1. The Care Act 2014,The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 and Possible Offences
Jeremy Allin

2. The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
Replace the 2010 Regulations.
The following factors are established by the new regulations:
Fundamental Standards
Duty of Candour
Fit and Proper Persons Requirement for Directors
Under the regulations, CQC is now able to prosecute cases where someone using a registered service is harmed or is at risk of harm.

3. The Fundamental Standards
The ‘Essential Standards’ in the 2010 regulations have been replaced by the ‘Fundamental Standards’ under the 2014 Regulations.
The Fundamental Standards are clearer statements of the standards of care that providers are expected to meet at all times.
There are also two new regulations: the fit and proper person requirement for directors and a statutory duty of candour.
The Fundamental Standards come into force for all registered providers on 1 April 2015.

4. Comparison of the old standards and the fundamental standards
Current regulations
New regulations
• Care and welfare of service users
• Assessing and monitoring the quality of service provision
• Safeguarding service users from abuse
• Cleanliness and infection control
• Management of medicines
• Meeting nutritional needs
• Safety and suitability of premises
• Safety and suitability of equipment
• Respecting and involving service users
• Consent to care and treatment
• Complaints
• Records
• Requirements relating to workers
• Staffing
• Supporting workers
• Cooperating with other providers
• Person-centred care
• Dignity and respect
• Need for consent
• Safe care and treatment
• Safeguarding service users from abuse
• Meeting nutritional needs
• Cleanliness, safety and suitability of premises and equipment
• Receiving and acting on complaints
• Good governance
• Staffing
• Fit and proper persons employed
and
• Fit and proper person requirement for directors
• Duty of candour
Comparison taken from CQC’s
“Guidance for providers on meeting the fundamental standards and on CQC’s enforcement powers”, July 2014.

5. Under the 2014 regulations, some of the regulations allow for direct prosecution when the Fundamental Standards are breached.
When breaches of regulations do not constitute a criminal offence, CQC can enforce the Fundamental Standards using civil powers to impose conditions, suspend or cancel a registration. If providers do not comply with the requirements under the civil powers, they will be committing a criminal offence and could be prosecuted.

6. Duty of Candour Regulation 20
Aims to ensure that providers are open and transparent with service users and ‘other relevant persons’ (those acting lawfully on their behalf) regarding their care and treatment.
Introduces a legal requirement requiring all health and adult social care providers registered with CQC to be open with people if things go wrong.
CQC will be able to take enforcement action if this requirement is breached.
Came into force for NHS bodies on 27 November 2014, and will apply to all care providers from 1 April 2015.

7. Key Definitions Openness Transparency Candour
“Enabling concerns and complaints to be raised freely without fear and questions asked to be answered.”
Transparency
“Allowing information about the truth about performance and outcomes to be shared with staff, patients, the public and regulators.”
Candour
“Any patient harmed by the provision of a healthcare service is informed of the fact and an appropriate remedy offered, regardless of whether a complaint has been made or a question asked about it.”

8. In order to comply with Regulation 20, providers must:
Act in an open and transparent way regarding care and treatment provided to service users;
Inform the person as soon as reasonably practicable if something goes wrong, and provide support;
Provide an account of the incident which is true of all the facts the provider is aware of;
Advise on any further enquiries;
Offer an apology.

9. The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015
These regulations introduce Regulation 20A. This requires providers to display their CQC rating (Outstanding, Good, Requires Improvement or Inadequate).
Applies to all providers when they have received a CQC rating.
The rating must be displayed legibly and conspicuously at the premises and on the website.
Failing to do so will mean that CQC can prosecute, and they can move directly to prosecution without first serving a warning notice.
Comes into force 1 April 2015.

10. The display of the CQC rating must include:
The CQC logo;
The name of the service;
The overall performance rating;
The rating for each of the five key questions and the performance in relation to particular premises or activities;
CQC’s website address and the location on the website where the ratings and assessment of the provider can be found;
The date the inspection report was published.

11. Fit and Proper Persons Requirement Regulation 5
Aims to ensure that directors are fit and proper to take on responsibility for the overall quality and safety of the care a service provides, and that it meets the requirements under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.
Applies to directors: executive, non-executive, permanent, interim and associate positions, irrespective of their voting rights.
Came into force for health service bodies on 27 November 2014, and will apply to all other providers from 1 April 2015.

12. In order to comply with Regulation 5, providers must:
Make every reasonable effort to assure themselves of the suitability of their directors by all means available;
Provide evidence that suitable systems are in place to ensure all new and existing directors are fit for the role;
Ensure directors are of good character and that no appointments meet any of the unfitness criteria:
Bankruptcy, insolvency, appearing on barred lists, being prohibited from holding directorships, involved in a serious misconduct, mismanagement of failure of care.
If someone no longer meets the requirement, inform the regulator.

13. Breaching Regulation 5
If someone who does not meet the FPPR is appointed, or is already in place, this will be a breach of Regulation 5. Evidence of this breach could be:
There are no proper systems in place for a provider to make the assessments required;
A director is unfit on a mandatory ground, for example bankruptcy, insolvency etc.
A provider receives information concerning the fitness of a director, and makes a decision regarding their fitness that is not one a reasonable person would make.
CQC can take enforcement action if a breach of FPPR occurs.

14. Offences
CQC will be able to bring prosecutions for breaches under The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 and The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015
Some of the new regulations have offences attached, and CQC will be able to bring prosecutions if these regulations are breached. For regulations they cannot prosecute against, CQC may use other civil actions as set out in their enforcement policy.

15. CQC may prosecute breaches of the following regulations directly without first issuing a Warning Notice:
Regulation 11
Need for consent
Regulation 16(3)
Receiving and acting on complaints
Regulation 17(3)
Good governance
Regulation 20 (2) and (3)
Duty of candour
Regulation 20A
Requirement as to display of performance assessments
A defence to these offences is available where the registered persons took all reasonable steps and acted with all due diligence (Regulation 22(4)).

16. CQC can prosecute for the following offences, but only if the breach of the regulation results in people who use services being exposed to avoidable harm, a significant risk of such harm occurring or suffering a loss of money or property as a result of theft, misuse or misappropriation:
Regulation 12
Safe care and treatment
Regulation 13 (1) to (4)
Safeguarding service users from abuse and improper treatment
Regulation 14
Meeting nutritional and hydration needs
For breaches of the remaining regulations not listed on these slides, CQC can take regulatory action other than prosecution.

17. Health and Safety Incidents
Transfer of responsibility from the Health and Safety Executive to CQC in deciding whether regulatory action will be taken in relation to reported incidents of health and safety involving people using services regulated by CQC.
It will fall to CQC to investigate incidents such as deaths of service users following poor treatment, physical restraint, choking and falls.
A recently published Memorandum of Understanding between CQC, HSE and local authorities aims to ensure ‘effective, co-ordinated and comprehensive regulation of health and safety’.
Comes into force from 1 April 2015.

18. Contact me Jeremy Allin Partner Jeremy.Allin@LA-law.com 01202 786154
Connect with me on LinkedIn
Find us on Facebook
Follow