Updated 06/04/2010
Questions and answers
What were the allegations?
University Hospitals Bristol NHS Foundation Trust was made aware
of concerns about potential misdiagnosis in histopathology between
2000 and 2008. 26 cases over this period were brought to our
attention.
These concerns were not limited to any one type of
histopathology or to any individual Pathologist.
The position of the board of UH Bristol is that whilst there is
no evidence to suggest a significant diagnostic error rate in its
histopathology services it is determined to ensure that patients
continue to have full confidence in the histopathology services it
offers and the board believes that this Inquiry will afford that
confidence to patients.
Were the patients involved told about these concerns?
Concerns about the original diagnosis in each case will have
been dealt with at the time that they arose between 2000 and 2008,
through established clinical procedures.
I am a patient at UH Bristol. In the light of these
allegations, how can I be sure of the quality of the Trusts
Histopathology service?
University Hospitals Bristol NHS Foundation Trust and North
Bristol Trust have been working jointly for some years to minimise
any procedural obstacles to effective diagnosis. On an ongoing
basis, UH Bristol has agreed with NBT that if an issue of concern
presents itself to any employee, or is brought to the attention of
an employee, they should document those concerns in writing to the
appropriate Executive Director to raise formally with the other
Trust concerned
In addition, the University Hospitals Bristol NHS Foundation
Trust Histopathology Department was fully accredited by Clinical
Pathology Accreditation UK Ltd (known as CPA) in April
2009.
CPA accreditation involves an independent, external audit of the
Departments ability to provide a service of high quality by
measuring it against defined standards of practice, which are
confirmed by peer review.
The Laboratory also participates in national, technical,
external quality assurance schemes. All Consultant
Histopathologists at University Hospitals Bristol NHS Foundation
Trust participate in national, external quality assurance schemes
for diagnostic services.
What is University Hospitals Bristol NHS Foundation Trusts
response to these concerns?
The Trust is confident about the quality of its pathology
services and believes that there is no evidence to suggest a
significant error rate in Histopathology.
However, the Trust takes concerns over clinical performance
extremely seriously and has therefore decided to commission an
independent, external review of the histopathology service to
establish if there is a significant error rate and identify any
areas of concern requiring further action.
Each individual case where concerns have been raised is also
being re-examined by two independent pathologists from outside the
South West.
What is a significant error rate in Pathology diagnosis?
The Royal College of Pathologists define errors in
Histopathology as those errors where two independent Pathologists
confirm their disagreement with the original diagnosis.
Published, professional research suggests that a diagnostic
error rate between 1% and 2% is within the normal range. Complex
cases, in particular, are frequently an issue of opinion rather
than definitive diagnosis. A significant error rate would be one
that is outside the expected range for the caseload in question. It
is important to understand that a pathology report is one input to
the diagnosis of a patients condition. Other inputs include the
patients medical history, physical examination, results of other
investigations such as x-rays and scans, family history and so
on.
Where cancer is a possible diagnosis, all this information will
be considered by a range of professionals at special
multi-disciplinary team meetings specifically designed to identify
the best course of treatment for the patient concerned. It is not
unusual in complex cases for a range of possible diagnoses to be
suggested or for additional pathology opinions to be sought.
Who will be carrying out the audit and how will it be
conducted?
University Hospitals Bristol NHS Foundation Trust has taken
advice from the Royal College of Pathologists and statistical
experts, both inside and outside the Trust, to establish the
methodology for an independent review.
An independent organisation has been commissioned to review the
individual cases raised as specific concerns and to audit a random
sample of 3,500 histopathology cases across all specialties from
2007. Each case will be reviewed by independent specialists from
outside the South West of England.
Expert advice was that a random sample of 3,500 cases was
sufficiently large to allow statistically significant results to be
stratified both by histology type and by individual clinician. The
sample will be drawn from specimens taken in 2007 as this is the
most recent year about which concerns have been raised.
What will happen with the results of the audit?
The Trust has established an independent review group, which
will investigate concerns raised about possible misdiagnosis of
histopathology specimens. It will establish what actions were taken
by the Trust to address these concerns and decide if those actions
were appropriate, timely and sufficient.
