Title HSC — California Health & Safety Code

Unless the context otherwise requires, the definitions in this article govern the construction of this chapter.

“Biologics” includes the following products which are offered for sale or distribution for the prevention or treatment of disease, except biologics which are registered pursuant to Chapter 1.5 (commencing with Section 9201), Part 1, Division 5 of the Food and Agricultural Code: (…

“Blood bank” means any place where human whole blood, and human whole blood derivatives specified by regulation, are collected, prepared, tested, processed, or stored, or from which human whole blood or human whole blood derivatives specified by regulation are distributed.

“Blood collection center” means a stationary auxiliary to a blood bank which is designed, equipped, and staffed to procure human whole blood or blood components which are to be transported to the blood bank for processing, storing, and distribution.

“Stationary” means a nonmobile room or building maintained at a fixed address.

“Mobile unit” means a transportable auxiliary to a blood bank designed, equipped, and staffed to procure human whole blood and to transport this blood to the bank for processing, storing, and distribution.

“Blood bank depository” means any place other than a blood bank where human whole blood and human whole blood derivatives specified by regulation are stored and held for transfusion. Such blood bank depositories shall be clinical laboratories, licensed in accordance with the prov…

“Blood component” or “blood derivative” means any product produced from whole blood.

“Distribution” includes sale and exchange.

“Production” includes collection, preparation, testing, processing, storage, and distribution of biologics under a license issued by the department.

“Department” means the State Department of Health Services.

“Carrier donor” means any donor of human whole blood whose blood donation has been found, either by laboratory tests or by the tracing of a transfusion-associated hepatitis case where there was a single donor, to contain viral hepatitis, or any donor of human whole blood who has …

“Possible carrier donor” means any donor of human whole blood whose blood donation was administered where multiple transfusions from multiple donors were administered to a recipient and such transfusions result in a case diagnosed by a physician as transfusion-associated hepatiti…

“Carrier of viral hepatitis” means a person under treatment by a physician who has contracted viral hepatitis which has been confirmed by voluntary laboratory tests or who exhibits symptoms which lead a physician to render a diagnostic opinion that the person has contracted viral…

(a) No person shall engage in the production of human whole blood or human whole blood derivatives unless the person is licensed under this chapter and the human whole blood or human whole blood derivative is collected, prepared, labeled, and stored in accordance with both of the…

(a) No person shall import any human whole blood or human whole blood derivative produced outside the state unless that blood or blood product meets the standards set forth in the latest edition of the “Standards for Blood Banks and Transfusion Services,” as published by the Amer…

(a) Except as provided in this subdivision, no blood or blood components shall be used in vivo for humans in this state, unless the blood or blood components have been tested and found nonreactive for HIV or the blood or blood components are used for research or vaccination progr…

(a) Each blood bank or plasma center shall require as identification either a photographic driver’s license or other photographic identification that is issued by the Department of Motor Vehicles, pursuant to Division 6 (commencing with Section 12500) of the Vehicle Code, from al…

(a) Before donation of blood or blood components, a donor shall be notified in writing of, and shall have signed a written statement confirming the notification of, all of the following: (1) That the blood or blood components shall be tested for evidence of antibodies to HIV. (2)…

(a) Notwithstanding Chapter 7 (commencing with Section 120975) of Part 4 of Division 105, or any other provision of law, no public entity or any private blood bank or plasma center shall be liable for an inadvertent, accidental, or otherwise unintentional disclosure of the result…

(a) Notwithstanding any other provision of law, every person engaged in the production of blood shall, if the product is intended for transfusion, label each container of blood which the person produces with a label, upon which the following designations shall be printed in lette…

The distribution or release for distribution by blood banks of human whole blood, or those human whole blood derivatives specified by regulation, shall be made only to blood bank depositories or to other licensed blood banks.

(a) Notwithstanding any other provision of law, in order to provide umbilical cord blood banking storage services, a blood bank shall be licensed pursuant to this chapter. Any additional standards for blood banks to store umbilical cord blood may be implemented by the department …

Establishments which receive human whole blood and human whole blood derivatives specified by regulation and are not subject to license in accordance with this chapter shall be considered as blood bank depositories. Laboratory tests and other procedures with respect to the prepar…

The procurement, processing, distribution, or use of whole blood, plasma, blood products, and blood derivatives for the purpose of injecting or transfusing the same, or any of them, into the human body shall be construed to be, and is declared to be, for all purposes whatsoever, …

(a) Notwithstanding any other law, licensed clinical laboratory bioanalysts, licensed clinical laboratory technologists, registered clinical laboratory technologist trainees, licensed vocational nurses, registered nurses, and blood donor phlebotomists, as defined by the American …

(a) Notwithstanding any other provision of law, a person who has attained the age of 17 may consent to the donation of his or her blood and to the penetration of tissue which is necessary to accomplish such donation, and a blood bank may accept such donation. (b) Notwithstanding …

This chapter does not repeal or in any manner affect any provision of the Business and Professions Code relating to the practice of medicine.

