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Vol. 31 No. 1 March 2008 1320 Old Chain Bridge Road, Suite 450, McLean, VA 22101 Phone: 703-827-9582 Fax: 703-356-2198 Website: www.aatb.org Board of Governors The new Board of Governors took office during the 31st Annual Meeting in Boston. Please join us in congratulating: President: Francis Hornicek, M.D., Ph.D. President-Elect: Diane Wilson, RN, CTBS Secretary: Kathy Pearson, CTBS Treasurer: Thomas Cycyota Immediate Past President: James Forsell, Ph.D., CTBS Members at Large: Glenn Greenleaf, CTBS Perry Lange, CTBS Council of Accredited Tissue Banks: Mary Beth Fisk, CTBS Kenneth Blair, CTBS Musculoskeletal: Simon Bogdansky, Ph.D. Physicians’: David Smith, M.D. Reproductive: Donna Ridder Skin: Christian Manders Tissue Bank: John Lee, CTBS “Giving from the Heart” float at the 2008 Rose Bowl Parade AATB is proud once again to be a patron of Donate Life’s Rose Parade float. The 119th Rose parade themed Passport to the World’s Celebrations, took place on Tuesday, January 1, 2008 at 11:00 a.m. (EST). In support of the parade theme, the Donate Life float theme focused on what it means and how it feels to receive the gift of life. Our float rider contingent consisted of 22 organ, tissue and blood recipients from all corners of the country, with a collective goal of having the most diverse float in the history of the Rose Parade. In this newsletter... People in the News … 2 LifeNet Partners with IMS and LOPA … 2 Calendar of Events … 2 AATB Remembers … 3 Congrats 2007 CTBS Examinees … 4-11 Labs at Bonfils … 11 2008 Abstract Submission Update … 11 CTBS Exam 2007 … 12-14 AATB Bulletins … 15 LifeNet Health Gala … 15 New Accredited Banks… 16 Re-Accredited Banks 16-17 Report on Variance Request to Standards… 18 Tissue Donor Suitability Workshop Registration… 19 2008 CTBS Exam and Training Application … 20-22 32nd Annual Meeting, Exhibitor Information … 23-24 2005-2006 Audit Report 25-28
Transcript

Vol. 31 No. 1 March 2008 1320 Old Chain Bridge Road, Suite 450, McLean, VA 22101 Phone: 703-827-9582 Fax: 703-356-2198 Website: www.aatb.org

Board of Governors The new Board of Governors took office during the 31st Annual Meeting in Boston. Please join us in congratulating:

• President: Francis Hornicek, M.D., Ph.D. • President-Elect: Diane Wilson, RN, CTBS • Secretary: Kathy Pearson, CTBS • Treasurer: Thomas Cycyota • Immediate Past President: James Forsell, Ph.D., CTBS • Members at Large: Glenn Greenleaf, CTBS Perry Lange, CTBS • Council of Accredited Tissue Banks: Mary Beth Fisk, CTBS Kenneth Blair, CTBS • Musculoskeletal: Simon Bogdansky, Ph.D. • Physicians’: David Smith, M.D. • Reproductive: Donna Ridder • Skin: Christian Manders • Tissue Bank: John Lee, CTBS

“Giving from the Heart” float at the 2008 Rose Bowl Parade

AATB is proud once again to be a patron of Donate Life’s Rose Parade float. The 119th Rose parade themed Passport to the World’s Celebrations, took place on Tuesday, January 1, 2008 at 11:00 a.m. (EST). In support of the parade theme, the Donate Life float theme focused on what it means and how it feels to receive the gift of life. Our float rider contingent consisted of 22 organ, tissue and blood recipients from all corners of the country, with a collective goal of having the most diverse float in the history of the Rose Parade.

In this newsletter...

People in the News … 2

LifeNet Partners with IMS and LOPA … 2

Calendar of Events … 2

AATB Remembers … 3

Congrats 2007 CTBS Examinees … 4-11

Labs at Bonfils … 11

2008 Abstract Submission Update … 11

CTBS Exam 2007 … 12-14

AATB Bulletins … 15

LifeNet Health Gala … 15

New Accredited Banks… 16

Re-Accredited Banks 16-17

Report on Variance Request to Standards… 18

Tissue Donor Suitability Workshop Registration… 19

2008 CTBS Exam and Training Application … 20-22

32nd Annual Meeting, Exhibitor Information … 23-24

2005-2006 Audit Report 25-28

People in the News D. Ted Eastlund, M.D. has been appointed Associate Medical Director of LifeNet Health. Dr. Eastlund is a Past President of AATB and a 2004 recipient of AATB’s Kenneth W. Sell Distinguished Service Award. LifeNet Health has appointed Mary Macukas Vice President of Development and Executive Director of the LifeNet Health Foundation and Jim Springer as Director of Recovery Partner Relations. Ms. Macukas will lead development efforts at LifeNet Health to raise funds for research and development, community educa-tion, and bereavement care. Mr. Springer will oversee tissue recovery partnerships and new opportunities as Director of Recovery Partner Relations.

Upcoming AATB Meetings More information on AATB meetings

online at www.aatb.org

12th Annual Spring Meeting Sunday, March 30 – Tuesday, April 1 (Pre-Meeting Events begin on Saturday, March 29)

Hyatt Regency Savannah 2 West Bay Street Savannah, Georgia 31401

CTBS Training and Review Course Thursday May 1 – Sunday, May 4 REGISTRATION NOW OPEN

Hilton Arlington Hotel 950 N. Stafford Street Arlington, Virginia 22203

Tissue Donor Suitability Workshop Saturday, May 3 – Monday, May 5 REGISTRATION NOW OPEN

Hyatt Regency Reston 1800 Presidents Street Reston, Virginia 20190

32nd Annual Meeting Saturday, September 6 – Tuesday, September 9 EXHIBITOR REGISTRATION IS OPEN

Marriott Chicago Magnificent Mile 540 North Michigan Avenue Chicago, Illinois 60611

Quality Assurance Workshop X Wednesday, November 12 – Friday, November 14

Loews Ventana Canyon Resort 7000 N. Resort Drive Tucson, Arizona 85750

NON-AATB MEETINGS 2008 International On-Line Tissue Banking Course-www.tpm.org 5th World Congress on Tissue Banking in conjunction with 12th International Conference of Asia Pacific As-sociation of Surgical Tissue Banks - www.wctb08.com 9th Australasian Tissue Banking Forum (ATBF) Scien-tific and Business Meeting- www.atbf.org EATB/BATB Joint Annual Meeting, 2008, Edinburgh, Scotland– www.batb.org.uk www.eatb2008.com

LifeNet Health Partners with IMS and LOPA

LifeNet Health has announced a strategic partnership with Integrated Medical Systems International, Inc. (IMS) to create new software tools for LifeNet Health customers, improving the tracking of allograft bio-implants. The agreement calls for the development, marketing, distribution, and support of a LifeNet Health vendor version of IMS’ tissue tracking software. The new software will help LifeNet Health customers better track their tissues and inventory, and create a stream-lined system that provides life-enhancing tissue grafts to hospitals in a timely process. The system will track tissue implants throughout hospital locations specified by the user, and the technology will manage and con-trol inventory for them. This specific system, designed to meet the needs of LifeNet Health’s customers, will help ensure safety and meet current regulations. LifeNet Health has also announced a strategic affilia-tion with Louisiana Organ Procurement Agency (LOPA). The LifeNet Health - LOPA partnership will significantly enhance LOPA’s tissue donor program providing an expanded biomedical allograft tissue product line for Louisiana surgeons and patients.

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With profound sadness MTF announced the passing of Amy Gamble, Vice Presi-dent of MTF Technical Operations Department, this past September. Many will remember Amy as a committed member of AATB, A colleague and friend to many within the tissue and organ recovery communities.

Amy joined MTF and the tissue bank industry in 1994, bringing wide-ranging knowledge and exceptional leadership skills that she had developed during an already extensive nursing career as an acute-care RN and Nurse Manager. Amy contributed greatly to the growth and development of MTF and its employees in varied roles and escalating positions of responsibility culminating in her leadership of the MTF Technical Operations Department.

