That the Grand Committee do report to the House that it has considered the Health and Social Care Act 2008 (Registration of Regulated Activities) Regulations 2009.

Relevant Document: 3rd Report from the Joint Committee on Statutory Instruments.

Last October we brought into force the legislation to set up the Care Quality Commission—the new single regulator for health and adult social care. The noble Baroness, Lady Young, has given us a daily countdown to CQC kick-off. The draft regulations before us now are part of a package of secondary legislation which will enable the commission to take on its functions from 1 April this year.

Part 1 of the Health and Social Care Act 2008 provides for a new registration system for the regulation of health and adult social care. These regulations are the first step in bringing the NHS into a system of registration for the first time, alongside the independent and voluntary sector and social care providers. At present NHS providers are required to comply with the code of practice for the prevention and control of healthcare-associated infections issued under the Health Act 2006. The regulations before us carry forward the essential requirements of the existing code and place them into the new legislative framework. Regulations 3 and 5 require NHS providers of healthcare to be registered with the commission and to meet a single registration requirement on the protection of persons against identifiable risks of healthcare-associated infections. The regulations cover the same providers that are obliged to comply with the existing code. In January we laid an order enabling the registration process to begin.

Alongside the regulations there is a revised code of practice which sets out the nine compliance criteria and guidance that the commission will use to judge whether registered NHS providers of healthcare are complying with the regulation on HCAI. It will be an offence to fail to comply with the regulation and registered providers may be prosecuted. On summary conviction, this could result in a fine of up to £50,000 for each offence, as set out in these regulations. The Act also gave the commission a range of other enforcement powers to use where providers are not complying with requirements. These include: the power to suspend or cancel registration, the power to issue a warning notice or a fixed-penalty notice, and the power to attach conditions to a provider’s registration. The greater range of enforcement powers enables the regulator to take a more flexible and proportionate approach to breaches of registration requirements. This will benefit patients by encouraging quicker progress in tackling infections. These regulations set out further details in relation to fixed-penalty notices and set the penalties at between £1,250 and £4,000 depending on the offence. A number of administrative matters are also set out, such as the timescale for payment.

Until 2010 the new Care Quality Commission will continue to regulate private and voluntary healthcare providers and adult social care providers under the Care Standards Act 2000. These providers will continue to have to comply with the regulations and national minimum standards under the 2000 Act, which include requirements on infection control. In 2010 the registration system under the 2008 Act will be widened from covering just NHS providers to cover private and voluntary health and adult social care, and with a wider set of safety and quality requirements.

If the registration system is to operate effectively and transparently it is important that the public and commissioners have access to information about services and service providers. These regulations make a number of provisions to ensure that information about the commission’s regulatory action is available and they require the commission to keep a register of persons registered as service providers. The regulations also make a number of provisions requiring the commission to make public information relating to certain enforcement action it has taken. The commission is authorised to make certain other information available.

The Act requires the commission to notify PCTs, local authorities, strategic health authorities, Monitor and anyone else it considers appropriate when it issues certain notices, such as a notice proposing cancellation of registration. However, to ensure that these requirements are not overly burdensome, Regulation 9 sets out certain exemptions from this requirement, such as where notices relate to certain administrative matters such as the process of considering and granting initial applications for registration. Regulation 10 sets out further details about who must be notified.

In carrying out its functions the commission will need to look at documents and information as well as talk to providers and those using the services. The commission will need in the course of carrying out its functions to question people for explanations of any relevant matters. These regulations set out the people who must provide an explanation to the commission if requested to do so. The Act makes it an offence for these persons to fail to comply with a requirement from the commission for an explanation of a matter. The regulations will give the commission a stronger role in relation to the provision of healthcare by NHS bodies and in tackling HCAIs. These are the first in a series of regulations that will be brought before the House to widen the registration system across providers of health and social care services. I commend the regulations to the Committee.

First, perhaps I may apologise to the Minister for being slightly late. I shall of course read the opening sentences of her speech, those that I missed, in Hansard. I thank her for introducing these regulations, but because of the helpful briefing session that she was kind enough to organise a couple of weeks ago, I have only a very few comments and questions.

The CQC’s task of registering all providers of health and social care is a very considerable one, so it is not surprising that the Government have allowed it to be tackled in two stages. The regulations we are looking at provide only for the registration of NHS providers, and then only in relation to a single set of requirements, namely those covering healthcare-acquired infections. It is understood that further registration requirements will be introduced for these NHS bodies next year and that adult social care providers and the independent healthcare sector will also be brought within the scope of the new regime in 2010.

If we focus on this initial round of registrations, the first question that arises is whether there is a performance threshold below which the CQC will simply refuse to register a provider and, if so, what that threshold is. Those may sound like odd things to ask, but if these requirements are to mean anything, surely it is essential that every NHS body should have to demonstrate a minimum acceptable standard of cleanliness and hygiene and an acceptable recent track record in rates of healthcare-acquired infections if they are to qualify for a registration certificate. But what is that standard? The Healthcare Commission in general has done a good job in driving improvements in this area, but we know that a number of NHS trusts have been found seriously wanting in their recent performance on HCAIs. In those cases, what action has the CQC insisted be taken, or what improvements has it insisted on seeing before agreeing to issue a registration certificate? Rather like a game at a fairground where everyone is a winner, are we in practice looking at a 100 per cent success rate in the NHS bodies up for registration? Are any conditional registrations being agreed?

It is important to understand how strict and how stern the CQC is being with providers with a poor track record. We know from the Government’s own figures that MRSA affected around 6,000 people in 2006-07 and C. difficile about 56,000. The numbers may be falling, but they are still very high. Indeed, we would all say that they are unacceptable. It would be helpful to hear from the Minister whether the CQC is simply focusing on the existence of systems within provider trusts, or are they also looking at the quality of those systems in terms of the results actually being achieved?

