ORGANS AND TISSUES
Yes. Normal tissues are the standard. Diseased tissues are by request.
Anatomical specimens—have an average death to preservation (DTP) time, or post mortem interval (PMI), of 8 hours. They are not flushed and thus possess much lower to negligible viability. They cannot be used for cell culture but are excellent for anatomical research, DNA extraction, tissue slices, surgical techniques and a variety of other research projects. Specialty specimens—have a death to preservation (DTP) time, or post mortem interval (PMI), of less than 8 hours. They can be perfused or rinsed on request and shipped within a reasonable time to ensure good quality organs and tissue. The organs and tissues are not generally recommended for cell culture applications, but can be used for a wide range of processes, from biomechanic research to protein harvesting.
These organs and tissues can be used for biomedical, pharmaceutical, research and/or education applications. It is, however, the client company’s responsibility to follow all FDA guidelines in the use of these tissues.
Organs and tissues come to us through LifeLegacy’s own nationwide Donor Program. LifeLegacy works cooperatively with OPOs (Organ Procurement Organizations) to maximize donations to their fullest.
The standard serology testing for all tissues is a three-panel test that includes HIV 1 and 2, and hepatitis B and C. Serology testing for CMV, HTLV 1 and 2, and RPR can be done on request. Other testing, such as PCR (polymerase chain reaction) and NAT (Nucleic Acid Amplification Technology), are available but must be requested at the time of placing the order. Associated fees are based on types of tests required and testing protocols.
VRL Laboratories. This laboratory is CLIA (Clinical Laboratory Improvement Amendments) certified.
All specimen requests must be received by LifeLegacy in writing 24 hours prior to shipment. To ensure inventory availability of requested tissues, we recommend at least a two week notice of tissue specimen needs.
DONOR RECORDS AND SEROLOGY RESULTS
Donor demographic, medical and social history, cause of death, and serology results are available for a fee.
First, a completed LifeLegacy Application Form must be submitted and approved through the LifeLegacy Application and Approval Committee. The researcher/client company may then request to audit LifeLegacy facilities. The auditing agency or researcher/client company will provide LifeLegacy with its questions, guidelines, and information on tissue needs. An appointment can then be scheduled. LifeLegacy completes annual self-audits for AATB accreditation using the STAR self-assessment guide as its inspection tool.
Organs and tissues are shipped using only qualified freight fowarding carriers ensuring a timely delivery to meet the needs of the client. LifeLegacy does ship internationally. Due to shipping time and potential customs delays involved when shipping outside the U.S., we recommend tissue be frozen when shipped. Fresh tissue can be shipped only when prior special arrangements have been made. Fresh tissue is scheduled to arrive at its destination within 24 hours of shipment.
TISSUE TRACKING AND DISPOSITION
Each shipment includes a comprehensive packet of information and instructions that will guide clients through the entire process from tissue receipt to disposition. This includes our Chain of Custody (COC) documentation which requires the client to track and document each tissue while in the client’s custody and return this documentation to LifeLegacy.
There are two ways for clients to handle the final disposition of tissue:
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