Section 450.710  Inspections

a)         All clinical laboratories required to have a license or permit shall be open to inspection by representatives of the Department at all reasonable times.  The premises and operation of all clinical laboratories shall be inspected to study and evaluate the effect of the location, operation, supervision and procedures of such facilities on the health and safety of the people of this state.  These inspections will be made at such time as may from time to time be determined by the Department, and may be announced or unannounced.  These inspections may include on site review of records and reports pertaining to the technical operations of the laboratory.

b)         The Department may submit forms such as check lists to be completed by the director of the laboratory in advance of inspection. These forms may include questions relating to the construction, sanitation, equipment, procedures, and records which will be reviewed by the Department and will assist it in making inspections to determine compliance with the Act and this Part.

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