C Compliance with IR(ME)R in radiotherapy departments across England A summary of our programme of inspections during 2007 to 2009 January 2011
Introduction During 2007 to 2009, we carried out a programme of proactive inspections of radiotherapy departments in England, as part of our regulatory activities to monitor compliance with the Ionising Radiation (Medical Exposure) Regulations 2000, known as IR(ME)R. This report is an overview of our findings and recommendations from the 31 inspections carried out over that period. These are listed by regulation number and include a summary of the recommendations we made with respect to that regulation, together with examples or pointers to some of the more interesting findings. We hope it will help organisations and healthcare professionals to meet the requirements of IR(ME)R and to develop relevant procedures and protocols, especially if read alongside the inspection reports for individual organisations published on our website. Regulation 4, Duties of Employer We made over 70 recommendations for this regulation, many relating to the employer s written procedures as required under regulation 4(1) and schedule 1. These included recommendations in respect of: Clarifying written procedures to improve the link between the procedures and the employer where necessary, through some form of delegated authority. Giving support to initiatives to develop externally-accredited quality management systems (QMS), as a way of managing employer s written procedures and integrating these with related work instructions and other relevant documentation. The need for a quality assurance (QA) programme for employer s written procedures, relating in particular to the review period for the procedures and associated documentation. The pregnancy question, including the age range and the use of signs in waiting areas to remind patients to declare a potential pregnancy. Encouragement for recruitment initiatives where difficulties with staffing levels below establishment requirement were in danger of impacting on IR(ME)R compliance or the quality of radiation protection of the patient. When inspecting the employer s written procedures, we noted that these were generally managed and labelled around some form of numerical reference system. However, we found that one organisation had decided to use descriptive titles, for example, Preg indicating a procedure relevant to pregnancy, in an attempt to help duty holders to navigate the procedures. Under regulation 4(2) the employer is required to ensure that exposure protocols are in place for standard examinations and regulation 4(3) requires referral criteria to be set. We saw a variety of approaches in relation to treatment protocols and referral criteria and in some departments these were not fully developed, instead comprising 'work in progress'. We noted that the referral criteria were evidence-based, using the guidance document from the Royal College of Radiologists Radiotherapy Dose-Fractionation, Ref No: BFCO(06)1, although we saw some criteria amended in response to the publication of the results of clinical trials for that particular treatment. Care Quality Commission Compliance with IR(ME)R in radiotherapy departments across England 1
In relation to protocols for planning exposures, we saw that these were usually maintained separately in CT or simulation and had not been included within the relevant treatment protocol. We suggested that linking or cross-reference from the treatment protocol to the imaging protocols, including the factors that appear on the scanner console, would be worthwhile as an integrated tumour-specific protocol covering both treatment and concomitant exposures. We found that treatment protocols were generally written by the clinical lead or clinical oncologist for each tumour or subspecialty area and endorsed by a multidisciplinary-group. We noted that with suitable reference, this was a mechanism by which authority for the treatment protocols could be formally delegated from the chief executive of the trust as the employer. We learned that treatment protocols were reviewed at frequencies varying from one to three years, although after the guidance Towards Safer Radiotherapy was published by the Royal College of Radiologists part way through the inspection programme in 2008, this rate settled on a two-yearly cycle, or more frequently if the revision related to new staff, treatments, evidence or the equipment used. We saw a wide variation in the level of detail and layout associated with treatment protocols, which could suggest difficulties locally for junior staff as they move from department to department on rotation. Review of our findings, along with advice from colleagues at the Health Protection Agency (HPA), suggests that a standard treatment protocol should have the following characteristics. Tumour site-specific definition. Clearly defined aim as radical or palliative. Clinical investigations required prior to decision to treat. Timing of radiotherapy, including concurrent chemo information, if appropriate. Gap category for management of unscheduled interruptions. Pre-treatment imaging requirements. Target planning outlining/definition and appropriate responsibilities. Organs at risk, definition and tolerances. Patient immobilisation requirements. Identification of need of accountability or formal sign-off. Whether the treatment is part of an agreed clinical trial protocol. Treatment technique(s). Prescribed dose and gross monitor unit range. Dose reporting requirements such as dose distribution, maximum and minimum dose points in planned treatment volume and dose volume histograms. Verification including in vivo dosimetry and imaging protocol. Treatment review definition and schedule. Patient information regarding side effects. Regarding treatments off-protocol, we found that most organisations required the lead clinical oncologist or a second consultant to countersign any deviations from established protocols. Care Quality Commission Compliance with IR(ME)R in radiotherapy departments across England 2
