Accreditation Policies for Transplant Tissue Banks
TABLE OF CONTENTSI. ACCREDITATION PROGRAM – GENERAL PROVISIONS
A. Definition of a Tissue Bank
B. Tissue Bank Inspection Requirements
C. Certificate of Accreditation
D. Accreditation Compliance Requirements
E. Limitation of Assurances of Accreditation
F. Logo Use Privileges
G. Agreement with Accreditation RequirementsII. REQUIRED ELEMENTS
A. Compliance with Current AATB Standards (Requirement)
B. Good Faith Provisions
C. Inspection for Compliance with Accreditation Requirements
D. Certification of Activities/Services Provided by Others
E. Joint Activities Certification Requirements
F. Use of AATB Logo and Name
G. Medical Director/Management with Executive Responsibility Attendance
at AATB Meetings/Workshops III. ACCREDITATION COMMITTEE
A. Board of Governors Responsibility
B. Accreditation Committee Responsibilities
C. Membership Requirements
D. Ex Officio Members
E. Confidentiality Agreement
G. Confidentiality Protection
H. Inquiries IV. CONFIDENTIALITY AND DISCLOSURE
A. Access to Confidential Information Limits
B. Disclosure V. REPORTABLE EVENTS
A. Contrary Event and Major Operational Changes Requiring Notice
B. Documentation of Reportable Events
C. Submission of 483s and Responses to AATB
D. Review and Assessment of Information Provided
E. Re-inspection Evaluation VI. EXPIRATION OF ACCREDITATION
A. Three Year Term
B. Application for Accreditation Time-Lines
C. Extension While in Process
D. Extensions Requested in Writing
E. Lapse of Accreditation Consequences VII. PUBLIC RECOGNITION
A. AATB Publication of Accredited Banks
B. Removal from List
C. Unauthorized Use of AATB Accreditation Status VIII. ACCREDITATION PROCESS
A. Eligibility Requirements
B. Self Audit and Application Requirements
C. Pre-Inspection Checklist
D. Documentation Requirements
E. Current Status Regarding Federal, State, and Local Authorities
F. Confirmation of Application Receipt
G. On-site Inspection Scheduling
H. Review of SOPM
I. Length of Inspection
J. Scope of On-site Inspection
K. Inspection Report to AATB
L. Draft Inspection Report with Nonconformities/Observations
M. Committee Chair Review
N. Committee Review
O. Inspector Participation in Committee Review
P. Committee Options
Q. Board of Governor’s Actions Regarding Committee Recommendations IX. INSPECTIONS WITH OR WITHOUT NOTICE
A. Inspections Performed Without Notice
B. Ordering an Inspection
C. Type of Inspection
D. Prior Notice of Inspection
E. Scope of Inspection Without Notice
F. Non-Compliance with AATB Accreditation Requirements
G. On-site Inspection of Major Changes X. REPORTING VIOLATIONS OF ACCREDITATION REQUIREMENTS
A. Reporting Suspected Accreditation Requirement Violations
B. Reviewing Reports of Suspected Accreditation Requirement Violations
C. Acting on Reports of Suspected Accreditation Requirement Violations XI. WITHDRAWAL OF ACCREDITATION
A. Withdrawing Accreditation
B. Appeals XII. TRANSFER OF ACCREDITATION
B. Request for Transfer Requirements
E. Board of Governor’s Actions
Appendix I – Standards for Non-Transplant Anatomical Donation for Education and/or
American Association of Tissue Banks
Accreditation Policies for Transplant Tissue Banks
Distributed: February 29, 2012
Effective: 90 days from publication date
These Accreditation Policies are specifically for tissue banks that primarily provide tissue for transplantation and may provide tissue for education/research that is unsuitable for transplantation.
Separate Accreditation Policies have been developed for Non-Transplant Anatomical Donation Organizations (NADOs). If the organization primarily obtains Non-transplant Anatomical Materials (NAM) for education and/or research and does not obtain tissue for transplant as a primary activity, then these organizations must comply with the Accreditation Policies for Non-Transplant Anatomical Donation Organizations. I. ACCREDITATION PROGRAM—GENERAL PROVISIONS
A. A tissue bank, tissue distribution intermediary, or tissue dispensing service, 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. TISSUE BANK SATELLITE FACILITY - An establishment in a physically separate location where any activities occur that contribute to recovery, transport, processing, storage, packaging, labeling, distribution, etc., 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 organization’s 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 organization’s SOPs; 4) Each satellite facility has onsite SOPs supporting procedures; 5) The parent organization audits the satellite facility every 12 months to assure compliance.
B. See Appendix 1 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 activities 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 Association’s 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 Association’s “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 bank’s 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 bank’s 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 that/those entity(ies) seeks AATB accreditation, each entity must apply separately for accreditation if it uses a separate identifying business or trade name. All such entities must be identified at the time of application and may be included in the on-site inspection.
F. The AATB does not authorize and expressly prohibits non-AATB-accredited distributors from making statements or distributing any printed materials that imply that the distributor is AATB-accredited even if the tissue bank that supplies tissue to the distributor is accredited (Ref. AATB Policy for Use of Trademarks, Service Marks and Certification Marks).
