Ga. Comp. R. & Regs. R. 511-5-5-.07 - Approved Laboratories

(1) A private laboratory may seek approval from the Department to conduct newborn screening laboratory analysis by showing to the Department's satisfaction that it holds a valid Certificate of Accreditation or Certificate of Registration from CMS to perform high-complexity testing of newborns for the conditions listed in DPH Rule 511-5-5-.03(c) through (gg), and that it can perform consistent and reliable testing in accordance with the Rules of the Department.

(2) Approved laboratories performing analysis of a Georgia Newborn Screening Specimen Card shall conduct testing for all of the conditions listed in DPH Rule 511-5-5-.03(c) through (gg) and shall report the results of the testing to the appropriate newborn screening follow-up provider and submitter on the day that testing is completed.

(3) Approved laboratories shall retain the Cards according to the retention schedule in the current Georgia Newborn Screening Program Policy and Procedure Manual.

Notes

Ga. Comp. R. & Regs. R. 511-5-5-.07

O.C.G.A. §§ 31-2A-6; 31-12-5 through -7; 31-22-2.

Original Rule entitled "Approved Laboratories" adopted. F. May 13, 2014; eff. June 2, 2014. Amended: F. June 14, 2019; eff. July 15, 2019, as specified by the Agency. Amended: F. Nov. 29, 2021; eff. Dec. 29, 2021, as specified by the Agency.