Susan Pollitt

Dear Ms Kearsley Regulation 28: Report to Prevent Future Deaths (ref: ) Thank you for your letter of 31 July 2024 enclosing your report into the death of Mrs Susan Pollitt. I am very sorry to hear of the tragic circumstances surrounding Mrs Pollitt’s death and I extend my condolences to her family and friends. I am responding as the Medical Director and Director of Education and Standards at the GMC. I have considered your report and the concerns it raises about the treatment Mrs Pollitt received at the Royal Oldham Hospital (ROH). The absence of statutory regulation of physician associates (PAs) may have contributed to the circumstances of her death. Regulation by the GMC, which will begin at the end of this year, should help address several of the issues you have highlighted. This should, in turn, bring benefits for patients, patient safety, PAs themselves and those that employ and work alongside them. However, based on your report, there appear to be wider concerns about the clinical governance arrangements at the Trust including the roles, supervision and relevant policies supporting the use of ascitic drains and the deployment of PAs. I will return to this at the end of my response. Lack of a regulatory body with oversight of PAs The GMC agrees that statutory professional regulation of healthcare professionals involved in the treatment of patients better protects the public. PAs are not subject to such regulation at the moment but, as you note in your letter, the GMC will become the regulator of PAs and anaesthesia associates (AAs) in December this year. I thought it would be helpful to outline the history of how the GMC was chosen to be the regulator of these professions, the work that we have done thus far to prepare for regulation and the next steps before we begin regulating PAs later this year.

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In 2017, the Department of Health and Social Care (DHSC) consulted on which healthcare regulator would be most suitable to regulate one, some, or all the medical associate professions, which include PAs and AAs. Surgical care practitioners are the third profession in this group but are not included in those we will regulate. Following the consultation, the Government determined the GMC was most appropriate and formally asked us to take on the regulation of PAs and AAs which we agreed to do. The UK and Scottish parliaments approved the legislation (Anaesthesia Associates and Physician Associates Order 2024) earlier this year and it has been granted Royal Assent. This means the GMC will become the regulator of PAs and AAs from December 2024 and, from December 2026, they will have protected titles in law (‘Physician Associate’ and ‘Anaesthesia Associate’). Regulation will bring many benefits and make an important contribution to assuring patients and employers that PAs are safe to practise and can be held to account if serious concerns are raised about their conduct or performance. PAs are part of the multi-disciplinary team and make decisions about patient care affecting diagnosis and treatment. Although they work in regulated healthcare settings and must be supervised by a registered and licensed doctor, at present there aren’t any profession-specific mandatory standards for their pre-qualification education, training or conduct. Nor is there any professional accountability to a statutory body if their practice raises concerns that would warrant some action, and certainly not on a legally enforceable basis. Once regulation by the GMC is fully in force, PAs will need to be registered with us and they will be required to adhere to Good medical practice, our core set of professional standards that all our registrants (which currently only includes doctors) are expected to follow. Regulation allows us to take action in the event that an individual registered with us falls significantly below the standards we set and poses a risk to the public or public confidence. We recently consulted on the rules, standards and guidance needed to implement the legislation that gives us the power to regulate PAs and we’re now considering the responses so that we can finalise our approach. Once regulation begins, we will have powers to: ⚫ Set the standards of patient care and professional behaviours PAs need to meet. ⚫ Set the outcomes and standards that students qualifying from PA courses must meet to achieve registration, and approve the curricula that courses must deliver. ⚫ Set a two-part assessment of clinical knowledge and skills that a PA needs to pass before registration. ⚫ Check who is eligible to work as a PA in the UK and that they continue to meet the professional standards we set throughout their careers. ⚫ Give guidance and advice to help PAs understand what’s expected of them. ⚫ Investigate where there are concerns that patient safety, or the public’s confidence in PAs, may be at risk, and take action if needed.

