Ionising Radiation Safety Type: Policy Register : 14022 Status: Public Developed in response to: Contributes to CCQ Core Outcome 4 For compliance with the Ionising Radiations Regulations 1999 Consulted With Post/Committee/Group Date Jane Renals Imaging Services manager December 2017 Dr Nicholas Railton Lead Radiologist December 2017 Professionally Approved by: Technically Approved by: Radiation Protection Group Patricia Clinch Radiation Protection King s College Hospital December 2017 Version Number 2.0 Issuing Directorate Radiology Ratified by: DRAG Chairmans Action Ratified on: 2 nd January 2018 Trust Executive Sign Off Date February 2018 Implementation Date 30 th January 2018 Next Review Date December 2020 Contact for Information Andrea Francis, Radiology Governance/Clinical Lead Policy to be followed by (target staff) All Trust staff who work with or are involved in work with ionising radiations Distribution Method Intranet & Website Related Trust Policies (to be read in conjunction with) Risk Management Strategy and Policy Health and Safety Policy Health & Safety Policy Radiation Safety Management: Ionising and n Ionising Radiations, Radioactive Substances and Medical Radiation Exposures, n-ionising Radiation Safety policy Document Review History Version Reviewed by Active Date 1.0 Andrea Francis, Radiology September 2014 2.0 Andrea Francis, Radiology 30 January 2018 1
Contents 1. Purpose 2. Introduction 3. Scope 4. Commencing Work with Ionising Radiations including Radioactive Substances 4.1 Prior notification to the Radiation Protection Adviser (RPA) 4.2 Designation of areas 4.3 Prior radiation risk assessment 4.4 Radiation Protection Supervisor (RPS), local rules and contingency plans 4.5 Prior authorisation and training 5. Duties of Employees 6. Personal Dosimetry 6.1 Dosimetry programme 6.2 Dose Investigation Levels 6.3 Duties of staff 6.4 Working at other hospitals 6.5 Classified persons 7. Use of Personnel Protective Equipment (PPE) in X-ray Rooms and Theatres 7.1 Duties of staff 7.2 When to wear PPE - fluoroscopic procedures (fixed installations) 7.3 When to wear PPE - CT procedures 7.4 When to wear PPE - mobile radiography and fluoroscopy (e.g. in wards and theatres) 7.5 Labeling and testing PPE 8. Management of Radioactive Substances 9. Management of Radiation Equipment 9.1 Selection of equipment 9.2 Critical examination 9.3 Commissioning 9.4 Routine performance testing 9.5 Maintenance 10 Training 11 Monitoring & Auditing 12 Communications and Implementation 13 Equality and Diversity 2
14 References 15 Appendices Appendix 1. Personal Dosimetry Questionnaire Appendix 2. Instructions for use of dosemeters 3
1. Purpose 1.1 The purpose of this document is to set out requirements on all staff who use or who are involved in the use of ionising radiation and/or radioactive substances on Trust premises. This includes the use of X-ray generators and the use of sealed or unsealed radioactive sources. Further Trust Procedures for the Control of Radioactive Substances give additional requirements for those staff using radioactive sources in order to meet the conditions of Environment Agency Permits. 2. Introduction 2.1 The Trust has implemented the following levels of documentation to ensure compliance with legislative requirements regarding radiation safety: 2. Introduction 2.1 The Trust has implemented the following levels of documentation to ensure compliance with legislative requirements regarding radiation safety: Level 1: Policy on Radiation Safety Management This policy is the overarching management document and is prepared by the Radiology department in conjunction with the Radiation Protection Adviser. Level 2: Trust-wide Procedures entitled: Trust Procedures addressing Ionising Radiation Safety, n-ionising Radiation Safety and the Control of Radioactive Substances that are written by the appropriate Advisers. Trust Procedures for Medical Exposures (standard operational IR(ME)R) that are written by the Head of the Department that undertakes the medical exposures in liaison with other senior staff and a Medical Physics Expert. Level 3: Departmental Instructions including: Departmental Local Rules that are the key safety instructions for staff and visitors. These are written by the appropriate Adviser, in liaison with the Head of Department and the appropriate Radiation or Laser Protection Supervisor. Departmental Standard Operating Procedures or Protocols that set out the way in which work with radiation is carried out or how clinical diagnosis or treatment is undertaken Level 4: Departmental Records: 2.2 These procedures, in conjunction with Departmental Local Rules and Standard Operating Procedures and Records, aim to address the requirements of the following legislation and guidance. HMSO. Ionising Radiations Regulations, 1999 SI 1999. 