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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.—
- Care and treatment must be provided in a safe way for service users.
- Without limiting paragraph (1), the things which a registered person must do to comply with that paragraph include—
- assessing the risks to the health and safety of service users of receiving the care or treatment;
- doing all that is reasonably practicable to mitigate any such risks;
- ensuring that persons providing care or treatment to service users have the qualifications, competence, skills and experience to do so safely;
- ensuring that the premises used by the service provider are safe to use for their intended purpose and are used in a safe way;
- 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;
- 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;
- the proper and safe management of medicines;
- assessing the risk of, and preventing, detecting and controlling the spread of, infections, including those that are health care associated;
- 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
Component of the regulation |
Providers must have regard to the following guidance |
12(1) Care and treatment must be provided in a safe way for service users. |
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12(2) without limiting paragraph (1), the things which a registered person must do to comply with that paragraph include– |
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12(2)(a) assessing the risks to the health and safety of service users of receiving the care or treatment; |
All this applies when people use a service. This includes when they are admitted, discharged, transferred or move between services. |
12(2)(b) doing all that is reasonably practicable to mitigate any such risks; |
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12(2)(c) ensuring that persons providing care or treatment to service users have the qualifications, competence, skills and experience to do so safely; |
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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; |
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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; |
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12(2)(g) the proper and safe management of medicines; |
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12(2)(h) assessing the risk of, and preventing, detecting and controlling the spread of, infections, including those that are health care associated; |
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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. |
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Related legislation
The Controlled Drugs (Supervision of Management and Use) Regulations 2013
The Electricity at Work regulations 1989
The Gas Safety (Installation and Use) regulations 1998
Health and Safety at Work etc. Act 1974
The Health and Safety (First-Aid) Regulations 1981
The Health and Safety (Miscellaneous Amendments) 2002
The Ionising Radiations Regulations 1999
The Ionising Radiation (Medical Exposure) Regulations 2000
Management of Health and Safety at Work Regulations 1999
The Manual Handling Operations Regulations 1992
The Health and Safety (Miscellaneous Amendments) 2002
The Medical Devices Regulations 2002
The Medical Devices (Amendment) Regulations 2012
The Medicines Act 1968 is still the current Act of legislation but there has also been a further piece of work carried out to consolidate all the amendments made to the Act which was completed in 2012. See The Human Medicines Regulations 2012.
The Human Medicines Regulations 2012
Mental Capacity Act Code of Practice
Code of Practice (Mental Health Act 1983)
The Misuse of Drugs (Safe Custody) Regulations 1973
The Misuse of Drugs and Misuse of Drugs (Safe Custody) (Amendment) Regulations 2007
Public Interest Disclosure Act 1998
The Workplace (Health, Safety and Welfare) Regulations 1992
The Health and Safety (Miscellaneous Amendments) Regulations 2002
Related guidance
Abortion/termination of pregnancy
Guidance in relation to requirements of the Abortion Act 1967 (Department of Health, May 2014)
Termination of pregnancy: An RCN nursing framework (Royal College of Nursing)
The care of women seeking induced abortion (Royal College of Obstetricians and Gynaecologists, 2011)
Guidance in relation to requirements of the Abortion Act 1967 (Department of Health, May 2014)
Termination of pregnancy: An RCN nursing framework (Royal College of Nursing)
The care of women seeking induced abortion (Royal College of Obstetricians and Gynaecologists, 2011)
Buildings/premises and equipment
For all services
DH health building notes (Department of Health)
Electrical safety and you (Health and Safety Executive)
Electrical safety at work (Health and Safety Executive)
Gas safety toolbox (Health and Safety Executive)
Health Building Note 00-10 Part D: Windows and associated hardware (Department of Health)
Lighting at work (Health and Safety Executive)
Medical devices regulation and safety
PAT - Portable appliance testing FAQs (Health and Safety Executive)
Provision and use of work equipment regulations (Health and Safety Executive)
