1. Overview

Systems or processes must be established and operated effectively to ensure compliance with the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

They must be in place to enable the registered person, in particular, to:

  1. assess, monitor and improve the quality and safety of services in relation to providing regulated activity (including the quality of the experience of service users);
  2. 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 providing regulated activity;
  3. maintain securely an accurate, complete and contemporaneous record in respect of each service user, including a record of the care and treatment provided and of decisions taken in relation to their care and treatment;
  4. maintain securely such other records as are necessary to be kept in relation to:
    • staff employed in regulated activities, and
    • the management of the regulated activity;
  5. seek and act on feedback from relevant persons and other persons on regulated activity services, so as to be able to continually evaluate and improve services;
  6. evaluate and improve their practice in relation to processing information referred to in 1-5 above.

The registered person must send to the Care Quality Commission, when requested to do so and by no later than 28 days after receiving the request:

  • a written report setting out how, and the extent to which, in their opinion the requirements of 2) and 3) above, are being complied with; and
  • any plans that they have for improving the standard of the services provided to service users, in relation to ensuring their health and welfare.

2. Ensuring Compliance

The service must have systems and processes in place such as regular audits of the services provided and must assess, monitor and improve the quality and safety. These audits should be base lined against Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 and should, wherever possible, include the experiences people who use the service. They must have a process in place to make sure this happens at all times and in response to the changing needs of people who use the service (see Displaying Performance Assessments).

Systems and processes should be continually reviewed to make sure they are fit for purpose; that is:

  • the systems and processes enable the service to identify where quality and / or safety are being compromised and to respond appropriately and without delay;
  • the service has access to all necessary information.

This must include scrutiny and overall responsibility at Board level or equivalent.

Information must be up to date, accurate and properly analysed and reviewed by staff with the appropriate skills and competence to understand its significance. When required, results should be escalated and appropriate action taken.

The service should have effective communication systems to ensure that service users, those who need to know within the service and where appropriate those external to the service, know the results of reviews about the quality and safety of the service and any actions required following the review.

The service should actively seek the views of a wide range of stakeholders including people who use the service and their families, staff, partner agency professionals, professional bodies, commissioners, local groups, members of the public and other bodies, about their experience of, and the quality of care and treatment delivered by the service. It must be able to show how it has:

  • analysed and responded to the information gathered, including taking action to address issues where they are raised, and
  • used the information to make improvements and demonstrate that they have been made.

The service must seek professional / expert advice as needed and without delay, to help it to identify and make improvements. It must monitor progress against plans to improve the quality and safety of services, and take appropriate action without delay where progress is not achieved as expected. Subject to statutory consent and applicable confidentiality requirements, It must share relevant information, such as information about incidents or risks, with other relevant individuals or bodies. These bodies include Safeguarding Adults Boards, coroners and regulators. Where it identifies that improvements are needed these must be made without delay. Senior managers in the service should read and implement relevant nationally recognised guidance and be aware that quality and safety standards change over time when new practices are introduced, or because of technological development or other factors.

3. Minimising Risk

The service must have systems and processes that enables it to identify and assess risks to the health, safety and / or welfare of service users, and have processes to minimise the likelihood of risks and to minimise the impact of risks on them.

Where risks are identified, it must introduce measures to reduce or remove the risks within a timescale that reflects the level of risk and impact on service users. Risks to the health, safety and / or welfare of service users must be escalated within the organisation or to a relevant external body as appropriate. Identified risks to service users and others (such as staff, visitors, tradespeople or volunteers) must be continually monitored and appropriate action taken where a risk has increased.

4. Recording

See also Record Keeping.

Records relating to the care and treatment of each person using the service must be kept and be fit for purpose.

Records relating to the management of regulated activities includes anything relevant to the planning and delivery of care and treatment. It may include governance arrangements such as policies and procedures, service and maintenance records, audits and reviews, purchasing, action plans in response to risk and incidents.

Records relating to staff and volunteers and the management of regulated activities must be created, amended, stored and destroyed in accordance with current legislation and guidance.