Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 475 - LABORATORY SERVICE FEES › Section 475.20 - Submission of Samples or Specimens

Current through Register Vol. 48, No. 28, July 12, 2024
Each sample or specimen submitted to the Laboratory for any
				analysis shall be delivered or shipped in a container and manner to preserve
				the sample/specimen from contamination or destruction and to allow it to reach
				the Laboratory in a condition that permits a reliable laboratory
				analysis.
a The person submitting the
			 sample/specimen shall deliver it to the Laboratory or send it in a package
			 approved by the U.S. Postal Service or another commercial carrier for shipping.
			 Any sample/specimen that is submitted in a package that violates the U.S.
			 Postal Service's guidelines (or another commercial carrier's guidelines if an
			 alternative carrier is used), is damaged in transit, is not received within the
			 prescribed time frame for analysis, or is otherwise received in a condition
			 that does not permit a reliable laboratory analysis, will be discarded. When
			 this occurs, the laboratory result will be reported as indeterminate or
			 unsatisfactory, and the submitter will be notified so that another
			 sample/specimen can be collected and submitted for analysis.
b For those laboratory services offered, the
			 Laboratory will provide, upon request, sample/specimen collection materials or
			 devices and mailing containers that meet the U.S. Postal Service
			 regulations.
c Prior to delivering
			 or shipping any sample/specimen to the Laboratory, the person submitting the
			 sample/specimen shall confirm with the Laboratory the availability of the
			 desired laboratory service/analysis and identify which Laboratory site or sites
			 (e.g., Chicago, Springfield, Carbondale or a contract laboratory site) will
			 perform the desired service/analysis and any testing authorization procedures
			 that are required. Samples/specimens shall be delivered or sent only to a
			 specific Laboratory site designated as performing the requested laboratory
			 service or to an alternative site agreed to in advance.
d The person submitting the sample/specimen
			 shall pay for the postage or transport fee of the package unless alternative
			 arrangements are made with the Laboratory in advance of mailing or shipping a
			 sample/specimen to the Laboratory.
e Clinical specimens received by the
			 Department will be retained for a minimum of one month. If all test results
			 obtained from a specimen are determined to be within normal range, the specimen
			 will be retained for a maximum of four months. If any test result obtained from
			 a specimen is determined to be abnormal (i.e., out of normal range), the
			 specimen may be retained for a maximum of six years. Specimens that the
			 Department retains may be used within the Department for quality control
			 purposes as required under CLIA. Based on the Department's testing
			 capabilities, specimens with an abnormal result may be referred to other
			 clinical laboratories for supplemental testing to further characterize the
			 abnormality. After the maximum time period for retention, the Department will
			 destroy all specimens.
f Cultures,
			 isolates and extracts of pathogens that are provided to the Department or
			 result from testing samples/specimens that have been provided to the Department
			 may be shared by the Department with other public health entities for quality
			 assurance or method development purposes, provided that any and all patient
			 identifiable information has been removed.