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of the American Society for Microbiology. All rights reserved. No part of this publication may
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Library of Congress Cataloging-in-Publication Data
Clinical laboratory management / Lynne S. Garcia, editor in chief, LSG & Associates, Santa Monica,
CA ; editors, Paul Bachner, Department of Pathology & Laboratory Medicine, University of
Kentucky Chandler Medical Center, Lexington, KY [and eight others].
— 2nd edition.
pages cm
Includes bibliographical references and index.
ISBN 978-1-55581-727-5 — ISBN 978-1-55581-728-2 (e-ISBN) 1. Medical laboratories—
Administration. 2. Pathological laboratories—Administration. I. Garcia, Lynne Shore, editor of
compilation. II. Bachner, Paul, editor of compilation.
[DNLM: 1. Laboratories—organization & administration. 2. Clinical Laboratory Techniques.]
R860.C56 2014
610.72’4—dc23
2013036960
doi:10.1128/9781555817282
Printed in the United States of America
10 9 8 7 6 5 4 3 2 1
Address editorial correspondence to: ASM Press, 1752 N St., N.W., Washington, DC
20036-2904, USA.
Send orders to: ASM Press, P.O. Box 605, Herndon, VA 20172, USA.
Phone: 800-546-2416; 703-661-1593. Fax: 703-661-1501.
E-mail: books@asmusa.org
Online: http://www.asmscience.org](https://image.slidesharecdn.com/78412-250531022542-668ad3db/75/Clinical-Laboratory-Management-2nd-Edition-Bachner-10-2048.jpg)
![xviii Contents
45 The Current State of the U.S. Food
and Drug Administration Process
and Regulations for Diagnostic
Laboratory Assays 809
Donna M. Wolk, Natalie N. Whitfield, Elizabeth M.
Marlowe, and Marilyn M. Marshall
Introduction 809
Background: The FDA Processes for Classification and
Assessment of New IVDs 810
Premarket Approval (PMA) • Premarket Notification [510(k)] and
510(k) Review • Alternative Application Submission Approaches •
The Pre-IDE Process • The Expedited Review
Miscellaneous FDA Requirements 813
Establishment Registration • Medical Device Listing • Good
Manufacturing Practices and Quality System Regulations • Quality
Control
Automated Laboratory Assays 814
Postmarket Review 814
Limitations Inherent to Current FDA Processes 814
Summary 815
KEY POINTS 815
GLOSSARY 815
REFERENCES 816
46 The Clinical Trial Laboratory:
Research Compliance for Clinical
Research Microbiologists 818
Donna M. Wolk and Marilyn M. Marshall
Introduction 818
Funded Clinical Research in Laboratory Medicine 819
Sponsored Projects • Office of Research and Contract Analysis
(ORCA)
Compliance with Human Subject Regulations 820
Background for Human Subject Regulations • Regulatory
Requirements for Human Subject Protection • Human Subject
Research: Classifications Based on Risk • Human Subject Training
Requirements and Site Authorization • Informed Consent • Special
Populations • Continuing Review by the IRB • Records Retention
for HSPPs
Compliance with HIPAA 822
Compliance with Conflict of Interest Policies 823
Intellectual Property Considerations
GLP and GCP Regulations 825
Sponsor Responsibilities • Study Director and Responsibilities •
Quality Assurance Office: Organization, SOPs, Inspections,
Reporting Data • GLP Background • Equipment and Equipment
Validations • Standard Operating Procedures • Reagent and
Solutions: Test and Control Article • Final Research Reports
Summary 827
KEY POINTS 827
GLOSSARY 827
REFERENCES 829
APPENDIX 831
47 Clinical and Evidence-
Based Research in the Clinical
Laboratory 832
Donna M. Wolk
Introduction 832
Types of Studies 833
Observational Studies • Mechanistic Studies • Therapeutic Studies •
Large-Scale Clinical Trials • Meta-Analysis
Translational Research 833
Sequence of Investigation • Literature Search • Hypothesis
Generation • Designing the Study To Test the Hypothesis
Biostatistics 835
Descriptive Statistics • Inferential Statistics: General Issues for
Medical Devices • Other Issues for Diagnostic Studies
Other Research Considerations 837
Systematic Reviews and Laboratory Medicine Best
Practices 837
Evidence-Based Laboratory Medicine • Laboratory Medicine Best
Practices Initiative
Summary 839
KEY POINTS 840
GLOSSARY 840
REFERENCES 845
APPENDIX 848
Section IX
Clinical Trials and Evidence-Based Laboratory Medicine 807](https://image.slidesharecdn.com/78412-250531022542-668ad3db/75/Clinical-Laboratory-Management-2nd-Edition-Bachner-24-2048.jpg)
![Contents
xix
48 Benchmarking and Performance
Monitoring for the Clinical
Laboratory 851
Lionelle D. Wells, Washington C. Winn, Jr., and
Michael R. Lewis
Introduction 851
Why Benchmark? 852
The Payoff from Benchmarking 852
The Basic Steps 852
Prioritization • Data Collection and Analysis • Development and
Implementation of Plans
Where Do We Find Information about
Benchmarks? 853
Quality Benchmarks • Financial Benchmarks
General Approach to Financial Benchmarking and
Performance Monitoring 854
The Problem of Comparability • The Problem of Cost
Accounting • Workload Recording • The Search for
Simplicity • Selection of Indicators for Benchmarking
or Performance Monitoring • Problems Associated with
Benchmarking by UOS • UOS Benchmarking in a Competitive
Environment
Measuring Laboratory Financial Performance 857
Performance Monitoring • External Benchmarking
Interpretation of Performance Monitoring Data 862
Summary Measure as Unifying Force • Prerequisites for Effective
Use of a Summary Measure
Interpretation of External Benchmarking Data 862
Measuring Laboratory Performance in the Broader
Clinical Setting 863
Effect of Accountable Care Organizations • Linkage of Payment to
Measures of Quality • Laboratory-Related Standards in Broader
Accreditation Programs
Summary 865
KEY POINTS 865
GLOSSARY 865
REFERENCES 866
APPENDIXES 868
49 Test Utilization and Clinical
Relevance 876
Michael L. Wilson, Gary W. Procop, and L. Barth
Reller
Introduction 876
Evaluating Potential and Real Problems 877
Clinical Relevance • Cost-Effectiveness Analysis, Cost-Benefit
Analysis, and Cost-Utility Analysis
Documenting the Extent of the Problem 878
Literature Review • Centralized Studies • Local Data
Laboratory-Based Approaches to Control 880
Newsletters • Policy Changes • Personal and Ad Hoc
Communication • LIS/HIS-Based Controls on Test Ordering • LIS-
Based Feedback in Reports
Institution-Based Approaches to Control 882
Working with the Medical Staff • Formal Protocols Validated by
Medical Staff • Working with the Nursing Staff • The Concept of
the Laboratory Test Formulary • Using Major Events To Effect
Change (e.g., Institutional Quality Assurance [QA] Office, Root
Cause Analysis)
What Works and Doesn’t Work: How To Take the First
Steps 884
Putting It All Together 885
Base Policy Approaches and LIS/HIS-Based Controls on Evidence-
Based Medicine • Track Results • The Plan, Do, Study, Act Model •
The Future: Better Teaching and Training
Summary 886
KEY POINTS 886
GLOSSARY 887
REFERENCES 887
APPENDIX 889
50 Benchmarking and Performance
Monitoring: What Is Appropriate for
Your Laboratory? 890
Ronald J. Bryant and Michael R. Lewis
Introduction 890
Starting at the Beginning: What To Measure? 891
Where Can We Get Help? 892
How Will I Fund This? 892
Evaluation of Data and Monitoring of
Performance 892
Summary 892
KEY POINTS 893
GLOSSARY 893
Section X
Defining and Measuring Standards for Success 849](https://image.slidesharecdn.com/78412-250531022542-668ad3db/75/Clinical-Laboratory-Management-2nd-Edition-Bachner-25-2048.jpg)
