Download Summary report from retrospective review of cancer care

Summary report from retrospective review
of cancer care
Main authors: Dr Penny Newman, Amanda Dell, Ayo Adebamowo
Contributors: Ian Craddock, David Traynier, Orla Thunder, Michelle Fisher, Lorna Dewar, Hether
Buckle, Sandra Lyons, Dr Mary McStay, Dr Devy Basu, Dr Jennifer Collins, Denise Gale
Executive Sponsor: Dr Sean MacDonnell
Final Report for IMT
This report was commissioned by Colchester Hospital University NHS Foundation Trust at
the request of the multiagency incident management team (IMT).
Dr Christine Macleod, on behalf of the Assurance Panel of the IMT, endorses the findings
within this report.
Signature:
Date: 16/12 /2014
Dr Christine Macleod, Medical Director
NHS England, Essex Area
Signature:
Date: 16/12 /2014
Dr Lucy Moore, Chief Executive
Colchester Hospital University Foundation Trust.
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Our gratitude goes to the following:
Colchester Hospital University NHS Foundation Trust

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Main authors: Dr Penny Newman (Programme Director, Director of Service Integration, GP
and Consultant in Public Health), Amanda Dell (Project Management Consultant), Ayo
Adebamowo (Lead Cancer Information Analyst)
CHUFT Contributors and Review Team members: David Traynier (Audit support/Analysts),
Lorna Dewar (Oncology Clinical Trials Manager), Orla Thunder (Clinical Trials Data Nurse),
Michelle Fisher (Research Nurse), Ian Craddock (Site Matron, Senior Auditor), Heather
Buckle, Sandra Lyons (Clinical Auditors), Dr Mary McStay, Dr Devy Basu, Dr Jennifer Collins
(Lead Clinicians), Denise Gale (Cancer Programme Director), Valerie Northcroft-Brown
(Project Support)
Executive sponsor: Dr Sean MacDonnell (Medical Director)
Business Informatics team and in particular Michele Figg (Head of Business Informatics)
Health Records team and especially Barry Moult (Head of Information Governance & Health
Records),Teresa Frost (Health Records Manager) and Phil Frances (Health Records Clerk)
The Assurance Panel
Dr Christine Macleod (NHS England Essex Area Team Medical Director and Chair of Retrospective
Assurance Panel), Dr Shane Gordon (Clinical Chief Officer, NHS North East Essex Clinical
Commissioning Group), Karen Hindle (Senior Associate (communications) interim hub manager,
North, Midlands and East Communications), Dr Thomas Nutt (Chief Executive Officer, Healthwatch
Essex), Paul Pharoah, (Professor of Cancer Epidemiology, Department of Public Health and Primary
Care, University of Cambridge and Honorary Consultant in Public Health, Public Health England), Pól
Toner (NHS England Essex Area Team Director of Nursing and Quality). Observer: Representatives of
the Information Commissioner’s Office, Support: Christine Cooper (PA to NHS England Essex Area
Team Medical Director)
External reviewers
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The East of England Strategic Clinical Network, particularly Dr Rory Harvey (SCN Cancer
Clinical Director) and Kate Patience (Rehabilitation & Quality Improvement Lead for East of
England SCN Cancer Team), all the external review Consultants and Karen Harland (Karen
Harland, Cancer Services Manager, HOPE Clinical Unit, Hinchingbrooke Health care NHS
Trust)
The Royal Marsden NHS Foundation Trust and particularly Nicky Browne (Director of
Performance & Strategy Implementation)
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Contents
Abbreviations and Acronyms Used in this Report .................................................................................. 4
Summary of the Colchester Hospital retrospective review and its findings........................................... 5
Key action points and recommendations ............................................................................................... 7
1.0 Retrospective review of cancer care at Colchester Hospital NHS Foundation Trust ........................ 8
2.0 Background to retrospective review ............................................................................................... 10
3.0 Methods .......................................................................................................................................... 12
4.0 Results ............................................................................................................................................. 13
5.0 Discussion........................................................................................................................................ 18
6.0 Conclusion ....................................................................................................................................... 22
7.0 Summary of recommendations ...................................................................................................... 23
Appendices............................................................................................................................................ 30
Appendix 1 Cancer Waiting Times Guidance (vs 8.0) .......................................................................... 30
Appendix 2 Project management and governance............................................................................... 31
Appendix 3 Comparative results one each audit .................................................................................. 32
Appendix 4 Executive Summary – Error Rate Study 1 .......................................................................... 34
Appendix 5 Executive Summary - Long waits study 2........................................................................... 37
Appendix 6 Executive Summary – Delayed Diagnosis Study 3 ............................................................ 43
Appendix 7 Executive Summary – Upper GI ....................................................................................... 49
Appendix 8 Executive Summary – Bladder cancer surveillance ........................................................... 53
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Abbreviations and Acronyms Used in this Report
2WW Two Week Wait
NEE North East Essex
CCG Clinical Commissioning Group
NHS National Health Service
CHUFT Colchester Hospital University NHS
Foundation Trust
ONS Office for National Statistics
CNS Clinical Nurse Specialist
COSD Cancer Outcome and Service Dataset
CQC Care Quality Commission
CUP Cancer of Unknown Primary
CWT Cancer Waiting Times
DNA Did Not Attend
DFS Disease-free survival
DTT Decision to Treat
ECAD Earliest Clinically Appropriate Date
ECRIC Eastern Cancer Registration and
Information Centre
OPD Outpatients’ Department
PAS Patient Administration System
PH Public Health (England)
RMH Royal Marsden Hospital
RRT Retrospective Review Team
RTT Referral to Treatment
SCN Strategic Clinical Network
SCR Somerset Cancer Registry
TYA Teenagers and Young Adults
TRUS Transrectal ultrasound scan
USS Ultrasound
UGI Upper Gastro-Intestinal pathway
EUS Endoscopic ultrasound scan
FDT First Definitive Treatment
FT Full Time
GDP General Dental Practitioner
GI Gastro-Intestinal
GIST Gastro-intestinal Stromal Tumour
GMP General Medical Practitioner
GP General Practitioner
HR Human Resources
IMAS Interim Management and Support
SI The definition of a serious incident is: ‘An
incident of such seriousness that it causes or
threatens to cause serious harm to patients,
staff, volunteers, members of the public,
contractors or the Trust itself. There are
specific criteria used to define SIs and this
includes the risk of reputational harm to the
NHS. A Never Event is a serious incident
which should never happen if known
preventive measures had been in place’
(Series Incident Procedure Trust Policy No
63a, 2014)
IMT Incident Management Team
IT Information Technology
LGI Lower Gastro-Intestinal
MD Medical Director
MDT Multi-Disciplinary Team
MDTC Multi-Disciplinary Team Coordinator
MEHT Mid-Essex Health Trust
NAO National Audit Office
Please note where an SI is mentioned
throughout all reports in the retrospective
review this refers to an incident report form
(datix) being completed and referral for
serious incident investigation. The
investigation process can take up to 45 days
at which point a final report is submitted to
North East Essex CCG for review. Some
investigations are still on-going at time of
writing this report
NE North East
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Summary of the Colchester Hospital University NHS Foundation Trust
retrospective review and its findings
1. Following the Care Quality Commission (CQC) inspection in November 2013, Colchester
Hospital University NHS Foundation Trust (CHUFT) undertook a retrospective review of
cancer care to identify any potential data manipulation in cancer waiting times (CWT) and to
establish whether this had led to harm. The study protocols were developed by NHS England
and the Incident Management Team (IMT), to whom the Trust reported directly and through
an Assurance Panel.
2. The studies are based on the experience of 822 patients treated at the Trust between 1 April
2010 and March 2014. The patients for review were specifically selected as those most
likely to have problems in data recording or clinical care and represent a relatively small
proportion of the 33,000 patients seen at the Trust over the study period.
3. All studies evaluated both the CWT and individual clinical pathways, and the relationship
between them. In doing so they uncovered issues other than that of potential data
manipulation.
4. Key findings were: i) national cancer waiting times data collection, recording and reporting
were poor; ii) care pathways for individual patients were stopped erroneously by clinicians
and non-clinicians alike; iii) there was a large number of preventable delays unrelated to
data recording; iv) patient care pathways were often poorly coordinated; v) four specialties
had more data irregularities and clinical issues than others; vi) a small number of patients
experienced sub-optimal care.
5. Data manipulation or deliberate, inappropriate data entry was considered a possibility in a
small number of patients, 16 in total. In these cases it was not possible to establish intent.
6. There was a large number of minor discrepancies between recorded and actual dates. There
was evidence of a small, systematic bias in recording of the Decision to Treat (DTT) date such
that recorded waits were shorter than in reality in one study (error rate). It was not possible
to exclude intent underlying this bias, but this seems unlikely. More likely is a minor, but
erroneous interpretation of the CWT (Cancer Waiting Times) guidelines. Nor was it possible
to establish that this bias led to financial gain for the Trust.
7. Data errors and delays occurred for several reasons including poor understanding and
application of CWT guidance, problems booking appointments, patient choice or their being
temporarily unfit, and transfers of care within the Trust and between hospitals. Delays
occurred mostly in the diagnostics phase of cancer pathways.
8. It would be difficult to determine a causal relationship between data error and harm. In
addition, the CWT tool was not used for individual patient tracking but for audit and
reporting purposes. It was thus not possible for erroneous CWT data entry, fraudulent or
otherwise, to have led to individual patient harm.
9. In looking in detail at the CWT and the clinical pathways, a number of patients were seen to
have received sub-optimal care and experience to varying degrees. This related to the
recording and hence communication of patient information, delayed investigations,
uncoordinated and/or unresponsive pathways of care, delayed diagnoses and treatment and
potentially incorrect diagnosis.
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10. Between 4% and 9% of patients reviewed may have experienced emotional and/or physical
harm, depending on the study. These cases were unrelated to any data manipulation but
due to the complexities of cancer care and clinical risk.
11. Any patient reviewed who may have been subject to clinical error had their care scrutinised
by clinical auditors, one of three lead doctors, a multidisciplinary panel and the Medical
Director to ensure any outstanding remedial actions have already been taken.
12. These findings are broadly consistent with that of the Strategic Clinical Network
independent review of 10% of cases that emphasised the deficiencies in the internal cancer
management processes but did not identify any systemic data manipulation.
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Key action points and recommendations
This is likely to be one of the most detailed reviews of cancer care undertaken in the NHS. The
findings are illustrative of a system under considerable strain in implementing a complex data
collection system without the necessary resource in place to ensure data quality assurance.
The next step is to use the findings to ensure that future patients receive the best quality of care at
the Trust.
1. The reports from the retrospective review of cancer care should be used as a catalyst to
develop excellence at the Trust and improve the care and experience of patients with cancer
for them and for their families.
2. This report and its recommendations should be checked against the 2013/14 cancer action
plan to ensure any outstanding actions are included in the in 2014/15 Cancer Board Work
Programme.
3. The Trust should develop a communications plan to ensure that the findings from this
review and other reports are widely disseminated throughout the Trust.
4. The Trust should consider whether further intervention is necessary into those specialties
highlighted as part of the retrospective review.
5. The Trust should establish a dedicated team for CWT data monitoring and employ a full time
Cancer Services Data Manager.
6. The Trust should develop a strategy for quality improvement based on the findings of this
review. It should seek to become a case study to inform other Trusts in highly stressed
systems on interventions to improve quality of care using the latest evidence on
improvement science methodologies.
7. The reports and relevant patient data should be shared with the Strategic Clinical Network
and other Trusts to improve pathways, communication and responsiveness elsewhere. This
should also apply to GPs facilitated by the CCG.
8. More work should be undertaken to develop measures of harm to bench-mark Trust
performance.
9. Patient involvement and on-going use of patient experience is required to ensure care
continuously improves. This should include training in communication skills, patient centred
care and self-care support.
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1
Retrospective review of cancer care at Colchester Hospital
University NHS Foundation Trust
“In trying to achieve remedy, your most certain and productive pathways will be built on the
enormous strengths of the NHS – its people, their commitment, its charter, much of its track record,
and the affection and wisdom of patients and carers. I hope that you will invest even more than ever
before in learning, growth, development, ambition, and pride. This is the route that can make the
NHS a “learning organisation” in every sense of the term, and it can unleash momentum for
improvement that no simple, top-down, control-oriented, requirement-driven culture ever can.
This is not to excuse or ignore the whole story, as Robert Francis and we understand it. Very
occasionally at the root of harm do lie wilful, reckless behaviours or neglect that cannot be tolerated,
any more than reckless driving can be. There is an important role for responsive regulation by
experts, enforcement, and consequences in such circumstances. It is equally important to be alert to
early warning signs of possible serious quality and safety problems, and to investigate and act on
them. Your recent advisors – Robert Francis, Sir Bruce Keogh, and we – do converge in our
recommendations for clarity, timeliness, and reliability in taking action when such alarms sound.
But, as I think you know, this – acting on rare and outlying behaviours and on exceptional cases of
poor performance – though necessary, will not create an overall far safer and better NHS; it cannot.
A culture of learning can. And the likelihood of such a culture thriving in the NHS depends, more than
on anything else, on how you, the senior leaders, behave, speak, and invest”.
Letter from Don Berwick to Senior Government Officials and Senior Executives in the Health Service,
A promise to learn– a commitment to act. Improving the Safety of Patients in England
National Advisory Group on the Safety of Patients in England, August 2013
1.0 Introduction
This report is an overview of five studies that make up the retrospective review of cancer care
provided between October 2010 and March 2014 at Colchester Hospital University NHS Foundation
Trust (CHUFT). The review was undertaken between February and December 2014 based on original
protocols developed by the Incident Management Team (IMT).
This report is written for IMT to provide assurance on cancer care at the hospital by demonstrating
that all themes identified by the CQC, and any outstanding issues around patient care, have since
been addressed. It is informed by five comprehensive technical documents written on each study
and their recommendations.
As well as identifying overriding themes this summary report also includes Executive Summaries
from each study (appendix 4-9), discussion of study findings and a summary of all recommendations.
The next step is to share findings with clinicians and managers within the Trust as a quality
improvement tool.
Other reports are available that supplement this summary:
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A “plain English version” of the summary for the public and stakeholders
A report on the management of patients who used the Trust helpline, made complaints or
were investigated as Serious Incidents (SIs) at the time of the CQC investigation
The Troop/Taylor-Brown report on governance at the Trust
The cancer pathways reports written by NHS England and Strategic Clinical Network.
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In addition to the reports above, three reports should specifically be read in conjunction with this
summary of the reviews:
1. The Strategic Clinical Network was asked to provide external senior clinical assurance to
judge whether there was evidence of data manipulation of patients on cancer pathways, if
patients had experienced harm as a consequence, and whether appropriate actions had
been taken by the trust. In total the external reviewers looked at 81 cases; 15 delayed
diagnoses, 25 error rates, 28 long waits, one bladder surveillance and 12 from the upper GI
pathway. Overall the external review process provided assurance to the Trust’s internal
investigation. This external review emphasised the deficiencies in the internal cancer
management processes but did not identify any systemic data manipulation1.
2. Report on Trust Actions. A detailed exercise has been undertaken by Denise Gale, Cancer
Programme Director, reconciling the actions delivered through the Cancer Action Plan
during 2014 against the findings and/or recommendations from the retrospective review
study reports. These are detailed in a separate report which should be read together with
this review and are also outlined against specific recommendations in section 6.02.
3. Healthwatch Essex. Cancer Services in Colchester. This report undertaken by Healthwatch
Essex (represented on the Assurance Panel) describes a three phase, largely qualitative
multi-method, approach to reveal people’s feelings and lived experience of cancer care. The
study recommends the Trust seeks to improve communication and ways of ensuring
patients and carers’ views and experiences are listened and responded to3.
1
East of England Strategic Clinical Network. Colchester Hospital University NHS Foundation Trust Retrospective
Cancer Pathway Review September 2014.
2
Retrospective Review: reconciliation of findings from the six study areas with actions in the CHUFT Cancer
Action Plan, Denise Gale, Cancer Programme Director, Dec 2014
3
Corrigan O, McGuiness N, Nutt T, Hallowell N, Wood D, Haines S. Cancer Services in Colchester: A study of
Patient and Carer Experience. October 2014
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2.
Background to retrospective review
Following concerns about cancer care at the Trust in 2013, Colchester Hospital University NHS
Foundation Trust (CHUFT) was inspected by the Care Quality Commission (CQC), who reported
inconsistencies in data held on the Cancer Waiting Times system (CWT) and within medical records.
In 22 of these cases, the delay in treatment may have had an impact on patients (see below).
“During our examination of 61 patient medical records we noted there to be inconsistencies
between information that was held on the cancer wait time’s system (CWT) and that which was
contained within people’s medical records. In total 22 of the files showed discrepancies in a
person’s pathways.
We found that entry dates on the CWT system did not always correlate with the patients' medical
records. We found that in 22 cases the treatment dates recorded on the system had been changed.
Details and examples of the altered records are reflected in the section for 'records' in this report.
The changes to the patient cancer pathway was identified through a review of the medical records
which demonstrated that treatment had been provided on a date different to the one recorded on
the CWT system. The changes in those 22 cases meant that people could have experienced a
negative impact in the form of their treatment being delayed. The risk of delayed treatment could
impact on their care and longer term health”.
CQC Report into Cancer Services at Colchester Pages 12 and 7, Published 5th November 2013.
2.0 Aims of review
The Retrospective Review of cancer care was commissioned by NHS England and IMT as part of a
suite of measures arising from the inspection and review of cases identified by the CQC with the
following aims:
1. To identify and report on the following through clinical and non-clinical audits in cancer care
to determine their nature and extent at an individual and system level:
 Any evidence of manipulation of data
 Causation factors and where possible, whether these were intentional
 Where patients have been exposed to any risk of harm
 Remedial actions required including the on-going management and monitoring of cancer
services.
2. To provide transparency and external validation through regular reporting to an External
Retrospective Review Assurance Panel and publish results.
3. To refer to the police any cases of possible intentional manipulation of data. This is defined
as cases where there is no valid explanation why CWT has been altered to meet national
reporting standards and data does not reflect actual patient experience
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
