CurrentOregon Health AuthorityPolicy PH 22-2025

Newborn bloodspot screening program coverage criteria and panel updates

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Governs Oregon newborn bloodspot screening procedures, definitions, specimen collection timing, use/retention of residual specimens, and the list of conditions tested; applies to facilities, practitioners, and the Oregon State Public Health Laboratory involved in newborn screening in Oregon.

Policy Summary

PayerOregon Health Authority

PolicyNewborn bloodspot screening program coverage criteria and panel updates

Policy CodePolicy PH 22-2025

Change TypePanel addition and rule updates

Effective DateNov 1, 2025

Next Review Date

Key ActionCollect newborn specimens using the OSPHL kit at specified timing windows and submit to OSPHL or a CLIA-certified laboratory.

SourceLink

POLICY UPDATE CHANGES

Infantile Krabbe Disease is added to the newborn screening panel effective November 1, 2025.

Timing for a third specimen in premature or low birth weight infants changed from 'one month' to '28 days'.

Definitions clarified for 'higher-tier testing', 'kit', 'specimen', 'facility', and others in OAR 333-024-1010.

Residual specimen use and release rules updated, including repeal of use for unspecified educational activities and a 12-month retention/destruction rule.

1new condition added to panel

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CurrentOregon Health AuthorityPolicy PH 22-2025

Newborn bloodspot screening program coverage criteria and panel updates

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Sign up for Oregon Health Authority Policy PH 22-2025 alerts

Get alerted when Policy PH 22-2025 changes without checking for updates manually.

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Policy Summary

PayerOregon Health Authority

PolicyNewborn bloodspot screening program coverage criteria and panel updates

Policy CodePolicy PH 22-2025

Change TypePanel addition and rule updates

Effective DateNov 1, 2025

Next Review Date

Key ActionCollect newborn specimens using the OSPHL kit at specified timing windows and submit to OSPHL or a CLIA-certified laboratory.

SourceLink

POLICY UPDATE CHANGES

Infantile Krabbe Disease is added to the newborn screening panel effective November 1, 2025.

Timing for a third specimen in premature or low birth weight infants changed from 'one month' to '28 days'.

Definitions clarified for 'higher-tier testing', 'kit', 'specimen', 'facility', and others in OAR 333-024-1010.

Residual specimen use and release rules updated, including repeal of use for unspecified educational activities and a 12-month retention/destruction rule.

1new condition added to panel

Coverage Criteria and Program Requirements

Program requirements

Providers and facilities must follow these requirements for newborn screening collection, testing, and specimen handling:

Specimen collection timing: Collect first specimen as soon as possible after 24 hours of age but before 48 hours of age; collect second specimen between 10 and 14 days of age; collect an additional specimen at approximately 28 days for infants born <34 weeks gestation or weighing <2000 grams; collect additional repeat specimens if requested by the Oregon State Public Health Laboratory and submit according to the timeline identified by the Oregon State Public Health Laboratory.timing windows as stated

If an infant under six months enters care and testing history is unknown, collect and send a specimen within two weeks of the first visit.

Specimen collection materials and submitters: Use the Oregon State Public Health Laboratory specimen collection kit (filter paper collection card with attached demographic form) and ensure specimens are properly collected, dried, and submitted to the Oregon State Public Health Laboratory or, at OSPHL's discretion, another CLIA-certified laboratory.proper collection on kit

Collection must be performed by facilities or individuals defined as facility or practitioner under the rules.

Testing panel and methods: Every properly collected specimen will be tested for the conditions listed in OAR 333-024-1070 using the methods specified (including tandem mass spectrometry, fluorescent immunoassay, PCR, electrophoresis/liquid chromatography, colorimetric/fluorometric assays, and higher-tier molecular or biochemical analysis where indicated); Infantile Krabbe Disease is added to the panel effective November 1, 2025.conditions and methods enumerated in rule

OSPHL may use equivalent or better alternative methods consistent with CLIA.

Higher-tier testing: Perform higher-tier testing on the same specimen as needed to reduce false positives; higher-tier methods may include biochemical markers or molecular analysis as specified for particular disorders.laboratory discretion with CLIA compliance

Higher-tier testing purpose is to reduce false-positive results.

Residual specimen use, release, and retention: Residual specimens may be used by OSPHL for quality assurance, method development, program evaluation, and quality improvement; specimens may be released only as specified (to third-party labs, by court order, or to a parent/guardian with written authorization) and not within 30 days of the report of screening results; specimens are retained for 12 months and then destroyed unless retained longer for permitted purposes, in which case they will be deidentified.12 months retention

Use of residual specimens for unspecified educational activities has been repealed; release to parents requires OSPHL procedure and cannot occur within 30 days of result report.

