Fundamental standardsElderly care conference 2015 – Andrew Peel

Fundamental standards

Andrew Peel, Browne Jacobson LLP

What are the fundamental

standards•

•

standards below which care must never fall

came into force for all health and adult social care

from 1 April 2015

services

• form part of changes to the law recommended by Sir RobertFrancis following his inquiry into care at Mid Staffordshire

NHS Foundation Trust

Health and Social CareAct 2008 (RegulatedActivities)

Regulations 2014 (Part 3)

Care Quality Commission (Registration) Regulations 2009

(Part 4)

•

•

THE TWELVE FUNDAMENTAL STANDARDS

Dignity and respect Good governance

Consent Premises and equipment

Safety Fit and proper staff

Safeguarding from abuse Duty of candour

Food and drink Display of ratings

Person-centred care Complaints

CQC’s five key questions

• CQC ask five key questions about a service, is it

–

–

–

–

–

safe?

effective?

caring?

responsive

well-led?

to people’s needs?

Legal footing for guidance

• CQC must take into account its guidance onthe regulations when

meeting

–

–

–

–

granting a registration

refusing an application for registration

cancelling or suspending a registration, or

varying, removing or imposing conditions on a registration

• impact of guidance

– CQC guidance on meeting the regulations is central to

registration

inspection and ratings

enforcement

Breach without harm

• a breach of the following offencesprosecuted directly

may be

–

–

Regulation 11- need for consent

Regulation 16(3) – receiving and acting on

complaints

–

–

–

Regulation

Regulation

Regulation

17(3) – good governance

20(2)(a) – duty of candour

20A – requirement to display

performance assessments

Breach with avoidable harm

• to be able to prosecute for the following offences, the

breach must result in people who use services being

exposed to avoidable harm or significant risk of such

harm occurring or suffering a loss of money or property

as

–

–

a result of theft, misuse or misappropriation

Regulation

Regulation

treatment

Regulation

12

13

–

–

safe care and treatment

Safeguarding from abuse and improper

– 14 – meeting nutritional and hydration needs

Regulation 11 – need for consent

• 11.—(1) care and treatment of service users must onlybe provided with the consent of the relevant person–

–

(2) paragraph (1) is subject to paragraphs (3) and (4)

(3) if the service user is 16 or over and is unable to give such consent

because they lack capacity to do so, the registered person must act in

accordance with the Mental Capacity Act 2005

(4) but if Part 4 or 4A of the Mental Health Act 1983 applies to a

service user, the registered person must act in accordance with the

provisions of that Act

(5) nothing in this regulation affects the operation of section 5 of the

Mental Capacity Act 2005, as read with section 6 of that Act (acts in

connection with care or treatment)

–

–

Sanction - consent

• CQC can prosecute for a breach of this regulation orpart of the regulation and can move directly to

prosecution without first serving a warning notice

criminal offence attracts maximum fine of £50,000

CQC can issue a fixed penalty notice of £4,000

additionally, CQC may also take other regulatory action

CQC must refuse registration if providers cannot satisfy

them that they can and will continue to comply with

this regulation

•

•

•

•

Regulation 16(3) – receiving and

acting on complaints• 16.—(1) any complaint received must be investigated and

necessary and proportionate action must be taken in response to

any failure identified by the complaint or investigation– (2) the registered person must establish and operate effectively an accessible

system for identifying, receiving, recording, handling and responding to complaints

by service users and other persons in relation to the carrying on of the regulated

activity

(3) the registered person must provide to the Commission, when requested to do so

and by no later than 28 days beginning on the day after receipt of the request, a

summary of

(a) complaints made under such complaints system

(b) responses made by the registered person to such complaints and any further

correspondence with the complainants in relation to such complaints, and

(c) any other relevant information in relation to such complaints as the Commission

may request

–

–

–

–

Sanction - complaint

• failure to provide CQC, when requested to do so, a summary of

complaints, responses and any other relevant information they

seek is a criminal offence, directly prosecutable under the

Regulations, maximum fine £2,500

CQC can move directly to prosecution without first serving a

warning notice

CQC may also take other regulatory action

CQC must refuse registration if providers cannot satisfy them that

they can and will continue to comply with this regulation

•

•

•

Regulation 17(3) – good

governance• 17.—(1) systems or processes must be established and operated

effectively to ensure compliance with the requirements in this Part– 17(2): these systems must enable the registered person to

assess, monitor and improve the quality and safety of the services provided

assess, monitor and mitigate the risks relating to the health, safety and welfare

of service users

maintain securely an accurate, complete and contemporaneous record in

respect of each service user, including a record of the care and treatment

provided to the service user and of decisions taken in relation to the care and

treatment provided

maintain securely such other records as are necessary to be kept in relation to

employees and management of the regulated activity

17(3): provide report to CQC upon request regarding compliance of the above–

Sanction - governance

• CQC prosecution for a breach of part of regulation(17(3)) if failure to provide written report upon request

(within 28 days of request)

–

–

criminal offence punishable by a fine of £2,500

CQC may prosecute without serving warning notice

as failure may prevent provider from taking appropriate

timely action

regulatory action for other parts of regulation

CQC must refuse registration if not satisfied regulation can be

complied with

–

–

Regulation

candour

20(2)(a) – duty of

• 20.— (1) registered persons must act in an open

and transparent way with relevant persons in

relation to care and treatment provided to service

users in carrying on a regulated activity

Duty of candour – what it means?

