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"the 1997 Act" means the National Health Service (Primary Care) Act 1997[4];

"the Audit Commission" means the Audit Commission for Local Authorities and the National Health Service in England and Wales[5];

"clinical governance arrangements" means - 

(a) in the case of a Special Health Authority, Primary Care Trust, NHS trust or service provider, arrangements for the purpose of monitoring and improving the quality of health care[6] for which it has responsibility;

(b) in the case of a Strategic Health Authority - 


(i) arrangements for the purpose of monitoring and improving the quality of health care for which it has responsibility; and

(ii) arrangements for the purpose of monitoring and improving the quality of health care for which the Primary Care Trust or Trusts in relation to which it is the relevant Strategic Health Authority have responsibility, and which is provided to individuals in the Authority's area;

"clinical governance review" means a review conducted by the Commission under section 20(1)(b) of the Act or regulation 2(c) or (d);

"the Commission" means the Commission for Health Improvement established by section 19 of the Act;

"financial year" means the period of 12 months ending with 31st March;

"health care profession" means a profession to which section 60(2) of the Act applies;

"health service inquiry" means an inquiry, held or established by the Secretary of State, the National Assembly for Wales or an NHS body, into any matter relating to the management, provision and quality of health care for which NHS bodies or service providers have responsibility;

"inspection" means an inspection conducted by the Commission under section 20(1)(db) of the Act[7];

"investigation" means an investigation conducted by the Commission under section 20(1)(c) of the Act[8] or regulation 2(e);

"local review" means a review conducted by the Commission under section 20(1)(d) of the Act that relates to health care for which a particular NHS body or service provider has responsibility[9];

"national service review" means a review conducted by the Commission under section 20(1)(d) of the Act that relates to a particular type of health care for which NHS bodies or service providers have responsibility;

"Part 2 services" means general medical services, general dental services, general ophthalmic services or pharmaceutical services under Part 2 of the 1977 Act;

"relevant Primary Care Trust" means, in relation to a service provider or NHS trust, any Primary Care Trust with which the service provider or NHS trust has made arrangements to provide services;

"relevant Strategic Health Authority" means, in relation to a Primary Care Trust - 

(a) where the area for which the Primary Care Trust is established falls wholly within the area of a Strategic Health Authority, that Strategic Health Authority; or

(b) where the area for which the Primary Care Trust is established falls within the areas of two or more Strategic Health Authorities, each of those Strategic Health Authorities;

"service provider"[10] means a person, other than an NHS body[11], which - 

(a) provides Part 2 services;

(b) provides services in accordance with a pilot scheme under the 1997 Act; or

(c) provides services in accordance with arrangements made under section 28 of the Health and Social Care Act 2001;

"quality of data review" means a review under section 20(1)(da)[12] of the Act.

    (5) In these Regulations, references to health care for which a person has responsibility are to be construed in accordance with section 20(5) of the Act.

    (3) The Commission may provide advice or information on clinical governance arrangements to any other person or body requesting such advice or information.

Exercise of the function of providing advice or information on clinical governance arrangements
     5. In exercising its functions under section 20(1)(a) of the Act and regulation 2(a) and (b) the Commission shall take into account - 

(a) any guidance relating to clinical governance arrangements given by the Secretary of State or the National Institute for Clinical Excellence[13];

(b) any advice or guidance relating to clinical governance arrangements given by any body responsible for the regulation of a health care profession.

Special interest reports - clinical governance reviews
     8.  - (1) If in the course of a clinical governance review a matter comes to the notice of the Commission which it considers should, in the public interest, be brought quickly to the attention of - 

(a) any of the persons or bodies to which paragraph (2) applies; and

(b) the public,

the Commission shall make the matter the subject of an immediate report in addition to the report to be made at the conclusion of the review.

    (2) The persons and bodies referred to in paragraph (1) are - 

(a) the NHS body which is the subject of the review;

(b) in a case where a Primary Care Trust is the subject of the review, the relevant Strategic Health Authority;

(c) in a case where an NHS trust is the subject of the review, the relevant Primary Care Trust and the Strategic Health Authority which is, in relation to that Primary Care Trust, the relevant Strategic Health Authority;

(d) the Secretary of State.

