2010 California Code
Health and Safety Code
Article 2. Human Whole Blood And Human Whole Blood Derivatives

1602.5.  (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 following:
   (1) The standards set forth in the 13th Edition of "Standards for
Blood Banks and Transfusion Services," as published by the American
Association of Blood Banks and in effect on November 15, 1989, or any
amendments thereto or later published editions or amendments
thereto. These shall be the standards for all licensed blood banks
and blood transfusion services in the state.
   (2) Those provisions of Title 17 of the California Code of
Regulations that are continued in effect by subdivision (c) or that
are adopted pursuant to subdivision (b).
   (b) The department may, by the adoption of regulations, establish
and require compliance with requirements in addition to, or in lieu
of, those in subdivision (a) as the department deems appropriate to
reflect changing technology or to improve the safety of human whole
blood or human whole blood derivatives. Any standards adopted
pursuant to this subdivision shall be adopted after consultation with
representatives of the American Association of Blood Banks.
   (c) Until the time superseded by any regulation adopted pursuant
to this section, all of the provisions of Group 1 (commencing with
Section 950) of Subchapter 1 of Chapter 2 of Part 1 of Title 17 of
the California Code of Regulations shall remain in effect with the
exception of the following:
   (1) Subdivisions (i) to (k), inclusive, of Section 997.
   (2) Sections 999 and 1001.
   (3) Subdivisions (a) to (c), inclusive, of Section 1002.
   (4) Paragraphs (2) and (3) of subdivision (e) of Section 1002.
   (5) Subdivisions (f) and (g) of Section 1002.
   (6) Paragraphs (2) to (6), inclusive, of subdivision (h) of
Section 1002.
   (7) Subdivisions (i), (k), and ( l) of Section 1002.
   (8) Subdivisions (a) to (c), inclusive, of Section 1004.
   (9) Sections 1010, 1012, 1013, 1014, 1024, and 1024.1.
   (10) Subdivisions (a), (b), and (e) of Section 1025.
   (11) Paragraphs (1) to (3), inclusive, of subdivision (c) of
Section 1025.
   (d) (1) Any amendment to the 13th Edition of "Standards for Blood
Banks and Transfusion Services," any later editions, or any
amendments thereto, published by the American Association of Blood
Banks shall become effective in California 90 days after the
effective date of this section, or 90 days after publication by the
association, unless the department sends written notice, within such
a 90-day period, to all persons licensed under this chapter to engage
in the production of human whole blood or human whole blood
derivatives, indicating which portions shall not become effective.
   (2) The department may determine that no portion of any amendments
or later editions shall become effective. The department shall
determine that no portion of an amendment or later edition shall
become effective pursuant to this section whenever the department has
not received a copy of the amendment or later edition by the date it
is published by the American Association of Blood Banks.



1602.6.  (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 American Association of Blood Banks, or any later
published editions or amendments thereto.
   (b) Any later editions of the "Standards for Blood Banks and
Transfusion Services," or amendments thereto, published by the
American Association of Blood Banks, shall become effective for
purposes at this section 90 days after the effective date of this
section, or 90 days after publication by the association, whichever
is later, unless the department sends written notice, within the
90-day period, to all persons who import human whole blood or human
whole blood derivatives produced outside the state that have
requested this notice, stating the portions of those later editions
or amendments that shall not become effective.
   (c) The department may determine that no portion of any later
editions or amendments shall become effective for purposes of this
section. The department shall determine that no portion of a later
edition or amendment shall become effective for purposes of this
section whenever the department has not received a copy of the later
edition or amendment by the date it is published by the American
Association of Blood Banks.
   (d) The department shall administer and enforce this section in
accordance with this chapter and in a manner that assures, to the
greatest degree, consistency with Section 1602.5.



