The victim impact statements from families of the babies murdered and harmed by Lucy Letby describe the harrowing and tragic consequences of her actions. The handling of the case also demonstrates why lessons still need to be learned when clinical harm occurs and questions are rightly being asked about the role and accountability of senior managers.
Following the conclusion of the criminal case and sentencing, the government ordered an inquiry to identify system failures and to make recommendations around how such tragic events can be avoided in the future.
While the conclusions of any future inquiry into the Letby case will take some time, there are several issues that have come under the spotlight which translate across all areas of healthcare, including pharmacy.
Consultants working at the Countess of Chester NHS Trust had raised concerns with hospital management about the significant numbers of babies suffering unexplained, serious collapses in the neo-natal ward as long ago as 2015. However, police were only contacted in 2017. Despite the severity of the concerns raised, the senior management team reinstated Letby to duties on the ward, implying that there were staff shortages and forced the clinicians to apologise. The threat of a referral to their regulator was left hanging over the heads of the clinicians. The system seemed incapable of dealing with the concerns raised by clinicians about an individual who it transpired, was deliberately causing death and injury to patients in her care.
Previous inquiries
Governments are often very quick to order an inquiry after such high-profile cases which raise concerns about the operational and governance processes in place within NHS settings, but they are often reluctant to implement the recommendations made by these inquiries. The Institute of Government in 2017 noted:
There is no routine procedure for holding the Government to account for promises made in the aftermath of inquiries, the implementation of recommendations is patchy, in some cases repeat incidents have occurred and there is no system for allowing inquiries to build on the learning of their predecessors. [1]
The past 25 years have seen several high-profile inquiries and one area where the government has implemented substantial reform is around the regulation of individual healthcare professionals.
However, despite many of the inquiries also highlighting the role of managers and senior leaders within the NHS settings where patient harm has occurred, many aspects around the regulation of these managers have still not been accepted by government.
Indeed, as far back as the Bristol Inquiry, set up to investigate the deaths of 29 babies undergoing heart surgery at the Bristol Royal Infirmary, there have been calls to regulate senior managers. Recommendation 91 of the Kennedy Report is clear:
Managers as healthcare professionals should be subject to the same obligations as other healthcare professionals, including being subject to a regulatory body and professional code of practice. [2]
Twelve years later, the Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry also made a recommendation, in the event that the other recommendations around the regulation of managers had been assessed:
An alternative option, which should be kept under consideration, preferably until after a period in which the licensing solution is followed through, would be to set up an independent professional regulator as was recommended by Sir Ian Kennedy. The need for this, as opposed to the ‘fit and proper person’ solution suggested above, would be greater if it were thought appropriate to extend a regulatory requirement to a wider range of managers and leaders. The proportionality of such a step could be better assessed after reviewing the experience of a licensing provision for directors. [3]
The government opted for the ‘fit and proper person’ test as the appropriate mechanism to improve the standards of senior leadership and governance within NHS Boards and this was introduced in 2014.
However, just four years later, in 2018, the Inquiry into the failings at the Liverpool Community Health NHS Trust made a specific recommendation:
The Department of Health should review the working of the Care Quality Commission fit and proper person’s test, to ensure that concerns over the capability and conduct of NHS executive and non-Executive Directors are definitively resolved and the outcome reflected in future appointments. Action: Department of Health.
This led to the government commissioning a review, undertaken by Tom Kark, into the effectiveness of the ‘fit and proper persons test’. The review was given a short 3-month timescale to deliver its recommendations to government. It made a number of recommendations for changes to the ‘fit and proper persons test’. [4]
It is notable that Sir Robert Francis in his written evidence to parliament following the publication of the Kark review stated:
My observation is that we do not lack for authoritative advice on what action is needed to fix the problem, but actual effective action to take that action. [5]
The need for regulation
There is currently no regulatory accountability for the actions of non-registered managers who exert power and influence over registered healthcare professionals. Without the appropriate regulatory traction, their decision-making and influence, which has direct impact on patient safety, might never be called into question.
It is essential that the government accepts the advice of the Kennedy and Francis Inquiries and either constitutes a new arm’s length body to regulate NHS managers or give that task to an already constituted regulator.
Casework and requests for support from PDA members inform the PDA that incidents where non-registered managers influence decisions and operations based on commercial or reputational factors, rather than patient safety, are not uncommon and not isolated to the NHS Trust environment.
In the specific arena of pharmacy practice, the PDA has significant concerns around the role of unregulated managers who exert authority and control over registered pharmacists. This is especially the case in community pharmacies which are contracted to provide NHS services but are operated by often large private companies.
Whilst the Letby and similar cases achieved national attention, there are very many more, less extreme examples of patients being affected by the actions of unregulated managers in positions of authority. The PDA routinely receives reports from members about such episodes. For example:
- The request for a medicine that the pharmacist deems inappropriate and unsafe, which their non-pharmacist manager has overruled and sold.
- The area manager who has demanded a pharmacist delivers a greater volume of vaccinations, despite the concerns raised by the pharmacist that the rest of the pharmacy operation could not be suitably supervised due to severe shortages of staff.
- The temporary closure of pharmacies for purely commercial reasons depriving patients of access to vital medication.
Whilst these episodes and many more do not receive national headline attention, they nevertheless impact patients and corrode the ability of pharmacists to protect the interests of the public by maintaining safety.
Based on the many experiences of its members and in the wake of the Francis Inquiry, in 2015, the PDA had a meeting with the pharmacy regulator, the General Pharmaceutical Council (GPhC) to press for the introduction of the regulation of non-registered managers. However, this request was not accepted.
In a response to the GPhC’s consultation about indicative sanctions in 2015, the PDA highlighted that “The Francis Report found that in many instances the Duty of Candour had not been exercised. However, what it also found was that whilst many healthcare staff often attempt to comply with this duty, this can be suppressed by the management and organisational culture of the employing organisation.
Without the support of the employer or at the very least without the reassurance that there will be no internal disciplinary sanction for discussing the details of an error or other problem with patients/healthcare professionals, the Duty of Candour becomes much more difficult for healthcare staff to exercise. Consequently, placing the emphasis of the guidance on sanctions against pharmacists in the absence of placing any kind of requirements upon employers and non-pharmacists will lead to unbalanced and disproportionate regulation.”
Ten years on from the recommendations of the Francis Inquiry, and 22 years after the recommendations of the Bristol Inquiry, now is surely the time to double down on the introduction of regulation of non-registered healthcare managers at all sites where NHS services are delivered. It should not take a further public inquiry and/or more patient deaths to recognise that the regulation of those in management posts is essential to ensure that they do not disregard concerns that are raised about the actions of individuals, patient safety, and the risk of harm.
[1] How public inquiries can lead to change
[2] The Report of the Public Inquiry into children’s heart surgery at the Bristol Royal Infirmary 1984-1995
[3] Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry
[4] A review of the Fit and Proper Person Test Commissioned by the Minister of State for Health
[5] Written evidence from Sir Robert Francis – Health Select Committee, Note to the committee on the Kark Review of the fit and proper person test from Sir Robert Francis QC
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