Health and Social Care Bill

Debate between Baroness Pitkeathley and Baroness Finlay of Llandaff

Tuesday 13th March 2012 Lords Chamber

[Baroness Pitkeathley]

It is a great pleasure to follow the noble Baroness, Lady Howarth, who I deservedly call my noble friend. I very much hope that the Minister will give her the assurances that she seeks. With regard to my noble friend’s amendments on the General Social Care Council, I take the view that we are where we are, however much I wished that different decisions had been taken. Noble Lords will appreciate that, as the first chair of the General Social Care Council, I would say that, wouldn’t I?

However, I take this opportunity to pay tribute to the councils and staff of both the General Social Care Council and the Health Professions Council for the professional and mature way that they have approached the difficult situations in which they found themselves. Their behaviour has been an example to us all and particularly, as far as concerns the GSCC, the fact that high staff morale has been maintained throughout this process is nothing short of a miracle and a great tribute to its leadership.

I agree with other Lords who have called the social work profession fragile. It needs to be promoted and defended if we are to maintain and extend the recruitment that the noble Baroness, Lady Howarth, has reminded us is so important for those people who do the difficult work in our society—which is rarely recognised until the tabloid press attacks it. I must draw your Lordships’ attention to the College of Social Work, which has just been established, which will have the promotion and defence of this fragile profession as part of its remit. It has had a difficult start, as is well known, but I believe that it has the potential to promote and support the profession to which we are all so indebted.

[Baroness Finlay of Llandaff]

My Lords, I have my name to two amendments in this group. They do not affect social work and therefore I have waited to intervene until the debate on social work had been completed.

I want to discuss two groups: clinical perfusion scientists and clinical physiologists. The clinical perfusion scientists are responsible for the single most invasive tool used in surgery today and are routinely responsible for the administration of potentially fatal controlled drugs. The numbers are small—there are only 350 clinical perfusionists—and they operate in a regulatory vacuum; they are the only non-regulated members of the cardiac surgical team. Yet their management routinely involves significant life-threatening risks to patients daily. Because they are not a regulated profession, in July 2009 the Department of Health produced a good practice guide to clinical perfusion in response to the Gritten report of 2005. It states that the Government fully recognise the need for clinical perfusionists to be regulated by statute and it draws attention to the fact that the document is an interim measure until they are subject to statutory regulation. Indeed, the document states that this has implications in law for their role in working with medicines.

Since the Gritten report in 2005, about a quarter of a million cardiac patients have had their hearts stopped for surgery by perfusionists, who use highly toxic substances and blood products. They feel that they need statutory regulation so that they can be supplementary prescribers, as there is a questionable legality at the moment around drug administration. They are in a unique position. It is this supplementary prescriber role that causes them much concern, because they would like to be assured that what they are doing falls fully within the Medicines Act. I hope that when the Minister responds he will be able to explain quite clearly precisely how, if they are not subject to a statutory register, everything they do complies fully with the Medicines Act.

As for assessing the risk and the need for a profession to be registered, the review of the Professions Supplementary to Medicines Act was debated in another place in 1999. The key test stated in that review is,

“whether there is the potential for harm arising either from invasive procedures or application of unsupervised judgement made by the professional which can substantially impact on patient/client health or welfare”.

In response to that test and in relation to clinical perfusionists, the right honourable Andrew Lansley, said:

“It seems to me that perfusionists entirely match that criterion”.

It seems odd, having had that debate and that being on the record, that clinical perfusionists are still trying desperately to argue that they should be subject to statutory regulation and feel that they are failing to achieve that.

The other group that I want to discuss is clinical physiologists. I suggest again that they fall within that criterion. They are a very skilled group of people who are often alone with patients, including children, in situations in which they are responsible for conducting sometimes complex investigations and interacting closely with whoever is the patient in front of them. For the past 10 years, they have had a voluntary register, which they feel is flawed and demonstrates the need for statutory regulation. As a group they will not gain either in status or financially by having a statutory register. They want it because they are concerned about patient safety. Their view is that there is currently no incentive to register; they are in short supply anyway and can get another job without too much difficulty.

As a group, they sent me an individual case study, which I found quite worrying. I will try to summarise for the House briefly, because this is Report. They cited a clinical physiologist who had been working unsupervised in a room alone with children and working one to one with them. Following a holiday to Amsterdam, he was found to be in possession of child pornography, prosecuted and placed on the sex offenders register. Among his papers, the police found that he was a clinical physiologist and alerted the appropriate group. They alerted the employers but discovered that even though he lost the job he was in, he was rapidly re-employed in another hospital, which they also alerted. They followed it up to find that he had changed his name and, under another name, again had sought employment. They are very concerned that this is one they know about but that there may be others they do not know about. The group does not see how its voluntary registration system gives patients and the public the protection that they ought to have.

Health and Social Care Bill

Debate between Baroness Pitkeathley and Baroness Finlay of Llandaff

Monday 19th December 2011 Lords Chamber

[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.

Health and Social Care Bill

Debate between Baroness Pitkeathley and Baroness Finlay of Llandaff

Monday 19th December 2011 Lords Chamber

[Baroness Finlay of Llandaff]

My Lords, I support the amendment. It raises a very important issue, namely what happens when an error occurs. At the moment, there is an enormous disincentive for the pharmacist to do what one would say is the right thing, which is immediately to contact the patient, or their family, carer or nursing home, to try to put an immediate stop to the further use of that medication and to do all they can to correct the error. In the law as it is written at the moment there is an in-built incentive to a pharmacist to attempt a cover-up, to weigh up whether the error is a major or minor one or one which they might just get away with, or perhaps even to make a phone call that fudges the issue and tries to cover up the fact that they have made a dispensing error, and to reclaim the medication in another way.

In addition to the importance of a spirit of openness, there is an actual safety issue here. We know from looking at medicine and nursing that when you make it easier for people to admit immediately that they have made an error and to do all they can to correct that error, they are much more likely to handle things in an open and honest way and to learn from it. Certainly I say to all my junior staff, “I know that you will make mistakes. The only thing that I will hold against you for the whole of your career is if you do not immediately notify whoever is the consultant covering you at the time. Mistakes will happen, but you must let people know immediately and take every step to correct them”. I do not see why we should be treating pharmacists in law in a way that works against that type of principle and which is inappropriately punitive.

[Baroness Pitkeathley]

My Lords, I, too, support this amendment. I remind the Committee of my role as chair of the Council for Healthcare Regulatory Excellence, which has an oversight role with the General Pharmaceutical Council. We believe that single dispensing errors should be treated in a proportionate way that still prosecutes those who have been negligent or have committed a deliberate act but does not penalise pharmacists who want to declare a dispensing error in the interests of patient safety—and I very much agree with the noble Baroness, Lady Finlay, that this is about patient safety.

In the interests of patient safety and public protection, we of course expect the regulator to be able to co-operate with other agencies if it is aware of a pattern of repeated single-dispensing errors that might reflect wilful and deliberate acts with the intention of harming patients. In those circumstances, there would of course still be recourse to criminal prosecution. With these exceptions, I very much support this amendment.