A Guide to Understanding the Implications of the Ionising Radiation (Medical Exposure) Regulations in Radiotherapy

Transcription

1 IPEM A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy The Society and Coege of Radiographers The Roya Coege of Radioogists Institute of Physics and Engineering in Medicine

2 Do you know that? IR(ME)R is aimed at protecting patients (see Section 1.2) IR(ME)R is egisation made as crimina aw rather than civi aw (see Section 1.2 and 5.11) Duty hoders under IR(ME)R A referrer, who requests that the patient is treated, is required to provide sufficient cinica information to aow justification of the treatment (see Section 2.6) A practitioner is responsibe for justifying any radiation exposure (see Section 2.8). (Justification is the process of weighing up the potentia benefits of the exposure against the potentia detriment to the individua.) An operator is personay responsibe for their own contribution to the patient s treatment (see Section 2.12) Practitioners and operators are required to foow defined written protocos (see Section 4.1) Human error that eads to a radiation exposure much greater than intended must be reported to the responsibe authority (see Section 5.3) In the event of an error resuting from a breach of reguations, individuas or empoyers may be prosecuted (see Sections 5.9 and 5.11) The empoyer has a statutory duty to make sure written procedures, written protocos and quaity assurance programmes are in pace (see Sections 1.3 and 4.1) The empoyer is responsibe for ensuring that practitioners and operators are adequatey trained and keeping records of this training (see Section 2.3) When an operator task is being undertaken under supervision, the supervisor is fuy responsibe as operator for that task (see Section 2.19) A exposures must be justified and authorised before they are made, and the signed prescription is the evidence of authorisation that treatment can proceed (see Section 3.2) Your signature means that you are taking responsibiity for that specific part of the radiotherapy process. It woud be inappropriate for you to sign for something outside your contro, for which you have not been trained and do not have the toos to compete. Written procedures shoud expicity state which duty hoder is responsibe for each eement of a process (see Sections ) When severa staff are invoved in a particuar task, the empoyer must define in written procedures whether they a have equa ega responsibiity or whether one person is acting as the responsibe operator for the purpose (see Sections 3.5 and 3.12) When using the word check in a written procedure, it must define exacty what is meant and what an individua is required to do and what responsibiity they have (see Section 3.13) When checking something is correct, you shoud aways seek to find ways to carry out a process in a different way to maximise the chance of identifying an error (see Sections 3.13 and 3.15) If an operator initiates treatment without evidence of a check being competed, they are then hed responsibe if it has not been done (see Section 3.13) The arrangements for justifying and authorising radiotherapy exposures for out-of-hours emergencies shoud be as robust as those in pace during the norma working day (see Section 3.18)

3 Contents Foreword 5 1 Introduction Who is this working party document for? The purpose of this working party document The Ionising Radiation (Medica Exposure) Reguations Duties and definitions Who is the empoyer? The empoyer s responsibiities The empoyer s responsibiities for training Training records to be kept for inspection If I change jobs, how wi my new empoyer know what I have been trained to do? What is meant by a referrer? Information required for a referra What is meant by a practitioner? What is justification? Detriments to be considered in justifying an exposure What is the core of knowedge? What is meant by an operator? Are service engineers or in-house equipment technicians cassed as operators? What is meant by authorisation? What is meant by optimisation? What is meant by cinica evauation? The roes of the radiation protection advisor and the medica physics expert under IR(ME)R The roe of individuas who are not registered heathcare professionas such as radiotherapy assistant practitioners and cinica technoogists in practica aspects of the exposure. What supervision and training shoud be avaiabe? What is meant by supervision? Does this impy a physica presence? What is necessary to satisfy the requirement for procedures for the assessment of patient dose and administered activity? Are diagnostic reference eves necessary for treatment panning exposures? 20 3 Responsibiity The difference between professiona and ega responsibiity under IR(ME)R What constitutes a prescription? What does a signature on a prescription mean a practitioner is responsibe for? If I am asked to sign something, what is the ega significance of this and how do I know that this is appropriate under IR(ME)R? The impications of one cinician signing another cinician s pan Cinica oncoogists may fee that they are entirey responsibe for the whoe care of the patient. Is this correct under IR(ME)R? Can you deegate a task whie retaining responsibiity? Do I have to ask every femae patient if they are pregnant? 25 A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy 3

4 3.8 Who shoud justify images in centres where verification images invove additiona radiation? What is the roe of countersigners under IR(ME)R? Is this different from the countersignature cuture evident in Cancer Standards (Engand)? How shoud referra for concomitant exposures additiona to those documented in an origina referra be made? Who shoud justify pretreatment and concomitant exposures? Can you have mutipe operators performing eements of one defined task but ony one of them taking responsibiity? Is it necessary to define what is meant when using the term checking? The roe of the mutidiscipinary team (MDT) in referra for radiotherapy What shoud be incuded in a patient identification procedure? What is meant by Reguation 7(7(b)) which states that the practitioner and operator sha pay specia attention to medica exposure of chidren? What is my responsibiity for patient care when I am away from work? What arrangements are appropriate for the prescription of radiotherapy for emergencies out of hours? What are my responsibiities if I discover an error? 31 4 Procedures, protocos and auditing How shoud procedures and protocos be managed? What is meant by quaity assurance? The reationship between a quaity system and IR(ME)R The impications for research of impementing IR(ME)R in radiotherapy Where do responsibiities ie when patients are treated in research studies? 35 5 Inspection and reporting of incidents Responsibiity for enforcement of IR(ME)R What sort of inspections can the appropriate authorities undertake? The requirements to report under IR(ME)R Notifying the appropriate authority and the information they want in an initia report How is a notification deat with? The possibe outcomes of a notification The possibe outcomes of an investigation which eads to a reactive inspection Reporting of incidents that do not fit the IR(ME)R notification criteria How does IR(ME)R, written under crimina aw, fit with an open reporting cuture? How do we demonstrate due diigence has been exercised to impement IR(ME)R? The impications of ega action under IR(ME)R; where wi I seek ega support? 41 References 42 Appendix 1. Entited referrers and practitioners 44 Appendix 2. Training matrices 45 Appendix 3. A checkist for a proactive inspection to assess IR(ME)R compiance 47 Appendix 4. Appropriate authorities for notification of incidents 49 Gossary 50 Working Party Membership 51 4 A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy

