26 August 2020
Almost 500 NHS patients have received cancer and other urgent treatment at Spire South Bank Hospital, under a landmark p…
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In April 2013, Spire commissioned a report on the governance arrangements at Spire Parkway and Little Aston hospitals in the light of concerns raised about the surgical practice of Mr Ian Paterson, a consultant surgeon employed by the Heart of England NHS Foundation Trust, who also operated in Spire’s Parkway and Little Aston hospitals.
The report was conducted by Verita – an independent consultancy that has worked closely with the NHS and other organisations to improve the quality of services they provide.In order to make the report as comprehensive as possible Spire wrote to over 700 patients who have been treated by Mr Paterson inviting them to participate in the review. Verita analysed over 5,500 pages of documentation, and conducted 47 interviews, including with patients, senior Spire managers, current and previous Spire CEOs, the Spire Group Medical Director, the Medical Director of the HEFT, fellow consultants of Mr Paterson, and General Practitioners who had referred patients to Mr Paterson.
In March 2014, upon completion of the report, Spire published its reaction to the findings. Read the original executive summary and recommendations. The findings and recommendations of the report were discussed at length amongst the Spire Healthcare Board and management team and today we are presenting this update one year on setting out our actions in response to the recommendations.
1. The chief operations officer for Spire, in conjunction with the group medical director, should review the job descriptions for the hospital director and matron/head of clinical services. This is to ensure that they clearly reflect their responsibilities for granting, reviewing and withdrawing practising privileges, the review of consultants’ performance generally and their role on the medical advisory committees (MAC).
Job descriptions for both Hospital Directors (HDs) and Matrons/Head of Clinical Services were amended soon after this recommendation to clearly reflect their responsibilities for granting, reviewing and withdrawing practising privileges, the review of consultants’ performance generally and their role on the medical advisory committees (MAC), in March 2014. A signed, returned copy from each HD was produced at the request of the Chief Operations Officer.
An induction programme for newly appointed HDs includes the roles and responsibilities of a Registered Manager. The first regular refresher training sessions for all RMs addressing regulatory and governance requirements were held in March 2014 and will be repeated on an annual basis. New RMs will have an appropriate induction as part of a wider ‘New to Spire’ induction plan.
January 2020 update: The annual Registered Manager training day, introduced to provide an update on governance and regulatory requirements, has been held every year since 2014. The induction framework for new Registered Managers has also been updated and includes shadowing another Registered Manager and time with a number of head office departments.
2. The executive management team should assure itself that there is a shared understanding between the hospitals and HQ regarding the matters that need to be reported to Spire HQ. This will enable hospital directors to seek and receive corporate guidance and support.
Confirmation was sent to all HDs and Matrons in March 2014 stating that summary information on individual adverse events – the event itself, investigation findings and actions taken as a result – must be recorded in the practising privileges file of the relevant consultant. This information is available to appraisers in the NHS as data to support the annual whole practice appraisal of doctors.
In June 2014 a list of notifiable events and the process of reporting them was introduced to the business to clarify the circumstances in which events must be reported nationally by HDs.
January 2020 update: We have introduced automated reports to support whole practice annual appraisal and review of practising privileges, including a practice profile and a summary of claims, complaints, incidents and serious incidents for consultants to submit for discussion at their annual appraisal.
3. The hospital directors at Spire Parkway and Little Aston hospitals should ensure that:
A review of hospital and corporate governance structures by the legal firm DAC Beachcroft was undertaken in early 2014. The result is the ‘Spire Standards for Hospital Governance’ which has been made available to every hospital. This document sets out the minimum governance structures for hospitals, including committees, standard agendas (including discussion of consultant-identifiable performance issues and practice reviews), recording of actions and ‘Ward to Board’ arrangements for reporting. The requirement to discuss any concerns regarding consultants at the MAC in a non-anonymised way has also been included in Spire’s Consultants’ Handbook.
Spire has also confirmed in writing to all HDs and Matrons the requirement to comply with:
January 2020 update: In addition to Spire’s Standards for Hospital Governance, our new policy for Medical Governance and Assurance describes our approach to Medical Governance, and is aligned to the principles of the Medical Practitioners’ Assurance Framework, recently published by the Independent Healthcare Providers Network. The roles and responsibilities of the MAC Chair, MAC Speciality Representative and Designated Consultant for Clinical Governance are now included in this policy, together with the MAC Terms of Reference and template meeting agenda. We have also reviewed the process for appointing MAC chairs, with a proposed appointment now requiring the approval of the Group Medical Director, and introduced an assessment process which must be completed before chairs are appointed for a second term.
4. The hospital directors at Spire Parkway and Little Aston hospitals, with the support of the medical advisory committee chairs, should ensure compliance with Spire’s policy regarding biennial review of consultants with practising privileges. For Parkway, this means improving the system of reviews for all consultants with practising privileges; at Little Aston, it means continuing to carry out such reviews but documenting the discussion at the relevant medical advisory committee.
