(a) CLIA.
- (1) The laboratory must meet the conditions set forth under the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88), 42 U.S.C. § 263a, in order to be certified to perform testing on human specimens.
- (2) All laboratory services, including andrology and embryology, are subject to CLIA ’88.
- (3) A referenced laboratory may be used.
- (b) Rapid hormonal assays of estradiol and luteinizing hormones must be available seven (7) days per week.