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

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 express. I commend the regulations and the order to the Committee.