Section 450.610  Criteria for Licensure

a)         Illinois licensure is required if clinical laboratories located outside of this state accept specimens referred by clinical laboratories located in Illinois.

b)         Out-of-state laboratories shall:

1)         Apply for an Illinois license in the same manner as facilities located in this State and pay the same licensee fees.

2)         Comply with all standards applicable to laboratories located in Illinois. In cases in which the standards of practice permitted in the state in which the laboratory is located are not in accordance with these standards, the out-of-state laboratories shall comply with these Illinois standards when serving licensed physicians, dentists, hospitals, blood banks, or clinical laboratories located in Illinois which are required to have a license or permit.

3)         Submit such reports as may be required, including but not limited to periodic reports of Illinois laboratories or blood banks referring specimens to the out-of-state laboratory.

4)         Accept evaluation specimens referred by the Illinois Department of Public Health or participate in evaluation of specimens in programs approved by the Department.

5)         If located in a state which licenses clinical laboratories, must hold a currently valid state license.

6)         Submit with each state license application, a copy of the laboratory's current license to conduct interstate laboratory services under the Federal Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578, effective October 31, 1988). Such license shall be used by the Department to determine compliance with this Act.

(Source:  Amended at 13 Ill. Reg. 11573, effective July 1, 1989)