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TERRITORIAL EXTENT
The Care Quality Commission
90. Part 1 of the Bill extends to England and Wales only, with the exception of two clauses which permit the Commission to make arrangements with Ministers of the Crown and Northern Ireland Ministers to perform certain functions on their behalf. Those two clauses extend 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
91. Much of Part 2 of the Bill has a UK extent. The regulation of most of the healthcare professions is reserved to Westminster, but for some professions this is devolved to the Scottish Parliament, as it will be for professions introduced to regulation in the future. A Legislative Consent Motion is to be lodged in the Scottish Parliament, seeking its agreement that the Bill's provisions which will legislate in devolved areas in respect of provisions relating to the regulation of the healthcare professions should be considered by the UK Parliament. Legislation extends to Northern Ireland by consent.
92. 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.
93. 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, 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
94. Part 3 of the Bill 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
95. Certain of the clauses 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
96. The changes regarding the duty on PCTs to improve the quality of healthcare and funding of pharmaceutical services extend to England and Wales only.
97. The clause on indemnity schemes applies only to England.
Weighing and measuring of children
98. The clauses extend to England and Wales only, giving regulation-making powers for the Secretary of State in relation to England, and Welsh Ministers in relation to Wales.
Social care
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 clauses 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 clause extends to the UK.
Consent of the Scottish Parliament
104. At Introduction this Bill contains provisions that trigger the Sewel Convention. They are as follows:
- The requirement that all the regulators of healthcare professions apply the civil rather than the criminal standard of proof in their consideration of fitness to practise cases. Two of the regulators - the Health Professions Council and the General Dental Council - regulate professions which include professions for which regulation is devolved.
- The powers for the Scottish Ministers to request advice from the Council for Healthcare Regulatory Excellence on any matter connected with a profession appearing to be a health care profession, and to require the Council to investigate and report on a particular matter. The regulation of some professions is devolved.
- The provisions for consultation on draft section 60 Orders with all relevant representatives of the professions being regulated. The regulation of some existing professions, and the future regulation of any "new" professions, are devolved.
- The provision that only the regulatory bodies and the new Office of the Health Professions Adjudicator can administer procedures relating to misconduct, unfitness to practise and similar matters. Two of the regulatory bodies operate in devolved as well as reserved areas.
- The provisions that allow Orders made under section 60 of the Health Act 1999 to amend or repeal enactments, including Acts of the Scottish Parliament. Where this is not merely incidental to, or consequential on, provision that (if so included) would be outside the competence of the Scottish Parliament, such an Order would be laid before, and approved by resolution of, the Scottish Parliament and where it is not, such an Order would not be laid before the Scottish Parliament but the Secretary of State must consult the Scottish Ministers on the proposed amendment.
- The provisions relating to the regulation of pharmacists and, under the Medicines Act 1968, pharmacy premises. The function of enforcing the Medicines Act is devolved to the Scottish Ministers.
- The repeal of the provision in the Health Act 1999 which prevents Privy Council functions from being exercised by a different person. This will facilitate changes intended to be made in subordinate legislation to put in place new arrangements in various areas where Privy Council involvement is no longer considered to be necessary. This will affect all the regulators, including those operating in devolved areas.
105. The Sewel Convention provides that Westminster will not normally legislate with regard to devolved matters in Scotland without the consent of the Scottish Parliament. If there are amendments relating to such matters which trigger the Convention, the consent of the Scottish Parliament will be sought for them.
Territorial application: Wales
The Care Quality Commission
106. The functions of MHAC under the Mental Health Act are transferred to the Commission in relation to England and to Welsh Ministers in relation to Wales.
Regulation of Health Professions and Health and Social Care Workforce
107. The clauses on the regulation of the social care workforce apply to England and Wales. However, regulations will be made in both territories independently by the appropriate Minister.
Public Health Protection
108. The public health protection clauses apply to England and Wales. However, regulations will be made in both territories independently by the appropriate Minister.
Weighing and measuring of children: Wales
109. Clause 133 gives Welsh Ministers the power to lay regulations in relation to Wales.
Social Care
110. The extension of direct payments covers Wales to the same extent as section 57 of the Health and Social Care Act 2001 does now. However, subsection (8) of clause 134 amends section 64 of that Act to enable the National Assembly for Wales to pass a resolution annulling any statutory instrument containing regulations made by the Welsh Ministers under section 57.
National Information Governance Board for Health and Social Care
111. It is intended that the functions of the National Information Governance Board in relation to Wales will be the same as those of PIAG conferred by section 252 of the National Health Service Act 2006.
