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10. Concluding remarks
10.1 Introduction
10.1 This incident occurred because of mistakes made by BOC treatment planning staff against a background of circumstances that were not conducive to error-free working. Therefore, while it has been relatively straightforward, with the cooperation of BOC staff, to identify who was responsible for making the critical error and for failing to identify it prior to treatment delivery, the issue of levels of blame is more complex.
10.2 This question can be looked at in two areas. Firstly, what level of responsibility should be attached to those members of the Treatment Planning staff who were involved directly with the incident. Secondly, who were responsible and at what level for the prevailing circumstances at the BOC that contributed to the risk of occurrence for the errors in question. These two issues are addressed separately in Sections 10.2 and 10.3.
10.3 Section 10.4 considers the general lessons to be learned for the BOC and for other radiotherapy centres in Scotland and elsewhere.
10.2 Levels of responsibility for treatment planning staff.
10.4 While the critical error was made by Planner B, it is clear from this investigation that he was assigned planning functions for preparation of Miss Norris's treatment that were inappropriate at a time in his career when he was not qualified either by formally assessed competence or by experience to undertake a task of this complexity, other than under close supervision. The appropriate level of direct supervision was not provided. Further, the BOC procedures were clear that Planner B carried no formal responsibility for these functions. In addition the supporting work instruction for medulla planning was out of date and contained no instruction relevant to the normalization procedure that became necessary with the change made to practice following the upgrade of the treatment planning computer system in May 2005.
10.5 The person who assigned treatment planning duties to Planner B was Principal Planner A. However, his own Treatment Planning Structures document (Sub-section 6.2.2 in this report) indicates that planning duties for procedures of this complexity should be allocated to staff with a much higher level of experience than Planner B. With hindsight, therefore, assignment to Planner B was inappropriate and suggests poor professional judgement on the part of Principal Planner A. However, he has explained this decision in terms of (a) the prevalent lack of staff with the experience necessary to create this plan and (b) the consequent need for accelerated training of such junior staff as were available and had demonstrated the necessary aptitude.
10.6 Principal Planner A also took principle responsibility for supervising the planning activities of Planner B but the insufficiency of this supervision is evident from the mistakes that were made by Planner B in creating the plan. Again, however, he has explained this in terms of the critical demand for his input to other treatment planning priorities.
10.7 Both Principal Planner A and Senior Planner C were responsible according to BOC procedures for checking the plan produced by Planner B. Whereas this checking successfully identified errors for the spine fields, both failed to identify the critical error for the head fields. Principal Planner A's participation as both supervisor and checker was incompatible with the requirement for independence in these two roles. The same explanation applies.
10.8 In summary, although it was Planner B who made the critical error, the circumstances whereby he was assigned this task without the appropriate levels of training, experience, supervision or documentary support were such that little blame can be allotted. Senior Planner C became involved when asked by Principal Planner A to check that part of the treatment plan where he had already identified and corrected errors in the spine fields. As noted in Paragraph 5.36, the precise role of each in the checking process is a matter of recollection rather than of record and is therefore difficult to assess. Senior Planner C's recollection is that the head fields had already been checked by Principal Planner A. Further, there was nothing in Senior Planner C's training record to indicate that he was aware that the 'Output' entry on the Medulla Planning Form was a potential source of error. Senior Planner C was at fault for signing the form to indicate that he had checked the plan whereas, in fact, he had either (in accordance with his recollection) not checked the head fields or had checked and failed to identify the error. Given the circumstances of Senior Planner C's involvement, it is again apparent that little blame can be attributed. (It should be noted also that Senior Planner C was the 'checker' for the similar plan that was prepared subsequently by Planner B and again failed to identify the same error.)
10.9 The responsibilities of Principal Planner A can be considered in three different contexts. Firstly, as Planner B's supervisor for this plan and as a checker, he was at fault both for failing to provide the level of supervision necessary to prevent the critical error and for failing to identify the error during checking. Secondly, Principal Planner A was responsible for assigning this plan to Planner B. Thirdly, Principal Planner A was fully involved in the decisions made about how different techniques should be planned and should have been instrumental in ensuring that the supporting documentation was in place. Taking these responsibilities together, it must be concluded that most of the blame that can be attributed to staff in the treatment planning section falls to Principal Planner A. However, the actual level of attributable blame requires due consideration of the background circumstances discussed in Section 10.3.