5 Foreword The Ionising Radiation (Medica Exposure) Reguations (IR(ME)R) 2000 is egisation intended to protect the patient from the hazards associated with ionising radiation. Major errors within radiotherapy are reported under IR(ME)R and investigations are conducted under crimina aw and under the threat of caution. This may be seen as at odds with the deveopment of a no bame cuture, but serves to emphasise appropriate responsibiity. IR(ME)R compiance has not yet been tested in the courts, and there is confusion among radiotherapy professionas about the impications of IR(ME)R for their practice. The objective of the Ionising Radiation (Medica Exposures) Reguations (IR(ME)R) Working Party was to bring together representatives from the professiona bodies representing cinica oncoogy, therapeutic radiography and radiotherapy physics to produce a guide to hep empoyers and cinica coeagues understand and impement IR(ME)R egisation as it pertains to radiotherapy. The Coege is gratefu to the Heath Protection Agency (HPA) for expert advice. A series of frequenty asked questions has been produced to hep the reader navigate their way through IR(ME)R. This guidance is not intended to be definitive and there is not a singe correct answer; the advice given is wide-ranging and does not undermine an empoyer s ega responsibiities for impementing compiant oca procedures. This document shoud be read in conjunction with IR(ME)R and pubished guidance. I woud ike to thank Dr David Boomfied (chair), Dr Sian Davies, Steve Ebdon-Jackson, Michae Graveing, Phiip Mayes, Maria Murray and Caro Nix for their work in producing this document. I woud aso ike to thank the referees for their hepfu comments. Michae Wiiams Dean of the Facuty of Cinica Oncoogy The Roya Coege of Radioogists A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy 5

6 1 Introduction 1.1 Who is this working party document for? The purpose of this working party document The Ionising Radiation (Medica Exposure) Reguations A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy

7 1.1 Who is this working party document for? This guide wi be of benefit to chief executives, medica directors, human resources departments and a professionas invoved in the deivery of radiotherapy. 1.2 The purpose of this working party document The objective of the Ionising Radiation (Medica Exposure) Reguations (IR(ME)R) 1 Working Party was to bring together representatives from the professiona bodies representing cinica oncoogy, therapeutic radiography and radiotherapy physics to produce a guide to hep empoyers and cinica coeagues in UK cancer centres understand and impement IR(ME)R egisation as it pertains to radiotherapy. The Heath Protection Agency was aso represented on the working party. IR(ME)R 1 is egisation aimed at the protection of the patient against the hazards associated with ionising radiation. It is made as crimina aw rather than civi aw. The main difference being that if there is a breach of civi aw then the aw seeks to estabish faut and award compensation; in crimina aw, an iega act is punished, compensation is a secondary issue. To date, IR(ME)R compiance has not been tested in the courts, and there is confusion and understandabe anxiety among radiotherapy professionas around the impications of IR(ME)R to their practice. A fundamenta principe is that IR(ME)R is fexibe and aows a wide variety of practices to be undertaken as ong as they are ceary justified. It is imperative that roes and responsibiities are ceary set out in procedures and that everyone understands their individua roe. Responsibiity for compiance with IR(ME)R rests with the empoyer and a entited duty hoders as defined in the reguations. It is neither possibe nor advisabe to deiver a tempate for nationa use. There is a wide range of good practice which can take into account oca needs. We aim to describe commony encountered cinica situations and provide exampes of good practice. As definitive interpretation of the aw can ony be estabished in the courts, the guidance given here shoud be regarded as an expression of professiona opinion rather than as a definitive statement of the ega position. This document aims to address a series of frequenty asked questions (FAQs) which have come up in forma inspections or have been brought to the attention of the Working Party by its members from their own departments and professions. This document shoud be read in conjunction with IR(ME)R and pubished guidance Definitions used throughout this document Cinica oncoogist means a speciaist doctor trained in the non-surgica management of cancer using radiotherapy and accredited through the Feowship examination of The Roya Coege of Radioogists (FRCR) or equivaent approved training. Physicist means an individua who has carried out training as a radiotherapy physicist. Where a physicist registered with the Heath Professions Counci is intended in this document, cinica scientist is used. Radiographer means a therapeutic radiographer registered with the Heath Professions Counci (HPC). Quotations from the Reguations are shown in itaics and itaics are aso used to indicate that words such as practitioner, operator and entited have the specific IR(ME)R meanings. The exampes quoted are taken from documents provided to the Working Party by severa trusts and are not intended to be prescriptive. 1.3 The Ionising Radiation (Medica Exposure) Reguations 2000 The Ionising Radiation (Medica Exposure) Reguations (IR(ME)R) 1 derive from the European Counci Medica Exposures Directive. 4 They are designed to ensure patient safety and were made under Section 2(2) of the European Communities Act but are enforced as if made under Section 15 of the Heath and Safety at Work etc. Act Guidance on the appication of IR(ME)R is provided by the Medica and Denta Guidance Notes 2 (which aso covers the medica appication of the Ionising Radiations Reguations [IRR]). 7 This was produced by a working group of the Institute of Physics and Engineering in Medicine (IPEM) in association with the Nationa Radioogica Protection Board (NRPB now the Heath Protection Agency Radiation Protection Division; HPA-RPD), the Heath and Safety Executive, the Heath Departments and the Environment A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy 7

