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Health and Social Care Act 2008 (Regulated Activities) Regulations 2010

Volume 718: debated on Monday 8 March 2010

Considered in Grand Committee

Moved By

That the Grand Committee do report to the House that it has considered the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010.

Relevant documents: 8th Report from the Joint Committee on Statutory Instruments and 11th Report from the Merits Committee.

My Lords, there is one set of regulations and one order in front of the Committee. The regulations deal with the new registration system for health and adult social care providers of regulated activities. The order makes consequential amendments required when the existing system under the Care Standards Act 2000 is replaced by the new registration system. The Committee will recall that the Health and Social Care Act 2008 put in place provision for a new system of regulation of healthcare and adult social care to be operated by the Care Quality Commission.

I shall set out briefly what the regulations do. Part 1—Regulations 1 and 2—deals with the definitions in relation to the regulations. Part 2—Regulation 3, along with Schedules 1 and 2—then sets out the detailed scope of the new registration system; that is, the delivery of those activities which will require a provider to be registered with the Care Quality Commission. The activities cover both health and social care. Part 2 sets out the stages at which different providers will be brought into the new registration system.

On 1 April 2010, NHS providers of healthcare-regulated activities will be brought into the new system, followed by private and voluntary healthcare and adult social care providers of regulated activities on 1 October 2010. The regulations then bring in primary dental care and private ambulance providers on 1 April 2011 and, finally, primary medical care providers on 1 April 2012. Noble Lords will recognise that this is an enormous workload for the Care Quality Commission; by April 2012, around 50,000 providers will have been registered. By phasing in the introduction of different providers in this way, the Care Quality Commission will be able to manage the workload effectively and give applications for registration the scrutiny that they require.

Part 3 of the regulations—Regulations 4 to 7—deals with requirements relating to the person carrying on or managing the regulated activity. These regulations set out requirements such as the requirement for the registered person and registered manager to have the necessary skills, qualifications and experience to carry on or manage the regulated activity. Part 4—Regulations 8 to 24—then sets out the 16 essential safety and quality requirements with which registered providers must comply. These cover areas such as meeting nutritional needs, and respecting and involving people who use services.

Part 5 of the regulations—Regulations 25 to 27—creates the offence of failing to comply with any of the requirements set out in Part 4, with a penalty, on summary conviction. of up to £50,000. The actual level of the fine in individual cases is decided by the courts. Under Regulation 27, the Care Quality Commission must issue a warning notice in respect of a breach of regulations prior to bringing prosecution proceedings. Part 5 also makes provision for the guidance and code of practice that registered providers and managers must have regard to for the purposes of compliance with the regulations.

Part 6—Regulation 28—deals with fixed penalty notices that may be issued by the Care Quality Commission in lieu of prosecution. Schedule 4 sets out the offences that are fixed penalty offences, including failure to comply with registration requirements, and the penalty notice amounts ranging from £300 to £4,000 depending on the offence. Regulation 28 sets out various administrative matters in relation to the issuing of penalty notices, such as the timescale for payment.

In addition to the regulations, we are also considering the Health and Social Care Act (Consequential Amendments No. 2) Order 2010. This technical order makes amendments to a number of Acts that cross-refer to various kinds of establishments defined by the Care Standards Act 2000. As these provisions in the Care Standards Act will be repealed on introduction of the new registration system, the amendments are necessary to ensure that the various Acts continue to cover those same types of establishments by replacing the references as required.

The Care Quality Commission took over the regulation of health and adult social care in April last year. Since then, it has already put in place a new registration system for NHS providers of healthcare; they are currently required to comply with a single requirement in relation to healthcare-associated infections. For private and voluntary healthcare and adult social care providers, the commission has continued to operate the registration system under the Care Standards Act 2000. The regulations that we are considering now are the next step in strengthening the regulatory system and bringing together the regulation of health and adult social care into a single integrated system. This new regulatory system will make a number of improvements to the current systems, bringing together providers of health and adult social care from all sectors into a single regulatory system for the first time. The enhanced range of enforcement powers under the Health and Social Care Act will mean that the Care Quality Commission can take swift and effective action to ensure that those using regulated services are protected from unsafe care and treatment. The system will provide the public with assurance that the essential safety and quality are being met.

