TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER d: LABORATORIES AND BLOOD BANKS
PART 450 ILLINOIS CLINICAL LABORATORIES CODE
SECTION 450.1300 HEALTH SCREENING AND APPROVED HEALTH SCREENING TESTS


 

Section 450.1300  Health Screening and Approved Health Screening Tests

 

a)         All health screenings shall be conducted under a protocol approved by a physician licensed to practice medicine in all its branches that includes, but is not limited to, provisions concerning disclosure of the purpose and limitations of the screening tests to test subjects, proper collection of samples, and administration of tests, including staffing, staff training and equipment monitoring, adequate procedures for protecting the confidentiality of test subjects and test results, and appropriate referrals for medical attention."Health Screening" means the performance of any of the following tests for the purpose of assessing a phase of the general state of health of human subjects (Section 2-120(a)2-102.1 of the Act):

 

1)         Blood total cholesterol testing by finger stick method, and

 

2)         Blood glucose testing by finger stick method.

 

b)         Health screening protocols in this Part shall be exempt from the provisions of Sections 7-101 and 7-102 of the Act.  (Section 2-120(b) of the Act)Health screening activities may only be conducted by the following entities:

 

1)         Laboratories which only perform health screenings on a not-for-profit or free-of-charge basis.  Not-for-profit or free-of-charge basis means screenings performed for a fee calculated to recover the actual cost of the test material and equipment and direct labor costs, excluding any cost associated with test interpretation or other administrative costs or with no direct cost to the recipient;

 

2)         Licensed or permitted laboratories; and

 

3)         Licensed Hospital laboratories which are exempt from regulation under the Act and not precluded from such activities under the Hospital Licensing Act. (Section 2-102.1(a)(3) and (b) of the Act)

 

c)         Any entities which conduct more than one health screening event per calendar year shall file established protocols with the Department in accordance with the provisions of this Subpart.  A health screening event, as used in this Section, shall mean any day or continuous series of days not exceeding five on which health screening activities are conducted in the same location other than the principal location of the laboratory such as a health fair.  Tests listed as health screening tests may be conducted at the principal location of the laboratory without the protocol required by this Subpart.  (Section 2-102.1(a)(2) of the Act). Class III permit laboratories must submit a protocol regardless of where the health screening is conducted.

 

cd)       AGENCY NOTE:  Health screening tests shallshould not be used as diagnostic tests.

 

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