12804012741 orh paediatric review

8/9/2019 12804012741 Orh Paediatric Review

1/49


2/49

1

REVIEW OF PAEDIATRIC CARDIAC SURGERY SERVICES AT

OXFORD RADCLIFFE HOSPITALS NHS TRUST

CONTENTS

PREFACE p2

EXECUTIVE SUMMARY p3

1. INTRODUCTION p4

2. BACKGROUND p7

3. METHODS p10

4. FINDINGS: THE DEATHS p11

5. FINDINGS: THE SURGEONS p13

6. FINDINGS: THE UNIT p16

7. FINDINGS: CLINICAL GOVERNANCE p22

8. CONCLUSIONS AND RECOMMENDATIONS p28

APPENDIX: STATISTICAL ANALYSIS p37


3/49

2

PREFACE

This report covers the findings of a review into services for childrens heart surgery in

Oxford. These services are complex and challenging. The babies whom they treat suffer

from conditions that can have devastating consequences, and are often life-threatening. To

restore as healthy and full a life as possible and sometimes just to offer any prospect of

survival takes intensive and technically demanding work from a clinical team including

many professional disciplines as well as surgery. Even then, success is far from

guaranteed, because the inherent risks of both the underlying condition and the treatment

are high, often very high. Sometimes despite excellent treatment and superb teamwork, the

outcome is sadly the death of the patient; nor is it always possible to say what has tipped the

delicate balance in an individual patient and precipitated a post-operative death.

The families of babies who require these services face extraordinary demands. Within abrief period of time, they must come to terms both with the existence of a condition that will

threaten their newborn babys health and life, and with the need for one or more operations

which carry a significant further risk. They must then place their babys future into the hands

of the clinical team, initially strangers but whom they will generally come to know and rightly

trust. I am conscious that to such families, our report must come as an intrusion, probably

unwanted, into that relationship. I am deeply sorry for that intrusion. They have suffered

enough.

Our purpose in carrying out the review was not to pick over the detail of individual cases it is

now too late to change, nor to castigate those who did all that they could. We wereconcerned to discover whether more deaths had occurred than expected, and if so what may

have contributed to that occurrence, so that we could recommend how to improve systems,

organisations and services. I believe that we have a duty to do that for the sake of future

patients and their families.

In reporting the results of our review, we have had to remain detached and analytical, and

the language we have used may at times appear cold as a result. I apologise for that too.

Despite our necessary detachment, we have not lost sight of the human tragedies inherent

in the events that we have reviewed.

Dr Bill Kirkup

Review Panel Chair


4/49

3

EXECUTIVE SUMMARY

In March 2010 the South Central Strategic Health Authority (the SHA) commissioned an

independent review of paediatric cardiac surgery and clinical governance at the OxfordRadcliffe Hospitals NHS Trust (the Trust). The SHA convened an independent panel to carry

out this review.

The Review followed four deaths after paediatric cardiac surgery between December 2009

and February 2010 by a newly appointed surgeon. The SHA asked the panel to review all

deaths from January 2009, and mortality statistics from 2000.

The Panels statistical analysis found that overall there were more deaths than would have

been expected from national mortality rates for the procedures carried out, but in only two

groups of patients was the difference statistically significant in the sense of being unlikely to

have occurred through chance alone. First, the fifteen cases operated on by the newsurgeon, for which the rate of mortality was 4.8 times higher than that expected from national

rates. Second, less common procedures (those that were carried out fewer than 11 times

each) between 2000 and 2008 for which the rate of mortality was 5.3 times that expected

from national rates.

The panels review of the clinical notes for babies operated on from January 2009 identified

eight deaths within 30 days of surgery from cardiac causes. We found no errors of judgment

that directly led to any of the deaths. All the cases were complex and surgery was high risk.

The panels experts, however, considered that several cases may have had a better

outcome with different surgical management. In Mr Salihs four cases we found no evidence

of poor surgical practice, but that he would have benefitted from help or mentoring by a more

experienced surgeon; and that it was an error of judgment for him to undertake the fourth

case.

All other aspects of care, including nursing, were at least adequate and were widely praised

by the families panel members met.

Arrangements for clinical governance, which the Trust was already beginning to improve,

were in the period reviewed less than adequate.

The panel discusses what it believes were the root causes of the problems. These include

the decision to appoint a new surgeon; planning for the arrival of the new surgeon; his

induction and mentoring; his impact on team working; and the surgical team and clinical

leadership. The panel also considers the Trusts recognition and handling of the problem;

and early warning systems.

The panel makes a number of recommendations for improvement to the paediatric cardiac

surgical service at the Oxford Radcliffe including more effective operational planning; new

clinical governance arrangements; an overhaul of the system for dealing with serious

untoward incidents; more effective clinical and managerial leadership; and the wider

adoption of techniques to identify adverse trends in surgical outcome earlier. It also

recommends that paediatric cardiac surgery remain suspended in Oxford until or unless theservice can safely be expanded.


5/49

4

1. INTRODUCTION

In March 2010 the South Central Strategic Health Authority (the SHA) commissioned an

independent review of paediatric cardiac surgery and clinical governance at the Oxford

Radcliffe Hospitals NHS Trust (the Trust). This followed reports of an untoward sequence of

deaths in the paediatric cardiac surgical unit.

The SHA convened an independent panel to carry out this review. This is the Panels report

to the SHA. It is also being presented to the Board of the Trust, and to the families of the

deceased children.

The report does not give information from which individual cases could readily be identified.

All the families were given the opportunity to be briefed, separately and in confidence, bypanel members on our view of the care their baby received.

Our full terms of reference from the SHA were as follows:

Your inquiries will include but not be limited to:-

Consider concerns about the paediatric cardiac surgical services with specific reference to:-

1. All deaths of babies following paediatric cardiac surgery from January 2009 until the

service was suspended in February 2010

Why did they die and were their deaths unexpected

Could care have been better and if so, in what way

Was the decision to operate correct and was surgery carried out at the right time and in the

right way

2. The surgeons and the team, their capability and experience.

What is their overall mortality and morbidity and is it within normal limits as drawn from

national data from 2000

Are they appropriately trained and experienced to operate on the casemix treated

Was the appropriate level of senior supervision available to the surgeons

3. The paediatric cardiac unit (including theatres and PICU) and how it functioned on a

routine basis from 2000 compared to national practice

What is the overall current paediatric cardiac surgery mortality and morbidity and is it within

normal limits from the period 2000 and as compared to national data

Are staffing levels appropriate both within Paediatric Cardiac Intensive Care Unit (PICU) and

Theatre


6/49

5

Was access to intensive care appropriate or an issue

Is perfusion and bypass practice of a high standard

Case selection and referral what were the referral protocols for the period in question had

there been a change?

Were there any other untoward incidents during any of the babies care included within this

group identified by case note review and Trusts incident reporting system.

4. The systems and process for clinical governance within the Trust

Was appropriate, proportionate and timely action taken by the right personnel when

concerns were raised

Were appropriately robust mechanisms in existence within the Trust for the identification of

risk, monitoring of paediatric cardiac surgical outcomes and incident reporting and were they

used.

Are the Clinical Governance and Risk systems within the Trust appropriate, widely

understood and used

5. To make recommendations for action, learning and change, should they be identified.

The SHA also specified that:

This review is distinct and separate from the National Specialist Services Review and is in

response to the deaths of babies following Paediatric Cardiac Surgery at the Hospital from

January 2009 until the service was suspended in February 2010. It is not about the long termfuture of Paediatric Cardiac Surgical Services at the Oxford Radcliffe Hospital

Membership

Chairman, Public Health - Bill Kirkup [previously Associate Chief Medical Officer of England]

Paediatric Cardiac Surgeon Bill Brawn [Birmingham])

Paediatric Cardiologist John Gibbs [Leeds]

Paediatric Cardiac Intensivist Paul Baines [Alder Hey]

Paediatric Cardiac Anaesthetist Duncan Macrae [Brompton]

Paediatric Theatre Nurse Tracey Anthony [Great Ormond Street ]

Paediatric Cardiac Intensive Care Nurse Diana Robertshaw [Great Ormond Street]

Director of Nursing & Quality Cathy Geddes [Whipps Cross]

Perfusionist Alex Robertson [University College London Hospitals]

Statistician - David Spiegelhalter [Cambridge University]

SHA Non Executive Director Alyson Coates

Oxfordshire Primary Care Trust Non Executive Director Ros Avery


7/49

6

Lay members Julie Wootton [Childrens Heart Federation]; Martin Woodcock [Young

Hearts]

Care Quality Commission Roxy Boyce, Elizabeth Haslam

Secretariat Paul Marshall [previously Secretary to the Clinical Standards Advisory Group]


8/49

7

2. BACKGROUND

2.1. The Oxford Radcliffe Hospitals NHS Trust is one of the largest NHS teaching trusts in

the country. It provides a wide range of general and specialist clinical services and is

a base for medical education, training and research; the Oxford Biomedical Research

Centre is a partnership between the Trust and the University of Oxford.

