Christopher Donnellan Q.C. Meeting the Challenge of Regulatory Decisions Christopher Donnellan Q.C. 36 Bedford Row London WC1R 4JH T +44 (0) F +44 (0) Web address: Bedford Row London WC1R 4JH T +44 (0) F +44 (0) Web address

a Legislation – just some! Health and Social Care Act 2008 (amended) Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Care Act 2014

Inspection - moving away from “compliance led” assessment to ask 5 key questions of all services: Are they safe? Are they effective? Are they caring? Are they responsive? Are they well-led?

Grading Outstanding Good Requires Improvement Inadequate No rating/under appeal/rating suspended

Unannounced: be prepared for the knock on the door: Carry out mock inspections Make staff available to support inspectors: Observe and note the inspection process as it is happening Ensure you receive immediate feedback: The CQC should always be able to identify serious concerns to you during the inspection. Respond professionally during inspection process: Challenge both at feedback stage and draft report stage.

Challenges to Inspection Reports etc. Through the internal CQC processes Challenges are considered on factual accuracy CQC is a Regulatory Body and therefore is open to challenge by way of Judicial Review

Other challenge Challenges to decisions on registration, conditions and cancellation through written representations take you on a route to a first tier Tribunal. The Tribunal Procedure (First-tier Tribunal) (Health, Education And Social Care Chamber) Rules 2008 S.I No. 2699

, Judicial Review - High Court (Administrative Court) Judicial reviews are a challenge to the way in which a decision has been made, rather than the rights and wrongs of the conclusion reached. The Court in general terms is not really concerned with the conclusions of that process and whether those were ‘right’, as long as the right procedures have been followed. The court will not substitute what it thinks is the ‘correct’ decision.

, Judicial Review Has the CQC followed its own procedures, and reached conclusions having followed considered and applied, – Statute – Regulations – Guidance issued

, The inspection process may be triggered by a sudden event reported to the CQC, or a complaint to the CQC, and the inspectors arrive. The framework in which they are operating is set out in the regulations. They will be consider the information provided before they arrive, and on arrival may be looking to gather evidence to identify failings that may result in penalty notices and /or prosecution for offences.

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 These Regulations sit in a context of ensuring that regulated activities (Reg. 3) including “personal care”, (Sch1 para 1) and “nursing care” (Sch. 1 para 13) are carried out only by registered individuals. Section 10 of the Health and Social Care Act makes it an offence carrying a maximum 12 months imprisonment and unlimited fine, or both, to carry on a regulated activity without being registered in respect of the carrying on of that activity.

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Other than provisions that were brought into force in November 2014 this is the framework that will apply from 1 st April 2015

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Regulations 4-7, (with Schedules 3 and 4), contain a “fit and proper” requirement applying to persons registered for carrying on, or management of, a regulated activity. From April a defined ‘fit and proper’ person test will apply to all service providers, whether individual, partnership, or a body other than a partnership (Regs. 4 and 6); and likewise for a registered manager (Reg. 7); In short the relevant individual must be of good character and have the necessary qualifications skills experience to carry out, or supervise or manage the regulated activity as the case may be, and the regulations require certain information to be available in relation to those persons.

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Regulations 8-19 prescribe the fundamental standards that must be complied with and will be closely scrutinised on inspection. Failures to meet the requirements of the regulations are offences and may incur penalty notices as set out in Schedule 5, or lead to criminal prosecution.

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Fundamental Standards: Regulations 9 to 19 provide that: care and treatment must be appropriate and reflect service users’ needs and preferences (reg. 9), service users must be treated with dignity and respect (reg. 10), care and treatment must only be provided with consent (reg. 11), care and treatment must be provided in a safe way (reg. 12), service users must be protected from abuse and improper treatment and systems and processes must be established and operated effectively in that regard (reg. 13),

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Fundamental Standards (continued) service users’ nutritional and hydration needs must be met (reg. 14), all premises and equipment used must be clean, secure, suitable and used properly (reg. 15), complaints must be appropriately investigated and appropriate action taken in response (reg. 16, which (reg. 16(3)) includes a requirement relating to the provision of information to the Care Quality Commission (“the commission”) in respect thereof, when requested),

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Fundamental Standards (continued) systems and processes must be established to ensure compliance with the fundamental standards (reg.17), which (reg. 17(3)) includes a requirement relating to sending a written report to the commission in respect thereof, when requested); sufficient numbers of suitably qualified, competent, skilled and experienced staff must be deployed (reg. 18), and employees must be of good character, have the necessary qualifications, skills and experience, and be able to perform the work for which they are employed (reg. 19).

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Fundamental Standards (continued) Regulation 20 - duty of candour - requires health service bodies to be open and transparent with service users about their care and treatment, and this includes notification requirements where a notifiable safety incident has occurred.