There is variance between CWT and other data sources AND
There is no valid reason AND/OR
Other sources give rise for concern e.g. complaints.
The reviews included six studies and case reviews of about 1,500 patients (table 1). This report is
based on studies 1-5 covering about 800 patients and over 3,000 data entry points and patient
interactions with the Trust. The final study (6) will be reported to the Trust Board in early 2015.
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The rationale for each study was that a risk for patients had been identified from review of the
original 22 patients identified by the CQC. The governance structure is outlined appendix 1.
Study
Description
To determine the error rate of the Cancer
Waiting Tool (CWT)
Number
of cases
250 case
notes
Sample
type
Stratified
sample
1
2
Long waits - to identify long waits (over 91 days)
in cancer.
290 case
notes
Cohort &
look back
3
To determine the prevalence of ‘delayed
diagnoses’ in cancer pathways (defined as ‘those
patients restarting a cancer pathway within 90
days from stopping an initial cancer pathway’).
Upper GI - to identify patients whose pathway
was changed without appropriate clinical input1.
364 case
notes
120 case
notes
Cohort
halted at
147
patients
Two
samples
Urology - to identify patients who have been lost
to superficial bladder cancer surveillance.
Surveillance – review of all calls to the helpline,
complaints and significant events following the
CQC investigation2
15 case
notes
599
patients
Stratified
sample
Patient
log
East of England Strategic Clinical Network review
of 10% sample of studies 1-5
81
patients
10%
sample
4
5
6
7
Dates of
review
April 1, 2010
- October 31,
2013
April 1, 2010
- October 31,
2013
April 1, 2010
- October 31,
2013
April 1, 2010
– Dec 31,
2013
January 2013
- March 2014
5th
November
2013 - 31st
January 2014
April 1, 2010
- March 2014
8.
Summary report on retrospective review (this
822
All studies April 1, 2010
report)
patients
- March 2014
9.
Report on the cancer action plan and action
N/A
N/A
December
taken against recommendations by Cancer
2014
Programme Director
10.
Plain English report of all relevant reports
N/A
N/A
N/A
including retrospective review for public and
stakeholders
Table 1. Summary of studies and reports included in cancer retrospective review
Note 1. The delayed diagnosis study was halted at 147 case reviews following discussion of an
interim report with the Assurance Panel and IMT given that no new themes were emerging and it
was highly unlikely that any further interventions would be required for individual patients given the
time frame of the study and that all patients had by definition received treatment.
Note 2. This study was not undertaken by the review team and hence is not included in this report.
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3.
Methods
Each of the five studies investigated both the clinical and CWT data pathway, the extent of which
varied depending on the study objectives, and any relationship between them:
1. The cancer waiting times (CWT) data pathway to identify data inaccuracy
2. The clinical pathway to identify any potential clinical harm
3. The relationship between the two to identify a potential causal relationship.
Cases were assessed according to a six-stage process (figure 1). The sampling methods differed for
each review (table 1) and are outlined in detail in each technical report. Most studies included
patients selected to be most informative rather than random samples.
Following sampling, cases were initially assessed by clinical auditors who entered data onto the audit
tool. Cases which required further expertise were subsequently referred to a CWT expert and/or to
one of three Trust doctors and subsequently a multidisciplinary clinical panel and Medical Director
for review.
The Assurance panel assessed all cases of potential data manipulation against four key questions
1.
2.
3.
4.
Has there been potential data manipulation (against agreed criteria)?
Did this possible manipulation lead to a delay?
Could this have caused harm?
Is referral to the police required?
Figure 1. Six stage audit process
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4.
Results
This overview is of key themes arising from these five audits. Appendix 2 provides comparative data
from each audit. Appendices 4-9 provide the five Executive Summaries, each supported by detailed
technical reports. Where results are given from a specific audit this is described in brackets.
1. Study population. The population of each sample on the whole were selected cohorts rather
than random samples. Patient selection enabled a comprehensive review, but each cohort
represents a relatively small proportion of the total number of patients treated on that
pathway during the study period at the Trust. E.g. the cohort of patients who waited over
91 days was 6.5% of all patients treated in 62 day pathways (long waits).
2. Poor documentation and record keeping. There was a lot of missing data in most studies,
including data in CHUFT data systems and/or the notes, and data shared with other Trusts.
There was particular evidence of missing data on name of staff authorising a CWT pathway
stop, date of pathway stop (upper GI audit) and date of tertiary referral (long waits audit).
MDT discussions were poorly documented at times, including those from other Trusts.
Between 55% and 88% of cases had at least one data error in multiple fields and there were
errors in about 10% of recorded data items, notably in decision to treat and treatment start
date. As the upkeep of case notes was poor e.g. legibility, filing, and maintenance of data,
and there were multiple cancer databases, information was often difficult to find.
3. Inconsistency between cancer waiting times (CWT) tool and patient records. There was
frequent inconsistency between dates recorded in the notes and on the CWT tool. Dates
recorded on the CWT tool were before and after those recorded in the notes and the
difference in the majority of cases was small i.e. dates recorded in the CWT tool was within
five days before or after dates recorded in the notes.
4. Cause of data errors. There were multiple causes of data error. The main reasons as defined
by IMT varied in degree depending on the objectives of each study. They included data entry
errors, misinterpretation of national guidance, operating process issues and poor
information sharing, management and recording i.e. documents which could not be located
or were incorrectly reported. As well as errors made due to lack of knowledge, incorrect
application of the CWT guidance and incorrect data entry, 36 cases were reviewed by the
assurance panel for potential data manipulation of which 16 may possibly have had data
adjusted on the CWT tool to meet target dates. The assurance panel was unable to establish
any clear evidence of intent to manipulate the data.
The study looked at dates recorded on the CWT tool and in the notes and the difference
between them. Most discrepancies were minor resulting in CWT calculated waiting times
being both shorter and longer than reality. However, in the recording of one of three fields
(the Decision to Treat (DTT) date) there was some statistical evidence of a small, systematic
bias, making waits seem slightly shorter on average than in reality. This is most likely due to
erroneous interpretation of the CWT guidelines, such as a decision recorded as the date the
MDT made the recommendation rather than the date the patient made the decision. The
methods of this study did not allow an assessment of whether this led to financial gain.
5. Uncoordinated and protracted pathways. Individual patient care pathways were often not
actively managed, and patients tracked through the system, hence their experiencing delays
in booking and re-arranging appointments. It was sometimes unclear where responsibility
lay in advocating for patients along their journey to ensure follow up was co-ordinated in a
timely and responsive way.
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Some patients waited a considerable time for their cancer to be treated. In the long waits
audit (of patients who had waited more than 91 days for treatment) the average waiting
time from referral to treatment was 118 days and 10 and nine days longer respectively if
patients were also treated at another Trust and/or had already breached their two-week
wait or 31 day target. There were a few patients who were significant outliers in urology.
Most delays occurred early in the pathway during the diagnostic phase. Delays principally
occurred in booking appointments as a result of patient factors (failure to attend, choice),
because of delayed or missing tests or due to tardy internal or external transfers of care.
It is likely that processes internal to the Trust were responsible for the majority of delays (~
57%) of which many were considered preventable, mainly in urology and lower GI. Although
there were problems with booking appointments, and rebooking after cancellations and
pauses, it was not possible to determine if this was due to capacity issues.
6. Availability, use and recording of diagnostics. Investigations were not sequentially ordered
or always acted on responsively. Some cancer pathways were changed to routine pathways
before investigations were reported. The main cause of delay related to ordering, recording,
interpreting and using results, such as CT scan reports, blood tests, and radiology reports.
Patient pathways were changed from ‘cancer” to ‘routine’ while still undergoing
investigation e.g. for colonoscopy, and referrals onto a second CWT pathway were
subsequently triggered by investigation results (47%, 69 of 147). The majority of patients in
the delayed diagnosis audit (62% or 91 of 147) were considered by clinical auditors to have
experienced a “delayed diagnosis” primarily as a consequence of waiting for investigations.
7. Patient choice. The studies identified some patients who presented late despite having
symptoms for a significant time. This is supported by the finding of a high conversion rate for
referrals to the upper gastro-intestinal service (upper GI) where cancer was found in 20% of
patients (compared to the national conversion rate of 7%). Many delays in treatment were
attributable to patient choice e.g. attending family events before treatment, patients
cancelling appointments, holidays, DNAs, declining investigations and treatment, taking time
to consider their treatment options and requesting a second opinion. Patient who chose to
delay their investigation or treatment could have been more actively followed up as this
often led to disproportionate delay.
8. Pathway stops. There was a significant evidence of a lack of understanding of CWT
guidance. This was particularly the case in decisions to stop or pause CWT pathways, when
to open new ones, consultant upgrade and change to a routine pathway. As a result,
theCWT pathway did not always reflect clinical pathways. In the delayed diagnosis audit, the
auditors considered the cancer pathways may have been stopped or changed to a routine
pathway outside national CWT guidance in over a third of cases (37% or 55 of 147), either by
clinicians (25%, 36 of 147) or by non-clinicians (13%, 19 of 147) alike.
The delayed diagnosis audit looked at those patients restarting a cancer pathway within 90
days from their initial CWT pathway being stopped: Only 50% had evidence of a non-cancer
diagnosis in the notes prior to the pathway stop. CWT pathways were stopped incorrectly
while still waiting for diagnostic results (delayed diagnosis and upper GI studies), some
patients were erroneously discharged with ongoing red flag symptoms (19 of 147, delayed
diagnosis) and several patients were incorrectly taken off following a first DNA or first
cancellation of appointments. Sometimes two pathways ran simultaneously.
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In the delayed diagnosis study 53% of patients were started on a second pathway in the
same speciality within 90 days of the first having been stopped. About half of patients were
transferred to another pathway within the Trust rather than being totally discharged.
There were instances where non-clinicians exceeded their authority in either stopping
pathways or changing their priority without clinical sign-off. In the delayed diagnosis audit
just over half (56%) of CWT stops were by a clinician and 38% specifically by a Consultant. In
the upper GI study 10% of CWT pathway stops were by a clinician and non-clinicians were
responsible for authorising 48% of stops (57 of 120), with one manger alone responsible for
86% (49 of 57) of these. In this audit, in a sample of cases selected to have a high proportion
of pathway stops by non-clinical staff, the majority were for non-cancer diagnoses and there
was no evidence that the practice led to an increased potential for harm.
9. Consultant to Consultant referrals. There was some confusion about consultant to
consultant referrals, with patients on occasion being referred back to their GP to re-refer
back to the Trust. In some cases this may have been as a result of misinterpretation of
restrictions on consultant to consultant referrals required by the Primary Care Trust (PCT) at
the time.
10. The management of complex patients. Delays were most prevalent where patients had
multiple co-morbidities requiring referral for cardiology and anaesthetic assessments,
multiple tumours that required transfer within the Trust e.g. inter MDT referrals and rare
tumours e.g. hepatobiliary requiring tertiary referral. The care of these patients provided
particular challenges but was not expedited. Vulnerable patients did not always have an
advocate to support them through the pathway. Co-morbidities outside the main speciality
were sometimes overlooked. Some patients would have benefited from an earlier palliative
care referral.
11. Shared pathways with other Trusts. Nearly a third of patients (31%, 88 of 283) who had
waited over 91 days were on a shared pathway involving CHUFT and at least one other
hospital. Patients with waits over 91 days on a shared pathway had skin, lung, breast
urology, upper GI and hepatopancreatobiliary cancers. There was a consistent issue of data
not being available and poor communication between Trusts regarding patients’ care on
shared pathways. Patients quite often breached before transfer to a tertiary centre both to
and from CHUFT. Upper GI raised particular issues regarding availability of endoscopic
ultrasound scan (EUS) and referral for hepatobiliary cancers.
12. GP/Trust communication. GP referrals were routine in 5% of cases in the error rate report
indicating not all cancers were seen as urgently as they could; the Trust needs to work with
primary care colleagues to improve early recognition of cancer. There was evidence of poor
GP/Trust communication including lack of co-ordination with GPs on tests being made
available prior to appointments or tests booked by GPs but not utilised e.g. CT replaced by
bronchoscopy. Discharge letters held inadequate instructions on what tests were needed
and by when, and also on a plan for patients e.g. what action to take if on-going iron
deficiency anaemia. GPs were occasionally not clear about the correct site they were
referring e.g. for moles with examples of an incorrect site described on referral letters.
Vulnerable patients were sometimes not clearly identified in referrals by GPs.
13. Quality of care. Although the study primarily looked at data errors and their relationship to
harm, in doing so it identified patients over the three-year study period who had
experienced sub-optimal care in their investigation, diagnosis and treatment. This was seen
in particular in the pathways of the cases where there was auditor concern, who were
15
16th December 2014
subsequently reviewed by the lead doctors, multidisciplinary panel and Medical Director
(135 patients).
Levels of sub-optimal clinical care and experience related to:
a. Poor recording and documentation in the notes, referral or discharge letters leading to a
breakdown in communication and transfer of information on patient care
b. Delayed investigations (12% or 16 of 132), or tests not reported or acted on in an
appropriate or timely manner, impacting on diagnosis and management
c. Uncoordinated and/or unresponsive pathways and transfers of care hence patients
having a disjointed and unnecessarily tardy journey through the system e.g. due to
premature discharge from one pathway onto another, including via their GP (delayed
diagnosis), and from delays in pre-operative assessments or to tertiary providers (long
waits)
d. Patients experiencing delayed diagnosis (34 cases), delayed investigation (16 cases),
delayed treatment (51 cases) and potentially incorrect diagnosis (8 cases)
e. A few patients experienced harm. The total number of patients referred for SI (Serious
Incident) investigation from the total sample was 6%. This includes 28 patients whose
care was referred for further investigation from the audit and 19 patients whose care
had previously been investigated as a result of issues raised through other routes
following the CQC report. The clinical panel judged between 4% and 9% of patients may
have experienced emotional and/or physical harm depending on the study.
14. Results by speciality. Cases where there was auditor concern regarding clinical care (plus
cases of potential data manipulation) were reviewed by a multidisciplinary clinical panel
made up of the medical director, programme director, project manager, review lead doctors,
senior nurse auditor and cancer programme director. Table 2 shows the number of cases
reviewed by speciality, with higher numbers in upper and lower GI, urology and skin.
Hae
Head
Bre Gynae mato &
Lower
Upper
Grand
ast cology logy
Neck GI
Lung Skin
GI
Urology Total
0
0
0
0
0
0
0
0
0
0
3
1
1
0
10
6
5
8
29
63
Audit
Error Rate
Long Waits
Delayed
Diagnoses
2
0
0
3
18
2
8
UGI
0
0
0
0
0
0
0
Bladder
0
0
0
0
0
0
0
Grand Total
5
1
1
3
28
8
13
Table 2. Cases reviewed by the multidisciplinary panel by specialty
5
24
0
37
8
0
2
39
46
24
2
135
15. Urology had the highest number of data items showing variance between CWT and notes
(error rate), the longest average waits, disproportionately high numbers of patients with
long waits over 91 days, all nine patients with exceptionally long waits (range 191 – 855 days
wait), the highest proportion of preventable delays (long waits), and the highest proportion
of cases where the first and second pathways were in the same speciality (delayed
diagnosis).
There was evidence of occasional poor responsiveness to investigations results causing
delay, follow up of patients and rebooking of cancellations, indicating better systems needed
to be in place.
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16th December 2014
During the timeframe of the audit the most common delay in urology was due to MRI
(Magnetic Resonance Imaging) being undertaken after a transrectal ultrasound scan (TRUS)
and biopsy for prostate cancer and the six-week gap required for patients to recover (as was
common practice). The MRI is now performed before the TRUS biopsy, reducing the six
week wait.
16. Lower GI had high rates of data errors in Decision to Treat (DTT) dates and numbers of data
items showing variance between CWT and notes (error rate). High numbers of patients
experienced long waits over 91 days, preventable delays and 2 week wait breaches (long
waits). Patients were often referred back on the same pathway within 90 days (delayed
diagnosis). The lower GI pathway had the highest number of patients whose pathway
priority was altered by clinicians from ‘target’ to routine and in whom the subsequent
routine investigations identified a tumour (delayed diagnosis).
Following urgent rigid sigmoidoscopy in a number of cases the target cancer pathway were
changed to a routine pathway for colonoscopy which later revealed a tumour. Patients with
suspected lower GI cancers sometimes waited 2-3 weeks for their initial colonoscopy after
first being seen. Delays occurred in diagnostics, pre-operative assessments and follow up of
patients who DNA. There is a need for implementation of an iron deficiency protocol with
primary care.
17. Upper GI There was evidence of poor data recording around DTT, high numbers of data
items showing variance between CWT and notes and high numbers of 2WW breaches. Nonclinicians inappropriately stopped the CWT pathways and few stops were authorised by
clinicians. A few urgent cancer pathways were shut down with no recorded clinical
authorisation following endoscopy despite ongoing investigation and red flags symptoms.
There is need for consistent implementation of an iron deficiency protocol and clarity
regarding referral for lower GI investigation following referral to upper GI and vice versa.
Delay occurred particularly in relation to referral of complex patients to Broomfield for EUS
and oesophageal cancer and to the London and St Bartholomew’s Hospitals for hepatobiliary tumours. These pathways need to be reviewed.
18. Dermatology and medical photography. There were particular issues related to medical
photography in dermatology including incorrect site referral and photography and discharge
without being seen in person by a clinician or confirmation from histology. As a result there
were occasional delayed diagnoses.
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16th December 2014
5.
Discussion
This study represents the experience of 822 patients treated mainly between October 2010 and
December 2013 at the Trust. However, it is also illustrative of a system under considerable strain in
implementing a complex CWT data collection system without the necessary resources in managerial
support systems for CWT data quality assurance.
Study methodology
This report is the result of five detailed studies of cancer care. The reviews were of cohorts of
patients selected to be the most informative in specialties known for data errors, waiting over 91
days, who had a second cancer pathway started within 90 days of the first ending, who had their
cancer pathway potentially stopped by a non-clinicians and who were having on-going follow up for
superficial bladder cancer. As such they are not a representative sample and constitute a relatively
small proportion of all patients treated at the Trust. For example, in long waits delayed diagnosis the
audit sample was 6.5% of the total number of patients treated on 62 day pathways in the same time
period. This highly selected patient group were much more likely to have experienced problems in
their care than average.
As well as summarising data across the study sample, the review was concerned with findings
related to the care of individual patients. Any patient reviewed who may have been subject to
clinical error had their care scrutinised by clinical auditors, one of three lead doctors, a
multidisciplinary panel and the Medical Director to ensure any outstanding remedial actions have
been taken.
There were limitations to the methodology developed by IMT:





