RADIATION SAFETY POLICY. Controlled Document Number: Version Number: 3 Controlled Document Sponsor: Controlled Document Lead: Approved By:

Transcription

1 RADIATION SAFETY POLICY CONTROLLED DOCUMENT CATEGORY: CLASSIFICATION: PURPOSE Controlled Document Number: Version Number: 3 Controlled Document Sponsor: Controlled Document Lead: Approved By: Policy Health & Safety To ensure safe use of radiation within the Trust 114 Chief Operating Officer Head of RRPPS CEAG On: 6 th August 2015 Review Date: 6 th August 2018 Distribution: Essential Reading for: Information for: All Managers in departments using ionising or non-ionising radiation All staff Radiation Safety Policy 1/23

2 Contents 1. Policy Statement Scope Framework Duties Implementation and Monitoring References Associated Policy and Procedural Documentation Appendix A - Monitoring of the Policy Appendix B - Quality Assurance Programme (Ionising radiation) Appendix C - Quality Assurance Programme (Lasers & Ultrasound, MRI) Appendix D - Trust Organisation for the Radiation Safety Programme Appendix E - Training Requirements Appendix F - Local Radiation Safety Audit Radiation Safety Policy 2/23

3 1. Policy Statement 1.1. The Trust will ensure, as far as is reasonably practicable, the safety of patients, members of the public (including the families of patients), staff and, others who may be exposed to hazards arising from the use of ionising radiations (e.g. x-ray, gamma rays etc.) and non-ionising radiations (e.g. lasers, magnetic fields, ultrasound and optical radiation sources) The Trust will ensure that the legal obligations contained within the regulations described in section are met The Trust will ensure that an appropriate radiation protection programme is implemented and reviewed and that appropriate organisational arrangements are in place to facilitate it The Trust is committed to a policy of keeping exposures to ionising and nonionising radiation as low as reasonably practicable. 2. Scope This policy applies to all employees (including contractors, volunteers, students, locum and agency staff working on the premises) of the Trust and to all members of the public, patients and contractors whilst they are on sites managed by the Trust. It also applies to University staff whilst working in areas for which the Trust is responsible. 3. Framework 3.1. This section describes the broad framework for ensuring radiation safety. Detailed operational instructions for the implementation of this policy are contained within the associated documents listed in section 7. The associated documents may be amended by authority of the document sponsor (the person responsible for the document within the controlled document procedure), provided that such amendments are compliant with this policy The Trust will: Maintain a radiation protection management structure to implement radiation safety requirements; Appoint suitable Radiation Safety Advisers (RSAs) to advise on all matters concerning the safe use of ionising or non-ionising radiations; Where appropriate, appoint Supervisors to cover each department using ionising or non-ionising radiation to enable work with radiation to be carried out in a safe manner and ensure that local rules are followed; Radiation Safety Policy 3/23

4 Comply with the relevant Regulations and Good Practice Guides (see References) covering the use of ionising and non-ionising radiation Ensure that medical examinations involving the use of ionising radiation will only be carried out: (a) where there is sufficient medical justification; and (b) in accordance with Trust standard operating procedures and protocols Ensure that radiation doses to patients from diagnostic procedures are kept as low as reasonably practicable consistent with the intended clinical outcome. Therapeutic doses of ionising radiation will be in accordance with site-specific medical treatment portfolios developed and reviewed within the Oncology quality system or protocols within Nuclear Medicine controlled documents To ensure that radiation doses for all personnel will be as low as reasonably practicable Expert Advice and Support Medical physics support and advice for radiation safety is provided as follows RRPPS a) Radiation Safety Advisers (RSAs) (section 4.4). b) Approved personal monitoring service providing whole body, extremity and eye dosemeters for ionising radiation (section 3.7.1). c) Ionising radiation instrument calibration service for and Qualified Persons (section 4.10) relating to the calibration and testing of both protection level and diagnostic radiology quality assurance instruments (section 3.7.3). d) Medical Physics Experts (MPEs) for diagnostic radiology and nuclear medicine (section 4.9.4). e) Radioactive Waste Adviser (RWAs) (section 4.12). f) Radiation surveys and quality assurance testing of diagnostic x-ray, MRI, lasers and other non-ionising facilities and quality assurance tests of ultrasound equipment (section 3.4.3) Radiotherapy Physics a) MPEs for radiotherapy treatments (section 4.9.4) Radiation Safety Policy 4/23

