Scope of registration

Description

This activity covers a treatment that is:

• provided by or under the supervision of a defined list of healthcare professionals (see what this means in our glossary of terms) or by a multi-disciplinary team that includes a listed healthcare professional, or
• provided by or under the supervision of a social worker where the treatment is for a mental disorder, or by a multi-disciplinary team that includes a social worker where the treatment is for a mental disorder, and is
• for a disease, disorder or injury.

Treatment of a disease, disorder or injury covers a wide range of treatments. We don’t provide a complete list here, but it includes examples such as:

• emergency treatment
• ongoing treatment for long-term conditions
• treatment for a physical or mental health condition or learning disability
• giving vaccinations or immunisations
• palliative care.

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

What this regulated activity does NOT include:

• Interventions carried out purely for cosmetic purposes.
• Alternative and complementary medicine, with the exception of the practice of osteopathy or chiropractic.
• First aid where it is delivered by:
  • healthcare professionals in unexpected or potentially dangerous situations requiring immediate action
  • non-healthcare professionals who are trained to deliver first aid
  • organisations established for the purpose of providing first aid
• Treatment provided in a sports ground or gymnasium (including associated premises) where it is provided for the sole benefit of people taking part in, or attending, sporting activities and events.
• Treatment provided through temporary arrangements for sporting or cultural events (such as festivals, sporting or motor sport events).
• Hyperbaric oxygen therapy provided to workers in connection with their work or when governed by the Diving at Work Regulations 1997 or Work in Compressed Air Regulations 1996.
• Activities authorised by a licence granted by the Human Fertilisation and Embryology Authority.

Read Schedule 1 (4)(3) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 for the full list of excluded activities.

Sometimes, Treatment of disease, disorder or injury is provided as only one part of a service, for example in a large care home that has just a few intermediate care or specialist palliative care beds. If the activity is carried out by or under supervision of a listed healthcare professional employed by the provider, you will still need to register for it in addition to any other activities that you may need to register for your service.

If another body provides those services, our guidance on hosted services in Who has to register? applies.

Other regulated activities covered by this regulated activity

If you are registered for Treatment of disease, disorder or injury, and when delivering it you provide:

• Personal care
• Nursing care

you do not need to apply for those additional regulated activities.

Additional regulated activities you may need to register for

You should also apply for other regulated activities if you are providing them. Examples might include, but are not limited to:

• Surgical procedures
• Diagnostic and screening procedures (where not provided as part of a treatment)
• Assessment or medical treatment for persons detained under the Mental Health Act 1983
• Services in slimming clinics.

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

You will need to register for this regulated activity if your service includes treatment that is carried out by:

• a listed healthcare professional (see what this means in our glossary of terms), or if this professional supervises the treatment, or
• a social worker where the treatment is for a mental disorder, and is intended to treat disease, disorder or injury.

See the specific definition of a healthcare professional for this regulated activity only.

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

Where the situation is unclear, we will consider each case individually. For example:

• If the person providing treatment is not acting in the capacity of a listed healthcare professional, even if they hold a professional qualification. For example, a beautician who is also a registered nurse may be carrying out a cosmetic or aesthetic service. Similarly, a psychiatrist may also be qualified as a psychotherapist. Where they practise as a psychiatrist (a registered medical practitioner) it may be in the scope of this activity. Where they practise solely as a psychotherapist, it would not be in scope of this activity.
• Where it is not clear whether 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.
• In community mental health care (including primary mental health care) some psychological therapies may be provided by healthcare professionals, social workers or by others with specific qualifications. In these cases, some service providers will need to register, whereas others will not. This depends on whether they use healthcare or social work professionals to deliver or supervise treatment.

Professionals who are NOT included in the scope of this regulated activity

The list of professionals in the regulations does not include:

• clinical psychologists
• occupational therapists
• physiotherapists
• pharmacists
• opticians
• dietitians
• nursing associates.

If you are one of these professionals and you run a standalone treatment service, you do not need to register for Treatment of disease, disorder or injury.