G. Once the tissue bank is accredited, the Medical Director and the person most responsible for compliance with AATB requirements, including Standards and Accreditation Policies must attend at least one AATB meeting/workshop and acquire a minimum of 15 CMEs/CEUs every three years. Documentation of this attendance must be provided during the AATB inspection. In order to obtain a Certificate of Attendance for the various AATB meetings/workshops, the participant must complete the online evaluation form. The AATB Executive Office will send a Certificate of Attendance following the workshop/meeting. A certificate of attendance will not be issued if the evaluation form is not completed within the specified time frame.III. ACCREDITATION COMMITTEE
A. The BOG is responsible for the Association’s accreditation program and approves changes to accreditation requirements.
B. The Accreditation Committee:
1. Develops accreditation requirements (Ref. Section II(A));
2. Submits recommendations for changes to these requirements to the BOG for approval;
3. Reviews inspection reports;
4. Approves or rejects applications for accreditation as provided for in these policies;
5. Provides inspector training as needed; and
6. Revises these Accreditation Policies as required.
C. Appointment of Members and Chair of the Committee is subject to the following requirements:
1. The Chair must have past experience as a member of the Accreditation Committee;
2. Each Committee member must have at least five years of tissue banking and/or NTAD experience prior to appointment to the Committee;
3. No Committee member may serve more than two consecutive terms; and
4. No more than two individuals from a single tissue bank may serve concurrently on the Committee.
D. The Chief Executive Officer (“CEO”) and the Director of Accreditation are ex officio, non-voting members of the Committee.
E. Each Accreditation Committee member is required to review and sign the Association’s Confidentiality Agreement and Conflict of Interest policy.
F. The Accreditation Committee meets in person or by conference call as needed to conduct the business of the Committee. The Chair does not vote as a member of the Committee, except in the case of a tie.
G. To maintain impartiality and confidentiality, inspection reports, and responses are “blinded” by the AATB Executive Office by removing all identifiers that indicate the identity of the bank prior to being sent to individual Committee members. The Chair will receive original (“unblinded”) inspection reports and responses from the AATB Executive Office along with the Committee’s blinded copy.
H. Accredited tissue banks should address any questions or issues related to accreditation to the Accreditation Program staff at the AATB Executive Office.IV. CONFIDENTIALITY AND DISCLOSURE
1. AATB will treat all information regarding an applicant seeking accreditation, and all documents related thereto, as confidential.
2. Unblinded information may be given only to the Accreditation Committee Chair or designee, AATB Executive Office staff, AATB Inspectors, and the BOG, who shall treat such information as confidential.
3. If the Accreditation Committee Chair believes it may be a conflict of interest to review and act on documentation pertaining to a particular facility, the Accreditation Committee Chair may designate another Accreditation Committee member (generally the Accreditation Committee Vice Chair) to handle the Chair’s responsibilities for that facility. The designee will treat all information regarding the applicant as confidential.
4. Committee members will receive information only in blinded form.
1. Information obtained as a result of the accreditation process will be maintained as confidential and will not be released by the AATB unless:
a. The applicant has specifically authorized release of such information;
b. The information is included in aggregate form or with other information so as to ensure that the applicant cannot be identified;
c. The information is already a matter of public record;
d. Release of the information is required by federal, state or local statute or regulation, or court order; or
e. Release of the information pursuant to Section IV(B)(2) is deemed necessary.
2. In the event that the AATB Executive Office becomes aware of information relating to an accredited tissue bank or an applicant for accreditation, that presents a serious hazard to human health, the AATB will provide such information to responsible federal, state and/or local government agencies having jurisdiction over the tissue bank.
3. AATB will identify accredited tissue banks on its Website (Ref. VII(A)) and will respond to telephone inquiries regarding a tissue bank’s current accreditation status by indicating:
a. Whether the tissue bank is accredited or not;
b. What activities the bank is accredited for; and,
c. If asked, when the bank was first accredited.
4. Except as noted above, AATB will not publicly disclose any information relating to an applicant or accredited tissue bank without the consent of the tissue bank.V. REPORTABLE EVENTS
A. Accredited tissue banks and applicants must send written notice to the AATB Executive Office within 30 calendar days prior to any major planned change in operations, or within 15 days following any contrary event or unplanned major change in operations. Failure to notify AATB of a contrary event or major change may result in proceedings to withdraw accreditation.
1. Reportable contrary events include, but are not limited to:
a. Any federal, state or local actions, including but not limited to:
i. Warning letters
ii. Recall notices
(Recalls involve actions to retrieve tissue that has been distributed. The entity that released the tissue for distribution is responsible for notifying AATB of the recall).
iii. Changes in licensure (actual or proposed), etc.
b. Any other recall, voluntary or otherwise.
c. Confirmation of any adverse event, contamination, or disease transmission.
d. Deviation reports submitted to the FDA (or equivalent if international member), but only if the deviation:
i. Involved tissue that had been distributed
ii. Occurred in your facility, or in a facility that performed a manufacturing step for you; and
iii. Was required to be reported to the FDA (or equivalent if international) pursuant to 21 CFR 1271.350(b). If the event was not required to be reported to the FDA (or equivalent if international), you are not required to submit it to the AATB.
iv. To comply with this reporting requirement, you may simply submit a copy of the deviation report that is submitted to FDA (or equivalent agency if international), or you may use another format that contains a description of the deviation, what tissue(s) was affected, and a description of corrective action that has been or will be taken.
v. Deviation reports will become part of your file, which will be made available to the AATB inspector prior to the inspection. AATB may also trend deviations and provide aggregate data and information to the AATB membership.
