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.
Statutory/Other Authority
ORS 413.042 & ORS 433.110 - 433.770 (as amended by 2025 OL, Chapter 203)
Statutes/Other Implemented
ORS 433.110 - 433.770 (as amended by 2025 OL, Chapter 203)
History
PH 22-2025, amend filed 10/30/2025, effective 11/01/2025
PH 77-2024, amend filed 10/29/2024, effective 11/20/2024
PH 24-2019, amend filed 11/18/2019, effective 11/25/2019
PH 283-2018, adopt filed 12/20/2018, effective 01/01/2019