Social workers

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, and the provider of that service will need to register. For example, where treatment includes 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 in the scope of this regulated activity.

Nursing associates

The role of nursing associate introduced in 2019 is not included in the list of healthcare professionals who can carry out activities covered by the regulated activity of Treatment of disease, disorder or injury. This means that a provider cannot register for this regulated activity based on the employment of nursing associates alone, though they may be employed to work as part of a nursing team with other listed healthcare professionals.

What we mean by treatment "under the supervision of" a listed healthcare professional or social worker

A person’s treatment is ‘under the supervision of’ a healthcare professional (as listed in paragraph 4(4) of Schedule 1 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014) where the healthcare professional:

• is part of the team that directly provides health care to the person, or
• directly reviews the person's case and sets out a plan of care for them even if this plan is carried out by another person, or
• authorises a protocol of care, which is used by other care givers, that:
  • they are directly accountable for, and
  • they are required to continually monitor, and
  • can only be authorised by the healthcare professional by virtue of their professional registration, and
  • directly records the details of the people who receive care when the protocol is used.

Where a service solely produces Patient Group Directions (PGDs) (see what this means in our glossary of terms), it is not carrying on a regulated activity. This is because there is no treatment ‘by or under the supervision of’ a healthcare professional from the service that produces the PGD, even though a healthcare professional may be involved in creating and/or authorising the PGD itself.

‘Delegation’ of healthcare tasks

Delegation is different to supervision. A healthcare professional employed by a provider registered for Treatment of disease, disorder or injury can delegate a procedure to a care worker or nursing associate who is employed by a second provider operating, for example, a care home without nursing or a domiciliary or homecare care agency. The healthcare professional, for example a nurse employed by a community trust, must ensure that a task is appropriately delegated and assess that it is within the worker’s competence.

The second provider cannot be considered to be carrying on this regulated activity and is not required to register for it, as they are not employing healthcare professionals to provide or supervise the activity. The first provider remains responsible for the treatment of a person using the second provider’s service, including the outcome of any healthcare task they delegate to staff working for the second provider. However, a provider cannot be responsible for the day-to-day supervision of staff who are employed by another provider. It is therefore the second provider’s responsibility to ensure that they do not allow their staff to accept delegated tasks unless the staff have enough support, supervision, education and training to competently undertake the aspects of care that are being delegated.

The professional standards that registered nurses, midwives and nursing associates must uphold are set out in The Code: Professional standards of practice and behaviour for nurses, midwives and nursing associates 2019 (Nursing and Midwifery Council). Registered nurses, midwives and nursing associates must act in line with the Code. This includes requirements about accountability for decisions to delegate tasks and duties, and for the outcome of the delegated tasks. The Royal College of Nursing also provides guidance on accountability and delegation.

Administering medicines

The activity of Treatment of disease, disorder or injury will apply:

• In a situation when a listed healthcare professional (see what this means in our glossary of terms) is required to either prescribe or administer medicines.
• When the listed healthcare professional (see what this means in our glossary of terms) is required to have knowledge or training to administer the medicines, or when a person would not normally be considered able to administer the medicine by themselves.
• When administering any intravenous (IV) product that includes any one or all of: mathematical calculation, reconstitution and use of equipment for the purpose and subsequent care of the patient and IV site.
• When administering chemotherapy in a person’s home, a residential home, or in any other setting. This will require training in administration, IV pumps, checking blood results, examination and care of the IV site, and what to do if there is extravasation (unintentional leaking of vesicant medicines from the vein into the surrounding tissue causing blistering and tissue injury).

The activity will not apply:

• When a care worker or a healthcare professional administers medicines that have either been prescribed and dispensed for a person, or are a 'homely remedy' (including over-the-counter medicines, complementary therapies and herbal preparations), where:
  • the person using the service would normally be able to administer the medicines for themselves, including drawing up and injecting insulin and taking a controlled drug orally, but because of circumstances or personal choice, they have consented for the medicine to be administered to them, or
  • the person would normally be able to administer the medicines for themselves but because of circumstances, or where they are unable to make a decision about taking their medicines, it has been agreed to be in their best interest for the medicine to be administered to them.
• When a care worker prompts and/or supervises a person to take their prescribed medication.
• When a care worker or nursing associate cares for people receiving nutritional support through a PEG feed or provides care for pressure areas delegated by a district registered nurse (a listed healthcare professional) who works for another provider.

