Section 450.1110  Responsibilities of Director

The director(s) of a clinical laboratory shall:

a)         Establish, implement, monitor, and document a quality control program which at a minimum meets the requirements of this Subpart.  This quality control program shall include documentation of corrective actions taken.

b)         Determine the laboratory procedures which will be performed and the instruments and methodologies that will be used.

c)         Establish a program to validate new procedures before laboratory results are reported.  The validation procedure for quantitative methods must have provisions to determine accuracy and precision.

d)         In accordance with the weekly schedule established by the Director, assess the activities of the laboratory by personal observation, evaluation, and review of reports of laboratory findings.  The director shall establish a policy for review of all abnormal findings.

e)         Determine the format of laboratory report forms and decide what information is to be contained on the report forms.

f)         In accordance with the weekly schedule established by the Director, consult with supervisors and other staff members and review the adequacy of the quality control program.

g)         Confer with those served by the laboratory on matters that relate to test performance and determine the nature and scope of technical and administrative information to be released by the laboratory staff.

h)         Ensure that proper personnel qualifications are met.  (See Subpart D)

i)          Ensure that all reagents used in the laboratory are not beyond their expiration date.

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