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- 9. WASHINGTON, DC Clinical Laboratory Management Lynne S.Garcia, EDITOR IN CHIEF LSG & Associates, Santa Monica, California EDITORS: Paul Bachner Department of Pathology & Laboratory Medicine, University of Kentucky Chandler Medical Center, Lexington, Kentucky Vickie S. Baselski Clinical Microbiology, University of Tennessee Health Science Center at Memphis, Memphis, Tennessee Michael R. Lewis Department of Pathology, Fletcher Allen Health Care, Burlington, Vermont Andrea J. Linscott Department of Pathology, Ochsner Medical Center, New Orleans, Louisiana Dale A. Schwab Nichols Institute, Quest Diagnostics, Inc., San Juan Capistrano, California John C. H. Steele, Jr. Clinical Pathology Laboratories, Department of Pathology, Medical College of Georgia, Georgia Regents University, Augusta, Georgia Alice S. Weissfeld Microbiology Specialists Inc., Houston, Texas David S. Wilkinson Department of Pathology, VCU School of Medicine, Richmond, Virginia Donna M. Wolk Clinical Microbiology, Department of Laboratory Medicine, Geisinger Health System, Danville, Pennsylvania, and Wilkes University, Wilkes-Barre, Pennsylvania SECOND EDITION
- 10. Copyright © 2014American Society for Microbiology. ASM Press is a registered trademark of the American Society for Microbiology. All rights reserved. No part of this publication may be reproduced or transmitted in whole or in part or reutilized in any form or by any means, electronic or mechanical, including photocopying and recording, or by any information storage and retrieval system, without permission in writing from the publisher. Disclaimer: To the best of the publisher’s knowledge, this publication provides information concerning the subject matter covered that is accurate as of the date of publication. The publisher is not providing legal, medical, or other professional services. Any reference herein to any specific commercial products, procedures, or services by trade name, trademark, manufacturer, or otherwise does not constitute or imply endorsement, recommendation, or favored status by the American Society for Microbiology (ASM). The views and opinions of the author(s) expressed in this publication do not necessarily state or reflect those of ASM, and they shall not be used to advertise or endorse any product. Library of Congress Cataloging-in-Publication Data Clinical laboratory management / Lynne S. Garcia, editor in chief, LSG & Associates, Santa Monica, CA ; editors, Paul Bachner, Department of Pathology & Laboratory Medicine, University of Kentucky Chandler Medical Center, Lexington, KY [and eight others]. — 2nd edition. pages cm Includes bibliographical references and index. ISBN 978-1-55581-727-5 — ISBN 978-1-55581-728-2 (e-ISBN) 1. Medical laboratories— Administration. 2. Pathological laboratories—Administration. I. Garcia, Lynne Shore, editor of compilation. II. Bachner, Paul, editor of compilation. [DNLM: 1. Laboratories—organization & administration. 2. Clinical Laboratory Techniques.] R860.C56 2014 610.72’4—dc23 2013036960 doi:10.1128/9781555817282 Printed in the United States of America 10 9 8 7 6 5 4 3 2 1 Address editorial correspondence to: ASM Press, 1752 N St., N.W., Washington, DC 20036-2904, USA. Send orders to: ASM Press, P.O. Box 605, Herndon, VA 20172, USA. Phone: 800-546-2416; 703-661-1593. Fax: 703-661-1501. E-mail: books@asmusa.org Online: http://www.asmscience.org
- 11. v Section I Basic Conceptsand the Current Healthcare Environment 1 Contributors xxiii Preface xxvii Acknowledgments xxviii Contents 1 Principles of Management 3 Jeffrey Casterline and John R. Snyder Introduction 3 Leadership, Management, and Administration 4 Leadership • Management • Administration Management Concepts 6 Cultural Lag • Review of Management Thought Decision Making 11 What Is Decision Making? • Types of Decisions • Individual versus Group Decision Making • The Problem-Solving/Decision-Making Process • Risk Management Ethics 17 Definitions • Characteristics of High-Ethics Organizations • Benefits of Strong Workplace Ethics • Management Roles and Responsibilities Summary 19 KEY POINTS 19 GLOSSARY 19 REFERENCES 20 OTHER READING 21 APPENDIX 22 2 Management Functions 23 Laurence P. Vetter Introduction 23 Planning 24 Strategic Planning • Selecting a Planning Group • Environmental Analysis • SWOT Analysis • Vision and Mission Statements • Goals and Strategies • Prioritization • Accountability • Measuring Success (Metrics) Organizing 28 Organizational Chart • Time Management • Policies • Procedures • Workflow • Staffing Directing 31 Communicating • Delegating • Motivating • Managing Change • Coaching Controlling 35 Setting Performance Standards • Evaluating Employee Performance • Problem Solving • Decision Making Summary 38 KEY POINTS 38 GLOSSARY 38 REFERENCES 39 APPENDIXES 40 3 Relevant Economic and Business Concepts 43 Roxanne Mercer and Ann L. Harris Introduction 43 Overview of Laboratory Industry Trends during the Past Decade • Forecast for the Future Strategic Business Planning Overview 45 Market Assessment • Key Strategies Competitive Environment 47 Clinical Laboratory Competitive Market • Business Entities, Strategic Alliances, Joint Ventures, Mergers and Acquisitions, and Integrated Networks The Economic Environment 49 Four Stages of the Business Cycle • The National Economy: Fiscal and Monetary Policies • Assess Infrastructure and Develop Production Strategies • Cost Accounting Principles • System-Wide
- 12. vi Contents Approach toEstablishing a Fee Schedule • Consumer Price Index • Pricing Strategies Promotional (Marketing and Sales) Strategies 53 Market Research • Marketing Strategies • Sales Strategies • Advertising Strategies Customer-Focused Concepts and Service Strategies 59 Who Is the Customer? • Understanding Customer Behavior • Key Concepts and Recognized Customer Service Strategies • Service Delivery Strategies Summary 64 KEY POINTS 64 GLOSSARY 65 REFERENCES 67 ADDITIONAL READING 68 APPENDIX 70 4 Current Challenges to Financial Stability within the Diagnostic Laboratory 71 Roxanne Mercer and David S. Wilkinson Introduction 71 Workforce 71 Availability of Personnel • Training Programs • On-the-Job Training • Recruitment and Retention • Generational Diversity Workplace 74 Centralized versus Decentralized Operations • Local and Regional Integration of Laboratory Services Work Flow 76 New Technology • Testing Site Options Doing More with Less 78 Systematic Approaches to Managing Change • Rightsizing Shrinking Reimbursement 79 Gross versus Net Revenue • Medicare • Managed Care • Billing Regulations and Unfunded Mandates 79 Regulations • Unfunded Mandates Summary 80 KEY POINTS 80 GLOSSARY 80 REFERENCES 81 APPENDIX 83 5 The Impact of Regulatory Requirements 84 Susan D. Roseff, Denise E. Russell, Christina E. Anderson, and Roxanne Mercer Introduction 84 Brief History • Overview of the Current State of Laboratory Regulations Regulation of Workplace Safety and Human Resource Management 85 Occupational Safety and Health Administration • American National Standards Institute • National Institute of Occupational Safety and Health • CLSI • Centers for Disease Control and Prevention • Food and Drug Administration • Equal Employment Opportunity Commission • Department of Transportation and International Air Transport Association • Hazard Communication Standard • Blood-Borne Pathogens • Ergonomics • Tuberculosis • Latex • Sharps • General Laboratory Safety • Chemicals • Transportation of Clinical Specimens • Employment Discrimination Accreditation and Licensure 93 Brief History • Laboratory Inspection and Accreditation • Personnel Certification and Licensure Regulations Affecting Transfusion Medicine 99 Overview of Changes in Transfusion Medicine that Have Resulted in Increased Scrutiny • Safety • Regulatory Organizations that Specifically Impact Transfusion Medicine • Biological Product Deviation Reporting • The Cost of Increasing Regulatory Oversight Regulation of Laboratory Business Practices 109 Negotiated Rule-Making Process • Corporate Compliance • Key Elements of a Model Compliance Plan for Hospitals • The Legal Environment Laboratory Reimbursement and Medical Necessity 113 Medicare • Other Federally Funded Programs • National Coverage Determination and Local Medical Review Policies • Reimbursement Methods • Code of Medical Necessity (Reasonable and Necessary Services) • Overview of the Reimbursement Process • Registration and Coding • Claims Processing and Submission • Remittance Advice • Audit and Benchmark Monitors Compliance—the Next Generation: HIPAA 124 Covered Entities • Privacy Standards: Rules Governing Protected Health Information • Administrative Requirements • Personnel Policies and Procedures • Patient Informed Rights • Business Associates and Business Associate Agreements • Standards for Electronic Transactions • HIPAA Compliance and Enforcement Summary 128 KEY POINTS 128 GLOSSARY 128 REFERENCES 133 APPENDIXES 137 6 The Changing Practice of Medicine 139 Susan D. Roseff, Denise E. Russell, and Margaret M. Grimes Introduction 139 Overview of Major Changes 139 Shift from Inpatient to Outpatient Care • Shift from Centralized to Decentralized Testing • Shift to Primary Care: Patient-Centered Medical Home • Shortages of Qualified Staff • Quality of Care and Error Reduction • Pay for Performance • Healthcare Reform • Advances in Technology • Wellness and Prevention • The Aging Population • Recognition of Women’s Health Needs
