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;
6.7. The laboratory
identification number;
7.8. The specimen
type;
8.9. The date of
collection of the specimen;
9.10. The type of test
ordered on the specimen; and
10.11. 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;
6.7. The laboratory
identification number;
7.8. The specimen
type;
8.9. The date of
collection of the specimen;
9.10. The date of the
result of the test;
10.11. The type of test
completed on the specimen;
11.12. 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
12.13. 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.
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.
