Ariz. Admin. Code § 9-13-201
Current through Register Vol. 30, No. 45, November 8, 2024
Section R9-13-201 - DefinitionsIn this Article, unless otherwise specified:
1. "Abnormal result" means an outcome that deviates from the range of values established by: a. The Department for an analysis performed as part of a bloodspot test or for a hearing test, orb. A health care facility or health care provider for critical congenital heart defect screening.2. "Admission" or "admitted" means the same as in A.A.C. R9-10-101.3. "AHCCCS" means the Arizona Health Care Cost Containment System.4. "Amino acid disorder" means a congenital disorder characterized by the abnormal accumulation of an amino acid or another nitrogen-containing molecule due to a defective enzyme. 5. "Arizona State Laboratory" means the entity operated according to A.R.S. § 36-251.6. "Audiological equipment" means an instrument used to help determine the presence, type, or degree of hearing loss by:a. Providing ear-specific and frequency-specific stimuli to an individual; orb. Measuring an individual's physiological response to stimuli.7. "Audiologist" means the same as in A.R.S. § 36-1901. 8. "Birth center" means a health care facility that is not a hospital and is organized for the purpose of delivering newborns.9. "Blood sample" means capillary or venous blood, and possibly arterial blood but not cord blood, applied to the filter paper of a specimen collection kit.10. "Bloodspot test" means multiple laboratory analyses performed on a blood sample to screen for the presence of congenital disorders listed in R9-13-203. 11. "Congenital disorder" means an abnormal condition present at birth, as a result of heredity or environmental factors, that impairs normal physiological functioning of a human body. 12. "Critical congenital heart defect" means a heart abnormality or condition present at birth that places a newborn or infant at significant risk of disability or death if not diagnosed soon after birth. 13. "Department" means the Arizona Department of Health Services.14. "Diagnostic evaluation" means a hearing test performed by an audiologist or a physician to determine whether hearing loss exists, and, if applicable, determine the type or degree of hearing loss.15. "Discharge" means the termination of inpatient services to a newborn or an infant.16. "Disorder" means a disease or medical condition that may be identified by a laboratory analysis.17. "Document" means to establish and maintain information in written, photographic, electronic, or other permanent form.18. "Educational materials" means printed or electronic information provided by the Department, explaining newborn and infant screening, any of the congenital disorders listed in R9-13-203, hearing loss, or critical congenital heart defect.19. "Electronic" means the same as in A.R.S. § 44-7002.20. "Endocrine disorder" means a congenital disorder characterized by an abnormal amount of a hormone being secreted from a gland into the blood stream.21. "Fatty acid oxidation disorder" means a congenital disorder characterized by the inability of the body to break down fatty acids as a source of energy.22. "First specimen" means a specimen that is collected from a newborn who is less than five days of age and sent to the Arizona State Laboratory for testing and recording of demographic information. 23. "Guardian" means an individual appointed by a court under A.R.S. Title 14, Chapter 5, Article 2.24. "Health care facility" means a health care institution, as defined in A.R.S. § 36-401, where obstetrical care or newborn care is provided.25. "Health care provider" means a physician, physician assistant, registered nurse practitioner, or midwife.26. "Health-related services" means the same as in A.R.S. § 36-401.27. "Hearing screening" means a hearing test to determine the likelihood of hearing loss in a newborn or infant.28. "Hearing test" means an evaluation of each of a newborn's or an infant's ears, using audiological equipment to: a. Screen the newborn or infant for a possible hearing loss;b. Determine that the newborn or infant does not have a hearing loss; orc. Diagnose a hearing loss in the newborn or infant, including determining the type or degree of hearing loss. 29. "Hemoglobinopathy" means a congenital disorder characterized by abnormal production, structure, or functioning of hemoglobin.30. "Home birth" means delivery of a newborn, outside a health care facility, when the newborn is not hospitalized within 72 hours of delivery. 31. "Hospital" means the same as in A.A.C. R9-10-101.32. "Hospital services" means the same as in A.A.C. R9-10-201. 33. "Identification code" means a unique set of numbers or letters, or a unique set of both numbers and letters, assigned by the Department to a health care facility, a health care provider, an audiologist, or another person submitting specimen collection kits to the Arizona State Laboratory or hearing test results to the Department.34. "Infant" means the same as in A.R.S. § 36-694.35. "Initial specimen" means the earliest specimen that was collected from a newborn or infant and sent to the Arizona State Laboratory for testing.36. "Inpatient" means an individual who:a. Is admitted to a hospital,b. Receives hospital services for 24 consecutive hours, orc. Is admitted to a birth center.37. "Inpatient services" means medical services, nursing services, or other health-related services provided to an inpatient in a health care facility. 38. "Medical services" means the same as in A.R.S. § 36-401. 39. "Midwife" means an individual licensed under A.R.S. Title 36, Chapter 6, Article 7, or certified under A.R.S. Title 32, Chapter 15. 40. "Newborn" means the same as in A.R.S. § 36-694.41. "Newborn care" means medical services, nursing services, and health-related services provided to a newborn.42. "Nursing services" means the same as in A.R.S. § 36-401.43. "Obstetrical care" means medical services, nursing services, and health-related services provided to a woman throughout her pregnancy, labor, delivery, and postpartum.44. "Organ" means a somewhat independent part of a human body, such as a salivary gland, kidney, or pancreas, which performs a specific function.45. "Organic acid disorder" means a congenital disorder characterized by the abnormal accumulation of organic acids in the blood and urine due to a defective enzyme.46. "Parent" means a natural, adoptive, or custodial mother or father of a newborn or an infant.47. "Parenteral nutrition" means the feeding of an individual intravenously through the administration of a formula containing at least glucose and amino acids, as well as possibly lipids, vitamins, and minerals.48. "Person" means the state, a municipality, district, or other political subdivision, a cooperative, institution, corporation, company, firm, partnership, individual, or other legal entity. 49. "Physician" means an individual licensed under A.R.S. Title 32, Chapters 13, 14, 17, or 29.50. "Physician assistant" means an individual licensed under A.R.S. Title 32, Chapter 25. 51. "Pulse oximetry" means a non-invasive method of measuring the percentage of hemoglobin in the blood that is saturated with oxygen using a device approved by the U.S. Food and Drug Administration for use with newborns or infants less than six weeks of age.52. "Registered nurse practitioner" means the same as in A.R.S. § 32-1601.53. "Second specimen" means a specimen that is sent to the Arizona State Laboratory for testing and recording of demographic information, after being collected from an individual who is at least five days and not older than one year of age.