As part of Spire’s further actions as a result of the review, a Head of Regulatory Assurance was appointed in October 2014 to assess and provide regular assurance of the business compliance with healthcare related regulatory and statutory requirements.
Compliance with practicing privileges documentation audit was added to the national clinical audit programme for every Spire hospital, with results reported on a regular basis to the executive management team (EMT) and Board.
In addition, a corporate practicing privileges database was developed to enable relevant, up to date information to be stored for individual consultants, and to be accessed remotely where necessary to enable remote audit and assurance.
The Consultants’ Handbook was updated in June 2014 to include clarification that in signing up to practicing privileges consultants must now agree to the review of their identifiable performance data by the MAC.
The enhanced clinical review process – namely on-site hospital review undertaken at least annually and led by Spire's Chief Nursing Officer - includes assessment of:
In addition, an audit of practicing privileges documentation was undertaken and results shared with all HDs with ongoing monitoring via the clinical scorecard.
January 2020 update: We have strengthened arrangements for review of practising privileges including a defined standard operating procedure, incorporating improved feedback from all key staff and shared hospitals. Practising privileges for some groups of consultants are now reviewed every year, rather than every two years. We have also significantly enhanced our regular clinical review programme (known as “Patient Safety and Quality Reviews”) which is designed to mirror the CQC’s inspection framework, including the ratings. The programme has been further developed to include a more comprehensive review of the record keeping of MACs, review of practising privileges documentation and review of compliance with the biennial review process.
5. For ensuring effective biennial review, the hospital matrons/heads of clinical services should hold the range of information available on site about consultants in individual practising privileges files. As a minimum, each file should contain adverse clinical events, complaints, evidence of satisfactory appraisal in line with sector guidelines, scope of practice and any documented areas of concern. The information should be kept up to date, be stored securely and be readily available including (with the exception of confidential file notes and correspondence) to the consultant.
As well as the development and roll out of a corporate practicing privileges database, as outlined in the response to recommendation 4, the Consultants’ Handbook was updated in June 2014 to include guidance on the range of information that should be available in a practicing privileges file, including individual adverse events. By having an electronic database holding all the information necessary to maintain practising privileges in line with Spire's Consultants’ Handbook, this will enable regular auditing by the national clinical services team with timely action being taken to address instances where information or evidence is not available.
January 2020 update: We have introduced automated reports to support whole practice annual appraisal and review of practising privileges, including a practice profile and a summary of claims, complaints, incidents and serious incidents for consultants to submit for discussion at their annual appraisal. We have introduced regular central reporting of compliance against targets for the mandatory documentation required to maintain practising privileges – medical indemnity, appraisal, biennial review, DBS and Hepatitis B immunity – together with cross cover arrangements for consultants with admitting rights and evidence of appropriate resuscitation standards and safeguarding training for those who treat children.
6. The Spire group medical director should consider developing objective criteria – for inclusion in the Consultants’ Handbook - setting out the requirements for maintaining practising privileges, and the scenarios that may result in their suspension or withdrawal. This would be useful guidance for the hospital directors and members of medical advisory committees (MAC).
Spire's Consultants’ Handbook has been updated to include objective criteria and requirements for maintaining practising privileges including scenarios in which these may be suspended or withdrawn.
The Spire policy on ‘Managing Performance Concerns about Consultants’ was updated in June 2014 to include a requirement to notify senior members of staff and the MAC whenever a consultant has been restricted from undertaking certain procedures.
January 2020 update: Spire has introduced a new policy – the Medical Governance and Assurance Policy – aligned to the recently published Medical Practitioners' Assurance Framework. This is intended to supplement the Consultants’ Handbook and includes revised standard operating procedures for granting and reviewing practising privileges, introducing new interventional procedures, outlier management, managing performance concerns and clinical research.
7. The medical advisory committee’s standing agenda item on practising privileges should be in two parts: a) new applications for practising privileges, and b) the biennial review of practising privileges for existing consultants. The minutes should reflect these two separate issues where relevant and record the names of the individuals considered and the decisions made.
Spire has confirmed in writing to all HDs and Matrons the requirement to comply with accurate MAC minute-keeping (as two separate agenda items) relating to new applications for practising privileges, and biennial review of existing practising privileges. The Consultants’ Handbook was updated to provide both guidance on the process to be followed for biennial reviews and information on the updated MAC agenda.
January 2020 update: The relevant item on the medical advisory committees’ standing agenda, now incorporated into our Medical Governance and Assurance Policy, is divided into three parts to include (a) applications for practising privileges, (b) biennial review of practising privileges and (c) consultant suspensions / withdrawal of practising privileges. We have also issued further guidance to MAC members in the form of a MAC Chairs and Specialty Handbook. The record keeping of hospital MAC’s is also reviewed during our on-site Patient Safety and Quality Reviews.
