The National Health Service (General Medical Services Contracts) (Scotland) Regulations 2018

Meaning of controller etc.

64A

For the purposes of this Part—

• “controller” has the same meaning as in Parts 5 to 7 of the Data Protection Act 2018 (see section 3(6) and (14) of that Act);

• “data protection officer” means a person designated as a data protection officer under the data protection legislation;

• “personal data” and “processing” have the same meaning as in Parts 5 to 7 of the Data Protection Act 2018 (see section 3(2), (4) and (14) of that Act).

Requirement to provide vaccination services

20A

• (1) A contract must include terms which have the same effect as paragraph 1 of schedule 2A.

• (2) A contract which includes the provision of any vaccination services must—

• (a) in relation to all such services, contain a term which has the same effect as that specified in paragraph 2 of schedule 2A; and

• (b) in relation to each such service which the contractor is required to provide, contain terms which have the same effect as those specified in schedule 2A which are relevant to that service.

Services generally

Additional obligations in relation to practice premises

Certificates

Finance

Fees and charges

Arrangements on termination

Other contractual terms

Implied contract terms

Transitional arrangements for vaccination and immunisation services

33A

• (1) Where on 17 October 2021 a contract included a requirement to provide the vaccinations and immunisations additional service, the childhood vaccinations and immunisations additional service, or both services in accordance with schedule 1—

• (a) the Health Board may serve notice to the contractor requiring the contractor to continue to provide the vaccinations and immunisations additional service, the childhood vaccinations and immunisations additional service, or both services, for a period specified in the notice;

• (b) despite the revocation of paragraphs 4 and 5 of schedule 1, where the Health Board has given notice under sub-paragraph (a), paragraphs 4 and 5 of schedule 1 continue to have effect in relation to that contract on and after 18 October 2021 as they had effect immediately before that date, until the end of the period specified in the notice; and

• (c) where the Health Board has given notice under sub-paragraph (a), in relation to that contract, the definition of “additional services” in regulation 3(1) is to be read as including “vaccinations and immunisations” and “childhood vaccinations and immunisations”.

• (2) A notice served by the Health Board under paragraph (1)(a) must—

• (a) be served not later than 1 December 2021; and

• (b) specify a period which ends no later than 1 April 2022.

• (3) A notice served by the Health Board under sub-paragraph (1)(a) must list all of the vaccinations and immunisations which the contractor is required to provide as a consequence of the notice, as of the date of the notice.

• (4) A letter stating that the contractor is to continue to provide the vaccinations and immunisations additional service, the childhood vaccinations and immunisations additional service, or both services, for a period specified in the letter, which is sent by the Health Board to the contractor’s official correspondence address (specified in accordance with regulation 14) before the coming into force of this regulation is deemed to have the same effect as a notice under sub-paragraph (1)(a), if it complies with the requirements of this regulation.

• (5) The Health Board may reduce the duration of the period specified in a notice served under paragraph (1)(a) by serving the contractor with a further notice.

• (6) Where the contractor is required to provide vaccination services in accordance with schedule 2A, the contractor’s obligation to provide services in accordance with a notice served under paragraph (1)(a) will end on the date on which the contractor’s obligation to provide vaccination services begins.

• (7) Subject to paragraph (9), prior to the contractor’s duty to provide vaccination and immunisation services under this regulation ceasing the Health Board and the contractor must discuss how to inform patients of the change to how vaccinations and immunisations will be delivered to them.

• (8) Subject to paragraph (9), if the Health Board requests it, the contractor must inform the contractor’s patients of the change to how vaccinations and immunisations will be delivered to them by—

• (a) placing a notice in the practice’s waiting room; and

• (b) including the information in the practice leaflet.

• (9) Paragraphs (7) and (8) do not apply where the contractor is ceasing to provide the vaccinations and immunisations services under this regulation but will immediately begin providing vaccination services in accordance with schedule 2A.

SCHEDULE2A — VACCINATION SERVICES

Requirement to provide vaccination services

1

• (1) Subject to the provisions of this paragraph, where the Health Board is satisfied that by reason of distance, inadequacy of means of communication, or other exceptional circumstances, the Health Board will have serious difficulties in delivering any vaccination service to the contractor’s patients, the Health Board may require the contractor to provide those services to the contractor’s patients until further notice.

