WSR 16-15-009

PREPROPOSAL STATEMENT OF INQUIRY

[Filed July 7, 2016, 2:18 p.m.]

Subject of Possible Rule Making: Chapter 246-XXX WAC, Blood establishments, the department of health (department) is adding a new chapter to Title 246 WAC to establish requirements related to a public registry to ensure the transparency of blood establishments pursuant to SHB 2580 (chapter 47, Laws of 2016).

Statutes Authorizing the Agency to Adopt Rules on this Subject: SHB 2580 (chapter 47, Laws of 2016).

Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: SHB 2580 was enacted by the 2016 Washington state legislature requiring the department to: (1) Establish and administer a registration process for blood-collecting or blood-distributing establishments that collect or distribute blood for allogeneic transfusion in Washington state that are licensed by the United States Food and Drug Administration (FDA); (2) create and maintain an online public registry of all registered blood establishments that supply blood products for transfusion in Washington state; and (3) set fees for applying for or renewing a registration. The purpose of the registry is to ensure the safety and transparency of Washington's blood supply.

Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: United States FDA, the department will coordinate the rule with FDA as necessary and appropriate.

Process for Developing New Rule: Collaborative rule making.

Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication. Interested parties may participate in the development of draft rules prior to a formal proposal or may receive information on how to participate in rule making by contacting Susan Walker, Lab Quality Assurance Supervisor, 20425 72nd Avenue South, Suite 310, Kent, WA 98032, e-mail susan.walker@doh.wa.gov, phone (253) 395-6745, fax (253) 395-6365.

July 7, 2016

John Wiesman, DrPH, MPH

Secretary