PROPOSED RULES
Original Notice.
Exempt from preproposal statement of inquiry under RCW 34.05.310(4).
Title of Rule: WAC 246-338-990 Fees, medical test site rules.
Purpose: The proposed changes adjust the licensing fees for medical test sites. The fee increase is needed to defray the cost of administering the medical test site licensure program, as mandated under RCW 70.42.090.
Statutory Authority for Adoption: RCW 70.42.090.
Statute Being Implemented: RCW 70.42.090.
Summary: Medical test site rules, WAC 246-338-990, fees will be increased by 3.32%, as allowed under I-601.
Reasons Supporting Proposal: RCW 70.42.090 requires the department to set fees at a sufficient level to defray the cost of administering the medical test site licensure program. Increased costs to the program includes salary increases and inflationary costs. The proposed fee increase will allow the program to operate at the current level of service, which is the minimum required to maintain exemption from federal regulation and assure the quality of clinical laboratory testing.
Name of Agency Personnel Responsible for Drafting and Implementation: Gail Neuenschwander, 1610 N.E. 150th Street, Seattle, 98155-9701, (206) 361-2805; and Enforcement: Gary Bennett, 2725 Harrison Avenue, Olympia, 98504-7852, (360) 705-6652.
Name of Proponent: Washington State Department of Health, governmental.
Rule is not necessitated by federal law, federal or state court decision.
Explanation of Rule, its Purpose, and Anticipated Effects: The medical test site rule licenses all sites that perform clinical laboratory testing in the state. The state law was passed to take the place of federal regulation (CLIA). The proposed fee increase will generate the necessary revenue to operate the medical test site program at its current level of service, which includes performing biennial inspections of sites and ongoing monitoring of proficiency testing. The current level of activity is necessary to assess and assure the quality of clinical laboratory testing in the state and to maintain exemption from federal regulation. The amount of the proposed 3.32% fee increase ranges from a low of $3.00 for the lowest category of license to a high of $192.00 for the highest category of license. All licenses are effective for a two-year period.
Proposal Changes the Following Existing Rules: The proposed amendment increases fees by 3.32% for a two-year license for all categories of licensed medical test sites.
No small business economic impact statement has been prepared under chapter 19.85 RCW. This proposal is exempt under RCW 34.05.310(4) and therefore does not require a small business economic impact statement.
RCW 34.05.328 does not apply to this rule adoption. Section 201, chapter 403, Laws of 1995 do not apply to rules that set or adjust fees or rates pursuant to legislative standards (RCW 34.05.328 (5)(b)(vi)).
Hearing Location: Department of Health, Target Plaza, Training Room, 2725 Harrison Avenue N.W., Olympia, WA 98502, on November 23, 1999, at 10:00 a.m.
Assistance for Persons with Disabilities: Contact Theresa Phillips by November 9, 1999, TDD (800) 833-6388, or (360) 705-6652.
Submit Written Comments to: Theresa Phillips, Facilities and Services Licensing, P.O. Box 47852, Olympia, WA 98504-7852, e-mail REGMAIL@doh.wa.gov, fax (360) 705-6654, by November 23, 1999.
Date of Intended Adoption: November 29, 1999.
October 19, 1999
Eric Slagle
for Mary Selecky
Secretary
OTS-3523.1
AMENDATORY SECTION(Amending WSR 96-12-011, filed 5/24/96,
effective 6/24/96)
WAC 246-338-990
Fees.
(1) ((For the purpose of this
section, the following words and phrases have the following
meanings:
(a) "Accredited by organization" means a testing site is accredited, certified, or licensed by an organization meeting the requirements of WAC 246-338-040, Approval of accreditation bodies;
(b) "Limited testing" means a medical test site performing not more than seven hundred fifty licensed tests per year;
(c) "Low volume" means a medical test site performing greater than seven hundred fifty licensed tests per year, and not more than two thousand licensed tests per year;
(d) "Category A" means a medical test site performing greater than two thousand licensed tests per year, not more than ten thousand licensed tests per year and three or less specialties;
(e) "Category B" means a medical test site performing greater than two thousand licensed tests per year, not more than ten thousand licensed tests per year and at least four specialties;
(f) "Category C" means a medical test site performing greater than ten thousand licensed tests per year, not more than twenty-five thousand licensed tests per year and three or less specialties;
(g) "Category D" means a medical test site performing greater than ten thousand licensed tests per year, not more than twenty-five thousand licensed tests per year and four or more specialties;
(h) "Category E" means a medical test site performing greater than twenty-five thousand, but not more than fifty thousand licensed tests per year;
(i) "Category F" means a medical test site performing greater than fifty thousand, but not more than seventy-five thousand licensed tests per year;
(j) "Category G" means a medical test site performing greater than seventy-five thousand, but not more than one hundred thousand licensed tests per year;
(k) "Category H" means a medical test site performing greater than one hundred thousand, but not more than five hundred thousand licensed tests per year;
(l) "Category I" means a medical test site performing greater than five hundred thousand, but not more than one million licensed tests per year;
(m) "Category J" means a medical test site performing more than one million licensed tests per year;
(n) "Direct staff time" means all state employees' work time, including travel time and expenses involved in functions associated with medical test site licensure or complaint investigation including:
(i) On-site follow up visit; and
(ii) Telephone contacts and staff or management conferences in response to a deficiency statement or complaint.
(2))) The department ((shall)) 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 a medical test site adds licensed tests that result in a change of category; and
(c) Determine fees according to criteria ((below :))
described in Table 990-1.
microscopic procedures . . . . . . . . . . . . |
158 per biennium; |
| direct staff time.)) |
| Table 990-1 License Categories and Fees |
||
| Category of License | Number of Tests/Year | Biennial Fee |
| Certificate of Waiver | N/A | $ 108 |
| PPMP | N/A | $ 163 |
| Accredited | N/A | $ 325 |
| Limited Testing | 1-750 tests | $ 543 |
| Low Volume | 751-2,000 tests | $1,086 |
| Category A | 2,001-10,000 tests, 1-3 specialties | $1,629 |
| Category B | 2,001-10,000 tests, 4 or more specialties | $1,955 |
| Category C | 10,001-25,000 tests, 1-3 specialties | $2,281 |
| Category D | 10,001-25,000 tests, 4 or more specialties | $2,715 |
| Category E | 25,001-50,000 tests | $3,259 |
| Category F | 50,001-75,000 tests | $3,802 |
| Category G | 75,001-100,000 tests | $4,453 |
| Category H | 100,001-500,000 tests | $5,105 |
| Category I | 500,001-1,000,000 tests | $5,432 |
| Category J | > 1,000,000 tests | $5,974 |
| Follow-up survey for deficiencies | Direct staff time | |
| Complaint investigation | Direct staff time | |
(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.
[Statutory Authority: RCW 70.42.090. 96-12-011, § 246-338-990, filed 5/24/96, effective 6/24/96. Statutory Authority: Chapter 70.42 RCW. 94-17-099, § 246-338-990, filed 8/17/94, effective 9/17/94; 93-18-091 (Order 390), § 246-338-990, filed 9/1/93, effective 10/2/93; 91-21-062 (Order 205), § 246-338-990, filed 10/16/91, effective 10/16/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-338-990, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. 90-20-017 (Order 090), § 248-38-120, filed 9/21/90, effective 10/22/90.]