"the Act" means the Care Standards Act 2000;

"agency" means an independent medical agency;

(a) is an individual, who carries on the establishment or agency - 


(i) otherwise than in partnership with others, and he satisfies the requirements set out in paragraph (3);

(ii) in partnership with others, and he and each of his partners satisfies the requirements set out in paragraph (3);



(b) is a partnership, and each of the partners satisfies the requirements set out in paragraph (3);

(c) is an organisation and - 



(i) the organisation has given notice to the Commission of the name, address and position in the organisation of an individual (in these Regulations referred to as "the responsible individual") who is a director, manager, secretary or other officer of the organisation and is responsible for supervising the management of the establishment or agency; and

(ii) that individual satisfies the requirements set out in paragraph (3).

    (3) The requirements are that - 

(a) he is of integrity and good character;

(b) he is physically and mentally fit to carry on the establishment or agency; and

(c) full and satisfactory information is available in relation to him - 


(i) except where paragraph (4) applies, in respect of each of the matters specified in paragraphs 1 to 7 of Schedule 2;

(ii) where paragraph (4) applies, in respect of each of the matters specified in paragraphs 1 and 3 to 8 of Schedule 2.

(a) meet his individual needs;

(b) reflect published research evidence and guidance issued by the appropriate professional and expert bodies, as to good practice in the treatment of the condition from which the patient is suffering; and

(c) are (where necessary) provided by means of appropriate equipment.

    (2) The registered person shall ensure that all equipment used in or for the purposes of the establishment, or for the purposes of the agency is - 

(a) suitable for the purposes for which it is to be used; and

(b) properly maintained and in good working order.

    (3) Where reusable medical devices are used in an establishment or agency, the registered person shall ensure that appropriate procedures are implemented in relation to cleaning, disinfection, inspection, packaging, sterilisation, transportation and storage of such devices.

    (4) The procedures implemented in accordance with paragraph (3) shall be such as to ensure that reusable medical devices are handled safely and decontaminated effectively prior to re-use.

    (5) The registered person shall make suitable arrangements for the ordering, recording, handling, safe keeping, safe administration and disposal of medicines used in or for the purposes of the establishment, or for the purposes of the agency.

    (6) The registered person shall make suitable arrangements to minimise the risk of infection and toxic conditions and the spread of infection between patients and staff (including medical practitioners with practising privileges).

    (7) If an establishment provides food for patients, the registered provider shall ensure that it is - 

(a) provided in adequate quantities and at appropriate intervals;

(b) properly prepared, wholesome and nutritious; and

(c) suitable for the needs of patients,

(a) the premises are of sound construction and kept in a good state of repair externally and internally;

(b) the size and layout of rooms are suitable for the purposes for which they are to be used and are suitably equipped and furnished;

(c) all parts of the establishment or agency are kept clean and meet appropriate standards of hygiene;

(d) all parts of the establishment or agency to which patients have access are so far as reasonably practicable free from hazards to their safety; and

(e) if surgical procedures are undertaken, life support systems are used, or obstetric services and, in connection with childbirth, medical services, are provided in the establishment or agency, such electrical supply is provided during the interruption of public supply as is needed to safeguard the lives of the patients.

    (3) The registered person shall provide for employees and medical practitioners with practising privileges - 

(a) suitable facilities and accommodation, other than sleeping accommodation, including - 


(i) facilities for the purpose of changing; and

(ii) storage facilities; and



(b) where the provision of such accommodation is needed by employees in connection with their work, sleeping accommodation.

    (4) The registered person shall, after consultation with the fire authority - 

(a) take adequate precautions against the risk of fire, including the provision and maintenance of suitable fire equipment;

(b) provide adequate means of escape in the event of a fire;

(c) make arrangements for persons employed in the establishment or for the purposes of the agency and medical practitioners to whom practising privileges have been granted to receive suitable training in fire prevention;

(d) ensure, by means of fire drills and practices at suitable intervals, that the persons employed in the establishment or for the purposes of the agency and, so far as practicable, patients and medical practitioners to whom practising privileges have been granted, are aware of the procedure to be followed in case of fire; and

(e) review fire precautions, the suitability of fire equipment and the procedure to be followed in case of fire at intervals not exceeding twelve months.

(a) the responsible individual or one of the partners, as the case may be;

(b) another of the directors or other persons responsible for the management of the organisation or partnership; or

(c) an employee of the organisation or partnership who is not directly concerned with the conduct of the establishment or agency.

    (3) Visits under paragraph (1) or (2) shall take place at least once every six months and shall be unannounced.

    (4) The person carrying out the visit shall - 

(a) interview, with their consent and in private (if necessary, by telephone), such of the patients and their representatives and such employees as appears to him to be necessary in order to form an opinion of the standard of treatment and other services provided in or for the purposes of the establishment, or for the purposes of the agency;

(b) inspect records of any complaints and, in the case of an establishment, its premises; and

(c) prepare a written report on the conduct of the establishment or agency.

    (5) The registered provider shall supply a copy of the report required to be made under paragraph (4)(c) to - 

(a) the Commission;

(b) the registered manager; and

(c) in the case of a visit under paragraph (2) - 


(i) where the registered provider is an organisation, to each of the directors or other persons responsible for the management of the organisation; and

(ii) where the registered provider is a partnership, to each of the partners.

