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Health and Social Care Bill

Volume 733: debated on Monday 19 December 2011

Committee (14th Day) (Continued)

Debate on Amendment 338 resumed.

My Lords, I shall speak to Amendments 338 and 340, to which I have added my name in support of the noble Baroness, Lady Emerton. For those of your Lordships not familiar with the amendments, they are to do with the regulation of healthcare support workers. As many noble Lords will know, these workers were introduced into the health service just over a decade ago, and they are untrained, unqualified and unregulated. There are 300,000-plus of them in the health service, with many more working in nursing homes.

Any debate about the regulation of healthcare support workers will need to take account of current workforce trends. In April 2011, the Royal College of Nursing reported that NHS trusts were increasingly looking to reassess nursing roles in order to deliver short-term reductions in the wage bill without a full clinical assessment of the impact of this action on patients’ safety and the quality of patient care. The RCN reported a notable change in the skill mix of teams, with an increased reliance on unregulated healthcare support workers.

The other workforce in nursing is trained and regulated. It is made up of registered general nurses and registered midwives, and we also used to have state-enrolled nurses. The view could be taken that it is the responsibility of employers to make sure that their workforce is adequately trained and has the skills to deliver the care, but many recent reports with which noble Lords are familiar highlight poor-quality nursing care. Some of them have appeared in the press and include the failings at Stafford Hospital, where hundreds died unnecessarily, and at Winterbourne View care home, where staff were filmed abusing vulnerable patients, as well as a series of critical reports, most recently from the Care Quality Commission, which has condemned NHS care for the elderly. Some, including regulatory authorities and particularly the Council for Healthcare Regulatory Excellence, favour the employer-led model of training of healthcare support workers or of those who are not trained yet provide nursing care. This model was introduced in Scotland. The important thing is that it has never been evaluated. That needs to be done first. Secondly, and more importantly, the ratio of trained nurses to untrained support workers is quite different in Scotland. Anyone who promotes this model needs to look at that first.

I return to some of the issues. The noble Baroness, Lady Emerton, made all the points in an excellent introductory speech. It is a pity that we did not have a continuation of the debate so that we could have heard her comments and responded to them. However, the Bill proposes that the regulators of healthcare professionals should have the ability to establish voluntary registers for currently unregulated workers and professionals who are, or have been, engaged in work that supports or otherwise relates to work engaged in by members of the profession that the body regulates.

In proposing voluntary registration, the Government have accepted that unregulated workers supporting healthcare professionals represent a risk to public protection that needs to be addressed. If they did not, why would they even consider voluntary registration? It must be because they think it is a risk. Voluntary registration for healthcare support workers carrying out tasks delegated by nurses or midwives is not sufficient to protect the public.

The other argument used is that it is the trained nurses—the registered nurses—who supervise these support workers who are not trained or regulated. How can a nurse, or two nurses, in a ward of 15 or 16 intensive care patients, supervise three or four unregulated, untrained workers, who then carry out nursing tasks? The noble Baroness, Lady Emerton, cited a real case of such a worker measuring blood pressure who did not understand why she was doing it. If one is going to have people who look after ill, frail people, one needs to make sure that they are trained properly, that their training is assessed, and that they are regulated. I understand that this cannot be done overnight, particularly as we now have nearly 400,000 such people working in the health service, but there ought to be some mission to do this in a relatively short time, maybe even in two or three years. To go after voluntary registration is not the answer.

There is currently no consistent UK-wide training standard for healthcare support workers. Courses can range from an hour-long induction up to NVQ level 3. Assistant practitioners are experienced health support workers. They are different, and they may receive training up to NHS-level band 4, which is equivalent to the level of the previous state-enrolled nurses, but, again, there is no consistency across the UK. Clause 231 gives no indication that a voluntary system will be underpinned by consistent UK-wide standards of training that will assure the public that employers who employ health support workers have the knowledge and skills that they need to practise safely. I strongly support this amendment. Whenever the noble Baroness wishes to call a vote, I will join her.

My Lords, I have long been an advocate in the cause of statutory regulation and registration of healthcare support workers. When one has been around the health service for a long time, it is not unusual to see the wheels turn full circle. We went from support staff to auxiliary nurses, to nursing assistants, to state-enrolled assistant nurses. Then the word “assistant” was dropped and we had state-enrolled nurses. Then, as the noble Baroness, Lady Emerton, said earlier, the roles of the state-enrolled nurse and the registered nurse became very confused and the titles became interchangeable, which should never have happened. Then we moved to Project 2000 and the move from hospital-based training to higher education, and we are now moving from diploma to an all-degree profession, which is right and proper.

In 1999, my union, the Confederation of Health Service Employees, supported Project 2000, but we foresaw a gap that would be left by the ending of enrolled nurse training, which would lead to there being many more auxiliaries or healthcare assistants, as they became. We called for support workers to have about a year’s training to an agreed national standard and statutory regulation by the United Kingdom Central Council for Nursing, Midwifery and Health Visiting, as the regulatory body was called. We did not get that. The idea was opposed because it was argued that it would replicate the then existing confusion between enrolled nurses and registered nurses.

Where are we now? We have an explosion in the number of support staff who have taken the place of enrolled nurses; there are far more than any of us ever envisaged at the time. As the noble Lord, Lord Patel, said, more than 300,000 support workers are now employed in various roles with a number of job titles. One figure that I saw in research produced by UNISON said that there were more than 120 different job titles for healthcare support workers, which is astonishing.

