House of Commons - Explanatory Note

Health And Social Care Bill - continued	House of Commons

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Regulation, code of practice and guidance

Clauses 16-21: Requirements in relation to regulated activities

148. Clauses 16 - 21 provide for regulations to be made setting out the detailed requirements to be met by providers and managers of regulated activities. They also provide for a Code of Practice and guidance to be issued about how compliance with those requirements will be assessed by the Commission.

149. Subsection (1) of clause 16 gives the Secretary of State a general power to make regulations imposing any requirements he sees fit in relation to regulated activities. He is obliged to consult on these regulations or any significant change to them (subsection (8)).

150. The regulations made may, in particular, include provision intended to safeguard the health, safety and welfare of people who receive regulated health and adult social care, and to ensure that those services are of the necessary quality (subsection (2)).

151. Subsection (3) sets out specific issues which any regulations made under this clause may deal with. It provides for regulations to be made which set out who are fit people to register as service providers or managers, including requirements relating to the financial solvency of service providers. It also provides for regulations to be made which set out who may be considered to be fit to deliver regulated activities. For example, there may be requirements regarding their management and training.

152. Regulations may cover issues such as the use of appropriate premises. They may also make provision about the way in which a regulated activity is carried on.

153. The regulations may also cover issues relating to the recipients of regulated activities, such as requirements regarding the appropriate use of control and restraint, or the provision of information.

154. They may also cover more practical issues around record keeping, accounting, arrangements for dealing with and learning from complaints and disputes, and may require registered providers to prepare and make available to the public a report about the review of the quality of services they offer, and information about charges made for those services.

155. Subsection (5) enables regulations to include requirements for preventing and controlling health care associated infections ('HCAIs') such as MRSA and Clostridium difficile. These will cover the steps that service providers and managers must take to safeguard people using or providing health and social care services from such infections.

156. Under clause 17 the Secretary of State may also issue a code of practice about compliance with the requirements relating to the prevention and control of HCAIs. This code will replace the code that NHS bodies currently follow (issued under sections 47A-47C of the Health and Social Care (Community Health and Standards) Act 2003, as amended by the NHS Act 2006). The new code will apply to all regulated activities, rather than only those carried out by NHS bodies. Clause 18 sets out the consultation process that the Secretary of State must follow when preparing to issue the code of practice, or revisions to it.

157. For the rest of the requirements set out in the regulations made under clause 16 the Commission must issue guidance on how service providers and managers should demonstrate compliance with them (clause 19). The guidance can also relate to requirements in other legislation that the Commission believes to be relevant. For instance, it is intended that it will cover requirements imposed on relevant providers in the Mental Health Act for which the Commission will take on responsibility. Clause 20 sets out the consultation process that the Commission must follow when it proposes to issue or revise guidance on compliance with requirements.

158. Under clause 21 the Code of Practice on infection control, and the Commission's guidance on compliance with other registration requirements have to be taken into account by the Commission when it takes decisions such as:

whether or not a person is fit to be registered;

whether they are complying with the conditions of their registration;

whether they are complying with the requirements in regulations under clause 16;

whether it should suspend or cancel someone's registration;

whether to prosecute someone;

other decisions that it will make under the Chapter on registration in respect of health or social care.

159. The Code of Practice and the Commission's guidance must also be taken into account in decisions such as the urgent cancellation of a person's registration under clause 26, or in appeal proceedings.

160. Although a failure to comply with either the Code of Practice or the Commission's own guidance does not in itself constitute an offence, they may both be used as evidence in criminal or civil proceedings as examples of what is expected behaviour in the areas they cover.

Registration procedure

Clauses 22 and 23: Notices of proposals and rights to make representations

161. Clause 22 requires the Commission to give written notice to applicants or registered persons of any proposal in relation to the:

granting of an application for registration which is subject to conditions that have not been agreed with the applicant (this excludes a registered manager condition required under clause 9(1));

refusal of an application for registration;

cancellation of registration (except where the registered person has applied for cancellation of registration under clause 15, or the Commission has applied for an order to urgently cancel a registration under clause 26);

suspension of registration (except where the Commission has urgently suspended a registration under clause 27);

amendment of the conditions of registration (except where the Commission has urgently varied a condition or imposed an additional one under clause 27);

refusal of an application by a provider or manager of regulated activities made under clause 15(1) to vary or remove a condition, cancel their registration, or cancel or vary a period of suspension.

