Regulations for service providers and managers

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Abuse

Under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, 'abuse' means:

• Any behaviour towards a person using services that is an offence under the Sexual Offences Act 2003(a).
• Ill-treatment of a person whether of a physical or psychological nature.
• Theft, misuse or misappropriation of money or property belonging to a person using services, or
• Neglect of a person using services.

Accredited voluntary register

A register that has been accredited by the Professional Standards Authority. This means that the organisation that holds the register meets demanding standards set by the Authority in: governance, setting standards for registrants, education and training, managing the register, providing information and handling complaints. A voluntary register differs from a statutory register because practitioners are not obliged to be registered in order to practise.

Adequate

Sufficient for a specific requirement.

Advance decision

A decision to refuse specified medical treatment, made in advance by a person who has the mental capacity to do so. In this way, people can refuse medical treatment for a time in the future when they may lack the capacity to consent to, or refuse, that treatment.

Advocacy

The action of an advocate, or the services provided by one or more advocates on behalf of another person. It involves taking action to help people to say what they want, securing their rights, representing their interests and obtaining the services they need. Advocacy is most effective when carried out by a person who is independent of the services being provided.

Advocate

Advocate can be used in a general sense, as one who speaks on behalf of another, or it can have special meanings derived from the Mental Health Act 1983 and the Mental Capacity Act 2005.

There are formal and informal advocates and these can be:

• Individuals acting informally:
  • Carers
  • Relatives
  • Partners
  • Neighbours or friends
  • Staff.
• Those prescribed by legislation, such as Independent Mental Health Advocates and Independent Mental Capacity Advocates.
• Those provided by schemes run by local authorities, the NHS and charities.

Agreement (in relation to a signed document)

Usually a document that sets out the understanding between two or more individuals or entities about their enforceable rights and duties regarding their performance and consideration in accordance with their agreement. While an agreement usually leads to a written contract, it can also be recorded in different ways and may also be spoken, rather than written.

Apology

An expression of sorrow or regret in respect of a notifiable safety incident.

Appropriate care and treatment

Making sure that care and treatment is actually what the person needs. Not over-treatment, unnecessary care or treatment, or care or treatment that is disproportionately involved or complicated.

Audit

A thorough examination or evaluation.

Autonomy

Independence or freedom.

Bankruptcy Restriction Order

An order made by a court in a bankruptcy case if it feels that the person who filed for bankruptcy has engaged in culpable or dishonest conduct. A person subject to a Bankruptcy Restriction Order is under certain restrictions for a period of between two and 15 years. A Bankruptcy Restriction Order is not lifted when the bankruptcy is discharged.

Barred lists

Lists maintained by the Disclosure and Barring Service (DBS) of individuals who are unsuitable to work with children or vulnerable adults.

Bind over

An adult accused of an offence may be bound over to appear at a court, or to be of good behaviour, or to keep the peace. If they refuse to accept a bind over, the person may be committed to prison. A bind over may be imposed with other penalties following conviction but is not a conviction and does not go onto a criminal record.

Capacity

The ability by someone to make a specific decision for himself or herself in a given situation. It is assumed that anyone aged 16 or over has capacity unless proven otherwise.

There are no degrees of capacity: either a person has capacity to make a particular decision or does not. People may have the capacity to make some decisions but not others. Children under 16 are assumed not to have capacity unless they have sufficient understanding and intelligence to enable them to understand fully what is proposed.

Capacity is defined by the Mental Capacity Act 2005 as:

"People who lack capacity:

1. For the purposes of this Act, a person lacks capacity in relation to a matter if at the material time he is unable to make a decision for himself in relation to the matter because of an impairment of, or disturbance in the functioning of, the mind or brain.
2. It does not matter if the impairment or disturbance is permanent or temporary.
3. A lack of capacity cannot be established merely by reference to:
   1. A person's age or appearance,
   2. A condition of his, or an aspect of his behaviour, which might lead others to make unjustified assumptions about his capacity."

Carer

Carers look after their family, partners or friends who are in need of help because they are ill, frail, or have a disability. The care they provide is unpaid.

Carers include young carers.

The term does not include paid care workers or people who undertake voluntary work.

Caring

By caring, we mean that staff involve and treat people with compassion, kindness, dignity and respect.

Carry on

To provide, run or manage the provision of, a regulated activity.

Child/children

The Children Act 1989 and the Children Act 2004 define a child as being a person up to the age of 18 years. However, the Children Act 2004 states that in certain circumstances safeguarding, protection and cooperation between services may be continued through to a young person's 19th birthday or beyond.

