WSR 17-22-104 PREPROPOSAL STATEMENT OF INQUIRY STATE BOARD OF HEALTH [Filed October 31, 2017, 8:54 a.m.] Subject of Possible Rule Making: Chapter 246-650 WAC, Newborn screening, the Washington state board of health (board) is proposing to amend the newborn screening (NBS) rules to add Pompe disease and Mucopolysaccharidosis type I (MPS I) to the list of mandatory conditions for newborn screening conducted by the department of health; create a new section outlining critical congenital heart disease screening requirements for hospitals and health care providers attending a birth outside of a hospital to align with RCW 70.83.090; update language concerning the use and release of dried blood spots to align with the federal Newborn Screening Saves Lives Reauthorization Act of 2014; improve clarity and usability. Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: Pompe disease and MPS I are both severe conditions that can result in significant physical and mental morbidity or death if not detected and treated early. Early diagnosis of these conditions through NBS is essential to improve the quality of life for impacted infants and their families and in saving lives. Other changes the board is considering would provide clarity and consistency for stakeholders by aligning the rules with current state and federal statutes and federal regulations. Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: The United States Department of Health and Human Services and the Newborn Screening Saves Lives Reauthorization Act of 2014 regulate the protection of human subjects during research. These policies have minor overlap with the board's NBS rules, and the board is considering changes to the rule to ensure consistency with the federal requirements. Process for Developing New Rule: Collaborative; the board and the department of health used a multidisciplinary NBS advisory committee to evaluate whether Pompe disease and MPS I met the board's criteria for inclusion in the NBS panel. The board discussed the recommendations and comments from the advisory committee members, written and oral comments from the public, and the scientific literature and data, and now wants to proceed with rule making to consider rules that would allow the testing to occur. Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication by contacting Alexandra Montano, P.O. Box 47990, Olympia, WA 98504-7990, phone 360-236-4109, fax 360-236-4088, TTY 360-833-6388 or 711, email michelle.davis@sboh.wa.gov. Additional comments: Presentations to the board and the board's motion related to Pompe disease and MPS I are available at the board's web site http://sboh.wa.gov. If you would like to be added to the listserv for this rule making email WSBOH@SBOH.WA.GOV with the subject line "Newborn Screening - Subscribe." October 30, 2017 Michelle A. Davis Executive Director |