TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER d: LABORATORIES AND BLOOD BANKS
PART 450 ILLINOIS CLINICAL LABORATORIES CODE
SECTION 450.5 SCOPE AND APPLICABILITY


 

Section 450.5  Scope and Applicability

 

a)         This Part provides regulatory oversightThe major thrust of this regulatory scheme is to require some form of regulation of all entities certified pursuant to 42 CFR 493, that perform analysis of human specimens for health assessment or to diagnose, prevent or treat disease.under the following five stage classification scheme:

 

1)         Exempt Laboratory;

 

2)         Class I Permit Laboratory;

 

3)         Class II Permit Laboratory;

 

4)         Class III Permit Laboratory;

 

5)         Licensed Laboratory.

 

b)         All certified CLIA laboratories will be regulated as one of these five levels of classification as set forth in 42 CFR 493 and described in the State Operations Manual (Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services), issued by the Department of Health and Human Servicesdepending upon the tests they conduct, the source of the specimens, and organizational structure. Each of these levels, except exempt laboratories, has regulatory requirements concerning the qualifications of the laboratory director, qualifications of laboratory personnel, proficiency testing and quality control as set forth in this Part. (See Appendix C).

 

1)         Exempt Laboratory

 

A)        In order to qualify as an exempt laboratory, the laboratory must meet the definition of a "Class I Permit" laboratory and only conduct those tests specified in the regulations. As set forth in the  Illinois Clinical Laboratory Act (Ill. Rev. Stat. 1989 and 1990 Supp., ch. 111½, par. 621 et seq.) ("the Act") and this Part, an exempt laboratory can be any "single practice of medicine, podiatry or dentistry" which owns and operates a laboratory exclusively for its patients, or a local health authority or designated agency which owns and operates a laboratory for its own clients or patients, at stated locations when testing is limited to tests which are set forth in Section 450.35(a).

 

B)        If an exempt laboratory conducts tests other than those listed it must seek another level of classification. Furthermore, health screening activities under Section 1-103 and 2-120 of the Act may be conducted by laboratories at locations other than the location or locations set forth in the permit or licensure application, however such health screenings must be conducted in accordance with Sections 450.1300, 450.1310, 450.1320, and 450.1330. An Exempt Laboratory is not exempt from the provisions of this Part concerning health screening.

 

C)        The Department expects physicians, podiatrists, dentists, local health authorities, and designated agencies to qualify as exempt laboratories.

 

2)         Class I Laboratory

 

A)        As set forth in this Part, a "Class I Permit" laboratory can be any "single practice of medicine, podiatry or dentistry" which owns and operates a laboratory exclusively for its patients or a local health authority or designated agency which owns and operates a laboratory for its own clients or patients at stated locations when testing is limited to simple tests and those tests or categories of tests set forth by regulations as defined of this Part. Some or all testing may be done by a laboratory assistant under the direction of the physician, podiatrist or dentist.

 

B)        The "Class I Permit" laboratory must obtain a permit annually from the Department. Generally, the other major requirements are as follows:

 

i)          the minimum level for the qualifications of the laboratory director include any physician (M.D., D.O., or D.C.), dentist, podiatrist, or person with at least a master's degree with a major in chemical or biological sciences.

 

ii)         the minimum level for the qualifications of laboratory personnel include a laboratory assistant. Section 450.450 of this Part specifies that a laboratory assistant is any person who meets the education and experience requirements set by the laboratory director.

 

iii)        the minimum level of proficiency testing requires proficiency testing for all tests conducted by the laboratory when available from an approved proficiency testing service.

 

iv)        the minimum level of quality control requires such testing for all tests conducted by the laboratory.

 

C)        The Department expects physicians, podiatrists, dentists, local health authorities, and designated agencies to seek "Class I Permit" Laboratory status. Health screening activities under Section 1-103 and 2-120 of the Act may be conducted by class I laboratories at locations other than the location or locations set forth in the permit or licensure application, however such health screenings must be conducted in accordance with Sections 450.1300, 450.1310, 450.1320, and 450.1330 of this Part.

 

3)         Class II Laboratory

 

A)        As set forth in this Part, a "Class II Permit" laboratory can be any laboratory at a stated location operated and maintained exclusively for the patients of physicians, podiatrists or dentists at that location and who own the laboratory or are employed by the owner, or a local health authority or designated agency which owns and operates a laboratory for its own clients or patients or for clients or patients of other local health authorities or designated agencies at stated locations.

