wa-26-21-069: Health, Department of — WSR 26-21-069

WSR 26-21-069 (26-21)WSR 26-21-069PROPOSED RULESDEPARTMENT OF HEALTH[Filed October 20, 2026, 8:12 a.m.]Original Notice.Preproposal statement of inquiry was filed as WSR 26-17-020.Title of Rule and Other Identifying Information: The department of health (department) is proposing rule amendments to update fees for medical test sites, WAC 246-338-990. Without a fee increase, current revenue projections indicate inadequate funds to support regulated activities and ensure sufficient reserve levels. Hearing Location(s): On December 1, 2026, at 3:00 p.m. Register in advance for this webinar at https://us02web.zoom.us/webinar/register/WN_Ioy4U0ZMTxifFEGG-V3mxg. After registering, you will receive a confirmation email containing information about joining the webinar.Date of Intended Adoption: December 8, 2026.Submit Written Comments to: Heather Cantrell, P.O. Box 47850, Olympia, WA 98504-7850, email HSQAfeerules@doh.wa.gov, web https://fortress.wa.gov/doh/policyreview, beginning the date and time of this filing, by December 1, 2026, at 11:59 p.m.Assistance for Persons with Disabilities: Contact Heather Cantrell, TTY 711, email HSQAfeerules@doh.wa.gov, by November 17, 2026.Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The department is proposing amendments to WAC 246-338-990 regarding an adjustment to initial license, renewal, and other charges for medical test sites to address funding requirements. The requirement in RCW 43.70.250 states that fees must cover regulatory program expenses, which necessitates the program to be self-funding and changes to rules are the only way to make fee adjustments.    Reasons Supporting Proposal: Revenue from medical test site fees must support mandated licensing and regulatory activities, such as issuing licenses and ongoing inspections and investigations. In addition to covering current expenses, the revenue level must also provide a reserve for unexpected program costs. The office of financial management recommends a reserve level of two months of expenditures. Based on a regular review, it was discovered that current revenue may not be adequate to support regulated activities and ensure sufficient reserve levels. Fees were last adjusted in 2023. The department is anticipating a negative fund balance in 2028 due to increased federal Clinical Laboratory Improvement Amendment fees, operational costs, expanded services, and slower-than-anticipated growth in the number of licensed facilities following the COVID-19 pandemic.Statutory Authority for Adoption: RCW 43.70.110, 43.70.250, and 70.42.090.Statute Being Implemented: RCW 43.70.250.Rule is not necessitated by federal law, federal or state court decision.Name of Proponent: Department of health, governmental.Name of Agency Personnel Responsible for Drafting: Heather Cantrell, 111 Israel Road S.E., Tumwater, WA 98501; Implementation and Enforcement: Jessica Holloway, 111 Israel Road S.E., Tumwater, WA 98501.A school district fiscal impact statement is not required under RCW 28A.305.135.A cost-benefit analysis is not required under RCW 34.05.328. This rule is exempt from analysis according to RCW 34.05.328 (5)(b)(vi) because it is a rule that sets or adjusts fees pursuant to legislative standards.This rule proposal, or portions of the proposal, is exempt from requirements of the Regulatory Fairness Act because the proposal: Is exempt under RCW 19.85.025(3) as the rules set or adjust fees under the authority of RCW 19.02.075 or that set or adjust fees or rates pursuant to legislative standards, including fees set or adjusted under the authority of RCW 19.80.045.Explanation of exemptions: The proposed rules set and adjust fees for medical test sites under RCW 34.05.310 (4)(f).Scope of exemption for rule proposal:Is fully exempt.October 19, 2026Kristin Peterson, JDChief of Policyfor Dennis E. WorshamSecretary of HealthRDS-7408.1AMENDATORY SECTION(Amending WSR 23-04-099, filed 1/31/23, effective 4/1/23)WAC 246-338-990Fees.(1) The department will assess and collect biennial fees for medical test sites as follows:(a) Charge fees, based on the requirements authorized under RCW 70.42.090 and this section;(b) Assess additional fees when changes listed in WAC 246-338-026 occur that require a different type of license than what the medical test site currently holds;(c) Charge prorated fees for the remainder of the two-year cycle when the owner or applicant applies for an initial license during a biennium as defined under WAC 246-338-022 (2)(c);(d) Charge prorated fees for licenses issued for less than a two-year period under WAC 246-338-024(3); and(e) Determine fees according to criteria described in Table 990-1.Table 990-1 License Categories and FeesCategory of LicenseNumber of Tests/YearBiennial FeeCertificate of WaiverN/A(($260))$400PPMPN/A(($300))$450Low Volume1-2,000 tests(($620))$1,000Category A2,001-10,000 tests, 1-3 specialties(($1,900))$2,600Category B2,001-10,000 tests, 4 or more specialties(($2,450))$3,350Category C10,001-25,000 tests, 1-3 specialties(($3,410))$4,700Category D10,001-25,000 tests, 4 or more specialties(($3,910))$5,400Category E25,001-50,000 tests(($4,700))$6,500Category F50,001-75,000 tests(($5,810))$8,200Category G75,001-100,000 tests(($6,930))$9,850Category H100,001-500,000 tests(($8,090))$11,650Category I500,001-1,000,000 tests(($14,390))$21,750Category J˃ 1,000,000 tests(($17,260))$26,250Accredited:  Low Volume1-2,000 tests(($230))$350Category A2,001-10,000 tests, 1-3 specialties(($290))$450Category B2,001-10,000 tests, 4 or more specialties(($320))$500Category C10,001-25,000 tests, 1-3 specialties(($730))$1,150Category D10,001-25,000 tests, 4 or more specialties(($780))$1,220Category E25,001-50,000 tests(($1,090))$1,700Category F 50,001-75,000 tests(($1,740))$2,750Category G75,001-100,000 tests(($2,390))$3,800Category H100,001-500,000 tests(($3,090))$4,950Category I500,001-1,000,000 tests(($8,920))$14,450Category J˃ 1,000,000 tests(($11,330))$18,350Follow-up survey for deficiencies ((Direct staff time))$1,200Complaint investigation ((Direct staff time))$1,200(2) The following programs are excluded from fee charges when performing only waived hematocrit or hemoglobin testing for nutritional evaluation and food distribution purposes:(a) Women, infant and children programs (WIC); and(b) Washington state migrant council.