(a) the death of a patient - 


(i) in an establishment;

(ii) during treatment provided by an establishment or agency; or

(iii) as a consequence of treatment provided by an establishment or agency within the period of seven days ending on the date of the death, and the circumstances of his death;



(b) any serious injury to a patient;

(c) the outbreak in an establishment of any infectious disease, which in the opinion of any medical practitioner employed in the establishment is sufficiently serious to be so notified;

(d) any allegation of misconduct resulting in actual or potential harm to a patient by the registered person, any person employed in or for the purposes of the establishment or for the purposes of the agency, or any medical practitioner with practising privileges.

(a) those defined in section 2(3)(a)(i) of the Act except establishments excepted by regulation 3(2); and

(b) those in which medical treatment, including cosmetic surgery, is provided under anaesthesia or sedation.

(a) each operating theatre is designed, equipped and maintained to an appropriate standard for the purposes for which it is to be used;

(b) all surgery is carried out by, or under the direction of, a suitably qualified, skilled and experienced medical practitioner;

(c) an appropriate number of suitably qualified, skilled and experienced employees are in attendance during each surgical procedure; and

(d) the patient receives appropriate treatment - 


(i) before administration of an anaesthetic or sedation;

(ii) whilst undergoing a surgical procedure;

(iii) during recovery from general anaesthesia; and

(iv) post-operatively.

(a) subject to paragraph (4), he is a registered person;

(b) notice has been given to him in accordance with paragraph (3);

(c) the period specified in the notice, beginning with the date of the notice has expired; and

(d) the person contravenes or fails to comply with any of the provisions of the regulations mentioned in the notice.

    (3) Where the Commission considers that the registered person has contravened or failed to comply with any of the provisions of the regulations mentioned in paragraph (1), it may serve a notice on the registered person specifying - 

(a) in what respect in its opinion the registered person has contravened or is contravening any of the regulations, or has failed or is failing to comply with the requirements of any of the regulations;

(b) what action, in the opinion of the Commission, the registered person should take so as to comply with any of those regulations; and

(c) the period, not exceeding three months beginning on the date on which the notice is given, within which the registered person should take action.

    (4) The Commission may bring proceedings against a person who was once, but no longer is a registered person, in respect of a failure to comply with regulation 21 and for this purpose, references in paragraphs (2) and (3) to a registered person shall be taken to include such a person.



Signed by authority of the Secretary of State for Health


Jacqui Smith
Minister of State, Department of Health

11th December 2001

(a) the name, address, telephone number, date of birth and marital status of each patient;

(b) the name, address and telephone number of the patient's next of kin or any person authorised by the patient to act on his behalf;

(c) the name, address and telephone number of the patient's general practitioner;

(d) where the patient is a child, the name and address of the school which he attends or attended before admission to an establishment;

(e) where a patient has been received into guardianship under the Mental Health Act 1983, the name, address and telephone number of the guardian;

(f) the name and address of any body which arranged the patient's admission or treatment;

(g) the date on which the patient was admitted to an establishment or first received treatment provided for the purposes of an establishment or agency;

(h) the nature of the treatment for which the patient was admitted or which he received;

(i) where the patient has been an in-patient in an independent hospital, the date of his discharge;

(j) if the patient has been transferred to a hospital (including a health service hospital), the date of the transfer, the reasons for it and the name of the hospital to which the patient was transferred;

(k) if the patient dies whilst in an establishment or during treatment provided for the purposes of an establishment or agency, the date, time and cause of his death.

     2. A register of all surgical operations performed in an establishment or by an agency, including - 

(a) the name of the patient on whom the operation was performed;

(b) the nature of the surgical procedure and the date on which it took place;

(c) the name of the medical practitioner or dentist by whom the operation was performed;

(d) the name of the anaesthetist in attendance;

(e) the name and signature of the person responsible for checking that all needles, swabs and equipment used during the operation have been recovered from the patient;

(f) details of all implanted medical devices, except where this would entail the disclosure of information contrary to the provisions of section 33(5) of the Human Fertilisation and Embryology Act 1990 (restrictions on disclosure of information).

     3. A register of each occasion on which a technique or technology to which regulation 42 applies has been used; including - 

(a) the name of the patient in connection with whose treatment the technique or technology was used;

(b) the nature of the technique or technology in question and the date on which it was used; and

(c) the name of the person using it.

     4. A register of all mechanical and technical equipment used for the purposes of treatment provided by the establishment or agency including - 

(a) the date of purchase of the equipment;

(b) the date of installation of the equipment;

(c) details of maintenance of the equipment and the dates on which maintenance work was carried out.

     5. A register of all events which must be notified to the Commission in accordance with regulation 28.

     6. A record of the rostered shifts for each employee and a record of the hours actually worked by each person.

     7. A record of each person employed in or for the purposes of the establishment, or for the purposes of the agency and each medical practitioner to whom practising privileges have been granted, including - 

(a) his name and date of birth;

(b) details of his position in the establishment or agency;

(c) dates of employment; and

(d) in respect of a health care professional, details of his professional qualifications and registration with his professional regulatory body.

(a) examination for congenital abnormalities including congenital dislocation of the hip;

(b) measurement of the circumference of the head of the child;

(c) measurement of the length of the child;

(d) screening for phenylketonuria,

details of such examination and the result.