How to register under the Health and Social Care Act 2008

A new system of registration How to register under the Health and Social Care Act 2008 Guidance for new October 2010

Introduction This guidance is for all new who are required to register under the Health and Social Care Act 2008. It covers: Adult social care. Independent health care. NHS trusts and primary care trust (PCT). It gives an overview of: The new registration system and what it will mean for you. What you need to do to make an application. What we will do with the information you give us. Background to the registration system 1. The Health and Social Care Act 2008 introduced a new, single registration system that applies to all health care and adult social care services. The registration system is based on our assessment of the ability of to ensure the quality of people s experiences of the care they receive. 2. If a provider carries out a regulated activity as defined by the Government in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010, they are required to register with us under the Health and Social Care Act 2008. 3. The Government has set out essential standards of quality and safety that apply across the health care and adult social care sector in those same registration regulations. 4. We have produced Guidance about compliance: Essential standards of quality and safety, which explains what need to do to meet the requirements set out in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010. This replaces the existing National Minimum Standards for adult social care and independent health care and the Standards for Better Health that apply to NHS. This guidance describes the essential standards of quality and safety. Our guidance about compliance contains the expected outcomes what people who use services should experience when comply with the law. 5. A registered provider is responsible for the quality of the services that they provide. It is up to the putative provider to demonstrate to us that they will meet the essential standards of quality and safety before we will proceed to register them. 6. We will provide a registration service to applicants that is: Efficient Transparent Proportionate Robust

As consistent as possible across our organisation. 7. There is a flowchart at the back of this guidance to summarise the process. General guidance on the system 1 Why do I have to apply to register to provide my services? Under the Health and Social Care Act 2008, all new must register if they intend to offer regulated activities that come within the scope of registration as set out in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010. It is illegal to provide regulated activities without being registered. 2 Who has to register? Registration is at the provider level. Our register will show who is entitled to provide a service, and the conditions under which they may do this. The provider is the legal entity that carries on the regulated activities. If the provider is an organisation, the register will show the name of the company or NHS trust. A partnership or individual may also be a provider. Each provider will be registered once for each of the regulated activities they provide across all their services. However, the provider needs to identify locations at which they provide the regulated activity, and their ability to carry on the activity will be limited to those locations through the use of conditions of registration. Where the application is as a result of a merger or acquisition, additional guidance is available on our website. 3 How do I decide which regulated activities I need to apply for? The following list sets out the types of regulated activities. For the full definitions, please see the Health and Social Care Act 2008 (Regulated

Activities) Regulations 2010, which are on our website. You can also read the Scope of registration document on our website. 1. Personal care. 2. Accommodation for persons who require nursing or personal care. 3. Accommodation for persons who require treatment for substance misuse. 4. Accommodation and nursing or personal care in the further education sector. 5. Treatment of disease, disorder or injury. 6. Assessment or medical treatment for persons detained under the 1983 (Mental Health) Act. 7 Surgical procedures. 8. Diagnostic and screening procedures. 9. Management of supply of blood and blood derived products etc. 10. Transport services, triage and medical advice provided remotely. 11. Maternity and midwifery services. 12. Termination of pregnancies. 13. Services in slimming clinics. 14. Nursing care. 15. Family planning services. Guidance to help you before you put in your application pre application stage 4 How do I apply for registration? You will need to complete an application form either electronically or on paper. An electronic version is the preferred method and is available to download from our website. If you have any questions, you will need to call us on 03000 616161 or email enquiries@cqc.org.uk.

5 Which forms do I need to complete? You will need to complete one application form to be registered. There are separate forms for: Organisations Partnerships Individuals. You must declare compliance with requirements for each regulated activity and for each location you wish to provide services from. New will not be registered if they cannot declare full compliance. In addition, you need to make sure that a registered manager application is included, where this is required. The manager and provider applications must be submitted in the same email or the application will be considered incomplete and invalid and will be returned. A partnership is required to have a registered manager. Where a partner is to be in day-to-day charge, he or she must also complete a separate application form to be the registered manager. 6 Do I need to fill in a separate application for each regulated activity and location where I provide services? No. All information will be included in the same application form. You need to make a declaration of compliance with the regulations within your application. A separate declaration is made for each regulated activity at each location you wish to provide services. 7 Some of the activities I provide don t have to be registered. Do these need to be included in my application? No. Your application only needs to be for activities that must be registered under the Health and Social Care Act 2008. For example, a company that provides personal care through a domiciliary care agency, plus an employment agency that only supplies staff to care homes, would only need to register for the personal care activities, not for the activities of the employment agency.

