8 Amendment of Schedule 1 to the principal Regulations
1 Schedule 1 (Additional services) shall be amended as provided in the following paragraphs.
2 For paragraph 4, substitute—

“4 Vaccines and Immunisations
1 This paragraph applies to a contractor whose contract includes the provision of vaccines and immunisations but does not apply in the case of the provision of—
(a) childhood immunisations; and
(b) the combined Haemophilius influenza type B and Meningitis C booster vaccine.
2 A contractor must comply with the requirements in sub-paragraphs (3) and (4).
3 The contractor must—
(a) offer to provide patients, all vaccines and immunisations (other than those mentioned in sub-paragraph (1)(a) and (b)) of the type and in the circumstances which are set out in the GMS Statement of Financial Entitlements;
(b) taking into account the individual circumstances of the patient, consider whether immunisation ought to be administered by the contractor or other health professional or a prescription form ought to be provided for the purpose of the patient self-administering immunisation;
(c) provide appropriate information and advice to patients about such vaccines and immunisation;
(d) record in the patient’s record, any refusal of the offer referred to in paragraph (3)(a);
(e) where the offer is accepted and immunisation is to be administered by the contractor or other health professional, include in the patient’s record—
(i) the patient’s consent to immunisation or the name of the person who gave consent to 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 the case where two vaccines are administered by injection, in close succession, the route of the administration and the injection site of each vaccine;
(v) any contraindications to the vaccine; and
(vi) any adverse reaction to the vaccine; and
(f) where the offer is accepted and the immunisation is not to be administered by the contractor or other health professional, issue a prescription form for the purpose of self-administration by the patient.
4 The contractor must ensure that all staff involved in the administration of immunisations are trained in the recognition and initial treatment of anaphylaxis.
5 In this paragraph “patient’s record” means the record which is kept in accordance with paragraph 68 of Schedule 5.”

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3 In paragraph 5—
(a) in the heading for that paragraph and in sub-paragraph (1), for “childhood vaccinations and immunisations”, substitute “childhood vaccines and immunisations”;
(b) for sub-paragraph (2)(a), substitute “offer to provide to children, all vaccines and immunisations of the type and in the circumstances which are set out in the GMS Statement of Financial Entitlements”;
(c) in sub-paragraph (2)(b), for “vaccinations” substitute “vaccines”; and
(d) in sub-paragraph (2)(d)—
(i) omit “vaccinations and”;
(ii) in sub-paragraph (i), omit “vaccination or”; and
(iii) in sub-paragraphs (v) and (vi), in each place “vaccination or immunisation” occurs, substitute “vaccine”.