- 13. Contents vii The Impact ofTechnology 142 The Electronic Medical Record • Meaningful Use/Value- Based Purchasing • Patient Access to Information • Patient Confidentiality • Advances in Diagnostic Testing The Emergence of Clinical Practice Guidelines 144 The Role of Evidence-Based Medicine and Outcomes Data • Concerns about Utilization and Quality • Clinical Practice Guidelines and Clinical Pathways Defined • Use of Clinical Practice Guidelines • Pros and Cons • Developing Clinical Pathways and Guidelines Medicolegal Issues 148 Malpractice Litigation • Patient Safety • Disclosure of Adverse Events/CMS Never Events • CMS Serious Reportable Events • Enterprise Risk Management • Insurance • HIPAA and Patient Confidentiality • Contracts • Specimens • Documentation • Research Liability Training Physicians for Practice in the 21st Century 153 The Educational Goal: The Complete Physician • New Paradigms in Medical Training • Incorporating New Knowledge and Training Techniques into the Curriculum • Training Physicians for the Managed-Care Environment External Forces Impacting Undergraduate and Graduate Medical Education 156 Finding the Right Mix: How Many Physicians Do We Need? • Current Challenges to Academic Centers Summary 157 KEY POINTS 157 GLOSSARY 157 REFERENCES 159 APPENDIX 163 7 The Changing Healthcare Environment 164 Ann Harris and David S. Wilkinson Introduction 164 Changing Reimbursement Models 168 Change from Traditional Indemnity to Managed-Care Insurance • Four Stages of Managed-Care Market Development • Reimbursement Strategies in a Managed-Care Market • Healthcare Stakeholders in a Managed-Care Market Impact of Healthcare Reform 173 Patient Protection and Affordable Care Act • Payment Reform and Provider Reimbursement Strategies • Current Trends and Issues with Healthcare Reform • Hospitals and Laboratories: Concerns in Healthcare Reform Changing Emphasis on Quality and Value 179 Health Maintenance Organization Network Management • Patient Management • Disease Management • Healthcare Reform: Demonstration Projects The Educated Consumer 184 Baby Boomers and Generation Xers: The Educated and Savvy Consumer • Consumer-Driven Healthcare • The Increasingly Litigious Environment Changing Technology 186 Technological Advances • Direct Consumer Access • Direct Access Testing • Advances in Genetic Testing and Molecular Pathology • Personalized Medicine • New Regulations to Address Changing Technology: HIPAA • Impact of Reform on Electronic Health Records and Meaningful Use Consolidation in the Healthcare Industry 198 Overview: Laboratories, Hospitals, Physician Practices, and Managed-Care Organizations • Integrated Delivery Systems • Laboratories: Change from Revenue Centers to Cost Centers • Internal Consolidation in Hospital Laboratories • Regional Integrated Laboratory Networks Strategies for Success in the 21st Century 200 Strategic Redesign • Developing System-Wide Thinking and a Common Culture • Differentiating a Competitive Advantage • Training Adequate, High-Quality Laboratory Professionals for the Future Workforce • Moving from Top-Down Management to Bottom-Up Customer Focus • Evidence-Based Medicine • Meaningful and Relevant Information Summary 205 KEY POINTS 206 GLOSSARY 206 REFERENCES 210 APPENDIXES 214 Section II Managerial Leadership 217 8 The Foundations of Leadership 219 David S. Hefner and Katharine R. Becker Introduction 219 Distinguishing Management from Leadership 219 What Is “Leadership” and How Do You Become a Leader? • Management • Leadership The First Foundational Factor Is Integrity 221 The Definition of Integrity • Honoring Your Word • The Pitfalls in Honoring Your Word • What Is Your Word? • What Is the Current State of Your Word? • Trust and Its Relationship to Honoring Your Word • Preparation for Making a Commitment or Giving Your Word The Second Foundational Factor Is Authenticity 224 The Definition of Authentic • Knowing Yourself • How Do You Respond in Various Situations? • The Importance of Context • The Path to Authenticity
- 14. viii Contents The ThirdFoundational Factor Is Commitment to Something Bigger than Yourself 226 Succeeding as a Leader • What Happens Next? Summary 227 KEY POINTS 227 ACKNOWLEDGMENTS 229 REFERENCES 229 APPENDIXES 231 9 Employee Needs 232 John C. H. Steele, Jr. Introduction 232 The Laboratory Workforce—Is There an Approaching Crisis? 232 Theories of Human Needs 233 Maslow’s Hierarchy of Needs • Alternative Theories Meeting Employee Needs 234 Level 1 and 2 Needs • Level 3, 4, and 5 Needs • Higher-Level Needs The Role of Generational Differences 236 Characteristics of the Generations • Meeting the Needs and Wants of the Four Generations Summary 240 KEY POINTS 240 GLOSSARY 240 REFERENCES 240 APPENDIX 242 10 Motivating through Intelligent Leadership 243 Christa Pardue What Is Motivation? 243 Knowledge of Self 244 Creating the Vision • Humility • Basic Needs Knowing What Others See in You 245 Factors of Motivation • The Right People Need the Right Leader • Actually Fix the Problems Knowing the Emotions of Leading 246 Emotional Intelligence • The Need for Purpose • Human Motivation Theory Summary 248 KEY POINTS 248 GLOSSARY 248 REFERENCES 249 11 Successful Communication 250 Diane C. Turnbull Introduction 250 Channels of Communication 251 Formal Channels of Communication • Informal Channels of Communication Types (Methods) of Communication 251 Oral (Face-to-Face) Communication • Telephone Communication • Written Communication • PowerPoint Presentation • Electronic Communication • Visual Communication • Body Language and Other Nonverbal Communication Barriers to Communication 255 Physical Barriers • Nonverbal Barriers • Verbal Barriers • Psychological Barriers The Importance of Listening 256 Effective Listening • Ineffective Listening • Stages of Listening Types of Listening 257 Nonlistener • Marginal Listener • Evaluative Listener • Active Listener Elements of Effective Communication 257 Skills for Effective Communication • Organizational Climate • Using Body Language • Using Positive Language Leadership Essentials for Improving Communication 259 The Interaction Process • Adapting Communication Styles Summary 260 KEY POINTS 260 GLOSSARY 261 REFERENCES 261 APPENDIX 263 12 Effective Meetings 264 Mark G. Hanly Introduction 264 Things To Do before the Meeting 265 Determine If There Is a Need for a Meeting • Determine What Type of Meeting Is Needed • Develop the Agenda • Use of the Consent Agenda • Determine Whom To Invite to the Meeting • Determine the Venue of the Meeting • Determine the Technology/ Equipment Required for the Success of the Meeting Things To Do during the Meeting 268 Things To Do after the Meeting 269 Calculating the Cost of Meetings 269 Recurrent Meetings 269 How To Be an Effective Participant in a Meeting 269 Summary 270 KEY POINTS 270 GLOSSARY 271 REFERENCES 271 13 Conflict Management 272 Jean Egan Introduction 272 Conflict Defined 272
