Transcript Slide 1

The Care Act 2014,The Health and
Social Care Act 2008 (Regulated
Activities) Regulations 2014 and
Possible Offences
Jeremy Allin
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.
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been replaced by the ‘Fundamental Standards’ under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.
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
Comparison taken from CQC’s
• Duty of candour
“Guidance for providers on meeting the
fundamental standards and on CQC’s
enforcement powers”, July 2014.
– 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.
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.
Key Definitions
Openness
“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.”
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.
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.
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.
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.
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.
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.
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.
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)).
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.
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.
Contact me
Jeremy Allin
Partner
[email protected]
01202 786154
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