Policy responses and statements

Name of organisation:

Scottish Government

Name of policy document:

Regulation of Independent Healthcare in Scotland

Deadline for response:

8 October 2010

Background: This paper concerns future arrangements for the regulation of independent healthcare in Scotland and sought views on the definition and scope of independent healthcare services that should be regulated. The scope of regulation of independent healthcare was set out in the Regulation of Care (Scotland) Act 2001 (the 2001 Act), and national care standards have been developed for a range of services. The available powers in this legislation have not, however, yet been fully commenced. Currently, the bodies which are regulated by the Care Commission are independent hospitals, voluntary hospices and private psychiatric hospitals. The powers in relation to independent healthcare will transfer to Healthcare Improvement Scotland in terms of the Public Service Reform (Scotland) Act 2010.

The independent healthcare sector in Scotland supplies a diverse range of healthcare services, and the number of providers has grown in recent years – for example, the growth in cosmetic surgery and treatment services1, and in laser eye surgery. The public generally is entitled to expect that healthcare services are supervised and regulated, to ensure that those providing them are skilled and competent to deliver the services they are offering, and that services are delivered to high standards. However there are different models for such regulation.

The main areas of independent healthcare in Scotland are: independent hospitals and clinics; private hospices; private dental services; private medical services; independent midwives; independent specialist clinics; and independent ambulance
services.

The approach to regulation needs to reflect risks and benefits. The form and intensiveness of regulation should be proportionate to the risks involved, and it should be possible to demonstrate benefits from regulation in terms of public confidence and reassurance, and improved delivery and quality of services, withbetter outcomes for service users.

The changing pattern of delivery of independent healthcare raises some questions relating to the definition of, and criteria for registration for, independent hospitals, in particular where the NHS and the independent sector are working closely together. For example there may therefore be a need to clarify the definition of “independent hospitals” to ensure that independent healthcare activities can be appropriately regulated, and there is clarity as to registration and regulatory requirements. There is also a need to consider whether to extend the definition of independent clinics to include premises from which services are provided by healthcare professionals other than doctors or dentists. This might include registered nurses, allied health professionals and dental care professionals, all of whom can be involved in cosmetic treatments and other services.

Alternatively, the scope of regulation could be based on the kinds of services delivered, rather than depending on the type of qualification or registration of the person delivering the service. Services which might be regulated could include: independent hospitals and clinics; private hospices; private dental services; private medical services; independent ambulance services; independent midwives; independent specialist clinics, including cosmetic surgery and treatment services, laser eye surgery, and addiction services. However it should be recognised that such widening of regulation would involve a significant extension to the current arrangements.

Given the mix of NHS and private provision which exists, dental services raise particular issues as to how regulation should be approached, how wholly private dental services should be regulated, and how far existing NHS arrangements should be relied on where there is "mixed" private and NHS provision.

The UK White Paper, Trust, Assurance and Safety – The Regulation of the Health Professionals in the 21st Century, published in February 2007, proposed that the regulatory and other impacts of developing a more effective system of registration and inspection for agencies providing health professionals should be considered. In discussion since 2007, following the White Paper, there has been support from stakeholders in Scotland for the regulation of locum agencies for healthcare professionals generally. At present the cost of regulating independent healthcare services is met by fees paid by the providers to the regulator. Extending regulation will mean additional costs for services and providers that are not currently within the scope of regulation.

COMMENTS ON

SCOTTISH GOVERNMENT

REGULATION OF INDEPENDENT HEALTHCARE IN SCOTLAND

The Royal College of Physicians of Edinburgh is pleased to respond to the Scottish Government on Regulation of Independent Healthcare in Scotland.

Question 1

1. Do you agree that regulation of independent healthcare services that is proportionate to risk is justified to safeguard and provide reassurance to the public and users of services?

Yes, strong regulation of the independent health care sector including medical dental and allied professionals is needed to protect patients' safety. Regulation of independent healthcare services should be proportionate to the risk that is justified, but the independent health care provider should be able to demonstrate adherence to the core standards of good clinical practice regardless of the type of care or treatment procedures being undertaken.  The level of risk needs to be defined to ensure that regulation doesn’t become too restrictive.

2. What would you see as the main potential benefits of service regulation?

The main benefits are consistency of standards both in private and state services, to ensure quality of care, the maintenance of clinical standards and encourage reflective practice.  Patients using independent healthcare facilities quite rightly expect the same regulation that applies to the NHS services that dominate most areas of healthcare in Scotland. A properly regulated independent sector ensures that patients can cross between independent and NHS services safely. This is mutually beneficial for independent and NHS providers.