- 15. Contents ix What Conflict Isand Is Not 273 Constructive Conflict 273 Destructive Conflict 273 Common Causes of Conflict 273 Internal and External Origins of Conflict 274 Internal Sources of Conflict • External Sources of Conflict Power Is the Underlying Issue 275 Two Basic Beliefs about Handling a Conflict 275 Five Conflict Resolution Styles 275 Working with Each Style To Resolve Conflict 276 Creating an Environment Where Conflict Is Addressed and Resolved 276 The Role of the Manager • The Role of the Staff • Creating the Right Environment To Resolve Conflict A Communication Model To Manage and Resolve Conflict 277 The GGMG Model A Seven-Step Plan for Resolving Conflict 277 When Conflict Resolution Fails 278 Key Steps in Resolving Conflict What the Organization Can Do 278 Summary 278 KEY POINTS 279 GLOSSARY 279 REFERENCES 279 APPENDIX 280 14 Managing Change 281 Kellie Gibbs Introduction 281 Key Concepts of Change 282 Types of Change 282 Factors Affecting Change 283 The Change Curve 283 Laboratory Change Roles 284 How To Become an Agent of Change 285 Why People Resist Change 285 Fear • Lack of Trust • Comfort • Perception of Need • Lack of Knowledge/Competence • Poor Communication • Exhaustion/ Saturation Forms of Resistance to Change 286 Steps to Managing Change 286 Prepare • Implement • Monitor • Sustain • Reevaluate Changes that Are Common Today 286 Looking Ahead 286 Paradigm Shifts in Today’s Healthcare Industry 287 Trends and Changes 287 Competing in the Future in the Healthcare Arena 288 Summary 289 KEY POINTS 289 GLOSSARY 289 REFERENCES 289 APPENDIX 291 Section III Personnel Management 293 15 Employee Selection 295 Anthony S. Kurec Introduction 295 Diversity in the Workplace 296 Criterion-Based Job Description Requirements 296 Job Description Review • Minimal Personnel Requirements Search Process 299 Search Committee • Advertising Interview Process 300 Screening Résumés • Interview Formats • Interview Questions • Interview “Do’s and Don’ts” Hiring Process 302 Orientation 302 Documentation 304 Retention 304 Resignation and Termination 305 Progressive Discipline 305 Summary 306 KEY POINTS 306 GLOSSARY 306 REFERENCES 306 APPENDIX 308 16 Performance Appraisals and Competency Assessment 309 Kari Jones, Diane C. Halstead, and Donna L. Oblack Introduction 309
- 16. x Contents Performance Appraisals309 Definition of Performance Appraisals • Purpose of Performance Appraisals • Benefits of Performance Appraisals • Appraisal Types: Formal and Informal Appraisals • Responsibility for Developing a Performance Appraisal Program • Legal Aspects of a Performance Appraisal Program • Elements of a Meaningful Formal Performance Appraisal • Competency-Based Appraisals • Rating Methods • Other Types of Performance Appraisals • Who Should Perform the Appraisal? • Preappraisal Preparation • Steps to a Successful Performance Appraisal Interview • Benefits of Becoming a Mentor • Salary Adjustments • Strategies To Reinforce Appropriate Behaviors • Guidelines for Appraising Poor Performers • Dealing with Emotional Outbursts during Performance Appraisals • Completed Performance Appraisal Documents • Improvement Plan • Web-Based Software Products and Websites Competency Assessment 318 Regulatory Foundation for Competency Assessment • Timing of Competency Assessment • Methods for Assessment of Competency • Practices • Personnel Excellence Summary 323 KEY POINTS 323 GLOSSARY 323 REFERENCES 324 APPENDIXES 327 17 Staffing and Scheduling 362 Patti Medvescek Introduction 362 Laboratory Personnel: Current Dynamics Affecting Staffing 362 Labor Shortage • Business Need • Increasing Opportunities for Medical Technologists Personnel Requirements 363 Education • Training and Competence Assessment • Functional Definitions • Generalist versus Specialist Laboratory Staffing 365 Staffing Requirements • Basis for Determination: Workload Recording Staff Scheduling 367 Key Success Factors • Metrics for Success • Alternatives • Special Considerations • Flexible Staffing Summary 370 KEY POINTS 379 GLOSSARY 379 REFERENCES 371 APPENDIX 372 18 Teams, Team Process, and Team Building 373 James W. Bishop, K. Dow Scott, Stephanie Maynard-Patrick, and Lei Wang Introduction 373 Definition of a Team 374 Distinguishing Teams from Work Groups • Types and Classifications of Teams • Why Define a “Team” So Precisely? Group Process and Teams 376 Guidelines for Choosing Whether To Have Teams 377 Common Purpose • Interdependent Tasks • Summary • A Cautionary Note Selecting Team Members 378 Task-Related Training • Team-Related Training Leading Teams 381 General Ideas about Leadership: A Brief Review • Leadership in a Team Environment • Team Leader Selection Motivating Team Performance 383 Goal Setting and Performance • Goal Setting and Teams • Evaluating Teams and Team Members • Pros and Cons of Rewarding Team Members Virtual Teams 384 Global Teams 384 Summary 385 KEY POINTS 385 GLOSSARY 385 REFERENCES 386 APPENDIXES 388 19 Labor Relations 392 Lynne S. Garcia Introduction 392 Labor Law 393 National Labor Relations Act (Wagner Act), 1935 • Fair Labor Standards Act (Black Act), 1938 • Labor-Management Relations Act (Taft-Hartley Act) • Labor-Management Reporting and Disclosure Act (Landrum-Griffin Act) • 1974 Amendments to the NLRA National Labor Relations Board 395 Description • Function • Structure • Processing of Cases • Authority To Secure Injunctive Relief from a Court • Current Issues Related to the NLRB Union Structure 396 Formal Structure • Union Membership • Function of the Union Steward Unionization Process 398 Individual, Group, and Union Image: Reasons Why Employees Join a Union • Relevance for Healthcare Employees Organizing Campaign 399 Authorization Cards • The Bargaining Unit • Information Distribution and Solicitation • Election • Certification Collective Bargaining 401 Issues for Bargaining • Preparation Phase • Negotiation Phase • Administration of the Agreement • Management Rights Clause Summary 403 KEY POINTS 403 GLOSSARY 403
- 17. Contents xi REFERENCES 405 APPENDIXES 406 20Workplace Drug Testing and the Clinical Laboratory 408 Jimmy R. Lea Introduction 408 Regulated and Nonregulated Testing 409 Whom To Test 409 Preemployment Testing • For Cause/Reasonable Suspicion • Random Testing • Return to Duty Drug Testing Protocol 411 Specimen Collection • Specimen Testing • Cutoff Concentrations • Drug Confirmation • Reporting Results Managing Clinical and Forensic Drug Testing 415 Summary 415 KEY POINTS 415 GLOSSARY 415 REFERENCES 416 APPENDIXES 417 Section IV Requirements for Effective Laboratory Management 419 21 Quality Management 421 Ron B. Schifman, George S. Cembrowski, Donna M. Wolk, and Joanne I. Brisbois Introduction 421 Quality Management of Preanalytical Processes 422 Test Selection and Ordering • Quality of Specimen Collection • Patient and Client Satisfaction • Specimen Transport, Storage, Receipt, and Preanalytical Processing Quality Management of Analytical Processes 425 Method Selection and Evaluation • Quality Control • Quality Control Rules • Frequency of Quality Control Analysis • Specification of MAE • Use of Patient Data for Quality Control • External Quality Control (Proficiency Testing) Quality Management of Postanalytical Processes 436 Turnaround Time 436 Corrected and Incomplete Reports 436 Document Control 437 Summary 437 KEY POINTS 438 GLOSSARY 438 REFERENCES 439 APPENDIXES 444 22 International Organization for Standardization 447 Anne Marsden and Amy Shahtout Introduction 447 ISO Background 447 Benefits of the ISO Standards 448 ISO 9000 Family 448 ISO 15189 449 ISO Certification Process 449 ISO 15189 and the CAP Summary 450 KEY POINTS 450 REFERENCES 450 23 Effective Communication in Laboratory Management 451 Elissa Passiment and Andrea J. Linscott Introduction 451 Delivering the Message 452 Communicating to Diverse Audiences 453 Means and Mechanics of Effective Communication 453 Spoken Word • Written Word • Intradepartmental Communication • Interdepartmental Communication • External Communication Summary 456 KEY POINTS 456 GLOSSARY 456 REFERENCES 456
