NATIONAL HEALTH SERVICE, ENGLAND Citation, commencement and extent 1 1 These Regulations may be cited as the National Health Service (Out of Hours Medical Services) and National Health Service (General Medical Services) Amendment Regulations 2002 and shall come into force on 1st November 2002. 2 These Regulations apply to England only. Interpretation 2 In these Regulations— “the 1977 Act ” means the National Health Service Act 1977; “the 1997 Act ” means the National Health Service (Primary Care) Act 1997 ; “accrediting authority” means, in relation to a service provider , the Primary Care Trust which is responsible, in accordance with regulation 4(3) and (4), for determining its application for approval; “accredited service provider” means a relevant service provider which is approved in accordance with these Regulations to provide out of hours services in a specified area; “assessing authority” has the meaning given to it by regulation 4(5); “existing service provider” means— a relevant service provider with which a doctor has an out of hours arrangement, which has been approved in accordance with paragraph 18A(9) of Schedule 2 to the General Medical Services Regulations ; or a relevant service provider which has an arrangement in connection with a pilot scheme under which personal medical services are performed outside the normal hours, otherwise than by the doctors named in the pilot scheme agreement as primarily responsible for the performance of those services; “General Medical Services Regulations” means the National Health Service (General Medical Services) Regulations 1992 ; “National Health Service Counter Fraud Service” means the service established by the Secretary of State to deal with inquiries and investigations relating to any allegation of fraud or corruption in the health service; “necessary quality standards” means the standards set out in the document entitled “Quality Standards in the Delivery of GP Out of Hours Services” published on 20th June 2002 ; “normal hours” means those days and hours specified in a pilot scheme agreement as being those days on which, and times at which, a doctor will normally be available to perform personal medical services; “out of hours arrangement” means an arrangement under paragraph 18A(2) of Schedule 2 to the General Medical Services Regulations; “pilot scheme agreement” means an agreement which constitutes, or is one of the agreements which together constitute, a pilot scheme under section 1(1) of the 1997 Act; “relevant service provider” means any service provider except— an individual medical practitioner; or a group of medical practitioners, whether in partnership or not, who provide out of hours services for each other under informal rota arrangements; “specified area” means— in relation to a relevant service provider, the geographical area in England for which it seeks approval, or in relation to an accredited service provider, the geographical area in England for which it is approved, to provide out of hours services. Meaning of out of hours period 3 1 The “out of hours period” has the meaning given to it in paragraphs (2) and (3). 2 In relation to the provision of general medical services under arrangements under section 29 of the 1977 Act, the “out of hours period” means— a the period beginning at 7pm on any day from Monday to Friday and ending at 8am on the following day; b the period between 1pm on Saturday and 8am on the following Monday; and c Good Friday, Christmas Day and bank holidays. 3 In relation to the provision of personal medical services under a pilot scheme agreement, the “out of hours period” means any period which does not fall within the normal hours. Application for approval 4 1 A relevant service provider shall make a written application for approval to any Primary Care Trust in whose area it proposes to provide out of hours services. 2 The application shall include the information and undertakings set out in the Schedule. 3 Where the specified area is entirely within the area of the Primary Care Trust to which the application is made, that Primary Care Trust shall be the accrediting authority. 4 Where the specified area includes the area of any other Primary Care Trust, the Primary Care Trust to which the application is made shall— a notify any other Primary Care Trust whose area is included in the specified area of the application; and b after consultation with any such Primary Care Trust, determine which Primary Care Trust shall be the accrediting authority. 5 The accrediting authority shall arrange with a Primary Care Trust whose area is not included in any part of the specified area (“the assessing authority”), for that Primary Care Trust to assess the application. 6 The relevant service provider shall provide the accrediting authority and the assessing authority with any further information they may reasonably require in relation to the application. 