We have a situation in which the patients do not know who is caring for them. It is not just a question of uniform, although that is important. Support staff carry out many duties that were previously the role of regulated nurses. Many of those roles, such as nasal gastric tubes, cannulation, catheterisation and blood pressure, are intimate and invasive, as we have heard. Almost uncannily, in view of what the noble Baroness, Lady Emerton, spoke about, I spent some time in hospital a couple of years ago when I had my blood pressure taken sitting in a chair beside the bed and my diastolic pressure was down to 40. I said to the healthcare assistant who took that blood pressure, “I had better get back to bed and I think you’d better call a senior nurse and doctor”. She said, “No, you are going down for an MRCP scan; just sit where you are”. Fortunately, being a nurse, I knew what I was talking about and I was able to get a doctor and a nurse, and before very long I had massive amounts of fluid pumped into my veins to restore my blood pressure. Had I not understood the situation, that could have resulted in a serious condition. It is quite frightening. You can be trained to take blood pressure, but not trained in the skills of observation and in understanding the readings that are being taken.

With the drive to reduce costs, there is, and will be, more substitution of registered nurses by healthcare workers. In effect we have a new second level, but that new second level is not regulated and not registered and the staff are not professionally accountable for their practice. That is not good enough. That is not in the interests of patients’ safety or protection. Nor will assured voluntary registration deal with the matter. Voluntary registers already exist for other professions and there are very real concerns about their inadequacies. They have no teeth, and staff can leave a voluntary register, particularly if there is any investigation for possible discipline.

The registration and regulation of healthcare support workers is supported by the Nursing and Midwifery Council, by the Royal College of Nursing, and by UNISON, although in fairness I should say that UNISON would prefer registration by the Health Professions Council. Registration is supported by the Queen’s Nursing Institute, by the health committee in another place and, most importantly, by healthcare assistants themselves.

In the Nursing Times of 6 December, I was interested to see in a small article about the Mid Staffordshire NHS Foundation Trust public inquiry that Robert Francis QC spoke of 20 issues that he would consider when drawing up his recommendations, which are due to be published next year, and the regulation and training of healthcare assistants was to be first on the list. I hope that that does not mean that they will carry the can for all the problems in Mid Staffordshire because that is certainly not the case; they go to a much higher level than that. Counsel to the inquiry, Tom Kark QC, said that the lack of regulation of healthcare assistants appeared to be surprising and dangerous.

There is inexorable pressure for this matter to be dealt with—and dealt with soon. It is not something that can be put on the long finger. If there is a strong recommendation from the Mid Staffordshire inquiry, we cannot leave it to be dealt with in a future Bill because we will not be getting another health service Bill for some time. This Bill gives us the opportunity to do this and to get it right. I strongly support the amendment by the noble Baroness, Lady Emerton. Healthcare assistants who have work delegated to them by nurses should be properly regulated and registered.

My Lords, I am very sorry to take issue with the opinions of noble Lords with whom I usually agree most heartily. I remind the Committee of my role as chair of the Council for Healthcare Regulatory Excellence. I should make it clear that I am in no way taking issue with noble Lords' concerns about the practice of healthcare assistants, nor with the emphasis—given particularly by the noble Baroness—on the need for proper training. The only thing I take issue with is whether statutory regulation is the correct solution to the problem.

I am not aware of any body of evidence that demonstrates that the risks of future harm presented by the practice of healthcare assistants could not be successfully managed by the existing processes and governance systems if they were applied effectively. That is the point. Healthcare assistants are already supervised by other staff who have the professional responsibility to supervise them. As we have heard, they almost always work in supervised settings, with supervision usually being the responsibility of staff who are statutorily regulated. Statutorily regulated professionals have a responsibility to ensure that the staff whom they manage offer safe care, conduct themselves professionally and are delegated only tasks that are within their technical competence. For example, the Nursing and Midwifery Council’s code states:

“You must establish that anyone you delegate to is able to carry out your instructions … You must confirm that the outcome of any delegated task meets the required standards … You must make sure that everyone you are responsible for is supervised and supported”.

In other words, we already have in place a governance system to ensure that healthcare assistants work safely and with proper delegation, supervision and support from a statutorily regulated professional. Employers are required to ensure safe systems of work, which will include providing support in delegating and supervising effectively.

Creating a list of people is not in itself an effective safeguard. Effective regulatory conditions are often much closer to home. For example, in an environment that is poorly managed and distant from scrutiny, poor standards of care can become the norm, with staff being drawn into collusion with poor care. We have seen many examples of this recently, particularly of the process of collusion, with people working in a poorly managed environment unable to resist the downward spiral of standards. The most effective way to invert the spiral is by employers properly managing the specific environment, not by establishing another structure.

Winterbourne View was referred to several times in this short debate. Perhaps it is worth reminding noble Lords that registered professionals were involved in delivering poor care there. Statutory regulation did not prevent it. We should always bear that in mind. Regulation is not necessarily the answer. Further, we cannot ignore the fact that statutory regulation would be expensive and cumbersome for a large, low-paid workforce with a high annual turnover. It is not proportionate to the risk, which can be managed by effective training, delegation and supervision.

The recent announcement by the Secretary of State about improving standards of training and the potential to develop a voluntary register of healthcare assistants is encouraging. I also welcome the Nursing and Midwifery Council's announcement that it will fully engage with the project that the Secretary of State announced, and with any further developments around assured voluntary registration for this particularly valuable group in the healthcare workforce. It is important that we make sure that we value this group, who are of such importance in the front line of the nursing and patient care environment.

My Lords, I am speaking because my name is also on this amendment. We need to reflect on several aspects relating to the context of this issue. I do not think that there is much doubt that we have a problem of some significance, or any doubt that the problem has been growing over a long time. I also do not think that it is an easy fix simply to jump to statutory regulation. I went through the process when the whole issue of regulating social workers arose, and that proved extremely difficult to introduce. I do not doubt that we will end up with statutory regulation of some kind, but we might have to go through some processes before we get to that point.

