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Annex 4: A copy of the Inspector's note of the incident investigation meeting held on 10 ^th February 2006

Note of a meeting to consider a Radiation Incident at Beatson Oncology Centre reported to the Inspector for the IR(ME) Regulations on 2 ^nd February 2006

Location of meeting: Beatson Oncology Centre
Date and time of Meeting: Friday 10th Feb 2006, beginning at 9.50 a.m.

1. Dr Johnston opened the meeting and distributed a copy of the proposed agenda (Annex A [ not included here]) together with notes on the scope and purpose of the meeting. All participants agreed to adopt this agenda and indicated also their agreement with the stated scope and purpose.

2. The business of the meeting began with a joint expression of concern by all participants for the distress caused to all of those involved in this incident. It was noted that staff at the Beatson Oncology Centre ( BOC) were providing ongoing support to both the patient and the patient's family and that a separate meeting with the patient and family was taking place later that day.

Agenda Item 1: Introductions

3. Introductions were made and employment and line management arrangements were clarified as follows:

• The Health Physics Section, of the Department of Clinical Physics and Bioengineering, Greater Glasgow Health Board ( GGHB) is independent of Radiotherapy Physics and deals with general radiation safety. The Head of Health Physics Section's line manager is The Head of Clinical Physics.
• The Head of Board Administration reports to the Chief Executive of GGHB
• The Medical Director of Beatson Oncology Centre reports to the Acting Chief Executive of North Glasgow Acute Division of GGHB.
• The line manager for the Head of Clinical Physics is the Clinical Director for Imaging.
• The Acting Head of Radiotherapy Physics has been in post since 1 ^st January 2006. His line manager is the Head of Clinical Physics.
• Carol Nix is a Senior Clinical Support Officer, with the Medical Exposures Department of the RPD- HPA. She has extensive clinical experience of radiotherapy treatment and of the legislative requirements governing the use of radiation in medicine. Her attendance was requested by the Scottish Executive Health Department ( SEHD) to provide the necessary expert advice
• Marianne Cook deals with radiation policy in the Scottish Executive Health Department and was also in attendance to take this formal note of key points raised during the course of the meeting
• Dr Arthur Johnston has been appointed by the Scottish Ministers as the warranted Inspector for the Ionising Radiations (Medical Exposures) Regulations 2000- "the IR(ME)R Regulations"*. (Details of his responsibilities are attached as Annex B [ not included here].)

(*A full copy of the IR(ME) Regulations 2000 can be found on the internet at http://www.opsi.gov.uk/si/si2000/20001059.htm . Guidance notes on good practice are at http://www.dh.gov.uk/assetRoot/04/05/78/38/04057838.pdf )

4. Following introductions, Dr Johnston made both his Inspection Warrant and copies of the powers bestowed on him by that warrant under the 1974 Health and Safety at Work Act (at Annex B) available to all present.

Agenda Item 2: Recording and reporting arrangements

5. Reporting arrangements were agreed. It was agreed that only one note of the meeting would be taken (by Marianne Cook) and that this would provide the basis for this subsequent meeting note and an Inspector's report.

Agenda Item 3: Purpose and scope of the meeting

6. The purpose of the meeting was discussed and agreed as (a) to advise the Inspector of the circumstances surrounding overexposure of this patient at the BOC, (b) to review a draft version of Dr Martin's formal incident report and consider the need for additional information, (c) to give initial consideration to the need for procedural changes aimed at minimising the possibility of recurrence of any incident of this nature at the Beatson Oncology Centre, and (d) to consider implications for other radiotherapy departments in the UK.

7. Dr Johnston noted further that this meeting would form part of a full investigation of the incident in question. A detailed Inspector's report will be produced subsequently, but it should be an aim of this meeting to make such additional recommendations as appropriate for immediate or longer term actions, aimed at minimizing the risk of any recurrence of an incident of this type at BOC and other radiotherapy departments in Scotland (with due regard to the wider implications for the other UK countries).

8. Dr Johnston advised the meeting that, based on legal advice, no discussion with those directly involved in the incident would be entered into at this time. He indicated also that his view of direct involvement extended to those who had written or were responsible for the relevant BOC procedures. However, he also advised that it remained likely that he would wish to interview these people at a later date, under appropriate provisions for legal representation and caution.

