Slough's semi-privatised NHS acute hospital, Wexham Park, is again in the news because of the gross incompetence of its top managers.
This time a heath watchdog, the Human Tissue Authority ('HTA'), made an unannounced inspection and discovered the hospital literally did not know what it was doing.
Afraid of more damaging publicity, top hospital managers decided to cancel Wexham Park's operating licence granted by the HTA.
The advantages of Wexham Park voluntarily cancelling its HTA licence are:
The disadvantage to some patients is they may have to be treated at another, better run, hospital. It could be Frimley Park hospital which is 20 miles away from Wexham Park.
It appears to the Slough Times that the hospital's latest management failure will disadvantage NHS patients.
The Slough Times puts the blame for this latest, in a long line of frequent patient failures, on the shoulders of the Wexham Park clique who run the hospital.
abandonedthe hospital during a flood of devastatingly bad reports into its management and operation - now managing director of Care UK Ltd (01668247) Secondary Care division. Care UK is a £6 million private company competing for NHS business against established NHS services.
cliquefor their comments
We will publish their replies.
As is the case with all external regulatory assessments/inspections, the Board ultimately is collectively responsible for any shortfalls or aspects of non-compliance identified.
As you are aware, the HTA report did identify shortfalls regarding the Trust's approach to the storage of bone products. During the inspection, the Trust took immediate action to address the concerns raised at the time.
More latterly, the Trust has engaged in a redesign of its care pathway so that the need for bone storage is no longer required, in line with other Trusts, which has addressed the HTA's concerns. Patients will not be disadvantaged in any way by this change.
Director of Corporate Affairs
stick their noses inis not a satisfactory situation especially when the governors are elected by the public.
Although the HTA found that the Heatherwood & Wexham Park
Foundation Trust (the establishment) had met some of the HTA standards, 16
shortfalls were found in relation to Governance and Quality Systems; Premises,
Facilities and Equipment; and Disposal. Five major shortfalls were
identified during the course of the inspection. These relate to the need for the
establishment to have robust procedures and documentation in place to ensure that
bone products are not used beyond their expiry date, and to the need for the
establishment to have appropriate risk assessments and incident reporting systems
in place in relation to the activities being carried out under the authority of
their licence. The remaining minor shortfalls relate to various aspects of the
establishment's governance and quality systems, including their approach to
document management, internal audit, the review of traceability logs and freezer
monitoring records, and staff training.
Although basic records of bone products were being kept at both
sites, these were generally incomplete, meaning that a robust traceability
audit could not be conducted at the time of the inspection. The audit also
revealed that the establishment lacked robust systems to appropriately adjust
(i.e. bring forward) the expiry dates of products in light of the temperature at
which the tissue was being stored. These issues, which had the potential to
result in the use of out of date products, are discussed in more detail below
(see 'Compliance with HTA standards').
Under the Human Tissue (Quality and Safety for Human Application)
Regulations 2007, the DI (designated individual) has a statutory duty to ensure
that the conditions of the licence are complied with. The DI must also be in a
position to secure that suitable practices are used in the course of carrying
out licensable activities, and that these activities are carried out by suitable
persons. Based on the inspection findings, detailed below, the HTA were not
satisfied that the DI had fulfilled these duties by taking sufficient steps to
ensure that suitable working practices are being followed.
Following the inspection, the establishment informed the HTA
that it has conducted a strategic review of orthopaedic services at the
Heatherwood and Wexham Park Hospitals. As a result of this exercise, a decision
has been reached by the establishment to revoke its HTA licence. The HTA
were informed that any future storage of bone products at the two hospitals would
be on a short-term basis only (i.e. less than 48 hours). As such, this activity
would fall outside the licensing requirements of the Human Tissue (Quality and
Safety for Human Application) Regulations 2007
Although the establishment has a number of basic standard
operating procedures (SOPs) in place relating to the licensable activities being
carried out, staff lack sufficient information to ensure the integrity of the
tissues being stored by the organisation.
For example, the SOP relating to the storage and use of bone for
orthopaedic procedures states simply that bone should be stored in accordance
with departmental procedures. These procedures are not defined within the SOP or
elsewhere in the establishment's documentation.
Furthermore, the SOP lacks sufficient information on the tissue
receipting process, including instructions on the information that must be
recorded and the steps that should be taken to adjust the expiry date of products
in light of the temperature at which they will be stored.
Although Trust-level documentation was seen to be subject to
appropriate levels of document control, there was an inconsistent approach to
the control of documents relating to the storage and use of human tissue. For
example, the SOP for the storage and use of digits and skin for plastic surgery
procedures and the form used to record fridge/freezer storage temperatures
lacked unique identifiers, version numbers, author information and review by
Robust systems were also lacking to ensure that only current
documents were in active use.
