Learning from Confidential Enquiries. New systems and

Report
Learning from Confidential Enquiries:
New systems and feedback
Heather Reid
Overview
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History to date
Learning
New processes – MBRRACE
Maternal Programme
Perinatal Programme
Confidential Enquiry
History
• Confidential Enquiry into Maternal Deaths (CEMD) – 1952
• Confidential Enquiry into Sudden Deaths in Infancy (CESDI) –
1992-93
• Confidential Enquiry into Maternal and Child Health (CEMACH)
was formed in April 2003
• Centre for Maternal and Child Health (CMACE) -2008
• Mothers and Babies Reducing Risk through Audit and
Confidential Enquiry (MBRRACE)
Learning
• Definition - the acquisition of knowledge or
skills through study, experience, or being
taught (Oxford Dictionary)
“Any fool can know. The point is to understand.”
― Albert Einstein
Confidential Enquiry
• Maternal and Infant Clinical Outcome Review
Programmes (CORPs)
Confidential Enquiry
Enquiries commissioned by Healthcare Quality Improvement
Partnership (HQIP)
• National Confidential Enquiry into Patient Outcome and Death NCEPOD (1982)
• National Confidential Inquiry into Suicide and Homicide by People with
Mental Illness - NCISH (1992)
• Confidential Enquiry into Maternal Infant and New-born and
Maternal Death
• Confidential Enquiry into Child Death (1952)
– Tendered In April 2010 under European procurement legislation
(£694,000 per year).
– Procurement halted March 2011 (CMACE closed April 2011) – interim
web portal for England and Wales – NI – business as usual!
– MBRRACE contract signed 1st June 2012
– End date: 31st March 2015/2017
Since June 2012
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Checking all CMACE paper data for completeness
Requesting missing data
Collecting case notes for notified cases
Seeking clinicians reports for notified cases
Extracting surveillance data
Taking new notifications
Planning for Confidential Enquiry processes and Annual Reports
Recruiting and training specialist assessors:
obstetrics, midwifery, anaesthetics, intensive care,
general practice, obstetric medicine, cardiology, neurology,
pathology, psychiatry, emergency medicine
• Developing electronic systems for assessment
• Planning morbidity confidential enquiries
• Organising selection of new morbidity confidential enquiry topics
MBRRACE-UK overarching aim
To provide robust UK-wide information to support service
improvement in the delivery of:
– Safe; equitable; high quality; patient-centred maternal,
newborn and infant health services
Achieve this through UK-wide:
• Surveillance and confidential enquiries of all maternal
deaths (to 1 year post pregnancy completion)
• Confidential enquiries of a rolling programme of
serious maternal morbidity – severe maternal sepsis in
2013
• Surveillance of late fetal losses (22-23 weeks),
stillbirths, neonatal and post-neonatal deaths
• Confidential enquiries of a rolling programme of infant
mortality and serious infant morbidity – congenital
diaphragmatic hernia in 2013
Progress since June 2012
• Secure electronic web-based data entry system – for the late
fetal losses, stillbirths and infant mortality data
– Developed a secure web-based data entry system – data collection via the
internet – modifications in progress for NI data
entry
– Identified the information to be collected (reducing the items where possible)
– Selected a new mortality classification system (CODAC) (expert advisory group –
including Dr Claire Thornton)
– Tested and launched the system – April 2013 (for inclusion of cases from births
1st January 2013 onwards)
– All Units in England, Wales and Scotland are registered
– All Units (except two) in E, W & S entering cases
• Added value of electronic data capture
– Internal validation features
– Print out of individual cases – file in the case notes, send to other data
recipients (CDOP/CDRs)
– Assessment of data quality and completeness
– Link to civil registration data (ONS) to assess completeness of case notification
Developmental:
– Further internal data validation checks
– Assessment of data quality and completeness (feed back to Units/NIMACH)
– General modifications and improvements to the data entry
– Units able download own dataset
– Tabulated outputs of Unit based data for Units own audits
Identification and management of
outliers
• Primary objective – provide risk adjusted analyses to monitor
performance and identify outliers
• Mortality data presented:
– Including & excluding late fetal losses (22-23 weeks)
– Excluding major congenital anomalies
– By case type
• Analysis and presentation using:
– Funnel plots – before & after risk adjustment
– Analysis of means
– Developing new methodologies
Identification and management of
outliers…..
