Title of Rule and Other Identifying Information: WAC 246-339-025 Exemptions for blood establishment registration (blood establishments), the department of health (department) is proposing amending WAC 246-339-025 to align with statutory language in chapter 70.335 RCW.

Hearing Location(s): On October 2, 2018, at 2:00 p.m., at the Washington State Department of Health, Town Center 2, Conference Room 158, 111 Israel Road, S.E., Tumwater, WA 98502.

Submit Written Comments to: Susan Walker, Manager, Lab Quality Assurance, Medical Test Sites, Washington State Department of Health, 20425 72nd Avenue South, Suite 310, Kent, WA 98032, email https://fortress.wa.gov/doh/policyreview, fax 253-872-6803, by October 2, 2018.

Assistance for Persons with Disabilities: Contact Susan Walker, phone 253-395-6745, fax 253-395-6365, TTY 360-833-6388 or 711, email susan.walker@doh.wa.gov, by September 24, 2018.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The department is proposing amending WAC 246-339-025(1) to remove the term "and distributes" from current rule language in order to provide clarification as to which hospitals are exempt from the department's registration requirements under chapter 70.335 RCW. The proposed deletion of this term aligns with statutory language in RCW 70.335.020(1).

Reasons Supporting Proposal: The department reopened chapter 246-339 WAC, Blood establishments, in January 2018, in response to a petition that was received by the department in 2017, shortly after the new chapter was adopted on June 23, 2017, and filed as WSR 17-14-026. The petition requested the department revise the existing blood establishments rules to clarify whether hospitals are exempt from the registration requirements of the chapter. After careful consideration, the department is proposing the deletion of the term "and distributes" from WAC 246-339-025(1) to align with statutory language in RCW 70.335.020(1). The proposed revision is intended to provide greater clarification to the public as to which hospitals licensed under chapter 70.41 or 71.12 RCW are exempt from the department's blood establishment registration requirements.

Name of Agency Personnel Responsible for Drafting: Maura Craig, 111 Israel Road S.E., Tumwater, WA 98502, 360-236-4997; Implementation and Enforcement: Susan Walker, 20425 72nd Avenue South, Suite 310, Kent, WA 98032, 253-395-6745.

A cost-benefit analysis is not required under RCW 34.05.328. The agency did not complete a cost-benefit analysis under RCW 34.05.328. RCW 34.05.328 (5)(b)(v) exempts rules the content of which is explicitly and specifically dictated by statute.

Is exempt under RCW 19.85.025(3) as the rules only correct typographical errors, make address or name changes, or clarify language of a rule without changing its effect; and rule content is explicitly and specifically dictated by statute.

A blood establishment is exempt from the requirements of this chapter if it meets one or more of the following:

(1) Hospitals licensed under chapter 70.41 or 71.12 RCW unless the hospital collects ((and distributes)) blood directly from donors for the purpose of allogeneic transfusions.

(2) Organizations that collect source plasma for the production of plasma derivatives by fractionation.

(3) Cases of individual patient medical need, as determined by a qualified health care provider, such as:

(a) An autologous or directed donation as defined in WAC 246-339-010; and

(b) An out-of-state blood establishment that supplies blood products for allogeneic transfusion based upon a request from a Washington state registered blood establishment in order to meet individual patient need, as determined by a qualified health care provider.