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