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6. Consideration of background circumstances at the BOC

6.1 Introduction

6.1 The primary cause of the overexposure has been identified as omission of the required normalization procedure by the treatment planner and consequent entry of an erroneous 'Output' figure on the Medulla Planning Form. Chapter 5 considered the particular circumstances that contributed to this error and has highlighted (i) the lack of training and experience of the treatment planner, (ii) inadequacy of supervision for this planner, (iii) lack of independence in the checking procedure and (iv) failure to update relevant written working procedures since 1998 and more recently following the introduction of the new Varis 7 software and the BOC decision to change practice regarding the dose entered into the planning computer. This chapter now considers the broader circumstances that underlie these apparent deficiencies in procedures and practice at the BOC.

6.2 Staffing pressures and workloads

6.2.1 Staffing levels in Scotland

6.2 A report published in 2006 by the Scottish Executive on 'Cancer in Scotland: Radiotherapy Activity Planning for Scotland 2011 - 2015' [3] ( http://www.scotland.gov.uk/Publications/2006/01/24131719/9 ) states that ' Using current recommendations from IPEM (Institute of Physics and Engineering in Medicine) an establishment of 58.5 WTE radiotherapy physicists is required for Scotland. The current establishment is 42.5 WTE [Whole Time Equivalent], a shortfall of 16 WTE posts. Also 8 WTE posts were vacant as at December 2004 and therefore only 34.5 WTE were in post, less than 60% of the recommended level' and ' Shortfalls also exist in the establishment of dosimetrists and engineers putting additional pressure on existing staff, particularly during this very busy period of rapid equipment expansion and replacement'.

6.3 The issue of workloads was also raised during the staff interviews that formed part of this incident investigation ( Annex 5).

6.4 It is therefore relevant to consider the extent to which the relationship between staffing levels and workload caused this error to occur and to remain undetected.

6.2.2 Staffing provisions for treatment planning at the BOC

6.5Annex 6 to this report is a summary of the staffing levels and experience for BOC's Treatment Planning Section as of December 2005.

6.6 In February of 2005, Principal Planner A produced a document outlining the structure of duties for treatment planning staff. In essence this divided both staff members and treatment procedures into a number of categories. Staff categories were A (most senior) to C (most junior) with a further division of staff category A into three sub-groups. Categories of treatment plans were A (simplest) to E (most complex). He then apportioned appropriate duties for each category of treatment plan to the appropriate staffing category. For example, staff in Group C were aligned with planning categories A, B and C with a requirement to ' Focus on routine planning workload: developing expertise'. These provisions are summarized in Table 6.1 where staff category A has been divided into sub-categories A1, A2 and A3.

Table 6.1 A summary of the staffing structures introduced by Principal Planner A in February of 2005. The second column (updated and adjusted from February 2005) shows the estimated number of staff in each category. The third column indicates time allocated to treatment planning (as opposed to other duties) in terms of the approximate number of whole time equivalent staff members in each of the staff categories that were available for treatment planning in December 2005 (absences not included). Column 4 outlines the main assigned duties for staff in each category.

* Whole Time Equivalent

6.7 The intent outlined in this staffing structure was therefore that planning duties for Category E (complex) plans should be assigned to either of the two treatment planners in staff Category A2. These two senior planners were on complementary weekly rotas. Reference to Annex 6 indicates that the first of these (designated A2.1) was assigned to treatment planning for the week beginning 12 ^th December, when treatment planning for Miss Norris was started. The other (designated A2.2) was absent from work for the whole of that week.

6.2.3 Staffing provisions for the treatment plan for Miss Norris

6.8 The question that arises, therefore, is why were the main planning duties for the Category E whole CNS plan under consideration here assigned to Planner B who was in staff Category C rather than to the rotaed senior planner in staff Category A2 or to any of the others in staff Categories A or B?

6.9 The training records for both of the senior planners in staff Category A2 place them in the 'Training' category for whole CNS planning. However, when questioned on the extent of this training, Principal Planner A indicated that as of December 2005, neither of these individuals had had any training or experience of whole CNS planning. Clearly, this lack of any competence for whole CNS planning appears to be at odds with their general assignment to Category E plans as 'planner and checker'. In this regard, Principal Planner A explained that allocation of a 'Training' category to any staff member did not imply any previous experience or training for the procedure in question, nor did it imply that any such training was necessarily expected within the next year. Rather, the allocation of 'Training' status to a member of the treatment planning staff indicated an intention to provide such training should the opportunity present. Training at the BOC normally involves participation in the preparation of actual patient plans. Therefore, access to training opportunities depends on the subsequent availability of plans of the type in question.

