Part 6 - General

87.     Part 6 provides for the territorial extent of the provisions of the Act and lays down the Parliamentary procedure which applies to orders and regulations made under powers contained in the Act. It also provides for the provisions of the Act to come into force in accordance with orders made by the Secretary of State (or by the Welsh Ministers in relation to a number of provisions in so far as they apply to Wales, or by the Department of Health, Social Services and Public Safety in Northern Ireland ('DHSSPSNI') in relation to a number of other provisions in so far as they relate to Northern Ireland, or by the Treasury in relation to Part 4). It confers power on the Secretary of State to make transitional, transitory, supplementary, incidental or consequential provision or savings by order. Power is also conferred on the Welsh Ministers to make transitional or transitory provision or savings in relation to those provisions of the Act which they have the power to commence.

OVERVIEW OF THE STRUCTURE

88.     Part 1 of the Act establishes a new regulator for health and adult social care services in England that will also take on the role (with the Welsh Ministers) of monitoring and other functions under the Mental Health Act. Part 2 contains changes to the regulation of health professions and the health and social care workforce. Part 3 amends the Public Health Act 1984. Part 4 creates a new payment for expectant mothers in the UK, to contribute towards the cost of a healthy lifestyle, including diet, during the final weeks of pregnancy and to help women to afford the other additional costs faced at this time. Part 5 of the Act makes various provisions regarding the National Health Service, the NCMP, social care, financial assistance related to the provision of health and social care services, the establishment of the National Information Governance Board, and the functions of the Health Protection Agency in relation to biological substances. Part 6 makes general provision about the Act.

TERRITORIAL EXTENT

The Care Quality Commission

89.     Part 1 of the Act extends to England and Wales only, with the exception of three sections, namely the general interpretation section and the sections which permit the Commission to make arrangements with Ministers of the Crown and Northern Ireland Ministers to perform certain functions on their behalf. The general interpretation section has a UK extent. The other two sections extend respectively to the whole of the UK (in the case of Ministers of the Crown) and to England and Wales and Northern Ireland (in the case of Northern Ireland Ministers).

Regulation of Health Professions and Health and Social Care Workforce

90.     Much of Part 2 of the Act has a UK extent.

91.     The provisions for the regulation of the social care workforce extend to England and Wales only. The regulation-making powers will enable the Secretary of State to make regulations in relation to England, and the Welsh Ministers to make regulations in relation to Wales.

92.     The provision about the conferral of functions on responsible officers in relation to the regulation of medical practitioners extends to the whole of the UK. The provision enabling certain additional functions to be conferred on responsible officers extends to England and Wales and Northern Ireland only, whilst that enabling a duty to be imposed on healthcare organisations to co-operate extends to England and Wales only.

Public Health Protection

93.     Part 3 of the Act has the same extent as the Acts which it amends. In particular, the Public Health Act 1984 extends to England and Wales only.

Health in Pregnancy Grant

94.     Certain of the sections in Part 4 extend to England and Wales and Scotland only, others extend to Northern Ireland only and others have a UK extent.

Amendments relating to National Health Service

95.     The changes regarding the duty on PCTs to improve the quality of healthcare and about funding of pharmaceutical services extend to England and Wales only.

96.     The section on indemnity schemes applies only to England.

Weighing and measuring of children

97.     These sections extend to England and Wales only, giving regulation-making powers to the Secretary of State in relation to England, and the Welsh Ministers in relation to Wales.

Social care

98.     The provision modifying the application of the Human Rights Act 1998 extends to England and Wales, Scotland and Northern Ireland.

99.     The extension of direct payments extends to England and Wales only.

100.     The changes to the National Assistance Act 1948 extend to England and Wales only.

Financial assistance related to provision of health or social care services

101.     These sections extend to England and Wales, but apply only in relation to social enterprises providing services in England.

National Information Governance Board for Health and Social Care

102.     The National Information Governance Board will operate in England and Wales only.

Functions of the Health Protection Agency in relation to biological substances

103.     This section extends to the UK.

Territorial application: Wales

104.     The Annex to these Explanatory Notes describes the effect of the Act on Wales and provides a table of new functions conferred on the Welsh Ministers.

