Section 450.410   General Supervisor

a)         Duties

In a licensed laboratory, there shall be at least one qualified director or supervisor on the laboratory premises during all hours in which tests are performed. In the absence of the director, the supervisor shall supervise technical personnel and reporting of findings, perform tests requiring special scientific skills and be held responsible for the proper performance of all laboratory procedures. During periods of time when the laboratory is open for emergency testing only, a director or supervisor is not required to be on the premises provided a qualified technologist (See Section 450.420) performs the emergency tests and the director or supervisor who is responsible for the work reviews and documents the review of the results during the next duty period when the laboratory is open to provide other than emergency testing or within 24 hours, whichever occurs first. An emergency shall be determined by the physician attending the patient, and in order to clearly indicate an emergency exists, the laboratory request form shall include an appropriate designation such as "Stat".

b)         An individual who meets one of the following qualifications shall qualify as general supervisor. These qualifications must be documented on the Department's form entitled "Laboratory Personnel Qualifications Appraisal". (See Section 450.50(c)(3)):

1)         The individual is a physician licensed to practice medicine in all of its branches or has an earned doctoral degree from an accredited institution in a medical laboratory science such as microbiology and clinical chemistry and subsequent to graduation has had at least 1 year of full-time experience in one of the laboratory specialties in an approved clinical laboratory.

2)         The individual has a Master of Arts or Master of Science degree from an accredited institution in a medical laboratory science such as microbiology and clinical chemistry and subsequent to graduation has had at least 1 year of full-time laboratory experience in an approved clinical laboratory.

3)         The individual is qualified as a medical technologist pursuant to the provisions of Section 450.420. If the individual qualifies as a medical technologist because the individual has successfully passed the United States Public Health Service Exam prior to July 1, 1989, the individual has either:

A)        an associate degree or at least 60 semester hours of academic credit from an accredited institution, including at least 12 semester hours in chemistry and biology courses and four years of full-time laboratory experience in an approved clinical laboratory; or

B)        six years of experience as a medical technologist in an approved laboratory.

4)         With respect to the specialty of diagnostic cytology, qualifies as a supervisory cytotechnologist because the individual qualifies as a cytotechnologist under Section 450.430(a), (b) or (c) and has had at least 4 years of full-time experience within the preceding 10 years as a cytotechnologist in a laboratory directed by an individual qualified to direct such a laboratory under Section 6-103 of the Act within the preceding 10 years.

5)         With respect to the specialty of genetics, qualifies as a supervisor because the individual meets the requirements of subsections (b)(1), (2) or (3) above a minimum of two years of experience, except that the experience requirements must be in a genetics laboratory.

c)         Exception to subsections (b) (1), (2), and (3) above

An individual serving as general supervisor of a clinical laboratory on September 15, 1970 and having had at least 15 years of pertinent laboratory experience prior to September 15, 1970 may continue to serve as supervisor of said laboratory:  provided, that a minimum of 30 semester hours credit toward a Bachelor's degree with a chemical, physical or biological science as his major subject shall reduce the required years of experience by 2 years, with any additional hours further reducing the required years of experience at the rate of 15 hours for 1 year.

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