Tissue Bank

New Application Checklist​

1. Form LAB 172​ (PDF) Tissue Bank Application (Including question #3)
2. Form LAB 1​69 (PDF) Personnel Report
3. Form LAB 170​ (PDF) ART Questionnaire, if applicable
4. Form LAB 184​ (PDF, 1.4 MB) 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, 1.5MB)
14. Application fee enclosed:
    • Refer to ​Fee Schedule webpage​​
    • 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​​​​