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In summary, we agree that the current lack of a regulatory body for PAs represents a risk to patient safety and believe the concerns raised in your report will be addressed once the GMC takes on this role. Existing voluntary register The existence of a managed voluntary register offers some assurance to employers that PAs have passed a national exam designed, set and delivered by the Royal College of Physicians of London. However, it cannot assure the quality of the course they have studied, the outcomes they have achieved, or the clinical experience they gained during their studies. That is why we, the Faculty of Physician Associates (FPA) and many system partners welcome the introduction of a statutory register of PAs from December 2024. We anticipate that employers will make GMC registration a condition for their PAs in the same way as they have done up to now in relation to voluntary registration. Although GMC registration doesn’t become a legal requirement for practice until December 2026, we will strongly encourage all PAs to join our register as soon as possible. I will leave it to the FPA to explain how they currently deal with concerns raised about a member of their voluntary register. The GMC currently has no power to investigate concerns raised about PAs as they are not yet regulated by us, and we have no role in determining the investigatory and disciplinary processes of the FPA. However, we can and will look at any outstanding concerns about an individual PA’s fitness to practise when considering their application for registration with us from December this year. It is also worth noting that, irrespective of whether a healthcare profession is regulated, each NHS trust has a duty to provide safe care to patients, and they also have a responsibility to ensure that standards are monitored and maintained. Guidance on training, supervision and assessing competence The issue of a perceived lack of national guidance surrounding the safe deployment of PAs has been raised in recent months. Several organisations have been working to develop guidance appropriate to their specialty or responsibility. For example, NHS England has issued guidance to NHS Trusts and primary care providers in England on the safe and effective integration of PAs into departmental teams and GP practices respectively. It may also be helpful to see NHS England’s supervision guidance for primary care network multidisciplinary teams, which sets out in some detail the key principles for effective supervision within GP practices, including how to meet the regulatory requirements set by the Care Quality Commission (CQC). For their part, the CQC has also recently issued guidance on supervising and overseeing PAs in general practice, and Health Education England’s Core Capabilities Framework for Medical Associate Professionals has been in place since 2022. We have also published our own advice for doctors who supervise PAs, and earlier this year we updated our clinical governance handbook to set out our expectation that organisations who employ PAs should make appropriate arrangements for their deployment and supervision.

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Regarding PA education and training - once regulation begins in December 2024, we’ll have powers to set the standards for course providers and regularly check that they’re being met. We have already published a range of guidance to support PAs student PAs and course providers pending the implementation of regulation. From December 2024 we will be able to formally approve courses and curricula to ensure that PAs will have the clinical knowledge and skills needed to work safely once they qualify. In preparation for the start of regulation we have already asked course providers to update their courses, including their syllabus and assessments, using the relevant curriculum as a guide, and we are checking that this has been done through our education quality assurance process. We are also finalising updated guidance for PA students on professional standards and the process for approving PA curricula. Finally, we have been supporting the work that individual royal colleges, and the Academy of Medical Royal Colleges, are currently leading on developing a range of guidance on supervision and how PAs can safely develop their skills and competencies over time once they have qualified and registered with us. The Royal College of Physicians is currently consulting on their guidance and the Royal College of General Practitioners plans to do so shortly. We are also encouraging colleges, NHS employers and others to ensure that all guidance being produced is aligned and consistent so as not to cause confusion for employers, supervisors or PAs themselves. Limited understanding and awareness of the PA role We agree it is vital that patients must always be clear about who is treating them and their role within the team. While PAs have been part of the UK healthcare workforce for around 20 years, the numbers are relatively small, so it is even more important that they are always clear about their roles and responsibilities with the patients they treat. Once again, regulation will be helpful in this context. Our professional standards say that PAs will have a responsibility to clearly communicate who they are and their role in the team, just as doctors must do now. In March this year we also announced that we would implement an alphabetical prefix for PA and AA GMC reference numbers and ensure the prominent labelling of profession type on our public-facing registers. This means that in future when patients search our registers it will be very clear whether an individual is a doctor, a PA or an AA not only because of the use of a prefix for PAs and AAs but also because the face of the register will actually spell out in full the professional title of each individual (‘Doctor’, ‘Physician Associate’, ‘Anaesthesia Associate’). The FPA also has guidance on ‘titles and introduction’ which provides a standardised way of using the PA title and highlights the importance of explaining it to patients and colleagues. The issue you raise about the need for distinct uniforms to help patients distinguish between professionals is for the NHS and employers to address.