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Compliance and Offences : Regulation 21 requires registered persons to have regard to guidance issued by the commission under section 23 of the 2008 Act in relation to – requirements in relation to person carrying on or managing regulated activities and – the fundamental standards (with a partial exception of reg. 12), and, any code of practice issued by the Secretary of State under section 21 of the 2008 Act in relation to the prevention or control of health care associated infections.

Co-operation The registered person must have regard to any Guidance issued by CQC under section 23, and co- operation is required with any inspection as obstructing entry and inspection, without reasonable excuse, could result in a fixed penalty £300, or a summary prosecution with a fine up to level 4 (£2,500). [Section 63(7) of the Act].

“Enforcement is a core part of our statutory functions, but historically has not always been used effectively. In preparation for the new fundamental standards regulations which come into effect in April 2015, we have undertaken a wider review of the approach to enforcement. We have set up a major programme of work to prepare for these new regulations, so that enforcement can be one of the four core components of our operating model, and a core part of every inspector’s job.” 21 st January 2015 CQC Public Board Meeting Agenda

“Based on the information we receive about the service, we make judgements on how well it is performing. We publish reports that clearly set out our judgement and the evidence we have used. Where we have concerns and we decide it is necessary, we will take enforcement action against the service.” CQC :

Cr

The CQC propose to follow a process with the aim to exercise their powers in a consistent and proportionate manner (Paper No: CM/01/15/05 CQC Public board Meeting 21/ 1/15) The proposed stages are: 1. Case selection process 2. First review: legal and evidential basis 3. Thresholds for selecting proportionate enforcement response 4. Final review: sector enforcement priorities

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Penalty Notices and Offences Failures to comply with Regulation 11, which requires that care and treatment must only be provided with consent, may be subject to a penalty notice up to £4,000 for a service provider / £2,500 for a registered manager, it is also a summary only offence which on conviction will result in a fine (maximum £50,000);

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Penalty Notices and Offences (continued) Failures to comply with Regulations for safe care and treatment (Reg 12), safeguarding from abuse (Reg 13) and meeting nutritional and hydration needs (Reg 14), where the failure results in (a)avoidable harm (whether of a physical or psychological nature) to a service user, (b)a service user being exposed to a significant risk of such harm occurring, or (c)in a case of theft, misuse or misappropriation of money or property, any loss by a service user of the money or property concerned may be subject to a penalty notice up to £4,000 for a service provider / £2,500 for a registered manager, and are summary only offences, with penalty of a fine up to £50,000,(Reg 22(2) (a)-(c)). There is a due diligence defence: It is a defence for a registered person to prove, (which should normally be on balance of probabilities) that they took all reasonable steps and exercised all due diligence to prevent the breach of any of those regulations that has occurred.

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Penalty Notices and Offences (continued) There is a due diligence defence: It is a defence for a registered person to prove, that they took all reasonable steps and exercised all due diligence to prevent the breach of any of those regulations that has occurred. Proving standard of “balance of probabilities” requires evidence:  records,  service users,  staff, and other witnesses  other material,

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Penalty Notices and Offences (continued) Complaints must be appropriately investigated and appropriate action taken in response,(Reg 16) and this includes a requirement relating to the provision of information to the CQC in respect of any complaint, when requested: reg. 16(3); Failure to comply with Reg 16(3) is an offence, a penalty notice with a fine up to £300 may follow or prosecution with a penalty on summary conviction is a fine maximum level 4 (£2,500) [Reg 22(1) (a)-(c)]

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Penalty Notices and Offences (continued) Good governance: systems and processes must be established to ensure compliance with the fundamental standards(Reg 17) and this includes a requirement relating to sending a written report to the commission: Reg 17(3); Failure to provide a written report of systems and processes to the CQC when requested, is an offence, and again, a penalty notice with a fine up to £300 may follow or prosecution with a penalty on summary conviction with a fine up to level 4 (£2,500)

Challenge the Penalty Notice? Challenge a penalty notice if you think it is wrong and particularly if you have evidence to support the due diligence test. Learn from the issue and rectify the matter promptly. If/when there is a subsequent matter of concern to the CQC it will consider the record of previous inspection, reaction, and previous enforcement steps In considering the action to take. A poor record may lead to a decision to prosecute It will be far more difficult to challenge them once a decision has been made to prosecute At trial, where relevant, previous transgressions, are likely to be adduced as evidence of “bad character”.

If facing prosecution for injury or death resulting from acts or omissions as an employer or employee the record of intervention by the Regulatory Body will be admissible in establishing the ingredients of the offences that may be brought under other legislation Corporate Manslaughter and Corporate Homicide Act Health and Safety At Work etc. Act 1974 – section 2 “the duty of every employer to ensure, so far as is reasonably practicable, the health, safety and welfare at work of all his employees” and – section 3 “the duty of every employer to conduct his undertaking in such a way as to ensure, so far as is reasonably practicable, that persons not in his employment who may be affected thereby are not thereby exposed to risks to their health or safety”.

The Regulations are essential reading

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