WSR 02-09-026

PROPOSED RULES

DEPARTMENT OF HEALTH


[ Filed April 9, 2002, 1:33 p.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 02-03-138.

Title of Rule: WAC 246-338-020 and 246-338-990 Fees, medical test site rules.

Purpose: WAC 246-338-020 establishes the license requirements for each type of license and WAC 246-338-990 sets the fee for medical test sites. The medical test site rules enable licensure of all sites that perform clinical testing in the state. The fees defray the cost of administering the medical test site licensure program under RCW 70.42.090.

Statutory Authority for Adoption: RCW 70.42.090, ESSB 6387.PL, section 220(1).

Statute Being Implemented: RCW 70.42.090.

Summary: The proposed changes to medical test site rules (WAC 246-338-020 and 246-338-990) adjust the licensing fees. Fees will be adjusted to correspond to the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) fee structure.

Reasons Supporting Proposal: ESSB 6387.PL, section 220 permits the department to increase fees over the I-601 limit. The proposed fee schedule will generate additional revenue to pay the increased federal (CLIA) exemption fee. This will keep regulation of clinical laboratories at the state level rather than under federal regulation.

Name of Agency Personnel Responsible for Drafting and Implementation: Gail Neuenschwander, 1610 N.E. 150th Street, Seattle, 98155-9701, (206) 361-2805; Enforcement: Gary Bennett, 2725 Harrison Avenue, Olympia, WA 98504-7852.

Name of Proponent: 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 rules license all sites that perform clinical laboratory testing in the state. The state law was passed to take the place of federal regulation (CLIA). An amendment is needed to increase the medical test site license fees in order to generate revenue to pay the increased fee charged by the federal government for exemption from federal regulation. This will keep regulation of clinical laboratories at the state level rather than under federal regulation. Advantages of keeping regulation at the state level include outreach and educational services such as training classes, technical assistance, monthly newsletter, consultation and other educational materials that would not be funded under CLIA. Maintaining licensing and regulation at the state level also provides faster response time for requests from licensees and for any enforcement action that is needed. The proposed fee schedule will generate sufficient revenue to fund the state medical test site program.

Proposal Changes the Following Existing Rules: The proposed fee schedule will set fees at the same level that they would be if the laboratories were licensed federally under CLIA. Along with the change in fees will be a restructuring of fee categories (WAC 246-338-020) based on the CLIA model.

No small business economic impact statement has been prepared under chapter 19.85 RCW. The 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 May 21, 2002, at 10:00 a.m.

Assistance for Persons with Disabilities: Contact Yvette Lenz by May 14, 2002, TDD (800) 833-6388, or (360) 705-6652.

Submit Written Comments to: Yvette Lenz, Facilities and Services Licensing, P.O. Box 47852, Olympia, WA 98504-7852, e-mail REGMAIL@doh.wa.gov, fax (360) 705-6654, by May 21, 2002.

Date of Intended Adoption: June 1, 2002.

April 8, 2002

Mary 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

LICENSE TYPE REQUIREMENTS INSPECTIONS
TYPE FREQUENCY
(1) Certificate of Waiver

Restrict testing to tests classified as waived.

Meet the requirements of WAC 246-338-020 Licensure--Types of Medical Test Site Licenses; WAC 246-338-022 Initial Application for Medical Test Site License; WAC 246-338-024 License Renewal/Reapplication Process; WAC 246-338-026 Notification Requirements; WAC 246-338-028 On-site Inspections.

Follow manufacturers' instructions for performing the test.

Complaint

Technical assistance

When indicated
(2) PPMP

Restrict testing to tests classified as PPMP or waived.

Meet the requirements of WAC 246-338-020 Licensure--Types of Medical Test Site Licenses; WAC 246-338-022 Initial Application for Medical Test Site License; WAC 246-338-024 License Renewal/Reapplication Process; WAC 246-338-026 Notification Requirements; WAC 246-338-028 On-site Inspections; WAC 246-338-050 Proficiency Testing (if applicable); WAC 246-338-060 Personnel; WAC 246-338-070 Records; WAC 246-338-080 Quality Assurance; WAC 246-338-090 Quality Control.

Follow manufacturers' instructions for performing the test.

Complaint

Technical assistance

When indicated
(3) Moderate/High Complexity
(a) ((Limited Testing,)) Low Volume, Category A-J

Perform tests classified as moderate or high complexity.

Meet the requirements of WAC 246-338-020 Licensure--Types of Medical Test Site Licenses; WAC 246-338-022 Initial Application for Medical Test Site License; WAC 246-338-024 License Renewal/Reapplication Process; WAC 246-338-026 Notification Requirements; WAC 246-338-028 On-site Inspections; WAC 246-338-050 Proficiency Testing (if applicable); WAC 246-338-060 Personnel; WAC 246-338-070 Records; WAC 246-338-080 Quality Assurance; WAC 246-338-090 Quality Control.

Follow manufacturers' instructions for performing test.

Initial

Routine

Complaint

On-site follow-up

Technical assistance

First 6 months of license

Every 2 years

When indicated

When indicated

When indicated

(b) Accredited: Low Volume, Category A-J

Perform tests classified as moderate or high complexity.

Meet the requirements of WAC 246-338-020 Licensure--Types of Medical Test Site Licenses; WAC 246-338-022 Initial Application for Medical Test Site License; WAC 246-338-024 License Renewal/Reapplication Process; WAC 246-338-026 Notification Requirements; WAC 246-338-028 On-site Inspections; WAC 246-338-050 Proficiency Testing (if applicable); WAC 246-338-060 Personnel; WAC 246-338-070 Records; WAC 246-338-080 Quality Assurance; WAC 246-338-090 Quality Control.

Follow manufacturers' instructions for performing the test.

Submit to the department upon request, or authorize the accreditation organization to submit:

Proof of accreditation;

On-site inspection results;

Statement of deficiencies;

Plan of correction for the deficiencies cited;

Any disciplinary action and results of any disciplinary action taken by the accreditation organization against the medical test site.

Validation

Complaint

On-site follow-up

Technical assistance

2.5 % of accredited sites annually

When indicated

When indicated

When indicated

[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.]


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

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) 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.]

Washington State Code Reviser's Office