54. "Sickle cell disease" means a hemoglobinopathy characterized by an abnormally shaped red blood cell resulting from the abnormal structure of the protein hemoglobin.55. "Sickle cell gene" means a unit of inheritance that is involved in producing an abnormal type of the protein hemoglobin, in which the amino acid valine is substituted for the amino acid glutamic acid at a specific location in the hemoglobin.56. "Specimen" means a blood sample obtained from and demographic information about a newborn or an infant.57. "Specimen collection kit" means a strip of filter paper for collecting a blood sample attached to a form for obtaining the information specified in R9-13-203(B)(3) about a newborn or an infant. 58. "Transfer" means a health care facility or health care provider discharging a newborn and sending the newborn to a hospital for inpatient medical services without the intent that the patient will be returned to the sending health care facility or health care provider.59. "Transfusion" means the infusion of blood or blood products into the body of an individual. 60. "Verify" means to confirm by obtaining information through a source such as the newborn screening program, a health care provider, a health care facility, or a documented record. 61. "Working day" means 8:00 a.m. through 5:00 p.m. Monday through Friday, excluding state holidays. Ariz. Admin. Code § R9-13-201
Amended effective October 26, 1977 (Supp. 77-5). Former Section R9-13-201 repealed, new Section R9-13-201 adopted effective July 16, 1981 (Supp. 81-4). Amended as an emergency effective September 21, 1982, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 82-5). Emergency expired. Permanent rule adopted effective March 22, 1983 (Supp. 83-2). Amended by adding paragraphs (3), (5) and (7) and renumbering remaining paragraphs effective November 23, 1983. Amended as an emergency, by adding paragraphs (32) and (42) and renumbering remaining paragraphs, effective November 23, 1983, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 83-6). Emergency amendment expired. Permanent amendment, adding paragraphs (32) and (42) and renumbering remaining paragraphs adopted effective March 19, 1984 (Supp. 84-2). Amended as an emergency effective November 6, 1989, pursuant to A.R.S. § 41-1026, valid for only 90 days (Supp. 89-4). Emergency expired. Readopted as an emergency effective February 7, 1990, pursuant to A.R.S. § 41-1026, valid for only 90 days (Supp. 90-1). Re-adopted as an emergency with changes effective May 7, 1990, pursuant to A.R.S. § 41-1026, valid for only 90 days (Supp. 90-2). Readopted as an emergency with changes effective August 6, 1990, pursuant to A.R.S. § 41-1026, valid for only 90 days (Supp. 90-3). Readopted as an emergency without change effective October 31, 1990, pursuant to A.R.S. § 41-1026, valid for only 90 days (Supp. 90-4). Readopted as an emergency with changes effective January 16, 1991, pursuant to A.R.S. § 41-1026, valid for only 90 days (Supp. 91-1). Readopted as an emergency without change effective April 11, 1991, pursuant to A.R.S. § 41-1026, valid for only 90 days (Supp. 91-2). Emergency amendments permanently adopted with changes effective July 3, 1991 (Supp. 91-3). Amended effective December 16, 1996 (Supp. 96-4). Section automatically repealed by final rulemaking at 3 A.A.R. 146, effective September 24, 1998 (Supp. 99-1). New Section recodified from R9-14-501 at 11 A.A.R. 3577, effective August 31, 2005 (Supp. 05-3). Amended by final rulemaking at 12 A.A.R. 1166, effective April 4, 2006 (Supp. 06-2). Amended by final rulemaking at 20 A.A.R. 953, effective 4/1/2014. Amended by exempt rulemaking at 29 A.A.R. 1083, effective 7/1/2015. Amended by final rulemaking at 23 A.A.R. 3262, effective 11/7/2017. Amended by final expedited rulemaking at 28 A.A.R. 223, effective 12/30/2021. Amended by final rulemaking at 28 A.A.R. 2543, effective 9/8/2022.