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Commentary |
1Department of Diagnostic Radiology, Hairmyres Hospital, East Kilbride G75 8RG and 2Department of Medical Physics, Ninewells Hospital, Dundee DD1 9SY, UK
Implementation of the European Directives on Basic Safety Standards and Medical Exposures [1, 2] in the UK has been achieved by the publication of the Ionising Radiations Regulations 1999 (IRR99) [3] and the Ionising Radiation (Medical Exposure) Regulations 2000 (IR(ME)R 2000) [4]. On the whole, implementation of IRR99 in medical practice has not been too onerous; provided that the standards required by the previous legislation (IRR85) had been put in place, the only major innovations are the need for formal (prior) risk assessment and the implementation of quality assurance programmes. In all likelihood, both will have been happening anyway, and the only extra burden will be formalization of the existing process. The situation is somewhat different with regards to IR(ME)R 2000. These regulations have introduced some new concepts such as "referrer", "practitioner" and "operator", and require production of quite explicit local procedures and establishment of a local management framework.
Although the introduction of IR(ME)R is undoubtedly a very positive move, which will encourage the adoption of good practice, there has been some confusion with the implementation of the regulations, with no consistent definition of who performs what role or to what degree of prescription procedures should be implemented. There is a widespread perception that there is very little guidance and that many centres are busily re-inventing the wheel, although maybe each wheel has a slightly different shape. Given the general disquiet surrounding the issues as well as the need for the regulatory framework to have been in place by 1 January 2001, a 1-day meeting was organized by the Radiation Protection Committee of the British Institute of Radiology (BIR) on 28 September 2000 to enable widespread discussion and sharing of practical experiences. The importance of this topic was exemplified by the attendance of approximately 200 delegates. There was considerable debate, with many issues being aired. Perhaps the most contentious of which was the identity of the "practitioner".
Mr Steve Ebdon-Jackson, Department of Health (DoH), London, opened the meeting and reminded the participants of the background to the new regulations. The present principles of radiation protection were laid down in Publication 26 of the International Commission for Radiation Protection (ICRP) [5], with a re-appraisal of the risks in Publication 60 [6]. ICRP Publication 60 resulted in changes in the European Directives. The main drivers for change in the UK were the production of the new European Directive coupled with changes in practice regarding medical exposures. Mr Ebdon-Jackson emphasized the importance of the employer and the justification process in the new regulations. Further guidance regarding diagnostic reference levels, training and exposures much greater than intended will be published shortly on the DoH website. A questioner was concerned that the communication pathway from the DoH was not all that it might be and that senior Trust management across the UK might not be aware of the impending changes in management policy. In reply, Mr Ebdon-Jackson indicated that the changes to the legislation had been notified to senior management via the chief executive bulletin.
Dr Peter Riley, Birmingham, reviewed the justification process with reference to the role of the practitioner. The practitioner must have an extensive knowledge of radiation, including its hazards and risks. He debated the question as to who should be the practitioner. His opinion was that, as a general rule, the practitioner should be the on-call radiologist, with a radiographer acting as an "authoriser", using clearly defined written procedures. Any procedure other than basic radiography would, in general, require a radiologist for justification. However, circumstances may exist where staff other than radiologists might act as practitioners. For example, cardiologists might be best placed to understand the clinical need for specific investigations in the cardiac catheterization laboratory. In this instance, the cardiologist might act as a referrer, practitioner and even operator. It should be noted that there was unease about the latter option since adoption of good practice means that a radiographer should perform all screening procedures, even though this is not presently achieved universally. However, whether the cardiologist was to act as practitioner or practitioner and operator, they would need suitable training. Considerable additional training would be required to act as an operator. Dr Riley wondered whether possession of an old POPUMET certificate was sufficient to allow a cardiologist to carry out the justification procedure for cardiology studies. There was no disagreement from the floor.
Mr Richard Cannon, London, discussed optimization and the role of the operator. He stressed the importance of ensuring that there is a clinical evaluation of any image, and that it is properly documented. A list of operators and allowed roles should be kept in some form. Exposure charts, use of automatic exposure control (AEC), good Quality Assurance (QA) and use of dose–area product (DAP) meters were described as essential. He felt that there should be a committee at local hospital level to oversee and enforce the regulations. He concluded by emphasizing the "as low as reasonably achievable" or ALARA principle and optimization, using image storage, reduced screening times, grid removal, adoption of pulse fluoroscopy and perhaps increased copper filtration.
