Biomedical Engineering Reference
In-Depth Information
ple archiving and experimental use. A research nurse or other trained repository per-
sonnel monitors the operating room (OR) schedule to determine when the patient's
surgery is going to occur from which tissue will be collected. The surgeon removes
the tissue according to whatever surgical procedure is indicated, and the tissue is
sent to the pathology laboratory. Once in the laboratory, the pathologist or patholo-
gist assistant examines the tissue and takes what is necessary for patient diagnosis
and determines what portion of the specimen is in excess and can be released to the
repository. The portion of the specimen intended for the repository is immediately
given to trained repository personnel who begin processing the specimen for
preservation and storage.
As with blood, RNA in tissue is susceptible to ischemia-induced injury and can
rapidly degrade once it is removed from the patient. Therefore, it is important that
the tissue be placed in a plastic bag, which is then placed in a container of slush ice
and rapidly transported to the laboratory for processing. If multiple tissue samples
(e.g., tumor and suspicious lymph nodes) are obtained, it is unacceptable to batch
the specimens—each tissue sample must be taken to the pathology laboratory as
soon as it is removed. For quality assurance purposes, the warm ischemia interval
(the time period based on when a tissue sample is removed from a patient to the time
of cryopreservation) should be carefully monitored. Because tissue-banking activi-
ties often deviate from the routine day-to-day activities of an OR, it is useful to
engage in active dialogue with the surgical team and to provide frequent in-services
about tissue handling procedures.
To protect patient confidentiality and to comply with federal patient privacy
regulations, all clinical samples collected for research should be deidentified.
Deidentified samples are those that have had all identifiers or codes removed such
that the ability to identify particular individuals, via clinical or demographic infor-
mation, would be extremely difficult for the researcher. The deidentification process
starts first with the patient, who should be assigned a unique patient-specific
research number, and continues with the data collection forms and clinical samples.
Deidentification is readily accomplished by a scannable barcode system, which links
each sample to a particular patient and tracks the specimens and associated
information throughout their lifetime in the repository.
3.4.2 Tissue Processing
The prioritization of patient diagnosis over collection of specimens for research pur-
poses is vital to ensuring that patient care is not compromised. As such, it is impera-
tive that the surgically excised specimen be examined by a pathologist. It is
unacceptable practice for a surgeon to aid in the process by removing a portion of a
tumor or other lesion intraoperatively, as the disruption of the specimen may ham-
per pathologic assessment of lesion size, margins, or other diagnostically important
characteristics. Once the sample arrives in the laboratory, the pathologist examines
the specimen in the fresh state, records all relevant pathologic information, and inks
the specimen as appropriate to assess margins. Tissue is harvested for research pur-
poses only after the pathologist has determined that all diagnostic requirements
have been satisfied. If removing tissue for research will compromise the diagnostic
integrity of the specimen (e.g., the lesion is very small or near a surgical margin),
Search WWH ::
Custom Search