Unintended overexposure of a patient during radiotherapy treatment at the Edinburgh Cancer Centre, in September 2015

7. Responsibilities under the Ionising Radiation (Medical Exposures) Regulations 2000

7.1 General provisions of the Regulations

The IR( ME) Regulations place duties on a number of 'duty holders'. They are 'the employer', 'the referrer', 'the practitioner', 'the operator' and the 'medical physics expert' (who is considered to be an 'operator'). This Section outlines the particular responsibilities of these duty holders under the IR( ME) Regulations, and considers whether these duties were properly being implemented at the time of this incident

With regard to these duty holders, Regulation 2(1) includes the following definitions:

"employer" means any natural or legal person who, in the course of a trade, business or other undertaking, carries out (other than as an employee), or engages others to carry out, medical exposures or practical aspects, at a given radiological installation'.

"referrer", means a registered health care professional who is entitled in accordance with the employer's procedures to refer patients for medical exposures;

"practitioner" means a registered health care professional who is entitled in accordance with the employer's procedures and whose primary responsibility is justification of the individual medical exposure;

"operator" means a person who is entitled in accordance with the employer's procedures to undertakes the practical aspects of the medical exposure;

"medical physics expert' means a person who holds a science degree or its equivalent, and who is experienced in the application of physics to the diagnostic and therapeutic uses of ionising radiation;

7.2 The duties of the employer.

7.2.1 General provisions for implementing employer's duties at the ECC

The IR( ME) Regulations place a number of statutory duties on the 'employer' which cannot be delegated to others. Therefore, in any such 'trade, business or undertaking', the employer, and the means by which that employer shall implement these duties, must be clearly identified.

In practice, however, there will be many undertakings, (including Health Boards) wherein it would be entirely unreasonable to expect the employer personally to implement these duties, such as providing a clinical protocol for a particular radiotherapy treatment. Therefore, whereas the statutory duties on the 'employer' cannot be delegated to others, it is entirely reasonable that the employer should make others responsible to him for ensuring that these duties and properly implemented, provided that the employer also takes reasonable steps to oversee proper implementation.

In this regard, the NHS Lothian 'Policy for the Implementation of the Ionising Radiation (Medical Exposure) Regulations 2000' includes the following:

• 'The Chief Executive of NHS Lothian takes overall responsibility for compliance with the duties of the employer under the Ionising Radiation (Medical Exposure) Regulations 2000 (as amended).
• 'The Medical Director of NHS Lothian is responsible to the Chief Executive for implementation of the provisions of this [ IR( ME)R] policy across the whole of Lothian NHS Board.'
• 'The Medical Director appoints an Associate Medical Director for NHS Lothian to act as ' IRMER Policy Lead'.
• 'The IRMER Policy Lead authorises, in writing, the Clinical Directors or Heads of Departments of those Directorates or Departments where medical exposures are carried out to discharge particular responsibilities in their respective Directorates or Departments.
• 'The particular duties of the Clinical Directors are;' [ inter alia]:
  'To ensure clinical audits are carried out.'
  .'To provide, maintain and disseminate employer's written procedures'
  'To entitle duty holders.'

In summary, the CEO has established and documented a clear chain of responsibilities leading back to him, and (as discussed in the following Sub-section) has made appropriate provision to oversee proper implementation of these responsibilities.

7.2.2 Clinical Audit

Regulation 8 requires that 'The employer's procedures shall include provision for the carrying out of clinical audits as appropriate'.

Regulation 2(1) defines 'clinical audit' as: 'a systematic examination or review of medical radiological procedures which seeks to improve the quality and the outcome of patient care, through structured review whereby radiological practices, procedures and results are examined against agreed standards for good medical radiological procedures, intended to lead to modification of practices where indicated and the application of new standards if necessary'.

Within NHS Lothian these annual clinical audits are the principal means by which the employer maintains oversight of proper implementation of the duties of the employer under the Regulations. NHS Lothian's Employer's Written Procedure number EP1-10 ' Provisions for Clinical Audit' requires that a pro-forma ' IRMER Clinical Audit Form' ( EP2\ ECC\0064) be completed annually by the Clinical Director of each relevant Directorate, and presented to the NHS Lothian Radiation Protection Committee.

