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The American Association of Tissue Banks
(AATB) is the organization that sets standards, inspects facilities, and accredits tissue
banks in North America. AATB trains and certifies Tissue Banking Specialists. In crafting
new federal regulations for tissue banking, the FDA has relied heavily on the expertise of
the AATB. Northwest Tissue Services has been accredited since 1991 and is recognized for its
leadership in AATB.
On December 14, 1993, the
Food and Drug
Administration (FDA) announced interim regulations for all U.S. tissue banks. The interim
rules became effective immediately and required that all tissue banks perform serological
tests to screen for viruses such as hepatitis and HIV The regulations outline criteria for
tissue donor selection, and they authorize the FDA to inspect any facility that recovers,
processes or distributes tissue for transplant. They also prohibit the importation of
tissue from abroad unless it has been shown to meet all FDA requirements. The Final Rule
was published in the Federal Register on July 29, 1997, with an implementation date of
January 29, 1998. The FDA has indicated that proposed new regulations for tissue banking
may include registration and good tissue practices (GTPs). Northwest Tissue Services has
actively sought uniform regulation. For current information about FDA regulation, you may
contact the Tissue Services.
Northwest Tissue Services (NTC) adheres to
strict policies and procedures in all activities. Policies and procedures are written and
revised to stay abreast of new developments and improved methods of tissue banking. All
staff are trained in new procedures that affect their job responsibilities.
Quality assurance and quality control are
central to the Tissue Services operations. Staff who do not have direct responsibility for
the documented activities review and approve the records. Quality audits are regularly
performed and feedback is provided to staff. The goal of all staff is to provide the
highest quality and safest tissue for transplant. |