We noted with some concern that one department had in place an infinity treatment protocol, which allowed treatment without an established end-point or prescribed dose and that this was not in accordance with current established practice. We were reassured when we found the protocol was amended before the planned inspection. During all inspections, we asked questions relating to the understanding of, and compliance with, Regulation 4(5), requiring notification of exposures much greater than intended. We discussed the detail of any notifications that were still open, or where there were trends or learning from previous notifications since closed. We asked about arrangements for internal governance and risk management, including reviews of incidents, near-misses and noncompliances with internal QMS standards. We sought assurances from organisations about lessons learned from major publications in radiotherapy, such as the Beatson report (Scottish Government, 2006), Towards Safer Radiotherapy (Royal College of Radiologists, 2008) and Guide to Understanding the Implications of [IR(ME)R] in Radiotherapy (Royal College of Radiologists, 2008). Regulation 5, Duties of the Practitioner, Operator and Referrer We found that generally there was good compliance with regulation 5, which is concerned with the responsibilities of duty holders. Overall we made 20 recommendations, which can be summarised as follows: The need for clarity of process of how staff are entitled and identified as duty holders, particularly for those acting as operators under the regulations. The need for a better understanding by some staff of their individual responsibilities as duty holders. Agreement and clarity within the radiotherapy department as to the significance of counter-signatures used on referral, planning and treatment documentation. The need to review referral criteria, in particular the nature of what is regarded as adequate or essential information to be provided in a referral. We saw a number of different approaches to how clinical oncologists undergoing training were entitled to refer, plan, prescribe and authorise treatment exposures. Many organisations had based entitlement on attainment of established training milestones, such as Fellowship of the Royal College of Radiologists (FRCR) Part-1, facilitating entitlement to refer and justify palliative treatments and planning exposures. Other centres had developed more personalised competence assessments, where in addition to RCR milestones, the responsible consultant clinical oncologist signed off the individual as competent and entitled to refer and prescribe following their period of training and practice. We noted that some departments could provide evidence of clinical oncologists maintaining competency through clinical audit or peer review, for example, by the assessment of a number of treatments of a particular type. In relation to radiographers and operator duties, most radiotherapy departments had retained the conventional practice of staff being held individually responsible for their particular tasks performed in delivering treatment. However, we noted how a number of departments regarded multiple operators as bearing joint responsibility, for example, pairs of colleague radiographers carrying out patient identity checks, enquiring as to pregnancy status, setting up and checking patient position and adjusting and checking machine settings and monitor units. The implication of this is that if a mistake occurred, the multiple operators involved were equally liable for the error. During inspection, we emphasised that procedures must reflect Care Quality Commission Compliance with IR(ME)R in radiotherapy departments across England 3
whatever model or arrangements were in place locally, and that all operators and practitioners must be fully aware and clear on the nature of their responsibilities as duty holders under IR(ME)R. Regulation 6: Justification of Individual Medical Exposures Under regulation 6, we made just 12 recommendations concerning the justification of medical exposures. The most common single recommendation was for the organisation to improve the practitioner s understanding of the dose and detriment arising from planning and verification exposures, including cone-beam CT and planar kv imaging. This included a greater awareness of the effective dose from routine planning CT scans. We acknowledged that such doses are generally expected to be significantly below that arising from treatment exposures. With regard to the justification of planning and verification exposures, we found that these were usually authorised by the practitioner on the referral or booking form as part of the intended patient journey. For additional exposures required outside the standard protocol, we saw departments taking different approaches some required clinical oncologists to make a separate referral that they also then justified, others adopted a more pragmatic approach allowing additional exposures, including CT scans, to be authorised by treatment radiographers as practitioners or operators acting under guidelines. As expected, we found that the vast majority of external beam treatment exposures