On 1 April 2015 new legislation comes into force which will affect registered care providers. The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (the ‘Regulations’) extend the requirement that directors are ‘fit and proper’ persons and the duty of candour to apply to all service providers, as well as NHS trusts. The Regulations also introduce 12 fundamental standards to replace previous standards and give greater powers to the Care Quality Commission (‘CQC’) to prosecute for breaches.

Fit and proper persons

The Regulations introduce a new requirement on registered service providers (other than individuals or partnerships). Service providers must not appoint or have in place an individual as a director, or performing the functions of, or functions equivalent or similar to the functions of, a director (hereafter referred to as ‘directors or similar’), who is not ‘fit and proper’. This requirement will apply to trustees of charitable bodies and members of the governing bodies of unincorporated associations.

The requirements to be ‘fit and proper’ are that the individual:

  1. is of good character (the assessment of which must include consideration of whether the individual has any convictions or has been struck-off by a regulator of health care or social work professionals);
  2. has the necessary qualifications, competence, skills and experience for the role;
  3. is able by reason of their health, after reasonable adjustments are made, of properly performing tasks which are intrinsic to the role;
  4. has not been responsible for, been privy to, contributed to or facilitated any serious misconduct or mismanagement (whether unlawful or not) in the course of carrying on a regulated activity (or providing a service which if provided in England would be a regulated activity); and
  5. none of the grounds of unfitness specified in the Regulations apply to the individual, which broadly relate to bankruptcy, inclusion in the barred list, and any prohibition from holding the office, position or carrying on the regulated activity.

Where an individual no longer meets the requirements, the service provider must take such action as is necessary and proportionate to ensure that the position is held by an individual who meets such requirements and, if the individual is a professional registered with a health care or social care regulator, inform the regulator in question.

The Regulations and the CQC’s guidance make clear that service providers must have robust processes in place to consider whether an individual is ‘fit and proper’. For example, if there is an allegation that an individual has been responsible for, privy to, contributed to or facilitated any serious misconduct or mismanagement, service providers should investigate the allegation and make independent inquiries. Furthermore, providers must assess and regularly review the fitness of directors or similar to ensure that they remain fit for the role. In particular, where any concerns come to light while the director is in place, these must be investigated and rectified in an appropriate and timely manner.

The duty of candour

The Regulations require service providers to act in an open and transparent way in relation to care and treatment and to notify service users (or, in certain circumstances, a person lawfully acting on their behalf) as soon as reasonably practicable when an unintended or unexpected incident occurs that, in the reasonable opinion of a health care professional: (i) appears to have resulted in death, impairment which has lasted or is likely to last for at least 28 days, changes to the structures of the service user's body, prolonged pain or psychological harm or the shortening of the life expectancy, or (ii) requires treatment to prevent death or such injury to the service user (referred to in the rules and guidance as a ‘notifiable safety incident’).

The detailed guidance explains that providers must promote a culture that encourages candour, openness and honesty at all levels. This should include:

  • a board-level commitment to openness and transparency;
  • introducing policies and procedures to support such a culture and ensuring that all staff follow them;
  • taking action to tackle bulling and harassment;
  • having a system in place to identify and investigate possible breaches, including where a member of staff may have obstructed another in exercising their duty of candour. This is likely to include an investigation and escalation process that may lead to referral to their professional regulator or other relevant body;
  • providers making all reasonable efforts to ensure that staff operating at all levels within the organisation operate within a culture of openness and transparency, understand their responsibilities and are supported to be honest with patients and apologise when things go wrong; and
  • appropriate training.

There is further guidance relating to notifiable safety incidents and other provisions in the Regulations.


The Regulations make significant changes to health and social care regulation, which have been introduced following the failures at Mid Staffordshire NHS Foundation Trust and Winterbourne View Hospital. Their coming into force coincides with the coming into force of the Care Act 2014 and related rules, which consolidate health and social care provisions as well as introducing a number of new principles which will affect local authorities and service providers.

For further information, please contact the Public & Regulatory department.

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Claire Whittle


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Posted on 30/03/2015 in Legal Updates

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