Under the current registration system, the Care Quality Commission registers establishments and agencies. This approach has become inflexible, particularly as care has moved from the acute sector into community settings. Under the new system, as it is the activities that are regulated, it does not matter where the activity is carried out. When making decisions about what activities should be within the scope of the new registration system, we made use of the information available on the potential risks and suffering that might be associated with a type of care. We considered the vulnerability of people who were receiving care, and we looked for evidence that bringing this care into registration with the Care Quality Commission would reduce these risks. We have consulted widely and engaged with stakeholders in drawing up this list of regulated activities, but we are nevertheless committed to keeping it under review.

As noble Lords may be aware, the regulations replaced earlier draft regulations that we withdrew in order to address issues raised by the Joint Committee on Statutory Instruments in its report. To ensure that the revised set of regulations that noble Lords are now considering deal appropriately with the issues raised by the committee, we worked with the legal adviser at the JCSI and departmental lawyers.

The key feature of the regulations is the registration requirements set out in Part 4. These set the essential levels of safety and quality that all providers of regulated activities will have to meet. They also define the outcomes that patients and service users can and do expect from the services that they receive. Failure to meet the registration requirements will result in enforcement action by the Care Quality Commission.

The registration requirements are intended to be outcome-focused without being overly prescriptive. They set out the outcomes that people who use services should be able to expect, while giving the provider flexibility to decide how best to deliver the outcome. The Committee may recall that my department consulted on the topics that these requirements should cover while the Bill was being debated. The responses to the consultation informed the drafting of the regulations, and we subsequently consulted on the detailed wording of the requirements. During Committee debates on the Bill, the issues of nutrition and complaints came up a number of times. I am sure that the Committee will be pleased to see that Regulation 14 covers “Meeting nutritional needs” and that Regulation 19 covers “Complaints”.

As set out in the 2008 Act, the Care Quality Commission must issue guidance that sets out how it will judge providers’ compliance with registration, and take this guidance into account in making its decisions. Final drafts of the Care Quality Commission’s Guidance about Compliance, together with the department’s code of practice on healthcare-associated infections, have already been made available to providers to support their preparations for the move to the new system.

The commission’s Guidance about Compliance provides further clarity about how providers can meet the registration requirements. However, we recognise that when it comes to bringing prosecutions, absolute clarity is essential. Regulation 27 therefore puts in place a compulsory mechanism requiring the commission to issue a warning notice prior to commencing prosecution proceedings. This will ensure that a registered person is informed of the conduct that the commission considers constitutes a failure to comply with the regulations. It will also give the registered person the opportunity to remedy the breach within a specified time. If they fail to take such remedial action, the commission will be able to bring a prosecution. I hope the Committee will agree that this achieves the right balance between focusing on the outcomes that matter to service users and providing clarity to providers before prosecution proceedings are taken.

I know that some concerns have been expressed about the size of fine attached to these offences. Failure to comply with any of the safety and quality registration requirements can result in harm to individual patients and service users. Preventing such harm has to be the central purpose of this system of registration. As such, it is right that the maximum fine—I stress, maximum—available to the courts is set at a high level of £50,000. In setting any fines, magistrates will follow current sentencing guidelines and consider, among other things, the seriousness of the offence and the ability of the registered person to pay.

The £50,000 fine applies only to the most serious offences. A further set of regulations subject to the negative parliamentary procedure—the Care Quality Commission (Registration) Regulations 2009—were laid before Parliament in November last year. These set out other requirements that providers of regulated activities must meet, such as statutory notifications of adverse events, and deal with other matters, such as provisions relating to the publication of information on enforcement action. Failure to comply with the requirements in these other regulations is also an offence, with a maximum penalty of level 4 on the standard scale, currently £2,500. The higher maximum penalty of £50,000 applies only to the 16 essential safety and quality requirements in the regulations that we are considering today.

