OAR 333-024-1010: Newborn Screening: Definitions

As used in OAR 333-024-1000 to 333-024-1110: (1) "Abnormal result" means a laboratory examination result that meets the screening criteria for a newborn screening panel condition requiring additional screening or diagnostic testing and medical follow-up. (2) "Clinical Laboratory Improvement Amendments (CLIA)" means the rules that apply to clinical laboratories in OAR 333-024-0005 to 333-024-0055. (3) "Facility" means: (a) Hospitals and freestanding birthing centers; and (b) Health care clinics and offices where practitioners and other health care professionals provide direct medical care to newborns or infants six months or younger. (4) "Freestanding birthing center" has the meaning given that term in ORS 442.015. (5) "Higher-tier testing" means additional testing performed after screening on the same specimen for the purpose of reducing the number of false-positive results reported for a given disorder. (6) "Hospital" has the meaning given that term in ORS 442.015 (7) "Kit" means the specimen collection card (also known as the filter paper collection device) and the attached demographic form for the purposes of collection and submission of specimens for newborn screening. (8) "Newborn screening panel" means the specific medical conditions screened for under OAR 333-024-1070 by the Oregon State Public Health Laboratory or a laboratory under contract with the Oregon Health Authority. (9) "Oregon State Public Health Laboratory" means the laboratory of the Oregon Health Authority that is CLIA certified, that performs testing pursuant to ORS 431A.750 and 433.285. (10) "PCR" means polymerase chain reaction. (11) "Practitioner" means: (a) A physician licensed under ORS chapter 677; (b) A naturopathic physician licensed under ORS chapter 685; (c) A nurse practitioner or advanced practice registered nurse licensed under ORS chapter 678; (d) A direct entry midwife licensed under ORS chapter 687; (e) A chiropractic physician licensed under ORS chapter 684; and (f) For purposes of OAR 333-024-1020(1) and OAR 333-024-1025(1) only, a licensed or unlicensed individual who takes responsibility for delivery or the health care of an infant born in Oregon; or being none, the individual in Oregon responsible for the health care of a pregnant person prior to the infant being born in Oregon. (12) "Residual specimen" means the part of the specimen that is left after newborn screening testing activities are complete. (13) "Specimen" means a blood specimen obtained from an infant by means of skin-puncture (heel stick) and placed on the specimen collection card and allowed to air dry. (14) "These rules" means OAR 333-024-1000 through 333-024-1110.