8 What standards do I have to meet to be able to offer a service? We have published guidance documents called the Essential standards of quality and safety and the Judgement framework. This guidance sets out the outcomes for people who use services that you have to be able to achieve to comply with the regulations. You can find it on our website. You will need to familiarise yourself with this before you can declare compliance in your application form. There are 28 regulations in total. Sixteen of these focus directly on quality and safety. The remaining 12 outline other legal requirements and definitions that must be considered and complied with. 9 I have heard about the National Minimum standards. Do these still apply? No. The Health and Social Care Act 2008 and the essential standards of quality and safety supersede all the National Minimum Standards and the Care Standards Act 2000. 10 What is a location? Our definition of a location is set out in a separate guidance document on our website. 11 How should a partnership apply for registration? A partnership is an arrangement where two or more individuals have joined together in order to carry on the service. It is the partnership that should be registered, not the individual members of the partnership. All partners in a partnership must sign the application form to declare that you are skilled and competent to provide the regulated activities. You can

find this form on our website with supporting guidance. The provider must give the names of all partners and the address of the service. (Only the service address will appear on the register that we are legally required to keep and make available to the public.) Even silent partners must show that they are skilled and competent. Under the Health and Social Care Act 2008, all partners must be skilled and competent to provide the regulated activities and therefore the term silent is no longer relevant to the way we assess a partnership s application. Please note: This does not include LLP (Limited Liability Partnerships), which is an organisation. 12 I am an organisation running a service in partnership with other organisations. Do I have to identify individuals to represent the partnership? You will need to clarify which organisation will lead the service and explain the nature of the way the organisations work together. That organisation will complete the application form. A partnership may consist of two or more organisations and therefore we may register the partnership of organisations as a single entity, depending on individual circumstances. 13 Which services are required to have a registered manager? Regulation 5(2) of the Health and Social Care Act 2008 (Miscellaneous Provisions) Regulations 2010 exempts NHS trusts from the requirement to have a registered manager where the regulated activity consists wholly, or mainly, of the provision of health care. All adult social care and independent healthcare are required to have a registered manager, along with NHS trusts who provide accommodation with nursing, except for individuals or partnerships. If you are an individual or partner who is in day-to-day management of the service, you are not required to have a separate manager. A partner can be appointed as a registered manager. However, the partner must complete a manager application form and submit this at the same time. Your application will not be deemed valid unless it is accompanied by a registered manager application, where applicable. Both applications will be authorised at the same time.

14 I want to offer the regulated activity termination of pregnancy services. Are there any additional requirements? Yes. Please note that all new registrations of a offering termination of pregnancy clinics who are independent (not NHS) will require a licence from the Department of Health before starting the new service. You must complete the Department of Health s Declaration Form and the Procedures for the Approval of Independent Sector Places for Termination of Pregnancy from the Department s website. 15 My service will use controlled drugs. Do I have to register this separately? Under legislation, hospitals must appoint an accountable officer to be responsible for the management of controlled drugs and related governance issues in their organisation. If registration is granted, you must provide us with details of your accountable officer. You can find further information and a specific form to complete on our website. The following applies if your service requires a registered manager 16 Will the manager applicant have to submit a CRB check and other documents as part of the registration application? Yes. We have produced guidance for registered managers. Please see our website for full details. You need to obtain a CRB disclosure from the Care Quality Commission before you submit your application, which we will countersign. Please ensure that the name you apply for in your CRB disclosure matches exactly your application details. This includes all former names and middle names. When applying for registration and after registration has been agreed, an organisation must have the information and documents specified in Schedule 3 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 about their nominated individual.