Moreover, noble Lords should note that the Act also gives the commission a range of other enforcement powers to use where providers are not complying with registration requirements. These include the power to suspend or cancel registration, the power to issue a warning notice, the power to issue a fixed penalty notice in lieu of prosecution and the power to attach conditions to a provider’s registration.

These enforcement powers enable the commission to take a flexible and proportionate approach to breaches of registration requirements and mean that people who use services will see prompt and effective regulatory action where providers are failing to comply with the requirements. The Care Quality Commission’s enforcement policy, which has been published, sets out how it intends to use these powers. The new registration system will give the commission a stronger role than under the current regulatory system to ensure that all providers of regulated activities, including the NHS, are providing services that meet central safety and quality requirements. Their tough enforcement powers will enable the commission to take prompt action when providers are not delivering the outcomes that people can rightly expect. I commend the regulations and the order to the Committee.

My Lords, the Committee will be grateful to the Minister for her explanation of these regulations, which, as she said, take us to the next stage of the journey for the Care Quality Commission in setting out the full range of its statutory functions as a regulator of health and social care services. In reading the regulations, as I have, I am struck immediately by the length of the list of regulated activities and, hence, the sheer size of the task that the commission faces. The commission has within it a lot of dedicated and hard-working people, and not all of the activities listed have to be tackled immediately. Dentists and GPs are not to be registered until 2011 or 2012. Nevertheless, I feel that I should start by asking the Minister the simple question of whether the CQC's programme of work to register all relevant providers by 1 April this year or, as the case may be, 1 October, is on track. Is she aware of any hint from the CQC that the commission may find the timetable difficult to meet?

It is a slight pity that the regulations are so difficult to interpret. Perhaps it is just me but, if we look at Schedule 2, we find a list of general exceptions to the regulated activities named in the earlier part of the order. However, paragraph 5 of Schedule 2 sets out a list of exceptions to the exceptions listed in paragraph 4. Paragraph 5(e) even has an exception to the exception to the foregoing exception. I had to think about that one quite hard. But that is not all, because we then have to remember that paragraphs 3, 6, 7, 9 and 11 of Schedule 2 are only exceptions for a limited length of time, as is made clear in Regulation 3 at the beginning of Part 2. I am still unclear whether hyperbaric therapy, which is excepted in Regulation 5 and then de-excepted from the exceptions in Schedule 2, is, or is not to be, a regulated activity.

On a more substantive level, will the Minister explain for the record why defence medical and dental services are not to come under the wing of the CQC and why medical services provided by employers or government departments are not covered?

One of the criteria which the CQC is to use when deciding whether or not to register an individual or a partnership as a registered provider of regulated services is whether the person or persons concerned are of good character and physically and mentally fit to carry on the regulated activity. There are similar requirements in relation to managers and those in charge of organisations other than partnerships. What tests will be used to determine whether someone is of good character, and how do you prove that you are? It does not seem to me that an absence of criminal convictions is sufficient to meet that test. How does a person show that he or she is physically and mentally fit? Unless the guidance on these things is crystal clear, we may be in danger of creating hurdles that are not simply bureaucratic but also highly subjective. That surely cannot be the way to go.

I do not intend to spend time discussing each and every regulated activity. However, there is one activity which perhaps merits special attention, as it is one to which the Minister referred, which we have debated on several occasions in the past—the one listed in Regulation 14, meeting nutritional needs. The regulation is framed in a way that I cannot fault. It speaks of the need to ensure that service users are protected from the risks of inadequate nutrition and dehydration by means of the provision of a choice of suitable and nutritious food and hydration in sufficient quantities to meet service users' needs. My question relates to the standards that the CQC will take as its benchmark for this purpose. There is an initiative in train, which the Minister will know about, called the Healthier Food Mark, to be promoted in public sector organisations. This potentially has a lot going for it, but, unfortunately, in my view, it is flawed.