Professional roles and protected titles

The use of professional titles is protected by law. If a person uses a professional title, the assumption will be that the service is being carried out by someone acting in their capacity as a registered healthcare 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 we find that the service does not involve the professional qualification, and the service may be using the protected title inappropriately in the description of the service or solely for other purposes (such as marketing), we may refer the matter to the relevant professional regulator.

You must consider whether the person providing the service is using their professional qualification in the job they are employed to do. For example, where a care home without nursing has employed a registered nurse or other healthcare professional as a care worker. Where the employee’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.

Examples: A qualified psychoanalyst, who is also qualified as a psychiatrist but is not prescribing or using medical interventions, will not need to register for their psychoanalytic practice. They are acting in their capacity as a psychoanalyst (not in the list of healthcare professionals) and not as a doctor. They are not using the specific skills taught in medical training but are using the specific skills taught in psychoanalytic training. They are not using statutory authority or powers, which require a medical qualification (for example, prescribing). They are not presenting themselves as a psychiatrist, but as a psychoanalyst.

A drug and alcohol worker, who is also qualified as a social worker, will not need to register to provide a service where they are only working as a drugs worker. However, if they are working as a social worker then the service will need to register. We can tell whether they are working as a social worker if they are clearly using the specific skills taught as part of social work training, or they are presenting themselves as a social worker and using that protected title to describe their work.

Registering for specific services

Lasers and intense pulsed light (IPL)

Healthcare professionals and beauty therapists often use lasers and IPLs for non-surgical procedures. For example, in cosmetic procedures such as hair removal, and for therapeutic procedures such as minor dermatological conditions.

These procedures can constitute appropriate treatment of recognised medical disorders and beauty therapists who are trained to use the laser or IPL can carry out the procedures safely and appropriately. Dermatologists sometimes refer or advise patients to visit a beauty therapist. This is because, even in a clinical service such as dermatology or plastic surgery, very few laser or IPL procedures require the skills of a healthcare professional.

Use of lasers and IPLs is not part of professional training in healthcare professions. Although a healthcare professional’s knowledge of physiology and physical and mental conditions may add value to a service, it is usually useful as background knowledge rather than using their professional training.

If you provide laser and IPL services that are delivered by listed healthcare professionals, you will only need to register where:

• the specific skills of a listed healthcare professional are used, for example 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 healthcare professional qualification, for example prescribing, or
• you describe the service as being carried out by someone acting in their capacity as a registered healthcare professional.

Intravenous (IV) products

Intravenous administration of vitamins and products that are prescription only medicine (including 0.9% saline) that are used to improve or enhance wellbeing constitutes treatment of a disease or disorder. We consider a ‘disease’ to include a pathophysiological response to internal or external factors, and a disorder to include a disruption to regular bodily structure and function.

If you provide intravenous administration services you will need to register for the regulated activity if the procedures you offer:

• are delivered by, or under the supervision of, a listed healthcare professional and
• include administering prescription-only products intravenously or products that require a prescription when delivered in intravenous form and
• claim to alter a person’s physiological state in response to a defined concern.

We do not consider this type of procedure to be alternative or complementary medicine.

Orthodontics – clear aligner treatment

Clear aligner treatment is an orthodontic treatment that corrects misaligned or crooked teeth using clear dental appliances. We consider the treatment planning and diagnosis associated with aligners to be a regulated activity, regardless of how the treatment is initiated. If you are a provider of clear aligner treatment, you are likely to need to register for the regulated activity of Treatment of disease, disorder or injury.

Treatment of obesity

The regulated activity of Services in slimming clinics only applies where a medical practitioner provides or supervises advice or treatment in a clinic, including prescribing medicines, for the purposes of weight reduction.