- 18. xii Contents 24 TheLaboratory Information System: Making the Most of It in the Clinical Microbiology Laboratory 458 Joseph M. Campos Introduction 458 The Microbiology Laboratory in the 21st Century 459 A Primer on Information System Terminology and Architecture 460 A Primer on the LIS LIS Interfaces 461 Admission/Discharge/Transfer (ADT) Interface • Order-Entry Interface • Results-Entry Interface • Instrument Interface • Billing Interface • Reference Laboratory Interface • Peripheral Hardware Laboratory Informatics 463 Laboratory Data Repository • Data-Mining Tools • Connectivity Miscellaneous Applications 465 Preparation of a Periodic Antibiogram • Electronic Surveillance for Clusters of Hospital-Associated Infections • Unique Device Identifiers Summary 465 KEY POINTS 467 GLOSSARY 467 REFERENCES 470 25 Management of Point-of-Care Testing 471 Glen L. Hortin and Christopher D. Doern Introduction 471 Organizational Challenges 472 Political Challenges • Setting Goals for POCT Management • Developing Management Structures for POCT • Laboratory Licensure and Accreditation Operational Challenges 474 Determining the Scope of POCT Services • Weighing Alternatives to POCT • Analyzing Costs and Benefits • Assessing the Impact of POCT Services • Quality Assurance Challenges • Information Systems and Billing POCT in Developing Countries and Rural Settings 480 Challenges • Organizing POCT in Resource-Limited Settings Technological Challenges 481 Rapid Changes of Menu, Devices, and Technology • Lack of Equivalence between POCT and Central Laboratory Tests • New Monitoring Technologies Summary 483 KEY POINTS 483 GLOSSARY 483 REFERENCES 484 APPENDIX 487 26 Principles of Preanalytic and Postanalytic Test Management 488 Adarsh K. Khalsa, Michael Santa Cruz, and Michael A. Saubolle Introduction 488 Preanalytic Activities 489 Test Selection and Implementation • Appropriate Test Utilization • Specimen Acquisition, Transport, and Storage • Test Ordering Postanalytic Activities 498 The Report • Storage and Retention • Assessment of Test Results on Patient Outcomes Summary 502 KEY POINTS 502 GLOSSARY 503 REFERENCES 503 27 Selection and Implementation of New Equipment and Procedures 506 Paula Revell and Lakshmi Chandramohan Introduction 506 Defining the Laboratory’s Requirements 507 Technical/Performance Considerations 508 Physical/Technology Requirements 509 Human Resources 510 Financial 510 Confidentiality and Conflict of Interest Information Review 511 Implementation and Product Placement 511 Verification and Validation 512 Verification • Validation Personnel Competency Assessment and Training 512 Proficiency Testing 512 Summary 513 KEY POINTS 513 GLOSSARY 513 REFERENCES 513 28 Laboratory Safety 515 James J. Dunn and David L. Sewell Introduction 515 Safety Management Plan and Responsibilities 516 Laboratory Hazards 517 Biological Hazards • Chemical Hazards • Physical Hazards • Radiation Hazards Standard Precautions 518
- 19. Contents xiii Hazard Prevention andContainment 518 Risk Assessment • Handwashing • Barrier Protection • Engineering Controls • Work Practices • Respiratory Protection • Immunization • Warning Signs and Labels • Biological Safety Cabinets and Chemical Fume Hoods Sterilization and Decontamination 524 Spill Management 526 Biological • Chemical Fire Safety 527 Waste Management 527 Regulatory Oversight • Management Program Packaging and Shipping Infectious Substances 528 Infectious Substances Classification • Packaging, Labeling, and Shipping Regulated Material Personnel Training 530 Training Program • Methods • Documentation • Monitoring and Evaluation Summary 533 KEY POINTS 533 GLOSSARY 533 REFERENCES 534 APPENDIXES 537 29 Emergency Management 545 Andrea J. Linscott, Patti Medvescek, and David L. Sewell Introduction 545 Emergency Management Plan 546 Purpose or Policy • Hazard Analysis • Incident Management System Elements of an EMP 548 Emergency Operations Center • Communications • Medical Treatment Areas • Decision To Shut Down Laboratory • Damage Assessment • Evacuation • Personnel Pool • Personnel Care • Locator System • Security • Training • Monitoring and Evaluation Disasters 551 Fire • Hazardous Materials • Radioactive Material • Utility Failure • Bomb Threat • Natural Disasters • Terrorism Threats • Civil Disorder Summary 553 KEY POINTS 553 GLOSSARY 553 REFERENCES 554 APPENDIXES 555 Section V Financial Management 565 30 Financial Management: Setting the Stage 567 Ronald B. Lepoff Introduction 567 The Hospital Environment 568 Operating in the Inpatient Hospital Setting • Operating in the Outpatient Hospital Setting The Non-Hospital Environment 571 Summary 572 KEY POINTS 572 GLOSSARY 572 REFERENCES 572 31 Strategic Planning 573 Paul Valenstein Introduction: What Is Strategy? 573 Evidence To Recommend Strategic Planning 574 Randomized Controlled Trials • Case Studies • Economic Theory Developing and Maintaining a Business Strategy: The Strategic Planning Process 575 Structure of the Clinical Laboratory Industry 576 Size of the Testing Market • Concentration of Competitors • Barriers to Entry • Separation of Payor, Purchasing Agent, and Beneficiary • Economies of Scale • Restrictions on Markups and Kickbacks • Powerful Sellers and Buyers • Substitute Products • Unique Economics of Inpatient Care • Conclusions Competitor Analysis 578 Competitors’ Goals • Competitors’ Assumptions • Competitors’ Capabilities • Interactions of Competitors • Conclusions Strategic Positions in the Laboratory Industry 580 What Are Strategic Positions? • Types of Strategic Positions • Strategic Positions of Clinical Laboratories • Conclusions Implementing the Strategy: Activity Fit 582 What Is Activity Fit? • Activity Fit Involves Trade-Offs Failure of Strategy 582 Straddling • Growth Trap • Profitability Trap • Hubris Summary 584 KEY POINTS 584 GLOSSARY 584 REFERENCES 585 APPENDIXES 586
- 20. xiv Contents 32 HumanResources at the Local Level: An Important Component of Financial Management 589 Washington C. Winn, Jr., Fred Westenfeld, and Michael R. Lewis Introduction 589 Constraints on Managerial Function 590 The Cardinal Rules for Optimizing Performance 591 Get It Right at the Outset • Expect Cooperative Behavior and Best Possible Performance • Lead by Example • Involve All Members of the Team • Perceived Fairness Is More Important than Rigid Equality • Maintain Communication in All Directions • Keep Your Eyes and Ears Open • Act Quickly and Decisively • When Problems Surface, Involve the Laboratory Manager Immediately; Involve Human Resources as Appropriate Classic Situations that May Interfere with Optimal Performance 593 The Underperforming Employee • The Overperforming Employee • The Intrusion of Personal Issues • The Underground Troublemaker • The Cabal • Weakness at the Top Practical Issues in Utilization of Personnel Resources 594 Skill Mix of Personnel • Cross-Training and Rotation • Mix of Employment Arrangements • Coverage of Vacations, Holidays, and Routine Shifts • Use of Overtime Summary 595 KEY POINTS 596 GLOSSARY 596 REFERENCES 596 33 Costs, Budgeting, and Financial Decision Making 597 Geoffrey C. Tolzmann and Richard J. Vincent Introduction 597 Cost Accounting 598 Classification of Costs • Behavior of Costs • Measuring Full Cost • Average versus Marginal Costs • Actual Cost versus Standard Cost • Costing Issues • A Formula for Developing Laboratory Costs • Laboratory Costing Examples Break-Even Analysis 600 Equipment Purchase • Capitation Contract Capital Acquisition Concepts 605 Time Value of Money • Depreciation Budgeting 698 Types of Budgets • The Budgeting Process • Budget Examples Variance Analysis 610 Financial Statements 613 Financial Ratios Summary 615 KEY POINTS 616 GLOSSARY 616 REFERENCES 617 34 Financial Decision Making: Putting the Pieces Together 619 Ronald J. Bryant and Michael R. Lewis Introduction 619 Contextual Considerations 619 Analytical Underpinnings of a Decision 620 Executing the Plan 620 Summary 620 KEY POINTS 621 Section VI Generation of Revenue 623 35 Correct Coding of Billable Services in the Clinical Laboratory 625 Vickie S. Baselski, Alice S. Weissfeld, and Fran Sorrell Introduction 625 Procedure Coding: What Test Procedures Have Been Performed? 626 The CPT System 626 Description • Types of CPT Codes • Modifiers • The Process for Change • Procedure Coding Guidance Procedure Coding Alternatives 629 Capitated Services 629
