QUALITY – The conformance of tissue or a process to pre-established specifications or standards. VALIDATION – Confirmation through the provision of documented objective evidence that predefined specifications have been fulfilled and can be consistently reproduced. Library of Congress Catalog Card Number 84-7269 Printed in the United States of America About the cover: Scanning electron micrograph of freeze-dried, decellularized cancellous bone, taken with a Carl Zeiss Sigma FESEM, magnification 99x. DOCUMENT OF GIFT – The donor’s legal record of the gift of tissue permitting and defining the scope of the postmortem recovery and use of tissues for transplantation, therapy, research and/or education. organizational behavior 14th edition solutions case 2, organizational behavior stephen p robbins 12th edition, pearson organizational behavior global edition 18 e, w 7 thirteenth edition fred luthans brett c luthans gbv, shop solution amp test bank store, solution manual Van Wicklin, MSN, RN, CNOR, CRNFA, CPSN-R, PLNC (AORN) Martell Winters (AAMI) AATB Inspectors Murray L. Anderson, CTBS Karen Baier, MT (ASCP) Sue Brewster, RN, CQA (ASQ), CTBS Mark Durivage, CQA (ASQ), RAC, CTBS Sabrina Qualley, BA, MLT (ASCP), CQA (ASQ), CTBS Randy Thoma, PhD, CQA, CMQ/OE AATB Accreditation Program Staff Scott A. Brubaker, CTBS (Senior Vice President of Policy) Jenny Chatman, CTBS (Coordinator) Michelle Lewis, ASQ CBA, RAC, CTBS (CAPA Analyst) Jason LoVerdi, MHA, CTBS (Manager) iii2015 Work Group Volunteers The following volunteers worked during 2015 to review sections and parts of the 13th edition of Standards to provide recommendations for updates to the Standards Committee: Introduction - Karen Norman and Timothy Maye Section A - Jason LoVerdi (leader) and Scott Brubaker Section B - Jonna Turner (leader), Debbie Sage, Michelle Bute and Phil Mellinger Section C - Joel Osborne (leader), Jessica Donovan, Patty Malone and Diane Wilson Section D - Glenn Greenleaf (leader), Jeff Cox and Greg Ray MD Section E - Tracy Ross (leader), Sheldon Dean, Glenn Greenleaf, Rebecca Hurst, Phil Mellinger, Josh Murphy, Jonna Turner and Diane Wilson Section F - Jonna Turner (leader), Casey Ming, Marc Germain MD, Alan Tillis MD, Diane Wilson, and Jennifer Wright Section G - Bridget Reardon (leader), Sharon Berardi, Michelle Bute, Miriam Estrano, Debbie Sage and Guobao Wei Section H - Bridget Reardon (leader), Sharon Berardi, Michelle Bute, Miriam Estrano, Debbie Sage and Guobao Wei Section J - Patty Malone (leader), Stephanie Cozby, Christine Crone, Carla Johnson, Rochelle Maney, Peter Mecenas, Darilyn Million and Diane Wilson Section K - Patty Malone (leader), Stephanie Cozby, Christine Crone, Carla Johnson, Rochelle Maney, Peter Mecenas, Darilyn Million and Diane Wilson Section L - (update planned later) Section M - Sarah Lopez (leader), Rusty Adams, Tonya Carraway, Lisa Cranford, Chuck Hall and Lindsay Kiolbassa Appendix I - Karen Norman Appendix II - Marc Germain, MD and Greg Ray, MD Reproductive tissue (R) - Donna Ridder and Martha Wells iv2014 -2015 Voting Members Michael A. Bergevin, MD, CTBS Timothy Maye, CTBS (Vice Chair) Jeff Cox, MS, CTBS, CBF Phil Mellinger Matthew Crump, CTBS Casey Ming, CTBS Sheldon W. Dean III, CTBS Karen G. Norman, CTBS Nancy L. Dock, PhD Joel C. Osborne, CTBS Marc Germain, MD, FRCP Mike Poole, CTBS Glenn Greenleaf, CTBS Gregory S. Ray, MD Peter Jenkins, CTBS Donna M. Ridder, CRCS Paul Kostiak, MHA, CTBS James Rogers Jeanne V. Linden, MD, MPH Catherine Springford Dan Mahaffey, MBA, RAC Chris Talbot, MS Patty Malone, MT (ASCP), CQA Michelle Timmins, ASQ CBA, RAC, CTBS Stephanie Mammino, CTBS, CQA Martha Wells, MPH, RAC 2014-2015 Non-voting Members Pallavi D. Annambhotla, DrPH (CDC) David Campagnari (ASTM) Karoll Cortez, MD, MHS (FDA/CBER) Jennifer DeMatteo, MCM, CIC (EBAA) Liz Anne Gillham-Eisen (Health Canada) Melissa A. Greenwald, MD (FDA/CBER) Andrew Henderson (Health Canada) LCDR Elizabeth Lybarger, USPHS (FDA/CBER) Michelle L. McClure, PhD (FDA/CBER) Patrick Ooley (AABB) Stephen Patten, MSN, RN, CNS, CNOR (AORN) Simone P. Porter, MD MPH (FDA/CBER) Debbie Seem, RN, MPH (CDC) Laura St. Martin, MD (FDA/CBER) Sharon A. Alert And Action Levels 25 X. Problems that occur in areas of manufacture other than processing, such as at recovery and during storage, would be included as possible areas from which the deviation originated, but the deviation would only qualify if it had an affect on an tissue that was distributed.Guidance Document Providing Service to Tissue Donor Families [No. To assist with recognizing updates, two documents have been created and are available at these links: Additionally, AATB Interim Guidance Document No. For more than 60 years, society has recognized the medical and humanitarian value of donating and transplanting organs and tissues. Proof of current laboratory licensure and accreditation must be maintained. 