in radiotherapy were justified by clinical oncologists. However, we saw a small number of situations where consultant radiographers had been entitled to refer and justify within an agreed limited scope of practice, for example, as part of a radiographer-led breast treatment service. We took particular interest in our inspections to enquire whether those acting as practitioner were aware of their role and responsibilities, particularly where more than one clinical oncologist can be involved in a patient s management and care. For example, we were aware of the situations where a consultant initiates a treatment plan, but when going on leave asks a junior colleague to complete the plan and prescribe treatment. We wished to see clarity in procedure and understanding in practice, that those involved understood their duties and responsibilities as practitioner or operator. During our inspections, we asked about the arrangements for reducing the possibility of irradiating an unknown pregnancy and also the justification of exposures to patients who were known to be pregnant. Regarding the latter, we enquired about any local experience and any possible difficulties encountered in balancing the best interests of the patient and their baby. We learned that clinical staff took advice from their medical physics experts (MPE) to assess dose and risk to the baby in order to inform the patient's consultant before counselling and consent. Regulation 7: Optimisation The need for optimisation in radiotherapy treatment means ensuring that the target volume is irradiated while sparing surrounding tissues and organs at risk, as defined by treatment protocols and appropriate planning processes. In our inspections, we tested if there were Care Quality Commission Compliance with IR(ME)R in radiotherapy departments across England 4
appropriate checking mechanisms in place for prescription, planning and treatment, including the use of verification and patient dosimetry. Overall, optimisation was not identified as a significant issue and we made just six recommendations. These related to the need for increased checks or use of monitor unit calculators, use of in-vivo dosimetry and the avoidance of transcription or other errors in planning or set up. We found that it was established practice to perform checks throughout the planning and delivery of treatment, to ensure that treatment was delivered according to prescription and protocol. We saw that checks were independent where practicable and many used reverse checking mechanisms. We found that checks were undertaken by staff entitled to perform those tasks. We saw evidence of the use of software tools, checking signatures on check sheets, monitor-unit checkers, image verification and the use of in-vivo dosimetry. We heard different opinions across the radiotherapy community with regard to the usefulness of in-vivo dosimetry. We asked for evidence of quality control systems being in place for equipment delivering medical exposures in the radiotherapy department. We saw that planning and treatment equipment were tested in accordance with professional guidance and established national standards, including recommended test frequencies, action levels and tolerances. We enquired about the treatment of children during our inspection programme, and were assured that children were only treated in clearly identified oncology centres, both across the NHS and in the independent sector which had specialist expertise in paediatric treatments. We found that in such establishments, there was a paediatric specialist clinical oncologist and other relevantly trained staff. We heard how some departments additionally arranged for a dedicated multidisciplinary meeting with other paediatric specialists in attendance. There is a need under IR(ME)R for the evaluation of medical exposures and we found the arrangements addressed consistently across radiotherapy. We heard how CT and other planning exposure were evaluated as part of the planning process and that evaluation of verification exposures occurred before and during treatment, the latter now a well-established task for treatment radiographers who had undergone the necessary training. We learned that they were entitled to evaluate images, take specified remedial action and/or to escalate to others as appropriate. We received confirmation, too, of clinical evaluation of the treatment exposure. We heard how treatment staff completed the record-and-verify system and wrote summary clinical reports, and how a letter summarising treatment was forwarded to the patient s GP. Regulation 8: Clinical audit We found that clinical audit was being performed in radiotherapy departments and we made only three recommendations to improve compliance with this regulation. These were mainly addressed to the independent healthcare sector, where we found that clinical audit was not as well embraced as in the NHS, partly explained by the lack of training grades who often undertake audit projects as part of training. The few recommendations related to the need for a more systematic approach to clinical audit, including a multidisciplinary approach with a larger proportion of staff participating. Some departments, particularly, but not exclusively those associated with teaching and involved in development or research, could demonstrate an extensive audit programme, often Care Quality Commission Compliance with IR(ME)R in radiotherapy departments across England 5
