SENATE BILL REPORT

SB 5378

BYSenators Wojahn and Kreidler

Licensing laboratories conducting prenatal test.

Senate Committee on Human Services and Corrections

Senate Hearing Date(s):January 22, 1987; February 25, 1987; March 2, 1987

Majority Report:  That Substitute Senate Bill No. 5378 be substituted therefor, and the substitute bill do pass.

      Signed by Senators Wojahn, Chairman; Stratton, Vice Chairman; Anderson, Deccio, Kiskaddon, Kreidler, Tanner.

Senate Staff:Scott Plack (786-7409)

                  March 10, 1987

AS REPORTED BY COMMITTEE ON HUMAN SERVICES & CORRECTIONS, MARCH 2, 1987

BACKGROUND:

Scientific advancements in the area of genetic diagnosis have resulted in the development of prenatal tests for identifying congenital and heritable disorders.  Some tests now available require substantial quality control measures in order to assure accuracy.  Counseling for both physicians and patients is often necessary to fully understand test results, and options available to address problems identified by the tests.  One example of these tests is the maternal serum alpha-feto protein (AFP) screening test.  State mandated quality control standards for laboratories performing these tests do not exist. 

SUMMARY:

A laboratory licensing process is established within DSHS for conducting certain genetic tests. The State Health Coordinating Council is directed to review prenatal tests and recommend which shall be performed by a licensed laboratory.  DSHS shall enumerate these tests in rule.

An advisory committee is created to make recommendations to DSHS regarding specific laboratory licensure rules.  The advisory committee is to develop recommendations on:

      *minimum number of tests to be performed in a given period of time,

      *required quality control systems,

      *minimum data base,

      *procedures to share data with the state,

      *minimum educational, experience and licensure requirements for laboratory personnel,

      *guidelines to facilitate coordination with existing prenatal testing programs in DSHS.

Rules are to be adopted by December 1, 1988.

DSHS is required to establish fees and collection procedures.  An appropriation of $40,000 is made for the biennium.

DSHS is granted disciplinary authority to take action against license holders upon a finding of violation.  The disciplinary process is defined, including specific procedures, appeals, sanctions, and definition of unprofessional conduct.

All persons licensed to provide prenatal care or practice medicine in the state are directed to provide information regarding the use and availability of prenatal tests to pregnant women within time limits prescribed by DSHS.  This requirement becomes effective December 31, 1988 when licensure has commenced.

Effective January 1, 1989 all third-party contracts for disability, health care services and health maintenance organizations providing prenatal care are required to offer coverage for prenatal diagnosis of congenital disorders.

Appropriation:    $40,000

Fiscal Note:      requested

EFFECT OF PROPOSED SUBSTITUTE:

A data reporting program is created for laboratories performing prenatal tests. The program is established in DSHS.  The Board of Health is directed to review prenatal tests and recommend which shall be included in the data reporting program. DSHS shall enumerate these tests in rule.  An advisory committee is formed to assist the Department in the development of laboratory reporting rules.  All persons licensed to provide prenatal care in the state are directed to provide information about the use and availability of prenatal tests to pregnant women within time limits prescribed by DSHS.  Effective January 1, 1989 all new or renewed third party group contracts for disability, health care services and health maintenance organizations that cover hospital, medical or surgical expenses and provide pregnancy, childbirth or related medical conditions to enrollees shall offer benefits for prenatal diagnosis of congenital disorders if such services are deemed medically necessary in rule by the State Board of Health.

Senate Committee - Testified: Dr. David Shurtleff, UW; Dr. John D. Batser, Swedish Hospital; Dr. Ronald Scott, UW; Patti Kough; Barbara Goeckel; Dr. Horace Thuline, DSHS; Dr. Dennis Peck, St. Peter Hospital; Joan Gaumer, Blue Cross of Washington & Alaska; Ken Bertrand, Group Health