Registration of NHS primary medical services Providers of NHS GP out-of-hours services How to apply November 2011 Introduction The Health and Social Care Act 2008 introduced a new, single registration system that applies to both healthcare and adult social care. From 1 April 2012, providers of GP out-of-hours services in England who carry on 'regulated activities' − in both the NHS and the private sector − must be registered with the Care Quality Commission (CQC). When applying to be registered with us, a provider must demonstrate whether or not they meet a number of statutory and regulatory requirements set out in the Health and Social Care Act 2008 and associated Regulations. These regulations are set out in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 and the Care Quality Commission (Registration) Regulations 2009. The first stage of the registration process is enrolment through a short online form to gather information about a provider and the contact details of the person who should receive the statutory notification about the need to apply. This guidance is for providers of NHS GP out-of-hours services who have already completed their enrolment and have been invited to apply to register. It will help you to understand the process of registering with CQC and specifically when completing the application webform following enrolment. It includes information about the key stages, deadlines, details of the people who need to register and the information you should include in your application. Further information about registration is also available in supporting documents on our website. For a general introduction to the new registration system and a definition of an NHS GP out-of-hours service, please read our booklet for providers of GP out-of-hours services Your guide to registration, which is available on the primary medical services pages of our website at: www.cqc.org.uk/primarymedicalservices. For detailed guidance about who has to be registered and which types of services are defined as regulated activities, please read our document The scope of registration, available at: www.cqc.org.uk/scopeofregistration. Providers of NHS GP out-of-hours services: How to apply Providers of NHS GP out-of-hours services: How to apply 1 1 1 Before you apply You will need to consider a number of things before you start to apply. The first step is for you to decide who is going to complete the webform application for you as the provider. If you are registering as an individual, you should complete the application form yourself. If you are registering as a partnership, one of the partners should complete the application form. However, the other partners must have read and understood the contents of the form and what has been submitted. If you are registering as an organisation, a person who is duly authorised to complete the form and receive statutory notices on behalf of the organisation should be responsible for completing the application form. The directors must also have read and understood the content of the form and what has been submitted. If you intend to register as an organisation, you will also need to nominate a person to represent your organisation. This person will be our main point of contact with you and is referred to in the legislation as the 'Nominated Individual'. You will need to determine the 'locations' from where regulated activities are provided or managed from. For each location specified on the application form, you will need to ensure that the manager who is in day-to-day charge of one or more regulated activities provided or managed from each location applies to register with us (the 'registered manager') where required. Finally, you will need to determine whether or not you are compliant with the essential standards of quality and safety. We have published guidance on our website to support you in the application process and to help you decide whether you are compliant: • Guidance about compliance: Essential standards of quality and safety. This guidance tells you about what providers must do to meet the essential standards (www.cqc.org.uk/standards). We have also reproduced the relevant regulations at the end of that document. Alternatively, you can use our online interactive version, which enables you to collect and print out the guidance that applies to your particular types of service at www.cqcguidanceaboutcompliance.org.uk. • The Judgement framework. This sets out the way we judge whether a provider is compliant with the regulations. The judgement framework includes case studies from different service types and it outlines how our approach will be targeted and proportionate to levels of risk: www.cqc.org.uk/judgement. Providers of NHS GP out-of-hours services: How to apply Providers of NHS GP out-of-hours services: How to apply 2 2 Before making your online application, you should: • • • • • • Familiarise yourself with the regulations and the guidance listed above. Check your governance systems. Decide who you will appoint as nominated individual(s) and registered manager(s) where required. Determine what your locations are using our guidance on locations. Identify compliance with the essential standards of quality and safety and prepare the evidence that demonstrates this. Identify any non-compliance with the essential standards of quality and safety and decide how you will achieve compliance. After you have completed your online enrolment form, we will send you your log-in and password details so that you can apply in the time period allocated to you to complete your application form (see the next section for more information about submission dates). The application process opens in November 2011. Remember: As a provider, it is your responsibility to ensure that you register even if you have not received formal notification from us. If you need to contact us about this, the details are at the end of this guide. You must make a single registration application covering all of the regulated activities that you carry on at or from each of your 