Section 490.410  General Supervisor – Laboratory

a)         Duties

            There shall be at least one qualified medical director or supervisor on the blood bank premises during all hours of laboratory operation.  In the absence of the director, the supervisor shall supervise technical personnel and reporting of findings, perform tests requiring special scientific skills commensurate with education, training, and experience of the individual and be held responsible for the proper performance of all procedures.  During periods of time when the blood bank is open for emergencies only, a director or supervisor is not required to be on the premises provided a qualified technologist (Section 490.420 of this Part) performs the emergency work and director or supervisor who is responsible for the work reviews and documents the review during the next duty period when the blood bank is open to provide other than emergency work or within 24 hours.  An emergency shall be determined by the medical director or his physician designee.  There shall be a written policy defining an emergency.

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 490.40 (c)(6)).

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 blood bank.

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 or clinical chemistry and subsequent to graduation has had at least 1 year of full-time laboratory experience in an approved blood bank.

3)         The individual is qualified as a medical technologist pursuant to the provisions of Section 490.420 of this Part.  If the individual qualifies as a medical technologist because the individual has successfully passed the United States Public Health Service exam, that individual shall have 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.  Subsequent to the date of qualifying as a medical technologist, the individual shall have at least four years of pertinent full-time laboratory experience in an approved clinical laboratory.

c)         Exception to Section 490.410(b)

            An individual serving as general supervisor of a blood bank 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 or biological science as the major subject shall reduce the required years of experience by 2 years, with an additional hours further reducing the required years of experience at the rate of 15 hours for 1 year.