3232. [http://www.legislation.gov.uk/uksi/1999/3232/pdfs/uksi_19993232_en.pdf] HSE, 2000. Work with Ionising Radiations: Approved Code of Practice and Guidance (Health and Safety Executive, L121, 2000) [http://www.hse.gov.uk/pubns/books/l121.htm]. HSE 2001. Guidance te PM77 (3rd ed): Equipment used in connection with medical exposure. [www.hse.gov.uk/pubns/guidance/pm77.pdf] HSE and Health Departments, 2001. An employer s overview of the regulatory requirements for medical exposure from ionising radiation. [http://www.hse.gov.uk/pubns/books/hsg223.htm] I PEM, 2001. Medical and Dental Guidance tes. York: Institute of Physics and Engineering in Medicine 4
2.3 The Radiation Protection Advisers, supported by the Radiation Protection Service, fulfil other regulatory requirements on behalf of the Trust in accordance with their own Standard Operating Procedures. 3. Scope 3.1 This policy covers all staff who use or who are involved in the use of ionising radiation and/or radioactive substances on Trust premises. This includes the use of all X-ray generators within the Trust, mobile or static and the use of sealed or unsealed radioactive sources. 4. Commencing Work with Ionising Radiations including Radioactive Substances 4.1 Prior notification to the Radiation Protection Adviser (RPA) The Head of Department shall notify the RPA of an intention to commence new work or to make changes to an existing work practice with ionising radiation in sufficient time for the work to be reviewed by the RPA and for the mandatory requirements below to be executed. 4.2 Prior radiation risk assessment The Head of Department shall ensure that a prior radiation risk assessment is performed and reviewed and the findings implemented. The RPA shall prepare a generic risk assessment that is supplemented by a specific risk assessment written by departmental staff. Risk assessments shall be reviewed every three years or sooner if there are significant changes to the work practice. 4.3 Designation of areas The RPA shall advise on the need to control or supervise areas where work with ionising radiation is undertaken. 4.4 Radiation Protection Supervisor (RPS), local rules and contingency plans Departments with designated areas shall have local rules in place and one or more appointed Radiation Protection Supervisors to ensure that the local rules are adhered to. Staff working with ionising radiation shall sign that they understand and will abide by the local rules. The Head of Department shall ensure that contingency plans are in place for dealing with emergencies involving ionising radiation. These plans shall be outlined in the department s local rules. Staff shall be aware of contingency plans. 4.5 Prior authorisation and training Staff shall not undertake work with ionising radiation unless they are suitably qualified and trained and have received prior written authorisation to do so by the Head of Department. The Head of Department shall set out the requisite education and training requirements for the particular role, which shall include certificated training in radiation protection. 5. Duties of Employees 5.1 Any employee working with ionising radiation and/or radioactive substances shall: t knowingly expose himself or any other person to ionising radiation to an extent greater than is reasonably necessary for the purposes of his work. Abide by the departmental local rules and work instructions. Make full and proper use of any personal protective equipment supplied by the employer. 5
Report to the Trust, via the Head of Department and/or RPS, any defect in personal protective equipment. Ensure that personal protective equipment is correctly stored. Comply with any reasonable requirement for dose assessment. tify the Trust, via the Head of Department and/or RPS, if he has reason to believe he has received an overexposure. tify the Trust, via the Head of Department and/or RPS, of any radiation incident or accident involving staff, visitors or patients. tify the Trust, via the Head of Department and/or RPS, without delay if he has any reason to believe that radioactive substances or radioactive waste have been lost, stolen or escaped from the store or the premises. 