7 The assessing authority shall— a visit the relevant service provider and make such other enquiries as it considers necessary in order to assess the application; b prepare a written report on the application and forward it to the relevant service provider; c invite the relevant service provider to make written representations on the report within 28 days of receipt of the report; and d having considered any such representations, recommend to the accrediting authority whether or not approval should be granted, and if it recommends approval, whether approval should be granted— i under regulation 5(1)(a)(i) or (ii) or, as the case may be, (1)(b); ii in relation to the whole of the specified area or any part of it. 8 The accrediting authority shall, taking into account the recommendation of the assessing authority, approve the application in accordance with regulation 5 or refuse it in accordance with regulation 6. Approval 5 1 The accrediting authority shall approve the relevant service provider to provide out of hours services if it is satisfied— a in the case of an existing service provider— i that it meets the necessary quality standards; or ii in relation to any respect in which it is not meeting the necessary quality standards, that its proposals to do so are realistic and achievable; b in any other case, that the relevant service provider has the capacity to provide the service, and that its proposals to meet the necessary quality standards are realistic and achievable. 2 In approving the application, the accrediting authority shall also specify the geographical area in respect of which approval is granted. 3 If approval is granted under paragraph (1)(a)(i), it shall be for a period of up to three years, beginning with the date on which the decision to approve is notified to the relevant service provider. 4 If approval is granted under paragraph (1)(a)(ii) or (1)(b), it shall be for a period of up to twelve months beginning with the date on which the decision to approve is notified to the relevant service provider. 5 At the end of any period of approval granted under paragraph (4), the accrediting authority shall if it is satisfied that the relevant service provider is meeting the necessary quality standards, approve the relevant service provider for a period of three years, beginning with the date on which the decision under this paragraph is notified to the relevant service provider. Grounds for refusal 6 1 An accrediting authority may refuse an application if it is satisfied that a relevant service provider— a does not have the capacity to provide the service; or b does not meet the necessary quality standards and has not made satisfactory proposals to address the shortcomings. 2 When refusing an application, the accrediting authority shall notify the relevant service provider— a of its decision and the reasons for it (including any facts relied upon); b of its right of appeal under regulation 10; and c that it has 28 days from the date of the decision in which to appeal, and how to do so. Requirements with which an accredited service provider must comply 7 1 An accredited service provider shall comply with any reasonable request from the accrediting authority or the assessing authority for information about its provision of out of hours services. 2 An accredited service provider shall, on receipt of a written request from the assessing authority admit at all reasonable times for the purposes of assessing its provision of out of hours services a person authorised by the assessing authority for the purpose. 3 An accredited service provider shall comply with the undertakings set out in the Schedule. 4 An accredited service provider shall provide a report on its compliance with the necessary quality standards to— a the accrediting authority; b any other Primary Care Trust whose area is included in the specified area. 5 The report referred to in paragraph (4) shall be provided at such intervals as the accrediting authority may require, but in any case at least— a quarterly, where the accredited service provider is approved for a period of three years; and b monthly, where the accredited service provider is approved for a period of up to twelve months. Withdrawal of accreditation 8 1 Subject to paragraphs (2) and (3), an accrediting authority may withdraw the approval of an accredited service provider if— a the accredited service provider has persistently failed to meet any of the necessary quality standards; b the accredited service provider has failed to comply with any requirement of regulation 7; or c the accrediting authority considers that it is necessary to do so for the protection of members of the public or is otherwise necessary in the public interest. 2 Where an accrediting authority is considering withdrawing approval from an accredited service provider under paragraph (1), it shall— a give the accredited service provider notice in writing of its intention to withdraw approval and specifying, in a case to which paragraph (1)(a) applies, the respects in which the necessary quality standards are not being met; b inform the accredited service provider that it may within 28 days of the date of the notice, make written representations to the accrediting authority, to include, in a case to which paragraph (1)(a) applies, its proposals to address its shortcomings; and c inform the accredited service provider that it may request an oral hearing before the accrediting authority within the 28 day period mentioned in sub-paragraph (b). 3 In a case where paragraph (1)(a) applies, if, in the opinion of the accrediting authority any proposals provided in accordance with paragraph (2)(b), would, if implemented, rectify the shortcomings, the accrediting authority shall not withdraw approval for a period of six months, beginning with the date on which it notifies the accredited service provider that its proposals are accepted. 4 If no representations are received within the period specified in paragraph (2)(b), the accrediting authority shall notify the accredited service provider of its decision and the reasons for it (including any facts relied upon). 