WSR 22-05-012

PREPROPOSAL STATEMENT OF INQUIRY

STATE BOARD OF HEALTH

[Filed February 4, 2022, 7:10 a.m.]

Subject of Possible Rule Making: Chapter 246-650 WAC, Newborn screening. The Washington state board of health (board) is considering adding ornithine transcarbamylase defiency [deficiency] (OTCD) to the list of mandatory conditions for newborn screening conducted by the department of health (department).

Statutes Authorizing the Agency to Adopt Rules on this Subject: RCW 70.83.050 and 70.83.020.

Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: OTCD is a severe condition with rapid onset that can result in significant morbidity and mortality if not detected and treated early. OTCD is a urea cycle disorder which causes ammonia to accumulate in the blood, affecting the liver and other body systems. Newborn screening, resulting in possible early diagnosis, is essential to improve quality of life for infants and their families, and reduce infant mortality.

Process for Developing New Rule: Collaborative; the board convened with the department, a technical advisory committee of multidisciplinary members to assess OTCD against a set of criteria for inclusion on the newborn screening panel. The board discussed the committee's recommendations and voted to proceed with rule making to consider rules that would allow for screening for OTCD in the newborn screening program.

Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication by contacting Samantha Pskowski, P.O. Box 47990, Olympia, WA 98504-7990, phone 360-789-2358, TTY 711, email samantha.pskowski@sboh.wa.gov, website https://sboh.wa.gov/Rulemaking/CurrentRulesandActivity/NewbornScreeningOTCD.

Additional comments: To be added to the listserv for notifications regarding this rule making, email Samantha.pskowski@SBOH.wa.gov with the subject line "Newborn Screening - OTCD." For more information, please view the website at https://sboh.wa.gov/Rulemaking/CurrentRulesandActivity/NewbornScreeningOTCD.

February 3, 2022

Michelle A. Davis

Executive Director