2.2. The Trust has been given the top rating of 'excellent' for the quality of services to

patients in the last annual health check by the Care Quality Commission, based on

data from 2008/9. The Trust is working with the Strategic Health Authority with a view

to attaining Foundation Trust status in 2012.

2.3. The John Radcliffe Hospital was opened in the 1970s and is Oxfordshire's main

accident and emergency site. It is situated in Headington, about three miles eastof Oxford city centre, and is the largest of the Trust's hospitals, covering around 66

acres. It houses many departments of Oxford University Medical School, and is base

for most medical students who are trained throughout the Trust.

2.4 All of the Trusts clinical services are part of three large management divisions:

Division A (medicine, emergency care, cardiothoracic services, renal services and

specialist medicine); Division B: (cancer services, general surgery and trauma,

critical care, anaesthetics and theatres, and specialist surgery and neurosciences);

and Division C (childrens services, laboratory medicine, pharmacy and therapies,

radiology, and womens health). Elements of the paediatric cardiac surgery serviceare split between all three divisions, with cardiac surgeons and perfusionists in

Division A, intensivists, anaesthetists and theatre staff in Division B, and paediatric

cardiologists and paediatric/neonatal nursing staff in Division C.

2.5. In 2007 a new Childrens Hospital opened on the site. This houses the cardiac ward

(Bellhouse Ward), day care and adolescent facilities available for use by cardiac

patients and outpatient facilities. The Paediatric Intensive care Unit (PICU) and

Paediatric High Dependency Unit (PHDU) remain in their original building in the adult

hospital close to the adult ITUs but are managed within the Children's Directorate

(Division C). Cardiac Neonates are cared for in the Neonatal Unit, which is in theWomen's Centre, until suitable for transfer or a bed is available pre/post-operatively

in the paediatric areas (Ward, PHDU/PICU).

2.6. The hospital includes the Oxford Heart Centre, the Cardiothoracic Unit, which is a

regional and supraregional specialist unit for adult and congenital (adult and

paediatric) cardiothoracic surgery. This Unit serves a population of 2 million in

Oxfordshire and nearby counties.

2.7. The Oxford Heart Centre has been subject to several reviews in recent years. For

adult cardiac surgery, there were critical reports by the South East Regional Office of

the NHS in 2000; by the Healthcare Commission in 2007; and concerns were


9/49

8

expressed by the Care Quality Commission in late 2009/10 following mortality alerts

for some types of coronary artery by-pass grafts from Dr Foster. For paediatric

cardiac surgery, apparent high mortality was reported in a BMJ paper in 2004, based

on Hospital Episode Statistics (HES), but the subsequent review by the Thames

Valley Strategic Health Authority which reported in February 2005 found that this was

explained by the hospitals reporting more of its cases, including deaths, on HESthan did other centres. When more complete audit data reported to the Central

Cardiac Audit Database (CCAD) were analysed, the units mortality figures were

within the range expected for the procedures carried out.

2.8. Previous reports have drawn attention to concerns over the functioning of the adult

cardiac surgery unit, particularly about team working. It should be noted that several

other cardiac centres have been subject to review since the Kennedy Report on

paediatric cardiac surgery at the Bristol Royal Infirmary in 2001.

.

2.9. The paediatric cardiac surgery unit in Oxford had its origins in the appointment ofProfessor Stephen Westaby in 1986 as an adult and paediatric cardiac surgeon. He

has been the mainstay of the unit since, splitting his time between adult and

paediatric work. Between 1989 and 2005 another surgeon also divided his time

between adult and paediatric work, but Professor Westaby was the only surgeon in

the unit again from 2005 until December 2009, still spending half of his time in

paediatric work.

2.10. The paediatric cardiac service is responsible for about 120 paediatric cardiac surgical

procedures a year, on some 100 patients, and these numbers have been broadly

unchanged in recent years. Some 20 patients a year are transferred for treatment toother centres, principally for more complex procedures. This workload makes the

Oxford unit the smallest of the eleven paediatric cardiac surgery units in England,

with about half of the annual surgical operations of the next smallest unit.

2.11. During 2008, the Trust reconsidered its strategy for paediatric cardiac surgery,

prompted by concern over the viability of the unit in the longer term. It took the

decision that the units capacity should be expanded to deal with a larger workload.

This meant appointing a new surgeon solely for paediatric cardiac work, increasing

the surgical complement from 0.5 whole-time equivalents (wte) half of Professor

Westabys time to 1.5 wte. The Trust planned to take up the resulting additional

capacity through a combination of seeking more referrals from surrounding areas and

increasing the complexity of treatment in Oxford, leading to fewer referrals out to

other centres.

2.12. Following interviews, Mr Caner Salih was appointed to the new consultant post. The

post started from 1 December 2009, Mr Salih having been allowed to extend to two

years his posting to Melbourne, Australia in the meantime, partly funded by the Trust.

2.13. By the end of December 2009, Mr Salih had let it be known to some colleagues that

he had accepted another consultant post, in London, and he formally resigned on 21

January 2010, with the intention of working until 31 March 2010.


10/49

9

2.14. The unit comprises many more staff than the surgeons, all essential to its effective

functioning. These include cardiologists, anaesthetists, intensivists, perfusionists and

nurses in the PICU, childrens wards and theatres. The paediatric cardiac surgeons

operate in the cardiac theatres (shared with adult cardiac cases) and their patients

transfer to PICU (shared with all other critically ill children). There were no specific

plans to change these elements of the team as part of the planned expansion.

2.15. Between 22 December 2009 and 18 February 2010 four deaths occurred post-

operatively in the unit, where generally between three and four deaths had occurred

in a year. After these four deaths Mr Salih - they were all patients under his care -

decided to cease operating and informed colleagues on 19 February. Subsequently

all paediatric cardiac surgery was suspended in the unit, and a serious untoward

incident was notified on 3 March 2010. This review was commissioned by the SHA

on 5 March 2010.


11/49

10

3. METHODS

3.1. The panel organised its members into overlapping sub-groups to perform five

functions: consideration of clinical notes, statistics, clinical governance, patient liaisonand interviews.

Clinical Notes

3.2. Members of this sub-group, led by Bill Brawn, considered the notes of all 143

procedures on 125 patients from January 2009 until suspension of the service in

February 2010 in order to select notes for scrutiny by all clinical members of the

panel. It selected 16: those for the 12 patients who died, and 4 other clinically

unusual cases. Within these it identified 8 patients who died from cardiac causes,

and these were considered in greater detail.

Statistics

3.3. This sub-group, led by David Spiegelhalter, considered data from the Central Cardiac

Audit Database on all paediatric cardiac surgical centres in England from 2000 to

2008; and data from the Oxford Radcliffe NHS Trust on all its cases from January

2009 to February 2010.

Clinical Governance

3.4. This sub-group, led by Cathy Geddes, considered documents from the Trust and

interviewed Trust staff.

Family Liaison

3.5. This sub-group, led by Julie Wootton, offered the opportunity to meet panel members

to the families of any patient who received paediatric cardiac surgery at the Trust

from January 2009; and specifically invited the families of the 16 patients selected for

case note scrutiny (see above). As well as explaining the panels role, it asked

families to describe the clinical care their child received. Where families had still had

questions about their childs care it offered a second meeting, led by the panel

cardiologist.

Interviews

3.6. 18 staff of the Trust were interviewed, some by the full panel, some by sub-groups of

members with directly relevant expertise, and some by the clinical governance sub-

group. All staff interviewed were given the opportunity to agree the draft interview

notes. These notes were then shared with all panel members.

