OAR 333-024-1010
Newborn Screening: Definitions

As used in OAR 333-024-1000 (Newborn Screening: Purpose) to 333-024-1110 (Newborn Screening: Failure to Comply):
(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 (Purpose) to 333-024-0055 (Incompetence).
(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 (Definitions).
(5) “Hospital” has the meaning given that term in ORS 442.015 (Definitions)
(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 (Newborn Screening: The Newborn Screening Panel and Methods of Testing) 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 (Examinations by state laboratory) and 433.285 (Policy to control metabolic diseases).
(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 (Newborn Screening: Persons Responsible for Ensuring that First Specimens are Collected and Submitted)(1) and OAR 333-024-1025 (Newborn Screening: Persons Responsible for Ensuring that Second, Third and Repeat Specimens are Collected and Submitted)(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 (Newborn Screening: Purpose) through 333-024-1110 (Newborn Screening: Failure to Comply).

Source: Rule 333-024-1010 — Newborn Screening: Definitions, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-024-1010.

333‑024‑0005
Purpose 333‑024‑0010
Definitions 333‑024‑0012
Licensure 333‑024‑0016
Licensure Categories 333‑024‑0020
Licensure for Performance of Laboratory Specialties 333‑024‑0021
Qualifications and Responsibilities of Directors for High Complexity Laboratories 333‑024‑0022
Qualifications and Responsibilities for Director of Moderate Complexity Laboratories 333‑024‑0023
Qualifications and Responsibilities of Consultants, Supervisors and Testing Personnel for Moderate and High Complexity Laboratories 333‑024‑0026
Equipment and Facilities 333‑024‑0035
Internal Quality Control for Moderate and High Complexity Laboratories 333‑024‑0037
Specialty and Subspecialty Quality Control 333‑024‑0040
External Quality Control (Proficiency Testing Programs and On-Site Inspections) 333‑024‑0043
Quality Assurance 333‑024‑0045
Venereal Disease Testing 333‑024‑0050
Records and Reports 333‑024‑0053
Accreditation Organizations and Accredited Laboratories 333‑024‑0055
Incompetence 333‑024‑0260
Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Purpose 333‑024‑0265
Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Procedure 333‑024‑0305
Testing for Substances of Abuse: Purpose and Scope 333‑024‑0310
Testing for Substances of Abuse: Definitions 333‑024‑0315
Testing for Substances of Abuse: Licensure 333‑024‑0320
Testing for Substances of Abuse: Qualifications and Responsibilities of Directors 333‑024‑0325
Testing for Substances of Abuse: Incompetence 333‑024‑0330
Testing for Substances of Abuse: Specimen Collection, Chain of Custody, Records, and Reports 333‑024‑0335
Testing for Substances of Abuse: Internal Quality Assurance 333‑024‑0340
Testing for Substances of Abuse: External Quality Control (Proficiency Testing Program and On-Site Inspections) 333‑024‑0345
Testing for Substances of Abuse: Confirmatory Testing 333‑024‑0350
Testing for Substances of Abuse: Equipment and Facilities 333‑024‑0360
Testing for Substances of Abuse: Special Category Laboratories 333‑024‑0365
Testing for Substances of Abuse: Substance of Abuse Registration 333‑024‑0370
Health Screen Testing: Purpose 333‑024‑0375
Health Screen Testing: Definitions 333‑024‑0380
Health Screen Testing: Permits 333‑024‑0385
Health Screen Testing: Testing Site Schedule 333‑024‑0390
Health Screen Testing: Personnel Qualifications and Responsibilities 333‑024‑0395
Health Screen Testing: Tests Performed 333‑024‑0400
Health Screen Testing: Quality Assurance 333‑024‑1000
Newborn Screening: Purpose 333‑024‑1010
Newborn Screening: Definitions 333‑024‑1020
Newborn Screening: Persons Responsible for Ensuring that First Specimens are Collected and Submitted 333‑024‑1025
Newborn Screening: Persons Responsible for Ensuring that Second, Third and Repeat Specimens are Collected and Submitted 333‑024‑1030
Newborn Screening: Timing for Collecting Specimens 333‑024‑1040
Newborn Screening: Manner of Submitting Specimens 333‑024‑1050
Newborn Screening: Religious Exemption from Newborn Testing 333‑024‑1060
Newborn Screening: Improperly Collected Specimens 333‑024‑1070
Newborn Screening: The Newborn Screening Panel and Methods of Testing 333‑024‑1080
Newborn Screening: Result Reporting and Follow-up 333‑024‑1090
Newborn Screening: Use, Release and Retention of Residual Specimens 333‑024‑1100
Newborn Screening: Ordering Specimen Collection Kits and Fees 333‑024‑1110
Newborn Screening: Failure to Comply 333‑024‑2000
Fees for Communicable Disease Tests Performed in the State Laboratory
Last Updated

Jun. 8, 2021

Rule 333-024-1010’s source at or​.us