2. Major changes include, but are not limited to:
a. Change in the person most responsible for compliance with AATB requirements, including Standards and Accreditation Policies, medical director, or the quality management representative. (CVs for these new personnel must be submitted with the notification);
b. Change in scope of operations of the tissue bank, specifically changes in the activities for which the tissue bank is accredited and the addition of new tissue banking activities for which the bank is not accredited;
c. Change in facilities because of expansion, relocation, renovations or structural changes that affect tissue banking operations;
d. Change in ownership or management, acquisition by or of, or merger with another tissue bank;
e. Subcontracting or assignment to a third party, whether or not accredited by AATB, of any tissue banking task or responsibility covered by AATB accreditation;
f. Legal name change; or
g. Dissolution of the tissue bank, or any stoppage in operations.
B. Notice given to AATB pursuant to this section must be sufficiently detailed and documented to explain the nature and extent of the event and/or change and the implications for the accredited tissue bank’s current and future compliance with AATB accreditation requirements.
1. The tissue bank must also provide AATB with copies of pertinent documents, or portions of documents, relating to such operational changes.
2. The following information must be submitted regarding recalls:
a. Name of bank;
b. Type of tissue being recalled;
c. How many donors;
d. How many tissues are being recalled;
e. Reason for recall;
f. Nature of recall (voluntary, mandatory);
g. If distributed internationally, how much tissue, what type of tissue, and where it was distributed); and
h. Brief description of corrective action, when available (if applicable).
3. AATB accredited tissue banks must notify AATB of recalls, even when the tissue is processed by an AATB-accredited bank and only distributed abroad.
C. AATB-accredited tissue banks must submit a copy of any 483s received (or equivalent document if inspected by an agency equivalent to the FDA) along with the bank’s response. This documentation must be submitted within two weeks of receiving the 483, or if a response is submitted, within two weeks of submitting the response. This information will be blinded and submitted to the Accreditation Committee for review.
D. The Director of Accreditation and/or the Accreditation Committee Chair will review major operational changes and consider whether another inspection should be performed prior to expiration of the current accreditation (Ref. Section IX).
E. The Director of Accreditation will notify the tissue bank if a re-inspection is necessary.VI. EXPIRATION OF ACCREDITATION
A. Accreditation expires three years from the date of original approval of accreditation, hereinafter referred to as the “expiration date.” Privileges of accreditation cease on that expiration date, unless AATB withdraws/extends accreditation prior to that date.
B. An accredited tissue bank that applies for re-accreditation shall request an application for accreditation from the AATB Executive Office. The completed application form must be received by the AATB Executive Office no more than twelve months and no fewer than nine months before the expiration date.
C. An accredited tissue bank that applies for re-accreditation will not lose its current accredited status during the accreditation process so long as the tissue bank meets published timelines, completes each stage of the process in good faith, and no potential hazards to human health occur during the process. The anniversary date will remain the same regardless of the length of the accreditation process. (The anniversary date is the month and day the bank received initial accreditation. The only thing that changes is the year).
D. A tissue bank that has not complied with the requirements and whose accreditation expires during the accreditation process will not have its accreditation automatically extended beyond its current accreditation expiration date. In such circumstances, the bank may apply for an extension in writing to the Director of Accreditation prior to the expiration date of the applicant’s current accreditation. The Director of Accreditation will determine if an extension is to be awarded.
E. If a tissue bank’s accreditation expires and it is not extended pursuant to these policies, the bank must immediately remove all indicia of AATB accreditation from its forms, letters, signs, labeling and advertisements.VII. PUBLIC RECOGNITION
A. At least monthly, AATB will update the list of accredited tissue banks on the AATB Website. This list may be distributed to those who request it from the AATB Executive Office.
B. The following circumstances will necessitate removing the name of a tissue bank from the list of accredited tissue banks:
1. Accreditation has been suspended;
2. Accreditation has expired or been withdrawn;
3. Accreditation has been denied;
4. Tissue banking operations have ceased.
C. A tissue bank not currently accredited is not authorized to state in its literature or elsewhere that it is accredited by AATB, that it has applied for AATB accreditation, or that it meets, complies with, follows, or exceeds AATB accreditation requirements.VIII. THE ACCREDITATION PROCESS
A. A tissue bank may submit an application for initial accreditation at any time. At the time of the on-site inspection, the tissue bank must demonstrate that it has been in continuous compliance with AATB Standards for at least the previous six months and has provided or engaged in one or more services that may include donor qualification, recovery, processing, storage, labeling and/or distribution of tissue from a minimum of five donors (and/or donors/client depositors for reproductive banks) and that it has a minimum of five completed donor records.
B. Prior to submitting an application for initial accreditation, each applicant must perform an internal self-audit. Each element of the audit must be performed by one or more members of the applicant’s staff whose usual responsibilities are separate from those being audited. If no member of the applicant’s staff meets this requirement, then such elements of the audit must be performed by a qualified person from outside the applicant’s tissue bank. The audit must be performed using the AATB Self-assessment Tool/Audit Report (STAR), which can be obtained upon request from the AATB Executive Office or from the AATB web site (aatb.org, accreditation, accreditation documents), or an audit tool that has been pre-approved by AATB.