5 b) Quality assurance testing and calibration of radiotherapy equipment (section 3.4.3) Nuclear Medicine a) MPEs for nuclear medicine and bone mineral densitometry (section 4.9.4) b) Site Officer (section 4.8) c) Radioactive Waste Adviser (section 4.12) d) Quality assurance testing of nuclear medicine imaging equipment (section 3.4.3) 3.4. Radiation Facilities and Equipment All radiation facilities will be designed to meet the requirements of relevant Regulations, Codes of Practice and Guidance Notes (see References), to ensure that doses are below relevant nationally agreed dose constraints and the appropriate security measures are included. Local Rules will be prepared to cover procedures using ionising radiation and non-ionising radiations as required. The Rules will contain or reference operational instructions designed to minimise radiation doses. Radiation doses to staff who work with ionising radiation will be monitored as deemed appropriate by a Radiation Protection Adviser (RPA) The minimising of radiation doses to patients will be a prime factor in the selection and use of diagnostic equipment Quality assurance tests, including tests before the equipment is put into clinical use and subsequent regular checks at appropriate intervals, will be carried out (See Appendices B & C) When new facilities are being planned the appropriate RPA should be involved to advise on the best method of achieving the required dose constraints Where appropriate, advice will be sought from the relevant MPE regarding the selection, purchase and replacement of all ionising radiation equipment Any equipment or apparatus used in connection with medical exposures will, as far as reasonably practicable, be selected, installed and maintained so that it is capable of restricting the exposure of the patient in accordance with the intended clinical purpose An RPA must carry out a critical examination of all equipment emitting ionising radiation before it is used. A laser protection Radiation Safety Policy 5/23

6 adviser (LPA) must examine laser equipment and other hazardous optical equipment before it is used on patients. Similarly a Magnetic Resonance Safety Expert (MRSE) must check magnetic resonance imaging equipment Equipment will not be brought on to site by staff or manufacturers etc for demonstration, trial or testing purposes without prior consultation with the appropriate RSA and consideration of indemnity. 1 An appropriate Health and Safety Adviser may also be involved Any radioactive material will be transported in accordance with the relevant Regulations Risk Assessments Risk assessments must be undertaken for all radiation activities prior to any work commencing. The assessments must be reviewed if the activity, equipment or location changes. All assessments must be reviewed at least annually Where risks are identified, appropriate measures must be put in place to reduce the dose and hence risk to as low as reasonably practicable. Such measures should include the following in the order specified: a) Engineering controls (e.g. shielding, interlocks and other safety features); 3.6. Work Instructions b) Changes to working procedures and provision of training to ensure these are correctly followed; c) Protective equipment (e.g lead aprons, gloves, aprons). Safe Working Practices shall be established for the safe use of ionising radiation equipment, magnetic resonance scanners, and the use of hazardous optical equipment Monitoring Radiation whole body doses to staff routinely using ionising radiation on a daily basis will be monitored. Periodic monitoring of other staff (including extremity and eye monitoring) and of environmental doses in the workplace will be carried as deemed 1 This is so that the relevant statutory provisions such as notification to HSE, prior risk assessments can be satisfied. The supplier of the equipment is responsible for providing details concerning the necessary safety arrangements including (a) documentation proving that the equipment is safe to use and describing the necessary safe working procedures, (b) testing and maintenance requirements of the equipment whilst on loan and (c) any additional personal safety equipment and staff training that might be necessary. Radiation Safety Policy 6/23

