Memorandum submitted by Which? (H&SC 8)
Which? welcomes the opportunity in the Health and Social Care Bill to create a truly patient and service user centred approach to regulation by reforming the system of regulating healthcare providers and professionals. This is something we have been campaigning for over many years. However, in order to achieve a significant improvement in consumer protection we want the Bill to go further to ensure that all healthcare wherever and by whoever it is provided is safe, effective and of high quality.
This evidence sets out the main areas in which we want the Bill to be strengthened. These include:
· Extending the regulatory scope of the Care Quality Commission to cover all healthcare providers (both public and independent sectors), and ensure that new developments in delivering healthcare are included;
· Introducing a duty on the Care Quality Commission to consult with patients, the public, service users and their informal carers.
· A strong patient voice on every regulator's governing council.
Part 1: The Care Quality Commission
Creating a level playing field by Regulating all healthcare providers
Which? believes that the Bill is an opportunity to deliver consistent regulation of all healthcare provision. As the Secretary of State, Alan Johnson, said at Second Reading:
'The Government recently published their response to the consultation on the future regulation of health and adult social care in England. The consultation highlighted clear support for an independent, integrated regulator with a stronger focus on assuring safety and quality. For the first time, the regulation of the national health service, social care and independent sector providers will be carried out by the same organisation.'
Which? believes that the Care Quality Commission should regulate all healthcare providers in the public and independent sectors. We support the provisions in the Bill to require registration with the Care Quality Commission of any person who carries out a 'regulated activity', i.e. one that involves or is connected with the provision of healthcare [Clauses 4(2) and 6(1)]. We welcome the broad definition of healthcare in the Bill [Clause 5(2)] but want this to incorporate all healthcare including the provision of cosmetic surgery and treatments, such as the use of lasers for cosmetic purposes and injections of Botox and dermal fillers.
Which? is calling for: The extension of the regulatory scope of the Care Quality Commission beyond that of the Healthcare Commission to cover all public and independent healthcare services used by consumers. This should include all new types of services emerging in the reformed NHS, such as walk-in centres, GPs with special interests and polyclinics as proposed by Lord Darzi's NHS review. This also needs to apply outside the NHS to include services such as cosmetic treatments.
Why this is needed:
The public want and expect all healthcare to be well-regulated and required to meet certain standards. As things stand, differences in the regulation of independent services compared to NHS services leads to loopholes and inconsistencies, as services are regulated in different ways and to different standards. Currently consumers of some privately provided services, such as dentistry, are less protected by regulators than they would if that service was provided by the NHS. There are also numerous regulatory loopholes in the field of cosmetic surgery and treatments. Our research shows 98 per cent of those planning cosmetic surgery would welcome a logo which would indicate that practitioners and providers had been checked. This would act as a simple identifier of adherence to standards and act as a short cut to allow consumers to choose safer, better quality or more reliable providers. This Bill must establish a level playing field for healthcare consumers through registration of all service providers based on common standards.
It is also essential that this Bill ensures that the regulatory system can accommodate future patterns of service delivery. New developments include walk-in centres, GPs performing minor surgery in their practices, polyclincs and a wider range of services at pharmacies.
Outside the NHS, new services are emerging which are subject to little or no regulation. For example in the rapidly growing cosmetic treatments market invasive procedures such as injections of medicines and the use of strong chemicals for topical treatments such as chemical peels are poorly covered. This leaves consumers at risk and can have harmful and sometimes permanent consequences.
Examples of practices Which? has found that highlight these problems include:
· Sale of Botox (currently a prescription-only medicine) on e-Bay by a former nurse turned beauty therapist who will come to your home, and admitted injecting people when they were drunk.
· Botox 'parties' held in inappropriate environments such as hotel rooms.
· Invasive procedures such as 'smart-lipo' being undertaken in offices.
· Injections of semi-permanent dermal fillers by beauty therapists in salons or dentists not licensed by the Healthcare Commission.
· The Isolagen treatment which involved a biopsy of skin to harvest a patients' own cells, their culture in a laboratory and subsequent re-injection into the skin to smooth out wrinkles. This treatment was not classified as either a medicine or medical device and so was outside current regulatory controls.
· Tooth whitening administered by beauty therapists again in unlicensed premises.
It's worth noting that calls to bring procedures such as Botox and aesthetic fillers within the remit of regulations for healthcare providers were also made by the Chief Medical Officer's Expert Working Group on Cosmetic Surgery (January 2005).