Each study was highly complex and developed from scratch, involving thousands of data
points in multiple data fields
On the whole, the review team did not include relevant speciality expertise e.g. all cases
with moles were not seen by dermatologists
Clinical auditors were not experts in CWT pathways and referred cases for CWT expert
guidance
Many of the assessments were subjective e.g. in quantifying delayed diagnosis and harm.
Clinical auditor assessments were higher than the clinical panels due to inter-observer
differences, and the latter are more likely to reflect reality given the multidisciplinary
discussion of each case required as many were extremely complex.
These reports are likely to represent the most comprehensive assessment of cancer care in
an acute Trust and as such there are no comparison studies to benchmark the results.
The National Audit office has demonstrated an error rate of 57% (incorrectly recorded or no
evidence) in waiting times data that are not cancer specific 4. More difficult to qualify and bench
mark is level of harm. The reviews assessed harm using multiple processes: two assessments by
different clinicians using CQC categories of emotional and/or physical harm and secondly, according
to the rate of SI investigations against national criteria, many of which maybe later stood down. The
threshold for SI investigation may vary between Trusts so be incomparable. Research evidence is
that levels of harm range from 3-25% in acute care5. A more sensitive assessment of degree of harm
is needed for similar case reviews to benchmark data with other Trusts.
4
http://www.nao.org.uk/report/nhs-waiting-times-elective-care-england/
The Health Foundation. Evidence Scan. Levels of Harm.
http://www.health.org.uk/public/cms/75/76/313/2593/Levels%20of%20harm.pdf?realName=PYiXMz.pdf
5
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16th December 2014
The results have been subject to rigorous measures to ensure transparency and mitigate the
potential for self-interest including regular reporting to the assurance panel, and external CWT
expert and Consultant review. Draft reports have been tested with relevant external specialist and
CWT experts who have advised on the recommendations below. The main author of the reports and
Programme Manager is a GP and Consultant in Public Health only recently employed by the Trust.
In addition to the external review by the Strategic Clinical Network, a smaller review of CWT data
assessment was also undertaken by the Royal Marsden Hospital of 10% of cases in the error rate
audit. The results of both these external reviews, broadly consistent with the assessments
undertaken by the Trust, have been seen by the Assurance Panel and hence provide reassurance on
the robustness of this review.
Study findings
This study found:





A high proportion of data errors and inconsistency between the notes and CWT pathway
resulted from lack of knowledge, poor application of CWT guidance and poor data recording
Avoidable delays were caused by difficulties booking appointments, the availability and use
of diagnostics, uncoordinated cancer pathways and lack of prioritisation in the management
of complex patients. In addition there were patient factors such as late presentation, failure
to attend appointments and choice to delay investigation and treatment.
Cancer pathways were erroneously stopped, including by non-clinicians, and as well as
referring onwards to other specialists or changed to a routine pathway type, some patients
were prematurely discharged
Many patients experienced different levels of sub-optimal care and a few experienced harm
unrelated to data issues.
Documentation, communication and/or responsiveness needs improvement, including
between GPs and the Trust, within the Trust between specialties and between the Trust and
other hospitals on shared pathways.
It is of concern that patients’ pathways were not actively managed and the Trust was responsible for
most preventable delays. Much more attention is required to proactively manage pathways early on
especially for patients with multiple co-morbidities, rare tumours and impaired mental capacity. In
these complex patients e.g. where a primary is not obvious, a dedicated service should be
considered for initial investigation to prevent the need for multiple referrals. More capacity and
responsiveness is needed in relation to diagnostics to ensure patients can move swiftly through the
system overall.
The audit on readmission to a second CWT pathway in 90 days was the most sensitive assessment of
quality of care and picked up the most cases of potential harm. The Trust should therefore assess
this on a quarterly basis going forward and use it as a performance indicator.
Four specialties, urology, upper and lower GI and skin, stand out as having more substantive issues
in relation to both CWT data and clinical pathways. Careful consideration needs to be given as
whether these specialties have sufficiently addressed the issues identified in this report especially as
this review was under taken in the main by generalists and not specialist clinicians.
A particular theme was around hand over of care between teams both within the Trust and between
Trusts. The Strategic Clinical Network needs to work with other local Trusts to improve pathways
and communication, and in particular hepatobiliary, urology and upper GI pathways. The CCG needs
to work with the Trust and local GPs to improve joint working on referral, discharge and availability
of tests.
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16th December 2014
This study illustrates that both CWT and clinical pathways were not always well managed and were
uncoupled in terms of alignment of managerial and clinical processes, as illustrated particularly
around CWT pathway stop. Both CWT data and clinical pathways affect quality of care and patient
experience as do the relationships between clinicians and managerial colleagues, requiring them to
take collective responsibility for both pathways. Clinicians are responsible for the whole pathway of
care for their patients and not solely the “technical aspects”, as well as providing leadership to the
team on the whole service they provide.
Discrepancies between dates recorded in the notes and CWT tool were mostly minor. There was
evidence of a small systematic bias in the Decision to Treat (DTT) date on the CWT tool such that
recorded waits were shorter than in reality. While it was not possible to exclude unscrupulous
intent, a more likely explanation is a minor, but erroneous interpretation of the guidelines. It was
not possible to establish that this bias led to financial gain for the Trust.
Data manipulation was considered a possibility in 16 cases. In these patients it was equally difficult
to establish intent and in none did erroneous data entry lead to harm.
The assurance panel assessed the possibility of a causal relationship between harm and changes in
the CWT data. It considered whether CWT data inaccuracies had caused delay and whether this
delay may have led to harm; this would have required referral to the police. From the patient
perspective the possible harms are both individual and systemic.
Individual harms would be where an erroneous CWT data entry led to delay or other
mismanagement that led to harm. However it became clear during the audits and review process
that the CWT tool was not used for individual patient tracking but for audit and reporting
purposes. Therefore erroneous data changes, fraudulent or otherwise, would not have been the
cause of changes to patient’s care and so could not have led to individual patient harm.
Systemic harms that might arise from inaccurate data entry occur if the data were used to evaluate
performance, and performance was seen as acceptable when it was not, and problems with the
system were either ignored or missed. This sort of harm cannot be assessed by review of individual
records of patients who have had erroneous data recorded.
It therefore can be seen that the lack of organisation in some pathways (systemic problems) caused
delays and it was the lack of organisation and delays that caused any erroneous or potentially
fraudulent data entry, not the other way around.
Patients in this audit experienced delays which were likely to have caused considerable anxiety and
inconvenience. It is also clear that the experience of many could have been significantly improved.
However, this was highly unlikely to have been caused by systematic data manipulation unless
erroneous reporting caused system problems to be overlooked.
Wider implications
The studies illustrate the complex nature of booking appointments and that cancellations and
pauses caused disproportionate delay. This seemingly chaotic booking system e.g. patients being
discharged from one pathway then returning on another, may result from an over stressed system
resulting from limited capacity, poor management systems and high patient demand which then all
together create a negative feedback loop and reinforce inefficiency.
The national guidance for CWT recording is extremely complex and only understood in detail by a
few. The Trust found it extremely difficult sourcing cancer waiting times expertise to advise the
20
16th December 2014
project including through the Strategic Clinical Network. This illustrates only a few people hold the
vital information to ensure CWT data is as accurate as possible. It may be unrealistic that many
clinicians and managers hold this knowledge and are able to update and apply it effectively, and a
dedicated manager is required.
For a patient on a cancer pathway clinicians should make a reasonable clinical effort to exclude
cancer before CWT pathway stop. Reasonable effort would include onward referral for further
investigation when clinically indicated i.e. either a test or another specialist. It may be impossible to
definitely exclude cancer. There will remain a cohort of patients for whom initial reasonable
investigation based on 2-week rule symptoms do not identify cancer but will subsequently have a
cancer diagnosed. For these potential patients a clear system of safety netting needs to established
in primary care.
Cancer mortality statistics show the Trust’s population within the national normal range. NE Essex
CCG one-year survival index is within the normal range for all cancers combined for adults, and one
and five-year survival rates and mortality 2008-2012 by cancer type are all within the normal range.
Therefore these studies may identify actions that improve cancer survival in the Trust and also in the
wider NHS. Other districts are likely to have similar issues but cancer mortality rates may not be a
sensitive indicator for these types of problem.
Equally this review has identified a gap in peer review. However, this study looking at cancer on a
case by case basis was highly resource intensive costing over £500K and taking 10 months to
complete. On-going audit should be part of continuous quality improvement.
The National Audit Office recommends that patients understand their rights in terms of waiting
times. The highly complex nature of the CWT guidance creates considerable opportunity for error
and potential for misuse and disempowers patients to be able to negotiate their care against
understandable milestones. Resources should be matched to the complexity of the task. The Trust
should make patient engagement and patient centred care central to next steps to provide
compassionate service and more effectively manage demand through self-care support.
21
16th December 2014
6.
Conclusion
This study investigated potential data manipulation in a selected group of patients and evaluated
whether such manipulation might have caused harm. In doing so it looked in depth at cancer care
and uncovered may other issues related to both CWT and other data as well as clinical pathways of
care.
There were a large number of data errors in the CWT tool and/or notes, but no harm arising from
these was identified. Indeed any putative causal relationship between a specific data error and
harm to an individual patient was extremely unlikely as the CWT tool was used for audit and not
individual patient tracking purposes. There was suspicion of potential data manipulation in 16 cases,
most likely to be due to erroneous interpretation of complex guidance although it was not possible
to establish intent. Disproportionate levels of harm outside what is usually expected in a hospital
dealing with high risk did not appear to be caused by data errors or by managers erroneously
stopping cancer data pathways. However suboptimal standards of care were found, outside of the
study objectives.
Data entry and quality needs urgent attention, the knowledge and application of CWT guidance
significant improvement, cancer pathways to be managed more proactively and pathway stops only
authorised by clinicians. The Trust needs to develop a culture of high standards and excellence
promoted through collective responsibility and accountability, accepting risk and error is
unavoidable and best managed as a learning organisation seeking continuous quality improvement.
This study has provided considerable insight for the Trust. The next steps should now be about
minimising harm for future patients, improving the experience of patients with cancer and working
towards improving cancer mortality rates in the Trust, local system and wider the NHS using these
results as a stimulus for change.
22
16th December 2014
7.
Summary of recommendations
7.1 Clinical and managerial leadership and dissemination
7.1.1
The reports from the retrospective review of cancer care should be used as a catalyst to
develop excellence at the Trust. This will require clinical leadership, improved team work,
adherence to agreed standard operating procedures and national guidelines and clear
personal, team and divisional accountability to improve standards of care.
The Trust Cancer Board should incorporate any additional recommendations arising
from the retrospective review report that have not already been addressed in the
2014 Cancer Action Plan into the 2015 Cancer Board Work Programme
(The 2015 Cancer Board work programme is in the process of being developed to incorporate
any actions identified in the Retrospective Review not already delivered).
7.1.3
An implementation plan for this report dissemination and actions should be developed
including sharing reports:
Across the Trust
With all Divisional Directors and Teams.
At specialty governance meetings and include review of all cases discussed at the
clinical review panel and the external review team’s assessment.
(This recommendation has been covered in the development of the 2015 Cancer Board Work
Programme).
7.1.4
The Trust should develop a strategy for quality improvement based on the findings of this
review. It should seek to become a case study for necessary interventions to improve cancer
care using the latest evidence on improvement science methodologies as a pilot to inform
other Trusts.
(Section B10 of the Cancer Action Plan; Continuous Quality Improvement Programme ratified
at Cancer Board May 14).
7.1.5
Patient involvement and on-going use of patient experience is required to ensure care
continuously improves. This should include clinicians being trained in communication skills,
patient-centred care and self-care support.
(Development of patient experience has been agreed as a key component of the 2015 Cancer
Board Work Programme which is in development).
7.1.6
The NAO recommends that Clinical commissioning groups and trusts should work together to
impress on patients their rights and responsibilities.6 The Trust and CCG should work with
patients to understand their rights and responsibilities around cancer waiting times.
CWT data and recording
7.2.1
The Trust needs to emphasise the importance of clinical and administrative record-keeping,
with legible and well-ordered case notes and computer records and ensure that it is
reflected in job descriptions.
6
Department of Health, “NHS waiting times for elective care in England,” HC964 Session 2013-14 23 January
2014, National Audit Office, p. 11.
23
16th December 2014
(Cancer Action Plan reference B4.1, B4.3 and B5 – Somerset implementation; letter from
Medical Director to Consultants and Nurse Specialists setting out guidance on information to
be recorded in clinical correspondence to ensure key cancer waiting time milestones can be
readily identified – December 2014).
7.2.2
The Trust should consider implementing an electronic patient record as a high priority.
Patient paper records should be stored together, a central inventory of clinical systems
created and Departments and service areas develop clear maps of where they store data
and who has access rights.
(Cancer Action Plan reference B4.1, B4.3 and B5 - Somerset implementation; implementation
of Medway Clinical Portal system December 2014).
7.2.3
The term ‘urgent’ by clinicians for diagnostic and appointment requests should be clearly
defined in terms of timescale and clinicians and managers across primary and secondary
care informed.
7.2.4
There should be improved staff training in Cancer Waiting Times (similar to Referral to
Treatment (RTT) and greater accountability for data recording measured through an ongoing programme of assessment. Those with specific responsibility should have regular CPD,
testing, mentoring and continual on-hand support and guidance from a CWTs expert.
(Cancer Action Plan reference B1.1, B1.4, B2.5, B2.2, B4.1 and C2.2 relating to Cancer
Waiting Times training).
7.2.5
The employment of a full time Cancer Services Data Manager by the trust should be a
priority. The fundamental role of this individual would be robust data validation on every
pathway prior to any submission to Open Exeter to ensure complete accuracy and full
compliance with the CWT Guidance.
(Cancer Action plan reference C2.1 standard operational policy for cancer services)
7.2.6
The Trust should establish a dedicated team for CWT data monitoring and support.
Implementation of weekly PTL meetings between the MDT Co-ordinators, Data Manager,
Lead Cancer Manager and relevant Operational Managers reviewing each patient on the
cancer pathway, what day of the pathway they are on and what stage within their clinical
pathway they are on, what steps need to happen next and if any escalation is required.
(Cancer Action plan reference B7.1, B7.2, B7.3 and B8 relating to weekly PTL
meetings. PTL process document ratified at Cancer Board June 14).
7.2.7
Given that awareness of CWT guidance and data reporting needs fundamental improvement
one of the roles of the Cancer Services Data Manager would be to ensure MDT Co-ordinator
have robust, thorough and continuous training in the use of the CWT national guidance. The
Data Manager will also act as an on-going mentor for the co-ordinators.
(Cancer Action Plan reference Section C relating to MDT Co-ordinator training; reference
C2.2 relating to development of e-learning module for Cancer Waiting Times).
7.2.8
Whilst awaiting the implementation of an electronic ordering system, all investigation
requests for a patient on cancer pathway should be ‘flagged’ in such a way that they can be
clearly identified and appropriately prioritised.
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16th December 2014
7.2.9
The Trust should ensure clear documentation of clinical decisions and use of name stamps
when making cancer diagnosis and stopping CWT for medico-legal purposes and named
authorisation when using computer records including at MDT meetings. A stamp that flags
the notes that the patient is a priority i.e. a 2WW stamp, should also be considered.
Quality assurance
7.3.1
There should be a process to assess data quality in cancer through a rolling programme of
audits reporting to the Board, which also reports on the quality of case notes as well as
accuracy of electronic records.
(Cancer Action plan reference, Section B Data Collection and Governance; daily/weekly/
monthly data reports implemented January 2014).
7.3.2
A sample of patients’ records should be subject to regular audit by the Trust using the
templates developed in this study. In particular the audit in delayed diagnosis (where
patients are on consecutive cancer pathways) should be repeated quarterly and a way found
to identify these patients in real time to ensure they are managed effectively, and necessary
changes put in place.
(Cancer Action Plan reference, Section B; pathway audits by each tumour site implemented in
February 14 by Cancer Board with sample size based on volume of referrals).
7.3.3
All patients who breach at 31 days should be prioritised and regular analysis of 62 day
breaches put in place to ensure these patients’ care is expedited. Monthly or six weekly
review of breaches in the diagnostic and or treatment phase (like mortality reviews) would
aid shared understanding and ownership of issues.
(Cancer Action plan reference B2.3, B7.1, B7.2, B7.3 and B8 relating to weekly PTL meetings.
Programme of review of breaches prior to upload to national cancer waiting times database,
Open Exeter, in place).
7.3.4
The Trust should adopt the on-going audit of data on Somerset to indicate compliance with
CWT guidance. Checks to be put in place to ensure Cancer Recording System (currently
Somerset Cancer Registry, previously CWT Database) and PAS data matches, and
discrepancies between the two systems are resolved (e.g. alter SCR if PAS is correct, alter
PAS if SCR is correct).
(Cancer Action Plan reference B2.2, B2.3 relating to daily reconciliation of
information between PAS and Somerset and upload to national cancer waiting times
database, Open Exeter; daily/weekly reconciliation of 1st appointment, treatment
and deceased patients).
7.3.5
This report and others have highlighted deficiencies in the way the hospital monitors and
gathers data relating to patient experience. Systems to capture and triangulate this kind of
data need to be established and should form part of routine performance monitoring and
governance.
CWT and clinical pathways
25
16th December 2014
7.4.1
The Trust should prioritise the development of a step down policy (removing the patient
from their cancer pathway), outlining the roles and responsibilities of the MDT. All staff
should be reminded:
 that practicing clinicians alone are authorised to stop cancer pathways following
appropriate training; without clinical sign off a cancer pathway cannot be stopped.
 Patients must not be removed from a pathway before target investigation reporting.
(Letter from Medical Director to all Consultants and Nurse Specialists setting out guidance on
information to be recorded in clinical correspondence to ensure key cancer waiting times
milestones can be readily identified – Dec 14)
7.4.2
There needs to be clear understanding that target referral is to rule out malignancy. Until
malignancy has been excluded based on the clinical presentation the cancer pathway should
remain open. It may be transferred from one site to another but closed only after :
 Cancer has been confirmed;
 Or the clinician is confident to inform the patient they do not have cancer.
(Letter from Medical Director to all Consultants and Nurse Specialists setting out guidance on
information to be recorded in clinical correspondence to ensure key cancer waiting times
milestones can be readily identified – Dec 14)
7.4.3
A standard proforma should be developed for recording changes in each patient’s CWT
pathway and shared with the GP with every letter.
(Cancer Action plan reference – Section B Data Collection and Governance; Somerset system
has ability to record changes made by individuals. Clinical and nursing sections of the system
have the ability to record discussions with patients which will support changes to pathway
priorities).
7.4.4
If a patient is waiting for target appointments and gets admitted as an emergency for the
same symptom, this should be highlighted and lead to prioritising investigations as an
indication of acceleration of disease progression.
(Clinical Portal (Medway) system enables cancer patients to be flagged so are visible to
