Inspection report. Inspection of compliance with the Ionising Radiation (Medical Exposure) Regulations 2000

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1 Inspection report Inspection of compliance with the Ionising Radiation (Medical Exposure) Regulations 2000 Organisation Site inspected Date of inspection Date of publication County Durham and Darlington NHS Foundation Trust Cardiology Department University Hospital of North Durham, Durham 20 November 2009 August

2 This report is available to download from our website on Please contact us if you would like a summary of this report in other formats or languages. Phone our helpline on or enquiries@cqc.org.uk Care Quality Commission September 2010 This publication may be reproduced in whole or in part in any format or medium for non-commercial purposes, provided that it is reproduced accurately and not used in a derogatory manner or in a misleading context. The source should be acknowledged, by showing the publication title and Care Quality Commission

3 About the Care Quality Commission The Care Quality Commission is the independent regulator of health care and adult social care services in England. We also protect the interests of people whose rights are restricted under the Mental Health Act. Whether services are provided by the NHS, local authorities or by private or voluntary organisations, we make sure that people get better care by: Driving improvement across health and adult social care. Putting people first and championing their rights. Acting swiftly to remedy bad practice. Gathering and using knowledge and expertise, and working with others. Introduction enforcing the regulations In addition to its regulatory activities under the Health and Social Care Act 2008, the Care Quality Commission (CQC) is responsible for enforcing the Ionising Radiation (Medical Exposure) Regulations 2000, as amended in 2006, known as IR(ME)R. CQC assesses the compliance of health care providers with the regulations. The regulations are intended to: Protect patients from unintended, excessive or incorrect exposure to radiation and to ensure that in each case, the risk from exposure is assessed against the clinical benefit. Ensure that patients receive no more exposure than is necessary to achieve the desired benefit within the limits of current technology. The regulations also apply to exposures as part of medical or biomedical, diagnostic or therapeutic research and those undertaken for medico-legal purposes. Methodology for inspections Our inspections form part of a programme of proactive compliance inspections of cardiology X-ray departments in England. When we have identified potential candidates for inspection we write to the organisation s senior managers giving four to six weeks notice, allowing the organisation time to reallocate resources for clinics and cardiac laboratories and to allow clinical staff the opportunity to participate in the inspection. We identify who we would like to meet on the day of inspection. During the inspection, two IR(ME)R inspectors from CQC visit the organisation, meet with representatives of the clinical department and management, and assess compliance. 3

4 During all proactive IR(ME)R inspections, we also explore risk management and review any notifications made to us under regulation 4(5), of exposures much greater than intended. Three months after the inspection report is published, we ask the organisation to declare that they have complied with any recommendations that we made. Background to the inspection The County Durham and Darlington NHS Foundation Trust provides a cardiac catheterisation laboratory service from its University Hospital to a local population of approximately 250,000 in the north of County Durham. The service was established in 2004 and presently utilises 4 sessions per week from its dedicated day unit adjacent to the radiology department. We learnt that the service utilised a single plane dedicated cardiac angiography facility with a digital flat-plate detector, and digital image archiving and reporting features. Staff carry out over 500 catheterisation procedures each year. Staffing comprised one whole time equivalent (WTE) cardiac radiographer, three consultant cardiologists, an associate specialist in cardiology and a trainee specialist registrar (SpR). In addition the laboratory was staffed by cardiac nurses, physiology technicians and assistant staff. We were provided with data on equipment, staffing and service activity in advance of the inspection. We met with the trust s executive director of operations and business, the lead cardiologist, the cardiac nurse and catheter lab manager, the superintendent radiographer and radiation protection supervisor, the radiology directorate manager, the radiation protection adviser, medical physics experts, radiology radiation protection supervisor, and cardiac physiologists. We adopted a patient journey approach to the inspection, seeking evidence from written procedures, some of which had been provided in advance of the visit, and from discussions with staff on the day. We examined how procedures, processes and practice from referral through to diagnosis, treatment and evaluation, meet the requirements of IR(ME)R. In particular, we examined the identity and responsibilities of the various duty holders, the nature of referral criteria, how X-ray diagnostic exposures were justified, authorised and optimised. At the time of the inspection, the centre had not notified us of any exposures much greater than intended arising from incidents in the cardiology department. The inspection This is a summary report of the findings from our inspection of the cardiology department. 4

