SECTIONS 1625-1626 - California Statutes

HEALTH AND SAFETY CODE

SECTION 1625-1626

1625. 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.

1625.1. 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.

1626. (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.
(e) (1) Commencing in January 1996, and every year thereafter
through the 2002 calendar year, those blood banks acquiring blood
platelets from paid donors shall report all of the following
information to the State Department of Health Services:
(A) The specific actions undertaken to obtain blood platelets from
volunteer donors.
(B) The percentage of compensated and volunteer donors from whom
blood platelets were obtained during the period covered by the
report.
(C) The number of repeat donors making platelet donations during
the period covered by the report.
(2) The department shall transmit the information received
pursuant to this subdivision to the Senate Health and Human Services
Committee and the Assembly Health Committee for review by those
committees consistent with subdivision (a). The department shall
monitor and assess the supply and distribution of hemapheresis
products, and shall recommend to the Legislature any action the
department believes beneficial to the supply, safety, and quality of
blood products used in this state.
(3) Paragraph (1) of this subdivision is not intended to require
the disclosure and reporting of information that would put the blood
banks at a competitive disadvantage in attracting volunteer donors.