R9-6-204. Clinical Laboratory Director Reporting Requirements

A. A director of a clinical laboratory that obtains a test result described in Table 2.3 or that receives a specimen for detection of an infectious agent or toxin listed in Table 2.3 shall, either personally or through a representative, submit a report, in a Department-provided format, and, if applicable, an isolate or a specimen to the Department within the time limitation and as specified in Table 2.3 and subsection (B) or (C). B. For each specimen for which an immediate report is required by subsection (A) and Table 2.3, a clinical laboratory director shall ensure the report includes: 1. The name and address of the laboratory; 2. The name and telephone number of the director of the clinical laboratory; 3. The name and, as available, the address, telephone number, and email address of the subject; 4. The date of birth of the subject; 5. The sex assigned at birth of the subject; 6. The race and ethnicity of the subject; 7. The laboratory identification number; 8. The specimen type; 9. The date of collection of the specimen; 10. The type of test ordered on the specimen; and 11. The ordering health care provider’s name, address, telephone number, and, if available, email address. C. Except as provided in Table 2.3, for each test result for a subject for which a report is required by subsection (A) and Table 2.3, a clinical laboratory director shall ensure the report includes: 1. The name and address of the laboratory; 2. The name and telephone number of the director of the clinical laboratory; 3. The name and, as available, the address, telephone number, and email address of the subject; 4. The date of birth of the subject; 5. The sex assigned at birth of the subject; 6. The race and ethnicity of the subject; 7. The laboratory identification number; 8. The specimen type; 9. The date of collection of the specimen; 10. The date of the result of the test; 11. The type of test completed on the specimen; 12. The test result, including: a. Qualitative results; b. Quantitative values and reference ranges, if applicable; c. Susceptibility testing data and a drug sensitivity pattern, if performed; and d. Variant type, if available; and 13. The ordering health care provider’s name, address, telephone number, and, if available, email address. D. Upon the request of the Department, the director of a clinical laboratory shall: 1. Include an equivocal result or a negative test result for any subject in the report of test results, required in subsection (C)(12), for an infectious agent or toxin for which a report is required by subsection (A) and Table 2.3; 2. Submit sequencing-related information, as available, in a Department-provided format; or 3. Submit to the Arizona State Laboratory an isolate of an infectious agent, if available, or a specimen from a subject.