Use of reagents and other materials
17.—(1)  An approved test provider must ensure that reagents (including quality control materials) that are used in the course of providing a service involving approved tests are —
(a)registered or provisionally approved by the Health Sciences Authority under the Health Products Act (Cap. 122D);
(b)stored and used under the conditions specified by the manufacturer;
(c)handled in a manner that minimises deterioration or exposure to the environment;
(d)not used beyond the shelf life or expiry date, whichever is earlier; and
(e)labelled with the date of opening and shelf life once opened for use.
(2)  For each reagent that is used, the approved test provider must ensure that the following information is recorded and retained for a period of 2 years after the date it is first opened for use:
(a)the lot number;
(b)the expiry date;
(c)the personnel who prepared the reagent.