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Annex 5: Staff interviews
A5.1 Introduction
A5.1 A total of seven people who were employed at the BOC or elsewhere in Greater Glasgow Health Board the time when the treatment for Miss Lisa Norris was planned have been interviewed individually by the Inspector. Some of these interviews were carried under caution against the possibility that the information provided might be used as evidence should any legal proceedings arise from this incident.
A5.2 A summary of the principal points emerging from each interview
A5.2 The following is a summary of the principal points emerging from each of these interviews:
Interview 1: Planner B
A5.3 Planner B agreed that it was he who had completed and signed the Medulla Planning form FM.14.014 for Miss Morris.
A5.4He accepted that his training record gave no indication of any recorded level of competence (either 'learning' or 'competent') for the whole CNS planning procedures. However, since he had planned a similar treatment in November 2005, under supervision, he was of the opinion that his current training record was not up-to-date and that his proper training category at the time of planning the treatment for Miss Norris was a 'learner' for the whole CNS planning procedure. He therefore considered it appropriate that he was asked to plan this procedure under supervision.
A5.5He stated that he had received no training in the procedure for normalization of Monitor Units to 100 centiGrays and that his supervision involved checking with others, at each stage, to establish that he was following the correct procedure.
A5.6 In planning the treatment for Miss Norris, Planner B stated that he considered himself to be acting as an 'operator' under the IR(ME) Regulations*.
A5.7 Planner B stated that, at the time of the incident, he was not aware of any quality system procedure having been in place for this particular procedure. He prepared a written list of steps in the planning procedure for his own reference.
* The IR(ME) Regulations require that employer's written procedures shall include procedures to identify individuals entitled to act as operators. No evidence has been presented by the BOC that he was so entitled at the time of the incident.
Interview 2: Senior Planner C
A5.8 Senior Planner C stated that he had been absent from work at the time when the treatment for Miss Norris was being planned and therefore had not been involved in creating the plan.
A5.9He stated that Principal Planner A had found errors in Planner B's calculations for the spine fields wax compensators and, having made the appropriate changes, had then asked him (Senior Planner C) to check them. He also stated that he had been involved in preparing a list of instructions for Radiography staff, to simulate the lower spine field and had ensured that the correct tray and monitor units had been applied for this particular compensator.
Interview 3: Principal Planner A
A5.10 Principal Planner A stated that his initial involvement in planning the treatment for Miss Norris was in positioning of the fields on the Eclipse treatment planning computer. That process was observed by Planner B. He then gave Planner B further directions and the opportunity to ask for clarification about the next steps and process. Planner B then conducted much of the rest of the planning. Principal Planner A had no recollection of whether or not Planner B came back to him with further questions.
A5.11 Principal Planner A stated his belief that he was responsible for updating of training records for Planner B but acknowledged that, due to pressure of other work, the proper level of updating had not been achieved. However, he expressed a view that because Planner B had been involved in one previous plan of this type, his training status was 'somewhere between learning and competent'. He indicated that he was concerned that training records should be of a better standard and that this has been raised through the BOC's quality management group. However, progress in this direction had also been affected by workload and staffing pressures. He further indicated that the need for Planner B to become involved in complex planning, such as whole CNS procedures, was the recognised shortage of experienced staff, a situation which, in his view, showed no prospect of improvement.
A5.12He confirmed that when he checked Planner B's completed plan initially, he identified errors in the spine fields. He corrected these then passed the plan to Senior Planner C for further checking.
A5.13 Principal Planner A expressed a number of related concerns regarding deficiencies in the BOC quality system documents and IR(ME)R procedures and the lack of available staff resources to address these issues.
A5.14He stated his awareness that within the BOC's ISO 9000 system, there was a requirement for annual review of each document in the system. However, he was of the view that no formal process of review and signing-off, of any of the quality system documents was in place.
A5.15 Regarding staffing pressures, Principal Planner A stated that he was the only remaining BOC employee out of the four full time principal staff who had worked in treatment planning two years ago. He expressed a view that these staff losses have not been adequately addressed, but acknowledged that recruitment of Physics staff, particularly experienced staff, is a national problem.
A5.16 Principal Planner A's generally stated opinion was that staffing of Treatment Planning at the BOC has not been compatible with his professional view of the quality of service required from this Section. He further indicated that representation of this view to senior BOC management through various fora had failed to bring adequate focus to these problems.
