The 12 Fundamental Standards

1.Care and treatment must be appropriate and reflect service users’ needs and preferences. This includes:

(a) carrying out, collaboratively with the relevant person, an assessment of the needs and preferences for care and treatment of the service user;
(b) designing care or treatment with a view to achieving service users’ preferences and ensuring their needs are met;
(c) enabling and supporting relevant persons to understand the care or treatment choices available to the service user and to discuss, with a competent health care professional or other competent person, the balance of risks and benefits involved in any particular course of treatment;
(d) enabling and supporting relevant persons to make, or participate in making, decisions relating to the service user’s care or treatment to the maximum extent possible;
(e) providing opportunities for relevant persons to manage the service user’s care or treatment;
(f) involving relevant persons in decisions relating to the way in which the regulated activity is carried on in so far as it relates to the service user’s care or treatment;
(g) providing relevant persons with the information they would reasonably need for the purposes of sub-paragraphs (c) to (f);
(h) making reasonable adjustments to enable the service user to receive their care or treatment;
(i) where meeting a service user’s nutritional and hydration needs, having regard to the service user’s well-being

2.Service users must be treated with dignity and respect. This includes:

(a) ensuring the privacy of the service user;
(b) supporting the autonomy, independence and involvement in the community of the service user;
(c) having due regard to any relevant protected characteristics (as defined in section 149(7) of the Equality Act 2010) of the service user.

3.Care and treatment must only be provided with consent.

If the service user is 16 or over and is unable to give such consent because they lack capacity to do so, the registered person must act in accordance with the 2005 Act.

4.Care and treatment must be provided in a safe way. This includes:

(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.

5.Service users must be protected from abuse and improper treatment.

• Systems and processes must be established and operated effectively to prevent abuse of service users.
• Systems and processes must be established and operated effectively to investigate, immediately upon becoming aware of, any allegation or evidence of such abuse.
• Care or treatment for service users must not be provided in a way that:

(a) includes discrimination against a service user on grounds of any protected characteristic (as defined in section 4 of the Equality Act 2010) of the service user
(b) includes acts intended to control or restrain a service user that are not necessary to prevent, or not a proportionate response to, a risk of harm posed to the service user or another individual if the service user was not subject to control or restraint
(c) is degrading for the service user
(d) significantly disregards the needs of the service user for care or treatment.

• A service user must not be deprived of their liberty for the purpose of receiving care or treatment without lawful authority.

6.Service users’ nutritional and hydration needs must be met.

This applies where the meeting of the nutritional or hydration needs of service users is part of the arrangements made for the provision of care or treatment by the service provider.

“Nutritional and hydration needs” means:

(a) receipt by a service user of suitable and nutritious food and hydration which is adequate to sustain life and good health
(b) receipt by a service user of parenteral nutrition and dietary supplements when prescribed by a health care professional
(c) the meeting of any reasonable requirements of a service user for food and hydration arising from the service user’s preferences or their religious or cultural background
(d) if necessary, support for a service user to eat or drink.

7.All premises and equipment used must be clean, secure, suitable and used properly.

• All premises and equipment used by the service provider must be:

(a) clean
(b) secure
(c) suitable for the purpose for which they are being used
(d) properly used
(e) properly maintained
(f) appropriately located for the purpose for which they are being used

• “Equipment” does not include equipment at the service user’s accommodation if:

(a) such accommodation is not provided as part of the service user’s care or treatment, and
(b) such equipment is not supplied by the service provider.

8.Complaints must be appropriately investigated and appropriate action taken in response.

• The registered person must establish and operate effectively an accessible system for identifying, receiving, recording, handling and responding to complaints by service users and other persons in relation to the carrying on of the regulated activity.
• The registered person must provide to the Commission, when requested to do so and by no later than 28 days beginning on the day after receipt of the request, a summary of:

(a) complaints made under such complaints system
(b) responses made by the registered person to such complaints and any further correspondence with the complainants in relation to such complaints
(c) any other relevant information in relation to such complaints as the Commission may request.

