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QUICK REFERENCE

27th Edition Chapters

1.0 Organization

2.0 Resources

3.0 Equipment

4.0 Supplier and Customer Issues

5.0 Process Control

General

Collection and Production of Components

Transfusion-Service-Related Activities

6.0 Documents and Records

7.0 Deviations, Nonconformances, and Adverse Events

8.0 Assessments: Internal and External

9.0 Process Improvement Through Corrective and

Preventive Action

10.0 Facili ties and Safety

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Copyright2011 by AABB. All rights reserved. No part of this book maybe reproduced or transmitted in any form or by any means, electronic, ormechanical, including photocopying, recording, or by any informationstorage and retrieval system, without permission in writing from thePublisher.

AABB ISBN 978-1-56395-314-98101 Glenbrook Road Printed in the United StatesBethesda, Maryland 20814-2749United States of America

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27th EDITION BLOOD BANK/TRANSFUSION SERVICE STANDARDSPROGRAM UNIT

Committee MembersThomas H. Carson, MD, ChairMichael K. Banbury, MDMaureen A. Beaton, MT(ASCP)BB, CQA(ASQ)Paula L. Brown, BS, MT(ASCP), JDPatricia Distler, MS, MT(ASCP)SBB

Jerome L. Gottschall, MDDale E. Hammerschmidt, MDSarah J. Ilstrup, MDLesley Ann Kresie, MD

Judith Levitt, MT(ASCP)SBBTerry M. Perlin, PhD

Sally Rudmann, PhD, MT(ASCP)SBBRebecca See, CQA(ASQ), MSMary Townsend, MDCynthia Zalek, MHA, CQA(ASQ), CQIA(ASQ)

Liaisons Representing Other AABB CommitteesAccreditation Program Committee, Donor Center Accreditation Program Unit

Geralyn M. Meny, MDAccreditation Program Committee, Transfusion Services Accreditation Program Unit

Beth H. Shaz, MDInformation Systems CommitteeWesley T. Stevens, MDQuality Management SubcommitteePatrick W. Ooley, MS, MT(ASCP), CQA(ASQ)Transfusion-Transmitted Disease CommitteeGary E. Tegtmeier, PhDUniform Donor History QuestionnaireJoy L. Fridey MD, MBA

Representatives from Other OrganizationsAmerican Association of Tissue BanksScott Brubaker, CTBSAmerican College of Obstetricians and GynecologistsGeorge R. Saade, MDAmerican Red CrossAnne F. Eder, MD, PhDAmerican Society for ApheresisNicholas Bandarenko, MDArmed Services Blood Program Office (DoD)Lt. Col. Ronny A. Fryar, MS, MT(ASCP)SBBCenters for Medicaid and Medicare ServicesPenelope Meyers, MA, MT(ASCP)SBBCollege of American PathologistsJean E. Forsberg, MDFood and Drug AdministrationJudy E. Ciaraldi, MT(ASCP)SBB, CQA(ASQ);Helen Cowley, MT(ASCP)SBB, CQA(ASQ)Plasma Protein Therapeutics AssociationMary Gustafson, MT(ASCP)SBBState of CaliforniaRonald N. Harkey