1. 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).

2. 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. 1. The name and address of the laboratory;
   2. 2. The name and telephone number of the director of the clinical laboratory;
   3. 3. The name and, as available, the address, telephone number, and email address of the subject;
   4. 4. The date of birth of the subject;
   5. 5. The sex assigned at birth of the subject;
   6. 6. The race and ethnicity of the subject;
   7. 7. The laboratory identification number;
   8. 8. The specimen type;
   9. 9. The date of collection of the specimen;
   10. 10. The type of test ordered on the specimen; and
   11. 11. The ordering health care provider’s name, address, telephone number, and, if available, email address.

3. 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. 1. The name and address of the laboratory;
   2. 2. The name and telephone number of the director of the clinical laboratory;
   3. 3. The name and, as available, the address, telephone number, and email address of the subject;
   4. 4. The date of birth of the subject;
   5. 5. The sex assigned at birth of the subject;
   6. 6. The race and ethnicity of the subject;
   7. 7. The laboratory identification number;
   8. 8. The specimen type;
   9. 9. The date of collection of the specimen;
   10. 10. The date of the result of the test;
   11. 11. The type of test completed on the specimen;

   12. 12. The test result, including:

       1. a. Qualitative results;
       2. b. Quantitative values and reference ranges, if applicable;
       3. c. Susceptibility testing data and a drug sensitivity pattern, if performed; and
       4. d. Variant type, if available; and
   13. 13. The ordering health care provider’s name, address, telephone number, and, if available, email address.

4. D. Upon the request of the Department, the director of a clinical laboratory shall:

   1. 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. 2. Submit sequencing-related information, as available, in a Department-provided format; or
   3. 3. Submit to the Arizona State Laboratory an isolate of an infectious agent, if available, or a specimen from a subject.

Table 3. Repealed

Historical Note

New Table 3 made by final rulemaking at 10 A.A.R. 3559, effective October 2, 2004 (Supp. 04-3). Table 3 amended by final rulemaking at 14 A.A.R. 1502, effective April 1, 2008 (Supp. 08-2). Table 3 repealed by final rulemaking at 23 A.A.R. 2605, effective January 1, 2018 (Supp. 17-3).

Table 2.3. Clinical Laboratory Director Reporting Requirements

Key:

□ Submit a report immediately after receiving one specimen for detection of the agent. Report the receipt of subsequent specimens within five working days after receipt.

🗲 Submit a report within 24 hours after obtaining a positive test result.

! Submit a report within one working day after obtaining a positive test result.

🖳 Submit a report within five working days after obtaining a positive test result or a test result specified in Table 2.3.

↖ Submit an isolate of the organism for each positive culture, if available, or a specimen for each positive test result to the Arizona State Laboratory within one working day.

+ Submit an isolate of the organism for each positive culture to the Arizona State Laboratory within one working day.

Footnotes:

When appearing after one of the symbols above, the following modify the requirement:

1 When reporting a positive result for any of the specified tests, report the results of all other tests performed for the subject as part of the disease panel or as a reflex test.

2 Submit a report only when an initial positive result is obtained for an individual.

3 Submit an isolate or specimen of the organism, as applicable, only when an initial positive result is obtained for an individual, when a change in resistance pattern or mechanism is detected, or when a positive result is obtained ≥ 12 months after the initial positive result is obtained for an individual.

4 Submit an isolate of the organism, if available, or a specimen when a positive result is obtained for an individual < 5 years of age.

Historical Note

Table 2.3 made by final rulemaking at 23 A.A.R. 2605, effective January 1, 2018 (Supp. 17-3). Amended by final rulemaking at 31 A.A.R. 1317 (April 25, 2025), effective June 2, 2025 (Supp. 25-2).

Historical Note

Adopted effective October 19, 1993 (Supp. 93-4). Former R9-6-204 renumbered to R9-6-302; new R9-6-204 made by final rulemaking at 10 A.A.R. 3559, effective October 2, 2004 (Supp. 04-3). Amended by final rulemaking at 14 A.A.R. 1502, effective April 1, 2008 (Supp. 08-2). Amended by final rulemaking at 23 A.A.R. 2605, effective January 1, 2018 (Supp. 17-3). Amended by final rulemaking at 31 A.A.R. 1317 (April 25, 2025), effective June 2, 2025 (Supp. 25-2).