Excerpts from Laws Relating to TISSUE BANKS
HEALTH AND SAFETY CODE SECTION 1635 – 1644.5
(a) "Donor" is an individual, living or deceased, from whom tissue is removed.
(b) "Person" is an individual, corporation, business trust, estate trust, partnership, association, state or
local government, or subdivision or agency thereof, or any other legal entity.
(c) “Tissue" is any human cell, group of cells, tissue or organ including the cornea, sclera, or vitreous
humor and other segments of, or the whole eye, bones, skin, arteries, sperm, blood, other fluids, and any
other portion of a human body.
(d) "Tissue bank" is any place, establishment, or institution that collects, processes, stores, or distributes
tissue for transplantation into human beings.
(e) "Transplantation" is the act or process of transferring tissue, including by ingestion, from a donor to
the body of the donor or another human being.
(f) "State department" is the State Department of Health Services.
1635.1. License: necessity; Inapplicability of chapter (Exceptions)
(a) Except as provided in subdivision (b), every tissue bank operating in California on or after July 1, 1992,
shall have a current and valid tissue bank license issued or renewed by the state department pursuant to
Section 1639.2 or 1639.3.
(b) This chapter shall not apply to any of the following:
(1) The collection, processing, storage, or distribution of human whole blood or its derivatives by blood
banks licensed pursuant to Chapter 4 (commencing with Section 1600) or any person exempt from
licensure under that chapter.
(2) The collection, processing, storage, or distribution of tissue for autopsy, biopsy, training, education,
or for other medical or scientific research or investigation, where transplantation of the tissue is not
intended or reasonably foreseeable.
(3) The collection of tissue by an individual physician and surgeon from his or her patient or the
implantation of tissue by an individual physician and surgeon into his or her patient. This exemption shall not
be interpreted to apply to any processing or storage of the tissue, except for the processing and storage of
semen by an individual physician and surgeon when the semen was collected by that physician and surgeon
from a semen donor or obtained by that physician and surgeon from a tissue bank licensed under this
(4) The collection, processing, storage, or distribution of fetal tissue or tissue derived from a human
embryo or fetus.
(5) The collection, processing, storage, or distribution by an organ procurement organization (OPO),
as defined in Section 485.302of Title 42 of the Code of Federal Regulations, if the OPO, at the time of
collection, processing, storage, and distribution of the organ, has been designated by the Secretary of Health
and Human Services as an OPO, pursuant to Section 485.305 of Title 42 of the Code of Federal
Regulations, and meets the requirements of Sections 485.304 and 485.306 of Title 42 of the Code of Federal
Regulations, as applicable.
(6) The storage of prepackaged, freeze-dried bone by a general acute care hospital.
1635.2. Inapplicability of Uniform Commercial Code - Sales
The Legislature hereby declares its intent that the collection, processing, storage, or distribution of
tissue for the purpose of transplantation, as regulated by this chapter, shall be deemed a service by
those persons engaged in these activities. Therefore, the collection, processing, storage, or distribution of
tissue for the purpose of transplantation, as regulated by this chapter, shall not be subject to the
requirements of Division 2 (commencing with Section 2101) of the Commercial Code.
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1639. Rules and Regulations; Minimum standards
(a) The department may adopt rules and regulations governing the administration and enforcement of this
(b) Regulations adopted by the department may include minimum standards for the following:
(1) Safe preservation, transportation, storage, and handling of tissue acquired or used for
(2) Testing of donors to determine compatibility when appropriate.
(3) Testing or assessment of donors to prevent the spread of disease through transplantation.
(6) Personnel qualifications.
(7) Any other area concerning the operation or maintenance of a tissue bank, not inconsistent with this
chapter, as may be necessary to carry out this chapter.
(c) The department shall report to the Legislature by January 1 2004, on the status of the regulations
developed pursuant to this section.
1639.1. Application for license
Any person desiring a license issued pursuant to Section 1639.3 shall file with the state department a
verified application on forms prescribed by the state department containing all of the following:
(a) The name of the applicant for licensure.
(b) The street address of the tissue bank. If more than one street address is occupied by the tissue bank,
all occupied street addresses shall be listed.
(c) Whether the applicant is an individual, partnership, unincorporated association, or corporation.
(d) Whether the applicant does business under a fictitious name, and, if so, the fictitious name and the
name of the locality wherein any fictitious name permit is filed.