9. Having advised all present of the position regarding interview of individuals directly involved, Dr Johnston then asked all GGHB staff present to confirm (a) that they were content with the decision not to include staff directly involved with the incident in this meeting and (b) that they regarded themselves as not being directly involved in the incident. Both were confirmed by all present.

Agenda Item 4: Consideration of the draft incident from the BOC report prepared by BOC.

10. It was noted that this incident was reported verbally to SEHD (under the IR(ME) Regulations 2000) on February 2nd 2006 and that this was followed on February 3rd 2006 by a copy of the 'initial report'. This report included details of three 'immediate changes' implemented by the BOC in respect of this incident.

11. A separate draft report on the incident was circulated by The Head of Health Physics. This was titled "Preliminary Report of Investigations on Incident Involving Delivery of a Higher Dose than Intended to the Brain During Treatment of the CNS at the Beatson Oncology Centre, Western Infirmary During January 2006". This report will form the basis of the formal incident report to be submitted to the Scottish Ministers (the 'appropriate authority') by the BOC under Section 4(5) of the IR(ME) Regulations 2000. The Head of Health Physics noted that this draft report was erroneously dated '6 ^th Feb 06' and that this should be corrected to '10 ^th Feb 06'. He also noted that a senior person involved in the planning process had yet to be interviewed as part of his report preparation.

12. The Head of Health Physics noted that an earlier draft of this report had been made available to Ms Carol Nix on the evening of February 9 ^th 2006. The Head of Clinical Physics then highlighted verbally the key changes made from this earlier version of this document. He also noted that a corrective action already implemented by the Beatson (and identified in Principal Planner A's earlier report) had been missed from this document in error. This agreed action was that, pending further consideration of changes to operating procedures, two checks will be undertaken for all future 'high-risk cases' and what constitutes a "high-risk" case will be defined clearly.

13. The Head of Health Physics' report included an analysis of the circumstances that caused this incident. Discussion of these circumstances, in the light of the additional documents presented at the meeting, indicated that the causes might be summarized as follows:

a. The intent of the referring physician was that the patient should receive a radiation dose of 35 Grays divided into 20 equal fractions of 175 centiGrays.
b. This data was input to the Eclipse treatment planning system except that the number of fractions was changed from 20 to 21. The precise reason for the change is unknown. The machine setting required for the delivery unit to deliver the (reassessed) 'Daily Total Dose' (167 centiGrays) was then calculated by the Eclipse treatment planning system. The calculated setting was 91 monitor units ( MU). ('Monitor units' (also referred to in BOC Work Instruction WI-13-67 as 'machine units') is the term used for the reading that arises from the monitor on the delivery unit that measures the total output of radiation from the delivery unit during an exposure).
c. BOC Work Instruction WI-13-67, Issue 4, dated 15/05/02 sets out the procedure to be followed by radiography staff during the pre-treatment processes for 'Medulloblastoma Calculations'. This requires that the number of 'Daily MU' should be calculated by multiplying the intended 'Daily Total Dose' by a parameter called the 'Output' and dividing by 100. The 'Output' is a figure that is calculated by the treatment planner and is entered on the treatment planning form (in this case on Medulla Planning Form FM.14.014). The 'Output' is the intended number of daily MU from the delivery unit 'normalized' to 100 centiGrays ( i.e. expressed in MU per 100 centiGrays). In this case, the normalized 'Output' should have been calculated (for 21 rather than 20 fractions) as 91 MU divided by 167 (centiGrays) and multiplied by 100 to give a required 'Output' of 54 MU per 100 centiGrays. (Paragraph 17 below considers the need for this normalization process.)
d. In this case, however, the dose planner omitted the normalization procedure and entered an erroneous 'Output' figure of 91 MU per 100 centiGrays on the Medulla Planning Form (FM.14.014, Issue 1, Dated 11/8/98) instead of the correct figure of 54. Subsequent application of the Daily MU calculation by the radiographer, as described in Work Instruction WI-13-67 (and in (c) above), (but in this case for the 20 dose fractions prescribed) led to Daily MU = ((175 x 91) / 100) = 159 MU.
e. The Daily Total Dose equivalent to 159 MU is 292 centiGrays and this is the dose that was delivered over 19 fractions before the error was discovered. The total dose to the patient was therefore approximately 55 Grays, which is 58% higher than the intended total dose of 35 Grays.
f. The bulk of the treatment planning was undertaken by a Planner B (see Paragraph 25 below) with supervision from a Principal Planner A. The erroneous entry on the Medulla Planning Form was made by Planner B. Checking of the resulting treatment plan by the two others identified a number of deficiencies but neither of the checkers identified the error in the number of monitor units entered on the Medulla Planning Form.

