Changes to the Technical Manual, 18th Edition Monday, November 17, 2014 12:00 p.m. – 1:30 p.m. (ET) / 5:00p.m. – 6:30 p.m. (GMT) When this file is opened, Acrobat Reader will, by default, display the slides including the Acrobat reader controls. To return to full screen mode, hit Ctrl-L on your computer keyboard or use your mouse to click View>Full Screen on the menu bar of the Acrobat Reader program. To take the slides out of full screen mode and display the Acrobat Reader controls, simply hit the Esc key on your computer keyboard. To advance slides during the program, use the Enter, Page Down, down arrow or right arrow on your computer keyboard. To back up slides during the program, use the Page Up, up arrow of left arrow on your computer keyboard. Please remember to logon to the Live Learning Center using your email address and password to complete an evaluation of the program and speakers. At this time, advance to the next slide and wait for the audioconference to begin. A 2014 Audioconference presented to you by AABB The AABB Technical Manual 18th Edition What’s new? www.aabb.org Technical Manual by the Numbers • 1953 =year of first edition • 69 = number of authors/editors this edition • 370,378 = word count • 96 = number of methods • 60 = number of countries where TM is used www.aabb.org It’s a Process www.aabb.org Overview of Changes Major • Molecular testing • Patient blood management • Cellular therapy • Methods Minor • Throughout www.aabb.org 1: Quality Systems 2: Facilities and Safety • These 2 chapters are comprehensive discussions of AABB core competencies • Updates made to keep the content current - Additional detail in table on internal event reporting and in appendix on quality-related CFR references - Information on work injuries formerly in table is now worked into the text • TL Motschman, BW Jett, SL Wilkinson • BW Jett, SL Wilkinson, TL Motschman www.aabb.org 3: Regulatory Issues • Significant revisions in the 17th edition underwent limited improvements this time • References updated • Transfusion therapy and safety citations formerly in table now worked into text and reference list • G Ramsey www.aabb.org 4: Disaster Management • Streamlining of content for easier reading • Lessons learned from recent disasters (May 2001 to present) now an online resource, continuously updated • RD Sylvester, W FitzGerald, W Trivisonno, T Wiegmann www.aabb.org 5: Blood Donor Selection • Substantially rewritten to reflect the changes that have taken place in the last 3-4 years - New donor deferrals - Updated DHQ - FDA approval of abbreviated DHQ • Less emphasis on how we got to where we are and more emphasis on what is key knowledge for today • AF Eder, M Muniz www.aabb.org 6: Whole Blood Collection • Reflects changes of the last 3-4 years - Move away from rejuvenation - Diversion pouch - New plasma products • Additive solutions used outside the US • LJ Dumont, M Papari, CA Aronson, DF Dumont www.aabb.org 7: Collection by Apheresis • FDA black box warning for HES • Information on Optia device for collection of granulocytes • Reflects the 2013 ASFA indication categories • JW Smith www.aabb.org 8: Infectious Disease Screening • Significant revisions in the 17th edition underwent limited improvements this time • Tables and text updated with EID information through March 2014 • SA Galel www.aabb.org 9: Storage, Processing, Distribution • Rewritten, new emphasis—Hospital Storage, Monitoring, Pretransfusion Processing, Distribution, and Inventory Management of Blood Components • Table of requirements for components now includes transportation conditions as well as those for storage • Inventory management aspects of massive and urgent transfusion—clinical aspects in Ch 15 • NM Dunbar www.aabb.org 10: Molecular Biology • A great chapter for reviewing the principles behind the test methods • Updated, particularly the section on antibody structure/function and its relationship to transfusion complications • JC Zimring, SL Spitalnik www.aabb.org 11: Blood Group Genetics • New content on DNA-based assays –Predicting blood groups –Use in prenatal practice –Testing antigen-negative blood donors –Confirming D type of donors –Discrepancies between phenotypes (serology) and genotypes (DNA testing) • C Lomas-Francis www.aabb.org 12: ABO, H, and Lewis • Author provided new insights without losing the core material • Excellent content from the 17th edition was retained, but updated • L Cooling www.aabb.org 13: Rh System • Updated Rh antigen table includes new antigens – RH59 (CEAG) – RH60 (PARG) – RH61 (CEVF) • Refreshed, yet retains the core material • GA Denomme, CM Westhoff www.aabb.org 14: Other Blood Groups • New ISBT blood group systems – FORS – JR – Lan – Vel • CD59 and mutations in erythroid-specific transcription factors • JR Storry www.aabb.org 15: Pretransfusion Testing • Text and references updated to reflect additions to the literature • Consolidated content on clinical aspects of massive and urgent transfusion • KA Downes, IA