Changes to the Technical Manual, 18Th Edition Monday, November 17, 2014 12:00 P.M

Total Page:16

File Type:pdf, Size:1020Kb

Changes to the Technical Manual, 18Th Edition Monday, November 17, 2014 12:00 P.M 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.
Recommended publications
  • Requirements for Blood and Blood Components Intended for Transfusion Or for Further Manufacturing Use
    Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use Office of Blood Research and Review CBER, FDA Ask the FDA Session – AABB Annual Meeting October 26, 2015 1 Outline • Overview – Historical Background – Intent of the Rule – Organization of the Rule • Selected Provisions – Relevant Transfusion-Transmitted Infection – Control of Bacterial Contamination of Platelets – Medical Supervision – Donor Acknowledgement – Alternative Procedures – Donor Eligibility • Implementation 2 GAO Oversight and FDA Concerns • Publish in the form of regulations the guidelines that FDA deems essential to ensure the safety of the blood supply • Concern about the delay in requiring testing for emerging infectious agents, e.g. HTLV • Concern about blood safety and the regulations being out-of-date • Concerns about donor safety 3 Intent of the Final Rule • To better assure the safety of the blood supply and to help protect donor health • To make donor eligibility and testing requirements more consistent with current practices and to provide flexibility with regard to emerging infectious diseases • To accommodate technological advances • To establish requirements for donor education, donor history, and donor testing 4 Organization of the Final Rule - 1 • A. General • B. Definitions (§§ 606.3, 610.39, 630.3, 640.125) • C. Standard Operating Procedures (§ 606.100) • D. Control of Bacterial Contamination of Platelets (§ 606.145) • E. Records (§ 606.160) • F. Test Requirements (§§ 610.40, 640.5, 640.71(a)) • G. Donor Deferral (§ 610.41) 5 Organization of the Final Rule - 2 • H. Purpose and Scope (§ 630.1) • I. Medical Supervision (§ 630.5) • J. General Donor Eligibility Requirements(§ 630.10) • K. Donor Eligibility Requirements Specific to Whole Blood, Red Blood Cells and Plasma Collected by Apheresis (§ 630.15) • L.
    [Show full text]
  • 27. Clinical Indications for Cryoprecipitate And
    27. CLINICAL INDICATIONS FOR CRYOPRECIPITATE AND FIBRINOGEN CONCENTRATE Cryoprecipitate is indicated in the treatment of fibrinogen deficiency or dysfibrinogenaemia.1 Fibrinogen concentrate is licenced for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenaemia and hypofibrinogenaemia,2 and is currently funded under the National Blood Agreement. Key messages y Fibrinogen is an essential component of the coagulation system, due to its role in initial platelet aggregation and formation of a stable fibrin clot.3 y The decision to transfuse cryoprecipitate or fibrinogen concentrate to an individual patient should take into account the relative risks and benefits.3 y The routine use of cryoprecipitate or fibrinogen concentrate is not advised in medical or critically ill patients.2,4 y Cryoprecipitate or fibrinogen concentrate may be indicated in critical bleeding if fibrinogen levels are not maintained using FFP. In the setting of major obstetric haemorrhage, early administration of cryoprecipitate or fibrinogen concentrate may be necessary.3 Clinical implications y The routine use of cryoprecipitate or fibrinogen concentrate in medical or critically ill patients with coagulopathy is not advised. The underlying causes of coagulopathy should be identified; where transfusion is considered necessary, the risks and benefits should be considered for each patient. Specialist opinion is advised for the management of disseminated intravascular coagulopathy (MED-PP18, CC-PP7).2,4 y Cryoprecipitate or fibrinogen concentrate may be indicated in critical bleeding if fibrinogen levels are not maintained using FFP. In patients with critical bleeding requiring massive transfusion, suggested doses of blood components is 3-4g (CBMT-PP10)3 in adults or as per the local Massive Transfusion Protocol.
