(This note is not part of the Regulations)
These Regulations are made under the Care Standards Act 2000 (“the Act”) and apply to independent hospitals and independent clinics in Wales. The Act provides in relation to Wales for the registration and inspection of establishments and agencies, including private and voluntary health care establishments, by the National Assembly for Wales and empower the National Assembly to make regulations governing their conduct.
Section 2 of the Act defines a number of “listed services” which (if they are provided in an establishment) bring an establishment within the definition of an independent hospital. Regulation 3 provides that “listed services” include treatment using the prescribed techniques and technology set out in regulation 3(1). Regulation 3(2) then excepts certain techniques and technology from being “listed services”, namely certain infra-red heat treatment, certain laser treatment and the use of ultra violet lamps for acquiring an artificial sun tan. Regulation 3(2) excludes certain establishments from the definition of an independent hospital under section 2 of the Act. The exceptions include establishments providing medical or psychiatric treatment but which have no overnight beds for patients, establishments which are service hospitals under the Armed Forces Act 1981, or which are establishments catering for offenders under the Prison Act 1952. In addition, independent clinics (as defined in these Regulations) are excluded, as well as establishments where general practitioners provide NHS services, but where there may be a small minority of private patients who also receive treatment. The private residence of a patient is also excluded provided that treatment is provided there only to that patient. There are also excluded surgeries and consulting rooms (which are separate from a hospital) which provide medical services under arrangements made on behalf of patients by their employers or others, and sports grounds and gymnasia where treatment is given to those taking part in sporting activities and events.
Regulation 3(4) modifies the definition of cosmetic surgery for the purposes of section 2(7) of the Act so that “listed services” do not include ear and body piercing, tattooing, injection of substances into the skin for cosmetic purposes and the removal of hair roots and small blemishes on the skin by the application of heat using an electric current.
Regulation 4 defines the meaning of the term “independent clinic”.
Each establishment must have a statement of purpose consisting of the matters set out in Schedule 1 and a patients' guide to the establishment which must be kept under review (regulations 5 to 7). By virtue of regulation 5(3) the establishment must be carried on in a manner which is consistent with the statement of purpose.
Regulation 8 sets out the policies and procedures which must be prepared and implemented in relation to an establishment.
Regulations 9 to 13 make provision about the fitness of the persons carrying on and managing an establishment and require full and satisfactory information to be available in relation to the matters prescribed in Schedule 2. Where the provider is an organisation, it must nominate a responsible individual in respect of whom this information must be available (regulation 9). Regulation 10 and 11 prescribe the circumstances where a manager must be appointed for the establishment and for the fitness requirements of a manager. Regulation 12 imposes general requirements in relation to the proper conduct of an establishment and the need for appropriate training. Regulation 13 requires offences and being charged for certain offences to be notified to the National Assembly.
Part III of the Regulations makes provision about the conduct of establishments, in particular about the quality of the services to be provided in an establishment, including matters relating to the privacy, dignity and religious observance of patients, the staffing of the establishment, the suitability of employees and about complaints and record keeping. Provision is also made about the suitability of premises and the fire precautions to be taken and the management of establishments. The registered provider is required to visit the establishment as prescribed (regulation 25) and regulation 26 imposes requirements relating to the financial viability of the establishment. Regulations 27 to 31 deal with the giving of notices to the National Assembly when certain events occur such as the death or serious injury of a patient; in the case of a manager’s absence from the establishment; where certain changes occur, for example, a change in the registered person and other personnel or significant changes to the premises; where liquidators and others are appointed and where the registered person dies.
Part IV and Schedule 4 sets out additional requirements that apply to independent hospitals in relation to pathology services, resuscitation, the treatment of children, certain surgical procedures, dental treatment, obstetric services and the use of certain techniques and technologies.
Part V (regulation 47) contains additional requirements where antenatal care is provided by an independent clinic.
Part VI deals with miscellaneous matters. In particular, regulation 49 provides for offences. A breach of regulations 5 to 14, 15(1) to (4), 16 to 31, 33 to 41 and 43 to 47 may found an offence.