7 appropriate by the RPA. All personal monitoring for the Trust will be carried out by a dosimetry service approved by the Health and Safety Executive for both dose assessment and record keeping, namely RRPPS. The Trust will follow the advice of the RPA regarding the designation of staff as classified persons 2 and the need for monitoring Local rules for ionising radiation will specify local investigations levels. Whenever a staff member receives a whole body radiation dose greater than the investigation level, the departmental manager will investigate and discuss any possible dose reduction strategies with the relevant RPA. The manager has responsibility to implement any necessary changes All equipment involved with the measurement of radiation hazards in connection with the Ionising Radiations Regulations 1999 will be tested annually under the supervision of the Qualified Person (see section 4.10) following national guidelines. All equipment used to calibrate or otherwise monitor performance of treatment machines (e.g. linear accelerators) will be tested according to procedures outlined in the Oncology quality management system Staff Training All staff working with ionising and non-ionising radiation must be trained to a level commensurate with the work being performed and the degree of hazard involved and to satisfy legal requirements. Appropriate training requirements are set out in Appendix E Incidents All radiation incidents will be reported in accordance with the Trust s Incident Reporting system In addition some incidents may need to be reported to external agencies. The appropriate RSA will give advice when this is necessary. 4. Duties 4.1. Chief Operating Officer Overall responsibility for ensuring that an appropriate management structure is maintained to implement, monitor and review the radiation protection policy will lie with the Chief Operating Officer. He/she will ensure that the Trust: 2 Classified persons are defined in the Ionising Radiations Regulations 1999 as employees who are likely to receive a dose more than three-tenths of the employee dose limits. Radiation monitoring and medical surveillance must be undertaken for Classified persons. Radiation Safety Policy 7/23

8 Appoints appropriately qualified and experienced RPA(s), RWA(s), NHRA(s) and LPA(s); radiation protection supervisors, laser protection supervisors and site officers; Establishes Standard Operating Procedures and Protocols that meet the requirements of the Ionising Radiation (Medical Exposures) Regulations {IRMER} 2000; Ensure that the relevant Inspectorate or Agency and Chief Executive are notified of any incident involving ionising or nonionising radiation as required Divisional Directors of Operations and Group Managers Divisional Directors of Operations and Group Managers are responsible for monitoring and auditing the arrangements within their Division or Group respectively to check that staff and facilities are complying with this policy Departmental/Service Manager Responsibility for the provision of radiation protection, staff and patient dose monitoring and radiation equipment quality assurance programmes within each Department will lie with the Departmental Manager using the services of the relevant section of the Medical Physics Department (RRPPS, Radiotherapy Physics or Nuclear Medicine). The Departmental Manager will ensure that: Local rules and written systems of work have been drawn up with approval by the appropriate Radiation Safety Adviser and are reviewed appropriately The necessary staff are provided with personal radiation monitors in accordance with any advice from the RPA, staff wear these monitors appropriately and return them for evaluation at the required intervals Staff carrying out work with ionising or non-ionising radiation are appropriately trained and that records of this training are kept Work with ionising radiation, lasers and magnetic resonance imagers is carried out in accordance with 'local rules' (under the supervision of the local supervisors ) and staff are notified of any changes in these local rules The necessary risk assessments are completed before carrying out work with ionising or non-ionising radiation The risk assessments are reviewed every year or whenever there is a significant change in working practice. Radiation Safety Policy 8/23

9 Recommendations made following inspections of their radiation equipment and facilities are followed up and actioned as necessary Any special measures required to restrict doses to staff, particularly for pregnant staff, are implemented An investigation is carried out whenever a member of staff receives a dose of ionising radiation exceeding the local investigation level set in the local rules or a dose of non-ionising radiation exceeding an exposure limit and any necessary action is taken to reduce doses in the future All medical radiation exposures carried out in their Department will be carried out in accordance with the Trust s Procedures for the Ionising Radiation (Medical Exposure) Regulations {IRMER} Any equipment or apparatus used in connection with medical exposures will, as far as reasonably practicable, be selected, installed and maintained so that it is capable of restricting the exposure of the patient in accordance with the intended clinical purpose An inventory of their own ionising radiation equipment is kept and all such equipment both satisfies radiation safety requirements and is also included in appropriate replacement programmes Quality assurance tests are carried out the appropriate intervals on all equipment involved in patient exposure with ionising and nonionising radiation. See Appendices C and D Incidents, which could require notification to the relevant inspectorate or agency 3 are reported to the appropriate RSA immediately in addition to following the normal incident reporting process. (The RSA will advise whether the relevant inspectorate or agency requires notification.) The appropriate RSA is consulted when the department is considering using ionising or non-ionising radiation for the first time or will be implementing a change in practice An appropriate RSA is notified when new ionising or non-ionising radiation equipment is installed so that the appropriate 3 For example doses above legal limits, doses to patients much larger than intended due to equipment failure and significant releases of radioactive material have to be notified to the Health & Safety Executive (HSE). Doses to patients (i) much larger than intended or (ii) to the wrong anatomical site, where both (i) and (ii) are due to procedural errors, have to be notified to the Care Quality Commission. Lost or stolen radiation sources have to be reported to the Environment Agency and the police (and possibly the HSE). Radiation Safety Policy 9/23