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Clinical governance Regulation is an important part of patient safety, but it alone cannot prevent future deaths. Good clinical governance by healthcare providers remains the most important factor. Your report raises significant questions that cannot be answered by those to whom the report is currently addressed, and are better explained by the trust: ⚫ How was it possible for a junior doctor to decide a drain was required after the consultants had deemed it not to be required? ⚫ Why was it decided Mrs Pollitt should remain on a respiratory ward (where likely there was little or no experience of managing the drain or of the nursing care required), rather than moved to a gastroenterology ward? ⚫ How was the decision made to delegate this task to the PA without seeming to assess the competence of the PA or give clear instructions as to how it should be managed once inserted (i.e., not clamped and only left in situ for six hours)? ⚫ What is the local policy for the use of ascitic drains that would address the above? ⚫ What was the role of the consultant in overseeing the overall care of Mrs Pollitt? The FPA will be able to explain the purpose and intended usage of the competency form that was used to assess the skills of the PA in this case. We are pleased to note from your report that the NCA has put a local trust framework in place and will be writing to them to request sight of this document and seek our own assurances around clinical governance at the ROH. Thank you for the opportunity to comment on this report. I hope this information provides reassurance around the work we are doing to bring PAs into regulation. We hope that work, along with action from others, will help ensure a similar incident does not happen again.

Dear Ms Kearsley

Royal College of Physicians response to Regulation 28 report to prevent future deaths

The Royal College of Physicians (RCP) notes with concern the content of the Regulation 28 report for the prevention of future deaths related to the death of Susan Pollitt.

We send our sincere condolences to the family of Susan Pollitt.

The Regulation 28 report is addressed to the president of the Faculty of Physician Associates (FPA). The FPA is a managed faculty of the RCP. Considerable work is required to enhance the safety of the deployment of physician associates (PAs) as part of multidisciplinary teams. We therefore believe it is helpful that the RCP also submit a response to this report.

Many of our fellows and members have significant concerns about the safe deployment of PAs, especially concerning regulation, scope of practice and supervision. The RCP held an extraordinary general meeting (EGM) to debate issues relating to PAs in March 2024.

Following a vote of the RCP fellowship, the RCP is now calling for a limit in the pace and scale of the roll-out of PAs. We have called on NHS England to review its projections for growth for the PA role as set out in the 2023 NHSE Long Term Workforce Plan.

The RCP also established a short life working group (SLWG) to make recommendations to RCP Council for how the EGM motions would be implemented. This group reported in May 2024. All recommendations are on track to be delivered by the end of the year. The RCP has now set up an oversight group for activity related to PAs (PA oversight group, or PAOG).

To ensure that the PA workforce is able to contribute to patient care actively and safely, the RCP believes that considerable changes need to be made. This will require time, commitment, coordination, transparency, and above all, collaboration between the NHS, patient groups, royal colleges, the GMC, and medical associate professionals, including PAs.

Matters of concern and the RCP response

1. There is no regulatory body with oversight of physician associates. It is understood that this is currently the subject of a consultation by the General Medical Council.

In the interests of patient safety, the RCP has campaigned for over 5 years for the regulation of PAs. It has been a long and unpredictable journey that will finally see the majority of regulatory provisions come into force in December 2024.

, who is acting as RCP president, and , chair of the PAOG, continue to meet regularly with the GMC. We have written to NHS England to ask whether they intend to review the projections for growth in the PA workforce. Both the GMC and NHS England will attend an RCP Council meeting in November 2024 to discuss the post-regulation landscape for PAs.

We responded to the GMC consultation on the regulation of PAs earlier this year, raising concerns around the content of the curricula for PA and anaesthesia associate (AA) postgraduate studies, issues around prescribing and medicines safety, the capacity of supervisors, and the impact of the PA role on training opportunities for resident doctors.

We understand that the GMC believes that further development of scope of practice should be determined locally. The RCP disagrees. Scope of practice for PAs (and the obligations of supervisors to maintain within scope of practice working) should be determined nationally to reduce variation and enhance patient safety.

This is key, and a widespread concern within the medical profession. It must be addressed to enable the PA workforce to work safely and successfully.

2. The Physicians Associate Managed Voluntary Register (PAMVR) held by the Faculty of Physician Associates (FPA) is voluntary. While employers are encouraged to check the register, there is no duty to do so, nor is it clear how the FPA would be made aware of any concerns relating to an individual physician associate.

The response of the FPA is noted.