6. Personal Dosimetry 6.1 Dosimetry programme 6.1.1 The following programme listed in the following tables is based on evidence of personnel monitoring results and/or assessments of likely radiation doses to staff undertaking work with radiation. 6.1.2 Personnel monitoring of any other staff not included in the staff groups below will be established following a risk assessment. 6.1.3 The extent of monitoring will depend on the type of work and the workload in accordance with Tables 6.1, 6.2 and 6.3 below. If the results show that doses are likely to exceed 1/10 of the relevant dose limit, then the Radiation Protection Adviser will advise on the frequency of monitoring and other protective measures that may need to be taken. The results will also be used to review the risk assessment for the area/room in question. Table A: Personal dosimetry requirements in cardiac and interventional radiology Staff group Clinician undertaking the procedure* Radiographer Clinician/ nurse assisting/ Radiographer with the procedure Nurses/ other staff attending to patient e.g. comforting/ monitoring Cardiac and interventional radiology Trunk badge beneath lead apron to measure whole body dose Type of dosimeter and position to be worn Collar badge outside lead apron to measure thyroid dose Eye dosimeter (to be worn on side nearest the primary beam) Finger ring to measure finger dose Nurses, radiographers and other staff 6
circulating in the room Technologists and other staff who always work behind a shielded screen within the X-ray room Table B: Personal dosimetry requirements in nuclear medicine Nuclear medicine Staff group Those who prepare and administer/inject radiopharmaceuticals Other technologists, scientists and consultants Type of dosimeter and position to be worn Trunk badge to monitor whole body dose Finger stall to measure finger-tip dose Radiographers in plain x-ray are not routinely monitored as determined by previous dose monitoring results but will be subject to ad-hoc monitoring. 6.2 Dose Investigation Levels 6.2.1 An investigation shall be undertaken by the RPA if during any monitoring period, any of the doses in Table D are exceeded. Table D: Dose investigation levels Period Whole body Collar (msv) Eye (msv) Finger (msv) (msv) 1 month 0.5 5 3 10 3 month 1.0 15 10 20 6.3 Duties of staff 6.3.1 Staff who are currently monitored for exposure to ionising radiation or who are about to be monitored shall complete a Personal Dosimetry Questionnaire and understand how they should be worn.(appendix 1and 2). 6.3.2 In accordance with the local rules, members of staff who are provided with a dosimeter shall wear it whenever they are working with radiation. Care must be taken not to inadvertently expose a dosimeter to radiation. Dosimeters shall be changed promptly at the end of each monitoring period. Legal duties are described in the HSE leaflet Wear your Dosemeter [http://www.hse.gov.uk/pubns/indg207.pdf]. 6.3.3 Loss of a dosimeter shall be reported to the RPS without delay. Should a badge be exposed to radiation when not being worn, e.g. left on the floor of an x-ray room, this shall 7
be reported to the RPS who will arrange for the issue of a replacement badge and investigate the dosimeter reading resulting from that exposure in liaison with the RPA. 6.3.4 A member of staff who suspects that she/he has been exposed to a greater radiation dose than is normal in the course of their work shall report this to the RPS, who will consult the RPA. 6.3.5 Willful failure to wear a personnel dosimeter when requested by the Radiation Protection Supervisor/Manager will be treated as a disciplinary offence by the Trust. 6.4 Working at other hospitals 6.4.1 Where a member of staff works with an outside employer who also uses ionising radiation they shall declare this on the Personal Dosimetry Questionnaire. The outside employer will be contacted to ensure that dosimetry arrangements are in place to correctly monitor staff in both employments and ensure that the total dose is estimated. It is the responsibility of the staff member to inform the Trust of all changes to their outside working arrangements. This includes the employee acting in a self-employed manner e.g. doctors working for private hospitals or radiographers working as locums or other part-time work with another organisation. 