The Fundamental Standards, Regulation 12: Safe Care & Treatment – Are you compliant?

The Fundamental Standards, Regulation 12: Safe Care & Treatment – Are you compliant?

As part of our series of articles addressing the Fundamental Standards and how you need to ensure your service meets those standards, here we consider Regulation 12 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Safe Care & Treatment (“the Regulation”).

It is important to note that the Fundamental Standards are a set of regulations. Each regulation is not entirely divisible from the other. For example, if you are not compliant with Regulation 18 (Staffing) and 19 (Fit and proper persons employed) it is unlikely you will be able to demonstrate compliance with Regulation 12(c).


To achieve compliance, you must be clear upon what you need to be compliant with and the Regulation itself sets this out for you:

 Safe care and treatment

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—

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

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

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

(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;

(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 is used in a safe way;

(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;

(g) the proper and safe management of medicines;

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

(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[1].

A “registered person” is a person who is the service provider or registered manager in respect of that activity.

The Regulation covers a breadth of areas and must be given due care and attention. Ensuring the provision of safe care and treatment can have no short comings and must be demonstrably sustainable.

The intention of Regulation 12 is to prevent persons receiving unsafe care and treatment and to prevent unavoidable harm or risk of harm. Evidence of a service user being subject to a risk  of harm is sufficient to breach Regulation 12.

The exposure of a significant risk of avoidable harm relates to both physical and or psychological harm.


Simply knowing the Regulation and where to find it isn’t enough. Now you need to analyse and think how does this apply to my service?

Regulation 12(1) is simple: you must provide care and treatment to all service users in a safe way.

The Regulation 12(2) also sets out mandatory “things” a registered person must do to achieve compliance with the provision of care and treatment in a safe way, which can broadly be summarised to a non-exhaustive list as follows:

  • Risk Assessments
  • Mitigation
  • Those providing the care and treatment have qualifications, competence, skills and experience
  • Safe use of premises
  • Safe use of equipment
  • Sufficient supply of equipment and medicines
  • Safe management of medicines
  • Prevention, detection and transmission of infection
  • Timely care planning and co-ordination with other services

The Regulation is drafted so that nothing listed in Regulation 12(2) limits the requirement to deliver safe care and treatment.

It is vital that you know your service and can demonstrably correlate your services users needs to your registered persons and teams competence and care delivery.


How can you demonstrate compliance? Two words: robust evidence.

To avoid a breach of Regulation 12, you must be able to provide upon request robust evidence demonstrating your knowledge and application of the mandatory requirements set out in Regulation 12.

As a starting point your robust evidence must be:

  1. Accessible;
  2. Clearly documented;
  3. Up to date; and
  4. Subject to regular reviews.

As well as the day to day delivery of care and ensuring clear, contemporaneous and consistent notes are documented for each service user, you also need to ensure records are up to date for each of your team and you can demonstrate handovers and clear engagement with other services engaged in the provision of care and treatment.

By way of an illustrative starting point:

  • Are all training logs up to date?
  • Do you have copies of relevant qualifications for each staff member delivering care?
  • Are your inventories and medicine logs up to date?
  • Do you have robust review processes in place?
  • How do you highlight problems and put into place action plans?
  • Are all action plans complete?
  • Are reporting processes clear and known?
  • Are your policies and procedures accessible, up to date and fit for purpose?
  • What is the condition of the relevant premises?
  • What regulated activities are being undertaken?

You must also have regard to guidance issued by the Care Quality Commission, and particularly in relation to the prevention or control of health care associated infections that you also have heed to guidance issued by the Secretary of State.

But how do I achieve all of this? Appoint some champions within the service. Identify 3 or 4 members of the team who are going to focus on one issue across the board, and make that the best it can be. One person might focus on training, another might focus on MAR charts and auditing of them. By giving team members individual responsibility this enables the Registered Manager and Provider to have greater oversight and cover more areas more quickly.

Non compliance with Regulation 12 can have far reaching consequences – for the health and safety of the people you support, but also for your own CQC registration.

Take the time to get it right. Even little changes can enhance the lives of the people you support and hopefully impress CQC too.

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