Date of Adoption: June 1, 2002.

     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.

     Citation of Existing Rules Affected by this Order: Amending WAC 246-338-020 and 246-338-990.

     Statutory Authority for Adoption: RCW 70.42.090.

     Other Authority: Chapter 371, Laws of 2002.

      Adopted under notice filed as WSR 02-09-026 on April 9, 2002.

     Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 2, Repealed 0.

     Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 2, Repealed 0.

     Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0;      Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 0, Repealed 0.
     Effective Date of Rule: Thirty-one days after filing.

May 31, 2002

M. C. Selecky

Secretary

OTS-5475.1

AMENDATORY SECTION(Amending WSR 01-02-069, filed 12/29/00, effective 1/29/01)

WAC 246-338-020   Licensure--Types of medical test site licenses.   After July 1, 1990, any person advertising, operating, managing, owning, conducting, opening, or maintaining a medical test site must first obtain a license from the department. License types are described in Table 020-1.

     (1) Certificate of waiver.

     Applicable if the medical test site performs only the tests classified as waived.

     (2) Provider performed microscopic procedures (PPMP).

     Applicable if the medical test site restricts its testing performance to one or more of the following moderate complexity tests performed by one of the licensed professionals listed, in conjunction with a patient's visit. In addition, the medical test site can perform tests classified as waived with this type of license.

     (a) PPMP may be performed only by one of the following licensed professionals:

     (i) Physician licensed under chapter 18.71 RCW, Physicians; chapter 18.57 RCW, Osteopathy--Osteopathic medicine and surgery; or chapter 18.22 RCW, Podiatric medicine and surgery;

     (ii) Advanced registered nurse practitioner, licensed under chapter 18.79 RCW, Nursing care;

     (iii) Midwife licensed under chapter 18.50 RCW, Midwifery;

     (iv) Physician assistant licensed under chapter 18.71A RCW, Physician assistants;

     (v) Naturopath licensed under chapter 18.36A RCW, Naturopathy; or

     (vi) Dentist licensed under chapter 18.32 RCW, Dentistry.

     (b) Microscopic procedures authorized under a PPMP license are:

     (i) All direct wet mount preparations for the presence or absence of bacteria, fungi, parasites, and human cellular elements;

     (ii) All potassium hydroxide (KOH) preparations;

     (iii) Pinworm examinations;

     (iv) Fern tests;

     (v) Postcoital direct, qualitative examinations of vaginal or cervical mucous;

     (vi) Urine sediment examinations;

     (vii) Nasal smears for granulocytes;

     (viii) Fecal leukocyte examinations;

     (ix) Qualitative semen analysis (limited to the presence or absence of sperm and detection of motility); and

     (x) Any other tests subsequently categorized under CLIA as provider-performed microscopy procedures.

     (3) Moderate/high complexity.

     (a) ((Limited testing,)) Low volume, Category A-J, as described in Table 990-1.

     Applicable if the medical test site performs any tests that are not classified as waived or qualified as PPMP under subsection (2) of this section. Under this type of license, the medical test site may also perform tests classified as waived.

     (b) Accredited: Low volume, Category A-J, as described in Table 990-1.

     Applicable if the medical test site performs any tests that are not classified as waived, and is accredited and inspected by an accreditation organization approved by the department under WAC 246-338-040. Under this type of license, the medical test site may also perform tests classified as waived.

020-1 Table of Requirements for Each License Type

[Statutory Authority: RCW 70.42.005, 70.42.060. 01-02-069, § 246-338-020, filed 12/29/00, effective 1/29/01. Statutory Authority: RCW 70.42.005, 70.42.060 and chapter 70.42 RCW. 00-06-079, § 246-338-020, filed 3/1/00, effective 4/1/00. Statutory Authority: RCW 70.42.005. 97-14-113, § 246-338-020, filed 7/2/97, effective 8/2/97. Statutory Authority: Chapter 70.42 RCW. 94-17-099, § 246-338-020, filed 8/17/94, effective 9/17/94; 93-18-091 (Order 390), § 246-338-020, filed 9/1/93, effective 10/2/93; 91-21-062 (Order 205), § 246-338-020, filed 10/16/91, effective 10/16/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-338-020, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. 90-20-017 (Order 090), § 248-38-020, filed 9/21/90, effective 10/22/90.]

     (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) 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	$ ((108)) 150
PPMP	N/A	$ ((163)) 200
((Accredited	N/A	$ 325
Limited Testing	1-750 tests	$ 543))
Low Volume	((751)) 1-2,000 tests	$((1,086)) 450
Category A	2,001-10,000 tests, 1-3 specialties	$((1,629)) 1,364
Category B	2,001-10,000 tests, 4 or more specialties	$((1,955)) 1,769
Category C	10,001-25,000 tests, 1-3 specialties	$((2,281)) 2,454
Category D	10,001-25,000 tests, 4 or more specialties	$((2,715)) 2,818
Category E	25,001-50,000 tests	$((3,259)) 3,382
Category F	50,001-75,000 tests	$((3,802)) 4,187
Category G	75,001-100,000 tests	$((4,453)) 4,991
Category H	100,001-500,000 tests	$((5,105)) 5,835
Category I	500,001-1,000,000 tests	$((5,432)) 10,369
Category J	> 1,000,000 tests	$((5,974)) 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 70.42.005, 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.]

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