5 Employer s written procedures Before the inspection the trust provided us with a document entitled Radiation Protection Policy, dated November 2009, which gave an overview of radiation protection arrangements within the trust. We were also given Employers Procedures for the Cardiac Catheterisation Laboratory University Hospital of North Durham, dated October We noted that these IR(ME)R procedures were specific to cardiology and had been prepared in the immediate lead-up to the inspection. Staff confirmed that the cardiology department procedures had previously been integrated with those of the radiology department, but it had become clear that these were not specific enough to the activities in the catheter laboratory. We noted that the document followed the patient journey and addressed the IR(ME)R core elements of referral, justification and optimisation, allocating responsibilities to the duty holders involved, including referrers, practitioners and operators. We also noted that the document had been approved by the radiation safety committee; evidenced by the minutes of the committee meeting. The link to demonstrate that they were the employer s written procedures was in the Radiation Safety Policy. We examined and discussed the content of other key parts of the written procedures, including patient identification checks and the pregnancy question. These were generally satisfactory although we noted that the enquiries required of female patients to determine pregnancy status did not include an age range. We were told that they were carried out on all females irrespective of age. We were satisfied from the written procedures and from responses to questions during the inspection that the responsibilities of duty holders were understood. However, there was some uncertainty as to whether the arrangements for referral surrounding the use of the booking form, together with the identity of referrers, was fully mirrored in the written procedures. Referral criteria were observed to have been established. We were informed at the inspection that there were no cardiac catheterisation exposures performed as part of research trials. Neither were there any medico-legal exposures carried out. Duty holders and their responsibilities Although procedures described the practitioner responsibility and process of authorisation for cardiac catheterisation exposures, discussion revealed that there was uncertainty around exactly how and when this took place. Inspectors drew attention to the requirement for authorisation to take place prior to the exposure. There was also a lack of clarity reflected in procedures whether the SpR and associate specialist were entitled to act as practitioners. 5

6 Exposure protocols During the inspection we observed that exposure protocols were in place for standard cardiology examinations. These included what views were regarded as routine and the automatic exposure factors as set on the equipment. At the time of the inspection these had not yet been adopted formally by the radiation safety committee on behalf of the employer. Optimisation Regarding the need for optimisation we were informed that there had been involvement from the equipment manufacturer, medical physics and clinical staff in setting up the equipment. We heard evidence of the understanding of the range of exposure between high and low dose settings and different frame rates. Quality control measurements and dose surveys were described, including the setting of diagnostic reference levels (DRLs). We saw from reports and heard from medical physics support how these were established based on regional data. Overall, we were provided with assurance that optimisation was taking place. However, during discussion with staff we felt that there could have been a better understanding and agreement on the nature of patient dose units in terms of dose-area product (DAP). During catheterisation procedures, exposure time was used as an immediate indicator of patient dose. Several areas of work, such as those above, provided us with assurance that staff working collaboratively and that there was cooperation between duty holders across the various professional disciplines. Training We asked about the training of cardiologists. We were informed that medical qualifications and registration status were checked by trust staff. However, we were informed that not all consultant cardiologists had attended an externally-accredited IR(ME)R training course for cardiologists, as is currently required by the Royal College of Physicians (RCP) for specialist registrars in order for them to complete their training. We heard that the SpR, who was involved in catheterisation procedures, worked under supervision and was following an established professional training scheme. Overall, inspectors felt that there was a lack of clarity on what the employer had decided locally was adequate training for cardiologists, particularly as regards entitlement to act as a practitioner and whether attendance on an IR(ME)R course was required. We also drew attention to the need for continuing education and training. The training of radiographic staff including training records was examined. Staff described how they had developed a training programme for radiographers who rotated through cardiology from the radiology department and received operator training on use of the equipment and which was subject to a competence 6

