Ariz. Admin. Code § 9-14-701

Current through Register Vol. 30, No. 45, November 8, 2024

Section R9-14-701 - Health Screening Laboratory Services

A. In this Section, unless otherwise specified, the following definitions apply:

1. "Activities of daily living" means the tasks that support everyday life, such as toileting, bathing, dressing, eating, moving about, and getting in or out of bed.

2. "Assist" means to give help, support, or aid to an individual in performing a task.

3. "Caregiver" means an individual, such as a home health aide, who receives monetary compensation for assisting another individual with activities of daily living.

4. "Certified laboratory" means the same as in A.R.S. § 36-451.

5. "Drug of abuse" means a chemical substance, such as a narcotic or hallucinogen, that is used by an individual for non-medicinal reasons.

6. "Family member" means an individual related to another individual by birth, marriage, or adoption.

7. "Forensic" means relating to the use of science or technology in the investigation and establishment of facts or evidence intended for use in a court of law.

8. "Guardian" means an individual appointed as a legal guardian by a court of competent jurisdiction.

9. "Health screening laboratory services" means health screening services that determine the need for medical services, as defined in A.R.S. § 36-401, through the performance of laboratory analyses.

10. "Health screening services" means the same as in A.R.S. § 36-401.

11. "Home health aide" means an individual who receives monetary compensation from a home health agency, as defined in A.R.S. § 36-151, or a hospice service agency, as defined in A.R.S. § 36-401, to provide assistance to another individual who is not physically or mentally able to perform one or more of the activities of daily living.

12. "In vitro diagnostic device" means a piece of equipment or tool:

a. Approved by the U.S. Food and Drug Administration for home use,

b. Used for the measurement of specific chemicals in materials derived from the human body,

c. Sold without a prescription, and

d. Specified in a list available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.cfm.

13. "Laboratory analysis" means a test performed by a laboratory on body fluid, tissue, or excretion for the purpose of determining the presence, absence, or concentration of various substances in the human body.

14. "Research" means a systematic investigation to establish facts that may contribute to knowledge from which an individual may draw inferences or a general conclusion.

B. Except as specified in subsection (C), only a certified laboratory shall perform health screening laboratory services.

C. This Section does not apply when:

1. A test is performed by an individual, a family member or guardian of the individual, or another individual under A.R.S. § 32-1471:

a. Using an in vitro diagnostic device, and

b. On materials derived from the individual's body;

2. An individual's caregiver assists the individual to perform a test:

a. Using an in vitro diagnostic device, and

b. On materials derived from the individual's body;

3. A laboratory analysis is performed solely for forensic or research purposes;

4. A laboratory analysis is performed on urine to test for drugs of abuse solely for employment purposes; or

5. A laboratory analysis is performed under the jurisdiction of the U.S. Department of Veteran's Affairs or a component of the U.S. Department of Defense.

Ariz. Admin. Code § R9-14-701

Adopted effective December 2, 1993 (Supp. 93-4). Section repealed; new Section made by final rulemaking at 12 A.A.R. 4694, effective February 3, 2007 (Supp. 06-4).