Interview 4: Chief Executive of Greater Glasgow Health Board
A5.17 The Chief Executive of Greater Glasgow Health Board has been in post since 1 st November 2001.
A5.18 He noted that cancer services at the BOC had been subject to external review in 2001 which resulted in a number of recommendations for service improvement. It had been his responsibility to oversee the implementation of these recommendations.
A5.19 He provided details of the management structure within GGHB including the changes arising from the dissolution of the NHS Trusts in 2004. The four former trusts within GGHB have now evolved into four Divisions and the Chief Executive is now the sole accountable officer for the whole of GGHB.
A5.20 Under GGHB's new management structure there are eight Clinical Directorates within the Acute Services Division. The Medical Director within the BOC is the medical director for specialist oncology services within the Directorate of Regional Services. The Head of Clinical Physics is the most senior physicist within the Physics Department and all physics staff are professionally accountable to him. However, for delivery of clinical care, radiotherapy physics and treatment planning staff are accountable, through the Head of Radiotherapy Physics, to the Medical Director. The Chief Executive's view is, therefore, that the line of accountability for implementation of the employer responsibilities under the IR(ME) Regulations is through the Medical Director.
A5.21 The Chief Executive stated that, prior to this incident, he had received no formal notification of any problems in treatment planning or radiotherapy physics that would affect either patient safety or maintenance of quality systems. He was therefore unaware of the prevailing difficulties in maintenance of written procedures and training records and concluded that insufficient attention had been given to keeping these up to date.
A5.22 He also expressed a view that, if there were any human resource issues, these had not been pursued with rigour and determination or relayed to his level of management. Therefore, given his awareness of staffing numbers and experience, notwithstanding the need for junior staff to be given the opportunity for development, he expressed surprise that principal planning duties for this complex treatment plan were assigned to Planner B.
Interview 5: Head of Clinical Physics, BOC
A5.23 The Head of Clinical Physics has been Head of the Physics Department In Glasgow since 1989. At the time of this incident, he reported to the Chief Executive of North Glasgow Division of GGHB. Under new organisation arrangements currently under development (whereby North Glasgow Division will cease to exist) his reporting line will be to the new Director of Diagnostics.
A5.24 The Head of Clinical Physics confirmed that the Head of Radiotherapy Physics reports professionally to him, but for clinical issues reports to The Medical Director.
A5.25 The Head of Clinical Physics stated that staffing complements for radiotherapy physics were assessed by the Head of Radiotherapy Physics in accordance guidance from the Institute of Physics and Engineering and Medicine. The Head of Radiotherapy Physics also assessed the necessary levels of staff experience. He added that at December 2005, following an aggressive recruitment campaign, staffing of radiotherapy physics was almost full complement and some very experienced staff had been appointed. Prior to 2005 the effect of staff turnover had been identified as a problem but not to the extent that it would compromise patient safety.
A5.26 Given his understanding of the available levels of staff numbers and experience, he expressed surprise that Planner B was assigned the treatment plan for Miss Norris.
A5.27 He stated his expectation that, in these circumstances supervision should be 'direct' in the sense that an experienced member of staff would oversee the procedure with the trainee step by step.
A5.28 The Head of Clinical Physics expressed surprise that written procedures and training records were not up to date.
A5.29 He stated his view that responsibility for the content of the treatment plan lies with the planner and checker, not the clinician and that the checker is responsible for production of plans as they sign them off before they are passed to the clinician. He further stated that since Principal Planner A acted as supervisor he should not also have been the checker.
A5.30 When asked directly for his view on whether any staff involved had been negligent in their professional duties, the Head of Clinical Physics replied that he did not believe that this was the case and had not taken disciplinary action against anyone involved. However, he added that, following this incident, Principal Planner A's duties had been reassigned away from treatment planning pending the results of the incident investigation.
Interview 6: Medical Director of Beatson Oncology Centre
A5.31 The Medical Director has been Medical Director of Beatson Oncology Centre since June 2005. At the time of this incident, he reported to the Acting Chief Executive of North Glasgow Acute Division of GGHB. Under new organisation arrangements currently under development his reporting line will be to the new Director of Regional Services.