• (2) The Health Board may not require a contractor to deliver services in accordance with sub-paragraph (1) unless it has first consulted the area medical committee regarding the matter.

• (3) The Health Board may not require a contractor to deliver a vaccination service in accordance with sub-paragraph (1) unless the contractor was, immediately prior to the Health Board notifying the contractor of the requirement, offering that particular vaccination service to the contractor’s patients as part of an additional service, an enhanced service or as part of a transitional arrangement under regulation 33A.

• (4) Nothing in sub-paragraph (3) prevents the contractor and the Health Board from agreeing that the contractor will deliver a vaccination service in accordance with this schedule.

• (5) The Health Board must give a contractor reasonable notice that the contractor is required to provide a vaccination service and must, if the contractor is no longer to be required to provide a service, give reasonable notice that the requirement to provide the service is to be discontinued.

• (6) A notice served by the Health Board under sub-paragraph (1) must list all of the vaccinations and immunisations which the contractor is required to provide as a consequence of the notice, as of the date of the notice.

• (7) A contractor which is required to provide a vaccination service may request that the Health Board reviews that requirement.

• (8) A review request under sub-paragraph (7) may not be made by a contractor—

• (a) unless the contractor has been providing the vaccination service for a period of not less than 6 months; and

• (b) the contractor has not made a review request in respect of the service in the 6 months prior to its present review request.

• (9) Where it receives a review request, the Health Board must—

• (a) acknowledge the review request within 30 days,

• (b) consider any comments which the contractor has provided to accompany the review request;

• (c) within 3 months of receiving the review request, provide the contractor with either—

• (i) a written statement of reasons as to why the contractor is required to continue to provide the vaccination service; or

• (ii) a written plan for the discontinuation of the requirement that the contractor provide the vaccination service which includes the date on which the requirement will end.

• (10) When considering whether it will have serious difficulty in delivering a vaccination service or serving notice under sub-paragraph (1) or when considering a review request submitted under sub-paragraph (7), the Health Board must comply with any directions given by the Scottish Ministers in relation to these matters.

• (11) For the purposes of this paragraph, a “vaccination service” comprises—

• (a) offering and administering to patients all doses necessary to complete the recommended course of vaccination for a single disease, or in the case of a combination vaccine which protects the patient against multiple diseases, all doses necessary to complete the recommended course of vaccination for all of the diseases for which that combination vaccine provides protection; and

• (b) providing appropriate information and advice to patients regarding the course of vaccination offered.

Conditions which apply to all vaccination services

2

The contractor must, in relation to each vaccination service which they provide, provide such facilities and equipment as are necessary to enable it to properly perform that service.

Vaccinations and immunisations

3

• (1) A contractor who is required in accordance with paragraph 1 to provide vaccinations and immunisations to their patients must comply with the requirements in sub-paragraphs (2) and (3).

• (2) The contractor must—

• (a) offer to provide to patients all vaccinations and immunisations (excluding childhood vaccinations and immunisations) of a type and in the circumstances for which a fee is provided for in directions given under section 17M of the Act;

• (b) where a patient has informed the contractor that the patient intends to travel outside of the United Kingdom, offer to provide the patient with all vaccinations and immunisations of a type and in circumstances for which a fee is provided for in directions given under section 17M of the Act;

• (c) provide appropriate information and advice to patients about such vaccinations and immunisations;

• (d) record in the patient’s record kept in accordance with paragraph 68 of schedule 6 any refusal of the offers referred to in sub-paragraph (a) and (b);

• (e) where an offer referred to in sub-paragraphs (a) and (b) is accepted, administer the vaccinations and immunisations and include in the patient’s record kept in accordance with paragraph 68 of schedule 6—

• (i) the patient’s consent to vaccination or immunisation, or the name of the person who gave consent to the vaccination or immunisation and that person’s relationship to the patient;

• (ii) the batch numbers, expiry date and title of the vaccine;

• (iii) the date of administration;

• (iv) in a case where two vaccines are administered in close succession, the route of administration and the injection site of each vaccine;

• (v) any contraindications to the vaccination or immunisation; and

• (vi) any adverse reactions to the vaccination or immunisation.

• (3) The contractor must ensure that all staff involved in administering vaccines are trained in the recognition and initial treatment of anaphylaxis.