10.3 Levels of responsibility for BOC and GGHB management.
10.10 Section 6.3 of this report refers to the lack of written allocation and common understanding of responsibilities at the BOC as a contributory factor in this incident. This lack of clear definition of who was responsible for what makes also makes it difficult to apportion blame appropriately among the senior management staff at the BOC, at North Glasgow University Hospitals Division and at Greater Glasgow Health Board.
10.11 This section therefore considers the level of responsibility for this incident that is attributable to management as a whole for their contributory failings. This includes staff at all levels of management from the Head of Treatment Planning at the BOC to the Chief Executive of GGHB. No attempt is made to allot blame for these failings individually.
10.12 In addition to the evident lack of definition of management and quality system responsibilities, the further 'corporate' failings that have been identified in this investigation include,
(i) failure to address the employer's statutory responsibilities under the IR(ME) Regulations for the provision and maintenance of written procedures and adequate training,
(ii) inadequacy of staffing provisions in relation to the proper establishment and maintenance of a suitable system of quality management for radiotherapy treatment planning at the BOC,
(iii) failure to ensure that flexible staffing provision for treatment planning workload was adopted such that the necessary level of training and experience could be brought to bear on planning for complex procedures,
(iv) failure to assess properly the implications of the upgrade to Varis 7 for working procedures at the BOC, with particular regard to patient safety,
(v) failure to learn and apply the lessons available from previous incidents elsewhere, in particular that at the NSRI which is discussed in Chapter 7 of this report.
10.13 Compliance with the requirement of the IR(ME) Regulations for maintenance of employers written procedures can be regarded as one element of the BOC's overall provisions for ISO 9000 quality system working and the same concerns apply. However, the general shortcomings relevant to IR(ME)R compliance, had been identified by senior management and a programme of remedial work was in place, with a target date for completion of July 2006. Given the backlog of work required and the level of staff availability, this is considered to have been a realistic timescale. However, the evidence of this investigation suggests that progress towards this target at December 2005 was behind schedule.
10.14 Regarding issue number (ii) of Paragraph 10.12, the International Atomic Energy Agency's ( IAEA) 2006 report on 'Applying radiation safety standards in radiotherapy' [8], with particular relevance to the maintenance of records, advises that ' When planning and developing an effective QA [Quality Assurance] programme, licensees need to recognize that it demands strong managerial commitment and support in the form of training and time, personnel and equipment resources.' However, the evidence of this investigation indicates that the general requirements for maintenance of quality system documents at the BOC (see for example Paragraph 6.18) were not being met due to an ongoing shortage of staff allocated to this task.
10.15 Regarding issue number (iii) of Paragraph 10.12, it is evident from this investigation that senior management at the BOC was aware of deficiencies in the combined levels of training and experience among treatment planning staff. Staffing levels for Treatment Planning at the BOC had improved during 2005 but the circumstances of this incident indicate clearly that the staffing provision at December 2005 was not sufficient to ensure that the appropriate level of training and experience was brought to bear on planning the treatment for Miss Norris.
10.16 Paragraph 6.21 of this report refers to RCR guidance on the commissioning of new equipment and the need for related evaluation of clinical safety. At interview, Principal Planner A stated that ' The schedule for implementation [of Varis 7] was short' and was ' in addition to the already very high clinical demands'. He also expressed a view that ' the timescale for implementation, should have been twice as long as we had' and that ' not enough attention was given to the amount of work involved, the resourcing and the impact on working practices'. These opinions are in keeping with the lack of evidence of any formal evaluation of the need for changes to working practices and supporting documentation and for training resulting from the upgrade to Varis 7 or, indeed, of the potential for improved clinical safety.