5 Subject to paragraph (6), if any representations are received in accordance with paragraph (2)(b), the accrediting authority must take them into account in reaching its decision, and shall then notify the service provider of its decision and the reasons for it (including any facts relied upon). 6 If the accredited service provider requests an oral hearing— a the hearing must take place before the accrediting authority reaches its decision; and b the accrediting authority must then notify the accredited service provider of its decision, and the reasons for it (including any facts relied upon). 7 When an accrediting authority notifies an accredited service provider of any decision under paragraph (4), (5) or (6), it shall also notify it— a of its right of appeal under regulation 10; and b that it has 28 days from the date of the decision in which to appeal, and how to do so. Suspension of approval 9 1 Subject to paragraph (7), if an accrediting authority is satisfied that it is necessary for the protection of members of the public or is otherwise in the public interest, it may suspend the approval of an accredited service provider— a while it decides whether or not to exercise its powers under regulation 8(1)(c) to withdraw approval; b where it has decided to withdraw approval under regulation 8(1)(c), but before that decision takes effect; or c pending an appeal of a decision under regulation 8(1)(c). 2 In a case falling within paragraph (1)(a), the accrediting authority must specify a period, which shall not exceed six months, as the period of suspension. 3 In a case falling within paragraph (1)(b) or (c), the suspension has effect until the expiry of any appeal period or, if the accredited service provider appeals under regulation 10, until the appeal has been disposed of. 4 Subject to paragraph (7), the accrediting authority may extend a period of suspension in a case falling within paragraph (1)(a), so long as the total period of suspension does not exceed six months. 5 The effect of suspension is that the accredited service provider is treated as not being an accredited service provider. 6 The accrediting authority may at any time revoke the suspension, and if it does so shall without delay inform the accredited service provider of its decision. 7 Where an accrediting authority is considering suspending the approval of an accredited service provider under paragraph (1), or extending a period of suspension under paragraph (4), it shall— a give the accredited service provider written notice of its intention to suspend its approval, and of the grounds of the proposed suspension; and b give the accredited service provider at least 24 hours written notice of the date and time of an oral hearing at which it may, if it wishes, make representations to the accrediting authority. 8 If the accredited service provider does not wish to have an oral hearing or does not attend the oral hearing, the accrediting authority shall notify the accredited service provider of its decision and the reasons for it (including any facts relied upon), and may suspend the approval with immediate effect. 9 If an oral hearing does take place, the accrediting authority shall take into account any representations made by the accredited service provider before it reaches its decision, and shall then notify the accredited service provider of its decision and the reasons for it (including any facts relied upon). 10 The accrediting authority may suspend the approval of the accredited service provider with immediate effect following an oral hearing. Appeal 10 1 A service provider or an accredited service provider (as the case may be) may appeal to the FHSAA against a decision mentioned in paragraph (2) by giving notice in writing to the FHSAA. 2 The decisions in question are— a a decision to refuse an application under regulation 6; and b a decision to withdraw the approval of an accredited service provider under regulation 8. 3 The appeal shall be by way of a redetermination of the accrediting authority’s decision. 4 On appeal the FHSAA may make any decision which the Primary Care Trust could have made. Notification 11 1 Where an accrediting authority— a refuses to approve a relevant service provider under regulation 6; b withdraws approval under regulation 8; or c suspends approval under regulation 9, it shall notify the persons and bodies specified in paragraph (2) of the matters set out in paragraph (3). 2 The persons and bodies specified for the purposes of paragraph (1) are— a the Secretary of State; b any Primary Care Trust whose area is included in the specified area; c any medical practitioner or party to a pilot scheme agreement who, to the knowledge of the Primary Care Trust, has made arrangements for the provision of out of hours services with the accredited service provider; d the local medical committee, being a committee recognised under section 44 of the 1977 Act as being representative of doctors in the area; e in a fraud case, the National Health Service Counter Fraud Service. 3 The matters referred to in paragraph (1) are— a the name and address of the relevant service provider or accredited service provider; b the date of, and a copy of the decision of the accrediting authority; c the name of an individual who may be contacted for further information. 4 The accrediting authority may also notify any person or body which it is satisfied is considering making arrangements with the relevant service provider for the provision of out of hours services or otherwise has a proper interest in receiving the information, of the matters set out in paragraph (3). 