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ST HELENS + KNOWSLEY NHS TEACHING HOSPITAL TRUST Specification for Radiation Protection Advisor (RPA) Services. OCTOBER 2014 Contents Page 1. Legal requirements 3 2. Radiation protection advice 4 3. New Installations 5 4. Training 5 5. Quality Assurance 5 6. Dosimetry 6 7. Unintended or Accidental Doses 7 8. Dose Audit 7 9. Radiation Safety Surveys 8 10. Breast screening 8 11. Nuclear medicine 9 12. Radio-pharmacy 10 13. Non-ionising Radiation 10 Magnetic resonance imaging Ultrasound Medical Lasers 10 11 11 14. Equipment Performance Checks 13 2 1. Legal Requirements The RPA is expected to be able to provide radiation safety advice and the appropriate scientific and technical support necessary to enable full compliance with the statutory requirements relating to work with ionising radiation. This will include: 1.1 IRR(99) The Ionising Radiation Regulations (IRR 99) statutory instrument 1999 No. 3232, state that every radiation employer shall consult such suitable radiation protection advisors (RPA’s) as are necessary for the purpose of advising the radiation as to the observance of the regulations and the matters which are set out in them. The radiation employer shall appoint the RPA in writing and shall include in that appointment the scope of the advice which the RPA is required to give. Requirements set out in IRR (99) include: Prior risk assessment before commencing any new work involving ionising radiation i.e. installation of new x ray equipment. Restriction of exposure and dose limitation. Contingency plans in the event of adverse incidents. Instruction and training of staff. Production of local rules. Designation and monitoring of classified persons. Investigation of overexposure. Arrangements for the control of radioactive substances, articles and equipment. Medical Physics Expert. 1.2 IR(ME)R 2000 The Ionising Radiation (Medical Exposure) Regulations 2000, statutory instrument 2000 No. 1059 include: Justification, optimisation and auditing of medical exposures. Access to expert medical physics advice regarding dose optimisation, dosimetry and quality assurance services. 1.3 IPEM 88 In addition the Institute of Physics and Engineering in Medicine – Report 88 – Guidance on the establishment and Use of Diagnostic Reference Levels for Medical X Ray Examinations requires the regular auditing of patient doses to ensure compliance with National DRLs. 3 2. Radiation Protection Advice Advice and assistance must be available by telephone or e-mail at any time during normal working hours. The RPA must keep the Trust updated on the contact details of all relevant staff and provide regular updates on their work and services to Trust users. The RPA must send a representative to the Annual Radiation Safety committee meeting and produce a written report on their work for the Trust on an annual basis. The RPA must be able to provide personnel on site at short notice as and when required to assist in the continuity of the business of the radiology department and the utilization of capacity. The RPA service will be required to cover all radiation equipment owned / loaned / leased or within an mes arrangement by the Trust whether on site or mobile units and any new equipment purchased / loaned / leased by the Trust after the commencement of the contract. Examples of the type of advice which may be required shall include: Legal requirements and their interpretation. Quality assurance and dose audit. Production of local rules, radiation safety polices and other documents. Equipment installation and maintenance. Radiation risk assessments. Appointment and training of radiation protection supervisors and other staff affected by work with ionising radiation Personnel dose monitoring. Environmental monitoring Advice regarding unintended or accidental doses or any other adverse incidents involving ionising radiation. Assessment of foetal doses for patients subsequently found to be pregnant after a radiological examination. Drawing up of contingency plans. Advice on the consequences of future radiation legislation Advice on compliance with HSE requirements, meeting with the HSE to discuss specific and general protection problems and liaison with the DoH over equipment failure problems The performance of critical examinations, with the agreement of both the supplier and customer Prior examination of plans for new equipment, installations and processes, and also any subsequent modification having radiation safety implications. Medical Physics Expert. 4 3. New Installations The RPA will be expected to advise on the design of new installations and the modification of existing facilities, including: Ensuring equipment used for medical purposes is designed and installed so as to be capable of restricting as far as is reasonable, the radiation exposure to the patient. The prior examination of plans and proposals, including relevant aspects of building design. Advice on equipment specifications and evaluation of new equipment. Surveys of new and modified installations to test conformity with design. 4. Training The RPA must provide a formal training course for at least two people on an annual basis to enable key staff to be able to fulfil the requirements of the Radiation Protection Supervisor role, and also regular updates for these staff. There is also a need to provide training in the safe use of medical lasers. There is also a requirement for at least one days training per year on relevant aspects of radiation safety to any number of Trust staff at a time and site specified by the radiology department. The RPA must also be available to provide initial and ongoing training and support in the use of any new radiation safety systems or equipment as required. 