Routine newborn screening

Routine newborn screening is covered when specimens are properly collected and submitted per program rules:

Eligible specimens: Every properly collected newborn screening specimen submitted to the Oregon State Public Health Laboratory (or, at OSPHL's discretion, another CLIA-certified laboratory) from infants born in Oregon who survive more than two days is eligible for routine newborn screening.properly collected specimen

Applies to every infant born in Oregon surviving more than two days unless exempt under OAR 333-024-1050.

Infants entering care with unknown testing status: If an infant under six months of age enters care and the practitioner cannot determine whether the infant has been tested, the practitioner must collect and send a specimen to OSPHL within two weeks of the first visit.within two weeks of first visit

Ensures infants entering care whose testing status is unknown receive screening.

Panel covered:

The rule repeals the prior allowance of using residual newborn screening specimens for unspecified educational activities because no specific educational activity requiring residual specimens is identified. Residual specimens are now limited to defined purposes and subject to release and retention conditions under OAR 333-024-1090.

Provider Responsibilities and Testing Operations

Prior Authorization

Testing performed by OSPHL or CLIA lab

Every properly collected newborn screening specimen will be tested by the Oregon State Public Health Laboratory (OSPHL) or, at OSPHL's discretion, by another CLIA-certified laboratory; no prior authorization is specified for these tests.

Step Therapy

Higher-tier testing on same specimen to reduce false positives

Higher-tier testing may be performed on the same specimen to reduce false-positive results; methods may include biochemical marker testing or molecular analysis as specified for particular conditions and at the laboratory's discretion.

Definition: "Higher-tier testing" means additional testing performed after screening on the same specimen for the purpose of reducing the number of false-positive results.
Examples in methods: higher tier molecular analysis for cystic fibrosis and molecular or biochemical higher-tier testing for lysosomal storage diseases.

Key Definitions

Higher-tier testing — definition and purpose

DefinitionHigher-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.

PurposeReduce number of false-positive results reported for a given disorder by performing supplemental biochemical or molecular analyses on the original specimen.

Performed byOregon State Public Health Laboratory or a laboratory under contract with the Oregon Health Authority in accordance with CLIA.

Kit — contents and use

DefinitionKit means the specimen collection card (also known as the filter paper collection device), the 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.

Contents

Specimen Frequency and Panel Timing

Newborn bloodspot screening — specimen timing and repeat triggers

First specimen timingCollect as soon as possible after 24 hours of age but before 48 hours of age.

Second specimen timingCollect between 10 and 14 days of age.

Additional specimen for premature/low birth weightCollect an additional specimen at approximately 28 days of age for infants born at <34 weeks gestation or weighing <2000 grams.

Repeat specimen triggersCollect additional, repeat specimens if requested by the Oregon State Public Health Laboratory and submit according to the timeline they identify.

Infants entering careIf an infant under six months enters care and testing status is unknown, collect and send a specimen to OSPHL within two weeks of the first visit.

Who May Order and Collect

Note

Who may collect specimens and rule for infants entering care

Specimens must be collected by individuals or facilities meeting the rule definitions of 'facility' or 'practitioner'; if an infant under six months enters care with unknown testing status, the practitioner must collect and send a specimen to OSPHL within two weeks of the first visit.

Facility includes hospitals, freestanding birthing centers, and clinics/offices providing direct care to newborns or infants six months or younger.
Practitioner collection and submission required within two weeks when prior testing cannot be confirmed for infants <6 months.

Not Covered Uses of Specimens

NOT COVERED: Use of residual specimens for unspecified educational activities has been repealed. Residual specimens may only be used for the limited purposes enumerated in OAR 333-024-1090 (quality assurance and method development to maintain CLIA compliance; program evaluation and quality improvement; and educational activities as required in ORS 433.290) and are otherwise not available for general or unspecified educational use.

Residual specimens are retained for 12 months and then destroyed using a secure method unless retained longer for one of the permitted purposes; specimens retained longer must be deidentified.

Background and Program Scope

BACKGROUND: Newborn bloodspot screening identifies conditions through testing of heel‑stick blood specimens placed on special filter paper. The Oregon rule updates focus not on the clinical intent of screening but on how residual specimens may be used, released, and retained. Under OAR 333-024-1090, the Oregon State Public Health Laboratory may use residual specimens for quality assurance and method development, program evaluation and quality improvement, and certain educational activities required by statute, while setting limits on release and a 12‑month retention period followed by secure destruction unless longer retention is necessary for permitted purposes and then deidentified.