- 21. Contents xv Diagnosis Coding: WhyIs the Service Being Performed? 630 Inpatient Diagnosis Coding • Outpatient Diagnosis Coding • Other Unique Patient Groups • ICD-CM • SNOWMED CT Service Location 631 Role of CLIA and State Licensing • Revenue Codes Documentation of Codes 632 Requisition • Claims • Code Mapping Summary 632 KEY POINTS 632 GLOSSARY 633 REFERENCES 634 APPENDIX 635 36 Approaches to Billing Laboratory Services 637 Vickie S. Baselski, Alice S. Weissfeld, and Fran Sorrell Introduction 637 Interactions in the Billing Process 638 Provider Mix • Payor Mix Terms of Coverage 640 Types of Services • Payment for Services Logistics of the Billing Process 641 Claim versus Invoice Submission • Invoice Billing • Claim Billing Capitated Arrangement Billing 642 Pay for Performance 643 Summary 643 KEY POINTS 643 GLOSSARY 643 REFERENCES 644 APPENDIX 645 37 Charges and Fees for Laboratory Services 646 Vickie S. Baselski, Alice S. Weissfeld, and Fran Sorrell Introduction 646 Calculating Costs and Charges 646 Setting Costs • Setting Charges Determining Payment Amounts 647 Fee Schedules • Medicare Clinical Laboratory Fee Schedule • Fee Setting for New Codes on the CLFS • The Medicare Physician Fee Schedule • Other Fee Schedules • Capitated Payments Keys to Success in Reimbursement 649 Retrospective Payment • Prospective Payment Summary 650 KEY POINTS 650 GLOSSARY 651 REFERENCES 651 APPENDIX 653 Section VII Profitability, Contribution, and Reimbursement 655 38 Rules and Regulations in Reimbursement 657 Vickie S. Baselski, Alice S. Weissfeld, and Fran Sorrell Introduction 657 General Criteria 658 Basic Rules 658 Procedure Code Edits 659 Basic Edits • National Correct Coding Initiative • Mutually Exclusive Codes • Comprehensive/Component Edits • Medically Unlikely Edits Conditions of Coverage 660 Medical Necessity • National Coverage Determination • Local Coverage Determination • Screening Tests • Experimental Testing • Administrative Policies Special Coverage Conditions 663 End-Stage Renal Disease • Skilled-Nursing Facility • Ambulatory Payment Classifications • Inpatients • Three-Day Window • Date of Service Rule • Other Private-Payor Rules Remittance Advice Review 664 Beneficiary Documents • Provider Documents • Auditing Remittance Advice Summary 665 KEY POINTS 665 GLOSSARY 665 REFERENCES 666 APPENDIXES 668
- 22. xvi Contents 39 Reimbursement Compliance670 Vickie S. Baselski, Alice S. Weissfeld, and Fran Sorrell Introduction 670 Improper Payments 671 Program Integrity 672 Authority for Program Integrity • Activities in Program Integrity Payor Integrity 674 Prepayment Review • Postpayment Review Laboratory Provider Integrity 675 The Seven Essential Elements • Specific Areas of Concern Coding and Billing Issues 676 CPT Coding • Modifiers • ICD-CM Coding • The Requisition • Special Ordering Situations Medical-Necessity Issues 678 Record Retention 679 Marketing Practices 679 Pricing and Inducements • Ordering Provider and Patient Communication Fraud Alerts and Advisory Opinions 680 Auditing and Monitoring 680 Response to Possible Fraud or Abuse 680 Laboratory Examples of Fraud and Abuse 681 Summary 681 KEY POINTS 681 GLOSSARY 681 REFERENCES 682 APPENDIXES 684 40 Determination of Profitability 685 Vickie S. Baselski, Alice S. Weissfeld, and Fran Sorrell Introduction 685 Pitfalls in Cost Accounting 686 Laboratory Profitability 686 Balance Sheets • Income Statements • Cash Flow Statements Key Indicators 687 Key Income Indicators • Key Expense Indicators Institutional Profitability 688 Human Profitability 688 Laboratory Value 689 Summary 689 KEY POINTS 689 GLOSSARY 690 REFERENCES 690 Section VIII Outside Marketing and Expansion 693 41 Outreach Considerations and Overall Goals 695 Charlene H. Harris Introduction 695 Considering an Outreach Program 695 Administrative Interest • Exploring the Market • Strategic Plan • Business Plan • Sales Plan Commitment from All Relevant Parties 705 Feasibility Report • Philosophical Understanding • Service and Financial Support Implementing the Outreach Program 706 People • Processes • Facilities • Equipment • Supplies Outreach Indicators 706 Growing the Outreach Program 707 Market Assessment • Client Needs Summary 707 KEY POINTS 707 GLOSSARY 708 REFERENCES 710 APPENDIXES 711 42 Outreach Implementation Requirements: A Case Study 740 Frederick L. Kiechle, Jack Shaw, and Joseph E. Skrisson Introduction 740 Outreach Plan Approval Process 741 Barriers to the Plan’s Approval • Consultants to the Rescue • Bureaucratic Simplification Equals Success Requirements for Outreach Implementation 743 Sales and Marketing Program • Courier Services: Basics and Logistics
- 23. Contents xvii Beaumont Reference Laboratory:1993 to 2004 747 Annual Growth and Its Implications • Projecting Future Volume • Send-Out Tests • Monitoring Financial Outcome Joint Venture Hospital Laboratories 754 History of JVHL • Benefits of BRL’s Affiliation with JVHL Summary 755 KEY POINTS 756 GLOSSARY 756 REFERENCES 756 43 Finance and Decision Making in Outreach 759 Michael G. Bissell and Harry E. Pukay-Martin Introduction 759 The Clinical Laboratory as a Business • The Phases of the Growth Curve Decision Making in Laboratory Outreach Management 760 Types of Costs 760 Direct and Indirect Costs • Fixed, Variable, and Mixed Costs • Unit Costs • Additional Cost Concepts for Decision Making • Characteristics of Laboratory Costs • Microcosting Levels of Decision Making in Outreach Operations 763 Menu: To Test or Not To Test • Operation: To Perform In-House or Send Out • Capital: Whether or Not To Acquire New Equipment • Financing Capital: To Lease or Buy Equipment Summary 766 KEY POINTS 766 GLOSSARY 767 REFERENCES 769 APPENDIXES 770 44 Outreach: Obstacles to Hospital Outreach and Enhancing Customer Satisfaction 777 Beth H. Deaton Introduction 777 Making Organizational Changes 777 Centralize Work • Place Laboratory Management on Off Shifts Give Outreach Its Due 778 Make Outreach High-Profile • Manage Outreach as a Business, Not a Department Information Technology Changes 778 Hospital Systems versus Separate Systems • Nonstaff Physicians • Data Interface • Patient Registration and Accounting Concerns • Populating the Patient Record • Physician Office Connectivity Meeting the Needs 780 Capital • FTEs Hospital versus Outreach Contracting 780 Defining Insurance Plans • Contracting • Acceptance of Payors Failure To Understand Financial Implications and Requirements 781 Unrelated Business Income Tax • Other Taxes Understanding the Hospital’s Point of View 781 Lower Cost per Test • Make Money Translating Hospital and Laboratory Compliance for an Outreach Operation 782 Physician Communication • Medicare Secondary Payor Questionnaires • Physician Acknowledgments • Advance Beneficiary Notices • Requisition Design • Pricing • Add-On Tests • National and Local Coverage Policies • Sanctioned Physicians • Contracts • Audits and Reviews • Participation and Cooperation Enhancing Customer Satisfaction: Communication 784 Newsletter • Marketing and Sales Team • Laboratory Guidebook • Website • Focus Group Customer Satisfaction Assessment 785 Surveys • Problem Reporting and Resolution Couriers: The First Line 787 Client Services 787 Access to Draw Sites and Patient Service Centers 788 Building and Retaining Your Client Base 789 Leverage the Continuum of Care • Keep Asking Why • Follow Up When Clients Leave Professional Marketing and Sales Personnel 789 Commission Plans • Reports • Prepackaged Information Technical Expertise Accessibility 790 Accounts That Require Special Care 790 Nursing Homes • Drug Accounts • Home Health Agencies • Veterinary Lab Services Define Service Area and Services 791 Range of Services • The Importance of Standardization Summary 793 KEY POINTS 793 GLOSSARY 793 REFERENCES 794 APPENDIXES 795