22SECTION C RECORDS MANAGEMENT C1.000 RECORDS MANAGEMENT C1.100 General Each tissue bank shall develop a donor record management system that will allow the detailed documentation of the tissue banking process(es) for which it is responsible. To fulfill that mission. For example, desiccation methods may include chemical (alcohol), critical/supercritical drying, simple air drying, or drying in a desiccator. ISO Standards 14160 (12) and ISO 14937 (13) provide guidance on selecting appropriate microorganisms for evaluating a sterilization process. CLIENT DEPOSITOR (R) – A person who consents to collection and/or storage of reproductive tissues for artificial insemination or assisted reproductive technology procedures for themself(ves) or a sexually intimate partner; not considered a reproductive tissue donor. DESICCATION – The removal of water from tissue. Check Pages 151 - 200 of AATB 14th edition in the flip PDF version. § An opportunity to honor and/or memorialize the donor. It is not possible, however, to revise each publication at the time such a change is adopted. The revision shall be initialed and dated by the individual making the revision. Found insideThis volume provides a comprehensive overview of surrogacy for clinicians, counsellors, attorneys, legislators and anyone interested in reproductive health policy by filling an immediate niche as a resource for those interested in third ... DISINFECTANT – An agent (e.g., heat or a chemical) capable of reducing the number of viable microorganisms. Document of Gift: The Donor’s legal record of the gift of tissue permitting and defining the scope of the postmortem recovery and use of tissues for transplantation, therapy, research and/or education. If aspects of a step or steps of a process are to be validated together, an important consideration is the number of variables involved. Their willingness to share experiences and best practices, to educate each other, and their ability to be forward-thinking regarding application of a quality culture to tissue banking operations, has led the way to maintaining a template (the Standards) that continues to be referenced not only by tissue banks, but also by end-user healthcare facilities, other standards- setting associations, and regulators worldwide. 1, v2 Tissue Donor Physical Assessment Form, 6- 27-05) • Appendix IV Prevention of Contamination and Cross-contamination at Recovery: Practices & Culture Results Requirements (formerly AATB Guidance Document No. Evaluations must be thorough and documented, and may require some degree of testing to verify assumptions made regarding the impact the change may have on the finished tissue. Aabb Technical Manual 28th Edition. Worst-case attributes of extraction process a. Worst-case attributes can be the maximum amount of tissue in the extraction step, shortest time of step (if a range is specified), lowest setting on mechanical component of the step or other variables determined during characterization studies. Tissue shipped at 10°C or below prior to and during shipment is safe; tissue does not need to be maintained at or below 8°C prior to and during shipment. This Guidance Document provides detailed information to assist tissue banks in development of a comprehensive microbiological surveillance program and describes steps to consider when validating processing of ‘conventional’ allograft tissue (e.g., skin, bone, cartilage, ligaments, tendons, dura mater, amnion, vessels, heart valves, and cellular tissue), similar autograft tissue, and allografts regulated as biologics, medical devices or combination products. CELLULAR TISSUE (CT) – viable cells that are autologous or allogeneic, committed or uncommitted, and non-expanded. QUALITY POLICY – The overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility. § An understanding that organizations that recover and prepare tissue have a responsibility to address Donor Family questions and/or concerns regarding tissue donation in a timely, effective, and compassionate manner. Swabbing: Swabbing has been the most common sampling method for obtaining pre- processing cultures and has also been used to obtain post-processing cultures. To clarify expectations for compliance, three documents previously referred to as “AATB Guidance Documents” each became incorporated as a separate appendix to the Standards. All requests and comments should be addressed to: American Association of Tissue Banks 8200 Greensboro Drive Suite 320 McLean, Virginia 22102 www.aatb.org For