6.10 Reference to Annex 6 indicates that training records for a total of nine members of staff had some entry for whole CNS planning. Of these, staff members A1.4 and A2.2 were either rotaed for other duties or were absent from work for the week beginning 12 ^th December 2005. Two of the remainder (staff members A2.1 and B3) had no previous experience of medulla planning. Of the remainder, only A1.1 and A1.5 had any recent experience of medulla planning and Principal Planner A has stated that both were heavily committed to other duties for the week in question. The remaining three of the nine all had some previous experience of medulla planning but none since 2004, and, of these, A1.2 was not available for planning duties in December of 2005 and A3.2 was only available for one day per fortnight. Staff member A3.3 had been involved with three medulla plans in 2004 and might therefore have been a more appropriate choice than Planner B. However, Principal Planner A has again stated that A3.3 was heavily committed to other duties and therefore not available to plan the treatment for Miss Norris.

6.11 When questioned further on this issue, Principal Planner A indicated that most of the work of the treatment planning section is done to very short timescales. He stated that around 80% of all planning requests are submitted on the actual date that the plan is required or on the day before (see also Paragraph 9.28). Thus, there is little opportunity for work scheduling to ensure that planning tasks are appropriately allotted.

6.12He further indicated that he was aware that two of his most senior staff would soon leave the Section and he was keen therefore to build on Planner B's evident good progress by moving him on to more complex work. Planner B had apparently been keen to progress his experience in the more complex planning procedures.

6.13 Thus, the decision to have Planner B undertake the main planning duties for Miss Norris appears to have been to some extent a forced one, in that he was the only staff member with any experience of medulla planning who was available, and to some extent a considered one, in that a conscious decision had been made to expand his experience of complex planning.

6.14 What is apparent from this analysis, however, is that if the senior planning staff were so heavily committed as to preclude their taking on the main planning responsibilities for Miss Norris, then their availability for the necessary supervision role would have been similarly compromised.

6.15 The conclusions that arise are that (a) the level of experience that was brought to bear on creating and on supervising the creation of the treatment plan for Miss Norris was less than that which should reasonably be expected and that which the BOC's own treatment planning structures and procedures would indicate to be necessary and (b) lack of staff availability was at least a contributory factor in causing this deficiency.

6.16 These same staffing pressures clearly affected the availability of an independent checker (Paragraph 5.36) and the further extent to which they might have compromised the identification of the error in checking of the treatment plan is a matter of conjecture. However, it should be noted that the fact that the checking process did identify a number of other deficiencies in the original plan (see Paragraph 5.37), indicates that checking had been carried out with some degree of diligence.

6.2.4 The effect of staffing pressures on the general integrity of the treatment planning system at the BOC

6.17 Further issues of importance regarding staffing levels include (i) the extent to which this caused the failure of the BOC to keep written procedures up to date (see Paragraph 5.13) and (ii) the level of effort that was committed to evaluating and addressing the potential consequences of the change to Varis 7 in May 2005.

6.18 In relation to issue (i), BOC quality system document QS 03 'Document and Data Control' states that ' All controlled documents are reviewed at least annually…'. This requirement clearly was not being achieved. Paragraph 44 of the note of the 10 ^th February meeting at the BOC ( Annex 4 to this report) notes that quality system audits at the BOC in 2005 had identified that ' Controlled documents are not being reviewed annually for validity via management review or audit'. Similar concerns for the effectiveness of document maintenance extend to those documents which were not controlled under the BOC's ISO 9000 quality system, such as training records and to employer's procedures required under the IR(ME) Regulations.

6.19 The same 10 ^th February meeting note also reports the views expressed by senior BOC staff that the evident failure to maintain these document reviews was due to a general lack of staff resource exacerbated by a number of other unusual demands on departmental staff. These demands included the installation and commissioning of a new radiotherapy facility at Gartnaval Hospital and purchasing and commissioning of new equipment including the Varis 7 system in 2005. (Previous concerns over staff resource resulted in a restructuring of the entire Radiotherapy Physics Department in 2000 and 2001.)

6.20 This view of why quality system procedures at the BOC had not been maintained to the required level was supported in subsequent interviews with Principal Planner A ( Annex 5).

6.21 Regarding issue (ii) in Paragraph 6.17, guidance from the Royal College of Radiologists on 'The Provision and Replacement of Radiotherapy Equipment' [4] ( http://www.rcr.ac.uk/docs/oncology/pdf/equip.pdf ) says of 'Treatment planning systems', that '…. a comparatively lengthy commissioning period [12 weeks] may be required to acquire and fully test all the data the system requires and hence to establish confidence in the clinical safety of the system before it enters clinical service'. Whereas a multidisciplinary 'Varis Implementation Team' was established to oversee the technical aspects of the introduction of the new Varis 7 system, no evidence has been presented by the BOC of any related evaluation of clinical safety having taken place. Had such an evaluation been conducted properly, it seems likely that the potential for the normalization error to occur would have been identified.

