2.  Any place, establishment, or institution that a chain of operations that includes 1. informing patients and obtaining the proper consent, 2. data acquisition, 3.tissue procurement, 4. annotation, 5. preservation, 6. storage, 7. quality control, 8. cataloguing, 9.managing of access and distribution of human biological material. www.ncbi.nlm.nih.govwww.ncbi.nlm.nih.gov ‎

3.  In California state alone, 3 new tissue banks are licensed every month.  Cadaveric transplant banks are about 60 - 70% of the banks licensed; the other 30 - 40 % are ART (“assisted reproductive technology” tissue banks, which are sperm banks and IVF clinics. California Department of Health Services,Tissue Bank Licensing / Laboratory Field Serves

4.  Broad consent and consent to future research studies. provided that personal information related to the research is handled safely, that donors of biological samples are granted the right to withdraw consent, and that every new study is approved by the ethics-review board.  Once donated, the tissue belongs to the institution  Emphasize altruisim and solidarity The Lancet Oncology, Volume 7, Issue 3, Pages 266 - 269, March 2006, the Moore CaseVolume 7, Issue 3

5.  Data must be de-identified  Each sample has the following: ◦ Informed patient consent either single or ◦ Single form combining consent to undergo an invasive procedure & consent to use surplus tissue for research.  Patient information: Gender, age, and other non-identifiers  Medical/Surgical/Family/Social History  Diagnostic procedures/Tests and reports  Basic clinical annotation

6. Specialists in tissue acquisition contracted by tissue banks for:  Routine storage of excess tissue  Willed donor programs  Diagnostic tissue  Protocol specific tissue including transplant.

7. Most expensive component of tissue bank  1. Frozen-- a sterile container, stored at - 70°C and dry ice.  2. Fresh----rapidly placed in a 4°C hypothermal solution within 30 minutes of resection.  3. Flash-frozen---place in a container and then flash freezing them in liquid nitrogen within 30 minutes of resection.  4. Dissociated.. cryopreserved in an animal protein free media that contains 10% DMSO.  5. Fixed specimens… eg buffered formalin, or a paraffin-embedded block Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004.2004/23/EC

8.  One voluntary standard applicable to all customer-focused organizations is the International Organization of Standards' ISO 9001, Quality Management Systems— Requirements. This standard outlines the requirements needed to ensure an organization provides consistent quality products or services to their customers while striving to meet or exceed their expectations.  ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories. However, as the name implies, 17025 standards only apply to biorepositories generating test results. Quality management systems  Certification and Accreditation Programs Biopreservation and Biobanking. August 2012: 403-404.