The regulated activity of personal care consists of the provision of personal care for people who are unable to provide it for themselves, because of old age, illness or disability, and which is provided to them in the place where those people are living at the time when the care is provided. As an example, this includes personal care provided by a domiciliary care agency. It also includes Shared Lives schemes, in which cases the provider of the scheme is registered for personal care and not the owners or providers of the individual homes (accommodation).

A person managing a prison or other similar custodial establishment is exempt from having to register if they provide personal care for persons detained. However, for the purpose of the regulations, a prison will be considered where a person is living for the time that they are detained there. This means that if a domiciliary care agency provides personal care in prisons or similar custodial settings, the provider of the domiciliary care agency is required to register with CQC, because the exemption only applies to the person managing the prison.  

A fostering agency that is inspected by OFSTED, whose services include the provision of personal care to children that are placed or being placed, is exempt from having to register with us for the activity of personal care.

You do not need to register for this activity if you are registered or registering to provide the people using your service with accommodation together with the personal care for example, 'accommodation for persons who require nursing or personal care' or 'accommodation and nursing or personal care in the further education sector'. You need to think about the service you provide and if you are registering to provide a service that is accommodation together with personal care but you also provide personal care services to people in the place they live, then you will also need to apply for 'personal care'.

CQC will normally impose conditions on a provider's registration that restrict a regulated activity to a given location. These conditions mean that if a provider runs a care home at location A as well as a domiciliary care service from location B, registering only for 'accommodation for persons who require nursing or personal care' at location A will not cover the provision of 'personal care' from location B. This needs to be registered as a separate regulated activity from this separate location (see guidance on locations).

You may need to apply for other regulated activities if they are being provided to people at the location that forms the accommodation (such as ‘diagnostic and screening procedures’). It may form part of a list of activities that a provider is registered for.

You should not register if you provide carers (in the role of an employment or introductory agency):

• To another organisation who will then be responsible for direct provision of the care, or
• To an individual who will then wholly take responsibility for the provision of their own care under a personal budget or private arrangement.

You should not register if you are a carer employed by an individual or a related third party (without the involvement of an employment agency or employment business) and working wholly under the direction and control of that individual or related third party in order to meet the individual's own personal care requirements. A related third party means:

• An individual with parental responsibility (within the meaning of section 3 of the Children Act 1989) for a child to whom personal care services are to be provided.
• An individual with power of attorney or other lawful authority to make arrangements on behalf of the person to whom personal care services are to be provided.
• A group of individuals mentioned in either of the above 2 bulleted points making arrangements on behalf of one or more persons to whom personal care services are to be provided.
• A trust established for the purpose of providing services to meet the health or social care needs of a named individual.

Applications from domiciliary care agencies for the regulated activity of personal care are the most likely to be delayed or refused. If you're making an application, check that you include all the required information.

Shared Lives schemes (previously known as adult placement schemes)

Shared Lives schemes (referred to in The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 should register only for the regulated activity of 'Personal care' and not the regulated activity 'Accommodation for persons who require nursing or personal care'. This is because:

• The provider of the scheme is registered and not the owners or providers of the individual homes (the accommodation).
• The accommodation aspect of the service supplied by the Shared Lives carer  is out of the scope of the regulations, and the homes where service users live are not 'regulated premises' that we can inspect.

However, Shared Lives schemes should only be registered for 'personal care' where they provide placements for people with personal care needs. If they do not provide this type of placement, they will be out of scope for this regulated activity.

We have published guidance for providers about the interpretation of 'ongoing direction and control of a service' in the description of this regulated activity. The guidance will help you decide if you need to be registered for personal care.

The regulated activity consists of providing residential accommodation together with personal care (for example, a care home) or nursing care (for example, a care home with nursing).

It is important to consider the relationship between the accommodation provider and the care provider – whether personal care or nursing care is provided 'together with' the accommodation or whether they are provided separately – so that we can be clear about where the boundaries of responsibility lie.

In some cases, this activity includes accommodation together with personal or nursing care provided in an institution in the further education sector. For this activity to apply in the further education sector, more than 10% of the students receiving both accommodation and education at the institution in question must also be receiving personal or nursing care. We will normally judge this by considering student numbers over 12 months, rather than just on a single day.

An institution within the further education sector means an institution conducted by a further education corporation, or an institution designated as such by an order of the Secretary of State for Children, Schools and Families.

This activity does not include the provision of accommodation for people who require nursing or personal care in schools.

This activity is explicitly exempt from the provision of accommodation together with personal or nursing care to an individual by a Shared Lives scheme under the terms of a carer agreement. Shared Lives schemes should register only for the regulated activity 'personal care' if personal care is being provided and not the regulated activity of 'accommodation for persons who require nursing or personal care'. See the section on personal care for more information.

You do not have to additionally register for the activities of personal care or nursing care if you provide 'Accommodation for persons who require nursing or personal care'. The only exception to this would be if, as a provider, you also provide domiciliary care as a separate service. However, a provider may need to apply for other regulated activities where these apply. For example, a care home that also has intermediate care or palliative care services provided by one of its own health care professionals, may need to think about also registering for 'treatment of disease, disorder or injury'.

This regulated activity consists of residential accommodation for people together with treatment for substance misuse.

This covers 'residential' accommodation, which is not the same as hospital accommodation, as in detoxification treatment. For this activity to be carried on, the accommodation has to be provided to the same residents 'together with' treatment. This means that this activity does not apply to hospitals that provide detoxification treatments for substance misuse. In such cases, the detoxification being provided in the hospital would be covered under the activity of 'Treatment of a disease, disorder or injury'.

