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Scottish Executive Health Department Directorate of Service Policy and Planning To: Providers of independent healthcare services regulated by the Care Commission Independent Hospitals Association Independent Healthcare Association Royal Colleges and Professional Organisations Care Commission

Community Care Division St Andrew's House Regent Road Edinburgh EH1 3DG Telephone: 0131-244 5387 Fax: 0131-244 4005 stephen.mitchell@scotland.gsi.gov.uk http://www.scotland.gov.uk Our ref: 2CCD/3/6 24 May 2005

CONSULTATION ON PROPOSED CHANGES TO THE REGULATION OF CARE (REQUIREMENTS AS TO CARE SERVICES) (SCOTLAND) REGULATIONS 2002

Responding to this consultation paper

We are inviting written responses to this consultation paper by 22 July 2005. Please send your response to:

standardsandsponsorship@scotland.gov.uk

or

Care Standards & Sponsorship Branch
Scottish Executive Health Department
2ES
St Andrew's House
Regent Road
EDINBURGH
EH1 3DG

If you have any queries contact Stephen Mitchell on 0131 244 5387.

This consultation, and all other Scottish Executive consultation exercises, can be viewed online on the consultation web pages of the Scottish Executive website at http://www.scotland.gov.uk/consultations. You can telephone Freephone 0800 77 1234 to find out where your nearest public internet access point is.

The Scottish Executive now has an email alert system for consultations ( SEconsult: http://www.scotland.gov.uk/consultations/seconsult.aspx). This system allows stakeholder individuals and organisations to register and receive a weekly email containing details of all new consultations (including web links). SEconsult complements, but in no way replaces SE distribution lists, and is designed to allow stakeholders to keep up to date with all SE consultation activity, and therefore be alerted at the earliest opportunity to those of most interest. We would encourage you to register.

Handling your response

We need to know how you wish your response to be handled and, in particular, whether you are happy for your response to be made public. Please complete and return the Respondent Information Form as this will ensure that we treat your response appropriately. If you ask for your response not to be published we will regard it as confidential, and we will treat it accordingly.

All respondents should be aware that the Scottish Executive are subject to the provisions of the Freedom of Information (Scotland) Act 2002 and would therefore have to consider any request made to it under the Act for information relating to responses made to this consultation exercise.

Next steps in the process

Where respondents have given permission for their response to be made public (see the attached Respondent Information Form), these will be made available to the public in the Scottish Executive Library by September 2005 We will check all responses where agreement to publish has been given for any potentially defamatory material before logging them in the library or placing them on the website. You can make arrangements to view responses by contacting the SE Library on 0131 244 4565. Responses can be copied and sent to you, but a charge may be made for this service.

What happens next ?

Following the closing date, all responses will be analysed and considered along with any other available evidence to help us reach a decision on the proposed amendment.

Comments and complaints

If you have any comments about how this consultation exercise has been conducted, please send them to Stephen Mitchell at the address above.

RESPONDENT INFORMATION FORM:
CONSULTATION ON PROPOSED CHANGES TO THE REGULATION OF CARE (REQUIREMENTS AS TO CARE SERVICES) (SCOTLAND) REGULATIONS 2002

THE SCOTTISH EXECUTIVE CONSULTATION PROCESS

Consultation is an essential and important aspect of Scottish Executive working methods. Given the wide-ranging areas of work of the Scottish Executive, there are many varied types of consultation. However, in general, Scottish Executive consultation exercises aim to provide opportunities for all those who wish to express their opinions on a proposed area of work to do so in ways which will inform and enhance that work.

The Scottish Executive encourages consultation that is thorough, effective and appropriate to the issue under consideration and the nature of the target audience. Consultation exercises take account of a wide range of factors, and no two exercises are likely to be the same.

Typically Scottish Executive consultations involve a written paper inviting answers to specific questions or more general views about the material presented. Written papers are distributed to organisations and individuals with an interest in the issue, and they are also placed on the Scottish Executive web site enabling a wider audience to access the paper and submit their responses ¹. Consultation exercises may also involve seeking views in a number of different ways, such as through public meetings, focus groups or questionnaire exercises. Copies of all the written responses received to a consultation exercise (except those where the individual or organisation requested confidentiality) are placed in the Scottish Executive library at Saughton House, Edinburgh (K Spur, Saughton House, Broomhouse Drive, Edinburgh, EH11 3XD, telephone 0131 244 4565).

All Scottish Executive consultation papers and related publications (eg, analysis of response reports) can be accessed at: Scottish Executive consultations ( http://www.scotland.gov.uk/consultations)

The views and suggestions detailed in consultation responses are analysed and used as part of the decision making process, along with a range of other available information and evidence. Depending on the nature of the consultation exercise the responses received may:

• indicate the need for policy development or review
• inform the development of a particular policy
• help decisions to be made between alternative policy proposals
• be used to finalise legislation before it is implemented

Final decisions on the issues under consideration will also take account of a range of other factors, including other available information and research evidence.

While details of particular circumstances described in a response to a consultation exercise may usefully inform the policy process, consultation exercises cannot address individual concerns and comments, which should be directed to the relevant public body.

A consultation paper on proposed changes to the Regulation of Care (Requirements as to Care Services)(Scotland) Regulations 2002.