The second question relates to an issue that is strictly outside the scope of the regulations but which bears closely on them. As I mentioned a moment ago, the registration process for independent sector healthcare providers is being tackled more gradually and the aim is to accomplish that by 2010, at which point those bodies would cease to be subject to regulation under the Care Standards Act 2000. What enforcement powers will the CQC have during that transition period in relation to independent sector healthcare providers and, for that matter, providers of adult social care? Legally speaking, is the CQC fully able to monitor and regulate those bodies during the next 12 months as tightly as we would wish it to do, and does it have the resources to do so?

The CQC has said that it will not hesitate to use the range of enforcement powers at its disposal if it needs to do so. Can the Minister assure the Committee that if in the last resort a provider of healthcare has its registration removed and thereby loses its right to be a provider, safeguards will be in place to protect the quality of patient care during the transition to a new provider? Although the power to issue fines as a penalty for poor service and poor infection control is undoubtedly a strong deterrent, there is in practice a downside to such fines. When NHS bodies are called on to pay fines, they will need to divert money from elsewhere in their budget to do so. In certain circumstances, one could imagine money being diverted from frontline patient care, which is the very opposite of what patients deserve in a situation where, if anything, they need enhanced protection. Will the Minister comment on that and will the CQC bear in mind that, in some situations, the imposition of a fine would run counter to the interests of the NHS organisation and of patients?

Finally, how often will the proposed register of persons providing services be updated and verified? Does the Minister agree that regular and thorough vetting of the list will be important?

I, too, thank the Minister for introducing the regulations and for the very helpful briefing that she and the relevant officials provided to us a couple of weeks ago. There is a degree of interest in this because these are the first of the regulations that will enable us to see just how the Health and Social Care Act 2008 will be implemented and how the CQC will assume responsibility for an area of work that all noble Lords would agree has been carried out extremely effectively by the predecessor bodies. Both the Healthcare Commission and CSCI have in the course of their work and by their reports driven up standards in this area.

I have many of the same questions as the noble Earl, Lord Howe, but I want to ask a few more. Can the noble Baroness define for us what is an offence? Is an offence the same thing as an incidence? Are different incidences of healthcare-acquired infection different offences? If they are, the potential penalties become of a different order. Potentially, they will become a large imposition on what in future will be a much broader range of much smaller providers. Although we tend to think of acute hospitals when we think about healthcare-associated infections, we should not forget that the infections that have been mentioned are prevalent in a lot of social care settings and, in particular, residential homes. If a small-scale provider of residential care ultimately becomes subject in 2010 to the same fine regime as a large acute hospital, that will have a disproportionate effect.

That is the first thing. The second is that I, too, have been thinking about the fact that in 2010 the independent sector will come under this regime. Has the department continued to think on in that vein about what happens if NHS patients exercise their right to seek treatment abroad if they have not been able to receive treatment in the United Kingdom? How do these orders relate to that? Looking to the future, what happens if individual budgets and direct payments bring in a whole tranche of small-scale healthcare providers? Who will regulate them?

This is an interesting order, and I will be interested in the Minister’s response. It is a fair reflection of the legislation that this House passed last year.

I shall tackle the different points raised by the noble Earl and the noble Baroness, Lady Barker. I thank both noble Lords, who have been helpful in the discussions we have had, which I, too, found very useful.

The noble Earl raised the issue of the threshold. The regulations are underpinned by the revised code of practice for the NHS, which I referred to in my speech, on the control of healthcare-associated infections and the related guidance, which was published alongside the draft regulations under the powers given to the Secretary of State by Section 21 of the 2008 Act. This new code sets out the criteria that the Care Quality Commission will use to check that the NHS organisations are complying with the requirements on the prevention and control of HCAIs. As the noble Earl will appreciate, we take that issue seriously. We are not complacent; we are pleased that the numbers of MRSA and C. difficile cases are down, but I agree that the situation will not be satisfactory until they have all gone.

The noble Earl raised the issue of how the CQC will act in assessing providers’ compliance and make decisions. It is doing so right now; it is making decisions on whether it will attach conditions to registration. I imagine that the noble Baroness, Lady Young, has her people hard at work on that right this minute.

On the issue of safeguarding, the enforcement powers will remain those under the Care Standards Act until providers are transferred to the new registration system under the 2008 Act. On the powers to close down healthcare facilities and wards, that is one of the range of interventional powers. The commission will need to consider the risk to patients and others using services of stopping a service against leaving a substandard service open, and it can do that only by liaising with the relevant PCTs and authorities. That is what we would expect it to do.

As I recall, the issue of what would happen to the fines was raised several times during the passage of the Bill. Where fines and penalties are incurred by NHS bodies as a result of a breach of safety requirements, we are working with HM Treasury to find a sensible way of returning the money collected to the local area where it can be reinvested into improving services.

The noble Earl asked how often the register will be updated. The Act allows for it to be live and to be done on an ongoing basis. The noble Baroness, Lady Barker, asked about an offence being a breach of the registration requirements. Of course, issuing a penalty notice is only one of the CQC’s enforcement powers, so it would be for the CQC to choose the most appropriate action in any given situation. As for the independent sector coming under this in 2010 and what will happen if people decide to seek treatment abroad, the CQC’s remit applies only to care in England.

I hope that I have covered all the points raised by noble Lords, but I shall look at what they have said and write to them if I need to provide a more satisfactory or full answer. I thank noble Lords for their comments on these regulations.

Motion agreed.