Or. Admin. Code § 333-024-1010

Current through Register Vol. 63, No. 12, December 1, 2024

Section 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 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) "Hospital" has the meaning given that term in ORS 442.015

(6) "Kit" means the filter paper collection device, attached demographic form, and other items provided by the Oregon State Public Health Laboratory for the purposes of collection or submission of specimens for newborn screening testing.

(7) "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.

(8) "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.

(9) "PCR" means polymerase chain reaction.

(10) "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 mother prior to the infant being born in Oregon.

(11) "Preterm" means an infant born prior to the start of the 37th week of pregnancy.

(12) "Residual specimen" means the part of the specimen that is left after newborn screening testing activities are complete.

(13) "Second tier testing" means additional testing performed for the purpose of reducing the number of false-positive results reported for a given disorder.

(14) "Specimen" means a blood specimen obtained from an infant by means of capillary-puncture or skin-puncture (heel stick) and placed on a special filter paper kit and allowed to air dry.

(15) "These rules" means OAR 333-024-1000 through 333-024-1110.

Or. Admin. Code § 333-024-1010

PH 283-2018, adopt filed 12/20/2018, effective 01/01/2019; PH 24-2019, amend filed 11/18/2019, effective 11/25/2019; PH 77-2024, amend filed 10/29/2024, effective 11/20/2024

Statutory/Other Authority: ORS 413.014, 433.285 & 431A.750

Statutes/Other Implemented: ORS 433.285, 433.290 & 433.295