Consultation on Regulation of Independent Healthcare in Scotland Consultation Report
Consultation on Regulation of Independent Healthcare in Scotland Consultation Report The Scottish Government, Edinburgh 2011
Crown copyright 2011 You may re-use this information (excluding logos and images) free of charge in any format or medium, under the terms of the Open Government Licence. To view this licence, visit http://www.nationalarchives.gov.uk/doc/open-government-licence/ or e-mail: psi@nationalarchives.gsi.gov.uk. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. This document is available from our website at www.scotland.gov.uk. ISBN: 978-1-78045-288-3 (web only) The Scottish Government St Andrew s House Edinburgh EH1 3DG Produced for the Scottish Government by APS Group Scotland DPPAS11833 (07/11) Published by the Scottish Government, July 2011
Consultation on Regulation of Independent Healthcare in Scotland Consultation Report Contents Section 1: Background. Section 2: Overview of responses. Section 3: Overview of questions and analysis of responses to specific consultation questions. Section 4: Outcomes Section 5: Next Steps Section 1 Background This paper reports the results of the Scottish Government consultation issued on 16 July 2010 on the 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 services was set out in the Regulation of Care (Scotland) Act 2001, and National Care Standards have been developed for a range of services. However the available powers in this legislation were not fully commenced. The bodies which were regulated by the Care Commission were independent hospitals, voluntary hospices and private psychiatric hospitals. The responsibility for regulating independent healthcare transferred on 1 April 2011 to Healthcare Improvement Scotland in terms of the Public Service Reform (Scotland) Act 2010 and the independent healthcare services they are regulating are currently the same as those regulated by the Care Commission. The independent healthcare sector in Scotland supplies a diverse range of healthcare services, and the number of providers has grown in recent years e.g. the growth in cosmetic surgery and treatment services, and in laser eye surgery. The main areas of independent healthcare in Scotland are: Independent hospitals and clinics There are currently (or planned to be) 17 private hospitals in Scotland, including independent hospitals which offer services ranging from routine medical investigations to complex surgery, as well as private hospitals specialising in psychiatric care. Many private hospitals cater for NHS patients as well as for individuals and organisations purchasing private healthcare. Private hospices There are 15 voluntary hospices which have charitable status and do not charge patients for their services. They provide specialist 1
palliative care and work closely with local NHS services, who also contribute part of their funding. Private dental services There are around 25 wholly private dental practices, as well as around 900 mixed dental services which provide both NHS and private dental care and treatment. Private medical services There are at least 10 wholly private medical services. Independent midwives There are a small number of independent midwives who practice in Scotland. Independent specialist clinics There are over 100 independent clinics which offer, for example, cosmetic surgery and treatment, laser eye surgery and addiction services. Independent ambulance services There are at least 10 independent ambulance services operating across Scotland, providing a range of services including transporting patients to and from independent healthcare facilities and providing clinical support at sporting and other events. The consultation paper asked respondents for views on a number of questions about which independent healthcare services should be regulated and what the model of regulation should be. It also asked for views on some specific questions around independent hospitals, dental services and medical agencies. The questions asked are set out through out the report along with a summary of their replies. Section 2 Overview of response rate The consultation document was issued to around 200 stakeholders including NHS Boards, Local Authorities, Independent Healthcare Providers, Regulatory Bodies, Professional Bodies and Equality groups. A total of 38 responses were received (20% return rate). The full non-confidential responses received are available at- http://www.scotland.gov.uk/publications/2010/11/12140723/0 No of Responses NHS Boards & Special Health Boards 6 Local Authorities 1 Regulatory Bodies 5 Professional Bodies 19 Independent Healthcare Providers 2 Individuals 5 Total 38 2
Summary of Questions and analysis of responses to specific consultation questions Question 1 A. 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? The majority of respondents who expressed a view agreed that regulation of independent healthcare services that is proportionate to risk is justified. There was broad support for the regulation of independent healthcare services to safeguard and provide reassurance to the public and users of services where there is no current regulation. A small number did not agree and suggested that if an individual is dissatisfied with independent healthcare services they may protest, withdraw their custom or sue. It was felt that for the state to intervene it would be unnecessary and expensive. A few respondents felt there is over-regulation in Scottish Hospices. Specific comments included: - The question is what criteria are used to define risk. The criteria should be transparent and based on sound principles. - Assessment of risk and whether there is a need for additional regulation must consider the service and the provider. - It should avoid duplication and should be integrated. That is the NHS and private services should be subject to the same regime with no conflicting standards. It should also be tailored to the characteristics of each healthcare sector, so that it is not so generic that it is difficult to apply, in this case, to dentistry. - The public should be able to be confident that healthcare services, regardless of whether they are in the public or independent sector are regulated to the same standard. B. What would you see as the main potential benefits of service regulation? Respondents suggested a number of benefits which could be gained by service regulation. Respondents felt the main potential benefits were: - minimum standard of quality of healthcare. Services all working to same standard, creating a level playing field and raising overall standards. 3