    [Show full text]
  • Blood Product Modifications: Leukofiltration, Irradiation and Washing
    Blood Product Modifications: Leukofiltration, Irradiation and Washing 1. Leukocyte Reduction Definitions and Standards: o Process also known as leukoreduction, or leukofiltration o Applicable AABB Standards, 25th ed. Leukocyte-reduced RBCs At least 85% of original RBCs < 5 x 106 WBCs in 95% of units tested . Leukocyte-reduced Platelet Concentrates: At least 5.5 x 1010 platelets in 75% of units tested < 8.3 x 105 WBCs in 95% of units tested pH≥6.2 in at least 90% of units tested . Leukocyte-reduced Apheresis Platelets: At least 3.0 x 1011 platelets in 90% of units tested < 5.0 x 106 WBCs 95% of units tested pH≥6.2 in at least 90% of units tested Methods o Filter: “Fourth-generation” filters remove 99.99% WBCs o Apheresis methods: most apheresis machines have built-in leukoreduction mechanisms o Less efficient methods of reducing WBC content . Washing, deglycerolizing after thawing a frozen unit, centrifugation . These methods do not meet requirement of < 5.0 x 106 WBCs per unit of RBCs/apheresis platelets. Types of leukofiltration/leukoreduction o “Pre-storage” . Done within 24 hours of collection . May use inline filters at time of collection (apheresis) or post collection o “Pre-transfusion” leukoreduction/bedside leukoreduction . Done prior to transfusion . “Bedside” leukoreduction uses gravity-based filters at time of transfusion. Least desirable given variability in practice and absence of proficiency . Alternatively performed by transfusion service prior to issuing Benefits of leukoreduction o Prevention of alloimmunization to donor HLA antigens . Anti-HLA can mediate graft rejection and immune mediated destruction of platelets o Leukoreduced products are indicated for transplant recipients or patients who are likely platelet transfusion dependent o Prevention of febrile non-hemolytic transfusion reactions (FNHTR) .
    [Show full text]
  • Guidance for the Provision of Intraoperative Cell Salvage
    Enter Organisation details here GUIDANCE FOR THE PROVISION OF INTRAOPERATIVE CELL SALVAGE Guidance Guidance forfor Australian Australian Health Health Providers Providers MARCH> MARCH 2014 2014 Guidance for the provision of Intraoperative Cell Salvage Page 0 Ref No: Enter Organisation Ref AUS ICS Version No: 1 March 2014 Enter Organisation details here With the exception of any logos and registered trademarks, and where otherwise noted, all material presented in this document is provided under a Creative Commons Attribution 3.0 Australia (http://creativecommons.org/ licenses/by/3.0/au/) licence. The details of the relevant licence conditions are available on the Creative Commons website (accessible using the links provided) as is the full legal code for the CC BY 3.0 AU license (http://creativecommons.org/licenses/by/3.0/au/legalcode). The content obtained from this document or derivative of this work must be attributed as the Guidance for the provision of Intraoperative Cell Salvage. © National Blood Authority, 2014. ISBN 978-0-9873687-3-7 This report is available online at: www.blood.gov.au For more information: Patient Blood Management National Blood Authority Locked Bag 8430 Canberra ACT 2601 Phone: 13000 BLOOD (13 000 25663) Email: [email protected] www.blood.gov.au Guidance for the provision of Intraoperative Cell Salvage Page 1 Ref No: Enter Organisation Ref AUS ICS Version No: 1 March 2014 Enter Organisation details here Guidance for the provision of Intraoperative Cell Salvage Author: Policy ratified by: Responsible Officer: Signature Date Insert Date Classification Clinical Date Issued Area Applicable Review Date Ref No: Version No: Disclaimer When using this document please ensure that the version you are using is the current, in date version by checking on your Organisation’s database for any new versions.
    [Show full text]
  • View Table of Contents
    Table of Contents Preface. xv About the Authors . xvii Section 1: ABO: The Birth of Blood Groups 1. Blood Groups—From Then ’Til Now . .1 Discovery . .1 Response and Reconsideration . .2 Beyond ABO . .4 M, N, and P . .5 Rh . .6 The Antiglobulin Test . .7 The Plot Thickens . .7 References . .8 2. Karl Landsteiner, Father of Blood Groups . .9 Beginnings . .9 Medical School . .11 The Young Researcher . .13 Priority Issues . .16 Decastello and Sturli: Another Blood Group . .18 Other Directions . .19 Life in Vienna . .21 References . .23 3. ABO Grows Up . .27 Transfusion History, 1600 to 1920 . .27 The Blood Groups Gain Attention . .29 Transfusion in World War I . .37 Advances in ABO Blood Group Serology . .39 References . .47 4. Genetics, Eugenics, and Blood Groups . .51 Heredity, 1900 . .52 The Rise of Genetics . .52 Genes and Blood Groups . .53 viii BLOODY BRILLIANT! Genes and Populations . 59 References . 62 5. Karl Landsteiner in New York . 65 At “The Rockefeller” . 65 Landsteiner Returns to the Blood Groups . 68 The Nobel Prize . 71 The Laureate at Work . 73 References . 74 6. Out, Damned Spot! Early Forensic Applications of ABO . 77 What Blood Can Tell . 78 Is It Blood? . 78 Is It Human Blood? . 79 Whose Blood Is It? . 81 References . 85 7. Who’s Your Daddy? ABO and Paternity Testing . 87 Establishing Paternity . 87 Paternity Testing and the Courts: Europe . 89 Paternity Testing and the Courts: Britain . 91 Paternity Testing and the Courts: United States . 92 Lights! Camera! Action! . ..
