Each donor undergoes a thorough screening process that begins with obtaining an Informed Consent from the donor’s legal next of kin. A dialogue is opened that allows for a detailed explanation of upcoming events, including how a recovery is conducted and specifically what tissues will be recovered. Family members are encouraged to ask questions and participate fully in the review of the donor’s medical and social history. Coercion in any form is prohibited as well as any form of monetary inducement.

Donor blood serum is tested according to federal regulations by CLIA certified laboratories. Using FDA licensed donor screening tests, the donor must be found negative or non reactive for the following tests including, but not limited to:

A complete medical history record is compiled on each donor for review by LifeTek’s in house Medical Director. The donor medical history record includes, but is not limited to, the Informed Consent, Medical/Social History Questionnaire, Recovery Documentation, Laboratory Results and Hospital Medical Records. Based on established criteria each donor’s medical history record is reviewed to determine eligibility for processing.

LifeTek aseptically process tissues in Class 100 Cleanrooms, significantly reducing the risk of airborne contaminants. Equipment and reagents used are sterilized in steam autoclaves. Grafts are further processed and sterilized using Clearant® Technology.

LifeTek allografts are provided either freeze-dried or frozen. Freeze-dried allografts are stored at ambient temperatures, while frozen allografts are stored at -40°C or colder. Freeze-dried allografts are provided with a maximum of two years expiration, frozen allografts are provided with a maximum of five years expiration.

Tissue Implant Records are provided with each allograft. It is the responsibility of the implanting facility to complete the implant record and return it. Implant information received is held in the strictest confidence according to HIPAA regulations.