As part of this investigation evidence was provided that the latest clinical audit had been satisfactorily completed on 10 December 2014 and signed-off by the Clinical Director of the ECC. The content of this 2014 clinical audit indicated that the requisite Employer's Written Procedures and Protocols were in place and up-to-date, and that provisions for entitlement of duty holders had been completed.

7.2.3 Employer's Written Procedures and Protocols

Regulations 4(1) and 4(2), require Employer's Written Procedures and Protocols to be in place and (Regulation 3(c)), to be subject to a written system for quality assurance. In practice this means that these documents must be 'controlled documents' within a robust quality system that ensures that they are fit for purpose and are subject to regular review and updating.

Generally speaking, Employer's Written Procedures comprise instruction from the employer on how specific tasks shall be undertaken, for example the procedure that must be applied for proper identification of the patient ahead of treatment, whereas Employer's Written Protocols define clinical practice for specific treatments, and allow for variation according to the clinical judgement of the user.

The NHS Lothian Employer's Written Procedures comprise a set of 13 quality controlled 'Level 1' documents that apply to the whole of NHS Lothian, and nine 'Level 2' documents, which are particular to each directorate, including the ECC. The titles of these nine Level 2 Procedures, for example 'Justification and authorisation of medical exposures' are listed in the NHS Lothian 'Policy for the Implementation of the Ionising Radiation (Medical Exposure) Regulations 2000'.

The Level 1 Procedures are authorized by the Associate Medical Director (as the NHS Board's ' IRMER Lead'), and Level 2 Procedures are authorized by the Directors of each of the relevant Directorates.

These two sets of Employer's Written Procedures cover all of the requirements of the IR( ME) Regulations, including those of 'Schedule 1'.

Within each of the NHS Lothian Directorates, where a particular Division requires additional Employer's Written Procedures, these are designated as 'Level 3' documents, and are authorized by the relevant Head of Division.

The NHS Lothian 'Policy for the Implementation of the Ionising Radiation (Medical Exposure) Regulations 2000' requires that each of these Employer's Written Procedures and Protocols be reviewed at least biannually.

Within the ECC, the Oncology Physics Division and the Therapeutic Radiography Division each have their own set of Level 3 Procedures.

As part of this investigation, this set of Procedures was reviewed to ensure proper compliance with the IR( ME) Regulations, and with the employer's own document quality assurance requirements.

In this regard, at the time of this investigation, there were a number of inconsistencies between the instructions given by the employer in written Policies and in Level 1 and Level 2 documents, and the content of the Oncology Physics and the Therapeutic Radiography Level 3 Procedures, and the numbering system for these documents appeared to be at odds with stated requirements. However, these are matters of internal consistency, rather than compliance with the Regulations, and in this latter regard no significant deficiencies were identified.

Those ECC Employer's Written Protocols relevant to the radiotherapy treatment for this patient were also scrutinized. Again, all of these documents were found to be up-to-date and, in general, fit for their intended purpose. However, there was evidence of duplication of information in among Procedures and Protocols and, again, of lack of internal consistency. These concerns are discussed further in Section 9 of this report.

7.2.4 Training and entitlement of duty holders

Regulations 4(4) and 11, together with Schedule 1(b) place duties on the employer to ensure that all 'referrers', 'practitioners' and 'operators' are 'identified as entitled to act' in these capacities, and that 'no practitioner or operator shall carry out a medical exposure or any practical aspect of a medical exposure without having been adequately trained'. Regulation 11(4) further requires that the employer shall keep appropriate training records for entitled practitioners and operators, and shall make these available for inspection by the appropriate authority, and Regulation 4(b) requires that the employer shall take steps to ensure their continuing education and training.

