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9. Actions and recommendations
9.1 Introduction
9.1 This investigation has sought to establish what was the precise course of events that led to the series of overexposures for Miss Lisa Norris, what were the contributory factors and who were the BOC staff involved. These findings are summarized in Chapter 8 of this report. The remaining objective is to ensure that appropriate and practical measures are identified that will minimize the possibility of a recurrence of an incident of this type and contribute more generally to the improvement of patient safety.
9.2 It should be stressed, however, that the principal responsibility for ensuring that corrective actions are identified and implemented remains with the employers and staff concerned, in accordance with their statutory responsibilities, the provisions of their professional regulation and their general duty of care. In this regard, the BOC's own internal investigations have identified a number of corrective actions. Feedback from the BOC to the Inspector indicates that most of these have already been implemented.
9.3 This chapter gives details of the actions already taken at the BOC in respect of this incident and makes further recommendations for improvements in procedures and practice at the BOC. Those recommendations that impinge on the BOC's responsibilities under the IR(ME) Regulations, are subject to separate consideration of enforcement action by the Regulator (Paragraph 9.41).
9.4 Consideration is also given (in Sub-section 9.4.2) to how the lessons learned and changes recommended in respect of this incident might extend to other radiotherapy centres in Scotland and the rest of the UK and to other relevant bodies.
9.2 Actions already taken by the BOC
9.5 As a result of the initial investigation of this incident by Principal Planner A and subsequent consideration by senior radiotherapy physics staff of the need for further action, management at the BOC has advised the Inspector that a number of changes have been implemented at the BOC. These include the changes summarized below in Paragraphs 9.6 to 9.14.
9.6 A list has been compiled of those planning procedures (including the whole CNS procedure) considered to be such as to present a high risk of error. Special provisions for checking plans within this 'high risk' category have been introduced.
9.7 A review of all Quality System documents relevant to Treatment Planning at the BOC has been initiated. All documents that do not reflect current practice will be subject to programmed updating with priority given to written procedures for 'high risk' plans. An instruction has been given that no high risk plan will be submitted unless a properly reviewed and suitably revised written procedure is in place.
9.8 New planning forms have been introduced which include provisions to identify clearly the roles of all participants, as planner, checker etc.
9.9 Reference check lists are being prepared for all planning procedures with priority given to 'high risk' and complex plans. These check lists will include the expected ranges for all critical parameters including the expected range of Monitor Units per treatment fraction.
9.10 Advice has been issued to all Treatment Planning staff that any concerns over non-compliances with quality systems procedures should be raised with a Quality Management Representative.
9.11 In future, all treatment plans that are created using Eclipse, must include the prescribed radiation dose. Quality System Documents referred to in Paragraph 9.7 above have been amended to reflect this change.
9.12 Maximal use will be made of the facility for electronic transfer of data from Eclipse to RTChart.
9.13 A thorough review and revision of training records and related documents has been initiated to ensure that the training status of all individuals is properly recorded and verified and that planning duties are allocated appropriately in relation to these records.
9.14 Piloting of a new ' Radcalc' software module which will increase the capability for Monitor Unit checking from the current level of 75% of plans with the extant, internal QASSUR system, to all plans, is complete. The Radcalc system has been fully implemented.
9.3 Additional actions recommended by the Head of Health Physics
9.15 Some of these actions address the recommendations made in Dr Martin's formal incident report to the SEHD Inspector (Paragraph 3.4 in this report). The additional recommendations within Dr Martin's report are summarized in Paragraphs 9.16 to 9.21.
9.16 A system should be introduced that ensures that checking of plans is totally independent of their creation.
9.17 Consideration should be given to the use of in vivo dosimeters to measure the radiation dose delivered in the first fraction for those treatments where an independent check of dose cannot be carried out by other means.
9.18 The level of adherence by BOC staff to Quality System procedures needs to be improved.
9.19 Consideration should be given to the introduction of a summary planning document to record key information as patients progress through the planning and treatment process. The aim would be to ensure that all parties involved in the treatment planning process have access to all relevant information and thereby to reduce the risk of error.
