NATIONAL HEALTH SERVICE, ENGLAND AND WALES PART I GENERAL Citation, commencement, application and interpretation 1 1 These Regulations may be cited as the Commission for Health Improvement (Functions) Regulations 2003 and shall come into force on 11th July 2003. 2 Subject to paragraph (3), these Regulations apply to England only. 3 This regulation and regulation 2 apply also to Wales. 4 In these Regulations— “ the Act ” means the Health Act 1999; “the 1977 Act ” means the National Health Service Act 1977; “the 1997 Act ” means the National Health Service (Primary Care) Act 1997 ; “the Audit Commission” means the Audit Commission for Local Authorities and the National Health Service in England and Wales ; “clinical governance arrangements” means— 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 for which it has responsibility; in the case of a Strategic Health Authority— arrangements for the purpose of monitoring and improving the quality of health care for which it has responsibility; and 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 ; “investigation” means an investigation conducted by the Commission under section 20(1)(c) of the Act 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 ; “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— 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 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” means a person, other than an NHS body , which— provides Part 2 services; provides services in accordance with a pilot scheme under the 1997 Act; or 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) 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. PART II ADDITIONAL FUNCTIONS OF THE COMMISSION Additional functions 2 The following functions are prescribed under section 20(1)(e) of the Act— a the function of providing advice or information with respect to arrangements by Strategic Health Authorities, Special Health Authorities or service providers for the purpose of monitoring and improving the quality of health care for which they have responsibility; b the function of providing advice or information with respect to arrangements by a Strategic Health Authority 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; c the function of conducting reviews of, and making reports on, arrangements by Strategic Health Authorities, or Special Health Authorities to which the duty in section 18 of the Act has been extended by regulations made under section 18(3) of the Act, for the purpose of monitoring and improving the quality of health care for which they have responsibility; d the function of conducting reviews of, and making reports on, arrangements by a Strategic Health Authority 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; e the function of carrying out investigations into, and making reports on, the management, provision or quality of health care for which Special Health Authorities have responsibility; f the function of providing advice with respect to the establishment and conduct of health service inquiries. PART III ANNUAL WORK PROGRAMME Annual work programme 3 1 Before the beginning of each financial year the Commission shall prepare a work programme setting out the activities the Commission is to undertake in that year in the exercise of its functions. 2 Each work programme shall, in relation to that year, set out— a any particular matters with respect to which the Commission is to provide advice or information on clinical governance arrangements; b proposals as to the NHS bodies in relation to which the Commission is to conduct clinical governance reviews; c proposals as to the persons or bodies in relation to which the Commission is to conduct local reviews; d any particular matters which the Commission is to consider or take into account when conducting a clinical governance review or a local review; e the particular types of health care which are to be the subject of any national service reviews; and f any particular matters with respect to which the Commission is to conduct quality of data reviews. 3 The work programme shall be subject to approval by the Secretary of State. 4 The work programme may be varied— a with the agreement of the Secretary of State; or b as the Secretary of State may determine. 5 Subject to the following regulations and to any directions given by the Secretary of State, the Commission shall exercise its functions in any financial year in accordance with the work programme relating to that year. PART IV ADVICE OR INFORMATION ON CLINICAL GOVERNANCE ARRANGEMENTS Persons to whom advice or information to be given 4 1 The Commission shall provide advice or information on clinical governance arrangements to— a the Secretary of State; b NHS bodies; and c service providers. 2 The Commission shall comply with any request by the Secretary of State to provide advice or information on such aspects of clinical governance arrangements as may be specified in the request to— a the Secretary of State; b such NHS bodies as may be specified by him in the request; or c such service providers as may be so specified. 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 ; b any advice or guidance relating to clinical governance arrangements given by any body responsible for the regulation of a health care profession. PART V REVIEWS Effectiveness and adequacy of arrangements 6 In conducting a clinical governance review the Commission shall assess the effectiveness of the arrangements by the NHS body concerned and consider whether those arrangements are adequate. Review reports 7 1 Following the conclusion of a clinical governance review, the Commission shall make a report to the NHS body concerned. 2 Following the conclusion of a local review, the Commission shall make a report to the persons or bodies which were the subject of the review. 3 Following the conclusion of a national service review the Commission shall make a report to the Secretary of State. 4 The reports referred to in 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 - 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. PART VI INVESTIGATIONS Investigations 11 1 The Commission shall carry out an investigation when requested to do so by the Secretary of State. 2 The Commission may carry out an investigation where— a the Commission receives a request to investigate from any person or body; or b it otherwise appears to the Commission to be appropriate to do so. 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. PART VII RIGHTS OF ENTRY AND OBTAINING INFORMATION Rights of entry 17 1 Subject to the following paragraphs of this regulation, persons authorised in writing by the Commission may at any reasonable time enter and inspect relevant premises for the purposes of conducting— 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 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 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. PART VIII MISCELLANEOUS Assisting the Audit Commission 21 The Commission may not assist the Audit Commission under section 21(2) of the Act without the consent of the Secretary of State. Exercising functions in relation to health service inquiries 22 1 The Commission shall not exercise its functions under regulation 2(f) in relation to a particular inquiry or proposed inquiry without the consent of the Secretary of State. 2 In exercising its functions under regulation 2(f) the Commission shall take into account any advice or guidance relating to health service inquiries given to NHS bodies by the Secretary of State. Revocation 23 The Commission for Health Improvement (Functions) Regulations 2000 and the Commission for Health Improvement (Functions) Amendment Regulations 2000 are revoked. Signed by Authority of the Secretary of State Warner Parliamentary Under Secretary of State, Department of Health 18th June 2003