We will only ask for some of the documentation to support the application, however we may ask for further information if we have any reasons to question the validity of the application. We will ask to see proof of identity when the registered manager applicant is interviewed and retain a copy for our records. 17 If I appoint a new registered manager after I have applied, would it be dealt with as part of this application? No. The proposed new registered manager will need to make a separate application to become a registered manager. However, any application from a new provider cannot be completed if the service does not have a manager where one is required to be in place. Equally, we will not authorise a registered manager s application form if there is not a related provider application form. Providers must have a nominated individual ; the following guidance sets out what you need to do 18 What is a nominated individual? Do all need a nominated individual? How do I decide who this should be? All applicants other than individuals and partnerships will need a nominated individual. Organisations include local authorities, NHS trusts, voluntary organisations, charities, limited companies and limited liability partnerships. The Regulations say that the nominated individual must be employed as a director, manager or secretary of the organisation with responsibility for supervising the management of the regulated activity. It may be that you appoint one nominated individual to cover one, several, or all of the regulated activity(ies) you provide. You must consider that individual s ability to fulfill the responsibility of supervising the management of the regulated activity. Providing the nominated person meets the requirements set out in the regulation, it is up to you to decide who the person is.

19 Do I need a different nominated individual for each regulated activity? Each regulated activity is seen in law as separate, therefore a nominated individual is required for each regulated activity. You are permitted to nominate the same person for some or all of the regulated activities that you are applying for. 20 Can I have a nominated individual per region that covers all regulated activities in that region? No. An application can only have one nominated individual per regulated activity - irrespective of the geographic coverage. 21 I am the nominated individual. Will I need to submit a CRB check and other documents as part of the registration application? Yes. You need to obtain a CRB disclosure from the Care Quality Commission before you submit your application, which we will countersign. Further guidance is available on our website. Please ensure that the name you apply for in your CRB disclosure matches exactly your application details. This includes all former names and middle names. When applying for registration and after registration has been agreed, an organisation must have the information and documents specified in Schedule 3 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 about their nominated individual. Initially we will only ask for some of the documentation to support the application, however we may ask for further information if we have any reasons to question the validity of the application. 10

Guidance to help you fill in your application and declaration application stage 22 If my service requires a registered manager, what do I need to submit with my application to show I am considered fit to manage a regulated activity as a manager? Please see the Essential standards of quality and safety for how we will assess your fitness. We will assess your personal fitness, therefore the list of information on the application form must be available or submitted as requested. The process looks at your compliance with the new regulations for the regulated activities that you are providing. There is separate guidance on our website on how to apply for a CRB check. We have supplied templates on the website that you can use for a: Professional reference. Medical reference. 23 As a nominated individual, what do I need to submit with my application to show I am considered fit to supervise the management of a service? Please see the Essential standards of quality and safety for how we will assess your fitness. We will assess your personal fitness, therefore the list of information on the application form must be available or submitted as requested. The process looks at your compliance with the new regulations for the regulated activities that you are providing. There is separate guidance on our website on how to apply for a CRB check. We have supplied templates on the website that you can use for a: Professional reference. Medical reference. 11

24 What do I do if my doctor will not give me a medical reference? Your GP will normally provide a medical reference, but he or she may charge a fee. If you are unable to find a medical practitioner who is willing to provide a medical reference, you must explain why and send details of: Your physical and mental health. Any past, present or long-term disability. Current treatment you are receiving from your GP, hospital doctor or another paramedical practitioner. Any illnesses or hospital admissions over the last five years. Any reasonable adjustments that have been made by the provider that enable you to fulfil the role. (Definitions of this can be found in the Essential standards of quality and safety.) At the end of the sheet, you should write the statement below, then date and sign it. I declare that to the best of my knowledge the information given about my physical and mental health is full and correct. I will notify you of any significant changes to my health. 25 What if I tell the Care Quality Commission or my doctor tells CQC that I am currently being treated for a serious health condition? We will look at whether you are considered physically and mentally well and able to perform your role. Remember, it is the provider who employs you to perform the role. Where reasonable adjustments have been made by the provider, please tell us about these in your declaration. Any decision will depend on what your medical practitioner tells us about your ability to perform the role based on his/her knowledge. If you self-declare your medical assessment, this will be explored at interview. We may refuse your application and you have the right to appeal against this. However, this does not mean that you cannot apply again when you are better. 12

