive (you can also request the screening to be carried out by someone of your

gender). You will also be asked to complete a second, shorter, screening form immediately

before the scan (the Second Screening Form).

Note that only ferromagnetic materials (e.g. steel) are likely to cause significant problems.

Normal dental amalgam fillings do not prohibit you from being scanned, but a dental plate or

braces which contain metal would and you would be asked to remove it. You will be asked to

remove metal from your pockets (coins, keys). You will also be asked to remove articles of

clothing (in a dedicated changing room) that have metal fasteners (belts, bras, etc), as well as

most jewellery. Please bring suitable clothing with you for the scan. Sweatshirts and jogging

trousers are ideal.

The magnetic field can cause damage to personal possessions such as watches and credit

cards. Such items should not be taken into the scanner, and should be placed in the lockers

provided in the lobby of the MR suite. The key will be placed in a secure location by the

scanner operator and returned to you after the MRI scan.

To be scanned, you will lie on your back or front on a narrow bed on runners, on which you will

be moved until your head or feet are inside the magnet. Whether you go in the scanner feet or

head first will depend on the body region being studied.

The scanning process itself creates intermittent loud noises, and you must wear ear-plugs or

sound-reducing headphones. We are able to talk to you while you are in the scanner through

an intercom. If you are likely to become very uneasy in this relatively limited space (suffer from

claustrophobia) you should NOT take part in the scan. If you do take part and this happens,


you will be able to alert the staff by activating an alarm and will then be removed from the

scanner quickly.

It is important that you keep your body as still as possible during the scan, and to help you with

this, you may be partially supported with padding. We will ask you to relax your body and keep

it still for the period of the scan. If this becomes unacceptably difficult or uncomfortable, you

may ask to be removed from the scanner.

The whole procedure will typically take between from 20 minutes to 1 hour, plus another 15

minutes to discuss with you the purposes of the scan and answer any questions you may

have. You will be able to say that you wish to stop the testing and leave at any time,

without giving a reason. This would not affect your relationship with the staff or University or

the UHBristol NHS trust in any way.

If you agree to participate you will be asked to sign the initial screening form that accompanies this information sheet, in the presence of an appropriate member of staff. It is perfectly acceptable for you to take time to consider whether to participate, or discuss the scan with other people, before signing. After signing, you will still have the right to withdraw at any time before or during the scan, without giving a reason. The images we obtain will be held securely and any identifiable information stripped from the scan. The information in the two screening forms will also be treated as strictly confidential and the forms will be held securely until eventually destroyed. Further information about the specific scan in which you are invited to participate may have been appended overleaf, if the person performing the scan has felt that this would be helpful. Otherwise, he/she will already have told you about the scan and will give full instructions prior to the scan. Please feel free to ask any questions about any aspect of the scan or the scanning procedure before completing the initial screening form.

The purpose of the scans we have invited you to have is [study specific information to be

inserted here]


Template 3: Clothing in the MRI scanner

This document describes suitable clothing for research participants undergoing an MRI scan.

It is important that that the clothes you wear for the MRI scan contain little or no metal. The reason for this is the MRI scanner works using a very strong magnetic field, which will pull on any metal fastenings. As well as being uncomfortable, while the scanner is working the metal can theoretically be heated causing burns. Finally, and most commonly, the presence of metal can distort the images we collect, rendering them useless.

For these reasons, we would ask all research participants to come dressed according to the following guidelines, or to bring a suitable set of clothes to change into. We have a private changing room, which includes secure lockers for valuables, in the MRI suite adjacent to the scanner. Note that we do not require MRI research participants to change into hospital-type clothing and we do not provide a change of clothes for hygiene reasons.

Ideally, the clothing you bring should be comfortable without any metal whatsoever. An ideal solution is a sweatshirt and drawstring jogging trousers.

Note that the most important requirement is that the clothing of the top-half of your body contains no metal. In our experience, trousers containing a single metal zipper do not normally cause problems, but we would prefer research participants to wear/bring trousers without any metal fastenings. From a privacy point of view, it is desirable that trousers are worn by all research participants, including females.

