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Registration under the Health and Social Care Act 2008
How to register an additional
regulated activity
Guidance for providers and registered managers
July 2011
PoC1C 100623 6.00 How to register an additional regulated activity: Guidance for providers and registered managers
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Introduction
This guidance explains how to apply to register an additional regulated activity for all providers
and managers who are currently registered under the Health and Social Care Act 2008.
It gives an overview of:
•
What you need to do to make an application.
•
What we will do with the information that you give us.
Background to the system
1. If you carry on a ‘regulated activity’, as defined by the Health and Social Care Act 2008, you
are required to be registered by the Care Quality Commission. This also applies to a person
seeking to be registered as a manager in respect of that activity.
2. The list of regulated activities is set out in the Health and Social Care Act 2008 (Regulated
Activities) Regulations 2010. These are available on our website (www.cqc.org.uk) and in
appendix C of our publication Guidance about compliance: Essential standards of quality
and safety.
3. To be registered by us, providers and managers must demonstrate that they meet essential
standards of quality and safety that apply across the health and adult social care sector.
4. To register an additional regulated activity, you must demonstrate in your application that
you will be compliant with the essential standards of quality and safety in respect of the new
regulated activity, and that any manager has the skills and ability to manage that activity,
for each location where you carry on that activity.
5. You are responsible for the quality of the services that you provide. It is up to you to
demonstrate to us that you meet the essential standards of quality and safety.
6. We will make a judgement on whether to register the new regulated activity based on the
information we already hold about you, along with the information you provide in your
application.
General guidance
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Why do we have to apply for an additional regulated
activity when we are already registered with you?
You need to apply to add an additional regulated activity because
section 10(1) of the Health and Social Care Act 2008 states: “Any person
who carries on a regulated activity without being registered under this
chapter in respect of the carrying on of that activity is guilty of an
offence.”
PoC1C 100623 6.00 How to register an additional regulated activity: Guidance for providers and registered managers
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You will need to complete an application form for each regulated activity
you want to add.
The registration regulations and outcomes in the publication Guidance
about compliance: Essential standards of quality and safety focus on
people’s experiences and what matters to them. Therefore, as a provider,
the statement that you give will need to show that you are meeting the
essential standards for the additional regulated activity you are applying
for, and will need to focus on demonstrating positive outcomes for
people who use services before you offer new services.
If you are applying as a manager, you must demonstrate your skills and
abilities to manage the additional regulated activity at the location(s)
where you manage.
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Which activities need to be registered under the Health
and Social Care Act?
The regulated activities are:
•
Personal care.
•
Accommodation for persons who require nursing or personal care.
•
Accommodation for persons 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 persons detained under the
1983 (Mental Health) Act.
•
Surgical procedures.
•
Diagnostic and screening procedures.
•
Management of supply of blood and blood derived products etc.
•
Transport services, triage and medical advice provided remotely.
•
Maternity and midwifery services.
•
Termination of pregnancies.
•
Services in slimming clinics.
•
Nursing care.
•
Family planning services.
For more detail of what is included within these activities, you should
read the Health and Social Care Act 2008 (Regulated Activities)
Regulations 2010, and also our Scope of registration document, available
on our website.
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Before you submit your application – pre-application stage
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What should we be doing now?
You need to look at the Essential standards of quality and safety so that
you are fully aware of the essential standards before you submit your
application. To prepare for the new activity, providers may have to make
changes to their premises. Also, you may need to demonstrate your
staff’s experience and training, and how the additional services will be
provided.
Managers should understand the outcomes that people who use services
will expect, for the additional regulated activity.
How to fill in your application and declaration – application stage
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Which forms do we need to fill in?
You need to complete one main application form to be registered for
each additional regulated activity. There are separate forms for providers
and managers. The forms are available on our website.
If applicable, the manager and provider applications must be sent in
together or the application will be considered incomplete and invalid.
5
If we want to provide or manage the activity at different
locations, do we need to fill in a separate form for each
location?
There is one main application form, which allows you to specify one
existing location and one new location. If you will provide the new
activity at more locations, there are supplementary forms for each
additional location.
If you are a provider, as part of your application you will need to declare
that you comply with regulations for the new regulated activity you wish
to be registered for, at each of the locations you have.
If you are a manager, you have to demonstrate your qualifications and
skills to manage the additional regulated activity.
You can download the supplementary forms from our website.
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How much information do we need to include in our
application?
You will be asked to give a statement of how you will comply with the
regulations that are relevant to the additional regulated activity you wish
to provide.
You will then need to declare your compliance with all the regulations.
It is important that you make true and accurate declarations. Where there
is any doubt we may ask for further evidence, and a false or misleading
declaration would be an offence under Section 37 of the Health and
Social Care Act 2008.
It is illegal to carry on a regulated activity before you are registered, and
you must not backdate the application form. You are only registered
when we issue you with a Notice of Decision.
Managers are asked to give details on how they are skilled to manage
this regulated activity, and whether this is a job share position.
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Will we have to submit evidence of our compliance with
regulations?
No. You don’t have to submit further evidence unless we ask for it.
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Do we need to send you supporting information, like
building certificates?
No. You do not need to include supporting information. If we require
evidence to demonstrate your compliance, we will ask for it separately.
You are, however, required to send in a copy of your revised statement
of purpose to reflect the application.
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Do we have to give additional information if we are
adding a new location at the same time as the new
regulated activity?