There are three levels of Healthier Food Marks: bronze, silver and gold. If the idea is to raise the quality of nutrition in hospitals to the highest standard, it is questionable whether having three levels of attainment will serve to achieve that. The CQC is concerned, above all, with upholding minimum standards of quality. It might be thought that a bronze certificate under this initiative served to define what those minimum standards should be. However, the bronze Healthier Food Mark sets standards that, frankly, could be achieved by an organisation that was not doing a great deal. For example, the need to cut down on salt is emphasised only in relation to cooking vegetables without added salt, but there is nothing about making sure that salt levels in other food are reduced. Nor is there any detailed prescription about keeping the level of saturated fat to an acceptable level. There is nothing about portion sizes or offering a choice of drinks without added sugar.

The problem is that anyone seeing a bronze certificate on the wall of a hospital may well conclude that that hospital was achieving a level that was only a rung or two below excellent. What incentive would the hospital have to improve its performance in those circumstances? It would surprise me if the Healthier Food Mark initiative did not in some measure act as a guide or benchmark to the CQC. I should be grateful if the Minister could say something to indicate how the CQC will be approaching its functions in this area.

I would, however, like to move on to a larger set of issues. The Merits Committee of your Lordships' House drew attention to a number of concerns relating to the way in which these regulations have been framed. The first of these is what it saw as a lack of sufficient clarity in the wording to enable someone to decide whether they are or are not in breach of the regulations. To the extent that this criticism is justified, which I believe it may be, it is a serious concern bearing in mind that the maximum penalty for breaching the regulations is set at £50,000, which is a large sum of money. Despite the Minister’s remarks just now, it is not clear why it has been thought appropriate that all breaches of the regulations should potentially attract a penalty of that order. I would like to ask the Minister why it was felt right to set the maximum figure at that level for offences that are not directly to do with harm to patients.

What all this opens up, of course, is the potential for highly subjective judgments to be made by inspectors, which then rebound on service providers. We are told that the regulations have been deliberately framed so as to focus on outcomes rather than process. As a principle, I am all for outcome-based measures; but the problem is that inspectors are powerful people, and if they decide that they wish to be prescriptive in pursuit of a particular outcome, it is likely that few service providers will feel brave enough to argue with them. The Merits Committee has therefore raised the question of how inspectors will be trained and how it will be possible to achieve consistency of assessment around the country. What we cannot have is marked differences of approach being taken, depending on geographical location. This really has to be a concern that the CQC takes seriously, and I should be glad to hear what the Minister has to say about it.

Nor is this a theoretical concern. I have spoken to several people who have already been on the receiving end of the CQC's ministrations. Apart from the rudeness and officiousness encountered in inspectors—which I confess dismayed me—they report something even more serious, which is an overzealous quest for information which has little or no bearing on the quality of care given to patients and service users.

The proprietors of a small outpatient clinic, in order to be registered, had to complete a voluminous form, some of which was barely comprehensible to them, and much of which demonstrated, if proof were needed, that the tick-box, process-driven approach to regulation is alive and kicking. Questions about gas meters and the positioning of electric sockets are not obviously to do with patient outcomes. One doctor who sought advice from a CQC inspector on how to complete a form was told quite candidly that the CQC was collecting a great deal of information that no one there really knew how to interpret.

It is as if questions had been included in the registration form simply to preserve the appearance of thoroughness against the remote risk of a rare adverse event. We can never legislate against the rare event; rare events will happen. They are rare because most professionals are competent. However, in the eyes of the CQC, most professionals are slapdash and need checking up on to make sure that they are achieving basic levels of patient care. One doctor told me that he was almost on his knees with exhaustion after the paperwork between him and the CQC had gone backwards and forwards several times long after his registration had been agreed.

