LifeLegacy is a nonprofit foundation committed to the ethical recovery and placement of nontransplantable human organs and tissues for the purpose of advancing medical research and education. Through informed consent, donors and their families are made aware of the procurement process and ? of the benefits to the medical community of their donations. LifeLegacy is recognized for both its ability ? to recover human organs and other tissues within a short amount of time, thus providing viable tissues, and to customize procurement protocols to meet researchers’ needs.

How does LifeLegacy differ from the competition?

LifeLegacy is the first 501(c)(3) nonprofit research tissue bank to be accredited by the American Association of Tissue Banks (AATB). We participate on several AATB committees, including Bylaws, Ethics and Government Affairs committees.
Many of our staff are Certified Tissue Bank Specialists (CTBS), certified by AATB.
To ensure the highest possible level of safety for our clients, LifeLegacy’s Medical Director reviews all of the donor cases including donor consent, donor medical and social history and serology results prior to release of tissue for distribution.
Tissues are procured per clients’ specific requests and protocols.
LifeLegacy provides a Tissue Escorting Service to allow the custody of the tissue to remain with LifeLegacy.
We accept all tissue back from clients for final disposition. g)? Our high level of service includes follow up on the delivery and quality of all tissue.

What are LifeLegacy’s accreditations, qualifications and memberships?

501(c)(3) nonprofit, American Association of Tissue Banks (AATB) accredited, qualified Organ Procurement Agency under the Arizona Anatomical Gift Act, licensed and inspected by New York State Department of Health, Better Business Bureau of Southern Arizona.

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 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?

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

ORDERS

How does a client place an order?

All orders must be received by LifeLegacy in writing 24 hours prior to shipment. To ensure inventory availability of requested tissues, we recommend a two week notice of tissue needs.

DONOR RECORDS AND SEROLOGY RESULTS

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

Our standard is that the client receives demographic, medical and social history, and cause of death information for each donor. Serology results are available for a fee.

Does LifeLegacy have the capacity to sequester and provide complete medical records on demand and provide written permission of informed consent?

Yes. LifeLegacy will supply an affidavit stating that these records do exist, are legal and are not able to be released with personal information. Most clients find this sufficient for their needs. Complete medical records can be provided for a fee within two weeks of request, but all personal identifying information will be removed as required by HIPAA regulations. Providing the signed informed consent form with all personal identifying information removed as required by HIPAA regulations is more involved. Please contact us for details.

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?

Within the U.S. fresh tissues and organs are shipped by Freight Services to ensure 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 dispose of tissue?

There are two ways for clients to dispose of tissue:

Clients can return tissue to LifeLegacy for 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.
Clients can use a local funeral home for tissue cremation. This requires the client to send LifeLegacy written proof of 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 representatives by calling 888-774-4438 or 520-575-5200 or by ? e-mailing info@LifeLegacy.org. 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.

LifeLegacy Foundation is a federally-approved 501(c)(3) nonprofit charity.