C. The applicant must also complete the AATB Pre-Inspection Checklist (Checklist). The applicant must ensure that it has answered each question and has appropriately addressed all applicable requirements included in the Checklist. The applicant must cite the policy number and section and/or page number of the Standard Operating Procedures Manual (SOPM) that corresponds to each standard in the Checklist. This helps ensure that all standards have been addressed by the applicant and assists AATB in performing the pre-inspection review of the SOPM. If a standard does not apply, the tissue bank should indicate “N/A” in the applicable entry on the Checklist. The Pre-Inspection Checklist is part of the accreditation application packet and is also available from the AATB Executive Office.
D. When the steps under Section VIII B and C have been completed, the applicant must send the following materials to the AATB Executive Office:
1. Application form;
2. Copy of Bank SOPM (hard copy or a CD with a hard copy table of contents). A CD is preferred;
3. Completed and signed Pre-Inspection Checklist and cover sheet;
4. Curriculum vitae of Medical Director and the person most responsible for compliance with AATB requirements, including Standards and Accreditation Policies and the quality management representative);
5. Application fee (non-refundable);
6. Audit Confirmation (page i of the STAR) for external audit(s), if applicable and, if applying for initial accreditation, page i of the STAR for the internal audit. The audit confirmation page is due by January 31 each year for activities audited as part of the annual internal audit during the previous year. It is advisable not to wait until the end of the year to perform the audit;
7. Organizational chart with names (include all tissue bank staff);
8. Floor plan showing both tissue banking and administrative function areas for all locations (including satellites);
9. Package Inserts; and
10. Sample contract or contract template, for each type of activity.
To ensure the integrity of these documents, it is required that the package be sent via a carrier with return receipt or other package tracking capabilities.
E. If a federal, state or local agency has initiated any action against the applicant applying for AATB accreditation, the applicant must immediately inform AATB in writing of that fact. AATB will review the circumstances of the pending action in order to determine the impact of such matters on the accreditation process. Failure to disclose such issues promptly as they occur at any time in the accreditation process may be considered failure to participate in good faith and may result in the denial or withdrawal of accreditation.
F. The AATB will send written acknowledgement, within ten business days, of receipt of the application. If additional documentation/items are required, the AATB Executive Office will request the missing items. If the applicant does not submit the missing items within 45 days, the bank may be required to submit a new application packet and application fee. If the applicant will be required to submit a new application packet and fee, this will be communicated in writing to the bank.
G. Upon determination that the applicant’s submission is complete and acceptable, AATB staff will contact the applicant to schedule the on-site inspection.
H. Within 30 calendar days of receipt of the applicant’s SOPM, the AATB inspector will review the manual to determine if applicable AATB accreditation requirements have been appropriately addressed. If there are requirements that have not been properly addressed in the applicant’s submission, the applicant will be notified in writing of changes or additions to the SOPM that must be made before the process moves forward. Such changes or additions must be made and submitted to AATB, together with any responses to inquiries made by AATB, within 45 calendar days from the date that AATB notifies the applicant in writing. If the applicant does not provide the information within 45 days, it will be assumed that the bank is not ready to complete the accreditation process. In this case, the applicant may be required to reapply by submitting a new application and application fee. If the applicant will be required to submit a new application packet and fee, this will be communicated in writing to the bank.
I. The Director of Accreditation will determine the length of time necessary for the on-site inspection based upon the size of the tissue bank and the scope of its operations. Once the on-site inspection has begun, the actual duration is at the discretion of the inspector.
J. On-Site Inspection:
1. The inspector will undertake a comprehensive review of the tissue bank operations and an inspection of the premises for compliance with the accreditation requirements. This inspection will include, but is not limited to:
c. Records; and
d. Evidence of adherence to the bank’s SOPM.
2. The inspector will be granted access to all spaces, records and personnel pertinent to AATB accreditation (Ref. Section II(B)).
3 The inspector(s) will conduct an opening conference and a closing conference.
a. An opening conference with the applicant’s senior staff will be held to gather information regarding the bank. The tissue bank representatives should include, at a minimum, the person most responsible for compliance with AATB requirements, including Standards and Accreditation Policies and the Medical Director. During this interview, the tissue bank staff should be prepared to provide information regarding the scope of the operation, mission, and policies and procedures relating to AATB accreditation requirements.
b. During the inspection, the applicant will provide appropriate staff to accompany the inspector(s) during the various steps of the inspection. The inspector will review, at a minimum, the following areas (as applicable):
i. Structure and functional components of the organization;
ii. Facility and equipment;
iv. Training records;
v. Adverse reaction reports, complaints, recalls, etc.;
vii. Donor records;
viii. Tissue recovery, processing, storage, labeling, distribution, and tracking (as applicable); and
ix. Quality Program.