    (3) Copies of any report under paragraph (1) shall be sent to the persons or bodies referred to in paragraph (2) and to any other NHS body or service provider or other person or body exercising statutory functions, to which the Commission considers the report should be copied.

Special interest reports - local and national service reviews
     9.  - (1) If in the course of a local or national service review a matter comes to the notice of the Commission which it considers should, in the public interest, be brought quickly to the attention of - 

(a) any of the persons or bodies to which paragraph (2) applies; and

(b) the public,

the Commission shall make the matter the subject of an immediate report in addition to the report to be made at the conclusion of the review.

    (2) The persons and bodies referred to in paragraph (1) are - 

(a) any person or body which is the subject of the review;

(b) in a case where a Primary Care Trust is the subject of the review, the relevant Strategic Health Authority;

(c) in a case where a service provider or NHS trust is the subject of the review, the relevant Primary Care Trust and the Strategic Health Authority which is, in relation to that Primary Care Trust, the relevant Strategic Health Authority;

(d) the Secretary of State.

    (3) Copies of any report under paragraph (1) shall be sent to - 

(a) any person or body which is the subject of the review and to whose attention the Commission considers that the matter should be brought;

(b) where that person or body is a Primary Care Trust, the relevant Strategic Health Authority;

(c) where that person or body is a service provider or NHS trust, the relevant Primary Care Trust and the Strategic Health Authority which is, in relation to that Primary Care Trust, the relevant Strategic Health Authority;

(d) the Secretary of State; and

(e) any other NHS body or service provider or other person or body exercising statutory functions, to which the Commission considers the report should be copied.

Further action following a clinical governance review or a local review
     10.  - (1) Paragraphs (2) to (4) below apply where an NHS body has been the subject of a clinical governance or local review.

    (2) Following the conclusion of the review, the NHS body concerned shall, with the assistance of the Commission, prepare a written statement of the action which it proposes to take in the light of the report made by the Commission.

    (3) A statement prepared under paragraph (2) shall be subject to approval by - 

(a) in the case of a Strategic Health Authority or Special Health Authority, the Secretary of State; and

(b) in the case of a Primary Care Trust, the relevant Strategic Health Authority;

(c) in the case of an NHS trust, the relevant Primary Care Trust and the Strategic Health Authority which is, in relation to that Primary Care Trust, the relevant Strategic Health Authority.

    (4) Before deciding whether to approve a statement prepared under paragraph (2), the Secretary of State or, as the case may be, the Primary Care Trust or Strategic Health Authority shall consult the Commission.

    (3) Where the Commission is carrying out an investigation at the request of the Secretary of State, it shall investigate such matters falling within section 20(1)(c) of the Act or regulation 2(e) as may be specified in the request.

    (4) Where the Commission is carrying out an investigation in any other case, it may investigate such matters falling within section 20(1)(c) of the Act or regulation 2(e) as it considers appropriate.

Notice of investigation
     12. Where it is reasonably practicable to do so, the Commission shall provide written notification of its intention to carry out an investigation and the proposed date on which that investigation is to commence to - 

(a) any person or body which is to be the subject of the investigation;

(b) in the case of an investigation under regulation 11(2) concerning a Strategic Health Authority or a Special Health Authority, the Secretary of State;

(c) in the case of such an investigation concerning a Primary Care Trust, the relevant Strategic Health Authority; and

(d) in the case of such an investigation concerning a service provider or NHS trust, the relevant Primary Care Trust and the Strategic Health Authority which is, in relation to that Primary Care Trust, the relevant Strategic Health Authority.

Carrying out an investigation of a body which is the subject of a review
     13.  - (1) Paragraph (2) applies where, in the course of conducting a clinical governance review, a local review or a national service review, the Commission commences an investigation.

    (2) Where this paragraph applies, the Commission may suspend or continue the clinical governance review or the local or national service review and, where the review is suspended, resume the review at any time.

