DEPARTMENT OF HEALTH
[Filed November 1, 2018, 2:06 p.m., effective December 2, 2018]
Effective Date of Rule: Thirty-one days after filing.
Purpose: WAC 246-339-025 Exemptions for blood establishment registration (blood establishments), the department of health (department) has adopted an amendment to WAC 246-339-025 in order to align with the statutory language in chapter 70.335
RCW. The adopted amendment removes the term "and distributes" to provide greater clarification as to which hospitals licensed under chapter 70.41
RCW are exempt from the department's blood establishments' registration requirements under chapter 70.335
Citation of Rules Affected by this Order: Amending WAC 246-339-025.
Adopted under notice filed as WSR 18-17-169 on August 21, 2018.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at the Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's own Initiative: New 0, Amended 1, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.
Number of Sections Adopted using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 1, Repealed 0.
Date Adopted: October 8, 2018.
John Wiesman, DrPH, MPH
AMENDATORY SECTION(Amending WSR 17-14-026, filed 6/23/17, effective 7/24/17)
WAC 246-339-025Exemptions for blood establishment registration.
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
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.