Regulation of Tissue Banks
Cal. HSC § 1639.1
California Statutes
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 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.