It will also consider the results of the external audit of
histopathology specimens and make recommendations on any actions
necessary to ensure the Trust provides safe and effective pathology
services for patients.
Chair of the review group is Jane Mishcon, Counsel at Hailsham
Chambers, London, a barrister with 30 years experience across a
wide range of cases involving most clinical specialities. She
has chaired nine independent inquiries and her main area of
practice is clinical negligence. Jane is ranked as a leading
barrister in both the Legal 500 and Chambers UK.
The other members appointed to the review group are: Sir James
Underwood, former Professor of Pathology at the University of
Sheffield Medical School; Ken Jarrold CBE, senior consultant at
Dearden Consulting and former chief executive of County Durham and
Tees Valley Strategic Health Authority. Dr Margaret Spittle
OBE MSc FRCP FRCR AKC, consultant clinical oncologist and emeritus
at University College London Hospitals NHS Foundation Trust and
Guys & St Thomas Hospitals NHS Foundation Trust replaced Dr
Fergus Macbeth, consultant oncologist and Director of the Centre
for Clinical Practice at the National Institute for Health and
Clinical Excellence on the panel in January 2010, following Dr
Macbeth's decision to stand down due to other work commitments.
Following consultation with the Patients Association, Michael
Summers, vice chairman of the Patients Association has been
appointed as patient representative.
How long will this take?
The audit of samples is completed, it is now being peer reviewed
and has been sent to the Royal College of Pathologists for comment.
The Independent Inquiry panel has met and has started interviewing
witnesses in November 2009. At this stage we do not know how
long the Independent Inquiry will take. The Trusts main
concern is that patient confidence in our histopathology services
remains strong and we believe their review will provide patients
with any reassurance they need and ensure that any allegations
about patient safety are investigated thoroughly. The Trust
is acutely aware of its responsibility to ensure public money is
spent wisely and this has been impressed upon the panel.
What if the audit does identify diagnostic errors?
If the audit formally identifies diagnostic errors, the records
of the patients concerned will be reviewed by the responsible
Consultant to see if their treatment would have been affected in
any way.
In the unlikely event that a patients condition is shown to have
been adversely affected by a misdiagnosis, they will be invited to
a special consultation to discuss the implications.
Who else is involved in this process?
The Trust has informed the two health service regulators, the
Care Quality Commission and Monitor (the independent regulator for
Foundation Trusts) of the steps it is taking to address these
concerns.
NHS Bristol is the co-ordinating Primary Care Trust for
University Hospitals Bristol, which means it will take a lead in
working with the Trust on behalf of all Primary Care Trusts in the
South West to ensure that the public can have confidence in the
quality of the Trusts services.
Why arent you releasing details of the cases where misdiagnosis
has been alleged?
This information cannot be released for reasons of patient
confidentiality. The list of cases includes medical details which
may personally identify patients.
How are you ensuring that the panel is fully Independent?
Whom the panel members wish to interview is for them to decide,
the Trust has placed no restriction on who they may approach.
The Trust has instructed Verita to manage the administration of the
Inquiry.
I would like to give evidence, how do I do that?
If you wish to give evidence, please contact Verita, who are
coordinating the Inquiry independently of the Trust. Please
telephone 0207 494 5670, or email enquiries@verita.net
What is histopathology?
Histopathology (or histology) is the branch of pathology which
concerns the analysis of human tissue for diagnostic purposes.
How many Histopathology specimens does University Hospital
Bristol deal with each year?
The Trust deals with an average of 18,500 adult histopathology
requests each year, excluding cervical cytology, of which around
10% are referred by GPs and 90 % by consultants.
Why is the audit being conducted now if concerns were raised
before?
University Hospitals Bristol NHS Foundation Trust and NBT have
been working together since 2008 to establish the basis for a joint
review into Histopathology services by the Royal College of
Pathologists.
However, University Hospitals Bristol NHS Foundation Trust has
now moved to commission an independent review of its own service
since allegations have been published in the media which may
undermine public confidence in the quality of those services.
What if I have personal concerns and want to discuss them?
Please call the following number to discuss any concerns you may
have: 0117 342 2050.