(e) If the applicant is a partnership, the names of all the members of the partnership, or unincorporated
association, whether general or limited.
(f) If the applicant is a corporation, the name of the officers, directors, shareholders holding a 5 percent or
more interest in the corporation, and any person, partnership, or corporation who or which has the
responsibility to manage or conduct the day-to-day operation of the tissue bank.
(g) The type of tissue collected, processed, stored, or distributed by the tissue bank.
(h) The names, titles, and qualifications of the persons responsible for the collection, processing,
storage, or distribution of tissue by the tissue bank.
(i) Any process utilized by the tissue bank to ensure safe preservation, transportation, storage, and
handling, of tissue acquired or used by the tissue bank.
(j) Any process utilized by the tissue bank to determine if, when appropriate, donors have been tested to
(k) Any process utilized by the tissue bank to determine if donors have been tested or assessed for the
transmission of disease through transplantation.
1639.2. Expiration; Renewal; Forfeiture of license
(a) Each license issued pursuant to subdivision (a) of Section 1639.3 before July 1, 1992, shall expire July
1, 1993. Every other license issued pursuant to subdivision (a) of Section 1639.3 shall expire 12 months
from the date of issuance.
(b) An application for renewal of a license issued pursuant to subdivision (a) of Section 1639.3 shall be
filed with the state department not less than 30 days prior to its expiration date and shall be accompanied
by the annual renewal fee required in Section 1639.5. Failure to make timely application or payment for
renewal shall result by operation of law in expiration of the license on its expiration date.
(c) Upon application and payment of the required fee, a renewal license issued under subdivision (a) of
Section 1639.3 shall be renewed for one- or two-year periods, at the option of the licensee,
as long as the licensee has been found to be in substantial compliance with this chapter and the rules and
regulations adopted under this chapter during the preceding license period.
(d) Any license issued pursuant to this chapter shall be forfeited by operation of law prior to its expiration
date when one of the following occurs:
(1) The tissue bank is sold or otherwise transferred.
(2) The license is surrendered to the state department.
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1639.3 Issuance of license; Grounds for denial; Provisional license
(a) Upon the filing of the verified application for licensure required by Section 1639.1, payment of the
application fee in the amount required in Section 1639.5, and full compliance with this chapter and the rules
and regulations adopted by the state department, the state department shall issue a license to operate a
tissue bank to the applicant.
(b) If the state department finds that the applicant is not in compliance with this chapter or the rules or
regulations adopted under this chapter, or if it finds that the applicant has acted in a manner which would
justify the revocation or suspension of a tissue bank license as described in Section 1643, the license shall
(c) The state department may, prior to a determination under subdivision (a) that the applicant is in full
compliance, but after the filing of a complete and verified application and payment of the application fee,
issue a provisional license to operate a tissue bank to the applicant. The provisional license shall remain in
effect until a license is either granted under subdivision (a) or denied under subdivision (b).
If this period is longer than a year from the date of filing the application for licensure, the applicant shall pay
an additional annual fee of nine hundred fifty dollars ($950) in order for the provisional license to remain in
effect for an additional one-year period. Failure to pay the additional annual fee shall result, by operation of
law, in automatic expiration of the provisional license one year from the date of its original issuance. If the
provisional license does so expire, the applicant may not continue to operate a
tissue bank pending the department's determination of whether a license shall be granted or denied.
1639.35. Informed consent form to accompany all applications and renewals
Any person, when submitting an application for a license, including the renewal thereof, pursuant to this
chapter, shall also submit, with the application, a copy of the applicant's standard informed consent form
required pursuant to Section 7158.3.
1639.4. Denial of application; Notice; Hearing; Petition; Conduct
Immediately upon the denial of any application for a license, the state department shall notify the applicant in
writing. Within 20 days after the state department mails the notice, the applicant may present a written
petition for a hearing to the state department. Upon receipt by the state department of the petition in proper
form, the petition shall be set for hearing. The proceedings shall be conducted in accordance with Section
1639.5. Fees; Exceptions
(a) The application and annual renewal fee for a tissue bank license shall be nine hundred fifty dollars
($950). Upon application for renewal of a license issued pursuant to subdivision (a) of Section 1639.3, the
amount of the annual renewal fee required shall be determined by the period of time for which renewal is
sought, which shall be either a one- or two-year period. The amount due shall be the amount prorated to the
length of time the renewal is sought, based on the annual nine hundred fifty dollar ($950) fee.
