Health and Social Care Bill

Baroness Finlay of Llandaff Excerpts

Monday 19th December 2011 Lords Chamber

[Lord Rea]

My Lords, in supporting this amendment I declare an interest. Not only my former patients but I, as a patient, have received skilled help from clinical physiologists. The pacing unit at St Mary’s Hospital, which is run by clinical physiologists, has monitored my pacemaker since it was fitted four and a half years ago. My life has literally been in their hands while they periodically adjust my heartbeat to get the best setting.

The Registration Council for Clinical Physiologists, which has been described, has been trying to persuade the Department of Health to include the profession in the mandatory regulatory framework for health professionals for the best part of a decade. The Health Professions Council recommended in 2004 that clinical physiologists should be included in its regulatory regime, as well as other clinical scientists whose work involves a potential impact on patient safety. The then Secretary of State accepted this recommendation but still no action was taken and has since not been taken despite frequent reminders from me, among others. On my count, 30 parliamentary Questions have been tabled on this issue. It has also been raised in your Lordships' House in a debate on an order to do with the Health Professions Council. I hope that this amendment will serve to speed up the process by focusing the Government’s attention on an overdue step that we feel needs to be taken.

[Baroness Finlay of Llandaff]

My Lords, this group of amendments is very interesting as it reveals the enormous number of people involved in healthcare who literally hold the lives of others in their hands and are not subject to any statutory regulation but are voluntarily registered. I have an amendment in this group which seeks to establish,

“a statutory register of Physicians’ Assistants (Anaesthesia)”

and of other healthcare professionals. I will speak about that in a moment in relation to clinical perfusion scientists.

Physicians’ assistants in anaesthesia already have a voluntary register in place and they applied to the Health Professions Council for registration and had their application accepted. However, that all went on hold with the emergence of this Bill. The Royal College of Anaesthetists does not allow physicians’ assistants in anaesthesia to become associates as they are not registered with the General Medical Council, but it permits them to have affiliate membership. However, the college does not have a regulatory role as such; it is tied up with education and standards.

Physicians’ assistants in anaesthesia urgently need statutory regulation, given the range of invasive, and potentially life-threatening, procedures that they perform and the knowledge and autonomy of practice required in the roles that they carry out. These practitioners perform tasks that, in the UK, were previously carried out only by doctors. They cannot get indemnity insurance for their practice or apply for prescribing rights, even though they sometimes have to be able to respond in a matter of seconds, not minutes, if something goes catastrophically wrong with an anaesthetised patient while the anaesthetist is outside the theatre for whatever reason. They are on a voluntary register, which provides some reassurance for patients and employers, but that cannot realistically be seen as an alternative to statutory regulation. I think that in 2009 they were identified by the Department of Health as being urgently in need of registration. The Health Professions Council felt that these assistants fulfilled sufficient of its criteria to warrant the recommendation for statutory regulation being accepted.

Irrespective of whether Members of this House have undergone a procedure requiring anaesthesia, would they consent to being rendered unconscious by an individual who was neither bound by a stringent professional code of conduct nor properly registered to practise? After all, we would not get into an aeroplane if we did not know that both the pilot and the co-pilot were appropriately qualified to a very high degree, with ongoing continuing professional registration. We trust them just as we trust these physicians’ assistants, but if something goes wrong in theatre it does so with catastrophic rapidity. When I did my training in anaesthesia, on more than one occasion I saw these physicians’ assistants recognise problems arising before the trainee anaesthetists had done so. They carry enormous responsibility during complex procedures.

I have included other healthcare professionals in my amendment as I am well aware that the Government do not like to have enormous lists in a Bill. My amendment would therefore leave the door open to include clinical perfusion scientists—the other group involved in theatre—whose role is primarily to maintain a patient’s circulation during open-heart surgery, during a period of surgical repair when the heart has been stopped. They were recommended in 2003 for statutory regulation.

There have been two high-profile cases involving clinical perfusion scientists. The first fatality, in 1999, led the Southwark coroner to recommend the immediate statutory regulation of clinical perfusion scientists. The second fatality, in 2005, was attributed to inappropriate drug administration by a clinical perfusion scientist during an operation on a five-month-old baby at Bristol Royal Infirmary. That led to the publication of the Gritten report, which concluded that:

“The incident occurred because of latent weakness that lay dormant for years hidden by healthcare professionals compensating for inadequacies within national and local systems”.

The report recommended that action at national level should include,

“regulation and guidance on perfusion practice in cardiopulmonary bypass”.

More recently, there have been fatalities that have led to clinical perfusion scientists’ actions being questioned by coroners—the most recent of these incidents occurring in 2010 at Nottingham City Hospital.

I do not want to scare people from going in for surgery and I do not want to scare Members of this House who may be going in for surgery, but in the current climate people need to know that these very critical roles are being undertaken by people who are on a voluntary register but do not enjoy indemnity, as they would if they were on a statutory register and subject to the rigours of being statutorily regulated.