I do not want to duplicate the history that other noble Lords have put forward most expertly. I came into this story as a very young civil servant at the end of the 1960s when the Salmon committee was set up. Some noble Lords may be old enough to remember the Salmon committee—I was assistant secretary to the committee. This was in the days when civil servants could not hold a job for long and were moved on at a tremendous rate. While doing this work we saw how things worked at the ward level. In those good old days of the 1960s and early 1970s there was a ward sister, state-registered staff nurses, nursing auxiliaries and state-enrolled nurses. We also had a set of arrangements in which oversight of cleaning was largely the duty of the ward sister. Furthermore, bank working was not that common.

What has happened since those “good old days” is that hospitals have become used more intensively. Bank working has meant that there is a higher flow of different people moving through the wards, and the profession, with good reason, has wanted to make itself a graduate profession. The context has changed a lot, so the dynamics of those wards has changed quite a lot.

Alongside that we have been growing another industry in the community: in nursing homes, residential care homes and—not quite as fast as one would like, within the health service—a district nursing service. One of the problems in both these areas, whether acute hospitals or the community, is that with the demand of patients for services, and the demography which has gone alongside that shift in time, the qualified and registered nursing profession has inevitably had to look for help from sub-professional groups to help carry the load. In the community there is not a strong management structure to oversee this, so to some extent it is difficult for district nurses to oversee any work done by unqualified personnel. Such oversight might be the theory but in practice it will often be difficult to achieve.

Community services are burgeoning, the hospital service has changed, and we have a problem of a growing need for more people who are not qualified and registered nurses to work alongside such nurses to provide some of the care. We are looking to the Government to produce a comprehensive review that examines the situation that we face now rather than the situation we faced 10 or 15 years ago and which was very different.

I suspect that we will have to move by interim steps towards statutory registration, and perhaps voluntary registration is an interim step. However, I am not convinced that we have a comprehensive set of answers to a continuing and serious problem. The Government need to think about how they will deal with this very serious problem.

My Lords, I also have some scepticism about assured voluntary registration, but I will come back to that when we debate the subsequent amendment. I have some sympathy with the noble Baroness’s amendment. I had not intended to speak on this amendment until I heard a number of noble Lords speak, and I take a slightly different lesson from the history of the past number of years in the development of the nursing profession.

Like the noble Lord, Lord Warner, I remember sisters, state registered nurses, state enrolled nurses, nursing auxiliaries and so on, but one of the key things was that all those professionals described themselves as nurses. Indeed, I very well remember as a young doctor that nurses would not say, “I looked after that person”, or “I was on the ward when that patient came in before”, but said, “I nursed that patient”. There was a quality of compassion and relationship that was critical to the profession. I think that not only nursing as a profession, but many other professions went down the wrong road when they took the view that the future was in tighter registration and a graduate profession because that was not fundamentally the need. I heard my right honourable friend in another place being asked questions in the past few days about poor care of patients with dementia, and he made a very important point. He said that you can find two wards beside each other in a hospital with nurses with exactly the same level of training and qualifications but in one of those wards the patients are cared for with compassion and in the other ward they are not. When we move to healthcare support workers, it seems to me that whatever we move to, we do not move to a title that expresses compassion and care for the patients who are being nursed.

My gratitude to the noble Baroness is not for the specific terms of her amendment, and I do not think that they were the burden of her bringing the amendment forward. It is that we engage in a serious, proper debate about this issue, not just for nurses, but for other professions. There are some for whom I believe that statutory registration is the proper way ahead, but there are others for whom it does not seem to be the case that always moving to graduate professions with training and registration is the sole and most important way of dealing with these questions. It is quite clear that making nurses graduates and having registered nurses only has simply opened a door that has had to be filled with other, less qualified and, it has to be said, less expensive employees. Now we have a problem with them not measuring up to the professional standards of compassion that all of those—or at least, almost all of those—who aspired to be nurses at whatever level in the past aspired to in the best sense.

I welcome the fact that the noble Baroness has tabled this amendment; I am not quite sure it is the precise solution, but I hope we find ways to come back to the serious ongoing debate that the noble Lord, Lord Warner, has pointed to because there is a crisis in this area. I remember saying this two, three, four years ago in your Lordships' House and noble Lords who are now on the Benches on the other side thought it was simply a party-political attack. It was not—it was a genuine sense of concern that things were deteriorating. They have continued to do so, and it will not be dealt with solely by registration, training and academic qualifications because a quality of care and compassion and a culture of compassion are necessary. That is not to take away from the question of assured voluntary registration, which I wish to explore in a further amendment.

My Lords, I, too, pay tribute to the noble Baroness, Lady Emerton, for her perseverance and determination in this very important area. Rather like the noble Lord, Lord Alderdice, I am clear that the role of healthcare assistants has to be seen in the context of a much more general debate about nursing care, including the compassion that he talked so eloquently about.

As the noble Baroness said to us rather earlier this afternoon, we had an excellent debate on nursing on 1 December, and we are presented with something of a paradox: on the one hand, we should not ignore the huge advances in the nursing profession over the past 20 years. There has been the move to a graduate profession and nurses have taken on much greater responsibility, including for complex care and specialist care, and I think that, overall, the public have welcomed that increased responsibility. At the same time, there has been real and mounting concern about basic standards of care and issues to do with hygiene, feeding of patients, nutrition, dignity and even face-to-face contact—the kind of compassion that the noble Lord, Lord Alderdice, has just spoken about. We have seen the reports from unannounced visits of various bodies. Recently, the CQC has undertaken important visits to many of our hospitals. There seems to be real evidence and concern about a falling of standards of basic care.