Investigation reports
     14.  - (1) Following the conclusion of an investigation which has been requested by the Secretary of State the Commission shall make a report to the Secretary of State and send a copy of the report to - 

(a) any person or body which has been the subject of the investigation;

(b) in the case of an investigation concerning a Primary Care Trust, the relevant Strategic Health Authority; and

(c) in the case of an investigation concerning a service provider or NHS trust, the relevant Primary Care Trust and the Strategic Health Authority which is, in relation to that Primary Care Trust, the relevant Strategic Health Authority.

    (2) Following the conclusion of an investigation which has been requested by any other person or body the Commission shall make a report to that person or body and send a copy of the report to - 

(a) the person or body which has been the subject of the investigation;

(b) in the case of an investigation concerning a Primary Care Trust, the relevant Strategic Health Authority;

(c) in the case of an investigation concerning a service provider or NHS trust, the relevant Primary Care Trust and the Strategic Health Authority which is, in relation to that Primary Care Trust, the relevant Strategic Health Authority; and

(d) the Secretary of State.

    (3) Following the conclusion of an investigation in any other case, the Commission shall make a report to the person or body which has been the subject of the investigation and shall send a copy of the report to - 

(a) in the case of an investigation concerning a Primary Care Trust, the relevant Strategic Health Authority;

(b) in the case of an investigation concerning a service provider or NHS trust, the relevant Primary Care Trust and the Strategic Health Authority which is, in relation to that Primary Care Trust, the relevant Strategic Health Authority; and

(c) the Secretary of State;

    (4) A report made under paragraphs (1) to (3) shall set out - 

(a) the findings and conclusions of the Commission; and

(b) any recommendations made by the Commission.

Special interest reports
     15.  - (1) If in the course of an investigation a matter comes to the notice of the Commission which it considers should, in the public interest, be brought quickly to the attention of - 

(a) any of the persons or bodies to which paragraph (2) applies; and

(b) the public,

the Commission shall make the matter the subject of an immediate report in addition to the report to be made at the conclusion of the investigation.

    (2) The persons and bodies referred to in paragraph (1) are - 

(a) any person or body which is the subject of the investigation;

(b) in a case where a Primary Care Trust is the subject of the investigation, the relevant Strategic Health Authority;

(c) in a case where a service provider or NHS trust is the subject of the investigation, the relevant Primary Care Trust and the Strategic Health Authority which is, in relation to that Primary Care Trust, the relevant Strategic Health Authority; and

(d) the Secretary of State.

    (3) Copies of any report under paragraph (1) shall be sent to the persons or bodies referred to in paragraph (2) and to any other NHS body or service provider or other person or body exercising statutory functions, to which the Commission considers the report should be copied.

Further action following an investigation
     16.  - (1) Following the conclusion of an investigation any NHS body concerned shall, with the assistance of the Commission, prepare a written statement of the action which it proposes to take in the light of the report made by the Commission.

    (2) A statement prepared under paragraph (1) shall be subject to approval by - 

(a) in the case of a Strategic Health Authority or a Special Health Authority, the Secretary of State;

(b) in the case of a Primary Care Trust, the relevant Strategic Health Authority; and

(c) in a case of an NHS trust, the relevant Primary Care Trust and the Strategic Health Authority which is, in relation to that Primary Care Trust, the relevant Strategic Health Authority.

    (3) Before deciding whether to approve a statement prepared under paragraph (1), the Secretary of State or, as the case may be, the Strategic Health Authority or Primary Care Trust shall consult the Commission.

(a) a clinical governance review;

(b) any review under section 20(1)(d) of the Act (and any inspection carried out in connection with such a review); or

(c) an investigation.

    (2) Each person authorised by the Commission under paragraph (1) shall be furnished with written evidence of his authority and on applying for entry to relevant premises for the purposes specified in paragraph (1) shall, if so requested by the occupier of the premises or a person acting on his behalf, produce that evidence.

    (3) A person authorised by the Commission under paragraph (1) shall not demand admission to relevant premises as of right unless the person or body which owns or controls the premises has been given reasonable notice of the intended entry.