Childhood vaccinations and immunisations

4

• (1) A contractor who is required in accordance with paragraph 1 to provide childhood vaccinations and immunisations to their patients must comply with the requirements in sub-paragraphs (2) and (3).

• (2) The contractor must—

• (a) offer to provide to children all vaccinations and immunisations of a type and in the circumstances for which a fee is provided for in directions given under section 17M of the Act;

• (b) where a patient has informed the contractor that the patient intends to travel outside of the United Kingdom, offer to provide the patient with all vaccinations and immunisations of a type and in circumstances for which a fee is provided for in directions given under section 17M of the Act;

• (c) provide appropriate information and advice to patients and, where appropriate, their parents, about such vaccinations and immunisations;

• (d) record in the patient’s record kept in accordance with paragraph 68 of schedule 6 any refusal of the offers referred to in sub-paragraph (a) and (b);

• (e) where an offer referred to in sub-paragraphs (a) and (b) is accepted, administer the vaccinations and immunisations and include in the patient’s record kept in accordance with paragraph 68 of schedule 6—

• (i) the patient’s consent to vaccination or immunisation, or the name of the person who gave consent to the vaccination or immunisation and that person’s relationship to the patient;

• (ii) the batch numbers, expiry date and title of the vaccine;

• (iii) the date of administration;

• (iv) in a case where two vaccines are administered in close succession, the route of administration and the injection site of each vaccine;

• (v) any contraindications to the vaccination or immunisation; and

• (vi) any adverse reactions to the vaccination or immunisation.

• (3) The contractor must ensure that all staff involved in administering vaccines are trained in the recognition and initial treatment of anaphylaxis.

Supplementary vaccinations and immunisations

5

• (1) Where directions given under section 17M of the Act have provided for a fee to be payable for the provision of a vaccination or immunisation of a specified type in specified circumstances, but those directions have not specified that the vaccination or immunisation is to form part of the vaccinations and immunisations described by paragraph 3 or the childhood vaccinations and immunisations described by paragraph 4, that vaccination or immunisation is to be considered a “supplementary vaccination and immunisation”.

• (2) Subject to paragraph 1, a Health Board may require a contractor to provide to their patients any of the supplementary vaccinations and immunisations.

• (3) A contractor who is required to provide supplementary vaccinations and immunisations to their patients must comply with the requirements in sub-paragraphs (4) and (5).

• (4) The contractor must—

• (a) offer to provide to patients all such vaccinations and immunisations which the Health Board may specify;

• (b) provide appropriate information and advice to patients about such vaccinations and immunisations or, where appropriate, if the patient is a child, provide this information and advice to their parents;

• (c) record in the patient’s record kept in accordance with paragraph 68 of schedule 6 any refusal of the offer referred to in sub-paragraph (a);

• (d) where the offer is accepted, administer the vaccinations and immunisations and include in the patient’s record kept in accordance with paragraph 68 of schedule 6—

• (i) the patient’s consent to vaccination or immunisation, or the name of the person who gave consent to the vaccination or immunisation and that person’s relationship to the patient;

• (ii) the batch numbers, expiry date and title of the vaccine;

• (iii) the date of administration;

• (iv) in a case where two vaccines are administered in close succession, the route of administration and the injection site of each vaccine;

• (v) any contraindications to the vaccination or immunisation; and

• (vi) any adverse reactions to the vaccination or immunisation.

• (5) The contractor must ensure that all staff involved in administering vaccines are trained in the recognition and initial treatment of anaphylaxis.

Anaphylaxis training

7A

The contractor must ensure that all registered medical practitioners and registered nurses routinely employed or engaged by the contractor are trained in the recognition and initial treatment of anaphylaxis.

Infection control

Duty of co-operation in relation to additional , enhanced services and vaccination services

1

The name of the contractor.

2

In the case of a contract with a partnership—

• (a) whether or not it is a limited partnership; and

• (b) the names of all the partners and, in the case of a limited partnership, their status as a general or limited partner.

3

In the case of a contract with a company—

• (a) the names of the directors, the company secretary and the members of that company; and

• (b) the address of the company’s registered office.

4

In the case of a contract with a limited liability partnership—

• (a) the names of all the members; and

• (b) the address of the registered office of the limited liability partnership.

