SENATE BILL REPORT

SB 5713

BYSenators West, Kreidler and Wojahn; by request of Department of Social and Health Services

Providing for licensure of medical test sites.

Senate Committee on Health Care & Corrections

Senate Hearing Date(s):February 27, 1989; March 1, 1989

Majority Report:  That Substitute Senate Bill No. 5713 be substituted therefor, and the substitute bill do pass.

      Signed by Senators West, Chairman; Smith, Vice Chairman; Amondson, Johnson, Kreidler, Wojahn.

Senate Staff:Scott Plack (786-7409)

                  March 3, 1989

AS REPORTED BY COMMITTEE ON HEALTH CARE & CORRECTIONS, MARCH 1, 1989

BACKGROUND:

Currently the state does not have a comprehensive licensure law regulating laboratories conducting medical testing.  Some regulation of laboratories does exists for those involved with specific tests or who receive Medicare reimbursement.  In addition, some private organizations have accrediting programs for laboratories.

Recent concerns over the accuracy of pap smear tests have drawn attention to the issues of quality control in laboratories.  Medical tests are becoming more complex as technology makes advances in areas such as genetic screening.  Accuracy in analyzing these tests raises concerns about the presence of adequate quality control procedures.

In response to these concerns Congress enacted in 1988 a national comprehensive laboratory licensing program.  The program affects laboratories located in all settings including physician offices.  Laboratories conducting any medical test are covered, though some exemptions exist for those conducting "simple" tests.  The federal government is in the process of developing regulations on the program and implementation will occur over the next few years.  The federal legislation provides that states may enact their own licensure program to substitute for the federal program.  The standards of the states' programs must be as stringent or more stringent than the federal program.

SUMMARY:

A state laboratory licensure program is created.  Laboratories are defined as any test site analyzing material derived from the human body for the purpose of health care, treatment or screening.  Exceptions are created for tests approved for self-administration in an individual's home.

DSHS is designated as the regulatory authority and given rule making authority.  All laboratories conducting medical tests are required to be licensed by July 1, 1990.  Waivers from licensure are granted to laboratories conducting simple tests determined to have an insignificant risk of an erroneous result.  Laboratories accredited, certified or licensed by other organizations approved by the department are automatically licensed but must meet department established proficiency standards.

The department shall adopt rules consistent with federal laws, governing test site quality control, quality assurance, recordkeeping, and personnel requirements.  Test sites are required to participate in approved proficiency testing programs.  DSHS may contract with third parties offering proficiency testing programs.  Test sites shall have a designated test site supervisor.

Specific standards are enumerated for quality assurance for cytology tests (pap smears).

The department shall establish fees for licensure.  A dedicated account is created for the program.  Application procedures are enumerated.  Specifics are outlined for conditions when the department may deny, limit or cancel, suspend or revoke a license or assess monetary penalties.  It is a misdemeanor to operate a laboratory without a license.

The department may conduct on-site reviews at any time to determine compliance.

EFFECT OF PROPOSED SUBSTITUTE:

Specific language enumerating standards for cytology tests is deleted.  Language is added to require licensure fees to cover costs of licensure.  The regulatory authority for the program is transferred from the Department of Social and Health Services to the Department of Health if the Department of Health is created by the Legislature.

Appropriation:    none

Revenue:    yes

Fiscal Note:      available

Effective Date:Section 24 is effective on July 1, 1989.

Senate Committee - Testified: Dr. Marden R. Kohler, Columbia BioMedical Lab (pro); Becky Board, Medical Laboratory Group (pro); Dr. John Batjer, Laboratory of Pathology of Seattle (pro);Dorothy Canavin, LASSA (pro); Joan Gaumer, WSSMT (pro); Wayne Ketchersid, WSSMT (pro); Pat Pierce, Eastside Medical Lab; James Dallas, Department of Social and Health Services (pro); Aggie Maza, Eastside Medical Lab (pro)