    [Show full text]
  • 2018 SBB/BB Exam Review
    2018 SBB/BB Exam Review 10/15/2018 Faculty Disclosures The following faculty have no relevant financial relationships to disclose: – Jayanna Slayten MS, MT(ASCP)SBBcm – Lorraine Blagg MA, MLS (ASCP)SBB – Katrina Billingsley MSTM, MT(ASCP)SBB – Catherine (Kate) Hernandez MT(ASCP)SBB www.aabb.org 2 Learning Objectives • Explain American Society of Clinical Pathologist (ASCP) SBB and BB exam requirements • Explain the topics outlined on the ASCP BB/SBB Exam Content Outline • Describe pertinent information which may be covered on these exams to aid in preparing for the BB or SBB exam • Discuss helpful hints for studying for and taking these exams www.aabb.org 3 2018 SBB/BB Exam Review AABB Annual Meeting Boston, MA October 2018 1 Outline of Presentation Introduction J.Slayten 825-830 Exam Requirements, Competencies and K. Hernandez 830-840 Content Outline Immunology and Complement, Genetics L. Blagg 840-925 and Lab Math Adverse Effects of Transfusion / K. Hernandez 925-940 Transfusion Reactions Hemolytic Disease of the Fetus and K. Hernandez Newborn Coagulation (topic falls under L. Blagg 940-1015 physiology/pathophysiology) October 2018 2 Outline of Presentation Blood Groups K. 1030-1120 Methods Billingsley DAT and Autoimmune Hemolytic Anemias Donors – Whole Blood and Apheresis J. Slayten 1120-1135 Component Preparation and Storage Component Quality Control Component Therapy Transfusion Transmitted Disease Testing & Re-entry Lab Management K. 1135-1145 Education Billingsley Quality Assurance/Quality Control BB/SBB Studying and Testing Strategies J. Slayten 1145-1155 Q and A 1155-1200 October 2018 3 SBB/BB Exam Review The SBB and BB Exams Requirements Competencies Content Kate Hernandez, MT(ASCP)SBBCM St.
    [Show full text]
  • Transfusion-Associated Graft-Versus-Host Disease
    Vox Sanguinis (2008) 95, 85–93 © 2008 The Author(s) REVIEW Journal compilation © 2008 Blackwell Publishing Ltd. DOI: 10.1111/j.1423-0410.2008.01073.x Transfusion-associatedBlackwell Publishing Ltd graft-versus-host disease D. M. Dwyre & P. V. Holland Department of Pathology, University of California Davis Medical Center, Sacramento, CA, USA Transfusion-associated graft-versus-host disease (TA-GvHD) is a rare complication of transfusion of cellular blood components producing a graft-versus-host clinical picture with concomitant bone marrow aplasia. The disease is fulminant and rapidly fatal in the majority of patients. TA-GvHD is caused by transfused blood-derived, alloreactive T lymphocytes that attack host tissue, including bone marrow with resultant bone marrow failure. Human leucocyte antigen similarity between the trans- fused lymphocytes and the host, often in conjunction with host immunosuppression, allows tolerance of the grafted lymphocytes to survive the host immunological response. Any blood component containing viable T lymphocytes can cause TA-GvHD, with fresher components more likely to have intact cells and, thus, able to cause disease. Treatment is generally not helpful, while prevention, usually via irradiation of blood Received: 13 December 2007, components given to susceptible recipients, is the key to obviating TA-GvHD. Newer revised 18 May 2008, accepted 21 May 2008, methods, such as pathogen inactivation, may play an important role in the future. published online 9 June 2008 Key words: graft-versus-host, immunosuppression, irradiation, transfusion. along with findings due to marked bone marrow aplasia. Introduction Because of the bone marrow failure, the prognosis of TA- Transfusion-associated graft-versus-host disease (TA-GvHD) GvHD is dismal.