questions on the content of the document, please contact the AATB at: (703) 827-9582 or (703) 356-2198 (Fax) Mention of specific products or equipment in this AATB publication does not represent an endorsement of such products or equipment by the AATB, nor does it necessarily indicate a preference for those products or equipment over other similar competitive products or equipment. In the early stages of tissue processing it might be more likely that the tissue would contaminate the environment, and in the later stages, that the environment might contaminate the tissue. DURA MATER (DM) – A type of soft tissue that includes the pachymeninx (thick, membranous) tissue covering the brain. B2.122 Resources The tissue bank shall have sufficient resources, including the assignment of trained personnel, for management, performance of work, and assessment activities to meet the requirements of these Standards. These fluids may be tested to represent the microbiological quality of the tissues provided that proper validation has occurred (e.g., recovery efficiency or Method Suitability testing depending on the test to be performed). See J1.300, J1.400, J1.600. The second phase is usually performed by the user of the surface disinfectant (e.g., a tissue bank) against a selected panel of additional microorganisms, including types that have been recovered in the processing facility or from the tissue. 11. o Are you interested in information about our volunteer program? On this page you can read or download aisc manual difference in 13th and 14th edition in PDF format. Annex E provides an example of establishing bioburden alert and action levels. AATB Standards of Tissue Banking. On this page you can read or download aisc 13th edition free download in PDF format. Other documents, however, provide guidance regarding this topic. The first edition of AATB’s Standards for Tissue Banking was published in 1984, combining similar, general operational standards from all of these categories. Lack of stepwise instructions for validating such procedures is a recognized gap that exists worldwide. Using Microbial Screening Studies Another option for selecting microorganisms is to implement a screening method for process- resistant microorganisms. This is confirmed through validation or verification that the size/volume yields bioburden that, per unit area, is representative of the finished tissue. An LD who gives her or his informed consent to donation shall sign a record of the informed consent. See K4.300. It cannot automatically be assumed that the microbiological status of the environment will have an impact on tissue. VI. Generally, they fall into two categories: Funciona de 6 a 12 volts. § Information should: 8o be presented with a modulated tone of voice; o be offered in smaller amounts (dosing) dependent on family needs; o be complete to ensure family understanding of tissue donation and transplantation, research, and compliance with regulations; o outline how family members may carry out the decedent’s donor designation; o provide an opportunity to make a donation decision; o include the tissues that might be available for donation, transplantation, and/or research, and how they could benefit others; o describe that tissues are recovered by specially trained technicians in a way that is similar to a surgical procedure; o include the time elements involved in tissue preparation (recovery, preparation, distribution and transplantation/research); o be about grief and mourning; o be presented with sensitivity and compassion in language and terms that are easily understood by the family; and o every reasonable effort should be made to ensure that the opportunity for donation is provided as needed when a Limited English Proficiency (LEP) scenario is encountered, such as: • utilizing interpreters when communicating with Donor Families identified with LEP; • employing bilingual support services personnel; and • translating the Document of Gift/Authorization into the Donor Family’s or Authorizing Person’s language of proficiency. 3. Appropriate documentation regarding tissue disposition or transfer to alternative storage would be expected if storage temperature limits were exceeded or were recognized to be in danger of being exceeded. It is the most sensitive of tests in that it does not rely on removal of microorganisms from the tissue. BLOOD COMPONENT – Any part of a single-donor unit of blood separated by physical or mechanical means. They were founded in 1976 by a group of physicians and scientists who saw a need for better defined tissue banking industry standards. 