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Ionising Radiation (Medical Exposure) Regulations: impact on clinical radiology

¹North Western Medical Physics, Christie Hospital NHS Trust, Manchester M20 4BX and ²Radiology Department, Royal Bolton Hospital, Bolton BL4 0JR, UK

	Introduction

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The Ionising Radiation (Medical Exposure) Regulations 2000 (IR(ME)R) [1] were enacted on 13 May 2000. These regulations incorporate into UK law the majority of the provisions of the European Medical Exposures Directive [2], which lays down the basic measures for the radiation protection of persons undergoing medical exposure to ionizing radiation for either diagnosis or treatment. The UK Department of Health has issued supplementary guidance, which is only available on their website [3].

Compared with the superseded regulations (i.e. the Ionising Radiation (Protection of Persons Undergoing Medical Examination or Treatment) Regulations 1988 (POPUMET) [4], IR(ME)R makes significant changes to the responsibilities for patient exposures, introduces an explicit requirement for justification, and requires a more concrete operational management framework for those with responsibility. Certainly, far more documentation is required. All radiology, radiotherapy and nuclear medicine departments are currently spending significant amounts of time trying to interpret and implement the requirements.

The following commentary is limited to the impact on users of diagnostic X-ray equipment in departments of clinical radiology, as it is probably within this area of work that IR(ME)R has the potential to result in the greatest change. Many of the points made are also applicable to nuclear medicine or radiotherapy.

	Referrers

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With the introduction of IR(ME)R, initiation of the chain of responsibility for patient exposure is now subject to legislative requirements. The employer must identify those individuals who can refer patients to the healthcare establishment and provide them with referral criteria. This duty will usually be delegated to the clinical radiology department, which will need to record the persons from whom they are willing to accept referrals and produce appropriate referral criteria. Anyone referring a patient for a medical exposure must provide "sufficient medical data" so that the practitioner (see below) can assess whether the examination is justified.

This gives clinical radiologists the opportunity to restrict referrals for certain types of investigations to specific individuals or grades of healthcare professional, be it consultant, junior doctor, general practitioner or nurse practitioner. This should be done with a view to reflecting the experience and specialist expertise of the referrer, and without denying patients access to appropriate imaging. This control has the potential to improve the quality of clinical information provided on requests, ensuring they are appropriate and, consequently, reducing unnecessary investigations. Departments of radiology must also be prepared to reject requests that contain inadequate demographic information to identify patients or inadequate clinical information that does not allow the justification process to be completed. This greatly strengthens the hand of radiology departments and they should be willing to grasp this opportunity to educate their referrers.

	Practitioners

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The next step is the decision to perform the examination. The responsibility for this is given to those persons the department decides, on behalf of the employer, are adequately trained to act as the so-called "practitioner". The previous POPUMET legislation merely required examinations to be done in line with "accepted practice". It could have been argued that accepted practice included the routine performance of many examinations (e.g. much radiography of the lower back) even though these could not be justified on the basis of net benefit to either the individual or society. In practice, POPUMET did not apply any great restriction on the examinations that could be performed. IR(ME)R explicitly introduces the concept of justification and makes it clear that anexamination cannot go ahead unless it is considered to be justified by the practitioner and has been authorized as such. This represents a significant change.

In the hospital setting, clinical radiologists will have the dominant role as practitioners. They will have the major responsibility for defining what examinations can be justified under the new legislation. The document A guide to justification for clinical radiologists issued by the Royal College of Radiologists (RCR) in August 2000 [5] provides a very useful summary, and emphasizes that the ideal starting point is the RCR publication Making the best use of a department of clinical radiology. Guidelines for doctors [6]. It is clear that unilateral introduction of these guidelines will not be universally acceptable to clinicians and therefore it is imperative that radiologists engage in discussions with appropriate clinical specialties to produce any local modifications of the guidelines required to make them fully acceptable to all concerned. Although such modified guidelines will provide broad referral criteria for "referrers", more detailed and "request specific" information will need to be included if these locally modified guidelines are to be used to provide appropriate guidance for radiographers to authorize (or refuse) requests as justified.

