BILL NUMBER: SB 765 CHAPTERED BILL TEXT CHAPTER 748 FILED WITH SECRETARY OF STATE OCTOBER 10, 1999 APPROVED BY GOVERNOR OCTOBER 7, 1999 PASSED THE SENATE SEPTEMBER 2, 1999 PASSED THE ASSEMBLY SEPTEMBER 1, 1999 AMENDED IN ASSEMBLY AUGUST 30, 1999 AMENDED IN ASSEMBLY JULY 15, 1999 AMENDED IN ASSEMBLY JUNE 24, 1999 AMENDED IN SENATE MAY 17, 1999 AMENDED IN SENATE APRIL 28, 1999 INTRODUCED BY Senator Schiff FEBRUARY 24, 1999 An act to add Sections 681, 1220.5, and 1288.3 to the Business and Professions Code, relating to biological specimens. LEGISLATIVE COUNSEL'S DIGEST SB 765, Schiff. Biological specimens. Existing law sets forth procedures governing the operation of clinical laboratories. A violation of these provisions constitutes unprofessional conduct. This bill would require, commencing July 1, 2000, every person licensed under specified provisions of existing law that regulate health care professionals who collects human biological specimens for clinical testing or examination to secure those specimens as specified. The bill would also require, on and after January 1, 2001, clinical laboratory employees, agents, and couriers who retrieve biological specimens located in a specified public place that are not secured in a locked container, as defined, to notify the licensee by attaching a specified form to the container and to mail a copy of the form to the Department of Consumer Affairs, as specified. This bill would require the State Department of Health Services to develop, and provide to all licensed clinical laboratories, a form in triplicate for the above-described notifications. The changes made by the bill would be contingent upon the enactment of AB 1558 adding Section 2244 to the Business and Professions Code, in which event they will become operative at the same time as AB 1558. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 681 is added to the Business and Professions Code, to read: 681. (a) Commencing July 1, 2000, every person licensed pursuant to this division who collects human biological specimens for clinical testing or examination, shall secure, or ensure that his or her employees, agents, or contractors secure, those specimens in a locked container when those specimens are placed in a public location outside of the custodial control of the licensee, or his or her employees, agents, or contractors. (b) Containers used for human biological specimens put into use on or after January 1, 2001, shall be marked "Caution: Biohazardous Material -Please Do Not Touch or Handle," or words of similar meaning. (c) This section shall not apply where the biological specimens have been placed in the mail in compliance with all applicable laws and regulations. (d) The licensing board having jurisdiction of the licensee may impose appropriate sanctions for violations of this section, including, if otherwise authorized by the licensing act, the imposition of a fine not to exceed one thousand dollars ($1,000). (e) As used in this section, "locked container" means a secure container that is fully enclosed and locked by a padlock, key lock, combination lock, or similar locking device. SEC. 2. Section 1220.5 is added to the Business and Professions Code, to read: 1220.5. (a) The Department of Health Services shall develop, and provide to all licensed clinical laboratories, a form in triplicate to be used by employees, agents, and couriers of licensed clinical laboratories to give notice when a specimen storage container has been improperly secured pursuant to Section 681. (b) The three copies of the triplicate form shall each contain instructions so that one copy is to be attached to the unlocked specimen storage container, one copy is mailed to the Department of Consumer Affairs to be forwarded to the appropriate licensing entity pursuant to Section 1288.3, and one copy is kept by the licensed clinical laboratory for its records. (c) This form shall be provided to all licensed clinical laboratories on and after January 1, 2001. SEC. 3. Section 1288.3 is added to the Business and Professions Code, to read: 1288.3. (a) If a clinical laboratory employee, agent, or courier retrieves biological specimens located in a public place outside of the custodial control of a licensee, or his or her employee, agent, or contractor, and those specimens are not secured in a locked container, the clinical laboratory employee, agent, or courier, utilizing the form provided by the State Department of Health Services pursuant to Section 1220.5, shall (1) notify the licensee by attaching the appropriate copy of the form to the unlocked storage container, and (2) mail the appropriate copy of the form to the Department of Consumer Affairs. The Department of Consumer Affairs shall forward all forms received to the appropriate licensing entity. (b) This section shall not apply where the biological specimens have been received by mail in compliance with all applicable laws and regulations. (c) For purposes of this section: (1) "locked container" means a secure container that is fully enclosed and locked by a padlock, key lock, combination lock, or similar locking device. (2) "Licensee" means a person licensed pursuant to this division 2 (commencing with Section 500), who collects human biological specimens for clinical testing or examination. (d) A violation of this section is not subject to Section 1287. (e) This section shall become operative on January 1, 2001. Nothing in this section shall be construed to require clinical laboratory employees, agents, or couriers to notify licensees or the Department of Consumer Affairs of an unsecured specimen if the State Department of Health Services has not provided the appropriate forms. SEC. 4. Sections 1, 2, and 3 of this act shall become operative only if Assembly Bill 1558 of the 1999-2000 Regular Session is enacted and adds Section 2244 to the Business and Professions Code, in which event it shall become operative at the same time as Assembly Bill 1558.