Amy held a genuine commitment to the ultimate mission of MTF and the tissue bank community in honoring the gift of the donor and donor family; she demon-strated this in all aspects of her work. Contributing to the quality and growth of our industry as a collaborative member of the AATB Standards Committee for many years, Amy was also co-chair of the Policy and Procedures Committee of MTF’s Medical Board of Trustees, chair of the Procurement Advisory Committee for MTF’s Donation Board of Trustees, as well as a valued member and leader of countless projects within MTF and across industry organizations. Known for her open, positive and determined approach to work and challenges as well as her sense of humor, Amy’s example of effective leadership, kind generous spirit, and smile remain with those of us who knew and worked with her.

Amy Gamble

Ron was a caring and dedicated professional. Spanning over 30 years until his untimely and tragic death in August 2007, Ron’s distinguished career in tissue banking began as a research assistant at the Shriners Hospital for Children -- Cincinnati in 1976. Thereafter, he served in major positions with the Ohio Val-ley Tissue & Skin Center, later known as U.S. Tissue and Cell, and most re-cently, with AlloSource. Ron was also a giving and responsible individual, who was dedicated to his profession. He served on the Association’s Board of Governors and many AATB committees, including the Accreditation and Standards Committees. He also served a two-year term as Chair of the Skin Council. An AATB Certified Tissue Bank Specialist (CTBS) for more than 15 years, Ron was the author of numerous scientific papers and book chapters on skin banking. Much of his work remains the standard today. Equally as important, Ron was a kind and gentle person, a friend. Throughout his professional career in tissue banking, he was a true humanitarian dedicated to organ and tissue donors and to the many patients who benefit from these gifts. On behalf of everyone associated with the AATB and tissue banking, we are proud to have counted Ron Plessinger as a colleague and a friend. He is and will continue to be sorely missed by his colleagues and by the Association.

Ron Plessinger

AATB Remembers... Amy Gamble and Ron Plessinger

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Congratulations Tissue Bank Specialists Certified by Examination September 2007

Natalie Abraham, LifeLink Tissue Bank, Tampa, Florida Cain Aguirre, LifeNet Health, Fresno, California Béatrice Allard, Héma-Québec/Tissus Humains, Québec,

Québec, Canada Rod Allen, Regeneration Technologies Inc., Gainesville, Florida Eduardo Álvarez Lozano, MD, PhD, Bone & Tissue Bank University Hospital

Madero y Gonzalitos, Monterrey, Nuevo Leon, Mexico

Hance Anderson, RTI Donor Services, Madison, Wisconsin Timothy Armstrong, LifeNet Health, Virginia Beach, Virginia Daniel Aro, AlloSource, Centennial, Colorado Travis Arola, Regeneration Technologies Inc., Alachua, Florida Judith Aster, AlloSource, Centennial, Colorado Michael Aussey, LifeNet Health, Virginia Beach, Virginia Vincent Avery, LifeLink Tissue Bank, Tampa, Florida Kelly Badger, South-East Regional Health Authority, Moncton, New Brunswick, Canada Cheryl Bagwell, Tutogen Medical Inc.,

Alachua, Florida Timothy Bailey, Community Tissue Services (CTS), Dayton, Ohio Karin Bankston, LifePoint Inc., Columbia, South Carolina Brenda Bardsley, Anatomy Gifts Registry, Hanover, Maryland Clayton Barker, LifeLink of Georgia, Norcross, Georgia Carolyn Barrett, AlloSource, Denver, Colorado

Sandra Bausback-Aballo, LifeCell Corporation, Brick, New Jersey Michael Becker, Tissue Center of Central Texas, Austin, Texas Yvonne Benton, Regeneration Technologies Inc., Gainesville, Florida Laurie Berkan, OneLegacy, Los Angeles, California David Bivens, Shriners Hospital for Children, Galveston, Texas Crystal Blackwell, Regeneration Technologies Inc., Alachua, Florida Connie Brais, DCI Donor Services, Nashville, Tennessee Michelle Brandeberry, (CTS), Dayton, Ohio Abigail Brentlinger, (CTS), Toledo, Ohio Karen Britt, Regeneration Technologies Inc., Gainesville, Florida Holly Brooks, (CTS), Dayton, Ohio Dana Bunkley, Regeneration Technologies Inc., Gainesville, Florida Lisa Burkey, Regeneration Technologies Inc., Alachua, Florida Michael Burnell, Regeneration Technologies Inc., Alachua, Florida Kimberly Bush, Donor Alliance, Denver, Colorado Maria Caiafa, Osteotech Inc., Eatontown, New Jersey Rodrigo Camacho, Tissue Center of Central Texas, Austin, Texas

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Thomas Cannan, Southeast Tissue Alliance (SETA), Gainesville, Florida Antolin Carrera, Jr., Midwest Transplant Network, Westwood, Kansas Aileen Cartier, New England Organ Bank (NEOB), Newton, Massachusetts Theodore Castellanos, Center for Organ Recovery & Education

(CORE), Pittsburg, Pennsylvania Jose Castro, RTI Donor Services, El Paso, Texas Penny Catton, LifeCell Corporation, Branchburg, New Jersey Monika Cavazos, Tissue Center of Central Texas, Austin, Texas Marvin Cerrato, Louisiana Organ Procurement Agency

(LOPA), Metairie, Louisiana Lai Chang, University of Miami Tissue Bank, Florida Randy Chisholm, RTI Donor Services, Staten Island, New York David Churchill, Tutogen Medical Inc., Alachua, Florida Matthew Cisne, Community Blood Center (CBC) / Com-

munity Tissue Services, Dayton, Ohio Danielle Clark, (CTS), Indianapolis, Indiana Jason Clarke, CryoLife Inc., Kennesaw, Georgia Patrick Cleary, LifeLink Tissue Bank, Tampa, Florida Hubert Clouatre, Tissue Bank Manitoba, Winnipeg, Manitoba, Canada Brittany Colling, Indiana Organ Procurement Organization

(IOPO), Indianapolis Kristi Connolly, OneLegacy, Los Angeles, California Jason Cordell, Tutogen Medical Inc., Alachua, Florida

John Cover, Science Care, Phoenix, Arizona Erin Cowherd, LifeNet Health, Virginia Beach Kristine Cox, Iowa Donor Network, Johnston Sara Craig, Tissue Center of Central Texas, Austin, Texas Gregory Crawford, University of California San Francisco

(UCSF) Tissue Bank/MTF, San Jose, California Jennifer Crump, Nutech Medical, Birmingham, Alabama Elizabeth Dahl, Northwest Tissue Center, Renton, Washington Michael Davis, Tutogen Medical Inc., Alachua, Florida Annelies De Grauwe, Belgian University Tissue Bank, Brussels, Belgium Judy DeBates, AlloSource, Centennial, Colorado Fred DeNegri, Jr., Tutogen Medical Inc., Alachua, Florida Linsey DeNegri, Tutogen Medical Inc., Alachua, Florida Sherry Dethrow, Tutogen Medical Inc., Alachua, Florida Jared DeWalt, Northwest Tissue Center, Renton, Washington Susan DiCenso, (NEOB), Newton, Massachusetts Gregory Dolan, Regeneration Technologies Inc., Alachua, Florida Kathryn Donahower, Globus Medical, Inc., Audubon, Pennsylvania Maria Donato, Doheny Eye and Tissue Transplant Bank,

Los Angeles, California Ryan Donohue, AlloSource, Salt Lake City, Utah Sheila Doran, LifeLink Tissue Bank, Tampa, Florida

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Justin Gebhardt-Kram, Anatomy Gifts Registry, Hanover, Maryland Christina Gent, Regeneration Technologies Inc., Alachua, Florida Petar Georgiev, MD, Tissue Banks International (TBI), San Rafael, California Krista Gilbertson, CryoLife Inc., Kennesaw, Georgia Wayne Godsmark, Jr., Regeneration Technologies Inc., Alachua, Florida Liliana Gonzalez, OneLegacy, Los Angeles, California Chase Goodman, AlloSource, Centennial, Colorado Liberty Goodman, (TBI), San Rafael, California Jenna Graciano, OneLegacy, Los Angeles, California Tracee Gruber, (CORE), Pittsburgh, Pennsylvania Christina Guillen, (CTS), Fresno, California James Gunter, CryoLife Inc., Kennesaw, Georgia Lindsey Haas, Midwest Transplant Network, Westwood, Kansas Helen Hahn, LifeCell Corporation, Branchburg, New Jersey Robert Hale, OneLegacy, Los Angeles, California Amanda Hamilton, Mountain Region Donor Services / DCI,