- 24. xviii Contents 45 TheCurrent State of the U.S. Food and Drug Administration Process and Regulations for Diagnostic Laboratory Assays 809 Donna M. Wolk, Natalie N. Whitfield, Elizabeth M. Marlowe, and Marilyn M. Marshall Introduction 809 Background: The FDA Processes for Classification and Assessment of New IVDs 810 Premarket Approval (PMA) • Premarket Notification [510(k)] and 510(k) Review • Alternative Application Submission Approaches • The Pre-IDE Process • The Expedited Review Miscellaneous FDA Requirements 813 Establishment Registration • Medical Device Listing • Good Manufacturing Practices and Quality System Regulations • Quality Control Automated Laboratory Assays 814 Postmarket Review 814 Limitations Inherent to Current FDA Processes 814 Summary 815 KEY POINTS 815 GLOSSARY 815 REFERENCES 816 46 The Clinical Trial Laboratory: Research Compliance for Clinical Research Microbiologists 818 Donna M. Wolk and Marilyn M. Marshall Introduction 818 Funded Clinical Research in Laboratory Medicine 819 Sponsored Projects • Office of Research and Contract Analysis (ORCA) Compliance with Human Subject Regulations 820 Background for Human Subject Regulations • Regulatory Requirements for Human Subject Protection • Human Subject Research: Classifications Based on Risk • Human Subject Training Requirements and Site Authorization • Informed Consent • Special Populations • Continuing Review by the IRB • Records Retention for HSPPs Compliance with HIPAA 822 Compliance with Conflict of Interest Policies 823 Intellectual Property Considerations GLP and GCP Regulations 825 Sponsor Responsibilities • Study Director and Responsibilities • Quality Assurance Office: Organization, SOPs, Inspections, Reporting Data • GLP Background • Equipment and Equipment Validations • Standard Operating Procedures • Reagent and Solutions: Test and Control Article • Final Research Reports Summary 827 KEY POINTS 827 GLOSSARY 827 REFERENCES 829 APPENDIX 831 47 Clinical and Evidence- Based Research in the Clinical Laboratory 832 Donna M. Wolk Introduction 832 Types of Studies 833 Observational Studies • Mechanistic Studies • Therapeutic Studies • Large-Scale Clinical Trials • Meta-Analysis Translational Research 833 Sequence of Investigation • Literature Search • Hypothesis Generation • Designing the Study To Test the Hypothesis Biostatistics 835 Descriptive Statistics • Inferential Statistics: General Issues for Medical Devices • Other Issues for Diagnostic Studies Other Research Considerations 837 Systematic Reviews and Laboratory Medicine Best Practices 837 Evidence-Based Laboratory Medicine • Laboratory Medicine Best Practices Initiative Summary 839 KEY POINTS 840 GLOSSARY 840 REFERENCES 845 APPENDIX 848 Section IX Clinical Trials and Evidence-Based Laboratory Medicine 807
- 25. Contents xix 48 Benchmarking andPerformance Monitoring for the Clinical Laboratory 851 Lionelle D. Wells, Washington C. Winn, Jr., and Michael R. Lewis Introduction 851 Why Benchmark? 852 The Payoff from Benchmarking 852 The Basic Steps 852 Prioritization • Data Collection and Analysis • Development and Implementation of Plans Where Do We Find Information about Benchmarks? 853 Quality Benchmarks • Financial Benchmarks General Approach to Financial Benchmarking and Performance Monitoring 854 The Problem of Comparability • The Problem of Cost Accounting • Workload Recording • The Search for Simplicity • Selection of Indicators for Benchmarking or Performance Monitoring • Problems Associated with Benchmarking by UOS • UOS Benchmarking in a Competitive Environment Measuring Laboratory Financial Performance 857 Performance Monitoring • External Benchmarking Interpretation of Performance Monitoring Data 862 Summary Measure as Unifying Force • Prerequisites for Effective Use of a Summary Measure Interpretation of External Benchmarking Data 862 Measuring Laboratory Performance in the Broader Clinical Setting 863 Effect of Accountable Care Organizations • Linkage of Payment to Measures of Quality • Laboratory-Related Standards in Broader Accreditation Programs Summary 865 KEY POINTS 865 GLOSSARY 865 REFERENCES 866 APPENDIXES 868 49 Test Utilization and Clinical Relevance 876 Michael L. Wilson, Gary W. Procop, and L. Barth Reller Introduction 876 Evaluating Potential and Real Problems 877 Clinical Relevance • Cost-Effectiveness Analysis, Cost-Benefit Analysis, and Cost-Utility Analysis Documenting the Extent of the Problem 878 Literature Review • Centralized Studies • Local Data Laboratory-Based Approaches to Control 880 Newsletters • Policy Changes • Personal and Ad Hoc Communication • LIS/HIS-Based Controls on Test Ordering • LIS- Based Feedback in Reports Institution-Based Approaches to Control 882 Working with the Medical Staff • Formal Protocols Validated by Medical Staff • Working with the Nursing Staff • The Concept of the Laboratory Test Formulary • Using Major Events To Effect Change (e.g., Institutional Quality Assurance [QA] Office, Root Cause Analysis) What Works and Doesn’t Work: How To Take the First Steps 884 Putting It All Together 885 Base Policy Approaches and LIS/HIS-Based Controls on Evidence- Based Medicine • Track Results • The Plan, Do, Study, Act Model • The Future: Better Teaching and Training Summary 886 KEY POINTS 886 GLOSSARY 887 REFERENCES 887 APPENDIX 889 50 Benchmarking and Performance Monitoring: What Is Appropriate for Your Laboratory? 890 Ronald J. Bryant and Michael R. Lewis Introduction 890 Starting at the Beginning: What To Measure? 891 Where Can We Get Help? 892 How Will I Fund This? 892 Evaluation of Data and Monitoring of Performance 892 Summary 892 KEY POINTS 893 GLOSSARY 893 Section X Defining and Measuring Standards for Success 849
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- 27. in the breastfrom a ball, and died in consequence of loosening the bandages at the news of the entrance of the French. Major Pedro Rodriguez also displayed much bravery. From that day until the appearance of Anzani in the Legion, I absented myself but little from the corps, although engaged at sea most of the time. About that period Anzani was at Buenos Ayres, where, receiving an invitation from me, he came to Montevideo. The acquisition of Anzani to the Legion was extremely valuable, especially for instruction and discipline. Although he was much opposed by Manceni and by the second chief, who could not submit to acknowledge his superior merit, being perfect in military knowledge and direction, he systematized the corps on as regular a footing as circumstances would permit. The flotilla, although of little importance, did not fail to be worth something to the defence of the place. Posted at the left extremity of the line of defence, it not only effectually covered it, but threatened the right flank of the enemy whenever it attempted an attack. It served as a link between the important position of the Cerro and the Island of Libertad, by greatly facilitating and coöperating in the attempts which were continually made upon the right of the enemy, who were besieging the Cerro. The Island of Libertad had been watched by the enemy, who laid a plan to get possession of it. Their squadron, under command of General Brown, was prepared to invade it and gain possession. It was determined that artillery should be placed upon it, and I transported to it two cannon, eighteen pounders. About ten at night, that operation having been performed, I left the island with a company of my countrymen, and returned towards Montevideo. Then happened one of those unforeseen and important events which, I love to say, are evidently brought about by the hand of Providence. The Island of Libertad, placed in advance of the coast of the Cerro at the distance of less than a cannon-shot, is less than three miles from Montevideo. The wind blew from the South, and caused some agitation of the sea in the bay in proportion to its force, and especially in that passage between the island and the mole. I had embarked in a launch, purchased by the government,