'locations' – not just the activities relating to your GP out-of-hours service. For example, if you have a walk-in centre or a GP practice that provides maternity services, such as those contracted to provide the Maternity Services Additional Service, then you will need to register for the regulated activity of 'maternity and midwifery services'. (See the next section for information on locations and regulated activities.) Providers of NHS GP out-of-hours services: How to apply Providers of NHS GP out-of-hours services: How to apply 3 3 2 Applying for registration All providers are responsible for ensuring that they submit a complete and accurate application for registration. You should consider all the requirements carefully and check that the information you declare is correct. When to submit your application You will be allocated a 28-day period to complete and submit your application form. Submitting your application within this period will give you protection against prosecution for providing regulated activities after 1 April 2012 while unregistered, in case we are unable to make a registration decision by this date. It will also help us to process all the applications from providers of NHS GP out-of-hours services as quickly as possible. If we receive your application after the last day of your application period, we will still process it, but we cannot guarantee that we will have reached a decision about registration by 1 April 2012. Where we have not reached a decision by 1 April because of a late application, the offence of carrying on a regulated activity while unregistered will apply from this date. This means that you could be in a position of providing regulated activities without being registered, which is a criminal offence and may result in prosecution. So it is very important that you submit a complete and accurate application form on or before the last day of your application period to avoid this risk. Please note: we will only assess applications received after the end of your application period when we have completed all those that were submitted on time. The application form You, and each registered manager where required, will need to complete certain sections of the application form. The form includes sections that ask for your details as a provider, the services and regulated activities you provide, the locations at which your activities are provided from, and who manages these services day-to-day. You will need to declare whether you comply with the regulations for each regulated activity in each of your locations, make a statement on data protection, and declare that you hold the specific information required for your nominated individual(s). Providers of NHS GP out-of-hours services: How to apply Providers of NHS GP out-of-hours services: How to apply 4 4 Things to remember: • • When completing the form online there is a 30-minute time-out that will close the form if you do not enter anything for 30 minutes, so remember to save regularly. When navigating the form do not use the browser 'Back' button. Instead, use the buttons at the bottom of the web form page: 'Save and Quit' when you want to leave a section or 'Save and Continue' when you want to carry on through a section of the form. • The 'Help' button at the top of each page provides supporting information relevant to the section you are completing, which you can use at any time. • It is important not to include any confidential personal information, such as names of patients, as this will result in your application form being rejected. • The questions you MUST complete are marked with an asterisk; please answer the other questions as well if you have the information. • If your application form is rejected, for example if it contains confidential personal information, even if you submitted it on time, you may then be at risk of missing your application period date and may not be protected from prosecution if we do not make a decision about your registration before 1 April 2012. As you progress through the online form, you will need to consider the following information. What do we mean by a 'location'? A location is a place in which or from where regulated activities are provided and/or managed. Your locations will be specified as conditions of your registration and you may provide and/or manage regulated activities only from those locations. It is important to ensure that you register all locations where you provide and/or manage primary medical services. When urgent or out-of-hours services are being provided, a location is defined as: • • A place from where triage and medical advice is being managed and provided, or A place from where care is being provided, such as a walk-in centre. If you are contracted to provide an out-of-hours GP service to a distinct geographical area (such as a PCT), a location will be the place from which the regulated activities for those services are managed. All of the premises you use for this service would be covered by the one main location. There is more information on locations on our website at www.cqc.org.uk/locations. Providers of NHS GP out-of-hours services: How to apply Providers of NHS GP out-of-hours services: How to apply 5 5 Registered managers The registered manager’s name and contact details are submitted by the provider. Registered managers then have to complete their own section of the application form, and are responsible for completing the section specific to their own registration. A registered manager must submit a General Medical Council (GMC) number or a CQC countersigned enhanced Criminal Records Bureau (CRB) number. If the registered manager is a medical practitioner and has a GMC number, they are not required to apply for a CQC-countersigned enhanced CRB as part of the application form. What do we mean by a 'provider'? We will register the provider who is legally responsible for the carrying on of regulated activities. There are some differences in how registration works for different types of providers. The legal provider may be: • • • An individual An organisation, or A partnership. It is your responsibility to declare what type of provider you are, and to ensure that you make an accurate application for registration. It is not our responsibility to research a provider’s status. More information about this is available in our booklet Your guide to registration, available at www.cqc.org.uk/primarymedicalservices. Criminal Records Bureau (CRB) checks If you are registering as a partnership or an individual, you must either submit a GMC number or a CQC-countersigned enhanced Criminal Records Bureau (CRB) number for each applicant. If an applicant is a medical practitioner and has a GMC number, they are not required to apply for a CQC-countersigned enhanced CRB check as part of the application form. This also applies to registered managers who are medical practitioners. If you have applied for a CRB check and are still waiting for the disclosure, you can submit a GMC number or the CRB application number in your application form. The individual or each partner must have one of these numbers in order to complete the form. More details are available on our website or through the online help button, including guidance on how to apply for a CQC-countersigned enhanced CRB check. If you have provided one or more GMC numbers for a registered manager, yourself as an individual, or for partners, you must complete a declaration stating that those with GMC numbers have had an enhanced CRB check with a PCT and have not been convicted or charged with any actual or alleged offences since their CRB disclosure was issued. If, for any reason, you are unable to make this declaration, it does not automatically mean these people will need a CQC-countersigned enhanced CRB check, but we may follow up the reason why you are unable to declare this as part of our assessment of your application. Providers of NHS GP out-of-hours services: How to apply Providers of NHS GP out-of-hours services: How to apply 6 6 If you need to submit an application for a CRB check to be countersigned by a CQC authorised signatory, we have arrangements with the Post Office to undertake all checks on CRB application forms from those that are required to register with us. There are over 100 Crown Post Offices that offer this service. For further information about their locations and how to get the CRB application form, see our website at www.cqc.org.uk/crb. The enhanced level of check takes into account the new vetting and barring scheme. Please see the CRB website for more information www.crb.homeoffice.gov.uk. Which activities should be registered? You must apply to register each of the 'regulated activities' that you provide (and including those that are in addition to your GP out-of-hours service). If you provide regulated activities in, or from, more than one location, you will need to state in which locations you provide each regulated activity. The regulated activity categories are: • • • • • • • • • • • • • • • Personal care. Accommodation for people who require nursing or personal care. Accommodation for people who require treatment for substance misuse. Accommodation and nursing or personal care in the further education sector. Treatment of disease, disorder or injury. Assessment or medical treatment for people detained under the Mental Health Act 1983. Surgical procedures. Diagnostic and screening procedures. Management of supply of blood and blood derived products. Transport services, triage and medical advice provided remotely. Maternity and midwifery services. Termination of pregnancies. Services in slimming clinics. Nursing care. Family planning services. Most providers of GP out-of-hours services will provide the following regulated activities: • • Treatment of disease, disorder and injury. Transport services, triage and medical advice provided remotely. Some providers of GP out-of-hours services may also provide the following regulated activity: • Diagnostic and screening procedures. Providers of NHS GP out-of-hours services: How to apply Providers of NHS GP out-of-hours services: How to apply 7 7 You must apply to register all of the regulated activities you provide, in addition to those that apply to your NHS GP out-of-hours service. It is your responsibility to ensure you apply for the correct regulated activities and register all services for which you are accountable for providing. If you provide the service described in a regulated activity (even when under exclusive contract to the NHS or another registered provider) you will normally need to register for that activity. There are a small number of exceptions where the definition of one activity specifically refers to another. For example, 'treatment of disease, disorder or injury' also includes nursing, personal and palliative care, so a provider registered for 'treatment' does not need to register for 'nursing care' as well. 'Nursing care' is defined so that it only includes nursing care that is not part of another regulated activity and we anticipate that registration for this activity will only apply to a small number of providers. For detailed information on regulated activities, please read the Scope of registration, available at www.cqc.org.uk/scopeofregistration and the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010. Nominated individual If you are registering as an organisation, you need to tell us about your nominated individual(s) and the activities they are responsible for. This person will represent your organisation and will be our main point of contact with you. You can choose to have a different person responsible for different regulated activities or someone responsible for all of them. Declaring compliance with the regulations In your application, you will be asked to declare whether or not you are compliant with each of the essential standards of quality and safety for each regulated activity you provide at each location. We will assess your compliance against this declaration as part of our decision about whether or not to grant your registration. To