PART 1 - THE CARE QUALITY COMMISSION

CHAPTER 1 - INTRODUCTORY

Section 1: The Care Quality Commission

105.     Section 1 establishes the Commission and abolishes CHAI, CSCI, and MHAC. It also gives effect to Schedule 1.

Schedule 1: The Care Quality Commission

106.     Schedule 1 deals with the constitution of the Commission. Paragraphs 1 and 2 set out its status and general powers and duties. Paragraphs 3 to 5 relate to the appointment and remuneration of the Commission's members and employees. In particular, paragraph 3 provides that the appointment of the chair and other members of the Commission will be carried out by the Secretary of State. It is expected that the Secretary of State will appoint the chair following pre-appointment scrutiny by Parliament, in line with proposals in the Government Green Paper on the Governance of Britain, but will delegate appointment of other members to the Appointments Commission under the Health Act 2006. In appointing the chair and other members of the Commission, the Secretary of State is required to ensure that, collectively, they include people with experience and knowledge relating to health care, social care and the Mental Health Act. Such experience and knowledge could, as an example, include experience a person has gained by involvement with groups who represent service users or carers.

107.     Paragraph 6 requires the Commission to establish an advisory committee, and to have regard to the advice and information provided by it when deciding how it should exercise its functions. The purpose of this provision is to ensure that the Commission takes account of the views of those with an interest in its work, such as those with relevant expertise in the provision of health or social care. Paragraph 7 enables the Commission to arrange for any of its committees (but not the advisory committee), sub-committees, members or employees or any other person to exercise any of its functions. Paragraph 8 enables it to arrange for persons to assist in the exercise of its functions.

108.     Paragraphs 9 and 10 deal with payments and loans to the Commission and its accounts. The Commission may only borrow money from the Secretary of State. It is required to produce annual accounts and provide copies to the Secretary of State, and the Comptroller and Auditor General. The Commission's annual accounts will also cover its functions under the Mental Health Act.

109.     Paragraphs 11 and 12 set out arrangements for the application of the Commission's seal and provide for documents purporting to be signed or sealed by or on behalf of the Commission to be accepted as evidence in court.

Section 2: The Commission's functions

110.     Section 2 sets out the main areas in which the Commission has functions. It also makes reference to functions the Commission may have under other enactments. This could include, for example, functions it is intended that it will have for monitoring the application of new Deprivation of Liberty Safeguards under the Mental Capacity Act 2005, functions under regulations under the European Communities Act 1972 relating to medical exposure to ionising radiation, or functions that other bodies may, by agreement, delegate to the Commission.

Section 3: The Commission's objectives

111.     Section 3 provides that the main objective of the Commission, in carrying out its functions, is to protect and promote the health, safety and welfare of people who use health and social care services. It also requires the Commission to perform its functions for the general purpose of encouraging: improvement in the activities within its remit; a focus on the needs of patients and other service users; and the efficient and effective use of resources. Subsection (3) provides a definition of health and social care services, which applies throughout Chapter 1.

Section 4: Matters to which the Commission must have regard

112.     Section 4 sets out the matters to which the Commission should have regard in performing its functions. These include requirements for the Commission to have regard to:

• the experiences of people who use health and social care services and their families and friends;

• views expressed by members of the public about health and social care services, or on their behalf by representative bodies, such as charities, and views expressed by Local Involvement Networks about the provision of health and social care services in their areas;

• the need to protect and promote the rights of people who use health and social care services including, in particular, the rights of children and the rights of people detained under the Mental Health Act or deprived of their liberty under the Mental Capacity Act 2005;

• the Government's five principles of good regulation (as set out in the Legislative and Regulatory Reform Act 2006), under which regulatory activity should be proportionate, accountable, consistent, transparent and targeted where it is needed;

• such aspects of Government policy as may be directed.

Section 5: Statement on user involvement

113.     Section 5 requires the Commission to publish a statement on user involvement, following consultation with such people as the Commission considers appropriate. The statement must include the Commission's proposals for promoting awareness among service users and carers of its functions and for engaging in discussion with them both about the provision of health and social care services and about the way in which the Commission exercises its functions. It must also set out the Commission's proposals for ensuring that proper regard is had to the views expressed by service users and carers and for arranging for any of its functions to be exercised by, or with the assistance of, service users and carers. The Commission is free to revise the statement from time to time but must consult again on any revision and publish the revised version. The Commission is required to report, as part of its annual report to Parliament under section 83, on the steps it has taken to implement the proposals in its statement on user involvement.

Section 6: Transfers of property, rights and liabilities

114.     This section gives effect to Schedule 2.

Schedule 2: Transfers of property and staff etc.

115.     Paragraph 1(1) of Schedule 2 enables the Secretary of State to make transfer schemes in order to transfer the property, rights and liabilities of CSCI and CHAI to the new Commission or to the Crown. It also enables transfer schemes to be made for the transfer of property, rights and liabilities of MHAC to the new Commission, to the Welsh Ministers or to the Crown. Transfer schemes may also transfer property, rights and liabilities of the Crown to the new Commission. Paragraphs 3 and 4 set out matters in relation to the transfer of staff to the new Commission.