14. Discussion of these circumstances focussed on (a) the need for manual rather than electronic transfer of data from the Eclipse treatment planning system to the Varis 7 recording and verification system, (b) the need for the process of normalization of the Total Daily Dose to MU per 100 centiGrays and (c) precisely why the wrong figure was entered on the Medulla Planning Form.

15. On the first of these issues, the Head of Health Physics' report indicates that the reason why transfer of data to the Varis 7 recording and verification system, which was first commissioned by the BOC in May 2005, was not carried out electronically was that it is not yet able to accommodate all the complexity of the medulla and spinal column exposure procedures. BOC representatives suggested that electronic transfer might be technically feasible but that this was an issue best discussed with the Head of the appropriate section.

16. Clarity was sought on whether the data that is entered directly into the Eclipse planning computer always included the prescribed dose. It was confirmed that this is the case for all but a very small number of complex cases. Factors which make a case "complex" include type and location of the tumour.

17. In relation to the need for normalization, BOC representatives explained that the need for this process reflected the variability of central nervous system treatments and the frequent need to change the prescribed radiation dose at different stages in the planning process, for example when other patient treatment issues made this clinically necessary. However, it was agreed that the attendant risk of over-exposure, as demonstrated by this incident, was such as to indicate that a detailed reconsideration of the need for this step in any exposure planning procedure (and particularly in Medulla Planning Forms FM 14.013 and FM 14.014 and in Work Instruction WI-13-67) must be reviewed. Meanwhile, it was noted that one of the immediate changes that has been introduced in response to this incident has been to change Medulla Planning Forms FM.14.013 and FM.14.014 and related written procedures to require that the number of monitor units per fraction will be entered on the planning forms along with the radiation dose per fraction. These modified forms and procedures should be made available to the Inspector forthwith.

[At this stage of the meeting a folder containing specific clinical information relating to the incident was made available to the inspection team by the BOC. Regarding the issue of data confidentiality, it was noted that this folder contains clinical details for a named patient. Pending clarification of the data confidentiality issues, it was agreed that the SEHD will retain a single copy of this folder for the purposes of this investigation. However, checks will be made to consider whether it is appropriate that this information should be held after the investigation has concluded.]

18. The circumstances whereby the wrong figure ('91' instead of '54' MU per centiGray) came to be entered on Medulla Planning Form FM.14.014 were then discussed.

19. The original 'Booking Form' ( BOC 00017 Version2/116353 dated 13/9/05 and signed by the referring Oncologist) for pre-treatment was referred to. The correct dose (35 Gy) appears on this form, as does the request for 20 fractions. BOC representatives indicated that this booking form was introduced in late 2004 after a pilot period. This booking form and CT data would then have been given to treatment planning staff to create a planning folder for the patient.

20. Additional documentation associated with this procedure ( Varis Version 7 implementation- 5th revision dated 14.04.05 and various associated flow charts) was shown at the meeting. However, these documents currently are not part of the BOC Quality System, though BOC representatives indicated that it was intended, at the time of drafting, that these documents would become practice and part of the Quality System.

21. It became clear that some questions relating to the procedures in place for planning the treatment of patients of this type, including procedures for planning the treatment of these patients from a CT scan and routine use of the planning computer, could best be addressed by the Head of the appropriate section.

At this point Dr Arthur Johnston, Ms Carol Nix and Ms Marianne Cook broke for independent discussion of the points already raised. They noted their view they were receiving full co-operation from BOC staff present both in terms of their response to questions and provision of relevant information. It was also noted that the incident reports provided to date were both timely and comprehensive.

Agenda Item 5: Review of additional documents.

22. Staff training and competency records for three individuals considered by the BOC to be directly involved in this incident were reviewed. These records indicate a graded approach to training where an entry is made in the appropriate 'check-box' indicating, for each identified competency, whether individuals are "in training", "competent", "authorised to check". The format of these training and competency records is different for each of the three individuals and there are no indications on any of these records that they from part of the BOC's quality system. In addition, BOC representatives indicated that there is no written procedure within the BOC's quality system that defines the structure and requirements of these records or who is responsible for their maintenance and authorization.