This does not necessarily mean that the treatment must be provided in the same place as the accommodation, it could be on a different site. For example, the treatment may be delivered in a community setting (a day centre or community centre), whereas people may be accommodated in separate facilities geographically. However, the accommodation and the treatment must be linked so that the accommodation is provided because someone requires and accepts treatment.

You do not have to additionally apply to register for the activities of 'personal care' or 'nursing care' if you provide this activity because they would be covered as part of the treatment being provided for the substance misuse. The only exception to this would be if as a provider you also provide personal or nursing care as a separate service (for example a domiciliary care service).

In respect of the regulated activity of 'treatment of disease, disorder or injury', the treatment for substance misuse is covered under the activity of 'accommodation for persons who require treatment for substance misuse'. The service would only have to apply for 'treatment of disease, disorder or injury' if other treatments were provided that are separate from the treatment of substance misuse. For example, this includes detoxification, but if a doctor from the substance misuse team treated a medical condition unrelated to the substance misuse, or was treating an eating disorder, or if a nurse was managing a holistic care plan for a dual diagnosis patient and administering treatment for both mental illness and for substance misuse, then the provider would also have to register for 'treatment of disease, disorder or injury'.

'Treatment' in this regulated activity would cover a range of recognised treatment interventions, such as managed withdrawal or detoxification or a structured psychosocial treatment programme. These types of treatment will always trigger the need for registration for this regulated activity if they are provided together with residential accommodation: this is not limited only to cases where they are provided by healthcare professionals.

This activity covers a treatment service that is:

1. provided by a health care professional (see list in glossary), or a social worker in the case of mental health treatment, or by a multi-disciplinary team that includes a listed health care professional, or social worker where the treatment is for a mental disorder, and is
2. related to disease, disorder or injury.

It includes a wide range of treatment, such as, but not limited to, emergency treatment, ongoing treatment for long-term conditions, treatment for a physical or mental health condition or learning disability, giving vaccinations/immunisations, and palliative care.

This regulated activity applies to the treatment of disease, disorder or injury in any setting, for example hospitals, clinics, hospices, ambulances, community services, and care homes.

What is included in this regulated activity?

• Any treatment that is for the treatment of a disease disorder or injury.

What is excluded from this regulated activity?

• Purely cosmetic interventions.
• Most alternative and complementary therapy.
• First aid where it is delivered by:
  • Health care professionals in unexpected or potentially dangerous situations requiring immediate action.
  • Non-health care professionals who are trained to deliver such treatment.
  • Treatment provided in a sports ground or gymnasium (for people taking part in, or attending, sporting activities or events).
• Treatment provided through temporary arrangements for sporting or cultural events (such as festivals, championship sporting events or motor sport events).
• Hyperbaric oxygen therapy provided to workers in connection with their work or when governed by the Diving at Work or Work in Compressed Air regulations.
• Activities authorised by a license granted by the Human Fertilisation and Embryology authority.

Sometimes, 'treatment of disease, disorder or injury' is provided as a minor component of a service – for example, a large care home that has just a few intermediate care or specialist palliative care beds. 'Treatment of disease, disorder or injury' if carried out by or under supervision of a listed health care professional will still require registration in its own right and in addition to any other activities that the provider may need to register for that service.

If those services are provided by another body (such as a primary care trust), please see the guidance on hosted services earlier in this document which will apply.

What other regulated activities do I need to register for?

You should apply for other regulated activities if you are providing them, for example:

• 'Surgical procedures'.
• 'Diagnostic or screening procedures'.
• 'Assessment or medical treatment for patients who are detained under the Mental Health Act'.
• 'Services in slimming clinics'.

Are any other regulated activities covered by this one?

Yes, if you are registered for this activity and its delivery includes:

• personal care
• nursing care

you would not need to additionally apply for those activities.

Who must carry out the regulated activity for it to be in scope?

The principle is that a provider will require registration for this regulated activity if the service includes treatment carried out by or under the supervision of a listed health care professional, or a social worker where the treatment is for a mental disorder, and is intended to treat disease, disorder or injury. Health care professionals are defined, for the purpose of this activity only, in a list (see glossary).

If a multi-disciplinary team includes one of these health care professionals (or a social worker in the case of mental health treatment), then the activity will be within scope and needs to be registered.

However, there may be occasions when the person providing treatment is not acting in the capacity of a listed health care professional, even if holding a professional qualification (for example, a beautician undertaking a cosmetic/aesthetic service who is also qualified as a nurse).

Also, there may be times when it is not clear if the service is treatment or is being carried out for another reason (for example, some interventions that are normally aesthetic, such as laser hair removal, may also be carried out in response to a clinical disorder).

It may also be unclear if a particular treatment is for a disorder (for example, obesity may in some cases be classified as a disorder, and a certain medical treatment recommended, while a person may also be seeking that same treatment for cosmetic or wellbeing reasons).

These scenarios will normally be rare, and will need consideration on a case-by-case basis. However, a significant area in which they may arise frequently is community mental health care (including primary mental health care). Some psychological therapies may be provided by health care professionals, social workers or by others with specific qualifications. In these cases, some services will require registration, whereas others will not, depending on the use of, or supervision by, health care or social work professionals.

What professionals would not be included in the scope of this regulated activity?

Certain defined professionals are not included on the list in the regulations. These include:

• Clinical psychologists
• Occupational therapists
• Physiotherapists
• Pharmacists.

Standalone treatment services run by these professionals are not required to register.

