Regulation, code of practice and guidance

Sections 20 to 25: Requirements in relation to regulated activities

144.     Sections 20 to 25 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.

145.     Subsection (1) of section 20 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)).

146.     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)).

147.     Subsection (3) sets out specific issues which any regulations made under section 20 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.

148.     Regulations may also make provision about the way in which a regulated activity is carried on. They may cover issues such as the use of appropriate premises and practical issues around record keeping or accounting. They may cover arrangements for dealing with and learning from complaints and disputes. For example, such regulations could require a service provider to maintain arrangements for ensuring that lessons learnt from justified complaints are properly applied. They may also require registered providers to review the quality of services they offer, prepare a report of the review, and make it available to the public; and require providers to make information available about charges made for those services.

149.     The regulations may also cover other issues, such as requirements regarding the appropriate use of control and restraint, or the provision of information.

150.     Subsection (5) allows 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.

151.     Under section 21 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 to 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. Section 22 sets out the consultation process that the Secretary of State must follow when preparing to issue the code of practice, or revisions to it.

152.     Section 23 requires the Commission to issue guidance on how service providers and managers should demonstrate compliance with all other requirements set out in the regulations made under section 20. 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 by the Mental Health Act for which the Commission will take on responsibility. Section 24 sets out the consultation process that the Commission must follow when it proposes to issue or revise guidance on compliance with requirements.

153.     Under section 25, 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 section 20;

• whether it should suspend or cancel someone's registration;

• whether to prosecute someone.

154.     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 section 30, or in appeal proceedings.

155.     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

Sections 26 and 27: Notices of proposals and rights to make representations

156.     Section 26 requires the Commission to give written notice to applicants or registered persons where it proposes to do any of the following:

• to grant 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 section 13(1));

• to refuse an application for registration;

• to cancel a registration (except where the registered person has applied for cancellation of registration under section 19, or the Commission has applied for an order to urgently cancel a registration under section 30, or the Commission has cancelled a registered manager's registration in accordance with the conditions set out in section 17(2));

• to suspend a registration (except where the Commission has urgently suspended a registration under section 31);

• to amend the conditions of registration (except where the Commission has urgently removed or varied a condition or imposed an additional one under section 31);

• to refuse an application by a provider or manager of regulated activities made under section 19(1) to vary or remove a condition, cancel their registration, or cancel or vary a period of suspension.

157.     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. Section 26 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 section 13(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 section 28.

158.     Section 27 sets out that a notice of proposal under section 26 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.

Section 28: Notice of decisions

159.     Section 28 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 section 13(1) and/or conditions already agreed in writing with the applicant (subsection (1)). The notice must state the conditions (subsection (2)).

160.     Where the Commission has decided to give effect to a proposal of which notice was previously given under section 26, subsection (3) requires the Commission to serve a further notice in writing of its decision.

161.     That further notice must explain the rights of appeal conferred under section 32. 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)).

162.     A decision made by the Commission under section 28 to adopt a proposal of which notice has been given under section 26 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.

Section 29: Warning notice

163.     Section 29 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 section 20.

164.     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.

165.     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.

Section 30: Urgent procedure for cancellation

166.     Under section 30 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 will be 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.

167.     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). The relevant bodies will need to consider whether to make alternative provision for services.

168.     Where the Commission makes an application under the urgent procedure regarding the registration of a PCT or 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 section 32.

Section 31: Urgent procedure for suspension, variation etc.

169.     Section 31 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 to change the conditions that apply to a person's registration, where it believes that any person will or may be exposed to the risk of harm. Notice of the action must be given in writing and the notice must state either the reasons for the change of conditions, or the reasons for the period of suspension, and explain the rights of appeal under section 32.

Section 32: Appeals to the Tribunal

170.     Section 32 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 section 30. A person can appeal within 28 days from the date of the service of notice of the decision or order.

171.     The appeal is to the Tribunal established under section 9 of the Protection of Children Act 1999, the Care Standards Tribunal, which currently hears appeals relating to registration under Part 2 of the Care Standards Act 2000. 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 vary or remove any of the conditions of registration, with the exception of any 'registered manager condition' required by section 13(1), or add a new condition, again with the exception of a 'registered manager condition'.

Offences

Sections 33 to 37: Offences

172.     Sections 33 to 37 set out further offences relating to registration under Chapter 2. 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.

173.     Section 33 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 section is a fine of up to £50,000 on summary conviction.

174.     It is an offence to carry on regulated activities without being registered to do so (section 10). Subsection (1) of section 34 also makes it an offence for registered service providers to continue carrying on regulated activities whilst their registration is suspended.

