Section 450.35  Testing Limitations For Exempt, Permit and Licensed Laboratories

This Section explains the tests as defined in Section 2-117 of the Act which can be performed by each of the laboratories regulated by the Act.

a)         Exempt Laboratories as defined in Section 1-103(c) of the Act may perform the following tests:

1)         Specific tests and test procedures permissible are the following:

A)        Urinalysis measured by the use of a chemically impregnated strip (dipstick) or tablet;

B)        Hematocrit by centrifugation;

C)        Occult blood;

D)        Urine pregnancy testing (semi-quantitative chorionic gonadotropin);

E)         Hemoglobin;

F)         Red Blood Cell (RBC) sickle cell screen using dithionite, sodium hydrosulfite;

G)        Wet mounts for Yeast or Trichomonas;

H)        Blood cholesterol;

I)          Blood glucose;

J)         Erythrocyte protoporphyrin using a hematofluorometer;

K)        Screening for drugs of abuse by latex agglutination or any other method which meets the simple test definition;

L)         Gonorrhea limited to cultures for growth or no growth, oxidase and lactidase, Gram stain;

M)       Microscopic examination of pinworm preparation; and

N)        Strep Screening Tests: Rapid group A strep antigen tests. (Section 1-103(c) of the Act)

2)         Any test performed (i.e., conducted and interpreted) by a physician, podiatrist or dentist for the benefit of his or her patients. (Section 1-103(c) of the Act);

3)         Any tests and test procedures approved by the United States Food and Drug Administration for over the counter sale.

4)         RPR tests for syphilis may be performed by exempt laboratories operated by local health departments under the following conditions:

A)        The Department has determined that the area served by the laboratory has a high incidence of early syphilis;

B)        The laboratory has a written procedure for the performance of RPR syphilis testing which complies with Section 450.1140 and Section 450.1150(f)(l) of this Part and maintains documentation of compliance with this procedure;

C)        The laboratory has written procedures for training of personnel who perform the tests;

D)        The laboratory successfully participates in an approved proficiency testing program for syphilis serology;

E)         All specimens tested are submitted to a laboratory operated by the Department for confirmation of the test results; and

F)         The laboratory is subject to inspection by the Department and agrees to immediately cease RPR syphilis testing if the Department determines that the laboratory is not in compliance with these conditions.

b)         Class I Permit Laboratories as defined in Section 2-108 of the Act may perform the following tests:

1)         All tests that can be performed by Exempt Laboratories;

2)         Any simple tests as defined in Section 450.10 (Section 2-108 of the Act); and

3)         Those tests or categories of tests set forth by the regulations promulgated pursuant to the Act.  The Department may give approval to a Class I permit laboratory to perform up to three tests which do not fall within the definition of a simple test, when the laboratory director submits documentation describing the purpose of each test, how it is performed, the specific training and experience of the personnel performing the test(s) and necessary quality control procedures appropriate to the test(s), and the extent of supervision provided by the laboratory director. The Department shall grant approval based upon the following criteria:

A)        the test(s) is unique to a specific healthcare practice and not readily available from a licensed clinical laboratory (e.g., not performed by a licensed clinical laboratory or hospital laboratory within 50 miles); or

B)        on-site prompt results (e.g., results are required in less time than sending a specimen to a reference laboratory) are necessary for the treatment or care of the patients of the healthcare provider because of the nature of the practice.

c)         Class II permit Laboratories as defined in Section 2-109 of the Act may perform the following tests:

1)         All tests that can be performed by Exempt Laboratories;

2)         All tests that can be performed by the Class I laboratory as detailed in subsection (b).

3)         Any complex tests.

d)         Class III Permit Laboratories as defined in Section 2-110 of the Act may perform the following tests:

Any health screening tests as defined in Section 450.1300(a).

e)         Licensed Clinical Laboratories as defined in Section 2-111 of the Act may perform the following tests:

1)         All tests that can be performed by Exempt Laboratories;

2)         All tests that can be performed by the Class I laboratory as detailed in subsection (b).

3)         Any complex tests.

(Source:  Amended at 15 Ill. Reg. 15727, effective October 18, 1991)