Section 450.5  Scope and Applicability

a)         This Part provides regulatory oversight of all entities certified pursuant to 42 CFR 493, that perform analysis of human specimens for health assessment or to diagnose, prevent or treat disease.

b)         All certified CLIA laboratories will be regulated as set forth in 42 CFR 493 and described in the State Operations Manual (Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services), issued by the Department of Health and Human Services.

c)         Clinical Laboratory

1)         The clinical laboratory shall maintain certification status in good standing as required by CLIA Law.

2)         A clinical laboratory shall examine specimens only at the request of:

A)        A licensed physician,

B)        A licensed dentist,

C)        A licensed podiatric physician,

D)        A licensed optometrist,

E)        A licensed physician assistant,

F)         A licensed advanced practice registered nurse,

G)        An authorized law enforcement agency or, in the case of blood alcohol, at the request of the individual for whom the test is to be performed in compliance with Sections 11-501 and 11-501.1 of the Illinois Vehicle Code,

H)        A genetic counselor with the specific authority from a referral to order a test or tests pursuant to subsection (b) of Section 20 of the Genetic Counselor Licensing Act, or

I)         A licensed pharmacist in accordance with Section 43.5 of the Pharmacy Practice Act.  (Section 7-101 of the Act)

d)         Physicians, corporations, individuals, local health authorities, and others that intend to conduct clinical tests on human specimens for health assessments or to diagnose, prevent or treat disease shall obtain certification status from the Centers for Medicare and Medicaid Services in accordance with CLIA Law. Health screening activities under Section 2-120 of the Act may be conducted by a clinical laboratory at the laboratory location listed on the CLIA certificate; however, health screening events shall be conducted in accordance with Sections 450.1300, 450.1310, and 450.1330.

(Source:  Amended at 50 Ill. Reg. 8297, effective May 26, 2026)