Patient Safety - Health Committee Contents


Memorandum by the Oxford Radcliffe Hospitals NHS Trust (PS 102)

PATIENT SAFETY

1.  SUMMARY

  1.1  This memorandum is submitted by the Oxford Radcliffe Hospitals ["the ORH"] NHS Trust, with the intention of assisting the Committee in its inquiry into patient safety, and specifically in its consideration of evidence relating to the case of Bethany Bowen, as laid before the Committee in PS24, PS79, and in oral testimony heard on 20 November 2008.

1.2  The ORH is very sorry that it failed to prevent Bethany's death, and for the grief and distress caused to the Bowen family.

1.3  In submitting this memorandum, the ORH emphasises that it values greatly Mrs Bowen's personal account of her experience, and commends her evidence to the Committee. Indeed, we have taken careful note of Mrs Bowen's account (and that of Mr Bromiley) and are grateful for the time that Mrs Bowen spent with senior members of the trust, articulating her perceptions of the issues first hand.

  1.4  If required, in relation to specific points raised in evidence laid before the Committee, the ORH would be happy to provide further detail to clarify factual accuracy.

  1.5  Based on the investigation into the specific details of the case and Mrs Bowen's contribution, the ORH identified several key lessons, which have led directly to specific changes in clinical practice and procedures, and in the processes of clinical governance across the Trust which the Committee may consider could be applied more generally within the NHS. Further detail of these changes is given below.

  1.6  In analysing all of the key issues arising, the ORH also identified principles for broader application, including the importance of developing an effective protocol to foster responsible innovation, while safeguarding the interests of patients and practitioners. The ORH Board is setting up an externally-chaired working party, to examine the future management of surgical risk, and would be happy to share its conclusions across the NHS.

2.  INVESTIGATION

  2.1  It is understood that details of Bethany's medical condition, and the surgery performed, have been provided to the Committee by Mrs Bowen.

2.2  The circumstances surrounding Bethany's tragic death during surgery in July 2006 have been subjected to lengthy and detailed investigation. There has been an internal Serious Untoward Incident ["SUI"] investigation, a three-day Coroner's Inquest, investigation of and response to the family's complaints and settlement of a clinical negligence claim. The ORH also obtained independent expert opinion[198] on the care that Bethany received. The Bowen family put their own questions to the independent expert, through their solicitor, and his report was shared with them, and with the Coroner.

  2.3  The conclusion drawn from all investigations undertaken was that Bethany suddenly deteriorated and was found to have sustained damage to her aorta, causing some blood loss and that despite repair of the aortic damage and initial stabilisation, Bethany deteriorated again and all attempts to resuscitate were unsuccessful and that she died. On the evidence provided to the coroner over three days, the Coroner's conclusion was that the damage to Bethany's aorta was caused by unspecified surgical instrumentation. Although Bethany's collapse coincided with the use of a mechanical morcellator, it was thought by the Coroner and the independent expert that it was unlikely that this had caused the damage to her aorta, but more likely that the damage had been inflicted by the surgical graspers routinely used in laparoscopic surgery. This conclusion was based on the nature of the injuries sustained, and the absence of significant injury to other intervening and surrounding structures. [It is of great regret to all who have been involved in examining this tragic case that a more definitive cause has not been established.]

  2.4  It is worthy of comment that, shortly after Bethany's death, the surgeon in charge met with her parents and explained (what the surgeon at the time thought to be the case) that the morcellator had caused the damage and that the bleeding from the damage to the aorta had caused the death. However, over the forthcoming days and weeks, and then extending to the inquest, surgeons and investigators and our external expert reviewer questioned whether this explanation made sense. We recognize that giving an initial explanation which is later questioned as different facts emerge can be perceived as becoming defensive. We hold firm, however, to the principle that we must be as honest as possible at all points throughout the process, even if conclusions are altered by the findings.

3.  LESSONS LEARNED

Use of new surgical techniques

  3.1  The ORH has identified key lessons with regard to regulating the introduction of any new surgical technique, including adaptation of an existing technique. Even if the morcellator was not the cause of the damage sustained in this case, very careful consideration needs to be given to the introduction of any such new approach, carrying significant potential risk. Without wishing to inhibit responsible innovation, any proposal to introduce a new (or newly adapted) surgical technique must now obtain formal approval from the Trust's Technologies Advisory Group ["TAG"], on the basis of its proven clinical effectiveness, and conditional upon the demonstration of appropriate training, an assurance of competencies and ongoing audit of the clinical outcomes.

3.2  The technique of mechanical morcellation has not been used again in paediatric splenectomy at the ORH nor, so far as we are aware, has it been used anywhere in the UK.

