Medical Test Sites (MTS) Rules in Progress

Rules in Progress

The rules writing process is open to the public. The public is welcome to take part in helping us write rules. Rules are also known as regulations, Washington Administrative Code, or WAC. The rule-making process includes public notices and workshops, and usually a public hearing before a rule becomes final.

Current rules in progress

WAC 246-338-020 and 246-338-026, Medical test site licensure and notification requirements. The Department of Health is adopting an emergency rule to amend WAC 246-338-026 mandating reporting of test results intended to detect SARS-CoV-2 or diagnose a possible case of the coronavirus disease 2019 (COVID-19) in alignment with the federal changes published in 85 FR 54820. WAC 246-338-020 is amended to add language referencing the new subsection in WAC 246-338-026. These changes will allow the new reporting, inspection, and fining processes in compliance with the new federal requirements which will ensure the current Clinical Laboratory Improvement Amendments (CLIA) exempt status is not threatened and will respond to the current public health emergency created by the COVID-19 pandemic.

Final rule changes

To address the rising costs of the medical test site program, address the negative cash flow, and build the recommended reserve, the department proposes raising medical test site licensing and renewal fees by 25 percent across all license categories effective October 31, 2020. The fee amounts proposed are what the department has determined are necessary to fund current and future program operations in accordance with RCW 43.70.250 (License fees for professions, occupations, and businesses), RCW 70.42.090 (regarding license fees for medical test sites), and the department's six-year fee recovery policy. Though the proposed fee change would go into effect November 1, 2020, existing labs will not incur the new fees until renewal in June 2021.

The rule change amended chapter 246-338 WAC—Medical Test Site (MTS) Rules to add the Centers for Medicare and Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA) new regulation regarding patients having access to laboratory results; to add directed corrective action plan requirements for clinical laboratories in Washington that the Department of Health (department) regulates; and to update and clarify existing MTS regulations.

More agency rule resources