3. What model of regulation would be most appropriate for regulation of independent healthcare services - for example would self-regulation of some services be more appropriate than statutory regulation?

The regulatory system should be fit for purpose, able to respond to the pressures of reform and operate within a framework of accountability.  The Model of regulation should be statutory regulation as self regulation is potentially open to abuse and it may be difficult to ensure correct quality standards throughout.  Self regulation should be limited to a commitment to improvement of services and training.

Question 2

1. Are there any specific issues that should be considered in relation to the regulation of independent hospitals? 

The regulation of independent hospitals should mirror that of NHS hospitals. Independent hospitals should publish their regulatory activity so that is accessible to the public.  Poor experience in the QA of some independent treatment centres in England suggests that there should be mandatory inspection of all licensing of private health care institutions and they should have to meet the same standards, for example, of infection control as the NHS.  This approach is logical, particularly where NHS patients are managed in private facilities to meet NHS waiting time targets.

2. Is there a need to clarify the criteria for defining an independent hospital? If so, how should this be done?

Yes.  The expansion of different private healthcare facilities, shared use of facilities with the NHS and new facilities offering cosmetic treatment delivered by practitioners who may not require a medical degree makes this important.

An independent hospital should be defined in terms of the services it offers and the equipment, appropriately qualified staff and estate and administrative support to provide these services.  A facility in which the funding of care is, in part or whole, provided by the patient either through self-funding or through insurance services.

Question 3

1. Should the scope of regulation of independent healthcare services be extended to include services delivered by healthcare professionals, other than registered medical and dental practitioners, or to healthcare services delivered outside the NHS?

The scope of regulation of independent healthcare services should be extended to include services delivered by healthcare professionals who are other than registered medical or dental practitioners.   This would ensure transparency of services provided.  Should this not be the case, the public should be made aware which of the services provided in this location are outwith the scope of regulation.

2. If the scope of regulation was widened as described in Question 3A, which services/professions should be included?

Paragraph 6.2 is a comprehensive list.  Plus those who offer medical services based on herbal remedies, Chinese medicine and homeopathy.

Question 4

1. Should regulation be based on a definition of services, rather than on whether or not it is a specific professional group providing those services?

Independent hospitals should have the same standards of care and safety as the NHS. The need for regulation is as great for those services not provided by a specific professional group as those that are.  The regulation should be based on the definition of the service eg Botox can be given by a variety of healthcare professionals, some of whom might be registered and some of whom might not be.  It is important to achieve consistency.

2. If so, how should the services to be regulated be defined? 

The services eg cardiology, should be defined by the regulator with advice from NHS practitioners based on guidelines of good practice eg NICE.

3. Does the list at para. 6.2 include the main services that should be considered for regulation? Are there any others that should be added? 

Yes, plus those who offer medical services based on herbal remedies, Chinese medicine and homeopathy.

Question 5

1. How should dental services - in particular "mixed" private and NHS services - be regulated in future?

Dental services should be regulated in a common approach across the NHS Boards and private sectors

2. Should statutory regulation apply only to those practices which are wholly private? 

No.

3. If so, how should the interests of private patients in mixed practices be safeguarded?

Private patients should have the same access to regulation as NHS patients ie to be treated by the same practitioner 

4. How should we ensure that regulation reflects appropriately current business models in dentistry? 

The same regulations apply then consistency occurs regardless of business model

Question 6

1. Do you agree that, in addition to nurse agencies, locum agencies which supply doctors and other healthcare professionals should be regulated in future?

Yes.  It is particularly important that the selection procedure for commercial locum agencies is vetted so that incompetent doctors are not employed.

2. What key standards and criteria should be set for these agencies?

There should be systems in place to ensure that recruits are fit to practice at the appointed level in UK hospitals.  Proper records of locums’ qualifications and competencies should be part of the external QA programme.  The burden of checking this should fall with the locum agency.  The standards that should be set for these agencies should be competency, evidence of up-to-date continuing professional development and language skills.

Question 7

What is the best approach to regulation to ensure that the costs are proportionate, and reflect the benefits to the public?

The charges should be relative to the perceived risk and consistent in both state and private sector.  To keep costs down, much of the communication about the quality of care can be conducted by e-mail in advance of site visits.  On-site visits are needed to confirm or refute compliance with NHS standards of care and safety and hygiene and to concentrate on issues where private hospitals are non compliant.  Where serious breaches of standards are found, hospitals should be revisited (planned with or without consent of the hospital).

Copies of this response are available from:

Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.

Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939

[13 October 2010]