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I. The Accreditation Program Philosophy
The AATB accreditation program was established to provide assurance that AATB member tissue banks understand and comply with AATB Standards for Tissue Banking, which are published and amended from time to time.
Since AATB is a voluntary association of organizations dedicated to obtaining human tissue for use as allografts and providing the medical profession and the public with the safest products possible, given present technologies, the program is educational and scientific in nature, not regulatory.
The accreditation program is not prescriptive; it does not tell member banks HOW to comply, but rather WHAT RESULTS are expected.
II. Accreditation Program Elements
The accreditation program tools include:
The on-site inspection, which is generally two days long, entails the following activities:
Since the inspection is generally just two days long, it is not possible to examine, in exhaustive detail, all aspects of a bank’s operations during the visit. Therefore, the inspector must use judgment as to apportionment of time and it is possible that some items will receive more attention than others items.
It should be pointed out that the AATB inspection is not meant to be, nor is it, a surrogate inspection for an FDA inspection. The accreditation program is meant to ascertain if good faith efforts are being made by the bank to comply with AATB Standards and that the bank has a self-assessment mechanism and corrective and preventive action procedures in place that will enable the bank to correct deficiencies.
The inspection report will contain items the inspector wishes to note as a result of reviewing and evaluating the:
III. Results and Outcomes
End results of the inspection process include a report to the Accreditation Program Director outlining pertinent findings or observations and the inspector’s opinion of whether the bank is:
The Accreditation Program Director receives and edits the report and develops possible recommendations for the Committee’s use.
At this point, the Accreditation Committee should have sufficient facts (inspection report) along with the recommendations to make an informed decision. If the Committee does not believe it has sufficient information to make the decision, the Committee may request additional information and every effort will be made to provide the requested information.
The Accreditation Committee will decide whether recommendations will be made to the inspected banks and what, if any, conditions must be met by the bank before conferring accreditation.
The bank will have 60 days to respond to a Level A Recommendation and to correct deficiencies. If deficiencies are numerous and/or substantial, the Committee may determine that another inspection is necessary.
If the Accreditation Committee determines that another inspection is necessary, the bank will have 90 days to respond to the Recommendations letter. Once the response is determined to be satisfactory by the Accreditation Committee Chair, a follow-up inspection date will be scheduled.
The Accreditation Committee will submit final accreditation deliberations to the Board of Governors for information and the Board will have five days to request additional information before accreditation is awarded to the bank.
If the Committee recommends that a bank not be accredited, the Board may review the case history and may become involved in determining the next course of action.
Generally, the scope of the inspection includes a “quality systems” audit approach to gain insight into the control of the processes performed by the bank. Through various tools utilized by the inspector, he/she will determine conformity of the bank’s operation within its own documented quality program, which should be in compliance with current AATB standards.
The inspection protocol will outline files that the inspector may review during the visit, offer a general audit schedule, and present a code of conduct the inspector and the accreditation committee practice.
Generally, this is a list of files that may be requested by the inspector at the time of the inspection. The bank will be expected to supply these files:
The inspector reviews the following regarding qualification, verification and validation:
The AATB accreditation process involves the following activities: