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.
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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:
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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.
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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.
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Before making your online application, you should:
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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.)
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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).
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Things to remember:
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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.
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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.
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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.
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The questions you MUST complete are marked with an asterisk; please
answer the other questions as well if you have the information.
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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:
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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.
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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:
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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.
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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:
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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:
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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:
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Diagnostic and screening procedures.
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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
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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.
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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
.
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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:
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Register you without compliance conditions, or
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Register you with compliance conditions, or
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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.
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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.
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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:
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Download from our website at www.cqc.org.uk/standards.
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Use a interactive online version at www.cqcguidanceaboutcompliance.org.uk,
or
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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:
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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
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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).