WSR 06-11-164

PROPOSED RULES

DEPARTMENT OF HEALTH


[ Filed May 24, 2006, 9:10 a.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 06-08-014 [06-08-015].

Title of Rule and Other Identifying Information: WAC 246-338-022 Initial application for medical test site license, 246-338-024 License renewal/reapplication process, and 246-338-990 Fees. These sections establish fees or the due dates for fees.

Hearing Location(s): Department of Health, Room 152, 310 Israel Road S.E., Olympia, WA 98501, on June 27, 2006, at 10:30 a.m.

Date of Intended Adoption: July 5, 2006.

Submit Written Comments to: Yvette Fox, 310 Israel Road S.E., Olympia, WA 98501, e-mail http://www3.doh.wa.gov/policyreview/, fax (360) 236-2901, by June 27, 2006.

Assistance for Persons with Disabilities: Contact Yvette Fox by June 21, 2006, TTY (800) 833-6388 or (360) 236-2928.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rule will change the due dates for license and renewal fees for medical test sites in order to bring the funding cycle in line with the allotment cycle. The funding currently begins sixteen months after the beginning of the biennial funding cycle. The proposal enables the department of health to prorate licensure and renewal fees for those licenses issued for less than two years.

Reasons Supporting Proposal: RCW 70.42.090 Medical test site fees -- Account, requires the department of health to establish a fee schedule for licenses, renewals, amendments and waivers. Aligning the funding cycle with the allotment cycle will provide consistency in the budgeting process.

Statutory Authority for Adoption: RCW 70.42.090.

Statute Being Implemented: RCW 70.42.090.

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, Implementation and Enforcement: Gary Bennett, 310 Israel Road S.E., Tumwater, WA 98501, (360) 236-2902.

No small business economic impact statement has been prepared under chapter 19.85 RCW. This proposal is exempt under RCW 19.85.030 and does not require a small business economic impact statement because the rule does not impose any additional costs on the regulated industry.

A cost-benefit analysis is not required under RCW 34.05.328. Section 201, chapter 403, Laws of 1995 do not apply to rules that set or adjust fees or rates pursuant to procedural rules according to RCW 34.05.328 (5)(a)(i), (c)(i)(B) or (c)(iii).

May 24, 2006

Mary C. Selecky

Secretary

OTS-8725.2


AMENDATORY SECTION(Amending WSR 00-06-079, filed 3/1/00, effective 4/1/00)

WAC 246-338-022   Initial application for medical test site license.   (1) Application procedure.

Applicants requesting a medical test site license must:

(a) Submit a completed application on forms furnished by the department, signed by the owner or authorized representative;

(b) File a separate application for each test site except under the following conditions:

(i) If the test site is not at a fixed location and moves from testing site to testing site, or uses a temporary testing location such as a health fair, the medical test site may apply for a single license for the home base location;

(ii) If the medical test site is a not-for-profit or state or local government and performs a combination of fifteen or less of either waived or moderate complexity test procedures at different locations, the owner may file an application for a single license;

(c) Furnish full and complete information to the department in writing:

(i) Name, address, phone number, and federal tax ID number of the medical test site;

(ii) Name of owner;

(iii) Number and types of tests performed, planned, or projected;

(iv) Name and qualifications including educational background, training, and experience of the director;

(v) Names and qualifications including educational background, training, and experience of technical personnel, if requested by the department;

(vi) Name of proficiency testing program or programs used by the medical test site and a copy of the enrollment confirmation form, if applicable;

(vii) Methodologies for tests performed, if requested by the department; and

(viii) Other information as requested by the department;

(d) Submit the designated fee in the time period indicated, upon receipt of a fee statement from the department;

(e) If applying for an accredited license, submit proof of accreditation by an approved accreditation organization. If application has been made to an accreditation organization, submit a copy of the application, followed by proof of accreditation within eleven months of issuance of the medical test site license.

(2) Issuing an initial license.

(a) An initial license will be issued for a medical test site when the applicant:

(i) Submits a completed application and any information requested by the department;

(ii) Pays the designated license fee; and

(iii) Meets the requirements of chapter 70.42 RCW and this chapter.

(b) License expiration dates will be based on a two-year licensure cycle, expiring on ((October 31st)) June 30th of ((even-numbered)) odd-numbered years. The license period for an initial license begins the day of the month that payment is received and expires on ((October 31st)) June 30th of ((the current or next even-numbered)) odd-numbered years.