c. The AATB Executive Office, Board of Governors, Accreditation Committee, and/or the inspector may determine that an inspection of a bank’s non-AATB-accredited recovery partner and/or satellite facility(ies), is warranted. If possible, the bank will be notified when the inspection is being scheduled that one or more of the recovery partners that are not AATB-accredited and/or satellite facilities, will be inspected by AATB; however, AATB reserves the right to make this determination during the inspection. The recovery partner/satellite facility inspection may occur during the AATB inspection, before, or after the inspection, depending on the inspector’s schedule and the location of the recovery partner/satellite facility. If the non-accredited recovery partner/satellite facility does not comply with AATB Standards, the following action may become necessary:
i. The accredited facility will be required to terminate the business relationship with the non-conforming bank if the non-conforming bank will not comply with AATB Standards.
ii. If the accredited bank does not terminate the business relationship, AATB may withdraw the bank’s accreditation.
d. A closing conference with the applicant’s senior staff will be held and should include, at a minimum, the person most responsible for compliance with AATB requirements, including Standards and Accreditation Policies and Medical Director. During this conference, the inspector(s) will present nonconformities and/or observations regarding any significant compliance problems. Members of the tissue bank staff will be allowed the opportunity to respond to the findings and clarify issues raised by the inspector(s).
4. Issues of concern (nonconformities or observations) shall be included in the inspector’s report.
a. Nonconformity – A finding that identifies a non-fulfillment of an accreditation requirement, policy, process, or procedure, which may have an impact on the safety or utility of tissue, or the safety of a tissue bank employee, that is more than a single occurrence or sporadic event and that can be supported by objective evidence.
b. Observation - May be a positive observation of an activity, or it may be a negative observation that identifies a non-fulfillment of an accreditation requirement, policy, process, or procedure, which is most likely a single or sporadic occurrence (isolated incident) that can be supported by objective evidence.
5. The Accreditation Committee, following review of the inspector’s report, will formulate an inspection report that may necessitate that corrective action(s) be implemented by the bank.
6. After the accreditation process has been completed, the AATB Executive Office will provide the applicant with a “Post Inspection Questionnaire” (PIQ) to enable the applicant to evaluate the inspection. The applicant should return the questionnaire within two weeks after receipt of the PIQ. The Director of Accreditation or designee, will review the completed questionnaires.
7. After the accreditation process has been completed, a member of AATB’s Accreditation Committee may contact the tissue bank to follow-up on the accreditation/inspection process and ask questions in order to further evaluate the accreditation program.
8. If the applicant voluntarily withdraws from, does not comply with, or does not complete the accreditation process after the on-site inspection, the bank will be responsible for all travel and other direct expenses related to the inspection(s).
9. If the applicant is located outside of North America, the applicant will be required to reimburse one-half of the inspector’s travel costs (air travel, lodging, meals, ground transportation, etc.). An invoice for these expenses will be submitted to the applicant after the inspection. If a follow-up inspection is required, the applicant will be required to reimburse all of the inspector’s travel costs.
K. Following the inspection, the inspector will complete the inspection report and forward it to the AATB Executive Office.
L. Within 30 days of receipt of the inspector’s report, the Director of Accreditation or responsible designee will prepare an initial draft of the inspection report that contains nonconformities and/or observations.
M. The drafted inspection report (in blinded and unblinded format) will be sent to the Accreditation Committee Chair.
N Following the Chair’s review, the blinded inspection report will be sent to the Committee members for discussion at the next scheduled meeting.
O. The Accreditation Committee will review and finalize the blinded inspection report. Whenever possible, inspectors will be present during the Accreditation Committee meetings and/or conference calls to answer questions about nonconformities and/or observations or other issues pertinent to the Committee’s evaluation of a tissue bank accreditation status.
P. Recognizing that there may be varying degrees of nonconformities noted during the inspection, as well as varying implications of these nonconformities, the Accreditation Committee will determine by majority vote which one of the following Committee actions is appropriate:
1. Immediate Approval for Accreditation:
a. Following a report of an on-site inspection that indicates that the applicant is operating in compliance with AATB Standards and accreditation requirements, the Committee may decide that the accreditation application be approved.
b. If minor nonconformities/observations are indicated, the Committee may agree to accredit the bank and send the inspection report to the bank for response. In such cases, the Chair or designee will review the bank’s response to the inspection report. The response should be submitted within 60 calendar days after receiving the accreditation certificate. If a response is not forthcoming, the bank may have accreditation denied, withdrawn or suspended.
2. Level A—Requires Corrective Action(s) as a Condition to Accreditation:
Following a report of an on-site inspection that indicates
nonconformities in the applicant’s compliance with accreditation
requirements, the Committee may determine that the nonconformities may be corrected and documented without need for a re-inspection to verify compliance because the
nonconformities do not appear to present a potential hazard to human health and the bank’s corrective action can be evaluated by reviewing paper documentation. The Committee will inform the applicant of the areas of non-compliance. The applicant may contact the Director of Accreditation or Accreditation Committee Chair for clarification of the nonconformity(ies)/observations, if necessary. In such cases:
a. The AATB Executive Office will transmit the inspection report to the applicant.
b. Within 60 calendar days of receiving the inspection report, the applicant must submit documentation that demonstrates compliance with the Standards and/or Accreditation Policies. Failure to do so will result in a recommendation for denial of accreditation, unless exceptional circumstances exist to justify an extension of the 60-day response period.
c. Upon receipt by the Director of Accreditation, the applicant’s response will be examined for completeness and compliance with the Standards. If additional information is required, the Director of Accreditation will request the information. If the response appears to be complete, the Director of Accreditation will forward the response to the Committee Chair or designee for review.