Yes. You must give more details about the location and whether it is fit
for purpose.
If you are a manager and you are adding a new location to your
registration, you will need to give more details but you are not required
to declare that the premises are compliant.
10
Do we also have to apply for a variation if we are adding a
new location alongside the new regulated activity?
No. The application for a new regulated activity allows CQC to ask for
sufficient information from both providers and managers within the
application form on any new location.
We may ask you to provide further details depending on the size and
complexity of the location you are adding to your registration.
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Do we have to give details of a nominated individual?
Yes. If you are an organisation, a nominated individual is required for
each regulated activity.
This may be a current nominated individual or a new person.
Where this is a new person, you must ensure that all the documents are
available for the assessor, if they request them.
The requirement for a nominated indvidual only applies to organisations.
It does not apply to individual providers, partnership providers or
managers.
12
What happens if our application is incomplete?
We cannot process incomplete applications and we will return or reject
them.
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Are we allowed to resubmit an application?
Yes, you can resubmit your application with the elements that were
missing from the first submission.
Once we have accepted an application, we will begin to process it.
If we require further information or evidence to support the application,
we will contact you.
If you subsequently need to amend your application, you will have to
confirm this in writing. We will let you know if the amendment can be
accepted.
Amendments may cause delay. If, as a result, we are not able to process
your application in time, you could be left operating without registration,
which is an offence.
You can read further guidance on making amendments on our website.
14
Is there a fee for this application?
No. There is no fee for adding a new regulated activity.
Where a new location is being added to your registration along with the
new regulated activity, any changes to your annual fee will be seen in
your next annual fee account. You will not incur any additional fees
before that date.
How we assess applications – assessment stage
15
What happens once you have accepted our application as
complete?
We will assess your application and declaration of compliance alongside
any information we already hold, including the outcomes from our
ongoing monitoring of your compliance.
We will let you know if we need any additional information.
We are most likely to telephone you to clarify any issues, or request
further documentation.
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In exceptional circumstances we may visit you, especially where facilities
may have been altered or where we do not have the information to make
a robust decision, or where there is evidence of ongoing non-compliance.
Where the application is part of a corporate group, we will liaise with the
quality and risk managers.
16
Do you expect us to notify you of any changes during the
application process?
Yes. You must inform us of any information that is relevant to the
application.
Further information is available in our guidance on making amendments,
available on our website.
17
Will existing conditions be transferred to our new
registration?
Some conditions are routinely applied to all providers and managers.
We will make any additional conditions where these are required.
18
Will you make a visit or any interviews as part of this
process?
We may need to speak to a provider or visit services to confirm
compliance but we do not anticipate this being necessary on a routine
basis.
Where a manager is applying, we may undertake a further interview
depending on the information supplied within their application form to
assess their fitness to manage the new regulated activity.
19
What if one of our services is subject to ongoing
enforcement activity. How will you take this into account?
If enforcement activity is underway in a service that is currently
registered and you wish to add an additional regulated activity, you
should be aware that depending on the enforcement activity this may
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have a bearing on your further applications and you should contact your
assessor to discuss your proposals.
This is also relevant to any manager who may have enforcement action
being taken against them.
20
Are you getting information from anyone else as part of
this process?
Yes. We may ask people who use services and other agencies for their
views and we are currently setting up systems to do this.
How we make our judgement – outcome stage
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How will you ensure your judgements are consistent?
We have a judgement framework in place to make sure that we are
making consistent decisions, both regionally and nationally.
We also have a quality framework in place to review the consistency and
quality of our registration decisions.
If a provider or manager is concerned about the outcome of their
application they will be able to make representations before a decision is
made.
We aim to complete all registrations in an eight-week period, but this
depends on the completed application form being correct at time of
submission. The timescale will be longer if:
• We have requested additional information but that information
has not been returned to us within five working days.
• There is a change to an application (or other delays) which is
beyond CQC’s control (these include slippage in completion dates
for changes in ownership and premises not being ready).
• An application is submitted more than (eight) weeks before the
date the registration will take effect.
• We carry out a site visit or interview an applicant a second time or
more because of concerns identified as part of our assessment.
• There are significant concerns regarding the provider’s operation,
or enforcement action that could affect the decision to vary
registration.
• We have to impose a condition of registration.
• We refuse registration.
• An application is submitted on paper copy rather than
electronically.
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The appeals process – representation and appeal stage
22
If we do not agree with your decision, can we appeal
against it?
If we make a proposal to register you in a different way than you applied
for, you will able to make representations against our registration
decision that was set out on the Notice of Proposal. We would then issue
you with a Notice of Decision.
If you are not satisfied with registration set out in the Notice of Decision
you can then appeal to the external tribunal.
The external tribunal is called the First-tier Tribunal. The address is:
First-tier Tribunal – Care Standards Appeals
Mowden Hall
Staindrop Road
Darlington DL3 9BG.
The end result and what happens next
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Will we get a certificate for each regulated activity?
We will issue a certificate to both the provider and manager for all of the
regulated activities we have approved.
The certificate specifies:
•
The regulated activities that can be undertaken by the service
provider.
•
The regulated activities that can be managed by the registered
manager.
•
The conditions of registration that apply at service provider level for
each location.
The certificate details the regulated activities carried on at each of the
locations and sets the locations as a condition of registration.
It also details the individual conditions to be applied at each location.
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