5. Investigation of the causes of the error
Investigation of the error has focussed on any failures by the employer or by Clinical Oncologist B with regard to the duties of the employer under the IR(ME) Regulations and on any other circumstances that might have been contributory factors.
5.1 Duties of the employer
The duties of the employer under the IR(ME) Regulations 2000 which were in place at the time of the incident and which are pertinent to this investigation include:
1. Ensuring that appropriate written procedures and protocols are in place and are kept up to date, (Regulation 4 (1), (2), (3)).
2. Ensuring that all duty holders are properly trained and entitled to undertake their assigned duties, and keeping relevant training records for inspection as required, (Regulation 11).
With regard to the first of these, the ECC documents of particular relevance to this treatment are:
EP2\ECC\1043 'Simple palliative radiotherapy for metastases to locations other than bone, skin, brain or chest'
EP2\ECC\1070 'Clinical management guidelines for lung cancer',
Examination of both of these documents found them to be in date and available at the time of the incident, and the content to be appropriate.
With regard to the second of these requirements; training and entitlement of duty holders, document EP2ECC\002 'Induction of staff and training and training records of entitled Practitioner and Operators' was also provided. The version provided was out of date (next review 21/9/17), but, as noted below, was covered by a 'concession'. It did not include details of the familiarization programme for incoming staff, nor of how this should be recorded.
In this regard it was confirmed by the ECC that Clinical Oncologist B underwent a six week induction/familiarization process on joining the ECC. However, no formal record of successful completion of this process was available in support of subsequent operator entitlement. (A similar report published by the Scottish Ministers on a previous ECC incident (Johnston A M 2016) recommended that 'where possible, there should be a clear linkage between each of the authorized competences and the training required prior to entitlement.')
During this investigation a general review of ECC documentation was undertaken to assess compliance with the ECC's documented approach to document quality control, as required by the IR(ME) Regulations. A copy of the index of current ECC documents was provided to the inspector at a meeting at the ECC on 9th May 2018. Of these, 6 of the 9 documents (all of those that should have been reviewed in 2017) that relate to IR(ME) Regulation compliance were found to be out of date and designated as 'concession'.
In this regard, the term 'concession' means permission to use a procedure that does not conform to specified requirements within specified limits. In this case the concession related to the timeliness of document review which was extended. The concession is generally limited for a period of time, and in this case the concession was granted pending finalization of the new IR(ME) Regulations (in February of 2017).
While there is merit in the decision to await implementation of the new IRME Regulations before reviewing some of the ECCs Employer's Written Procedures, it is also the case that it should have been known that any new requirements were highly unlikely to affect the content of some of these documents. Taken together with the concerns raised by ECC staff about staffing pressures, and the fact that these 'concessions' were still in place at the end of July 2018, it might reasonably be concluded that these pressures, together with the absence of the formal document quality control software available in other areas of NHS Lothian, were a contributory factor in postponing the required reviews of these documents.
However, in no sense was this considered to have been a contributory factor in this particular incident.
In summary, the current ECC provisions for recording of training prior to entitlement of duty holders were found to be deficient, and there is evidence for concern about for quality control of Employer's Written Procedures and Protocols.
5.2 Responsibilities of the duty holder
The legal responsibilities of referrers, practitioners, and operators under the IR(ME) Regulations 2000 (as amended in 2006) which were in place at the time of the incident which are pertinent to this investigation included:
1. The practitioner and the operator must comply with the employer's procedures, (Regulation 5(1)).
2. The practitioner is responsible for the justification of an exposure, (Regulation 5(2)).
3. The operator is responsible for each practical aspect which the operator carries out, (Regulation 5(4)).
4. The practitioner and the operator must cooperate, regarding practical aspects, with other specialists and staff involved in an exposure, as appropriate, (Regulation 5(6)).
With regard to item 3, field placement is an operator responsibility and in this case was the responsibility of Clinical Oncologist B. While an error was clearly made in carrying out this 'practical aspect' of the exposure, there is no indication that this was done carelessly or negligently or in any way that could be construed as the operator having failed to comply with the employer's procedures.
Further to this, evidence was provided that Clinical Oncologist B was adequately trained and appropriately entitled to 'justify, prescribe and define the target volume' for 'Palliative nodes'.
