PREPROPOSAL STATEMENT OF INQUIRY
Subject of Possible Rule Making: To consider amending the newborn screening rule to include which, if any, additional disorders should be included in the mandatory dried blood spot screening.
Statutes Authorizing the Agency to Adopt Rules on this Subject: Chapters 70.83, 43.20 RCW.
Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: Chapter 70.83 RCW delegates authority to the State Board of Health to determine which disorders, in addition to phenylketonuria (PKU), are to be included in the newborn screening required by the statute. Current regulation requires congenital hypothyroidism, hemoglobinopathies such as sickle cell disease, and congenital adrenal hyperplasia, in addition to PKU. Medical and technological advances in recent years have made it feasible to screen for an increasing number of additional disorders. Adding disorders to the panel could further prevent illness and death through early detection and treatment of affected newborns.
Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: Department of Health will work closely with the State Board of Health in the review process.
Process for Developing New Rule: Agency study, will involve significant public input to consider the merits of the numerous candidate disorders.
Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication by contacting Michael Glass, Department of Health, Newborn Screening Policy Liaison, 1610 N.E. 150th, Shoreline, WA 98155-9701, phone (206) 361-2890, toll free 1-866-660-9050, fax (206) 361-4996, e-mail mike.glass@doh.wa.gov; or Doreen Garcia, State Board of Health, Senior Policy Analyst, P.O. Box 47990, Olympia, WA 98504-7990, phone (360) 236-4101, e-mail doreen.garcia@doh.wa.gov. The Department of Health and the State Board of Health will establish an advisory group composed of interested parties to solicit and review information and obtain broad public input regarding which disorders should be recommended to the board for adoption. Input will be sought through publicized meetings and correspondence.
April 2, 2001
Don Sloma
Executive Director