The reasons for that are not clear. It is possible that nurse training is now too focused on academic performance rather than on practical nurse training. It is also at least possible that the drive for specialist nurses and modern matrons has taken from the ward the many experienced nurses who, in retrospect, might be better placed in leading their ward as ward manager or senior sister. What is not in doubt is the need for serious thinking about how we can enhance the overall quality in standards of basic care that nurses give.

That brings us to the role of healthcare assistants. Again, in our debate on 1 December, the noble Earl, Lord Howe, in responding, referred to the concerns that had been expressed about nursing in the acute sector in particular. He said he felt that that,

“related to inappropriate delegation by nurses to healthcare”,

assistants. He continued:

“Wherever there is a multidisciplinary team of regulated professionals and unregulated healthcare workers, appropriate delegation and supervision is vitally important. This is an area ripe for formal review”.

He also said that the Government welcomed,

“the NMC’s plans to update its guidance on delegation”,

and that they have,

“asked Skills for Health and Skills for Care to accelerate production of a code of conduct”.—[Official Report, 1/12/11; col. 419.]

I am sure that those actions by the Government are very generally welcomed. The question before us is whether they are sufficient. From what the noble Baroness, Lady Emerton, has said, it is clear that she does not think that they are. Powerful support for that argument has been received from the Nursing and Midwifery Council, which argues that a system of regulation for healthcare support workers should contain provisions for consistent UK-wide standards of training and practice that would assure the public and employers that they have the knowledge and skills to practice safely. It further suggests a mandatory register to ensure that workers who have been struck off the nursing and midwifery register are not re-employed in a healthcare support role, which has been the subject of some concerns. It is also notable that the House of Commons Health Committee supports mandatory statutory regulation of healthcare assistants, which it believes is the only approach that would maximise public protection.

However, we have heard from my noble friend Lady Pitkeathley, chair of the Council for Healthcare Regulatory Excellence, who has put a different view. It will be interesting to hear the response of the noble Baroness, Lady Emerton, on why she thinks that a voluntary register for healthcare assistants is the way forward. I should like to ask her whether she would support NHS bodies which require healthcare assistants to be voluntarily registered as a condition of employment. If that were the case, what safeguards does she think could be put in place as regards a worker who was dismissed because of poor conduct towards a patient? How could we ensure that in those circumstances that person could not then work in another part of the care sector? That seems to me to go to the heart of the issue of whether a voluntary register could work.

I have no doubt that NHS employers could be encouraged to make it mandatory but the problem with that is that too many people could slip through the net. I would also ask the noble Baroness to respond to my noble friend Lord Warner. I share his view that, clearly, we are crying out for a fundamental review of these issues around nursing quality and care, compassion, and dignity of care being given to patients, and that relationship to healthcare assistants. If the Government are not prepared to move on this and on the point about only going as far as a voluntary register, can they at least give some comfort and assurance that they recognise that this matter needs close attention?

I am not a great believer in royal commissions—I think it was Harold Wilson who said that they could be established in a minute but take years—but there is a strong case for a fundamental review of the nursing profession, embracing healthcare assistants. Would the Government be prepared to give us some comfort on this?

My Lords, these amendments seek to extend compulsory statutory regulation to healthcare support workers. I thank noble Lords for the amendments because they raise important issues about the ways in which we assure the quality and safety of those who work in support of our regulated health professionals. The Government are publishing a fact sheet on this issue that will contain further details about their proposals, which I hope will be helpful to noble Lords.

There are more than 200,000 nursing assistants and approximately a further 1 million people working in similar jobs in adult social care in England alone. The majority of support workers give the highest quality of care. However, a minority let patients down. This is rightly a cause for concern, although as a former historian I have to say that I do not fully recognise the notion of everything having been perfect in earlier periods but everything breaking down at this point. One needs only to look at what has been said from Florence Nightingale onwards about what happened during the interwar periods, during times of war and so on. This has always been more varied than perhaps noble Lords are allowing for. Nevertheless, it is extremely important that we try to drive up quality and ensure that quality holds good right across the health service and social care. It is right that there is discussion and debate about the best way of ensuring that high standards of care are delivered at all times.

As the noble Baroness, Lady Pitkeathley, pointed out, there are already existing tiers of regulation that protect patients and service users. Professionals struck off by their regulator or sacked by an employer who pose a risk to vulnerable adults or children should be referred to the Independent Safeguarding Authority, which has been very clear that it expects this to happen. In the same way, employers should make referrals about individuals from unregulated groups where they pose a risk of harm to vulnerable adults or children. Providers and employers also play a key role in ensuring safe, high quality care that patients and service users can be confident in, being both responsible and accountable for the staff they employ. Under the registration requirements of the Care Quality Commission, providers must take steps to ensure that at all times there are sufficient numbers of suitably qualified, skilled and experienced persons employed for the purpose of carrying on any regulated activity.

An individual being on a list does not alter this and would not remove employers’ responsibility to undertake a range of checks on the suitability of any persons who they appoint, including qualifications, relevant registrations, employment history and reference checks to ensure that an individual is competent for a specific role. Equally, appropriate delegation and supervision is a necessity within teams made up of both regulated and unregulated professionals and workers. Guidance by the Nursing and Midwifery Council is being updated so that nursing staff know how to delegate appropriately and safely.

We are not ruling out compulsory statutory regulation for healthcare support workers, but our view is that the case has not yet been made for imposing further compulsory statutory regulation, given the tiers of existing regulation and the duties on regulated professionals. There is no solid evidence that demonstrates that healthcare support workers and adult social care workers should be subject to compulsory statutory regulation. Research by King’s College London concluded that little evidence could be deployed to show that regulation of healthcare support workers would reduce the risk to the public, although it was clear that some healthcare workers were undertaking roles that had traditionally been done by nurses. The point is that quality is not always what is delivered. Therefore, we have to try to tackle that concern and not simply assume that regulation will deal with it. As the noble Baroness, Lady Pitkeathley, mentioned, there are regulated professions which are in some instances letting us down. We must focus on the real problem and figure out ways of tackling it.