10 commissioning tests and critical examinations are undertaken before use Equipment is not brought on to site for demonstration, trial or testing purposes without prior consultation with an appropriate RSA and consideration of indemnity All instruments used for monitoring levels of ionising radiation in controlled and supervised areas are tested and examined annually by the RRPPS Instrument Calibration Service In relation to work with radioactive materials, the Site Officer (section 4.8) is informed before any work with a new radionuclide commences or there are significant changes in workload, stock or disposal of radioactive material including transfers of work to new rooms or premises. the Department complies with the general conditions of Environmental Permitting Regulations {EPR}(2010) in relation to keeping and using radioactive materials and the local limits established by the Site Officer in relation to quantities of radioactive material held and disposed of. The appropriate reports (e.g. monthly stock values, disposal values etc) are sent to the Site Officer Arrangements within the department are monitored and audited to ensure that staff and facilities comply with the policy Radiation Safety Advisers (Ionising or Non-Ionising), RPA/LPA/MRSE Responsibility for advising the Trust managers, departmental managers, staff and the public on radiation matters will lie with the relevant Radiation Safety Adviser (RSA). Radiation Protection advisers (RPAs) cover ionising (diagnostic or therapeutic) radiation. The Head of Radiotherapy Physics will assist the RPAs in the provision of protection advice for radiation therapy. The safety adviser is referred to as the Laser Protection Adviser (LPA) specifically for the use of lasers and as the MR Safety Expert (MRSE) for MR imaging and spectroscopy respectively The appropriate RSA will be involved in the planning of all new radiation facilities and any changes to existing facilities RSAs have a duty to keep up to date with radiation safety requirements and maintain their competence in order to maintain their certification as advisers Radiation Protection Committee (RPC) The RPC will monitor the radiation protection programme, including Radiation Safety Policy 10/23

11 a regular review of all occupational, medical and public exposure to radiation The RPC is split into 4 branches, namely (i) diagnostic x-ray, (ii) radionuclides (iii) radiotherapy and iv) MRI. Other non-ionising issues will be dealt with via the x-ray branch. The chairman of the relevant branch of the RPC is responsible for arranging for that branch of RPC to meet at least yearly Radiation & Laser Protection Supervisors (RPS & LPS) The RPS should be familiar with the requirements of the local rules and relevant parts of the Ionising Radiations Regulations 1999 {IRR 99} and the Approved Code of Practice. The RPS assists the line manager in ensuring that the local rules are read, understood and, as far as possible, are followed by the relevant staff The LPS should be familiar with the requirements of the laser local rules and the relevant guidance notes. The laser local rules will stipulate Nominated Users of the lasers. The LPS assists the line manager in ensuring that the local rules are read, understood and, as far as possible, are followed by the relevant staff Other tasks that are carried out by the RPS/LPS are given in the appropriate local rules. Responsibility for these tasks remains with the line manager Consultant Occupational Health Physician Responsibility for medical supervision of staff in respect of radiation exposure will lie with the Consultant Occupational Health Physician Site Officer Responsibility for maintaining records of the quantities of radioactive material, kept on, and disposed on, or at, a particular site will lie with the Site Officer. The site officer: monitors the records and advises the RPA if the permit limits which apply to the particular site in accordance with EPR (2010) are likely to be exceeded. If a limit has been exceeded, the RPA and Site Officer will agree between themselves who will advise the Chief Operating Officer and formally notify the Environment Agency prepares annual summaries (of the releases of radioactive materials to air and water) for submission to the Environment Agency in accordance with the EPR (2010) may assign, to each working area, limits for the quantities of Radiation Safety Policy 11/23

