Laboratory Hemostasis: A Practical Guide for Pathologists PDF
Preview Laboratory Hemostasis: A Practical Guide for Pathologists
Laboratory Hemostasis Laboratory Hemostasis A Practical Guide for Pathologists Sterling T. Bennett, M.D., M.S. Medical Director, Intermountain Healthcare Central Laboratory, and Volunteer Adjunct Associate Professor of Pathology, University of Utah Health Sciences Center Salt Lake City, Utah Christopher M. Lehman, M.D. Associate Professor of Pathology University of Utah Health Sciences Center and Assistant Director of Hospital Clinical Laboratories ARUP Laboratories Salt Lake City, Utah George M. Rodgers, M.D., Ph.D. Professor of Medicine and Pathology Division of Hematology University of Utah Health Sciences Center and Medical Director, Coagulation Laboratory ARUP Laboratories Salt Lake City, Utah Editors With Contributions by Catherine Thompson, B.S., MT (ASCP), and Robert C. Blaylock, M.D. SterlingT.Bennett,M.D.,M.S. ChristopherM.Lehman,M.D. MedicalDirector AssociateProfessorofPathology IntermountainHealthcareCentral UniversityofUtahHealth Laboratory SciencesCenter VolunteerAdjunctAssociateProfessor SaltLakeCity,UT84132 ofPathology and UniversityofUtahHealth AssistantDirectorofHospital SciencesCenter ClinicalLaboratories SaltLakeCity,UT84143 ARUPLaboratories USA SaltLakeCity,UT84132 USA GeorgeM.Rodgers,M.D.,Ph.D. ProfessorofMedicineandPathology DivisionofHematology UniversityofUtahHealth SciencesCenter SaltLakeCity,UT84132 and MedicalDirector,CoagulationLaboratory ARUPLaboratories SaltLakeCity,UT84132 USA LibraryofCongressControlNumber:2006931198 ISBN-10:0-387-36838-8 e-ISBN-10:0-387-36840-X ISBN-13:978-0387-36838-2 e-ISBN-13:978-0387-36840-5 Printedonacid-freepaper. ©2007SpringerScience+BusinessMedia,LLC All rights reserved. This work may not be translated or copied without the written permissionofthepublisher(SpringerScience+BusinessMedia,LLC,233SpringStreet, New York, NY 10013, USA), except for brief excerpts in connection with reviews or scholarlyanalysis.Useinconnectionwithanyformofinformationstorageandretrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now knownorhereafterdevelopedisforbidden. Theuseinthispublicationoftradenames,trademarks,servicemarksandsimilarterms, eveniftheyarenotidentifiedassuch,isnottobetakenasanexpressionofopinionas towhetherornottheyaresubjecttoproprietaryrights. Whiletheadviceandinformationinthisbookarebelievedtobetrueandaccurateatthe dateofgoingtopress,neithertheauthorsnortheeditorsnorthepublishercanacceptany legalresponsibilityforanyerrorsoromissionsthatmaybemade.Thepublishermakes nowarranty,expressorimplied,withrespecttothematerialcontainedherein. 9 8 7 6 5 4 3 2 1 springer.com To Elizabeth Bennett, Julie Monahan and other family and friends for their unfailing support, and to the numerous residents and fellows and our faculty colleagues who have stimulated our interest in coagulation and inspired this book Preface In the course of our practice as coagulation laboratory directors, we have acquired personal libraries of hemostasis and thrombosis texts that serve as excellent references for the basic science and clinical aspects of hemostasis. What is missing, though, is a single reference text that provides practical information and guidance on the topics relevant to directing a coagulation laboratory.Wearesurewearenotaloneinwishingforsuchareference.After talkingaboutitforseveralyears,wehavenowattemptedtofillthevoidwith ahandbookcontainingtheinformationweprovidetotheresidentsandfellows thatwearehelpingtraintobecomelaboratorydirectors. Inwritingthisbookwehavetriedtocitetheconsensusrecommendations of authoritative bodies whenever possible, and otherwise, have cited reviews, chapters,andresearcharticlesofexpertsintheirrespectivefields.Theserefer- ences should act as a starting point for a more detailed study of the various aspectsofcoagulationtesting. It is our intent that pathologists, clinical laboratory scientists, and other physiciansservingaslaboratorydirectorswillfindthisbookhelpfultounder- stand and carry out their responsibilities. Another intent is that residents and fellowswillfindthisbooktobeausefultoolforlearningthebasicsofcoagu- lation testing and for studying for board examinations. We also hope that coagulation laboratory supervisors, technologists, and technicians find this to be a helpful reference for the day-to-day operation of the laboratory. Finally, cliniciansmayfindaspectsofthisbookhelpfulinunderstandingtheroleofthe coagulationlaboratoryinpatientevaluationandmonitoring. SterlingT.Bennett ChristopherM.Lehman GeorgeM.Rodgers Acknowledgments TheEditorswouldliketothankStephenJ.Klingforhisassistancewithprepa- ration of illustrations, Kathleen Gibbs and Ronda Crist for helpful comments onthemanuscriptandDeborahHoffmanforpreparationofthemanuscript. Contents Preface vii Acknowledgments ix 1. RoleandResponsibilitiesoftheLaboratoryDirector 1 SterlingT.Bennett 2. CollectionofCoagulationSpecimens 