
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.gov


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.
Field Serves
California Department of Health Services,Tissue Bank Licensing / Laboratory

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 Case


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
Specialists in tissue acquisition contracted by
tissue banks for:
 Routine storage of excess tissue
 Willed donor programs
 Diagnostic tissue
 Protocol specific tissue including transplant.
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 .

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.