The RCP has confirmed that the FPA will close in December, along with the PAMVR. The initial transfer of PAMVR data from the RCP to the GMC will begin on 31 October 2024. The GMC register will open on 13 December 2024, when regulation begins, but will continue to be voluntary for the first two years. The PAMVR will remain static, but searchable, until 31 March 2025 when it will be closed.

The post-EGM SLWG noted that the RCP is not, and has never been, a regulatory body. Holding the PAMVR has contributed to patient safety while the campaign for regulation was ongoing. The GMC starts regulation in December 2024 and there will be a transition period of two years while PAs join the register. From December 2026, it will become an offence to practise as a PA in the UK without being registered with the GMC.

The FPA has written to all its members to update them with this information and to clarify that all PAs should move onto the GMC register as soon as possible.

3. There is no national framework as to how physician associates should be trained, supervised and deemed competent. This is placing patients, physician associates and their employers at risk. The court heard that since the death of Mrs Pollitt, the Northern Care Alliance has put in place a local trust framework. Unlike all other clinical roles, there is no national guidance save for very recent guidance issued by the British Medical Association (March 2024).

The RCP agrees with this concern.

The RCP is developing draft guidance on safe and effective practice for employing PAs. The college recently carried out an external stakeholder consultation on the first draft of this guidance. Work is now taking place to review the consultation feedback, refresh the draft guidance, consider how fellows and members should be consulted, and take the final guidance to RCP Council for sign-off and publication by the end of 2024.

The draft guidance is clear that only consultants, GPs, specialist or associate specialist doctors should be the named clinical supervisors of PAs. PAs should always clearly explain their role to patients, colleagues and supervisors; and they should progress within a scope of practice, following a nationally defined pathway with training and competency assessments agreed beforehand.

Failings in scope of practice and supervision were important factors in the death of Susan Pollitt. The RCP is very concerned that capacity among senior doctor supervisors is extremely stretched and the effective implementation of guidance on supervision will be very difficult. The supervision of PAs must not be at the expense of the supervision of doctors.

The PAOG is also hosting an online roundtable with other royal colleges, faculties and specialist societies to discuss next steps on developing a clinical scope of practice for PAs. This will have a specific focus on medical teams and the physicianly specialties.

A comprehensive, national, safe and clear scope of clinical practice for PAs is essential. However, we note the following:

> There is insufficient central coordination or agreement within the NHS and among employers on how a national scope of practice should be developed and by whom. > There is limited awareness of what a PA can safely do in a clinical setting upon completion of PA studies and no agreed mechanism for extended clinical practice. > PAs are employed in a very wide range of clinical settings and specialties, and within both the NHS and private healthcare settings. System leaders, including the GMC, should take a leading role in developing and overseeing a national scope of practice for PAs. The RCP is strongly supportive of multidisciplinary working, but this must be supported by full regulation and competency assessment. We therefore strongly believe that a national framework for the employment and deployment of PAs is now required, with the understanding that national policy and guidance must be understood and delivered locally supported by good governance structures, including raising concerns.

4. There remains limited understanding and awareness of the role of a physician associate among medical colleagues, patients and their families. The lack of a distinct uniform and the title ‘physician’ gives rise to confusion as to whether the practitioner is a doctor.

The RCP recognises this concern. We acknowledge that there remains limited understanding of the role of PAs. This is supported by research from patient organisations, including HealthWatch England, which has found that only around half of patients (52%) in one survey agreed or strongly agreed that they ‘understood the difference between a physician associate and a doctor’.

In October 2023, the FPA published titles and introduction guidance which makes it clear that PAs are not doctors, and that PAs should introduce themselves clearly and with a full explanation about their role in the healthcare team. The RCP was supportive of this guidance, which was disseminated widely to stakeholders.

Working with our fellows and members, the RCP will continue to actively campaign to limit the pace and scale of roll-out of PAs in the NHS until we are reassured that there are safe systems in place for PA deployment. We have repeatedly made clear that PAs are not doctors, and they cannot and must not replace doctors. We have also called on the UK government and the NHS to develop and publish an evidence base and evaluation framework around the introduction of PAs. This should be a priority, and we are working with the RCP Patient Safety Committee to consider what more we can do to support this agenda.