23. Current practice for treatment planning staff is that training and competency records are reviewed by Principal Planner A. BOC representatives indicated their belief that assessment of competency is based on a mixture of both discussion and evidence. However, this requires further clarity from Principal Planner A. In this connection, it was further noted that some of the records looked at are initialled and dated but others are not. The initials on Principal Planner A's training record indicate that his competencies are reviewed by himself.

24. The training records for Planner B indicate no record of competence as either "training", "competent", "authorised to check" for the 'Spine/Medulla/ CNS' procedure in question.

25. Within the training records for Senior Planner C, the 'Planning Activities' section suggests (though there is some lack of clarity) that Senior Planner C is (a) 'Training' for the 'medulloblastoma/whole CNS' and 'brain' non- CT procedures and (b) 'Training' for the 'medulloblastoma/whole CNS' but is an authorised 'Practitioner' [not in the sense in which the terms is used in the IR(ME) Regulations] for the 'brain' CT procedures. However, the accompanying record for 'Treatment Planning Training' indicates that Senior Planner C is both 'Competent' and 'Authorised to check' both CT and non- CT plans described as 'Head and Neck - Advanced eg. Medulla, Ho'.

26. The training records for Principal Planner A indicate competence at all levels in the planning of 'Advanced Head and Neck' procedures and competence to check manual plans for 'Spine/medulla/ CNS' procedures.

27. BOC procedure QS.14.13- 'Checking and Issuing of Plans', (Issue 1, dated 5.8.96) states that; 'Calculations will be performed by a suitably trained member of the Physics Planning Staff, who will prepare and initial the plan'. The staff training records that were reviewed at this meeting (see Paragraph 25 above) give no indication that Planner B, who prepared the initial plan for this patient, was 'suitably trained' for either the spine or medulla procedures.

28. Principal Planner A's initial report of this incident indicates that planning by Planner B was supervised by both the Principal Planner A and Senior Planner C. The Head of Health Physics' draft report was less clear about the level of supervision provided by the Senior Planner C. [ In this connection it might be noted that Section 11(3) of the IR(ME) Regulations provides for a person in training to participate in 'practical aspects' of the procedure, which would include treatment planning, provided that 'this is done under the supervision of a person who himself is adequately trained'.]

29. BOC Work Instruction WI.14.13.01- 'Checking/Amending Plans', (Issue 1, dated 5.8.96) states that; 'All physics plans should be checked before they are issued.' and that 'Checking should only be performed by suitably qualified and experienced staff.' The completed Medulla Planning Form (FM.14.014) for this patient is initialled, in the box labelled 'Physics', by Planner B, the Principal Planner A and the Senior Planner C. However, there is no information on this form, nor on any other document provided at the meeting, to indicate in what capacity each of these individuals is initialling the form. Further, as these initials are not dated it is difficult to determine precisely when the form was completed and when it was checked.

30. The initial report of this incident makes it clear that both Principal Planner A and Senior Planner C were involved in checking aspects of the treatment plan. Some errors (unrelated to the incident) came to light at this stage and were corrected. The Head of Health Physics' report suggests that attention to these errors might have distracted the checkers' attention from the erroneous entry for the normalized daily dose.

31. It was noted that, while the treatment planning staff who had checked the plan were deemed competent to check manual plans for the 'spine/medulla/ whole CNS' procedures, this plan was a hybrid of manual-electronic planning for which no specific competency has been defined within the BOC's current procedures.

32. It was noted that the completed Medulla Planning Form (which is an authorized BOC quality system document) was heavily annotated outwith the prescribed boxes. Further, it was apparent that on the photocopy presented at the meeting, one of these annotations had a gap where a change might have been made. BOC representatives therefore sought and produced the original version of the completed form. From this, it was clear that part of this annotation had been erased using correction fluid.

33. BOC Work instruction WI 14.13.01 states that correction fluid should not be used and that any errors on quality system documents should be scored through with a single line and a correction should be initialled and dated. Since this procedure had not been followed it was not clear what the error was or when the changes were made and by whom.

34. It was established on further investigation that that the error in question was a simple misplacement of the word 'multiplied'. The Inspector made clear that, notwithstanding concerns over the misuse of correction fluid, he was satisfied that the data altered did not impact on the radiation dose and that there had been no attempt whatsoever to disguise or deceive.

