Introduction

Following the Francis enquiry report (into the events at Mid Staffordshire) the government consulted on proposals to change the registration requirements for NHS bodies and other providers registered with the Care Quality Commission (CQC). The consultation has resulted in proposed new regulations - the Health and Professional Care Act 2008 (Regulated Activities) Regulations 2014 - which will replace in their entirety the current equivalent regulations introduced in 2010. In summary, in addition to setting out the regulated activities (for which providers have to be registered with the CQC), the new regulations will introduce the following measures:

  • certain fundamental standards (for all providers from April 2015);
  • the "Duty of Candour" (for NHS bodies only from October 2014 and for all other CQC registered providers from April 2015); and
  • the requirements for directors of health and adult social care providers registered with CQC to be fit and proper persons for their role (again for NHS bodies only from October 2014 and for all other CQC registered providers from April 2015).

The proposed introduction of the new regulations is against the background of the Care Act 2014 which seeks to make the care and support system clearer and more accessible to those who need it and to enshrine in one statue the law relating to care and support (both social care and health care) instead of being scattered, as now, amongst a mixture of legislation, some of which is quite old. The Act contains the core legal duties and powers relating to adult social care and powers to make regulations to deal with the detail of these duties and powers. The Act will come into force in April 2015.

Fundamental Standards

The Francis enquiry recommended the introduction of new fundamental standards of safety and quality below which care should never fall. These standards are intended to be common sense statements that describe the basic requirements which a provider should always meet and set out the outcomes that care service users (and patients) should always expect to receive. All providers registered with CQC will have to meet these fundamental standards as indicated above.

There are 12 fundamental standards in total, comprising the following:

  • care and treatment must be appropriate, reflect people's needs and preferences, must only be provided with consent and must be provided in a safe way;
  • people must be treated with dignity and respect and be protected from abuse;
  • people's nutritional and hydration needs must be met;
  • all premises and equipment used must be clean, secure, suitable and be used properly;
  • complaints must be appropriately investigated and appropriate action taken in response;
  • systems and processes must be established to ensure compliance with the fundamental standards;
  • sufficient numbers of suitably qualified, competent, skilled and experienced staff must be deployed;
  • persons employed must be of good character, have the necessary qualifications, skills and experience, and be able to perform the work for which they are employed; – providers must be open and transparent with people about their care and treatment (the Duty of Candour).

The Statutory Duty of Candour

The new statutory Duty of Candour was a response to the issues and concerns identified in a number of enquiries including that for Mid Staffordshire. The new statutory duty will require providers of health and adult social care to be open with patients and, to apologise when things go wrong. The intention is to encourage providers to improve openness and transparency and, with that, safety. It will be an offence (a) not to notify a service user (or their representatives) that they have been involved in a notifiable safety incident and (b) not to carry out the steps required to be taken as part of the notification process.

The new duty will not apply to individuals but rather to provider organisations which will therefore be expected to implement the new duty through the education and the training of staff. Provider organisations may therefore need to develop new policies and systems and perhaps improve their identification and reporting structures.

Under the new regulations, the threshold for identifying when a notification needs to made under the new duty for adult social care will use the existing CQC notifiable safety incident harm definitions (the health care harm definitions will apply only to NHS bodies).

Fit and Proper Persons Requirement

This requirement aims to ensure that, in order for a social care provider to provide a high quality service, it has in place the right values and culture and the people who are fit to deliver these services. The purpose of the regulations is to require providers to take proper steps to ensure that their directors are fit and proper for the role as is already the case for staff. Requirements will therefore be placed on providers to undertake necessary checks that all directors exhibit the correct types of personal behaviours, competence and business practices required for their roles. The regulations will enable CQC to take action against unfit directors including barring them from individual posts.

Only a small number of the fundamental standards that directly relate to harm will be subject to an offence if breached. This will not include the fit and proper person requirement. Where CQC considers a director to be unfit, CQC can impose a condition of registration requiring the removal of that director. Breach of that condition would itself be an offence and could result in the cancellation of the service provider's registration.

The new regulations contain a "serious" threshold test of both misconduct and mismanagement. The service provider must not appoint or have in place an individual who has been responsible for, been privy to, contributed or facilitated any serious misconduct or mismanagement (whether unlawful or not) in the course of carrying on a regulated activity in England. CQC guidance will set out further details on what may constitute serious misconduct and mismanagement.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.