Section 450.220  Operational Participation of the Director

a)         The laboratory director is responsible for the operation and administration of the laboratory, including the employment of personnel who are qualified and competent to perform test procedures, maintain records, and report test results promptly, accurately and proficiently to assure compliance with applicable CLIA Law.

b)         The laboratory director, if qualified, may perform the duties of the technical supervisor, technical or clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications.

c)         The laboratory director shall be accessible to the laboratory to provide onsite, telephone or electronic consultation.

d)         The laboratory director shall follow the weekly schedule established in accordance with Section 450.1110(d), except for absences due to emergencies, illness, or professional meetings. In case of an absence for vacation or other purposes that does not exceed 30 days, the owner shall ensure director coverage by designating an acting director who is qualified to direct that laboratory.

e)         If the laboratory director is absent for more than 30 days, the owner shall designate an acting laboratory director who meets the qualifications in 42 CFR 493, Subpart M.  If the absence of the laboratory director will be permanent, the owner shall immediately submit a request for a laboratory director change to the Department.

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)