help you decide whether you are compliant, you need to take account of our Guidance about compliance: Essential standards of quality and safety. This is available on our website at www.cqc.org.uk/standards or you can use the online interactive version at www.cqcguidanceaboutcompliance.org.uk. This guidance describes the outcomes and prompts that indicate what providers should be doing to meet the requirements of the regulations. You are not legally required to comply with each of the prompts, as they are there to guide you on how to comply with the legal requirements set out in the regulations: it is the regulations that you must comply with. If there are prompts that you do not meet, consider the regulation and whether you can show evidence in some other way that you meet the requirements of that regulation. To navigate your way around the essential standards, you will find it helpful to decide which 'service type(s)' your activities fall under. Most providers of out-ofhours services will fall within the service type of 'Mobile Doctors Services', although other providers may also fall under different service types such as 'Urgent care Providers of NHS GP out-of-hours services: How to apply Providers of NHS GP out-of-hours services: How to apply 8 8 services'. Service types are different from regulated activities. Details of the different service types are included in the essential standards. The regulation that covers the prevention and control of healthcare-associated infections is one of those included in the essential standards of quality and safety. We have not produced guidance about compliance with this regulation because the Department of Health issues the guidance in The Code of Practice for health and adult social care on the prevention and control of infections and related guidance. The code of practice is available from the Department of Health’s website: www.dh.gov.uk, and also includes decontamination requirements such as HTM 0105. You will need to use this guidance to help you make your decisions about compliance with that regulation. It is important to consider compliance in terms of the outcomes and experiences of people using your services. You may find that this is different from other monitoring systems you may have used. When you consider evidence in the form of policies, procedures and systems, you should think about them in terms of the impact they have on people’s outcomes and experiences. Your own auditing, monitoring, benchmarking against other services, feedback from PCT commissioners and other inspection activity, and feedback from patients are all examples of outcome evidence that you may be able to use in assessing whether or not you are compliant. Declaring non-compliance As your service is already in existence, but is now required to be registered for the first time from 1 April 2012, you do not have to be fully compliant with all of the regulations at the point of registration. If you are not fully compliant, you can declare non-compliance in your application form against any of the regulations that you don’t comply with. Where you declare that you are not currently fully compliant, you must submit an action plan detailing what you will do to become compliant and the date by which this will happen. Non-compliance is a serious issue and we expect it to be resolved by the agreed date to avoid us having to take compliance or enforcement action against you. All outcomes apply to all service types. It is not within CQC’s power to exempt any provider from any part of the legal requirements. However, each outcome should be read and assessed in a way that is appropriate and proportionate to the service in question. For example, you may query how Outcome 5: 'Meeting nutritional needs' applies to providers of GP out-of-hours services. In order to consider this you should also look at the Regulation, reproduced on page 76 of the Essential standards of quality and safety, as well as the outcome, set out on page 77. You will see that the regulation sets out the requirements in situations where food and hydration are provided to people using the service. This may happen very rarely, or not at all, in your service and you must make a judgement, and be ready to explain and justify it, about whether you are compliant with the requirement to the extent that it applies to your service, even if food, for example, is never provided. Non-compliance with this regulation would mean that people who use the service are not protected from risks related to nutrition or hydration and that the provider is unable to manage these risks. Providers of NHS GP out-of-hours services: How to apply Providers of NHS GP out-of-hours services: How to apply 9 9 Where there is evidence of non-compliance (whether you declare this or not) and the non-compliance is expected to continue after 1 April 2012, we may register you subject to compliance conditions. Declaring non-compliance does not necessarily mean that your registration will be subject to compliance conditions. We will assess the risk to people using your services. If the risk is low and you can show that you are taking appropriate steps to become compliant within a relatively short period of time, you may for example only be asked to confirm when your action plan has been completed. Registration fees You do not have to pay a fee for applying to register. However, once you are registered you will be required to pay an annual fee. This will be payable in the first year of registration after you have received your certificate of registration, and annually thereafter. We are currently consulting on our proposals for fees from April 2012, including those for providers of NHS GP out-of-hours services. The details of our proposals and how to respond to our consultation are available at: www.cqc.org.uk/public/sharing-your-experience/consultations/regulatoryfees-scheme-consultation . Providers of NHS GP out-of-hours services: How to apply Providers of NHS GP out-of-hours services: How to apply 10 10 3 What happens once you have