Commissioner

A person or organisation that buys services on behalf of the people living in the area that the commissioner covers. This may be for a population as a whole, or for individuals who need specific care, treatment and support.

Competence

The application of the required level of knowledge and skills to a particular task. In applying these, a person demonstrates that they understand and use the required level of knowledge and skills.

Competent persons

People who have the required level of knowledge and skills for a particular task.

Complaint

An expression of dissatisfaction with something. This can relate to any aspect of a person's care, treatment or support and can be expressed verbally, in gesture or in writing.

Compliance

Meeting or conforming with defined requirements.

Composition, arrangement or trust deed with creditors

Various forms of agreement made by an insolvent or financially pressed debtor with two or more creditors to pay part or all of what they owe.

Consent

A person's agreement to, or permission for, a proposed action, particularly any form of examination, care, treatment, or support.

Professionals have their own codes of practice that indicate how they should manage the consent they need from people who use services.

In our guidance, we recognise that the consent of a person who uses services can involve another person, and that it can be obtained, given and recorded in different ways.

Culture

Learned attitudes, beliefs and values that define a group or groups of people.

Dignity

Dignity is concerned with how people feel, think and behave in relation to the worth or value that they place on themselves and others. To treat someone with dignity is to treat them as being of worth and respecting them as a valued person, taking account of their individual views and beliefs.

Director (Regulation 5)

'Director' includes all board level appointments of NHS foundation trusts, NHS trusts and special health authorities and other bodies carrying on a regulated activity that are responsible for the overall quality and safety of care and for making sure that care meets the requirements of the HSCA 2008 (Regulated Activities) Regulations 2014. It includes executive and non-executive, permanent, interim and associate positions, irrespective of their voting rights.

Discharge (in relation to care and treatment)

The point at which a person leaves hospital to return home or be transferred to another service or the formal point when they no longer use a service.

Discharge (in relation to bankruptcy)

A legal release from bankruptcy restrictions.

Diversity

Diversity describes the range of visible and non-visible differences that exist between people. It means understanding that each individual is unique and recognising our individual differences.

Duty of candour

The duty of candour requires providers to be open with the people who use their service. When a specified safety incident has occurred in respect of care provided, the regulation sets out a clear set of legal duties on registered providers about how and when to notify people using their service (or their relevant representatives) about those safety incidents. The regulation also describes when a notification about a safety incident needs to be made to CQC.

Effective

By effective, we mean that people's care, treatment and support achieves good outcomes, promotes a good quality of life and is based on the best available evidence.

Employment

The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 defines employment as:

• Employment under a contract of service, an apprenticeship.
• Practising privileges granted to a medical practitioner, which give permission to practise as a medical practitioner in a hospital managed by the service provider.

Although volunteers and Shared Lives carers are not strictly employees, they are included in the definition for the purposes of the regulations and therefore this guidance. References to 'staff' and 'employees' therefore apply to them and temporary or agency workers.

Enforcement action

This is when CQC imposes, varies or removes conditions of registration; when we suspend or cancel a registration whether using urgent procedures or not and issuing Warning Notices, penalty notices, simple cautions; or when we prosecute a provider.

Equipment

Machines and medical devices used to help, prevent, treat or monitor a person's condition or illness. The term 'materials' used in the regulated activity or by people employed by the service provider may refer to aids that could support a person's care, treatment, support, mobility or independence. For example, a walking frame, hoist, or furniture and fittings. It excludes machinery or engineering systems that are physically affixed and integrated into the premises. The definition of medical devices above does not include items such as sheets, curtains, pillows and towels.

Experience (of care treatment or support)

Experience can refer to the broad effects that care, treatment or support can have on a person, including their thoughts and feelings about the care, treatment and support they have received, how they interact with staff and others, or any wider impact on their life and those around them.

Experience (in relation to skills and knowledge)

Knowledge and capability gained from previous employment or direct, personal observation, participation or contact in relevant, previous employment related activities.

Fit

The person is of good character, as they are honest, reliable, trustworthy and respectful, and that they have the right qualifications, competence, skills and experience to perform their role.

Good character

A person who is of good character is honest, reliable, trustworthy and respectful. When assessing whether an individual is of good character, providers should make every effort to make sure that as a minimum, they seek all available information to confirm that:

• They have not been convicted of an offence in any country that would be considered an offence in the UK, if the offence relates to the conduct required in carrying on a regulated activity.
• They have not been erased, removed or struck off a professional register.

Harm

Physical or psychological damage or injury.

Healthcare

The preservation of mental and physical health by preventing or treating illness through services offered by the health professions, including those working in medical, surgical or social care settings.