This means most (but not necessarily all) specialist mental health services provided by social workers who are working in their professional capacity as a social worker will be within the scope of this regulated activity. For example, treatment includes the ongoing assessment of a person’s mental state or where the social worker is providing a psychological therapy. Other types of social work services will not be captured by this regulated activity.

Health care professionals and social workers are only relevant to this regulated activity where they are involved in it in their capacity as a listed health care professional or social worker. For example, a psychiatrist may also be qualified as a psychotherapist. Where he or she practices as a psychiatrist – a registered medical practitioner – it may be captured by this activity. Where he or she practices solely as a psychotherapist, it would not be captured by this activity.

This principle will apply in the same way to many other services in addition to the examples given and these will need to be considered on a case-by-case basis.

What is treatment "under the supervision of" a listed health care professional or social worker?

The care of the person is under the supervision of a health care professional (HCP) (as listed in paragraph 5(4) of Schedule 1 of the regulations) where the HCP:

1. Is part of the team who directly provides care to the person, or
2. Directly reviews the individual person's case and sets out a plan of care for the person even if this plan is executed by another person, or
3. Authorises a protocol of care, used by other care givers, that:
   1. they are directly accountable for, and
   2. they are required to continually monitor, and
   3. can only be authorised by them by virtue of their professional registration, and
   4. when it is used, the individual details of the people who are provided care under its remit are directly recorded for the purposes of the protocol

Is delegation different to "under the supervision of"?

Yes, when a health care professional employed by one provider delegates a procedure to a care worker employed by a second provider, such as a care home without nursing or a domiciliary care agency, the second provider cannot be considered to be carrying on the regulated activity. The provider accepting the delegated task will not be required to register for this regulated activity.

This is because a health care professional employed by one provider will not be responsible for the supervision of staff of another provider. A provider (employing staff) cannot accept vicarious responsibility for non-employees.

The Nursing and Midwifery Council (NMC) have published The Code: Standards of conduct, performance and ethics for nurses and midwives (2008), which sets out the requirements for registered nurses and midwives to delegate effectively to other people, and to always act within their area of competence. 

The NMC have also issued advice regarding delegation by nurses to other people such as carers. You can find this advice on the NMC website.

It is the employer’s responsibility to ensure that they do not allow their staff to accept delegated tasks unless the staff have sufficient support, supervision, education and training to competently undertake the aspects of care that are being delegated.

Examples

Administering medication where the activity of 'treatment of disease, disorder or injury' will not apply:

In the case of administration of medication that has been prescribed and dispensed for the person or is a 'homely remedy' (including over-the-counter medicines, complementary therapies and herbal preparations) and is administered by a carer or a health care professional, the regulated activity will NOT apply:

1. Where the person using the service would normally be able to administer the medication in question for themselves, but where, due to circumstances or personal choice, the person has consented for the medicine to be administered to them, or
2. Where the person would ordinarily be able to administer the medication for themselves but due to circumstances, or where the person is unable to make a decision in relation to taking their medication, it has been agreed to be in the person’s best interest for the medicine to be administered to them.

The following examples will also NOT constitute the activity of 'Treatment of disease, disorder or injury':

• A care worker or health care professional administers prescribed insulin that has been dispensed and the person cannot manage to draw up or inject the insulin themselves, where the person would normally be able to administer the insulin themselves.
• A care worker administers an oral prescribed controlled drug, where the person would normally be able to take their own prescribed drug.
• A care worker who prompts and/or supervises a person to take their prescribed medication.
• A care worker may care for people receiving nutritional support through a PEG feed or provide pressure area care delegated by a district nurse (a registered health care professional) who works for another provider.

The following WILL constitute the activity of 'Treatment of disease, disorder or injury':

• A situation when a nurse or health care professional is required to either prescribe or administer medication. 
• When the nurse or health care professional is required to have knowledge or training to undertake the administration of the medication, or when a person would not normally be considered to be able to administer the medicine by themselves.
• Administration of an intravenous (IV) antibiotic or other IV drug (requiring training in reconstitution, mathematical calculation, examination and care of the IV site and more).
• Administration of chemotherapy in a person’s home or a residential home, or any other setting. This will require training in administration, IV pumps, blood result checks, examination and care of the IV site, and what to do if extravasation occurs.

The list of professional roles are protected titles, why is this important?

Use of professional titles is protected by law. Where a professional title is used, the assumption will be that the service is being carried out by someone acting in their capacity as a registered health care professional and directly using their professional qualification. This means that if the profession is one of those on the list in the regulations, registration will usually be required.

If the service does not involve the professional qualification, and the protected title might be being used inappropriately in the description of the service or solely for other purposes (such as marketing), the matter may be referred to the relevant professional regulator.

Anomalies have occurred where care homes without nursing have employed nurses or other health professionals as care workers. The key question to consider is whether the person providing the service is using their professional qualification in the job they are employed to do.

Where the person's qualification is coincidental or only relevant as background knowledge, it will not trigger the need for registration. However, in this case the health professional should not be using their professional registration status, or presenting themselves as that health professional.

Example:

• A qualified psychoanalyst, who is also qualified as a psychiatrist but is not prescribing or using medical interventions, will not need to register for her psychoanalytic practice. She is acting in her capacity as a psychoanalyst (not in the list of health care professionals) and not as a doctor. She is not using the specific skills taught in medical training, but is using the specific skills taught in psychoanalytic training. She is not using statutory authority or powers, which require a medical qualification (e.g. prescribing).
  She is not presenting herself as a psychiatrist, but as a psychoanalyst.
• A drugs worker, who is also qualified as a social worker, will not need to register if he is working as a drugs worker. However, if he is working as a social worker then the service will require registration. It is possible to ascertain if he is working as a social worker because he is clearly using the specific skills taught as part of social work training, or he is presenting himself as a social worker and using that protected title to describe his work.