[Baroness Pitkeathley]

My Lords, I do not want to sound like a broken record in always resisting more statutory regulation or in disagreeing with colleagues with whom I normally agree, but I want to emphasise the application of light-touch regulation. We should use only the minimum regulatory force to achieve the desired result. Therefore, we should be considering extending regulation only where the risks to patient safety and public protection are such that other mechanisms such as those I previously mentioned—employer’s guidance, clinical governance, appropriate delegation and multidisciplinary teamworking—are unable to manage those risks.

When the Council for Healthcare Regulatory Excellence becomes the Professional Standards Authority for Health and Social Care, it will be accrediting voluntary registers as a more proportionate and targeted approach to developing high standards of care for people working in health and social care who are not statutorily regulated. I remind your Lordships that statutory regulation can be expensive and it is important that we explore and develop a range of options for maintaining and improving the quality of care delivered by people working in health and social care. It may be more proportionate, for instance, to promote greater co-operation and sharing of good practice. We seek to find the most efficient and common-sense solutions to the kind of problems that your Lordships have identified.

--- Later in debate ---

[Lord Alderdice]

It may seem a little unclear to the noble Lord, but it is not so unclear. Psychologists are qualified as psychologists, not as psychotherapists or as counsellors—they belong to a different professional body and have different qualifications and requirements. Psychologists themselves campaigned for many years for statutory regulation and finally got it through the Health Professions Council. Arts therapists and so on went through the HPC because many of them were occupational therapists, but try as I might—and I have been doing so for well over a decade—I cannot get successive Governments to address the question of psychotherapists and counsellors, despite the fact that they constitute a far larger number of people.

My dilemma with the current set of propositions is that, of the arguments adduced to try to persuade noble Lords that a quality-assured voluntary registration scheme is appropriate because the people referred to—the physiologists, the perfusion scientists and so on—are operating within the health service under supervision, are employed there and are smallish in number, none of them applies to this other group of people, for whom I have had precisely the same reply from the Minister. Therefore, I am keen to hear from the Government what the set of criteria is. Is it simply that this Government are not keen to pursue anything in the way of regulation except at the most modest level? If so, that is a legitimate argument but it needs to be made. If not, then I do not quite see the consistency of the current application.

[Baroness Finlay of Llandaff]

Perhaps I may add a small point. I do not know how many physicians in anaesthesia are employed in operating theatres in private hospitals, where an enormous amount of private surgery is done. One of the main reasons for people going to a private hospital is for surgery—particularly elective orthopaedic surgery. Therefore, although I cannot put any figures on this, I do not think that it is correct to assume that these people are necessarily operating only in the NHS and are subject to current NHS structures.

In the new world where we will have a broad range of providers, it will become even more important to know that there is a minimum standard and that all the people at each step of the way will be answerable. The patient may well choose to go to an organisation where these people are employed but the patient will not know that. No one gives him a list and says, “Of all these people looking after you, these will be statutorily registered but these may or may not be on a voluntary register”. If we are thinking about patients taking informed decisions regarding their future, I suggest that the coroners’ reports that we have had to date should already be sounding alarm bells.

--- Later in debate ---

[Baroness Northover]

I have already mentioned to the noble Baroness—she is probably totally familiar with this—that the Department of Health does not have evidence of there being a risk in this regard. Clearly, as I mentioned on the earlier group, these issues will always be kept under review. If the concerns that she has flagged up and if the association, which is particularly encouraging the regulation of clinical physiologists—that is fine; it is all part of professionalisation—flags up particular concerns that emerge from other evidence, then of course the department will take that very seriously. However, things need to be proportionate.

[Baroness Finlay of Llandaff]

I have listened very carefully to what has been said about the assistants relating to anaesthesia, but I also used the more catch-all phrase about the clinical perfusion scientists. I would be grateful if, after this debate, the noble Baroness would write to me and explain why coroner recommendations in relation to clinical perfusion scientists are not considered to be enough of a risk to take action. If one is trying to assess this on a risk spectrum, it would be helpful to understand why a coroner's decision to recommend that this small, contained group of clinical perfusion scientists should be regulated does not constitute enough of a risk to go down that route to regulate them and to have them on a statutory register.

[Baroness Northover]

I am very happy to take away what the noble Baroness has said and to discuss the situation further with her.

We expect the assured voluntary registration to be up and running by 2012. Therefore, afterwards that would need to be assessed to see whether anything further is required, as noble Lords have figured might be the case. We are hoping to see how it all works.

The noble Lord, Lord Walton, flagged up various groups which were regulated and he could not quite see why others were not. Given that I used to bump into the noble Lord, Lord Walton, in the Wellcome Library for the History and Understanding of Medicine, I think he will fully understand that the way in which regulation has grown up has not necessarily been logical or consistent. Therefore, I flag up the 2005 Hampton review on regulation which says that it should be proportionate to the risks that it seeks to mitigate and various other provisions. That is what we are seeking to do. Of course, we shall keep under review what we are doing to see whether it is adequate. In the mean time, I hope that the noble Baroness will be willing to withdraw the amendment.