1603.1.  (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 programs pursuant to an informed consent.
   Additional exceptions to the requirement of this subdivision are
as follows:
   (1) Blood or blood components released for transfusion in
emergency circumstances, as determined by the department.
   (2) Blood or blood components used for autologous purposes.
   (b) Blood banks and plasma centers shall make laboratory tests of
all human whole blood and blood components received to detect the
presence of viral hepatitis and HIV in the manner specified in
Section 1603.3. If the blood bank or plasma center finds the presence
of viral hepatitis, or an antigen thereof, in the blood or blood
components tested, it shall report that finding, the date of the
human whole blood or blood components donation, the name, address,
and social security number of the person who donated the blood or
blood components, and the name and address of the blood bank or
plasma center that received the human whole blood or blood components
from the person and any additional information required by the
department, to the local health officer within 72 hours of the
confirmation of the presence of viral hepatitis, or an antigen
thereof, in the blood or blood components tested.
   (c) A physician, hospital, or other health care provider shall
report all AIDS cases, HIV infections, and viral hepatitis
infections, including transfusion-associated cases or infections, to
the local health officer with the information required, and within
the timeframes established by the department, pursuant to Title 17 of
the California Code of Regulations.
   (d) Upon receipt of a report concerning any transfusion-associated
hepatitis or transfusion-associated HIV or AIDS cases, the local
health officer shall identify which blood bank or plasma center is
the source of the infectious blood or blood components and shall
report this fact to the blood bank or plasma center that issued the
blood or blood components. The blood bank or plasma center shall
undertake an investigation to determine the donor source of the
infectious blood or blood components.
   (e) Local health officials shall contact all persons who have
confirmed cases of AIDS, as determined by a person responsible for
the care and treatment of the person with AIDS, to suggest
appropriate treatment alternatives and for the purposes of
epidemiological studies and followup.
   (f) The department may adopt regulations governing the procedures
in this section as it deems necessary to protect the public health
and safety.
   (g) "Plasma center," as used in this chapter, means any place
where the process of plasmapheresis is conducted, as defined in
Section 1025 of Title 17 of the California Code of Regulations and
includes a place where leukopheresis or platelet pheresis, or both,
is conducted.
   (h) "AIDS," as used in this chapter, means acquired immune
deficiency syndrome.
   (i) "HIV," as used in this chapter, means human immunodeficiency
virus.
   (j) "Blood components," as used in this chapter, means
preparations separated from single units of whole blood or prepared
for hemapheresis and intended for use as final products for
transfusions.
   (k) A local health officer may disclose to a blood bank or plasma
center, on a confidential basis, whether blood or blood components
previously transfused may have been donated by a person infected with
HIV, in order to implement the blood bank's or plasma center's
program to notify a recipient of blood or blood components that might
have transmitted HIV. The blood bank or plasma center may not
disclose information that would identify a donor to which this
subdivision applies and shall destroy information communicated to it
as authorized by this subdivision immediately after reviewing its
records as necessary to implement this program.




1603.2.  (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 all donors of human whole blood or blood
components who receive payment in return for the donation of that
blood or blood components.
   (b) For the purposes of this section, "payment" means the transfer
by a blood bank or plasma center to any person of money or any other
valuable consideration that 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 or blood components transfusion charges.
   (2) Blood assurance benefits to a person as a result of a blood or
blood components donation to a donor club or blood assurance
program.
   (3) Time away from employment granted by an employer to an
employee in order to donate blood or blood components.