Females will be asked questions about metal bra-straps, as these cannot be allowed in the scanner. Research participants wearing underwear, such as bras, containing metal will be asked to remove these items when they change into their clothes for scanning.

Some experiments require the research participant to view visual stimuli that are projected on a screen above their head. A mirror above the research participant’s eyes allows them to see the screen. Sometimes, the research participant’s hair will obscure part of the view. In these cases you may be asked to wear either a hair-net or shower-cap, which we will provide. Glasses/spectacles cannot be worn in the MRI scanner therefore if the research project involves visual stimuli participants will need to be contact lens wearers. Alternatively if participants can provide their lens prescription there are MR compatible glasses available.

If you have any questions about this, or other issues regarding your scan, please contact the person who gave you this information


Annex B.5: Administration of intravenous gadolinium contrast agents policy

For the administration of Intravenous Gadolinium Based Contrast in MRI

The purpose of this document is to ensure the appropriate and safe use of Intravenous (IV)

Gadolinium based contrast media in research procedures.

Staff: If IV gadolinium based contrast media is required for a research project it can only be

administered by a radiologist, clinician or a radiographer who holds the Society of

Radiographers Certificate of competence in Administering IV Injections.

Procedure: The participants selected for the research project must have no history of renal

impairments and not be pregnant or breast feeding.

A clinician must be available in the CRICBristol MRI suite at the time of injection.

The PI has provided CRICBristol with results from a blood test (performed within 6 months of

MRI scan) that the participant’s eGFR is >30ml/min/1

Confirm participant is not pregnant or breast feeding

Checked participant has no significant allergies prior to injection

Check emergency drugs are available. Emergency drugs for contrast reactions are

kept in the MRI prep room.

Prepare a standard dose of the relevant contrast medium for injection using aseptic

technique

Record the serial & batch number, type and dose of contrast given

Observe the participant for 30 minutes after contrast injection for any related

reactions

Contrast and dose

Gadovist is used in adults, adolescents, and children aged 7 years and older.

Magnevist is used for children under 7 years of age, and neonates.

The recommended dose is 0.1 mmol per kilogram body weight (mmol/kg BW). This is

equivalent to 0.1 ml/kg BW of the 1.0 M solution.

Adverse reactions: In the unlikely event of an adverse reaction to the contrast, the

participant should be removed from the magnet room and brought into the corridor

immediately outside the magnet room, where the designated clinician can treat the reaction

as necessary. The emergency contrast reaction kit should be collected from the MRI prep

room. Given the risk of nephrogenic systemic fibrosis (NSF), researchers will be advised to

administer contrast only if eGFR (estimated glomerular filtration rate) is >30ml/min/1.73m2.

eGFR can be calculated using by entering creatinine, age, gender and race in the website

www.renal.org/eGFRcalc/. We are currently not providing the service to measure this in

CRICBristol.

http://www.renal.org/eGFRcalc/


Annex B.6: Working in MRI during pregnancy

Guidelines for Pregnant Staff Working in the MRI Scanner

There is no conclusive evidence that a static magnetic field can harm the developing foetus.

Pregnant users may enter the inner controlled area (magnet room) but have the option of not

doing so in the first trimester of pregnancy.

There is also no conclusive evidence that varying magnetic fields can harm the developing

foetus. But pregnant users should not remain in the Magnet Room during the scan.

References






Annex B.7: Procedure for safe MRI shut down in an emergency


Annex B.8: Fire emergency procedure risk assessment - MRI scanning out of hours



Annex B.9: Agreement for the use of CRICBristol for clinical purposes







Section C: Sleep Studies Suite local rules and procedures This document outlines the procedures for all researchers using the Sleep Study Suite (SSS). This applies to the use of the SSS in normal working hours (9am-5pm) and out of working hours (5pm-9am). The SSS is accessed by swipe card only and contains a foyer area, control room and two bedrooms (A and B) each with en-suite bathroom. The control room is accessed by fob only and contains the video monitoring and recording

equipment.

