Ariz. Admin. Code § 9-6-204

Current through Register Vol. 30, No. 50, December 13, 2024

Section R9-6-204 - Clinical Laboratory Director Reporting Requirements

A. Except as specified in subsection (D), 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 gender of the subject;

6. The laboratory identification number;

7. The specimen type;

8. The date of collection of the specimen;

9. The type of test ordered on the specimen; and

10. The ordering health care provider's name, address, telephone number, and, if available, email address.

C. Except as provided in Table 2.3 and as specified in subsection (D), 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 gender of the subject;

6. The laboratory identification number;

7. The specimen type;

8. The date of collection of the specimen;

9. The date of the result of the test;

10. The type of test completed on the specimen;

11. The test result, including quantitative values and reference ranges, if applicable; and

12. The ordering health care provider's name, address, telephone number, and, if available, email address.

D. When the Arizona State Laboratory obtains a test result from anonymous HIV testing sent to the Arizona State Laboratory as described in R9-6-1005, the director of the Arizona State Laboratory shall, either personally or through a representative:

1. Submit a report to the Department within five working days after obtaining a positive test result; and

2. Include in the report the following information:

a. The laboratory identification number of the subject;

b. The date of birth, gender, race, and ethnicity of the subject;

c. The date the specimen was collected;

d. The type of tests completed on the specimen;

e. The test results, including quantitative values if available; and

f. The name, address, and telephone number of the person who submitted the specimen to the Arizona State Laboratory.

Ariz. Admin. Code § R9-6-204

Adopted effective October 19, 1993 (Supp. 93-4). Former R9-6-204 renumbered to R9-6-302; new R9-6-204made 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 1/1/2018.