6.5 Classified persons 6.5.1 Any member of staff likely to exceed 3/10 of any annual dose limit shall be designated as a classified person. If at any time there are classified persons employed by the Trust, the Head of the Occupational Health Department shall be advised by the RPA so that a suitably qualified clinician within that Department, recognised by the Health and Safety Executive, may act as an Appointed Doctor to perform medical surveillance on the classified persons. 7. Use of Personnel Protective Equipment (PPE) in X-ray Rooms and Theatres 7.1 Duties of staff 7.1.1 Staff shall wear the PPE provided in accordance with the local rules and work instructions for the controlled area in which they are working. Staff shall not stand behind other members of staff in the controlled area without wearing PPE. 7.1.2 Refusal to wear protective clothing when it is a requirement of the local rules is an offence contrary to Section 7 of the Health and Safety at Work etc Act and will be treated as a disciplinary offence by the Trust. 7.1.3 Proper storage of lead aprons is important to maintain the integrity of the lead. Aprons need to be hung from the shoulders on a proper lead apron rack. Aprons shall not be folded as this promotes cracking. 7.2 When to wear PPE - fluoroscopic procedures (fixed installations) 7.2.1 Staff who cannot remain behind a lead protective panel shall wear appropriate PPE in accordance with the Work Instructions for the room/theatre. If PPE is not worn, then they should be asked to leave the room. For work with x-ray energies of less than 100kV, body aprons (tabard or two-piece) with a lead equivalence of 0.25 mm or greater shall be worn. For work with x-ray energies in excess of 100kV, body aprons (tabard or two-piece) with a lead equivalence of 0.35 mm or greater shall be worn. With an overcouch X-ray tube, C-arm, or other fixed Fluoroscopy units, lead glasses and a thyroid shield shall also be worn by those standing next to the patient, unless a suspended protective shield can be used. 8
7.3 When to wear PPE - CT procedures For CT interventional work, body aprons (tabard or two-piece) with a lead equivalence of 0.35 mm or greater, thyroid shields and lead glasses shall be worn. 7.4 When to wear PPE - mobile radiography and fluoroscopy (e.g. in wards and theatres) A lead protective apron (tabard or two-piece) with a lead equivalence of 0.25 mm or greater shall be worn by those who have to stand within the controlled area i.e. within 2 m around the X-ray tube and patient. For all theatre procedures, all members of staff within in the theatre should wear lead coats. 7.5 Labelling and testing PPE 7.5.1 Each item of PPE shall be labeled with a unique identifier that is recorded in the Departmental Radiation Safety Records Folder. In addition, a record with information regarding the last inspection for each lead apron should be kept. This will let staff know the date of the last inspection and that the apron passed. If the record shows that a lead apron has not been tested routinely, this should be recorded in the Radiation Safety Folder and the Radiation Protection Supervisor shall be notified. 7.5.2 Protective aprons and/or thyroid shields used in Cardiology and Theatre 19 shall be checked yearly by X-raying radiographically or preferably fluoroscopically for defects. In addition, visual checks of all PPE shall be made and recorded at least 6-monthly. Staff should also be encouraged to report defects at any time. Check also for perished lead rubber accumulating at the bottom of an apron inside the lining. A record of the date of the check, the type of check and who performed the check shall be recorded in the Departmental Radiation Safety Folder. 7.5.3 If a defect is found at the time of the inspection or on any other occasion, the item shall be removed from service immediately. An entry shall be made in the PPE record noting when the apron was removed from service. 7.5.4 Protective aprons and thyroid shields shall be removed from service if the protective layer has one of more cracks (except on top of the shoulder region of an apron). Pinholes do not signify failure unless there are many of them in a particular area. An apron showing signs of perishing shall be rejected. Lead glasses that have a cracked lens or damaged frame shall be repaired or replaced. 7.5.5 If an apron or thyroid shield has defects that do not quite meet the rejection criteria, they shall be monitored frequently and results recorded. 8. Management of Radioactive Substances 8.1 All aspects of the management of both closed and open radioactive sources including their acquisition, storage, use and disposal are addressed in a parallel document: Trust Procedures for the Control of Radioactive Substances. 9. Management of Radiation Equipment All the following paragraphs are applicable to equipment intended for medical exposures. Other equipment that emits ionising radiation but which is not intended for medical exposure is subject to the first parts of paragraphs 9.1, 9.3 and 9.5. 9.1 Selection of equipment 9.1.1 If a department intends to purchase, hire or otherwise obtain equipment that emits ionising radiation, the Head of Department must be satisfied that it is suitable and appropriate for the purpose for which it will be used. The Radiation Protection Adviser (RPA) shall be 9