5. Quality Assurance All equipment using ionising radiation for medical imaging purposes is required to have regular quality assurance checks with regard to tube output, limitation of field size and quality of image display. The RPA needs to give guidance as to which specific tests are required for each piece of equipment and at what frequency, the purchasing of specialist equipment required for performing the tests and the tolerance limits for the results of any such tests. The RPA should also provide a calibration service for any QA equipment used. The RPA will advise and assist the Trust in establishing in-house quality assurance programmes, which may incorporate the following elements: Reject analysis 5 Simplified X-ray tube and generator performance checks Simplified X-ray image intensifier – TV system performance checks Radiographic image quality checks when problems arise Automatic exposure control checks X-ray beam size and collimation checks CR processor monitoring. Digital Acquisition Systems (DR) PACS Display Components Ultrasound imaging equipment performance Patient dose audit Link with equipment providers and Radiology Information System to extract dose data The RPA also needs to provide an electronic system for the recording of all QA data with initial and on going training in the use of the system for all relevant staff. The Trust currently uses an electronic Quality Assurance and Dose Data System (QADDS). QADDS enables the Trust to undertake patient dose audits from any computer with an internet connection, improving accuracy and saving time in the department. Performance indicators, such as x-ray tube outputs and mean patient doses are easily viewable through the bespoke database and charting functionality. QADDS is ISO-compliant to the TickIT standard for software development. It is essential that this system is retained or a suitable substitute system with identical functionality be offered. The functionality of any systems offered must be detailed in the tender response. Any such system offered must be itemised and shown as a fully costed option in the response (This includes any hardware requirements, if required, installation and training and on going support). This will ensure all tenders provide comparably offers and hence will allow the Trust to make a like for like comparison of the core services. The Trust can then also opt to include or exclude these electronic systems. 6. Dosimetry Provision of a comprehensive dose monitoring service for the environment, staff and patient escorts to enable Trust compliance with current legislation to include: Advice on the extent and frequency to which personnel monitoring and environmental surveys are required. Provision of a comprehensive monitoring service to enable the Trust to demonstrate compliance with Regulation 8[1] and 18[2] of Ionising Regulations 1999 6 Advise on the provision, maintenance and testing of safety features and personal protective clothing. Maintenance of relevant records, including individual dose records, on behalf of the Trust in accordance with IRR 99, to include annual summaries. To provide the HSE with relevant summaries of dose records. Assisting in the assessment of doses where dosimetry equipment is lost or destroyed. Where appropriate the RPA will provide advice and assistance in monitoring intakes of radioactive material by staff and patients of the Trust, by means of the whole body monitor, whenever practicable in a manner approved by HSE. Where appropriate, the results of such monitoring will be included in individual dose records in accordance with statutory requirements and the conditions described earlier. To alert the Trust to any abnormally high dose readings, or overexposure of staff and to advise and assist in the investigation of these. Investigation of any annual cumulative staff dose which exceeds an effective dose of 6.0 mSv or of any equivalent dose limit. Investigation when doses received by staff are believed to be much greater or less than that recorded on individual dose meters Investigation when the results of any environmental dose monitoring indicates unsatisfactory conditions and when appropriate, liaison with manufactures representatives. 7. Unintended or Accidental Doses Estimation of foetal doses for patients subsequently found to be pregnant following radiological investigation and the potential impact of these, to include deterministic effects of foetal irradiation of increased lifetime cancer risk. These reports should be available within two working days of notification by Trust. Estimation of patient dose because of suspected equipment faults or operator error and the potential impact of these to include increased lifetime cancer risk. These reports should be available within two working days of notification by Trust. Advice regarding notification to the Care Quality Commission or other organisation following unintended or accidental doses. Advice to prevent re-occurrence of any unintended or accidental dose. 8. Dose Audit Provision of a dose audit service for those examinations which have national DRLs, using data sent electronically to the RPA from the radiology information system (RIS). 