- A properly regulated independent sector would ensure that patients can cross between independent and NHS services safely. This is mutually beneficial for independent and NHS providers. - The reassurance regulation would give to the general public that the service provided is carried out within agreed National Standards and that the standard is regularly checked. - Service user s ability to complain if unhappy. It provides protection and a structure of standards against which concerns and complaints can be articulated, and may provide an avenue for feedback and complaint if things go wrong. However a small number felt that there would be no benefits. Stating it would be unnecessary and expensive for the state to intervene. They suggested that dentistry and dentists are already regulated or inspected by a number of organisations and are also assisted by a number of other bodies who provide guidance and standards or act as a focus of patients' complaints. It was felt further layers of regulation would be superfluous and would not serve to increase standards by a great amount. C. What model of regulation would be most appropriate for regulation of independent healthcare services e.g. Would self-regulation of some services be more appropriate that statutory regulation? From the responses there was no clear preference as to which model of regulation, be it self-regulation or statutory regulation, would be more appropriate. The views received were evenly divided over each model. Though a small number felt that a combination of the two would be effective. Specific Comments included: - Statutory regulation is the more appropriate model of regulation as selfregulation is potentially open to abuse and that it may be difficult to ensure correct quality standards throughout. - Statutory regulation would have greater public confidence and the type of regulation should be consistent and equal across both the independent and public healthcare systems. - The development of self-regulation models should be encouraged for all services as ultimately service providers are accountable for the care and safety of people who use them. - Self-regulation may be appropriate for services that are offered by fully trained healthcare professionals. But that it should be noted that some services are now being carried out by beauticians and self-regulation in such circumstances would not be appropriate as they do not have as high a standard of training. 4
- The Scottish Government should take into account existing regulation models, for examples those for dental practices. Different models are likely to be appropriate for different situations. A small number believed that a combination of self-regulation and statutory regulation would be appropriate. For example, a 3 yearly statutory regulation process, plus annual self-regulating reporting. A combination of self-regulation with external scrutiny. This kind of mixed economy could be adjusted according to the proportionality of risk associated with services provided. Question 2 A. Are there any specific issues that should be considered in relation to the regulation of independent hospitals? Respondents suggested a number of possible issues in relation to the regulation of independent hospitals. Specific comments included: - Independent hospitals should publish their regulatory activity so that it is accessible to the public. - Where there is a gap between regulation of the NHS and the independent sector, there is a need for a joining-up of standards to ensure that the public can have the same confidence in the service they are receiving, whatever organisation is providing it and wherever it is being delivered. - That all staff comply with the same standards as staff within the NHS in relation to training and professional qualifications e.g. all staff should be on the specialist register and the job specification requirements should apply equally to those in the NHS and independent sector. - Individuals who are dually employed in the public and private sector should be able to cross-refer revalidation data, individuals working solely in independent private practice should have information reviewed by the employing institution as well as licensing authorities. - A system of regulation that recognised that hospices were independent hospitals, would be welcomed. B. Is there a need to clarify the criteria for defining an independent hospital? If so how should this be done? There was overwhelming support for a need to clarify the criteria for defining an independent hospital. A small minority said there was no need and existing legislation and definitions should be used. 5
Specific comments included: - The definition as to what constitutes an independent hospital has created a number of problems for many over the years, mainly in relation to services that are developed alongside NHS services. These legislative restrictions could be seen as holding back innovations in service delivery. - Mainstream private hospitals have a high level of internal regulation but other organisations seem not to be subject to any external peer review at all, yet use the word hospital which can be misleading to the public. - It could possibly be done by agreeing which key services are provided and then undertake an agreed risk assessment to identify those services that pose the greatest risk of harm to patients if not provided by well trained staff in appropriate care settings. Question 3 A. 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 majority of respondents who expressed a view agreed the scope of regulation of independent healthcare services should be extended to include services delivered by healthcare professionals, other than medical and dental practitioners, and to healthcare services delivered outside the NHS. However many indicated that this should only be the case where services are not already regulated to avoid duplication. Specific comments included: - The scope of regulation should be based on the risk associated with the service being carried out, not the professional role of the individual performing the treatment or the premises it takes place. B. If the scope of regulation was widened as described in question 3a, which services /professionals should be included? Respondents suggested a range of services / professions that should be included. Specific suggestions included: - Psychological therapies. - Medical herbalists and Chinese medicine. - Podiatry. - Homeopathy. - Acupuncture. 6