1603.3.  (a) Prior to a donation of blood or blood components, each
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) That the donor shall be notified of the test results in
accordance with the requirements described in subdivision (c).
   (3) That the donor blood or blood component that is found to have
the antibodies shall not be used for transfusion.
   (4) That blood or blood components shall not be donated for
transfusion purposes by a person if the person may have reason to
believe that he or she has been exposed to HIV or AIDS.
   (5) That the donor is required to complete a health screening
questionnaire to assist in the determination as to whether he or she
may have been exposed to HIV or AIDS.
   (b) A blood bank or plasma center shall incorporate voluntary
means of self-deferral for donors. The means of self-deferral may
include, but are not limited to, a form with checkoff boxes
specifying that the blood or blood components are for research or
test purposes only and a telephone callback system for donors to use
in order to inform the blood bank or plasma center that blood or
blood components donated should not be used for transfusion. The
blood bank or plasma center shall inform the donor, in a manner that
is understandable to the donor, that the self-deferral process is
available and should be used if the donor has reason to believe that
he or she is infected with HIV. The blood bank or plasma center shall
also inform the donor that it is a felony pursuant to Section 1621.5
to donate blood if the donor knows that he or she has a diagnosis of
AIDS or knows that he or she has tested reactive to HIV.
   (c) Blood or blood components from any donor initially found to
have serologic evidence of antibodies to HIV shall be retested for
confirmation. Only if a further test confirms the conclusion of the
earlier test shall the donor be notified of a reactive result by the
blood bank or plasma center.
   The department shall develop permissive guidelines for blood banks
and plasma centers on the method to be used to notify a donor of a
test result.
   (d) Each blood bank or plasma center operating in California shall
prominently display at each of its collection sites a notice that
provides the addresses and telephone numbers of sites, within the
proximate area of the blood bank or plasma center, where anonymous
HIV antibody testing provided pursuant to Chapter 3 (commencing with
Section 120885) of Part 4 of Division 105 may be administered without
charge.
   (e) The department may promulgate any additional regulations it
deems necessary to enhance the safety of donated blood and blood
components. The department may also promulgate regulations it deems
necessary to safeguard the consistency and accuracy of HIV test
results by requiring any confirmatory testing the department deems
appropriate for the particular types of HIV tests that have yielded
"reactive," "positive," "indeterminate," or other similarly labeled
results.
   (f) Notwithstanding any other provision of law, no civil liability
or criminal sanction shall be imposed for disclosure of test results
to a local health officer when the disclosure is necessary to locate
and notify a blood or blood components donor of a reactive result if
reasonable efforts by the blood bank or plasma center to locate the
donor have failed. Upon completion of the local health officer's
efforts to locate and notify a blood or blood components donor of a
reactive result, all records obtained from the blood bank or plasma
center pursuant to this subdivision, or maintained pursuant to this
subdivision, including, but not limited to, any individual
identifying information or test results, shall be expunged by the
local health officer.



1603.4.  (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 results of an HIV test.
   As used in this section, "public entity" includes, but is not
limited to, any publicly owned or operated blood bank or plasma
center, local health officer, and the department.
   (b) Neither the department nor any blood bank or plasma center,
including a blood bank or plasma center owned or operated by a public
entity, or local health officer shall be held liable for any damage
resulting from the notification of test results, as set forth in
paragraph (2) of subdivision (a) of, or in subdivision (c) of,
Section 1603.3.



1603.5.  (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 letters the size of which shall be no less
prominent than the proper name of the product.
   (1) If the person giving the blood received no payment for the
blood, the designation shall be "volunteer donor."
   (2) If the person giving the blood received payment for the blood,
the designation shall be "paid donor."
   (b) As used in this section:
   (1) "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 by industrial use.
   (2) "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.
   (3) "Payment" means the transfer by a blood bank, or any other
party, 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:
   (i) Cancellation or refund of the nonreplacement fees or related
blood transfusion charges.
   (ii) Blood assurance benefits to a person as a result of a blood
donation to a donor club or blood assurance program.
   (iii) Time away from employment granted by an employer to an
employee in order to donate blood.
   (c) Any blood bank receiving blood from a blood bank outside of
California shall comply with the labeling requirements of this
chapter. Any blood bank receiving this blood may label the blood as
"volunteer donor" blood only if the blood bank receives with the
blood a certificate from the out-of-state blood bank which states
either that the particular shipment of blood was acquired from
volunteer donors not receiving payment or that all blood processed by
the out-of-state blood bank is acquired from volunteer donors not
receiving payment. If the blood bank receiving such blood receives no
such certificate with the blood, the blood shall be labeled as "paid
donor" blood.
   (d) No warranty shall be implied from the fact that any blood is
labeled in accordance with the requirements of this section.



1604.  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.