24C1.500 Revisions Revisions to paper records shall be made with a single line drawn through the altered text. SIGNATURE – A record is signed when it has been authenticated or adopted by the signer by means in writing, or an electronic signature, symbol, sound, process or recording pursuant to applicable law. AATB Bulletin #17-05: Changes to Standards. B1.520 Inspections/Audits of Other Facilities (Refers to inspections/audits that an accredited tissue bank must perform for activities/services rendered by another entity.) The quantity of data obtained for air and surface microorganisms should be sufficient to demonstrate consistent microbiological control of the area. For example one can use a disinfectant to decontaminate surfaces or a disinfectant to disinfect tissue. These changes were announced with a six-month implementation period starting on July 31st, 2020 when Bulletin #20-13 was published. 3. These may be established initially based on process validation data, and periodically evaluated to assure they are still properly established. A process that is not very robust may require more stringent rules regarding the microbiological status of tissue subjected to that process. Additions to a completed record shall be initialed and dated by the individual making the additions. These organisms in a high humidity Page 28 of 55environment (especially where visible moisture is present) can rapidly grow and sporulate and contaminate the facility. These Standards are the only private tissue-banking standards … First published in 1984 and presently in its 14th edition, the AATB’s Standards for Tissue Banking are recognized in both the United States and around the world as the definitive guide for tissue banking. Written in a clear, concise and readable style, this volume allows the reader to obtain rapid answers to this challenging medical issue. Special emphasis is placed on diagnostic and treatment algorithms. In either case, controls should be adequate to prevent the risk of cross contamination. Additionally, there is no defined requirement regarding how much data must be obtained prior to initiation of use of the cleanroom. Depending on use of results, combining multiple tissues from the same donor might be appropriate. The 10th edition was published in 2002 and was the first edition to be numbered. PHYSICAL ASSESSMENT – A recent ante-mortem or postmortem documented evaluation of a deceased donor’s body that can identify evidence of: high-risk behavior and signs of HIV infection or hepatitis infection; other viral or bacterial infections; or, trauma to the potential recovery sites. Recovery efficiency details are outlined in Section XII. 4, version 2, March 9, 2015] Certain American Association of Tissue Banks (AATB) guidance documents describe mandatory requirements with which accredited tissue banks must comply fully, whereas other AATB guidance documents present only recommendations regarding possible approaches, but not necessarily the only approach, for compliance by accredited tissue banks with AATB Standards. Records shall be retained for at least 10 years beyond the date of distribution, date of transplantation (if known), date of disposition, or date of expiration of the tissue (whichever is the latest). This data can be compared to the “at rest” data to determine the impact that people and processes have on the controlled environment. Where applicable, the source of the definition is referenced. B. 20B2.130 Management Review Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of these Standards and the tissue bank’s established quality policy and objectives. 22, No 2. A. Distinguishing Validation of Methods from Validation of Processes Discussion of validation work in this section is in context of validating a process step rather than validating a test method. A process step may be implemented which is primarily intended to have a physical effect on the tissue, but which also has a microbial reduction aspect as a secondary benefit, or vice versa. TISSUES AND FLUIDS USED FOR TESTING Various types of tissues and fluid should be tested, and must be representative of the different tissue types processed. You must maintain any facility used in the manufacture of HCT/Ps in a clean, sanitary, and orderly manner, to prevent the introduction, transmission, or spread of communicable disease. September, 1995. : abbreviation for id est; that is; indicates a finite list. For Authorization purposes, this person may also be referred to as a ‘‘designated requestor.’’ Donor Risk Assessment Interview (DRAI)4: A documented dialogue in person or by telephone with an individual or individuals who would be knowledgeable of the donor’s relevant medical history and social behavior. 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