• providers should be open and transparent with

people who use services and those acting on their

behalf

regulation indicates specific requirements that

providers must follow when things go wrong with

care and treatment

•

Duty of candour

• what’s required

–

–

–

–

–

act in open and transparent way

soon as reasonably practicable

notifiable safety event

notify relevant person

provide reasonable support

• ‘notifiable safety event’

– incident where patient suffered (or could have suffered) unintended harm

that results in death, severe harm, moderate harm or prolonged

psychological harm

no inclusion of near miss

no harm events

–

Duty of candour - guidance

• providers must promote a culture that encourages candour,openness and honesty at all levels

– should be integral part of a culture of safety that supportsorganisational and personal learning

• board level (ortransparency

providers must

of candour

providers must

equivalent) commitment to openness and

• tackle bullying and harassment in relation to duty

• investigate any instances where a member of staff

may have obstructed another in exercising their duty of candour

Duty of candour - sanction

• criminal offence – CQC can prosecute if failure to

–

–

notify verbally

comply with requirements

• CQC can move directly to prosecution without first servingwarning notice

additionally, CQC may also take other regulatory action

a

•

• on

–

–

conviction

potential fine of £2,500

adverse media interest

• defence to show took all reasonable steps and exercised all duediligence to prevent the breach

Regulation 20A - requirement to

display assessments• 20A.—(1) this regulation applies where, and to the extent that, a

service provider has received a rating of its performance by the

Commission following an assessment of its performance under

section 46(1) of the Act (reviews and performance assessments)

what this means… you must•

–

–

–

display your CQC rating in a place where a service user can see it

include this information on your website

make available to service user CQC’s latest report

• regulation applies to

– any CQC rating (outstanding, good, requires improvement orinadequate) – the most recent rating should be displayed

all organisations including those rated before 1 April 2015–

Sanction – display assessment

•

•

level 2 fine - £500

CQC can prosecute for a breach of this regulation

or a breach of part of the regulation and can move

directly to prosecution without first serving a

warning notice. Additionally, CQC may also take

other regulatory action

CQC must refuse registration if providers cannot

satisfy us that they can and will continue to comply

with this regulation

•

Regulation

treatment

12 - safe care and

• 12.—(1) care and treatment must be provided in a safe wayservice users

what it means…

for

•

– you must not give unsafe care or treatment or put a service user atrisk of harm that could be avoided

providers must assess the risks to a service user’s health and safety

during any care or treatment and make sure staff have the

qualifications, competence, skills and experience to keep them safe

–

Sanctions - safety

• CQC prosecution for breach of this regulation (or a breach of part

of

–

–

–

it) if failure

results in avoidable harm to a person using the service, or

a person using the service is exposed to significant risk of harm

criminal offence

£50,000 fine, or

fixed penalty notice and fine a service provider £4,000 and registered

manager £2,000

•

•

•

CQC

CQC

CQC

do not have to serve a warning notice before prosecution

may also take other regulatory action

must refuse registration if providers cannot satisfy us that

they can and will continue to comply with this regulation

Regulation 13 – safeguarding

from abuse• 13.—(1) service users must be protected from abuse and improper treatment in

accordance with this regulation

(2) systems and processes must be established and operated effectively to prevent

and investigate allegations of abuse of service users

NB: a service user must not be deprived of their liberty for the purpose of receiving

care or treatment without lawful authority

safeguarding from abuse – what does it mean?

– service user must not suffer any form of abuse or improper treatment while receiving care

– this includes

neglect

degrading treatment

unnecessary or disproportionate restraint

inappropriate limits on freedom

NB: safeguarding must have the right level of scrutiny and oversight, with overall

responsibility held at board level or equivalent

•

•

•

•

Sanction - abuse

• CQC can prosecute for a breach of some parts of this regulation (13(1) to 13(4)) if afailure to meet those parts

–

–

–

results in avoidable harm to a person using the service, or

a person using the service is exposed to significant risk of harm

£50,000 maximum fine

•

•

CQC does not have to serve a Warning Notice before prosecution.

alternatively, CQC may issue a fixed penalty notice and fine a service provider

£4,000 and registered manager £2,000

CQC may also take any other regulatory action

CQC must refuse registration if providers cannot confirm compliance with this

regulation

NB: DoL is not directly prosecutable offence (may give rise to claim for unlawful

detention)

•

•

•

Regulation 14 – meeting

nutritional and hydration needs•

•

14.—(1) the nutritional and hydration needs of service users must be met

what does this mean?