5

The full name of each person performing services under the contract.

6

In the case of each health care professional performing services under the contract the health care professional’s professional qualifications.

7

Whether the contractor undertakes the teaching or training of health care professionals or persons intending to become health care professionals.

8

The contractor’s practice area, by reference to a map, plan or postcode.

9

The address of each of the practice premises.

10

The contractor’s telephone number and the address of the contractor’s website (if any).

11

Where the contractor offers its registered patients an online service in accordance with paragraph 72 of schedule 6, the website address where such patients can access and use the service and guidance on how such patients can access and use that service.

12

Whether the practice premises have suitable access for all disabled patients and, if not, the alternative arrangements for providing services to such patients.

13

How to register as a patient.

14

The right of patients to express a preference of practitioner in accordance with paragraph 15 of Schedule 6 and the means of expressing such a preference.

15

The services available under the contract.

16

The opening hours of the practice premises and the method of obtaining access to services throughout the core hours. Information on access to services should include any usual periods of consultation time provided during the opening hours.

17

The criteria for home visits and the method of obtaining such a visit.

18

• (1) Details of—

• (a) the out of hours period as set out in sub-paragraph (2);

• (b) the arrangements for services in the out of hours period; and

• (c) how the patient may contact such services.

• (2) The out of hours period is—

• (a) the period beginning at 1830 hours on any day from Monday to Thursday and ending at 0800 hours on the following day;

• (b) the period beginning 1830 hours on Friday and ending at 0800 hours on the following Monday; and

• (c) Christmas Day, New Year’s Day and any other public or local holiday.

19

If the services in paragraph 18 are not provided by the contractor, the fact that the Health Board referred to in paragraph 27 is responsible for commissioning the services.

19A

The details of the arrangements for the delivery of vaccinations and immunisations (and childhood vaccinations and immunisations) to the contractor’s patients.

20

The telephone number of NHS 24 and details of the NHS 24 website.

21

The method by which patients are to obtain repeat prescriptions.

22

If the contractor is a dispensing contractor the arrangements for dispensing prescriptions.

23

How patients may make a complaint or comment on the provision of service.

24

The rights and responsibilities of the patient, including keeping appointments.

25

The action that may be taken where a patient is violent or abusive to the contractor, the contractor’s staff, persons present on the practice premises or in the place where treatment is provided under the contract or other persons specified in paragraph 18(2) of Schedule 6.

26

Details of who has access to patient information (including information from which the identity of the individual can be ascertained) and the patient’s rights in relation to disclosure of such information.

27

The name, address and telephone number of the Health Board which is a party to the contract and from whom details of primary medical services in the area may be obtained.

Health Board support for contractors

18A

• (1) A contract must include terms which have the same effect as schedules 2B (community treatment and care services) and 2C (pharmacotherapy services).

• (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (3) Any support which the contractor receives from a pharmacist independent prescriber supplied by the Health Board in connection with dispensing services which the contractor provides (under paragraph 44 of schedule 6) is not to be treated as support for the provision of pharmacotherapy services.

Additional services

Opt outs of additional services

Requirement to provide vaccination services

Services generally

Additional obligations in relation to practice premises

Certificates

Finance

Fees and charges

Arrangements on termination

Other contractual terms

Implied contract terms

Duty to co-operate with Health Board support for contractors

10A

Where a Health Board is providing support to a contractor under paragraph 1(1) of schedule 2B (community treatment and care services) or paragraph 1(1) of schedule 2C (pharmacotherapy services), the contractor must—

• (a) co-operate with the Health Board to allow the Health Board to provide, in the case of support provided under paragraph 1(1) of—

• (i) schedule 2B, community treatment and care services, and

• (ii) schedule 2C, pharmacotherapy services,

• (b) comply in core hours with any reasonable request for information from the Health Board to the contractor in relation to such service provision, and

• (c) provide to its patients any aspect of—

• (i) community treatment and care services which the Health Board is to provide under paragraph 1(1) of schedule 2B, and

• (ii) pharmacotherapy services which the Health Board is to provide under paragraph 1(1) of schedule 2C,

if the patient requires the services immediately to prevent injury or worsening of their clinical condition and Health Board provision is not immediately available.

