Tissue Bank

New Application Checklist​

1. Form LAB 172​ (PDF) Tissue Bank Application (Including question #3)
2. Form LAB 169 (PDF) Personnel Report
3. Form LAB 170​ (PDF) ART Questionnaire, if applicable
4. Form LAB 184​ (PDF) Contact Person sheet
5. Either:
   • Tissue Bank Site Lease Agreement
   • Business Permit
   • Fictitious Name Permit
   Or:
   • Copy of hospital's California State license from Licensing & Certification
6. Ownership Substantiation:
   • Corporate organization chart structure detailing parent and intermediary owners
   • Partnership Agreement
   • Practice Management Assistance Agreement
   • Corporation documents:
     • Articles of Incorporation
     • List of Board of Directors and Officers
     • List of shareholders who own 5% or more
     • Management Agreements
7. Employee & Director Resumes or CVs (BRN# of RN employees on LAB 169 is sufficient)
8. Copy of all Policies and Procedures pertaining to: receipt and/or collection of tissue; processing and/or storage of tissue; preparation of tissue prior to implantation; recall; QA; documentation of performed procedures
9. Copy of Patient Consent Form(s)
10. STD Screening Policy Statement on company letterhead (See STD Statement PDF)
11. Copy of FDA Registration (if applicable)
12. Documents signed & dated
13. Operations Affirmation Letter (PDF)
14. Application fee enclosed:
    • $975
    • Made payable to: “CDPH” or “Tissue Bank Fund”
    • No license fee required for a tissue bank operated by the State, State agency, health care district, city, or county​​​​