2009 California Health and Safety Code - Section 1639-1641.1 :: Article 2. Regulation Of Tissue Banks

1639.  (a) The department may adopt rules and regulations governing
the administration and enforcement of this chapter.
   (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 transplantation.
   (2) Testing of donors to determine compatibility when appropriate.
   (3) Testing or assessment of donors to prevent the spread of
disease through transplantation.
   (4) Equipment.
   (5) Methods.
   (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.

1639.01.  (a) Notwithstanding Section 1639, the state department
shall adopt, on or before July 1, 2004, rules and regulations
governing licensed tissue banks engaged in the collection of human
musculoskeletal tissue, skin, and veins for transplantation in
humans. The regulations shall be substantially based upon the
criteria used by tissue bank trade associations in their respective
accreditation processes including, but not limited to, those of the
Eye Bank Association of America and the American Association of
Tissue Banks, and the scientific and technical data submitted by
individual tissue banks.
   (b) Regulations adopted by the state department, pursuant to
subdivision (a), shall include minimum standards for all of the
following:
   (1) Safe preservation, transportation, storage, and handling of
tissue acquired or used for transplantation.
   (2) Testing of donors to determine compatibility when appropriate.
   (3) Testing or assessment of donors to prevent the spread of
disease through transplantation.
   (4) Equipment.
   (5) Methods.
   (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) On or before July 1, 2003, the department shall report to the
appropriate policy and fiscal committees of the Legislature regarding
the status of the proposed regulations.

1639.1.  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 determine compatibility.
   (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.  (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.

1639.3.  (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 be
denied.
   (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.  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.  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 100171.

1639.5.  (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.

1639.55.  (a) There is hereby established in the State Treasury the
Tissue Bank License Fund. Notwithstanding any other provision of law,
if, at the end of any fiscal year, the unencumbered balance in any
account in the Tissue Bank License Fund exceeds 110 percent of the
amount appropriated from the account for the following fiscal year,
the state department shall reduce the application and annual renewal
fees which are deposited into the account. The amount of the
reduction shall be sufficient to reduce the unencumbered balance in
the account at the end of the following fiscal year to less than 110
percent of the amount appropriated in that fiscal year. The
adjustment of fees pursuant to this section shall not be subject to
the requirements of Chapter 3.5 (commencing with Section 11340) of
Part 1 of Division 3 of Title 2 of the Government Code.
   (b) The state department shall receive and account for all money
received pursuant to this chapter and shall deposit it with the
Treasurer who shall keep the money in the Tissue Bank License Fund.
   (c) Moneys deposited to the credit of the Tissue Bank License Fund
which are appropriated in the Budget Act or any other appropriation
act for support of or expenditure by the state department shall be
used by the state department to administer this chapter.
   (d) Upon the request of the State Director of Health Services, the
Director of Finance may make a loan to the Tissue Bank License Fund
from funds appropriated from the General Fund for that purpose. The
amount of any such loan shall be approved by the Director of Finance
and be repaid under those terms and conditions as prescribed by the
Director of Finance, but shall, in any event, be repaid not later
than June 30, 1995.

1639.56.  The department shall submit a report to the Legislature no
later than January 1, 2003, including, but not limited to, examining
and evaluating all of the following:
   (a) Administrative expenditures of tissue banks.
   (b) Current use of informed consent by tissue banks in tissue
donation and recovery, including recommendations for improving and
expanding informed consent policy.
   (c) Full disclosure requirements by tissue banks to the donor or
the person authorized to make a donation on behalf of a decedent of
all potential uses of donated and recovered tissues.
   (d) A system in which individuals with medically necessary
conditions for which donated tissues are part of the prescribed
treatment are given priority in receiving donated tissues, and the
feasibility of state subsidies to implement the system.
   (e) The current process for tissue recovery and distribution,
including recommendations for improvement, where necessary.

1639.6.  (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 performs.

1641.  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.  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.