Complying with current industry standards for donor eligibility and processing is critical to ensure the ongoing safety and availability of allografts. Tissue banking practices are determined by the: Food and Drug Administration (FDA), American Association of Tissue Banks (AATB) and Clinical Laboratory Improvement Amendments (CLIA).
The FDA regulations for tissue recovery, processing, and distribution of allograft tissue (known as the current Good Tissue Practices (cGTP) have increased requirements for allograft tissue. The regulations address tissue intended for transplantation relative to donor eligibility, good tissue practices and facility registration.
The American Association of Tissue Banks (AATB) sets standards, inspects facilities and offers accreditation and training for US tissue banks and their staff. AATB accreditation requires that AlloSource standards are met in: organizational requirements, records management, tissue acquisition, processing, distribution and quality assurance procedures. The AATB audits organizations and certifies their compliance to the standard in all facets of tissue recovery, processing and distribution.
AlloSource was one of the first national tissue networks to be accredited by the AATB and actively participates in the association through organizational and individual memberships.
The Clinical Laboratories Improvement Act, or CLIA became effective in September 1992. Every US site that conducts tests on human specimens is required to hold the appropriate CLIA certificate.