7 Comparison of results between national DRLs and actual exposures; and the establishment of local and regional DRLs by comparison with RIS data from other Trusts. Advice and support regarding collection of dose data and interpretation of any results. Provision of other data and information regarding aspects of radiation safety using information as recorded on the RIS. The RPA will be pro-active in providing advice/input into changing examination protocols and techniques, for example the transition from barium enema to CT colonography. 9. Radiation Safety Surveys The RPA will be expected to ensure that all hospital departments where ionising radiations are used routinely are visited at least annually, in order to review, in consultation with heads of departments (or their nominees), the protection measures laid down. A radiation survey of the working environment and review of protection measures should be carried out, in consultation with the Radiation Protection Supervisor (RPS) at specified intervals. The results of all surveys, together with any recommendations will be submitted in writing to the RPS, which should draw attention to any aspect of the equipment or other radiation safety provisions which fail to comply with relevant radiation safety legislation, codes of practice, guidance notes or British standards. Surveys should be performed in accordance with a routine programme. In addition all new installations and any equipment which has undergone major modification should be surveyed and inspected before coming into routine use with patients. Radiation safety checks and status checks of equipment should be carried out by arrangement with the department Leads / Operational Manager for each area at specified periods. The RPA will undertake to supply reports on periodic assessment checks to the RPS within one month from the end of the survey. However, any x-ray equipment, which at the time of the survey, fails testing procedures, or has radiation safety implications associated with it will be brought to the attention of the radiographer in charge at the time of the survey. The RPA will also as part of the radiation safety survey advise on any radiation safety documentation, policies and procedures and record keeping and make suggestions for improvement as required. 8 10. Breast Screening Regulation 9 of IR(ME)R 2000 requires a Medical Physics Expert to provide advice and support on the optimisation of radiation dose and image quality in line with relevant NHSBSP and other professional guidance. Performance testing of mammographic x-ray systems and associated equipment is required by Regulation 32 of IRR 99 and in compliance with recommended IPEM and NHSBSP standards. The RPA will provide advice on the selection of equipment for breast screening. This includes all radiographic and ultrasound items and instruments used for performing quality control tests. This includes the purchase of new equipment, relocation of existing equipment, the need to replace existing equipment and the timing of such replacements. Acceptance and commissioning tests will be performed on all new equipment before use, including those used for screening, assessment and stereotactic localisation attachments. Performance testing of mammographic equipment will be undertaken twice yearly. All tests will be performed according to agreed regional protocols that conform to Commissioning and Routine Testing of Mammography X-Ray Systems (currently IPEM 89) and Commissioning and Routine Testing of Full Field Digital Mammography Systems (currently NHSBSP Equipment Report 0604). Relevant tests will also be performed following replacement of the x-ray tube or AEC, or after major breakdowns. These will be done before the unit reenters clinical service. Acceptance and commissioning tests will be performed on all new ultrasound equipment before use. Performance tests will be undertaken twice yearly. All tests will be performed according to agreed regional protocols that conform to Further Revisions to Guidance Notes for Ultrasound Scanners in the Examination of the Breast, with Protocol for Quality Testing (MDA 98/52). Relevant tests will also be performed following replacement of the transducer, or after major breakdowns. These will be done before the unit re-enters clinical service. A written report will be submitted to the director of the Breast screening unit and a copy to the Principal Radiographer within 4 weeks of the survey date. 11. Nuclear Medicine 9 The RPA will provide advice and support to the Nuclear medicine Department. The working environment, where necessary, to be surveyed together with a staff survey of clothing and parts of the body at least biennially in all diagnostic X-ray departments Applications by staff of the Trust are sent to the RPA for approval prior to going to the Administration of Radioactive Substances Advisory Committee of the Department of Health. The allocated RPA will advise the Trust in obtaining from the Environment Agency Inspectorate as and when required, appropriate registration to keep and use radioactive substances and for the authorisation to dispose of radioactive waste and to advise the Trust on the most appropriate manner of compliance with such registration/authorisations. The RPA will maintain central records summarising waste disposal and check at least annually that departments are complying with the conditions of the authorisations or exemption orders. 