Printable Update for Insertion into Standards - Appendix 1

CHANGES TO AATB STANDARDS FOR TISSUE BANKINGAppendix I:PROCEDURES TO REQUEST A FOR VARIANCE FROM STANDARDSIntroductionAATB-accredited Tissue Banks may request a Variance when a policy, process, orprocedure is in conflict with requirements in current AATB Standards. A Variancerequest may be submitted for specific AATB Standards appearing in this edition or inannounced, approved updates to this edition. AATB-accredited Tissue Banks mayrequest a Variance to Standards but may not violate current Standards by implementingthe change without first receiving notice of written approval from the AATB ExecutiveOffice.A Tissue Bank seeking AATB accreditation for the first time may submit a Variancerequest for operations being performed prior to applying for accreditation. Requests forVariance cannot be acted upon if they are sent by an entity that is not an AATBaccreditedTissue Bank, or has not applied for AATB accreditation.The timeline for reviewing a request for Variance can be affected by additional requestsfor information by those who review the submission as well as by the time associatedwith response(s) by the requestor. The burden is on the Tissue Bank to providesupporting documentation that adequately describes how the proposed practice willmeet the ultimate intent of Standards.ProcessSUBMISSION:1) Tissue Banks requesting a Variance from current Standards must provide thefollowing information in writing to the Standards Committee AATB Chief PolicyOfficer by using the Request for Variance to AATB Standards SubmissionFormat that follows. The format must be completed in entirety and include:a) The request for Variance, including the particular Standardsnumber(s) that apply to the request;b) Information on Justification of the alternative procedure(s), policy orprocess which assure(s) equivalency to the intent of Standardsequivalent Safety and/or efficacy of the cells and/or tissue orprocedure; andPage 1 of 6

c) Supporting information such as worksheets, records, data, or otherinformation (e.g., Validation of the protocol to be used in theVariance or modification, including the scientific data and QualityAssurance steps) necessary to demonstrate equivalence withStandards.2) Within thirty (30) days of a request for Variance, the Chief Policy Officer and theChairperson of the Standards Committee will review the information submitted forapplicability and completeness. and forward the information to the AATB MedicalAdvisory Committee and/or appropriate Council. These individuals may requestmore information to complete the submission and may consult with officers ofappropriate committees and/or councils.REVIEW:3) Upon referral of a request for Variance from the Chairperson of the StandardsCommittee, the Medical Advisory Committee and/or appropriate Council willreview and evaluate the scientific and medical acceptability of the request. Ifadditional information is required, the Medical Advisory Committee and/orCouncil will request such information directly from the tissue bank.4) The Medical Advisory Committee and/or Council will render an opinion as to thescientific and/or medical validity of the request, and will deliver that opinion andits recommendation regarding the request for Variance to the StandardsCommittee within sixty (60) days of the date on which the request for Variancewas initially referred to the Medical Advisory Committee and/or Council by theChairperson of the Standards Committee. However, if additional information hasbeen requested from the tissue bank by the Medical Advisory Committee orCouncil (see paragraph 3, above), the time for delivery of the Committee’s orCouncil’s review and recommendation may be extended up to sixty (60) daysafter the Committee’s or Council’s receipt of the additional information from thetissue bank.5) Within thirty (30) days of receipt of the review and recommendation of theMedical Advisory Committee and/or Council, the Standards Committee willforward its recommendation and supporting data to the Board of Governors.1) The Chief Policy Officer will forward the request and supportive information to theStandards Committee. These documents may or may not be blinded, dependingon the nature of the submission and whether withholding the Tissue Bank’sidentity could adversely affect appropriate review of their submission. Thisdecision will be made in consultation with the person who submitted the Variancerequest.2) Variances are reviewed without prejudice, and individuals involved in thepreparation of the request or who have any conflict relating to the request are toPage 2 of 6