Treatment of disease, disorder or injury would apply where a medical practitioner provides treatment of obesity other than in a clinic (for example, through online services).

If you are another type of listed healthcare professional (see what this means in our glossary of terms) and you treat people for obesity, this is included in the regulated activity of Treatment of disease, disorder or injury. We interpret the term ‘treatment of obesity’ to include:

• using a medicine prescribed for this purpose
• supervising people’s treatment for obesity with a medicine prescribed for this purpose
• treating people in a clinic or through an online web-based service.

Contact us if you are not sure whether the obesity treatment you deliver needs to be registered, or if you are registered for the correct regulated activities.

Earwax removal treatments

Earwax build-up is a natural physiological problem that can result in a health problem or can worsen the symptoms of an existing medical condition, leading a person to seek assistance from a professional. Whichever type of treatment is used, earwax removal is a regulated activity if:

• the person and a listed healthcare professional both agree that there is a problem that needs an intervention; and
• the treatment is carried out by a listed healthcare professional.

You will need to register for Treatment of disease, disorder or injury if this applies.

First aid

You do not need to register if you only provide first aid as this is not regulated activity.

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 from 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 healthcare professionals.

If a healthcare professional administers first aid, they will not need to rely on their specific area of professional expertise but will only use skills and knowledge that will reasonably be expected of any person who has received training in first aid.

A first aid service may involve:

• Healthcare professionals, but only where they are acting in their capacity as a first aider alone. 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.
• Simple procedures for assessment that:
  • do not need to use a recognised professional diagnostic qualification (for example, as a radiographer or sonographer) and
  • are limited to only assessing the need for onward referral for treatment. This includes use of an electrocardiogram (ECG), automated non-invasive blood pressure measurement, pulse oximeter, use of a thermometer, sphygmomanometer or ophthalmoscope.
• Urgent procedures that can be carried out by volunteers. For example, where volunteers, including community first responders, are trained to carry out cardiopulmonary resuscitation (CPR) and use an automatic external defibrillator (AED) (sometimes called a community defibrillator or public access defibrillator (PAD)).

Care homes with nursing

If you are a provider of a care home with nursing, you are likely to need to register for this regulated activity. This is because you will probably employ registered nurses or other listed healthcare professionals who carry out these activities. There may be exceptions to this rule, but only when the registered nursing staff do not actually carry out or supervise the treatment for a disease, disorder or injury.

Care homes without nursing

Providers of care homes without nursing should not register for this regulated activity. This is because if you are carrying out these treatments in the care home, it will likely be by delegation from a healthcare professional working for another registered provider. This includes where you employ registered nursing associates, but they are carrying out treatment delegated by a listed healthcare professional such as a district registered nurse who is employed by another provider.

Treatment for substance misuse

The types of listed healthcare professionals that most commonly work in substance misuse services are:

• medical practitioners
• registered nurses
• social workers.

If any of these professionals are working in their registered capacity (under their protected professional titles) and providing treatment as part of a multi-disciplinary team, it means the whole team will be within the scope of registration as providers of this regulated activity. If you employ them you should register as your service is providing treatment for a disease, disorder or injury.

If your service provides substance misuse treatment but the team does not include a relevant listed healthcare professional working in their registered capacity, then you do not need to be registered for this regulated activity. For example, if you employ 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 healthcare professional such as a medical practitioner, registered nurse or social worker, then you do not need to register for this activity.

If your service does not provide residential accommodation but people are receiving detoxification treatment delivered by a listed healthcare professional working in their professional capacity, then you should be registered for the regulated activity of Treatment of disease, disorder or injury.

School nursing and health visiting

If you provide school nursing and health visiting services, you are likely to need to register for this regulated activity as you employ nurses or other listed healthcare professionals who deliver these activities. This can be the case even where the services delivered do not initially appear to include any treatment for a disease, disorder, or injury (for example, a baby weighing clinic). This is because treatment includes the ongoing assessment of a person’s physical or mental state and giving vaccinations or immunisations. This does not apply where a nurse is directly engaged and directed by a school.

Research settings

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

Check if you need to register for Treatment of disease, disorder or injury