Please note that all the Nurse Call and RED pull buttons in CRICBristol are non

functional. For emergencies requiring resuscitation team please follow procedure in Section 1.5

19. Sleep study suite booking procedures

To book the SSS for an overnight study the researcher must use Calpendo (https://cric-bristol.calpendo.com) the CRICBristol booking system. Researchers must first register as a user on Calpendo. When the researcher has been approved as a user, they can then register their project on Calpendo (using their CRICBristol project code) by entering their project details in the ‘create project’ section. Once the project has been approved the researcher can book the sleep facilities as needed. When booking sleep rooms using the Calpendo system, researchers need to book the study over the whole night. This involves booking the evening up to midnight on the first day and then from midnight to 9am on the second day. CRICBristol staff must then contact the appropriate security services and provide the following details:

Date and time of overnight study

Name and contact details of RAU during overnight study

Total number of persons present for overnight study

After a study has been completed, please write in the diary log in the control room the following:

The name of the study

The researchers that attended the study

Any information about the study; problems etc.

Where the data is stored, the folder and the file name. If it has been transferred please state where and by whom.

The consumables/equipment used who it was /is going to be cleaned by and if anything needs re-ordering.*

*If equipment needs ordering or if something is broken please inform CRICBristol staff to make sure that new supplies are ordered.




20. Responsibilities

20.1. Responsibilities of the Responsible Authorised User (RAU)

20.1.1 The RAU is responsible for booking the SSS and providing the names of all other

researchers, participant(s), and persons occupying SSS for their overnight study.

20.1.2 The RAU will be responsible for following the CRICBristol procedures for the health and safety of the researchers, participants and other persons present in their overnight study.

20.1.3 The RAU is responsible for signing in and out all researchers, participants and all

other persons who will be present in their overnight study in the sign in book located in reception.

20.1.4 The RAU assumes the responsibility of fire warden during the overnight study

20.2. Responsibility of CRICBristol

20.2.1 For the protection of researchers the CRICBristol unit has CCTV installed. All

CCTV recordings are not monitored but are recorded and stored for a maximum of 1 week.

20.2.2 If the researcher is under threat or needs security on site they should call 0117

34 2222 and request security assistance. In case of life threatening emergency call the police on 999

20.2.3 If during the overnight study one of the two researchers needs to leave

CRICBristol for whatever reason the CRICBristol policy does not allow for lone workers overnight. The overnight study needs to be terminated. Therefore all participants and researchers need to vacate the unit unless a replacement researcher can come to the unit to continue the overnight study.


21. Access and exit

All researchers using the SSS will be given CRICBristol Authorised swipe card access. The card will allow them to access all areas of the CRICBristol except the MRI controlled area.

21.1 Swipe card access will be activated for researchers with UHBristol staff cards

and UoB employees will be given CRICBristol swipe card.

21.2 RAUs that are UoB employees will be given a CRICBristol swipe card which they must collect and return during normal working hours (9am-5pm) before commencing their overnight study. The RAU will sign the card out and sign it back in upon its return to CRICBristol staff at reception.

21.3 For overnight studies (i.e. out of office hours 5pm-9am) researchers and

participants must use the CRICBristol entrance and exit at the far end of the corridor that the SSS is located. This is the entrance and exit to the Level-B corridor of St Michael’s Hospital. Therefore access to CRICBristol out of hours is via the St Michael’s Hospital main entrance on Southwell Street.

21.4 During overnight studies, the CRICBristol main entrance is to be used as an

Emergency Fire Exit ONLY and not as an entrance and exit. There is an intercom system in the sleep control room that allows researchers to open the main doors without leaving the room. DO NOT use this system out of working hours; only use the entrance via St Michael’s Hospital.