175.     Section 13 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. Section 34 provides that a person who is a registered manager is guilty of an offence if he continues to manage the activity during a period in which his registration is suspended, unless another person has been registered as a manager in his place (subsection (2)). A registered manager is also guilty of an offence if he continues to manage the activity while the registration of the service provider is suspended, if he knows or could reasonably be expected to know of the suspension (subsection (4)). A person whose registration as a manager has been cancelled is guilty of an offence if he continues to manage the activity after cancellation, but only if a service provider remains registered in respect of the activity, a registered manager condition is still in place and no new registered manager has been appointed (subsection (3)). The penalty for an offence under section 34 is a fine of up to £50,000 on summary conviction.

176.     Section 35 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 section 20 (regulation of regulated activities). The amount of the fine prescribed will not exceed £50,000 in respect of regulations made under section 20 (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.

177.     Section 36 makes it an offence for a person, with intent to deceive another, to claim that a concern is carrying on regulated activities, or that premises are used for carrying on regulated activities, if a person is not registered with the Commission to carry on those activities, or a person is 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 also makes it an offence for a person, with intent to deceive another, to claim that any person who is registered as a service provider is able to provide a particular service or do anything which would contravene a condition of their registration. The penalty for an offence under this section is a fine not exceeding level 5 on the standard scale (currently £5,000).

178.     Section 37 makes it an offence for someone knowingly to make a false or misleading statement in an application to the Commission. The section applies to 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 is a fine of up to level 4 on the standard scale (currently £2,500). 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

Section 38: Provision of copies of registers

179.     The Commission will have to make copies of its registers of service providers and managers available to the public. Section 38 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 will be made for the provision of a copy or extract except in circumstances prescribed in regulations or where the Commission decides that the copy or extract should be provided for free.

180.     However, there may be information that should not be released to the general public, such as certain information that identifies individuals. Section 38(3) allows regulations to be made setting out what information should not be accessible.

Miscellaneous

Section 39: Bodies required to be notified of certain matters

181.     Under section 39 the Commission will have to notify certain people when it issues warning notices, when it receives payment of a penalty under a penalty notice or when it decides to prosecute. The Commission must also notify certain people when it issues a notice of proposal under section 26 or a notice of decision under section 28. 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 proposes 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. Provision is also made for notifying 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.

182.     Subsection (1)(d) also provides the Commission with the discretion to determine other people it should notify in particular circumstances. Where the Commission has taken enforcement action against a specific person, for example, it would be expected to notify the relevant professional body. In the case of a registered manager who is also a registered social care worker, this would be the General Social Care Council.

Sections 40 to 42: Miscellaneous

183.     Section 40 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.

184.     Section 41 provides for regulations to be made which deal with the process that applies when companies or individuals 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.

185.     Regulations under section 42 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 sections of the Act to apply in a modified way to allow for this.

Power to modify provisions of Chapter

Section 43: Power to modify Chapter in relation to newly regulated activities

186.     Section 43 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 unforeseen issues which necessitate modification of the registration procedures. This power allows for that eventuality. The power to modify the Act under this section does not apply to the registration of NHS bodies or providers currently subject to regulation under the Care Standards Act 2000 but it will apply to regulated activities carried on by or on behalf of the Crown.

CHAPTER 3 - QUALITY OF HEALTH AND SOCIAL CARE

Health care standards

Section 45: Standards set by Secretary of State

187.     Section 45 gives the Secretary of State the power to prepare and publish statements of standards in relation to health care provided or commissioned by PCTs and to amend these statements from time to time.

188.     PCTs will be required to have regard to these standards in discharging their duty under the new section 23A of the NHS Act 2006 (see section 139) to secure continuous improvement in the quality of health care provided or commissioned by them. Subsection (3) allows the Secretary of State to direct another person to develop standards and to submit them for approval. In "High Quality Care for All", published on 30 June 2008, the Government indicated its intention to ask the National Institute for Clinical Excellence to develop these standards, with reference to the clinical priorities set out by a new National Quality Board, to be chaired by the NHS Chief Executive.

189.     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

Section 46: Periodic reviews

190.     In place of the annual reviews currently conducted by CHAI and CSCI, the Commission will carry out periodic reviews under section 46 of PCTs, NHS providers in England and local authorities in England.

191.     PCTs and local authorities provide health and adult social services but they also commission from other organisations health and adult social services 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.

192.     The Commission will therefore carry out reviews of the effectiveness of commissioning by reviewing the overall provision of health care in PCT areas under subsection (1) and of adult social services in English local authority areas under subsection (3). These reviews will assess how well the services they put in place, whether provided directly or commissioned from other people, are meeting the needs of their local populations.

193.     The Commission will also carry out individual reviews of NHS bodies that provide services, referred to as English NHS providers, under subsection (2). This includes English NHS Trusts and NHS Foundation Trusts. PCTs will also be reviewed in respect of the health care they provide, so that their performance in this regard can be distinguished from their effectiveness as commissioners.

194.     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. For reviews of PCTs and local authorities under subsections (1) and (3) 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.

195.     Reviews of English NHS providers under subsection (2) 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 English 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.

196.     For each type of review, 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.

197.     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.