consulted to provide advice on radiation protection matters such as shielding requirements for the installation. 9.1.2 If the equipment is intended for medical exposures then the Medical Physics Expert (MPE) shall also be consulted for advice. 9.2 Critical Examination 9.2.1 All equipment intended for medical exposures shall have a critical examination carried out on it. This shall be undertaken by the installer to ensure that the safety features and warning devices incorporated into the equipment are operating correctly and that there is sufficient protection of the staff and visitors against exposure to ionising radiation. The relevant Head of Department shall ensure that this critical examination is completed. 9.3 Commissioning 9.3.1 The Head of Department shall ensure that all radiation equipment is checked for radiation safety by the RPA before it is put into use. 9.3.2 The Head of Department, in consultation with the MPE, shall ensure that all equipment intended for medical exposures is subject to commissioning tests. The results of these tests shall be used as a baseline with which to compare future performance tests. 9.4 Routine Performance Testing 9.4.1 Routine performance testing shall be carried out regularly by staff using the equipment for medical exposures and annually by the Radiation Protection Service to monitor the performance of the equipment. 9.5 Maintenance 9.5.1 All radiation equipment shall be under a regular maintenance contract. Any work carried out on the equipment that may affect radiation safety shall be noted on the service report and shall be checked by the RPA before the equipment is put back into use. 9.5.2 Any work carried out on equipment used for medical exposures that may significantly affect patient dose (such as changes to X-ray output or factors relating to image quality) shall be noted on the report/handover form. The handover procedure shall be used to ensure that equipment is suitable for clinical use following service, repair or testing. 9.6 Equipment Replacement Programme 9.6.1 The Head of Department shall ensure that a replacement program is in place for equipment used for medical exposures. 10. Training 10.1 Training will be required for all employees required to work with or are involved in work with ionising radiation. 10.2 The Head of the Department shall set out the requisite education and training requirements for staff to ensure they are competent and confident with procedures. Legislation and equipment associated with ionising radiation. This will include certificated Radiation Protection Training for each x-ray modality area within the Trust. 11. Monitoring & Auditing 11.1 All risk events that have resulted in patient harm or near misses, must be reported via the Datix web system. The RPS will review all risk events. All incidents and any trend analysis will be reviewed at the Radiation Protection Group. 10
11.2 A quarterly audit of compliance will be undertaken by reviewing all risk events related to the operation of this guideline. 11.3 Any immediate training or educational issues relating to the lack of compliance with this guideline will be addressed on a one to one basis. 12. Communications and Implementation 12.1 The RPS will be responsible for issuing copies to relevant Heads of Departments to disseminate to relevant staff and ensure they fully understand the guidelines. 12.2 The approved procedure will be notified in the Trust s Staff Focus and made available on the Trust s intranet & website. 13. Equality & Diversity 13.1 The Trust is committed to the provision of a service that is fair, accessible and meets the needs of all individuals. 14. References The Health and Safety at Work Act, 1974 (HASAW). Radiation Safety Management Ionising Radiations and non ionising Radiation, Radioactive Substances and Medial Radiation Exposures Policy number 13005 The Ionising Radiation Regulations 1999 (SI 1999 3232) (IRR). The Environmental Permitting (England and Wales) Regulations 2010. (SI 2010 675) and amendment 2011 (EPR). The Ionising Radiation (Medical Exposures) Regulations 2000. (SI 2000 1059) and amendments 2006 and 2011 (IRMER). The Medicines (Administration of Radioactive Substances) Regulations 1978 (SI 1978 1006) and amendment 1995 (MARS). Trust Procedure for the Control of Radioactive Substances. Policy number 14015 n Ionising Radiation Safety Policy Number 14020 Departmental standard operating procedures/protocols, local rules and records. 11