Documents

3.7. Over 200 documents were requested, and received, from the Trust and seen by all

panel members. We also considered reports on past reviews, at the Trust and

elsewhere.


12/49

11

4. FINDINGS: THE DEATHS

4.1.Whydidtheydieandweretheirdeathsunexpected?

4.1.1. 12 babies died between January 2009 and February 2010 following cardiac surgery.

Of these 12, 3 died between 30 and 60 days after surgery; the deaths of these 3, and

one of those who died within 30 days, were in our view not related to cardiac surgery

the deaths would be likely to have happened whatever the outcome of the patients

cardiac surgery. The remaining 8 died from a variety of causes within 30 days of

surgery. Most of these cases were at the most complex end of the spectrum of

cardiac anomalies, and surgery carried a significant risk of mortality. In the absence

of surgery death could have been expected in the near future.

4.1.2. Our statistical analysis, at the Appendix, initially compares the number of deathswithin 30 days of surgery that occurred during 2009/10 with the expected deaths for

that number and type of operations given the results achieved by all units in the

country. The analysis shows that although there were slightly more deaths than

expected in Professor Westabys patients, this pattern could have occurred through

chance alone. Among Mr Salihs 15 patients, however, four deaths occurred where

less than one would have been expected, and this pattern was unlikely to have

occurred through chance alone.

4.1.3. What the analysis cannot show is whether any babies who died would have survived

if any of the elements of care had been different. That is why we carried out aclinical review of the babies operated on in the unit during 2009/10. Following

detailed scrutiny of 8 post-surgical cardiac deaths, expert panel members

commented adversely on some features of the surgical management in several

cases. However, in no case did they find a clinical decision, untoward incident or

other aspect of care that they regarded as having led directly to death or to another

adverse outcome.

4.1.4. This paradox we know that more deaths have occurred than expected but cannot

say which they are has occurred before, and it will no doubt occur again. Given the

multi-factorial chain of causality that often underlies death and the complex and

technically demanding nature of much clinical care, particularly when the individuals

concerned are very sick, it is perhaps not a surprise. However, it is understandably a

source of frustration to those who quite reasonably wish to know if a loved ones

death could and perhaps should have been avoided.

4.1.5. We have set out in this report the reasons why we believe that there were more

deaths than expected, and what we believe should be done in response. We cannot

say how this would have affected the care of any individual baby or how any

individual outcome may have been different.


13/49

12

4.2. Could care have been better and if so, in what way?

In general, the clinical care that all the babies received was adequate. As we note at

7.4 below, the care they experienced was generally praised by the families we met.Discussion of whether aspects of care could have been better is included in 4.3.

below.

4.3. Was the decision to operate correct and was surgery carried out at the right time and

in the right way?

4.3.1. In all cases the decision that an operation was needed was in our view correct. We

believe that it was an error of judgment, primarily by Mr Salih but also by the whole

multidisciplinary team, for Mr Salih to continue to operate on highly complex cases

unaccompanied by a more experienced surgeon after the difficulties he had

experienced with previous cases at the Trust. There is no evidence that

consideration was given to transferring any of these patients to other centres.

4.3.2. In several cases, the timing of the surgery was a difficult judgment, given all the

clinical circumstances. We should have preferred the notes to reflect more fully the

arguments for and against delaying the operation, or using a palliative procedure

while the baby grew or became fitter. In several cases surgery was delayed until a

PICU bed became available, although we do not believe these delays affected the

clinical outcomes.

4.3.3. We found no errors in judgment directly leading to any of the deaths. We are awarethat it is all too easy to criticise some aspect of treatment in any very complex case

with hindsight; we concluded, however, that several cases may have had a different

outcome with different surgical management.


14/49

13

5. FINDINGS: THE SURGEONS

TOR2. The surgeons and the team, their capability and experience.

5.1. What is their overall mortality and morbidity and is it within normal limits as drawnfrom national data from 2000?

5.1.1. Mr Salih had 4 deaths out of 15 paediatric cardiac operations at the Trust

between December 2009 and February 2010, compared with 0.84 deaths that

would have been expected based on mortality data for these procedures from

all English centres from 2000 to 2008. His standardised mortality ratio (SMR)

the ratio between observed and expected mortality was therefore 4/0.8 = 4.8.

This is unlikely to have occurred by chance alone (p=0.012), although this may

not fully take into account the additional complexities of specific patients. We

understand that he had previously had no surgical deaths in his practice.

.

5.1.2. Professor Westaby between January 2009 and February 2010 had 5 deaths out

of 128 operations, compared with 3.5 expected, giving an SMR of 1.4. This level

of variation would be expected to occur relatively often by chance alone (p=0.36).

Between 2000 and 2008, including a period when Professor Westaby was not the

only surgeon in the unit, there were 27 deaths compared with 18 expected

(disregarding miscellaneous operations), giving an SMR of 1.5. The probability

of this result occurring by chance alone was just statistically significant (p=0.044)

using the standard criterion of p


15/49

14

5.2.3. Mr Salih as a newly appointed consultant surgeon had much less experience, but

had been exposed to many procedures both during training and as a clinical

cardiac surgery fellow for two years and, latterly, as a locum consultant at the

Royal Childrens Hospital, Melbourne, which is one of the leading world centres

for paediatric cardiac surgery. He told us that, over two years at Melbourne,

procedures he had performed included four repairs of interrupted aortic arch andfive arterial switches for transposition of the great arteries, some unaccompanied

by another surgeon. His attachment was extended at his request for six months

in 2009 after his appointment to the Trust, and was part funded by the Trust.

5.2.4. Whether to undertake any particular case is a matter of clinical judgment, not just

for the surgeon but for the whole multi-disciplinary team. Based on our review of

the clinical notes of the babies operated on by Mr Salih, including those who died,

we believe that there was an unusual run of difficult cases. We agree with the

Trust that, typically, the infants were of lower birthweight or had a complex

congenital heart defect, increasing the risks for any surgeon, although thesurgical procedures themselves were not necessarily unduly complex. We

believe that it was an error of judgment for the clinical team to decide that Mr

Salih, as a new surgeon working with a team not yet used to his methods, should

undertake some of these procedures without assistance from another consultant

cardiac surgeon (see 5.3. below). We believe that the balance of argument

against his undertaking difficult cases increased with each procedure in which he

and the team had experienced difficulties, difficulties which Mr Salih told us had

surprised him and the cause of which he could not explain; and in particular by

the time that 3 babies on whom he had operated had died.

5.3. Was the appropriate level of senior supervision available to the surgeons?

5.3.1. When a doctor takes up a first substantive consultant post, it is good practice to

ensure that they have available a more experienced colleague to whom they can

turn for advice, support and if necessary assistance an arrangement generally

known as mentoring. This is particularly important in technically demanding

surgical specialities such as this. Mr Salih was relatively inexperienced (see

5.2.3 above) emphasising that a high level of supervision would have been

appropriate initially. Furthermore, within a month of taking up his post at the

Trust, Mr Salih accepted an appointment elsewhere. This, together with Mr

Salihs early dissatisfaction with the support he received from the Trust in terms

of equipment, operating slots and PICU access, and the comment from one

colleague that Mr Salih then appeared disengaged, further reinforce the need

for closer supervision and support.

5.3.2. The Trust had intended to appoint an experienced third paediatric cardiac

surgeon at the same time as Mr Salih, but this surgeon did not take up his

appointment.

5.3.3. Professor Westaby took three weeks leave as soon as Mr Salih arrived. This is

perhaps understandable since he had been working single-handedly in paediatric

cardiac surgery, but it placed an onus on both surgeons to agree the implications


16/49

15

until his return. Professor Westaby told us that he did not expect Mr Salih to

operate during his absence. On learning from the panel that Mr Salih had

operated during that time, he said that he did not expect that the operations were

complex. Mr Salih told us that he did not regard Professor Westabys absence as

relevant to what operations he carried out, and it was clear that the two had not

satisfactorily discussed the matter.

5.3.4. On Professor Westabys return he missed some multi-disciplinary team meetings

through absence on other work such as NICE Committees; and learnt that Mr

Salih intended to leave the Trust.