5. In June 2022 the Physician Associate had been signed off as competent for the insertion of ascitic drains. This sign off was completed by a liver nurse specialist using a competency form which was provided by the FPA. Whilst the competency form assessed the technical aspect of placing the drain, it did not include competency around the wider aspects of care such as taking consent risk factors and after care.

The RCP agrees with this concern.

To be able to perform a procedure safely, the healthcare professional should be able to demonstrate the required knowledge and skills around the procedure (‘technical skills’) and non-technical skills. Non-technical skills are a combination of cognitive and social skills, demonstrated by individuals and teams to reduce risk, error, harm and improve human performance in complex systems. Those skills involve decision making, situational awareness, teamworking, leadership, perception of risk, escalation and communication including consent. The perception, comprehension and projection of technical and non-technical skills is key to patient safety at individual and team level of the healthcare team.

The competency of any healthcare professional to undertake a procedure should be signed off by a competent supervisor who is able to make assessments of these skills.

The competency form did not adequately take into account wider aspects of care, and there is currently no national framework for post-qualification competencies for PAs (including procedures).

This is why the RCP will continue to campaign for a limit to the pace and scale of roll-out of PAs in the NHS until we are reassured that there are safe systems in place for PA deployment.

With best wishes,

Clinical vice president Royal College of Physicians

Dear Ms Kearsley

Faculty of Physician Associates response to Regulation 28 report to prevent future deaths

The Faculty of Physician Associates (FPA) notes with concern the content of the Regulation 28 report for the prevention of future deaths related to the death of Susan Pollitt.

We send our sincere condolences to her family.

We note the circumstances of death and factors that you have assessed as contributing to her death. Below we address the matters of concern that you have outlined.

1. There is no regulatory body with oversight of physician associates. It is understood that this is currently the subject of consultation by the General Medical Council.

We share the concern raised that there is no regulatory body for physician associates (PAs).

The FPA was established by the Royal College of Physicians (RCP) in 2015. This was to give PAs a professional home, set standards and, importantly, oversee the PA Managed Voluntary Register (PAMVR) pending formal regulation. It is disappointing that the regulation process has taken so long.

Since its inception, the FPA has lobbied successive governments for regulation. We have been disappointed by several delays to the statutory process, which led to the launch of the #RegulatePAsNow campaign in July
2022. The initial Department for Health and Social Care consultation that set out the intention to regulate the profession was launched back in 2017. We contributed to the latest consultation by the General Medical Council (GMC) on how regulation will work in 2024, the outcome of which is yet to be published.

Regulation is set to come into force on 13 December 2024, with ‘physician associate’ becoming a protected title on 13 December 2026. The FPA will close in December 2024, along with the PAMVR, which will remain static but searchable until March 2025.

Statutory regulation provides a welcome and overdue assurance for patient safety. When fully implemented, all PAs will have to be registered with the GMC to work in line with Good medical practice and be subject to fitness to practise procedures.

2. The PAMVR held by the FPA is voluntary. While employers are encouraged to check the register, there is no duty to do so, nor is it clear how the FPA would be made aware of any concerns relating to an individual physician associate.

This statement highlights why formal regulation is so important. Neither the RCP nor the FPA has regulatory powers to mandate registration. In the absence of this, the FPA writes to employers on a regular basis reminding them of the existence of the PAMVR and, importantly, of the need to check that a PA is registered on the PAMVR before employment, as well as checking at regular intervals during their employment.

We have also produced a leaflet that explains the PAMVR and can be shared with patients. Student PAs are advised that they should apply to the FPA for registration on the PAMVR post-qualification through university courses, as well as in FPA regular communications to student members.

The FPA code of conduct is regularly shared with FPA members. Should an employer, patient or others have a complaint about a PA, they can advise the FPA through emailing . The FPA website sets out the complaints procedure here. Attached is the process to adjudicate complaints.

3. There is no national framework as to how physician associates should be trained, supervised and deemed competent. This is placing patients, physician associates and their employers at risk. The court heard that since the death of Mrs Pollitt, the Northern Care Alliance has put in place a local trust framework. Unlike all other clinical roles, there is no national guidance save for very recent guidance by the British Medical Association (March 2024)

The FPA and its members are actively involved in writing PA-related guidance with medical royal colleges, academies and specialist societies and we want to help increase understanding of our role. We recognise that there are concerns about the lack of a post-qualification national career development and competency framework for physician associates. We are working with medical royal colleges and specialist societies as they develop their own pathways, including guidance of how PAs can be safely and effectively deployed within MDTs.