Appendix 1. Personal Dosimetry Questionnaire All staff monitored for exposure to ionising radiation must complete this form and sign the declaration. Title Surname Male/Female Start date of monitoring at this Trust Department Forename (s) Maiden Name Date of Birth Location Occupation Please give details of any outside employment in the current calendar year where you are/were employed as a radiation worker. Are you employed to work with radiation outside the Trust? Are you employed by an Agency? / / Outside Employers Name and address of other places of work Employment From To Occupation 12
Are you /were you designated as a classified person in any of your places of work? / If so, which ones? Appendix 2. Instructions for the use of dosimeters Dosimeters will be issued for periods that are set out in Section 4 of the Trust Procedures for Ionising Radiation Safety; these are determined by the type of radiation work that you undertake. All dosimeters issued to staff must be worn at all times when working with radiation. The basic types of dosimeter are: Whole body dosimetry badge (TLD badge). These are to be worn between waist and shoulder on the front of the body and on the side nearest the primary beam under the lead apron (when worn). They must not be worn in pockets. Please refer to http://www.hse.gov.uk/pubns/indg207.pdf for information on how to wear your badge. Eye dosimetry badge (TLD badge). These are worn at collar or shoulder level, outside the lead apron and thyroid shield as an indicator of maximum dose to the eye. Finger dosimeter (TLD). These are of the ring type and must be worn when issued to staff at all times when working with radiation. They will be worn under gloves so that they are not affected by radioactive contamination. They are worn on the finger closest to the radiation source. When not being worn, dosimeters must be kept out of radiation areas. Failure to wear a dosimetry badge, when issued, may result in individual prosecution of that staff member by the HSE. At the end of the monitoring period staff will ensure that their badge is available for collection. Loss of a dosimeter must be reported to the Radiation Protection Supervisor (RPS) without delay. Should a badge be exposed to radiation when not being worn e.g. left on the floor of an X-ray room, then this must be reported to the RPS, who will arrange issue of a replacement badge and investigate the dosimeter reading resulting from that exposure with the Radiation Protection Adviser (RPA). Should a member of staff suspect that they have been exposed to a greater radiation dose than is normal in their course of work they should report this to the RPS, who will consult the RPA. DECLARATION I will wear all radiation dosimeters issued to me when working in radiation areas, and will store these correctly when they are not in use. I understand that I may be at risk of prosecution if I fail to wear or use my dosimeters as instructed, and I will make my dosimetry badges available for collection at the end of the wear period. I understand I may be refused by this Trust access to work with radiation if I fail to use my dosimetry badge correctly. I will declare any outside employment* that involves me working with ionising radiation and will co-operate to enable my employers to monitor the doses of radiation I receive in my employments. 13
SIGNED DATE Please return the completed questionnaire to the RPS in the Radiology Department. Thank you for your co-operation. * te: Regulation 15 of the Ionising Radiations Regulations 1999 (IRR99) requires cooperation with other employers to ensure that each can comply with the Regulations. Co-operation is particularly important where staff employed by this Trust, work with ionising radiations in another Trust, private practice or as self-employed practitioners doing occasional work outside the Trust. By filling in this questionnaire, you will be helping us to comply with the legislation. 14