Explaining risk and obtaining consent from patients, parents or guardians

3.3  We have identified key lessons with regard to the information that should be given to a patient (or parent) when obtaining consent. Although the surgeon's use of the morcellator was based on consideration of its benefits (avoiding the need to extend the incision to remove Bethany's enlarged spleen), weighed against the potential risk, it was judged that the selection of equipment was regarded as a technical detail, which as such was not explained to Bethany's parents. Even if the morcellator was not the cause of the damage sustained in this case, any significant potential risk associated with the equipment selected should be explained. The ORH has therefore produced supplementary guidance for clinical staff, to emphasize this point, and to ensure that information offered should disclose whenever the equipment or technique to be used represents a different approach.

Documenting blood loss

3.4  A key lesson has been learned with regard to the importance of documenting a reasonably accurate estimate of blood loss, corroborated so far as possible by all available data. In Bethany's case, it was not possible to provide an estimate of blood loss with any great degree of accuracy, as swabs had been disposed of at the change of nursing shifts, at a time when it was thought that Bethany's condition had stabilised. While there is no validated way of measuring the exact volume of blood loss in paediatric patients undergoing surgery, in all cases where the assessment of blood loss might be important (including all cases where blood has been cross-matched, in the expectation that there may be a need to replace blood lost), it is now expressly required that swabs be weighed, and suction contents measured. Where appropriate, the estimate might be further refined by the anaesthetist applying specialist formulae and equations.

Disposal of equipment

3.5  The disposal of swabs, and of the morcellator blade, and the bag within which the spleen had been contained within the abdomen, significantly hindered the investigation undertaken, and meant that Bethany's family were denied some information, eg whether the intra-abdominal bag remained intact, indicating whether it could have been breached by the morcellator. The responsibility of the theatre teams to retain equipment and consumables which may be implicated in any incident is stipulated within the Trust's Medical Devices Management Policy, and its Incident Reporting Policy. This has been further under-scored by cascading the Medical Devices Alert to that effect, issued by the Medicines and Healthcare products Regulatory Agency ["MHRA"] in January 2008.

Clinical documentation

3.6  Following the investigation of Bethany's case, the Clinical Lead for Paediatric Surgery initiated a Review of Surgical Process, to review the entire care pathway for paediatric surgical episodes from referral to discharge. Noting deficiencies in written operation notes, this emphasized the importance of including all relevant detail (including an estimate of blood loss, where appropriate), and recommended that the written record be supplemented by digital recording where possible, with relevant images to be placed in the patient's record.

Paediatric Weighing

3.7  There had been an error in transcribing Bethany's weight, which was then used as the basis for calculating her pre-medication. Although the dosage given was still within the parameters of the British National Formulary for Children, it was recognized that such a transcription error could—in other circumstances—have caused harm. A Paediatric Weighing Protocol, requiring a second independent confirmation of a child's weight, has therefore been developed and introduced.

Investigation of Serious Untoward Incidents

3.8  Overall, we recognize that Bethany's family was not satisfied with the process of the investigation undertaken. Key lessons have been identified with regard to the investigation of serious untoward incidents, within the broader context of clinical governance arrangements across the Trust. Specific changes instituted include the clear designation of an appropriate individual who will have prime responsibility for ongoing family liaison following any SUI. In general terms, efforts are now better concentrated on undertaking a more comprehensive and detailed investigation of any SUI from the outset; ensuring clearer communication of the progress being made throughout the process. The Final Report of an SUI Investigation now details the root cause analysis undertaken, and organisational learning points are clearly identified, for dissemination. The ORH is committed to the ongoing process of keeping policies, procedure and practice under review, to make any changes necessary; and to ensure that these are clearly communicated and embedded throughout the organisation.

Clinical Governance at ORH

3.9  We note Mr. Bromiley's evidence that this tragic outcome represents a total failure of clinical governance. The principles of clinical governance require staff to be well trained and competent, to consider the risks and to follow evidenced guidelines. These principles reduce but can not completely eliminate clinical risk. At the time it was considered acceptable medical practice to be supervised in a new technique by an experienced practitioner.

We do not believe that the actions of the clinicians involved represented reckless or arrogant behaviour, although do believe with the benefit of hindsight, that tighter controls could and should be introduced to better safeguard patients. We are also trying to consider the challenge of enabling clinicians truly to see risk through the eyes of the patient and their parents and still have the courage and necessary focus to pick up and use the scalpel.

4.  CONCLUSION

  4.1  Bethany's death was a tragic event. Although this will be of little consolation to the Bowen family, the subsequent investigation raised a number of issues for us, which have resulted in changes in practice and procedure. We have submitted this memorandum in the hope that those changes may be of use to other NHS Trusts.

May 2009







198   From Mr Gordon MacKinlay, Consultant Paediatric Surgeon at The Royal Hospital for Sick Children, Edinburgh, and Senior Lecturer in Paediatric Surgery at the University of Edinburgh. Back


 
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Prepared 7 September 2009