Healthcare professional

Individuals regulated and/or licensed to provide some type of health or social care.

Human rights

The basic rights and freedoms contained in the European Convention on Human Rights. The Human Rights Act 1988 means that most of the convention rights are available to everyone in the United Kingdom, regardless of their age, nationality, race, ethnicity, gender or religion and beliefs. It is an offence for a public body to breach any person's human rights, and under the Health and Social Care Act 2008, 'public body' includes any provider that supplies accommodation together with nursing or personal care on behalf of a local authority.

Implied consent

A form of consent that is not expressly granted by a person, but rather inferred from a person's actions and the facts and circumstances of a particular situation (or in some cases, by a person's silence or inaction). The assumed agreement is that the person would approve a course of action if asked in a given situation, but is not presently able to be asked.

Independence

Freedom from the control or influence of others.

Involvement

Enabling people to get involved in the planning and delivery of their own care, treatment and support. This includes people acting on their behalf and groups of people who use services being involved together, for example through local involvement networks or a user forum.

Lawfully acting on their behalf

This refers to authority given under the Mental Capacity Act 2005, such as a valid and applicable advance decision to refuse treatment, Lasting Powers of Attorney for health and welfare containing relevant clauses, Court-Appointed Deputyship including relevant decision-making powers, a decision of a Court, the Mental Health Act 1983, or a best interest assessment in accordance with the Mental Capacity Act 2005. It can also refer to people having parental responsibility for any child aged under 18, which may be a natural or adoptive parent or a local authority if a care order is in place.

Medical device

Any instrument, apparatus, appliance, material or other article (whether used alone or in combination), including the software necessary to use it properly, intended by the manufacturer to be used for people for the purpose of:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease.
• Diagnosis, monitoring, alleviation of or compensation for any injury or disability.
• Investigation, replacement or modification of the anatomy or of a physiological process.
• Control of conception.

This also includes devices intended to administer a medicinal product.

Medicine

A substance or substances administered for the purpose of modifying, controlling, treating or diagnosing a medical condition, disease or illness.

Meeting needs

This term relates to clinical treatment and care outcomes.

Mental health

A person's ability to manage and cope with the stresses and challenges of life.

Misappropriation

Wrongly taking or using something that belongs to another person for your own use.

Moderate harm

For the purposes of Regulation 20 of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 "moderate harm" means—

1. harm that requires a moderate increase in treatment, and
2. significant, but not permanent, harm;

Moratorium period under a debt relief order

A debt relief order is an alternative to bankruptcy, which is intended to give debt relief to people in England and Wales who owe relatively little money, have little or no disposable income and no assets to repay what they owe, and cannot afford to make themselves bankrupt. The main effect of a debt relief order is to place a 'moratorium' period on the debts listed in the order. This means creditors cannot take any action to recover or enforce those debts during this period without a court order. The moratorium usually lasts for 12 months from the date of the order, although there may be exceptions, and after that time the listed debts will be discharged.

Needs

All needs, including emotional, social, cultural, religious and spiritual needs, should be included in assessments about the care and treatment people receive.

Neglect

The failure to meet a person's basic physical and/or psychological needs.

Nominated individual

Nominated individual means the person who is employed as a director, manager or secretary of a body and whose name has been notified to CQC as being the person who is responsible for supervising the management of the carrying on of the regulated activity by that body.

Nutritional and hydration needs

In Regulation 14 of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, 'nutritional and hydration needs' means:

1. A person's need to receive suitable and nutritious food and hydration that is adequate to sustain life and good health.
2. A person's need to receive parenteral nutrition (feeding intravenously to get nutrition into the body through the veins) and dietary supplements when prescribed by a health care professional.
3. Meeting any reasonable requirements of a person using the service for food and hydration arising from their preferences or their religious or cultural background, and
4. If necessary, supporting people to eat or drink.

Palliative care

The active, holistic care of people who use services who have advanced progressive illness. Managing pain and other symptoms, and providing psychological, social and spiritual support, is paramount. The goal of palliative care is to achieve the best quality of life for people who use services and their families. Many aspects of palliative care are also applicable earlier in the course of the illness, in conjunction with other treatments.

Patient Safety Alerts

Patient safety alerts are issued via the Central Alerting System (CAS), a web-based cascading system for issuing alerts, important public health messages and other safety critical information and guidance to the NHS and other organisations, including independent providers of health and social care.

People who use services

The legislation uses the term "service user", which means a person who receives services from a provider as they carry on a regulated activity.

Personalised

This is when the person using the service leads, with choice being the defining principle in relation to the care or treatment provided to meet their particular needs and preferences.

