Private and Voluntary Health Care (Wales) Regulations 2002

CHAPTER 1 QUALITY OF SERVICE PROVISION

Quality of treatment and other service provision

14.—(1) Subject to regulation 5(4), the registered person shall provide treatment and any other services to patients in accordance with the statement of purpose, and shall ensure that the treatment and any other services provided to each patient—

(a) meet the patient’s individual needs; and

(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 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, 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 drugs used in or for the purposes of the establishment.

(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;

and that the menu is varied at suitable intervals.

Care and welfare of patients

15.—(1) The registered person shall ensure that the establishment is conducted so as to promote and make proper provision for the welfare of patients and shall, so far as practicable, enable patients to make decisions about matters affecting their care and general welfare.

(2) The registered person shall ensure that patients are permitted to control their own money, except where a patient does not wish, or lacks capacity to do so, in which case the registered person shall ensure that patient monies are properly held and recorded and that receipts are issued as appropriate.

(3) The registered person shall, so far as practicable, ascertain and take into account the wishes and feelings of all patients in determining the manner in which they are cared for and services are provided to them.

(4) The registered person shall make suitable arrangements to ensure that the establishment is conducted—

(a) in a manner which respects the privacy and dignity of patients; and

(b) with due regard to the sex, religious persuasion, racial origin, and cultural and linguistic background and any disability of patients.

(5) The registered provider and the registered manager (if any) shall each take all reasonable steps to ensure that the establishment is conducted on the basis of good personal and professional relationships—

(a) between each other; and

(b) between each of them and the patients and staff.

Review of quality of treatment and other services

16.—(1) The registered person shall introduce and maintain a system for reviewing at appropriate intervals the quality of treatment and other services provided in or for the purposes of an establishment.

(2) The registered person shall supply to the appropriate office of the National Assembly a report in respect of any review conducted by the registered person for the purposes of paragraph (1) and make a copy of the report available to patients.

(3) The system referred to in paragraph (1) shall provide for consultation with patients and their representatives.

Staffing

17.—(1) The registered person shall, having regard to the nature of the establishment, the statement of purpose and the number and needs of patients—

(a) ensure that at all times suitably qualified, skilled and experienced persons are working in or for the purposes of the establishment in such numbers as are appropriate for the health and welfare of the patients;

(b) ensure that the employment of any persons on a temporary basis in or for the purposes of the establishment will not prevent patients from receiving such continuity of care as is reasonable to meet their needs.

(2) The registered person shall ensure that each person employed in or for the purposes of the establishment—

(a) receives appropriate training, supervision and appraisal;

(b) is enabled from time to time to obtain further qualifications appropriate to the work the person performs; and

(c) is provided with a job description outlining the person’s responsibilities.

(3) The registered person shall ensure that each person employed in or for the purposes of the establishment and any medical practitioner with practising privileges, receives regular and appropriate appraisal and shall take such steps as may be necessary to address any aspect of—

(a) a health care professional’s clinical practice; or

(b) the performance of a member of staff who is not a health care professional

which is found to be unsatisfactory.

(4) The registered person shall take reasonable steps to ensure that any persons working in or for the purposes of an establishment who are not employed by the registered person and to whom paragraph (2) does not apply, are appropriately supervised while carrying out their duties.

Fitness of workers

18.—(1) The registered person shall not—

(a) employ under a contract of employment a person to work in or for the purposes of the establishment unless that person is fit to do so ;

(b) allow a volunteer to work in or for the purposes of the establishment unless that person is fit to do so;

(c) allow any other person (including a medical practitioner seeking the grant of practising privileges) to work in or for the establishment in a position in which he or she may in the course of his or her duties have regular contact with a patient unless that person is fit to work in or for the establishment.

(2) For the purposes of paragraph (1) a person is not fit to work in or for the purposes of an establishment unless—

(a) the person is of suitable integrity and good character for the work which the person is to perform;

(b) the person has the qualifications, skills and experience which are necessary for that work ;

(c) the person is physically and mentally fit for that work; and

(d) full and satisfactory information or documentation, as the case may be, is available in relation to the person—

(i) except where paragraph (3) applies, in respect of each of the matters specified in paragraphs 1 to 7 of Schedule 2;

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

(3) This paragraph applies where any certificate or information on any matters referred to in paragraph 2 of Schedule 2 is not available because any provision of the Police Act 1997(1) has not been brought into force.

(4) The registered person shall ensure that—

(a) any offer of employment to, or other arrangement about working in or for the purposes of the establishment made with or in respect of a person described in paragraph (1) is subject to paragraph (2)(d) being complied with in relation to that person; and

(b) unless paragraph (5) applies, no such person starts work in or for the purposes of the establishment until such time as paragraph (2)(d) has been complied with in relation to that person.