12 4.9. Medical Exposures radioactive material which can be kept and used and limits for the accumulation and disposal of radioactive waste. All medical exposures involving the use of ionising radiation will be carried out within a management framework defined by Trust s IRMER Standard Operating Procedures and Protocols. IRMER 2000 define certain duty holders associated with the process of carrying out medical exposures. These are: Referrer The referrer is responsible for supplying the practitioner with sufficient medical data to enable the practitioner to justify the exposure Practitioner The practitioner is responsible for justifying the exposure and, within the extent of their involvement, keeping the dose to the patient as low as reasonable practicable consistent with the intended purpose Operator Operators are staff who carry out practical aspects of the exposure, including calibration, quality assurance or maintenance of the equipment used, and, in the case of radiotherapy, planning patient treatment. They are responsible for ensuring that, within the extent of their involvement, they keep the dose to the patient as low as reasonable practicable consistent with the intended purpose Medical Physics Expert (MPE) The MPE carries out and gives advice (as appropriate) on patient dosimetry, dose optimisation, clinical radiobiology, radiation risk assessment, quality assurance relating to the development and use of techniques and equipment for medical ionising radiation exposures. The Trust has entitled certain staff to carry out these roles as described within Imaging IRMER procedure 2 and, for radiotherapy, within procedure LRP01. All staff acting as operators or practitioners must (legally) follow the IRMER procedures laid down by the Trust and must take legal responsibility for those parts of any procedure for which they are responsible Qualified Person Radiation Safety Policy 12/23

13 The Qualified Person (as defined within the Ionising Radiations Regulations 1999) is responsible for completing appropriate tests and examinations on radiation monitoring equipment Dangerous Goods (Safety Adviser), DGSA The DGSA is appointed to advise on compliance with the transport of radioactive materials within the requirements of the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations Radioactive Waste Advisor, RWA The RWA provides advice to the Trust on radioactive waste management and environmental radiation protection. This advise will include assistance in applying for and complying with the conditions of the permits issued by the Environment Agency to accumulate and dispose of radioactive waste Employees It is the responsibility of every employee working with ionising or non-ionising radiation to be aware of the local rules and precautions necessary to carry out their work in a safe manner. It is their responsibility not to expose themselves or any other person to radiation to a greater extent than is reasonably necessary for the purpose of their work, to follow any local rules or procedures and thus comply with the relevant legislation to report incidents or defects in equipment in accordance with the Trust s Incident Reporting Procedure and to use and look after any protective equipment that is provided and to use, look after and return personal dosemeters appropriately. Any failure to comply with this policy and its associated documents could lead to disciplinary action and dismissal Summary The organisation structure for the radiation protection programme is given in Appendix D. 5. Implementation and Monitoring 5.1. Implementation This Policy will be available on the Trust s Intranet Site. The policy will also be disseminated through the management structure within the Trust Managers will ensure that radiation protection responsibilities are included in personal development review and personal objectives Radiation Safety Policy 13/23

14 5.2. Monitoring of their staff Appendix A provides full details on how the policy will be monitored. 6. References 6.1. Ionising Radiations Regulations The Medicines (Administration of Radioactive Substances) Regulations 1978 (SI 1978 No 1006). The Medicines (Radioactive Substances) Order 1978 (SI 1978 No 1004) Environmental Permitting (England & Wales) Regulations (SI 2010 No 675) and amendment Regulations 2011 (SI 2011 No 2043) Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009 (SI 2009 No 1348) and amendment Regulations 2011 (SI 2011 No 1885) The Ionising Radiations Regulations 1999 (SI 1999 No 3232). The Ionising Radiation (Medical Exposure) Regulations (SI 2000 No 1059) and amendment Regulations 2006 (SI No 2523) and 2011 (SI 2011 No1567). The Justification of Practices involving Ionising Radiation Regulations 2004 (SI 2004 No 1769) Codes of Practice, Guidance Notes, Health Service Guidance etc. IPEM (2002) HMSO (1999) Radiation Safety Policy 14/23 The Medical and Dental Guidance Notes. A good practice guide to implement ionising radiation protection in the clinical environment.. Institute of Physics in Engineering & Medicine, York Approved Code of Practice and Guidance, Work with Ionising Radiation, The Ionising Radiations Regulations London,. ARSAC (2014) Notes for Guidance on the Clinical Administration of radiopharmaceuticals and use