    [Show full text]
  • Download the PDF Catalog
    2021 PUBLICATIONS CATALOG aabb.org/marketplace AABB eCasts Invest in yourself, your profession and your organization. AABB’s eCasts offer a wide variety of education opportunities for professionals in blood banking, transfusion medicine and biotherapies. The programs are developed and led by world-renowned experts and are designed to help advance the field and promote professional development. These 60- to 90-minute interactive, online programs provide CE/CME credits* at your convenience. Programs are available both live and on-demand and can be purchased for individual or group viewing. aabb.org/eCasts * AABB offers continuing education credits/contact hours for most AABB eLearning activities. Continuing Medical Education (CME) activities have been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of CME Outfitters and AABB. CME Outfitters is accredited by the ACCME to provide continuing medical education for physicians. Foreword Table of Contents What a year! But despite all the challenges, AABB members — your colleagues — have developed a wealth of resources to help educate and empower you. Newcomers to publishing as well as Publications by Topic seasoned veterans have shared their expertise to make your AABB Standards. 2 day-to-day operations smoother and your career path easier. Quality . 5 The diversity of content reflects the AABB membership rather well. Readers will find updated classic resources or completely Cellular Therapies . 6 new texts whether their interests focus on molecular testing, Patient Blood Management . 7 pediatrics, quality systems, relationship testing, donor screening, reimbursement, blood administration, apheresis, Transfusion Practices .
    [Show full text]
  • DAT Online Version
    Investigating Positive DAT Results: A Case Study Approach (Questions Only) Copyright © 2016 by AABB. All rights reserved Table of Contents Preface . .iii Key to Abbreviations and Interpretation of Reactions . .iv Case Study 1 . 1 Case Study 2 . 6 Case Study 3 . 13 Case Study 4 . 17 Case Study 5 . 21 Case Study 6 . 26 Case Study 7 . 30 Case Study 8 . 34 Case Study 9 . 39 Case Study 10 . 43 Case Study 11. 47 Case Study 12 . 51 Case Study 13 . 56 Case Study 14 . 62 Case Study 15 . 67 Case Study 16 . 73 Case Study 17 . 76 Case Study 18 . 81 Case Study 19 . 85 Case Study 20 . 90 Case Study 21 . 94 ii Copyright © 2016 by AABB. All rights reserved Preface In the spirit of Antibody Identification: Art or Science? A Case Study Approach, this volume continues the presentation of cases designed to guide the learner to achieve mastery in the selection and use of the many serological procedures available for problem solving. As the complexity of a serological case increases, so to must the skill of the medical laboratory scien- tist in selection and interpretation of these tests. Each case study begins with a clinical scenario and initial test results which then guide the learner through a sequence of multiple choice questions that offer testing options and protocols for resolution. As in Art or Science, as each problem unfolds, the reader is provided with detailed feedback designed to enhance reflection and critical thinking. The difficulty of the cases ranges from basic to very advanced, allowing use by multiple levels of students and practicing medical laboratory scientists and physicians.
    [Show full text]
  • Circular of Information for the Use of Human Blood and Blood Components
    CIRCULAR OF INFORMATION FOR THE USE OF HUMAN BLOOD Y AND BLOOD COMPONENTS This Circular was prepared jointly by AABB, the AmericanP Red Cross, America’s Blood Centers, and the Armed Ser- vices Blood Program. The Food and Drug Administration recognizes this Circular of Information as an acceptable extension of container labels. CO OT N O Federal Law prohibits dispensing the blood and blood compo- nents describedD in this circular without a prescription. THIS DOCUMENT IS POSTED AT THE REQUEST OF FDA TO PROVIDE A PUBLIC RECORD OF THE CONTENT IN THE OCTOBER 2017 CIRCULAR OF INFORMATION. THIS DOCUMENT IS INTENDED AS A REFERENCE AND PROVIDES: Y • GENERAL INFORMATION ON WHOLE BLOOD AND BLOOD COMPONENTS • INSTRUCTIONS FOR USE • SIDE EFFECTS AND HAZARDS P THIS DOCUMENT DOES NOT SERVE AS AN EXTENSION OF LABELING REQUIRED BY FDA REGUALTIONS AT 21 CFR 606.122. REFER TO THE CIRCULAR OF INFORMATIONO WEB- PAGE AND THE DECEMBER 2O17 FDA GUIDANCE FOR IMPORTANT INFORMATION ON THE CIRCULAR. C T O N O D Table of Contents Notice to All Users . 1 General Information for Whole Blood and All Blood Components . 1 Donors . 1 Y Testing of Donor Blood . 2 Blood and Component Labeling . 3 Instructions for Use . 4 Side Effects and Hazards for Whole Blood and P All Blood Components . 5 Immunologic Complications, Immediate. 5 Immunologic Complications, Delayed. 7 Nonimmunologic Complications . 8 Fatal Transfusion Reactions. O. 11 Red Blood Cell Components . 11 Overview . 11 Components Available . 19 Plasma Components . 23 Overview . 23 Fresh Frozen Plasma . .C . 23 Plasma Frozen Within 24 Hours After Phlebotomy . 28 Components Available .
