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7.18 pm
The Parliamentary Under-Secretary of State for Health (Miss Melanie Johnson): First, I congratulate my hon. Friend the Member for Middlesbrough, South and Cleveland, East (Dr. Kumar) on securing today's debate. He has already demonstrated his interest in this important subject, and I emphasise that the Government share that interest.
My hon. Friend will know that the NHS does not routinely provide laser eye surgery to correct refractive errors. The Government's view is that spectacles or contact lenses can usually correct refractory errors in a safe and cost-effective way.
The majority of laser eye surgery, therefore, takes place in private hospitals, and there appears to be a growth in the number of occasions on which this procedure is undertaken.It is, of course, important that service standards are clear and that those standards provide patients who choose to have laser eye surgery with the necessary assurance that the procedure is being carried out safely and appropriately.
I am aware of information received from the Eye Laser Association that states that more than 100,000 laser eye procedures are carried out in the United Kingdom each year. Indeed, it informs us that laser eye surgery is the single most performed surgical procedure world-wide and that the number of procedures undertaken has run into millions.
Patient safety and quality assurance are the cornerstones of the new regulatory system for independent health care. Nevertheless, the Government are aware that people have concerns about laser eye surgery. That has been clear in Parliament, from questions from Members and early-day motions, as well as from news items that the media have carried. One of the concerns has been that the practice is not properly regulated. I hope to reassure my hon. Friend on that.
The debate gives me an opportunity to speak more widely about what the Government have done to improve the regulation of care provided by health
establishments in the independent sector overall. As my hon. Friend said, the Care Standards Act 2000 established the National Care Standards Commission as an independent regulator and sector watchdog for social and independent health care services in England. The commission began operating in April 2002. The aim of the Act was to modernise the regulatory system and to protect vulnerable people in society by introducing, for the first time, consistent national minimum standards for providers of social and independent health care in England. The commission's main aim is to drive up the quality of services and improve the level of protection for vulnerable people.The commission registers, inspects and regulates health and social care providers against regulations and national minimum standards set by the Government. In applying the standards, the commission looks for evidence that the facilities, resources, policies, work force, services and activities offered by providers lead to positive outcomes and experience for service users. The regulations and standards to which providers of services are required to adhere are stringent and service user-oriented. Providers are subject to annual inspections by the commission, which requires providers of laser eye surgery to keep records of each surgical procedure undertaken, including accidents or adverse incidents. It also requires independent hospitals where laser eye surgery takes place to submit annual figures to it showing the number of complaints made and the action taken in response to them.The NCSC currently has 77 corrective laser eye surgery establishments registered, with a further 18 applications pending. It has had to take no enforcement action on clinical issues against any of those establishments.
There are two types of national minimum standard: core standards, which cover general issues that apply to all independent health care providers, and service-specific standards. Core standards require a registered establishment to ensure that before an appointment any qualifications relevant to the post are verified, and that the relevant regulatory or licensing body is asked to confirm that the applicant is appropriately registered. Core standards also require employers to make arrangements for staff training and continuing professional development.
Service-specific standards are those developed for a particular sector and a particular service user group. They do not imply that all providers must offer a uniform level of service; instead, they set out a minimum level of service that will guarantee a basic level of care for service users. Of course some establishments already exceed many of the standards, and in doing so have developed excellent levels of service provision. They provide a very high standard of care. The commission is determined to promote innovative good practice where and when it finds it.
The type of laser used in laser eye surgery is a class 4 laser. Its use is regulated by the NCSC, and, as I have said, providers of laser eye surgery are required to be registered with the commission as a licence to trade. The commission maintains specific service standards in respect of the use of class 4 lasers.
The service standards that are specific to class 4 state that all staff using lasers and intense pulsed lights are to have regular, recorded update training, both planned and in reaction to relevant technological and medical
developments; and that they use the lasers and intense pulsed light only for treatments for which they have been trained and, where appropriate, hold qualifications. The standards also stipulate that an expert medical practitioner must produce a protocol. That protocol has to be followed and will set out the necessary pre-treatment checks and tests, the manner in which the procedure is to be applied, the acceptable variations in the settings used, and when to abort a treatment. A further standard deals with the protection of people in the controlled area around working lasers.The standards provide a tool for the commission and providers jointly to improve the quality of services and they are used in conjunction with the Private and Voluntary Health Care (England) Regulations 2001—the legal instrument that governs how independent providers operate. The regulations state that registered providers should ensure that they employ an appropriate level of suitably qualified, skilled and experienced persons and that they should ensure that each person receives appropriate training, supervision and appraisal, and that staff are enabled to obtain further qualifications, where available, appropriate to the work that they perform.
The NCSC board has in the past highlighted the issue of laser eye surgery and recommended that the procedures and practices around it be reviewed in greater depth in the future. Inspections and reviews undertaken by the commission have also discovered that some establishments have fallen short of the required standards; those establishments now have a legal obligation to improve.
As my hon. Friend said, there are no specific qualifications in refractive surgery. A doctor undertaking laser eye surgery must be registered with the General Medical Council. The Royal College of Ophthalmologists recommends that only qualified ophthalmologists should be able to undertake the procedure and that they should have undertaken appropriate additional specialist training. However, all doctors must work within the principles of "good medical practice"—the standards that a doctor must keep to ensure continued registration with the GMC. Those standards state that
- "in providing care you must recognise and work within the limits of your professional competence and be competent when making diagnoses and when giving or arranging treatment".
I am also aware that there has been some concern over a reported rise in complaints, which my hon. Friend highlighted, but that is not borne out by the figures—certainly not by the NCSC figures. Since the implementation of the Care Standards Act 2000 in April 2002, the NCSC has received only two official complaints relating to laser eye surgery. One has been resolved to the patient's satisfaction and one is still ongoing and is being reviewed by the commission.
It is right that, in order to minimise risks to service users, the commission continues to keep the position surrounding laser eye surgery under continuous review. If there is a need for the Government to act, we will do so. Nevertheless, as I stated earlier, the NCSC has not felt it necessary to take enforcement action on clinical issues against any such establishments. It is worth pointing out that if a complaint were made against a doctor, the GMC would have to take into account any advice from the Royal College of Ophthalmologists about who should be undertaking the surgery.
On the power of the NCSC, the legislation that it is charged with applying gives far-reaching powers to act in the interest of users and to champion their rights. The commission will use those powers wisely and with discretion to assist service providers to comply with standards wherever possible. It will nevertheless take swift and vigorous action if it finds that the health, safety and well-being of service users are being compromised.
It remains for me to say that the arrangements will continue under the Commission for Healthcare Audit and Inspection, and I am confident that the success of the present arrangements will be continued as the NCSC transfers its responsibilities to CHAI in April this year.
I hope that I have been able to allay some of my hon. Friend's concerns over the provision of laser eye surgery in England. I understand that he is due to meet representatives of the National Care Standards Commission shortly, and I hope that they will be able to allay his concerns still further.
- Adjourned accordingly at half-past Seven o'clock.
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