15 of sealed radioactive sources.. Administration of Radioactive Substances Advisory Committee 2006 (ARSAC Support Unit, Radiation Protection Division, HPA, Didcot, Oxon.) HSE (Third Edition) Fitness of Equipment used for medical exposure to ionising radiation. Health and Safety Executive Guidance Note PM77 df (accessed Jun 2015) HPA (2009) Protection of Pregnant Patient during Diagnostic Medical Procedures to Ionising Radiation. Health Protection Agency Joint Guidance from HPA, CoR, RCR. Doc HPA, RCE NPL (1999) The examination, testing and calibration of portable radiation protection instruments. Measurement Good Practice Guide 14. National Physical Laboratory, Teddington, London. HSE (2001) Working Safely with ionising radiation: Guidelines for expectant or breastfeeding mothers. Health & Safety Executive INDG334 03/01 C400. HSE/DH (2001) The regulatory requirements for medical exposure to ionising radiation. An employer s overview. Health and Safety Executive and Department of Health. HSE Books HSG Non-ionising Radiations Regulations Management of Health & Safety at Work Regulations 1999 (SI ) Control of Artificial Optical Radiation at Work Regulations 2010 (SI ) General HSE (2000) Approved Code of Practice & Guidance on The Management of Health & Safety at Work Regulations 1999., Health and Safety Executive, HSE Books L21 Lasers MHRA (2008) Device Bulletin. Guidance on the safe use of lasers, intense light source systems and LEDs Radiation Safety Policy 15/23

16 in medical, surgical, dental and aesthetic practices. DB2008(3) MRI MHRA (2014) Safety Guidelines for Magnetic Resonance Imaging Equipment in Clinical Use, v4 7. Associated Policy and Procedural Documentation 7.1. Local rules and working instructions are available for staff in individual departments using potentially hazardous radiation equipment 7.2. The Trust IRMER procedures, protocols and justification criteria describing the framework for the management of medical exposures undertaken for imaging are available on the Trust intranet The Trust IRMER procedures relating to therapeutic uses of ionising radiation are accessible by the appropriate staff on the Trust intranet The Trust Procedure for the Reporting of Incidents The Trust Procedure for the Reporting and Management of Incidents including Serious Incidents Requiring Investigation The Trust Waste Policy. Radiation Safety Policy 16/23

17 Appendix A - Monitoring of the Policy MONITORING OF IMPLEMENTATION Inspections to cover risk assessments, personal monitoring, training (local rules, competencies to use equipment and IRMER) and equipment records Summaries of significant noncompliances and incidents with respect to the relevant legislation. Written report Patient Safety issues MONITORING LEAD Directors of Operations Departmental Manager/Relevant Protection Supervisor Chair of relevant branch Of Radiation Protection Committee REPORTED TO PERSON/GROUP Health, Safety and Environment Committee Chair of relevant branch of Radiation Protection Committee Director of Corporate Affairs / Chair of Patient Safety Group MONITORING PROCESS Directors of Operations will carry out a rolling inspections of their departments using standard template Verbal report to RPC (RPC members) or written report (non attending RPSs). Provide Patient Safety Group with a report highlighting by exception any Patient Safety issue that need to be addressed by the Trust MONITORING FREQUENCY Rolling Programme Annual As appropriate Written report Health and Safety Issues Chair of relevant branch Of Radiation Protection Committee Director of Corporate Affairs Chair of Health Safety and Environment Committee Provide HS&E with a report highlighting by exception any Health and Safety issues that need to be addressed by the Trust As appropriate Programme of radiological equipment performance and radiation protection surveys Periodic reviews of radiation protection programme including, Departmental Manager Chair of relevant Branch Of Chair of relevant branch of Radiation Protection Committee Chief Operating Officer, Director of Cooperative Review of written reports issued by Medical Physics and local quality assurance tests. Minutes of RPC Annual Bi-annual Radiation Safety Policy 17/23

18 e.g. action on survey recommendations, occupational and patient doses, and radiation incidents. Action from Radiation Protection committee meetings Radiation Protection Committee Chair of Group Health and Safety Meeting Affairs, Chair of Patient Safety Group, Chair of Health Safety and Environment Committee Group Manager Completed Actions Quarterly Radiation Safety Policy 18/23

19 Appendix B - Quality Assurance Programme (Ionising radiation) Task Responsibility Frequency Preventative maintenance Radiation Protection & equipment performance Surveys Calibration of radiation protection instrumentation Quality assurance test by department Commissioning test/critical examinations Personnel Monitoring Manufacturer/ Outside Service Contractor In-house clinical technologists (radiotherapy equipment) Radiation Protection Service Radiotherapy Physics Service Department Manager to arrange Department Manager An RPA (after notification) by department manager assessment by RRPPS review by line manager/rps as recommended Community dental: 3 yearly Hospitals x-ray: annually Mammography: 6 monthly Radionuclide facilities: annually Radiotherapy equipment: as specified in QS Annually As determined by local protocols before use on patients continuous, staff monitored as required in conjunction with advice from RPA Appendix C - Quality Assurance Programme (Lasers & Ultrasound, MRI) Task Responsibility Frequency Preventative maintenance Manufacturer/Supplier As recommended Radiation Protection Surveys & equipment performance Quality assurance test by department Commissioning test Radiation Protection Service Department LPA (after notification) MRSE (after notification) Annually As recommended by Adviser Before use on patients Radiation Safety Policy 19/23