No person shall engage in the production of biologics other than human whole blood and human whole blood derivatives unless: (a) In a laboratory licensed by the Public Health Service, United States Department of Health, Education and Welfare. (b) In a laboratory licensed by the A…

The department shall make rules and regulations governing the production of all biologics produced in establishments under subdivision (c) of Section 1609.

The department may make rules and regulations governing the transportation or distribution of cultures of micro-organisms which may produce disease in man or animals.

Applications for licenses issued under this chapter shall be made upon forms issued by the department. The applications shall contain at least the following: (a) The name and address of the person owning the place, establishment, or institution in which biologics production is pl…

If the department does not within 60 days after the filing of the application issue a license, it shall state the grounds and reasons for its refusal in writing, serving a copy upon the applicant. The notice may be served by registered mail addressed to the applicant at his last …

(a) A license shall be automatically revoked when there is a change of address, ownership, or person in charge of biologics production. However, a new license may be secured for the new location, owner, or person in charge prior to the actual change if the contemplated change is …

(a) Each application for a license or license renewal under this chapter shall be accompanied by a fee determined by the director by regulations and in an amount sufficient to cover the cost of administering this chapter but not to exceed those costs, as specified pursuant to Sec…

(a) The fee required pursuant to Section 1616 for the calendar year commencing January 1, 1992, and for each fiscal year thereafter unless adjusted pursuant to subdivision (b), shall not exceed the following: One thousand five hundred dollars ($1,500) for a blood bank and no more…

(a) The department shall administer this chapter. (b) In order to carry out this chapter, any duly authorized representative of the department may do any of the following: (1) Enter or inspect on an announced or unannounced basis any building, premise, equipment, materials, recor…

(a) Licenses shall be suspended or revoked by the department for the violation of any provision of this chapter, or of any rule or regulation made by the department under authority conferred by this chapter. The proceedings shall be conducted in accordance with Section 100171. (b…

Nothing in this chapter shall be considered to be in conflict with Part 5 (commencing with Section 109875) of Division 104 of this code and all provisions of that division shall apply to biologics within the meaning of this chapter, except that this chapter shall not apply to pro…

The violation of any provision of this chapter is a misdemeanor punishable by a fine of not less than one hundred dollars ($100) nor more than one thousand dollars ($1,000), or by imprisonment for not more than 30 days, or by both.

As used in this article: (a) “Blood” means human whole blood or components of human blood, including plasma, which are prepared from human whole blood by physical, rather than chemical processes, but does not include blood derivatives manufactured or processed for industrial use.…

In addition to the requirements of Section 1602.1, subdivisions (a) to (c), inclusive, of Section 1002 of Title 17 of the California Administrative Code, and any other requirements identified by the State Department of Health Services, hemapheresis donors shall provide a medical …

(a) Except as provided in subdivisions (b) and (c), it shall be unlawful, in any transfusion of blood, to use any blood that was obtained from a paid donor. (b) Subdivision (a) shall not be applicable to any transfusion of blood that was obtained from a paid donor if the physicia…

(a) (1) The University of California is requested to develop a plan to establish and administer the Umbilical Cord Blood Collection Program for the purpose of collecting units of umbilical cord blood for public use in transplantation and providing nonclinical units for research p…

(a) The University of California may accept public and private funds for the purpose of implementing this article. (b) The Umbilical Cord Blood Collection Program Fund is hereby created in the State Treasury. Any fees collected pursuant to Section 103625 shall be deposited into t…

In implementing the program, the department shall make every effort to avoid duplication or conflicts with existing and ongoing programs and to leverage existing resources.

(a) On or before January 1, 2026, if it elects to administer the Umbilical Cord Blood Collection Program, the University of California shall provide a report to the Assembly and Senate Committees on Health that addresses, at a minimum, all of the following: (1) The number of cord…

This article shall remain in effect only until January 1, 2027, and as of that date is repealed.

Each county may develop an emergency medical services program. Each county developing such a program shall designate a local EMS agency which shall be the county health department, an agency established and operated by the county, an entity with which the county contracts for the…

Upon the request of a city or fire district that contracted for or provided, as of June 1, 1980, prehospital emergency medical services, a county shall enter into a written agreement with the city or fire district regarding the provision of prehospital emergency medical services …