6.22 In addition, an 'observation' raised in the report on the BOC's internal quality audit for 30 ^th March 2005 (Report number 05 IMK3BOC) was that ' It is not clear how purchased software updates are controlled. A procedure to clarify this should be looked at.' Again, no evidence was presented by the BOC of such a procedure having been produced.

6.2.5 How deficient were the BOC's staffing levels for Treatment Planning

6.23 Having identified staffing pressures as a significant underlying cause of the errors that led to this incident, the question which then arises is what was the actual level of understaffing for Treatment Planning at the BOC?

6.24 Further to the general concerns for staffing levels in Scotland as outlined in Paragraph 6.2, the conclusion of a review of 'Equipment, Workload and Staffing for Radiotherapy in Scotland 1997-2003' [5] ( http://www.rcr.ac.uk/docs/oncology/pdf/equipment_scot.pdf )' that was published by the Royal College of Radiologists ( RCR) in 2005' included a view that ' all departments are well below their minimum recommended level for physicists and dosimetrists, averaging just over 70% of that required. …. Glasgow has problems with recruiting physicists, as shown by their high number of vacancies.'

6.25 Regarding this latter statement, the BOC's Specialist Oncology Risk Register for October 2005 identifies the need for action in respect of the imminent departure of the Head of Radiotherapy Physics as well as ' Two Clinical Scientist and one MTO vacancy. A further MTO on maternity leave. One MTO on long term sick leave.'

6.26 At interview, the former Head of Radiotherapy Physics at the BOC (who left this post on 31 ^st December 2005) indicated that the required staffing levels for the Radiotherapy Physics Group were assessed in accordance with the relevant guidance from the Institute of Physics and Engineering in Medicine ('Guidelines: The provision of a physics service to radiotherapy. (2002) [7]). The resulting staff establishment (all grades) for the Treatment Planning Section for 2005 was determined to be 18 whole time equivalent ( WTE) staff. Against this establishment, figures from the BOC indicate that the number of available staff rose from 14.3 WTE in the first quarter of 2005 to 17.6 in the last. These figures include both treatment planners (Table 6.1) and other members of staff within the same Section who were involved in other aspects of patient dosimetry such as equipment calibration.

6.27 These figures, in themselves, suggest an ongoing improvement from the position identified in the RCR report [5] and imply that the available staff numbers at the BOC for the last quarter of 2005 were close to establishment levels. They might also suggest that the staffing numbers should have been sufficient to cope with the planning workload. However, it should be recognized that this does not take account of the extra workload imposed by the demands referred to in Paragraph 6.19 or of the evident backlog of deficiencies in quality system documents. The distribution of staff experience is also of importance. In this regard, one member of the treatment planning staff expressed a view that non-availability of senior staff for checking of plans was a frequent issue of concern.

6.28 Within the scope of this investigation, it has not been possible to gain a clear overview of the adequacy of the staffing levels for Treatment Planning at the BOC in relation to the requirements placed on the available staff both by routine dosimetry planning and unusual extra demands. However, it is apparent that whether as a consequence of deficient staff numbers and experience or of inefficient use of the staff resource available, the available staff were not able to maintain properly the relevant parts of the BOC quality system nor to bring the appropriate level of staff experience to bear in the creation of treatment plans for complex procedures.

6.3 Individual responsibilities.

6.29 Dr Martin's incident report (referred to in Paragraph 3.4 of this report) includes a recommendation that ' There should be more formal procedures relating to allocation of particular tasks as required by IR(ME)R 2000'.

6.30 In this regard, a recurring theme in the staff interviews that formed part of this investigation was a lack of clarity about who was responsible for what. This extends beyond the requirements of the IR(ME) Regulations to other areas of responsibility such as treatment planning documents, the BOCISO 9000 Quality System, staffing levels and staff training.

6.31 A particular example of this relates to Medulla Planning Form FM.14.014 ( Annex 2 to this report). In the completed version for Miss Norris, the box labelled 'Radiotherapist' is initialled by 'XX'. The box labelled 'Physics' is initialled by Planner B/Principal Planner A/Senior Planner C . In addition, on the back of the form is attached a glued label which states ' I have checked this physics plan and treatment may proceed'. This is initialled by YY (a BOC consultant clinical oncologist).