Scottish Executive Health Department

May 2005

Contents

Introduction
Background to legislation
Reason for change
What the change will do
Summary

Introduction

1. This consultation document seeks views on proposals to amend Regulation 15 of The Regulation of Care (Requirements as to Care Services) (Scotland) Regulations 2002 ² ("the 2002 Regulations").
2. Comments on the contents of this paper are invited by 22 July 2005. All responses should be sent to Stephen Mitchell, Care Standards and Sponsorship Branch, Scottish Executive Health Department, 2 E(S), St Andrew's House, Regent Road, Edinburgh EH1 3DG. Telephone 0131 244 5387.
3. Electronic responses may be sent to: standardsandsponsorship@scotland.gsi.gov.uk.

Background

1. The Care Commission was established on 1 April 2002 under the Regulation of Care (Scotland) Act 2001 ("the Act") to regulate a wide range of care services defined in section 2 of the Act, including independent healthcare services.
2. An independent healthcare service is defined as any of the following:

(a) an independent hospital;
(b) a private psychiatric hospital;
(c) an independent clinic; and
(d) an independent medical agency

1. These services are further defined in the Act. A note of those definitions is included in the attached Annex.
2. Regulation of independent healthcare services has commenced in respect of:

• Independent hospitals
• Private psychiatric hospitals
• A small number of independent clinics which were registered with Health Boards under the previous system

1. Regulation of the remaining independent healthcare services is to be phased in and no dates have been fixed.
2. As part of a suite of regulations made under the Act, The Regulation of Care (Requirements as to Care Services) (Scotland) Regulations 2002 ("the 2002 Regulations") set out the requirements with which providers of care services must comply. . As part of the regulatory process providers must be able to demonstrate to the Care Commission that they comply with all relevant requirements. The majority of the requirements apply to all care services with a few applying to specific services.
3. Regulation 15 of the 2002 Regulations relates to quality of independent health care and is specific to independent healthcare services as defined in the Act. The regulation states:

' A provider of an independent health care service shall make such arrangements as are necessary for securing that any treatment or services provided by the service are of a quality which is appropriate to meet the needs of service users'

Reason for change

1. The Care Commission has now had almost 3 years operational experience of regulating those independent healthcare services for which regulation commenced on 1 April 2002, including assessing their compliance with the 2002 Regulations. On the basis of their experience we now consider that further specific regulations need to be made to enable effective regulation of independent healthcare services. We are currently developing this specific set of regulations and hope to consult publicly on them later this year
2. The importance of clinical governance to the quality of treatment provided by healthcare services is widely recognised and account of this will be taken in the proposals for the set of specific regulations. The Scottish Executive considers that it would be appropriate in the meantime to strengthen and add further clarity to regulation 15 in terms of clinical effectiveness, a central element in clinical governance.

What the change will do

1. As drafted regulation 15 does not set out what steps providers must take to ensure quality of the treatment and services provided. The proposed change to Regulation 15 will make it more specific. It will set out clearly what an independent healthcare provider must do and the arrangements they must put in place to ensure that the quality of treatment and other care service provision meets the needs of those being treated and cared for. It will require providers to:

(i) Provide a service that meets individual service user's needs;
(ii) Provide a service that reflects published research based evidence and guidelines issued by appropriate professional and expert bodies, as to good practice;
(iii) Have a system for review of the quality of treatment and other services, which includes consultation with patients; and
(iv) Make the outcome of the review of the quality of treatment and other services available to the users of the service and the Care Commission.

1. The Care Commission will expect independent healthcare services to support a clinical governance framework which reflects, for example, patent safety, risk management and effective care.
2. This amendment helps further clarify for providers the extent of the Care Commission's regulatory requirements in respect of independent health care services.

Summary

1. You are invited to consider the proposed amendment to Regulation 15. We would welcome your comments on the proposal. You can send your comments in writing or electronically to the contact addresses shown in paragraph 2 above.

ANNEX A

The independent healthcare services set out in section 2(5) of the Regulation of Care (Scotland) Act 2001 ("the Act") are further defined in sections 77(1) and (2) of the Act. A note of those definitions is set out below.

Independent Hospital

A hospital which is neither a health service hospital nor a private psychiatric hospital. A part of a health service hospital is an independent hospital if

(i) it is carried on as a separate unit;

(ii) it does not provide treatment or nursing in pursuance of the National Health Service (Scotland) Act 1978; and

(iii) no part of it is contained within the same building as any such part which does provide treatment or nursing in pursuance of the Act.

Independent hospitals have been regulated by the Care Commission since 1st April 2002.

Private Psychiatric Hospital

Means a private hospital as defined in section 12 (2) of the Mental Health (Scotland) Act 1984

Private psychiatric hospitals have been regulated by the Care Commission since 1st April 2002.

Independent Clinic

A clinic which is not comprised in a hospital and in and from which services are provided, other than in pursuance of the National Health Service (Scotland) Act 1978, by a registered medical practitioner or registered dentist.

Only clinics which were registered before the 1st April 2002 under the Nursing Homes Registration (Scotland) Act 1938 are currently regulated under this heading.

Independent Medical Agency

Means an undertaking which is neither an independent clinic nor an undertaking comprised in a hospital and which consists of or included the provision of services, other than in pursuance of the National Health Service (Scotland) Act 1978, by a registered medical practitioner.

This heading has not been commenced yet.