10.—(1) As soon as practicable after the end of the reporting year, the person responsible for management of a hospital blood bank shall submit an annual report to the Secretary of State, which shall—
(a)include a declaration that the hospital blood bank has in place appropriate systems to ensure compliance with the requirements of these Regulations; and
(b)provide details of the systems which it has in place to ensure such compliance.
(2) The person responsible for management of a hospital blood bank shall without delay notify the Secretary of State of any changes to the matters in respect of which evidence has been supplied pursuant to paragraph (1) which might affect compliance with the requirements of these Regulations.