• Analysis for stillbirths:
– by unit type: tertiary / DGH
– by stillbirth group
– risk adjustment for plurality, ethnic group, deprivation (countryspecific IMD)
• Analysis for neonatal deaths:
– by neonatal network /Unit – what is the correct level of analysis??
– including / excluding transfers
– risk adjustment for case mix, gestational age, ethnic group, deprivation
(country-specific IMD), plurality
Performance monitoring – funnel
plots
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Adjusted
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Unadjusted
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QO
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SMR
SMR
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U A
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O W
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B
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1000
2000
3000
Number of Admissions
4000
5000
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1000
2000
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Number of Admissions
4000
5000
NAGCAE Outlier Protocol*
• Alert – 2SD from the average
• Alarm – 3SD from the average
– Unit checks data and send back report (25 days)
– If data at fault – corrected, re-analysis – if okay close
• If data correct – notify clinical governance lead, medical director, chief
executive; HQIP
• Chief executive to inform relevant bodies: CCGs, Care Quality Commission
• Public disclosure of comparative information
*National Advisory Group on Clinical Audit & Enquiries guidance,
published by the Department of Health (England)
Current Structure – Northern Ireland
DHSSPSNI
NIMACH
Steering group NIMI
Public Health Agency
Public Health Directorate
Service Development &
Screening Division
NIMACH
MBRACCE
Stakeholders
•Trusts – Midwifery and obstetric services,
neonatal intensive care, pathology
•Professional groupings
•Primary care
•RQIA
•HSC Safety Forum
•QUB / UUJ
•HSCB
•HSCB/PHA Maternity/Paediatric & Child Health
Commissioning Group
Northern Ireland Data Collection
Process
• Surveillance:
– Notifications from Trusts
– Manual returns (PDN / Maternal Death Forms)
– Sent to NIMACH office (follow up on missing data)
– PMs, placental histology
• Unit Coordinators
• Legal Requirements – Data Protection /
Section 251/ Secondary Use of Data
• Quality assurance – NISRA / GRO
Maternal Death Programme
MDR philosophy….to
recognise and respect
every maternal death
is a young woman who
died before her
time….goes beyond
counting numbers to
listen and tell
stories…..so as to
learn lessons that may
save other mothers
and babies
Impact of Maternal Deaths
• Maternal deaths – women who loose their
lives prematurely
• Live new-born deaths due to maternal causes
• Existing children loose their mother
• Existing children were in need of “care”
The maternal mortality or morbidity
surveillance cycle
1. Identification of
cases
5. Evaluation and
refinement
2. Information
collection
3. Analysis of results
4. Recommendations
for action
UK Mortality Rates – 1952-2008
Maternal Death – UK 1985-2008
Significant reduction in direct deaths – thromboembolism, haemorrhage
Direct & Indirect Rates
2006/08
Leading Cause Maternal Death 2006-08
Top 10 Recommendations
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Pre pregnancy counselling
Professional interpretation services
Communications and referrals
Women with potentially serious medical conditions require immediate
and appropriate multidisciplinary care
Clinical skills and training
Specialist clinical care: identifying and managing very sick women
Systolic hypertension requires treatment
Genital tract infection/sepsis
Serious Incident Reporting and Maternal deaths
Pathology
Back to Basics
Guidance to help with:
• Improving basic medical and midwifery practice, such as
taking a history, undertaking basic observations and
understanding normality.
• Attributing signs and symptoms of emerging serious illness
to commonplace symptoms in pregnancy.
• Improving communication and referrals.
