Biomedical Engineering Reference
In-Depth Information
lower temperatures (i.e.,
190°C) may help preserve the molecular integrity of the
specimens for long-term storage. FFPE tissue blocks and tissue microarrays should
be stored under conditions that protect them from extremes of temperature or other
damage (e.g., humidity). Many biorepositories use barcoded inventory systems to
track specimen location. Establishing SOPs for biospecimen storage and using a
barcoding inventory system ensure that specimens are stored appropriately and are
accessible for distribution when necessary.
Once specimens are placed into storage, it is necessary to monitor storage con-
ditions and to maintain equipment in good working order. Most repositories utilize
a monitored central alarm system, have electric backup or liquid nitrogen backup,
and maintain extra freezers to allow for quick transfer of specimens in the event of
equipment failure. Professional periodic maintenance is recommended. Finally,
periodic checks on stored biospecimens (e.g., testing RNA integrity) help to ensure
the quality and integrity of the samples distributed to researchers.
When shipping frozen tissue samples, the same principles that were described
for transporting blood apply. It is especially important that the frozen samples be
packed in sufficient dry ice to cover the specimen vials and that an overnight courier
service be used if possible to prevent thawing damage. Standardized shipping proce-
dures that are integrated with the repository's bioinformatics system aid in tracking
all shipments. Biospecimens sent to the repository from satellite sites and samples
sent from the repository to researchers can be efficiently tracked using a barcoded
inventory system.
3.4.4 Pathologic Characterization of Tissue Samples
For each tissue sample entered into a repository, a base set of pathologic data is
required. Pathologic annotation of specimens should ideally include site of origin
(e.g., breast), primary diagnosis (e.g., infiltrating ductal carcinoma), secondary
descriptors (e.g., well differentiated), pathologic stage, additional diagnostic studies
(e.g., estrogen and progesterone receptor analysis), and associated histopathologic
findings (e.g., fibrocystic changes, intraductal hyperplasia, microcalcifications).
Although many repositories rely on blinded surgical pathology reports to gather
this information, a data collection form with common data elements and standard-
ized terminology is preferred. Additionally, central review of H&E-stained slides
when available ensures accurate, consistent pathologic data, eliminates problems
associated with interobserver variability, and provides a valuable tool for oversight
of the quality of the tissue samples collected.
The amount of pathology information that is collected by a repository depends
on the specific needs of the repository and on the level of support provided by
pathologists. At the Clinical Breast Care Project, a federally funded military-civil-
ian collaboration based at Walter Reed Army Medical Center, each case—benign or
malignant—undergoes extensive histopathologic evaluation by the CBCP-dedi-
cated pathologist. All diagnostic slides (H&E sections, immunohistochemical
stains) are reviewed, including the matched H&E sections that are mirror images of
the submitted research samples. The relevant information is recorded on a stan-
dardized 12-page data collection form, followed by entry of the data into the reposi-
tory's bioinformatics system. The data collection form has a unique identifying
 
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