Person-centred

Putting the person who uses services at the centre of their care, treatment and support, ensuring that everything that is done is based on what is important to that person from their own perspective.

Preferences

This includes those relating to how people's care and treatment are provided or preferences about which provider they choose to provide it. It is recognised that in some circumstances a person's preferences may be limited. For example, when people are detained under the Mental Health Act 1983.

Premises

This is any building or other structure, including any machinery or engineering systems or other objects that are physically affixed and integral to the building or structure, or a vehicle. It includes accommodation provided as part of a person's care or treatment.

Privacy

To respect a person's privacy is to recognise when they wish and need to be alone (or with family or friends), and be protected from others looking at them or overhearing their conversations. It also means respecting their confidentiality and personal information.

Privy to serious misconduct or mismanagement

'Privy to' means that there is evidence that could lead the provider to reasonably conclude that a person was aware of serious misconduct or mismanagement but did not take the appropriate action to ensure that it was addressed.

Professional body

An organisation that exists to further a profession and to protect both the public interest, by maintaining and enforcing standards of training and ethics in its profession, and the interest of its professional members.

Protected characteristics

The protected equality characteristics are defined in the Equality Act 2010 and are:

• Age
• Disability
• Gender reassignment
• Marriage and civil partnership
• Pregnancy and maternity status
• Race
• Religion or belief
• Sex
• Sexual orientation.

Provider

An individual person, partnership or organisation registered with CQC to carry on one or more regulated activities.

Reasonable adjustments

The duty to make reasonable adjustments is set out in the Equality Act 2010, which says that employers and organisations such as hospitals, care homes and GP surgeries must take steps to remove the barriers people face because of their disabilities. There are three parts to the duty:

• Change the way things are done – a duty to take reasonable steps to change a practice, policy or procedure that makes it more difficult for people with a disability to access or use their services.
• Change a physical feature – a duty to take reasonable steps to remove, change, or provide a reasonable way of avoiding a barrier such as steps, doors, toilets, signs and so on.
• Provide extra aids or services – A duty to take reasonable steps to provide an additional aid or service where it would help people with a disability to benefit. For example, a portable induction loop for people with hearing aids, British Sign Language interpreters, providing information in alternative formats, such as Braille or audio CDs, or extra staff assistance.

Providers must not wait for people to ask them to do something. They should consider in advance what they need to do to make their services accessible to all disabled people.

When is it reasonable to make the changes?

Providers must make changes or adjustments to how they provide their services if it's reasonable to. Whether something is reasonable depends on the size, resources of the organisation and type of service they provide. It also depends on what changes or adjustments are needed and how practical or easy it is to do them. It's the courts who decide if something is reasonable or not.

Record

A formal written report or statement of facts, events or information, usually collected over a fairly long period. The act of maintaining individual records is called recording.

Registered person

A person who is the registered provider or registered manager in respect of one or more regulated activities.

Regulatory action

Actions we take as the regulator of health and social care services in England to address a registered person's breach of a regulation, condition of registration or other relevant requirement.

Relevant person (Regulations 9, 11 and 17)

In Regulations 9, 11 and 17, "relevant person" means the person using a service and/or any person who must be consulted when providing person-centred care to a person using a service. Where an adult who uses a service lacks the capacity to make a decision about their care, this would include any person acting lawfully on their behalf under the Mental Capacity Act 2005, such as with authority given by an advance decision to refuse treatment, Lasting Powers of Attorney for health and welfare containing the relevant clauses, or a Court appointed Deputy.

Where a person using a service is subject to the Mental Health Act 1983, it would include any person with the authority to determine care.

Where a person using a service is under 16 and not competent to make a decision about their care, this would include any person with parental responsibility or other legal authority (such as a local authority having a care order), or other recognised family member, carer or advocate.

Relevant person (Regulation 20)

In Regulation 20, "relevant person" means the person using the service or, in the following circumstances, a person lawfully acting on their behalf:

1. When the person using the service dies.
2. Where the person using a service is under 16 and not competent to make a decision in relation to their care or treatment, or
3. Where the person using the service is 16 or over and lacks capacity to make decisions.

Resources

The things needed to carry out a task or piece of work. Resources can include appropriately qualified staff, finances, suitable buildings and sufficient equipment.

Respect

Providers must demonstrate respect for people using their service by:

• Treating people with care and compassion
• Addressing them in the manner they have indicated they prefer, and
• Treating them all equally regardless of their level of understanding or ability to express their views.

