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.
Historical Note
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).