Miss Karen Davies, Health and Safety Executive (HSE), London, discussed those aspects of IRR99 that impinge on medical practice. IRR99 implements most of the Basic Safety Standards directive (96/29/Euratom) and also some of the Medical Exposures directive (97/43/Euratom), which is the source of the IR(ME)R regulations. There is no overlap within the legislation, since IRR99 covers equipment used for medical exposure (regulation 32), which is excluded from IR(ME)R. It is not expected that the introduction of IRR99 will have a major effect on practice. A new element in IRR99 is the need for a formal risk assessment to be carried out before work is started with ionising radiation. This builds on the requirements of the Management of Health and Safety at Work regulations (MHSWR). The HSE expect that risk assessments will have been taking place in any event, since they represent good practice and are a requirement of the MHSWR. Miss Davies announced that to reflect the increased emphasis on QA in IRR99, HSE Guidance Note PM77 [7] was being revised with extra importance given to QA. Publication of the revised document is expected in early 2001. She emphasized that communication is important, both within a department and with the HSE. Information should be shared on risk, maintenance needs, faults, etc. The risk of ionising radiation to comforters and carers needs to be defined, and employers procedures must be created to ensure they are fully informed of the risks involved.
Dr Bobby Corbett, East Kilbride, reviewed the development and definition of diagnostic reference levels (DRLs). He felt that while national DRLs have some use, locally developed DRLs could have a more meaningful value provided that they are derived and used in an appropriate way. Initially, UK national DRLs will be based on data published in National Radiological Protection Board Report R289 [8]. This is being reviewed, and new data may well allow a more realistic DRL to be created. National DRLs will be reviewed every 3–5 years. A joint Working Party to address the problem of DRLs has been set up by the Institute of Physics and Engineering in Medicine (IPEM), the BIR, the Royal College of Radiologists (RCR) and the College of Radiographers (CoR). Delegates were reminded that dose should not become so low as to give non-diagnostic images, as this would be unjustifiable. Means of obtaining DRLs for equipment were discussed and published experiences were reviewed.
Dr David Sutton, Dundee, discussed the implementation IR(ME)R 2000 with particular emphasis on research. He reviewed the definitions of biomedical research and discussed how radiation is used in medical research, how it is controlled and overseen in the National Health Service, how radiation might be controlled within a research environment and the requirements of both IRR99 and IR(ME)R 2000. The role of the ethical committee was emphasized. In essence, provided that IRR99 is being correctly implemented in the routine environment, there are no extra provisions required for research. Provided that research is being properly scrutinized by an ethical committee, then the requirements of IR(ME)R 2000 are for the most part met. Attention should be paid to consent and patient information. It is imperative that the ethical committee is informed of the risks associated with the radiation element of any research project. It may be advisable to set up a small subcommittee to advise in this respect. Reference should be made to ICRP Publication 62 [9], or EC Radiation Protection 99 [10].
The morning session concluded with a presentation from Dr Alan Hufton, Manchester, on writing and creating protocols. An exposure chart is required for each tube and a general description of how each procedure is to be carried out must be available. This description may well include routine projections, the type of filters to use, the use or otherwise of AECs and the recording of doses. These should be checked against the local DRL and any significant dose difference should be recorded and reported. A suitably designed exposure chart could address several of the documentation requirements of IR(ME)R 2000. He advised that it was not possible to be too detailed in the creation of procedures or to be totally comprehensive. Professional judgement must be recognized and used.
Dr Hamish McRitchie, Melrose, gave an overview of medicolegal exposures, emphasizing that they must have a "net benefit" and should comply with all the requirements of IR(ME)R 2000. Problems mainly occur with referrers. Self-referrers, such as immigrants or insurers, exist, as do referrals from other health care professionals, the police, social workers and even courts. Justification may only be possible on the grounds of net benefit to society as distinct to the referrer. Appropriate lists of approved procedures and referrers should be kept. An exposure of a person sent from work with the intention of protecting the employer from future litigation is not justifiable. Following road traffic accidents, there has to be enough pain or a clinical finding to bring a patient within the regulations and thereby justify a radiological examination. The thorny problem of child non-accidental injury was discussed, especially with regard to skeletal surveys. On balance, it was felt that providing there was sufficient reason for performing the examination, and that consent was forthcoming, then the outcome would definitely be in the best interests of the child.
Prof. Iain McCall, Oswestry, discussed the possible requirements for practitioner training courses. He defined the objective of training and reviewed possible times required. For example, a radiologist requires 30–50 h training in radiation protection, at least 20% of which should be given in practical training. The EC Directive requires extra training for those dealing with children. All staff should have appropriate continuing professional development in radiation protection. He reviewed the issues involved and outlined some of the problems, including the lack of trainers, inadequate resources, pressure upon the work force and finally the monitoring of compliance.