12. Radio pharmacy (Where applicable) The RPA will also provide advice and support to the radio-pharmacy department to include monitoring or personnel and the environment as detailed in section 6. There will be radiation safety surveys on a monthly basis in this area and advice and support in any emergency situations. 13. Non-ionising Radiation Radiation safety surveys and advice are also required in relation to work with non-ionising radiations e.g. magnetic resonance, ultrasound and medical lasers. Magnetic Resonance Imaging The RPA will provide advice regarding the methods of complying with the requirements of any relevant statutory provisions and codes of practice together with any other aspects of radiation safety which are considered necessary by the Trust. Examples include: Assessment of levels of exposure to patients in order to check that these are within national guidelines. 10 Assessment of levels of exposure in the working environment in order to check that these are within national guidelines. Assessment of imaging performance on acceptance and annually thereafter. Setting up QA tests and training local staff in the performance and interpretation of the tests. Advice and guidance on the safe operation of MR units and collaboration with local staff in the preparation and regular review of local rules. The interpretation and significance of exposures Prior consideration of proposals for new installations and any relevant matters raised by HSE inspectors. Ultrasound The RPA should provide services to enable the Trust to comply with advice and requirements form regulatory and advisory bodies e.g. DOH, HSE; including scientific and technical support on all aspects of the use of ultrasound. The schedule of work to be undertaken is detailed in the appendices. The service provision will include: Advice on the procurement of ultrasound systems and related peripheral equipment, including preparation of specifications, the appraisal of tenders and advice on the disposal of equipment. Performance testing of equipment. Advice on the safety of ultrasound techniques. Assistance with in-house quality assurance programme. Medical Lasers The RPA must provide advice and scientific and technical support to enable the Trust to comply with current legislative requirements. The schedule of work required is detailed in the appendices. Service provision is expected to include: Advice on the purchase and installation of laser equipment Advice on safe use of laser equipment Hazard assessment of laser installations Assistance in writing local rules Advice and assistance to the local Laser Protection Supervisor Advice on maintenance The Company will provide the Trust with suitably qualified and experienced Laser Protection Advisers (LPA’s) who shall have the following duties and responsibilities in all departments where work is 11 undertaken with laser equipment in classes 3b or 4 which gives rise to a significant radiation hazard. The LPA will provide advice regarding the methods of complying with the requirements of any relevant statutory provisions and codes of practice together with any other aspects of radiation safety which are considered necessary by the Trust. The LPA will provide advice and assistance in identifying those departments where a significant hazard from laser radiation exists and will ensure that all such departments are visited in order to review in consultation with heads of departments (or their nominees), the protective measures laid down. The LPA will provide advice and assistance with regard to the provision of appropriate arrangements for the working environment to be inspected and for the equipment to be surveyed on installation of a new source of laser radiation which entails a significant hazard, prior to the source coming into regular use and at least annually thereafter. The annual check of the performance of laser equipment in classes 3b and 4 will include: Checking that the equipment incorporates the radiation safety features specified in relevant DOH guidance notes and British Standards Checking that the maximum power output of the aiming beam is within the limits specified by British Standards Checking that the level of laser radiation is within 20% of that indicated by the meter readings or equipment settings as required in BS EN 60825 The Company will submit reports of inspections of medical lasers and laser controlled areas to the particular Laser Safety Officer with a copy to the Laser Protection Supervisor and the Medical Engineering Manager. The LPA will also advise and assist the Trust with regard to: The interpretation and significance of exposures Drawing up local rules, where appropriate Prior consideration of proposals for new installations having safety implications The provision, maintenance and testing of safety features and the requirements for testing personal protective equipment, where appropriate Verification of the supplied protective eyewear specification in accordance with BS EN 207 12 Any relevant mailers raised by HSE inspectors The appointment of departmental Laser Protection Supervisors The identification of laser controlled areas The Company shall assist the Trust in the registration and inspection of nonNHS premises using lasers, as required in relevant Health Circulars. With regard to this service the Company shall be entitled to charge an additional fee per inspection. The Company will assist the Trust to maintain the following records on behalf of the Trust: Details of all sources of non-ionising radiation identified which may constitute a significant hazard. Reports of all surveys, inspections and investigations carried out. The Company will submit annual reports to the Chief Executive of the Trust, or his nominee, of work undertaken by the Company in relation to non ionising radiation. 