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)

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A 2014 Audioconference presented to you by AABB

The AABB Technical Manual18th Edition

What’s new?

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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

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It’s a Process

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Overview of Changes

Major• Molecular testing

• Patient blood management

• Cellular therapy

• Methods

Minor• Throughout

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1: Quality Systems2: 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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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14: Other Blood Groups• New ISBT blood group systems

–FORS–JR–Lan–Vel

• CD59 and mutations in erythroid-specific transcription factors

• JR Storry

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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

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16: Antibodies to Red Cell Antigens

• New antigens included• Key tables reformatted for easier use

• PS Walker, JR Hamilton

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17: DAT and Immune-Mediated Hemolysis

• Significant revisions in the 17th edition needed only minor adjustments this time

• General updating and streamlining

• RM Leger

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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

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19: HLA System

• General updating and streamlining• Updated URLs for HLA database refs

• RA Bray, MS Pollack, HM Gebel

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20: Hemotherapy Decisions

• Revisions to chapter emphasize restrictive transfusion strategies

• Updates throughout; many new studies cited

• T Nester, S Jain, J Poisson

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21: Blood Administration

• New discussion on the use of premedication

• A little reorganization to better match the sequence of activities

• K Maynard

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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

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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

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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

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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

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26: Therapeutic Apheresis

• Updated to reflect 2013 ASFA indication categories

• New table on modalities

• RD Davenport

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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

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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

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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

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30: Cord Blood Banking

• Emphasis in chapter reflects changes “on the front lines”- Growth in UCB banking

- Regulatory activity

• AM Babic, DM Regan

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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

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32: Tissue Transplantation

• Reviewed by AATB • New clinical uses added• Core material updated as needed

• LD Trainor, RA Reik

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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

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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

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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

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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

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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

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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

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Time for Questions

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