5.3.5. A mentoring arrangement with a surgeon at Guys was agreed but was difficult to

implement because Mr Salih often did not know in advance when he would have

an operating slot. The mentor did attend one operation. He, like previous

colleagues elsewhere, including Melbourne, was available to give advice by

telephone; but that does not constitute mentoring in the full sense of supportingsomeone to manage their own learning so that they can realise their full potential;

and is no substitute for a second, experienced, pair of eyes and hands in the

theatre.

5.3.6. The clinical director for cardiac surgery did discuss with and give advice to Mr

Salih about the concerns Mr Salih was expressing, but the director was not a

paediatric cardiac surgeon.

5.3.7. We conclude that an appropriate level of senior supervision was not available to

Mr Salih.


17/49

16

6. FINDINGS: THE UNIT

TOR3. The paediatric cardiac unit (including theatres and PICU) and how it functioned on a

routine basis from 2000 compared to national practice

6.1. What is the overall current paediatric cardiac surgery mortality and morbidity and is it

within normal limits from the period 2000 and as compared to national data?

The unit had 9 deaths within 30 days of surgery between January 2009 and February

2010, compared with 4.2 deaths that would be expected based on mortality rates for

the specific procedures in all English centres from 2000 to 2008, giving an SMR of

2.2. This is unlikely to have occurred through chance alone (p=0.04). As we have

previously discussed, the SMR deviated significantly from one only after the new

surgeon took up post.

6.2. Are staffing levels appropriate both within Paediatric Cardiac Intensive Care Unit

(PICU) and Theatre?

PICU

6.2.1. PICU staffing at medical level was appropriate. There appeared to be good relations

between intensivists, surgeons, cardiologists and PICU staff.

6.2.2. Nurse staffing levels across PICU, the Paediatric High Dependency Unit (PHDU) andthe cardiac ward were at full establishment for senior grades (Band 6 and 7) with

several vacancies at more junior grade (Band 5) which were actively being recruited

into. The level of long-term sickness and maternity leave was not of concern.

However the small number of vacancies in PICU did account for the staffing of

almost one intensive care bed, and with any short-term sickness or absences in a

small PICU would make the difference between having 5 and not 6 beds open. This

had been rightly identified in the paediatric risk register in October 2009 and noted as

a low clinical risk: High vacancies in PICU, inability to staff 6 beds consistently [risk

of] Lack of capacity, loss of income potential risk of increased clinical

errors/complaints.

6.2.3. The role of PICU Modern Matron was being covered by the Neonatal Unit Modern

Matron at the time of the review.

6.2.4. The nursing staff held a range of appropriate specialist qualifications for the areas in

which they worked with a range of paediatric cardiothoracic, paediatric intensive care

and high dependency courses represented. The staff were supported actively to

pursue further training in specialist techniques with a view to expanding their

capabilities.


18/49

17

6.2.5. The relatively low volume of cardiac work was not conducive to less experienced

nurses gaining experience in the full range of different post-operative cardiac

situations.

6.2.6. Rostering of staff for PICU took into account the need to provide nurses experienced

in cardiac critical care for the days when routine cardiac surgery was scheduled.This advance planning cannot ensure the appropriate skill-mix of experienced staff

are rostered on duty for unplanned cardiac surgery on other days.

6.2.7. The specialist nature of the work limited the availability of agency staff to cover staff

shortages. Generally if extra staff were needed for a shift then the existing staff

came in to cover as extra/overtime shifts.

Theatre

6.2.8. The Trust was not up to it full establishment of 12 cardiac theatre staff; many NHS

units are, however, not at full establishment. The Trust had 9 theatre staff in early

2010; there were recruitment controls, with a reliance on overtime. The skill mix

seemed appropriate.

6.2.9. Nursing staff in theatre were using the WHO 2008 checklist; the theatre team did not,

however, routinely hold the small meeting before each theatre session of all staff (the

"surgical brief") which is commended by WHO but is not mandatory.

6.2.10. Perfusion staffing levels have always been in line with the code of practice of the

perfusion society, that staffing levels should be N+1, where N= the number of

operating theatres.

6.3. Was access to intensive care appropriate or an issue?

6.3.1. We found several references in the minutes of mortality and morbidity meetings to

lack of PICU beds and cancellation of cardiac surgery. The number of PICU beds in

use had in 2009 been increased from 4 to 6.

6.3.2. Several of the incidents reported by PICU (see 6.6.4. below) were cancellations of

cardiac surgery because of lack of PICU beds, and in one case non-cancellation of

cardiac surgery despite lack of PICU staff. Nevertheless, with the exception ofsudden illness/absence, the nurse staffing of the PICU was generally at an

acceptable level.

6.3.3. The greater problem appears to have been the high level of bed occupancy

coinciding with the scheduled days for cardiac surgery with no slack in the system.

The demand for PICU beds was high, especially in the winter, with emergency

admissions from A&E and retrieval services and planned surgical procedures

competing for the same PICU beds. Pre-booked beds in PICU were limited to two a


19/49

18

day with no guarantee that the bed would not be filled by an emergency during the

night.

6.3.4. Occasional difficulty in accessing PICU beds was arguably no more of a problem at

the Trust in this period than elsewhere in the NHS. What compounded the effects of

this problem at the Trust was the limited operating time allocated routinely andopportunistically - to the paediatric cardiac surgeons, and that the only regular

allocated slot for Mr Salih was at the end of the week (on Fridays) by when PICU was

more likely to have filled. If any routine theatre slot could not be used because of

shortage of PICU beds it was difficult for the team to plan when next it would be

possible to operate on the postponed case. This also led to more than one

cancellation of surgery for the same child.The difficulties were mitigated by the low

volume of paediatric cardiac cases. The plan to expand volumes at some stage in the

future may have been matched by an intention to increase PICU availability and

theatre time but staff were not aware of any planning for this.

.6.3.5. If the Trust expanded its cardiac surgery it would need more guaranteed PICU beds.

PICUs with general/trauma emergency admissions usually aim to run at 75% bed

occupancy, which can be difficult to achieve when combined with scheduled cardiac

surgery. Some hospitals with larger PICUs choose to have a specific bay or area or

a separate unit for the cardiac patients in order to safeguard the beds.

6.4. Is perfusion and bypass practice of a high standard?

6.4.1 Policies and procedures within the perfusion department were in line with current

practice elsewhere in England. The provision of paediatric perfusion services was

tailored to Professor Westabys practice. The paediatric caseload was low,particularly compared to the adult practice. Protocols were in place and were

adequate, although lacking in detail and sophistication. In some areas, practice

might be considered outdated and out of step with practice in other paediatric

centres. The paediatric cases were shared amongst all of the perfusionists. In

essence, it was an adult department that performed some paediatric work.

6.4.2 These shortcomings were acknowledged by the perfusion department, but there was

a sense that it was difficult to develop the paediatric service while the caseload

remained low and under a single surgeon. In light of this, and of financial constraints,

it would have been difficult for the perfusion department to build up and developpaediatric practice from within.

6.4.3 Following Mr Salihs appointment he requested that certain perfusion practices were

changed to match his way of working. There was a willingness within the perfusion

department to accommodate such change. In recent months there had been moves

to address some of these issues. Two perfusionists had been identified as having a

particular interest in paediatric work; one of them visited another paediatric perfusion

centre to gain experience and update practice, and a similar visit for the other was

planned. One heart-lung machine for cardiopulmonary bypass had been set aside

specifically for paediatric practice, and new equipment purchased.


20/49

19

6.4.4 The paediatric perfusion service was adequate, although not of the level of

sophistication of other centres. Some aspects of practice not yet adopted at Oxford

have been shown to reduce morbidity, although not mortality. Two perfusion-related

incidents have been identified in the course of this review, but have been found not to

have been related to patient mortality or morbidity and had already been the subject

of thorough internal inquiry. We note that Mr Salih expressed concerns about theability of the perfusionists to manage paediatric bypass, and in particular blood

pressure, after these incidents.

6.5. Case selection and referral what were the referral protocols for the period in

question had there been a change?