Gray, Tennessee Dawn Harimon, AlloSource, Centennial, Colorado Tyler Harmon, Gift of Life Donor Program, Harrisburg, Pennsylvania Angela Hartland-Richardson, RTI Donor Services, Marietta, Georgia Derek Hauge, Florida Tissue Services / LifeNet, Pensacola, Florida

Cheryl Dunaway, (CTS), Dayton, Ohio Carol Dungan, Tutogen Medical Inc., Alachua, Florida David Dunkley, VitalGift Tissue Services, San Jacinto, California Jason Easley, CryoLife Inc., Kennesaw, Georgia Amy Edwards, Cayman BioMedical Research Institute,

Ann Arbor, Michigan Rhonda Ekbald, AlloSource, Salt Lake City, Utah Amanda Ely, PhD, Regeneration Technologies Inc., Alachua, Florida Micheal Ezzelle, LiftGift Organ Donation Center, Houston, Texas Bryan Fairbanks, AlloSource, Centennial, Colorado Carrie Falcone, LifeCell Corporation, Branchburg, New Jersey John Feraud, CBC / CTS, Fresno, California Verónica Fernández, New York Organ Donor Network

(NYODN), New York City Katherine Fife, (NEOB), Newton, Massachusetts Joseph Fitzsimmons, AlloSource, Salt Lake City, Utah Emily Foster, DCI Donor Services Inc., Nashville, Tennessee Alison Fountain, (CTS), Toledo, Ohio Elizabeth Fowler, AlloSource, Centennial, Colorado Matthew Fretzs, AlloSource, Centennial, Colorado Nicole Fulgueira, LifeLink Tissue Bank, Tampa, Florida Karen Gaskalla, Tutogen Medical Inc., Alachua, Florida Anissia Gauff, AlloSource, Centennial, Colorado

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Karen Inocencio, Anatomy Gifts Registry,

Hanover, Maryland Tyler Isaacson, (MTF), Eatontown, New Jersey Ju Woong Jang, MD, PhD, Korea Bone Bank Co. Ltd., Seoul, South Korea Deborah Jefferson, New Brunswick Eye and Tissue Bank, St. Joseph’s Hospital, Saint John, New Brunswick, Canada Jin Young Jeong, MD, PhD, St. Vincent's Hospital, The Catholic University of Korea, Suwon, South Korea Angela Johnson, LifeSource, St. Paul, Minnesota Sharron Johnson, Intermountain Donor Services, Salt Lake City, Utah Michelle Johnson-Smith, (MTF), Edison, New Jersey David Jones, LifeNet Health, Virginia Beach Evan Jones, Regeneration Technologies Inc., Alachua, Florida Michael Judy, Living Legacy Foundation, Baltimore, Maryland Fatemeh Khamseh, AlloSource, Centennial, Colorado Shanaz Khan, Tutogen Medical Inc., Alachua, Florida Angela Kiracofe, (IOPO), Indianapolis, Indiana Delia Knapp, Donor Alliance, Denver, Colorado Trey Knight,

LifeLink Tissue Bank, Tampa, Florida Brenda Knighton, Regeneration Technologies Inc., Alachua, Florida Courtney Koontz, Carolina Donor Services, Winston-Salem, North Carolina Wesley Kouba, LifeNet Health, Virginia Beach Dave Koziarski, (CTS), Toledo, Ohio

Steven Hawkins, Medical College of Georgia Health Tissue

Donor Services, Augusta, Georgia Brian Henderson, AlloSource, Centennial, Colorado Gabriella Hernandez, Shriners Hospital for Children, Galveston, Texas Kristina Hill, LifeNet Health, Virginia Beach Pamela Hinton, Musculoskeletal Transplant Foundation

(MTF), Edison, New Jersey Nancy Hodge, JD., AxoGen Inc., Alachua, Florida Mark Hoffman, Midwest Transplant Network, Westwood, Kansas Faith Holbrook, CBC / CTS, Dayton, Ohio Charity Holihan, LifeNet Health, Virginia Beach Edward Holm, LifeNet Health, Richmond, Virginia John Holm, AlloSource, Centennial, Colorado Colleen Holman, LifeCell Corporation, Branchburg, New Jersey Sean Holman, (NEOB), Newton, Massachusetts Sarah Holsten, LifeLink Tissue Bank, Tampa, Florida Christopher Holtz, Washington Regional Transplant Consor-

tium (WRTC), Annandale, Virginia Kendra Honea, Lost Mountain Tissue Bank, Kennesaw, Georgia Stephen Hubbinett, Osteotech Inc., Eatontown, New Jersey Jennifer Hull, (SETA), Gainesville, Florida Kelly Hunt, Tutogen Medical Inc., Alachua, Florida Gabriel Hyams, International Biologics, Scottsdale, Arizona

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Ivan Maestre, LifeLink Tissue Bank, Tampa, Florida Enid Mangual, Regeneration Technologies Inc., Alachua, Florida David Martin, (CTS), Portland, Oregon Pedro Martinez, South Texas Blood & Tissue Center, San Antonio Michelle McClure, CryoLife, Inc., Kennesaw, Georgia Brett McDuffie, Nutech Medical, Birmingham, Alabama Rachel McGinnis, LifeGift Organ Donation Center, Lubbock, Texas Lisa McKee, Regeneration Technologies, Inc.,

Alachua, Florida Christina McKinley, Donor Alliance, Denver, Colorado Steven McLean, Tutogen Medical Inc., Alachua, Florida Nadine McNeal, Iowa Donor Network, North Liberty Patricia Milanese, LifeNet Health, Virginia Beach Gina Miller, AlloSource, Centennial, Colorado John Miller, Living Legacy Foundation of Maryland,

Baltimore Stephen Miller, PhD, Regeneration Technologies, Inc.,

Alachua, Florida Matthew Montoya, AlloSource, Centennial, Colorado Vanessa Montoya, AlloSource, Centennial, Colorado Kyoung Ho, Moon, MD, PhD, Inha University Hospital, Incheon, Korea Richard Morrison, (SETA), Jacksonville, Florida Chanel Nakanishi, Sierra Eye & Tissue Donor Services /

DCI, Sacramento, California Brian Naylor, AlloSource, Salt Lake City, Utah

Lorrie Krauss, (CTS), Toledo, Ohio Christina Kuhn, LifeNet Health, Virginia Beach Jarod Lagemann, LifeNet Health, Virginia Beach Cole Lansden,

AlloSource, Centennial, Colorado Dalin Larkin, AlloSource, Salt Lake City, Utah Wendy Lau, MD, The Hospital For Sick Children Tissue

Laboratory, Toronto, Ontario, Canada Kwang IL Lee, Korea Bone Bank Co. Ltd., Seoul, South Korea Misty Lee, Regeneration Technologies Inc., Alachua, Florida Seungeun Lee, CG Bio Co Ltd., Kyunggi-Do, Korea Ellyn Lentz, (MTF), Eatontown, New Jersey Julia Lewis, AlloSource, Centennial, Colorado Arnitha Lim, Gift of Hope, Elmhurst, Illinois Jennifer Littlefield, Northwest Tissue Center, Seattle, Washington Gang Liu, Comprehensive Tissue Center, Edmonton, Alberta, Canada Robert Lolley, (SETA), Tallahassee, Florida Bradford Lounsberry, AlloSource, Centennial, Colorado James Luczynski, LifeLink Tissue Bank, Tampa, Florida RoAna Lutz, OneLegacy, Los Angeles, California Donald Lynch, Carolina Donor Services,

Winston Salem, North Carolina Ronald Lynch, Carolina Donor Services,

Winston Salem, North Carolina Charles MacKenzie, LifeChoice Donor Services, Windsor, Connecticut

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Bruce Newman, Regeneration Technologies, Inc.,