CHAPTER 2 - REGISTRATION IN RESPECT OF PROVISION OF HEALTH OR SOCIAL CARE

Introductory

Sections 8 and 9: Introductory

116.     Section 8 enables regulations to be made to define what kind of health and social care activities will trigger the requirement to register with the Commission. These activities are to be known as regulated activities. Anybody who carries on a regulated activity will have to be registered. The Government publication "The future regulation of health and adult social care in England" (published November 2006) set out initial proposals for the broad types of activities that will be regulated activities. Subsequent to this, the Government published "A consultation on the framework for the registration of health and adult social care providers" (published March 2008), on the types of activities to be regulated, and the registration requirements to be imposed under section 20.

117.     Subsection (2) of section 8 provides that an activity must involve or be connected with the provision of health or social care in, or in relation to England, in order to be defined in regulations as a 'regulated activity'. In addition it must not involve the provision of care which is regulated by CIECSS.

118.     Subsection (3) of section 8 explains further the sorts of activities that are to be considered as being connected with the provision of health or social care. These might include the supply of nursing or care home staff, transport services for elderly or disabled people, and healthcare advice provided by phone.

119.     Section 9 defines the terms 'health care' and 'social care' for the purposes of Part 1 of the Act. The definition of health care includes provision of cosmetic procedures that are similar to procedures that might be provided in relation to a medical condition. It also includes public health services that provide health care to individuals. For example, this might include smoking cessation clinics, or sexual health clinics.

Registration of persons carrying on regulated activities

Sections 10 to 12: Registration of persons carrying on regulated activities

120.     Section 10 concerns the requirement for a person (referred to as a "service provider") to register in respect of the carrying on of a regulated activity. A person in this context means a legal 'person', which includes a company. Where two or more legal persons are involved, in different capacities, in carrying on the activities, regulations may set out who will be treated as the service provider. It is intended that this will be the person responsible for ensuring the service complies with the requirements laid out in this (and any other relevant) legislation.

121.     Under section 10, carrying on regulated activities without being registered will be an offence. For example, assuming that these were regulated activities, this might cover providing personal care services or carrying on a dialysis unit without being registered with the Commission to provide these services. Subsection (4) provides for the offence to be triable either way (by a magistrate's court or a Crown Court) and sets out the maximum penalties. The penalty on summary conviction is a fine of up to £50,000 or up to 12 months imprisonment, or both. The penalty on conviction on indictment is an unlimited fine or up to 12 months imprisonment, or both. It is intended that the Sentencing Guidelines Council should issue guidelines as to how the courts should exercise their discretion in sentencing.

122.     Section 281(5) of the Criminal Justice Act 2003 extends the maximum term of imprisonment on summary conviction from 6 months to 12 months. For offences that occur before that section is commenced the maximum term of 6 months will still apply.

123.     Section 11 sets out the process for applying to register with the Commission. Under section 11, a person required to register to carry on any of the activities set out in regulations under section 8 will have to apply to the Commission, providing such information as the Commission determines is necessary.

124.     The Commission may allow an applicant to make a single application to register to provide more than one type of regulated activity. For instance, NHS Trusts provide a wide range of activities. They will have to register separately in relation to each kind of regulated activity they provide, but could do so in one application.

125.     Section 12 deals with the grant or refusal of registration as a service provider. Under section 12, the Commission can only register an applicant if it is satisfied that the applicant is meeting, and will continue to meet, the requirements the Secretary of State has set down in regulations under section 20, as well as any other legislative requirements the Commission considers are relevant. The burden of proof is with the applicant rather than with the Commission. Anyone registered by the Commission to carry on any of the activities covered in regulations under section 8 will receive a certificate of registration.

126.     In granting registration as a service provider, the Commission can impose any conditions it thinks are necessary. Conditions may limit the types of services that a service provider may provide and where they may be provided. For example, the Commission will be able to impose conditions on the provision of care in residential homes, the effect of which would be to specify the categories of users of services and the number of residents that may be accommodated.

127.     The Commission may also impose a specific condition to take account of the circumstances of a particular case. For example, there might be a condition, the effect of which is that the provider is only permitted to operate from three specified sites. If the service provider is required under section 13 to appoint a registered manager, then this would also be a condition of their registration. The Commission can change the conditions of a service provider's registration at any time, which would allow additional conditions to be imposed. For example, there might be a condition requiring a particular hospital ward to be closed, or a restriction preventing further admissions until a breach of registration requirements has been corrected.

Registration of managers

Sections 13 to 15: Registration of managers

128.     Sections 13 to 15 provide that in certain circumstances a service provider can be required to appoint a registered manager to manage certain regulated activities which the service provider is registered to provide. They also set out the process for applying to register as a manager and how the Commission decides whether to grant or refuse registration.

