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: Nottingham University Hospitals NHS Trust Date of inspection: 20 January 2009 Date of publication: August

2 Report of inspection of compliance with the Ionising Radiation (Medical Exposure) Regulations 2000 Organisation: Nottingham University Hospitals NHS Trust Site inspected: Date of inspection: Nottingham City Hospital 20 January 2009 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 August 2009 This publication may be reproduced in whole or in part in any format or medium for noncommercial 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 2009.

3 About the Care Quality Commission The Care Quality Commission is the independent regulator of health and adult social care services in England. We also protect the interests of people detained under the Mental Health Act. Whether services are provided by the NHS, local authorities, private companies or voluntary organisations, we make sure that people get better care. We do this 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 The Care Quality Commission assesses compliance with the Ionising Radiation (Medical Exposure) Regulations 2000, known as IR(ME)R as amended in The responsibility for enforcing the regulations transferred from the Healthcare Commission to the Care Quality Commission on 1 April The regulations are intended to: Protect patients from unintended, excessive or incorrect exposure to radiation and ensure that, in each case, the risk from exposure is assessed against the clinical benefit. To ensure that patients receive no more exposure than is necessary to achieve the desired benefit within the limits of current technology. To protect volunteers in medical or biomedical, diagnostic or therapeutic research programmes and those undergoing medico-legal exposures. Our inspection sought information from interviews and observations within the clinical settings, which are supplemented by documentary evidence, where appropriate. This is a summary report of the findings from our inspection of the radiotherapy department, using information from the observations, interviews and documents collected. During the inspection, we recorded a summary of the evidence relating to the regulations. The inspection was carried out by the Healthcare Commission and this report is being published by the Care Quality Commission as the new regulator.

4 Background to the inspection Nottingham University Hospitals NHS Trust provides a radiotherapy service from the City Hospital campus to a population of approximately 1.1 million. It is part of the East Midlands Cancer Network. Each year, the radiotherapy centre sees 4,500 new cancer patients for radiotherapy and chemotherapy services. It provides specialist paediatric cancer services to a wider population, as well as specialist neurological and total body irradiation. Staff explained that the radiotherapy centre at Nottingham provided the greatest number of fractions (or daily patient treatment episodes) per machine in England, an average of 9,700 fractions for each of its four linear accelerator treatment machines. They also told us that extended working days were required to ensure that there were no breaches of the target for waiting times for cancer treatment. We noted that there was no replacement machine to provide a back-up service in case machines were out of action for maintenance or in case of breakdown. There were no reported long-term vacancies or shortages of staff when compared with professional guidance. The centre comprised 41 whole time equivalent (WTE) radiographers and administration staff, nine WTE physicists in radiotherapy physics and nine consultant clinical oncologists, with a further seven undergoing formalised training as specialist registrars. The inspection On 20 January 2009, two IR(ME)R inspectors from the Healthcare Commission visited the radiotherapy centre at Nottingham City Hospital, as part of a programme of proactive inspections of radiotherapy departments in England. We addressed the entire patient journey, from referral for pre-treatment imaging through to the evaluation of treatment. The inspection was limited to the areas where patients would attend following a diagnosis of cancer and the subsequent decision to treat with high-energy radiation using a linear accelerator. Between 1 November 2006 and the day of the inspection, we had received three notifications from the radiotherapy department of exposures much greater than intended. The decision to carry out an inspection did not arise from these notifications, nor was it prompted by any trust declaration in respect of the Commission s assessment of Core Standards. We also held a detailed discussion about risk management, including the three notifications that the trust had reported to us of exposures much greater than intended, near-misses not reported, its response to the recommendations made following the Beatson Oncology incident in 2006, and its management of treatment protocols, in particular, that for total skin electron therapy.

5 Summary of findings The trust had provided in advance of the inspection a copy of relevant procedures and sample treatment protocols available for its patients. In addition it provided a copy of its departmental structures, a number of trust-wide radiation protection procedures and copies of minutes of meetings that recorded how it had reviewed errors and nearmisses within the department s externally-accredited quality management system. The department was able to demonstrate how it had responded to the latest guidance on good practice in radiotherapy, including the guidance booklet Towards Safer Radiotherapy. The majority of the written procedures themselves were clear and during the inspection, we saw evidence that staff and management were aware of their responsibilities under the regulations. The department s management declared that it had sufficient numbers of trained staff and an adequate mix of skills. We saw that among the IR(ME)R operators, radiographers working in pairs took equal responsibility for each other s actions with both signatures on treatment and planning documentation allocating equal responsibilities. This approach was tested and found to be understood by staff. Radiotherapy physics services were available on-site under a service level agreement and we saw evidence of a clinical audit programme. We noted deficiencies in some areas. Two procedures were not available in written format. Some did not adequately allocate clear responsibilities to duty-holders, or were out of date, and there was no clear line of responsibility to the employer under the regulations. Areas of concern We found no areas of serious concern during the inspection. Conclusions and recommendations On the day of the inspection, the trust provided evidence which showed that the radiotherapy centre complied with IR(ME)R. The trust also provided the Commission with assurance that it had procedures in place that were in line with regulatory requirements and that risks were being managed within the centre s governance structures. 2

6 Regulation Recommendations Employer s procedures for the radiotherapy department and the clinical treatment protocols had been approved by the clinical director as head of service. However, they should also link effectively to the employer via traditional governance methods. Regulation 4: Duties of employer The trust should review procedures to ensure that they clearly allocate responsibilities to duty-holders. Schedule 1a concerning the formal identification of patients should be reviewed to ensure consistency with the centre s established custom and practice regarding inpatients. Procedures describing research activities must be written down and maintained within the quality management system, as required in schedule 1h. Arrangements concerning the restriction of exposures, as required in schedule 1k, should be brought together in a single written procedure. Regulation 5: Duties of the practitioner, operator and referrer Regulation 6: Justification of individual medical exposures Regulation 11: Training The department should review the benefit of including a date when the competence of an operator was assessed and approved, rather than simply indicating with a tick that competence had been achieved. The trust should consider how it can formalise who is entitled to sign off staff as being competent to carry out operator functions The details of patient doses arising from planning and verification exposures using the CT scanner and simulator should be made available to staff acting as practitioners. Records of the operator training of clinical oncologists should be systematically documented in the same way as they are for radiographers and physicists. 3