35. A sticker was also present on the reverse of this form which provides for a signatory to confirm that ' I have checked this physics plan and treatment may proceed'. This label has been initialled and dated but the provision included under 'CHECKED' had not been signed or dated. There is no indication on Medulla Planning Form FM.14.014 nor on any other document provided to the Inspector to indicate the status of this label nor the responsibility of the persons initialling it under the labels 'SIGNED' and 'CHECKED'. The BOC representatives present indicated a view that this label does not form part of the checking procedures for the plan as the sticker was initialled by a clinician. ( BOC representative indicated that it is always a clinician who initials this section of the form.)

36. It was agreed at the meeting that issues related to this label, both in terms of implied responsibilities and its status within the quality system needed to be addressed robustly. As a practical issue it was noted in addition, that stickers can be removed or can fall off and that serious consideration should be given to having their use within any part of the quality system replaced, for example, with the use of a permanent stamp.

37. Ms Nix raised a number of further, detailed issues about the treatment planning and checking procedures, which the BOC representatives present suggested could more accurately be addressed by the Head of the appropriate section. These included -

• How it could be ensured that checking process was independent of the original treatment planning
• Would the checker ensure that the correct CT scan had been used?
• Whether the field size was derived from the CT scan.
• Which elements of the treatment plan are checked by a suitably trained member of staff?
• Is there a reference checklist available for checking plans?
• Do specific working instructions exist for different planning procedures?
• Is there any documentation either within the BOC quality system or elsewhere that sets out the responsibilities of those involved in the treatment planning process?
• Do the planning staff consider that the term 'suitably trained' as it is used in document QS14.13- is synonymous with the term "competent" used on the training record?
• With regard to this incident, when the checkers identified errors in the compensators for the spine field and subsequent rechecking was done, was this recheck on the spine fields only, or on the whole of the treatment plan?

38. It was noted generally that the dates of issue on several of the Quality System documents, including both procedures and work instructions, indicated that they had not been amended for several years. (The earliest being dated 1996.) This despite the requirement in BOC quality system document QS 03 'Document and Data Control' that ' All controlled documents are reviewed at least annually…' and evident changes since their last date of issue, including the introduction of new equipment.

39. BOC representatives noted that this issue had already been recognized at Department and Section Head levels and by several internal BOC groups, including the Radiation Protection Group and the Quality System Review Group. Minutes of the April 2005 and September 2005 meetings of the Quality System Review Group at which this issue was discussed were provided as evidence that this problem had been recognized. Both of these documents refer to the visit of Ms C Nix to the BOC in March 2005 and her clearly stated views on the need for improvement in IR(ME)R procedures. Reference was also made to correspondence with the SEHD regarding previous incidents at the BOC which were reported under the provisions of the IR(ME) Regulations 2000. [A previous incident report to the SEHD Inspector in November 2004 was accompanied by a letter indicating that the Medical Director had requested that the radiotherapy Management Group and other senior managers undertake a review of policies and procedures in this area. The Inspector requested that this review should include representation from a former member of the Secretary of State's Inspection Team for the IR(ME) Regulations. The subsequent visit of Ms Carol Nix to the BOC in March 2005 was in support of this review.]

40. When questioned directly as to the reasons why, although identified on several occasions, procedures and documentation had not been updated as required by the BOC quality system, BOC representatives pointed to the following circumstances:

• Part of the difficulty in keeping the BOC quality system up to date relates to resourcing issues, particularly in the Radiotherapy Physics Department where it has been difficult to recruit and retain the full complement of physicists. The Department has drawn up priorities for producing and updating protocols and documentation but considerable expertise is required, including staff from physics, medical and radiography specialties. The issues of understaffing and under-funding at the BOC were acknowledged and an intervention was made by the Health Minister in 2001, whereby additional funding was made available.
• This resourcing issue was exacerbated by a number of other changes and pressures within the department, including; a restructuring of the entire Radiotherapy Physics Department in 2000 and 2001 (in an attempt to ameliorate the difficulties of staff resources); the installation and commissioning of a new radiotherapy facility at Gartnaval Hospital; purchasing and commissioning of new equipment including the Varis 7 recording and verification system in 2005.
• All of this activity was alongside delivery of treatment to approx 8,000 patients per year in line with current waiting time targets pressures.

41. BOC representatives advised that they have drawn up a detailed plan for full compliance with the IR(ME) Regulations and hoped to achieve the necessary compliance by June 2006.