d. If the response is satisfactory to the Chair, the blinded response will be sent to the Committee for review at the next meeting.
e. If the Committee decides that the applicant has corrected the nonconformities, the Committee will approve the tissue bank’s accreditation.
f. If the Committee decides that the applicant has not corrected the nonconformities, the Committee may, at its discretion:
i. Request clarification and/or additional information;
ii. Request that a Level B re-inspection be performed; or
iii. Indicate that accreditation be denied or withdrawn. At the discretion of the Accreditation Committee, a waiting period of up to one year may be required before re-application. The applicant is responsible for all direct expenses related to the Level B on-site re-inspection, including but not limited to the inspector(s)’ travel.
g. If additional information is requested and it is not forthcoming in a timely manner or is not satisfactory, the Committee may determine that a Level B re-inspection be performed or may determine that accreditation should be denied or withdrawn. At the discretion of the Committee, a waiting period of up to one year may be required before re-application. The applicant is responsible for all direct expenses related to the Level B on-site re-inspection, including but not limited to the inspector(s)’ travel.
3. Level B—Requires Corrective Action(s) and On-Site Re-Inspection as Condition to Accreditation:
a. Following an on-site inspection and an inspector’s report that indicates noncompliance with accreditation requirements, the Committee will request corrective action(s) and an additional on-site inspection to determine compliance with AATB Standards and accreditation requirements.
b. The Committee will notify the tissue bank of its recommendation for a Level B re-inspection and will forward to the applicant written nonconformities for actions that must be completed within 90 days before the Level B on-site re-inspection will be scheduled. (At the discretion of the Accreditation Committee this time period of 90 days may be changed.)
c. Upon receipt by the Director of Accreditation, the applicant’s response will be examined for completeness and compliance with the AATB Standards and Accreditation Policies.
i. If additional information is required, the Director of Accreditation will request the information;
ii. If the response appears to be complete, the Director of Accreditation will forward the response to the Committee Chair for review.
d. If the Chair determines that the response is satisfactory, a re-inspection will be scheduled.
e. If the Chair determines that the applicant has not rectified the nonconformities cited by the Committee, the Chair may:
i. Request clarification and/or additional information;
ii. Submit documentation to the Accreditation Committee to determine if accreditation should be denied or withdrawn. If accreditation is denied or withdrawn, a waiting period of up to one year may be required before reapplying for accreditation.
f. Scheduling of the Level B on-site re-inspection is dependent upon the applicant first submitting documentation that demonstrates compliance with the AATB Standards and Accreditation Policies. In such cases:
i. The Level B on-site re-inspection will take place no later than 180 calendar days after the date of receipt of the Committee’s original inspection report, unless exceptional circumstances indicate otherwise. The applicant is responsible for all direct expenses related to the Level B on-site re-inspection, including but not limited to the inspector(s)’ travel.
ii. Following the Level B on-site re-inspection, the Committee will review the inspector’s findings. If the applicant has failed to demonstrate that nonconformities have been addressed, the Committee may:
(a) Request additional information; or
(b) Decide that accreditation be denied or withdrawn.
iii. An applicant assigned a “Level B” status may receive only the one additional on-site inspection to demonstrate compliance with the Committee’s recommendations. However, if the inspector notes new or additional findings as a result of the on-site Level B inspection, the Committee may assign a “Level A” or a “Level B” based on these new or additional findings. The Committee will then issue another inspection report and/or order another on-site inspection.
iv. If a recommendation is made to deny or withdraw accreditation following the Level B on-site inspection, at the discretion of the Accreditation Committee, the Committee may recommend up to a one-year waiting period (from the notice of denial) before the tissue bank may reapply for accreditation. At that time, the tissue bank must submit a new application, and the other documents listed in VIII, D.
4. Denial or Withdrawal of Accreditation:
In the event that the on-site inspection and the inspector’s report reflect significant violations of AATB accreditation requirements, the Committee may determine that accreditation be denied without an opportunity for corrective action.
5. Suspension of Accreditation
a. There may be instances where the inspector’s report of the on-site inspection indicates noncompliance with the accreditation requirements, but the Accreditation Committee believes that these violations do not warrant withdrawal of accreditation, and that the bank could comply with the accreditation requirements in a short period of time. There may also be instances where regulatory agencies issue inspection-related observations, sanctions, or other actions against an accredited tissue bank that raise questions about the tissue bank’s compliance with the accreditation requirements. In such cases, the Accreditation Committee may suspend the tissue bank’s accreditation for a period of time not to exceed 90 days to allow it to correct its nonconformities.
b. Suspension applies only to accredited banks seeking re-accreditation, or to accredited banks that the FDA or another regulatory agency has sanctioned.
c. If the tissue bank does not bring itself into compliance with the accreditation requirements within the 90-day suspension period, the Accreditation Committee may extend the suspension for additional periods of 90 days or more, not to exceed one year. The Committee may also determine that a Level B inspection should be performed or may proceed to withdraw accreditation.
d. During the period of suspension, the tissue bank is not considered an accredited tissue bank or otherwise in good standing with the Association. In addition, beginning on the effective date of the suspension and continuing until the suspension is lifted, the tissue bank is prohibited from using the AATB accreditation logo on any tissue products produced during the period of suspension. The tissue bank is also prohibited from indicating AATB accreditation on its letterhead, brochures, advertising materials, and web site.