6.5.1 There are some 5000 paediatric cardiology outpatient attendances a year (fewer

individuals). Some 120 of these are referred for cardiac surgery, in each case

decided at weekly multi-disciplinary team meetings including the cardiologists and

cardiac surgeons and according to unit protocols. Some 100 are referred for surgeryin the Trust, and 20 are referred to other hospitals, particularly for more complex

surgery. We were told that patients were always transferred for some procedures,

including transplantation, procedures for hypoplastic left heart, procedures for

transposition of the great arteries and early reconstruction of pulmonary atresia. In

addition, Professor Westaby told us that he would transfer other patients if he thought

that results would be better elsewhere. For the period from January 2009 until the

end of February 2010 143 cases were referred for surgery in the Trust, and there

were 25 referrals to other centres, including 11 in the categories above (6 hypoplastic

left hearts, 4 transpositions, 1 transplant).

6.5.2 Other referrals elsewhere may be for a variety of parental/geographical reasons

which are discussed between family and cardiologist concerned, and normally at the

multi-disciplinary case conference

6.5.3 The Trust reported no change in the protocols or significant change in transfer rates

over time. We did note, however, that Mr Salihs 15 cases appeared to include a

high proportion that were described as particularly complex and that might have been

expected to be candidates for transfer elsewhere.

6.6. Were there any other untoward incidents during any of the babies care included

within this group identified by case note review and Trusts incident reporting

system?

6.6.1. The Trust follows NHS practice in defining incidents as follows:

Serious Untoward Incident (SUI): Any incident that could have or did lead to serious

harm, major permanent harm or unexpected death, or serious damage to or loss of

property, and with the potential to generate significant legal, media or other interest,

or to seriously compromise the reputation or integrity of The Trust.

Incident: Any event or circumstance arising that could have or did lead to unintended


21/49

20

or unexpected harm, loss or damage. Incidents may involve actual or potential injury,

damage, loss, fire, theft, violence, abuse, accidents, ill health, infection, near misses

and hazards.

6.6.2. The case note review, which covered the period from January 2009, identified

the perfusion-related incidents mentioned in 6.4.4. above which could have,but did not, lead to harm.

6.6.3. No other serious untoward incidents were reported within the Trust by

paediatric cardiac surgery in this period, ie until the cluster of 4 deaths

following surgery by Mr Salih were reported as a single SUI on 3 March by

the Director of Nursing and Clinical Leadership.

6.6.4. PICU reported 84 incidents from January 2009 to February 2010. Few of

these were of cardiac patients, and none of those incidents appear to have

affected the babies care. We note that Mortality and Morbidity meetings for

PICU routinely consider incidents that PICU had reported, whereas the

minutes of paediatric/congenital cardiac M&M meetings contain no references

to formal reports of incidents affecting their patients.

6.6.5. Cardiac theatres reported 17 incidents from January 2009 to February 2010.

These reports had good recommendations on how the Trust could learn from

the incident. None of these involved the 16 babies selected by the panel for

closer examination of their clinical notes. On one occasion not reported as an

incident the theatre did not have the type of shunt Mr Salih needed;

nevertheless Mr Salih began operating on the supplying companys

assurance that the new shunt would arrive by the time he needed it, which itdid.

6.7. THE IMPACT OF A NEW SURGEON

6.7.1. We heard from many interviewees that the unit was working well as a small,

tight-knit, highly professional team during 2009. It was, however, also made

clear to us that some aspects of team working were somewhat idiosyncratic,

and reflected strongly Professor Westabys particular approach. Both of

these features increased the need for adequate preparation for Mr Salihs

arrival.

6.7.2. Mr Salih was appointed in December 2008, took up his appointment on 1

December 2009 and performed his first procedure on 4 December. In our

view the unit was inadequately prepared for this, despite the long lead-time

available. We saw the business case for expansion of the service, approved

in April 2008, and an initial programme for Mr Salih comprising meetings over

his first 3 days that fell some way short of an adequate induction; but saw no

evidence of a plan to prepare the unit for his arrival.

6.7.3. The business case did discuss some of the risks of expansion, mainly thefinancial risk if the increase in referrals to the Trust was less than expected


22/49

21

and possible difficulties in recruitment especially of PICU nurses, and the

considerable risks if the service were not expanded. It did not, however,

recognise that expansion itself, with new staff and techniques and in time

more complex procedures, carried clinical risks that needed to be mitigated

by careful planning. We would have expected to see a project plan for

implementing the development of the service that was much wider than theinadequate induction programme for the new surgeon.

6.7.4. Mr Salih had insufficient time to familiarise himself with the units staff,

facilities and equipment, all of which were geared to working with Professor

Westaby. Mr Salih arrived from one of the worlds leading centres and was

used to using the latest techniques and equipment, which would imply

changes in the units ways of working, which takes time to introduce and

become familiar. The need for some new equipment was not identified until

after Mr Salihs arrival, not ordered until after he had had to press for it, and

not in use until after he had started operating. A need to update perfusionpractice was recognised in advance but specific changes emerged only after

Mr Salih began working with the perfusionists.


23/49

22

7. FINDINGS: CLINICAL GOVERNANCE

TOR4. The systems and process for clinical governance within the Trust

7.1. Was appropriate, proportionate and timely action taken by the right personnel whenconcerns were raised?

7.1.1. In December 2009 the Paediatric Directorate manager began to attempt to meet

concerns expressed by Mr Salih about several aspects of the support he was

receiving, especially theatre slots and equipment, but by February had not

succeeded, possibly because of difficulty in overcoming the cross-Divisional divide in

responsibilities. On 28 December Mr Salih told colleagues that he had accepted a

post elsewhere. On 21 January 2010, he formally tendered his resignation after only

having been at the Trust for less than 2 months, citing lack of theatre time as a

contributing factor. Mr Salih had only been allocated a half-day list on a Friday, with

any other operating he managed to do being ad hoc and based on random

cancellations. This surgeon was undertaking complex paediatric cardiac surgery and

therefore would need to undertake a sufficient amount of cases in order to ensure he

and the team supporting him maintained and developed their skills, and in February

2009 he had been promised two operating sessions a week. His lack of operating

time was noted on the Cardiac Directorate Risk Register although with a very low

residual clinical risk18/12/09 New paediatric surgeon started on 1 December but nodedicated operating list identified. A meeting is to be held on Monday 21 December.

7.1.2. The techniques used by Mr Salih were in line with up to datepractices. It was noted that the team was accustomed to the other

surgeon's techniques, some which have been superseded by the majority of

practitioners. This would have been difficult for staff initially and, with the lack of

regular theatre slots, their opportunities to get used to the new techniques would

have been limited. Even before then there are continuing references in clinical

governance meetings to lack of equipment and that some equipment, such as

ventilators, was not of an up to date specification. In combination these created a

clinical risk that does not seem to have been acted on.

7.1.3. Despite Mr Salihs tendering his resignation so soon after joining the Trust (bearing inmind that the Trust had supported his further development for a year in Australia,

prior to his formally joining them), little action appears to have been done to explore

whether any action was required, including the heightened surveillance discussed at

8.28 below. If this had been done, it may have been that concerns would have come

to senior managements attention sooner.

7.1.4. Mr Salih on Friday 19 February informed his colleagues that, due to a number of

unfavourable outcomes following several procedures he had undertaken, he was

ceasing to operate. This was escalated to the Chief Operating Officer (COO) on the

same day by the Paediatric Directorate Manager. COO confirmed that no caseswere listed for surgery (an anaesthetist was on leave) but no formal action was taken


24/49

23

on that day to suspend services. Mr Salih confirmed his intention in a letter dated 19

February but received after the weekend, on Monday 22 February. The Medical

Director and senior anaesthetist agreed that day to pause surgery, but formal

suspension did not happen until Wednesday 24 February (the COO was on annual

leave on Tuesday 23 February).

7.1.5. Whilst it would appear that no further children were affected by this delay in taking

formal action, it is unclear why the issue was not raised on Friday 19 Februarywith

the Medical and Nursing Directors who are responsible for clinical governance and

standards of care.

7.1.6. When the Medical Director and COO met on 24 February and COO decided to

suspend the service, on grounds of patient safety, it was not escalated to the Director

of Nursing and Clinical Leadership, who is responsible for Clinical Governance

(although we note that she was on leave until 1 March). We note that COO was

aware of only the fourth of the cluster of deaths.

