CHANGES TO AATB STANDARDS FOR TISSUE BANKING
SECTION B – GENERAL ORGANIZATIONAL REQUIREMENTS OF A TISSUE BANK
B1.000 GENERAL INSTITUTIONAL REQUIREMENTS
B1.500 Multi-Facility Tissue Banking
B1.521 Inspections/Audits of Other Facilities
(Refers to inspections/Audits that an accredited tissue bank must perform for activities/services rendered by another entity.)
Before an entity performs any activity under contract, agreement or other arrangement, the accredited tissue bank must ensure that the entity will comply with applicable AATB Standards, federal regulations, and applicable state or local laws. Thereafter, the accredited tissue bank is responsible for certifying, at least biennially, that the activities or service(s) has/have been performed in conformance with these Standards, federal regulations, and applicable state or local laws. This requirement does not apply to any other AATB-accredited entity. When applicable, thisThis must be documented on a form provided by, or pre-approved by, the AATB Accreditation Program Manager (refer to the AATB Accreditation Policies). The Verification of activities or services performed by others shall be documented (e.g., a paper Audit, on-site Audit, onsite inspections, etc.). Regardless of whether the facility erforming activities or services for others is accredited, it is the responsibility of the tissue bank receiving those activities/services to periodically verify that Procedures related to the activities/services performed are in compliance with these Standards, federal regulations, applicable state or local laws, and the written agreement/contract. The inspection/Audit plan, policies, and procedures shall be specified in the SOPM.
Documentation that an Audit/inspection specific for activities or services performed shall be maintained by the tissue bank. Such documentation shall itemize all operational systems that were verified to determine compliance with these Standards, federal regulations, applicable state or local laws, and the agreement/contract. This itemization of the systems reviewed shall be provided to AATB on-site inspectors upon request.
If, during the course of this contract, agreement, or other arrangement, information suggests that the entity may no longer be in compliance with such requirements, the accredited bank must take steps to ensure compliance. If it is determined that the entity will not comply, the contract, agreement, or other arrangement must be terminated.
Publication date: February 10, 2009 (AATB Bulletin No. 09-08)
Effective date: May 11, 2009 (in 90 days)