Alachua, Florida Robert Nichols, AlloSource, Centennial, Colorado Kristal O'Bryan, Regeneration Technologies Inc., Alachua, Florida Gregory Oliver, LifeCell Corporation, Cibolo, Texas Amory Ortega, Life Alaska Donor Services, Anchorage, Alaska Loida Ortiz, Regeneration Technologies Inc., Alachua, Florida Terri Oto, Tutogen Medical, Santa Barba, California Dawn Pagano, Osteotech Inc., Eatontown, New Jersey Melchor Paras, OneLegacy, Los Angeles, California April Parish, Lifeline of Ohio, Columbus, Ohio Steven Parr, Gift of Life Donor Program, Philadelphia, Pennsylvania Pamela Parrott, Tutogen Medical Inc., Alachua, Florida Ashish Patel, LifeLink, Tampa, Florida Regeneration Technologies Inc., Alachua, Florida Rusty Peace, LiftGift, Lubbock, Texas Arabella Pelina, LifeNet Health, Virginia Beach Norberto Perez, Gift of Hope Organ and Tissue Donor

Network, Elmhurst, Illinois Sunnie Perry, LifeNet Health, Virginia Beach Andrea Phillips, Anatomy Gifts Registry, Hanover, Maryland Tammy Phillips, Tutogen Medical Inc., Alachua, Florida Michael Pick, Nebraska Organ Recovery System,

Omaha, Nebraska

David Pitts, LifeShare Oklahoma, Oklahoma City Jennifer Prinz, DCI Donor Services,

Knoxville, Tennessee Chris Ringler, LifeLegacy Foundation,

Tucson, Arizona Tony Ritchie, Jr., LifePoint Inc.,

North Charleston, South Carolina Marcie Roberts, South-East Regional Health Authority,

Moncton, New Brunswick, Canada Hattie Robinson, LifeNet Health, Virginia Beach Susan Rooks, Regeneration Technologies Inc., Alachua, Florida Marie Rowe, Gift of Life Michigan, Ann Arbor Kristina Rudd, Gift of Life Donor Program, Philadelphia, Pennsylvania Matthew Rudd, Gift of Life Donor Program,

Philadelphia, Pennsylvania Sadaraka Sadaraka, AlloSource, Centennial, Colorado Voncile Sandlin, Tutogen Medical Inc., Alachua, Florida Carolyn Shaffer, Regeneration Technologies Inc., Alachua, Florida Alison Shea, Regional Tissue Bank, QEII Health Sciences Centre, Halifax, Nova Scotia, Canada Jennifer Shelton, Tennessee Donor Services/DCI, Nashville Ryan Shuput, AlloSource, Salt Lake City, Utah Oh Si Young, Samsung Medical Center,

Seoul, South Korea Michele Siebel, (CTS), Dayton, Ohio Carolyn Simmons, (SETA), Gainesville, Florida

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Steve Terpstra, LifeNet Health, Virginia Beach Ricardo Thomas, New Jersey Organ Sharing Network,

Springfield, New Jersey Tamara Thomson, Gift of Life Michigan, Ann Arbor Mary Tippen, ISTO Technologies Inc., St. Louis, Missouri Octavia Tobias, LifePoint Inc., Columbia, South Carolina Colleen Toole, Cayman Biomedical Research Institute,

Ann Arbor, Michigan Jesse Trach, LifeNet Health, Virginia Beach Darrell Trahan, III, Regeneration Technologies Inc., Dallas, Texas Donald Tran, (TBI), San Rafael, California Danny Tristan, University Texas Health Science Center,

San Antonio Debbie Trujillo, AlloSource, Centennial, Colorado Christopher Villafuerte, AlloSource, Centennial, Colorado Don von Kaenel, AlloSource, Centennial, Colorado Jeremiah Wagner, AlloSource, Centennial, Colorado Ramanjit Walia, LifeNet Health, Virginia Beach Laurie Wallace, (SETA), Gainesville, Florida Rosa Walton, Tutogen Medical Inc., Alachua, Florida LaGayette Washington, AlloSource, Buffalo, New York Chris Weeks, (MTF) Columbia, South Carolina Pauline Wehner, (CTS) Dayton, Ohio Jennifer Welter, New Jersey Organ Sharing Network,

Springfield, New Jersey Annette West, (CTS), Boise, Idaho

Candice Simonton, Anatomy Gifts Registry, Hanover, Maryland David Slown, (SETA) Jacksonville, Florida Jennifer Smith, Lifeline of Ohio, Columbus, Ohio Rebecca Smith, (CTS), Portland, Oregon William Snipes, LiftGift Organ Donation Center, Houston, Texas Kelly Snyder, Osiris Therapeutics Inc.,

Baltimore, Maryland Nicholas Sodemann, RTI Donor Services, Madison, Wisconsin Theresa Spicer, LifeNet Health, Virginia Beach Donna Squillace, PhD, Regeneration Technologies Inc., Alachua, Florida Kristin Steen, LifeLegacy Foundation,

Tucson, Arizona Douglas Steinbach, (SETA) Gainesville, Florida Andrea Stephens, AlloSource, Centennial, Colorado Jayme Stone, LifeNet Health, Virginia Beach Kriss Strand, Tutogen Medical Inc.,

Alachua, Florida Terrence Styba, Tissue Bank Manitoba, Winnepeg, Manitoba, Canada Gail Summers, Regeneration Technologies Inc., Alachua, Florida Jennifer Sundberg, LifeSource, St. Paul, Minnesota Joi Surgeon, LifeNet, Virginia Beach Gary Tautkus, AlloSource, Salt Lake City, Utah Matthew Tener, Midwest Transplant Network, Westwood, Kansas

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LABS Inc. Acquires Assets of Laboratories at Bonfils

LABS Inc. has reached an agreement with Bonfils Blood Center to acquire the assets of Laboratories at Bonfils, which is a subsidiary of the blood center. Laboratories at Bonfils, owned and operated by Bonfils Blood Center, is an industry resource for donor eligibility testing for ocular, tissue, reproductive, stem cell and organ transplants.

James Michael White, DCI Donor Services Tissue, Nashville, Tennessee Jacynith Whittle, Regeneration Technologies Inc., Alachua, Florida Lynn Wile, Regional Tissue Bank, QEII Health Sciences Centre, Halifax, Nova Scotia, Canada Ray Wilkes, AlloSource, Salt Lake City, Utah

Christina Williams, (NEOB), Newton, Massachusetts David Williams, OneLegacy, Los Angeles, California Tobi Wilson, (MTF) Edison, New Jersey Emily Wittekindt, (CTS), Portland, Oregon Samantha Wright, OneLegacy, Redlands, California Stacey Zermeno, LifeGift Organ Donation Center, Houston, Texas

2008 Annual Meeting Abstract Information

Greetings from the Scientific and Technical Affairs Committee (STAC), It is with great pleasure and adumbration that we announce a new on-line abstract submission process for the upcoming Annual AATB Meeting in Chicago (6 – 9 Sept 2008). This new web-based system will greatly facilitate the submission, organization, review and approval of both scientific and non-scientific abstracts. The STAC is working diligently with a third party company to make this change as seamless as possible while taking into consideration all of the unique facets of our industry. We are targeting an early May launch date, at which time a web link will be disseminated to the general membership with instructions on how to log on and upload your abstract as well as details regarding the review mecha-nism and minimum criteria. Upon completion of the review period, several outstanding abstracts will be recommended for podium presentations at the Annual meeting. We will be presenting more details regarding this new system at the mid-year meeting, Regards, Chad J. Ronholdt, B.Sc., MBA STAC Chair Director of Research and Development, AlloSource Ph: 720.873.4782 * Email: [email protected]