emergency admission teams. Implemented December 14).
Speciality action
7.5.1
Following review of cases and the external specialist, a systematic detailed review of each
cancer pathway including an approach to scheduling investigations, tracking tests acting on
results and planning treatments is needed to reduce the cumulative delays. All core and
non-core MDT members need to ensure they have a clear understanding of revised
pathways of care.
(Revisits of five cancer pathways, Urology, Brain & Central Nervous System, Sarcoma,
Radiology and Cancer Unknown Primary, in July 14). Report published by NHS England,
Progress Review of five cancer services at CHUFT, July 14.)
7.5.2
Action plans must be developed to be shared with the Medical Director and monitored
against delivery and agreed deadlines by the Cancer Board. While this should be done for all
specialties, it is particularly important in urology, lower and upper GI and skin.
26
16th December 2014
(Cancer Action Plan had dedicated actions for all specialties which has been delivered and
monitored throughout 2014.)
7.5.3
Named team members should be assigned to pro-actively track and manage the patients
through the systems. Complex patients with multiple tumours, multiple morbidity and
safeguarding issues should be prioritised, with the CNS coordinating and managing the
pathways liaising with tertiary CNSs.
(MDT Co-ordinator team are moving to prospective patient tracking methodology using
Somerset system.)
7.5.4
Urology standards of care and procedures should be considered as part of the pan Essex
cancer review. This should include inter trust referrals.
7.5.5
A surveillance protocol needs to be developed for patients who have superficial bladder
cancer to ensure systematic recording and planning especially in the event of a recurrence.
There should be a recording of when cystoscopies are due, and if not done then the reason
can be recorded as Declined/Not fit/clinical decision. Audits needs to be on-going in order to
identify if there is a problem in maintaining surveillance programs for bladder cancer.
7.5.6
There needs to be stronger management of waiting lists, in particular reconciling the clinical
decision for future dates for surveillance against that offered to the patient.
7.5.7
Pathways should be mapped for upper and lower GI to identify the relationship and criteria
for referral between them, including the development of an iron deficiency anaemia
protocol or updating the one in place. This should be undertaken and shared with GPs to
prevent simultaneous referral to both specialities leading to inefficiency.
7.5.8
Clinicians need to be actively involved in on-going audits to ensure changes are followed
through.
7.5.9
The Trust and NEE CCG should take a view on the need to develop a general clinic for work
up and cancer investigation when the primary source of cancer is not obvious to prevent
referral between multiple specialties.
(As part of the Cancer Action Plan work is being undertaken to define the parameters of a
Cancer Unknown Primary service within CHUFT).
7.5.10 The Trust should consider whether further intervention is necessary into those specialties
highlighted as part of the retrospective review.
Capacity
7.6.1
More diagnostic capacity is required as well as an assessment of its use to ensure efficiency.
This would include clear referral criteria, reducing times between tests and ensuring results
are available at appointments. All letters between Consultants and GPs should refer to
investigations required and completed to ensure tests are available and not duplicated.
(A direct access gastroscopy diagnostic service is being developed in conjunction with the
North East Essex CCG; Intensive support team capacity and demand toolkits have been
completed in each specialty to assess capacity.)
27
16th December 2014
7.6.2
When the PAS has been upgraded the Trust should implement an IT system for ordering and
reviewing results, to ensure all test results are acted on quickly and any delay monitored and
flagged with named clinician responsible recorded. Whilst awaiting the implementation of
an electronic ordering system, all investigation requests for a patient on a cancer pathway
should be ‘flagged’ in such a way that they can be clearly identified and appropriately
prioritised .
(Cancer Action Plan reference G14 1.3, Radiology protocol for Probable Unexpected
Malignancy; protocol ratified at Cancer Board March 14; audit report presented to Cancer
Board each month).
7.6.3
Outpatient capacity in booking appointments requires review as this contributes to delay,
and systems put in place to flag patients who are vulnerable including patients who Do Not
Attend (DNA) appointments.
(Intensive Support Team toolkits completed for all specialties during 2014; capacity is being
reviewed on an ongoing basis as part of the regional performance improvements.)
System issues
7.7.1
All cases reviewed by the clinical panel who are cared for elsewhere should also be reviewed
by the relevant Medical Directors of partner Trusts.
(Cancer Action Plan reference, Section F Inter Provider Transfers. Regional policy being
developed in conjunction with Essex Providers and Strategic Clinical Network)
7.7.2
All Trusts involved in these pathways need to consider this review. There is an urgent need
to improve communication between Trusts. The Strategic Clinical network has a role in
improving processes for inter trust referral and feedback particularly Upper GI cancer
referrals to Broomfield and hepatobiliary referrals to the Royal London. A review of capacity
for specialist investigations should also be included e.g. EUS.
(Cancer Action Plan reference, Section F Inter Provider Transfers. Regional policy being
developed in conjunction with Essex Providers and Strategic Clinical Network)
7.7.3
The named key worker and the MDT Co-ordinators should keep a track of inter-trust
referrals including dates informing and advising the patient as appropriate so that any delay
at any part of the transfer can be identified and addressed in an anticipatory manner.
(Cancer Action Plan reference, Section F, Inter Trust Referrals. All inter-trust referrals are
recorded on Somerset system. Essex Trusts have data sharing agreement involving read-only
access to Somerset systems.)
7.7.4
These results should be shared with GPs. There should be clear feedback when there is
insufficient or incorrect information on referrals. Clear referral protocols are needed
including diagrammatic representation when required e.g. for moles, site of breast lesions.
Discharge letters should include clear instruction on follow up and tests required for follow
up appointments. Cases where GPs refer simultaneously to multiple pathways for the same
symptoms should be reviewed.
(Letter from Medical Director to all Consultants and Nurse Specialists setting out guidance on
information to be included in clinic letters/documentation to GPs)
28
16th December 2014
7.7.5
The procedures for Consultant to Consultant referral and when patients do not attend (DNA)
need to be reviewed, shared to reduce confusion and monitored for compliance e.g. referral
back to GP to re-refer back to the Trust. Patients with on-going red flags should be actively
followed by booking clerk and MDT Co-ordinators if they DNA. The patient’s GP should be
informed and asked to follow up.
(Cancer Action Plan reference B7.7, B9 relating to single point of referral, Contact Centre
Cancer Hub, implemented December 2013.)
7.7.6
There will remain a cohort of patients for whom initial reasonable investigation based on the
symptoms does not identify cancer but who will subsequently have a cancer diagnosed. For
these patients a clear system of safety netting needs to established in primary care.
29
16th December 2014
Appendices
Appendix 1 Cancer Waiting Times Guidance (vs 8.0)
Two-Week Wait (2WW) is defined as “urgent GP (General Medical Practitioner (GMP) or General
Dental Practitioner (GDP)) referral for suspected cancer to first outpatient attendance”. Patients
referred on this pathway are required to be seen in the Trust within fourteen calendar days from the
receipt of their referral. Patients on this pathway are concurrently on both the 62-Day pathway
(from receipt of referral) and 31 day 1st definitive treatment pathway (from Decision to Treat (DTT)7).
31-Day First Definitive Treatment is defined as “decision to treat to first definitive treatment”.
Patients referred under this standard are required to commence first definitive treatment for a new
cancer diagnosis within 31 days of the date of decision to treat being made.
62-Day Standard is defined as “urgent GP (GMP or GDP) referral for suspected cancer to first
definitive treatment”. Patients referred with suspected cancer under the two-week wait standard
(2WW) are required to commence first definitive treatment, if cancer is diagnosed, within 62 days
from the date of receipt of referral for the suspected cancer, and within 31 days of the DTT.
The 62-Day Screening is defined as “urgent referral from NHS Cancer Screening Programmes (breast,
cervical (gynaecological) and bowel (Colorectal) for suspected cancer to first definitive treatment”.
These patients are required to commence first definitive treatment, if cancer is diagnosed, within 62
days from the date of receipt of referral for the suspected cancer.
31-Day Subsequent Treatment is defined as “decision to treat/earliest clinically appropriate date
(ECAD) to start of second or subsequent treatment(s) for all cancer patients including those
diagnosed with a recurrence where the subsequent treatment is surgery, anti-systemic cancer
treatment (drugs), or radiotherapy. These patients are required to commence treatment within 31
days of the date of decision to treat being made or earliest clinically appropriate date.
Waiting Time Adjustment (First Seen) records the number of days that patients should be removed
from the calculated waiting time for the two week wait period and potentially the 62 day period (if
cancer is confirmed).
Waiting Time Adjustment (Treatment) records the number of days that should be removed from
the calculated waiting time between the date of decision to treat and the treatment start date i.e.
the number of days that a clock can be paused for a 31 or 62 day period if a reasonable offer of
treatment in admitted care has been declined.
Consultant upgrade is defined as “62 days from a consultant’s decision to upgrade the urgency of a
patient (e.g. following a non- urgent referral) to first treatment for cancer. The non-urgent referral
can be upgraded by a consultant (or authorised member of the consultant team as defined by local
policy) because cancer is suspected.”
Downgrade: Two week wait referrals can only be ‘downgraded’ (taken off suspected cancer
pathway) by a GP - if a consultant thinks the two-week wait referral is inappropriate this should be
discussed with the GP and the GP asked to withdraw the two-week wait referral status – a GP should
not be asked to downgrade a patient (or withdraw the referral) simply because they are unavailable
to accept an appointment within two weeks. If the patient cannot ‘guarantee’ attendance for tests
or treatment within a certain timescale the patient should not be downgraded.
7
Decision to Treat (DTT) is defined as “the date the patient agrees a treatment plan”.
30
16th December 2014
Appendix 2 Project management and governance
To provide transparency and assurance the Retrospective Review Programme Steering Group in
tandem reported throughout the audit period every two weeks to the Assurance Panel. The External
Retrospective Review Assurance Panel was Chaired by the NHS England Essex Area Team Medical
Director, and included representatives from NHS England, Health Watch Essex, North East Essex
CCG, The Information Commissioner, the Department of Public Health and Primary Care, University
of Cambridge, and included the Trust Medical Director, Programme Director and Project Manager.
Members of the Assurance Panel reported to IMT and its own constituent organisations through
current processes.
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16th December 2014
Appendix 3 Comparative results one each audit
Code
Definition
Error
rate
Long
waits
Sample size
as a % of all
cases
Data missing
Delayed
diagnosi
s
8%
Upper
GI
Proportion of all 62 day N/A
6.5%
4.5%
pathways during the study
period
Data unavailable on CWT tool 6%
14%
NA
2%
and in notes
Data errors by the number of data entries entered onto the audit tool in a number of
fields
Data errors
by data field
Bladde
r
cancer
N/A
N/A
Proportion of date errors by 10%
9% (117
N/A
16%
the number of data items (142 of of 1,249
(35 of
reviewed that are present in 1,453
entries)
214)
the notes and on the CWT tool entries)
i.e. verified
Auditor assessment of data errors by case i.e. at least one data error in any field
N/A
No errors by
case
Data with
other
provider &
not audited
Total data
errors by
case
including:
Data entry
errors
Misinterpret
ation of the
national
guidance
Operating
process issue
Member of
staff working
outside the
scope of
their
responsibility
The record is found to be
accurate and complete in all
fields for each patient.
Data unavailable as a result of
treatment occurring at other
hospital.
When CWT and other sources
of
information,
including
patient notes, match although
the data has not been updated
e.g. on another pathway,
appointment brought forward,
incorrect treatment entry
When an incorrect entry
appears to have been made as
a result of a misunderstanding
of the national CWT guidelines.
A substantive error in a
process or procedure, as
opposed to the recording of
that process or procedure.
Clock stop on cancer pathway
by any non-practicing clinician
39%
(97 of
250)
6% (14
cases)
29% (68
of 233)
12%
(14 of
120)
0
N/A
17% (50
of 290)
46% (68
cases of
147)
1% (1
case)
55%
(139 of
250)
71% (165
of 233)
53% (78
of 147)
88%
(106 of
120)
N/A
40%
(100
cases)
16% (38
of 233)
3% (5
cases)
7% (4
of 57)
N/A
11%
(28
cases)
6% (13
of 233)
16% (24
cases)
10%
(12 of
120)
N/A
3% (7
cases)
45% (105
of 233 )
12% (18
cases)
15%
(18 of
120)
N/A
0 (no
case)
1% (2 of
233)
18% (26
cases)
55%
(66 of
120)
N/A
N/A
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16th December 2014
Potential
data
manipulation
Where there is no valid
explanation why CWT has been
altered to meet national
1
reporting standards and data
does not reflect actual patient
experience
• There is variance; and/or
• There is no valid reason
• Other sources give rise for
concern e.g. complaints
Other assessments
Potential
As determined by assurance
data
panel against criteria to asses
manipulation referral to police
New cases
for SI
investigation
Other cases
for SI
investigation
Potential
clinical or
emotional
harm
Potential
clinical or
emotional
harm
2% (4
cases)
3% (7 of
233 )
3% (5
cases)
1% (1
of 120)
0
4 cases
assesse
d, no
data
manipu
lation,
no
harm
12 cases
assessed,
8 cases
of data
manipula
tion, in
one
patents
further
investiga
tion
underwa
y
8
13 cases
assessed
, 4 cases
of data
manipul
ation, no
harm.
5 cases
assess
ed, 4
cases
of data
manip
ulation
, no
harm
0
11
2
2
Cases in the sample also on the 3
surveillance log (excluding
above)
Assessed by auditors and 2 of
clinical panel
250
9
5
2
0
33 vs 23
of 283
24 vs 13
of 147
10 vs 5
of 120
As determined by both auditors and clinical review
panel
8%-12%
9%-16%
4%-8%
As determined by the clinical 2
review panel
28% (2
patient
s)
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16th December 2014
Appendix 4 Executive Summary – Error Rate Study 1
Executive Summary
Following concerns about cancer care at the Trust, in 2013 Colchester Hospital University NHS
Foundation Trust (CHUFT) was inspected by the Care Quality Commission (CQC), who reported
inconsistencies in data held on the Cancer Waiting Times system (CWT) and within 61 medical
records. In 22 of these cases, the delay in treatment may have had an impact on patients’ health
(see below).
“During our examination of 61 patient medical records we noted there to be inconsistencies
between information that was held on the cancer wait times system (CWT) and that which was
contained within people’s medical records. In total 22 of the files showed discrepancies in a
person’s pathways.
We found that entry dates on the CWT system did not always correlate with the patients' medical
records. We found that in 22 cases the treatment dates recorded on the system had been changed.
Details and examples of the altered records are reflected in the section for 'records' in this report.
The changes to the patient cancer pathway was identified through a review of the medical records
which demonstrated that treatment had been provided on a date different to the one recorded on
the CWT system. The changes in those 22 cases meant that people could have experienced a
negative impact in the form of their treatment being delayed. The risk of delayed treatment could
impact on their care and longer term health”.
CQC Report into Cancer Services at Colchester Pages 12 and 7, Published 5th November 2013.
The Retrospective Review was commissioned by NHS England and the Incident Management Team
(IMT) as part of a suite of measures arising from the inspection and review of cases. The review aims
to investigate, through a transparent audit process, the extent of data inaccuracies in Cancer Waiting
Times in the Trust and their impact on clinical care. This report describes findings from Study 1 into
the error rate of cancer pathway data and is one chapter of six in the Retrospective Review’s overall
report.
The Retrospective Review looked at two aspects of patient care at the Trust and any relationship
between them:
4. The Cancer Waiting Times data pathway to identify data inaccuracy
5. The clinical pathway to identify any potential clinical harm.
This study on data error rate looked more specifically at data issues. Its aim was to assess the
historical accuracy of the data held on the CWT through case note review of a stratified sample of
250 records between April 1, 2010 and October 31, 2013 so that accurate Trust cancer waiting time
performance can be assured.
The audit was a six stage process including data sampling, template development, case note review,
expert cancer wait pathway and clinical review, analysis and report writing and an external review of
a random 10% of records. This was undertaken by a cancer data expert from the Royal Marsden NHS
Foundation Trust to check auditors’ accuracy of assessment and validity of results and external
Consultants identified by the Anglia Cancer Network to assess quality of care. Cases of “potential
data manipulation” were reviewed against criteria by an Assurance Panel made up of all key
34
16th December 2014
stakeholders and chaired by NHS England Medical Director to identify any need for referral to the
police.
No data inaccuracy was found in 97 of the 250 cases (39%) reviewed and in 14 cases (6%)8 the
dataset could not be entirely verified as the activity was at other Trusts.
The audit indicates that, in 55% (139) of cases, across most specialties reviewed and for a number of
reasons, there were data inaccuracies in the CWT database. For all patients on a cancer pathway,
reviewers considered up to nine data fields, and there was an error rate of 10% in all completed data
entries (142 of 1,453 cases).
Although the actual error rate of 55% may not be representative of the whole CWT database, as the
sample was taken from a selected cohort of specialties with known issues, the finding that over half
of cases reviewed had at least one data inaccuracy indicates poor data recording and quality. As the
upkeep e.g. legibility, filing, and maintenance of data in the case notes was often poor, and as there
were multiple cancer databases, information was difficult to find.
There were multiple causes of data error, which was categorised by IMT and are defined below:
No errors
The record is found to be accurate and complete in all fields.
Data entry errors
When CWT and other sources of information, including 40% (100
patient notes, match although the data has not been cases)
updated e.g. on another pathway, appointment brought
forward, incorrect treatment entry
When an incorrect entry appears to have been made as a 11% (28 cases)
result of a misunderstanding of the national CWT guidelines.
Misinterpretation
of the national
guidance
Operating process
issue
Data with other
provider
39% (97cases)
A substantive error in a process or procedure, as opposed to 3% (7 cases)
the recording of that process or procedure.
Data available on the CWT but could not be checked against 6% (14 cases)
data in the notes which were held elsewhere.
Other causes included poor information sharing, document handling and recording i.e. documents
mislaid or incorrectly reported, and mis-recording of Decision to Treat (DTT) following discussion or
Multi-Disciplinary Team (MDT) meeting.
There were 105 instances or data points along the Cancer Waiting Times pathway (“episodes”),
relating to 83 cases, where auditors recorded a difference (or variance) between the dates in the
CWT and the notes. These relate to four fields: referral received date; date first seen, decision to
treat, and treatment start date.
Comparing the dates recorded in the notes and on the CWT tool:

In most instances where an error was identified the difference between the date recorded
on the CWT and the date in the notes was small. In 58% of episodes (61 of 105) the date
recorded in the notes was within five days before or after the date recorded CWT Tool
8
While 8% of the patients were treated in other Hospitals, it was possible to verify some records as
information was available on RTT. Therefore only 6% of cases could not be verified due to shared care.
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16th December 2014




Dates recorded in the notes for all pathways range from between 77 days before to 52 days
after dates recorded in the CWT tool.
In the majority of episodes (65% or 68 of the 105 data points) the date recorded in the notes
was earlier than the date recorded on the CWT Tool.
For 10 patients, dates in the notes were between 10 and 52 days after dates recorded on the
CWT tool, indicating that, for some patients, and especially as the pathways may be
cumulative, there would have been unacceptable delays.
This study shows pockets of poor data recording, particularly in Upper and Lower GI and
Urology, especially around treatment dates. The size of the variance was larger in Lower GI
and Urology, although numbers are small.
On statistical analysis of the cases where there was a discrepancy in dates between the notes and
CWT there is some evidence of systematic bias making waits seem shorter than in reality. This could
have resulted from multiple causes as described above including erroneous interpretation of
complex CWT guidance or even subconscious bias. The methods of this study did not allow an
assessment whether this led to gain, for example, in recording of performance.
However, in the four individual cases assessed by the Assurance Panel in which auditors found data
irregularities, the Panel found no evidence of data manipulation. In these cases which were
assessed to determine if potential data manipulation might have led to delays harmful to patients,
there was no reason to refer any cases to the police.
In the sample of 250 cases, there were five cases referred for Serious Incident investigations (SI).
Two new referrals came from the retrospective review and three had already been referred
previously via the helpline, complaints, or the SI process. These latter three SIs related to aspects of
care other than those covered by the Error Rate audit. It should be noted that, during the period of
the helpline, the threshold for SI investigations was lowered. One case was considered by the
Assurance Panel a GP significant event (the equivalent to a Serious Incident but in primary care).
After reviewing these SIs, the Trust put new policies in place and reinforced aspects of the Cancer
Action Plan. As one significant event result from a GP referral on to a non-cancer pathway, and 5%
of GP cancer referrals were routine, the Trust needs to work closely with primary care to improve
early recognition of cancer and referral across the system. The Trust needs to work with other
hospitals to improve data sharing as, in 14 of 21 cases of shared care, insufficient data were available
to complete the audit.
The picture is of a problem with poor data quality in cancer. Data from other Trusts have not been
analysed to such a degree as a comparator. It is hoped that data recording will be addressed through
the introduction of the Somerset Cancer Registry information system.
In conclusion, although discrepancies in the recording of data were found in this study, there was no
evidence of this causing patient harm.
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16th December 2014
Appendix 5 Executive Summary - Long waits study 2
Introduction
This retrospective review of cancer care at Colchester Hospital University NHS Foundation Trust
(CHUFT) is one of six studies looking at data error, pathways over 91 days (“long waits”), delays in
diagnosis, pathway stops in upper gastrointestinal (upper GI) cancer, follow up care in superficial
bladder cancer and a review of serious incident investigations (SIs), help line calls and complaints
over the period of the Care Quality Commission (CQC) investigation.
The aim of this study 2 was to identify all patients who had experienced long waits, the reasons for
the delays and take appropriate clinical intervention if required. The audit involved review of 290
records of patients on the cancer waiting times pathway (CWT) between April 1, 2010 and October
31, 2013 whose cancer pathway was over 91 days. This study was a look back exercise considering a
specific cohort of patients rather than a random sample and therefore results cannot be generalised
to cancer care across the Trust.
The background of the retrospective review process including the six stage audit process are
described in other studies.
Summary of results
Between April 2010 and Oct 2013, 4,461 patients were treated for cancer on the 62-day pathway in
the 10 tumour sites reviewed of whom 290 (6.5%) waited over 91-days. Urology and lower GI had a
disproportionality high number of patients waiting over 91 days.
The study looked at how long patients waited after 91 days comparing the CWT tool and notes,
given the number of data errors found in other studies. There was a 9% inaccuracy in the overall
number of data items measured in this audit (117 of 1,249 verifiable data items) and 71% of patients
had errors in at least one data field (165 of 233 cases with complete records), compared to 10% and
55% in the error rate audit respectively. Most (54%) of the dates recorded on CWT tool were before
those recorded in the notes, and half were within 5 days (27 of 54 data items).
On average, patients in this cohort waited 118 days from referral to treatment using dates from both
the CWT tool and case notes. Nine patients in urology waited an extremely long time to be treated
(range 191 – 855 days).
Auditors recorded all potential delay points along each patient’s pathway at which a major delay
occurred. A total of 687 delay points were identified at four phases in each patient’s pathway, the
majority occurring in the ‘diagnostic phase’ i.e. between date first seen and date of decision to treat
(71% of delay points, 490 of 687 delay points). The table below lists the main causes for delay,
mostly due to problems in booking appointments.
Cause
Delay in booking
appointments
National CWT
guidance
Delayed/missing
tests
Patient choice
Description
An error or hold-up relating specifically to the booking
process
Delay allowed for in the National Cancer Waits
Guidance
Diagnostic procedures that were carried out late or
omitted e.g. an ultrasound, tissue biopsy, or endoscopy
Such as postponing treatment to take a holiday
% delay points
27% (185 of
687)
18% (124 of
687)
13% (88 of 687)
Patient unfit
Patients temporarily too unfit to undergo a procedure
6% (42 of 687)
14% (98 of 687)
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16th December 2014
Clinical decision
Inadequate capacity
Other reasons
or treatment (distinct from having co-morbidities) i.e.
from an infection or injury
Decision imposed on the process by the responsible
clinician
Situations when treatment or diagnostic facilities were
inadequate excluding staffing issues e.g. insufficient
free slots on a theatre list
Unclassified
4% (26 of 687)
5% (36 of 687)
13% (90 of 687)
Based on the evidence available from multiple sources overall clinical auditors considered CHUFT
internal processes responsible for 57% of all delays (294 of 688 points of delay).
Auditors considered about half of the delays preventable (51%, 352 of 687 delay points). Of all the
preventable delays, the clinical auditors reported that 86% of delays (301 of 352 delay points) were
the result of issues internal to the Trust, 10% (34 of 352 delay points) were due to other Hospitals
and 5% (17 of 352 delay points) were due to patient factors. The majority of all preventable delays
were in urology (55%, 94 of 352 delay points) and lower GI (20%, 71 of 352 delay points).
Nearly a third of patients (31%, 88 of 283 cases) who had waited over 91 days were on shared
pathway involving CHUFT and at least one other hospital. Patients were most often on a shared
pathway with skin (64% or 9 of 14 cases), lung (61% or 11 of 18 cases) and breast cancers (55% or 6
of 11 cases).
In this cohort patients who were treated on a shared pathway waited on average 10 days longer
than those on a single pathway between referral and treatment dates. In some of these cases,
patients were referred to and from CHUFT after considerable time, often after they had already
breached (68%, 19 of 28 cases).
Of all 88 cases that were referred between CHUFT and other Trusts where data was available, at
least 26% (23 cases of 88 cases) would have been referred after 42 days. For patients who have
already experienced delays at their Trust of origin, referral to another Trust adds additional waiting
time.
A number of cases as well as breaching the 62-day target, also breached the 2WW and/or 31 day
targets (76 of 283 cases). For these patients the average wait from referral to treatment was 127
days, 9 days longer than the average wait length of 118 days for the cohort. This illustrates that once
a patient has breached either target, the likelihood of meeting the 62 day target is reduced.
Auditors assessment
No impact
Potential harm (clinical and/or emotional)
- Potential clinical harm
- Potential emotional harm
- Potential clinical and emotional harm
Other e.g. impact unknown
66% (187 of 283)
12% (33 of 283)
5% (13 of 283)
1% (2 of 283)
6% (18 of 283)
21% (59 cases of 283)
Consultant/clinical
panel assessment
90% (255 of 283)
8% (23 of 283)
3.5% (10 of 283)
1.4% (4 of 283)
3.2% (9 of 283)
2% (5 of 283)
In the majority of cases (66%, 187 of 283 cases), auditors identified no potential emotional or clinical
harm, and that 12% of patients (33 of 283 cases) may have experienced clinical or emotional harm or
a combination of both. The clinical panel considered 90% of those reviewed had experienced no
harm, and overall 8% (23 of 283) of patients may have experienced clinical and or emotional harm.
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The clinical panel also identified a number of patients who had experienced delayed investigations,
diagnosis and treatment.
The total number of serious incident investigations was 6% or 17 of 283 cases including those
already referred at the time of the CQC investigation. Of these 17 cases, 8 were referred through
clinical panel or auditor assessment and nine were pre-existing SI cases. Seven cases were subject to
rapid action by the Medical Director after the clinical panel meetings.
The assurance panel assessed 12 cases of potential data manipulation. In four, there was some
evidence of potential data manipulation although none led to delay or caused harm hence none
required referral to the police.
The following themes were identified from qualitative analysis:
Data recording
There were examples of incomplete and poor record-keeping as in other
studies. MDT discussions were poorly documented at times, with incomplete
records.
Coordinating
Investigations were not sequentially ordered and acted on responsively leading
investigations
to delay e.g. echocardiogram, axillary biopsy, MRI, flexible sigmoidoscopy,
and assessments staging investigations, delay in endoscopy, Endoscopic Ultrasonography (EUS),
delay in requesting bone scans and acting on pathology results.
Uncoordinated
Pathways were not actively managed and patients tracked through the system.
and protracted
Excessive delays resulted from cancellation of appointments by the Trust and
pathways
patients, delayed diagnostics and pre-operative assessments. Delays were
often cumulative, with lack of co-ordination at the beginning of pathways e.g.
between diagnosis and MDT discussion, all adding up to substantial delays
overall.
Shared Care - There were delays resulting from issues of co-ordination and communication
Inadequate
between CHUFT and other providers including Broomfield, Addenbrookes, the
Coordination
Brompton and the London, particularly for upper GI.
GP/Trust
There was evidence of poor GP/Trust communication including on referral, in
communication
ordering and using tests and results, and on safeguarding issues.
Patient Choice
Some patient presented late despite having symptoms for some time and many
delays were attributable to patient choice. Patient choice for a pause could be
more actively followed up as these often led to disproportionate delays.
Complex patients Delays were most prevalent where patients had multiple co-morbidities, a rare
tumour or multiple tumours that required transfer within the Trust between
teams e.g. intra MDT referrals and referral for cardiology and anaesthetic
assessments, and between hospitals. Their care provided particular challenges
but was not expedited. Patients requiring safeguarding did not always have an
advocate to manage their appointments.
Urology
Delays occurred in cancer pathways due to investigations such as MRI for
prostate cancer, and for renal cancer, leading to occasional delays in diagnoses.
Upper GI
Delay occurred particularly in relation to referral of complex patients to
Broomfield for EUS and oesophageal cancer and to the London and St
Bartholomew’s Hospitals for hepatocellular carcinoma.
Lower GI
Delays occurred in diagnostics, pre-op assessments and follow up of patient
who DNA. Consistent implementation of the iron deficiency protocol is
required with primary care.
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16th December 2014
Discussion and conclusion
As in other studies, this study also found data inaccuracies within and between the CWT tool and the
notes. Given length of wait was an important measure, and to determine if adjustments had been
appropriately applied, all patients were identified where an incorrect adjustment would have meant
that patients had waited over 91 days. As a result 25 patients were included in the study who did not
meet the study inclusion criteria, identified before (14) and after (11) the audit was completed.
These patients were included in the analysis as issues were found by clinical auditors and this study
was a look back exercise.
In each study a proportion of cases were referred by the clinical auditors to lead doctors, all of
whom were then assessed by a multidisciplinary panel. Clinical auditors’ initial assessments e.g. of
harm, were higher than the doctors or clinical panel. This is due to inter-observer differences and
the clinical panel assessments are likely to be more robust based on multidisciplinary discussion of
often complex patients.
The report was of a selected cohort of patients and therefore results cannot be generalised.
However it shows about 7% of patients on cancer treatment pathways had delays over 91 days at
the Trust (on average 118 days) and a small number considerably more.
The introduction to CWTs guidance v8.0 (Page 5, para 3) reads ”It is not expected that all patients
will be seen and treated within these time frames. Some patients will choose to wait longer and
others will not be clinically able to be seen/treated within these time frames. To take account of this,
‘operational standards’ have been set that allow for a proportion of patients to breach these
standards due to medical reasons or choice”.
At the time of this study most patients in this cohort were being treated in urology and lower GI.
Urology made up the majority of patients (47%) and the long delays can be mostly explained by the
prostate cancer pathway where patients had to wait 6 weeks for MRI post biopsy. This was rectified
in December 2013 and MRI is now before biopsy cutting waiting times by 6 weeks. However, the
MRI and TRUS pathway did not explain all cases in urology where systems of care require review as
part of the Essex urology review.
Some delays were not preventable, particularly given patient choice and patients being temporarily
unfit for treatment. However, the review also shows that improvements need to be made as the
majority of preventable delays were within the control of the hospital including delays in booking
appointments and due to pending diagnostic tests and results.
Firstly, it appears that more capacity is required in the Trust especially in terms of the diagnostics.
Most delays occur in the diagnostic phase of the cancer pathway.
Secondly, more pro-active management is required of complex patients who transfer between
teams i.e. for pre op assessments, and between hospitals. When a patient breaches the 2 week wait
and 31 day target any delay may not be recovered, and patients then go onto breach the 62 day
target. These patients who breach and/or require transfer to other hospitals need to be prioritised
and their pathways, as others, more actively managed along with improved communication on inter
Trust referral.
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16th December 2014
This study as in others shows considerable error in entries onto the CWT tool. In the total cohort, 44
patients were included whose first definitive treatment records were not submitted to Open Exeter9
to ensure no eligible patient had been excluded through incorrect CWT adjustments being applied.
This cohort included 19 of the 25 patients that did not meet the study inclusion criteria. However,
this subgroup of patients were more likely to be on shared pathways, have higher numbers of data
errors, include patients with clinical and CWT pathway concerns and have experienced longer waits
indicating data quality were worse in this sub group compared to the cohort as whole. The Trust
needs to implement clear processes of data validation that would normally precede any submission
to Open Exeter.
The assurance panel looked at all cases of potential data manipulation (12), including the cases
referred to above, and recognised potential data manipulation in eight cases. It is extremely difficult
to establish a causal relationship between patient harm and erroneous recording in the CWT tool
which is used for performance purposes. Clearly awareness of CWT guidance and data reporting
needs fundamental improvement.
Clinicians as well as providing clinical leadership particularly in MDT teams and supporting more proactive patient management of pathways need to be vigilant in ordering and interpreting tests
responsively, in accurate diagnosis, and providing the most effective, timely and patient centred
treatment including early referral to oncology.
Summary against objectives
Objectives
Outcome Measures/Endpoints
Primary Objective
To identify patients
who have experienced
long delays within their
cancer pathway
Between April 2010 and Oct 2013, 4,461 patients were treated for cancer on
the 62-day pathway in the 10 tumour sites reviewed of whom 290 (6.5%)
waited over 91-days. Patients with long waiting times over this period had
cancers mainly in urology (137 or 47%) and lower GI (63, 22%),
Secondary Objectives
To identify the reasons Of 689 delay points, the biggest causes of delays were delays in booking
for the long delays
appointments (27%, 185) and due to patient factors including patient choice
(14% or 98) and co-morbidities (6% or 42).
Patients who had already experienced delays at their Trust of origin, and/or
breached their 2WW or 31 day target, were more likely to go on to experience
longer delays as delays are cumulative and not recovered.
About half of the delays were preventable (51% or 352 of 687 delay points), of
which processes internal to CHUFT were responsible for the majority, mostly in
urology and lower GI.
To ensure appropriate
clinical intervention for
any identified missed
diagnoses
Auditors assessed 12% patients as experiencing harm compared to 8%
reviewed by the Trusts clinical review panel.
Twelve patents underwent new SI investigations, and fifteen overall.
In five patients issues were identified which required immediate follow up by
9
Open Exeter is a web-enabled viewer from NHS Connecting for Health which gives opportunity to share information (i.e.
cancer waiting times, immunisations, and screening) with other organisations including GP Practices, Hospitals and
Laboratories. Note, security is of the highest importance and data protection regulations are observed at all times
41
16th December 2014
the Medical Director with individual clinicians.
To ensure systems /
processes exist to
prevent any further
long delays
See report on actions arising from the review and cancer action plan.
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16th December 2014
Appendix 6 Executive Summary – Delayed Diagnosis Study 3
Introduction and aims
This retrospective review of cancer care at Colchester Hospital University NHS Foundation Trust
(CHUFT) is one of six studies looking at data error, pathways over 91 days (“long waits”), pathway
stops in upper gastrointestinal (upper GI) cancer, follow up care in superficial bladder cancer and a
review of serious incident (SI) investigations, help line calls and complaints over the period of the
Care Quality Commission (CQC) investigation.
The aim of this study 3 is to determine the prevalence of ‘'missed diagnoses or delayed diagnoses' in
cancer pathways defined by the NHS England Incident Management Team (IMT) as in ‘those patients
restarting a cancer pathway within 90 days from stopping an initial cancer pathway’ between 1 April
2010 and 31 October 2013.
The retrospective review process included six stages and identifying the sample; developing the
audit tool and piloting; clinician case note review and triage of cases of concern; assessment by one
of three lead doctors followed by a multidisciplinary clinical panel review and/or cancer wait expert
if required; analysis and report writing and finally external Consultants and CWT experts assessed
10% of records to check auditor’s accuracy of assessment and hence the validity of results.
This report describes the results from an initial sample of 147 case notes from a total of 364 patients
who met the study criteria. The study was halted at this stage following discussion of an interim
report with the Assurance Panel and IMT given that no new themes were emerging and it was highly
unlikely that any further interventions would be required for individual patients given the time
frame of the study and that they had by definition all received treatment. The six retrospective
studies were highly resource intensive and on balance it was recommended this resource could add
greater value focussed on improvements going forward.
The total cohort of this study of 364 selected patients account for approximately 8% of the total
numbers of patients treated in the study period on 62 day cancer pathways. Neither are random
samples and therefore representative of cancer care at the Trust as a whole.
Results
2.1 First pathway