Although we expect clinical radiologists to take the lead role as practitioners within a clinical radiology department, there may well be some circumstances where it will be appropriate for radiographers to take this responsibility. The question of whether, and in what situations, radiographers should take on the role of practitioners will vary, depending on local circumstances. If radiographers increase their level of autonomy by becoming practitioners for a wide range of indications, they will inevitably take on correspondingly increased responsibility for their actions. For example, this change would have the potential for greater liability to citation in claims for medical negligence. This is a consequence to which many radiographers may not be willing to subject themselves. On a more practical note, one can envisage greater confrontation with both junior and senior medical staff if the advice that an examination is not justified comes from a radiographer, and not a radiologist. That is why it may be more pragmatic for most departments of clinical radiology to keep the responsibility for justification with radiologists, who will produce guidelines for good practice that will allow radiographers to be delegated the responsibility for authorizing appropriate requests.

Whoever takes on this responsibility as practitioner, the introduction of IR(ME)R provides a golden opportunity for departments to review their work, in conjunction with the referring specialties, and to ensure that only relevant and useful examinations are performed.

	Operators

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Under POPUMET, only two persons had responsibilities for patient dose optimization: the one clinically directing (i.e. making the decision to perform the exposure) and the one physically directing (i.e. giving the exposure). In practice, most exposures involve a team of individuals and this is acknowledged by IR(ME)R, which places responsibilities on all those undertaking "practical aspects" that can affect patient dose. All operators must be "adequately trained" and departments will need to review their record keeping of staff training to ensure that all are appropriately covered.

	Employer's framework

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IR(ME)R also increases the responsibilities placed on the employer. Their role is now to ensure that there is a management framework that facilitates the safe and optimal use of radiation for patient diagnosis and treatment. Written procedures are required and a minimum list of such procedures is given in Schedule 1 of the regulations [1]. Some of these are obviously worthwhile documents that will ensure that practice throughout the department is consistent and in line with agreed policy, e.g. patient identification and asking the pregnancy question. Most departments already have such procedures in place (although not always written and readily available to staff) and national guidance exists to help in their production [7, 8]. Other procedures are more obscure and guidance from the professional bodies or the Department of Health would be helpful in facilitating consistency between departments.

Written protocols for "every type of standard radiological practice for each equipment" are also required. Again, many exist, but how many departments have a full set with a system for review, authorization and staff training in place?

Another responsibility placed on the employer is to ensure that there is a clinical evaluation of each examination and that a record of the evaluation is made. This means that departments must ensure: (a) that all procedures are reported; (b) that any films going out of the department before a report has been provided are returned for reporting; or (c) that clinical specialties receiving unreported films undertake the responsibility to evaluate the film and to record that they have done this. This is a particularly difficult nettle to grasp and has implications for radiologist workload and interspecialty cooperation.

A further requirement is the setting of diagnostic reference levels (DRLs) for typical examinations. It is proper that a set of regulations, the main aim of which is the control of patient dose, should introduce some way of monitoring patient dose. However, much good work has been done over the last few years with the development of the National Protocol for Patient Dose Measurements in Diagnostic Radiology [9], which includes the introduction of national reference levels. This has been widely adopted and the introduction of it as a legal necessity under the Ionising Radiation Regulations 1999 (IRR99) [10] has meant that even the most recalcitrant of departments are now beginning to audit their dose levels. The introduction of DRLs must not be allowed to confuse the issue and stop the progress already made. It is hoped that a way can be found to merge the IRR99 and the IR(ME)R requirements, and the forthcoming report of a working party set up under the aegis of the Institute of Physics and Engineering in Medicine will address this issue.

Other requirements exist within IR(ME)R for specific areas of work, e.g. medicolegal exposures, exposures carried out as part of research projects, exposure of children and high dose procedures. Departments need to ensure that they give careful consideration to these areas of work and document any specific procedures that apply.

To ensure that this framework is put in place will take a significant amount of time and as such represents a hidden cost to the health service. The consultative document issued by the Department of Health in March 1999 [11] implied costs would be minimal and no extra funding has been made available to ease its introduction. Radiology departments in particular, and medical physics departments providing medical physics expert support, must find this time in addition to meeting the many other demands on their service, and it is unlikely that the full set of IR(ME)R procedures and protocols were in place in all clinical radiology departments when the end of the year deadline passed.