- Doctors, Nurses, Dentists and Dental Hygienists. - Midwifery services. - Agency nursing staff and locum Doctors. - Private sector hospitals, especially those dealing with cosmetic surgery and laser eye treatment. - Non-surgical procedures such as Botox, tooth whitening. - Beauticians. - Independent ambulance services. - Private clinics and hospices. - Physiotherapists. Question 4 A. Should regulation be based on a definition of services, rather than on whether or not it is a specific professional group providing those services? The opinion from the respondents, on this question, was divided. The majority felt that regulation should be based on a definition of services. While a small number believed that both the professional role and services should be regulated. Specific comments included: - Standards of regulation should be the same for all providers of Class 3B and 4 laser treatments and Intense Pulsed Lights whether they are located in a specialist cosmetic clinic and operated by a healthcare professional or the premises of a beautician or hairdresser. - A definition of services is required in order to prevent unqualified/ unskilled persons operating in healthcare who could potentially avoid regulation by claiming status as a non-specific professional. B. If so, how should the services to be regulated be defined? Respondents made a number of suggestions as to how the services could be defined. Specific suggestions included: - Generally, a service could be defined by the type of treatment being provided to patients, the procedures being used to deliver it, the professional group delivering it, or a combination of any of these factors. - Services should be risk assessed where there is no NHS link or monitoring role in already in place. - Unless regulation is based on a definition of service rather than professional group, these proposals could lead to a situation where providers with specialist training and medical supervision must be regulated in their use of lasers and 7
Intense Pulsed Lights, but providers who have no medical practitioners working at their company are not. - The legislation needs to be flexible enough to include everything or it will be a case of constantly updating the list of services. C. Does the list at paragraph 6.2 include the main services that should be considered for regulation? Are there any others that should be added? The majority of respondents who expressed a view regarding the main services that should be considered for regulation were content that the list in paragraph 6.2 was adequate. There were however some additional suggestions for inclusion to the list, which were: - Psychological therapy services i.e. Counselling and psychotherapy. - Chinese medicines and herbal remedies. - Homeopathy - Hygienists and Dental nurses - Nurses - Podiatrists - Cardiac profusionists - Operating dept practitioners and assistants - Radiographers - Physiotherapists - Ambulance services (excluding transport only services). - Optometry - Private healthcare screening services, e.g. Cardiac screening - Cosmetic services such as tooth whitening (carried out by persons other than Dentists), injectable cosmetics e.g. Botox and derma fillers. - Laser treatments e.g. tattoo removal, thread vein removal, class 3 and 4 lasers, Intense light treatments. However it was suggested that a specific list could imply that those not on the list are not subject to regulation, leaving the regulations open to abuse. It was suggested that it is important to define cosmetic surgery, in particular, as more and more invasive treatments are being offered in beauty salons. Question 5 A. How should dental services in particular mixed private and NHS services be regulated in future? Only a small number of respondents answered this question. Those who responded strongly agreed that dental services should be regulated in a common approach across the NHS and private sector. But that care should be taken to avoid over regulation in circumstances where there is already professional regulation. 8
Specific comments included: - It would be disproportionate for a mixed dental practice to comply with two sets of regulations and undergo two sets of inspections. Applying a second inspection would involve a considerable duplication of work but would also mean that patients cannot be treated. - The formal regulation of mixed dental services was likely to be complex and costly and that there will be difficulties in establishing where the line is drawn for what will fall to be regulated. - The most important consideration must be to establish whether there is any evidence to suggest that all dental services require additional scrutiny because of the risk posed to the public. - In developing and implementing a regulation model for Scotland it may be useful to learn from the extension of statutory regulation to all dentists in England and Wales. B. Should statutory regulation apply only to those practices which are wholly private? The majority of respondents who expressed a view did not feel that statutory regulation should only apply to those practices which are wholly private. Conversely, two respondents deemed regulation applying only to wholly private practices was reasonable. Specific comments included: - There should be consistency in the assessment of dental professionals - The public deserves the same quality of standard of treatment irrespective of whether it is NHS or privately funded. - Regulation should not apply to specific practices but to particular kinds of treatment or it may be more practical to bring wholly private dental services under the wing of regulatory mechanisms that already exist for NHS and mixed counterparts. C. If so, how should the interests of private patients in mixed practices be safeguarded? The majority of those who responded felt that private patients should have the same access to regulations as NHS patients i.e. to be treated by the same practitioner and to have professionals working to the same standards. It was suggested that looking at NHS, private and mixed dental practices differently would potentially add a further layer of complexity to dental services. 9