20 Appendix D - Trust Organisation for the Radiation Safety Programme Chief Executive Chief Operating Officer Director of Corporate Affairs Divisional Directors of Operations Trust Health & Safety & Environment Committee and Patient Safety Group RPA, LPA, MRSE, RWA, DGSA Site Officers for radioactive materials Group Managers Departmental Managers Radiation Protection Committee (X-ray Branch) (Radionuclide Branch) (Radiotherapy Branch) (Non-Ionising Branch) Radiation/Laser etc Protection Supervisors All Staff Monitoring Advice Implementation Radiation Safety Policy 20/23

21 Appendix E - Training Requirements Activity General Safety Awareness Medical exposures Administrations of Radiopharmaceuticals Lasers Magnetic Resonance Imaging (MRI) Transport of radioactive materials Training Requirement All staff working with ionising or non-ionising radiation must be trained to follow the relevant local rules and safe working instructions in their department. All Practitioners and Operators must have received adequate training as required by the Ionising Radiation (Medical Exposure) Regulations 2000 (IRMER). They must have received adequate instruction, including practical experience, in the techniques being used. Staff acting as practitioners for the clinical administration of radiopharmaceuticals or the clinical use of sealed radioactive sources must have appropriate certification from the Administration of Radioactive Substances Advisory Committee (ARSAC) as required by the Medicines (Administration of Radioactive Substances) Regulations All staff administering radiopharmaceuticals to patients must have permission, in writing, from the ARSAC certificate holder covering the particular type of administration (examination). All staff acting as LPS or operating medical or surgical lasers must have received adequate training as specified in the Medicines and Healthcare products Regulatory Agency guidance (MHRA DB2008(3)). All staff operating MRI equipment must have received adequate training and be approved by the responsible person listed in the local rules (MRI) as specified in Medicines and Healthcare products Regulatory Agency guidance (MHRA 2014). All staff transporting radioactive materials must be trained as required by The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations Radiation Safety Policy 21/23

22 Appendix F - Local Radiation Safety Audit 1. N (A component for Div Ops Health and safety Audits) Criteria Explanation Comments Risk assessments The risk assessment may be in the Trust YES/NO general format or may be specific to the a. Have risk assessments been completed type of radiation (e.g. x-rays, lasers) to cover the radiation risk in the department b. Are the risk assessments kept up to date YES/NO c. Have any actions required by the risk YES/NO a. Radiation Safety Policy 22/23 assessment been completed Training Local Rules Are local rules readily available for staff to access? b. Is there evidence that staff have read and understood the local rules? c. Other Training Records Records of basic training d. IRMER training Do staff know where to find relevant Trust IRMER procedures and protocols? e. Is there evidence that staff are familiar with these procedures & protocols Personal Monitoring a. Are staff wearing personal radiation monitors Local rules should exist to cover the safe use of x-rays, radioactive materials, magnetic resonance scanners, radiotherapy equipment, lasers, ultraviolet equipment etc. They should be readily available e.g. on intranet. Evidence may be signatures, training records). Cover several staff including clinicians in audit Are there some kind of competency records demonstrating staff are suitable trained to use equipment Application training records? Any staff involved with involved with exposing patients to ionising radiation exposures (practitioners and operators) should be familiar with Trust procedures and protocols E.g training records,pdrs Only applies for ionising radiation areas (x-ray, users of radioactive materials and radiotherapy) Cover several staff including clinicians in audit YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO b. Is the personal monitor they are Whole body badge have the issue period YES/NO

23 4. N wearing up to date Radiation Equipment a. Is a log kept of maintenance and repairs on the radiation equipment b. Are there records of regular quality assurance test performed by the department, including test after maintenance visits. marked on them This should apply whether maintenance is carried out by a third party or in house QA tests are required for ionising radiation equipment such as x-ray sets, nuclear medicine imaging equipment, radiotherapy treatment machines YES/NO YES/NO Radiation Safety Policy 23/23