Responsible for, contributed to or facilitated serious misconduct or mismanagement

This means that there is evidence that a person has intentionally, or through neglect, behaved in a manner that would be considered to be, or would have led to, serious misconduct or mismanagement.

Responsive

By responsive, we mean that services are organised so that they meet people's needs.

Restraint

In Regulation 13 of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, a person controls or restrains a person using services by:

1. Using, or threatening to use, force to enable them to carry out something that the person using the service resists, or
2. Restricting the person's liberty of movement, whether or not they resist, including by using physical, mechanical or chemical means.

Risk

The probability of an adverse event or issue occurring, which is related to a particular condition or treatment and consideration of how severe the consequences are likely to be.

The risk may come directly from the condition itself or indirectly from the process or method involved in the treatment or application. Risk does not mean bad things will happen. It allows people to make decisions about the world in which they live and the choices they have to make, because it is a balanced judgement of danger.

Risk assessment

The process of identifying all the risks to and from an activity, and assessing the potential impact of each risk.

Safe

By safe, we mean that people are protected from abuse and avoidable harm.

Safeguard

To protect and promote people's welfare, including:

• Protecting people from abuse or neglect.
• Preventing impairment of people's health or development.
• Ensuring that people receive care, treatment and support in circumstances consistent with the provision of safe and effective care, treatment and support.

Safeguarding

Ensuring that people live free from harm, abuse and neglect and, in doing so, protecting their health, wellbeing and human rights. Children, and adults in vulnerable situations, need to be safeguarded. For children, safeguarding work focuses more on care and development; for adults on independence and choice.

Serious misconduct or mismanagement

Behaviour that would constitute a breach of any duty, responsibility, legislation/enactment relevant to meeting these regulations or their component parts. "Serious misconduct" may include assault, fraud and theft or breaches of professional duties or codes of practice. "Mismanagement" may include mismanaging funds and/or not adhering to recognised practice, guidance or processes regarding care quality within which the individual is meant to work. These are not exhaustive lists.

Service user

A person who receives services provided in the carrying on of a regulated activity. Please note: The regulations refer to 'service users' and where we quote the regulation directly we use this phrase. Elsewhere in the guidance we have used the terms 'people who use services' or 'people'.

Social care

Social care includes all forms of personal care and other practical assistance provided for people who, because of age, illness, disability, pregnancy, childbirth, dependence on alcohol or drugs or any other similar circumstances, are in need of such care or other assistance.

For the purposes of regulation by the Care Quality Commission, this is care provided for, or mainly for, people over 18 years old in England. We sometimes refer to this as adult social care.

Staff

The entire group of people employed for the purposes of carrying on a regulated activity.

Statement of purpose

Schedule 3 of the Care Quality Commission (Registration) Regulations 2009 defines a statement of purpose as a statement that sets out:

1. The aims and objectives of the service provider in carrying on the regulated activity.
2. The types of services provided in order to carry on the regulated activity and the needs of the people who use the service, which those services are intended to meet.
3. In relation to the service provider and any registered manager, their:

• full name
• business address
• business telephone number
• email address where available.

In relation to the registered person:

• The postal address to which CQC may send any document, notice or other communication required to be delivered by these Regulations or the Act, and
• Where the registered person consents to this, an email address to which CQC may send any document, notice or other communication required to be delivered by these Regulations or the Act.

1. The legal status of the service provider.
2. Details of the locations at which the services are provided to carry on the regulated activity.

Supervision

A process to guide, support and assist employees to enable them to carry out the duties they are employed to perform.

Theft

Dishonestly appropriating property belonging to another person with the intention of permanently depriving the other of it.

Third party

A person or organisation other than the principals who are involved in a transaction or direct provision of a service.

Timely

As soon as can be reasonably achieved.

Treatment

In Regulation 2(2) of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, treatment includes:

• A diagnostic or screening procedure carried out for medical purposes
• The ongoing assessment of a person's mental or physical state
• Nursing, personal and palliative care, and
• Giving vaccinations and immunisations.

This regulation excludes the regulated activity of assessment or medical treatment for persons detained under the 1983 Act.

Warning Notice

Warning Notices tell a registered person that they are not complying with a condition of registration, requirement in the Act or a regulation, or any other legal requirement that we think is relevant and will usually require a registered person to comply with that requirement by a specified date.

Welfare

A person's state or condition, taking into account their physical, social and financial situation. A person's welfare will also take account of their emotional and spiritual states.

Well-led

By well-led, we mean that the leadership, management and governance of the organisation assures the delivery of high-quality person-centred care, supports learning and innovation, and promotes an open and fair culture.

Without delay

As soon as can be reasonably achieved.