Regulation 11(1) prohibits any operator from carrying out any practical aspect of a medical exposure or without having been adequately trained, but Regulation 11(3) allows that trainees may participate in practical aspects under the supervision of someone who is adequately trained. Regulation 4(4)(a) requires that the employer must take steps to ensure that operators comply with Regulation 11, and Schedule 1(b) requires that the Employer's Written Procedures shall include procedures to identify individuals entitled to act as operators.

Implementation of the duties of the employer for training and entitlement of duty holders at the ECC are described in Section 5 of this report.

A number of deficiencies in the keeping of records of training and entitlement have been identified. The most serious of these concerns was that the employer's record of entitlement dictated that Radiographer A should not have undertaken the manual calculation unsupervised. However, from inspection of the relevant training records for Radiographer A, it is accepted that this was an error of record keeping rather than an example of an operator undertaking a task for which he was not adequately trained or experienced

7.2.5 Involvement of a Medical Physics Expert

Regulation 9 requires that 'The employer shall ensure that a Medical Physics Expert ( MPE) shall...... be closely involved in every radiotherapeutic practice'.

In this regard, the 'Notes on good practice' issued by the UK Department of Health includes that ' In practice, the level of involvement of the MPE should be determined by the level of hazard and risk associated with the exposure and the amount of benefit expected from their advice. For most radiotherapy, MPEs are likely to be full-time contracted members of staff and will be available on site.'

Regarding 'the level of hazard or risk', this is one of the least complex of the procedures that treatment planners regularly undertake, and not one in which the MPE would have expected to be involved. Also, although treatment planning for this patient began at the weekend, when the MPE was not available 'on site', the manual and RadCalc calculations referred to here, took place on the Monday morning. The MPE was then available on site for consultation, had the treatment planners and the physicist considered this necessary.

An MPE was also involved in establishing the methodology for the manual calculations, and in initial commissioning of RadCalc.

In this regard, therefore, the employer acted correctly in ensuring that a properly qualified MPE was involved in establishing the treatment planning methodology, and was available for consultation, should the operators involved have considered this necessary.

7.3 Findings of this investigation regarding the duties of the employer

With regard to the duties of the employer referred to in Sub-section 7.2, the findings of this investigation are as follows:

i. Clinical audit: An up-to-date and satisfactory clinical audit in accordance with NHS Lothian's Level 1 Employer's Written Procedure EP1-10 had been carried out.
ii. Employer's Written Procedures and Protocols: With some concerns regarding the numbering and content of the Employer's Written Procedures and Protocols relevant to this incident, as discussed in Sub-section 7.2.3 of this report, these documents were in place and up-to-date.
iii. Training and entitlement of duty holders: A review of training records for Radiographers B, C and D and for Physicist A found that, in all cases, their training records were consistent with the requirements defined in the relevant ECC Employer's Written Procedures. However, some concerns were identified regarding the quality of record keeping and these are reflected in the recommendations in Section 9 of this report. In all cases, these duty holders had been properly 'signed'-off' for the operator competences relevant to their role in treatment planning for this procedure. Concerns regarding entitlement of Radiographer A are discussed in Sub-section 7.2.4, but it is accepted that this was a failure of record keeping rather than a deficiency in training that was likely to have contributed to this error.

The need for re-training of all operators concerned in manual calculations and in the use of RadCalc is considered further in Section 9

iv. Involvement of a Medical Physics Expert: Treatment planning for this patient began over the weekend when an MPE was not available 'on site', and no formal provision had been made for out-of-hours access to an MPE. However, under extant ECC provisions, only the most basic of treatments were planned out-of-hours, with the opportunity to defer treatments where MPE advice was considered necessary.

The finding of this investigation is that, in general, the duties of the employer relevant to this incident had been properly addressed. However, certain areas for improvement and change of practice have been identified. Of particular concern are the current deficiencies related to training and entitlement of operators, as summarized in Point iv above, which could be regarded as having been a significant factor in the cause of this incident.

7.4 Duties of the practitioner and operator

With regard to the duties of the practitioner and operators relevant to this incident: Regulation 5 includes requirements that:

(1) The practitioner and the operator shall comply with the employer's procedures.

(2) The practitioner shall be responsible for the justification of a medical exposure and such other aspects of a medical exposure as is provided for in these Regulations.