5 Where a decision is changed following an appeal under regulation 10, the accrediting authority shall notify the persons or bodies that were notified of the original decision of the later decision. Amendment of paragraph 18A of Schedule 2 to the General Medical Services Regulations 12 1 In Schedule 2 (terms of service) to the General Medical Services Regulations, paragraph 18A shall be amended in accordance with the followng provisions. 2 In sub-paragraph (1)— a before sub-paragraph (1)(a), insert— za “accredited service provider” and “necessary quality standards” have the meaning given to them by regulation 2 of the Out of Hours Regulations ; zb “Out of Hours Regulations” means the National Health Service (Out of Hours Medical Services) and National Health Service (General Medical Services) Amendment Regulations 2002 ; ; b in sub-paragraph (1)(c), at the end, add “referred to in sub-paragraph (2)(b).”. 3 For sub-paragraph (2) substitute— 2 Subject to the provisions of this paragraph, a doctor may, with the approval of the Primary Care Trust, make an arrangement to transfer his obligations under the terms of service during part or all of the out of hours period to— a an accredited service provider; or b a doctor who is included in the medical list. 2A An arrangement referred to in sub-paragraph (2)(a) shall— a terminate if the approval of the accredited service provider is withdrawn under regulation 8 of the Out of Hours Regulations; or b be suspended if the approval of the accredited service provider is suspended under regulation 9 of the Out of Hours Regulations. 2B Where an arrangement terminates or is suspended in accordance with sub-paragraph (2A), the provisions of paragraphs 18B and 18C shall not apply. 2C An arrangement referred to in sub-paragraph (2A)(b) shall terminate if the doctor with whom it is made ceases to be included in a medical list. . 4 In sub-paragraph (3), after “transferee doctors” insert “or accredited service providers”. 5 In sub-paragraph (6), after “on an obstetric list” add “, or the accredited service provider undertakes to provide a doctor who is on an obstetric list”. 6 In sub-paragraph (7)— a after sub-paragraph (7)(a) insert— aa the name and address of the accredited service provider; ; b in sub-paragraphs (c), (d) and (g), after each time that the words “transferee doctor” appear insert “or accredited service provider”. 7 In sub-paragraph (9)— a before sub-paragraph (9)(a) insert— za having regard to the overall provision of out of hours services in its area, that the arrangement is reasonable and will contribute to the efficient provision of such services in the area; ; b after sub-paragraph (9)(b) insert— bb that any arrangement referred to in sub-paragraph (2)(b) will be of an equivalent standard to an arrangement referred to in sub-paragraph (2)(a); bc that in the case of an arrangement referred to in sub-paragraph (2)(a), the practice premises are within the geographical area in respect of which approval is given under regulation 5 of the Out of Hours Regulations; . 8 In each of sub-paragraphs (14) and (15), after the words “has approved an out of hours arrangement” insert “with a transferee doctor”. Further amendment of Schedule 2 to the General Medical Services Regulations 13 1 Schedule 2 (terms of service) to the General Medical Services Regulations shall be further amended in accordance with the following provisions. 2 In paragraph 18B, in sub-paragraph (1) for “sub-paragraphs (a) to (d)” substitute “sub-paragraphs (za) to (d)”. 3 In paragraph 20(1)— a omit sub-paragraph (b); and b in sub-paragraph (c), omit the words “or such an organisation”. 4 Paragraph 22 (organisations providing deputy doctors) shall be omitted. Transitory provision 14 These Regulations and the General Medical Services Regulations shall apply to any relevant service provider which on or before 1 December 2002 makes an application for approval in accordance with regulation 4, as if that service provider were an accredited service provider in respect of the area specified in its application, until— a the date on which the application is approved under regulation 5; or b if the application is refused under regulation 6, the time allowed for any appeal has expired and no appeal has been submitted, or, where an appeal has been submitted, it has been determined by the FHSAA. Prescribed functions of Primary Care Trusts and Strategic Health Authorities 15 1 Each Primary Care Trust shall have the function of co-ordinating and facilitating the effective provision of out of hours general medical services in its area. 2 Each Strategic Health Authority shall have the function of co-ordinating and facilitating the effective provision of personal medical services provided out of hours in connection with pilot scheme agreements in its area. Amendment of the National Health Service (Functions of Strategic Health Authorities and Primary Care Trusts and Administration Arrangements) (England) Regulations 2002 16 1 The National Health Service (Functions of Strategic Health Authorities and Primary Care Trusts and Administration Arrangements) (England) Regulations 2002 shall be amended as follows. 2 In regulation 4 (functions relating to pilot schemes), in sub-paragraph (5)(b)— a at the end of sub-paragraph (i), the word “and” is omitted; and b at the end of sub-paragraph (ii), add— ; and the National Health Service (Out of Hours Medical Services) and National Health Service (General Medical Services) Amendment Regulations 2002 , regulation 15 (prescribed functions of Primary Care Trusts and Strategic Health Authorities). . Signed by authority of the Secretary of State for Health. John Hutton Minister of State, Department of Health 9th October 2002.