14. Equipment Performance Checks As part of the equipment survey as detailed above the RPA will ensure suitably qualified staff carry out the following safety and performance checks on those items of radio diagnostic and dental X-ray equipment specified below: X-ray tube and generators Miscellaneous checks of general radiation safety features X-ray output – Consistency and reproducibility Variation with kV setting Linearity with change in mA setting Linearity with change in exposure time setting Output waveform Screening doses to patients X-Ray tube filtration Exposure timer accuracy and consistency Accuracy of tube voltage settings X-ray beam filtration and half value thickness Alignment of X-ray field, light field and image receptor area Perpendicularity of X-ray beam to image receptor area Focal spot size X-ray tube and diaphragm leakage DR Detector based systems TOMOSYNTHESIS 13 Image intensifier – television systems Automatic brightness control – dose rate settings Field size and distortion TV grey scale test Limiting resolution – high contrast Low contrast imaging performance Overall imaging performance Conversion factor – if necessary Contrast ratio – if necessary Photo-fluorographic camera systems/digital units All the checks described above for the intensifier – TV System Fluorographic speed Field size and distortion Limiting resolution – high contrast Low contrast imaging performance Overall imaging performance Imaging performance in rapid sequence operation Flat panel detectors Automatic exposure control systems Reproducibility of radiographic density levels Check radiographic density levels are within acceptable range Consistency with change in control chamber Consistency with change in kV Consistency with change in mA (where applicable) Consistency with change in patient thickness Conventional tomographic systems Cut height calibration Cut height increment/decrement calibration Consistency of movement and radiation output Accuracy of angle of swing and symmetry DR tomosynthesis Mammographic systems All checks described above for x ray tubes, generators and AECs where applicable. Measurement of patient dose Assessment of image quality Dental X-ray machines Miscellaneous checks on general safety features Field size measurement Minimum focus–skin distance Accuracy and consistency of exposure timer Check on performance of Auto Technic control systems 14 X-ray output -Consistency Linearity V. time, auto-technique Magnitude Scatter measurements – upon request Patient dose Accuracy of tube kilo voltage Adequacy of mains supply X-ray beam filtration and half value thickness CT Scanners X-ray tube output Focal spot size Accuracy of tube kilo voltage Image noise Pixel size Spatial resolution Slice width Patient dose – Single scan profile Multi-slice Spatial Non-uniformity – Low atomic number materials High atomic number materials Structured noise Linearity of CT values Accuracy of patient positioning devices Alignment of scanner geometry Geometric image distortion Ultrasound imaging units Simple general checks of equipment condition and function Inspection of transducer condition Check optimisation of display settings Record Imaged Acoustic Range Check low contrast penetration for each transducer/dynamic focus Check high contrast penetration for each transducer/dynamic focus Check caliper accuracy Check accuracy of area calculation Measure the Dead Zone for each transducer/dynamic focus Measure the Lateral Imaged Beam Profile for each T/DF Measure slice thicknesses for each T/DF Check function of individual elements in linear array transducers The RPA will maintain records of all the equipment performance measurements on behalf of the Trust. The RPA will submit reports of the results of these measurements together with any relevant recommendations 15 to the Chief Executive of the Trust (or his nominee), the head of department and the Radiation Protection Supervisor. The RPA will submit an annual report through the Radiation Protection Committee summarising this work to the Chief Executive of the Trust (or his nominee). Radiation Protection Reports Reports should be sent via email to a designated Radiology Management Group for ease of electronic storage. A paper copy to also be sent. It will be expected that these will be received within 5 working days. Any urgent deficiencies or advice should be emailed to the Radiology Management Group All faults/errors/inconsistencies in equipment highlighted on the front page or in a conclusion. performance should be An action plan for resolution of these faults should be provided. Length of Contract/Pricing Structure It is envisaged that the minimum time for this contract would be 5 years to allow 2 bi-annual survey cycles to be completed with an option to extend for 2 years. To provide a 5 year pricing structure. To provide prices on a site specific basis eg Whiston, St Helens, Newton etc. To provide options with or without ultrasound surveys. To provide a mechanism for expansion of our service / equipment in the future eg acquisition of a new nuclear medicine scanner and possible acquisition of community dental services. 16