21.5 The RAU will be required to arrive at 5pm and complete their duties at 9am,

since responsibility for securing the building will be taken by CRICBristol daytime staff.

21.6 When the overnight study is complete the RAU is responsible for ensuring that

everyone has exited the building before setting the security alarm system.


22. Emergency procedure

22.1. Fire emergency

During overnight studies the RAU is the acting fire warden and is responsible for ensuring that everyone has exited the building The CRICBristol main entrance is used as an Emergency Fire Exit ONLY during overnight studies therefore it will remain unlocked for the duration of the overnight study. The main entrance can only be accessed by authorised personnel with a CRICBristol authorised swipe card In the event of a fire within CRICBristol, the alarm should be raised using the RED fire alarm

boxes located next to every fire door and all staff, research participants and visitors should

be evacuated. RAU familiarise themselves with the fire evacuation procedure in section 22.2

and have attended the CRICBristol fire training.

22.2. Fire evacuation procedure

22.2.1. Immediately call the Fire Service via Security emergency 0117 34 2222.The

nearest fire escape to the assembly point is the CRICBristol main entrance.

In the event of a fire:

swipe card panels for all swipe access doors are disabled, so these doors

can be used without restriction

the fire resistant doors along the two main CRICBristol corridors will

automatically shut

the front doors to CRICBristol will open automatically and will stay open for

the duration of time that the fire alarm sounds, as this is a fire escape

22.2.2. If the fire is in the Sleep Study Suite, the RAU should attempt to cut off the

medical gases supply if it is safe to do so. The medical gases cut off are found

in the corridor that the SSS is on, and are clearly marked on the Sleep Studies

Suite floor plan in Annex C.2. CRICBristol staff will show the RAU the location of

the medical gases cut off before the study commences as part of the RAU

induction to the unit.

22.2.3. The nearest fire extinguishers are located in the corridor to the left of the Sleep

Study Suite. Only Personnel who have received appropriate UHBristol fire

training should attempt to use the fire extinguishers and only if it is safe to do so.

22.2.4. Smoke detectors are fitted in all rooms of the sleep study suite. If the fire alarms

in the building sound with a continuous ring, the SSS should be evacuated even

if no fire is evident. Assemble at the designated Assembly Point which, for

CRICBristol, is beyond the main entrance on the pavement of St Michael’s Hill by

the CRICBristol sign and wait for permission to re-enter the building.

22.2.5. If a fire occurs outside normal working hours, the Fire Service should be met by

a RAU at the Fire designated Assembly Point for CRICBristol.

22.3. Medical emergency

For medical emergency the procedure in Section 1.5 should be followed.


Annexes to Section C of this Quality Manual

Annex C.1: General floor plan to the Sleep Study Suite in CRICBristol


Annex C.2: Floor plan of the Sleep Study Suite location, showing medical gases cut-

off


Annex C.3 Sleep study booking policy SOP

Cancellations

Cancelled bookings are chargeable. For any project, the first ‘chargeable’ cancellation will be overlooked, but subsequent cancellations will be charged at the following rate:

Bookings cancelled at less than 7 days will be charged at 50% of the fee (excepting bookings made less than 7 days before)

Bookings cancelled less than 24 hours before the scan will be charged at 100% of the fee (excepting bookings made less than 24 hours before)

The researcher should inform the Administrator ([email protected]) that the slot has been vacated

The following are also chargeable cancellations:

Researcher failing to arrive, or arriving late for the session

Participants failing to meet any criteria for the experiment Advance booking limit

3 months for patient groups. 2 months for other studies. Regular bookings

Projects that require a regular timeslot each week (e.g. clinical populations or large cohorts) can request this from the CRICBristol Centre Manager.

The timing of the regular slot will be accommodated as far as practical.

Regular bookings may have to be changed in future to accommodate changes in provision or demand.

Overnight Hours are defined as: Mon – Fri, 17.00pm - 09.00am Cancellations follow the same rules as for any other projects.

