Changes to the Technical Manual, 18 th Edition Monday, November 17, - - PowerPoint PPT Presentation

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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The AABB Technical Manual 18th 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 Systems 2: Facilities and Safety

• These 2 chapters are comprehensive discussions
• f 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
• f 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
• nly 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
• n 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

• f 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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