The Government’s view is that high standards for healthcare support workers and other professional occupational groups can be assured without imposing compulsory statutory regulation. That is why, in the wider context of supporting providers, we are creating through the Bill a system of external quality assurance for voluntary registers. To pick up the point made by the noble Lord, Lord MacKenzie, there are various examples of voluntary registration for groups of professionals. We are proposing a quality-assured voluntary approach, looking at how those registers are set up and operated and what training is offered and so on. A quality-assured voluntary register will set standards for training, conduct, competence and ethics that all registrants must meet.

My Lords, if the Government are putting so much faith in the quality-assured voluntary register, surely the evidence from King’s College would show that that was not necessary. They cannot have it both ways. Either regulation, and what comes with it, provides advantages or it does not.

Regulation and training are often put as two words in one sentence. Regulation may indeed include training; assured voluntary registers may also include training. The noble Baroness, Lady Emerton, talked about that. Perhaps I may come on to it, because it is potentially relevant here.

I am particularly grateful to the noble Baroness for her contribution to this debate, not only today but throughout her time in the House of Lords. We agree that common standards of training are needed for those working in both health and social care, as well as more role-specific training, and that this will lead to a more capable and flexible group of support workers. As we seek to integrate health and social care more effectively, this area deserves a lot of scrutiny.

We expect work on the standards to begin by April 2012 in terms of training, and for them to be agreed ahead of the establishment of voluntary registers for healthcare support workers and adult social care workers, which could be operational from 2013. This will allow unregulated workers to demonstrate that they meet a set of minimum standards for training and are committed to a code of conduct.

My Lords, I still do not understand this. If it is so important that the voluntary registers are established, for the reasons that the Minister has given, why on earth not go the full hog and make registration compulsory? If the Government do not think that it is important, they would not be pursuing the voluntary register approach. However, by taking that approach, they will leave lots of people outside the net.

As the noble Baroness, Lady Pitkeathley, and others have indicated, one has to be proportionate about this and not think that simply going down the route of regulation is going to crack it. Nevertheless, training and making sure that people are well prepared for the work that they are doing is clearly of great importance. We would expect a voluntary register, quality assured in the way that I have described, to provide a way for employers to assure what they are offering in terms of staff. There will therefore be greater take-up. Those who are on the quality-assured register will find themselves more employable, which will move things forward. Meanwhile, if, as we continue to debate this, voluntary registration does not seem sufficient and regulation seems the route to go down, the Government do not rule that out. However, it is extremely important to focus on the end point, which is to try to drive up quality, and not simply be deflected by thinking that this would crack it.

I assure noble Lords that we will keep this issue under constant review. We are well aware of people’s concerns and that standards need to be driven up in a much more even way across the board. As I say, we are developing the education and training which I hope will go some way towards this.

I wish to pick up on one point. Can the noble Baroness reassure us on what it is she will keep under constant review? I understood her to say that the Government will rely on employers to ensure that these support workers have some kind of training. There will be no national training standards and, once the employers are satisfied that these people have some kind of training, they will be entitled to go on a voluntary register. As I understand it, the logical thing here is first to establish a national standard of training; then to ensure that those national standards are implemented; and then to allow people to register. If they register, the next step would be regulation. The first step is not immediate regulation but national standards of training and assessment that those standards are being met, before people can go through any kind of registration. What is the noble Baroness agreeing to keep under review?

I should perhaps explain that more precisely. This issue will be constantly under review so that if there are concerns in this area they will be flagged up. The Government will of course continually consider how best to respond and make sure that standards are of the quality that we need. The noble Lord is right: national standards of training are indeed the start. Then people are admitted to a register and so on. A voluntary-assured register would demand that kind of national level of standards in training. I hope that in that regard I can at least reassure the noble Lord.

One question has puzzled me more and more as the noble Baroness has progressed. My noble friend Lady Pitkeathley laid great stress on the position of the regulated nurses and the fact that they will have to ensure that people working in the healthcare assistant type of roles under their supervision do not take on roles that they are not competent to fulfil. Going back to my description of the way the NHS works in reality, particularly in acute hospitals, there is a constant flow of different people on these wards—regulated and registered staff, agency or bank staff, are there particularly in the evenings, for unsocial hours and at weekends. We have heard a lot about employers. I am still puzzled about how the statutory regulated nurses satisfy themselves about the competence of the healthcare assistants working under their direction. They seem to be the people most exposed—at least theoretically—to cop it from their regulatory body if they have not made extensive inquiries about the competence of these healthcare assistants. How does the noble Baroness square that particular circle if we do not have much knowledge of the training of these people and they have not even registered on a voluntary basis?

The noble Lord will be familiar with being on wards at changeover time and when there is a pooling of information about who is on the ward and what the problems are. Issues are flagged up and one team passes information on to the next.

I have seen many, many changeovers. The proposal is being brought forward so that registered, regulated nurses have a better idea of when and how to delegate, and that is extremely important for the reasons that the noble Lord has just indicated. As I have indicated, the training and national standards of healthcare workers, to which the noble Lord, Lord Patel, referred, are also important—as is taking that forward so that the registered nurses are aware of the kind of training that those healthcare workers have had. I want to pick up on the case that the noble Baroness, Lady Emerton, mentioned about the healthcare worker who was taking a patient’s blood pressure but did not know what the reading meant. Surely, it was for the person to whom that was reported to take action on the significance of that. That information was to be passed on to somebody else to read, understand and interpret.

But if that healthcare assistant does not have the basic training or an understanding of the reading that she or he has just taken, they may not see the importance of reporting it to another nurse.