8. The hospital directors and their medical advisory committee chairs at Spire Parkway and Little Aston hospitals should consider how best to tighten the systems in place for knowing about and monitoring a consultant’s scope of practice.
As well as the development and rollout of a corporate practising privileges database as outlined in the response to recommendation 4, Spire has also explored the opportunity of a third party to identify where private undertakings do not match NHS practice. This approach has been limited by the inability of third parties to gain access to the NHS Hospital Episode Statistics data. Nevertheless, Spire is engaging with the Private Hospital Information Network (PHIN) to explore how this dataset could be incorporated into the process of biennial review. In addition, Spire has met with NHS England’s Responsible Officer Calibration and Operational Network (ROCON) in order to explore a more robust means for the private sector as a whole to monitor a consultants’ scope of practice, and meetings are ongoing.
January 2020 update: Checking scope of practice is incorporated into our process for reviewing practising privileges, with an increasing focus on consistency with sub-specialty scope of practice. Spire also submits required data sets to PHIN (admitted patient care, adverse events, patient satisfaction and patient reported outcomes) and is continually working to improve data quality. The recently published Medical Practitioners Framework does highlight that, currently, no single reliable and definitive view of any given doctor’s scope of practice, activity, outcomes or performance exists and together with other independent sector providers, we are supporting IHPN to help develop and implement a consultant information sharing system.
9. The hospital directors at Spire Parkway and Little Aston should assure themselves that all consultants with practising privileges are appraised in line with Spire’s appraisal policy.
Confirmation was sent to all HDs and Matrons in March 2014 stating that summary information on individual adverse advents – the event itself, investigation findings and actions taken as a result – is to be recorded in the practising privileges file of the relevant consultant. This information is available to appraisers in the NHS as data to support the annual whole practice appraisal.
As mentioned in responses to recommendations 1 and 2, the first regular refresher training sessions for all hospital RMs (typically the HD) addressing regulatory and governance requirements were held in March 2014 with excellent all-round feedback. These will be held on an annual basis with regular updates as required. New HDs will have an appropriate induction as part of a wider ‘New to Spire’ induction plan.
In addition, a compliance with appraisal policy audit was added to the national clinical audit programme, and results are monitored via the clinical scorecard and reported to the EMT and the Clinical Governance and Safety sub-committee of the Board.
January 2020 update: The requirements for annual appraisal are now incorporated into our new Medical Governance and Assurance Policy. We have also increased the targets for hospital compliance with the mandatory documentation (including appraisal) required for consultants to maintain practising privileges to 100% for all five mandatory documents. Compliance is reported weekly.
10. The Spire group medical director should continue to look at the value of comparing intervention ratios (ie the ratio of new appointments to theatre episodes to follow up appointments) within specialties across Spire hospitals (and ideally with surgeons in the NHS) as a possible way of identifying consultants that are over treating.
Spire is developing a tool to monitor and benchmark treatment and follow up intervention rates by consultant. This piece of work is well underway and a pilot is expected to be undertaken in the second quarter of 2015 following the rollout of the consultant database.
January 2020 update: We have developed three intervention ratio metrics designed to identify potential over-treatment (medical treatment that is not clinically indicated by published professional guidelines) by consultants across the Spire group, together with a process for hospital notification and investigation, overseen by the Group Medical Director. These were introduced in 2017 and we now run intervention ratio analysis every year.
11. Matrons/heads of clinical services at Spire Parkway and Little Aston hospitals should ensure that information on individual adverse events:
is reviewed by the medical advisory specialty representative before making their recommendation to the hospital director as part of the biennial review of practising privileges.
Confirmation was sent to all HDs and Matrons in March 2014 stating that summary information on individual adverse advents – the event itself, investigation findings and actions taken as a result – is to be recorded in the practicing privileges file of the relevant consultant. This information is available to appraisers in the NHS as data to support the annual whole practice appraisal. The Matrons at Spire Parkway and Little Aston hospitals are clear that information on individual adverse events are to be recorded in consultant practising privileges files, form part of the information that these hospitals make available to the NHS appraiser as part of whole practice appraisal, and is reviewed by the medical advisory specialty representative before making their recommendation to the HD as part of the biennial review of practising privileges.
A review of hospital and corporate governance structures by the legal firm DAC Beachcroft was undertaken in early 2014. The results are the ‘Spire Standards for Hospital Governance’ which have been made available to every hospital. This document sets out the minimum governance structures for hospitals, including committees, standard agendas (including discussion of consultant-identifiable performance issues and practice reviews), recording of actions and ‘Ward to Board’ arrangements for reporting.