There was considerable discussion about the training issue. A DoH Working Party had met in January 2000 to discuss the way forward. Representatives of the main colleges and faculties were present, together with learned societies such as the BIR and the IPEM. At that time, it was left for the DoH to discuss detailed arrangements for teaching courses and requirements for training as practitioners with the individual colleges. So far there has been no public sign of any progress. The need for such arrangements to be in place is now quite pressing.
The afternoon section of the meeting concluded with a second presentation from Mr Steve Ebdon-Jackson who outlined his approach to inspection. He explained that inspections are there to assist as well as to monitor compliance. Enforcement is rarely necessary. He reviewed the arrangements and the process of an inspection, emphasizing the review and feedback process. He liked to follow "a patient journey" throughout a department, as this gives a good idea of the effect of procedures, not just the fact that they exist. He concluded by addressing training issues, agreeing that training remains a problem. Unfortunately, in different countries of the European Union different terms have different meanings and the emphasis and feelings behind training courses can be lost. The problem is relatively ill defined. What is the value of any previous training? Whatever it must be relevant. Ongoing talks are progressing with the various Royal Colleges. Referrers need training to know that proper referrals should be made with all relevant data included.
The final part of the day was a round table discussion with, initially, short presentations on clinical experiences in fluoroscopy, interventional radiology and nuclear medicine.
There was a lively debate on the need or otherwise to keep lists of referrers, operators and practitioners. The question was distilled down to the practicality of doing so. The question of having lists of referrers led to the advice that maintaining a list of all medical practitioners likely to refer a patient was totally impracticable. However, generic statements could be made at Trust management level, for example all medical and dental members of staff employed by or having a contract with a health authority could be considered as being potential referrers. Local (i.e. departmental) protocol could then decide which groups could refer for which examinations. For example, general practitioner referrals for CT could be rejected at departmental level. An explicit list of non-medical referrers, however, was possible and desirable, again drawn up at local level. Similar arguments were rehearsed for operators and practitioners. It was felt that it was possible to define, at local level, classes of operator and practitioner, but the task of maintaining exhaustive lists at central level was verging on the impossible.
The old argument of radiologist vs radiographer acting as the practitioner was raised, but without definitive conclusion. The debate on this issue could have gone on for several hours. Equally persuasive arguments were advanced by both sides, which, it must be said, appeared to be polarized by profession. Perhaps a critical and impartial appraisal should be made.
The need for a clinical evaluation of all exposures generated significant debate. In some hospitals the majority of in-patient films are not reported by a radiologist. There was anecdotal evidence that non-radiologist reporting of radiographs remains a problem, as many health authorities and Trusts do not appear to have taken this seriously and reports are not yet appearing in case notes. Some participants were of the opinion that it was unreasonable to expect busy staff to make entries in the case notes. Others felt that there was no point taking the radiograph unless a record was made of how it affected the patient's management. Still others felt that members of the public would be outraged to learn that nobody was taking the responsibility of reporting radiographs. It was emphasized that the regulations require that an evaluation must be made for each exposure and that the evaluation should indicate how the exposure affected the patient's management. The evaluation need not be a formal report in the strict sense. However, the procedures required by IR(ME)R 2000 made it a management responsibility to ensure that such an evaluation was made. This area of the regulations provides an excellent platform for audit.
An "investigated" hospital admitted its procedures and forms had not been considered "legal enough". Mr. Ebdon-Jackson advised that the DoH does not consider that it is its role to provide forms or procedures, but it will advise if it feels that any authority's or department's procedures and forms are not satisfactory. It became clear that it is a very difficult and time consuming exercise to write guidelines on justification for all requests.
In conclusion, there is still much concern about the new regulations and their implementation. There is a general willingness to comply but there is doubt about the number and extent of procedures required by the regulators. There are concerns about re-inventing the wheel. Significant debate rages about whom exactly can be a practitioner. Doubts remain about training. There is some cynicism that the DoH are expecting hospitals to expend significant time and effort producing responses to IR(ME)R 2000 whilst not providing any guidance. However, it may be that the benefits of the inherent flexibility in IR(ME)R have been overlooked and may yet come to be appreciated. The best local solutions need to be tailored to local needs, and that cannot be achieved by centralized edict.
Received for publication January 11, 2001. Revision received May 17, 2001. Accepted for publication May 31, 2001.
References
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