Although some evidence of internal audits at the Wexham Park
Hospital was noted during the inspection, a clear schedule of audits across both
sites, encompassing all licensable activities was not in place.
Although staff at the Heatherwood Hospital complete signature log
sheets to evidence the reading and understanding of SOPs, those reviewed during
the inspection lacked information relating to the date of training. As a result,
it was not possible to determine what version of the SOPs had been read or whether
periodic re-training or competency assessment was needed.
It was also noted that a significant number of people were
completing freezer temperature monitoring logs and the bone receipt log without
having signed the appropriate SOP. In light of the inconsistent manner in which
logs were being completed (see comments elsewhere in this report), this finding
raises concerns over the rigor of staff training in relation to the carrying
out of licensable activities.
At the time of the inspection, regular audits of records were not
being undertaken by the establishment. As a result, inaccuracies in written
records, such as those noted in the bone and freezer logs, had not been identified
nor properly investigated and resolved.
Although staff at both sites keep basic records of femoral heads
received by the establishment, information critical to their safe and appropriate
storage and use was not consistently documented.
This included information relating to the date and time of
product receipt, the person responsible for receiving the tissue, unique product
identification information, and details on sample usage or disposal. Furthermore,
at the time of the inspection the establishment was not consistently revising
expiry dates in light of the temperature at which the tissue products were being
stored. As a result, recorded expiry dates, where present, did not always reflect
the actual expiry dates of the products (see also PFE3d below).
At the time of the inspection, the establishment's records
management policy did not clearly define the storage requirements for raw data
or traceability information as set out in the 'Guide to Quality and Safety
Assurance for Human Tissues and Cells for Patient Treatment' which forms the
Annex to Directions 003/2010.
Although staff at the establishment keep basic records of tissue
stored under the authority of their licence, logs were inconsistently completed
and the information they contained was insufficient to ensure a robust audit
trail without reference to ancillary records including patient notes or
information provided by the supplier upon request (see also Advice below).
Although the establishment has a Trust-level policy that includes
a reference to the need to report serious incidents relating to the storage and
use of human tissue to the HTA, detailed SOPs for incident reporting were not in
place at the time of the inspection.
As a result, the roles and responsibilities of personnel
investigating and reporting such events had not been clearly defined, nor had
the method (i.e. via the HTA's Portal) or timeframe (i.e. within 24 hours of
discovery) been adequately documented.
The establishment had also failed to put in place appropriate
procedures for the management of any tissues affected by an adverse event or
Although the Trust has a risk register that identifies the need
for the organisation to hold an HTA licence for the storage of bone products, at
the time of the inspection documented risk assessments were not in place for the
licensable activities being undertaken.
Once completed, risk assessments should be reviewed on a regular
basis to ensure that they remain relevant and continue to cover the full scope
of the establishment's activities.
A risk assessment of the premises had not been completed for
either site covered by the licence.
Although staff monitor the temperature of the fridges/freezers
used to store human tissue samples on a routine basis, the establishment does
not have robust procedures in place to identify and act upon deviations in
fridge/freezer temperature outside of the prescribed operating limits.
For example, the temperature monitoring log for the 'plastics'
fridge revealed numerous examples where the recorded temperature was outside of
the prescribed limits (2-4 °C) whilst tissue was in storage. Similar excursions
were also noted in the chart recordings for the freezer used to store bone
products at the Heatherwood Hospital. Despite this, there was no evidence of
these deviations having been logged as such and investigated, nor of a
concessional release process for the affected tissue having been followed.
Staff at the Heatherwood Hospital had also failed to identify the
fact that chart paper with the wrong temperature scale had been used in the past
in the freezer used to store bone products. As a result of this, for the period
in question, the establishment could not evidence the fact that the tissue had
been stored at the appropriate temperature.
At the time of the inspection, the establishment did not have
robust procedures in place to ensure that the expiry dates of bone products
were adjusted (i.e. brought forward) in light of the temperature at which they
were being stored on both sites. Consequently, accurate use-by dates for the
products in storage were not always documented.
Although staff at the establishment had identified alternate
equipment that could be used in the event of a malfunction in any of the primary
storage fridges/freezers, these contingency plans had not been formally
documented at the time of the inspection.
At the time of the inspection, a consistent approach to
documenting disposal of tissue was not being adhered to by staff at the
establishment. As a result, the method and reason for disposal of tissue was not
always being recorded.
At the time of the inspection, a copy of the Certificate of
Licence describing the activity authorised by the licence was not being
displayed on the licensed premises. This requirement is a standard condition on
all HTA licences.