exclude themselves from committee or council discussion. Subject matterexperts may be sought for consultation at the discretion of the StandardsCommittee Chairperson and/or Board of Governors.3) At the next scheduled meeting, the Standards Committee will review andevaluate the acceptability of the request.RESPONSE:a) If adequate information has been received, the Standards Committee mayvote to approve or disapprove the request. Within thirty (30) days, thisrecommendation will be forwarded to the Board of Governors.b) If additional information is required, the Chief Policy Officer or Chairpersonwill request information directly from the contact person who submitted therequest.The Standards Committee may determine that the request must be reviewedby another committee or council, or may seek consultation with other subjectmatter experts. For example, requests of a scientific nature may beforwarded to the Science and Technical Advisory Committee for review andrecommendation, and those of a medical nature may be forwarded to thePhysicians’ Council for review and recommendation.If consultation with another committee or council has been requested, therecommendation regarding the request shall be sent to the StandardsCommittee Chairperson and Chief Policy Officer within sixty (60) days ofreceipt. This time period may be extended if additional supportive informationis desired by reviewers, but should be no longer than ninety (90) days fromreceipt.Within thirty (30) days of receipt of the recommendation from anothercommittee, a council, or subject matter expert(s), the Standards Committeewill forward its recommendation, and rationale that supports therecommendation, to the Board of Governors.61) Within thirty (30) days of its receipt of the Standards Committee’srecommendation, the Board of Governors shall take formal action on the requestfor Variance and shall issue a written response to the Tissue Bank regarding itsrequest. Requests for Variance may be approved, delayed pending receipt ofmore information requested by the Board of Governors, rejected, or approved inmodified form.7) An ad hoc committee may be established by the Medical Advisory Committeeand/or Council to review information submitted in the request. Members of thiscommittee will be selected for their expertise in the area in question.Page 3 of 6

82) The Standards Committee shall provide notice of action on a request forVariance to the Accreditation Committee Program Manager for placement in theTissue Bank’s folder file. The Standards Committee shall also notify the MedicalAdvisory Committee and/or Council of the Board’s action on a request forVariance.The Board of Governor’s action on a request shall be communicated by the ChiefPolicy Officer to the Chairperson of each committee and/or council that reviewedthe request.Notice of the grant or rejection of a Variance from the Standards shall also bepublished in the AATB Newsletter.OTHER CONSIDERATIONS:91) All data and proprietary information provided to the AATB by the tissue bank inconnection with a request for Variance shall be treated in accordance withAATB’s policy governing confidential and proprietary information.102) A Variance from Standards may not be implemented by the Tissue Bank until therequest for Variance has been approved by the Board of Governors.113) Any Variance from Standards approved by the Board of Governors is applicableonly to the Tissue Bank that requested the Variance. However, should theStandards Committee consider the Variance to have universal application, theStandards Committee may recommend that the Board of Governors make theapproved Variance applicable to all accredited members under such conditionsas may be prescribed.124) If a Variance is granted, it shall remain in effect while the applicable standard isin effect, or until:a) the Variance or applicable standard is rescinded;b) by the applicable standard, or the federal, state, and/or local law and/orregulation on which the Variance is based, are amended or deleted therebyrendering the Variance null and void; orc) the Variance becomes meaningless due to changes in other circumstances.Page 4 of 6

Request for Variance to AATB Standards (current edition)- Submission Format -Standard for which a variance is submittedStandard number and title:Enter current text of standard:ReasonDescribe justification of variance request:Supporting InformationAttach worksheets, records, data, or other documentation that supports your request.List them here by title.Accredited Tissue Bank Name & Representative(This is the contact person for this request)Name:Title:Accredited Tissue Bank Name:Email address:Phone number:Statement of Tissue Bank RepresentativeI request that for purposes of AATB accreditation our Tissue Bank should be granted avariance from this standard.Signature:Date Submitted:Page 5 of 6

Publication date: January 24, 2008 (AATB Bulletin No. 08-04)Effective date: ImmediatelyPage 6 of 6