– service user must have enough to eat and drink to keep them in good healthwhile you receive care and treatment

CQC will take into assessed needs / wishes i.e. specialist eating disorder

services / palliative care etc.

you must follow people’s consent wishes if they refuse nutrition and hydration,

unless:

best interests decision under Mental Capacity Act 2005, or

other forms of authority such as advance decisions

–

–

Sanction - nutrition

• CQC prosecution for a breach of regulation / part of the regulationif a failure results in–

–

–

–

avoidable harm to a person using the service

or a service user is exposed to significant risk of harm

£50,000 maximum fine

fixed penalty notice and fine of service provider (£4,000) and registered

manager (£2,000)

• CQC can move directly to prosecution without first serving awarning notice

CQC may also take any other regulatory action

CQC must refuse registration if providers cannot confirm

compliance

•

•

Standards without prosecution

•

•

•

•

•

•

•

person centred care

dignity and respect

premises

staffing

fit and proper staff

fit and proper director

CQC cannot prosecute for a breach of these regulations but

–

–

can take regulatory action under its enforcement policy

must refuse registration if providers cannot satisfy CQC that they

and will continue to comply with this regulation

can

Regulation

care

9 – person-centred

• 9.—(1) the care and treatment of service users

must (a) be appropriate, (b) meet their needs,

and (c) reflect their preferences

Regulation 9 – what it means

Providers must

•

•

work in partnership with the service user

make any reasonable adjustments and provide

support to help them understand and make

informed decisions about their care and treatment

options, including the extent to which they may

wish to manage these options themselves

make sure that they take into account people’s

capacity and ability to consent•

Regulation 9 – what it means

• either the service user, or a person lawfully acting ontheir behalf, must be involved in the planning,

management and review of their care and treatment

provider must make sure that decisions are made by

those with the legal authority or responsibility to do

so, but within the requirements of the Mental

Capacity Act 2005, which includes the duty to consult

others such as carers, families and/or advocates

where appropriate

•

Regulation

respect

10 - dignity and

• 10.—(1) service usersrespect

what does it mean?

must be treated with dignity and

•

– all staff must treat them with dignity and respect at all times. Thisincludes staff treating them in a caring and compassionate way

all communication with people using services must be respectful

(suitability of means; right to engage or not engage in

communication)

–

• NB: balance between autonomy / independence and

assessed needs (mitigate risks to support

independence)

Regulation 15

equipment

– premise and

• 15. —(1) all premises and equipment used by the servicemust be

provider

–

–

–

–

–

–

(a)

(b)

(c)

(d)

(e)

(f)

clean

secure

suitable for the purpose for which they are being used

properly used

properly maintained, and

appropriately located for the purpose for which they are being used

• what does it mean? Property and equipment must be–

–

–

clean, suitable and looked after properly

secure and properly used

NB: includes personal safety ; personal property and money of service users;

surveillance must be in best interests of service user

Regulation 18 - staffing

• 18.—(1) sufficient numbers of suitably qualified,

competent, skilled and experienced persons must be

deployed in order to meet the requirements of this

Part

what is required?•

– a care provider must have enough suitably qualified,

competent and experienced staff to make sure they can

meet these standards

their staff must be given the support, training and

supervision they need to help them do their job–

Staffing guidance

• providers must prevent / limit staff from obtainingfurther qualifications appropriate to their role

providers must make sure that staff are able to meet

the requirements of the relevant professional regulator

throughout their employment (e.g. CPD)

support staff to join Accredited Voluntary Registers if

they wish

must not prevent or limit staff in meeting requirements

of professional regulators

•

•

•

Regulation 19

employees

– fit and proper

• 19.—(1) persons employed for the purposes of carryingon a regulated activity must

–

–

(a)

(b)

be of good character

have the qualifications, competence, skills and

experience which are necessary for the work to beperformed by them, and

– (c) be able by reason of their health, after reasonable

adjustments are made, of properly performing taskswhich are intrinsic to the work for which they are

employed

Regulation

director

5 - fit and proper

• 5.—(1) this regulation applies where a service provider is a bodyother than a partnership [or individual]

(2) unless the individual satisfies all the requirements set out in

paragraph (3), a service provider must not appoint or have in place

•

an

–

–

individual

(a)

(b)

the

as a director of the service provider, or

performing the functions of, or functions equivalent or similar to

functions of a director

Fit and proper

means

director – what it

• demands all board members

–

–

responsible for quality and safety of care

fit and proper to carry out role

• applies to all directors and

– governors of FT who sit on Trust Board as representatives of boardgovernors

senior managers

of

–

– for NHS bodies it applies to executive and non-executive, permanent,interim and associate positions, irrespective of their voting rights

the requirement will also apply to equivalent director posts in other

providers

e.g. trustees of charitable bodies and members of the governing bodies

unincorporated associations

–

of

Fit and proper person for

directors

• what’s required – section 5(3)

–

–

–

–

good character (Schedule 4 Part 2)

physically and mentally fit

have necessary qualifications, skills and experience

not responsible, privy to, contributed or facilitated

serious misconduct or mismanagement whether

unlawful or not

absence of bankruptcy / barred (Schedule 4 Part 1)–

Action list

• keep full records

– appropriate recruitment process

• review service contracts

– update policies

• keep your nose clean

– CQC can

bar a director

refuse registration

demand removal

Any questions?

Get in touch if you

questions or would

information.

have any

like further

t +(0)161 300 8030

e andrew.peel@brownejacobson.com