Other Equipment

If your study requires additional equipment (e.g. physiological monitoring) please ensure that this equipment is booked as well. This equipment is often used in other parts of the building, so does not imply these components are included

mailto:[email protected]?subject=CRICBristol%20booking%20cancellation


Section D: Clinical Investigation Suite local rules and procedures

The following document outlines the standard operating procedures for use of the

CRICBristol Clinical Investigation Suite (CIS).

CRICBristol CIS comprises of the following: 4 Clinical Rooms, Wet Lab, Clean Uility and

Dirty Utility.

23. Clinical rooms

23.1 Contents of each room

1 desk, 2 chairs, 1 examination bed, 1 clinical waste and 1 domestic waste bin. 1 UHBristol

computer (available in 3 of 4 rooms).

23.2 Study specific equipment

Any use of study specific equipment in clinical rooms must be detailed in the CRICBristol

project specification form. Request for storage of study specific equipment at CRICBristol is

subject to approval. Unless approval has been granted all study specific equipment and

testing materials must be removed after use of clinical room.

23.3 Booking and access

The CRICBristol booking policy applies to bookings made of the clinical rooms.

Keys and swipe cards are to be signed in and out at reception.

23.3.1. Clinical rooms booking policy

Cancellations: cancelled bookings are chargeable. For any project the first ‘chargeable’ cancellation will be overlooked, but subsequent cancellations will be charged at the following rate:

Bookings cancelled at less than 7 days will be charged at 50% of the fee (excepting bookings made less than 7 days before).

Bookings cancelled less than 24 hours before the scan will be charged at 100% of the fee (excepting bookings made less than 24 hours before).

The researcher should inform the Administrator ([email protected]) that the slot has been vacated. The following are also chargeable cancellations, which will usually be charged at 100% of the fee:

Researcher failing to arrive, or arriving late for the session.

Participants failing to meet any criteria for the experiment resulting in the need to cancel the booking.

Advance booking limit: The maximum time limit for booking in advance is 3 months for patient groups and 2 months for other studies.

23.3.2. Regular bookings

Projects that require a regular timeslot each week (e.g. clinical populations, or large cohorts) can request this from the CRICBristol Centre Manager. The timing of the regular slot will be accommodated as far as practical.



Regular bookings may be subject to change at the discretion of the CRICBristol Centre Manager; this will usually be due to unusual demand or disruption to the facilities. Any such change will be notified at least 7 days in advance and CRICBristol will use all reasonable endeavours to ensure that the booking can be re-scheduled in a timely manner. Core Hours are defined as: Mon – Fri, 09.00 – 17.00 Cancellations follow the same rules as for any other projects.

23.3.3. Booking other equipment

If a project requires equipment that is additional to that listed in section 23.1 (e.g. physiological monitoring), please book this equipment at the time of booking the CIS to ensure that it is available for the project. CRICBristol will notify you as soon as possible if the equipment requested is not available and you may wish to reschedule the booking to accommodate this.

24. Wet Lab

24.1. Projector in wet room

The projector is not to be adjusted under any circumstances. For any questions relating to the projector please contact a CRICBristol member of staff.

24.2. Centrifuge

You must not attempt to use the centrifuge if you have not undertaken the appropriate

training. Please ask the Centre Manager to arrange training on proper use of the centrifuge.

Researchers will be held liable for any damage caused to the centrifuge equipment if used

without appropriate training.

The following is the basic operating and safety procedures for the centrifuge (for further and

advanced operating procedures please refer to operating manual held in the Manuals folder

in the administrative area of CRICBristol). These guidelines have been written in line with the

UHBristol NHS Trust Standard Infection Control policy which can be found in the Quality

Manual folder in the administrative area of CRICBristol.

When using a centrifuge and handling bodily fluids, it is essential to minimise the risk of

injury to staff and cross-infection. This guideline describes safe practice and must be

followed by all staff involved in the use of centrifuges.