    (4) No person authorised by the Commission under paragraph (1) may enter any premises or part of premises used as residential accommodation for persons employed by any person or body, without first having obtained the consent of the officers residing in such accommodation.

    (5) Subject to regulation 20, a person authorised by the Commission under paragraph (1) to enter relevant premises under this regulation may inspect and take copies of any documents which - 

(a) appear to him to be necessary for the purposes of the review, inspection or investigation in question; and

(b) are held on the premises by - 


(i) the person or body which owns or controls the premises;

(ii) a chairman, member, director or employee of that person or body;

(iii) any other person acting on behalf of that person or body; or

(iv) a member of a committee or sub-committee of any body concerned.

    (6) In paragraph (5) and in regulation 18, "review" means a clinical governance review or a review under section 20(1)(d) of the Act.

Obtaining information and explanations
     18.  - (1) Subject to regulation 20, in conducting a review, inspection or investigation the Commission or a person authorised by the Commission under regulation 17(1) may require any of the persons to which paragraph (5) applies to produce any documents or information which appear to the Commission, or to the person authorised, to be necessary for the purposes of the review, inspection or investigation in question.

    (2) Subject to regulation 20, in conducting a review, inspection or investigation the Commission or a person authorised by the Commission may, if it or he thinks it necessary, require any of the persons to which paragraph (5) applies to give the Commission or, as the case may be, the person authorised an explanation of - 

(a) any matters which are the subject of the review, inspection or investigation; or

(b) any documents or information inspected, copied or produced under paragraph (1) or regulation 17(5).

    (3) The Commission may, if it considers it necessary, require a person required to - 

(a) produce documents or information under paragraph (1); or

(b) give an explanation under paragraph (2),

to attend before the Commission or a person authorised by the Commission under regulation 17(1) in person to produce the documents or information or give the explanation.

    (4) The Commission may not require a person to attend in person in accordance with paragraph (3) unless reasonable notice of the intended date of attendance has been given to that person.

    (5) The persons referred to in paragraphs (1) and (2) are - 

(a) an NHS body;

(b) a chairman, member, director or employee of an NHS body, or any other person acting on behalf of such a body;

(c) a member of a committee or sub-committee of an NHS body;

(d) a service provider;

(e) an employee of a service provider, or any other person acting on behalf of such a provider;

(f) a person who provides or assists in the provision of, or is a member or an employee of a person or body who provides or assists in the provision of, services under the 1977 Act, or in connection with a pilot scheme under the 1997 Act, in accordance with an arrangement made with an NHS body, a service provider or a person to which sub-paragraph (g) applies;

(g) a local authority which provides, or a person employed by a local authority to provide, services under the 1977 Act, or in connection with a pilot scheme under the 1997 Act, in accordance with arrangements made by virtue of section 31(1) of the Act.

Information held by means of a computer or in any other electronic form
     19.  - (1) In this regulation and in regulations 17 and 18, any reference to documents includes a reference to information held by means of a computer or in any other electronic form.

    (2) Where the Commission or a person authorised under regulation 17(1) is exercising - 

(a) the right under regulation 17(5) to inspect and take copies of documents; or

(b) the right under regulation 18(1) to require any person to produce documents,

and such documents consist of information held by means of a computer or in any other electronic form, the Commission or the person authorised may require any person having charge of, or otherwise concerned with the operation of, the computer or other electronic device holding that information to make that information available, or produce that information, in a visible and legible form.

Restrictions on disclosure of information to the Commission
     20.  - (1) The Commission or a person authorised under regulation 17(1) shall not inspect or take copies of documents under regulation 17(5) to the extent that - 

(a) those documents consist of confidential information[15] which relates to and identifies a living individual, unless one or more of the conditions specified in paragraph (3) applies; or

(b) the inspection or copying of those documents involves the disclosure of information where that disclosure is prohibited by or under any enactment, unless paragraph (4) applies.

    (2) A person shall not be required to produce documents or information under regulation 18(1) or give an explanation under regulation 18(2) to the extent that the production of those documents or that information or the giving of that explanation discloses information - 

(a) which is confidential and which relates to and identifies a living individual, unless one or more of the conditions specified in paragraph (3) applies; or

(b) the disclosure of which is prohibited by or under any enactment, unless paragraph (4) applies.