    [Show full text]
  • Standards for Blood Banks and Transfusion Services, 31St Edition
    Response to Comments Received to the 31st edition of Standards for Blood Banks and Transfusion Services Please note that public comments that were submitted address the proposed 31st edition of BBTS Standards, and not the final version. The changes are best understood when the proposed Standards are compared to the final published version. The committee has elected to make the substance of public comments that were submitted a part of this document. This document does not represent a full summary of significant changes to the 31st edition of BBTS Standards. Guidance that appears with the 31st edition of BBTS Standards in the Standards Portal provides a more in-depth look at the additions, deletions and changes and the rationales behind those decisions that what appears below. Standard Comment Change made? Outcome 1.1.1 We believe that this standard applies specifically to CLIA regulations and No The committee notes that as stated under patient testing, not to procedures and equipment used for routine blood center standard 1.1.1, all activities that occur in the component preparation such as an irradiator. Please clarify if this standard and blood bank or transfusion service would be the 42CFR 493.1251(d) applies to activities which are outside the scope of CLIA. responsibility of the medical director, not just When our facility responded to a similar nonconformance that the Medical the policies, processes and procedures under Director did not review and sign Amicus Separator qualifications, the response CLIA. dated August 12, 2016 was accepted. This response stated that “The Fenwal The intent of this standard is to ensure that the Amicus Separator does not involve patient testing and would not require medical director is aware of all policies, Medical Director review under CLIA Guidelines.” We believe the irradiator processes and procedures, and therefore a should be evaluated in the same way, under CLIA Guidelines.
    [Show full text]
  • 2013 AABB Blood Survey Report
    THE AABB BLOOD SURVEY REPORT Final The 2013 AABB Blood Collection, Utilization, and Patient Blood Management Survey Report Report Authors Barbee I. Whitaker, PhD Srijana Rajbhandary, BDS, MPH Andrea Harris, MPH Citation AABB, December 18, 2015 Table of Contents List of Tables. v List of Figures . .vii 1. Executive Summary. 1 US Blood Collection . 1 US Blood Utilization . 2 Patient Blood Management (PBM) . 3 2. Key Findings . .5 3. International Report . 9 Blood Collected and Produced . 9 Blood Transfusion . 10 4. Blood Collected and Produced in AABB Member Facilities: Trends in US Collections . 11 Total WB/RBC Collections. 11 Whole Blood (WB) . 11 Red Blood Cell (RBC) Apheresis. 12 RBC Distributions . 14 Non-RBC Components . 14 Platelets . .14 Plasma. 15 Cryoprecipitate . 17 Granulocytes . 18 Blood Center Inventory . 18 5. Blood Transfused by US-Based AABB Member Hospitals . 21 WB and RBCs Transfused . 21 Pediatric Transfusions . 21 Transfusion Recipients. 22 Non-RBC Components Transfused . 22 Outdated Units . 26 iii THE 2013 AABB BLOOD COLLECTION, UTILIZATION, AND PATIENT BLOOD MANAGEMENT SURVEY REPORT 6. Patient Blood Management (PBM) in AABB Member Facilities . 29 PBM Interventions . 31 Measure of Intervention Success . 34 Informed Consent . 35 Type and Screen before Procedures . 36 Transfusion Thresholds . 36 7. Current Issues in Blood Collection and Donor Screening . 43 Donor Hemovigilance . 45 8. Current Issues in Blood Transfusion . 47 US Collection Trends . 47 Blood Availability . 48 Blood Use. 50 Crossmatch Procedures . 52 Red Cell Age. 52 Platelet Age. 52 Hemovigilance . 52 9. Component Costs . 57 RBCs . 57 Plasma . 57 Apheresis Platelets . 58 Reimbursement . 58 Summary . 61 10. Component Modification .
    [Show full text]