Shulman www.aabb.org 16: Antibodies to Red Cell Antigens • New antigens included • Key tables reformatted for easier use • PS Walker, JR Hamilton www.aabb.org 17: DAT and Immune-Mediated Hemolysis • Significant revisions in the 17th edition needed only minor adjustments this time • General updating and streamlining • RM Leger www.aabb.org 18: Platelet and Granulocyte Antigens and Antibodies • New antigens included • New illustrations – Platelet antigen tables – Diagram of MACE and MAIPA – Neutrophil antigen table • BR Curtis www.aabb.org 19: HLA System • General updating and streamlining • Updated URLs for HLA database refs • RA Bray, MS Pollack, HM Gebel www.aabb.org 20: Hemotherapy Decisions • Revisions to chapter emphasize restrictive transfusion strategies • Updates throughout; many new studies cited • T Nester, S Jain, J Poisson www.aabb.org 21: Blood Administration • New discussion on the use of premedication • A little reorganization to better match the sequence of activities • K Maynard www.aabb.org 22: Perinatal Issues • Some reorganization to improve readability • Newer technology—Doppler ultrasound – Liley or Queenan graphs removed – Amniocentesis still used in some settings • MS Kennedy, M Delany, S Scrape www.aabb.org 23: Neonatal/Pediatric • Continues the discussion found in the 17th edition on RBC transfusion indications – RBC age; ARIPI trial data – Restrictive vs liberal transfusion strategies; TOP trial • Newer literature reports included in refs • CD Josephson, E Meyer www.aabb.org 24: Patient Blood Management • Completely rewritten • Explains how the scope of PBM encompasses more than operating room activities • Updates on newly available pharmacologic agents • Covers PBM program implementation • M Ghiglione, KE Puca www.aabb.org 25: Transfusion Support of HSCT • Most recent data are included, especially findings from recent studies on platelet support • New discussions – Information portability – Pediatric HSCT – Autologous HSCT • CA Tormey, JE Hendrickson www.aabb.org 26: Therapeutic Apheresis • Updated to reflect 2013 ASFA indication categories • New table on modalities • RD Davenport www.aabb.org 27: Noninfectious Complications • Revisions made to bring chapter up to date, but without losing the stellar content from the 17th edition • TRALI risk mitigation update • CA Mazzei, MA Popovsky, PM Kopko www.aabb.org 28: Blood Utilization Review • Revisions reflect the increased level of interest in this activity as part of PBM program implementation • Newest study data included • A Tinmouth, S Stanworth www.aabb.org 29: HPC Collection • Completely revised • Compares and contrasts the sources of HPCs - Collection - Processing • Primary focus on marrow- and apheresis- derived HPCs • SA Koepsell, EK Jacob, DH McKenna www.aabb.org 30: Cord Blood Banking • Emphasis in chapter reflects changes “on the front lines” - Growth in UCB banking - Regulatory activity • AM Babic, DM Regan www.aabb.org 31: Tissue-Derived Non-HPCs • Completely new chapter - MSCs from adipose tissue, cord blood, muscles, endometrial tissue, placentas, dental pulp, marrow - Isolation, expansion, storage - Clinical indications - Research directions • Y Jawed, B Johnstone, S Thirumala, K March www.aabb.org 32: Tissue Transplantation • Reviewed by AATB • New clinical uses added • Core material updated as needed • LD Trainor, RA Reik www.aabb.org 33: Blood- and Marrow-Derived Non-HPCs • Completely new chapter - DLI after HSCT - NL cells - CIK cells - Dendritic cells - MSCs - iPSCs • MBC Koh, ER Samuel, G Suck www.aabb.org Where have all the methods gone? • They are digital only--on flash card for easy adoption • In SOP format; CLSI template • If you are an end-user in a blood center, hospital or cell processing laboratory, you may copy the methods without getting permission in advance www.aabb.org Methods part deux • Notable changes other than format: − New method for blood and sample collection reflects use of diversion pouch − Removal of method on rejuvenating RBCs − Calibration of serologic centrifuge split into separate methods depending on intended use (immediate agglutination vs washing and antiglobulin testing) − New technique for prep of Cryo www.aabb.org Appendices • On the flash card with the methods • Same useful information • Listing of safety-related organizations now combined with the more general list of key organizations and agencies www.aabb.org It takes a village • Associate editors -Brenda J. Grossman, MD, MPH -Chris Hillyer, MD -Connie Westhoff, PhD, SBB * John Roback and the contributors to the 17th edition—we had a great baseline to start with * Many volunteers from AABB standing committees provided thoughtful reviews of the content www.aabb.org What About the CD-ROM Version? • CD-ROMs are being phased out • Online platform not ready yet • USB thumb drives sold at AM • were temporary measure, • while supply lasted; all sold • Online platform to be launched • Early 2015 www.aabb.org Time for Questions www.aabb.org.