Service specific guidance

Lasers and intense pulsed light (IPL)

Lasers and IPLs used for non-surgical procedures are often used for cosmetic procedures such as hair removal, and for therapeutic procedures, e.g. minor dermatological conditions. They are used by beauty therapists and health care professionals.

These procedures can constitute appropriate treatment of recognised medical disorders and can be safely and appropriately carried out by beauty therapists with training in the use of the laser or IPL. It is not uncommon for dermatologists to refer or advise patients to visit a beauty therapist because, even in a clinical service such as dermatology or plastic surgery, very few laser or IPL procedures require the skills of a health care professional.

Use of lasers and IPLs is not part of professional training in health care professions, and while a health care professional’s knowledge of physiology and physical and mental conditions may well add value to a service, it is usually as background knowledge rather than as use of professional training.

Providers of laser and IPL services provided by listed health care professionals will only need to register where:

• The specific skills of a listed professional are used, e.g. where the service is part of a package of clinical care and requires specialist physiological and psychological knowledge such as use of a laser as part of plastic surgery procedures (in this case the regulated activity of surgical procedures would apply), or
• The service is combined with other procedures that require a listed health care professional qualification, e.g. prescribing, or
• The service is described by the provider as carried out by someone acting in their capacity as a registered health care professional.

First aid

First aid is:

• The initial response to a sudden illness, condition or injury or exacerbation of an existing illness.
• Restricted to the aim of either alleviating it immediately through simple procedures and/or preventing it worsening until professional medical help is available.

First aid may include simple non-invasive physiological monitoring techniques carried out as part of the overall first aid care and be provided by lay people or health care professionals.

In the case of health care professionals, they will not rely upon broader knowledge and skills developed through professional training but will use only skills and knowledge that are to be reasonably expected of a person having received recognised training in first aid.

Our view is that:

• A first aid service may involve health care professionals, but only where they are acting only in their capacity as a first aider. For example, they are not prescribing, following a patient group directive, using specialist drug administration techniques, or using other specialist skills that reflect their professional training rather than their first aid training.
• A first aid service may involve simple procedures for assessment that do not require a recognised professional diagnostic qualification (eg as a radiographer or sonographer) and that are limited in their purpose to assessing the need for onward referral for treatment. This includes use of a 2- or 12-lead ECG, automated non-invasive blood pressure measurement, pulse oximeter, use of a thermometer, sphygmomanometer or ophthalmoscope.

Care homes with nursing

Care homes with nursing are likely to need to register for this regulated activity, as they will probably employ nurses or other listed professionals that carry out these activities. There may be exceptions to this rule, but only when the nursing staff do not actually carry out the treatment for a disease, disorder or injury.

Care homes without nursing

Care homes without nursing should not register for this regulated activity. This is because if they are carrying out these treatments, it will likely be by delegation from a health professional already registered under another provider.

Treatment for substance misuse

The types of professionals in the list that most commonly work in substance misuse services are medical practitioners, nurses and social workers. If any of these professionals are working in their registered capacity and providing treatment as part of a multi-disciplinary team, it means that the whole team will be within the scope of registration as providers of this regulated activity, and the organisation that employs them will have to be registered as providing treatment for a disease, disorder or injury.

However, if the service does provide substance misuse treatment but the team does not include any of these professionals working in their registered capacity (under their protected professional titles), then the provider does not need to be registered for this regulated activity. For example, if the service provider employs staff as drug and alcohol workers as part of a community based multi-disciplinary drug and alcohol team, but the team does not include a medical practitioner, nurse or social worker, then the provider does not need to register for this activity.

Where people are not being provided with residential accommodation and they are receiving treatment of detoxification, then the provider will have to be registered for the regulated activity of treatment for a disease, disorder or injury if prescribed professionals are involved in that activity.

Research settings

'Treatment of disease, disorder or injury' may also be provided, sometimes as a secondary purpose, in research settings. Where the research forms part of a person’s treatment for disease, disorder or injury, and is carried out by or under supervision of a listed health care professional, the provider will need to register for this regulated activity. Research organisations that carry out clinical trials on people who are not being treated will not be required to register for this activity. 

This regulated activity relates to the treatment of people who are detained in, or recalled to, hospital for assessment and/or medical treatment under the Mental Health Act 1983. This includes people whose initial detention was under another enactment but which has taken effect as a Mental Health Act detention.

This regulated activity only applies to the use of the Mental Health Act in hospitals, rather than its use in any other setting, so it does not apply to locations that are not a hospital (including prison, community or residential treatment settings for substance misuse or community-based mental health services). It excludes detention under sections 135 or 136 of that Act where people are removed to a designated place of safety (usually a hospital but which, under exceptional circumstances, can be a police cell). 

It includes the use of short term, emergency holding powers under Section 5 of the Mental Health Act. It therefore also applies to hospital services other than specialist mental health inpatient services, such as acute hospitals, where the Mental Health Act could be used to detain patients for short periods under temporary arrangements.

This regulated activity does not apply to assessment or treatment by a medical practitioner appointed to provide a second opinion. This means that treatment for the purposes of Part 4 of the 1983 Act in giving a certificate under section 57, 58 or 58A of the Act is exempt from registration. (This is commonly referred to as treatment or assessment by a SOAD.)

