Proven Record of Safety
Screening & Testing
RTI’s primary goal is to ensure patient safety. We adhere to strict donor screening criteria, including laboratory testing and donor eligibility assessment, as well as tissue preparation validated to address potential disease transmission to ensure the safety of our implants. In the event that any one of these stages is challenged, RTI’s tissue processing system includes built-in redundancies to ensure patient safety.
RTI, a tissue processor, receives donated tissue from independently registered tissue recovery organizations. To make an initial determination as to whether tissues may be appropriately recovered, these tissue recovery organizations are responsible for obtaining appropriate consents and conducting federally-mandated donor screening, such as a medical and social history interview with the next of kin. Following recovery, the tissue is provided to organizations such as RTI, which in turn prepare the tissue for transplantation.
Upon receipt of the tissue, RTI conducts processing-related donor screening to determine its medical suitability for transplantation. Processing-related donor screening performed by RTI includes laboratory testing and a donor eligibility assessment.
As part of its processing-related donor screening, RTI performs an extensive panel of serological and microbiological tests. These results are subject to stringent criteria in order to release the donor tissue to the processing stage.
Tests on the blood specimens from the donor are performed in a CLIA-certified laboratory. Serological testing includes:
- HIV 1 & 2 Antibody
- HTLV-I and HTLV-II Antibody
- HBV Surface Antigen
- HBV Total Core Antibody
- RPR for Syphilis
- HIV-I NAT
In addition to serological testing on the donor’s blood, microbiological testing is used throughout the process (where appropriate) to screen for potential contamination and to provide confirmation of tissue suitability for transplant.
The final determination on whether donated tissue is suitable for transplant is made by an RTI Medical Director, a licensed physician.
In order to determine donor eligibility, the Medical Director reviews all available records. These records include, but are not limited to, recovery records, the donor physical assessment, the donor risk assessment interview, hospital / ER records, laboratory / pathology reports, infectious disease testing results and the medical examiner/ autopsy report, if performed.