Specific comments included: - The best way to safeguard patients is to have professionals working to the same standards expected of them, in order to ensure safe and high quality care. - Any additional regulation should build on and work with the existing regulatory frameworks that the health professionals such as doctors, dentists, pharmacists and nurses are already working with. The core principle of any changes to the regulatory regime in Scotland should be one of consistency. - Private patients have recourse to the private patient s complaints scheme overseen by the General Dental Council. The current NHS quality assurance arrangements, including dental practice inspections, have been in place for many years and recently significant work has been undertaken to bring the vocational training standards and assessment models into one review model for dentists. D. How should we ensure that regulation reflects appropriately current business models of dentistry? The majority of respondents who expressed a view believed that both practices and the individual dentists should be subject to regulatory scrutiny and that if the same regulations apply then consistency occurs regardless of business model. Specific comments included: - If all dental services are to be included in the scope of regulation there needs to be a clear definition of what constitutes as a dental service and a dental provider. - The regulation of the facilities provision should be on a practice or clinic basis and should build on current practice inspections so that only one practice inspection every three years is required for compliance. - The provision of the actual care and treatment should be regulated on an individual practitioner/patient basis to reflect the way general dental services are provided. Question 6 A. Do you agree that in addition to nurse agencies, locum agencies which supply doctors and other healthcare professionals should be regulated in future? The majority of those who responded supported the regulation of locum agencies which supply doctors and other healthcare professionals. 10
Specific comments included: - Regulation of locum agencies like all other healthcare providers, is essential, especially as hospitals and healthcare centres become increasingly reliant on locum staff. - In relation to community pharmacy locum agencies are used by many employers. The standards that the locum should provide are those that any pharmacist should provide and are covered in great detail by General Pharmaceutical Council. Regulation of pharmacy locum agencies would ensure that owners and superintendents do not inadvertently breach General Pharmaceutical Council standards. - Consideration should take place of the risks involved and what other monitoring safeguards are in place. In other places these have previously involved regulating agencies only where they are supplied into a person s place of abode and not where they are supplied to a healthcare organisation. - An additional complexity arises when a service user contracts directly with an agency and there is no formal regulatory review of service provision. - If regulation is commenced there will need to be a clear definition of what a medical agency is. B. What key standards and criteria should be set for these agencies? From the respondents who expressed a view there was a general consensus that all patients have the right to good healthcare, whether treated by a locum or not. The standards and criteria should therefore be in line with that of all healthcare providers employed by the NHS. The key standards and criteria suggested for these agencies were: - - Scrutiny of applicants/locums qualifications. - Language proficiency (English language test). - Induction training. - Differences in medication. - Continual professional development. - Robust overseas checks where staff are supplied and/or introduced from other countries. - Safer recruitment. - Criteria setting out minimum level of training. - Monitoring standards. 11
Question 7 What is the best approach to regulation to ensure that the costs are proportionate, and reflect the benefits to the public? The majority of respondents who expressed a view agreed that the best way forward is to ensure the regulations are sufficiently flexible to take a proportionate, evidence and risk based approach and are consistent across public and privately provided services. Specific comments included: - Regulations should be derived following a risk/benefit analysis based on evidence data and research to ensure public confidence and support from the professions. - Having an agreed minimum level of inspection set for services would provide a high level of confidence in compliance with standards. Where services do not provide a satisfactory level of confidence in compliance, the frequency of inspection should be increased accordingly until confidence is restored or formal enforcement action is initiated. - An extension to current arrangements would not place a significant financial burden on most practices - For wholly private practices, inspection and monitoring quality of work should be paid for by private dentist. - The costs of regulating independent healthcare should not fall on the public purse, but care should be taken in increasing costs as these would inevitably be passed on to the consumer. 12
Key findings Section 4 The key findings of the consultation were:- The majority of respondents agreed that regulation of independent healthcare services that is proportionate to risk is justified; There was no clear preference whether self regulation or statutory regulation was more appropriate for independent healthcare services; There was support for a need to clarify the criteria for defining an independent hospital; There was support for the scope of regulation of independent healthcare services being extended to include services delivered by healthcare professionals, other than medical and dental practitioners and to healthcare services delivered outside the NHS; The majority of respondents felt that regulation should be based on a definition of services. While a small number believed that both the professional role and services should be regulated. There was support for a common approach to regulation of dental services across the NHS and private sectors; There was support for regulation of locum agencies which supply doctors and other healthcare professionals. Next Steps Section 5 The Scottish Government will use the results of this consultation to inform discussions on the future regulation of independent healthcare services with Healthcare Improvement Scotland and stakeholders. Plans for further commencement of independent healthcare services or any amendments to the scope of current regulation will be developed over the next year. 13
Crown copyright 2011 ISBN: 978-1-78045-288-3 (web only) APS Group Scotland DPPAS11833 (07/11) w w w. s c o t l a n d. g o v. u k