(5) Where the following conditions apply, the registered person may permit a person other than a health care professional to start work in or for the purposes of the establishment notwithstanding paragraph (4)(b)—

(a) the registered person has taken all reasonable steps to obtain full information in respect of each of the matters listed in Schedule 2 in respect of that person, but the enquiries in relation to any of the matters listed in paragraphs 3 to 6 of Schedule 2 are incomplete;

(b) full and satisfactory information in relation to that person has been obtained in respect of—

(i) the matter specified in paragraph 1 of Schedule 2; and

(ii) unless paragraph (3) applies, the matter specified in paragraph 2 of that Schedule; or

(iii) where paragraph (3) applies, the matter specified in paragraph 8 of that Schedule;

(c) in the reasonable opinion of the registered person the circumstances are exceptional; and

(d) pending receipt of, and being satisfied with regard to, any outstanding information, the registered person ensures that the person is appropriately supervised while carrying out his or her duties.

(6) The registered person shall ensure that any person working in or for the purposes of the establishment who does not fall within paragraph (1) is appropriately supervised at all times when they are in contact with patients.

Guidance for health care professionals

19.  The registered person shall ensure that any code of ethics or professional practice prepared by a body which is responsible for regulation of members of a health care profession is made available in the establishment to members of the health care profession in question.

Records

20.—(1) The registered person shall ensure that except in cases to which regulation 39(5) applies—

(a) a comprehensive medical record is maintained in relation to each patient, which includes—

(i) a contemporaneous note of all treatment provided to the patient;

(ii) the patient’s medical history and all other notes prepared by a health care professional about the patient’s case; and

(b) the record is retained for a period which is not less than that specified in Part I of Schedule 3 in relation to the type of patient in question or, where more than one such period could apply, the longest of them.

(2) The registered person shall ensure that—

(a) the medical record for a person who is currently a patient is kept in a secure place in the establishment premises; and

(b) the medical record for a person who is not currently a patient is stored securely (whether in the establishment or elsewhere) and that it can be located if required.

(3) In addition to the medical records maintained in accordance with paragraph (1), the registered person shall ensure that the records specified in Part II of Schedule 3 are maintained and that they are—

(a) kept up to date;

(b) at all times available for inspection in the establishment by any person authorised by the National Assembly to enter and inspect the establishment ; and

(c) retained for a period of not less than three years beginning on the date of the last entry.

(4) Where an establishment closes the registered person shall ensure that the records maintained in accordance with paragraphs (1) and (3) are kept securely elsewhere and shall make them available for inspection by the National Assembly at its request.

Staff views as to conduct of establishment

21.—(1) This regulation applies to any matter relating to the conduct of the establishment so far as it may affect the health or welfare of patients.

(2) The registered person shall make arrangements to enable any person employed in or for the purposes of the establishment and any medical practitioner with practising privileges to inform the registered person and the National Assembly of their views about any matter to which this regulation applies.

Complaints

22.—(1) The registered person shall establish a procedure (in these Regulations referred to as “the complaints procedure”) for considering complaints made to the registered person by a patient or a person acting on behalf of a patient.

(2) The registered person shall ensure that any complaint made under the complaints procedure is fully investigated.

(3) The registered person shall supply a written copy of the complaints procedure upon request, to—

(a) every patient;

(b) any person acting on behalf of a patient; and

(c) any person who is considering whether to become a patient.

(4) The written copy of the complaints procedure shall include—

(a) the name, address and telephone number of the appropriate office of the National Assembly; and

(b) the procedure (if any) which has been notified by the National Assembly to the registered person for making complaints to the National Assembly relating to the establishment.

(5) The registered person shall maintain a record of each complaint, including details of the investigations made, the outcome and any action taken in consequence and the requirements of regulation 20(3)(b) and (c) shall apply to that record.

(6) The registered person shall supply to the National Assembly at its request copies of records maintained under paragraph (5).

Research

23.—(1) The registered person shall ensure that—

(a) before any research involving patients, information about patients, or human tissue is undertaken in or for the purposes of an establishment, a research proposal is prepared and approval is obtained from the appropriate Research Ethics Committee; and

(b) all such research projects include adequate safeguards for patients and employees.

(2) For the purposes of paragraph (1)(a), “the appropriate Research Ethics Committee” means a research ethics committee established in accordance with guidance issued from time to time by the National Assembly.

(1)

See footnote to regulation 9(4).