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Contributors xxii Preface xxv Acknowledgments xxvii SECTION I: Basic Concepts and the Current Healthcare Environment 1 1 Clinical Laboratory Management: Basic Principles and Practices 3 Paul Wesolowski and Susan D. Roseff 2 Regulatory Issues in Laboratory Medicine 25 Glenn Ramsey and Christina E. Anderson 3 The Changing Practice of Medicine 53 Elizabeth A. Godbey, Susan D. Roseff, and Denise E. Russell 4 The Changing Healthcare Environment 67 Steven M. Armstrong and Sandra L. Lamm SECTION II: Managerial Leadership 93 5 The Foundations of Leadership 95 David S. Hefner and Katharine R. Becker 6 Employee Needs 108 Kathleen G. Beavis 7 Motivating through Intelligent Leadership 116 Christa Pardue 8 Effective Communication 123 Marianna Hofmeister 9 Effective Meetings 135 Mark G. Hanly 10 Conflict Management 144 Christopher Naugler 11 Leading People Through Change in Pathology and Laboratory Medicine 151 Gabriel E. Ayala SECTION III: Personnel Management 159 12 Employee Selection 161 Anthony S. Kurec 13 Performance Appraisals and Competency Assessment 182 Lynne S. Garcia 14 Staffing and Scheduling 202 Patti Medvescek 15 Teams, Team Process, and Team Building 212 James W. Bishop, Dow Scott, Stephanie Maynard Patrick, and Ji-Yeon Seok 16 Labor Relations 226 Emily A. Snavely and Lynne S. Garcia 17 Workplace Drug Testing and the Clinical Laboratory 242 Lindsay A. L. Bazydlo SECTION IV: Requirements for Effective Laboratory Management 251 18 Quality Management 253 Lynne S. Garcia 19 International Organization for Standardization 271 Anne Marsden and Amy Shahtout 20 Effective Communication in Laboratory Management 278 Andrea Linscott and Elise Occhipinti 21 Laboratory Information Systems 285 Melinda L. Doherty and Kenneth E. Youens 22 Management of Point-of-Care Testing 298 Laura Smy, Kristine Apfeld, Sarah Ampomah, and Molly Thieme 23 Principles of Preanalytic and Postanalytic Test Management 315 Lynne S. Garcia and Andrea J. Linscott 24 Selection and Implementation of New Equipment and Procedures 333 Paula Revell and Lakshmi Chandramohan 25 Laboratory Safety 343 Cameron A. Brown and James J. Dunn 26 Emergency Management 372 Andrea J. Linscott and Natalie Williams-Bouyer SECTION V: Financial Management 387 27 Financial Management: Setting the Stage 389 Lynne S. Garcia 28 Strategic Planning 396 Jonathan R. Genzen and Paul Valenstein 29 Human Resource Management in the Laboratory: An Important Component of Financial Management 408 Fred Westenfeld and Michael R. Lewis 30 Costs, Budgeting, and Financial Decision Making 416 Geoffrey C. Tolzmann, Richard J. Vincent, and Michael R. Lewis SECTION VI: Coding, Billing, and Charges for Laboratory Services 443 31 Correct Coding of Billable Services in the Clinical Laboratory 445 Vickie S. Baselski, Alice S. Weissfeld, and Fran Sorrell 32 Approaches to Billing Laboratory Services 460 Vickie S. Baselski, Alice S. Weissfeld, and Fran Sorrell 33 Charges and Fees for Laboratory Services 468 Vickie S. Baselski, Alice S. Weissfeld, and Fran Sorrell SECTION VII: Reimbursement, Compliance, and Profitability 475 34 Rules and Regulations in Reimbursement 477 Vickie S. Baselski, Alice S. Weissfeld, and Fran Sorrell 35 Reimbursement Compliance 492 Vickie S. Baselski, Alice S. Weissfeld, and Fran Sorrell 36 Determination of Profitability 506 Vickie S. Baselski, Alice S. Weissfeld, and Fran Sorrell SECTION VIII: Outside Marketing and Expansion 513 37 Hospital-Based Laboratory Outreach 515 Richard Adams, Daniel Kelly, and Lynne S. Garcia 38 Finance and Decision-Making in Outreach 527 Ziad Peerwani 39 Outreach: Obstacles to Hospital Outreach and Enhancing Customer Satisfaction 550 Beth H. Deaton SECTION IX: Clinical Trials and Evidence-Based Laboratory Medicine 573 40 The Current State of the US Food and Drug Administration Process and Regulations for Diagnostic Laboratory Assays 575 Donna M. Wolk, Natalie N. Whitfield, and Fran White 41 The Clinical Trial Laboratory: Research Compliance for Clinical Microbiologists 584 Donna M. Wolk, Amanda M. Styer, and Natalie N. Whitfield 42 Clinical Trials and Evidence Based Research in the Clinical Laboratory 595 Donna M. Wolk and Natalie N. Whitfield SECTION X: Defining and Measuring Standards for Success 607 43 Benchmarking and Performance Monitoring for the Clinical Laboratory 609 Lauren N. Pearson and Michael R. Lewis 44 Test Utilization and Clinical Relevance 626 Michael L. Wilson, Gary W. Procop, and L. Barth Reller SECTION XI: The Future of Clinical Laboratories 639 45 The Future of Pathology and Laboratory Medicine: Political, Social, Economic, and Regulatory Impacts 641 Lisa M. Stempak and Mark Rodgers 46 The Future of the Clinical Scientist Workforce 652 J. Frame, Donna Gaffney, and Jana Bagwell 47 Electronic Health Records and Their Implications and Opportunities for Laboratories 660 Roger L. Bertholf 48 Current Trends in Instrumentation and Technology: A Look toward the Future 674 Patrick B. Kyle and Lauren McVoy 49 The Future Practice of Laboratory Medicine 690 Christopher Zahner and Peter McCaffrey SECTION XII: Pandemics and Healthcare Institutions 701 50 Epidemics and Pandemics:< Lessons from the Past, Concerns for the Future 703 Charles S. Bryan 51 One Health in Pandemic Planning, Prevention, and Response 717 Craig Stephen 52 Pandemic Planning: Roles of Clinical and Public Health Laboratories 727 Robert T. Ball, Jr., Joseph F. John, Jr., and Michael G. Schmidt 53 Laboratory Preparedness 744 Deirdre Church INDEX 763