WSR 03-02-101

PREPROPOSAL STATEMENT OF INQUIRY

DEPARTMENT OF HEALTH

STATE BOARD OF HEALTH

[ Filed January 2, 2003, 10:04 a.m. ]

Subject of Possible Rule Making: Stewardship of human biological specimens that are submitted to the Department of Health's public health laboratories for testing. To define conditions of storage, access, use, and disposal of these specimens to protect patients' privacy and confidentiality rights and allow appropriate use of specimens for health care, quality assurance and properly approved research purposes.

Statutes Authorizing the Agency to Adopt Rules on this Subject: RCW 43.17.060, 43.70.130, 70.83.050.

Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: Rapid advances in genetic testing and mapping of human genome has increased public concern for the privacy and confidentiality of information available from DNA. Because DNA is found in all biological specimens, assuring responsible stewardship of human specimens submitted to the state's public health laboratories is important to maintaining the public's trust. Recognizing this, the genetics task force, convened by the Board of Health under legislative directive, included in its recommended strategies to safeguard civil rights and privacy related to genetic information to "adopt in rule the existing administrative policies protecting the privacy of newborn screening specimens and other tissue samples held by the state."

Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: The State Board of Health adopts rules related to newborn screening (RCW 70.83.050) and directs hospitals to submit dried blood spot specimens to the public health laboratories (chapter 246-650 WAC). The department and the board will work jointly in the rule development process.

Process for Developing New Rule: Agency study.

Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication. Proposed rule language will be circulated to interested parties for review and comment. If sufficient interest is identified, public meetings will be held to facilitate further discussion and consideration.

Department of Health Contact: Michael Glass, Director Newborn Screening, 1610 N.E. 150th Street, Shoreline, WA 98155, phone (206) 361-2890, fax (206) 361-4996.

State Board of Health Contact: Don Sloma, Executive Director, 1102 Quince Street, P.O. Box 7990, Olympia, WA 98504-7990, phone (360) 236-4102, fax (360) 236-4088.

December 18, 2002

M. C. Selecky, Secretary

Department of Health

Don Sloma, Executive Director

State Board of Health

Washington State Code Reviser's Office