In no sense, therefore, was Clinical Oncologist B (or any other individual duty holder) found to have failed to comply with these requirements.
5.3 Other relevant factors
The relevant ECC team for this form of treatment comprises five Clinical Oncologists. Of these the usual compliment for Monday to Thursday is between three and five, but normally only two on a Friday. The relevant team does not have routine site specific planning sessions on Fridays.
This incident occurred on the last working day (Friday) before the Christmas Bank Holiday when Clinical Oncologist B was the only member of the relevant team on site.
With regard to these provisions generally and to this Friday in particular, at interview, Clinical Oncologist B identified the following concerns:
- Clinical Oncologist B is often the only appropriately trained clinical oncologist from the relevant team in the department on a Friday. This was the case on the day that the patient attended (22 December 2017 – i.e. the Friday before the Christmas break) when Clinical Oncologist B was very busy and as such did not have the time to process his thoughts about the planning for this case.
- They often feel isolated within the team as there is no one available to ask for advice or reassurance on those occasions when it might be required. This is due to the pattern of work of clinical oncologists within the team which includes part time working and off site work for the outreach service. This has resulted in some communication difficulties, e.g. mostly email rather than phone or face to face communication.
In response to these concerns, the ECC has indicated that on those occasions where there is only one Consultant Clinical Oncologist from a particular team on site at the ECC, if there is another Consultant Clinical Oncologist from the same team involved in off-site work for the outreach service, they can be contacted by phone for advice, support or reassurance. If this is not available and advice is still required, for non-urgent cases the Clinical Oncologist can discuss the case at a subsequent team meeting or peer review meeting, and for urgent cases which require immediate treatment decision because of clinical urgency, such as spinal cord compression, an on-call Clinical Oncologist is available 24/7 to provide telephone advice, support and reassurance, or to attend the ECC site. All ECC Consultant Clinical Oncologists have been reminded of these provisions.
- Clinical Oncologist B felt somewhat unsupported in certain aspects of his IR(ME) Regulations entitlement for his expanded role, in that these did not appear to have been reviewed or updated and feedback on an appropriate action plan and progression had been scant.
In addition to these concerns Clinical Oncologist B also expressed concerns about lack of continuity of care within the relevant oncology clinic at the time of the event which resulted in clinical oncologists looking after patients who were not previously known to them (as in this case) and planning for their radiotherapy for metastatic disease.
When questioned further about particular staffing pressures on the day of the incident, Clinical Oncologist B accepted that lone working on a day (the last working day before the Christmas break) when 'loose ends' were being addressed and, in the case of this patient, the abnormal pressure for urgent treatment that arose because of the impending hiatus in treatment over the Christmas break, had probably contributed to difficulties in focussing on the various tasks in hand.
5.3.2 'Ad-hoc' versus regular treatment planning sessions
A further contributory factor cited by Clinical Oncologist B was that planning for this patient was carried out during an 'ad-hoc' rather than a 'regular;' planning clinic. When questioned further on this concern, the following points were noted:
- The need for ad-hoc clinics for the planning of urgent cases is an essential aspect of the work of the ECC.
- The term 'ad-hoc' simply means that these single planning sessions occur at a different time from the regular planning clinics wherein more appointments for similar site specific treatments are planned together. In all other senses, prior booking, available time etc., the sessions are the same.
- The principal concerns for these ad-hoc clinics that were cited by Clinical Oncologist B and acknowledged by ECC senior staff are that these sessions are more subject to distraction and interruption, and that regular sessions allow for greater 'focus of mind'. However, the view of the ECC remains that whereas there is an increased possibility of error, the risk is not unacceptable in relation to necessity of this aspect of the service.
5.3.3 Conclusions regarding contributory factors
In considering the various concerns cited above, there seems little doubt that the occurrence of this incident during an ad-hoc planning clinic on the last working day before the Christmas when Clinical Oncologist B was working alone (in this case due to sickness absence of a second colleague) was not coincidental. Indeed, it has been acknowledged by the ECC that non-uniformity of staffing provision is an issue that needs to be addressed.
The general conclusion must therefore be that staffing pressures were a contributory factor in the occurrence of this incident.
Email: Richard Dimelow