I am afraid that we may have unwittingly created a monster. We are in danger of losing sight of what is common sense. If we are not careful, the result will be that we will land up with a bureaucracy that is effectively out of control. I recount this feedback from service providers only because the stories they have told me are so consistent. The questions with which I leave the Minister are these: will she make it her business to look at first hand at the registration processes employed by the CQC, and will she bring the comments that I have made to the attention of the chief executive?

My Lords, I echo the remarks of the noble Earl in his appreciation of the Minister, who is trying to take us through the regulations. Like him, I have a degree of sympathy for her because of the complexity of the task that she faces. These regulations are by no means straightforward, and the complexity is to be seen not in the number of pages but in the way that they are approached.

I start positively by saying that I am very supportive of and sympathetic to the requirements for professional regulation and the regulation of activities of this kind. In fact, I have spent a good deal of time trying to promote and develop further regulation—for example, in psychological therapies—to which I will return. My colleagues and I are not instinctively against the notion of regulation. I am very supportive of the way that health and social care are being brought together in a relatively integrated way, at least in principle, as far as the regulatory approach is concerned. The integration of health and social care has been a fact in my part of the United Kingdom for many decades, and it has been largely positive for those receiving the care and for the various professionals working together to provide it.

However, from then on, I become rather concerned about the way in which the regulation and the integration are being brought forward. Although it is appropriate to integrate health and social care, it may not necessarily be appropriate to provide precisely the same approach to the regulation of a large National Health Service acute hospital as to that of a small individual practitioner or group of practitioners in a rural area, for example. As the noble Earl has pointed out, the difficulty with this rather monolithic body, the CQC, is that it tends to try to produce an approach to regulation that will fit the large, almost industrial, bodies that are many of our acute hospitals, and then apply it to much smaller entities, for which it is not appropriate.

Paragraphs G48 to G77 on pages 83 to 88 of the impact assessment—no minor document—look at the impact on small providers but there seems to be no appreciation at all that a small provider may often be much better than a larger one. It is all couched in terms of whether the smaller ones can match up to the gold standard of the large NHS provider. From recent events, including situations where the CQC has given a positive report, it is absolutely clear that the fact that it is a large NHS acute hospital which has the CQC check of approval does not necessarily mean high-quality service at all. Sometimes it can be covering something quite different.

I am extremely concerned that a perverse incentive is actively at work, which makes it increasingly difficult for the small provider to survive. The only way in which some of them can survive is by coming together into a larger group, which makes it impossible for them to provide the very personal care that is necessary in some circumstances. Indeed, the level of bureaucracy required is quite extraordinary.

I take one example. Many of these matters are predicated on a large acute NHS hospital because that is where the pressure comes from. Another area mentioned in the regulations is the provision of care for those with alcohol or drug addictions. We spoke about this last week in your Lordships’ House. Increasingly, the NHS is not able to provide the services required and there are many such people for whom the NHS is not necessarily an appropriate facility. There are alcohol-free and drug-free therapeutic communities where people provide care and treatment in quite a different therapeutic community context.

Healthcare workers and providers may not fall under any of the titles in this relatively long list; they may be counsellors or psychotherapists who are not currently registered. The kind of care which they provide can be quite different. For example—I reflect back to when I spent some time working in one of these situations myself—in order for the patients to connect with the real world and take responsibility for themselves, they are required to participate in the preparation of food for themselves and others. Although that is clearly an important and beneficial part of the treatment programme in a therapeutic community, it is made completely impossible by regulations which require them to undergo training in food preparation in order to operate in the kind of facilities appropriate for cooks in a large NHS acute hospital. Those required to undergo various training programmes under supervision are members of professions which are not currently statutorily regulated anyway.

