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Accreditation Process

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If you have any questions, please do not hesitate to contact Debbie Butler Newman. 

Accreditation Process Overview

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:

• Self-Assessment - using an audit form and pre-inspection checklists to ascertain compliance of bank policies and procedures with current Standards.
• On-Site Inspection – whereby a trained AATB inspector visits and reviews all aspects of the operations conducted by the bank. Prior to the on-site inspection, the inspector will have reviewed the bank’s Standard Operating Procedures Manual (SOPM) to confirm the bank has comprehensive procedures.

The on-site inspection, which is generally two days long, entails the following activities:

• A comprehensive review and critique of various documents
• Inspection of the premises
• Interviews with select tissue bank staff members
• Compilation of documents to augment the inspection report
• A summary session with selected staff members to review the preliminary results of the inspection
• On-site correction of deficiencies that might be easily corrected. Any corrections will be indicated in the inspection report and should not be cited again, unless additional documentation is required to ensure compliance with standards.
• Review of a percentage of donor charts (based on the donor chart checklist formula).

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:

• Premises
• Operations occurring during the time of the inspection
• Statements of operations and procedures
• Case histories
• Donor recordsProcessing records and data
• Labeling procedures
• Storage and distribution records
• Equipment preventive maintenance and calibration activities and documentation
• Accident, error, and complaint documentation
• Quality assurance program
• Personnel records
• SOPM management
• Document archiving.

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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:

• In substantial compliance with AATB Standards
• In compliance with listed exceptions that are remedial
• Not in compliance with AATB Standards and exhibits serious deficiencies.

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:

• Training Records
• Adverse Experiences, Errors and Accidents, Complaints
• Recalls
• Audit Log and Reports (internal and external)
• Preventive Maintenance and Calibration of Equipment
• Environmental Monitoring
• Medical Director’s License
• Medical Advisory Committee Minutes (if applicable)
• Board of Director’s Minutes
• Organizational Chart(s)
• Floor Plan
• Agreements with Outside Organizations (regarding retrievals, processing, distribution, sterilization of equipment and/or tissue, and laboratory testing)
• Business Licenses (state, county, CLIA, etc.)
• Temperature Storage Records for Tissue (charts, tapes, logs, etc.)
• Health and Safety Manual
• Computer/Data Processing Controls
• Donor List (numbers for the last three years).

The inspector reviews the following regarding qualification, verification and validation:

• Facilities
  o Clean room safety cabinets
       º Installation
       º Calibration
       º Preventive Maintenance
       º Filter Testing
  o Quarantine and Storage Spaces
       º Adequacy
       º Security
  o Records Storage Security
  o Power Supply
       º Back up
       º Monitoring
  o Layout
  o Cleanliness
• Processing
  o SOP Descriptions
       º Clarity
       º Details
       º Completeness
  o Disinfection
       º Reagents
       º Time Validation
  o Work Surface Cleaning
  o Instrument
       º Cleaning
       º Sterilization
       º Calibration
  o Reagent
       º Preparation
       º Control
       º Inventory
  o Environmental Controls
  o Ischemic Temperature Controls
  o Cryogenic Processing
       º Equipment Calibration/Monitoring
       º Storage Environment Oxygen Sensors
• Labeling
  o Storage
       º Time/Temperature
       º Legibility
  o Packaging
       º Storage
       º Time/Temperature
       º Toxicity
• Transport Containers
  o Insulation
  o Temperature Maintenance
  o Packaging Material Suitability
• Computer Systems (non-releasing)
  o Suitability
  o Backup
  o Access Controls
  o Use Authorization.

The AATB accreditation process involves the following activities:

1. The bank applying for accreditation must submit:
   a. Completed Accreditation Application
   b. Completed Pre-Inspection Checklist
   (The bank indicates where each applicable standard is addressed in the bank’s policies and procedures)
   c. Standard Operating Procedures Manual(s)
   d. Organizational Chart
   e. Accreditation Application Fee.
2. If the above documents are complete and accurate, AATB will contact the bank to set up an inspection date. Generally, the inspector will require two days for the visit.
3. The inspector will submit an inspection report to the AATB.
4. If applicable, a document containing recommendations will be developed, approved by the Accreditation Committee, and submitted to the bank.
5. Once the Accreditation Committee determines the response to be satisfactory, the Committee recommends to the Board of Governors that accreditation be awarded.
6. The Board of Governors makes the final determination on granting accreditation. Initial accreditation is granted for three years.
7. If the bank’s response to recommendations is determined to be unsatisfactory, the bank may be requested to:
   a. Submit additional information and/or
   b. Wait for a period of time then re-apply.
8. If deficiencies are numerous, present a safety issue, and/or are not corrected to the satisfaction of the Accreditation Committee. the Accreditation Committee may determine that accreditation be denied (for new banks) or withdrawn (for existing banks).
9. Generally, the accreditation takes nine months from receipt of the SOPM until accreditation is awarded.