(4) The operator shall be responsible for each and every practical aspect which he carries out...

(6) The practitioner and the operator shall cooperate, regarding practical aspects, with other specialists and staff involved in a medical exposure, as appropriate.

and Regulation 6 includes requirements that:

(1) No person shall carry out a medical exposure unless -
(a)it has been justified by the practitioner as showing a sufficient net benefit...
(b) it has been authorised by the practitioner..

and Regulation 11(1) requires that: ... no practitioner or operator shall carry out a medical exposure or any practical aspect without having been adequately trained.

In practice, justification by a practitioner is a clinical judgement that the exposure will do more good than harm, and authorization by a practitioner is the means whereby the practitioner advises the operator that the exposure is justified and can go ahead, in this case by initialling and dating the space provided on the Radiotherapy Prescription Sheet.

7.5 Findings of this investigation regarding the duties of the practitioner and operators

With regard to these practitioner duties, the finding of this investigation is that, in all senses, the exposure had been properly justified and authorized by the practitioner, and recorded as such on the Radiotherapy Prescription Sheet. Further, the prescribed radiation dose, method of delivery, and fractionation were as expected for treatment of this condition, and in accordance with ECC Employer's Written Protocol number EP2\ ECC\1017 'Clinical Management Guidelines for Myeloma', and were properly described by the practitioner on the Radiotherapy Prescription Sheet.

In summary, therefore, all aspects of the duties of the practitioner were properly and diligently carried out, and in no way influenced the errors in treatment planning.

Clearly, this incident was caused, by errors made by the operators who were responsible for 'practical aspect' of the exposure, in particular for treatment planning. The question arising here is whether any of these errors resulted from failure of any of these operators to comply with the legal duties defined in the Regulations.

In this regard, the finding of this investigation is that methods used by the operators concerned in carrying out their treatment planning duties were in accordance with the ECC Employer's Written Procedures and Protocols (albeit that they made errors in doing so), that the treatment that they planned had been properly authorized, and that, with regard to Regulation 5(6), they co-operated with each other and with the requirements prescribed by the practitioner.

Regarding Regulation 11(1), the question of whether any of the practical aspects undertaken by these operators was outwith the scope of their training and entitlement is considered further in Section 6 of this report. The general conclusion here is that the nature of the involvement of Radiographers B, C, and D and Physicist A was within the scope of both the training that was considered adequate by their employer and of their entitlement. While Radiographer A had also received the training considered adequate by the employer for manual calculations, he was not formally entitled by the employer to undertake such calculations unsupervised. However, it is accepted that Radiographer A was firmly of the view that he had 'been adequately trained' for this task, and this view is supported by available training records. It is also accepted that Radiographer A was unaware on the status of his entitlement in this regard, and that this was due, at least in part, to deficiencies in the structure and accessibility of the scope of entitlement for treatment radiographers.

Concerns regarding the definition and recording of the scope of entitlement for duty holders and the relationship between training and entitlements are discussed further in Section 9 of this report.

With regard to the use of the RadCalc independent MU calculation system, while there was a general belief among the operators concerned and among the senior staff who defined the training requirements that all concerned were adequately trained, the evidence that has emerged in this investigation suggests otherwise. While this might be due in part to lack of re-training following the changes to ECC's Employer's Written Procedure EP2\ ECC\3422 'RadCalc instructions' referred to in Sub-section 4.7 of this report, there are clear indications that the operators concerned lacked a general understanding of the RadCalc process and that this contributed to their lack of confidence in its outputs.

In carrying a 'practical aspect without having been adequately trained', the operators concerned were in breach of Regulation 11(1). However, it is accepted that this insufficiency in training has been identified mainly by the hindsight provided by this incident, and that those operators concerned did not knowingly act in breach of this Regulation.

Notwithstanding the concerns regarding entitlement of Radiographer A and the adequacy of training relevant to the use of RadCalc, the finding of this investigation is that all of the actions taken by the operators involved in planning and delivering this treatment were properly in accordance with their legal duties under the IR( ME) Regulations.