janine mcilwraith - slater & gordon lawyers - systemic failures’ leading to multiple...
TRANSCRIPT
© S
late
r and G
ord
on L
imited 2
015
1
Project titleDate Month 2014
Systemic failures &
significant morbidity 26 February 2016
© S
late
r and G
ord
on L
imited 2
015
2
Case examples
Bristol Royal Infirmary
Canterbury Hospital
Bundaberg Base Hospital
Bacchus Marsh Hospital
Royal Adelaide Hospital /
Flinders Medical Centre
Common themes
Mechanisms for change
Possibilities
Ideas
Overview
© S
late
r and G
ord
on L
imited 2
015
3
Bristol Royal Infirmary
© S
late
r and G
ord
on L
imited 2
015
4
1990s BRI - babies dying at high rates after cardiac surgery
1986-1987 - concerns about the PCS first raised
1988 - concerns began to be raised in the BRI.
1990 - Dr Bolsin first wrote to Dr Roylance (Chief Executive, UBHT)
and thereafter Dr Bolsin collected data
1990 - clinicians in Bristol had data on their own poor performance
1992 - a member of the SRSAG had evidence that BRI was
performing badly in terms of mortality
Background
© S
late
r and G
ord
on L
imited 2
015
5
significantly higher mortality rate for open-heart surgery on children
under 1 than that of other centres in England
1988 - 1994 the mortality rate at Bristol was roughly double that
elsewhere in 5 of the 7 years
mortality rate failed to follow the overall downward trend over time
which could be seen in other centres
a substantial and statistically significant number of excess deaths,
between 30-35, occurred in children under 1 undergoing PCS in
Bristol between 1991 and 1995.
The problem
© S
late
r and G
ord
on L
imited 2
015
6
+ October 1998 – July 2001
+ Terms of Reference: “to inquire into the management of the care of children receiving
complex cardiac surgical services at the Bristol Royal Infirmary between 1984 and
1995”
+ Chaired by Prof Ian Kennedy QC
+ The work was divided into 2 phases:
+ phase 1 –events in Bristol
+ phase 2 - future
+ Interim report May 2000 – Removal and Retention of Human Material
+ Final Reported in 2001 – 529 pages
Inquiry
© S
late
r and G
ord
on L
imited 2
015
7
+ national shortage in specialists in paediatric cardiology
+ the surgeons at BRI operated on adults & children
+ children were nursed alongside adults in a mixed ICU
+ no external system for monitoring and assuring the quality of care
+ questions as to whether open-heart surgery on the under-1s should have been
designated a supra regional service in Bristol – “we observe a paediatric open-heart
service with high aspirations . . . simply overreaching itself, given its limitations, and
failing to keep up with the rapid developments elsewhere in PCS”
+ gap between the level of resources needed to properly meet the goals of the PCS
unit and the level actually available
Findings
© S
late
r and G
ord
on L
imited 2
015
8
Children:
• children in hospital must be cared for in a child-centred environment.
• Specialist care must be concentrated in a limited number of centres
Safety:
• NHS must promote openness and the preparedness to acknowledge errors and to
learn lessons.
• Healthcare professionals should have a duty of candour to patients.
The NHS is still failing to learn from things that go wrong and has no system to put
this right. The Government’s proposed National Patient Safety Agency should be an
independent agency to which certain sentinel events are reported so as to be
analysed with a view to disseminating lessons throughout the NHS.
Recommendations
© S
late
r and G
ord
on L
imited 2
015
9
The competence of healthcare professionals:
• it must be part of all healthcare professionals’ contracts with a trust that they undergo
appraisal, continuing professional development and revalidation to ensure that all
healthcare professionals remain competent to do their job
Organisation:
• doctors, nurses and managers must work together as healthcare professionals with
clear lines of accountability
Openness:
• there must be openness about clinical performance. Patients should be able to gain
access to information about the relative performance of a hospital, or a particular
service or consultant unit
Recommendations continued
© S
late
r and G
ord
on L
imited 2
015
10
Standards of care:
• there must be agreed and published standards of clinical care
• there must be standards for hospitals as a whole - hospitals which do not meet these
standards should not be able to offer services
Monitoring:
• there must be effective systems within hospitals to ensure that clinical performance is
monitored.
• there must also be a system of independent external surveillance to review patterns
of performance over time and to identify good and failing performance
• multiple systems for collecting data must be reduced – data must be collected as a
by-product of care
• the monitoring of clinical performance should be brought together and co-ordinated
by one body, an independent Office for Monitoring Healthcare Performance which
would be part of the Commission for Health Improvement. It could also carry out a
surveillance role.