January 2020 update: We have introduced automated reports to support whole practice annual appraisal and review of practising privileges, including a practice profile and a summary of claims, complaints, incidents and serious incidents. Review of practising privileges also incorporates the gathering of soft intelligence, with MAC chairs or Specialty representatives involved in the review when the information included in the process raises any concerns.
12. The hospital directors at Spire Parkway and Little Aston hospitals should ensure that consultant surgeons operate only on patients with breast cancer when there is evidence that they have undergone ‘triple assessment’ and been discussed at an appropriate multidisciplinary team meeting.
Compliance with the triple assessment pathway for breast care was introduced as an audit in 2014, the results of which were reported to the EMT and Board. The updated Consultants’ Handbook specifies that triple assessment is a standard requirement for patients presenting with a breast lump, and that results are to be discussed at an appropriate multi-disciplinary team (MDT) meeting.
January 2020 update: We now require confirmation that evidence of a Cancer MDT meeting treatment pathway recommendation is made available prior to any patient with a new (or recurrent) diagnosis of cancer being admitted for treatment. In urgent cases - where delaying treatment for MDT discussion would place the patient at unacceptable clinical risk - the hospital Matron may approve treatment to proceed, provided that evidence of MDT discussion is submitted retrospectively. Compliance with this requirement is audited and reviewed at our on-site Patient Safety and Quality Reviews.
13. In order for Spire breast cancer patients to have access to an effective multidisciplinary team, the hospital directors should either:
A service line agreement for hospitals to use with local NHS Trusts to formalise arrangements for discussion of cancer patients at a peer reviewed multi-disciplinary team (MDT) meeting was developed and sent to hospitals in June 2014. This was sent along with guidance and expectations for compliance with Spire Cancer Standards, which was incorporated into the updated Consultants’ Handbook released in June 2014.
An electronic MDT platform (Ardeo) is in the process of being rolled out to create a specific electronic record for Spire cancer patients in order to facilitate both Spire and NHS Trust MDT discussions. This will be in place across all hospitals for breast cancer and chemotherapy patients before being extended to cover all tumour types.
January 2020 update: In addition to ongoing audits of compliance with MDT requirements, we have now introduced the Ardeo Cancer Platform, incorporating the treatment pathway for chemotherapy patients. We have also introduced iQemo, an electronic chemotherapy prescribing system, supported by a sign-off process designed to ensure that new treatment regimens are valid and appropriate, and established two new roles for clinical specialists in oncology pharmacy to support expert review of chemotherapy protocols.
14. The Spire Group should consider its arrangements for reviewing and recalling Mr Paterson’s remaining breast patients and his general surgery patients in order to ensure that it has processes and resources in place to establish as quickly as possible whether or not they have had appropriate treatment. It should set a deadline for the work.
The review team briefed the EMT and Board in May 2014 on the process for reviewing and recalling remaining patients and for expediting the existing programme. Progress is reported on a monthly basis to the EMT and the Board.
As of March 2015, all known breast surgery patients have had their care reviewed by an independent Consultant specialist surgeon, with all general surgery patients also having their care reviewed and recall appointments expected to be completed by July 2015.
January 2020 update: All appointments were completed by July 2015.
15. The hospital directors at Parkway and Little Aston should ensure that senior members of staff and members of the medical advisory committee are informed if a consultant is under investigation either by an NHS trust or by the hospital itself. In addition they should inform theatre managers immediately whenever a consultant has been restricted from performing certain surgical procedures.
In March 2014, Spire confirmed in writing to all HDs and Matrons the requirement to comply with the process for informing senior members of staff and the MAC if a consultant is under investigation by the NHS or the hospital itself, as set in the policy ‘Managing Performance Concerns about Consultants’.
The whistleblowing policy was revised and strengthened in February 2014 to reinforce clear guidance on the notification of concerns raised by non-employed healthcare professionals including other doctors. In addition, an independent whistleblowing policy helpline was launched in February 2014 and a poster campaign commenced April 2014.
January 2020 update: We have introduced Surgical Safety Guardians in every theatre department. Each has received additional “human factors” training and they play a key role in reducing patient safety incidents, challenging poor behaviour and delivering training on matters relating to surgical safety. Additionally, we have appointed hospital Freedom to Speak up (FTSU) Guardians in every hospital and non-hospital site to further grow and support a culture of speaking up where staff, particularly those working directly with patients, have the means and confidence to raise concerns, with a focus on issues that could compromise staff and patient safety or affect service quality. As of 1 June 2018, all Spire staff can submit a FTSU concern anonymously using our adverse event reporting system. A national FTSU Guardian has also been appointed.
Although the Verita Review was limited to Spire Little Aston and Parkway hospitals, Spire adopted these actions across the entire Spire hospital network. In addition to the Verita recommendations, Spire itself decided to take the following further actions to improve its processes, all of which have been completed:
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