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2007 CTBS EXAMINATION The American Association of Tissue Banks (AATB) administered its annual examination for the certification of tissue bank specialists on September 15, 2007. The examination, consisting of 125 multiple-choice items given in a single three-hour session, was administered to 375 candidates in 18 test sites, including one each in Canada, Bel-gium, and Korea. This was the largest candidate population in the history of the examination, more than 12% lar-ger than the two prior largest populations in 2005 and 2006. Test Development The test is developed by members of the American Board of Tissue Banking (ABTB) and a group of item writers. These individuals include specialists in medicine and tissue banking, with support by AATB staff and a consulting psychometrician. New items are developed throughout the year, and some new items are included in each exam. Existing items are periodically reviewed and updated when needed, and standards changes are incorporated into new or existing items. The ABTB and item writers have been trained on how to develop items for this exam, and items are developed using a standardized format. The test was developed following standard operating procedures to conform to a test content outline. An abbreviated form of this document, displayed in Table 1, lists the major content areas and the range administered in each. The range of items indicates the relative emphasis or importance of each content area based on the judgment of the ABTB regarding the frequency with which the knowledge is used, and its criticality regarding a satisfactory outcome in a tissue bank. The 2007 examination was the second in which items contained visual images (pictures). Eight items included color photographs referencing anatomical structures and tissue recovery issues. These items required candidates to apply knowledge in selecting the correct response. The ABTB developed these items because they elevate the clinical applicability of the examination. Candidates performed at expected levels on these items, and the Board anticipates developing and administering additional types of visual-based items for future examinations. Examination Results All examinees are scored twice before any results are disseminated. The first scoring is to evaluate the quality of the items. This typically leads to changes in the test key. The second scoring incorporates these changes, and the final examinee scores are then generated. One of the functions of the psychometric consultant is to flag all test items with questionable performance for re-view by the ABTB. The subject matter experts (SMEs) review the statistical analysis and conduct a telephone con-ference call with the psychometric consultant. Any statistically flagged or critiqued item, and any additional item of concern to the SMEs, is re-reviewed to determine if it is flawed. Examples of flawed items are those that inad-vertently have no correct answer, more than one correct answer, are not of entry level appropriateness, or are am-biguous in some other way. All items that the SMEs identify as flawed are deleted from the final scoring. In addi-tion, items identified as initially miskeyed are rekeyed prior to final scoring. For the 2007 examination, five items were deleted from the final scoring. Table 1: Test Content Outline Content Area Range of Test Items 1. Distribution 10-13 2. Donor Screening 22-28 3. General Knowledge 11-14 4. General Processing 20-25 5. General Retrieval 26-31

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All candidates receive a critique form at the beginning of the test and are encouraged to use it to anonymously comment on any aspect of the test content (e.g., a potentially flawed item) or test administration (e.g., distracting external noise). These comments are transcribed and printed for subsequent SME review. These qualitative data complement the quantitative data in helping to identify flaw items. The critique procedure is an additional aspect of fairness for all candidates. The item analysis is the most important component of the conference call review. The statistics for each item include difficulty and discrimination indices for each option. In addition, difficulty indices are provided for can-didates with failing, low passing, and high passing scores. The analysis also includes a scatterplot that graphs item performance of candidates at various breakpoints in the test score distribution. This graphical component facilitates SME determination of which items are flawed and the nature of the flaw. An example of the item analysis is displayed in Figure 1.

Figure 1: Example of Item Analysis Item # 35 P RPBI P P Lo- P Hi- Resp Total Total Fail Pass Pass ---- ----- ----- ----- ----- ----- PERCENT OF CORRECT RESPONSES BY GROUP A 0.06 -0.26 0.18 0.05 0.01 GROUP 1 #| * B 0.17 -0.29 0.31 0.23 0.04 GROUP 2 #| * C 0.06 -0.20 0.14 0.06 0.01 GROUP 3 #| * *D 0.71 0.48 0.37 0.64 0.93 GROUP 4 #| * E 0.00 0.04 0.00 0.00 0.01 GROUP 5 #| * OMIT 0.00 -0.03 0.00 0.01 0.00 +---+---+---+---+---+---+---+M--+---+--- 0 20 40 60 80 100

The pass-fail cutoff score was determined using a criterion-referenced procedure based on the Nedelsky tech-nique. Using this procedure, a performance standard or index (referred to as an item MPI or minimum perform-ance index) is determined for each test item on the basis of its perceived level of difficulty. The exam pass-fail standard is then computed as the average of each of the item performance indices. The unique consideration of the Nedelsky technique is that it treats item difficulty as a function of the degree to which the wrong answers (distractors) approximate the correct response, and are therefore too difficult for the minimally competent candi-date to eliminate. Items with a greater number of these difficult or "sophisticated" distractors are considered to be more difficult to answer correctly and therefore, have a lower standard or performance expectation than items determined to be easier on the basis of having fewer, if any, "sophisticated" distractors. This standard setting methodology is applied by the ABTB before the test is administered, thus eliminating "grading on the curve" or inappropriate competition among candidates for acceptable scores. Table 2 displays the mean score for each of the six content areas. The lowest mean (61.6%) was in Distribution; while the highest mean score (79.0%) was in General Retrieval. This represents a wider range in subtest per-formance than exhibited in recent examinations. Each candidate receives a score report in a similar format that indicates the number of items scored in each of the six content areas, and his or her corresponding percentage of correct responses. For candidates who pass, these performance data may be suggestive of where continuing edu-cation would be useful. For candidates who did not pass, these data may underscore specific areas of weakness that can facilitate preparation for the subsequent test.

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Additional Analyses Additional analyses were conducted to profile the candidate population and compare the related performance pat-terns. To obtain the profile data, candidates were asked to respond to a series of demographic and practice-related questions on their bubble answer sheet prior to the beginning of the test. Specific available fields on the form were designated for this use. Candidates were given directions to read, which were also read aloud by the chief proctor in the test center. Candidates were informed that the data they provided would be used for statistical and research purposes only, and would not be used in scoring. The model candidate is a female in practice for two years or less, working in a full-time technical capacity process-ing musculoskeletal tissue. She works in the U.S., with English as her primary language, and has multiple addi-tional health-related certifications. She has a baccalaureate degree and did not attend the AATB Training Course. Of particular significance with regard to the mean and pass rate, candidates who hold at least a baccalaureate de-gree performed at a substantially higher level than candidates whose highest degree attained is a high school di-ploma. Candidates with a master’s degree performed at a particularly high level. Another performance-related background trait is having four years of tissue banking experience. Candidates with this amount of experience attained a substantially higher mean score and pass rate than candidates with either less or more experience. The next administration of the AATB certification examination is scheduled for September 6, 2008.

ITEM WRITERS NEEDED AATB depends on volunteers to participate in item writing activities. If you are a CTBS and are interested in de-veloping some test items, please email Debbie Butler Newman at [email protected] and provide your name, company name, address, and area of expertise. We will have an item writing training session scheduled the day before the AATB Spring Meeting on Saturday, March 29, in Savannah, Georgia, from 8:00 a.m. until noon. No item writing experience is needed.

REGISTRATION IS NOW OPEN FOR CTBS EXAM 2008! (See Page 21)

Table 2: Content Area Performance Number of Mean Content Area Items Scored Score (%) 1. Distribution 12 61.6 2. Donor Screening 27 73.3 3. General Knowledge 12 66.7 4. General Processing 24 69.5 5. General Retrieval 25 79.0

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The following AATB Bulletins were issued between July 9, 2007 and March 14, 2008. 07-45 Announcement of First AATB/FDA Liaison Meet-

ing 07-46 Changes to Standards & Guidance – Recovery & Collection 07-47 FDA Issues Four HCT/Ps “Questions and Answers” 07-48 31st Annual Meeting Sponsorship 07-49 Election Results 07-50 Health Canada Publishes Final CTO Regulations

and Issues Draft Guidance for Comment 07-51 FDA Announces Workshop on “Processing of Or-

thopedic, Cardiovascular, and Skin Grafts” 07-52 FDA Replacement Final Guidance: Eligibility De-

termination for Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)

07-53 Requirements for Donor Testing and Testing Labo-ratories

07-54 Changes to Standards 07-55 Department of Veterans Affairs Issues an Interim

Final Rule Allowing Veterans Health Administra-tion to Disclose Medical Records to Organ, Eye, and Tissue Banks for the Purpose of Donation

07-56 FDA Issues Small Entity Compliance Guide for the Regulation of HCT/Ps

07-57 National Geographic To Air Program on Organ and Tissue Donation 07-58 Revised Accreditation Policies 07-59 Changes to Standards – Donor Criteria 07-60 Changes to Standards – Change in Release Termi-

nology 07-61 Changes to Standards – Labeling 07-62 FDA/AATB Liaison Meeting Report

07-63 National Geographic Program on Organ and Tissue Donation – Sunday November 11

07-64 HIV Transmissions from Transplanted Organ 07-65 Changes to Standards – Training Record Retention 07-66 Changes to Standards – Donor Testing and Testing