I am not suggesting that they would. What I am suggesting is that the registered nurse might go and check the chart.

My Lords, perhaps I could be helpful at this stage. I am grateful to noble Lords who have contributed to this debate. A large number of issues have been brought forward; I shall start with the title “nurse”. As noble Lords have mentioned, a person who is nursed—and feels that they have been nursed—experiences care, compassion, respect and dignity. There has been a lot of discussion among the public, and indeed in this House, about registered nurses becoming graduates and whether they will be too posh to wash, to put it colloquially. To me, a nurse who is a graduate would be only too grateful to be able to attend to the basic needs of patients, because that is part of holistic care. When you do various intimate things for patients, you learn a great deal about their condition.

The point that has been raised about the nurse is very important. We talk about support workers but we cannot talk about support nurses, because the term “nurse” is completely left for the statutory requirement of a regulated nurse. We are looking for a support worker who is able to do tasks which they understand, with the skills of the graduate nurse—because by 2013, we will be producing all-graduate nurses—within holistic care. That is the point I was trying to make this morning: it is the holistic care we are looking for in the delivery of care. However, it is not only holistic care in the acute sector; we are looking at the holistic care which is integrated with social care, because we are now looking at patients going into the community. Indeed, people working in the acute sector need to understand that the patients they are discharging are going into the community, which is a different scene and which may require not only a nurse but social care support. Therefore, somewhere in our education we need to bring together a basic core of understanding healthcare, nursing care and social care.

The point that the noble Lord, Lord Warner, made is very important. We need to conduct this review. On the other hand, the research evidence shows us that as regards highly qualified registered staff, the higher the proportion, the less likely it is that patients will have a longer stay in hospital. They will have a better clinical outcome. I hope that the Government are not going to ignore that research. If possible, we should carry out a truly safe cost-benefit analysis into increasing the number of trained staff, seeing where they are needed, rather than having a higher proportion of support workers.

The Royal College of Nursing has been resolute in putting forward the regulation of healthcare support workers because it feels that that is the way to ensure that they are answerable to a registered nurse. We talk about employers but I am not sure who the employers are going to be—social workers, managers or the nursing profession. This whole issue needs to be taken away and looked at, and perhaps we could return to it. I do not know whether these comments are helpful but I feel strongly about this issue, as noble Lords may have gathered. I pass it back to the Minister.

I hear what the noble Baroness says. She is extremely well informed, as ever, and I hope that she will continue to engage as we take this forward, as she has done up to now. However, at this point I hope that she will withdraw her amendment.

My Lords, I am prepared to withdraw but we will probably come back to this on Report. I beg leave to withdraw the amendment.

Amendment 338 withdrawn.

Amendment 338ZA

Moved by

338ZA: After Clause 205, insert the following new Clause—

“Power to regulate clinical physiologists in England

(1) Section 60 of the Health Act 1999 (regulation of health care professions) is amended as follows.

(2) In subsection (1) after paragraph (b) insert—

“(ba) regulating the clinical physiology profession in England,”.(3) In that section, after paragraph (bb) insert—

“(bc) regulating clinical physiologists in England who appear to require regulation in pursuance of this section,”.”

My Lords, I shall speak also to Amendments 338ZB, 338F and 339ZB. We return to a regulatory issue. Amendments 338ZA and 339ZB are new clauses relating to the power to regulate clinical physiologists in England. Amendment 338ZB is a new clause requiring clinical physiologists to be registered by the Health Professions Council. Amendment 338F says that the Health Professions Council, in exercising its functions, shall co-operate with the regulation of clinical physiology in England and with the provision, supervision or management of services of people engaging in clinical physiology in England. The noble Baroness, Lady Finlay, has an amendment in this group and we support what she is proposing.

I am sure that other noble Lords have received the helpful briefing note from the Registration Council for Clinical Physiologists, which highlights that the Government’s current approach—a preference for voluntary registration, as the Minister outlined in the previous debate—has been applied to clinical physiologists, despite a recommendation from the Health Professions Council in 2004 for statutory regulation. The RCCP has a substantial amount of evidence suggesting that, in the case of clinical physiologists, voluntary self-regulation is not as effective as statutory regulation.

In the Command Paper Enabling Excellence: Autonomy and Accountability for Health and Social Care Staff, the Government stated that statutory regulation would be considered for those professions where a compelling patient safety case could be made and be supported by an evidence-based cost-benefit risk analysis. Ten months later, though, no such risk assessment has been undertaken, and the RCCP continues to believe that clinical physiologists should be statutorily regulated.

The disciplines that are covered by clinical physiology are audiology, cardiology, gastrointestinal physiology, neurophysiology and respiratory physiology. Clinical physiologists work directly with patients, performing sensitive procedures such as assessments of pacemakers, testing lung function and assessing and diagnosing hearing loss. Many of the procedures performed by clinical physiologists in the UK are performed by statutorily regulated professionals in much of western Europe and by clinicians in the United States.

A body that I have mentioned, the Registration Council for Clinical Physiologists, maintains a voluntary register of clinical physiologists in the UK and Northern Ireland. It has more than 5,000 registrants across a number of different disciplines in clinical physiology. These professionals play an integral part in the process of diagnosis and treatment, undertaking procedures such as ECGs, which pose significant risks to patients. That, really, is the point here.

While the profession as a whole enjoys an excellent reputation and high standards of working practice, the continued lack of statutory regulation for its registrants means that there will continue to be gaps in its oversight, which comes with inherent risks to patients. Therefore, we believe that the Government’s preference for regulation through assured voluntary registration is not sufficient for this particular group of healthcare workers. They need to be statutorily protected; a voluntary scheme is not sufficient and there is a threat to patient safety. I hope that the Government will consider this a reasonable request on the profession’s part. I have to say that I fail to understand why this has not been taken forward and I hope that the Minister will be able to explain to the Committee why clinical physiology cannot have statutory regulation in the context of patient protection. I beg to move.