162. The written notice must set out the reasons for the proposal (subsection (6)). For example, in the case of a person applying to register for the first time, the notice of proposal must explain why the Commission takes the view that the person does not meet the relevant requirements or why particular conditions are thought to be necessary. Clause 22 does not apply where the Commission decides to grant an application for registration unconditionally. Neither does it apply where the registration is subject only to a registered manager condition under clause 9(1) or where the Commission and the service provider have already agreed the conditions (this must be by way of a written agreement). These situations are covered by clause 24.

163. Clause 23 sets out that a notice of proposal under clause 22 must state that the person has 28 days to make written representations to the Commission if they wish to dispute the Commission's proposal. This ensures that the person has an opportunity to make their point known. The Commission cannot make a decision until it has either received written representations, or it has received written confirmation that the person does not intend to make representations, or the 28-day period has elapsed.

Clause 24: Notice of decisions

164. Clause 24 requires the Commission to give the applicant notice of its decision to grant an application unconditionally, or subject only to a registered manager condition under clause 9(1) and/or conditions already agreed with the applicant (subsection (1)). The notice must state the conditions (subsection (2)).

165. Where the Commission has decided to give effect to a proposal of which notice was previously given under clause 22, subsection (3) requires the Commission to serve a further notice in writing of its decision.

166. The notice must explain the rights of appeal conferred under clause 28. In the case of a decision to grant an application subject to conditions, or to vary the conditions of an existing registration, the notice must set out the conditions, or the changes to them. In the case of a decision to suspend registration, the notice must state the period of the suspension (subsection (4)).

167. A decision made by the Commission under clause 24 to adopt a proposal of which notice has been given under clause 22 will take effect, either from the date that the Commission receives notice that the provider does not intend to appeal, or after the outcome of any appeal has been determined or the appeal has been abandoned, or after 28 days if no appeal is brought.

Clause 25: Warning notice

168. Clause 25 allows the Commission to give a warning notice to a registered person when they have failed to comply with the relevant requirements. For example, the Commission may issue a warning notice where a registered person has failed to comply with regulations made under clause 16.

169. The warning notice must set out the failure that appears to the Commission to have taken place and the requirement that appears to have been breached. It may also require the registered person to comply with the requirement within a specified timeframe, stating that further action may be taken if the failure is not put right in that time. No further action may be taken by the Commission in relation to the failure set out in the notice if the failure is remedied in that time.

170. Where the warning notice relates to a failure that has already been rectified when the notice is issued, no further action may be taken by the Commission.

Clause 26: Urgent procedure for cancellation

171. Under clause 26 the Commission may apply to a justice of the peace for the immediate cancellation of registration (known as the 'urgent procedure'). The order may only be made where it appears to the justice of the peace that there is a serious risk to a person's life, health or well-being unless the order is made. An order made under this section will have immediate effect.

172. Subsection (3) requires the Commission to notify the relevant local authority and/or the relevant PCT in accordance with regulations, if it makes an application to a justice of the peace under the urgent procedure. This is necessary so that the relevant bodies can comply with their statutory duties (for example, in the case of a local authority, to provide or arrange alternative care for service users in accordance with their duties under section 47(1) of the National Health Service and Community Care Act 1990). The relevant bodies will need to consider whether to make alternative provision for services.

173. Where the Commission makes an application under the urgent procedure regarding the registration of an NHS Trust, the Commission must notify the relevant Strategic Health Authority. If the urgent procedure will affect an NHS Foundation Trust, the Commission must notify the Independent Regulator of NHS Foundation Trusts ('Monitor'). The Commission must also notify any other persons it considers appropriate. It is important that all bodies that may be affected by the cancellation of a provider's registration have as much notice as possible to make any necessary arrangements. As soon as possible after an order is made, the Commission must provide a copy of the order to the registered person, and details of their rights of appeal under clause 28.

Clause 27: Urgent procedure for suspension or variation

174. Clause 27 allows the Commission to immediately suspend, or extend the period of suspension of, a person's registration as a service provider or registered manager, or vary or impose a condition, where it believes that any person will, or may be exposed to the risk of harm. Notice of the decision must be in writing and state either the reasons for the variation of a condition, or the imposition of a condition, or the reasons for the period of the suspension and the rights of appeal under clause 28.

Clause 28: Appeals to the Tribunal

175. Clause 28 provides for an appeal against a decision by the Commission under Chapter 2 (excluding decisions to give warning notices). It also allows for an appeal against an order made by a justice of the peace under clause 26. A person has 28 days to appeal from the date of the service of notice of the decision or order.