9.20 More formal procedures should be introduced for allocating responsibilities for particular tasks to individual staff members, as required by the IR(ME) Regulations.
9.21 An improved multi-disciplinary team approach to treatment planning and delivery should be pursued.
9.22 Provisions pursued normally in Scotland for incident reporting and investigation under the IR(ME) Regulations, require the BOC to respond to the Inspector giving details of their approach to Dr Martin's recommendations. A response has been received and the changes indicated will be subject to subsequent review by the Inspector.
9.4 Further recommendations arising from this investigation
9.4.1 Recommendations for action to be taken by the BOC
9.23 The actions and recommendations identified in Sections 9.2 and 9.3 of this report represent an appropriate and proportionate response to this incident. However, in consequence of the findings of this investigation, the following additional measures in Paragraphs 9.24 to 9.33 of this Sub-section are recommended for action by the BOC.
9.24 A comprehensive review of the responsibilities of all staff at the BOC with responsibilities related to areas covered by the IR(ME) Regulations should be undertaken to ensure that individual responsibilities are well documented and commonly understood. The aim should be to ensure that all areas of responsibility are properly and unambiguously addressed. The outcome should include a clear, written statement of the duties of operators, referrers, practitioners and employers under the IR(ME) Regulations and who is responsible for all elements of the working system including the ISO 9000 Quality System. A single BOC staff member should be made responsible for annual review and redistribution of this written statement or for interim updates. This written statement should be part of the BOC's quality system.
9.25 With reference to Paragraph 6.36 of this report, the need for a clearer understanding of the line management responsibilities for staff in the Radiotherapy Physics Group should be addressed. Any related implications of emerging structural arrangements whereby the Head of Clinical Physics and Bioengineering and the Medical Director for Specialist Oncology Services report through different Clinical Directorates should be evaluated carefully.
9.26 A comprehensive review of the adequacy of staffing provisions for treatment planning at the BOC should be undertaken, taking account not only of IPEM recommended staffing numbers but also of (a) the distribution of staff training and experience in relation to the annual distribution of plans among the various categories of complexity and risk of error, (b) any extraneous demands on treatment planning staff currently or in the foreseeable future, (c) future developments at the BOC with regard to the projections and recommendations contained in the 2006 report by The Radiotherapy Activity Planning Steering Group on 'Cancer in Scotland: Radiotherapy Activity Planning for Scotland 2011 - 2015'. The findings of this review should be reported formally to the SEHD.
9.27 The current system of rotation of treatment planning staff among different sections should be reviewed with particular regard to the effect of this system on staff training and development.
9.28 Principal Planner A informed the Inspector (Paragraph 6.11) that some 80% of requests for treatment plans at the BOC are submitted either on the same day or on the day before the plan is required. Such a position would be contrary to the proper distribution of work among treatment planning staff. Other information received by the Inspector from BOC management indicates that the relevant figure is considerably less than 80%. This position should be clarified and addressed appropriately.
9.29 In keeping with the requirements of Schedule 1(k) of the IR(ME) Regulations and with the relevant recommendations of the Baldwin Report on the incident at North Staffordshire Royal Infirmary (Section 7.4 of this report) a written procedure should be introduced within the BOC's Quality System requiring that all changes to the treatment planning and delivery systems must be subject to a formal review of possible safety implications by suitably qualified staff. A formal written report on any such review, appropriately signed, should be kept on record for a specified period.
9.30 Consideration should be given to the possible advantages to patient safety of all available technology e.g. electronic data transfer and where appropriate, the use of operator specific electronic passwords in conjunction with the replacement of any paper treatment planning forms requiring handwritten inputs with equivalent electronic data and recording mechanisms. The possible advantages include ensuring completion of mandatory fields, and the ability to set limits on the access of individuals depending on competence.