(b) Notwithstanding subdivision (a), no license fee shall be required for any tissue bank operated by the
state or any state agency, or by a district, city, county, or city and county, or any subdivision or agency
thereof, or by a "mothers' milk bank," as defined in subdivision (b) of Section 14132.34 of the Welfare and
Institutions Code, that has applied for tissue bank licensure prior to January 1, 1995.
1639.6 Rights of department to inspect, copy, photograph or secure sample or
(a) In order to carry out the purpose of 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, records, or information at any reasonable time to secure compliance with, or prevent a violation of,
this chapter or the rules or regulations adopted by the state department.
(2) Inspect, photograph, or copy any records, reports, test results, test specimens, or other information
related to the requirements of this chapter or the rules or regulations adopted by the state department.
(3) Secure any sample, photograph, or other evidence from any building or premise for the purpose of
enforcing this chapter or the rules or regulations adopted by the state department.
(b) The state department may require licensed tissue banks to demonstrate satisfactory performance in a
proficiency testing program approved by the state department in laboratory procedures which the tissue bank
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1641. Violations; Misdemeanor; Penalties
Any person who violates this chapter or who willfully and repeatedly violates any rule or regulation adopted
under this chapter, is guilty of a misdemeanor and upon conviction thereof shall be punished by a fine not to
exceed one thousand dollars ($1,000) or by imprisonment in a county jail for a period not to exceed 180
days, or by both fine and imprisonment.
1641.1. Injunction against tissue bank operating without license
The state department may bring an action to enjoin the violation or threatened violation of Section 1635.1 in
the superior court in and for the county in which the violation occurred or is about to occur. Any proceeding
under this section shall conform to the requirements of Chapter 3 (commencing with Section 525) of Title 7 of
Part 2 of the Code of Civil Procedure, except that the state department shall not be required to allege facts
necessary to show or tending to show lack of adequate remedy at law or irreparable damage or loss. With
respect to any action brought pursuant to this section alleging actual violation of Section 1635.1, the court
shall, if it finds the allegations to be true, issue its order enjoining the continuance of the violation.
1643. Suspension or Revocation of License: Grounds
The state department may suspend or revoke any license issued under this chapter for any of the following
(a) Violation by the licensee of this chapter or any rule or regulation adopted under this chapter.
(b) Aiding, abetting, or permitting the violation of any provision of this chapter, the rules or regulations
adopted under this chapter or the Medical Practice Act (Chapter 5 (commencing with Section 2000) of
Division 2 of the Business and Professions Code).
(c) Proof that the licensee has made false statements in any material regard on the application for a tissue
(d) Conduct inimical to the public health, morals, welfare, or safety of the people of the State of California
in the maintenance or operation of the premises or services for which a license is issued.
(e) Conduct prohibited under Section 367f of the Penal Code and under Section 274e of Title 42 of the
United States Code.
(f) The conviction of a licensee or the person in charge of the tissue bank of any crime which is
substantially related to the qualifications or duties of the licensee or the person in charge of the tissue bank
or which is substantially related to the functions of the tissue bank. For purposes of this section, a conviction
means a plea or verdict of guilty or a conviction following a plea of nolo contendere. An action to revoke or
suspend the license may be taken when the time for appeal has elapsed or the judgment of conviction has
been affirmed on appeal or when an order granting probation is made suspending the imposition of
sentence, notwithstanding a subsequent order pursuant to Section 1203.4 of the Penal Code permitting
withdrawal of a plea of guilty and entry of a plea of not guilty, or setting aside the v erdict of guilty, or
dismissing the accusation, information or indictment. The director shall take into account all competent
evidence of rehabilitation furnished by the licensee or person in charge of the tissue bank.
1643.1 . Conduct of proceedings
Proceedings for the suspension or revocation of licenses under this chapter shall be conducted in
accordance with Section 100171.