8 Agencies and in co-operation with The Roya Coege of Radioogists and the Society and Coege of Radiographers. Nonstatutory guidance was issued by the Department of Heath (DH). 3 Both of these guidance documents woud need to be supported in court by an expert witness, but provide a basis for action. The essentia eements of IR(ME)R are presented in Figure 1. Figure 1. Essentia eements of IR(ME)R Proof of competence Empoyer Scope of entitement Training Duty hoders Perform functions The concept of entitement is not we understood in medicine but is required within IR(ME)R. In entiting professionas to act as duty hoders, the empoyer must aso specify the scope of this entitement. This is most obvious for operators, who undertake a range of functions, but appies to a duty hoders and is consistent with cinica governance and good professiona practice. The scope of entitement of any individua is supported by their training records, which demonstrate that the individua is competent to undertake specific functions. This approach aows for deveopment of duty hoders and extension of their scopes of entitement, as ong as this can be supported by evidence of training Definition of roes IR(ME)R (Reguation 2) defines four duty hoders, incuding the empoyer and three distinct types of duty hoder who provide a professiona contribution to radiation therapy (and diagnosis). The duties of the empoyer are defined in Reguation 4 and the duties associated with the other professiona roes are defined in Reguations 5 and 9. These are: The referrer who requests that the patient is treated and is required to provide sufficient cinica information to aow the justification of the treatment to be determined. In the EU egisation, the term used is the prescriber, but this is not the interpretation appied in the UK reguations. The practitioner who is responsibe for the medica exposure and for justifying any radiation exposure. The use of the word practitioner is unfortunate because it has become associated with roe extension in heath service professiona groups. The term justifier may better describe the roe. As the practitioner may aocate (Reguation 5(3)) practica aspects of the medica exposure to others, there is an impication that the practitioner has the cinica oversight of the treatment. The operator who carries out any practica aspect of the treatment process (incuding, for exampe, machine caibration or treatment panning). This roe is not expressy recognised in the EU directive. IR(ME)R states that a operators are personay responsibe for their own contribution to the patient s treatment. In addition, the Reguations identify the medica physics expert (MPE) as a specific operator. The MPE must be cosey invoved in a radiotherapy treatment. The Reguations do not define who may fufi these roes, except that the referrer and practitioner are required to be registered heathcare professionas, but require that each empoyer produces a ist of named individuas entited to act as practitioner or operator together with a record of their training (Reguation 11). The empoyer must estabish procedures to define who may act as referrer, practitioner or operator (Schedue 1b). 8 A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy

9 1.3.2 Justification Reguation 6 addresses justification of exposures. This requires that the benefit and detriment of the exposure are considered by the practitioner, taking into account the intention of the exposure and the characteristics of the individua patient. In radiotherapy, a whoe course of treatment fractions intended to provide a therapeutic effect is considered and justified as one tota exposure. Any necessary panning and verification exposures, if specified as part of a protoco, can be justified at the same time, or aternativey can be justified separatey. Any such exposures performed that are not covered by the protoco must be justified separatey. Optimisation Reguation 7, which deas with optimisation of exposures, incudes the requirement that exposures of target voumes are individuay panned to ensure that non-target tissues are given doses as ow as reasonaby practicabe and that the equipment seected for treatment shoud be appropriate. It is a requirement that every exposure is cinicay evauated (see Section 2.16) Empoyer s procedures Schedue 1 ists the minimum set of written procedures that empoyers are required to define, but the empoyer may define other procedures in addition to these. In radiotherapy, there must be procedures to ensure that: Patients are correcty identified Their pregnancy status is estabished Quaity assurance programmes are in pace The dose is assessed Exposures are evauated and recorded. Procedures are required to ensure that the probabiity and magnitude of accidenta or unintended doses are minimised. Practitioners and operators are required to foow the defined procedures (Reguation 5). Operators must identify the patient and ensure that the exposure has been justified and authorised (Reguation 6) before exposing the patient to radiation Investigation of errors IR(ME)R (Reguations 2 and 4) requires that a human error that eads to an exposure much greater than intended must be reported to the responsibe authority; that is, The Heathcare Commission in Engand 1,8 The Nationa Assemby for Waes 1 The Scottish Ministers in Scotand 1 The Department of Heath, Socia Services and Pubic Safety in Northern Ireand. 9 This is in parae to the requirement in IRR that such unintended exposures that are caused by equipment faiures are reported to the Heath and Safety Executive and the Medicines and Heathcare products Reguatory Agency (MHRA) 10 under its adverse incident notification system. The responsibe authority may investigate such errors (and potentiay prosecute individuas or empoyers in the event that the error resuted from a breach of the reguations). IR(ME)R does not define much greater than intended, athough the DH guidance 3 referred to the guidance issued under IRR 7 (see Section 5.3). A course of radiotherapy may not be compromised by a significant error (even 20%) in a singe fraction and it is accepted that for this purpose the course shoud be treated as a whoe. Errors in positioning of the beam may be as significant as errors in the magnitude of the dose and where they have a potentia impact on treatment outcome, shoud aso be reported. As the requirement for reporting of exposures much greater than intended derives from a reguatory framework designed to protect against the hazards of ionising radiation, there is no requirement for reporting underdoses under IR(ME)R, even though they may aso compromise treatment outcome. Notifications are required whenever the trigger eves are met which are described on the DH website. A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy 9

10 1.3.5 Training The requirement for staff to be adequatey trained is as much an important part of the reguations as it is of the European Counci Medica Exposures Directive. 4 Comprehensive records of staff training must be kept in association with the ist of practitioners and operators (Reguation 11). A ist of topics that training must cover is in Schedue 2. Whie the empoyer is required to maintain training records, Reguation 11 aso paces a duty on the practitioner and operator not to carry out an exposure without adequate training. The reguations make cear that adequate training refers specificay to the items isted in Schedue 2 (Reguation 2) and that an appropriate certificate issued by an institute approved to issue degrees or dipomas constitutes sufficient evidence of such training, provided that this is stated on the certificate. This impies that the training referred to is generic rather than specific to an individua department. It is, however, essentia that training shoud be provided to operate the specific equipment (see Appendices 1 and 2, pages 44 and 45) Equipment The empoyer is required to draw up a ist of equipment hed which shoud incude information about the manufacturer, seria number and year of manufacture and instaation (Reguation 10). There is a requirement that the equipment is imited to the amount necessary, impying that superseded equipment must be decommissioned. 10 A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy

11 2 Duties and definitions 2.1 Who is the empoyer? The empoyer s responsibiities The empoyer s responsibiities for training Training records to be kept for inspection If I change jobs, how wi my new empoyer know what I have been trained to do? What is meant by a referrer? Information required for a referra What is meant by a practitioner? What is justification? Detriments to be considered in justifying an exposure What is the core of knowedge? What is meant by an operator? Are service engineers or in-house equipment technicians cassed as operators? What is meant by authorisation? What is meant by optimisation? What is meant by cinica evauation? The roes of the radiation protection advisor and the medica physics expert under IR(ME)R The roe of individuas who are not registered heathcare professionas such as radiotherapy assistant practitioners and cinica technoogists in practica aspects of the exposure. What supervision and training shoud be avaiabe? What is meant by supervision? Does this impy a physica presence? What is necessary to satisfy the requirement for procedures for the assessment of patient dose and administered activity? Are diagnostic reference eves necessary for treatment panning exposures? 20 A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy 11

