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

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 might 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 to… guides 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 it is 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.