7.1.9. Despite the fact that a service was suspended we understand that at no time did

anyone consider raising this as an SUI or reporting it to the SHA. Indeed the

suspension was widely understood among clinical staff to be only a pause, and

several senior clinicians who were aware of the 4 deaths regarded suspension as an

over-reaction. The most concerning factor here is that, even during our interviews, a

number of people still said that they would not consider raising this as an SUI and

cannot see how it would meet SUI criteria. The COO did safeguard patient safety by

suspending the service on 24 February and he did ask that a meeting be convened.

This action did not have the implications of declaring an SUI: for example the

meeting was not convened urgently nor was the SHA informed. The meeting, on 2

March, initiated an internal review of the 4 deaths, but again no-one outside the Trust

was informed or involved.

7.1.10. This suggests a lack of understanding about the SHA policy; a lack of understanding

as to why SUIs are raised, with too high a threshold for reporting SUIs; and a closed

culture where honesty and open reporting is not the norm. One interviewee

suggested that a factor may have been an emotional attachment and drive to

sustain the service that led in his perception to a desire to compartmentalise the

problems and not see the bigger picture. We believe that although the surgicaldeaths and the suspension of service were relevant factors, it was not until the media

story threatened to break when Independent Television News became involved that

the Director of Nursing was informed and a serious untoward incident declared on 3

March.

7.2. Were appropriately robust mechanisms in existence within the Trust for theidentification of risk, monitoring of paediatric cardiac surgical outcomes and incidentreporting and were they used?


25/49

24

7.2.1. Several staff cited external reporting as an element of their clinical governance. None

of the external reporting arrangements are designed to provide contemporaneous

monitoring, nor can be expected to identify trends until well after the event.

7.2.2. Clinical outcome data for cardiac surgery is reported to the Central Cardiac Audit

Database (CCAD), whose analysis is made available some two years later.

7.2.3. All deaths of children are reported to the Oxfordshire Child Death Overview Panel

(CDOP).The terms of reference for each CDOP are to consider deaths only of

residents of its county, so Oxfordshire CDOP passed reports for non-Oxfordshire

children to the appropriate county CDOP: 5 deaths were reported to CDOP during

January but only 1 was considered at the next regular meeting, on 1 February: 3

were forwarded to other counties, 1 was not considered because subject to an

Inquest.

7.2.4. All deaths are included in data by HRG monitored by Dr Foster, which had recentlydeclared an alert for adult cardiac deaths (CABG other) leading to correspondence

between the Trust and CQC; the February 2010 meeting of the Clinical Governance

Committee reviewed Dr Foster data for November 2009 (ie the data has a 3 months

lag). HRG data is not, however, analysed by sub-specialties eg paediatric cardiac

surgery.

7.2.5. Incidents are reported to the National Patient Safety Agency (NPSA): the Trust has

good numerical record of reporting incidents, although in cardiac surgery the

threshold for reporting a Serious Untoward Incident (SUI) appeared to have been

high, and incidents appear to have been declared mainly by nurses (Mr Salihappears not to have been aware of the incident reporting arrangements). We were

told that the tendency for there to be no feedback from an incident report acted as a

disincentive to reporting incidents.

7.2.6. Internally, clinical performance in terms of clinical outcomes appears to be formally

monitored in the main through Mortality and Morbidity (M&M) meetings. The review

panel heard from a number of interviewees that M&M meetings are held differently

across the Divisions with the method of recording the outcomes and following up

actions differing greatly. This is despite guidance being issued by the Medical

Director in June 2006.

7.2.7. Paediatric cardiac surgery cases were reviewed at M&M meetings that were

scheduled every 2 months (70 days from 26 November 2009 to 4 February 2010).

Attendance at these was variable as was the recording of actions agreed.

7.2.8. In 2009 the time of these meetings was changed to coincide with the early morning

weekly meetings of multidisciplinary teams (MDT), which was often not convenient

for non-medical staff; the paediatric cardiologists and paediatric surgeons do,

however, usually attend. Risk assessment staff and nurses did not normally attend in

this period. Due to the timing of these meetings, 2 of the cases were reviewed in one

meeting (on 4 February) but no trends identified, with the remaining two deaths

occurring after the scheduled M&M meeting. A further M&M meeting was held on 25


26/49

25

February and the minutes combine those for 4 February and 25 February, so it is not

clear whether any learning from the 4 February meeting was being applied in the

interim. Once the media drew attention to the run of 4 cases an extraordinary M&M

was called, but did not meet until 21 days after the fourth death, and was not

attended by Professor Westaby nor one of the paediatric anaesthetists

7.2.9. Formal arrangements include monthly Paediatric Directorate Board meetings

included clinical governance as a standing item, and, unlike M&Ms, have attendance

from the corporate Governance team. In addition Divisions have quarterly

Accountability Reviews which include scrutiny of Directorate Risk Registers. The

Cardiac Directorate monthly meetings looked at activity and outcomes in adult

cardiac surgery but only activity in paediatric cardiac surgery.

7.2.10. There are some indications that paediatric clinicians had timely discussions among

themselves in informal settings. Several staff referred to discussions of the deaths in

weekly MDT meetings, or in informal conversations (eg over coffee), but there is norecord of these.

7.2.11. It is clear that there was a lack of information available to M&M meetings, clinical

quality meetings and clinical governance meeting that would enable outcomes to be

monitored. M&M meetings, for example, would consider each death we believe

thoroughly and in detail despite the lack of adequate documentation but would be

able to detect the emergence of an adverse trend only informally and

impressionistically, and not based on statistical analysis. In fact several clinicians

told us that they did not believe that the numbers were large enough to permit valid

statistical analysis. We do not agree.

7.2.12. The appendix shows the application of a basic statistical process control method to

Mr Salihs cases. Discussions before the operation leading to Mr Salihs fourth death

suggest that clinicians were aware of his 3 recent deaths. Mr Salihs third death

occurred when the total procedure-expected mortality was 0.53 and could reasonably

have been considered a more formal alert for staff outside the MDT if the Trust had

been using this method. We are aware that few other units, perhaps only one, has

adopted this approach, but we believe that techniques such as this should be more

widely used to identify earlier the emergence of trends that would warrant further

assessment. A relatively straightforward addition to CCAD reporting of procedure-

specific expected mortality would allow units to introduce this approach more easily.

7.3. Are the Clinical Governance and Risk systems within the Trust appropriate, widelyunderstood and used?

7.3.1. The clinical governance structure within the Trust is complex and fragmented. The

Medical Director described separate avenues for executive accountability and for

assurance, one through a clinical quality structure and one through a clinical

governance and risk structure.


27/49

26

7.3.2. This reliance on reporting through Divisional structures adds a further complexity to

the process for providing assurance with regard to Paediatric Cardiac Surgery as this

service spans 3 divisions: Cardiac in Division A, Theatres & Anaesthetics in Division

B and. Paediatrics in Division C.

7.3.3. The Director of Nursing recalled that when she had first spoken to staff with regard tothis incident, each of the Divisions had a different view of its responsibilities for the

paediatric cardiac surgical service and thus for its clinical governance.

7.3.4. The Chair of the Governance Committee described his discomfort with the

responsibilities of Non Executive Directors when he took over the chair, and gave an

example of the previous committee agenda having 31 items on it. He was attempting

to streamline the work of the Committee and increase its focus on assurance.

7.3.5. In addition to the clinical governance structure that runs through the Divisions, there

are at least 19 smaller committees and groups covering safety, quality and risk thatall report to the Care Quality Board. This is in addition to the Health & Safety

Committee, Technologies Advisory Group, Dr Foster review group, Information

Governance Group plus others that also report into the CQB. The review team found

it difficult to grasp the entire number of committees and their respective reporting

lines, and would question whether these are widely understood within the Trust. This

complexity of groups and committees lays itself open to confusion and there is a

significant risk that key risks get missed and are not escalated in a timely manner to

ensure appropriate action is taken. We recognise that the Trust has been trying to

bring greater clarity to these arrangements.

7.4. THE FAMILIES

7.4.1. Members of the panel met, usually in their homes, family representatives of the 16

cases identified by the Notes Sub-group for detailed review of their case notes who

chose to accept our invitation, and several other families who asked to meet us.

7.4.2. Generally the families praised the care their children received and feel they were kept

well informed of their childs condition and progress. There were, however, two

aspects of the Trusts contacts with some of the families which could have beenimproved. These mainly concern communication of the risk of surgery when asking

families to consent to an operation; and of the position on post-mortems in the case

of death. On one occasion we also identified that a family had not understood what

the Trust clinicians had told them probably because certain terms widely used among

clinicians may mean something different to a lay listener.