129.     Regulations can set out cases where the registered service provider will be required to appoint a registered manager. The Commission will also have discretion to determine whether a registered manager should be required in other instances. The factors the Commission must take into account when exercising this discretion will be set out in regulations made by the Secretary of State.

130.     A service provider might still decide to appoint a manager in instances where he is not obliged to do so. Under those circumstances, there is no requirement for the manager to be registered with the Commission and the Commission will have no power to register anyone as manager.

131.     As with service providers, applications to register as a manager with the Commission will have to include such details as the Commission requires. The Commission may allow someone to make one application to manage more than one kind of activity carried on by a service provider. A registered manager will be responsible, in the same way as the service provider, for ensuring that the regulated activity in question is carried on in compliance with relevant requirements.

132.     Under section 13, the Commission is only obliged to register a manager if it is satisfied that the applicant is managing, or will be managing, services that meet, and will continue to meet, the requirements the Secretary of State has set down in regulations under section 20, as well as any other legislative requirements the Commission considers are relevant. The burden of proof is with the applicant rather than with the Commission. Anyone registered as a manager by the Commission will be issued with a certificate of registration.

133.     In granting registration as a manager, the Commission can impose any conditions it thinks are necessary. Where relevant, conditions that apply to the service provider will also apply to the manager but there may be additional conditions which are specific to the registered manager. The Commission can change conditions imposed on a manager's registration in the same way it can for a provider's registration.

Further provision about registration as a service provider or manager

Section 16: Regulations about registration

134.     Section 16 provides a power to make regulations on the details of the registration process. Regulations may be made under paragraph (a) to set out what information the Commission needs to include on the register. Although the Commission will determine what must be included in applications to register, regulations may be made under paragraphs (b) and (c) to cover issues such as requirements to attend interviews or to notify the Commission of any relevant change in circumstances following the submission of the application. Under paragraph (d), regulations may set out requirements for registered persons to provide the Commission with an address for the service of documents.

Sections 17 and 18: Cancellation / suspension of registration

135.     Section 17 gives the Commission the power to cancel the registration of a manager or service provider where:

• the person registered has been convicted of or admitted a relevant offence;

• any other person has been convicted of a relevant offence in relation to the regulated activity;

• the regulated activity is being or has been carried on in any way that is not in accordance with the conditions of registration or requirements under Chapters 2 or 6 or requirements under other legislation which the Commission considers to be relevant.

136.     The section defines relevant offences as:

• offences under Part 1 of the Act or regulations made under it;

• offences under the Registered Homes Act 1984 or Part 2 of the Care Standards Act 2000 (or regulations made under them);

• such other offences as the Commission considers to be relevant.

137.     Further grounds for cancelling registration may be specified in regulations. For instance, regulations may require that all staff receive appropriate training in handling medicines, and state that failure to provide this training would be grounds for cancellation.

138.     Cancellation of registration would not normally be the first step in formal enforcement action. It is more likely to be used where other actions, such as issuing a warning notice or penalty notice or prosecution for an offence, have failed to ensure compliance, though this will depend on the severity of the breach. If a registered service provider or manager is convicted of a relevant offence, such as breaching a condition of registration (an offence under section 33) and fails to remedy the breach, the Commission could then cancel the person's registration.

139.     The Commission will also have the power to suspend a person's registration as a service provider or a manager under section 18 for a fixed period of time if they are failing to comply with the requirements of Chapter 2, or a requirement imposed by or under Chapter 6, or requirements of any other relevant legislation. In this instance the person would continue to be registered but could not carry on or manage the regulated activities in respect of which they are registered until the end of the suspension. Neither could they hold themselves out as being registered to carry on these activities.

140.     Under section 17 the Commission must cancel the registration of a manager in respect of a regulated activity where there is no longer a registered service provider in respect of that activity, or a registered manager condition ceases to apply to the registration of the service provider.

Section 19: Applications by registered persons

141.     Section 19 enables registered service providers and registered managers to apply: to change the conditions of their registration (for example to change the number of people they are registered to accommodate); voluntarily to cancel their registration (for example, if they plan to close or sell the business); or to amend or lift any suspension of their registration (for example, if they believe they can demonstrate that they are once again complying with any relevant requirements).

142.     It is not, however, possible for a service provider to apply to change any mandatory condition imposed as a result of regulations made under section 13 requiring him to appoint a registered manager (subsection (1)(a)). Neither is it possible for either a service provider or a manager to apply to voluntarily cancel their registration if the Commission has given notice that it intends to, or has decided to, cancel it already (subsections (2) and (3)).

143.     If the Commission decides to grant an application to change conditions of registration or to amend or lift a suspension, the Commission must write to the applicant to inform the applicant of its decision, setting out how the conditions or suspension have changed and, if relevant, issue a new certificate of registration (subsections (5) and (6)).