26 Is there a fee for this application? For both and managers, there may be a fee applicable. Please check the fees guidance on our website. When sending in an application fee, please ensure that it is clear whose application the fee relates to. If a cheque or banker s draft is being sent, please give details on the application form of whose signature will be on the fee. 27 What is a statement of purpose? Every service provider is required by law to have a statement of purpose. The statement of purpose should provide: Information about services and their locations, to a level of detail that enables us to understand what actually happens in the location, so that we can consider the broad level of risk involved. For example, instead of saying we carry out surgery at hospital x the statement of purpose would need to make clear what type of surgery is provided and who it is for Surgery includes specialist surgery such as neurosurgery and cardiac and is provided for children as well as adults. An overview of the provider's regulated activity and the locations that they are carried on from, alongside the formal line of accountability and contact details for them. By law, the statement of purpose must include: 1. The aims and objectives of the service provider in carrying on the regulated activity. 2. The kinds of services provided for the purposes of carrying on the regulated activity and the range of service users needs which those services are intended to meet. 3. The full name of the service provider and of any registered manager, together with their business address, telephone number and, where available, email addresses. 4. The legal status of the service provider. 5. Details of the locations at which the services provided for the purposes of the regulated activity are carried on. 13

You will need to send us a copy of your statement of purpose as part of your application to register. A template is available on our website for you to use if you wish. 28 What happens if my application is incomplete? We cannot process incomplete applications. These will be returned and they may be rejected. We strongly advise you to take care to complete your application fully and accurately, as gaps may hold up your application or mean that we have to request further evidence or carry out a visit. This may cause further delay. 29 Am I allowed to resubmit my application? Once we have accepted your application, we will begin processing it. If we require further information or evidence of your compliance, we will let you know. If you need, subsequently, to amend your application, you will have to confirm this in writing. Further guidance on submitting amendments can be found on our website. We will tell you if your amendment can be accepted. Amendments may cause delay and may mean that we are not able to process your application in time. If you make changes to your application we may ask for further information. If the changes to the application are substantial, you will have to make a new application with a full fee. So we strongly recommend that you ensure that your application is full and complete on first submission. 30 How much information will I need to include in my application? You need to send some supporting information, but you do not need to send anything that is not listed on the application form. 14

You will need to declare your compliance for each regulation. It is important that you make true and accurate declarations. Where there is any doubt, we may ask for further evidence. A false or untrue declaration would be an offence under Section 37 of the Health and Social Care Act 2008. The application form asks you to confirm that you have documentation around planning and estates, and this should be available if we request it. The information we need from you is detailed on the application form. We will return any additional information sent with the application form that has not been requested. 31 What information am I expected to give when I answer the questions about respecting and involving people who use services? Our assessment includes looking at the way involve people who use their services. We are asking for evidence (both past and planned for the future) about your activities in: Involving people directly in planning the services they want to be registered to provide in a range of ways to suit people s circumstances. Routinely making use of the views and experiences of people (individuals using the service, their carers and representative groups who reflect the population they serve) to ensure that you meet the essential standards of quality and safety. 32 What information am I expected to give when I answer the questions about equality, diversity and human rights as outlined in the Essential standards of quality and safety? As above, when making our assessment we are asking for information about your activities (both past and planned for the future) in: Ensuring that human rights and equality and diversity needs are addressed in your service. Developing the capacity to respond to diverse needs. Promoting independence and choice. Promoting human rights and diversity issues as being equal in importance to other issues. Providing information that is accessible to people who use it. Ensuring that your staff understand and respect the beliefs and customs of people s faith and understand their responsibilities 15

