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The Health and Social Care Act 2008

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Presentation on theme: "The Health and Social Care Act 2008"— Presentation transcript:

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HEALTHCARE The Fundamental Standards The ‘Essential Standards’ in the 2010 regulations have been replaced by the ‘Fundamental Standards’ under the 2014 Regulations The Fundamental Standards are clearer statements of the standards of care that providers are expected to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.


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