Regulation 20A

[F1SCHEDULE 2AVACCINATION 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 [F2of 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.]