A duty to consult and involve
Which? believes the Bill should provide for more meaningful and influential patient and public involvement in the work of the Care Quality Commission. Currently the draft Bill calls on the Commission to have regard to the views of public. This simply isn't enough and is wholly out of keeping with wider Government policy of patient involvement in healthcare, for example in the duty placed on NHS organisations to consult, through section 242 of National Health Service Act 2006. It is a startling omission that the new body charged with overseeing the quality of health and social care will not have a duty to take patients' views into account in the course of their work.
Which? is calling for: a duty on the Care Quality Commission to consult with patients, the public and service users.
Why this is needed:
Delivering patient-centred healthcare means listening to the views of patients, and acting on what they say. Our research makes it clear that the NHS needs to do more not less to engage with its patients and act on what they say. For example, our research with hospital inpatients revealed that many were unhappy with the quality of food, ward cleanliness, the way care is organised and the degree of respect and dignity they are shown by some staff members. However, for every unhappy patient who raised their concern with staff another unhappy patient remained silent.
If the aspiration of patient-centred care is to be met, the duty to consult and involve must include all organisations with a responsibility for the safety and quality of healthcare whether national or local. A similar duty already exists elsewhere in the Bill for the Council for Healthcare Regulatory Excellence and the Office of the Health Professionals Adjudicator. The Care Quality Commission should not be exempt from this duty otherwise the bill is a retrograde step that fails patients and service users.
improve Hospital Food
Which? is calling for the Care Quality Commission to have explicit responsibility for monitoring the implementation of the nutritional guidelines produced by the Food Standards Agency and reporting to the Department of Health and the public where they are being ignored.
Why change is needed:
Research consistently shows that patients are unhappy with the poor quality of hospital food. New Which? research shows that:
· One in three (32 per cent) of the recent hospital patients we spoke to were unhappy with the quality of the food they were served and 25 per cent of patients said the food was so bad they had to buy their own or get someone to bring some in. Two thirds (67 per cent) of hospital staff think improvements need to be made to hospital food. A fifth of staff (21 per cent) would be unhappy to eat the food they serve to patients.
· The Food Standards Agency has produced nutritional guidelines for major institutions, including hospitals. It is essential that the Care Quality Commission is required to monitor the implementation of the guidance and to take action where Trusts ignore them. Without this, the guidelines will have a limited impact on improving hospital food for patients.
Part 2: Regulation of Health Professions and Health and Social Care Workforce
Which? broadly welcomes Part 2 of the Bill. We believe the current system has failed to protect patients and the public adequately from rogue or incompetent health professionals, as recent evidence from the Shipman and other inquiries has shown.
Important elements of the proposed changes to professional regulation are not contained within the Bill, but instead likely to be detailed within Statutory Instruments (Orders in Council) enabled by Section 60 of the Health Act 1999. Which? is concerned that this piecemeal approach will mean it will take considerable time to adopt and implement all the proposed changes within the 'Trust, Assurance and Safety' White Paper for all the healthcare regulators. This will result in greater inconsistencies and public confusion.
While recognising that individual regulators may have particular issues that require a more tailored approach, the proposed reforms are based on some consistent principles that can and should be introduced in one go. The Government must place all the intended legislative proposals within both the Bill and related statutory instruments, before Parliament at the same time.
We want to see the following introduced into the Bill:
A strong patient voice on every regulator's governing council (new provision)
Which? is calling for:
· A lay majority of one on the governing bodies of all regulators' councils.
· A clear definition of 'lay', as someone who is not or has never been a registered healthcare professional.
· All council members including professional members to be independently appointed by the NHS Appointments Commission.
Why this is needed:
For too long the regulatory bodies have been dominated by professional interests which has undermined public confidence in their operation and decision making. A lay majority of one will help to ensure that the public and patient interest is firmly embedded in all the work of each professional regulatory body. However, Which? believes that there should also be a much clearer definition of what is 'lay' to exclude any other health professionals or those who were once a registered health professional.
Patients and the public must have confidence in the work of the regulatory bodies and their ability to maintain the public interest and to hold professionals properly to account. A clear indication is required that high level decisions taken by the organisations governing council are not only free from the domination of vested interests, but also in touch with the everyday views and needs of consumers.
