A. A tissue bank, tissue distribution intermediary, or tissue dispensing service, (henceforth called tissue bank) as defined in the AATB Standards for Tissue Banking (Standards) and below, that voluntarily agrees to abide by the Accreditation Policies of the American Association of Tissue Banks (AATB) is eligible to apply for AATB accreditation.
1. TISSUE BANK An entity that provides or engages in one or more services involving tissue from living or deceased individuals for transplantation, research, or medical education purposes. These services include assessing donor suitability (donor risk assessment), recovery, processing, storage, labeling, and distribution of tissue.
2. TISSUE DISTRIBUTION INTERMEDIARY An intermediary agent who acquires and stores tissue for further distribution and performs no other tissue banking functions.
3. TISSUE DISPENSING SERVICE A facility responsible for the receipt, storage, and delivery to the ultimate user (e.g. transplanting surgeon, surgical center or research facility) of tissue for immediate transplantation or for research. Tissue dispensing services may or may not be tissue banks, depending on what other functions they perform.
4. SATELLITE FACILITY - An establishment in a physically separate location where any activities occur that contribute to recovery, transport, processing, storage, packaging, labeling or distribution of human tissue under the management or direct supervision of the same corporate entity or its employees.
a. If the satellite facility is merely a staging area for personnel to collect supplies for recoveries, AATB will include the satellite facility in the accreditation of the Parent Organization and will occasionally inspect the satellite facility. The satellite facility will not routinely store tissue or maintain donor records at this location. Supplies may be stored, but are not sterilized/disinfected at this location.
b. If the satellite facility maintains donor records and/or routinely stores donor tissue (even temporarily), or performs other tissue banking activities, the satellite facility must be inspected by AATB. The satellite facility will usually receive its own certificate of accreditation.
c. In the case of tissue banks that are accredited purely as Tissue Distribution Intermediaries, the satellite facility will be permitted to be accredited as part of the parent organizations accreditation providing that: 1) the satellite facility acquires and stores tissue for further distribution only from the parent organization; 2) No other tissue banking activities are performed; 3) Tissue storage and distribution from the satellite facility is in compliance with AATB
Standards and the parent organizations SOPs; 4) Each satellite facility has on-site SOPs supporting procedures; 5) The parent organization audits the satellite facility every 12 months to assure compliance.
B.
See appendix I to determine which Standards the tissue bank must comply with.
C. Applicants for accreditation must successfully demonstrate compliance with current accreditation requirements. Accreditation requirements include the AATB
Standards for Tissue Banking and the
Accreditation Policies (Ref. Section II(A)). Upon approval, a letter and certificate of accreditation will be issued to the tissue bank. The certificate will indicate the following:
1. Date that accreditation was approved;
2. Expiration date of accreditation;
3. Specific tissue banking services that are being accredited; and
4. Specific types of tissue for which accreditation is conferred.
D. An accredited tissue bank must maintain compliance with all applicable accreditation requirements. As provided for in these policies, an inspection to verify compliance may be performed by AATB at any time. In addition, to maintain accredited status, an accredited tissue bank is required to complete the AATB Annual Survey, the Self-assessment Tool/Audit Report (STAR) (or AATB-approved audit form, see page i of the STAR), and tender timely payment of its annual maintenance fee. Also, each tissue bank must maintain records demonstrating that it has performed internal audits annually and notified AATB of the audits using page i of the STAR.
E. Conferring accreditation on a tissue bank is intended to indicate that the general operation and procedures of the bank were found to be in compliance with the Associations accreditation requirements at the time of its review. Accreditation is not to be construed as reflecting or warranting that the accredited tissue bank, in any or all instances, either before or after accreditation, has properly followed the AATB accreditation requirements.
F. Accreditation confers the privilege to use the AATB-accreditation logo. The accreditation logo may be used only by accredited banks in accordance with the Associations Policy For Use of Trademarks, Service Marks And Certification Marks. Accreditation does not confer the right to use any other trademark of the Association, including its general logo.
Accreditation logo usage information and the accreditation logos are on the AATB website as follows: aatb.org, select Resource Center, select Communications and Media, select Trademark and Logo Use Guide for how to use the logo and select AATB Approved Logos for the actual logos. G. By accepting AATB accreditation, the tissue bank agrees to abide by the accreditation requirements.
II. REQUIRED ELEMENTS #
A. AATB accreditation requires compliance with the current
Standards, including periodic updates and/or revisions about which the tissue bank will be notified in writing, and these
Accreditation Policies. On-site inspections are performed in order to evaluate the tissue banks compliance with these AATB accreditation requirements.
B. Each tissue bank that seeks accreditation must engage in the accreditation process in good faith. Failure to participate in good faith, including, but not limited to, falsification of documents, intentional provision of incorrect information, withholding of requested information, or failure to cooperate in any inspection conducted in accordance with these policies, constitutes grounds for denial or withdrawal of accreditation. Accredited tissue banks, and applicants for accreditation, may not present any false or misleading information regarding their accreditation status. Providing false or misleading information may be grounds for denial or withdrawal of accreditation. In addition, if any of these conditions are noted during an inspection, the inspection may be terminated immediately.
C. AATB accreditation requires that tissue banks be inspected for compliance with the accreditation requirements for all activities that it performs. A tissue bank may not elect to be inspected for certain activities and not for others. Tissue banking activities include but are not limited to:
1. Donor suitability assessment (including donor risk assessment and tissue evaluation);
2. Tissue recovery;
3. Tissue processing;
4. Labeling and packaging;
5. Storage; and
6. Tissue distribution.
D. A tissue bank that has any of its activities or services performed by another entity will be inspected and accredited only for the specific activity(ies) or service(s) that the tissue bank itself performs. However, the tissue bank is responsible for
verifying biennially, on a form to be provided by AATB (or the banks form pre-approved by the AATB), that the activity(ies) or service(s) performed by others has/have been performed in conformance with the accreditation requirements.
This requirement does not apply to any other AATB-accredited organization.
E. If a tissue bank contracts with, or uses the tissue banking activity(ies) or service(s) of any other entity(ies) and