applied? How we assess applications We will check your application for any confidential personal information (CPI) and that it has been completed accurately. If the application does not contain CPI and has been completed accurately, it will be assessed by a national registration assessor. We will assess your application alongside any other information available to us about your service. We will let you know if we need any additional information to support your application, but you are not required to submit any information with your online application form. We may also wish to speak to you or visit some or all of your services. However, our assessment activities will be targeted and proportionate. For example, if we don't have enough information about a provider from other sources, we are more likely to visit them or ask them for more information. We may also ask for information from third party organisations, or from patients and their representatives. Our decision about your registration Our registration assessors will use our guidance about compliance and judgement framework to help them decide whether or not to grant your registration. We will either: • Register you without compliance conditions, or • Register you with compliance conditions, or • Refuse all or part of your registration. Some conditions will be routine. For example, they will specify that you can only carry out a regulated activity at a particular location. These are called restrictive conditions. Where we have concerns about non-compliance, we may attach conditions that require you to make improvements to your service in order to meet the essential standards of quality and safety. These are compliance conditions. If we approve an application, we will issue a Notice of Decision. If you do not agree with our decision (including any conditions we impose), you can make written representations to us within 28 calendar days. Providers of NHS GP out-of-hours services: How to apply Providers of NHS GP out-of-hours services: How to apply 11 11 If we propose to refuse an application, we will send you a Notice of Proposal. You will also have 28 days to make written representations if you disagree with the proposed decision. We will send a final Notice of Decision either after the representations have been considered, or after the 28-day period has expired. If you do not accept the decision reached, you will have the right to appeal to the independent First-tier Tribunal. You can find further information about this on the Tribunals Service website at www.carestandardstribunal.gov.uk/. Services that are not compliant with the essential standards of quality and safety We want providers to make accurate declarations. If your service does not comply with the essential standards of quality and safety, you will need to submit an action plan that details what you are going to do to address the situation, and when you will do it by. We will consider the action plan alongside any other information we hold to make a decision about whether to register your service, with or without conditions. If a provider recognises its non-compliance, declares that in their application, and is already taking steps to address the problem, we will be proportionate in our response. After you are registered When your service becomes registered, we will send your registration certificate by email. The certificate will outline the details of the registered provider, the regulated activities you are registered to provide and the locations from which these are provided and/or managed. If the registration has further conditions applied, they will be described on the certificate. We will publish the register of providers on our website and keep it up to date. The register will describe each provider, the date of registration and any conditions applied. Each provider has a responsibility to inform us if they want to make any changes to their registration. If you want to provide a regulated activity at a new location – for example, carry on the same regulated activity but move to a new building – then you must apply to us for a variation of your existing registration. If you want to offer a new regulated activity, then you must apply to us for a new registration in respect of that activity. If your organisation changes, for example, because of a merger or acquisition, it is likely that the new organisation will need to re-register. Providers of NHS GP out-of-hours services: How to apply Providers of NHS GP out-of-hours services: How to apply 12 12 4 Keep up to date Get the latest information and guidance from our website: www.cqc.org.uk/primarymedicalservices. Join our provider reference group at www.cqc.org.uk/prg. Get a copy of our Guidance about compliance: Essential standards of quality and safety. You can either: • Download from our website at www.cqc.org.uk/standards. • Use a interactive online version at www.cqcguidanceaboutcompliance.org.uk, or • Order a hard copy from our publications line on 0870 240 7535. If you have any questions about registration or you need more information, you can: • • • Call us on 03000 616161 (press option 3 for registration, then option 2 for enquiries about primary medical services). Email us at [email protected], or Write to us at: CQC HSCA Registration Citygate Gallowgate Newcastle upon Tyne NE1 4PA Providers of NHS GP out-of-hours services: How to apply Providers of NHS GP out-of-hours services: How to apply 13 13 Need help? If you have any questions about registration or you need more information, you can: Look at our website: www.cqc.org.uk/primarymedicalservices Call our customer services on: 03000 616161 (press option 3 for registration, then option 2 for enquiries about primary medical services). Email us at: [email protected] Write to us at: CQC HSCA Registration Citygate Gallowgate Newcastle upon Tyne NE1 4PA Please contact us if you would like a summary of this document in another language or format (for example, in large print, in Braille or on audio CD).
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