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Final Report of the Primary Care Skin Cancer Review Group
Summary
1. Introduction
This report presents the results of an investigation into the poor quality management of
some patients with skin cancer in the community in Hillingdon in the past. It describes
the actions that were taken to ensure that these patients have now been appropriately
treated; the steps taken to ensure that high quality care is being provided and will be so
in the future; and the lessons learnt from the incident
2. Background
2.1 In 2008, Hillingdon PCT commissioned two private companies to provide
dermatology community assessment and treatment services (CATS). These services
started seeing patients in July 2008. In January 2009, significant concerns about the
management of patients with skin cancer by the two CATS providers were reported to
the PCT by The Hillingdon Hospital (THH). There were also some concerns about the
minor surgery dermatological practice of some local GPs.
2.2 At the request of the PCT, in February 2009 the West London Cancer Network
(WLCN) undertook an independent review of a sample of cases with skin cancer which
had been seen by the CATS providers. This found serious concerns about the
management of some patients and identified two definite serious untoward incidents
(SUIs) and a further four possible SUIs. It noted that the service specification for the
CATS was not compliant with the NICE guidance. The CATS services were then
suspended in March 2009 to new referrals although they continued to see follow-up
patients until the summer of 2009. At that point the contracts with the CATS providers
were cancelled and services ended.
2.3 By the end of April 2009, two SUIs had been declared relating to the care of three
patients with melanoma by CATS providers. The problems included: biopsies of
suspected skin cancer outside of NICE guidance; and delayed referral of patients to
secondary care following biopsy. The WLCN report had noted a similar range of
problems and also noted evidence of poor excision margins in skin surgery. In order to
oversee the work, and actions that were required, the report recommended that a
multidisciplinary steering group should be established. It also recommended that an
audit should be undertaken to reassure the PCT that CATS non-cancer services had
been provided in accordance with the specification and that no untoward incidents had
occurred in relation to non-cancer dermatology patients.
2.4 In June 2009, the PCT set up a working group to ensure that patients receiving
dermatology care in the community had been appropriately treated and would be so in
future. The final report of this group was produced in September 2009 and stated that a
thorough audit of CATS patients had been carried out and reviewed by the PCT. The
PCT PEC chair wrote to all Hillingdon GPs requesting that they follow NICE guidance on
the management of skin cancer.
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2.5 In July 2009, a third SUI relating to a patient with skin cancer who had been biopsied
by a CATS service was reported. This patient had not been sent a hospital outpatient
appointment following their biopsy, leading to delayed treatment and possible long term
consequences. The SUI report was eventually completed in December 2009. In April
2010, a relative of the patient contacted the PCT and concerns were raised about why
the delay in the patient’s care had not been picked up by the PCT in its previous
investigations in 2009. The PCT therefore decided to review the original SUI report and
investigate the adequacy of actions undertaken in 2009 to ensure that there had been
adequate follow-up of relevant patients treated by CATS services.
3. Current Review
3.1 The Primary Care Skin Cancer Review Group (PCSCRG) first met in June 2010
under the initial chairmanship of the PCT Chief Medical Officer with representation from
the WLCN and THH. It is now chaired by the Director of Public Health. The group is
advised by an experienced consultant dermatologist, who attended the meetings and
undertook the clinical review of patients. The review of the third SUI found that the
adequacy of the patient’s care had not been checked by the PCT following the concerns
about the management of patients by the CATS services in early 2009. In general it
concluded, based on the evidence available at the time, that the actions taken by the
PCT in 2009 could not be relied upon to have ensured that all skin cancer patients
treated by the CATS services had received appropriate care. In addition it was found
that two patients in the earlier SUI reports had not been informed by the PCT of these
investigations.
3.2 As a result, the PCSCRG decided to undertake a review of all patients with skin
cancer who had been biopsied in CATS services and in general practice from 1st
January 2008 to 1st June 2010. The aim was to ensure that all these patients had been
followed up in appropriate specialist secondary care services after their biopsy. Patients
were identified from THH pathology systems, and any past secondary care attendance
was identified from THH records and if necessary GP records. Those patients without
any record of secondary care follow up were invited in October 2010 to be seen by a
consultant dermatologist at Hillingdon Hospital. A total of 101 patients who had been
biopsied were identified, of whom 34 were invited to a review clinic. All 34 patients had
basal cell carcinoma (BCC), one of the least serious types of skin cancer, as it does not
carry a significant risk of mortality.
