Newborn Screening - Adding OTC Deficiency, GAMT Deficiency, and ARG1-D

Summary

The Washington State Department of Health (Department) tests all babies born in Washington State for rare but treatable health issues through a process called “newborn screening.” This is done using a small blood sample collected from a baby’s heel. State law requires the State Board of Health (Board) to establish rules for newborn screening. This includes the list of conditions that all babies are tested for after birth. Since 2021, the Board has approved adding three new conditions to the required screening panel: OTC Deficiency, GAMT Deficiency, and ARG1-D. The Department anticipates starting testing for these new conditions by early 2026.

For More Information

Statutory Authority: RCW 70.83.050
Board Contact: Molly Dinardo, molly.dinardo@sboh.wa.gov
Department of Health Contact: Megan McCrillis, megan.mcrillis@doh.wa.gov
To receive future updates on these rules, including email notices about next steps and public involvement opportunities, please complete the newborn screening rulemaking interest form online here: https://airtable.com/appInSCDg3PQGljEz/pagbfxJg9B2dCn04R/form

Share Your Input on Updates to the Board’s Newborn Screening Rules

The Board wants your feedback on proposed updates to the rules for newborn screening in Washington State. The purpose of these updates is to add three new conditions to the list of conditions that all newborns must be screened for at birth in Washington State. This is your chance to share ideas, ask questions, and suggest changes before the rules hearing scheduled for Wednesday, November 19, at 11:00 a.m.

The proposed rule is available in English. 
 

To submit comments on the proposed rule, use any of the following methods:

  • You may submit written comments through October 27, 2025, using the following options:
  • You may provide verbal comments during the rules hearing open to the public on November 19, 2025. The rules hearing begins at 11:00 a.m.
    • You may give verbal comments in person at the physical meeting location at:
      Washington State Department of Health
      111 Israel Road S.E.
      Tumwater, WA, 98501
      Building: Town Center Two (TC2, Rooms 166 & 167) OR
    • You may give verbal comments online by registering for the meeting via Zoom Webinar: https://us02web.zoom.us/webinar/register/WN_DlI0Jo2yQUe1KBgX_fIccw

Note: The Board will review and consider all written comments received as part of the official rulemaking file. All written comments received are public record and will be shared on the Board’s website.
 

Important Information for the Rules Hearing:

  • You may attend the rules hearing in person at the above address or virtually via Zoom Webinar.
  • To give verbal comments on Zoom, you must access the meeting using your computer, laptop, or device. Your computer, laptop, or device must have speakers and a microphone.
  • The rules hearing will provide Spanish and ASL interpretation services via the Zoom platform.
  • If you need the meeting interpreted in a different language, please contact Board staff by November 5, 2025.

To request documents in an alternative format or a different language or to request meeting accommodations, please contact the State Board of Health at 360-236-4110 or by email at wsboh@sboh.wa.gov.

Additional Background

Newborn Screening is a program within the Department that tests all babies for rare but treatable conditions using a dried blood sample. Under RCW 70.83.050, the Board is responsible for establishing rules for the program. This is outlined in chapter 246-650 WAC and includes the list of conditions that all newborns must be screened for.

Since 2021, the Board has approved adding three conditions to the mandatory screening panel:

A Technical Advisory Committee (TAC) recommended and evaluated these additions using the Board’s established process and criteria (updated August 20, 2025).

The Board filed two CR-101s (Proposed Statements of Inquiry) in February 2022 and November 2023. The filing notified the public of its intent to add these conditions to chapter 246-650 WAC.

Before the Board can add new conditions and screening begins, the Department must secure legislative approval to increase the newborn screening fee. This fee funds new tests, staff time, follow-up for positive results, and related administrative costs. The Health Care Authority (HCA) covers more than 40% of births in the state. Therefore, it must also seek approval to adjust Medicaid managed care rates to cover the increased fee.

During the 2025 legislative session, the Department and HCA secured funding to include the three new conditions. Testing is expected to begin in early 2026.

On February 4, 2022, the Board announced the project to add OTCD. You can find the announcement under WSR-22-05-012 (CR-101).

On November 28, 2023, the Board announced the project to add GAMT Deficiency and ARG1-D. You can find the announcement under WSR 23-24-016 (CR-101).

The draft proposed rules and rules hearing were announced on September 30, 2025, and are listed under WSR 25-20-091 (CR-102).

Related Links

October 9, 2023, Board Meeting

September 8, 2023, Newborn Screening Technical Advisory Committee (TAC) Meeting

April 12, 2023, Public Meeting