My Lords, I should just like to add my support for this amendment. Clinical physiologists, who perform some very invasive procedures, feel that they need statutory regulation. They have had a voluntary scheme, which they say is not adequate.

My Lords, I should like to ask the Minister to clarify a point of some importance. Many years ago, in the early stages of my neurological career, I was involved in interpreting electroence- phalograms. Subsequently, I was heavily involved in the pursuit of electromyography—a technique for measuring the electrical activity of the muscles in health and disease—and in measuring nerve conduction velocity. I also looked at evoked nerve potentials. A group of individuals grew up in that field originally; it was called the EEG Society. Then there was the Electrophysiological Technologists’ Association—the EPTA—of which I was briefly president. Eventually they came together to form the association of clinical neurophysiologists.

The Health Professions Council regulates 15 health professions, including biomedical scientists and clinical scientists. My understanding is that clinical neurophysiologists, like other clinical physiologists, are not included in or embraced by the term “clinical scientist”. However, I wish to know whether they are covered by the Health Professions Council. If they are not, it is important that they should be regulated. For that reason, if they are not included at present under the terms of the Health Professions Council, I strongly support this amendment.

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.

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.

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.

What proportion of voluntary persons employed in operating theatres are expected to be affected? Is it not the case that the great proportion of them are specialists who are subject to statutory regulation?

Currently, a great proportion are in statutory regulation, given that voluntary regulation is being developed. The CHRE is currently working on that.

My Lords, I should like to press this question in the context of the amendments in this group. What is the Government’s rationale for making a difference between statutory registration and quality-assured voluntary registration? The noble Baroness, Lady Pitkeathley, has used terms such as “light-touch”, “proportionate”, “appropriate”, “not so expensive” and so on. However, I have difficulty in seeing consistency here.

On the one hand, we can see that there are very small groups such as clinical perfusion scientists who are employed in only a few centres where open-heart surgery is being done. One could see that there may be a degree of expense in setting up a whole scheme of statutory registration. However, when it comes to groups such as clinical scientists and physiologists, there is a much larger number, but almost all of them are employed in the National Health Service. I understand the argument that they are all, or almost all, operating under the supervision of people who are statutorily registered and are operating in the context of the NHS, which deals with financial claims and so on.

However, as noble Lords will know, I have raised repeatedly—perhaps even tiresomely—the question of statutory registration of psychotherapists and counsellors. When I raised it again not so long ago with the Minister, he responded that, no, the Government did not want to go ahead on that front; they wanted quality-assured voluntary registers. The same kind of rules do not apply. Why? First, there is a huge number of these people—certainly enough for it not to be a financial question, as small contributions from all of them would be enough to set up a statutory registration scheme. Secondly, the majority of psychotherapists and counsellors work outside of, and therefore are not subject to the kind of regulation that takes place in, the National Health Service. On top of that, a large proportion of them work on their own, so they are not supervised by statutorily registered colleagues and they are not employed by employers who, Ministers have assured us, would consider their qualifications and supervision.

Although, in the context of the current crop of amendments, the argument has been made on the basis of expense and on the basis that these people operate within and are employed by the health service—and are therefore under the supervision of statutorily registered senior colleagues—none of those arguments applies to those who are working in the private sector on their own account. Such people are employed only by the patients who are consulting them, and there is a large number of them.

What requirements help Her Majesty's Government to judge whether a profession has statutory registration or quality-assured voluntary registration? None of the arguments that have been adduced is applied consistently.

What is troubling me about this whole exercise is that, under the Health Professions Council, statutory regulation applies to art therapists, biomedical scientists, chiropodists, clinical scientists, dieticians, hearing-aid dispensers, occupational therapists, operating department practitioners, orthoptists, paramedics, physiotherapists, practitioner psychologists —in what way do practitioner psychologists differ from the psychologists to whom the noble Lord referred?—and many others. A lot of these people are already regulated. Where the statutorily regulated bodies end and the voluntarily regulated bodies begin is very unclear.

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.

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.

My Lords, I support this group of amendments. I want to make just a couple of points, as I think that most of the others have already been covered.

I am looking at some information sent in an open letter from the Registration Council for Clinical Physiologists to Anne Milton, the Parliamentary Under-Secretary of State in another place. Interestingly, in that open letter the registration council, which operates a voluntary register, takes the view that the council is rather toothless. It says that the professions covered by clinical physiologists will continue to be,

“saddled with a toothless system of voluntary registration, in which those managing the registers are exposed to unacceptable legal risk when attempting to enforce the meagre sanctions at their disposal and maintain professional standards”.

It says it is evident that those administering the current inadequate voluntary registration process are being threatened with civil action by those whom they are forced to reprimand. It is a pretty poor state of affairs when those who are trying to enforce professional standards are themselves threatened with legal action.

I know from talking to people involved with the registration council that people leave the register when disciplinary issues come to the fore. I gather that in one instance a person left the register when faced with discipline, emigrated to Australia, continued to practise and got in trouble there. As I understand it, the Australian statutory body that exists for clinical physiologists was astonished to discover that there was no statutory regulation in force in this country.

I do not think that we can continue with this so-called voluntary system and light touch. We need to do what other countries do and have statutory responsibilities and statutory training and registration for these very important groups of staff.

My Lords, these amendments seek to extend compulsory statutory regulation to physicians’ assistants in anaesthesia and clinical physiologists and to make changes to legislation to further provide for the compulsory statutory regulation of clinical physiologists.

