1. The Health and Social Care Act 2008
(Regulated Activities) Regulations 2014
in practice
28 September 2015| Alison Wood

2. HEALTHCARE
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
HEALTHCARE
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The ‘Essential Standards’ in the 2010 regulations have been replaced by the ‘Fundamental Standards’ under the 2014 Regulations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 came into force for all registered providers on 1 April 2015

4. standards and the fundamental standards
HEALTHCARE
Comparison of the old
standards and the fundamental standards
Current 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
New regulations
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. HEALTHCARE
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. How are the new regulations working in practice? Inspections
HEALTHCARE
How are the new regulations working in practice?
Inspections
CQC promised a “new and better approach to inspections” being “expert-led” and “based on what matters most to people who use the services”.
Does this happen in practice?

7. Inspections: Provider Information Return (PIR)
HEALTHCARE
Inspections: Provider Information Return (PIR)
A PIR will be used to help guide the inspection.
These should always be completed where requested. If they are not completed, CQC will not normally rate better than ‘requires improvement’ for the well-led question.
PIR’s will not always be requested before an inspection, particularly if this is a responsive inspection.

8. Inspections: Judgments and Ratings
HEALTHCARE
Inspections: Judgments and Ratings
Deciding on a rating:
Does the evidence demonstrate that CQC can rate the service as good?
If yes, does it exceed the standard of good and could it be outstanding?
If no, does it reflect the characteristics of requires improvement or inadequate?
If requires improvement or inadequate, CQC will consider whether any regulations have been breached.

9. Inspections: Ratings Principles
HEALTHCARE
Inspections: Ratings Principles
At least two of the five key questions must be rated as ‘outstanding’ and the other three questions must be rated as at least ‘good’ before an aggregated rating of ‘outstanding’ will be awarded.
The overall rating will be ‘good’ if there are no ratings of ‘inadequate’ and no more than one question rated as ‘requires improvement’
If two or more are rated ‘requires improvement’, the overall rating will be ‘requires improvement’.
If two or more are rated ‘inadequate’, the overall rating will be ‘inadequate’.
Providers can ask for a rating review after publication of the report if the inspector did not follow the process for making ratings decisions and aggregating them.

10. Focus on the new regulations
HEALTHCARE
Focus on the new regulations
Although many of the new regulations mirrored the previous ones, there were two new notable duties:
The duty of candour; and
The fit and proper person requirement for directors.

11. Duty of Candour Regulation 20 HEALTHCARE
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 for all care providers since 1 April 2015

12. Regulation 20, providers must:
HEALTHCARE
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 (‘notifiable safety incident’), 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
Keep a written record kept securely
Written notification including details of enquiries undertaken and still to be undertaken and an apology

13. Duty of Candour: Criticisms
HEALTHCARE
Duty of Candour: Criticisms
A number of criticisms have been voiced about the difference in wording between the duty of candour for NHS bodies and the duty of candour for other bodies.
For NHS bodies, the duty applies to incidents that could have resulted in harm. Whereas for other non-NHS bodies, the duty arises for incidents that appears to have resulted in harm.
The charity, Action Against Medical Accidents have argued that the narrower test for non-NHS bodies means that this will lead to errors resulting in harm being treated differently depending upon who makes the mistake.
The Department of Health is planning a public consultation in response and has confirmed that the duty is, in any event, being kept under review.

14. HEALTHCARE
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
Came into force 1 April 2015
‘Special Measures’

15. CQC rating must include:
HEALTHCARE
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

16. Fit and Proper Persons Requirement Regulation 5
HEALTHCARE
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 for all other providers from 1 April 2015

17. In order to comply with Regulation 5, providers must:
HEALTHCARE
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

18. Breaching Regulation 5 HEALTHCARE
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

19. HEALTHCARE
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

20. HEALTHCARE
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 (8) 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))

21. HEALTHCARE
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 Safe care and treatment
Regulation 13 (1) to (4) Safeguarding service users from abuse and improper treatment
Regulation Meeting nutritional and hydration needs
For breaches of the remaining regulations not listed on these slides, CQC can take regulatory action other than prosecution.

