Section 450.30  Laboratories Covered

a)         This Section provides references to help understand the differences among these laboratories. The Department assigns an identification number to a laboratory at the time of license or permit application. This number is only for purposes of filing material for that laboratory in the Department. Such identification number is not a license or permit. A license or permit is issued only after an inspection of the facility finds compliance with all pertinent requirements, except for a class I permit laboratory where an inspection is not required.

1)         An exempt laboratory meets the criteria set forth in Section 1-103(c) of the Act, and Sections 450.30(c)(3) and 450.35(a) of this Part.

2)         A class I permit laboratory meets the criteria set forth in Section 2-108 of the Act; Section 6-101(2)(a) of the Act; and Sections 450.30(b) and 450.35(b) of this Part.

3)         A class II permit laboratory meets the criteria set forth in Section 2-109 of the Act; Section 6-101(2)(b) of the Act; and Sections 450.30(b) and 450.35(c) of this Part.

4)         A class III permit laboratory meets the criteria set forth in Section 2-110 of the Act; Section 6-101(2)(c) of the Act; and Sections 450.30(b) and 450.35(d) of this Part.

5)         A licensed laboratory meets the criteria set forth in Section 2-111 of the Act; Section 6-101(2)(d) of the Act; and Sections 450.30(b) of this Part with no testing limitations, provided the director qualifies.

b)         The following are required to obtain a permit or be licensed pursuant to the Act:

1)         All clinical laboratories and Blood Banks located within the State of Illinois except as otherwise provided in Section 450.30(c). 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).

2)         Laboratories located in hospitals licensed under the Hospital Licensing Act but where the laboratory is not operated by the governing authority of such hospital, including laboratories operating under a lease arrangement with another person or entity.

3)         Laboratories outside of Illinois receiving specimens referred from laboratories located in Illinois that are required to obtain a license or permit under this Act.

c)         The following are not required to obtain a permit or be licensed under the Clinical Laboratory Act:

1)         Clinical laboratories operated by the United States Government.

2)         Clinical laboratories located in hospitals licensed under the Hospital Licensing Act that are under the control of the governing board of such hospitals owned by the exact same entity identified as owner/operator of the hospital as indicated on the last hospital license application filed with the Department; located at the same site and contiguous with the hospital; subject to the regulations and hospital by-laws; and where the entity which receives payment for the laboratory services is the same entity that owns the hospital.

3)         Exempt Laboratories:   Laboratories which fit the definition of Class I Permit Laboratories but perform a small number of minor tests as compared to other Class I Permit Laboratories as set forth by regulations promulgated  pursuant to this Act (See Section 450.35(a)), or any tests performed by the physician, podiatrist or dentist for the benefit of his or her patients, do not require a license or permit.  (See Section 1-103(c) of the Act).

4)         Laboratories which only perform health screenings in accordance with Section 2-120 of The Act and Sections 450.1300, 450.1310, 450.1320, and 450.1330 of this Part, on a not-for-profit or free-of-charge basis are exempt from all other provisions of this Act. (Section 1-103(d) of the Act)

5)         Law enforcement agencies and probation and court services departments performing urinalysis and blood tests to determine drug and alcohol use by humans. (Section 1-103(e) of the Act)

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