27 SterlingT.Bennett 3. InstrumentationfortheCoagulationLaboratory 41 ChristopherM.LehmanandCatherineThompson 4. ValidationofCoagulationAssays,InstrumentsandReagents 57 SterlingT.Bennett 5. HemostasisScreeningAssays 85 GeorgeM.RodgersandChristopherM.Lehman 6. TestingforInheritedBleedingDisorders 103 GeorgeM.Rodgers 7. TestingforAcquiredPlateletDisorders 121 ChristopherM.Lehman 8. AcquiredCoagulationDisordersandTTP 137 GeorgeM.Rodgers 9. TestingforInheritedandAcquiredThromboticDisorders 143 GeorgeM.Rodgers 10. MonitoringAnticoagulantTherapy 167 SterlingT.Bennett 11. CoagulationTestingandTransfusionMedicine 207 RobertC.BlaylockandChristopherM.Lehman Index 227 1 Role and Responsibilities of the Laboratory Director Sterling T. Bennett Role and Responsibilities of the Laboratory Director Clinical laboratories provide essential services and information for the practice of medicine. The majority of electronic medical data consists of laboratory results and laboratory results are vital information for many clinical decisions. Accordingly, laboratories have the potential of making great contributions to patient safety and medical outcomes when their services are timely and results are accurate. Serving as a laboratory director is an interesting, challenging, and rewarding job, and one that carries great responsibility. The director is accountable for all aspects of the laboratory service and is the key bridge between laboratory operations and clinical practice. As such, the laboratory director needs to have a broad knowledge of clinicalmedicine,pathologydisciplines,basicmedicalsciences,clinical laboratory sciences, laboratory operations, and quality management systems. Knowledge of and skills in informatics, data analysis, and business management are also important assets. The breadth of knowledgeandskillsrequiredofalaboratorydirectorisoneaspectthat makes the job so attractive. In the midst of all this knowledge, it is vital for the success of the laboratory that the director clearly understands his or her role and responsibilities. Definitions of the laboratory director’s respon- sibilities have been published by the College of American Pathol- ogists, American Association of Blood Banks, International Organi- zation for Standards (ISO), Clinical Pathology Accreditation (UK) Ltd., National Pathology Accreditation Advisory Council, European Society of Pathology, and Canadian Association of Pathologists, to 2 SterlingT.Bennett name a few1−8. In addition, the United States’ Code of Federal Regulations defines the laboratory director’s responsibilities under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88)9. Table 1.1 provides a summary listing of the laboratory director’s responsibilities. For any given laboratory, the laboratory director’s responsibil- ities are defined in large measure by prevailing regulations and the standards of accreditation bodies. Responsibilities may be further definedbytheorganizationalstructureoftheinstitutionandcontractual arrangements between the institution and laboratory director; however, organizational structure and contracts do not absolve the laboratory director of responsibilities defined by regulations and accreditation standards. Each set of regulations or accreditation standards is unique, with its own emphasis on the director’s responsibilities. Some define detailedresponsibilitieswhileothersprovidefewspecifics.Tables1.2– 1.8 illustrate these differences by listing the duties specifically attributed to the laboratory director in four sets of regulations or standards. These tables are not intended to be a comprehensive cross- reference between various standards and regulations, but to illustrate the commonalities and differences in the level of detail that different organizations give to the specific responsibilities of the director. Many other regulations and standards exist beyond those listed. These tables include only those items that are specifically identified as responsi- bilities of the “laboratory director” by the regulations of the Clinical Laboratory Improvement Amendments of 1988 (US)9 and the College of American Pathologists1, the “person providing supervision and direction” by the National Pathology Accreditation Advisory Council (Australia)7,or“laboratorymanagement”byClinicalPathologyAccred- itation(UK)Ltd.4.Theonepointonwhichallagreeisthatthelaboratory director is responsible for assuring the laboratory complies with all provisions of the regulations or standards. An abstraction from the various definitions suggests the laboratory director’s responsibilities may be broadly categorized into general responsibilities, personnel, facilities and safety, test procedures, quality management, consul- tation and education, communication, and operational management. This chapter will discuss specific responsibilities within each of these categories.
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