9.31 A written procedure should be introduced within the BOC's quality system giving clear instruction on the level of supervision required for trainees undertaking planning duties and on what form that supervision must take.
9.32 All documents relating to IR(ME)R procedures should be produced in an appropriate, common style with clear identification of who is responsible for authorizing and maintaining the content. Wherever possible, such procedures should be incorporated into a single document along with the requirements of the ISO system, but recognising that there are different requirements in these two approaches (for example, the IR(ME)R procedures will need to include a clear statement of duty holder responsibility and how this is demonstrated whereas ISO does not).
9.33 In accordance with the requirements of Schedule 1(e) of the IR(ME) Regulations a written procedure should be introduced to ensure that quality assurance programmes are followed.
9.4.2 Recommendations for action by other parties
9.34 The lessons and recommendations arising from this incident and the resulting investigations have implications for other radiotherapy centres and for the relevant professional organisations. In addition to the actions and recommendations in Sections 9.2, 9.3, and 9.4.1 the recommendations in Paragraphs 9.35 to 9.40 should be considered for actions by parties outwith the BOC.
9.35 A Short Term Sub-Group, of the Radiotherapy Advisory Group (which is current active in Scotland) should be established to review treatment planning provisions at all five Scottish radiotherapy centres and report their findings to the Scottish Cancer Group. The aim should be ensure that all the provisions at all five centres for regulatory compliance, staffing and quality system working are such as to ensure an appropriate level of patient safety.
9.36 The Scottish Executive's 2006 report on ' Cancer in Scotland: Radiotherapy Activity Planning for Scotland 2011 - 2015' [3] predicts that the number of radiotherapy treatment fractions to be delivered in Scotland will increase from 175,954 in 2003 to between 242,384 and 318,422 in 2015. The Short Term Sub-Group should consider what measures might be required for treatment planning, in addition to those identified in the Scottish Executive's 2006 report, to safeguard and improve patient safety in the face of this level of increase in demand.
9.37 Particular consideration should be given also to the ways of maximising the uniformity of provisions among the five centres. For example, the provisions described in Paragraph 9.6 of this report could be extended to include unified 'numbering' of each individual planning procedure, under a scheme that identifies its assigned categories of complexity and risk of error. This might then form a basis for agreement between centres on all aspects of the planning requirements for individual procedures including the training and experience required for planners, supervisors and checkers.
9.38 The Royal College of Radiologists ( RCR) should review the status and content of the 1999 Draft report of the Generic Radiotherapy Working Group of the Clinical Oncology Information Network Guidelines for External Beam Radiotherapy [2]. At present, it is not clear whether this document continues to constitute formal RCR guidance and how this guidance might be updated in the future. As indicated in Paragraph 6.32 of this report, some of the recommendations of this guidance seem inappropriate and should be reviewed by the RCR.
9.39 The Scottish Executive Health Department should consider the need to extend the guidelines currently in preparation by the National Institute for Health and Clinical Excellence ( NICE) to include some of those detailed provisions of The Department of Health's Manual of Cancer Services 2004 [5] that relate to radiotherapy planning.
9.40 National bodies including the Royal College of Radiologists and the recently-formed Medical Practices Sub-Committee of the Committee of Medical Aspects of Radiation in the Environment should consider how information on incidents involving accidental or inadvertent radiation exposures in medical practice can best be shared among radiotherapy centres in the UK.
9.5 Further actions under the IR(ME) Regulations
9.41 Those deficiencies identified during this investigation that constitute non-compliances with the statutory requirements of the IR(ME) Regulations will be addressed by the appropriate authority (The Scottish Ministers) in accordance with the relevant regulatory provisions. An improvement Notice has been served on the BOC by the inspector, in accordance with the provisions of Section 21 of the Health and Safety at Work Act 1974.
9.42 Satisfactory completion of the required changes to the BOC's IR(ME)R procedures and of any additional requirements specified by the regulator for the IR(ME) Regulations should be subject to a formal IR(ME)R Inspection at an appropriate date.
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