The draft PA curriculum sets out guidance on the competencies expected from a newly qualified physician associate. This provides higher education institutions (HEIs) across all four UK nations with a standardised framework to ensure high-quality education for PA students. It is owned by the FPA and has been aligned to the GMC’s generic and shared outcomes for PAs and anaesthesia associates.

PAs must complete the full university scheme of assessment before being put forward to sit the PA national exam (PANE). This national exam will change its name to the PA registration assessment (PARA) once regulation with GMC begins. This is mapped to the GMC-approved PARA content map and, prior to this, the core conditions framework. This assures competency at the point of qualification.

Once a PA has passed the PANE (or, from 2025, the PARA), PAs, employers and clinical supervisors will be required to follow local policy and guidelines for PA training. The scope of practice of a PA is currently agreed on an individual basis.

The FPA believes that there should also be a national approach to creating a comprehensive framework. This would support employers and PAs, with specific emphasis on the role of the clinical supervisor, annual appraisal and routes of escalation if there are concerns about practice.

4. There remains limited understanding and awareness of the role of physician associates among medical colleagues, patients and their families. The lack of a distinct uniform and the title ‘physician’ gives rise to confusion as to whether the practitioner is a doctor.

We agree that there should be a national public and patient information campaign to create better awareness of the PA role. We will continue to work with other stakeholders, including the RCP Patient and Carer Network (PCN), to improve how we communicate the role and responsibilities of PAs. We welcome the opportunity to work collaboratively with others on this.

In October 2023, the FPA published titles and introduction guidance for PAs, supervisors, employers and organisations. The guidance was drawn up with a multi-professional panel of stakeholders, including representation from the RCP PCN, to clarify the role of a PA within a multidisciplinary team. The aim is to ensure appropriate introductions to patients and explanation of the role, particularly highlighting that PAs are not doctors. We recognise that there is a continued need to inform the public, healthcare services and the clinical professions on the role and remit of physician associates.

We acknowledge the lack of a distinct uniform. The medical associate professions were excluded from the National Healthcare Uniform Programme, and we would strongly support their inclusion in the future. We advise employers that distinct name badges with role are important, as well as consideration in local uniform policies.

5. In June 2022, the physician associate had been signed off as competent for the insertion of ascitic drains. This sign-off was completed by a liver nurse specialist using a competency form which was provided by the FPA. While the competency form assessed the technical aspect of placing the drain, it did not include competency around the wider aspects of care such as taking consent risk factors and aftercare.

There is currently no national framework for post-qualification competencies (including procedures). PAs increase their clinical skills and competencies post-qualification similarly to other healthcare professionals. The FPA e-Portfolio was launched in October 2023 for qualified PAs and uses workplace-based assessment (WBPA) or supervised learning event (SLE) forms. This also includes Direct Observation of Procedural Skills (DOPS) forms, which were first made available to FPA members in October 2021.

Clinicians supervising a DOPS need to be competent in the procedural skill that is being assessed, and the associated management including consent and aftercare. A key component of a DOPS is the wider aspects of the procedure as shown in the attached document. It is important that the assessor is agreed by the clinical supervisor and has the appropriate knowledge and skills, including the wider aspects that you have noted. This should be emphasised to the supervising senior doctor. In addition, continued assurance as part of appraisal is required. We will review the DOPS form to see whether it can be enhanced, and we will take on board what has been raised by your report.

The FPA and any successor professional body for PAs will continue to work with the GMC, the NHS, specialist societies, royal colleges and other stakeholders to ensure that the practice and supervision of physician associates, as part of the multidisciplinary team, are safe.

We hope that these explanations clarify the areas you have raised. We have highlighted where we are taking action and where we think action is required, including our support for a national approach to setting competencies and career development for PAs.

Once again, our thoughts are with the family of Susan Pollitt, and we wish to share our sincere condolences with them. We will continue to work with our members and other stakeholders to make sure that the role of PAs within the multidisciplinary team is clear to our colleagues and the wider public.

With best wishes,

President Faculty of Physician Associates