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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