1643.2 Temporary suspension prior to hearing; Notice and accusation;
The state department may temporarily suspend any license issued under this chapter prior to any hearing,
when it has determined that the action is necessary to protect the public welfare. The state department shall
notify the licensee of the temporary suspension and the effective date thereof and at the same time shall
serve the licensee with an accusation. Upon receipt of a notice of defense by the licensee, the matter shall,
within 15 days, be set for hearing. The hearing shall be held as soon as possible but not later than 30 days
after receipt of such notice. The temporary suspension shall remain in effect until such time as the hearing is
completed and the state department has made a final determination on the merits. However, the temporary
suspension shall be deemed vacated if the state department fails to make a final determination on the merits
within 60 days after the original hearing has been completed.
For purposes of this chapter, "donor," "person," "tissue," "transplantation," and "state department" shall have
the meaning as defined for those terms in Section 1635.
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1644.5 Transplantation, Screening tests, Regulations, Prohibition of use of Infected
(a) No tissues shall be transferred into the body of another person by means of transplantation, unless the
donor of the tissues has been screened and found nonreactive by laboratory tests for evidence of infection
with HIV, agents of viral hepatitis (HBV and HCV), human T lymphotrophic virus-1 (HTLV -1), and syphilis.
The state department may adopt regulations requiring additional screening tests of donors or tissues when,
in the opinion of the state department, the action is necessary for the protection of the public, donors, or
(b) Notwithstanding subdivision (a), infectious disease screening of blood and blood products shall be
carried out solely in accordance with Article 2 (commencing with Section 1601) of Chapter 4.
(c) All donors of sperm shall be screened and found nonreactive as required under subdivision (a), except
in the following instances:
(1) A recipient of sperm, from a sperm donor known to the recipient, may waive a second or other
repeat testing of that donor if the recipient is informed of the requirements for testing donors under
this section and signs a written waiver.
(2) A recipient of sperm may consent to therapeutic insemination of sperm or use of sperm in other
advanced reproductive technologies even if the sperm donor is found reactive for hepatitis B,
hepatitis C, or syphilis if the sperm donor is the spouse of, partner of, or designated donor for that
recipient. The physician providing insemination or advanced reproductive technology services shall
advise the donor and recipient of the potential medical risks associated with receiving sperm from a
reactive donor. The donor and the recipient shall sign a document affirming that each
comprehends the medical repercussions of using sperm from a reactive donor for the proposed
procedure and that each consents to it. Copies of the document shall be placed in the medical
records of the donor and the recipient.
(3) Sperm whose donor has tested reactive for syphilis may be used for the purposes of insemination
or advanced reproductive technology only after the donor has been treated for syphilis. Sperm
whose donor has tested reactiv for hepatitis B may be used for the purposes of insemination or
advanced reproductive technology only after the recipient has been vaccinated against hepatitis B.
(d) Subdivision (a) shall not apply to the transplantation of tissue from a donor who has not been tested or,
with the exception of HIV, has been found reactive for the infectious diseases listed in subdivision (a) or for
which the state department has, by regulation, required additional screening tests, if both of the following
conditions are satisfied:
(1) The physician and surgeon performing the transplantation has determined any one or more
of the following:
(A) Without the transplantation the intended recipient will most likely die during the period of time
necessary to obtain other tissue or to conduct the required tests.
(B) The intended recipient already is diagnosed with the infectious disease for which the donor has
(C) The symptoms from the infectious disease for which the donor has tested positive will most
likely not appear during the intended recipient's likely lifespan after transplantation with the
tissue or may be treated prophylactically if they do appear.
(2) Consent for the use of the tissue has been obtained from the recipient, if possible, or if not
possible, from a member of the recipient's family, or the recipient's legal guardian. For
purposes of this section, "family" shall mean spouse, adult son or daughter, either parent,
adult brother or sister, or grandparent.
(e) Human breast milk from donors who test reactive for agents of viral hepatitis (HBV and HCV), human T
lymphotrophic virus-1 (HTLV-1), HIV, or syphilis shall not be used for deposit into a milk bank for human
ingestion in California.
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HEALTH AND SAFETY CODE SECTION 100171
100171. Notwithstanding any other provision of law, whenever the department is authorized or required by
statute, regulation, due process (14th amendment, United States Constitution; subdivision (a) of Section 7 of
Article I, California Constitution), or a contract, to conduct an adjudicative hearing leading to a final decision
of the director or the department, the following shall apply:
(a) The proceeding shall be conducted pursuant to the administrative adjudication provisions of Chapter
4.5 (commencing with Section 11400) and Chapter 5 (commencing with Section 11500) of Part 1 of Division
3 of Title 2 of the Government Code, except as specified in this section.
