Section R9-6-204. Clinical Laboratory Director Reporting Require- ments

A.      Except as specified in subsection (D), a director of a clinical laboratory that obtains a test result described in Table 3 or that receives a specimen for detection of an infectious agent or toxin listed in Table 3 shall, either personally or through a rep- resentative, submit a report and, if applicable, an isolate or a specimen to the Department within the time limitation and as specified in Table 3 and subsection (B) or (C).

B.       Except as provided in Table 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 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, if available, the address and telephone number 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 if available; and

12.     The ordering health care provider’s name, address, and telephone number.

C.      For each specimen for which an immediate report is required by subsection (A) and Table 3, a clinical laboratory director shall submit a report that includes:

1.        The name and, if available, the address and telephone number of the subject;

2.        The date of birth of the subject;

3.        The gender of the subject;

4.        The laboratory identification number;

5.        The specimen type;

6.        The date of collection of the specimen;

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

8.        The ordering health care provider’s name, address, and telephone number.

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.

E.       The Department shall supply the director of each clinical labo- ratory with forms that may be used by the clinical laboratory when making a report required under subsection (A) or (D) and Table 3.

F.       A clinical laboratory director shall submit a report by tele- phone; in a document sent by fax, delivery service, or mail; or through an electronic reporting system authorized by the Department. Except as provided in Table 3, each report shall contain the information required under subsection (B), (C), or (D).

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).

) Arboviruses +,ã Haemophilus influenzae, other, + Plasmodium spp.       isolated  from a  normally sterile       %,(,ã   Bacillus anthracis   + site Hantavirus       +   Respiratory syncytial virus

Table 3.          Clinical Laboratory Director Reporting Requirements

(,ã           Bordetella pertussis                        +1   ),ã            Brucella spp.                                   +1       +1   +1			Hepatitis A virus (anti-HAV-IgM serologies)	(,+	Rubella virus and anti-rubella- IgM serologies
			Hepatitis B virus (anti-Hepatitis B	), ã	Salmonella spp.
			core-IgM serologies, Hepatitis B
			surface or envelope antigen serol-
			ogies, or detection of viral nucleic
			acid)
			Hepatitis C virus	(	SARS-associated corona virus
			Hepatitis D virus	), ã	Shigella spp.
+	CD4-T-lymphocyte    count    of fewer than 200 per microliter of	+1,+	Hepatitis E virus (anti-HEV-IgM serologies)	+	Streptococcus Group A, isolated from a normally sterile site
	whole blood or CD4-T-lympho- cyte percentage of total
	lymphocytes of less than 14%
+	Chlamydia trachomatis	+	HIV (by culture, antigen, antibod-	+	Streptococcus Group B, isolated
			ies  to  the  virus,  or  detection  of		from a normally sterile site in
			viral nucleic acid)		an infant younger than 90 days
					of age
%, (	Clostridium   botulinum   toxin	+	HIV—any test result for an infant	+,ã	Streptococcus  pneumoniae  and
	(botulism)		(by culture, antigen, antibodies to		its drug sensitivity pattern, iso-
			the  virus,  or  detection  of  viral		lated from a normally sterile site
			nucleic acid)
+	Coccidioides spp., by culture or	+	Influenza virus	+	Treponema pallidum (syphilis)
	serologies
)	Coxiella burnetti	+,ã	Legionella spp. (culture or DFA)	+	Trypanosoma cruzi (Chagas dis-
					ease)
+	Cryptosporidium spp.	),ã	Listeria spp., isolated from a nor-
			mally sterile site
)	Cyclospora spp.	(,+	Measles  virus  and  anti-measles-	),ã	Vancomycin-resistant or Vanco-
			IgM serologies		mycin-intermediate      Staphylo-
					coccus aureus
+	Dengue virus	+2	Methicillin-resistant Staphylococ- cus aureus, isolated from a nor- mally sterile site	),ã	Vancomycin resistant Staphylo- coccus epidermidis
%,(	Emerging   or   exotic   disease	),+	Mumps  virus  and  anti-mumps-	%,(	Variola virus (smallpox)
	agent		IgM serologies
+	Entamoeba histolytica	+,ã3	Mycobacterium tuberculosis com-	),ã	Vibrio spp.
)	Escherichia coli O157:H7		plex and its drug sensitivity pat- tern	%,(	Viral hemorrhagic fever agent
),ã	Escherichia   coli,   Shiga-toxin	+	Neisseria gonorrhoeae	+	West Nile virus
	producing
%,(,ã	Francisella tularensis	(,ã	Neisseria   meningitidis,   isolated	),ã	Yersinia spp. (other than Y. pes-
			from a normally sterile site		tis)
(,ã	Haemophilus  influenzae,  type	+	Norovirus	%,(,ã	Yersinia pestis (plague)
	b, isolated from a normally ster-
	ile site
Key:

%     Submit a report immediately after receiving one specimen for detection of the agent. Report 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 3.

ã     Submit an isolate of the organism for each positive culture to the Arizona State Laboratory at least once each week, as applicable.

+      For each positive test result, submit a specimen to the Arizona State Laboratory within 24 hours after obtaining the positive test result.

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.

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

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

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).