PREPROPOSAL STATEMENT OF INQUIRY
DEPARTMENT OF HEALTH
[Filed August 19, 1998, 11:05 a.m.]
Subject of Possible Rule Making: The Office of Laboratory Quality Assurance (LQA) will rewrite the medical test site rules, chapter 246-338 WAC, to make them clearer, easier to understand, and better organized.
Statutes Authorizing the Agency to Adopt Rules on this Subject: Chapter 70.42 RCW, Medical test sites.
Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: The rules are already in place. The rewrite will be done to improve the organization and clarity of the current rules.
Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: The federal Health Care Financing Administration (HCFA) has granted an exemption to federal regulation (CLIA) for clinical laboratories in Washington, as they have judged the state medical test site rules as equivalent to CLIA. All changes to the medical test site rules must be approved by HCFA for the state to retain its exemption.
Process for Developing New Rule: We will work with all interested parties and licensees in drafting the new rules through workgroups and mailout of drafts for input.
Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication. An initial workgroup of interested parties will assist the Office of Laboratory Quality Assurance in completing a first draft of the new rules. This draft will be passed on to a secondary group for review and comment. The draft will then be sent to all licensees for input and comment. If you wish to participate on the initial draft, and can attend workgroup meetings, or if you wish to have your name added to the secondary review group, please contact Gail Neuenschwander, Office of Laboratory Quality Assurance, 1610 N.E. 150th Street, Seattle, WA 98155, (206) 361-2805, fax (206) 361-2813, e-mail firstname.lastname@example.org.
July 29, 1998
K. Van Gorkom