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Article 7. Blood Donations of California Health And Safety Code >> Division 2. >> Chapter 4. >> Article 7.
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.
(b) "Cytapheresis" means the separation and collection of blood cells by hemapheresis.
(c) "Hemapheresis" means the removal of whole blood from a donor, separation of the blood into components, retention of the desired components, and return of the recombined remaining elements to the donor.
(d) "Industrial use" means a use of blood in which the blood is modified by physical or chemical means to produce derivatives for therapeutic or pharmaceutic biologics, laboratory reagents, or in vitro diagnostics.
(e) "Paid donor" means a person who donates blood and who receives payment in return for the donation of such blood.
(f) "Payment" means the transfer by a blood bank to any person of money or any other valuable consideration which can be converted to money by the recipient, except that payment shall not include any of the following:
(1) Cancellation or refund of the nonreplacement fees or related blood transfusion charges.
(2) Blood assurance benefits to a person as a result of a blood donation to a donor club or blood assurance program.
(3) Time away from employment, with or without pay, granted by an employer to an employee in order to donate blood.
(g) "Person" means any individual, blood bank, hospital, firm, corporation, or any other entity.
(h) "Transfusion" means a use of blood in which the blood is administered to a human being for treatment of sickness or injury.
(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.
(b) "Cytapheresis" means the separation and collection of blood cells by hemapheresis.
(c) "Hemapheresis" means the removal of whole blood from a donor, separation of the blood into components, retention of the desired components, and return of the recombined remaining elements to the donor.
(d) "Industrial use" means a use of blood in which the blood is modified by physical or chemical means to produce derivatives for therapeutic or pharmaceutic biologics, laboratory reagents, or in vitro diagnostics.
(e) "Paid donor" means a person who donates blood and who receives payment in return for the donation of such blood.
(f) "Payment" means the transfer by a blood bank to any person of money or any other valuable consideration which can be converted to money by the recipient, except that payment shall not include any of the following:
(1) Cancellation or refund of the nonreplacement fees or related blood transfusion charges.
(2) Blood assurance benefits to a person as a result of a blood donation to a donor club or blood assurance program.
(3) Time away from employment, with or without pay, granted by an employer to an employee in order to donate blood.
(g) "Person" means any individual, blood bank, hospital, firm, corporation, or any other entity.
(h) "Transfusion" means a use of blood in which the blood is administered to a human being for treatment of sickness or injury.
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 history questionnaire completed by a
trained interviewer who questions and verifies the accuracy of
responses before every donation.
The department may require testing or examinations to reflect
changing technology and to increase the safety of blood products.
(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 physician and surgeon performing the transfusion has determined, taking into consideration the condition of the patient who is the recipient of the transfusion, that other blood of a type compatible with the blood type of the patient cannot reasonably be obtained for the transfusion.
(c) Subdivision (a) shall not apply to blood platelets secured from paid donors through the hemapheresis process if all of the following requirements are satisfied:
(1) The blood platelets are ordered by a doctor holding a valid California physician's and surgeon's certificate.
(2) The blood platelets are secured from a single donor and are sufficient to constitute a complete platelet transfusion.
(3) The donor's identification number is recorded on the platelet label and is kept in the records of the entity providing the blood platelets for a minimum of five years.
(4) The donor has been examined by a doctor holding a valid California physician's and surgeon's certificate, and a repeat donor is reexamined at least annually.
(5) The transfusion is performed in a general acute care hospital.
(6) The blood platelets are processed according to standards issued by the American Association of Blood Banks, pursuant to Section 1602.1.
(7) The donor and blood are tested in accordance with regulations issued by the State Department of Health Services.
(8) The entity providing the blood platelets is licensed by the State Department of Health Services.
(9) The information that the donor of the blood platelets was compensated is printed on the label in accordance with Section 1603.5.
(10) In all instances, a potential donor shall provide a blood sample, which shall be tested with the standard panel of blood tests required by the State Department of Health Services for all blood donations. The results of the testing shall be obtained, evaluated, and determined to be acceptable prior to allowing the potential donor to provide his or her first donation of platelets. In addition, all donors shall be required to schedule an appointment for platelet donation.
(11) Any entity that is not collecting blood platelets from paid donors on August 1, 2000, shall obtain written permission from the director prior to compensating any donor for blood platelets.
(d) Subdivision (c) shall become inoperative on January 1, 2003.
(b) Subdivision (a) shall not be applicable to any transfusion of blood that was obtained from a paid donor if the physician and surgeon performing the transfusion has determined, taking into consideration the condition of the patient who is the recipient of the transfusion, that other blood of a type compatible with the blood type of the patient cannot reasonably be obtained for the transfusion.
(c) Subdivision (a) shall not apply to blood platelets secured from paid donors through the hemapheresis process if all of the following requirements are satisfied:
(1) The blood platelets are ordered by a doctor holding a valid California physician's and surgeon's certificate.
(2) The blood platelets are secured from a single donor and are sufficient to constitute a complete platelet transfusion.
(3) The donor's identification number is recorded on the platelet label and is kept in the records of the entity providing the blood platelets for a minimum of five years.
(4) The donor has been examined by a doctor holding a valid California physician's and surgeon's certificate, and a repeat donor is reexamined at least annually.
(5) The transfusion is performed in a general acute care hospital.
(6) The blood platelets are processed according to standards issued by the American Association of Blood Banks, pursuant to Section 1602.1.
(7) The donor and blood are tested in accordance with regulations issued by the State Department of Health Services.
(8) The entity providing the blood platelets is licensed by the State Department of Health Services.
(9) The information that the donor of the blood platelets was compensated is printed on the label in accordance with Section 1603.5.
(10) In all instances, a potential donor shall provide a blood sample, which shall be tested with the standard panel of blood tests required by the State Department of Health Services for all blood donations. The results of the testing shall be obtained, evaluated, and determined to be acceptable prior to allowing the potential donor to provide his or her first donation of platelets. In addition, all donors shall be required to schedule an appointment for platelet donation.
(11) Any entity that is not collecting blood platelets from paid donors on August 1, 2000, shall obtain written permission from the director prior to compensating any donor for blood platelets.
(d) Subdivision (c) shall become inoperative on January 1, 2003.