12 2.1 Who is the empoyer? The definition in IR(ME)R states, empoyer means any natura or ega person who, in the course of a trade, business or other undertaking, carries out (other than as an empoyee), or engages others to carry out, medica exposures or practica aspects, at a given radioogica instaation. It is important to recognise that empoyer within IR(ME)R reates to heath and safety functions rather than empoyment matters. The empoyer, as a duty hoder under IR(ME)R, is responsibe for providing a framework within which professionas undertake their functions. This framework is created through written procedures, written protocos and quaity assurance programmes. The empoyer has a statutory duty to make sure these are in pace. The empoyer shoud be considered to be the chief executive uness an aternative individua has been formay designated as the empoyer. The individua undertaking the roe of the empoyer must hod a senior position within the organisation, usuay at board eve. The individua s roe must reate to a those professiona groups that provide eements of the radiotherapy service and ideay shoud incorporate a other services using ionising radiation such as radioogy and nucear medicine. It is usua for the detaied impementation of IR(ME)R to be deegated to an appropriate professiona. 2.2 The empoyer s responsibiities The duties of the empoyer are set out in Reguation 4 and are mainy sef-expanatory. Under IR(ME)R, the empoyer is egay responsibe, when estabishing practices for the safe deivery of radiotherapy, for ensuring that robust procedures exist incuding those isted in Schedue 1, (Reguation (4(1)). It is essentia that procedures are reguary reviewed and updated. Such procedures must be documented and define how every exposure is justified and optimised, as we as defining the responsibiities of every individua invoved in the process. The individua who is the empoyer must identify who is entited (entited means given permission to act/authorised to act by the empoyer [see Section 1.3.1]) to act as a referrer, practitioner and operator and take steps to ensure that a practitioners and operators compy with written procedures. The empoyer aso has responsibiity for putting referra criteria in pace and making sure these are avaiabe to referrers. In radiotherapy, these guideines are commony deveoped as cancer network protocos and mutidiscipinary (MDT) patient pathways, suppemented by oca departmenta protocos for urgent and paiative patients. Referra for radiotherapy requires a suitaby competent individua to assess a the avaiabe patient information against any referra criteria and they must be entited by the empoyer to make that decision. The empoyer shoud aso recognise that referra criteria cannot be written for every cinica situation and entite suitaby knowedgeabe individuas to refer for radiotherapy in those cases. It might be appropriate to imit this to consutant staff. Additionay, the empoyer is responsibe for: Having a quaity assurance programme in pace Reguation (4(3b)) (see Section 4.2, 4.3) For estabishing dose constraints for research Reguation (4(3d)) (see Section 4.4, 4.5) For ensuring that practitioners and operators are adequatey trained Reguation (4(4)) (see Section 2.3, 2.4) For investigating and reporting incidents where a dose much greater than intended has been deivered to a patient Reguation (4(5)) (see Sections ). A of these issues are covered in more depth ater in this document. 2.3 The empoyer s responsibiities for training The empoyer has a responsibiity to ensure that a entited practitioners and operators are adequatey trained to perform the tasks in their defined scope of practice (Reguation 4((4)a and (4) b)) and simiary practitioners and operators sha not carry out a medica exposure or any practica aspect without having been adequatey trained. (Reguation 11(1)) The empoyer sha keep and have avaiabe for inspection by the appropriate authority an up-to-date record of a practitioners and operators engaged by him to carry out medica exposures or any practica aspect of such exposures showing the date or dates on which training quaifying as adequate training was competed and the nature of the training. Reguation 11(4) Adequate training to achieve and maintain professiona registration is determined by the reevant reguatory body as defined in the Nationa Heath Service Reform and Heathcare Professions Act For the purposes of demonstrating adequate 12 A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy

13 training to be a duty hoder in radiotherapy under IR(ME)R, this training needs to have specificay covered training in radiation safety issues for radiotherapy. Non-registered heathcare staff can be entited to act as operators, such as radiotherapy assistant practitioners (APs), who have trained on a Society and Coege of Radiographers (SCoR) approved course, and some trainees in other discipines who have received radiation specific training, but this may not be the case for a staff such as some cinica technoogists. The empoyer wi need to address any additiona training needs before entiting these staff to act as operators. For a practitioners and operators, this initia training shoud ony be considered as a starting point rather than an endpoint in demonstrating adequate training within a oca department. Responsibiity for ensuring that adequate and up-to-date oca training is deivered and recorded, rests with the empoyer and must be consistent with the tasks the individua is entited to carry out. When an empoyer identifies a member of senior staff as having responsibiity for IR(ME)R documentation, assessment of staff competence and maintaining training records then the empoyer must ensure that this individua s empoyment contract gives sufficient time and resources to discharge this responsibiity. 2.4 Training records to be kept for inspection As individuas join a department, there is often a period of induction into oca procedure. Training thereafter is continuous, as part of continuing professiona deveopment (CPD) and in response to the introduction of new equipment, new techniques or as upgrades to operating software and systems of work occur. For this reason, training records need to refect this continuous deveopment and oca department-specific training, as we as that achieved through additiona externa quaifications and courses. Practitioner training records Professiona quaifications in cinica oncoogy (for exampe, Feowship of The Roya Coege of Radioogists [FRCR] by examination and the subsequent award of a competion of speciaist training certificate [CCST] by the Postgraduate Medica Education and Training Board [PMETB]) are suitabe for use as evidence of competence to act as a practitioner for a defined scope of treatment and concomitant exposures. This scope of practice needs to be specified in oca documentation. This may be further guided by recognition of site speciaisation and entitement shoud be appropriate to the skis and up-to-date training and experience of the individua as this duty carries a ega responsibiity under IR(ME)R. Registered heathcare professionas who are not medicay quaified can be entited by their empoyer to act as practitioners for a defined scope of practice; for exampe, justification of concomitant images or paiative radiotherapy. In a simiar way, their forma professiona training may be used as evidence of the training necessary to carry out such roes, but this wi need to be reviewed on an individua basis. It is necessary that this forma training incudes the benefits versus detriment of exposure to ionising radiation. Consideration shoud be given ocay to any additiona training or experience required, reevant to the pre-registration training and the imaging and treatment modaities in use. An exampe of how to demonstrate practitioner entitement and training is shown in Appendix 1, page 44. As verification imaging is a deveoping area of practice, the empoyer must ensure that a those individuas justifying such exposures have received adequate up-to-date training and are competent, before entiting them to act in this capacity; for exampe, when introducing cone-beam computed tomography (CT) on the inear acceerator, where the benefit versus detriment of the radiation exposure wi be different to that inherent in 2-D porta imaging. This can be achieved by offering in-house or externa training. There is a requirement for additiona training and documentation for both medica and non-medica staff as new technoogies are impemented. This wi require assessment on an individua basis. Further information is avaiabe in a future pubication on verification by The Roya Coege of Radioogists in conjunction with the Society and Coege of Radiographers and the Institute of Physics and Engineering in Medicine. 15 Operator training records The empoyer must have documented and up-to-date evidence of training. Training records for physicists and radiographers to undertake operator tasks (that is, practica aspects of the exposure) are often we deveoped and up to date, refecting A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy 13