    (3) The conditions referred to in paragraphs (1)(a) and (2)(a) are - 

(a) the information is disclosed in a form in which the identity of the individual cannot be ascertained;

(b) the individual consents to the information being disclosed;

(c) the individual cannot be traced despite the taking of all reasonable steps;

(d) in a case where the Commission is exercising its functions under section 20(1)(c), (d) or (db) of the Act[16] or regulation 2(e) - 


(i) it is not practicable to disclose the information in a form in which the identity of the individual cannot be ascertained;

(ii) the Commission considers that there is a serious risk to the health or safety of patients arising out of the matters which are the subject of the investigation, review or inspection; and

(iii) having regard to that risk and the urgency of the exercise of those functions, the Commission considers that the information should be disclosed without the consent of the individual.

    (4) This paragraph applies where - 

(a) the prohibition on the disclosure of information operates by reason of the fact that the information is capable of identifying an individual; and

(b) the information in question is in a form in which the identity of the individual cannot be ascertained.

    (5) In a case where the disclosure of information is prohibited by paragraph (1) or (2) and the prohibition operates by reason of the fact that the information is capable of identifying an individual, the Commission or a person authorised by the Commission under regulation 17(1) may require the person holding the information to put the information in a form in which the identity of the individual concerned cannot be ascertained, in order that the information may be disclosed.

[2] 1999 c. 8; see sections 20(7) and 23(6) for the definitions of "prescribed". The functions of the Secretary of State under sections 20(2) and 23 of the Act and sections 17 and 126(4) of the National Health Service Act 1977 ("the 1977 Act") are, so far as exercisable in relation to Wales, transferred to the National Assembly for Wales by article 2(a) of, and the entries for the 1977 Act and the Act in Schedule 1 to, the National Assembly for Wales (Transfer of Functions) Order 1999, S.I. 1999/672, as amended by section 66(5) of the Act. Section 20(2) was amended by section 12(1) and (4) of the National Health Service Reform and Health Care Professions Act 2002 (c. 17) ("the 2002 Act") and section 23 was amended by section 13(2) of that Act.back

[3] See the entry for the Act in Schedule 2 to the National Assembly for Wales (Transfer of Functions) Order 1999, as inserted by section 66(6) of the Act.back

[4] 1997 c. 46.back

[5] The Audit Commission was continued in being by section 1 of the Audit Commission Act 1998 (c. 18).back

[6] See sections 18(4) and 20(7) of the 1999 Act for the definition of "health care".back

[7] Section 20(1)(db) was inserted by section 13(1) of the 2002 Act.back

[8] Section 20(1)(c) was amended by Schedule 1, paragraph 49, of the 2002 Act.back

[9] Section 20(1)(d) was amended by section 12(1) and (2) of the 2002 Act.back

[10] By virtue of section 40(3) of the 1997 Act, the reference in the definition of "service provider" in section 20(7) of the Act to a person who provides services in accordance with arrangements under section 28C of the 1977 Act includes a reference to services provided in accordance with a pilot scheme under the 1997 Act; the definition was amended by regulation 27 of S.I. 2002/2861, to add a reference to services provided in accordance with arrangements under section 28 of the Health and Social Care Act 2001 (c. 15).back

[11] See section 20(7) of the Act for the definition of "NHS body"; the definition was amended by Schedule 1, paragraph 49, to the 2002 Act.back

[12] Section 20(1)(da) was inserted by section 12(2)(c) of the 2002 Act.back

[13] See S.I.1999/220 as amended by S.I.1999/2219.back

[14] See section 23(6) of the Act (inserted by section 13(2) of the 2002 Act) for the definition of "relevant premises".back

[15] See section 23(6) of the Act for the definition of "confidential information".back

[16] Section 20(1)(db) was inserted by section 13(1) of the 2002 Act.back

[17] S.I. 2000/662 as amended by S.I. 2000/797 and 2002/2469.back

[18] S.I. 2000/797.back

 

© Crown copyright 2003

Prepared 20 June 2003