Clinical Laboratory Management

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

Apply the principles of management in a clinical setting with this vital guide

Clinical Laboratory Management, Third Edition, edited by an esteemed team of professionals under the guidance of editor-in-chief Lynne S. Garcia, is a comprehensive and essential reference for managing the complexities of the modern clinical laboratory. This newly updated and reorganized edition addresses the fast-changing landscape of laboratory management, presenting both foundational insights and innovative strategies. Topics covered include:

• an introduction to the basics of clinical laboratory management, the regulatory landscape, and evolving practices in the modern healthcare environment
• the essence of managerial leadership, with insights into employee needs and motivation, effective communication, and personnel management, including the lack of qualified position applicants, burnout, and more
• financial management, budgeting, and strategic planning, including outreach
• up-to-date resources for laboratory coding, reimbursement, and compliance, reflecting current requirements, standards, and challenges
• benchmarking methods to define and measure success
• the importance of test utilization and clinical relevance
• future trends in pathology and laboratory science, including developments in test systems, human resources and workforce development, and future directions in laboratory instrumentation and information technology
• an entirely new section devoted to pandemic planning, collaboration, and response, lessons learned from COVID-19, and a look towards the future of laboratory preparedness

This indispensable edition of Clinical Laboratory Management not only meets the needs of today’s clinical laboratories but anticipates the future, making it a must-have resource for laboratory professionals, managers, and students. Get your copy today, and equip yourself with the tools, strategies, and insights to excel in the complex and ever-changing world of the clinical laboratory.

About the Author

Lynne S. Garcia, L&G Asssociates, Santa Monica, California