14 training and competency achieved as they earn different skis. This is often not the case for cinica oncoogists who aso undertake practica aspects such as the use of computer panning and virtua simuation software, positioning of brachytherapy appicators and evauation of images, incuding verification images. Good practice requires that training in oca departmenta practice shoud be documented in an overview of training records for a professiona groups. To simpify writing procedures and avoid engthy descriptions about different staff groups at different eves of training having to be defined in such procedures, it can be hepfu to incude a statement such as in Exampe 1. Exampe 1. Treatment panning can ony be carried out by an adequatey trained, entited operator. A trainee can undertake treatment panning under direct supervision of an entited operator who is responsibe for the task being competed correcty. An up-to-date matrix of a treatment panning techniques and tasks and those entited operators is hed and maintained by the head of the radiotherapy treatment panning section. 2.5 If I change jobs, how wi my new empoyer know what I have been trained to do? Accredited training such as the FRCR and the quaifications required to achieve the status of registered heathcare professiona wi be straightforward when moving to another empoyer. Training for speciaist registrars in cinica oncoogy often rotates between different cancer centres, but within the same training scheme. It woud therefore be appropriate for evidence of training in a form recognised as suitabe for incusion in their persona training portfoio to be reviewed by a designated cinica oncoogist on behaf of the empoyer. They can then be entited to undertake a defined practitioner roe (for exampe, certain paiative treatments in and out of working hours). It woud aso be appropriate for evidence of core training to be agreed within a rotation, and for the individua trust s IR(ME)R documentation to refect this. Many individuas are required, as part of their continued registration to practice, to demonstrate CPD. This wi aso assist a new empoyer to assess training and to determine the scope of practice for which the individua can be entited. It is more difficut and, particuary for those individuas who do not have to be a registered heathcare professiona, to demonstrate oca additiona and equipment-specific training. It is, therefore, advisabe to obtain copies of any empoyer s training records before moving on. Athough these may be in a different format from those of the new empoyer, they wi provide a foundation to estabish what an individua is trained to do and what additiona training might be required. This is particuary reevant if an individua is expected to extend their scope of practice and take an additiona responsibiity in the new post. 2.6 What is meant by a referrer? The referrer must be a registered heathcare professiona as defined in IR(ME)R (see Section 3.14). Referrers are entited by the empoyer to request that a patient is exposed to ionising radiation as part of the whoe treatment process. The empoyer shoud specify the scope of practice for which an individua can refer. This may be imited to referra for panning, referra for treatment, referra for verification images or be any combination of the three. It is important to make this distinction in written procedures. This can often best be demonstrated by using a tabe simiar to that shown in Tabe 1, Appendix 1, page 44. Confusion has arisen in the past because the term referra is we understood in the context of one heathcare professiona requesting that a coeague takes forward the management of a patient based on either a confirmed or suspected diagnosis. The date that this type of referra is received is coected routiney for waiting times data. In practice, an appointment is made for a patient to see a cinica oncoogist or a member of a site-specific mutidiscipinary team (MDT) for an opinion on the management of the patient. If, as the resut of such an appointment, the patient requires 14 A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy

15 radiotherapy treatment, a radiotherapy request or booking form wi be competed or this information wi be entered into the patient s notes. This request for a patient to be exposed to ionising radiation constitutes a referra in the context of IR(ME)R. 2.7 Information required for a referra IR(ME)R requires that the referrer provides the necessary information to the practitioner. The referrer sha suppy the practitioner with sufficient medica data (such as previous diagnostic information or medica records) reevant to the medica exposure requested by the referrer to enabe the practitioner to decide on whether there is a sufficient net benefit as required by Reguation 6(1)(a). A referra must be made by a registered heathcare professiona as defined by IR(ME)R. Referrers are entited by the empoyer to request that a patient is exposed to ionising radiation as part of the treatment process. It is essentia that the referrer provides sufficient cinica data so that the exposure can be justified. For a radiotherapy treatment referra, this means detais, as appropriate, of: Diagnosis Histoogy Cinica finding and staging examinations must be made avaiabe. It is not safe to rey on second-hand information, and the source documents or copies shoud be avaiabe throughout the radiotherapy process, particuary at critica points such as panning and prescription as these data are essentia for justification. For referra for additiona panning or verification images, the empoyer shoud define the referra criteria and what cinica information is required from the referrer. How a referrer carries this out and documents this at a parts in the radiotherapy pathway shoud be described in written procedures. 2.8 What is meant by a practitioner? IR(ME)R states that the practitioner must be a registered heathcare professiona and that the practitioner and operator shoud compy with the empoyer s written procedures. (Reguation 5(1)) The practitioner is entited by the empoyer to justify and authorise (see Section 2.14) the exposure of a patient to ionising radiation as part of the whoe treatment process. To do this, the request for the exposure is assessed against the cinica data suppied by the referrer. The practitioner must have adequate training and be competent to weigh up the potentia detriment of the exposure against the potentia benefits for that individua (see Section 2.9). This judgement shoud take into account a the associated risks incuding the risk of second cancer induction from concomitant exposures and the ikeihood that such exposures wi improve the accuracy of treatment and so reduce side-effects. The possibiity of aternative treatment and verification techniques, incuding perhaps a technique which does not use ionising radiation, shoud aso be considered. In radiotherapy, the referrer and practitioner for a course of treatment may be the same person and entited to undertake both functions (for exampe, a consutant fiing in a radiotherapy action sheet at a mutidiscipinary meeting). Nevertheess, it shoud be emphasised that these are two distinct parts of the process by which a patient comes to be exposed and that the requirements of both functions must be met. This shoud be made cear in the empoyer s written procedures. It may be appropriate to require two separate signatures to provide evidence of referra and of justification, but the need for this wi depend on the requirements of the specific procedures. The empoyer shoud specify the scope of practice for which an individua can act as a practitioner. The scope of practice may be imited, for exampe, to justification of panning exposures or to additiona verification exposures on treatment or to any combination incuding treatment itsef. It is important to make this distinction in written procedures and this can often be best demonstrated using a tabe (Appendix 2, page 45). Practitioners sha not carry out a medica exposure or any practica aspect without having been adequatey trained. (Reguation 11(1)) It is aso the practitioner s responsibiity to ensure that the treatment is individuay panned and that the dose to non-target tissues is as ow as reasonaby practicabe athough this does not mean that the practitioner personay needs to carry out the treatment pan. (Reguation 7(2)) A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy 15