3.3 Thirty of the 34 patients have attended a recent dermatology clinic. Clinical evidence
of recurrence of the original BCC was found in six patients. Five had been biopsied by
CATS, one by their GP. So far, histopathology has confirmed recurrence in four patients.
An assessment of the quality of clinical care given by the service performing the initial
biopsy was made by a consultant dermatologist He considered that there was evidence
that eight patients had received poor care in the past. Most cases involved a failure to
follow-up or re-excise a lesion following a pathology report showing incomplete excision.
A further nine cases had been sub-optimally managed.
3.4 During the course of this review, it became clear that the original search strategy
used to select community histopathology reports showing skin cancer had not identified
all cases and that there were some patients with possible skin cancer whose care should
be reviewed. Therefore the histology reports of all skin biopsies taken in the community
(just over 2,000 in total) between 1/1/08 and 1/6/10 were reviewed by a consultant
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dermatologist to identify any further patients requiring a check to confirm they had been
adequately managed. This identified a further eleven patients who had not attended a
specialist at Hillingdon Hospital for their biopsy condition, none of whom were
considered to have definite skin cancer. The GPs of all these patients have been written
to by the consultant dermatologist asking about the patients’ past management and
recommending further action, if necessary.
3.5 The group carefully considered whether other patient groups treated by CATS
should be followed up. It was decided that this was not proportionate. In view of the time
elapsed since the last patient was seen by CATS services, and that there had been no
reports of any incidents since July 2009, the risk of significant patient harm was felt to be
low although not negligible.
4. Results and actions of PCSCRG
4.1 Investigation of past events
4.11 There were failings in the operation of the CATS services in 2008-9 leading to
treatment delays for some patients who had been biopsied by them and skin cancer
found. Three SUIs were reported in 2009, relating to four patients.
4.12 There is evidence that some GPs were inappropriately performing biopsies for
suspected skin cancer.
4.13 There were deficiencies in the commissioning of the CATS services by the PCT in
2008. The service specification was not compliant with NICE guidance and there
appears not to have been an effective system to ensure that GP referrals of patients who
were suspected of having skin cancer were not directed to the CATS services. It also
can be concluded that whatever systems were put in place for monitoring the quality of
care at these new providers were ineffective. There was no involvement of Hillingdon
Hospital dermatologists in contract development and monitoring.
4.14 There were delays in the PCT’s investigation of a SUI and response to a complaint
in 2009.
4.15 The initial investigation by the PCSRG on past actions by the PCT was made more
difficult and time consuming as the key staff had left the organisation and there were
difficulties obtaining information and documentation.
4.16 The actions taken by the PCT in 2009 to ensure that skin cancer patients treated by
CATS services had received appropriate care were not adequate.
4.17 Prior to June 2010, the PCT had not commissioned an effective failsafe system to
ensure that patients with skin cancer, who were biopsied in the community, were
referred to specialist care.
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4.2 Main actions undertaken by the PCSCRG
4.21 The records of all patients who had a skin biopsy taken in CATS or general practice
between 1/1/08 and 1/6/10 which showed skin cancer or where there was a suspicion of
skin cancer have been reviewed to identify those who had not been seen by a specialist
following their biopsy. Those who had not been seen by a secondary care specialist
following their biopsy have now either been seen by consultant dermatologist or advice
given to their GP.
4.22 The clinical reviews of patients in late 2010 found evidence that some patients with
BCCs had been poorly or sub-optimally managed. Six of these patients required further
treatment for their original cancer but it is not expected that they will suffer any long term
consequences to their health.
4.23 A system was put in place in June 2010 to ensure that patients with skin cancer,
who are biopsied in the community, are referred to specialist care. This system was
reviewed by the PCSCRG in January 2011 and amendments made to include possible
skin cancer cases in the system.
4.24 All Hillingdon GPs were written to by the PCT’s medical director in 2010 asking
them to follow NICE guidance on the management of skin cancer. GP practice is now
monitored by reports from the system noted in para 4.23 which are sent to the Director
of Public Health.
4.25 The Care Quality Commission has been kept informed of the progress of the
investigation and has been asked to consider whether it needs to undertake any further
investigations or action with respect to the CATS providers, as these services are no
longer operational in Hillingdon.
