HOUSE BILL REPORT

ESSB 5713

As Amended by the House

BYSenate Committee on Health Care & Corrections (originally sponsored by Senators West, Kreidler and Wojahn; by request of Department of Social and Health Services)

Providing for licensure of medical test sites.

House Committe on Commerce & Labor

Majority Report:  Do pass with amendments.  (11)

      Signed by Representatives Vekich, Chair; Cole, Vice Chair; Patrick, Ranking Republican Member; Jones, R. King, Leonard, O'Brien, Prentice, Smith, Walker and Wolfe.

House Staff:Joan Elgee (786-7166)

Rereferred House Committee on Appropriations

Majority Report:  Do pass as amended by Committee on Commerce & Labor as such amendments are amended by Committee on Appropriations.  (22)

      Signed by Representatives Locke, Chair; Grant, Vice Chair; H. Sommers, Vice Chair; Silver, Ranking Republican Member; Appelwick, Belcher, Bowman, Brekke, Bristow, Ferguson, Hine, May, McLean, Nealey, Peery, Rust, Sayan, Spanel, Sprenkle, Valle, Wang and Wineberry.

Minority Report:  Do not pass.  (2)

      Signed by Representatives Braddock and Brough.

House Staff:      Dave Knutson (786-7136)

AS PASSED HOUSE APRIL 10, 1989

BACKGROUND:

Currently, limited regulation of medical testing laboratories exists.  Some laboratories which receive Medicare reimbursement or perform specific tests are regulated.  In addition, private organizations conduct accrediting programs for certain laboratories.

Recent publicity over the accuracy of pap smear tests has drawn attention to the issue of quality control in laboratories.

In response to these concerns, in 1988 Congress enacted a comprehensive laboratory regulatory program.  All laboratories, including those in physicians' offices, must obtain a certificate from the Secretary of Health and Human Services.  Laboratories must maintain a quality assurance and quality control program and submit to proficiency testing.

The federal law creates an exemption for states which establish a program at least as stringent as the federal program.

SUMMARY:

A state testing facility ("test site") licensure program is created. Any test site, public or private, which analyzes materials derived from the human body for the purposes of health care, treatment, or screening must be licensed by the Department of Social and Health Services (or the Department of Health, if created).  Sites (including residences) where only self-administered non-commercial testing is done are excluded.

The department shall adopt standards for quality control, quality assurance, recordkeeping, and personnel requirements.  Each test site must also participate in a proficiency testing program.  The department may conduct on-site reviews at any time to determine compliance.  Fees shall be imposed, which shall meet the costs of the program.

A waiver from licensure is authorized for test sites which only conduct examinations determined to have an insignificant risk of an erroneous result.  Test sites regulated by an organization or agency approved by the department shall automatically receive a license.

The department may deny, condition, suspend, or revoke a license for specified violations, and may also impose a monetary penalty up to $10,000 for specified violations.

The provisions take effect July 1, 1990, except that the department may adopt rules to implement the program beginning July 1, 1989.

Revenue:    The bill has a revenue impact.

Fiscal Note:      Available.

Effective Date:Sections 1 through 22 take effect July 1, 1990.  Section 23 takes effect July 1, 1989.

House Committee ‑ Testified For:    (Commerce & Labor) Senator West; Joan Gaumer, Gail Apley, and Wayne Ketchersid, Washington State Society for Medical Technology; Carole Washburn, Department of Social and Health Services; Susie Tracy, Washington State Medical Society; Becky Bogard, Medical Lab Group, David J. Corwin, Laboratory of Pathology of Seattle.

(Appropriations) Bob Shirley, DSHS; Joan Gaumer, Washington State Society for Medical Technology; Susie Tracy, State Medical Association; Becky Bogard, Medical Labs Group.

House Committee - Testified Against:      (Commerce & Labor) None Presented.

(Appropriations) None Presented.

House Committee - Testimony For:    (Commerce & Labor) Licensure of medical test sites will ensure that all medical testing is subject to quality controls.  State licensure is much preferable to federal regulation. Costs will be lower, sites already have a good working relationship with the state, and the department's approach of working with sites, in contrast to the federal "hammer" approach, is much more likely to result in quality.

(Appropriations) State regulation of medical testing sites promote accurate and reliable analysis and protect the public interest.

House Committee - Testimony Against:      (Commerce & Labor) None Presented.

(Appropriations) None Presented.