A break for lunch was taken between 1.30-2.10

42. Ms Carol Nix asked for verification that the correct physician's intent was added onto Varis 7 recording and verification system for this patient. In seeking to respond, the Acting Head of Radiotherapy Physics left the meeting to review the relevant records and verified on his return that the correct physician's intent was entered onto Varis database on 28/11/2005 by Radiographer A as part of the registration process. The records showed that the data entered was 20 fractions of 175 centiGrays.

The Head of Health Physics left at approx 2.50pm, after confirming with the inspectorate that there were no further questions for him at this point.

43. Returning to the issue of maintenance of quality system documents, it was noted by the BOC representatives that, in accordance with Quality Standard document QS 03, all Quality Assurance Procedures are authorised by the relevant Head of Department. QS 03 also requires (see Paragraph 39 above) that all quality system documents should be subject to an annual review. No evidence was presented at the meeting of regular review of documentation having taken place. Nor was it apparent from written procedures how evidence of such reviews would be recorded, in particular where the review had indicated no requirement for change.

44. In this regard it was noted specifically that BOC Audit Report Number 05 IMK3 BOC arising from an ISO9000 Internal Quality Audit dated March 2005 had also identified as a 'Corrective Action Request' ( CAR 05 BOC1) that 'Controlled documents are not being reviewed annually for validity via management review or audit'.

45. It was noted at the meeting that Quality Standard document QS 03 does not clarify what the signatures that are required in the "Authorised by" and "Issued by" sections of the document footer actually mean in terms of responsibilities for each document. In this regard also, QS 03 states that The Quality Management Representatives ( QMRs) have full responsibility for the accuracy, control and issue of all controlled documents. However, there is no indication of how these stated QMRs responsibilities relate those of the aforementioned signatories and these QMR responsibilities do not appear to accord with other parts of the QS 03 document that identify responsibilities for Heads of Department etc. The BOC representatives confirmed that QS 03 was currently being revised and that these points had been noted.

Agenda Item 6: Consideration of actions to be taken at the BOC and implications for other radiotherapy units.

46. The following recommendations, some of which had been enacted prior to this meeting, were noted and agreed by the BOC representatives:

Treatment planning procedures

(i) Each treatment planning procedure for complex procedures or procedures considered to be within a high risk category (which, in both cases, will be identified and listed in Quality System procedures) will have its own individual written protocol which will be part of the BOC's quality system documentation.
(ii) All treatment plans for complex or high risk procedures shall be checked by two checkers who were not involved in creating the plan. Checkers must be identifiable within the BOC quality system as being trained and competent for the procedure in question.
(iii) Reference check list shall be prepared and these shall include the expected ranges of values for critical parameters such as the minimum and maximum number of monitor units that would be expected for the procedure in question.
(iv) In future the exact dose per fraction will be input directly into the planning computer and no use will be made of scaling (normalization) factors or calculations. The only exception to this might be in brachytherapy but further discussions with senior Treatment Planning staff will be necessary. An instruction to this effect will be issued to staff and incorporated into the relevant Quality System procedures.
(v) An immediate review of the practice of manual planning and its relationship to the electronic planning system shall be undertaken with a view to minimizing the need for manual re-entry of dosimetric data to the electronic planning system. The aim will be to optimize the use of the Eclipse Treatment Planning System and the Varis 7 Recording and Verification System and also to extend the use of the new RadCalc Monitor Unit Checking System to all suitable plan types.
Training and competency
(vi) Immediate action will be taken to ensure that only those staff who are identified in an appropriate quality system document as being competent in treatment planning procedures can create plans. Provision will be made, where appropriate, in terms of Regulation 11(3) of the IR(ME) Regulations for trainees to undertake planning activities under strict supervision. The same requirements will apply of those checking plans.
(vii) Training records must be more robust and procedurally based and should be brought within the BOC quality system. The criteria whereby competency is judged must be documented clearly.
(viii) For staff under supervision, the supervisor should have documented responsibility for treatment planning and a suitably qualified third individual, not involved in the preparation of the treatment plan must check.
(ix) Those who are competent to train must be identified clearly and the criteria for attaining such competence must be documented.
(x) Individuals who can determine competency must be clearly identified and this procedure documented, to include the criteria whereby competencies will be assessed.
Treatment planning forms.
(xi) The Medulla Planning Form FM.14.014 and any other whose current design requires the addition of annotations should be redesigned to ensure that space exists for all required text to be placed in the properly assigned boxes (rather than the case at present where forms are annotated). This redesign should include consolidation of the label currently stuck to the back of the form together with reconsideration of the text on the current label for improved clarity. The responsibilities of signatories (under 'SIGNED and 'CHECKED' on the current label) must be identified clearly and clear instruction added to the BOC quality system of the qualifications required for the provision of these signatures.
(xii) FM.14.014 and those planning forms for other BOC procedures that form part of the quality system should also be amended to require that all individuals involved initial and date at an appropriate place in the form that identifies clearly their involvement, whether it be in dose calculation, checking or adding data to the form.
(xiii) The use of stickers should cease and should, where necessary, be replaced with stamps. Any use of stamps should be allowed for in quality system documentation and form FM.14.014 and those planning forms for other BOC procedures that form part of the quality system should be changed to properly accommodate any necessary stamps.
Checking of treatment plans
(xiv) Clarification is required within the BOC quality system on what information and data those checking treatment plans should check. For example, the checks performed must include a check of the training record to ensure that anyone who initials or signs the treatment planning form as a treatment planner is either identified within the BOC quality system as competent for the procedure in question or was properly supervised in accordance with written BOC quality system provisions.
Other quality system documents
(xv) The BOC 'Booking Form' ( BOC 00017) for pre-treatment radiation exposures should be brought clearly within the BOC's quality system with a robust protocol that describes its use and status and clarifies the responsibilities of signatories. The form should also be redesigned to reflect its status as a quality system document. In redesigning this form, particular attention should be paid to (i) proper accommodation of patient details, (ii) clear definition and identification of 'mandatory fields', (iii) the responsibilities of the signatories (under 'Signed' and 'Countersigned') with particular regard to which of these is responsible for the IR(ME)R requirements for referral, justification and authorisation of the medical exposure.
(xvi) The relationship between pre-treatment Booking Form BOC 00017 and the 'Radiographer's General Prescription Form' should be established clearly within the BOC's quality system with particular regard to the responsibilities of signatories. In particular, the process whereby the patient is referred for actual treatment should be defined and documented clearly and should include clarity about the purpose and status of related forms as well as the individual responsibilities of signatories for referral, justification and authorisation of the medical exposure. The need to include the 'Radiographer's General Prescription Form' within the BOC quality system should be considered.
(xvii) These changes to documents should be made with due urgency but should be seen as part of the general plan for compliance with the IR(ME) Regulations by June 2006, referred to in Paragraph 42 above.

Amending quality system documents

(xviii) No use of correction fluid shall be allowed on any documents that form part of the BOC quality system and all staff must be made aware of the correct procedure for correcting errors.

47. It was agreed that these issues will be addressed urgently by the BOC and that consideration should also be given to whether any of the lessons learned can be applied across other radiotherapy centres in the UK, to ensure no recurrence of this type of incident.

48. Dr Johnston requested that the BOC staff provide him with copies of the following documentation which was not available on the day of the meeting, in the week commencing 13 Feb 2006-

• A chronology of events for this patient, including key milestones such as when planning commenced, when this was checked, when the error was spotted and when the patient was informed
• A departmental accountability structure
• A revised version of the Head of Health Physics' report taking account of the issues discussed at this meeting
• Terms of reference of the Beatson Oncology Centre Radiotherapy Group who oversee the ISO9000 system and IR(ME) Regulations.

49. For the purposes of any immediate need to communicate the purpose and conduct of this meeting externally, it was agreed that the meeting could be summed up as follows;

"This is a very regrettable incident and our concerns are with the patient and the patient's family.

An initial meeting has taken place between senior staff at the Beatson Oncology Centre and the Inspector appointed by Scottish Ministers, supported by staff from the Scottish Executive Health Department and a radiation expert from the Health Protection Agency.

Further information relating to the incident has been gathered and a number of preliminary actions, in addition to those already identified and implemented by the Beatson Oncology Centre as part of its own investigation, have been agreed upon.

The Inspector was satisfied that the Beatson Oncology Centre co-operated fully with the inspection team and that all materials requested were made available. Senior staff at the Beatson Oncology Centre have stated their willingness to continue to provide any additional information required by the Inspector.

Further steps are currently being discussed"

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