Practice websites

74A

• (1) The contractor is required to publish a website for its practice which—

• (a) displays the information specified in schedule 8,

• (b) is capable of providing the online services described by paragraph 72 (patient online appointment services).

• (2) The contractor must make reasonable efforts to maintain the accuracy of the information on the website.

• (3) Where the website is not operational, the contractor must inform the Health Board.

Inquiries about prescriptions and referrals

Provision of information to a medical officer etc.

Annual return and review

Notifications to the Health Board

Notice provisions specific to a contract with persons practising in a limited liability partnership

Notification of deaths

Notifications to patients following variation of the contract

Entry and inspection by the Health Board

SCHEDULE 2B — Community treatment and care services

1

• (1) The Health Board must provide the contractor with support by providing community treatment and care services.

• (2) The Health Board must act in accordance with any directions given by the Scottish Ministers in relation to the extent and manner of the community treatment and care services which it must provide in terms of sub-paragraph (1).

• (3) Subject to the following provisions of this paragraph, where the Health Board is satisfied that by reason of distance, inadequacy of means of communication, or other exceptional circumstances, the Health Board will have serious difficulties in providing the community treatment and care services which it must provide in terms of sub-paragraph (1), or part of those services, to the contractor’s patients, the Health Board may agree with the contractor that the contractor will provide those community treatment and care services or a specific part of those services (“agreed CTAC services”), to their patients, from a specified date.

• (4) The Health Board must, after reaching agreement with the contractor under sub-paragraph (3), serve notice on the contractor, which notice must—

• (a) list the agreed CTAC services, and

• (b) set out the date from which the contractor will provide those services.

• (5) No notice may be served under sub-paragraph (4) unless the Health Board has first consulted the area medical committee regarding the matter.

• (6) In the event that either the Health Board or the contractor wishes the notice served under sub-paragraph (4) to be withdrawn, the Health Board will withdraw the notice and the contractor will cease to provide the agreed CTAC services to its patients—

• (a) within a timescale agreed between the Health Board and the contractor, or

• (b) after a period of 6 months from withdrawal of the notice,

whichever date is earlier.

• (7) Where the contractor is to cease to provide the agreed CTAC services to its patients, the contractor must comply during core hours with any reasonable request from the Health Board for information in relation to the provision by the contractor of the agreed CTAC services.

• (8) The Health Board must comply with any directions given by the Scottish Ministers in relation to the matters provided for in sub-paragraph (3).

SCHEDULE 2C — Pharmacotherapy services

1

• (1) The Health Board must provide the contractor with support by providing pharmacotherapy services.

• (2) The Health Board must act in accordance with any directions given by the Scottish Ministers in relation to the extent and manner of the pharmacotherapy services which it must provide in terms of sub-paragraph (1).

• (3) Subject to the following provisions of this paragraph, where the Health Board is satisfied that by reason of distance, inadequacy of means of communication, or other exceptional circumstances, the Health Board will have serious difficulties in providing the pharmacotherapy services which it must provide in terms of sub-paragraph (1), or part of those services, to the contractor’s patients, the Health Board may agree with the contractor that the contractor will provide those pharmacotherapy services or a specific part of those services (“agreed pharmacotherapy services”), to their patients, from a specified date.

• (4) The Health Board must, after reaching agreement with the contractor under sub-paragraph (3), serve notice on the contractor, which notice must—

• (a) list the agreed pharmacotherapy services, and

• (b) set out the date from which the contractor will provide those services.

• (5) No notice may be served under sub-paragraph (4), unless the Health Board has first consulted the area medical committee regarding the matter.

• (6) In the event that either the Health Board or the contractor wishes the notice served under sub-paragraph (4) to be withdrawn, the Health Board will withdraw the notice and the contractor will cease to provide the agreed pharmacotherapy services to its patients—

• (a) within a timescale agreed between the Health Board and the contractor, or

• (b) after a period of 6 months from withdrawal of the notice,

whichever date is earlier.

• (7) Where the contractor is to cease to provide the agreed pharmacotherapy services to its patients, the contractor must comply during core hours with any reasonable request from the Health Board for information in relation to the provision by the contractor of the agreed pharmacotherapy services.

• (8) The Health Board must comply with any directions given by the Scottish Ministers in relation to the matters provided for in sub-paragraph (3).