Changes to the Technical Manual, 18th Edition Program #144835 Monday, November 17, 2014 12:00 pm-1:30 pm (ET) ~ 5:00 pm-6:30 pm (GMT)
This audioconference will summarize the new and different content in the 18th edition of the AABB Technical Manual. Ample time will be provided for audience questions.
Objectives:
Identify changes in the new edition. Describe the rationale behind the major updates.
Faculty: Connie Westhoff, PhD, (ASCP) SBB Director New York Blood Center
Mark Fung, MD, PhD Medical Director, Blood Bank and Transfusion Services Fletcher Allen Health Care/ University of Vermont
In accordance with AABB Policy on Disclosure of Faculty Relations, the faculty for this event have signed a conflict of interest form in which they have disclosed any significant financial interests or other relationships with industry relative to the topics that they will discuss at this program. Such disclosures allow you to better evaluate the objectivity of the information presented in the lectures.
Faculty: Connie Westhoff, PhD, (ASCP) SBB Director New York Blood Center Disclosures: No disclosures given
Mark Fung, MD, PhD Medical Director, Blood Bank and Transfusion Services Fletcher Allen Health Care/ University of Vermont Disclosures: No disclosures given
Name/Role in Content Planning Disclosure Nature of relationship Manufacturer/Provider Colleen Aronson, planning none committee member Robert Braun, planning committee none member Nancy Dunbar, planning committee none member Jennifer Ford, planning committee none member GASCO Eastern District Federal Credit Union - Michele Hayes, planning committee yes Professional Chair of Supervisory member Committee
Nora Hirschler, board representative yes Professional ABC Member Gail Moskowitz, planning committee Board of Directors, Guide to yes Professional member Cord Blood Foundation Jayanna Slayten, planning committee none member Linda Stefaniak, planning committee none member Kristina Williams, planning none committee member Sharon Moffett, staff member none Lauren Rohde, staff member none Alyson Wagner, staff member none
Accessing your Continuing Education Credits Online!
1. Log into the Live Learning Center from the www.aabb.org website
2. Go to “Professional Development”
3. Click on red link that says “AABB Live Learning Center” on the left side of the page
4. Click on red link that says “AABB Live Learning Center” in the center of the page
5. Click the “My Account” link at the top of the page.
6. Log in using your e-mail address and password.
7. Click on the link that says “My Transcripts”
8. Go to the “Select Conference” drop down menu and select 2014 Audioconference Series
9. Choose the appropriate audioconference title. 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 Upcoming Audioconference:
Top 10 Cellular Therapy Non-Conformances November 19, 2014 2:00 pm to 3:30 pm (ET); 7:00 pm to 8:30 pm (GMT) Program # 144830
A nonconformance (NC) is a failure to fulfill the requirements of an AABB standard. Hear from the field experts, the top ten cellular therapy (CT) nonconformances cited during AABB assessments performed around the globe. Avoid these common pitfalls by evaluating your facility's level of compliance with the 6th ed. of the AABB Standards for Cellular Therapy Services. In this audioconference examples of best practices and suggestions on how to avert noncompliance with AABB standards will be shared. AABB assessors will also discuss examples of challenging standards and what facilities are doing to comply. There will be ample opportunity to ask questions of these subject matter experts.
Objectives:
Hear the top ten most common AABB CT non-conformances. Identify ways to correct commonly cited non-conformances and achieve compliance with AABB Standards for Cellular Therapy Services. Find out which standards facilities struggle with and share best practices.
Intended Audience: Technologists, Managers/Supervisors, CEOs/CFOs
Event Level: Basic to Intermediate
Director/Moderator: Sarah Dickerson, BSMT (ASCP) CT Accreditation Manager AABB
Faculty: Frances Ivester, MNS, SI(ASCP), CQA(ASQ) Lead Assessor AABB
Mary Elizabeth Smith, MT(ASCP)SBB, CQA(ASQ) Lead Quality Assessor AABB AABB would like to thank the members of the AABB Distance Learning Program Unit for their assistance in developing these programs:
2014 Distance Learning Program Unit
CHAIR Kristi Williams, MT(ASCP)SBB, CQA, CQIA(ASQ) Manager, Biomedical Headquarters IRL Operational Support, American Red Cross Washington, IL
Colleen Aronson, MT(ASCP)SBB Quality Programs Coordinator, Northshore University Healthsystem Evanston, IL
Meghan Delaney, DO, MPH Assistant Medical Director, Puget Sound Blood Center Seattle, WA
Nancy Dunbar, MD Assistant Professor, Dartmouth-Hitchcock Medical Center Hanover, NH
Michele Hayes, MT(ASCP)SBB Director of Immunohematology Reference Laboratory, American Red Cross Johnstown, PA
Nora Hirschler, MD CEO, Blood Centers of the Pacific San Francisco, CA
Drew Minardi, Director of Education for School of Medical Laboratory Science, Atlantic Health Saddle Brook, NJ
Sharon Moffett, CAE Director of Education and Professional Development, AABB Bethesda, MD
Gail Moskowitz, MD Independent Consultant New York, NY
Lauren Rohde Programs Manager, AABB Bethesda, MD
Jayanna Slayten, MS, MT(ASCP)SBB Reference Laboratory Supervisor, Indiana Blood Center Indianapolis, IL
Alyson Wagner Cellular Therapy Program Manager, AABB Bethesda, MD