Section 450.10  Definitions

"Accredited Institution" or "Accredited College or University" means a college or university located in the United States which has been accredited by one of the regional accreditation programs recognized by the U.S. Office of Education or a college or university located outside the United States where the individual provides documentation that his/her education is equivalent to that provided in the United States by: documenting that the foreign degree has been accepted by an accredited institution in the United States at which the person is or was enrolled in a graduate program; or having his/her credentials evaluated by the Credentials Evaluation Service, Inc., Los Angeles, California.

"Act" or "Clinical Laboratory Act" means Illinois Clinical Laboratory Act (Ill. Rev. Stat. 1987, ch. 111½, par. 621 et seq., as amended by P.A. 85-1025, effective June 30, 1988; P.A. 85-1202, effective August 25, 1988, and P.A. 85-1251 effective August 30, 1988.).

"Approved Clinical Laboratory" means a clinical laboratory – (with a director at the doctoral level) – of a hospital, health department, university, or medical research institution; or a clinical laboratory having a license or class II permit under the Illinois Clinical Laboratory Act; or a blood bank licensed under the Blood  Bank Act; or a clinical laboratory licensed under the Clinical Laboratories Improvement Act of 1967; or, a clinical laboratory approved under 42 CFR 405, Subpart M effective September 30, 1977.

"Blood Bank Act" means the Illinois Blood Bank Act, (Ill. Rev. Stat. 1987, ch. 111½, pars. 601-101 et seq.)

"Class I Permit" means a permit issued to a single practice of medicine, podiatry or dentistry to own and operate a clinical laboratory at stated locations exclusively for the patients or the members of that practice, and is limited to simple tests and those tests or categories of tests set forth by the regulations promulgated pursuant to this Act; or a permit issued to a local health authority or designated agency to own and operate a clinical laboratory at stated locations without acceptance of referred testing, and is limited to those tests or categories of tests set forth by regulations promulgated pursuant to this Act. (Section 2-108 of the Act)

"Class II Permit" means a permit issued to the owner of a clinical laboratory at a stated location in which the laboratory is operated and maintained exclusively for the patients of the physicians, podiatrists or dentists who practice at that location and who own the laboratory or are employed by the owner; or

A permit issued to a local health authority or designated agency to own and operate a clinical laboratory at stated locations and at which referred testing may be accepted from other local health authorities or designated agencies; or

A clinical laboratory which fits the definition of a Class I Permit Laboratory but performs more complex tests than those under a Class I Permit.

Tests performed by a laboratory holding a Class II Permit shall be limited to those tests or categories of tests set forth in the regulations promulgated pursuant to this Act. (Section 2-109 of the Act)

"Class III Permit" means a permit issued to the owner of a clinical laboratory which is operated and maintained exclusively for the purpose of conducting health screening tests by a person, corporation, organization, association or group which provides health screening services in accordance with provisions of Section 2-120 either directly or indirectly on a for-profit basis. (Section 2-100 of the Act)

"Clinical Laboratory" or "Laboratory" means a facility which performs laboratory tests or issues reports resulting from such tests. (Section 2-103 of the Act)

"Complex Test" means any test which does not meet the definition of a simple test. (Section 2-119 of the Act).

"Controlled Substance" means a drug, substance, or immediate precursor as defined in the Illinois Controlled Substance Act (Ill. Rev. Stat. 1987, ch. 56½, pars. 1100 et seq., as now and hereafter amended.)

"Dental Practice Act" means The Illinois Dental Practice Act (Ill. Rev. Stat. 1987, ch. 111, par. 2301 et seq., as now and hereafter amended.)

"Demonstration of proficiency" means the laboratory meets the standards for acceptable proficiency testing as stated in Section 450.720(f) by means of on site analysis of specimens sent to the laboratory by agencies approved by the Department for that purpose.

"Department" means the Illinois Department of Public Health.

"Designated Agency" means an association, organization, group or agency which operates a clinical laboratory for the purpose of meeting the requirements of a state or federal program. (Section 2-122 of the Act).

"Full-time experience" means experience in the field being referred to consisting of at least 35 hours per week conducting activities required by the specific position or field such as conducting the tests referred to in Section 2-103 of the Act.