7 assessment carried out by senior colleagues. Registration and qualifications were also a requirement for radiographic staff. Medical physics experts IR(ME)R requires the involvement of medical physics experts (MPE) in medical exposures. We heard how clinical staff were supported by medical physicists, based both in a nearby tertiary centre as well as on-site, and we were informed of a service level agreement which was nearing completion, serving to formalise the arrangements. Support included consultation on optimisation, radiation dose assessments, compliance with regulatory requirements and setting relevant local DRLs following regional dose surveys. We heard how regional dose data has been used across a large number of catheter laboratories in the region showed that the doses here for coronary angiography were towards the lower end of the range and below the DRL and national reference dose. Risk management and clinical audit We held discussions concerning risk management and clinical audit, including what arrangements were in place within the department for review of incidents and near misses. We noted that audit arrangements were listed in procedures and during the inspection we heard about an audit of patient identity checks and an audit of femoral versus radial approach. We also received assurances on arrangements for identifying where excessive skin doses might be received. We heard that for bariatric patients where difficulties might be anticipated, management of the patient may not include catheterisation procedures. It was reported that any high doses recorded were discussed at review meetings. It was described how the evaluation of the exposure, an integral part of the cardiologist s report after the examination or treatment, was recorded via a dedicated electronic reporting system. 7

8 Areas of concern We found no areas of serious concern on IR(ME)R compliance during the inspection. However, we did identify several topics relating to employer s procedures, protocols, authorisation and training which require action or merit review. Conclusions and recommendations On the day of the inspection, the trust provided evidence which showed that the cardiology X-ray department complied with most of the IR(ME)R requirements and its key framework of referral, optimisation and evaluation of medical exposure. The department provided the Commission with evidence and assurance that it had procedures in place that were in line with regulatory requirements, that duty holders were identified and understood their responsibilities under the procedures. We saw too that audit and MPE support was in place and that risks were being managed within the centre s governance structures. Although we found no serious concern during the inspection, we did find one or two areas where action is required to meet the requirements, in particular the need for authorisation of medical exposures, identity of referrers and consideration of cardiologist training and entitlement. We also highlighted several areas where the department could improve IR(ME)R compliance, in relation to employer s procedures, exposure protocols and dose understanding. We make the following recommendations to the trust. Regulation Regulation 4: Duties of employer Regulation 5: Duties of the practitioner, operator and referrer Recommendations 1. To review written procedures and arrangements concerned with referral to ensure that referrers are clearly identified and to ensure that practice mirrors procedure. 2. To establish a clear link from the examination protocols required under IR(ME)R, through to the chief executive or via a scheme of delegated authority to a committee or individual to formally adopt the written employer's procedures and examination protocols. 3. Procedures, entitlement and authorisation guidelines, must be reviewed to ensure clarity around the practitioner role and authorisation responsibility of the specialist registrar and associate specialist. 8

9 Regulation 6: Justification of individual medical exposures Regulation 7: Optimisation 4. To make practical arrangements reflected in procedures, for the necessary justification and authorisation of an exposure, by the practitioner or an operator working to guidelines on behalf of the practitioner, prior to the exposure taking place. 5. To review the nature of the recording and understanding of patient doses, with regard to the units used for dose-area product. Regulation 8: Clinical audit Regulation 9: MPE s Regulation 10: Equipment Inventory Regulation 11: Training No recommendation No recommendation No recommendation 6. To review training requirements of cardiologists with the aim of defining adequate training, particularly in relation to attendance at externally-accredited IR(ME)R training course. To ensure that all staff are adequately trained. 9

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