9.Systems and processes must be established to ensure compliance with the fundamental standards.

• Such systems or processes must enable the registered person, in particular, to:

(a) assess, monitor and improve the quality and safety of the services provided in the carrying on of the regulated activity (including the quality of the experience of service users in receiving those services);
(b) assess, monitor and mitigate the risks relating to the health, safety and welfare of service users and others who may be at risk which arise from the carrying on of the regulated activity;
(c) maintain securely an accurate, complete and contemporaneous record in respect of each service user, including a record of the care and treatment provided to the service user and of decisions taken in relation to the care and treatment provided;
(d) maintain securely such other records as are necessary to be kept in relation to:
(i) persons employed in the carrying on of the regulated activity, and
(ii) the management of the regulated activity;
(e) seek and act on feedback from relevant persons and other persons on the services provided in the carrying on of the regulated activity, for the purposes of continually evaluating and improving such services;
(f) evaluate and improve their practice in respect of the processing of the information referred to in sub-paragraphs (a) to (e).

• The registered person must send to the Commission, when requested to do so and by no later than 28 days beginning on the day after receipt of the request:

(a) a written report setting out how, and the extent to which, in the opinion of the registered person, the requirements of paragraph (2)(a) and (b) are being complied with, and
(b) any plans that the registered person has for improving the standard of the services provided to service users with a view to ensuring their health and welfare.

10.Sufficient numbers of suitably qualified, competent, skilled and experienced staff must be deployed.

Persons employed by the service provider in the provision of a regulated activity must:

(a) receive such appropriate support, training, professional development, supervision and appraisal as is necessary to enable them to carry out the duties they are employed to perform,
(b) be enabled where appropriate to obtain further qualifications appropriate to the work they perform, and
(c) where such persons are health care professionals, social workers or other professionals registered with a health care or social care regulator, be enabled to provide evidence to the regulator in question demonstrating, where it is possible to do so, that they continue to meet the professional standards which are a condition of their ability to practise or a requirement of their role.

11.Persons employed must be of good character, have the necessary qualifications, skills and experience, and be able to perform the work for which they are employed (fit and proper persons requirement).

1. Persons employed for the purposes of carrying on a regulated activity must:

(a) be of good character
(b) have the qualifications, competence, skills and experience which are necessary for the work to be performed by them
(c) be able by reason of their health, after reasonable adjustments are made, of properly performing tasks which are intrinsic to the work for which they are employed.

2. Recruitment procedures must be established and operated effectively to ensure that persons employed meet the (above) conditions
3. The following information must be available in relation to each such person employed:

(a) the information specified in Schedule 3
(b) such other information as is required under any enactment to be kept by the registered person in relation to such persons employed.

4. Persons employed must be registered with the relevant professional body where such registration is required by, or under, any enactment in relation to:

(a) the work that the person is to perform
(b) the title that the person takes or uses.

5. Where a person employed by the registered person no longer meets the criteria in paragraph

The registered person must:

(a) take such action as is necessary and proportionate to ensure that the requirement in that paragraph is complied with
(b) if the person is a health care professional, social worker or other professional registered with a health care or social care regulator, inform the regulator in question.

• Paragraphs (1) and (3) of this regulation do not apply in a case to which regulation 5 applies.

12.Registered persons must be open and transparent with service users about their care and treatment (the duty of candour).

Applies only to health service bodies but for the purposes of compliance with the requirements set out in these Regulations, the registered person must have regard to:

(a) guidance issued by the Commission under section 23 of the Act in relation to the requirements set out in Part 3 (with the exception of regulation 12 in so far as it applies to health care associated infections);
(b) in relation to regulation 12, in so far as it applies to health care associated infections, any code of practice issued by the Secretary of State under section 21 of the Act in relation to the prevention or control of health care associated infections.

Use to answer question 1.1b of the Care Certificate