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Surgical scandal, regulatory ineptness, independent inquiry and Government response – what next in the Ian Paterson affair?

Background

Between 1997 and 2011 there were “failures across the entire healthcare system” which included failures of a healthcare regulatory system, and failures of colleagues and managers of the disgraced surgeon Ian Paterson. These failures allowed his “shocking” malpractice to go unchecked.

The initial inquiries investigating that malpractice and the healthcare system failures resulted in the Kennedy Review commissioned by Heart of England NHS Foundation Trust (HEFT) – now part of University Hospitals Birmingham NHS Foundation Trust - and the Verita Review commissioned by Spire Healthcare. Recommendations emerged for those organisations but left the wider concerns to be picked up by the independent inquiry established to ensure patients and the public got answers.

The independent inquiry was led by the Bishop of Norwich. Over a two-year period, it heard evidence of patients’ experiences, making 15 recommendations to enhance patient protection and safety. The report was published in early 2020. The Government’s delayed response was published on the 16 December 2021.

Themes

The Government identified three themes covering:

  • The patient’s initial consultation with a clinician, and the information they receive during treatment to ensure they receive the highest standard of care
  • The fitness of their clinicians to practice
  • Post-treatment activity to ensure ongoing scrutiny and measurement of outcomes, pathways for raising concerns, and rapid action when something has gone wrong

Paterson injured so many because objective information was denied to patients, preventing them having control of their own care, and that lack of data could be, as it was with Paterson, a mask for poor practice.

Accountability

Although well-resourced, the system of regulation did not work adequately or in the interests of patients. Regulators were unclear about where responsibility lay. The inquiry raised specific concerns about responsibility and accountability in the independent sector, where Paterson was perceived to be “renting a room” in a private hospital and where there was limited if any understanding on the part of the patient about how their care was being managed and paid for and where responsibility and liability lay. That was identified by the inquiry as the independent sector not taking responsibility for monitoring the activity of consultants granted practising privileges at their sites.

Summary of Government response to recommendations

The inquiry made 15 recommendations, which along with the three themes identified above will be the subject of three further articles on this “affair”.

The recommendations should be understood to have been made on the back of the findings of the inquiry, but in circumstances where some changes have already been implemented in the intervening period, regarding both the regulatory and operational management of care across the NHS and independent sectors.

In relation to some of the recommendations, there are ongoing consultations which will allow the Government to review proposals for change in the context of the original consultation and the findings of the inquiry. Those are largely around the availability of indemnity arrangements for doctors, and the availability of measurable KPIs on patient outcomes which might, or might not, be shared with the public.

The recommendations

  1. There should be a single source or repository identifying the practice of consultants across England, setting out their practising privileges and critical performance data

Accepted in principle.

  1. It should be standard practice for consultants to write to patients outlining their condition and treatment and copy the letter to the patient’s GP.

Accepted

  1. How care is organised in the NHS and independent sector should be explained to patients.

Accepted

  1. Introduce a period of time in the consent process, so that patients can reflect on their diagnosis and treatment options

Accepted

  1. The CQC should ensure that all hospital providers are complying with national guidance on the use of Multi-Disciplinary Team meetings

Accepted.

6a.  Information about how to escalate a complaint is more effectively communicated

Accepted.

6b.  All private patients should have a right to the mandatory independent resolution of their complaint.

Accepted in principle.

7.    The board of University Hospitals Birmingham NHS Foundation Trust – which now managed what used to be the services provided by HEFT, should check that all patients of Ian Paterson have been recalled, and to communicate with any have not been seen.

Accepted.

8.    Spire should check all Paterson’s patients have been recalled, communicate with those who have not been and check they all have ongoing treatment plans in place in the same way as has been provided for in the NHS.

Accepted.

9.    The development of a national protocol for the recall of patients across the NHS and independent sectors.

Accepted.

10.  As a matter of urgency, the Government should reform the current regulation of indemnity products for healthcare professionals in light of the serious shortcomings identified by the inquiry and introduce a nationwide safety net to ensure patients are not disadvantaged.

The Government’s response on this recommendation is pending.

In 2018, the Government launched a consultation on appropriate clinical negligence cover for regulated healthcare professionals which sought views on whether legislation was required to ensure that all such professionals not covered by Crown indemnity should hold regulated insurance, rather than the unregulated discretionary indemnity offered by traditional defence organisations such as the MDU. The Government has recently extended this programme to consider the issues raised by the inquiry and is committed to bringing forward proposals for reform in 2022.

11. The system of regulation and the collaboration of regulators should give patient safety top priority.

Accepted.

12a. When a healthcare professional’s behaviour is investigated by a hospital, any perceived risk to patient safety should result in the suspension of the individual.

Not accepted. Whilst acknowledging that exclusions or restrictions on practice might be necessary while an investigation is ongoing, it would not be fair or proportionate to impose such a blanket rule.

12b. If a healthcare professional works at another provider, concerns about them should be communicated to the other provider.

Accepted in principle.

13.  The use of so-called practising privileges does not adequately resolve questions of a hospital or health provider’s legal liability for the actions of consultants, and the Government are asked to address this gap in responsibility and liability.

Accepted in principle.

14.  When things go wrong, the board should apologise at the earliest stage of investigation without fear of the consequences of their liability.

Accepted.

15.  If these recommendations are accepted the Government should ensure they apply across the whole independent sector if they are to qualify for NHS contract work.

Not accepted - but is to be kept under review.

Conclusion

The Government has stated it is committed to working with the NHS and independent sector to ensure appropriate measures are in place so that regardless of where a person is treated or how care is funded they can be confident that:

  • The care they receive is safe;
  • The care meets the highest standards with appropriate protections; and
  • They are supported by clinicians to make informed decisions about the most appropriate course of treatment.

Our follow up articles will look at the themes and recommendations in more detail.   

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