I am very sympathetic to ensuring that there are appropriate standards but I fear that we have now come to a counterproductive point in this process of regulation. The process goes something like this: we add on regulations; inevitably there is a problem somewhere; an inquiry brings forward more regulations; and so the amount of bureaucracy increases. When bureaucracy gets beyond a certain point, those involved feel less sense of responsibility and attend more to ticking the boxes and ensuring that the forms are filled out rather than taking responsibility for themselves. The increasing bureaucracy of regulation leads not to increased responsibility but to a reduction in a sense of responsibility, and therefore problems arise. The more bureaucracy there is, the less attention people give to providing care and the more they attend to feeding the machine. I think that we are very much at this point in the NHS.

The question of fees and money also comes into this matter. The result of the organs inquiry, for example, was that the Government had to completely abandon their requirement for 10 per cent of all deaths in hospital to be audited by way of a post-mortem because no one would give permission for post-mortems after that. However, an organisation had been put into being in order to approve, monitor and regulate all mortuaries, so now mortuaries are having to pay thousands and thousands of pounds every year to be regulated and inspected with smaller and smaller numbers of post-mortems being carried out in them. The point has now been reached where some pathologists will end up qualifying without having done very many post-mortems at all. Therefore, the whole process of regulation and bureaucracy is adversely affecting the work.

Those are the kinds of concerns to which I believe the noble Earl was pointing, and in general terms—and, indeed, in some very specific terms—I share them. One body does not have to mean one approach to regulation; one body could have a number of different approaches if it got into thinking in a different fashion and began to understand that a very different approach was necessary for the small provider in community non-acute services compared with the large provider, such as an NHS hospital providing acute services in surgery, obstetrics and gynaecology or medicine. There would be a question of fees and the problem of fines, and there would be the burden of the increased number of administrative staff that small practices—not necessarily medical practices; others as well—would have to take on in order to service this machine. I think that that presents a real danger.

The one reassurance that I found in this process was when looking at the summary sheet of the impact assessment. The noble Baroness’s right honourable friend in another place, the Minister, Mike O’Brien, says almost as his final comment that within three years there will be a review to monitor how proportionate the burden of regulation is to the mitigation of risks outlined in the impact assessment. Whether it is the noble Baroness, her colleague the Minister, another colleague or another party that ends up supervising that monitoring is of course an open question. However, at least there is an assurance that some review will be undertaken at that point. I mention that specifically because I think it will be important for us to review the whole matter after three years.

My Lords, I think that it would have been enormously helpful to have had the input of the noble Lord, Lord Alderdice, during the passage of the legislation. I can see why at this point this measure might seem more complex than I suspect it is. It is complex because it needs to deal with every different type of provider from the very small to the very large and because it deals with health and social care together. However, it is not complex in that it involves one body which is outcomes-focused. I shall come back to that during the course of answering several of the questions because it is very important to bear that in mind.

During the passage of the legislation, we were aware that the diversity of establishments that came under this regulatory framework meant that you would have to look at what the establishments did rather than their size—you would need to address the outcomes of the services that they were providing.

On the specific questions, the noble Earl, Lord Howe, asked why defence medical services were excluded from the regulations. The reason is that defence medical services are primarily primary care services and so would not come under regulation until further down the road. We have, however, asked the CQC to work with the defence medical services to give an independent assurance of safety, although at the moment that would happen outside registration. It is not that they were forgotten but that their interests are slightly different. I suspect that they may be caught as we move forward towards primary care regulation.

Both the noble Lord and the noble Earl raised the question of fines and asked how the sanctions would work. We believe it is right that a significant maximum fine is available to the courts where providers fail to meet the essential requirements and expose service users to the risk of harm. Of course, as we discussed during the passage of the Bill, £50,000 is a great deal of money for a very small provider. However, £50,000 is not necessarily a great deal of money for a very large health provider, so it is important to have the scale that we need. That is why we have set that maximum.

The noble Earl asked about using the term “fit” in the regulations to allow a provider to be a fit person to deliver that service. The term “fitness” comes from the Health and Social Care Act 2008, under which the requirement regulations are being made. It has been used in regulations for consistency with primary legislation. Reference to fitness in the regulations should be read in conjunction with, and implemented with, all the disability discrimination legislation and, indeed, other legislation relating to that. My understanding is that the references to fitness and the tests which are already in place are not only about a criminal record but are to do with people’s qualifications, background, history and a variety of other data which need to be considered.