176. The appeal is to the Tribunal established under section 9 of the Protection of Children Act 1999. Subsections (3) to (6) provide for the Tribunal's powers in considering an appeal. The Tribunal may confirm or overturn a decision made by the Commission or a justice of the peace. It may also vary the length of a suspension or any of the conditions of registration, with the exception of any 'registered manager' condition required by clause 9(1).

Offences

Clauses 29-33: Offences

177. Clauses 29 to 33 set out the offences under this Chapter of the Bill. The Commission will be the prosecuting authority in respect of these offences, using its powers of entry and inspection under Chapter 6 to gather evidence.

178. If convicted of an offence under these clauses the registered person would be liable to a fine.

179. Clause 29 makes it an offence for a service provider or a registered manager to fail to adhere to the conditions of their registration. The penalty for an offence under this clause is a fine of up to £50,000 on summary conviction.

180. It is an offence to carry on regulated activities without being registered to do so (clause 6). Subsection (1) of clause 30 also makes it an offence for registered service providers to continue carrying on regulated activities whilst their registration is suspended.

181. Clause 9 obliges the Commission to place a condition on the registration of a service provider requiring them to have a registered manager to manage certain regulated activities in prescribed circumstances. Where a registered manager has had his registration cancelled or suspended, clause 30 makes it an offence for him to continue to manage the activities in respect of which he is registered. It also makes it an offence for a registered manager to knowingly continue to manage activities if the registered service provider for whom he manages those activities has had his registration cancelled or suspended. The penalty for an offence under this clause is a fine of up to £50,000 on summary conviction.

182. Clause 31 allows regulations to be made under chapter 2 that will make failure to comply with specified regulations an offence. For instance, it is intended that it will be an offence to fail to comply with certain requirements made in regulations under clause 16 (regulation of regulated activities). The amount of the fine prescribed will not exceed £50,000 in respect of regulations made under clause 16 (regulation of regulated activities) and in any other case will not exceed level 4 (currently £2,500) on the standard scale. Regulations may not provide for offences to be triable on indictment or to carry penalties of imprisonment.

183. Clause 32 makes it an offence for a person to claim that a concern is carrying on regulated activities, or that premises are used for carrying on regulated activities, if they are not registered with the Commission to carry on those activities, or they are registered to carry them on but their registration has been suspended. This would apply to someone who provides care to people under false pretences, for example a hotel claiming to be a nursing home. It would also apply to someone who misrepresents the nature of their registration, by claiming, for instance, that they are registered to care for a particular category of resident when they are not. It also makes it an offence for any person to claim they are a service provider able to provide a particular service or do anything which would contravene a condition of their registration. The penalty for an offence under this clause is a fine not exceeding level 5 (£5000) on the standard scale.

184. Clause 33 makes it an offence for someone to knowingly make a false or misleading statement in an application to the Commission. This includes applications to register as a service provider or registered manager, to vary or remove conditions on their registration, to vary or cancel the suspension of their registration or to cancel their registration. The penalty will be a fine of up to level 4 (£2500) on the standard scale. Application forms will inform people of this offence so that they are aware of the potential result of failing to complete their applications accurately.

Information to be available to public

Clause 34: Provision of copies of registers

185. The Commission will have to make copies of its registers of service providers and managers available to the public. Clause 34 allows members of the public to view them at the Commission's offices or to request copies of the full register or an extract. It will be up to the Commission to determine the best way to make information available but it may choose to improve accessibility through electronic means. A charge may be made except where prescribed in regulations or where the Commission decides that the copy or extract should be provided for free.

186. However, there may be information that should not be released to the general public, such as certain information that identifies individuals. Clause 34(3) allows regulations to be made setting out what information should not be accessible.

Miscellaneous

Clause 35: Bodies required to be notified of certain matters

187. Under clause 35 the Commission will have to notify certain people when it issues warning notices, when it issues a penalty notice or when it decides to prosecute. The Commission must also notify certain people when it issues a notice of proposal under clause 22 or a notice of decision under clause 24. It will also have to notify these people in relation to any urgent suspension of registration or any urgent variation of the conditions of registration. For instance, if the Commission proposed to change the conditions of an NHS Trust's registration it must notify the relevant Strategic Health Authority (as determined by regulations). In the case of a Foundation Trust it must notify Monitor. In other cases, it must notify PCTs or local authorities in accordance with regulations. For example, regulations may require PCTs or local authorities who are commissioning services from the person in question to be notified.

Clauses 36-38: Miscellaneous

188. Clause 36 enables regulations to be made requiring persons who are registered to carry on regulated activities to make returns to the Commission. The regulations may also specify the frequency of the returns, their content, the period that the returns relate to, and the date by which returns must be made.