10.17 Regarding issue number (v) of Paragraph 10.12, the importance of 'lessons learned', the IAEA's 2006 report on 'Applying radiation safety standards in radiotherapy' [8] advises that ' Feedback from operational experience and lessons learned from accidents or near misses can help identify potential problems and correct deficiencies, and therefore should be used systematically as part of the QA programme.' The similarities identified in Chapter 7 of this report between the underlying failures that contributed to both this incident and that at the NSRI indicate that the lessons and recommendations arising from the latter incident had not been adopted at the BOC. This applies particularly to the need for evaluation for the clinical safety of the relevant working procedures at the BOC following the upgrade to Varis 7.
10.18 Had all of these issues been addressed properly, then the risk of occurrence for this incident would have been reduced significantly. The evident failure to address these issues is due, at least in part, to the absence of a clear definition of management responsibilities referred to in Paragraph 10.10. Therefore, it must be concluded that corporate failings were responsible for creating the conditions under which the mistakes identified in this report were made and that management at all levels must share the blame for these failings.
10.4 Lessons arising from this incident.
10.19 The 1992 report of the independent inquiry into the NSRI incident makes a useful and appropriate reference to the 'barbarian boxer' of Athenian lore who consistently took heavy punishment because he always placed his guard where he had last been hit. In this regard, whereas those actions already taken by the BOC (summarized in Section 9.2 of this report) relate primarily to prevention of a recurrence of a similar incident, the recommendations in Section 9.4 and in this section are aimed more generally at an enhanced commitment to quality system working.
10.20 Those with responsibilities for the clinical safety of patients at radiotherapy centres in Scotland and elsewhere must ensure that the lessons arising from this incident are understood and acted upon within their own organizations. Particular attention should be paid to the considerations in Paragraphs 10.21 to 10.28.
10.21 The IR(ME) Regulations came into force in 2000 and should have been implemented fully by January 2001; including provision by the employer of written procedures. For example, failure to indicate that documents issued prior to January 2001 have been reviewed following implementation of these regulations indicates serious shortcomings in a quality system. Any significant changes in practice such as changing to the use of CT image data rather than orthogonal films and the use of a planning computer rather than hand planning should be incorporated in a planned and systematic way, which includes revision of documentation required under the IR(ME) Regulations.
10.22 Management and quality system responsibilities must be clearly and unambiguously assigned and understood by all and must be subject to a proper system of accountability through regular audit of performance.
10.23 There must be an appropriate degree of managerial commitment at all levels to the maintenance of an effective quality system.
10.24 Staffing of treatment planning and delivery units must be reviewed regularly to ensure that levels are suitable and sufficient in terms of (a) the numbers of staff and (b) the required levels of training, experience and seniority. Such review should take account of routine demands for treatment of patients, research and development and maintenance of quality systems and of any unusual pressures such as the commissioning of new equipment or new systems of working. It is not sufficient to define staffing complements on the guidelines of professional bodies (such as the IPEM) alone.
10.25 The introduction of new equipment or new systems of working must be accompanied by a thorough review of the implications for patient and staff safety, both positive and negative. Such reviews should be conducted in accordance with a well defined plan and the outcomes documented formally.
10.26 Where systems of working allow for on-the-job training by completion of tasks under supervision, there must be a clear definition of the nature of supervision that is required. In particular, where the task in question has implication for the safety of patients or staff, supervision must be 'direct' in the sense that the supervisor must have direct involvement in overseeing all aspects of the work of the trainee.
10.27 Management should ensure that all staff involved in the planning and delivery of procedures involving ionising radiation are appropriately trained and that this training includes a proper understanding of the requirements for quality system working and awareness of the lessons learned from incidents reported previously.
10.28 The scheduling of demand for treatment planning (Paragraphs 6.11 and 9.28) must be such as to ensure that sufficient time is allowed for the work to be allocated to appropriately trained staff.
10.29 Finally, with due acknowledgement of the seriousness of this incident, attention is redirected to Paragraphs 5.42 and 5.43 of this report which demonstrate the potential for yet wider patient harm to have arisen.
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