Laboratories 07-67 “The Gift That Heals: Stories of Hope, Renewal

and Transformation Through Organ and Tissue Donation” A New Book from Reg Green

07-68 Donor Screening Question – Neurological Disease 07-69 Annual FDA Registration for Tissue Establishments 07-70 IRS Releases Revised Form 990 08-01 CTBS Exam Day Survey 08-02 12th Annual Spring Meeting Sponsorship 08-03 5th World Congress on Tissue Banking Meeting 08-04 Changes to Standards - Request for Variance 08-05 12th Annual Spring Meeting Sponsorship 08-06 12th Annual Spring Meeting-Pre-Meeting Social

Events Golf Outing and Savannah Riverboat Lunch Tour

08-07 USP Workshop on Tissue-Based Products 08-08 AAMI's Seminar on Radiation Sterilization

of Biologics - A New Guidance Document 08-09 Hearings Tomorrow in New York 08-10 Forged AATB Accreditation Certificates 08-11 Hearings on BTS Tomorrow in New York 08-12 Yesterday's BTS Hearing in New York 08-13 12th Edition of AATB Standards Now Available 08-14 Abbott Notice to Retire Certain Infectious Disease Test Kits; and Updates FDA Website for Donor

Screening Tests 08-15 AATB's 2nd Annual Tissue Donor Suitability

Workshop: Saturday, May 3 –Monday, May 5, 2008

LifeNet Health’s 25th Anniversary LifeNet Health celebrated its 25th anniversary on November 3rd with a fundraiser at Norfolk’s Half Moone Cruise and Celebration Center. The event included dinner, dancing, and a special program where LifeNet Health’s execu-tives and transplant leaders spoke of LifeNet Health’s growth and highlights. In 1982, Bill Anderson founded an organization that today stands as LifeNet Health. “Over the last 25 years, LifeNet Health has done exceedingly well in this field and is today considered a highly respected and innovative leader. LifeNet Health has saved 5,500 lives through organ transplantation, and it has restored or improved the quality of human lives by providing more than 1.7 million safe tissue grafts to patients and hospitals,” said Rony Thomas, LifeNet Health CEO, at the gala event. More than 580 people attended the event to honor LifeNet Health and mark the official launch of the LifeNet Health Foundation. “The foundation will serve as a focal organization that raises funding for Community Educa-tion, Research and Development, and Donor Family Services in the field of organ and tissue transplantation,” said Ed Thomas. More than $250,000 was raised from the 25th Anniversary Gala to benefit the LifeNet Health Foun-dation. Many industry leaders and partnering OPOs from across the country attended the event and helped cele-brate LifeNet Health’s mission of “Saving lives and restoring health.”

AATB Bulletins Issued

15

Banks Re-Accredited Bacterin Belgrade, Montana Processing, storage and distribution of musculoskeletal tissue for transplantation and research (The) Blood and Tissue Center of Central Texas Austin, Texas Recovery of skin; and recovery, storage and distribu-tion of cardiac, vascular and musculoskeletal tissue California Transplant Services, Inc. Carlsbad, California and Phoenix, Arizona Recovery of cardiac and vascular tissue for transplanta-tion and research; recovery, storage and distribution of skin and musculoskeletal tissue for transplantation and research; and storage and distribution of autologous tissue Community Tissue Services – Dayton Dayton, Ohio Recovery, storage and distribution of cardiac and vas-cular tissue; recovery, processing, storage and distribu-tion of skin and musculoskeletal tissue for transplanta-tion and research; and processing, storage and distribu-tion of autologous tissue Community Tissue Services – Northwest Ohio Toledo, Ohio Recovery of cardiac and vascular tissue; and recovery, storage and distribution of skin and muscu-loskeletal tissue Community Tissue Services – Portland Portland, Oregon Recovery, storage and distribution of skin and muscu-loskeletal tissue for transplantation and research; recov-ery, storage and distribution of cardiac and vascular tissue; and storage and distribution of autologous tissue CryoLife, Inc. Kennesaw, Georgia Processing, storage and distribution of cardiac and vas-cular tissue for transplantation and research; and distri-bution of musculoskeletal tissue Donor Network of Arizona Phoenix, Arizona Recovery of skin, cardiac, vascular and musculoskele-tal tissue

New Banks Accredited Alabama Organ Center Birmingham, Alabama Recovery of cardiac, vascular and musculoskeletal tis-sue for transplantation and research International Biologics, LLC Scottsdale, Arizona Processing, storage and distribution of musculoskeletal tissue ISTO Technologies, Inc. St. Louis, MO Processing, storage and distribution of osteoarticular musculoskeletal tissue for transplantation and research Florida Tissue Services, a Subsidiary of LifeNet Health Pensacola, Florida Recovery of skin, cardiac, vascular, and musculoskele-tal tissue The Gift of Life Donor Program (GLDP) Philadelphia, Pennsylvania Recovery of skin, cardiac, vascular and musculoskele-tal tissue for transplantation and research The University of Texas Health Science Center at San Antonio Allograft Resources San Antonio, Texas Recovery, storage and distribution of cardiac and mus-culoskeletal tissue and research; recovery of skin and vascular tissue for transplantation and research Upstate New York Transplant Services, Inc. Buffalo, New York Recovery of skin, cardiac, vascular and musculoskele-tal tissue VitalGift Tissue Services Hemet, California Recovery of skin, pericardium and musculoskeletal tissue Washington Regional Transplant Community Annandale, Virginia Recovery of skin, cardiac, vascular and musculoskele-tal tissue

16

Iowa Donor Network North Liberty, Iowa Recovery of skin, cardiac, vascular and musculoskele-tal tissue Life Alaska Donor Services Anchorage, Alaska Recovery of skin, cardiac and vascular tissue; and re-covery, storage and distribution of musculoskeletal tissue for transplantation and research LifeBanc Cleveland, Ohio Recovery of skin, cardiac, vascular, and musculoskele-tal tissue Lifeline of Ohio Columbus, Ohio Recovery of skin, cardiac, vascular and musculoskele-tal tissue LifeLink Tissue Bank Tampa, Florida Recovery of skin, cardiac, and musculoskeletal tissue; and processing, storage, and distribution of muscu-loskeletal tissue for transplantation and research Louisiana Organ Procurement Agency Metairie, Louisiana Recovery of skin, cardiac, vascular and musculoskele-tal tissue Musculoskeletal Transplant Foundation Edison, New Jersey and Jessup, Pennsylvania Recovery, processing, storage and distribution of skin, cardiac, and musculoskeletal tissue for transplantation and research; and processing, storage and distribution of pericardium for transplantation and research

New England Organ Bank Newton, Massachusetts Recovery of skin, cardiac, and vascular tissue; and re-covery and storage of musculoskeletal tissue Nevada Donor Network, Inc. Las Vegas, Nevada Recovery of skin, cardiac, vascular and musculoskele-tal tissue Regeneration Technologies, Inc. Alachua, Florida Adds storage and distribution of cardiac and vascular tissue to the already accredited processing, storage and distribution of musculoskeletal tissue for transplanta-tion and research Rubinoff Bone & Tissue Bank Toronto, Ontario Recovery of cardiac tissue; storage and distribution of autologous tissue; processing, storage and distribution of surgical bone for transplantation and research; and recovery, processing, storage and distribution of mus-culoskeletal tissue for transplantation and research Tutogen Medical, Inc. Alachua, Florida Processing, storage and distribution of skin, pericar-dium and musculoskeletal tissue for transplantation and research

Registration is now open!

• CTBS Training and Review Course 2008 (Page 21-22) • Tissue Donor Suitability Workshop (Page 20) • 32nd Annual Meeting—Exhibitor Registration

(Pages 23-24) 17

Report on Variance Requests to Standards

Variance Requests Approved for Standard C2.000 Construction of Records (11th edition, 2006): Variances to this standard submitted by Héma-Québec (Saint-Laurent, Québec), The Dr. Donald MacLellan Tissue Bank (Moncton, New Brunswick), and The Regional Tissue Bank (Halifax, Nova Scotia) were recommended for approval by the Standards Committee and were granted final approval by the Board of Governors. The requests were directed at this relevant part of Standard C2.000 Construction of Records:

“Records must be in English or, if in another language, must be retained and translated to Eng-lish and accompanied by a statement of authenticity by the translator that specifically identifies the translated document.”