Recommendations continued
© S
late
r and G
ord
on L
imited 2
015
11
• named 8 individuals
• commented adversely on some aspects of particular individuals conduct or
behaviour:
• flaws in their approach to management
• a lack of leadership and insight.
• failed to treat parents with appropriate respect and candour.
• there were individuals with the Supra Regional Services Advisory Group and the
Department of Health who could have taken action.
Individuals
© S
late
r and G
ord
on L
imited 2
015
12
“Perhaps the most significant change we call for is one which does not
attract a specific Recommendation. This is the change which is
needed in the culture of the NHS. We see changes to that culture as
being a product of the Recommendations as a whole. If the
Recommendations are implemented, changes in the culture will
follow.”
Change
© S
late
r and G
ord
on L
imited 2
015
13
Canterbury Hospital
© S
late
r and G
ord
on L
imited 2
015
14
On 7 June 1999 on completion of an ERCP it was noted by a scout
nurse that the solution used as contrast medium during the
procedure was the caustic solution, Phenol 10% in 60% Conray
280. The intended contrast medium was Conray 280, 20ml
On 8 June 1999 the Commissioner met with the CEO and
Chairman of the Central Sydney Area Health Service. The same
day the CSAHS reported an incident to the Director-General of
NSW Health. The incident concerned the injection of a solution
containing phenol, a caustic substance, into the biliary tree and / or
pancreatic duct or patients undergoing endoscopic procedures at
the Canterbury Hospital operating theatres in the period between 4
Feb and 7 June 1999
Background
© S
late
r and G
ord
on L
imited 2
015
15
24 patients / 28 procedures - incorrect solution
30yo to 80+ yo
supplies of Conray 280, 20ml had been substituted with 5ml bottles
of a diluted form of Conray 280 which also contained 10% phenol
Phenol 10% in 60% Conray 280 is designed to cause scarring of
tissues under radiographic control for procedures such as nerve
blocks
The problem
© S
late
r and G
ord
on L
imited 2
015
16
Report on an investigation of incidents in the operating theatre of
Canterbury Hospital: 8 February - 7 June 1999 / Health Care Complaints
Commission
Inquiry
© S
late
r and G
ord
on L
imited 2
015
17
computerised requisition system was inadequate
staff had inadequate training in the use of the requisition system
there was no feedback loop in the requisitioning system to detect a
significant change in a pattern of requisitioning
a contrast medium was replaced with a caustic solution and no
health professional in the operating theatre adequately checked the
solution before it was injected into the patient
Findings
© S
late
r and G
ord
on L
imited 2
015
18
protocols be developed to address the deficiencies in the requisition
and supply of goods
process be developed to ensure unusual orders are flagged and
followed up
responsibilities of nursing staff be reviewed
program to review of surgeon’s preference sheets be developed
and implemented
In view of the “broader systemic similarities to another investigation”
the Commission also made state-wide recommendations including:
The establishment of a multidisciplinary working party to review
and develop requisition and supply systems; and develop a
protocol for checking of solutions and other pharmaceuticals
before use in operating theatres
Recommendations
© S
late
r and G
ord
on L
imited 2
015
19
referred Dr Daskalopoulous to NSWMB for consultation. Dr
Daskalopoulous prosecuted before the Medical Tribunal for
unsatisfactory professional conduct which was found but later
overturned by the NSWCA: Daskalopoulos v Health Care
Complaints Commission [2002] NSWCA 200 (2 July 2002)
also investigated the standard of care provided by the nursing staff
and consulted with the NSW Nurses Registration Board
nurse team leader – dismissed; unsuccessfully challenged that
decision in the NSWIRComm: Nicholls and Central Sydney Area
Health Service [2000] NSWIRComm 161 (25 August 2000)
Individuals
© S
late
r and G
ord
on L
imited 2
015
20
Bundaberg Base Hospital
© S
late
r and G
ord
on L
imited 2
015
21
In his 24mths at BBH, staff or patients made over 20 complaints
about Dr Patel
22 March 2005 - Queensland Shadow Minister for Health, Stuart
Copeland raised the issue of Patel's clinical practice during
Question Time; he had been alerted to Patel's inadequacies by Toni
Hoffman, a nurse at the Bundaberg Base Hospital.
Hedley Thomas, a journalist at The Courier-Mail won a Walkley
Award for his part in uncovering Patel's past
Background
© S
late
r and G
ord
on L
imited 2
015
22
13 deaths in which an unacceptable level of care on the part of Dr
Patel had contributed to the adverse outcome
4 deaths in which it may have contributed
31 surviving patients where Dr Patel’s poor standard of care may
have contributed to an adverse outcome.
The problem
© S
late
r and G
ord
on L
imited 2
015
23
Bundaberg Hospital Commission of Inquiry
Commissioner Anthony Morris QC
Interim report 10 June 2005
Recommended:
legislative changes regarding the process for doctors obtaining
registration
administrative changes with regards to the process for declaring “areas
of need”
Raised potential grounds for prosecution of Dr Patel
terminated by Order of The Supreme Court, made on 2 September
2005, on basis of reasonable apprehension of bias by the
Commissioner
Inquiry
© S
late
r and G
ord
on L
imited 2
015
24
Queensland Hospital Commission of Inquiry
commenced its first public hearing on 8 September 2005
whole of the evidence admitted in the Bundaberg Hospital
Commission of Inquiry other than the evidence of Mr Leck and Dr
Keating was admitted:
the transcript of evidence of 84 witnesses
311 exhibits.
sat for a total of 30 days:
37 witnesses
200 exhibits
Hervey Bay Hospital, Townsville Hospital, Charters Towers Hospital,
Rockhampton Hospital and cardiac care at Prince Charles Hospital.
2nd Inquiry
© S
late
r and G
ord
on L
imited 2
015
25
Medical Board negligently failed to properly check Patel’s paper
credentials and to make any assessment of whether he had the
qualifications and experience for practising surgery in Bundaberg
Came to be employed without any assessment of his clinical skill
and competence – this should have been done by the hospital prior
to him commencing work
Assigned to a position where he was not subject to supervision or
peer assessment
Findings
© S
late
r and G
ord
on L
imited 2
015
26
5 deficiencies which contributed, they were:
inadequate budget defectively administered;
defective administration of area of need registration;
absence of credentialing and privileging of doctors;
failure to implement any adequate monitoring of performance or of
investigation of complaints;
culture of concealment by Government, Qld Health administrators, and
hospital administrators.
Findings continued
© S
late
r and G
ord
on L
imited 2
015
27
Abandoning the system of using an historical budget with an
efficiency dividend
Greater involvement of doctors and nurses in the allocation of
individual hospital budgets
Providing financial incentive to experienced doctors to take
positions in regional hospitals
Changes to the ‘area of need’ provisions
Strict adherence by hospitals to departmental guidelines for
credentialing
All hospitals have an effective clinical audit system which is
transparent and independent
Regional hospitals should engage the private sector as much as
possible eg VMOs
Recommendations
© S
late
r and G
ord
on L
imited 2
015
28
All primary referral hospitals should aim to gain accredited training
status with the relevant Colleges
Creation of a ‘one stop shop’ independent of Queensland Health
and the registration boards:
having sole power to act upon complaints
power to investigate, conciliate and adjudicate
power to immediately suspend a practitioner’s registration
Obliging insurers to notify of claims for negligence to such a body
Category of persons protected by whistleblower legislation be
expanded
Recommendations continued
© S
late
r and G
ord
on L
imited 2
015
29
recommended possible criminal and disciplinary action against
several Queensland Health bureaucrats
Recommended assault, grievous bodily harm, manslaughter and
fraud charges against Dr Patel
June 2010, Dr Patel was convicted of three counts of manslaughter
and one case of grievous bodily harm, and sentenced to seven
years imprisonment.
August 2012, all convictions were quashed by the full bench of the
High Court of Australia and a retrial was ordered
A retrial for one of the manslaughter counts resulted in acquittal and
led to a plea deal where Patel pleaded guilty to fraud and the
remaining charges were dropped
15 May 2015 he was deregistered
Individuals
© S
late
r and G
ord
on L
imited 2
015
30
Djerriwarrh Health Service
© S
late
r and G
ord
on L
imited 2
015
31
March 2015 the Victorian Government Department of Health and
Human Services was notified by the Consultative Council on
Obstetric and Paediatric Mortality and Morbidity (CCOPMM) of a
cluster of perinatal deaths at Djerriwarrh Health Services during
2013 and 2014.
