Monday, 20 May 2019
Monday, 4 August 2014
Updated 5 August 2014

Heath Watchdog says 5 major and 11 minor breaches risks patients' safety

Shamed Wexham Park bosses close hospital facility to avoid more safety checks

Report and photographs: Paul Janik

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.

  • Safety records never existed.
  • Procedures for reporting safety breaches never existed.
  • The hospital failed to care about patients' safety.
  • The hospital negligently failed to implement risk assessments and, consequently, the hospital failed to regularly review the risks to patents' safety.
  • Human bones and tissues used in operations could not be traced to the donor. If the donor was later identified as a heath risk, patients given the human bones and tissues, during orthopaedic operations, could not be traced.

Hospital management cancel patient facility

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:

  • No more deeply embarrassing HTA inspections.
  • No more public scandals exposing management's professional incompetence.
  • Avoiding the possibility of the HTA revoking Wexham Park's operating licence and the resulting nation-wide scandal.

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.

Who is to blame ?

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.

  1. Phillipa Slinger, chief executive - who abandoned the 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.
  2. Grant McDonald, deputy chief executive.
  3. Thomas Lafferty, chief spin doctor.
  4. Mike O'Donovan, chairman of the hospital directors and chairman of the the hospital governments.
  5. Paul Henry, chief hospital governor

We ask the clique for their comments

The questions

  1. Do you feel any personal responsibility for the devastating HTA inspection report ?
  2. How many patients will be disadvantaged by the hospital trust cancelling its HTA operating licence ?
  3. Is there anything you personally wish to say to the public ?

We will publish their replies.

5 August 2014

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.

Thomas Lafferty
Director of Corporate Affairs

Basic facts

  1. Wexham Park hospital, with its subsidiary hospital Heatherwood in Ascot, form the Heatherwood & Wexham Park Hospitals NHS Foundation Trust.
  2. A 'foundation trust' is the Labour Party's (Tony Blair's) attempt to semi-privatise the public's NHS. It removes some direct government control of its activities.
  3. Foundation trusts have a 'company secretary', a vigorous public relations team, a chief spin doctor, a chief executive, both executive and non-executive directors, extremely high salaries for the bureaucrats who gain massive £1+ million pension entitlements funded by the public.
  4. Foundation trusts have 'governors' but their remit prevents them acting like genuine governors. To prevent them being effective, the directors' chairman is imposed upon the governors as their chairman. Limiting the governors ability to stick their noses in is not a satisfactory situation especially when the governors are elected by the public.
  5. The Human Tissue Authority ('HTA') is a government health regulator. Its task is to ensure patients's safety when human tissues and human bones are used in patient operations.
  6. Wexham Park was licensed by the HTA for the storage of human tissues and human bones before they were used in operations.
  7. The HTA inspected Wexham Park on 26 and 27 February 2014. Several Wexham Park persons were shocked by the HTA discovery. Wexham Park declined to give us much information. It seemed another management organised cover-up was underway.
  8. The Slough Times upset Wexham Park's top bosses by publishing a preliminary article.
  9. Later the hospital's management tried to silence hospital governors.
  10. The 18 pages HTA report, released to the public on 30 July 2014, is available in PDF from www.hta.gov.uk/_db/_documents/2014-02-27

Extracts from the HTA report

Page 1

Although the HTA found that the Heatherwood & Wexham Park Hospitals NHS 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.

Page 3

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').

Page 4

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

Page 5

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.

Page 6

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 dates.

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.

Page 7

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.

Page 8

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 non-conformance.

Page 9

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.

Page 10

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.

Page 11

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.

SOLA 011427