4.26 The London Strategic Health Authority has been kept informed of the progress of
the investigation.
4.27 The PCT’s complaint systems have been reviewed and monitoring systems put in
place to avoid delays in responding to complaints
5. Key Conclusions
5.1 Cause of the Incident
The incident occurred because of poor commissioning and monitoring of the CATS
services by the PCT and administrative and clinical under-performance by the CATS
providers. In addition there was under-performance in relation to the minor surgery
dermatological practice of some GPs. The reinvestigation was required because of
inadequately rigorous procedures carried out by the previous investigation team.
5.2 Harm caused to patients
Three serious untoward incidents involving four patients seen by CATS were reported in
2009. In two cases it is possible that the long term outcome of the patients may be
worse due to delays in treatment. The recent investigation uncovered eight further
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patients who had been poorly managed and nine who were sub-optimally managed in
the community. Expert advice is that there will be no long term adverse clinical
consequences for these patients. All the above cases have a diagnosis of skin cancer.
Patients with other dermatological conditions seen by the CATS services have not been
reviewed. It is considered that these other dermatological conditions are less serious
and therefore any mismanagement of these cases would have less significant
consequences for the patient
5.3 Are all patients with skin cancer who were identified as being poorly treated
being appropriately treated now?
All patients identified as being poorly or sub-optimally managed are now being
appropriately managed. An independent consultant dermatologist was used to review
their management.
5.4 What is the likelihood that further mismanaged cases of skin cancer due the
incident are identified?
It is not possible to give a categorical assurance that all mismanaged cases of skin
cancer due to this incident have been identified. However a thorough investigation has
been undertaken and it is very unlikely that further cancer cases will come to light.
5.5 Are the current dermatological services in Hillingdon fit for purpose?
Although the CATS services were discontinued in the summer of 2009, it is appropriate
that the Incident Team comments on the fitness for purpose of current dermatological
services in Hillingdon.
Authoritative guidance on the management of skin cancer has been sent to local GPs
which states that they should not biopsy suspected skin cancer. However the group
recognised that, as it is not always possible to recognise suspected skin cancers
clinically, there may be occasions when a skin cancer is biopsied in general practice. To
deal with this, an effective system is now operation at the Hillingdon Hospital to ensure
that any cases of skin cancer biopsied by GPs are seen by the appropriate specialist.
:
Although the Hillingdon Hospital was not responsible for the incident, policies and
procedures at the Hospital have been improved as a result of addressing central
guidance, learning lessons from this incident and responding to recent audits. As part of
this process, there will be an external review of the Trust dermatology department in July
2011 which will provide a further opportunity to ensure that a high quality service is
available to patients
6. Recommendations
6.1 The PCT should provide all the necessary information from the review to the Care
Quality Commission (CQC), so that the CQC is in a position to decide whether it needs
to undertake any further investigation or actions with respect to the CATS providers.
6.2. The local cluster needs to review the governance and quality assurance
mechanisms for minor surgery in general practice. It should consider how it can best
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support good practice in GP minor surgery. On-going training and involvement of audit
activities is essential. Mechanisms for accreditation should be considered.
6.3 The local cluster should review the commissioning strategy for minor surgery in
general practice in the light of population needs and policies on low priority treatments.
6.4 Commissioning of Services. If the PCT contracts for similar community based
services in the future there needs to be robust specifications, quality checks and
monitoring by the PCT. Of particular importance is the need for high quality clinical
advice from appropriate specialists in contract development and monitoring. There
should be adequate fail safe mechanisms to ensure that referrals are sent to and
received by secondary care, and that patients receive an appointment.
6.5 Management of Clinical Incidents. The PCT should make available guidance on
systems, policies and documentation to assist staff in managing substantial clinical
incidents. Such incidents should be properly project managed. Incident teams should
include a senior manager who was not involved in the commissioning or operation of the
services involved and there should be regular review and challenge by the wider
management team. In some incidents it would be worth considering commissioning
independent advice on the adequacy of any investigations and subsequent actions.
6.6 Record Keeping and Handover. The PCT needs to make sure that when senior staff
leave the organisation, there is access to key documentation on the issues they have
been leading on and that there is a clear handover to other senior staff.
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