Section 450.1010  Necessary Records

a)         Complete records in regard to each specimen examined shall be kept on file in the laboratory for not less than five years.  Such records shall contain:

1)         Laboratory number or other identification of the specimen.

2)         The name of the person from whom the specimen was taken, except in cases of anonymous HIV testing or of anonymous or coded premarital syphilis testing.  The names and addresses of persons who have chosen to have HIV testing done anonymously may not be recorded in the files, except that any existing records referring to testing done before anonymity was chosen may be retained without linkage to the anonymous testing.

3)         The name of the licensed physician or other authorized person, clinical laboratory, or blood bank submitting the specimen.

4)         The date the specimen was collected and the date the specimen was received in the laboratory.

5)         When a specimen is forwarded to another clinical laboratory for tests, the name, the date when the specimen was forwarded to such laboratory, the date it was tested, and the date the report of the findings of the test was received from such laboratory.

6)         In case the specimen is an unsatisfactory specimen, the condition of the specimen when received.

7)         The types and numbers of tests performed annually.

8)         The results of the test conducted by the laboratory, the method used, the signature of the examiner.

9)         Results of laboratory tests are to be reported to the referring laboratory and/or practitioner in accordance with Sections 3-101, 7-102, and 7-103 of the Act.

b)         Reports to be submitted to the Department.

A laboratory shall submit reports containing such information and data concerning its technical operations, as may be requested by the Department. The Department may require that such reports be notarized and signed by the owner and director of the laboratory, if these are different.

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