19A.—(1) This regulation applies to and in relation to the conduct of any simple in vitro diagnostic test that is incidental to the provision of a blood banking service by a licensee.
(2) The licensee must ensure that any simple in vitro diagnostic test on a specimen or an individual must be conducted —
(a)
using testing material, where —
(i)
the earlier of the following dates has not passed:
(A)
the expiry date of the testing material;
(B)
the shelf life of the testing material; and
(ii)
the personnel who administers the test does not suspect or have any reason to suspect that the testing material is no longer fit for use; and
(b)
in accordance with the instructions specified by the manufacturer of the testing material.
(3) The licensee must ensure that any testing material that may be used to conduct any simple in vitro diagnostic test is stored under the conditions, and handled in the manner, specified by the manufacturer of the testing material so as to lower the risk of contamination, unnecessary exposure of the testing material to the environment and early deterioration of the testing material.