Regulations for service providers and managers

Page last updated: 7 August 2024

Downloads

Regulation 12: Safe care and treatment

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 12

The intention of this regulation is to prevent people from receiving unsafe care and treatment and prevent avoidable harm or risk of harm. Providers must assess the risks to people's health and safety during any care or treatment and make sure that staff have the qualifications, competence, skills and experience to keep people safe.

Providers must make sure that the premises and any equipment used is safe and where applicable, available in sufficient quantities. Medicines must be supplied in sufficient quantities, managed safely and administered appropriately to make sure people are safe.

Providers must prevent and control the spread of infection. Where the responsibility for care and treatment is shared, care planning must be timely to maintain people's health, safety and welfare.

CQC understands that there may be inherent risks in carrying out care and treatment, and we will not consider it to be unsafe if providers can demonstrate that they have taken all reasonable steps to ensure the health and safety of people using their services and to manage risks that may arise during care and treatment.

CQC can prosecute for a breach of this regulation or a breach of part of the regulation if a failure to meet the regulation results in avoidable harm to a person using the service or if a person using the service is exposed to significant risk of harm. We do not have to serve a Warning Notice before prosecution. Additionally, CQC may also take other regulatory action. See the offences section for more detail.

CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation.

Note:
The regulation does not apply to the person's accommodation if this is not provided as part of their care and treatment.

The regulation in full

12.—

  1. Care and treatment must be provided in a safe way for service users.
  2. Without limiting paragraph (1), the things which a registered person must do to comply with that paragraph include—
    1. assessing the risks to the health and safety of service users of receiving the care or treatment;
    2. doing all that is reasonably practicable to mitigate any such risks;
    3. ensuring that persons providing care or treatment to service users have the qualifications, competence, skills and experience to do so safely;
    4. ensuring that the premises used by the service provider are safe to use for their intended purpose and are used in a safe way;
    5. ensuring that the equipment used by the service provider for providing care or treatment to a service user is safe for such use and is used in a safe way;
    6. where equipment or medicines are supplied by the service provider, ensuring that there are sufficient quantities of these to ensure the safety of service users and to meet their needs;
    7. the proper and safe management of medicines;
    8. assessing the risk of, and preventing, detecting and controlling the spread of, infections, including those that are health care associated;
    9. where responsibility for the care and treatment of service users is shared with, or transferred to, other persons, working with such other persons, service users and other appropriate persons to ensure that timely care planning takes place to ensure the health, safety and welfare of the service users.

Guidance

This sets out the guidance providers must have regard to against the relevant component of the regulation.

12(1) Care and treatment must be provided in a safe way for service users.

12(2) without limiting paragraph (1), the things which a registered person must do to comply with that paragraph include–

12(2)(a) assessing the risks to the health and safety of service users of receiving the care or treatment;

12(2)(b) doing all that is reasonably practicable to mitigate any such risks;

12(2)(c) ensuring that persons providing care or treatment to service users have the qualifications, competence, skills and experience to do so safely;

12(2)(d) ensuring that the premises used by the service provider are safe to use for their intended purpose and are used in a safe way;

12(2)(e) ensuring that the equipment used by the service provider for providing care or treatment to a service user is safe for such use and used in a safe way;

12(2)(f) where equipment or medicines are supplied by the service provider, ensuring that there are sufficient quantities of these to ensure the safety of service users and to meet their needs;

12(2)(g) the proper and safe management of medicines;

12(2)(h) assessing the risk of, and preventing, detecting and controlling the spread of, infections, including those that are health care associated;

12(2)(i) where responsibility for the care and treatment of service users is shared with, or transferred to, other persons, working with such other persons, service users and other appropriate persons to ensure that timely care planning takes place to ensure the health, safety and welfare of the service users.