Healthcare professionals to be regularly assessed (new provision)
Which? is calling for:
· Introduction of regular assessment (revalidation) of all healthcare professionals to ensure they demonstrate their continuing fitness to practise, in all areas within their current professional practice. This should encompass softer skills, such as communication, to ensure a patient centred approach.
· The registration and regulation of all health and social care professionals including students, healthcare assistants and support workers.
Why this is needed:
The introduction of regular assessment or revalidation will help ensure that all professionals maintain appropriate standards of competence and conduct, keeping their skills up to date throughout their professional career in all areas of their current practice. The process of revalidation is a clear demonstration to patients and the public that an individual healthcare professional retains their continuing fitness to practice. It will also help identify the current areas of specialist practice he or she currently works in to both the patient and the regulator.
From the very beginning anyone involved in the care of patients, even during training and at the most junior level, should be registered with the appropriate statutory body to ensure they are subject to common standards of conduct and regulatory accountability. Student nurses are often involved in providing many aspects of the care needed for a patient in hospital, but not registered with the Nursing and Midwifery Council. Even if there as a student, a hospital ward is a professional environment, and no-one should be exempt from the responsibility to deliver patient-centred healthcare.
Currently a health professional may practise within a particular specialism or undertake a procedure without having undertaken any additional training or assessment of their skills in this area. For example, doctors, nurses and dentists are increasingly administering Botox or other dermal fillers to fee-paying patients, without specific training or insurance to cover this type of procedure. This leaves consumers open to serious risk.
Improved consumer protection when things go wrong (Clause 104)
We welcome the introduction of a civil standard of proof in any fitness to practise cases, already adopted by some professional regulators, should apply to all regulators.
Why this is needed:
The civil standard of proof will ensure greater protection for consumers. In some cases, there has been a failure to take disciplinary action because it has not been possible to meet the high evidence standards of the criminal standard of proof, even though there have been significant concerns about the practice of the individual professional. If public protection is to be paramount, then professional regulation must be based on precautionary principles and action taken against healthcare professionals where there is strong evidence that they are unfit to practise.
Currently six of the nine statutory healthcare regulators operate fitness to practise disciplinary hearings on the basis of a civil standard of proof - the balance of probabilities. However, the General Medical Council, the Nursing and Midwifery Council and the General Optical Council are the exceptions to the rule, and operate instead on the basis of a criminal standard of proof - beyond all reasonable doubt.
Consistency is key across all of the statutory regulators to prevent confusion for the public, and to ensure greater consistency in the way that different health professionals involved in a single incident are treated. We welcome that the civil standard of proof will also apply in the work of the Office of Health Professions Adjudicator (Clause 91-104).
Council for Healthcare Regulatory Excellence (Clauses 105-109)
Which? welcomes changes to strengthen the powers and functions of the Council for Healthcare Regulatory Excellence (CHRE). We particularly welcome:
· The explicit obligation on the CHRE to promote the health, safety and well being of patients and other members of the public (Clause 105).
· the explicit duty on the CHRE to consult and inform the public (Clause 108).
However, Which? is concerned about the proposed composition of the CHRE Council. The Bill needs to ensure that Non Executive Directors are not registered health professionals or formerly registered health professionals, and appointment by the Privy Council to the CHRE Council must be based on competencies, with a transparent appointment process that is based on open competition and assessment.
The Office of the Health Professions Adjudicator (Clauses 91-102 and Schedule 6)
The duty in Clauses 100-101 to inform and consult the public is welcome; however the scope of the Adjudicator should apply to all health professionals, not just to doctors and opticians. Clarity is also needed about who can be a non executive director, with an assurance that the definition in Schedule 6 does not solely include a registered or formerly registered healthcare professional.
 Which? research with consumers how had received cosmetic procedure in the UK in the past three years (107) or were actively planning to have a private cosmetic procedure in the next three years (107). Respondents were selected via a large-scale online consumer panel to achieve a nationally representative sample of UK adults aged 18-65. September 2006.
 'Botox on e-Bay', Consumer News, Which? magazine, December 2007.
 Cosmetic Treatments: UK consumers - the cosmetic guinea pigs?', Which? campaign briefing, August 2007.
 Which? interviewed 1000 patients online during August 2007. All respondents to the survey had spent at least one night in hospital in the last 12 months.
 Which? interviewed 1000 patients online during August 2007. All respondents to the survey had spent at least one night in hospital in the last 12 months. Which? interviewed 250 hospital staff (including mixed speciality doctors, nurses, caterers, porters and receptionists) during August and September 2007.