1604.6.  (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 through the adoption of regulations.
   (b) (1) The department may adopt emergency regulations to
implement and make specific subdivision (a) in accordance with
Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3
of Title 2 of the Government Code. For purposes of the Administrative
Procedure Act, the adoption of regulations shall be deemed an
emergency and necessary for the immediate preservation of the public
peace, health and safety, or general welfare.
   (2) (A) Notwithstanding Chapter 3.5 (commencing with Section
11340) of Part 1 of Division 3 of Title 2 of the Government Code,
these emergency regulations shall not be subject to the review and
approval of the Office of Administrative Law. Notwithstanding
Sections 11346.1 and 11349.6 of the Government Code, the department
shall submit these regulations directly to the Secretary of State for
filing.
   (B) Emergency regulations adopted pursuant to this section shall
become effective immediately upon filing by the Secretary of State,
shall be subject to public hearing within 120 days of filing with the
Secretary of State, and shall comply with Sections 11346.8 and
11346.9 of the Government Code, or shall be repealed by the
department.
   (3) The Office of Administrative Law shall provide for the
printing and publication of emergency regulations adopted pursuant to
this section in the California Code of Regulations.
   (4) Notwithstanding Chapter 3.5 (commencing with Section 11340) of
Part 1 of Division 3 of Title 2 of the Government Code, and subject
to subparagraph (B) of paragraph (2), the emergency regulations
adopted pursuant to this subdivision shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised
or repealed by the department.


1605.  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 preparation of blood for transfusion shall be the sole
responsibility of the blood bank depository.



1606.  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, the rendition of a service by each and every
person, firm, or corporation participating therein, and shall not be
construed to be, and is declared not to be, a sale of such whole
blood, plasma, blood products, or blood derivatives, for any purpose
or purposes whatsoever.


1607.  (a) Notwithstanding any other provision of 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 Association of Blood Banks,
may perform skin puncture and venipuncture for the purposes of
collecting human blood if both of the following are satisfied:
   (1) The acts are performed in a blood bank licensed pursuant to
this chapter and personnel training and standards meet accreditation
requirements of the American Association of Blood Banks.
   (2) The acts are performed under the direct and responsible
supervision of a licensed physician and surgeon. The licensing and
registration referred to in this section shall be licensing and
registration pursuant to the Business and Professions Code.
   (b) In accordance with the American Association of Blood Banks
standards, the medical director of the blood bank shall be
responsible for all medical and technical policies and procedures
that relate to the safety of staff members, donors, and patients,
including, but not limited to, ensuring that the blood bank has a
qualified and competent staff to perform all tasks involved in the
collection, storage, processing, and distribution of blood and blood
components. The employer blood bank shall be responsible for
determining the appropriate mix of qualified, competent employees
that meets the accreditation requirements of the American Association
of Blood Banks and is consistent with the services rendered.
   (c) Personnel who are explicitly authorized by the blood bank and
who meet the education, training, and competency standards of the
blood bank, may obtain a predonation medical history and perform
predonation screening. When unlicensed personnel perform these
duties, the review of work required by federal regulations relating
to good manufacturing practices, as set forth in Part 211 and Part
606 of Title 21 of the Code of Federal Regulations, shall be
performed by those staff members who are licensed health care
personnel.
   (d) The collection of blood from autologous patients and other
individuals who do not meet the American Association of Blood Banks
criteria for regular volunteer donation shall be conducted by
licensed health care personnel.
   (e) Nothing in this chapter shall prohibit the collection of blood
at a state institution, a blood bank licensed pursuant to this
chapter, or other establishment, under conditions established and
acceptable to the department, by the personnel of the collecting
entity.
   (f) A staff position for a blood donor phlebotomist created as a
consequence of this section shall not be the only cause for the
displacement of any licensed personnel employed in a licensed blood
bank as of the effective date of the statute amending this section
during the 1995-96 Regular Legislative Session. As used in this
section, the term "displacement" shall mean a reduction in hours of
nonovertime work, the loss of wages, or the loss of employment.
   (g) Nothing in this section shall be construed to limit the rights
of employees or employee organizations to bargain in good faith on
matters of wages, hours, or other terms and conditions of employment,
including the negotiation of workplace standards within the scope of
collective bargaining as authorized by state and federal law.




1607.5.  (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 any other provision of law, a person who has
attained the age of 15 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,
if he or she has the written consent of his or her parents or a
guardian, and the written authorization of a physician and surgeon.
   (c) As used in this section "donation of blood" means a giving of
blood in which the donor of the blood receives no payment therefor.




1608.  This chapter does not repeal or in any manner affect any
provision of the Business and Professions Code relating to the
practice of medicine.