Q. The Accreditation Committee’s decision on an application for accreditation, after review by the Chief Executive Officer, is final unless, within five days following notification, a member of the Board of Governors requests that the BOG review the Committee’s decision.IX. INSPECTIONS WITH OR WITHOUT NOTICE
A. AATB reserves the right to perform on-site inspections at any time. Conducting such an inspection without notice does not necessarily indicate a suspected violation of AATB accreditation requirements.
B. The Accreditation Committee, or the BOG, with the concurrence of the Chief Executive Officer, may order an inspection for cause and/or as a stipulation of accreditation.
C. Such inspections may be general or focused and the scope will be defined by the party who ordered the inspection. The inspection may be of the accredited tissue bank and/or its recovery partner(s) even if the recovery partner(s) is not accredited by AATB.
D. Without limiting AATB’s right to inspect without notice, where circumstances permit, AATB may give prior notice to the tissue bank of its intent to inspect.
E. The inspection will be conducted according to the SOPM of the AATB’s Accreditation Program, using the AATB Standards and the Accreditation Policies currently in force.
F. If the inspector(s)’ report indicates that the tissue bank is not in compliance with AATB accreditation requirements and the bank appears to be operating in a manner that would adversely affect the safety of tissue recipients or others, the inspector(s) must notify the Director of Accreditation, who in turn will notify the Accreditation Committee Chair and the AATB Executive Office immediately. Otherwise, the procedures outlined in Section VIII(J) through VIII(P) shall be followed.
G. If the tissue bank’s location and/or activities change, or there are other major changes, the Director of Accreditation and Accreditation Committee Chair will review the changes to determine if an on-site inspection is required. If an inspection is required, the bank will reimburse the costs of the inspection.
1. If an inspection is performed and nonconformities or observations are not indicated, and the bank’s activities have not changed, the Accreditation Committee Chair will review the unblinded report for acceptance. This will not be submitted to the BOG for review.
2. If an inspection is performed and nonconformities or observations are indicated, and the bank’s activities have not changed, the bank will be asked to address the issues and the Accreditation Chair will review the unblinded inspection report and the bank’s response for acceptance. This will not be submitted to the BOG for review.
3. If an inspection is performed and the bank’s activities have changed from those that are listed on the accreditation certificate, the Accreditation Committee will review the inspection report and the bank’s response (if applicable) (blinded) for accreditation and the accreditation recommendation will be submitted to the BOG. The Accreditation Committee Chair will review the blinded and unblinded documents.X. REPORTING VIOLATIONS OF ACCREDITATION REQUIREMENTS
A. Reports of suspected violations of the accreditation requirements by accredited tissue banks must be made in writing to the Executive Office and signed with the name(s), address(es) and telephone number(s) of the individual(s) alleging the violations. The Association will treat the identity of the person(s) alleging a violation as confidential.
B. Upon receipt, the Director of Accreditation and the Chair of the Accreditation Committee will review any report alleging violations of the accreditation requirements by an accredited tissue bank. If they conclude that there is sufficient reason to believe that a violation has occurred, the Accreditation Committee, by majority vote, with the concurrence of the Chief Executive Officer, may order an investigation and an on-site inspection with or without notice as provided for in Section IX. If an inspection is ordered, the Association will assume the costs of the inspection.
C. Following an investigation and any on-site inspection, the Director of Accreditation will submit a written report to the Accreditation Committee. Upon receipt of the report and if a violation of the accreditation requirements is noted, the Director of Accreditation and Accreditation Committee Chair will convene an emergency meeting of the Accreditation Committee within five days. The Accreditation Committee will determine what, if any, action to take.XI. WITHDRAWAL OF ACCREDITATION
A. Accreditation of a tissue bank may be withdrawn pursuant to the following procedures:
1. Following review by the Accreditation Committee, the Chair of the Accreditation Committee will present a detailed written report, together with the recommendation of withdrawal, to the President. The recommendation must indicate that the tissue bank has violated the terms of its accreditation and is operating contrary to the AATB accreditation requirements. Should the President, Committee Chair, and Director of Accreditation agree to proceed with a recommendation for withdrawal, the Director of Accreditation will notify the Accreditation Committee of the pending recommendation at least one week prior to its meeting.
2. If the Accreditation Committee votes to confirm the recommendation of withdrawal, the Chief Executive Officer will notify the tissue bank of the decision in writing using a carrier with return receipt or other package-tracking capabilities. The notice will also outline the reasons for the decision and the organization's right to appeal.
1. If a tissue bank is notified that its accreditation has been denied, suspended, or withdrawn, or if transfer of accreditation has been denied, it shall have 15 calendar days from the date of receipt of the notification to appeal. The appeal must be submitted in writing to the AATB Executive Office, using a carrier with return receipt or other package-tracking capabilities. If an accredited tissue bank appeals the decision to withdraw its accreditation in a timely manner, the proposed withdrawal will be stayed pending the outcome of the appeal, provided there is no potential hazard to human health. In the event that the tissue bank does not appeal the decision to deny, withdraw, suspend, or deny transfer of accreditation within 15-calendar-days, the proposed suspension, denial, or withdrawal of accreditation will become final.