MBRRACE
• Maternal death – highest priority for MBRRACE
• Includes late maternal death – up to 1 year
• Process of case ascertainment (estimate 85%
deaths captured to date – complete information
on around 50%)
• Recruitment of specialist advisors to assess case
notes
• 1st MBRRACE Maternal Mortality Report –
December 2014
• Yearly reporting thereafter
Notification and case note collection
Total cases known by
year
Evaluated as
complete
Cases with no
notes of any kind
2009
114
91 (80%)
10 (9%)
2010
126
38 (30%)
10 (8%)
2011
106
Not yet evaluated
26 (25%)
2012
131
Not yet evaluated
65 (50%)
2013
57
Not yet evaluated
34 (60%)
Total
534
Maternal Death - 2011
• ~100 maternal deaths (11 per 100,000
maternities)
Maternal Morbidity and Mortality
Annual Report Topics
• Year 1 (2014): Sepsis, haemorrhage, amniotic fluid
embolism, anaesthetic, neurological, other
indirect (deaths 2009-2012)
• Year 2:, Psychiatric, thrombosis, other direct, late
and coincidental
• Year 3: Pre-eclampsia and eclampsia, cardiac,
early pregnancy
Perinatal and Infant Mortality
MBRRACE Changes
• Inclusion of late fetal losses
• Notification of neonatal death – 20 weeks or
>500g where gestational age not available
• Extension to 1 year 9previously 28 days)
– 2013 confined to deaths in neonatal units only
– 2014 plans to expand data collection to all deaths up
to 1 year (different data set)
• Links with Child Death Review (CDOP)
• Coding / Classification
Cause of death
• Challenges in coding systems (many
unclassified)
• Limitations in comparisons between countries
and across time
• CODAC (Cause of Death and Associated
Conditions) – hierarchical tree of potential
causes. Main cause of death is identified along
with associated factors at three levels
Perinatal Mortality - UK
Perinatal Mortality Report - UK
• First UK ‘perinatal’ surveillance report of
stillbirths and neonatal deaths in the 2013 UKnational birth cohort: May 2015 (delay due to
access to the denominator data & deaths data
for confirmation of completeness of case
notifications)
Northern Ireland – Perinatal Mortality
Reports
Stillbirth, perinatal and neonatal mortality rates
(crude) and Total births, Northern Ireland ~ 2001 –
2013
Northern Ireland
Stillbirth Rate – Northern Ireland –
2001 - 2012
Stillbirth – Northern Ireland
Neonatal Death – Northern Ireland –
2001 - 2012
Neonatal Death – Northern Ireland
2001 - 2012
Time of death
Time between Birth and Death in ENND as percentage of total ENND
2012
2011
<1 hr
27%
28%
1-12 hr
38%
43%
>12 hr
35%
29%
Deaths associated with factors known to increase risk
of mortality: Northern Ireland Births 2007 – 2012
Gestation <22 weeks^
Lethal Malformations ^
Birth Weight <500g^
Gestation <22 weeks^
Lethal Malformations ^
Birth Weight <500g^
Gestation <22 weeks^
Lethal Malformations ^
Birth Weight <500g^
2007
0
13
5
6
27
7
0
8
0
2008
0
13
3
Stillbirths
2009
0
16
7
2010
0
12
8
2011
0
16
8
2012
0
24
9
1
16
11
Early Neonatal Deaths
12
10
34
37
16
20
19
31
28
10
29
12
0
7
0
Late Neonatal Deaths
0
0
9
6
0
0
0
7
1
0
5
0
Stillbirths Associated with High Risk
Factors
Neonatal deaths associated with high
risk factors
Stillbirth by gestation – Northern
Ireland - 2012
Neonatal Death by Gestation –
Northern Ireland - 2012
Risk factors - BMI
Confidential Enquiries
Uses of confidential enquiry data - Reasons
• Confidential enquiry is a qualitative approach: narrativebased medicine
• Describes not just the ‘what’ but the ‘why’
• Detailed investigation of care against accepted standards
• Does not generate new information to change evidencebased practice, but does identify when current practice is
not evidence-based
• Stories are powerful and can be uniquely persuasive in
changing practice
Confidential enquiry methodology
• Systematic, multi-disciplinary, anonymous review of all OR a sample of
cases occurring in a defined population during a defined period of time;
• Where the numbers of a specific type of condition are small in number it
is appropriate to review all the cases;
• Where numbers are large it is usual to take a sample of cases;
• Review is by either individual or paired reviewers or during a panel
process;
• Comparisons of care are made against guidelines, quality standards or
best practice where guidelines have not been developed;
• The aim is to identify avoidable or remediable factors associated with the
cases so as to inform future practice and improvements in care which may
make a difference to outcomes in the future.
