Section 450.210  Qualifications of the Director of a Clinical Laboratory

a)         Qualifications of Directors. Every clinical laboratory shall be under the supervision and direction of a Director who possesses one of the following qualifications. These qualifications must be documented on the Department form entitled "Laboratory Personnel Qualifications Appraisal". (See Section 450.50(c)(3))

1)         The individual is a physician licensed to practice medicine in all its branches in Illinois and certified by the American Board of Pathology or the American Osteopathic Board of Pathology in clinical pathology, or who possesses qualifications which are equivalent to such certification (Board eligible).

2)         The individual is a physician licensed to practice medicine in all its branches in Illinois with special qualifications in the performance of the test or tests offered by the clinical laboratory, whose training and experience are acceptable to the Department.

A)        A physician having not less than one year of post-graduate training in diagnostic laboratory procedures in a residency training program approved for training purposes by the American Board of Pathology or the American Osteopathic Board of Pathology.

B)        A physician having not less than two years of supervised experience in an approved clinical laboratory carrying out procedures in the field or fields or science which encompass the program and services provided by the laboratory which this individual will direct.

C)        To be director of a genetics laboratory, the physician shall have 4 or more years of post-graduate genetics laboratory experience in an approved clinical laboratory.

D)        To be director of a histocompatibility laboratory, the physician shall have 4 or more years of immunology laboratory experience in an approved clinical laboratory, subsequent to becoming a physician, 2 years of which have been in histocompatiblity testing.

E)         To be director of a toxicology laboratory which performs tests for controlled substances, the physician shall have 4 or more years of post-graduate experience in an approved clinical laboratory which performs tests for controlled substances or have formal academic education from an accredited institution in drug metabolism, drug kinetics, and the use and limitations of analytical procedures used in drug analysis.

3)         In the case of a laboratory, the principal place of business of which is outside the State of Illinois, the individual is a physician licensed to practice medicine in all of its branches in that state and possesses special qualifications in the performance of the test or tests offered by the clinical laboratory with training and experience acceptable to the Department.

A)        A physician having not less than one year of post-graduate training in diagnostic laboratory procedures in a residency training program approved for training purposes by the American Board of Pathology or the American Osteopathic Board of Pathology.

B)        A physician having not less than two years supervised experience in an approved clinical laboratory carrying out procedures in the field or fields of science which encompass the program and services provided by the laboratory which this individual will direct.

C)        To be director of a genetics laboratory, the physician shall have 4 or more years of post-graduate genetics laboratory experience in an approved clinical laboratory.

D)        To be director of a histocompatibility laboratory, the physician shall have 4 or more years of immunology laboratory experience in an approved clinical laboratory, subsequent to becoming a physician, 2 years of which have been in histocompatibility testing.

E)         To be director of a toxicology laboratory which performs tests for controlled substances, the physician shall have 4 or more years of post-graduate experience in an approved clinical laboratory which performs tests for controlled substances or have formal academic education from an accredited institution in drug metabolism, drug kinetics, and the use and limitations of analytical procedures used in drug analysis.

4)         The individual is a physician (i.e. physician licensed to practice medicine in all its branches or a chiropractic physician), dentist or podiatrist licensed in Illinois.

5)         The individual holds a degree above baccalaureate level from a college or university acceptable to the Department, with a major in chemical or biological sciences and has satisfied the Department of his training and proficiency in those tests for which this license is sought.

A)        An individual who holds an earned graduate degree above the baccalaureate level from an accredited institution in a medical laboratory science or with a chemical or biological science as a major subject may direct a laboratory which requires a class I, II, or III permit or a license, provided the individual documents that the individual has had 3 more years of full-time clinical laboratory training and experience in an approved clinical laboratory, subsequent to graduation, in each area of the laboratory in which testing is performed. The laboratory areas are bacteriology/mycology, parasitology, virology, immunology/serology, hematology, immunohematology, and chemistry. Experience as a technologist in an approved clinical laboratory which was gained prior to acquiring the graduate degree may be substituted on an equivalency basis of 1.5 years of such experience for every 1 year of post degree training and experience required; and experience as a general supervisor in an approved clinical laboratory, which was gained prior to acquiring such degree, may be substituted on a 1-for-1 basis. Such documentation shall be made on a form entitled "Laboratory Personnel Qualifications Appraisal" (See Section 450.50(c)(3)).

B)        To be director of a histocompatibility laboratory, the individual shall hold an earned doctoral degree from an accredited institution with a chemical or biological science as a major subject and have 4 or more years of postdoctoral laboratory experience in immunology in an approved clinical laboratory, 2 of which have been in histocompatibility testing.

C)        To be director of a genetics laboratory, the individual shall hold an earned doctoral degree from an accredited institution with a chemical or biological science as a major subject and have 4 or more years of postdoctoral genetics laboratory experience in an approved clinical laboratory.

D)        To be director of a toxicology laboratory which performs tests for controlled substances, the individual shall hold an earned doctoral degree from an accredited institution with a chemical or biological science as a major subject and have 4 or more years of post-graduate experience in an approved clinical laboratory which performs tests for controlled substances; or have formal academic education from an accredited institution in drug metabolism, drug kinetics, and the use and limitations of analytical procedures used in drug analysis.

6)         An individual listed as the Director, prior to August 23, 1965, of one clinical laboratory which was registered with the Department under the provisions of this Act, may continue to direct one laboratory, and an individual who directed two such laboratories simultaneously may continue to direct two laboratories, except that the Department, upon recommendation of the Clinical Laboratory and Blood Bank Advisory Board , may, as a condition precedent to the issuance of an original license hereunder, require such individual to pass a practical examination in the event that it deems such an examination necessary to determine the competence of the individual to direct a clinical laboratory. The Department will not require a practical examination.

7)         The individual is a physician licensed to practice medicine in all its branches in Illinois.

8)         To be director of a pathologic anatomy laboratory, the individual must be a physician licensed to practice medicine in all its branches in Illinois and certified or determined to be board eligible by the American Board of Pathology in anatomic pathology or the American Osteopathic Board of Pathology in anatomic pathology, or the individual is a dentist licensed in Illinois and certified by the American Board of Oral Pathology; except that bone marrow interpretations may be done by a hematologist who is certified or determined to be Board eligible by the American Board of Internal Medicine.

b)         Minimum requirements for laboratory direction and staffing. A permit or license to operate a clinical laboratory shall be issued only if the following technical staff are employed to provide supervision and direction during testing as required by regulations promulgated pursuant to this Act:

1)         A class I permit requires a Director qualified under subsections (1), (2), (4), (5), (6) or (8) of subsection (a) of this Section to provide supervision and direction, with or without a laboratory assistant.

2)         A class II permit requires a Director qualified under subsections (1), (2), (5), (6), (7) or (8) of subsection (a) of this Section to provide supervision and direction, with the employment of technicians or technologists.

3)         A class III permit requires a Director qualified under subsections (1), (2), (5), (6) or (7) of subsection (a) of this Section to provide supervision and Direction, with the employment of laboratory assistants or technicians.

4)         A license requires a Director qualified under subsections (1), (2), (3), (5), (6) or (8) of subsection (a) of this Section to provide supervision and direction, with the employment of a general supervisor if necessary to provide supervision in the absence of the Director.

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