PREPROPOSAL STATEMENT OF INQUIRY
Subject of Possible Rule Making: Amending chapter 246-650 WAC, to include cystic fibrosis in the mandatory disorders for newborn screening conducted by the Department of Health.
Statutes Authorizing the Agency to Adopt Rules on this Subject: RCW 70.83.050, 43.20.050.
Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: An increasing body of knowledge from medical and scientific research, as well as experience from newborn screening programs in other states and countries, indicates that children who have cystic fibrosis experience significantly better outcomes if their disease is detected shortly after birth through screening performed on the same dried blood spots that are tested for phenylketonuria (PKU) and other congenital disorders. The board intends to evaluate the evidence to determine if newborn screening for cystic fibrosis meets the criteria that the board has adopted for inclusion in mandatory newborn screening.
Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: None.
Process for Developing New Rule: Expert technical review of medical/scientific evidence for cystic fibrosis treatment and, if significant health benefit is found, full review by a broadly representative Newborn Screening Advisory Committee. The committee will develop recommendations for the board to consider.
Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication by contacting Michael Glass, Director Newborn Screening, Washington Department of Health, 1610 N.E. 150th Street, Shoreline, WA 98155, voice (206) 418-5470, fax (206) 418-5415, e-mail mike.glass@doh.wa.gov. Meetings will be open, and any written information or findings will be available to the public.
February 23, 2005
Craig McLaughlin
Executive Director