189. Clause 37 provides for regulations to be made which deal with the process that applies when companies or people that are registered as service providers go into liquidation or receivership, or are declared bankrupt. The regulations may require the Commission to be notified and a suitably qualified manager to be appointed to manage the regulated activities.

190. Regulations under clause 38 may require the Commission to be notified if a person who is registered as a service provider dies. They may also enable someone else to continue to carry on, for a limited period, the regulated activities which the deceased person was carrying on, and for the clauses of the Bill to apply in a modified way to allow for this.

Clause 39: Power to modify Chapter in relation to newly regulated activities

191. Clause 39 enables the Secretary of State to make regulations modifying Chapter 2 in its application to newly regulated activities of a prescribed description. The registration provisions are designed to work to cover care which is already subject to regulation and to cover care directly provided by NHS bodies. When other forms of care are eventually brought within the ambit of the registration regime, there may be unforeseeable issues which necessitate modification of the registration procedures. This power allows for that eventuality.

CHAPTER 3 - QUALITY OF HEALTH AND SOCIAL CARE

Health care standards

Clause 41: Standards set by Secretary of State

192. Clause 41 gives the Secretary of State the power to prepare and publish statements of standards in relation to the provision of health care by and for PCTs and to amend these statements from time to time.

193. It is envisaged that these standards will be benchmarks of expected behaviour and good practice. Subsection (3) allows the Secretary of State to direct another person to develop standards and to submit them for approval, and it is envisaged that this will allow primarily professional bodies to work on new suites of standards or to submit existing suites for approval. The Secretary of State may also ask any person to keep statements of standards under review, and to provide advice on any changes they consider should be made to the standards by submitting amended statements of standards.

194. Subsection (4) provides that the Secretary of State must consult on the content of such statements of standards, or amended statements of standards which effect a substantial change in the standards, before they are published. The Commission has no role in monitoring or assessing compliance with these standards.

Reviews and investigations

Clause 42: Periodic reviews

195. In place of the annual reviews currently conducted by CHAI and CSCI, the Commission will carry out periodic reviews under clause 42 of PCTs, NHS providers in England and local authorities in England.

196. PCTs and local authorities provide health and adult social services but they also commission health and adult social services from other organisations that they consider necessary to meet the needs of their local populations. For example, a local authority might pay for people with particular kinds of needs to be cared for in a private facility that specialises in catering for such people.

197. The Commission will therefore carry out overall reviews of the provision of health care in PCT areas under subsection (1) and adult social services in local authority areas under subsection (3); these reviews will assess how well the services they provide and commission are meeting the needs of their local populations.

198. Reviews will be by reference to a set of indicators which will either be devised by the Secretary of State in whole or in part or devised by the Commission and approved by the Secretary of State. It is intended that these will primarily be based on outcomes that the Government has decided are the most appropriate measurements by which to judge the performance of PCTs and local authorities. The Government intends that the indicators set under this power in relation to local authorities (working alone or in partnership with PCTs, other NHS bodies or other local service providers) will be part of the single set of national indicators to which the Government committed itself in the Local Government White Paper - Strong and Prosperous Communities in October 2006.

199. The Commission will also review NHS bodies that provide services, referred to as English NHS providers. This includes NHS Trusts and Foundation Trusts. PCTs will also be reviewed in respect of the health care they provide. The Secretary of State will again have responsibility for setting the indicators, but may delegate this function wholly, or in part, to the Commission. Where this function is delegated, the Secretary of State must still approve the indicators that the Commission proposes. Reviews will need to ensure that providers are complying with registration requirements. Reviews will also look broadly at the quality of care provided, taking account of the same outcomes against which commissioners are assessed. The intention is that the Commission will be given responsibility for setting the indicators used for provider reviews from the outset. Reviews of English NHS providers under subsection (2), and reviews of the overall quality of provision in PCT or local authority areas under subsections (1) and (3) may well use much of the same information. In these cases it is intended that the Commission will only collect that information once.

200. The Commission must devise a methodology for assessing and evaluating bodies against relevant indicators, and this methodology must be approved by the Secretary of State. It must publish its methodology, as well as the indicators used for reviews, whether they are set by the Secretary of State, or set by the Commission and approved by the Secretary of State.

201. Following a review the Commission will publish a report of its assessment. Regulations may set out the procedure that should apply to allow people to make representations to the Commission before the report is published. The reason for setting out this procedure is to ensure that the reviewed body is given time to comment, and that any comments are considered by the Commission.

Prepared: 16 November 2007