(c) For licenses issued for a period of less than two years, the license fee will be prorated for the remainder of the two-year cycle under WAC 246-338-990.

(d) The department may issue a provisional license valid for a period of up to two years when a medical test site applies for licensure for the first time.

(((d))) (e) The department will terminate a provisional license at the time a two-year license for the medical test site is issued.

(((e))) (f) License fees are listed under WAC 246-338-990.

[Statutory Authority: RCW 70.42.005, 70.42.060 and chapter 70.42 RCW. 00-06-079, 246-338-022, filed 3/1/00, effective 4/1/00.]


AMENDATORY SECTION(Amending WSR 00-06-079, filed 3/1/00, effective 4/1/00)

WAC 246-338-024   License renewal/reapplication process.   (1) The department will issue a renewal license for a medical test site when the owner:

(a) At least thirty days prior to the expiration date of the current license, submits a completed renewal application form, available from the department, in compliance with WAC 246-338-022(1) and submits the designated fee; and

(b) Meets the requirements of chapter 70.42 RCW and this chapter.

(2) A license is issued for a period of two years. License expiration dates are based on a two-year cycle, expiring on ((October 31st)) June 30th of ((even-numbered)) odd-numbered years.

(3) For licenses issued for a period of less than two years, the license fee shall be prorated based on the two-year fees listed under WAC 246-338-990.

(4) The department may extend a license for a period not to exceed six months beyond the expiration date of the license.

(((4))) (5) The department will require the owner of the medical test site to reapply for a license if proof of accreditation is not supplied to the department within eleven months of issuance of an accredited license.

(((5))) (6) The owner or applicant of a medical test site must reapply for licensure within thirty days, if the acceptance of approval of the accreditation organization for the medical test site is denied or terminated.

(((6))) (7) If at any time any of the changes listed in WAC 246-338-026 occur, the medical test site may require a different type of license than what the medical test site currently holds. If so, the owner must submit a reapplication form, within thirty days of the change, and pay applicable fees.

[Statutory Authority: RCW 70.42.005, 70.42.060 and chapter 70.42 RCW. 00-06-079, 246-338-024, filed 3/1/00, effective 4/1/00.]


AMENDATORY SECTION(Amending WSR 02-12-105, filed 6/5/02, effective 7/6/02)

WAC 246-338-990   Fees.   (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; ((and))

(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 Fees
Category of License Number of Tests/Year Biennial Fee
Certificate of Waiver N/A $ 150
PPMP N/A $ 200
Low Volume 1-2,000 tests $ 450
Category A 2,001-10,000 tests, 1-3 specialties $1,364
Category B 2,001-10,000 tests, 4 or more specialties $1,769
Category C 10,001-25,000 tests, 1-3 specialties $2,454
Category D 10,001-25,000 tests, 4 or more specialties $2,818
Category E 25,001-50,000 tests $3,382
Category F 50,001-75,000 tests $4,187
Category G 75,001-100,000 tests $4,991
Category H 100,001-500,000 tests $5,835
Category I 500,001-1,000,000 tests $10,369
Category J > 1,000,000 tests $12,443
Accredited:
Low Volume 1-2,000 tests $ 165
Category A 2,001-10,000 tests, 1-3 specialties $ 211
Category B 2,001-10,000 tests, 4 or more specialties $ 231
Category C 10,001-25,000 tests, 1-3 specialties $ 531
Category D 10,001-25,000 tests, 4 or more specialties $ 559
Category E 25,001-50,000 tests $ 787
Category F 50,001-75,000 tests $1,254
Category G 75,001-100,000 tests $1,722
Category H 100,001-500,000 tests $2,227
Category I 500,001-1,000,000 tests $6,428
Category J > 1,000,000 tests $8,168
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 and 2002 c 371. 02-12-105, 246-338-990, filed 6/5/02, effective 7/6/02. Statutory Authority: RCW 70.42.005, 70.42.060. 01-02-069, 246-338-990, filed 12/29/00, effective 1/29/01. Statutory Authority: RCW 70.42.090. 99-24-061, 246-338-990, filed 11/29/99, effective 12/30/99; 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.]

Washington State Code Reviser's Office