Centrifuge Basic Function and Operating

Time - Alters the running time

Speed - Alters the speed in increments of 100 1/min or rcf (relative centrifugal force)

Start - Starts the run. The symbol flashes whilst the motor is running.

Stop - Stops the centrifuge

Stand-by - The centrifuge is on stand-by mode

Open - Releases the lid latch

Temp - Changes the nominal temperature value


24.2.1. Procedure

a) Prepare blood bottles, freezing tubes and documentation prior to collecting samples.

b) When handling all samples gloves, apron, and eye protection must be worn at all times. Do not leave clinical area whilst still wearing gloves – they must be removed and hands washed immediately at designated area.

c) If sharps bin is full please seal the bin and place in the waste hold. New sharps bins

are stored in the cleaner’s store.

d) Place blood/sample bottle(s) in rotor/bucket within centrifuge, counter balance with exactly the same size blood/sample bottle (containing the same amount of water as the blood bottle contains blood, e.g. 4mls) and ensure lid is down firmly. No samples should be loose within the rotor.

e) Adjust setting to required speed and time, as required per trial protocol. Press start if

required.

f) If load is unbalanced and machine starts to shake, switch off immediately and clear the area until the machine stops. Some centrifuges will cut out if the load is unbalanced. Rearrange the load, so it is balanced and restart the centrifuge.

g) The centrifuge lid should not open whilst the rotor is spinning. NEVER try to open the

centrifuge while the rotor is spinning

h) Once centrifuge has finished spinning, release door and put gloves and apron on. Open lid of rotor/bucket carefully (in case of breakage see Section 24.2.2).

i) Ensure all tubes for freezing are correctly and clearly labelled with indelible pen prior

to storing in freezer. Guidelines for freezer storage are in Section 27.1.

j) Discard pipettes and blood bottles no longer needed into sharps bin, gloves and aprons into orange clinical waste bin.

k) Update refrigerator log if necessary (sample storage log template provided at Annex

D.1).

Never use a centrifuge if:

You have not been fully trained.

The lid does not shut properly.

There is any sign of corrosion on the buckets, or any parts or screws are missing off the rotor head.

It is unbalanced.

There is any visible wearing in the electrical wires.

24.2.2. Breakages

In the event of specimens breaking in the centrifuge, you MUST consult a member of staff with regard to a suitable method of cleaning and prevention of cross contamination.


25. Clean and dirty utility

25.1. Definition of clean and dirty utility rooms:

Clean and dirty articles are not stored in the same place in order to prevent contamination. Clean rooms are used to store clean, unused equipment. Dirty rooms are rooms used to store contaminated items such as, rubbish, contaminated equipment and basic laboratory tests. These guidelines have been written in line with the Linen and Laundry policy of the UHBristol, a copy of which can be found in the Quality Manual folder in the administrative area of CRICBristol. 25.2. Store and handle linen

25.2.1. Clean linen. Store clean linen in a clean room marked for clean linen only. Prevent the contamination of clean linen by:

a) Washing hands before handling clean linen

b) Keeping linen from touching floor or any other known dirty surface

c) Keeping linen from touching uniform

25.2.2. Dirty or soiled linen. Dirty linen is linen that has been used, and may be contaminated with blood, urine, faeces, and so forth. Put used (but unspoilt) linen in a white linen bag. Put any contaminated linen in a red bag. Linen bags should be stored in the Waste Hold for collection by Hotel Services. Information on the colour coding for linen bags can be found in Annex D.3. Prevent the spread of contamination by following these rules:

a) Do not shake or toss dirty linens.

b) Do not allow uniforms/clothes to come into contact with dirty linens.

c) Remove dirty linen from the area using procedures established by local standing operating procedures (SOP).

25.3. Store and handle equipment and supplies

a) Store clean and dirty equipment and supplies in separate areas.

b) Cleanse dirty equipment thoroughly before placing with clean equipment for reuse by another patient/researcher.

c) Use disposable equipment whenever possible.

d) Use separate disposable items for each research participant.