7.4.3. Families were not informed that some of the most technically demanding procedures

were either performed rarely at the Trust or were transferred to other units. It is also

sub-optimal for consent for surgical procedures to be taken, on occasion, by the

cardiologist rather than the surgeon. The surgical procedures undertaken on thecluster cases were not complex themselves but were undertaken on children with


28/49

27

more complex conditions. The risks conveyed to the families by both surgeons and

cardiologists were broadly in line with national averages which do not relate directly

to the unit, the team, the individual surgeon, or take in to account the added risk

posed by the individual case. The risks conveyed to parents tended to be under-

estimates. There may be benefit from some standardisation of procedure, in an

internal protocol or guidance note.

7.4.4. On post mortems, in cases that have not been referred to the coroners office, we

understand that a clinicians main criterion in deciding whether to propose

conducting a post mortem will primarily be learning ie will it benefit future children -

rather than whether it will help bereaved families better understand the cause of their

childs death. Several families we met had not had this explained to them by the

Trust. Again, there may be benefit from some standardisation of procedure, in an

internal protocol or guidance note.


29/49

28

8. CONCLUSIONS AND RECOMMENDATIONS

8.1. The previous chapters have summarised the evidence considered by the panel. In

this chapter, we set out our view of the root causes of the events that unfolded inOxford in December 2009, January and February 2010.

Decision to appoint a new surgeon

8.2. We believe that the origin of these events lay some time previously, when the

decision was made to appoint a new paediatric cardiac surgeon in Oxford. The

paediatric cardiac surgical unit in Oxford is the smallest in the country. Over the past

decade, it had carried out about half the number of surgical procedures of the next

smallest unit. For four years leading up to 2009 the surgical workload had been the

responsibility of a single surgeon who divided his time roughly equally between adultand paediatric cardiac surgery, and more complex cases had been referred from

Oxford to other centres that could sustain larger and more specialised teams.

8.3. This background was well known to the Trust, and it is quite clear that the impending

initiation of the Safe and Sustainable review of the configuration of paediatric

cardiac surgical services nationally prompted the Trust to question the viability of the

unit in light of what the review might recommend.

8.4. Their response was to prepare a business case to expand paediatric cardiac surgical

services, based on diverting more referrals into Oxford from surrounding areas andon increasing the complexity of cases managed within Oxford. Central to this

strategy was the appointment of a new, full time paediatric cardiac surgeon.

8.5. It is not within our terms of reference to comment on the appropriateness of that

decision in light of the impending Safe and Sustainable review. What we did

observe, however, was that the risks inherent in the strategy were not properly

recognised and that there was insufficient consideration of how to mitigate risk. In

particular, the challenge to effective multidisciplinary team working of simultaneously

increasing potential workload and case complexity whilst introducing a new surgeon

with different techniques and requirements was simply not recognised.

Planning for the arrival of the new surgeon

8.6. Having taken the decision to appoint a new surgeon, it should have been clear that

there would be a significant impact on the unit. Adding a full time surgeon to the

existing set up tripled surgical capacity, and was done in pursuit of an explicit

strategy to expand workload as well as to increase case complexity. Yet there was

no increase in the provision of paediatric intensive care facilities or staff, already

known to be a bottleneck, or anaesthetic input. Theatre time was actually reduced

prior to the arrival of the new surgeon, and for some time he did not have a

scheduled operating session, before one was found on a Friday morning, less than


30/49

29

ideal for complex operations likely to present demanding challenges post-operatively,

and when paediatric intensive care capacity was more likely to be stretched .

8.7. In addition, it was always likely that a newly appointed surgeon would arrive with

preferences for different equipment and surgical approaches, and this proved to be

the case. No preparations had been made for this, however, and problems had to beresolved urgently either immediately preoperatively or during the course of surgery.

8.8. All of these factors acted, we believe, to the detriment of the effective team working

necessary for the care of vulnerable babies with complex problems; nor should their

impact on the state of mind of a new and relatively inexperienced surgeon be

underestimated. They were all avoidable with better planning.

Induction and mentoring

8.9. It is good practice, we believe commonly implemented, to ensure that there arerobust arrangements for mentorship of new surgeons in such a complex and

demanding specialty as paediatric cardiac surgery, and an induction programme to

introduce new colleagues, operational procedures and established ways of working.

8.10. In a larger unit than Oxfords it would generally be straightforward to arrange for

mentorship to be provided by an experienced surgeon with similar outlook and

interests. In this case, the only possible mentor in Oxford, Professor Westaby, had

such a different approach and outlook that neither he nor Mr Salih believed that he

could act as a mentor by the time of the latters arrival, despite the clear intention that

this would work at the time of Mr Salihs appointment.

8.11. Mr Salih did have a mentor, but one who lived and worked in London. Although this

mentor did offer advice by telephone, and did come to Oxford to assist Mr Salih at his

request in one operation, it did not prove possible for him to do any more than this.

One further attempt was made to arrange an operation at which he could scrub with

Mr Salih, but the lack of a regular theatre slot made this impossible.

8.12. We believe that this arrangement was unsatisfactory. Mentorship by telephone is a

poor substitute for face to face contact, especially when a key element is support

during the surgical procedure itself. The panels clinical experts commented that they

felt that the presence of a mentor during surgery would have been beneficial in at

least one case.

8.13. We found no sign of an effective induction programme for the new surgeon, a gap

partly filled by the Childrens Service Director on her own initiative some time after his

arrival. This appears to have been a consequence of the divided reporting

arrangements between Childrens Services and Cardiac Services and their

respective Divisions,

Impact on team working


31/49

30

8.14. Statistical analysis tells us that the run of four deaths that occurred between 22

December 2009 and 18 February 2010 was very unlikely to have occurred by chance

alone. On the basis of current national results for the 15 procedures carried out by

Mr Salih, fewer than one death would have been expected; four deaths occurred.

The probability that this would result from random variation alone is less than one in

eighty. This pattern was a new departure: between 2000 and 2008, 27 deathsoccurred where 18 would have been expected, and in 2009 before Mr Salih began

operating 5 deaths occurred where 3.5 would have been expected; but this degree of

variation is not sufficiently unlikely to have occurred by chance alone that it could be

regarded as significant.

8.15. Given that this run of deaths occurred after the arrival of the new surgeon and that all

four were his patients, we were concerned initially that this might have reflected an

inadequately experienced or insufficiently accomplished surgeon. It is important to

state that we did not find evidence of either. We interviewed members of the clinical

team of all disciplines and assessed how they functioned. The clinical experts on thepanel reviewed the records of all babies operated on in the unit during 2009/10.

They concluded that care had generally been adequate, and made no further

comment on the care of all but four of the 125 babies. In the remainder, each of

whom died, the panel commented on aspects that they felt could or should have

been done differently. It is important to state, however, that in no case could the

panels clinical experts identify an individual factor that would have led directly to the

ensuing death.

8.16. As a result of careful consideration of the evidence, we conclude that the occurrence

of significant problems in the unit that culminated in a greater number of deaths thanexpected arose not from individual shortcomings but from the complex interplay of

systemic factors. In particular, as well as the inadequate risk assessment and poor

planning already described, we were concerned about the effect of rapid changes in

techniques and case complexity on the functioning of the team and on decision

making.

8.17. Decisions about the approach to clinical management of patients in the paediatric

cardiac surgical unit should except in emergency be taken as a result of a

multidisciplinary team meeting involving all of the relevant professionals. This is

particularly important given that the care is complex and requires co-ordinated work

from a wide range of disciplines, and the patients are often very small and very sick.

The clinical experts on the panel drew attention to the selection of surgical procedure

in three of the patients who died (in one of these, the alternative would have required

referral elsewhere for surgery): these were decisions for the multidisciplinary team

meeting. We were told that team meetings were often scheduled for inconvenient

times that made it very difficult for all relevant members to attend, and this may have

contributed to their effectiveness being more limited than it should have been.

