Safety and Quality
All donated tissues are recovered or collected by our recovery partners across the United States are processed and distributed from our site in Phoenix AZ.
Pinnacle Transplant Technologies complies with guidelines and regulations from the American Association of Tissue Banks, the Food and Drug Administration and many state or international health departments.
Our tissues are prepared from donors determined to be suitable for transplant by the Pinnacle Medical Director based on the results of screening and testing.
Recovery or collection of donated tissues is performed by our recovery partners using sterile surgical procedures.
Pinnacle’s controlled tissue processing environment and controlled procedures are designed to ensure tissue allograft quality and safety. Pinnacle utilizes a proprietary series of disinfection soaks that reduce bioburden prior to terminal sterilization using either electron beam or gamma irradiation.
Pinnacle only accepts donors from federally designated Organ Procurement Organizations (OPOs) or qualified tissue recovery partners. As these organizations are focused primarily on organ donation and tissue recovery, Pinnacle is responsible for donor screening, tissue processing, and distribution services for our partners. Each partner is routinely audited to verify that their recovery practices meet current FDA regulations, AATB standards and Pinnacle's own stringent guidelines.
Prior to release for transplantation, each donor is subjected to a thorough eligibility evaluation including review of the donors medical and social history, hospital records, infectious disease screening, autopsy report (if performed), and physical assessment. Testing includes, but is not limited to, the following:
• HBsAg: Hepatitis B Surface Antigen
• HBcAb: Hepatitis B Core Antibody
• HCVAb: Hepatitis C Antibody
• HIV 1/2/Ab: Human Immunodeficiency Virus Types 1/2 and O Antibody
• HCV NAT: Hepatitis C Virus
• HIV NAT: Human Immunodeficiency Virus
• HBV NAT: Hepatitis B Virus
• RPR/STS or Equivalent: Syphilis
All required communicable disease tests must be negative or nonreactive.
Communicable disease testing is performed by laboratories that are registered with the FDA to perform donor testing and certified to perform such testing on human specimens in accordance with Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, or that has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services (CMS).
Based on all the screening and testing results all donated human tissues will be determined to be suitable for transplant by the Medical Director and Quality Assurance.