Protocol For Conducting The Health Screening Events In The State Of Illinois
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3Health Screening Events in the State of Illinois
The state of Illinois requirements for health screening is specified under title 77 of the Public Health.
Please note one change that affects the previously required class Permit III for laboratories performing health screenings
for profit. The application for Class III Permits for Laboratories was Repealed at 14 Ill. Reg. 2360, effective January 26,
1990, and is no longer required.
The state of Illinois follows the Federal Clinical Laboratory Improvement Act (CLIA) for laboratory licensing. Facilities
operating in our state or receiving specimens from other states to be tested in our state, must have a current CLIA
certificate that is appropriate, valid, and in good standing.
All laboratories interested in conducting health screening events in the state of Illinois must have the correct endorsement
for temporary testing added to their CLIA certificate. (For questions regarding CLIA certificate temporary testing, out of
state laboratories must call their state CLIA program).
Please note that the state of Illinois laboratory requirements, are to follow the active Illinois Clinical Laboratory and
Blood Bank Act of the Title 77: Public Health Admin Code Part 450 and failure can lead to penalties or fines.
Under the code, the health screening tests that are allowed are:
1) Blood total cholesterol testing and 2) blood glucose testing. Both tests are to be conducted by the finger stick method.
These two allowed waived tests are exempt from the required (authorized person) state law and can be ordered by any
private individual, as long as the tests performed are conducted following an approved protocol by a licensed physician.
AGENCY NOTE: Although there are only two allowed tests at present, the Department accepts requests for
additional tests for review. Please note that approval to perform any additional test(s), can be revoked at any time
as our current state laws are being reviewed.
Reporting and Notification
All health screening entities shall file a health screening protocol with the Department.
All test performed must be under the category classifies as CLIA waived.
All health screening entities shall notify the Department of all personnel anticipated to conduct any health screening event
including name, professions, training background, street address, city, ZIP code at least seven days prior to any health
screening event.
All health screening entities are required to notify the Department of all health screening sites including street address,
city, ZIP code and any other identifying data that are available at least seven days prior to any health screening event. The
notification is to be e-mailed to our office.
Illinois Department of Public Health
CLIA Laboratory Certification Program
525 W. Jefferson St., Fourth Floor
Springfield, IL 62761
Phone: 217-782-6747
Fax: 217-782-0382
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