Confidential enquiry topics:
• Serious maternal morbidity (report Dec 2014)
– 2013 maternal sepsis in 2013 (UKOSS sample of cases)
– 2014 postpartum psychosis in women who have a past psychiatric history
of bipolar affective disorder or postpartum psychosis following a previous pregnancy
(case sampling being explored)
– 2015 pregnancy in women with artificial heart valves (UKOSS)
• Infant mortality and serious infant morbidity
(report mid 2014)
– 2013 congenital diaphragmatic hernia (UKOSS/BAPS-CASS sample
of cases)
– 2014 unexpected antepartum stillbirth of a normally
formed fetus at term (MBRRACE-UK sample)
– 2015 - call for topic proposals is open until 31st Dec 2013
Confidential Enquiry Assessors
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16 Obstetricians
19 Anaesthetists
3 Obstetric Physicians
4 Cardiologists
2 Neurologists
15 Midwives
3 GPs
7 Intensive care consultants
1 Emergency medicine consultant
8 Pathologists
6 Psychiatrists
Infectious disease physicians TBA
Assessment of care
Assessors are asked to assign cases to one of the following three
categories after assessment:
• Good care; no improvements identified as being needed
• Improvements in care* identified which would have made no
difference to outcome
• Improvements in care* identified which may have made a
difference to outcome
(*Improvements in care are interpreted to include adherence to guidelines, where
these exist and have not been followed, as well as other improvements which would
normally be considered part of good practice, where no formal guidelines exist.)
HQIP cause for concern guidance
Assessors have been asked to flag cases a cause for concern according
to HQIP protocol:
• Death (child or adult) attributable to abuse or neglect, in any
setting, but no indication of cross agency involvement (i.e. no
mention of safeguarding, social services, police or LSCB).
• Staff member displaying:
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Abusive behaviour (including allegations of sexual assault)
Serious professional misconduct
Dangerous lack of competency
But not clear if incident has been reported to senior staff
• Standards in care that indicate a dysfunctional or dangerous
department or organisation, or grossly inadequate service
provision.
Sepsis Confidential Enquiry progress
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Topic Expert Group convened
Key standards identified
32 Cases selected (UKOSS sample) (2 from NI)
Case notes and local clinician reports requested
Key standards - sepsis
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Recognition
– RCOG Green-top Guideline 64a: Bacterial sepsis in pregnancy: Sections 5 and 6
– RCOG Green-top Guidelines 64b: Bacterial sepsis following pregnancy: Section 7
2.
Response and management
– Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and
Septic Shock, 2012: Tables 5,6 and 8, Figure 1.
– The Sepsis Six (http://survivesepsis.org/the-sepsis-six/):
– RCOG Green-top Guideline 64a: Bacterial sepsis in pregnancy
– RCOG Green-top Guidelines 64b: Bacterial sepsis following pregnancy
3.
Investigations
– Surviving Sepsis Campaign Bundles:
(http://www.survivingsepsis.org/bundles/Pages/default.aspx)
4.
Condition-specific guidance
– British Thoracic Society guidelines for the management of community acquired pneumonia in
adults: update 2009: Figure 8
– Critical care management of adults with influenza with particular reference to H1N1 (2009)
– Surgical site infection – NICE Guideline CG74 Prevention and treatment of surgical site
infection
CDH confidential enquiry
• Planning the confidential enquiry work for the CDH cases
– Sample of 66 cases identified through a recent joint UKOSS and BAPS-CASS
study
– Qualitative panel process guided by a care pathway developed by a Topic Expert
Group (Dr Alyson Hunter, Royal Jubilee Maternity Hospital)
– Recruitment of panel members
– Panels will be case specific – TOP, Stillbirths, Neonatal deaths, deaths postsurgery, survivors following surgery
– Dates for panels set
– Training will be provided at the panels
– Units have received requests for anonymised copies of selected case notes
shortly (5 sets received)
Learning from surveillance and enquiry
• Room for improvement
• Learn from others
• Challenges and barriers
– Identifying preventable deaths
– Understanding our data
– Improving MDT mortality review
– Service capacity – pathology, review
Reality check?
and finally……….any Questions?
“Tell me and I forget, teach me and I may
remember, involve me and I learn.”
Benjamin Franklin
NIMACH Office
• Office based within Public Health Agency,
Linenhall Street, Belfast
• Heather Reid, Regional Manager:
heather.reid@hscni.net
• Joanne Gluck, Clinical Research Midwife:
joanne.gluck@hscni.net
• Malcolm Buchanan, Administrator:
malcolm.buchanan@hscni.net
Telephone number: 028 90553611

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