PART 1 - THE CARE QUALITY COMMISSION
CHAPTER 1 - INTRODUCTORY
Clause 1: The Care Quality Commission
112. Clause 1 establishes the Commission and abolishes CHAI, CSCI, and MHAC. It also gives effect to Schedule 1.
Schedule 1: The Care Quality Commission
113. 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 delegate this function to the Appointments Commission.
114. Paragraph 6 requires the Commission to establish an advisory committee whose advice and information it must have regard to 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 the providers and users of health and social care services. 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.
115. Paragraphs 9 and 10 deal with payments, loans and 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.
116. Paragraphs 11 and 12 set out arrangements for the application of the Commission's seal and for documents purporting to be signed or sealed by or on behalf of the Commission to be accepted as evidence in court.
Clause 2: The Commission's functions
117. Clause 2 sets out the main areas in which the Commission has functions, and things it should have regard to in performing its functions. These include requirements for the Commission to have regard to:
- the need to safeguard the rights of children and vulnerable adults;
- the public's views on activities that fall within the remit of the Commission;
118. The clause requires the Commission to perform its functions for the general purpose of encouraging improvement in the activities within its remit.
Clause 3: Transfers of property, rights and liabilities
119. This clause gives effect to Schedule 2.
Schedule 2: Transfers of property and staff etc.
120. 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 further include the transfer of 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
Clause 4 and clause 5: Introductory
121. Clause 4 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) sets out initial proposals for the broad types of activities that will be regulated activities. There will be a further consultation on the types of activities to be regulated, and the registration requirements to be made under clause 16 during the passage of the Bill through Parliament.
122. Subsection (2) of clause 4 sets out 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.
123. Subsection (3) of clause 4 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.
124. Clause 5 defines the terms 'health care' and 'social care' for the purposes of Part 1 of the Bill. The provision of some cosmetic procedures is included in the definition of health care.
Clauses 6-8: Registration of persons carrying on regulated activities
125. Clause 6 concerns the requirement for a person to register in respect of the carrying on of a regulated activity (referred to as a "service provider"). A person in this context means a legal 'person', which includes a company. Where more than one legal person is involved in carrying on the activities, regulations may set out who will be classed 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.
126. Under clause 6, 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. The Department of Health intends to liaise with the Sentencing Guidelines Council with a view to issue guidelines as to how the courts should exercise their discretion in sentencing.
127. 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.
128. Clause 7 sets out the process for applying to register with the Commission. Under clause 7, a person required to register to carry on any of the activities set out in regulations under clause 4 will have to apply to the Commission, providing such information as the Commission determines is necessary.
129. 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.
130. Clause 8 deals with the grant or refusal of registration. Under clause 8, 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 clause 16, 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 clause 4 (referred to in this legislation as a 'service provider') will receive a certificate of registration.
131. In granting registration as a service provider, the Commission can impose any conditions it thinks are necessary. These conditions may include restrictions on the types of services that a service provider may provide and where they may provide them. For example, the Commission will be able to impose conditions on the provision of care in residential homes specifying the categories of users of services and the number of residents that may be accommodated.
132. 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 that the provider can only operate from three specified sites. If the service provider is required to appoint a registered manager under clause 9, 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 applied. 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
Clauses 9-11: Registration of managers
133. Clauses 9 - 11 deal with when a service provider must 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.
134. Regulations will set out when 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.
135. 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 them.
136. 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. Registered managers will be responsible for ensuring that the activities they manage comply with relevant requirements in the same way the service provider will be.
137. Under clause 11, 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 clause 16, 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.
138. 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
Clause 12: Regulations about registration
139. Clause 12 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 keep 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.
Clauses 13 and 14: Cancellation / suspension of registration
140. Clause 13 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;
- any other grounds that are specified in regulations apply.
141. The clause defines relevant offences as:
- offences under this Part 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 may be prescribed.
142. 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. Regulations may also make provision for registration to be cancelled where a person ceases to carry on or manage regulated activities.
143. 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, 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 clause 29) and fails to remedy the breach, the Commission could then cancel the person's registration.
144. The Commission will also have the power to suspend a person's registration as a service provider or a manager under clause 14 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 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.
Clause 15: Applications by registered persons
145. Clause 15 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); to voluntarily 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).
146. It is not, however possible for a service provider to apply to change any mandatory condition imposed as a result of regulations made under clause 9 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)).
147. If the Commission decides to grant an application to change conditions of registration, amend or lift a suspension, it must write to the applicant to inform them of their decision, setting out how the conditions or suspension have changed and, if relevant, issue a new certificate of registration (subsections (5) and (6)).
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