WSR 16-03-083
PREPROPOSAL STATEMENT OF INQUIRY
[Filed January 20, 2016, 10:24 a.m.]
Subject of Possible Rule Making: Chapter 246-338 WAC, Medical test site rules, considering amending rules to comply with federal regulations and statutory requirements.
Statutes Authorizing the Agency to Adopt Rules on this Subject: RCW
70.42.220 and
43.70.041.
Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: The department of health (department) is considering amending medical test site (MTS) rules to: (1) Add a new Centers for Medicaid and Medicare (CMS) Clinical Laboratory Improvement Amendments (CLIA) regulation regarding patients having access to their laboratory results; and (2) comply with statutory requirements to simplify processes and reduce the regulatory burden on laboratories without compromising public health and safety. The considered amendments would enable the department to comply with federal regulations listed at 42 C.F.R. 493.1291(l), clarify existing MTS regulations, and would maintain the department's state exempt status.
Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: The United States Department of Health and Human Services' CMS has granted an exemption to federal regulation for clinical laboratories in Washington, as CMS has judged the state's MTS regulations the equivalent to CLIA. All activity (collection of fees, inspection of laboratories, complaint investigations, and enforcement action) are conducted by the state. CMS reviews all changes made to the department's MTS rule to ensure the department continues to meet the requirements for the CLIA exemption.
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 by attending workshops and providing input on draft and proposed materials. Interested parties can receive information on how to participate by contacting Susan Walker, MTS Program Manager, Department of Health, 20425 72nd Avenue South, Suite 310, Kent, WA 98032, phone (253) 395-6745, fax (253) 395-6365, e-mail susan.walker@doh.wa.gov.
January 20, 2016
John Wiesman, DrPH, MPH
Secretary