I make it clear at the start that healthcare scientists such as clinical physiologists play an important and highly valued role as part of clinical teams, and this is also true of physicians’ assistants. It is a testament to their professionalism that the Department of Health is not aware of any general concerns about the standards of practice of either group. Furthermore, we need to be absolutely clear that the purpose of regulation is to protect the public, not to support the development of a profession.

Given the wider systems of assurance in place such as the Care Quality Commission’s registration requirements, and the vetting and barring scheme, the Government do not consider that the case for compulsory statutory regulation of these groups of healthcare scientists not already subject to regulation, and physicians’ assistants, has been made. However, we agree that there need to be processes to ensure high standards of care, and assured voluntary registration overseen by the Professional Standards Authority for Health and Social Care has the potential to provide this. It will ensure that there are robust standards of conduct and training. It will be open to employers and commissioners to insist on only recruiting staff on voluntary registers. Those doing so would secure many of the benefits of compulsory regulation. Both healthcare scientists and physicians’ assistants already have established voluntary registers and would be well placed to seek accreditation from the authority.

The noble Baroness, Lady Thornton, asked why we were not taking forward the regulation of clinical physiologists as recommended by the Health Professions Council. The recommendations of the Health Professions Council were not based on an assessment of the risk presented by a profession, but rather on whether that profession had already developed processes of assurance which prepared them for professional regulation. There is therefore no evidence that compulsory statutory regulation is necessary to mitigate the risks posed by the professions recommended for such regulation by the Health Professions Council. This is probably why the previous Government did not decide to regulate, although this is an issue that has been flagged up for a number of years. The professions recommended by the Health Professions Council for compulsory statutory regulation will be well placed to join the system of assured voluntary registration that we are proposing.

The noble Baroness, Lady Thornton, asked about research in terms of regulating clinical physiologists. We are not planning on commissioning research into the case for regulating them, but we will review the case for introducing compulsory statutory regulation for clinical physiologists and, obviously, others in the light of experience of assured voluntary registration, and the evidence about risks available.

Perhaps the Minister could tell us what sort of timescale she envisages for this, or whether it will have to wait until an accident happens like the noble Baroness, Lady Finlay, recorded and then the Government will deal with it.

The noble Baroness will be fully aware, because she was a health Minister, that if there is no evidence of there being a risk then you do not choose to regulate. That is presumably why the previous Government chose not to.

The noble Baroness, Lady Finlay, flagged up the position of anaesthetists’ assistants. I had interesting discussions yesterday with an anaesthetist and an anaesthetist’s assistant, and it was very enlightening. As the noble Baroness will know, the anaesthetist is of course ultimately responsible. Assistants must always be supervised by a consultant who needs to be available within two minutes. The issue that the noble Baroness raises is one of quality assurance. As she knows, the Royal College of Anaesthetists runs the training and the registration for those assistants. After they have done a science degree, generally it is 27 months of practice. If the Royal College of Anaesthetists judges that that is inadequate, on the basis of the kind of concerns that the noble Baroness raises, then it is clearly for it to say that there are risks, it has encountered risks, and that needs to be addressed. If this system comes under the quality assurance system that I mentioned earlier, there will be another body looking at whether that kind of training, assurance and registration is adequate. However, there have not been cases flagged up as causing concern. I also point out that there are few anaesthetists’ assistants. They are more generally used in other countries, I gather, but not so much in the United Kingdom. The noble Lord, Lord Alderdice, asked why there is not more statutory regulation. In some ways I think I have addressed that. Although compulsory statutory regulation is sometimes necessary, one has to look at the risks and at what is proportionate.

The health Minister Anne Milton said that those professions in which a patient safety case can be made, including that of clinical physiologists, will be considered for statutory regulation subject to a cost-benefit risk analysis. Will the Government carry out that analysis and, if so, when and in what time? I do not particularly want an answer about what my Government may or may not have done or may or may not have decided. The noble Baroness’s own Minister has pronounced on this matter since the general election so it seems to me that she needs to answer the question: when will they do the risk analysis?

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.

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.

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.

My Lords, I thank the Minister, but this is not yet a satisfactory situation. We might be moving towards one but we are not there by any means. If I were on the register of clinical physiologists I would find it slightly offensive for the Minister to suggest that I was asking for statutory regulation as a kind of professional development of the organisation. Physiologists are very clear in all of their briefings that they think that this is important for patient safety. That is why they want statutory regulation and that is why we need to listen to them very carefully.

I thank the noble Baroness for that. The noble Baroness, Lady Finlay, made a graphic and powerful case. I thank my noble friend Lord Rea, the noble Baroness, Lady Masham, and the noble Lord, Lord Walton, for their support for the amendment. My noble friend Lady Pitkeathley and the Minister are coming at it from a different point of view. It is entirely possible that an arbitrary decision was taken, quite possibly by my Government, that there was enough statutory regulation. It is possible that this Government need to think that that was an arbitrary decision in the history of regulation and that exceptions need to be made.

There are questions about the limits of assured voluntary registration. Do clinical physiologists carry out invasive procedures that could harm patients? Yes, they do. Are clinical physiologists incentivised to join the voluntary register? No, they are not. A small number of NHS and private employers notionally require applicants to be on their register but there is no mandatory requirement for this. Are professionals incentivised to maintain the voluntary register? No, their activities are carried out on a voluntary basis by the chair and other officers. Does the voluntary register empower patients to make formal complaints? No. While the Health Professions Council operates a system whereby anyone can make a complaint about the fitness to practise of a professional on its register, in most instances members of the public are not aware of the existence of voluntary registers. Finally, does the voluntary register have any powers of enforcement? No, it does not. The RCCP operates a disciplinary code and procedure but it cannot protect patients from continuing to be treated by practitioners who have not been registered and who are potentially unfit to practise. I beg leave to withdraw the amendment.

Amendment 338ZA withdrawn.

Amendment 338ZB not moved.

House resumed.