working closely with the trust's clinical audit department. Their audit work was planned in advance with progress reports and presentations, often by specialist registrars at the end of rotation or radiographers who had developed a special interest in a specific area. Some work was published in wider trust audit activities. Overall, we noted that audit subject areas were often drawn from the Royal College of Radiologists Clinical Governance and Revalidation guide, available from the website (www.rcr.ac.uk). Regulation 9: Expert Advice Regulation 9 requires that a medical physics expert (MPE) is closely involved in every radiotherapeutic practice and we found that in accordance with IR(ME)R guidance, MPEs in radiotherapy were full-time contracted members of staff and available on-site. Overall, we made just three recommendations, which related to where staffing was below recommended levels and where the deficiencies accounted for increased risks to patient safety, such as delays in implementing new treatments or monitoring systems including in-vivo dosimetry. We saw how, subject to internal directorate structures, some organisations felt the need to establish a service level agreement to describe the support to clinical colleagues. We found that MPEs were particularly involved in the fields of treatment planning and dosimetry, but that with associated scientific and technical support, a wider range of services such as those below were often provided. Provision and/or supervision of treatment planning. Patient dosimetry services. Radiation beam dosimetry and calibration. Quality control of equipment. Equipment first line maintenance Imaging optimisation. Investigation of unintended/accidental exposures. Support in developing new treatment protocols. Research and development. Regulation 10: Inventory of equipment We made only one recommendation relating to the completeness of the necessary equipment inventory, which the provider was able to implement quickly. Regulation 11: Training The adequate training of operators and practitioners is a key requirement under IR(ME)R and overall, we found a very good level of compliance. We made just six recommendations, mostly relating to the lack of evidence that clinical oncologists were adequately trained as operators, for example in their operation of simulator equipment, treatment planning computer systems Care Quality Commission Compliance with IR(ME)R in radiotherapy departments across England 6
and using volume outlining software tools. This was a conclusion from our discussions with oncologists rather than direct inspection of their personal training records. When asking about arrangements for inspecting original degrees and checking the necessary registration of healthcare professionals, we found that departmental managers and/or human resources departments performed the necessary checks and kept appropriate records. We enquired about induction training for new staff who were to become duty holders under IR(ME)R. We found that such training took place and that most departments had arrangements where staff were required to complete induction training and to sign that they had read and understood the employer s procedures as part of that induction. During inspections, we explored the arrangements in place for those duty holders, or prospective duty holders, who were undergoing training, including those on established training schemes such as assistant practitioners, student radiographers, clinical scientists and clinical oncologists undergoing training leading to FRCR. We found that training programmes were being followed and records were kept. When we asked about the arrangements for supervision, we received assurances and observed that supervision was in place. We also explored the level of understanding of the significance of 'countersignatures' on documentation where this related to the supervision of trainees. We looked at the arrangements for competence assessments as part of training and how this linked to entitlement, including the necessary delegation of that responsibility from the employer. Arrangements were in place for trainees, new staff and where competence was being re-validated following a career break or maternity leave. We were also keen to explore whether students had any entitlement as duty holders under the employer s written procedures and found that they had no such entitlement until signed off as trained and competent. We noted that, in addition to an 'operator training matrix', larger departments had adopted the practice of using of using an 'entitlement matrix' for record keeping and management purposes, as a planning tool to identify gaps in service provision. Some departments had appointed a dedicated 'learning and development coordinator' to provide support. Overall, we saw that in the vast majority of cases, comprehensive and clear records were kept of the adequate training of physicists and radiographers. We also received assurances and saw evidence of the necessary continuous education and training required of operators and practitioners. We hope you find this summary to be of use, and we welcome your feedback for future reports. If you have any queries, please contact the IR(ME)R team at: Care Quality Commission Finsbury Tower 103-105 Bunhill Row London EC1Y 8TG Tel: 020 7448 9039 Email: IRMER@cqc.org.uk Care Quality Commission Compliance with IR(ME)R in radiotherapy departments across England 7
Care Quality Commission 2011 Published January 2011 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 2011.
How to contact us Phone: 03000 616161 Email: enquiries@cqc.org.uk Registered Office: Care Quality Commission Finsbury Tower 103 105 Bunhill Row London EC1Y 8TG Please contact us if you would like a summary of this document in another format or language.