26. Disposal of waste materials

The Human Tissue Act 200417 must be complied with at all times. For studies that have

received NHS ethics approval the research must be undertaken in accordance with the

ethically approved documentation, this will detail the procedure for handling and storing

tissue samples. For general information on the Act please see:

http://www.bris.ac.uk/red/research-governance/human-tissue/

Written in accordance with the UHBristol policy for Waste management, a copy of which can

be found in the Quality Manual Folder in the administrative area of CRICBristol.

26.1. Non-clinical (domestic) waste

Waste generated that is not contaminated and does not have any other special

disposal requirements. Normally destined for disposal at landfill site, but may also be taken

for incineration or recycling.

Includes:

General Office Waste

Paper

Cardboard

Confidential Waste

26.2. Clinical waste

Clinical Waste is defined legally in the List of Wastes (England) Regulations 2004.

“Wastes from human or animal healthcare and or related research consisting of body

parts and organs, including blood bags and blood preserves; medicines including

cytotoxic and cytostatic medicines, swabs or dressings or syringes, needles or other

sharp instruments, being waste which unless rendered safe may prove hazardous to

any person coming into contact with it”; and

“Any waste arising from medical, nursing, dental, veterinary, pharmaceutical or similar practice, investigation, treatment, care, teaching or research or the collection of blood from transfusion, being waste which may cause infection to any person coming into contact with it results from contamination with bodily secretions and requires special handling.”

17

http://www.legislation.gov.uk/ukpga/2004/30/contents

http://www.bris.ac.uk/red/research-governance/human-tissue/

http://www.legislation.gov.uk/ukpga/2004/30/contents


26.3. Disposal guidelines

Waste Storage Disposal

Domestic waste Black plastic bag or recycling bin

Hotel services

Glass Collect in a cardboard box and label

Hotel services

Cardboard Break down flat and place in waste hold

Hotel services

Contaminated waste Orange clinical waste bag Hotel services

Sharps Trust approved yellow sharps bins

When ¾ full label and seal, place in waste hold and inform hotel services


27. Storage

27.1. Refrigerators & freezers

The temperature of the refrigerators and freezers (in Wet Room and Clean Utility) are strictly

controlled by CRICBristol staff. Do not change the setting without prior consent from a

member of staff.

Clean and check temperature of refrigerators according to study protocol.

Contents should be labelled and dated. All stored samples must be logged in the sample storage log, the log template is provided at Annex D.1. Any samples which are not logged and/or clearly labelled may be disposed of by CRICBristol staff without prior warning.

27.2. Drug cabinet

CRICBristol has two secure drug cabinets: one in the Clean Utility, and one in the MRI

Preparation Area. The keys are kept in key cabinet in the administrative area of CRICBristol.

All requests to store drugs used in research studies must be submitted on CRICBristol full

project specification. The key will be signed out at reception to the research user responsible

for the drug handling as named in the full project specification form and must be returned

and signed back in at reception. All research drugs must be kept in accordance with the

ethically approved study documentation.

Contents should be labelled and dated. All stored samples must be logged in the drug cabinet log, the log template is provided at Annex D.2. Any items which are not logged and/or clearly labelled may be disposed of by CRICBristol staff without prior warning.

27.3. Storing sample

All sample storage in CRICBristol is subject to request made on CRICBristol full project

specification form and must follow approved study protocol. Freezer samples can only be

stored up to - 30°C. CRICBristol cannot provide long term storage facilities. All study

samples must be removed if requested by CRICBristol staff who will contact the project

chief/principal investigator giving written or verbal notice of 5 working days to remove from

site.

27.4. Other considerations

Standing liquids (including medications). Time, date, and label all standing liquids at time of change. Standing liquids should be changed every 24 hours unless otherwise directed.


Annexes to Section D of this Quality Manual

Annex D.1: Sample storage log


Annex D.2: Drug cabinet log


Annex D.3: Colour coding for laundry bags

Documents

MRI Local Rules & Procedures