If you apply for this regulated activity and you also provide treatment for persons who are not detained or not liable to be detained, you may also need to apply for the activity of ‘treatment of disease, disorder or injury’.

You would not need to additionally apply to register for the activities of personal care or nursing care if you provide these activities in the same service. However, you would need to apply for other regulated activities if you were providing them, for example, treatment for disease, disorder or injury in cases where treatment is provided for informal patients (those not detained in hospital under the Mental Health Act).

Medical treatment in relation to mental health and this regulated activity

Medical treatment, only for this regulated activity, is defined in the Mental Health Act 1983 as including:

• Nursing, psychological intervention and specialist mental health habilitation, rehabilitation and care offered to alleviate, or prevent a worsening of, a mental disorder or one or more of its symptoms or manifestations.

This regulated activity covers the following procedures carried out by a healthcare professional:

• Surgical procedures for the purpose of treating disease, disorder or injury; or cosmetic surgery; or for religious observance (eg circumcision)
• Surgery carried out for the purpose of sterilisation or reverse sterilisation.

However, minor surgical procedures are not captured if they are:

• Undertaken by a medical practitioner and the minor procedures are limited to:
  • curettage (scraping), cautery (burning) or cryocautery (freezing) of warts, verrucae or other skin lesions, and
  • are carried out using local anaesthesia (or no anaesthesia).

or

• Undertaken by any health care professional and the procedures are limited to:
  • nail surgery and nail bed procedures on the foot and which are carried out using local anaesthesia (or no anaesthesia)
  • curettage (scraping), cautery (burning) or cryocautery (freezing) of warts, verrucae or other skin lesions on any area of the foot and which are carried out using local anaesthesia (or no anaesthesia).

What does the regulated activity cover?

The regulated activity covers the surgical procedures referred to above. A provider of surgical procedures will usually need to register for other regulated activities. For example, the use of imaging techniques during surgery may require registration for 'diagnostic and screening'.

It covers all pre- and post-operative care associated with the surgical procedures. In relation to pre-operative care, this might include, for example, assessment by an anaesthetist shortly in advance of the procedure (where that assessment is an assessment of the patient’s suitability directly related to the procedure) but would not include an initial consultation with a surgeon before the procedures had been decided.

In relation to post-operative care, the activity must be related to the procedure for it to be captured and this will normally mean that it is planned to be related to them. This may include, for example, post-anaesthetic care (recovery), follow-up in an intensive care unit, or rehabilitation where they are part of a planned pathway of care. The extent of pre- and post-operative care may include a planned subsequent follow-up consultation after surgery, but would not include any further treatment (that is additional, beyond checking on the procedures) that is decided in that follow-up consultation. It would include other treatment where that is directly related to the surgical procedures and carried out under the surgical team. For example, if a pre-existing prescription for medicines is temporarily changed by the anaesthetist in order to avoid any conflict with anaesthetic drugs. But if the treatment goes beyond the surgical team, for example, change of prescription not by the anaesthetist but by the patient’s cardiologist, then that is considered to be treatment in its own right rather than associated with the surgical procedures.

The key principles are that the activity must be:

• Directly related to the surgical procedures, so only from the point at which the surgical procedures are decided upon.
• Only the planned pathway of care, not subsequent treatment.
• Only within the surgical team, not the activity of other health care teams that may be taking place at the same time.

Surgical procedures carried out for religious reasons, such as circumcision, are included where they are carried out by a health care professional. Where a health care professional carries out surgery for religious purposes they will be acting in their capacity as a health care professional rather than in a religious or spiritual role. This is because a registered health care professional's code of practice will prohibit them from disregarding the need to have appropriate skills, experience, equipment and facilities for this procedure and they cannot 'opt out' of their core duties and responsibilities as a registered health care professional, even if they are acting in a spiritual or religious role.

Cosmetic surgery

Cosmetic surgery is not defined separately but the procedures that are captured by this regulated activity include those described as being for cosmetic purposes if they involve the insertion of instruments or other equipment into the body. For the avoidance of doubt, the activity does not include:

• Piercing
• Tattooing
• Subcutaneous injections to enhance appearance
• Removal of hair or minor skin blemishes by application of heat using an electric current.

As an example, we consider liposuction involving the insertion of instruments into the body to be included in this activity. This is regardless of whether the liposuction is carried out using general or local anaesthesia, or whether the procedure involves the administration of a laser through a cannula inserted into the body. However, a procedure such as the external application of ultrasonic energy without any incision or insertion of instruments into the body is not considered a surgical procedure.

Hospices

A hospice should not ordinarily be registered for the regulated activity of 'surgical procedures'.

This is because it is unlikely that a hospice would carry out surgical procedures other than pleural taps and abdominal paracentesis. These will instead be considered as treatment under the regulated activity of 'treatment for disease, disorder or injury' for the purpose of registration.

This regulated activity includes a wide range of procedures related to diagnostics, screening and physiological measurement.

All diagnostic procedures involving the use of any form of radiation (including x-ray), ultrasound or magnetic resonance imaging to examine the body are included. This will include all main forms of diagnostic radiology, radiography and sonography (including antenatal ultrasound scans), but it will not include use of the same technology for therapeutic purposes such as radiotherapy or some forms of interventional radiology (those will require registration for the activity of 'treatment of disease, disorder or injury'). The activity also includes the analysis and reporting of the examinations that are carried out.