A5.32 Regarding his individual responsibilities, he considered that his general responsibility was to work with others to ensure the overall integrity of the whole service. He was uncertain as to who would be regarded as the 'employer' under the IR(ME) Regulations but stated his presumption that this would be GGHB with some responsibility on himself, though he had received no written statement indicating that he was responsible for implementing IR(ME)R requirements. Regarding the quality system and quality management, he considered that he had no written, formal responsibility and had no personal involvement in quality system audits.
A5.33 Regarding the requirement under the IR(ME) Regulations that employers should have procedures in place to ensure that the probability and magnitude of accidental or unintended doses to patients is reduced so far as is reasonably practicable, his view was that there is no need for a separate document stating how to minimise risk since this should be addressed in other documents within the system. He stated that a lot of work is ongoing in quality system development and that the BOC hoped to be fully compliant with the IR(ME) Regulations by July of 2006.
A5.34 When asked whether any formal representations had been made to management about staffing resources, the Medical Director responded that he was aware that some members of the treatment planning staff, including Principal Planner A, had raised concerns about workload with their management since at least 2005. However, the details of these concerns were never discussed directly by that individual with the Medical Director. He was not aware of any concerns having been raised that work could not be completed because of a lack of staff resources.
A5.35 When asked directly for his view on whether any staff involved had been negligent in their professional duties, the Medical Director replied that he was strongly of the opinion that there was no indication of negligence. His view was that the incident was the result of a human error which unfortunately was not identified by an otherwise highly competent supervisor.
Interview 7: Former Head of Radiotherapy Physics
A5.36 The Head of Radiotherapy Physics at the BOC was in post from October 2003 until he left the organisation on 31st December 2005. Immediately prior to his departure from the BOC, he worked closely with his deputy, who then took over as acting Head of Radiotherapy Physics.
A5.37 Regarding staffing levels at the time of the incident, the Head of Radiotherapy Physics agreed that a table showing staffing levels 17.6 staff employed against a recommended complement of 18.0 was an accurate representation of the situation at December 2005. He regarded his responsibility as ensuring that required numbers of staff in treatment planning were properly assessed in relation to the relevant guideline levels. He considered that Principal Planner A was responsible for ensuring that the level of experience of treatment planning staff was appropriate. He further stated that he would have expected Principal Planner A to have made him aware of any issues around staff numbers or experience but had not been made aware of any specific problems within treatment planning.
A5.38 He stated that he, along with his predecessor, had devised the rota system whereby staff were assigned different tasks on a weekly basis. The purpose had been to broaden the availability of scientific staff for the range of tasks which require to be undertaken by the Department and to increase the variety of work as an aid to recruitment. He considered that the rota system was effective and that staff valued the ability to contribute across the radiotherapy physics field and this gave them improved career prospects.
A5.39 He stated that he was not aware that at the time when this incident occurred, the relevant training records and written protocols were not up to date and regarded this as Principal Planner A's responsibility. In particular he was surprised that the medulla planning work instruction did not appear to have been reviewed since 1998.
A5.40 Regarding quality systems at BOC, the Head of Radiotherapy Physics stated that he had been party to BSI inspections and received inspection reports. Following these inspections, he held discussion with Principal Planner A who, as Quality Management Representative, was responsible for maintaining all documentation in the system. However, he noted that since Principal Planner A had been finding it increasingly difficult to allocate time to the quality system, his responsibilities for quality system management were passed to another member of staff in October or November of 2005.
A5.41 He was of the view that responsibility for the employer's duties under IR(ME)R lay with the Medical Director. He stated that it was the Medical Director who chaired monthly meetings of the radiotherapy management group which was the main forum for I(RM)ER issues
A5.42 When shown the Medulla Planning Form for Miss Norris, the Head of Radiotherapy Physics considered that it was not clear from the initials what each of the individuals was responsible for what aspects of the plan.
A5.43 He stated that since this a complex procedure, he would have expected there to have been direct supervision whereby someone explained the process step by step.
A5.44 Regarding the commissioning of Varis 7, the Head of Radiotherapy Physics explained that a multidisciplinary project group had been established to oversee its introduction and that this should have included issues related to identification and management of risks. He stated that Principal Planner A was responsible for treatment planning issues and had been asked during the implementation process to update all relevant documentation as a result of the introduction of Varis 7. He further stated that even if a decision was made not to update a particular piece of documentation following the introduction of Varis 7, then this decision should have been recorded.
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