6.32 In this regard, the Clinical Oncology Information Network of the Royal College of Radiologists 'Guidelines for External Beam Radiotherapy', [2] http://www.rcr.ac.uk/docs/oncology/other/radiotherapy.htm includes the following recommendations:

• Recommendation 30: One individual clinical oncologist, the planning clinician, is responsible for the whole planning process.
• Recommendation 45: The planning clinician is responsible for acceptance of the final plan.
• Recommendation 46: Acceptance of the plan should be indicated by the planning clinician's dated signature.

6.33 Adherence to these guidelines would imply that responsibility for the content of the Medulla Planning Form FM.14.014 for Miss Norris lay with either of the clinical oncologists whose initials appear on the form. However, there is nothing in BOC procedures to suggest that this was the case. Indeed, there was general agreement among the BOC staff interviewed that it would be illogical to expect that a clinical oncologist would be able to assess the accuracy of the detailed treatment delivery parameters arising from the treatment planning process.

6.34 The situation that emerges, therefore, is that there was no written indication and no common understanding among BOC staff regarding who was responsible for the accuracy of the information on Medulla Planning Form FM.14.014 for Miss Norris.

6.35 In other instances, even where BOC documentation does allocate responsibilities, it is apparent that these allocations are not commonly known or acted on. For example, BOC Document QS 10 on 'Training' states that ' The Training Record of each member of staff will be endorsed by the Departmental Heads or their deputies to show that training needs have been reviewed'. However, all of the training records for the Treatment Planning staff that were examined as part of this investigation were signed by Principal Planner A (including his own record) who is neither a Departmental Head nor a deputy.

6.36 A further complication at the BOC, in terms of allocation of responsibilities, is that whereas line management responsibilities for staff in the Radiotherapy Physics Group come under the Head of Clinical Physics and Bioengineering, these same staff are responsible to the Medical Director for the quality of their input to clinical care. In this regard, the Department of Health's 'Manual of Cancer Services 2004' [6] ( http://www.dh.gov.uk/assetRoot/04/08/53/48/04085348.pdf ) recommends that ' Where there is no common line management for medical physics and radiotherapy, a service level agreement should exist between the two.' (While this document has not been issued in Scotland, this recommendation nevertheless has validity to the situation at the BOC.)

6.37 In general, therefore, the situation regarding written allocation and common understanding of responsibilities at the BOC is not conducive to proper maintenance of quality system working. This clearly is an unsatisfactory position.

6.4 Compliance with IR(ME)R procedures

6.38 The IR(ME) Regulations [1] which came into force in the UK in May 2000 are made under EU Council Directive 97/43/Euratom. One of the requirements of this Directive is for a system of inspection by a competent authority for compliance with the Regulations.

6.39 Between 2001 and 2004, members of the Inspectorate of the Secretary of State for Health for the IR(ME) Regulations were commissioned through the Department of Health in England to undertake a programme of proactive inspection visits for premises in Scotland covered by the IR(ME) Regulations. However, the BOC was not among the premises included in these visits.

6.40 Senior management at the BOC had, nevertheless, been concerned that provisions in place in respect of the IR(ME) Regulations were inadequate. In particular, in response to his concerns over a series of reportable incidents in 2004, the Medical Director requested that the Radiotherapy Management Group and other senior managers undertake a review of policies and procedures. This review took place in March 2005 and, at the request of the Scottish Executive Health Department, included representation from Ms Carol Nix from the Radiation Protection Division of the Health Protection Agency (a former member of the Secretary of State's Inspectorate). A result of this review was Ms Nix's clearly stated views on the need for improvement in the BOC's IR(ME)R procedures. Action on this recommendation was ongoing at the BOC at the outset of this investigation.

6.41Annex 7 to this report identifies the particular IR(ME)R requirements for which this incident investigation has found evidence of non-compliance. The findings detailed in Annex 7 are summarized in Paragraphs 6.42, 6.43 and 6.44.

6.42 Planner B was not qualified to act as operator under the Regulations and the level of supervision provided by Principal Planner A was not sufficient for him properly to adopt and discharge the operator's regulatory responsibilities.

6.43 The employer's written procedures and training records were not in compliance with the Regulations.

6.44 The requirements of Schedule 1k of the Regulations for employers to have in place ' procedures to ensure that the probability and magnitude of accidental or unintended doses to patients from radiological practices are reduced so far as reasonably practicable' were not being met.

6.45 In summary, the contributory factors in this incident with direct relevance to IR(ME)R compliance were (a) delays at the BOC in achieving compliance with employers responsibilities under the IR(ME) Regulations and (b) failure to ensure that all practical aspects of the treatment planning procedure were carried out by someone who was properly qualified to act as an operator under the regulations and was identified as such by the employer.

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