If the provider using the x-ray, ultrasound or magnetic resonance imaging is the same provider who is carrying out the analysis and reporting, then this may be included within a single registration; if a remote contractor is used for diagnostic analysis, the analysis and reporting will require registration in its own right.

Where diagnostic images are reported remotely by a subcontracted provider who is outside England, the subcontractor will not be registerable as they fall outside of CQC's remit. However, we will hold to account the registered provider who made the contract with the subcontractor for the way the service is delivered and to make sure that there are appropriate arrangements for the service to be delivered, including arrangements for quality assurance.

The activity includes many, if not all, forms of endoscopy because it captures procedures if they involve the use of:

• Instruments or equipment, which are inserted into the body to:
  • view inside of the body, or
  • gather physiological data.

The activity includes instances of taking a sample or biopsy because it captures procedures if they involve removal of tissue, cells or fluids from the body, for the purpose of diagnosing disease, disorder or injury or monitoring its cause or extent. Therefore, anyone who 'removes' tissue, cells or fluids from the body for diagnostic reasons must register.

The activity also includes anyone who uses equipment to examine tissue, cells or fluids from the body to obtain information on the cause and extent of a disease, disorder or injury. If the provider removing the sample is the same provider who is carrying out the examination then this may be included within a single registration; if a remote contractor is used for diagnostic analysis, such as a laboratory company, the analysis will also require registration in its own right.

There are a number of exclusions that apply to this activity, which are set out further on in this section.

This regulated activity also includes physiological measurement; that is the use of equipment to measure or monitor physiological data in relation to the following systems:

• audio-vestibular
• vision
• neurological
• cardiovascular
• respiratory
• gastro-intestinal system, or
• urinary system

for the purposes of obtaining information on the causes and extent of a disease, disorder or injury, or the response to a therapeutic intervention, where such information is needed for the purposes of the planning and delivery of care or treatment.

Physiological measurement diagnostic services provide a wide range of specialist investigations and procedures that are often an essential part of care and treatment for patients. Physiological measurement includes not only assessment of the function of major organ systems, but also measurement and tests that are part of normal clinical care when carrying out other regulated activities that a provider will already be registered for under the Health and Social Care Act 2008 (HSCA).

Exclusions

The following physiological tests are not included within the definition of physiological measurement and so will not lead to registration for this regulated activity:

• 12 lead electrocardiograph recording (ECG).
• Pulse oximetry when used for 'spot' recording.
• Peak expiratory flow measured by a peak flow meter.
• Screening or non-diagnostic spirometry.
• Non-ambulatory blood pressure recording.
• Use of an auroscope.
• Carrying out a hearing needs assessment or supply and fitting of a hearing aid carried out by a hearing aid dispenser or a person acting under the direction or supervision of a hearing aid dispenser, where:

1. The person is aged 19 or over, or
2. The person is under 19 and the procedure is carried out in, or arranged by, a school or 16-19 Academy.

The following procedures are also excluded from this activity:

• Procedures carried out for research, or analysing and reporting such procedures. However, this exemption only applies where those research procedures do not form part of a person's care or treatment. As an example, a university that has an imaging department would only be required to register with us if they carry out a radiological examination as part of the care of a patient. This is because such procedures would be part of a person's treatment pathway. They would not be required to register with us if they restricted their examinations to research exposures on subjects or for teaching purposes using 'phantoms'.
• The national cancer screening programmes are excluded. However, other national screening programmes are not excluded and must register if they are providing any aspect of the regulated activity.
• The taking of x-rays by registered chiropractors or the use of ultrasound by registered physiotherapists.
• Fitness screening procedures in a gymnasium, related to the use of fitness equipment or fitness activities, (treadmill tests for clinical purposes, however, are not exempt).
• Blood tests carried out by means of a pin prick test, or removing blood from a vein where the sample is not sent to a laboratory for analysis.
• Taking urine samples where the sample is not sent to a laboratory to be analysed.
• The sending of samples of body fluids to a place to be analysed, where the samples are not collected or taken by the provider. For example, when a person produces a urine sample and the provider sends it away to be tested.
• Procedures carried out by a person in connection with any of the activities authorised by a licence granted by the Human Fertilisation and Embryology Authority.
• The taking or analysing of samples of tissue, cells or fluids in order to determine the existence of a genetically inherited disease or disorder, or to determine the influence of an individual’s genetic variation on a drug response. However, such tests are not exempt if carried out as part of:

1. the planning or delivery of the individuals treatment or care, or
2. a national screening programme other than a national cancer screening programme.

A provider may be registered for this regulated activity in addition to any number of other activities. This activity is not restricted to services provided by health care professionals.

There are certain low risk procedures that we will consider as part of a provider's overall registration with us; in other words providers registered with us will not have to register for this activity solely because they carry out the following procedures:

• Taking blood or urine samples.
• The analysis of urine or stools by means of a dip stick or other reagent.
• The taking of a swab from any external part of the body or from the mouth, ear, nose or throat.
• Removing skin scrapings.

This regulated activity covers the management of:

a. The supply of blood, blood components and blood-derived products for transfusion. For example, this will include the management of supply of blood by NHS Blood and Transplant; a provider managing the supply of blood to another provider; or a service from a dedicated unit, such as a central or regional facility set up for the purpose of providing this service to individual hospitals in a corporate group.

b. The supply of tissue or tissue-derived products for transplant, grafting or use in surgery. For example, this will include supply of organs or tissue by NHS Blood and Transplant or any other provider of transplant organs.

c. The matching and allocation of donor organs, stem cells or bone marrow for transplant or transfusion. For example, this will include the role of NHS Blood and Transplant or any other organisation that is involved in managing the supply of donor organs.