16 2.9 What is justification? Justification is the process of weighing up the potentia benefit of the exposure against the potentia detriment for that individua. This judgement shoud take into account the probabiity that the requested exposures wi achieve the desired outcome and whether different exposures, using a different technique or another dose woud be suitabe instead. Account must aso be taken of the possibiity of using techniques which do not use ionising radiation which can be addressed at the tumour-specific mutidiscipinary team meeting. In justifying therapy doses, it is important to consider possibe aternative treatments which do not use radiotherapy. For instance, in stage I testicuar seminoma which has a 15% risk of reapse, options incude: Risk stratification and surveiance of ower risk patients with CT scans 16 Para-aortic radiotherapy which has been used in this roe for about 50 years. There is a arge amount of ate foow-up data, indicating a 1.4-fod increase in the reative risk of second cancer. At 30 years foow-up, when patients are approaching 60 years of age, cancer incidence in the untreated popuation is 17%. In the irradiated popuation it is 25%. This represents an absoute increase of 8% in cancer incidence 17 Carbopatin this treatment with a singe dose of chemotherapy has been shown to reduce reapse rate to 4% (the same as radiotherapy); foow-up data are imited and there are few ong-term resuts. 18 Another exampe of an aternative management strategy woud be in the management of carcinoma of the cervix: patients with eary-stage disease can be treated with radiotherapy or with radica surgery. For most patients, the atter is the best option as there are fewer ong-term side-effects and no increased risk of a second maignancy Detriments to be considered in justifying an exposure The detriments to be considered incude ong-term and short-term side-effects and these must be weighed against the benefit and aso must be compared with other approaches not using ionising radiation. For radiotherapy treatment, these issues form an important part of the consent process. (It shoud be noted that consent is not within IR(ME) reguations.) There is a very ong ist of acute medium-term and ong-term side-effects with which staff shoud be fuy famiiar from their training. Of particuar concern are the ong-term hazards of infertiity, about which patients shoud be counseed before treatment. It is extremey important to try to avoid accidenta irradiation of pregnant patients due to the risk of affecting organogenesis. Detaied panning and dosimetry are required to justify the intentiona irradiation of a pregnant patient. 20 The other major ong-term hazard is of carcinogenesis. The risks vary with the part of the body irradiated and with the dose. In addition, some patients may have a genetic predisposition to carcinogenesis by radiotherapy and it is beieved that this may be impicated in the very high risk of breast cancer in young women who received radiotherapy for Hodgkin s disease. 21 Another exampe of a high-risk group is chidren with neurofibromatosis type I who are at an inherent high risk of secondary cancer which can be increased by radiotherapy. 22 There is aso an increased risk of radiation-induced vascuopathy 23 and inteectua deterioration. 22 These considerations ead to chemotherapy being the firstine treatment strategy for ow-grade maignancy of a centra nervous system sites for chidren with neurofibromatosis type 1. Most radiotherapy patients in the UK are treated for maignancies but some are sti treated for benign disease and these require carefu consideration. Chidren and young peope are more sensitive to the carcinogenic risks of radiotherapy, 21, 24 with chidren being ten times as sensitive as oder patients. They wi therefore require specia consideration. Cacuation of ifetime risk is compicated but there have been pubications which attempt to address this issue. 25 Training wi aso be required in the communication of these issues to patients to enabe consent. 26 The practice of medicine aways invoves assessing risk and benefit. Radiotherapy is for many patients an effective and appropriate curative or paiative anti-cancer treatment What is the core of knowedge? Core of knowedge was a term identified in the previous Ionising Radiation (Protection of Persons Undergoing Medica Examination or Treatment) Reguations (POPUMET) which were revoked in Reguation 14 of IR(ME)R and repaced by Schedue A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy

17 The core of knowedge training provided education such that the use of radiation in medica exposures woud be soundy based. Under IR(ME)R, the requirement that practitioners and operators must be adequatey trained is guided by information provided in Schedue 2 of the Reguations. The Schedue outines subjects which need to be addressed with regard to theoretica knowedge (incuding reguatory requirements) and practica experience: (a) Reevant to their functions as practitioners or operators (b) Reevant to the specific area of practice. The intentions of both POPUMET and IR(ME)R were to cover those professionas who wished to undertake medica exposures but woud not consider this to be their primary function and therefore woud not have received theoretica knowedge and practica experience as part of their forma training. An exampe of this woud be an orthopaedic surgeon who wished to undertake exposures to guide a surgica procedure. For radiotherapy, the requirements of Schedue 2 are argey addressed by specific professiona quaifications and experience. The exception to this may be where individuas undertake functions associated with roe deveopment and extension, in which case the contents of Schedue 2 must be addressed and evidence of this shoud be avaiabe before entitement is extended What is meant by an operator? The operator does not have to be a registered heathcare professiona. The definition of operator is stated in IR(ME)R as any person who is entited, in accordance with the empoyer s procedures, to carry out practica aspects. The empoyer shoud specify the scope of practice and the tasks for which an individua can act as an operator and be abe to demonstrate they are adequatey trained to undertake these tasks. Using a matrix is a simpe way to demonstrate this, as shown in Appendix 2. Individua training records for operators require reguar updating as individuas deveop, and equipment and techniques are constanty changing. It is important to incude cinica oncoogists as entited operators for the practica aspects they carry out such as eements of computer panning. Written procedures coud then incude statements such as in Exampe 2. Exampe 2 Radiotherapy treatment must be deivered by an entited operator (see training matrix). The operator initiating the exposure is responsibe for. and wi sign in coumn A on the treatment sheet. Outining of the GTV must be carried out by an entited operator (see training matrix). Reguation 5(1) states, The practitioner and operator shoud compy with the empoyer s written procedures. Reguation 11 states that, No practitioner or operator sha carry out a medica exposure or any practica aspect without having been adequatey trained Are service engineers or in-house equipment technicians cassed as operators? Operators are duty hoders who are entited to carry out practica aspects of a medica exposure. Practica aspects incude the physica conduct of the exposure and other supporting aspects that have a direct infuence on radiation dose to the patient. The non-statutory guidance 2 on operators states that, Third-party service engineers woud not normay be considered as operators. Where significant changes to equipment have been made, these shoud be checked where practicabe by an operator (for exampe, an empoyee of the NHS trust) before equipment is brought into cinica use. In most circumstances in radiotherapy, third-party engineers, whether providing initia instaation or servicing, are responsibe for presenting a machine in a safe condition, but they are not responsibe for the equipment being in a state fit for cinica use. Foowing initia instaation or service, third-party engineers wi reease to the NHS trust equipment that conforms to specification and wi demonstrate this by presenting data on performance, ogs of servicing undertaken and so on, but further measurements and verification are needed before the equipment can be used cinicay. It foows, therefore, A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy 17

18 that the third-party engineers have undertaken work that wi be checked before equipment is used to make medica exposures and therefore the work of third-party engineers cannot be considered to directy infuence practica aspects of an exposure and therefore they are not considered as operators. Further measurements are then undertaken by in-house cinica technoogists, physicists or by those who are responsibe, as entited by the empoyer (in this exampe the NHS trust) for presenting or returning the equipment in a state fit for cinica use. These staff coect, provide or verify data that are used directy in cacuation and deivery of treatment to patients. As such, they are providing supporting aspects to the medica exposure that directy infuence the radiation dose to patients and are therefore operators under IR(ME)R What is meant by authorisation? Authorisation is not formay defined in the Reguations. Reguation 6(1)(a) requires that a exposures be justified by the practitioner. In addition, Reguation 6(1)(b) requires that no person sha carry out a medica exposure uness it has been authorised by the practitioner or by an operator. Reguation 6(5) permits an operator to authorise an exposure in accordance with guideines issued by the practitioner if the practitioner is unabe to do so. Reguation 6(5) has a imited vaue in radiotherapy and is unikey to be used often in the justification of therapeutic exposures, athough it is widey used for verification imaging and for correction protocos. Authorisation is the verification that the process of justification has taken pace and is usuay demonstrated by the signature of the practitioner or operator as aowed above. Justification itsef is an inteectua process (see Section 2.9) What is meant by optimisation? Reguation 7 describes the requirements for optimisation of exposures. Optimisation in this sense is one of the three basic principes of radioogica protection (justification, optimisation and dose imits) and is defined by the Internationa Commission on Radioogica Protection as the process to keep the magnitude of individua doses as ow as reasonaby achievabe beow the appropriate dose constraints, economic and socia factors being taken into account. 24 Thus, optimisation in radiotherapy incudes ensuring that: Exposures of target voumes are individuay panned ensuring that doses to non-target tissues are as ow as reasonaby practicabe whie achieving the intended radiotherapeutic purpose of the exposure The equipment used is appropriate to minimise any unnecessary dose Adequate quaity assurance is in pace Patients invoved in research are fuy informed and dose constraints associated with the research are adhered to A cinica evauation of the outcome of each exposure is recorded. Reguation 7 requires that particuar attention is paid to medica exposures of chidren, pregnant women and breastfeeding women (in the case of radionucide therapy). It may be regarded as a reasonabe interpretation of this Reguation that wherever possibe non-target norma tissues shoud be shieded as in conforma therapy What is meant by cinica evauation? The requirement that a cinica evauation of the outcome of a exposures must be recorded (Reguation 7(8)) is incuded within the optimisation requirements and is primariy designed to prevent unnecessary exposures being made in the diagnostic context. If an exposure is not to be evauated then it cannot be justified and therefore shoud not be made. The decisions made foowing cinica evauation shoud be consistent with safe and effective practice guidance. Radiotherapy incudes a range of medica exposures and the purposes of cinica evauation for each of these incuding medica exposures reating to panning, verification and treatment are different. The evauation must be carried out by an adequatey trained operator who may be a cinician but coud aso be a non-medica operator, such as a therapeutic radiographer (as is often the case with porta images). 18 A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy

