Medical Researcher: Frequently Asked Questions

ORGANS AND TISSUES

Does LifeLegacy provide both normal and diseased tissues?

Yes. Normal tissues are the standard. Diseased tissues are by request.

What are the tissue procurement timelines for research purposes?

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.

Can LifeLegacy provide tissue for either biomedical or pharmaceutical applications?

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.

SOURCES

What are LifeLegacy’s sources for human organs and 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.

TESTING

What tests are typically done?

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.

Which testing laboratories does LifeLegacy currently use, and are these laboratories CLIA certified?

VRL Laboratories. This laboratory is CLIA (Clinical Laboratory Improvement Amendments) certified.

SPECIMEN REQUESTS

How does a client make a request for specimens?

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

What donor information is available to the client for each tissue?

Donor demographic, medical and social history, cause of death, and serology results are available for a fee.

AUDITING

What is the process for a potential researcher/client company to audit LifeLegacy’s facility?

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.

SHIPPING

How are organs and tissues shipped to clients within the U.S. and internationally?

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

How does LifeLegacy track tissue to final 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.

How do clients handle final disposition of tissue?

There are two ways for clients to handle the final disposition of tissue:

1. Clients can return tissue to LifeLegacy for final disposition. Tissue must be packaged appropriately with dry ice and shipped overnight. There is a fee for this service and the client is responsible for shipping.
2. Clients can use a local funeral home for tissue cremation. This requires the client maintain written proof of final disposition from the crematory.

WORKING WITH LIFELEGACY

How does a researcher start the process if interested in ordering non-transplantable organs or tissue?

Contact one of LifeLegacy’s experienced Client Services representatives by calling 888-774-4438 or 520-575-5200 or by e-mailing This e-mail address is being protected from spambots. You need JavaScript enabled to view it . The representative will be able to answer any questions and provide the LifeLegacy Application Form. All researchers must submit a completed LifeLegacy Application Form and be approved through the LifeLegacy Application and Approval Committee before being able to acquire non-transplantable organs or tissue. This review process usually takes less than two weeks.