The primary language in Québec is French, the New Brunswick Province is bilingual, and some of the provinces in which the Regional Tissue Bank works are also bilingual. Records produced by tissue bank personnel, as well as relevant medical records or Third Party Records, may be in French. The variance to allow such records to be main-tained in French was granted with a description of requirements applicable to each tissue bank’s submission. All of these requests for variances described that the tissue bank will provide a translator, if needed, to assist AATB inspectors with record reviews. None of these tissue banks distribute tissue to the United States (US) for transplantation in the US. Variance Requests Not Approved for Revised AATB Standard D2.300 Signatures: Three accredited tissue banks submitted variance requests that involved an update to this standard announced on April 24, 2007 in AATB Bulletin No. 07-36. The revisions included a requirement to record all tissue donation consents obtained by telephone and to implement a sampling plan to verify the documentation of the consent ob-tained by telephone. None of the submissions were approved and compliance with this standard remains as ex-pected. The following list offers some points that justify denial and address issues or concerns specifically raised in the submissions:

1. The recording of tissue donor consent is legal in your (region);

2. Recording telephone consents is not onerous;

3. Recordings should be confidential, and only the process that includes acknowledgement of consent need be taped, not the entire conversation from beginning to end;

4. Ample time is afforded for coming into compliance with this change;

5. An “audit sampling plan” as described in the revised standard is not used to verify the identity of the con-senting party, which was a concern described in the variance request. It is used to verify the documenta-tion of the conversation surrounding the consent, and that assurance is necessary for this critical opera-tion.

6. The recording requirement and an audit sampling plan are used to verify the documentation of the consent conversation, not solely as tools to thwart falsification of records.

7. The consent/authorization process for tissue donation is not considered “health information” so it would not be affected by the Health Information Act described, which requires written consent prior to any re-cording of health information;

8. AATB Bulletin No. 07-36 described that “requiring the recording of consents obtained by telephone sur-passes requirements of consent laws in most states and requiring that a verification program be imple-mented surpasses requirements in all states.”; and

9. To address fears of donor family perceptions that recording consent will be an intrusion of privacy, or that recording consent may be linked to delaying the time of recovery and potential loss of donations, other AATB-accredited tissue banks are willing to offer assistance. Some tissue banks have many years of ex-perience with recording telephone consents and have developed successful donor family approaches that do not impede donation. If this collaboration is desired, the AATB Executive Office can arrange it.

18

19

American Association of Tissue Banks

Tissue Donor Suitability Workshop

Saturday, May 3 – Monday, May 5, 2008

Hyatt Regency Reston 1800 Presidents Street • Reston, Virginia 20190

Phone: 703.709.1234 • Website: www.reston.hyatt.com Last Name: First: MI: Degree: MD PhD CTBS CRCS Other No. Years in Tissue Banking Institution: Street Address: City: State: Zip Code: Country: Phone: E-mail: Please check one of the following registration options:

Member Rate* $350

Non-Member Rate: $535

Government Rate: $150

Speaker (fee waived)

*Member rate is available to AATB accredited bank employees.

Membership Status – Check One: I have paid my 2008 dues. My 2008 dues ($185) are enclosed. *

• New membership MUST be accompanied by an application. • Access the Individual Membership Form at www.aatb.org

MEETING: Please include check (U.S. currency only), money order, or credit card information with this form, payable to: American Association of Tissue Banks, c/o Meeting Services, 1320 Old Chain Bridge Road, Suite 450, McLean, VA, 22101; Phone: 703-827-9582; Fax: 703-356-2198.

Check enclosed in amount of $ (U.S. currency only). (Payment can include membership dues.) OR VISA, MC, AMEX: $ Signature: Card # Exp. Date

American Association of Tissue Banks • 1320 Old Chain Bridge Road, Suite 450 • McLean, Virginia 22101

Phone: 703.827.9582 • Fax: 703.356.2198 • www.aatb.org

20

AMERICAN ASSOCIATION OF TISSUE BANKS

2008 CERTIFIED TISSUE BANK SPECIALIST (CTBS) TRAINING AND REVIEW COURSE

Hilton Arlington and Towers, May 1 – 4, 2008

Eligibility: Open to those who wish to obtain an introduction to the field of Tissue Banking. Although the course materials aregenerally designed for tissue bank personnel with at least three months’ experience, those with a background in any related healthcare profession would find the course understandable and useful. Course Description: Four-day didactic workshop with Tissue Sound Out (Jeopardy-like Session) on Tissue Banking. Course Content: Preparing for Exam;, Introduction to Tissue Banking & Critical Thinking Skills; Regulatory Environment &Quality Assurance; Anatomy & Physiologic Basis of Allograft Success; MS Recovery; Donor Families & Informed Consent;Donor Screening & Testing; Physical Assessment; Processing; Storage & Distribution; Skin Banking & Clinical Applications;Cardiac & Vascular Clinical Applications; MS Clinical Applications. Dates: Thursday (noon), Friday, Saturday, Sunday (until 1pm), May 1 – 4, 2008. Location: Hilton Arlington and Towers, 950 North Stafford Street, Arlington, Virginia. Accommodations: Single and DoubleOccupancy $165. For reservations, please phone 800-445-8667 or 703-528-600. The deadline for making hotel reservations isMonday, April 1, 2008. After this date the AATB negotiated rate cannot be guaranteed. The discounted rate may sell out beforeApril 1; please make your reservations early. Registration Fee: $1,250. Includes Lectures, Workshop Materials; Luncheon on Friday; Continental Breakfast Friday - Sunday;Coffee and Soft Drink Breaks everyday; and a Reception on Thursday night. If the AATB Training & Review Course is taken theTissue Bank Specialist Exam fee of $500 is waived. The exam is given every year in conjunction with the Annual AATBMeeting. Payment options are check, MasterCard, VISA or AMEX. Registration Deadline and Cancellations: Advance registration is required with full prepayment on a first-come, first-servedbasis. Cancellations will be accepted in writing only (full refund if received prior to April 1, 2008). Written confirmation will beforwarded to all participants who register before April 19, 2008.

Registration Form Mr. Ms.

Last Name First Name MI Degree Institution Address City State Zip Code Phone Fax E-mail

I agree to have my email address, phone and fax numbers published on the attendee list. Please check one: $1,250 Government rate: $750 CTBS $1,000 Return this form with payment (U.S. currency only) to: American Association of Tissue Banks, 1320 Old Chain Bridge Road, Suite 450, McLean, VA 22101. Phone: 703-827-9582, Fax: 703-356-2198.

My check is enclosed My credit card information is provided below

Card # (Visa, MC or AMEX) Expiration Date Signature

AMERICAN ASSOCIATION OF TISSUE BANKS TISSUE BANK SPECIALIST EXAMINATION APPLICATION FORM

Marriott Chicago Downtown, September 6, 2008, 10:30 am CT

Examination of candidates for certification as Tissue Bank Specialists by AATB will be held at 10:30 am CT, SaturdaySeptember 6, 2008. A confirmation letter and study guide will be forwarded to each candidate after July 25, 200Applications will be accepted on a first-come, first-served basis; preference given to those who have completed the AATTraining and Review Course.

(PLEASE COMPLETE ENTIRE 2 PAGE FORM AND RETURN WITH PAYMENT) Mr. 1.Name: Ms. (last) (first) (MI) (degree) (Social Security # SSN/SIN) 2. Organization: 3. Street Address: (city) (state) (Country) (zip) 4. Telephone: Fax: email: ______________________________ (Please provide home address and phone below. Also indicate where to send your confirmation packet/study guide) 5. Home Address: (city) (state) (zip) 6. Home Phone: Home Fax: email: _______ 7. Send confirmation and study guide to my job. Send confirmation and study guide to my home. 8. All prospective candidates for examination must submit (1) an endorsed Code of Conduct and (2) a statement signed by the Director of the organization (Tissue Bank) verifying that the candidate has a high school diploma or general education diploma (GED) AND meet the requirements in either ‘A’ or ‘B’ below (check one): A. ____ Minimum of 12 months inclusive of 480 hours of experience within the past two years in one or more of the following tissue banking services: assessing donor suitability; tissue recovery; tissue processing, storage or distribution; tissue banking quality assurance or quality control, OR B. ____ Minimum of 6 months inclusive of 240 hours of experience within the past two years in one or more of the following tissue banking services: assessing donor suitability; tissue recovery; tissue processing, storage or distribution; tissue banking quality assurance or quality control AND at a minimum one of the following: (1) ____Associate or baccalaureate degree in a life science

(2) ____Registration or certification in a health-related field (e.g., LPN, RN, PA, CORT, MT, SBB, EMT)

(3) ____Completion of AATB's training course for tissue bank specialists taken within past two years.