19 Panning exposures The evauation of panning exposures is demonstrated by their use. Such exposures are either fit for purpose or not. The CT dataset or orthogona images used shoud be identifiabe from records. Audit of panning exposures that are deemed not to be fit for purpose shoud inform future processes and training needs. This shoud resut in reduction of unnecessary exposures for future patients. Pretreatment verification The evauation of these exposures is essentia to demonstrate that the intended therapy can be deivered as prescribed. For these exposures, the diagnostic quaity of the image produced is a secondary consideration. On-treatment verification Porta images and kv images taken during treatment must be evauated for correctness and this check documented by entited operators as part of a written procedure. For these exposures, the quaity of the image produced is a factor. These evauations wi provide the basis for adjustment or continuation of treatment and must therefore be carried out in a timey manner. Treatment Reguar cinica reviews shoud be conducted whie the patient is on treatment by entited adequatey trained staff. At the concusion of treatment, an end-of-treatment summary provides a cinica evauation of the radiotherapy course. As a minimum, the evauation shoud record the deivered treatment dose and any reasons why this differs from that intended. Immediate cinica effects, for exampe, a skin reaction, shoud be incuded as part of the evauation The roes of the radiation protection advisor and the medica physics expert under IR(ME)R The radiation protection advisor (RPA) has no statutory responsibiity under IR(ME)R. The medica physics expert (MPE) is defined in IR(ME)R as a person who hods a science degree or its equivaent and who is experienced in the appication of physics to the diagnostic and therapeutic uses of ionising radiation. Reguation 9 requires that the MPE must be cosey invoved in every radiotherapeutic practice other than standardised therapeutic nucear medicine practices. The roe of the MPE is further defined as consutation on optimisation, incuding patient dosimetry and quaity assurance, and to give advice on matters reating to radiation protection concerning medica exposure, as required, in a other radioogica practices. Therefore, from the statutory point of view, any issue that arises from matters covered by IR(ME)R are the province of the MPE and anything arising under IRR 7 is the province of the RPA. One area where there is cear overap is in the quaity assurance of radiotherapy equipment which is a requirement of both sets of Reguations. In practice, it is common for the RPA to be an independent cinica scientist who provides advice on an occasiona basis, whereas the MPE is fuy invoved in the work of the radiotherapy department. It is important to note that, in contrast to the MPE, the RPA is not expected under the terms of either egisation to be activey invoved in doing the work and therefore has a more restricted remit. There is, however, no reason why the two roes shoud not be performed by the same individua, but when this happens it is advisabe that advice given in the capacity of RPA is ceary identified as such The roe of individuas who are not registered heathcare professionas such as radiotherapy assistant practitioners and cinica technoogists in practica aspects of the exposure. What supervision and training shoud be avaiabe? Quaified cinica technoogists and quaified radiotherapy assistant practitioners are not registered with any reguatory body (such as the HPC) but are trained to carry out specific practica aspects of radiotherapy and as such can be entited operators for those aspects. A vountary register of cinica technoogists is currenty in pace and may in future be incorporated under the HPC. Before entiting a cinica technoogist or a radiotherapy assistant practitioner to act as an IR(ME)R operator, the empoyer must ensure that the person is adequatey trained and that the training meets the requirements of Schedue 2 of the Reguations. The scope of such entitement shoud be ceary documented. Simiar considerations coud appy to other staff groups where specific training is appied. Training shoud be given and documented for the tasks an individua wi be entited to undertake. A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy 19

20 The roe of the radiotherapy assistant practitioner has been deveoped as part of the Society and Coege of Radiographers four-tier structure of assistant practitioner, practitioner, advanced practitioner and consutant. Further guidance is avaiabe in Education and Professiona Deveopment: Moving Ahead by the Society and Coege of Radiographers. 27 It is important to note that the use of the tite practitioner in this context differs from the use of the tite practitioner under IR(ME)R. Radiotherapy assistant practitioner education courses approved by the Society and Coege of Radiographers incude the fundamenta principes of medica radiation generation, interaction, modification and protection as defined in Schedue 2 of the Reguations. 3 Further guidance is avaiabe in The Learning and Deveopment Framework for Cinica Imaging and Oncoogy by the Society and Coege of Radiographers. 12 The eve of supervision required to be given to a radiotherapy assistant practitioner wi depend on oca circumstances and wi be infuenced by the entited scope of practice and competence of the individua (see Section 2.19) What is meant by supervision? Does this impy a physica presence? When an operator task is being undertaken under supervision, the supervisor is fuy responsibe as operator for that task. The situation in which the supervised person is aready competent to carry out the task but is nevertheess not an entited operator requires ess supervision than a trainee who has never carried out the task before. In the atter case, direct supervision is appropriate with the supervisor constanty present and watching what is being done. More indirect supervision woud be appropriate in the former situation, and the supervisor might consider it appropriate to simpy check what has been done after it is compete. However, if, for exampe, a compex pan is being done it may be difficut to ensure that the pan has been carried out correcty by examination of the finished product and coser supervision wi therefore be necessary. A student therapeutic radiographer or trainee assistant practitioner who is not trained in a specific aspect cannot act on their own and needs direct supervision and cannot be an operator. However, an assistant practitioner who is fuy trained and quaified in a specific aspect can act on their own and can be an operator but shoud have someone avaiabe to them to provide advice and act in a supervisory capacity and avaiabe in such a way that the supervisor can, for exampe, infuence the exposure in a timeframe consistent with the cinica episode. It is essentia that the supervisor has agreed to oversee a particuar piece of work before the work commences, and that the supervisee is cear who is supervising them. Since the supervisor is taking fu responsibiity for the work once it is compete, the supervisor has the right to dictate the eve of supervision required. However, if the competence of the supervisee has been formay assessed, it is reasonabe for the supervisor to rey on that assessment as vaid. If a particuar action wi have an immediate effect on a patient (such as turning on the radiation beam), direct supervision is aways required. Where a person carrying out the task is considered fuy competent to do so it is normay appropriate that they shoud be authorised to act as an operator in their own right, rather than reying on a supervisor. Athough radiotherapy assistant practitioners operate professionay under the supervision of an HPC-registered therapeutic radiographer, when these individuas are acting as entited IR(ME)R operators, they are egay responsibe for their actions. Further guidance is avaiabe in The Scope of Practice of Assistant Practitioners in Radiotherapy by the Society and Coege of Radiographers 28 and Breaking the Moud: Roes, Responsibiities and Skis Mix in Departments of Cinica Oncoogy by The Roya Coege of Radioogists What is necessary to satisfy the requirement for procedures for the assessment of patient dose and administered activity? A radiotherapy department wi have many procedures reating to the assessment of patient dose such as procedures which dea with the preparation of treatment pans and the caibration of inacs and seaed and unseaed sources. The use of in vivo dosimetry is another method for the assessment of patient dose and procedures reating to this shoud aso be incuded. For simuators and CT scanners, a record shoud be kept of the exposure factors and voume parameters which affect radiation dose Are diagnostic reference eves necessary for treatment panning exposures? IR(ME)R requires that diagnostic reference eves (DRLs) are estabished for radio-diagnostic examinations. The purpose of radiotherapy panning exposures is not diagnosis and they are not therefore required for these exposures. However, as stated in the Medica and Denta Guidance Notes Section 8.87, the genera principe of as ow as reasonaby practicabe must sti be appied. 2 Records of a simuation exposures shoud be maintained in order to demonstrate this principe. 20 A Guide to Understanding the Impications of the Ionising Radiation (Medica Exposure) Reguations in Radiotherapy