Section 450.30  Laboratories Covered

The following are required to be licensed by DPH:

a)         All clinical laboratories and blood banks located within the State of Illinois.  This includes facilities that issue reports resulting from laboratory examinations, but do not perform laboratory examinations at that facility. (See Section 2-103 of the Act.)

b)         Laboratories located in hospitals licensed under the Hospital Licensing Act that are not operated by the governing authority of the hospital, including laboratories operating under a lease arrangement with another person or entity.

c)         Laboratories outside of Illinois receiving specimens referred from laboratories located in Illinois shall be certified under CLIA Law, or certified by, and in good standing with, their state laboratory program.

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)