"Hospital Licensing Act" means the Hospital Licensing Act (Ill. Rev. Stat. 1987, ch. 111½, pars. 142 et seq., as now and hereafter amended.)

"License" means a license issued to the owner, local health authority or designated agency or person to operate a clinical laboratory at a stated location to accept specimens from any person authorized to submit such specimens under this Act, with test limitations based upon the qualifications of the Director as set forth by the regulations promulgated pursuant to this Act. (Section 2-111 of the Act).

"Local Health Authority" means the full-time, official health department or Board of Health, as recognized by the Department, which has jurisdiction over a particular geographical area. (Section 2-121 of the Act).

"Medical Practice Act" means the "Medical Practice Act of 1987" (Ill. Rev. Stat. 1987, ch. 111, pars. 4401-1 et seq., as now and hereafter amended.)

"Minor Test" means any uncomplicated laboratory examinations and procedures which the Director of the Department determines have an insignificant risk of erroneous result including those which have been approved by the United States Food and Drug Administration for home use, which employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible. Tests determined by the Director to be "minor" and permissible for a Registration class laboratory are set forth in Section 450.35(a).

"Physician" means, unless otherwise indicated in this Act, a person licensed by the Department of Professional Regulation, pursuant to the requirements of the Medical Practice Act of 1987; (i.e. a physician licensed to practice medicine in all its branches and a chiropractic physician) or a person licensed as a physician under the laws of another state or territory of the United States. (Section 2-116 of the Act).

"Podiatry Act" means Podiatric Medical Practice Act of 1987 (Ill. Rev. Stat. 1987, ch. 111, pars. 4801 et seq., as now and hereafter amended.)

"Prepackaged Reagent Analyser" means an automated instrument in which a specimen or a diluted specimen is reacted with reagents contained within individual packet(s) containing all of the measured reagents required for the analysis for a given analyte.

"Proficiency Testing" means a program for monitoring laboratory performance on a periodic basis which is adopted or approved by the Department. (Section 1-123 of the Act.)

"Simple Test" means a test or categories of tests which generally have the following characteristics:

Interpretation of a visual signal by pattern recognition, color definition or numeric information using an established control example which can be observed directly by the operator and requires no manipulation or interpolation by the operator to derive a result; or

The use of simple addition, subtraction, multiplication or division; or

The use of manufacturer-prepared reagents or solutions which are combined without requiring numerous (i.e. no more than five sequential steps which should not include sample acquisition or sample preparation such as centrifuge to obtain serum) specific calibrated volume measurements or sequential applications.

In addition, the following considerations are used to determine if a test or test procedure meets the definition of Simple Test:  the examinations and procedures performed and the methodologies employed, the degree of independent judgment involved, the amount of interpretation involved, the difficulty of the calculations involved, the calibration and quality control requirements of the instruments used, the type of training required to operate the instruments used in the methodology, and such other factors as the Director considers relevant.

Interpretation of the types of tests or categories of test which meet this definition shall be determined by the Department in consultation with the Clinical Laboratory and Blood Bank Advisory Board established by Section 5-101 of the Act. (Section 2-118 of the Act).

The Department will compile a list of tests and test procedures which it determines meets the definition of a simple test. Such compilation will be available upon request and updated annually.

"Single practice" means a medical, dental or podiatric practice, partnership, professional service corporation or medical corporation of one or more licensed practitioners who share facilities, personnel, income and expenses for a clinical laboratory that is used solely as an adjunct to the care of patients of the members of the single practice.

"Test" means laboratory examinations and issuance of reports resulting from the biological, microbiological, serological, chemical, immunohematological, radioimmunological, hematological, biophysical, cytological, pathological, toxicological or other examination of materials derived from the human body for the purposes of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of, the health of humans including determining drug use by humans. (Section 2-117 of the Act).

"Toxicology Laboratory" means a licensed laboratory which performs tests to detect drug abuse in the workplace, among job applicants, or for other similar purposes.

(Source:  Amended at 13 Ill. Reg. 11573, effective July 1, 1989)