2. Should the tissue bank file an appeal within the 15 calendar days after notification, a Hearing Panel will be established and shall consist of the following members: the President-Elect, who shall act as Chair of the Hearing Panel, the Immediate Past President, and the Chief Executive Officer.
3. The hearing will be held within 45 calendar days of AATB's receipt of the request for such hearing. The hearing may be held in person or by teleconference.
4. At the hearing, the tissue bank's person most responsible for compliance with AATB requirements, including Standards and Accreditation Policies and/or Medical Director may appear and may be accompanied by up to three other members of the organization. At least five business days prior to the date of the hearing, the tissue bank must submit to the AATB a written statement of specific reasons indicating why suspension, withdrawal, or denial of accreditation is in error, as well as all written and documentary evidence in support of the organization's position. Testimony, if any, should be presented by sworn affidavit. The tissue bank will be allotted one hour to present its position and such additional time as needed to respond to the Panel’s queries.
5. The Hearing Panel will reach its decision by simple majority vote. The Panel's recommendation will be presented to the BOG in writing within ten business days of the hearing. The BOG will decide either to uphold or rescind the prior action for suspension, withdrawal, or denial. The tissue bank will be notified in writing within five business days of the BOG’s decision. The decision of the BOG is final.
6. Unless waived by the BOG, a tissue bank that has its accreditation withdrawn is not eligible to reapply for accreditation for one year from the date of notification of withdrawal.XII TRANSFER OF ACCREDITATION
A. General. An accredited tissue bank may request that its accreditation, or any portion thereof, be transferred when the bank is reorganized or dissolved and a successor entity is incorporated. An accredited tissue bank may also request a transfer of its accreditation, or any portion thereof, when the bank has merged with or been acquired by another AATB accredited tissue bank. AATB accreditation, however, does not automatically transfer to the successor entity. The tissue bank requesting the transfer must provide advance notice of the reorganization, merger or acquisition. The tissue bank must also provide appropriate documentation that demonstrates continued compliance with the accreditation requirements. All transfers of AATB accreditation must be approved by the Accreditation Committee.
B. Request for Transfer. To transfer AATB accreditation, an accredited tissue bank that reorganizes, merges with, or is acquired by another organization must first request that its AATB accreditation be transferred to the new entity. The request must be made in writing, signed by the person most responsible for compliance with AATB requirements, including Standards and Accreditation Policies, and sent to the AATB Executive Office at least thirty (30) days prior to the date of the proposed changes. The request must specify the reasons for the requested transfer, identify the entity to which it wants the Accreditation to be transferred, and provide the necessary documentation as described below. At the time the request is made, the accredited tissue bank must be in good standing and its accreditation must be current. Failure to file a timely and complete request may result in the denial of such a request or withdrawal of accreditation.
C. Documentation. In addition to the written request for transfer of accreditation as outlined above, the requesting party must also supply sufficient information and documentation to show:
1. The nature and extent of the ownership and operational changes;
2. Any changes in the scope of the tissue bank’s operations or management responsibilities;
3. Any changes that would alter the tissue bank’s continuing compliance with the accreditation requirements; and
4. Any outstanding audits, findings, or enforcement actions by any governmental agency affecting either the petitioning tissue bank or the merging or acquiring tissue bank.
D. Review. AATB’s Director of Accreditation and the Chair of the Accreditation Committee will review the request and documentation.
E. The decision, after review by the Chief Executive Officer, is final unless, within five days following notification, a member of the BOG requests that the Board review the committee’s decision.
Standards for Non-Transplant Anatomical Donation for Education and/or Research Implementation:
1. Tissue banks currently accredited under the Standards for Tissue Banking that perform activities intended primarily for transplant/medical therapy, will not
require accreditation under the Standards for NTAD.
2. Tissue banks currently accredited under the Standards for Tissue Banking that perform activities primarily intended for transplant/medical therapy but the tissue
could be determined not suitable for this use and alternatively be used for
research, will follow section “H2.000 Tissue for Research - General Policies and
Procedures” in the Standards for Tissue Banking.
3. Tissue banks currently accredited under the Standards for Tissue Banking that perform activities primarily intended for transplant/medical therapy but also
perform activities where the primary intent is for non-transplant use may apply for additional accreditation under the Standards for NTAD when their accreditation term is due for renewal. (If tissue was originally recovered from the donor specifically to use for non-transplant [never intended for transplantation], this qualifies as a primary intent for research and/or education).
4. Non-Transplant Anatomic Donation Organizations (NADOs) that participate only in non-transplant use, and are currently accredited under the
Standards for Tissue Banking will be required to re-apply for accreditation under
the Standards for NTAD when their accreditation term is due for renewal.
5. Non-Transplant Anatomic Donation Organizations (NADOs) currently accredited under the Standards for Tissue Banking that perform activities primarily intended for non-transplant use, but also perform activities where primary intent is for transplant/medical therapy, may apply for additional accreditation under the Standards for NTAD and the applicable standards in the Standards for Tissue Banking when their accreditation term is due for renewal.
6. A Non-Transplant Anatomic Donation Organization (NADO) that is not currently accredited to AATB Standards should consider applying for accreditation under
the Standards for NTAD.