The surgical team and clinical leadership

8.18. Prior to the arrival of the new surgeon, the clinical team was led by a surgeon

spending half of his time on paediatric cardiac surgery who had been in post since


32/49


33/49

32

8.24. The principal mechanism in the Directorate and more widely within the Trust to

identify emerging concerns over clinical outcomes was the morbidity and mortality

meetings. Untoward events including all post-surgical deaths were reviewed and

discussed thoroughly in morbidity and mortality meetings. In the case of paediatric

cardiac surgery, these meetings were held bi-monthly; it was not usually possible toarrange meetings so that all relevant members of the team could attend, which we

believe hindered both complete analysis and proper dissemination of conclusions

and any lessons learned, as did incomplete documentation. In addition, we were

concerned to hear that there was no formal consideration of trends in the occurrence

of untoward events and deaths, and no data were presented that would have helped

to identify any patterns at an early stage. Trust-wide data on incident reports were

analysed, and many individual incident reports made excellent recommendations for

action, but it is notable that no incidents (other than one, perfusion-related) in to

paediatric cardiac surgery were reported in the period reviewed.

8.25. The other potential mechanism to identify concerns with service outcomes is the

clinical governance system. We found that clinical governance systems within the

Trust at that time lacked clarity and transparency, and accountability was not always

obvious or understood by individual clinicians and managers. This was particularly

evident in relation to paediatric cardiac surgery, where different parts of the overall

team belonged to different Divisions within the Trust. Although this pattern is not

unusual in other Trusts for services such as paediatric cardiac surgery, it does

require that consideration be given to clear lines of communication and

accountability, which did not appear to be the case for this service. In addition,

clinical performance was split between two reporting lines, one covering clinicalgovernance and the other clinical quality, further complicating responsibilities. We do

not believe that these arrangements were effective or adequate for a complex and

challenging service such as this. Nor were either the relevant clinical governance or

clinical quality committees well served with meaningful data that would enable them

to monitor outcomes.

8.26. In the absence of effective monitoring of patterns by the morbidity and mortality

meetings or by clinical governance systems, we enquired how an adverse trend

should have become apparent. Although opinions varied amongst interviewees, the

most prevalent view was that the surgeons themselves together with cardiologists

and anaesthetists were best placed to identify emerging problems and report them to

the relevant clinical director and if necessary the Trusts medical director. This is in

effect what happened after the fourth death. Several interviewees also told us that

they had been reassured by the absence of alerts from external bodies, whether the

Care Quality Commission, the Central Cardiac Audit Database, or the Child Death

Overview Panels. We believe that this reflects a misunderstanding of the data these

bodies analyse, necessary delays in the validation and analysis by them of data, and

of their purpose.


34/49

33

Early warning of problem

8.27. It would have been possible to track surgical deaths as they occurred in the unit and

to look for the emergence of any adverse trend. It was put to us that the smallnumbers involved would make this futile, because of random fluctuations. In the

absence of any yardstick for comparison, we would agree. However, the existence

of good, validated information from the Central Cardiac Audit Database should allow

the generation of expected numbers of deaths procedure by procedure, against

which the actual number can be assessed and the probability calculated of any

divergence from expected by chance alone. We accept that the CCAD information is

not currently presented is such a way as to make that easy, and it appears that few if

any paediatric cardiac surgical units are doing so currently. It is one of the

techniques that we used to analyse the data, and we believe that its use for real

time monitoring of cardiac surgery and other specialities would offer considerableadvantages.

8.28. In the example of this run of deaths in Oxford, it is clear that the pattern of deaths

reached a significantly higher level than expected with the occurrence of the third

death. That is to say, at that point the number of deaths was such that it would be

expected to occur by chance alone is once in fifty occurrences. The fourth death

does not increase the standardised mortality ratio due to its high expected mortality

see Figure 4 in Appendix A - but does reduce the probability of it occurring by chance

to less than one in eighty occurrences. Had this information been available, it seems

likely that the second death would have suggested heightened surveillance (it would

have been expected to occur by chance in slightly less than once in sixteen

occurrences, which is not statistically significant) and the third confirmed the need for

review. Heightened surveillance after the second death, on 15 January, would have

noted Mr Salihs letter of resignation on 21 January (although this intention to resign

had been known since 28 December) and the reasons he cited, which included

criticisms of the Trusts commitment to providing him with a fixed operating slot. It

might have led to Professor Westaby being more closely involved in decisions by the

multi-disciplinary team that Mr Salih would undertake the operations on the third and

fourth patients who died.

8.29. Although not based on statistics, it is clear that at least one member of the clinical

team had reservations about the wisdom of operating on the next scheduled patient

after the third death, and spoke to Mr Salih accordingly. Mr Salih confirmed to us

that he had not had a surgical death (within 30 days of operation) in his practice until

arriving in Oxford, and that the next case was a particularly complex one in a very

sick baby. He decided to proceed with surgery. We believe that this decision

shared with the rest of the multidisciplinary team was questionable.

8.30. Nevertheless, it must be clearly stated that the next operation presented a very

complex problem with a high inherent risk of death. It is very likely that the outcome

would have been the same wherever the surgery was performed.


35/49

34

Initial handling

8.31. We could find no evidence that there was a clear plan of action during the initial 11

days after the surgeons letter prompted by the fourth death. On the contrary, thereseems to us to have been attempts to minimise the scale of the problem and to

restrict knowledge of it. Neither the clinical governance nor clinical quality

mechanisms were used in responding to concerns. Until prompted by the

involvement of Independent Television News in response to anonymous information

on the next day, the twelfth day after the surgeons letter, no serious untoward

incident report was raised, the Trust Board was not informed, and the SHA remained

unaware.

8.32. It was evident to us that over this period there was considerable pressure within the

clinical directorate to handle concerns internally and to limit knowledge of the eventsexternally. We heard that this was to avoid adverse perception of the paediatric

cardiac surgical unit at the time its sustainability was about to be reviewed. This

clearly did not constitute an appropriate response to a serious untoward incident.

RECOMMENDATIONS

8.33. We focussed our review on the reasons why paediatric cardiac surgery services at

the Trust experienced higher than expected mortality in 2009-2010. We focus our

recommendations on actions aimed at reducing the probability of mortality and

morbidity in paediatric cardiac surgery. The aspects of the service they address did

not necessarily all contribute to the deaths in 2009/2010, but could be factors in the

future if action on them is not taken by The Trust. These include recommendations

on clinical governance based on our review of how it functioned in the paediatric

cardiac surgical service up to February 2010; we recognise that there have since

been significant changes in arrangements for clinical governance following the

Trusts own review, which took account of how it was functioning in all the Trusts

services.

8.34. We were specifically asked not to make recommendations about the long term future

of the paediatric cardiac surgical service at the Trust. We believe that our

recommendations, if implemented, would make that service safer than it was in 2009-2010; that is not the same as saying it would be as safe as it could be. We discuss

this in 8.35 below

Recommendation 1: the Trust should ensure that management decisions about clinical

services are subject to a proportionate appraisal of relevant facts and information, and

include a risk assessment that takes clinical risks into account.

Recommendation 2: the Trust should ensure that there is effective operational planning for

clinical service changes that takes account of the expected impact on the capacity and

capability of the relevant clinical teams, the level of support services required and theprovision and utilisation of facilities such as theatres and intensive care.


36/49

35

Recommendation 3: the Trust should ensure that all new members of staff receive

appropriate induction on joining the Trust. The nature of the induction will depend on the

nature of the post, but for consultant staff must include relevant clinical governance and

multidisciplinary team working systems.

Recommendation 4: the Trust should ensure that all newly appointed consultant staff have

access to an appropriate mentoring arrangement. The nature of this will vary according to

the nature of clinical practice, but for technically demanding specialties such as paediatric

cardiac surgery must include arrangements that facilitate joint operating.

Recommendation 5: the Trust should ensure that the effect of appointing a new consultant

on clinical practice is identified before arrival, together with any consequences for equipment

provision and potential impact on other members of the multidisciplinary team. Expectations

of how the new consultant will work with other consultant members of the team must be

explicit and agreed from the outset.

Recommendation 6: the Trust should implement new clinical governance systems without

delay that set out explicit responsibilities service by service with a single line of

accountability to the Trust Board.

Recommendation 7: the Trust should strengthen its approach to incident reporting, based on

a just and open culture, to promote full reporting by responsible clinicians (including

consultant medical staff), analysis and promulgation of lessons learned.

Recommendation 8: the Trust should act to ensure that staff can indent