(4) ____Successful completion of a College/University Tissue Banking Program 9. Indicate method of payment below: ____ I enclose a check in the amount of $500. ____ No fee necessary, I attended the 2007 or 2008 AATB Training. ____ Please charge $______________ (amount) to my _____VISA or _____MasterCard or _____AMEX Account #: Expiration Date: Cardholders Signature: Today’s Date: Mail or fax completed application form, letter of verification and payment to: AATB, CTBS Examination, 1320 Old Chain Bridge Road, Suite 450, McLean, VA. 22101 (Full refund prior to August 4, 2008; no refund thereafter) For more information, phone AATB: 703-827-9582; or fax: 703-356-2198. Email: [email protected]

-over- 21

CERTIFICATION CODE OF CONDUCT I recognize that admission to take the certification examination and the CTBS/CRCScertification, once granted, may be revoked at any time if: it is established that information provided for certification or for recertification is not accurate and/or complete; if I engage in illegal or inappropriate conduct during the exam or oncecertification is conferred; or if I violate the AATB Certification Code of Conduct. To the best of my knowledge, I certify that the information on the certification application is true, complete, and accurate. I authorize AATB to verify the accuracy of anyinformation contained in, or supplied in support of the application from any person(s) having knowledge of such information. By my signature, I attest that I will maintain mycertification as required and uphold the AATB Certification Code of Conduct. I understand that violation of the Code of Conduct may be grounds for disciplinaryaction and possible denial or revocation of certification. Therefore, I agree to:

1. Work to promote the highest standards of the profession. 2. Comply with AATB certification and recertification requirements and policies. 3. Not obtain or attempt to obtain certification by misrepresentation, bribery, fraud,

or deception. 4. Not make misrepresentations regarding certification or renewal of this

certification. 5. Not engage in cheating or other dishonest behavior that violates exam security,

including: memorization, reproduction or distribution of secure test content, and tampering with the contents of the exam.

6. Not participate in negligent, harmful, and/or intentional misconduct in professional work.

7. Report to AATB any disciplinary or legal action taken against me by a regulatory entity and any criminal charges or civil actions that are relevant to my employment in tissue banking.

_________________________________________ _____________________Name (printed) Date _________________________________________ Signature

22

AMERICAN ASSOCIATION OF TISSUE BANKS 32nd Annual Meeting

Chicago Marriott Downtown Magnificent Mile September 6 – 9, 2008

www.marriott.com

EXHIBIT PROSPECTUS Exhibit Fee: Standard booth, single (10 x 10) = $2,000

Standard booth, double (10 x 20) = $4,000 Exhibit Hours: Saturday, September 6 – Noon to 6 pm (Set-up ONLY)

Sunday, September 7 – 7:00 am to 7:00 pm Monday, September 8 – 7:00 am to 2:30 pm (Tear-down immediately after)

Booth Personnel: Each booth includes two staff who are welcome to participate in all aspects of the

meeting. Two additional booth staff may register at the special reduced rate of $250 each. All others must register for the meeting at the member rate of $550 each.

Booth Specifications: Standard booths are 10’ x 10’ with a skirted 6’ table, 2 chairs, a wastebasket, and an

identification sign. The Exhibit Hall is carpeted, but you may purchase additional carpet from the exposition company if you wish. AATB will provide standard 110v electricity for each booth.

Shipping: Shipping instructions and extra booth accessories order forms will be provided electronically in a

forthcoming Exhibitor Services Packet from the Exposition Company (GES). Booth Assignments: Exhibitors will be allowed to choose their own booth on a first come-first served basis.

The layout will be posted on the web site and booth assignments will be requested by phone with Kathy Crandall. Apply early! The room layout is in the approval process. I will call you in the correct order when the layout can be posted on our web site. -Kathy

Security: As a service to its exhibitors, AATB will provide security in the exhibit area during overnight, non-

exhibit hours. The Association is not responsible for stolen or damaged exhibit material. Cancellations: All cancellation requests must be made in writing. Cancellations received by August 15,

2008, will result in a refund of $1,500. No refunds thereafter. Hotel Accommodations: Please follow hotel registration instructions for attendees found on our web site.

Remember to apply early, as you will be choosing your own booth. Applications will be documented on a first come-first served basis.

Applications are being Accepted NOW.

Placements will follow shortly.

23

American Association of Tissue Banks 32nd Annual Meeting

Chicago Marriott Downtown Magnificent Mile September 6 – 9, 2008

www.mariott.com

APPLICATION FOR EXHIBIT SPACE Company Name: Address:

city state zip code

Telephone: ( ) Fax: ( ) Company Contact Person: E-mail Address (Exhibitor packet will be sent electronically): Web Address (A link to your web site will be placed on our web page): Meeting Representatives (two are included in the booth price): please be sure this is the way you wish your badge to read. We need your e-mail address to register your name in our meeting database and for communication. 1. E-mail 2. E-mail In order to reserve exhibit space at AATB’s 32nd Annual Meeting, please enclose full payment of $2,000 with this application and return by August 8, 2008. FORM OF PAYMENT: Full Payment: $2,000 and Extra Staff $

Check Enclosed or VISA MasterCard American Express Card #: Exp. Date: Cardholder's Name: Signature: ** I understand that payment in full is due by August 8, 2008, to secure exhibit space: ** Authorized Exhibitor Signature: Today’s Date:

Submit completed application form with payment to: American Association of Tissue Banks Meeting Services, 1320 Old Chain Bridge Rd., Ste. 450, McLean, VA 22101

Phone: (703) 827-9582; Fax: (703) 356-2198.

24

Award Nominations Solicited AATB bestows three annual awards: the Jeanne C. Mowe Distinguished Service Award, the George W. Hyatt Memorial Award and the Kenneth W. Sell Memo-rial Award. The membership is invited to participate in the nomination of re-cipients. For details about the awards, check our website, www.aatb.org, or contact Gloria Irvine by e-mail, [email protected]

Council Elections Upcoming; Petitions Will Be Accepted Nominations for council offices will be due from the Councils’ Nominating Committees by April 1 (Chair, Vice-Chair and Secretary). For those not nominated by the coun-cils’ nominating committees, individual AATB members may make additional nominations by petition after April 2 through May 1, 2008. A nomination form will be available on our website (www.aatb.org) . According to Bylaws, a nominating petition must be signed by at least five AATB individual members of that par-ticular Council to which the petition is addressed. For further information about nomina-tions by petition, contact Gloria Irvine at [email protected].

Are you coming to Savannah?

Spring has sprung!

• Don’t forget your sunglasses, sun screen and spring attire.

• Stop by the registration desk and meet your AATB Staff.

American Association of Tissue Banks ORDER FORM

2008 - Standards for Tissue Banking – 12th Edition AATB plans to issue revised editions of the Standards for the next several years.

Name: Institution: Address: City: State: Zip code: Phone: Fax: E-Mail: * Member rate includes staff of accredited banks

Quantity MEMBER rates * NON-MEMBER rates Single copy $75 each $100 each 2 – 4 copies $70 each $95 each 5 – 9 copies $65 each $90 each 10 – 19 copies $60 each $85 each 20 – 29 copies $55 each $80 each 30 or more $50 each $75 each 50 Standards per carton $2,500 per carton ** $3,750 per carton **

** Carton prices include free shipping No additional charge for single shipments to U.S. and Canada. However, shipping charges for multiple quantities and foreign countries will apply; contact the AATB Executive office for rates. Please indicate how many Standards you wish to order: Quantity: Price: $ Total: $ I have enclosed a check for $ I have enclosed a Purchase Order # , please invoice me. I prefer to charge my credit card (VISA, Master Card, or AmEx): Card #: Exp. Date: Cardholder’s Name: Signature:

Prepayment or valid purchase order is required on all publications. Please return this form to the

American Association of Tissue Banks 1320 Old Chain Bridge Road, Suite 450, McLean, VA 22101

Ph: 703-827-9582 Fax: 703-356-2198


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