(b) Notwithstanding Section 11502 of the Government Code, whenever the department conducts a hearing
under Chapter 4.5 (commencing with Section 11400) or Chapter 5 (commencing with Section 11500) of Part
1 of Division 3 of Title 2 of the Government Code, the hearing shall be conducted before an administrative
law judge selected by the department and assigned to a hearing office that complies with the procedural
requirements of Chapter 4.5 (commencing with Section 11400) of Part 1 of Division 3 of Title 2 of the
(c) (1) Notwithstanding Section 11508 of the Government Code, whenever the department conducts a
hearing under Chapter 4.5 (commencing with Section 11400) or Chapter 5 (commencing with Section 11500)
of Part 1 of Division 3 of Title 2 of the Government Code, the time and place of the hearing shall be
determined by the staff assigned to the hearing office of the department, except as provided in paragraph (2)
or unless the department by regulation specifies otherwise.
(2) Formal hearings requested by institutional Medi-Cal providers and health facilities shall be held in
(d) (1) Unless otherwise specified in this section, the following sections of the Government Code shall
apply to any adjudicative hearing conducted by the department only if the department has not, by regulation,
specified an alternative procedure for the particular type of hearing at issue: Section 11503 (relating to
accusations), Section 11504 (relating to statements of issues), Section 11505 (relating to the contents of the
statement to respondent), Section 11506 (relating to the notice of defense), Section 11507.6 (relating to
discovery rights and procedures), Section 11508 (relating to the time and place of hearings), and Section
11516 (relating to amendment of accusations).
(2) Any alternative procedure specified by the department in accordance with this subdivision shall
conform to the purpose of the Government Code provision it replaces insofar as it is possible to do so
consistent with the specific procedural requirements applicable to the type of hearing at issue.
(3) Any alternative procedures adopted by the department under this subdivision shall not diminish the
amount of notice given of the issues to be heard by the department or deprive appellants of the right to
discovery suitable to the particular proceedings. Except as specified in paragraph (2) of subdivision (c),
modifications of timeframes or of the place of hearing made by regulation may not lengthen timeframes
within which the department is required to act nor require hearings to be held at a greater distance from the
appellant's place of residence or business than is the case under the otherwise applicable Government Code
(e) The specific timelines specified in Section 11517 of the Government Code shall not apply to any
adjudicative hearing conducted by the department to the extent that the department has, by regulation,
specified different timelines for the particular type of hearing at issue.
(f) In the case of any adjudicative hearing conducted by the department, "transcript," as used in subdivision
(c) of Section 11517 of the Government Code, shall be deemed to include any alternative form of recordation
of the oral proceedings, including, but not limited to, an audiotape.
(g) Pursuant to Section 11415.50 of the Government Code, the department may, by regulation, provide for
any appropriate informal procedure to be used for an informal level of review that does not itself lead to a
final decision of the department or the director. The procedures specified in Article 10 (commencing with
Section 11445.10) of Chapter 4.5 of Part 1 of Division 3 of Title 2 of the Government Code shall not apply to
any such an informal level of review. Informal conferences concerning appeals by institutional Medi-Cal
providers and health facilities may be held in Sacramento or Los Angeles.
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(h) Notwithstanding any other provision of law, any adjudicative hearing conducted by the department that
is conducted pursuant to a federal statutory or regulatory requirement that contains specific procedures may
be conducted pursuant to those procedures to the extent they are inconsistent with the procedures specified
in this section.
(i) Nothing in this section shall apply to a fair hearing involving a Medi-Cal beneficiary insofar as the
hearing is, by agreement or otherwise, heard before an administrative law judge employed by the State
Department of Social Services, or insofar as the hearing is being held pursuant to Division 4.5 (commencing
with Section 4500) of the Welfare and Institutions Code in connection with services provided by the State
Department of Developmental Services under applicable federal medicaid waivers. Nothing in this
subdivision shall be interpreted as abrogating the authority of the State Department of Health Services as the
single state agency under the state medicaid plan.
(j) Nothing in this provision shall supersede express provisions of law that apply to any hearing that is not
adjudicative in nature or that does not involve due process rights specific to an individual or specific
individuals, as opposed to the general public or a segment of the general public.
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