The department commissioned an independent review by senior
obstetrician, Euan Wallace which concluded that of the 10 stillborn
and perinatal deaths during that period, 7 were avoidable
The problem
© S
late
r and G
ord
on L
imited 2
015
32
perinatal mortality rate at Bacchus Marsh is significantly higher than
the state average and much higher than would be expected from a
‘low risk’ unit
Misuse and/or misinterpretation of fetal surveillance by (CTG) was a
recurrent feature of the perinatal deaths reviewed
Inadequate staffing infrastructure supporting midwifery education
The lack of out-of-hours / emergency paediatric cover for neonatal
resuscitation and care was a likely contributor to poorer than
expected outcomes
There was a lack of formal expert multidisciplinary perinatal
mortality and morbidity review
Lack of high quality staff education
The clinical governance framework did not allow the health service
to monitor and respond to adverse outcomes in a timely manner
Findings
© S
late
r and G
ord
on L
imited 2
015
33
All medical and midwifery staff be required to complete formal fetal
surveillance education
Consideration be given to the purchase of a centralised electronic
fetal surveillance system
The lack of on-call paediatrics for maternity services be addressed
Quarterly multidisciplinary perinatal morbidity and mortality review
meetings – with consideration to inviting an external expert to be a
member of those meetings
Weekly or fortnightly CTG review meetings
Relationships with larger hospital be strengthened
The department report the GSPMR on all
maternity services
Recommendations
© S
late
r and G
ord
on L
imited 2
015
34
The secretary of the department also requested the Australian
Commission on Safety and Quality in Health Care to conduct an
independent review and report of the department’s actions in
detecting, responding to and managing perinatal deaths at
Djerriwarrh both before and after the notification from the COPPMM
and more broadly to examine its capacity to detect and
appropriately respond to emerging critical issues in public hospitals
ACQSHC Report
© S
late
r and G
ord
on L
imited 2
015
35
there may have been ‘early warning signs’ regarding the problems
but they were not within the knowledge of the department and / or
the department’s response was appropriate. They included:
An external review of a maternity presentation transferred from
Bacchus Marsh to another hospital and the resignation of the Clinical
Services Director as Chair of a Maternity Quality and Safety Committee
Failure of the Bacchus Marsh campus to meet certain National Safety
and Quality Health Care Standards in July 2013.
Concerns raised by the Australian Nursing and Midwifery Federation
(ANMF) regarding the standards of clinical care at Djerriwarrh in
January 2014.
Findings
© S
late
r and G
ord
on L
imited 2
015
36
The department does not have a robust capacity to undertake
routine surveillance of serious clinical events other than those
events reported by staff as sentinel events
The department does not use reports of serious adverse events to
monitor hospital performance or as a base for ongoing surveillance
Findings continued
© S
late
r and G
ord
on L
imited 2
015
37
The Department:
strengthen its performance review role of local health by
strengthening its monitoring of clinical governance including
auditing compliance with Clinical Governance Framework
improve its capacity to meaningfully interrogate reports of incidents
consider including unexpected intra-partum stillbirth and term or
near term perinatal deaths on the list of sentinel events
review the effectiveness of the incident reporting system
investigate strengthening the system to facilitate systematic
analysis
Recommendations
© S
late
r and G
ord
on L
imited 2
015
38
3 of the doctors were the subject of notifications to AHPRA - 2 of
them had conditions and restrictions placed upon their registration
while they were practising at Bacchus Marsh.
Dr Surinder Pahar - conditions placed on his registration in June
2015, following a 28-month investigation by AHPRA. He was
reported to AHPRA by the Head of Obstetrics at Western Health in
2013 but AHPRA allegedly failed to act for 2 years. He resigned and
then retired in July 2015 after having been with the hospital for 30
years.
Dr Claude Calandra - 15 writs against him for alleged medical
negligence in 14 years. He settled all of those cases. He did not
deliver any of the stillborn babies discovered in the stillborn cluster
of 2013-14, but some of the writs are for stillborn cases
ABC 7.30 Report
Individuals
© S
late
r and G
ord
on L
imited 2
015
39
Royal Adelaide Hospital /
Flinders Medical Centre
© S
late
r and G
ord
on L
imited 2
015
40
July 2014 – January 2015
5 patients at RAH
5 Patients at FMC
Received a daily dose of Cytarabine instead of a dose twice a day
RAH’s protocol contained the incorrect dose
The problem
© S
late
r and G
ord
on L
imited 2
015
41
5 August 2015 – SA Minister for Health & Ageing and the CE of SA
Health requested an independent review be conducted
Independent Review Into The Incorrect Dosing of Cytarbine to Ten
Patients With Acute Myeloid Leukemia at Royal Adelaide Hospital
and Flinders Medical Centre
Terms of reference included to review:
The events and decisions that led to the incorrect dosing
The system of reporting incidents and the process of investigation and
open disclosure
The systems of governance
And to make recommendations to assist in mitigating the risk of
reoccurence
The Inquiry
© S
late
r and G
ord
on L
imited 2
015
42
Underdosing of Cytarabine was caused by a series of significant
clinical governance failures including:
Failure to follow processes for the development, review and publishing
of chemotherapy protocols
Failure to advise patients that the protocol was non-standard
Failure to provide adequate supervision to nursing staff
Certain clinical staff did not comply with SA Health incident
management and open disclosure policies by failing to:
Report the incidents
Conduct open disclosure
Provide an immediate clinical response
The conduct of certain clinicians demonstrated a lack of adequate
knowledge, skill, are and judgment
Findings
© S
late
r and G
ord
on L
imited 2
015
43
Consideration be given to referring relevant clinicians to the
Australian Health Practitioner Regulation Agency for review
Ensure staff fully understand their responsibility to act in
accordance with SA Health policies, particularly incident
management and open disclosure policies
Implement a rectification plan to ensure that the appropriate
governance frameworks are in place within SA Pathology
Ensure appropriate processes and procedures for the development,
review and publication and, where indicated, revision of
chemotherapy protocols are developed and implemented that are
consistent with the current evidence base.