	Training

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The issue of "adequate" training for practitioners and operators is the most uncertain aspect associated with the introduction of IR(ME)R. The wording of the regulation is nearly identical to POPUMET; the only change being an expansion of the syllabus in Schedule 2. However, the authors had always understood that it was theintention under IR(ME)R to tighten up the training requirements and get away from the scenario of individuals carrying out examinations having merely sat through 4 h of lectures.

The issue of training is most acute when dealing with other specialties that may use X-ray equipment belonging to the radiology department. At present, it is common practice for such specialists as orthopaedic surgeons, gastroenterologists and cardiologists to act as practitioners for procedures in which they are involved. Occasionally, they will also be acting as an operator, e.g. if they have control of the fluoroscopy footswitch.

One way of circumventing the training requirements for such staff is to ensure that they do not act as either practitioner or operator. This requires that there is an agreed arrangement with the radiology department whereby such clinicians work under guidelines agreed with a radiologist as described earlier in the section on practitioners. The radiographer involved in the procedure would authorize the procedure as justified following these guidelines. In this scenario, the radiologist who prepared the guidelines would then be the practitioner and the radiographer would be performing an operator action in carrying out the authorization. It would also be essential for all practical aspects to be performed by members of the radiology staff. Such arrangements will need cooperation between the specialties in setting them up and it would be helpful if the relevant Royal Colleges could give some national guidance on this issue.

The alternative is to provide training for medical practitioners in other specialties, preferably as part of the specialist registrar training, and once again the relevant Royal Colleges have a significant role to play in this. It is understood that the Royal College of Physicians is considering the introduction of such training for cardiologists, although the time-scale is unknown, and we are not aware of any other initiatives. Another aspect requiring attention is the provision of top-up training for clinicians already in post, and again no action has been taken on this issue at a national level.

It is felt that it is inappropriate for each Trust to have different methods of dealing with this situation, possibly with different criteria for judging the adequacy of any training. This would greatly hinder the movement of staff between Trusts. It is essential that further talks are held between the Department of Health and the professional bodies to lay down a national framework for the application of the training requirements under IR(ME)R. In the meantime, it would be helpful if the Department of Health would acknowledge that in the current transitional phase the training required by the different professional groups has not been established, so it is difficult for employers to comply fully with the legal requirements.

	Summary

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Overall, the introduction of the Ionising Radiation (Medical Exposure) Regulations 2000 has the potential for improved practice within clinical radiology. Departments should grasp this opportunity to ensure that referrers supply adequate information, to ensure that only justifiable examinations are performed and to make sure that all examinations are evaluated. In the short-term this will inevitably lead to an increased workload for the radiology departments and an apparent increase in bureaucracy. Further guidance from both the Department of Health and the relevant professional bodies would be helpful to provide some consistency of application on a national basis.

Received for publication November 2, 2000. Revision received February 8, 2001. Accepted for publication February 22, 2001.

	References

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1. Department of Health. Ionising Radiation (Medical Exposure) Regulations 2000, Statutory Instrument No. 1059. London: HMSO, 2000.
2. European Commission. Council Directive 97/43/EURATOM of 13 May 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure. Official J Eur Commun 1997;40:L180.
3. Department of Health. The Ionising Radiation (Medical Exposure) Regulations 2000, with supplementary guidance on good practice. http://www.doh.gov.uk/irmer.htm
4. Department of Health. Ionising Radiation (Protection of Persons Undergoing Medical Examination or Treatment) Regulations 1988, Statutory Instrument No. 778. London: HMSO, 1988.
5. Royal College of Radiologists. A guide to justification for clinical radiologists. London: RCR, 2000.
6. Royal College of Radiologists. Making the best use of a department of clinical radiology. Guidelines for doctors (4th edn). London: RCR, 1998.
7. The Society and The College of Radiographers. Patient identification protocols. London: The Society of Radiographers, 1998.
8. National Radiological Protection Board, Royal College of Radiologists, College of Radiographers. Advice on exposure to ionising radiation during pregnancy. Chilton: NRPB, 1998.
9. Dosimetry Working Party of the Institute of Physical Sciences in Medicine. National protocol for patient dose measurements in diagnostic radiology. Chilton: NRPB, 1992.
10. Department of Health. The Ionising Radiations Regulations 1999, Statutory Instrument No. 3232. London: HMSO, 1999.
11. Department of Health. Proposals for the Ionising Radiation (Medical Exposure) Regulations 1999: consultative document. London: DoH, 1998.

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