Safe premises (Health and Safety Executive)
Health technical memoranda series (Department of Health)
Policies and principles of healthcare engineering (HTM 00) (Department of Health, 2014)
Domestic gas health and safety (Health and Safety Executive)
DSDC Good practice guidelines on lighting (Stirling Dementia Service Development Centre)
Health technical memoranda series (Department of Health)
Policies and principles of healthcare engineering (HTM 00) (Department of Health, 2014)
Caldicott
For all services
Caldicott principles - revised principles 2013
Caldicott review: information governance in the health and care system
Care, treatment and support
For all services
Common core principles for self-care (Skills for Care)
Data protection
For all services
Data Protection Act 1998: guidance
ICO guidance on data protection (Information Commissioner's Office)
Information governance and Caldicott principles (Department of Health)
Deprivation of liberty
Dignity and respect
For all services
Dignity in Care – SCIE guide 15 (Social Care Institute for Excellence, June 2010 (updated May 2013))
General resource
For all services
National Institute for Health and Care Excellence (NICE)
Health and safety
For all services
Guidance for health and social care services (Health and Safety Executive)
Health and Safety Executive guidance
Health and safety in care homes (Health and Safety Executive, June 2014)
Leadership (Health and Safety Executive)
Leading health and safety at work (Health and Safety Executive)
Managing for health and safety - HSG65 guidance (Health and Safety Executive)
Managing for health and safety (Health and Safety Executive)
Natural rubber latex sensitisation in health and social care (Health and Safety Executive)
NHS Employers: Workplace health and safety standards
Selection latex gloves (Health and Safety Executive)
Sharp Instruments in Healthcare Regulations 2013 (Health and Safety Executive)
Sharps injuries (Health and Safety Executive)
Infection control/cleanliness
For all services
Decontamination guidelines (British Society of Gastroenterology)
Health building note 00-09: Infection control in the built environment (Department of Health, 2013)
The revised healthcare cleaning manual (National Patient Safety Agency, 2009)
Wipe it out (Royal College of Nursing)
Prevention and control of healthcare-associated infections: Quality improvement guide
Prevention and control of healthcare-associated infections: Quality improvement guide
Infection prevention and control in care homes: Information resource (Department Head)
National specifications for cleanliness: care homes (National Patient Safety Agency)
Medicines
For all services
Medicines management (National Institute for Health and Care Excellence)
Standards for medicines management (Nursing and Midwifery Council)
Handling of medicines in social care (Royal Pharmaceutical Society)
Managing medicines in care homes (National Institute for Health and Care Excellence)
Mental capacity
For all services
Mental Capacity Act 2005 Code of Practice
Mental health
Provision of mental health care for adults who have a learning disability (Royal College of Nursing)
Provision of mental health care for adults who have a learning disability (Royal College of Nursing)
Moving and handling
For all services
Hoisting (Health and Safety Executive)
Moving and handling in health and social care (Health and Safety Executive)
Personalised care
Guidance on personalisation (Social Care Institute for Excellence)
Restrictive practice/restraint
Risk assessment
For all services
Health and Safety Executive, Sensible risk assessment in care settings
Managing risk from hot water and surfaces in health and social care (Health and Safety Executive)
Risk assessment (Health and Safety Executive)
Bed rail risk management - Sector information minute SIM 07/2012/06 (Health and Safety Executive)
Safe use of bedrails device bulletin (Medicines and Healthcare Products Regualtory Agency)
Bed rail risk management - Sector information minute SIM 07/2012/06 (Health and Safety Executive)
Safe use of bedrails device bulletin (Medicines and Healthcare Products Regualtory Agency)
Safeguarding
Safety
For all services
Safety alerts published by NHS England
Safety warnings, alerts and recalls published by the MHRA
Slips, trips and falls
For all services
Falls from windows or balconies in health and social care (Health and Safety Executive)
Slips and trips in health and social care (Health and Safety Executive)
Staff support and training
For all services
Resuscitation Guidelines 2010 (Resuscitation Council UK)
Staffing and recruitment
Uniforms and workwear: guidance on uniforms and workwear for NHS employers (Department of Health)
Uniforms and workwear: guidance on uniforms and workwear for NHS employers (Department of Health)
Waste management
For all services
Safe management of healthcare waste - version 2.0, 2nd edition (Department of Health,2012 )
Water systems (including legionella)
For all services
Management of Pseudomonas - addendum to HTM 04-01 (Department of Health)
Management of Pseudomonas - addendum to HTM 04-01 (Department of Health)
Whistleblowing
For all services
Whistleblowing guides (Social Care Institute for Excellence)
- Last updated:
- 29 May 2017