22. Enforcement HEALTHCARE
In addition to CQC’s new powers of prosecution, it still has its existing and additional new enforcement powers.
Requirement notices
Warning notices
Impose, vary or remove conditions of registration
Suspend registration
Cancel registration
Urgent powers:
Impose conditions
Special measures

23. Enforcement HEALTHCARE
Requirement notices – Used if no immediate risk of harm. Notifies a provider that a breach has occurred and requires a response as to what action will be taken in response.
Warning notices – representations can be made within 10 working days . Can also make representations against publication.
Impose, vary or remove conditions of registration – flexible powers. Representations can be made within 28 days.
Suspend registration – rarely used. May be used if a breach can be rectified in a set time period. Representations can be made within 28 days.
Cancel registration - One of the most powerful sanctions. Again, representations can be made within 28 days.

24. Enforcement: urgent powers
HEALTHCARE
Enforcement: urgent powers
Urgent powers:
Impose conditions
Suspend registration
Cancel registration
Used if a person “will or may be” exposed to harm.
If appealed, these cases will be heard far more quickly at the Tribunal. Once an appeal is submitted, CQC have 3 days to provide a response and a hearing is usually listed within 10 days.

25. Enforcement: special measures
HEALTHCARE
Enforcement: special measures
Routes in to special measures:
Special measures are normally triggered by an inadequate rating, rather than specific regulatory breaches.
If an inadequate rating is received, a service will automatically be placed in special measures.
If a service is rated inadequate for one of the five key questions, it will be given 6 months to improve from the date of publication of the report.
A second inspection will then follow and if sufficient improvements have not been made, the service will be placed in special measures.

26. Enforcement: special measures
HEALTHCARE
Enforcement: special measures
Routes out of special measures:
Once in special measures, a service will be re-inspected within 6 months.
If the service is rated at least ‘requires improvement’ for all the key questions and CQC consider that sufficient improvements have been made, the service will be taken out of special measures.
If, after 6 months, the service is still rated as inadequate in any of the key questions, CQC will take action to prevent the provider from operating the service.
A further inspection will then take place within 6 months and if sufficient improvements have been made, the service will be taken out of special measures.
If there are still inadequate ratings after this time, the registration will be cancelled.

27. Criminal Justice & Courts Act 2015
HEALTHCARE
Criminal Justice & Courts Act 2015
S.20….ill treatment or wilful neglect: care worker offence
S.21….ill treatment or wilful neglect: care provider offence

28. HEALTHCARE S.20 Ill-treatment or wilful neglect: care worker offence
(1) A care worker commits an offence if-
he has care of another individual by virtue of being a care worker; and
he ill-treats or wilfully neglects that individual
“care worker” means an individual who, as paid work, provides:
(a) health care for an adult or child (other than excluded health care), or
(b) social care for an adult,
Including an individual who, as paid work, supervises or manages individuals providing such care or is a director or similar officer of an organisation which provides such care

29. HEALTHCARE S.21 Ill-treatment or wilful neglect: care provider offence
(1) A care provider commits an offence if-
(a) an individual who has the care of another individual by virtue of being part of the care provider’s arrangements ill-treats or wilfully neglects that individual
(b) the care provider’s activities are managed or organised in a way which amounts to a gross breach of a relevant duty of care owed by the care provider to the individual who is ill-treated or neglected, and
(c) in the absence of the breach, the ill-treatment or wilful neglect would not have occurred or would have been less likely to occur

30. HEALTHCARE “Care Provider” means-
a body corporate or unincorporated association which provides or arranges for the provision of -
health care for an adult or child, other than excluded health care, or
social care for an adult, or
an individual who provides such care and employs, or has otherwise made arrangements with, other persons to assist him or her in providing such care.

31. HEALTHCARE
Penalties
Fine
Remedial order
Publicity order

32. Practical advice: contracts
HEALTHCARE
Practical advice: contracts
Ensure you have a contract in place that is signed by the resident or their validly appointed deputy.
Ensure that the resident has the capacity to enter into the contract. If the resident does not have capacity, ensure that the contract is signed by their validly appointed deputy.
Power of attorney
Court appointed deputyship
Obtain a copy of the authority and retain this in the file.

33. Contact me HEALTHCARE 01202 786179 alison.wood@LA-law.com 01202 786187
Laura avises providers of adult care homes, nursing homes, supported living facilities, independent hospitals, children’s homes andschools on a range of issues. Her work includes local authority or CCG contractual disputes, disputes with residents, Court of Protection cases, safeguarding investigations, inquests and police investigations.
Alison advises healthcare providers on a range of issues, including contractual disputes, safeguarding investigations, inquests and Court of Protection cases. Her work includes defending regulatory enforcement action by CQC and other regulatory bodies.