A cancer status of “no cancer identified by healthcare provider” was recorded in the cancer
waiting times (CWT) tool for all patients to stop their first pathway in line with CWT rules.
Auditors found “no cancer” recorded in the notes in 50% of cases (74 of 147), although all
patients went onto subsequently develop cancer.
There were higher numbers of patients represented in the sample from lower GI, skin, head
and neck and urology on the first pathway and urology on the second.
In 56% of cases (83 of 147) auditors found evidence a clinician had authorised the CWT
pathway stop, the majority by Consultants (67%, 56 of 83 of clinician stops, and in 38% of all
cases).
Where dates were recorded (76%, 111 of 147), first pathways were stopped mostly within
14 days of the patient being first seen (59%, 66 of 111).
Following the stop half (50%, 74 of 147) of the patients remained managed within the
hospital system – 35% (52 of 147) were transferred to 18-week (Referral to Treatment, RTT)
and other pathways, 15% (23 of 147) were referred to other Consultants for suspected or
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16th December 2014

confirmed cancer, 3% (4 of 147) referred back to their GP who was asked to re-refer. In 20%
(30 of 147), patients were discharged and 27% were coded as “other” (39 of 147).
The majority of pathways stops were considered correctly made (56%, 83 of 147). CWT
pathways may have been stopped incorrectly by both clinicians (24%, 36 of 147) and nonclinicians (13%, 19 of 147) alike.
2.2 Second pathway







Whilst most patients were initially 2 week wait GP referrals (2WW) (84%, 123 of 147), just
over half of subsequent referrals onto the 2nd pathway were made by consultants (52% or 76
cases). Very few patients entered the 2nd pathway via emergency attendance 3% (5).
Having stopped the initial cancer pathway 45% of cases were re-referred within 30 days onto
the 2nd cancer pathway (66 of 147). Second pathway referrals were mostly triggered by
investigation results (47%, 69 of 147).
13% of patients (19 of 147) had persistent red flag symptoms on the second pathway, of
whom nine were discharged by clinicians, and 6% (9) had developed new red flag symptoms
relating to another tumour site.
Of the 147 patients, 53% (78 of 147) were re-referred for the same cancer, 37% (54 of 147)
for a different cancer and 10% (15 of 147) for a related cancer. The highest proportion of rereferrals for the same tumour sites were urology, skin, breast, head and neck and lower GI in
descending order.
When patients were referred back onto a 2nd CWT pathway that was the same as the first,
they were not treated any more quickly, than if they were referred from one tumour site to
another (88 and 89 days from referral on 1st pathway to DTT on 2nd pathways respectively).
The majority of patients (62% or 91 of 147) were considered by auditors to have experienced
a “delayed diagnosis”. Of those cases where auditors requested a second opinion from a
multidisciplinary clinical panel due to concerns in clinical care, 37% were thought to have
experienced “delayed diagnosis” (17 of 46).
The reasons for clinical auditors coding delayed diagnosis are listed in the table below.
Basis of coding as “delayed diagnosis”
Patient investigated but not diagnosed at the time of
investigation
Patient not investigated or referred for investigation
Not investigated for tumour site where cancer found
Patient diagnosed incorrectly
Positive test result/diagnosis not communicated effectively to a
clinician with the ability to act on the information
Positive test result/ diagnosis is not acted upon and treatment
commenced as appropriate
Proportion of cases
43% (39 of 91)
38% (34 of 91)
12% (11 of 91)
4% (4 of 91)
2% (2 of 91)
1% (1 of 91)
Other reasons for delay included:


Pending investigations (21%, 19 of 91) and delayed or missing tests e.g. an ultrasound, tissue
biopsy, or endoscopy (13%, 12 of 91)
In offering appointments including after a patient did not attend (DNA) (24%, 22 of 91).
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Clinical Impact





Potential harm was assessed in different ways: by the clinical auditors (mainly nurses),
review team lead doctors, a multidisciplinary panel, through referral to the SI team for
investigation, by the external Consultants and CWT assessors in a 10% sample and by the
Assurance Panel in relation to data manipulation.
In the majority of cases (80%, 118 of 147), clinical auditors perceived that patients had
experienced no harm. In 16% (24 of 147), they considered patients may have experienced
some element of harm.
Of the 46 patients referred to the multidisciplinary review panel, 13 were thought to have
experienced harm or 9% of all cases (13 of 147). In five, rapid action was taken by the
Medical Director in writing to clinicians for lessons learnt, an explanation and whether action
had been taken on an investigation result.
A total number of 11 patients were referred either for a datix or new serious incident
investigation in lower GI (2), upper GI (2), skin (3), and urology (4). In addition five patients in
the sample had already been referred for serious incident investigation through the
surveillance log of calls to the helpline, SI investigations and complaints at the time of the
CQC investigation. The total number of patients requiring investigation was, therefore, 16 or
11% of 147 cases.
The assurance panel assessed 13 cases, of whom they considered four cases may have been
subject to data manipulation although this did not lead to harm and so did not require
referral to the police.
3.1 Themes arising from the review



In 38 cases auditors requested a clinical opinion due to a concern, and timelines and case
notes were reviewed by lead specialists and then a multidisciplinary review panel. These
cases were in lower GI (15), skin (7), urology (6), upper GI (4), breast (2), lung (2) and head
and neck (2).
As well as taking any necessary remedial action for individual patients, thematic analysis was
conducted on these 38 cases and also on all cases which auditors coded as “non-clinical
action”.
The following main themes include both qualitative thematic analyses:
Key theme
GP/Trust
communication
Inappropriate
stopping and
restarting
pathways
Poor
documentation
Coordinating and
acting on
investigations
Uncoordinated and
protracted
pathways.
Summary
There was often evidence of poor GP/Trust communication including on
referral, ordering necessary tests prior to appointments, on discharge and
concerning safeguarding issues.
There were numerous instances where pathways were stopped
incorrectly, by managers working outside their responsibility as well as
clinicians. The clinical and CWT pathways were often not aligned and
there is evidence of a significant lack of understanding of CWT guidance.
There was poor documentation of when cancer pathways were stopped,
by whom and on whose authority. There was poor record-keeping overall.
Investigations were not sequentially ordered and always acted on
responsively. Pathways were stopped before investigations were
reported.
Pathways were not actively managed and patients tracked through the
system with delays in booking and re-arranging appointments. It was
sometimes unclear where responsibility lay in advocating for patients
along their journey to ensure follow up was co-ordinated in a timely and
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responsive way.
There was some confusion about consultant- consultant referrals, with
patients on occasion being referred back to their GP to re-refer back to
the same or other consultants. In some cases this may have been as a
result misinterpretation of restrictions on consultant to consultant
referrals by the PCT.
Complex patients
A number of patients were particularly complex including elderly with comorbidities, patients with rare tumours and those who are seen at other
providers. Their care was not expedited. Co-morbidities outside the main
speciality are sometimes overlooked.
Dermatology and
There were particular issues related to medical photography in
medical
dermatology including incorrect site referral and photography and
photography
discharge without being seen in person by a clinician or confirmation from
histology.
Lower GI (15 cases) Following urgent rigid sigmoidoscopy in a number of cases the CWT
pathway was stopped or downgraded and a colonoscopy booked which
later revealed a tumour.
Upper GI and iron
Pathways were sometimes shut down with no recorded authorisation
deficiency anaemia following endoscopy despite ongoing investigation and occasionally red
flags. There is need for implementation of an iron deficiency protocol and
clarity regarding referral for lower GI investigation following referral to
upper GI and vice versa. There were delays especially in the hepatobiliary
pathway which requires review if not already done so.
Urology
The majority of patients who were entered onto the same 1st and 2nd
pathways were in urology. There was a lack of protocol for PSA monitoring
over time and how this relates to the CWT tool. There was evidence of
occasional poor responsiveness to investigations results causing delay,
follow up of patients and bookings e.g. with cancellation on day of
surgery, indicating better systems need to be in place.
Table 11. Themes arising from cases reviewed by lead clinicians and the multidisciplinary panel
Consultant –
Consultant referral
Discussion and conclusion
This study was of a sample of 147 patients, from a selected cohort of 364, who met the study criteria
and hence are not representative of all patients treated for cancer at the Trust. To ensure all
patients were appropriately assessed, following initial review clinical auditors referred a number of
cases to a clinical panel for a second opinion if they had any concern about the clinical pathway.
However, these cases were on the whole not assessed by clinicians in the same specialty apart from
by the external review Consultants. Numbers of cases were small especially by tumour site making
results difficult to interpret.
The CQC definition adopted of emotional and/or physical harm is subjective and clinical auditor
assessments were higher than the clinical panels due to inter-observer differences.
Panel assessments are more likely to reflect reality given the need for multidisciplinary discussion of
each case as many were extremely complex.
Given these limitations in design, this study indicates that CWT data recording, particularly in some
specialties, were haphazard. Patients’ CWT pathways were stopped while they waited for
investigation notably colonoscopy, further PSA testing or MRI. Cancer waiting times pathways were
incorrectly stopped by clinicians and non–clinicians alike, the latter acting out of scope of their
responsibility.
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16th December 2014
The main causes of delay related to appropriately ordering, interpreting and using results from
investigations; in booking appointments including after patients DNA; and as pathways were often
poorly co-ordinated, particularly those spanning more than one specialty and/or Trust, for more
complex patients with multiple morbidities, rare tumours, or safeguarding issues.
The picture is complex but seems to be due to poor documentation and responsiveness, and a lack
of understanding of the CWT guidance on stopping pathways as found in other studies. There was
suspicion of data manipulation in 13 cases as assessed by the assurance panel although this did not
lead to harm, and it was difficult to establish intent.
The relationship between CWT pathway stop and harm is unclear. Although the CWT pathway was
stopped in all cases, just over half of patients (53%) remained managed by the hospital in some way.
Review of cases by the clinical panel indicates that in some where an incorrect stop was made it led
to a delay, while in others there was none or negligible impact. The CWT is an audit and not a
tracking tool, and a formal process of tracking patients through the system by MDT co-ordinators
more pro-actively is required as well as accurate use of CWT guidance.
However, irrespective of the CWT data pathway this study revealed different levels of suboptimal
care:




The majority of the patients would have experienced long waits which may have caused
anxiety and inconvenience.
Many patients experienced a delay in diagnosis (auditors assessment 62% 91 of 147, clinical
review panel assessment 37%, 17 of 46), mainly as patients were not diagnosed at the time
of investigation (43%, 39 of 91)
Some patients were referred back to the Trust on their second CWT pathway for ongoing red
flag symptoms (19), of whom nine were discharged by clinicians. Of those patients seen by
the clinical panel a number experienced potentially incorrect diagnosis (15%, 7 of 46),
delayed investigation (9%, 4 of 46) and potentially incorrect treatment (7%, 3 of 46).
Using the CQC categories about 10% of patients experienced emotional and/or physical
harm, and 11% overall were referred for SI investigation.
Risk in diagnosis and treatment is inherent in clinical care and this study looked at patients over a
three year period. There will remain a cohort of patients for whom initial reasonable investigation
based on 2 week rule symptoms do not identify cancer but who will subsequently have a cancer
diagnosed. Levels of harm range from 3-25% in acute care according to recent research although this
would relate to the all patients receiving cancer care rather than a selected sample 10.
In order to reduce risk and levels of harm while recognising it is inevitable, both this review and the
cancer network’s external review team point to a need for greater accountability and responsibility
in actively managing both clinical and CWT pathways and ensuring they are aligned. This audit
identified the highest levels of harm of all the studies and therefore should be repeated for
continuous quality improvement.
10
The Health Foundation. Evidence Scan. Levels of Harm.
http://www.health.org.uk/public/cms/75/76/313/2593/Levels%20of%20harm.pdf?realName=PYiXMz.pdf
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The IMT protocol asked five questions which are answered below in Table 3 below.
1. Reason(s) for stopping of initial
cancer pathway
Although all patents went on to have a diagnosis of
cancer, there was evidence of “no cancer” diagnosis
recorded in 50% of the notes (73 of 147), compared to
100% recorded on the CWT tool. Just over half (56% or 83
of 147) were stopped correctly.
2. Reason(s) for restarting of same or The second pathway referrals were triggered by
investigation results (47% or 69 of 147 cases); persistent
different cancer pathway
red flag symptoms (13%, 19); new red flag symptom (6%,
Were there any ‘red flags’ related to 9); cancer as an incidental finding (4%, 6) and for other
red flags on the initial referral at the reasons (30%, 44)
time the pathway was stopped
3. Is this a 'delayed diagnosis' or not? 62% of the 147 patients assessed by clinical auditors
experienced a delay in diagnosis, compared to 26% (17) of
the 65 cases referred to the clinical panel for a second
opinion
4. Where the patients entered
Following the stop 53% of patents remained managed by
another pathway, such as 18 weeks, the Trust. Just under a quarter of patents (23%, 34 of 147)
were discharged and in 27% (39) other actions were taken.
is there evidence that this was a
reasonable decision at that time?
In over a third of cases (37%, 55 of 147) CWT pathways
may have been stopped incorrectly by both clinicians and
non-clinicians alike.
5. Is there any outstanding clinical
action required?
A total number of 11 patients were identified through the
audit as needing new serious incident investigation in
addition to five patients identified through the
surveillance log of calls to the helpline, SI investigations
and complaints at the time of the CQC investigation (11%
16 of 147 cases).
In five, rapid action was taken by the Medical Director in
writing to clinicians for lessons learnt, an explanation and
whether action had been taken on an investigation result.
Table 3. Summary of review on delayed diagnosis
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Appendix 7 Executive Summary – Upper GI
The aim of this study is to determine the clinical impact of decisions made by staff working in a nonclinical role to remove patients from the upper GI cancer care pathway between 1st April 2010 and
31st December 2013.



To estimate the proportion of patients in the upper GI pathway for whom the decision to
remove from the care pathway was made by staff in a non-clinical post.
Determine whether there was a documented clinical decision to stop the cancer pathway.
Where no clinician decision was identified, to assess whether actions were required to
assure that patients’ care needs were being met.
Between 1st April 2010 and 31st December 2013 2,683 patients were referred to the upper gastrointestinal service. The study therefore involved two random samples of 60 patients each, Group A
and B, equivalent to 4% of the total caseload over the study period.
Sample Source
No. of Cases
% of Cases
Group A. Random sample of upper GI cases whose CWT pathway was
authorised by staff in a non-clinical role identified by HR and through
comments on the CWT tool
Group B. Random sample of patients on the CWT tool for upper GI
over the study time period
TOTAL
60
50%
60
50%
120
Summary of key findings








Data was available in the notes and CWT tool on the identity of staff who authorised CWT stop
in the majority of cases (58%: 69 of 120). About three quarters of cases (74%: 89 of 120)
included documentation of the date of CWT pathway stop.
A considerable proportion of cases did not include documentation of the authorising name and
date of the pathway stop recorded on the CWT and/or in the notes. The identity of staff
authorising pathway stops could not be established in 42% of cases (51 of 120). In 9% (11 of 120)
the date of pathway stop was not documented and in 17% (20 of 120) it could not be verified
from the notes.
Staff in a non-clinical role were responsible for authorising 48% (57 of 120) of upper GI cancer
pathway stops in the audit period while clinical staff were responsible for 10% (12 of 120).
All 57 cancer pathway stops authorised by staff in a non-clinical role were done by just four
managers with one individual responsible for 86% of the stops (49 of 57). All 12 clinician-led
pathway stops were authorised by nine clinicians including one clinical nurse specialists (CNS).
Pathways stops were authorised by managers mostly from the stratified cohort Group A (88%,
51 of 58). Although managers also authorised pathway stops in the random sample Group B
(54%, 6 of 11 stops).
Only in a minority of cases (11%, 6 of 57) were authorisations by managers also confirmed by a
consultant, the majority were not (89%, 51 of 57 stops).
Overall 24 (20%) patients had a confirmed cancer diagnosis, eight were confirmed through both
gastroscopy and histology, one through gastroscopy alone, two through histology alone and the
remaining thirteen through other investigations.
The review of the decision by managers to authorise pathway stops was judged by clinical
auditors as clinically appropriate in the majority of cases (49 of 57, 86%). In 12% (7 of 57) it was
not and in 2% (1 of 57) the auditors were unable to assess this from the information available.
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16th December 2014





Patients with pathway stops authorised by managers (2 of 57) experienced delayed diagnosis
whereas in this sample patients with clinically-authorised pathway stops did not (0 of 12).
In none of the pathways stopped by clinicians was cancer subsequently diagnosed after the stop
whereas three of the patients whose pathways were stopped by managers were eventually
diagnosed with cancer (5%, 3 of 57).
Following pathway stop overall, 48% of patients (57 of 120) did not require follow-up, 23% (27 of
120) required follow up and 30% (36 of 120) required other actions. Pathway stops by clinicians
and managers had similar pattern of follow up or 25% (3 of 12) vs 25% (14 of 57) of patients
having planned follow up and 50%, (6 of 12) vs 54%, (31 of 57) not respectively.
Of those with a cancer diagnosis, 15 patients had a diagnosis made before the pathway stop and
nine after. Of the 8% (9 of 120) diagnosed with cancer after pathway stop, three had their stops
authorised by a manager while the identity of staff responsible for the remaining six could not
be established. Two of the nine diagnoses were in the upper GI pathway, six were in a different
tumour site and one a tumour of unknown origin. No conclusion was made by the auditors as to
whether any of these was a case of missed cancer related to the initial referral.
There doesn’t appear to be any correlation between the role of staff who stopped a pathway
and the potential impact on the patients. Patients who suffered potential harm had CWT stops
authorised by both managers (4%, 2 of 57) and clinicians (8%, 1 of 12). The identity of staff who
stopped the pathways of the remaining seven cases of potential clinical harm could not be
established (14%, 7 of 51).
Discussion and conclusion
Methodologically this study presented particular difficulties in identifying inappropriate CWT stops
by staff in a non-clinical role. Given the large numbers of patients seen by the endoscopy service, a
stratified sample was required. As data on many patients were not available and the incidence of
cancer compared to the numbers of referrals was small, the actual numbers of patients studied was
small (particularly with a cancer diagnosis), and therefore it is difficult to make generalisations.
However overall, although the picture is highly complex, it can be seen that as in other studies there
is evidence of poor data recording and inappropriate CWT cancer pathway stops. In many cases the
name of the person authorising the stop was not recorded and hence it is difficult to determine if
issues related to stops authorised by managers are based mostly on a recording issue i.e. a different
conclusion would be drawn if more stops had been documented by clinicians.
Cancer Waiting Times Guidance advises that it is reasonable to stop the cancer pathway on clinical
grounds. ‘The key is what the patient has been told i.e. if the clinician is confident to tell the patient
that they do not have cancer without having pathology then that would end the 31/62 day cancer
pathways.’.
Of the CWT pathway stops that could be verified, in the majority of cases, stops were authorised by
a single manager in a non-clinical role. This cohort of patients had higher proportions of
gastroscopies, lower levels of cancer diagnoses and higher levels of discharge back to their GP
indicating this practice was mostly reserved for a particular group of lower risk patients.
In the majority of cases no cancer was found. However, in a few patients where managers had
authorised the pathway stops cancers were eventually diagnosed in other tumour sites.
In a few instances of CWT stops authorised by managers patients may have experienced delay in
diagnosis (4%, 2 of 57) and potential harm 4%, (2 of 57) although the latter also occurred with
clinician CWT stops (1 of 12 respectively).
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Manager stops occurred in both groups on patients studied in Group A (mainly managers) and B, the
random sample of all referrals to upper GI on the CWT pathways. It can therefore be inferred,
although numbers are small, that the stopping of pathways was commonly done by non-clinical staff
(6 out of 11 stopped pathway from the random sample: 55% [23 -83%]). However, in the sample of
cases selected to have a high proportion of pathway stops by non-clinical staff (Group A) the
majority were for non-cancer diagnoses and there was no evidence that the practice led to an
increased potential for harm.
The incidence of cancer was 20% and only nine of the 24 cancers diagnosed were picked up on
gastroscopy. Given that red flag symptoms are often unexplained by gastroscopy and that patients
are referred to upper GI with cancers in other tumour sites that may require onward referral, it is
inappropriate for tracking on the CWT tool to be stopped by non-clinicians even after normal
gastroscopy unless authorised by the accountable clinician.
Clinicians should make all reasonable clinical effort to exclude cancer, including onward referral for
further investigation when clinically indicated i.e. either a test or another specialist. However there
will inevitably remain a cohort of patients for whom initial reasonable investigation based on 2 week
rule symptoms do not identify cancer but will subsequently have a cancer diagnosed. Given this risk
a stop by a manager is never appropriate unless they are following a clear guideline.
Overall assessment against study objectives
Objectives
Outcome Measures/endpoints
Primary Objective
To estimate the proportion of patients in the
upper GI pathway for whom the decision to
remove from the care pathway was made by
staff in a non-clinical role.
Staff in a non-clinical role were responsible for
authorising 48% (57 of 120) of upper GI cancer
pathway stops in the audit period. The identity of
staff authorising 43% (51 of 120) of entries could
not be verified from the CWT tool.
Secondary Objectives
Determine whether there was a documented
clinical decision to stop the cancer pathway.
Clinical staff were responsible for 10% (12 of 120) of
pathway stops.
Where no clinician decision was identified, to
In very few instances of CWT stops authorised by
assess whether actions were required to assure managers patients may have experienced delay in
that patient’s care needs were being met.
diagnosis (4%, 2 of 57) and potential harm 4%, (2 of
57). All cases were there has been any concern
about inappropriate stop and the clinical pathways
have been followed by lead doctors and the clinical
panel.
To document impact of delays in pathways.
 Estimated number of patients with ongoing investigations and new noncancer diagnosis related to the referral.
 Estimated number of patients with
subsequent delays in diagnostics,
related to this referral
 Estimated number of patients with a
missed cancer, related to this referral
Overall 19% of patients (23 of 120) had on-going
investigations and new non cancer diagnoses at the
time of the pathway stop.
Overall only 6% of patients (7 of 120) were deemed
by auditors to have experienced delayed diagnosis.
This was the subject of study 3
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Identify and record on standard pro-forma:
Patient pathways were stopped for a number of
1. Reason(s) for stopping of initial cancer reasons:
pathway,
2. Confirmation of a clinical entry to stop
 70.8% (85 of 120 of cases) were stopped
the pathway Y/N
because no cancer was found.
3. Appropriateness of stopping the
 11.7% (14 of 120) were stopped because
pathway
patient commenced first definitive
4. Delays in diagnostics as a result
treatment following a new primary cancer
5. Any outstanding clinical action
diagnosis.
required
 13.% (15 of 120) were stopped for other
6. Any missed cancer related to the initial
reasons including through patient choice,
referral
DNA, and for other reasons.
 1% (2of 120) were stopped because a
tumour in another tumour site was
diagnosed
 1.7% (2 of 120) were stopped for patient
reasons
 1.7% (2 of 120) were stopped – reason not
recorded
Overall 87% of patients (104 of 120) had their CWT
pathways stopped appropriately.
Outstanding clinical actions have been addressed by
Medical Director (table 12.0).
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Appendix 8 Executive Summary – Bladder cancer surveillance
The aim of this study was to undertake a retrospective review of all patients who had had a
confirmed superficial bladder cancer diagnosis between January 2013 and March 2014 in order to
determine whether they had been correctly followed up.
Identifying the sample for this study was extremely complex without an electronic surveillance
system. In 2012, the Trust introduced a paper tracking system for cystoscopy and in February 2014
this was replaced by a new IT recall system following the CQC investigation and an internal audit by
the Trust looking into follow up of 78 cases treated between August 2011 and January 2013. This
study therefore looked at follow-up of patients with superficial bladder cancer after the Trusts
internal audit and prior to the new IT system January 2013 – March 2014.
It is difficult to generalise the results of this small audit to the population of patients diagnosed with
bladder cancer, given that the final sample size was seven compared to the initial data extraction of
2,029 patients.
Fifteen patients who had been diagnosed with superficial bladder cancer between 2009 and 2014
were initially identified as meeting the study criteria and who had waited for four months or more to
have cystoscopy between January 2013 and March 2014. Of these only seven cases were reviewed
as four patients were found to have invasive tumours (rather than superficial), and four were
diagnosed with cystitis. These seven patents had thirteen cystoscopies over the study period.
The investigation identified that in the period studied, 8 of 13 cystoscopies were performed to
schedule. However in four cases, the waiting list management was variable with patients being
offered dates for admission that were over the target period; not being offered a date for admission
after their target period, or admission dates being cancelled by the hospital due to capacity issues.
Within this small sample, two cases were referred for serious incident investigation due to delays for
six months and 186 days from decision to treat. The problem is putting documented decisions
quickly into practice and ensuring they are followed through with active tracking as found in other
studies from the retrospective review.
This would suggest that despite putting a paper system in place for bladder surveillance since 2012,
more was still required to ensure proactive management and follow up for bladder cancer and
monitoring implementation of processes. The new IT system for recall will need to be monitored
regularly with clinician engagement and support given the complexity of assessing cystoscopy
surveillance.
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