 

B)        The "Class II Permit" laboratory must obtain a permit annually from the Department. Generally, the other major requirements are as follows:

 

i)          the minimum level for the qualifications of the laboratory director includes a physician licensed to practice medicine in all of its branches, or a person with at least a master's degree with a major in chemical or biological sciences.

 

ii)         the minimum level for the qualifications of laboratory personnel includes a laboratory technician. Section 450.440 of this Part specifies that a laboratory technician is any person who completes at least 60 hours of academic credit including chemistry and biology, a high school graduate who has completed a 1 year accredited training program, or a high school graduate who has completed an official military medical laboratory procedures course of at least 50 weeks.

 

iii)        the minimum level of proficiency testing requires proficiency testing for all tests conducted by the laboratory.

 

iv)        the minimum level of quality control requires such testing for all tests conducted by the laboratory.

 

C)        The Department expects physicians, local health authorities, and designated agencies to seek "Class II Permit" laboratory status. Health screening activities under Section 1-103 and 2-120 may be conducted by class II laboratories at locations other than the location or locations set forth in the permit or licensure application, however such health screenings must be conducted in accordance with Sections 450.1300, 450.1310, 450.1320, and 450.1330.

 

4)         Class III Laboratory

 

A)        As set forth in this Part, a "Class III Permit" laboratory can be any laboratory which is operated and maintained exclusively for the purposes of conducting health screening tests by a person, corporation, organization, association or group directly or indirectly on a for profit basis. The health screening tests are listed as glucose and cholesterol by fingerstick in this Part.

 

B)        The "Class III Permit" laboratory must obtain a permit annually from the Department and must comply with Sections 450.1300, 450.1310, 450.1320, and 450.1330. The "Class III Permit" laboratory has no other regulatory requirements. Generally, the other major requirements are as follows:

 

i)          the minimum level for the qualifications of the laboratory director include a physician licensed to practice medicine in all of its branches, or a person with at least a master's degree with a major in chemical or biological sciences.

 

ii)         the minimum level for the qualifications of laboratory personnel include a laboratory assistant or laboratory technician.  Section 450.450 of this Part specifies that a laboratory assistant is any person who meets the education and experience requirements set by the laboratory director.  Section 450.440 of this Part specifies that a laboratory technician is any person who completes at least 60 hours of academic credit including chemistry and biology, a high school graduate who has completed a 1 year accredited training program, or a high school graduate who has completed an official military medical laboratory procedures course of at least 50 weeks.

 

iii)        the minimum level of proficiency testing requires proficiency testing for all tests conducted by the laboratory.

 

iv)        the minimum level of quality control requires such testing for all tests conducted by the laboratory.

 

C)        The Department expects corporations and groups to seek "Class III Permit" laboratory status.

 

c5)       Licensed Laboratory

 

1A)      As set forth in this Part, a "licensedLicensed" laboratory is acan be any laboratory licensed by the Department under the standards set forth in CLIA laws and regulations (CLIA Law) to accept and test clinical humanat a stated location regardless of ownership which accepts specimens from a person, authorized by law in accordance with Article VII of the Actto submit such specimens when testing is limited to that which is within the qualifications of the Director as set forth in this Part.

 

2B)      The licensed"Licensed" laboratory shall maintain certification status in good standing as required by CLIA Law.must obtain a license annually from the Department. Generally the other major requirements are as follows:

 

i)          the minimum level for the qualifications of the laboratory director includes a physician licensed to practice medicine in all its branches who is Board certified or eligible or who possesses acceptable qualifications as set forth in this Part, or a person with at least a master's degree with a major in chemical or biological sciences.

 

ii)         the minimum level for the qualifications of laboratory personnel include a general supervisor. Section 450.410 of this Part specifies that a general supervisor may be any physician with additional qualifications, a medical technologist, a person with a master's degree in medical laboratory science or other similarly qualified individuals.

 

iii)        the minimum level of proficiency testing requires proficiency testing for all tests conducted by the laboratory.

 

iv)        the minimum level of quality control requires such testing for all tests conducted by the laboratory.

 

dC)      PhysiciansThe Department expects physicians, corporations, individuals, local health authorities, and others that intend to conduct clinical tests on human specimens for health assessments or to diagnose, prevent or treat disease shall obtain certification status by the Department in accordance with CLIA Lawto seek "Licensed" Laboratory status. Health screening activities under Section 1-103 and 2-120 of the Act may be conducted by a licensed laboratory at the laboratory location listed on the CLIA certificate;locations other than the location or locations set forth in the permit or licensure application, however, such health screeningscreenings events shallmust be conducted in accordance with Sections 450.1300, 450.1310, 450.1320, and 450.1330.

 

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