The Blood Safety and Quality (Modification) Regulations 2009

• Citation: S.I. 2009/3307
• Sections: 2

Section 1 Citation, commencement, interpretation and duration

(1) These Regulations may be cited as the Blood Safety and Quality (Modification) Regulations 2009 and shall come into force on 16th December 2009.

(2) In these Regulations “the principal Regulations ” means the Blood Safety and Quality Regulations 2005 ;

(3) For the period from 16th December 2009 to 30th June 2010, the principal Regulations shall apply with the modifications specified in regulation 2 of these Regulations.

Section 2 Modification of regulation 7 of the principal Regulations

In regulation 7 of the principal Regulations (blood establishment requirements)—

(a) in paragraph (2)(d), before “apply” insert “except where paragraphs (2A) to (2C) applies,”;

(b) after paragraph (2) insert—

(2A) Where the conditions in paragraph (2B) are satisfied, a blood establishment shall apply the eligibility criteria for donors of blood and blood components in accordance with Part 3 of the Schedule (eligibility criteria for donors of whole blood and blood components) subject to the following modifications applying for the period in paragraph (2C)—

(a) in paragraph 1.2 (haemoglobin levels in donors blood), “125” is modified to “120” and “135” is modified to “130”; and

(b) in paragraph 2.2.1 (duration of deferral period), in relation to the entry for “Flu-like illness” the period in column 2 is modified from “2 weeks” to “1 week”.

(2B) The conditions are that—

(a) the latest “HPA Weekly National Influenza Report” published by the Health Protection Agency states that—

(i) the weekly GP consultation rate for flu-like illness is equal to or greater than 200 cases for every 100,000 persons in the UK population; or

(ii) the weekly estimated incidence of flu-like illness is equal to or greater than 200,000 new cases a week; and

(b) the Secretary of State—

(i) is satisfied that there is a serious risk of shortage or an actual risk of shortage in the supply of blood and blood components directly due to the A(H1N1) influenza pandemic; and

(ii) has advised the blood establishment that the eligibility criteria for donors of whole blood and blood components may be modified in accordance with paragraph (2A).

(2C) For the purpose of paragraph (2A) the period shall begin on the date that the conditions in paragraph (2B) are satisfied and shall end on the date following the date on which the blood establishment has notified the Secretary of State that stock levels of blood and blood components for all groups are equal to or exceed 5 days supply.