The noble Earl also asked how prepared the CQC is and whether it will be overwhelmed—I think that was the expression used. It has of course been preparing for this for some time, as, indeed, have the bodies that came in to form the CQC. This month, the commission will write to all providers moving from the current registration system under the Care Standards Act 2000 to the new system in October 2010, informing them how to apply for registration. The intention is to register people in batches from April to August. For each batch, there will be a four-week application window. The commission will write to all providers before their application window to give them time to prepare. In April, the commission plans to launch an online learning module to guide providers through the application process. Hard copies of How toguides will also be made available to providers, who will be able to contact the commission’s assessors and national contact centre for advice.

The commission’s guidance about compliance will give providers more detail on how it will judge their compliance with the registration requirements. Following on from the remarks about transition, the Care Quality Commission is also responsible for the content of applications for registration under the 2008 Act, so it is making the registration process as easy as possible for providers. However, there will be no automatic passporting through to the new system.

Returning to the question of penalties, the penalty amounts have been set to correspond with the potential impact of any offence on people who use the services. The 16 safety and quality registration requirements set out the essential levels of safety and quality of care that people have a right to expect. Therefore, as I have already said, significant fines are available where providers fail to meet essential requirements.

The noble Earl raised the issue of nutritional needs and made very useful comments about the Healthier Food Mark and the various levels of quality and so on. We will, of course, be assessing registration providers against essential levels of safety and quality. We will be encouraging all providers to provide high-quality services that go well beyond registration requirements. In the case of the NHS, this could be achieved through performance management rather than registration against levels of safety and quality. Therefore, we will be looking for basic levels of safety and quality and then for further activity and progress through levels of bronze, silver and gold.

Both noble Lords raised the issue of bureaucracy. That is an important point, because we would not want this to be an over bureaucratic process. There is always a danger that that can happen, but we are not in the business of creating enormous burdens, particularly on small providers. I hope that, because the system is focused on outcomes and not processes, it will allow providers to meet the requirements in a way that is suitable for their size and the complexity of their services. We anticipate that over a period of time this will reduce the burden on providers, who are already regulated, including small businesses. I take on board the point that the noble Earl made. I undertake to raise with the Care Quality Commission chief executive the points that he made about bureaucracy and to have a look at the forms myself. I have not looked at them in recent times since we did the consultation, but I shall look at them and talk to people and see how they are working. That is a reasonable expectation to place on me.

I believe that I have covered the point about why we want a single set of requirements and why that is a good idea. We hope that the guidance relating to compliance will set out how the commission will judge compliance with registration requirements. It will also set out how we would expect the regulations to be interpreted consistently but how people could ensure that they were being treated fairly and in a consistent fashion. We have to see how that guidance works out, but that is a very important point.

The new registration system’s focus on outcomes is essential to ensuring that providers deliver the care and treatment that people want rather than focusing on processes. We have already discussed that. Under these regulations, if the commission feels that enforcement powers need to be taken in the most serious cases, it must always issue a warning notice under Section 29 of the 2008 Act before prosecuting a provider for breached registration requirements. This is laid out in complete clarity in these orders.

The noble Lord, Lord Alderdice, raised the question of drug and alcohol addiction therapies being provided in small, non-NHS environments. A wide range of services can be described as psychotherapy, as the noble Lord understands. Our analysis of those services shows that the level of risk varies enormously, but the lack of clarity around the definition of the services means that it is difficult to distinguish between them. Proposed changes to professional regulation in this area are expected to bring more clarity to the definition of psychotherapy services provided by people who are not currently in one of the registered healthcare professions. We are keeping those services under review.

I hope that I have answered most of the points raised by noble Lords. If I have not, I shall write.

Motion agreed.