This activity does not apply to the management of supply of products described in paragraphs a) and b) where that management does not involve direct physical contact with patients or donors from whom products are administered or derived.

In relation to blood and tissue products, this activity concerns the management of the supply. That does not include storage of, access to, and use of these products within a hospital. Having appropriate equipment and supplies, and storing them, will be part of other activities such as 'treatment of disease, disorder or injury' or 'surgical procedures', rather than an activity in its own right.

This activity does not capture a taxi service or other form of transport provision that transports blood, organs or tissue products between providers.  

It does not capture autologous transplant, in which tissue is taken from an individual and stored in order to be implanted back into him/her later. For example, a dental provider removing and storing tissue or bone from a patient and re-implanting it into the same patient at a later date. It also does not include autologous blood transfusion.

It does not capture situations in which a provider’s role is only to remove an organ where the patient has chosen to be a donor (for example, removing an organ from a donor would be registerable under the regulated activity of 'surgical procedures'). In this case, a separate agency such as NHS Blood and Transplant will be responsible, and would need to be registered for the onward supply of the organ to the transplantation service provider.

In relation to donor organs, stem cells or bone marrow, the activity covers all of the supply procedures, from donation to matching and allocation.

It does not cover the organ demand procedures, such as managing requests or waiting lists for transplantation. 

This regulated activity covers two main service types:

• Transport (ambulance) services, and
• Remote medical advice.

Transport services

Services are captured by this regulated activity where they involve a vehicle that was designed for the primary purpose of transporting people who require treatment. Transport services provided in vehicles that have a different primary purpose (such as taxis, volunteers using their private cars, or mortuary vehicles and Dial-A-Ride vehicles) are not captured in this regulated activity, even though they may be registered with the Driver and Vehicle Licensing Agency as ambulances. Search and rescue transport services are also currently exempt because the service is provided under arrangements made on people’s behalf by a government department.

Because it is the nature of the vehicles used that determines the need to register, transport services provided in ambulances operated by hospital providers will require registration, as well as transport services provided by ambulance only providers. The term 'designed for' will apply to vehicles used to transport people who require treatment not only where this was the manufacturer's original design, but where a vehicle has been made suitable for this purpose (e.g. modification, livery, etc). Air ambulances and water ambulances are also included in this regulated activity. However, providers of air ambulances services are exempt from the activity where the aircraft used is registered with the Civil Aviation Authority and that same provider is not carrying out treatment to a patient. Air ambulance providers are also exempt if the transport is not carried out in England or if it is carried out under travel insurance arrangements. Refer back to section 2 of this document and in particular ‘third party exemptions’ for further detail. 

This regulated activity relates to transport, but will not cover other activities that may be provided in or from a vehicle, such as 'treatment of disease, disorder or injury' or ‘diagnostic and screening procedures’.

Our view is that this regulated activity will normally cover routine, planned patient transport related to treatment.

The transport activity will not apply where a provider only uses a vehicle to transport a person within the confines of an event site. As an example, if a person attending or participating in a sporting event requires treatment, and as such, is carried in a vehicle from one part of the event ground to another, then registration for that transport is exempt. However, if the same situation arose and the person was carried from the event ground to hospital, then registration will be required.

We will take a proportionate and reasonable approach if emergency, unplanned treatment in this context includes some aspects of other regulated activities on an exceptional basis (such as 'diagnostic and screening procedures', 'surgical procedures' or 'maternity and midwifery services'). We will also take a proportionate and reasonable approach if, in exceptional circumstances, a provider transports a patient outside an event ground and ordinarily would not consider or plan to do this.

Some ambulance providers may also need to register for the regulated activity of 'treatment of disease, disorder or injury'. For example, where they employ health care professionals and ordinarily carry out treatment.

Where procedures are carried out, such as emergency tracheotomy, insertion of a chest drain or intubation, for the purpose of registration these would be considered as treatment for disease, disorder or injury, not as the regulated activity of 'surgical procedures'.

Where procedures that require specialist surgical training and equipment are an expected part of the service, for example, thoracotomy or amputation, we regard these as constituting the regulated activity of ‘surgical procedures’. Therefore providers that are equipped, and expect to carry out such procedures must register for that activity. However, if a provider carries out emergency procedures unexpectedly, we would be proportionate and would not regard this as committing an offence where they are not separately registered for 'surgical procedures'.

Providers registering for this activity will not have to additionally register for the regulated activity of 'diagnostics and screening procedures' if they only carry out the following diagnostic procedures along with transport:

• 12-lead ECG.
• Use of an AED.
• Pulse Oximetry.
• Use of a Sphygmomanometer.
• The analysis of urine or stool samples by means of dip stick or other reagent.
• Taking blood, urine samples or swab specimens.

Remote advice

Remote advice is a regulated activity when:

• The advice is medical, and
• It is responsive, i.e. for immediate attention or action (as opposed to, for example, a service in which a person electronically submits questions to a provider who provides responses at some later time, or when a person seeks general health care or lifestyle advice), or
• It constitutes triage (see glossary), and
• It is provided over the telephone or by electronic mail, and
• It is provided by a body established for that purpose (as opposed to, for example, the occasional provision of advice by a body such as a hospital or university on an informal basis).

The second consideration above means that:

• NHS Direct and any other organisation established for the purpose of providing telephone or internet-based medical advice where immediate action or attention is needed or triage provided will be covered.
• Ambulance control centres will be covered where they provide triage by means of telephony services.

