Rule 111-8-10-.11 - Quality Control for Serology/Immunology(1) Serologic and immunologic tests on unknown specimens shall be run concurrently with a positive control serum of known titer or controls of graded reactivity plus a negative control in order to detect variations in reactivity levels. Controls for all test components shall be employed to ensure reactivity and uniform dosage. Test results shall not be reported unless the redetermined pattern of the control is obtained.(2) Each new lot of reagent shall be tested with one of known acceptable reactivity, or with known control sera before or concurrent with the new lot of reagent being placed into routine use.(3) Equipment, glassware, reagents, controls and techniques for tests for syphilis shall conform to manufacturers' specifications, where applicable.Ga. Comp. R. & Regs. R. 111-8-10-.11
O.C.G.A. § 31-22-1et seq.
Original Rule entitled "Quality Control for Serology/Immunology" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.