Department of Health
Friday, 28 March, 2014

Introduction

This consultation sets out proposed amendments to CQC’s registration requirements, in order to introduce Fundamental Standards of care.

Our proposals to amend the CQC registration requirements are part of a wide-ranging set of changes designed to improve the regulation of health and social care providers, and provide assurance that service users receive safe, quality care and treatment.

Our proposed changes are designed to meet a number of recommendations arising from several inquiries, reviews, consultations and policy initiatives. These include:

  • The Mid Staffordshire NHS Foundation Trust Public Inquiry (the Francis Inquiry);
  • The Winterbourne View Review;
  • The Berwick Review in to Patient Safety;
  • The government’s Red Tape Challenge.

Our plans to introduce Fundamental Standards were originally set out in Patients First and Foremost - The Initial Government Response to the Report of The Mid Staffordshire NHS Foundation Trust Public Inquiry, published in March 2013.

Over the summer, CQC’s consultation A New Start - consultation on changes to the way CQC regulates, inspects and monitors care included a number of specific questions about Fundamental Standards.

Hard Truths, the full Government response to the Francis Inquiry report, set out in more detail the role that Fundamental Standards will play alongside the other changes being made to the health and social care system in response to the Francis Inquiry.

This document provides our response to the questions asked in A New Start, and asks further consultation questions about the draft regulations in Annex A, and about the impact of our proposals.

Duty of Candour and Fit and Proper Persons Test.

This consultation does not cover the proposed new Duty of Candour or the Fit and Proper Persons requirement for Directors of providers registered with CQC.

The Department of Health will consult separately on each of these proposals, although the intention is to introduce these measures alongside the Fundamental Standards as part of the same set of regulations.

Royal College of Physicians of Edinburgh Response to the Department of Health consultation on Introducing Fundamental Standards:  proposals to change CQC registration regulations

The Royal College of Physicians of Edinburgh (“the College”) has 50% of its UK Fellows and Members working in the NHS in England, and is pleased to respond to the Department of Health consultation on fundamental standards for health and social care providers.

1. Do the Fundamental Standards (regulations 4-14) make clear the kinds of outcomes we expect providers to meet/avoid?

Yes - the outcomes that providers need to meet to ensure good care for an individual are clearly documented.

The College would appreciate some further clarity, however, on the definition of the standards: for example regulation 13 refers to having the correct number of staff present. This is a significant issue for many Trusts as staff costs are the greatest single budget pressure, and this standard must complement the guidance NICE is currently producing to help ensure NHS services have safe and efficient staffing levels, which will be published from August 2014.

2. Do you think the Fundamental Standards (regulations 4-14) reflect the policy aims we have set out for the Fundamental Standards in Chapter 4?

Yes.

3. Are the Fundamental Standards clear enough that they could be used as a basis for enforcement action?

Yes.

4. Regulation 17 sets out which of the regulations are offences for which CQC will still need to issue a pre-prosecution notice, alongside those that could be prosecuted immediately. Do you think this split reflects our intention (see chapter 4) that only breaches related to a harmful outcome can be prosecuted without a pre-prosecution notice being issued in advance? 

The College feels the regulation clarifies the situation for a provider.

5. Do you agree that CQC's guidance about complying with these regulations should set out criteria for cases in which it would consider bringing a prosecution?

The standards and guidelines clearly state when harm falls on a patient, then prosecution will occur.  This clarity makes it impossible for a company to abdicate its responsibility.  If a serious case of abuse occurs within a home owned by a large company, it may be necessary to look at the overall care in all homes run by that company.  However, the CQC must be sophisticated in triangulation of evidence to identify serial poor behaviour/management rather than focusing on single incidents.

6. Do you agree that the health and adult social care system should always seek to meet the standards outlined in chapter 4?

While the standards overall are sensible, the College has some misgivings about regulation 9. This standard raises the right of an individual to have adequate nutrition.  The statement is made “to sustain life”.  There are a small number of patients who stop eating as part of their terminal illness or develop swallowing problems as part of their neurodegenerative condition.

Good practice dictates that a clinician, speech and swallowing therapist and other clinicians will have discussed this with either the patient or their family prior to this crisis occurring. However, it is not unusual for a patient to develop an acute problem on top of a chronic swallowing problem.  Hospital clinicians may therefore be placed in the difficult position of inserting feeding tubes in patients who lack capacity who are in their final phase of life.

7. Do you think any changes are needed to the draft regulations to ensure they reflect the policy aims we have set out in chapter 4?

No.

8. Do you have any other comments about the draft regulations?

No further comments.

9. Do you have any concerns about the impact of the proposed regulations on people sharing protected characteristics as listed in the Equality Act 2010?  (The protected characteristics are age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex and sexual orientation.)

No particular concerns.

10. Do you have any comments about the estimated costs and benefits of these regulations, as set out in the draft impact assessment (published alongside this consultation)? See Annex C for more detailed questions on impact.

No particular comments.