This regulated activity covers maternity and midwifery services where they are carried out by, or under the supervision of, a registered health care professional.

Organisations that provide advice, support or information related to childbirth and parenting are not included in this regulated activity, so long as the provision of health care (other than that advice, information and support) is not their main purpose.

This means that a hospital provider would not become exempt if providing advice, because its main purpose is health care. But an organisation that is not primarily a health care provider and that provides this advice (such as the National Childbirth Trust) would not have to register, even if the advice is provided by a health care professional employed by such an organisation.

Exemptions

Services by midwives are exempt in the following specific circumstances:

• The midwife must be acting on their own behalf (i.e. self-employed rather than acting for a partnership or organisation), and
• Providing non-NHS care (e.g. not under contract for an NHS service), and
• Providing services to their patients only in the patients' homes (e.g. not as part of a hospital or clinic based service).

This exemption would not apply unless all of the circumstances set out above are met.

For the avoidance of doubt, this activity does not cover arrangements that local social services authorities may make under the NHS Act 2006, for the care of pregnant women and women who are breastfeeding.

Antenatal care or postnatal care

Where antenatal or postnatal services are provided as part of primary medical care, the primary medical provider should register for this activity. Where maternity services are provided as a community or outreach service, the provider is likely to need to register.

The current exemptions that apply to independent midwives providing services in a woman’s own home were expected to be changed by the Department of Health at some point in the future. However, at the time of publishing this guidance, the exemption remained in place. It may be helpful to note that The Health Care and Associated Professions (Indemnity Arrangements) Order 2014 came into force in July 2014. This Order is relevant to many health care professionals, including individual midwives that meet the exemption set out above.

Response to the Department of Health's consultation on proposed changes to regulations for Care Quality Commission registration.

The termination of pregnancy, by surgical or medical methods, including feticide is included in this activity. Advice on termination of pregnancy is not included. The 'morning after pill' is not a form of termination of pregnancy when used as emergency contraception and has its effect before the earliest stages of implantation.

Where the service provider is not an NHS body, the provider should refer to Regulation 20 of the Care Quality Commission (Registration) Regulations 2009, SI no. 3112, available at www.opsi.gov.uk/si/si2009/uksi_20093112_en_1 (or in continuously updated form on our website). These regulations place certain obligations on registered providers.

Providers may need to register for other regulated activities such as 'treatment of disease, disorder or injury' if, for example, they are providing treatment for sexually transmitted infections alongside termination of pregnancy services.

This regulated activity captures services provided in a slimming clinic that:

• Consist of advice or treatment and include the prescription of medicines for the purpose of weight reduction, and
• Are provided by, or under the supervision of, a registered medical practitioner.

In order to be registerable, "clinic" in this activity means it must be carried out in a physical location rather than being a remote website service.

This regulated activity applies if advice or treatment is being provided by or under the supervision of a medical practitioner, and the service includes the prescription of medicines for weight reduction.

It may still be necessary to register for other regulated activities. For example, the regulated activity of 'treatment of disease, disorder or injury' may apply if treatment is also being provided for a condition that is not an obesity/weight disorder.

This activity does not apply in cases where a slimming clinic is not prescribing medicines for the purpose of weight loss. As an example, a slimming clinic that provides diet plans written by or authorised by a medical practitioner will not be required to register unless that service or clinic also prescribes medicine for the purpose of weight loss.

This regulated activity covers nursing care, where it is not part of another regulated activity.

Nursing care means any service provided by a nurse and involving:

1. The provision of care, or
2. The planning, supervision or delegation of the provision of care, other than any services which, by their nature and the circumstances in which they are provided, do not need to be provided by a nurse.

If nursing care is provided as a necessary part of another activity, then there is no need to register separately for nursing care. This regulated activity normally covers services that do not constitute treatment.

Most treatment or care carried out by a nurse will involve another regulated activity. For example, health visiting may include vaccination (which will be included in the activity of 'treatment of disease disorder or injury'), or a test that is included in 'diagnostics and screening procedures'. Sexual health advisory services may be carried out by a doctor or other health care professional and are not required to be carried out solely by a nurse. Similarly, smoking cessation services may be carried out by an appropriately trained person and not necessarily by a nurse.

Exemptions

• The supply of nurses by an employment agency or employment business to another service provider is not a regulated activity. Nurses' agencies providing agency or locum nurses may not have to register. This exemption only applies where the agency is not responsible for directing or supervising the role of the nurse in any way.
• Introductory services, through which an individual is put in contact with nurses, from which the individual may select a nurse who he/she will then employ or use, are exempt. This might be, for example, where a nurse is introduced to someone who directs their own care through private funding or a personal budget arrangement. This exemption requires that the provider of the introductory service has no ongoing role in the direction or control of the service that is subsequently provided to the individual. Where a person makes a private arrangement and secures a nurse for his/her own care, under his/her direction, the service provided is exempt even if it did not involve an introductory agency or employment agency. This may include, for example, where an individual uses a personal budget or a self-pay arrangement.

The above exemptions do not apply to other regulated activities that the nurse may be providing. For example, ‘treatment of disease, disorder or injury’.  

This regulated activity involves services for the insertion or removal of an intrauterine contraceptive device by, or under the supervision of, a health care professional.

This activity includes insertion or removal of all types of intrauterine contraceptive device regardless of whether they are an intrauterine system or intrauterine device.

Providers may need to register for other regulated activities such as 'treatment of disease, disorder or injury' if, for example, they are providing treatment for sexually transmitted infections or menstrual disorders  alongside the family planning services.