PERMANENT RULES
Effective Date of Rule: Thirty-one days after filing.
Purpose: This 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 establishes a requirement for the department of health to charge a prorated licensure and renewal fee for those licenses issued for less than two years.
Citation of Existing Rules Affected by this Order: Amending WAC 246-338-022, 246-338-024, and 246-338-990.
Statutory Authority for Adoption: RCW 70.42.090.
Adopted under notice filed as WSR 06-11-164 on March [May] 24, 2006.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 3, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 3, Repealed 0.
Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 3, Repealed 0.
Date Adopted: July 5, 2006.
M. 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.]
(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.]
(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 | |
(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.]