Recommendations
© S
late
r and G
ord
on L
imited 2
015
44
Common Themes
© S
late
r and G
ord
on L
imited 2
015
45
“The story of the paediatric cardiac surgical service in Bristol is not an
account of bad people. Nor is it an account of people who did not
care, nor of people who wilfully harmed patients.
It is an account of people who cared greatly about human suffering,
and were dedicated and well-motivated. Sadly, some lacked insight
and their behaviour was flawed. Many failed to communicate with
each other, and to work together effectively for the interests of their
patients. There was a lack of leadership, and of teamwork.
It is an account of healthcare professionals working in Bristol who were
victims of a combination of circumstances which owed as much to
general failings in the NHS at the time than to any individual failing.
Despite their manifest good intentions and long hours of dedicated
work, there were failures on occasion in the care provided to very sick
children.” [emphasis added]
Bristol
© S
late
r and G
ord
on L
imited 2
015
46
“The Commission has completed the fact finding part of the
investigation and found that this complaint involves a trail of errors
that raise serious concerns about existing mechanisms established to
keep patients safe” [emphasis added]
Canterbury
© S
late
r and G
ord
on L
imited 2
015
47
“It is clearly an issue that we had one piece of information but not
the whole picture. Other agencies had information we didn’t know
about. We all have to find better ways of sharing information, within the
law, to better protect patients” AHPRA CEO Martin Fletcher [emphasis added]
Bacchus Marsh
© S
late
r and G
ord
on L
imited 2
015
48
+ ‘Whistleblower’
+ inadequacy of internal clinical governance
+ organisational culture inimical to safety
+ Lack of monitoring by management
+ Doctor/s in senior position/s at the centre of the controversy
+ Poor mechanisms for addressing concerns over individual doctors competence
+ Cascading of error / issues
+ No central oversight
+ No collective learning
+ Inadequate open disclosure
+ Poor compliance with incident reporting
requirements
Common themes
© S
late
r and G
ord
on L
imited 2
015
49
• Systems to identify and remove doctors consistently performing below
standard
AHPRA has committed to developing a more comprehensive risk assessment of
all notifications so high risk cases are identified earlier, specially managed with
targeted investigative strategies matched to the level of risk
• Self regulation
• “The Council may control the ultimate sanction of removing a doctor’s
licence to practise, but its influence is not felt everyday: to the average
doctor it feels distant. In contrast, teachers and colleagues have both
power and everyday influence. Royal colleges and postgraduate deans
also have great influence, and they must recognise their role in self
regulation. It is this local, everyday self regulation that is being taken
seriously. The challenge is to maintain the impetus for improvement
created by the Bristol case and turn fine words into effective actions.”
Richard Smith, Editor, BMJ 1998:316:1917-1918
Mechanisms for change
© S
late
r and G
ord
on L
imited 2
015
50
• Mechanism for sharing of information from civil proceedings with
disciplinary boards (AHPRA reportedly looking at possibility of sharing
information with insurers)
• An external body charged with oversight of safety and investigation of
adverse events
Possibilities
© S
late
r and G
ord
on L
imited 2
015
51
• Performance indicators programmed into portable technology – captures
near misses as well – self-reporting: Faunce & Bolsin MJA 2004; 181: 44-
47
• Improved data collection and greater scrutiny of that data
• Work of Marie Bismark & David Studdert et al: PRONE score – an algorithm
for predicting doctors’ risks of formal patient complaints using routinely
collected administrative data BMJ quality and safety 2015: 24(6)
Possibilities continued
© S
late
r and G
ord
on L
imited 2
015
52
Other ideas?
© S
late
r and G
ord
on L
imited 2
015
53
Thank you