under equalities legislation. Managing themes in complaints about race, age, gender (including gender identity), sexual orientation, disability, religion. Ensuring that there is a culture of openness and inclusion. 33 What information am I expected to give when I complete the financial reference form before sending to my bank or building society? You must show how you are going to finance the business before and during the start-up process. This may include a business plan to show full consideration of all ongoing costs. This business plan may be requested to support your financial statement. Please ensure that the financial statement and application forms match. If the service provider name and financial reference names are different, we may reject the application. 34 If I answer yes to the question on administration and receivership how will you deal with this? It may not be applicable. The information you provide will be judged with the supporting evidence on your ability to carry on or manage a service. You will be given the opportunity to discuss the details fully if needed. 35 What information do I need to give about other businesses that are carried on in the same premises as the regulated activity? This information needs to detail where you have shared services for example, water, electricity and gas, and what your responsibilities are for contracts and maintenance. If the business is another provider of regulated activities and you have any interests or management responsibilities for the company, you should include these in the form. 16

36 Why do you need bed numbers? CQC holds this information about all, as it gives an indication about the people who use services for each regulated activity. The NHS does not have to supply this information directly to us as we can source this elsewhere. Guidance about how we assess applications assessment stage 37 What happens once my application has been accepted as complete? We will assess your application and declaration of compliance. We will let you know if we need any additional information. We will let you know if we need to speak to you or visit any of your services in order to assess your compliance. 38 Do I need to notify you of any changes during the application process? Yes. You must inform us of any information that is relevant to the application and update this information accordingly. Your application may be rejected if there are significant changes and you will need to re-apply. 39 Will you undertake a visit or any interviews as part of this process? Yes. We will make a site visit in most cases for a new application. We will carry out an interview for all registered manager positions. 17

40 Are you getting information from anyone else as part of this process? Yes, we may use information if you are currently providing other services, but in most cases where this is a first application, there may be no other information available. Guidance about how we make our judgement outcome stage 41 When will you complete my registration? We aim to register all new within 12 weeks of accepting the application. If we need further information to support your application, then this timescale may be longer. 42 What are conditions of registration? A condition may be attached to your registration that: Restricts your service; for example, you can not treat children. States what services you are permitted to provide; for example, diagnostic, surgical procedures (no cardiac surgery). States the locations that the services may only be provided from (this will be all the addresses you have listed on your application form). States whether a registered manager has to be in post. 43 How will I know your judgements are consistent? We will have systems in place to review the consistency and quality of our registration decisions, including the judgement framework. We will publish these on our website. 18

Guidance about the appeals process representation and appeal stage 44 If I don t agree with your decision, can I appeal against it? Yes. You will be able to make representations to us about any proposal to refuse to register you, or any proposal to register you subject to conditions if you disagree with it. After that, if we do not uphold your representations, but confirm our proposal, you can appeal against our decision to an independent tribunal. We provide information about the tribunal whenever people have a right to appeal to it. The tribunal service s address is: First-tier Tribunal Care Standards Appeals Mowden Hall Staindrop Road Darlington DL3 9BG Guidance about the outcome of the application and what happens next 45 Will I get a certificate for each service? We will issue a certificate electronically for the whole provider registration, which will list all the locations and the regulated activities that you are registered to provide. Each registered manager also receives a separate certificate. 46 Will there be categories of registered services for the public in the new system? Yes. We will develop a system of categorising the service you provide, so that this can be represented in our web directory. 19

Appendix: Application flow chart Stage 1: Pre-application Take time to understand the requirements of the new regulations and our Guidance about compliance: Essential standards of quality and safety and Judgement framework. Nominated individual(s) and registered manage(s) get their CRB documents. Consider the evidence you need to demonstrate outcomes and experiences of people who use services. Ensure any new buildings are fit for purpose and ready to meet the needs of the people who will use the service. Stage 2: Application Complete the application form and make the declaration. Submit all additional documentation along with the application form. Submit the correct fee for the application. Stage 3: Assessment of application The Care Quality Commission processes your application. Inform CQC if there are any changes when the application is being processed, for example, the manager leaves. Stage 4: Judgement and outcome CQC tells you whether you are registered with or without conditions, or if your application has been refused. Stage 5: Appeals If you don t agree with the decision, you can appeal. Stage 6: Registration You receive your certificate and are registered under the new Act. You have to continue to meet the essential standards of quality and safety. You let CQC know if there are any changes to your registration. 20