- 28. and had withme sailors enough to perform the service just executed, and the large lighter in tow, in which the artillery had been transported. Between the waves rolling in from the south and the weight of the boat, which was also exactly square in shape, we proceeded slowly, drifting considerably towards the north end of the bay, when, all at once, several vessels of war were discovered to the leeward, and so near that the sentinels were heard calling to the men, "Keep quiet!" It was doubtless the enemy's squadron. We wonderfully escaped being captured by them; but the principal cause of our safety was, that the small vessels and the boats of the enemy had gone to attack the island, and there was nothing left that could pursue us. If this had not been the case, we should doubtless have been taken: but, more than this, the enemy did not fire a shot, though they might easily have sunk our little vessels, for fear of alarming their troops who had gone to the island, to surprise it. But what an escape it appeared to me when I reached the mole, and began to hear a terrible discharge of musketry on the Island of Libertad! I immediately reported the proceedings to the government, and then went on board my little vessels, to prepare them to go in aid of the troops on the island. They were only about sixty there, not well armed, and with but little ammunition. I set sail at dawn of day, with only two small vessels, called yates; the third, and only remaining one of the flotilla, not being fit for use at that time. We proceeded, and soon entered between the island and the Cerro, uncertain whether the enemy had got possession or not in their night attack. But the brave Italians, although taken unexpectedly, had fought with bravery, and had not only repulsed the enemy, but driven them back with much loss; and the corpses of Rosas' soldiers floated about in the waters of the harbor several days after. Having sent a skiff to the island to ascertain its fate, I soon received welcome intelligence of the successful resistance. I speedily landed the munitions, and one of my officers with some men to serve the guns; and this had hardly been accomplished when the enemy opened their fire, and the island replied with its two cannon. I then, with my two boats, got to windward of the enemy's vessels, and did all I could against them. But the combat was unequal in the
- 29. extreme. I hadagainst me two brigantines and two schooners, and one of the former had sixteen guns. The cannons on the island had platforms, and were ill-supplied with ammunition, and therefore did not fire well, or produce much effect. Had they been better provided for, they might have done good service. Although the sea was not very rough, it was sufficiently so to prevent the guns of my two little vessels from firing with precision; and, in short, it seemed impossible that the engagement could fail to be to the enemy successful. But once more God provided for us! Commodore Purvis, then commander of the British station at Montevideo, sent a messenger to Brown, on account of which he ceased firing. From that moment the affairs turned to negotiation. The enemy's squadron left the harbor, and the island did not again fall into the power of another. Whatever the reasons of the Commodore may have been, it is undeniable that some degree of chivalrous generosity towards an unfortunate but courageous people entered into the sympathies and into the act of the philanthropic son of Albion. From that moment Montevideo knew that she had in the English Commodore not only a friend, but a protector.
- 31. CHAPTER XXI. EXPLOITS OFTHE ITALIAN LEGION DURING THE SIEGE —TRES CRUCES—THE PASS OF BOJADA—THE QUADRADO—GENERAL RIVERA DEFEATED AT INDIA MUERTA, BUT WITHOUT DISCOURAGING EFFORTS, INTERVENTION CONTINUED—AN EXPEDITION IN THE URUGUAY, THE FLOTILLA BEING UNDER MY COMMAND. The affair of the island increased the fame and importance of the arms of the Republic, although its favorable result was more due to fortune than to anything else, and although nothing more was gained by defending it. Thus it was, that by insignificant, or at least small but successful enterprizes, a cause was fostered and raised up, which had been considered by many as desperate. A patriotic and excellent administration of the government, at the head of which was Pacheco; the management of the war by the incomparable General Paz; the fearless and powerful support given by the people, then purged from their few traitors and cowards; and the arming of the foreign Legions,—in short, everything promised a happy result. The Italian Legion, whose formation was ridiculed by some, and especially by the French, had now acquired so much fame, that they were envied by the best troops. They had never been beaten, though they had shared in the most difficult enterprizes and most arduous battles. At Tres Cruces, (the Three Crosses,) where the fearless Colonel Neva, from an excess of courage, had fallen within the enemy's lines, the Legion sustained one of those Homeric battles described in history, fighting hand to hand, and driving the troops of Ourives from their strongest positions, until they brought away the dead
- 32. body of thechief of the line. The losses of the Legion on that day were considerable, compared with their small numbers, but on that account they gained more honor. That success, which seemed as if it might exhaust it, on the contrary fostered it exceedingly. It grew in numbers, with new recruits, soldiers of a day, but who fought like veterans! Such is the Italian soldier; such are the sons of the despised nation, when struck with the generous idea of what is noble. At the Pass of the Bajada, on the 24th of April, was one of the most serious conflicts. A corps of the army under the command of General Paz, had marched out from Montevideo, passed by the right wing of the enemy, proceeded along the shore of the north bend of the bay to Pantanoso, where, joining the Republican forces of the Cerro, he intended to make a decisive blow on the enemy's army,— who were thus drawn out of their strong positions of the Cerrito,—to surprise two battalions, stationed on the shores of that marshy little stream. As that operation was not successful in consequence of a want of concert, they were obliged to go through the Pass, involved in a very sharp action. Of the two divisions comprising the corps, which were about seven thousand, that which formed the rearguard was so much pressed by the enemy, that, when recovered from surprise, they endeavored to regain their ground. This they would have saved with the greatest possible effort, in consequence of the extreme difficulty of the place. I commanded the division of the centre; and the general ordered me to re-pass and support the troops in that danger. I obeyed, but, to my surprise, found the battle a desperate one. The Republicans were fighting bravely: but the enemy had surrounded them, and then occupied a very strong salting establishment, (called Saladero,) between us and the rearguard, who had exhausted their ammunition. The head of the Italian column entered the Saladero, just when the head of one of the enemy's columns had entered. Then commenced a very warm contest, hand to hand; and finally Italian bravery triumphed. At that place the ground was encumbered with dead bodies; but my friends were safe, and the fight proceeded, with advantage to our side. Other corps came in to support them, and the retreat was effected
- 33. in admirable order.The French Legion, on that day, going to operate simultaneously on the line of the city, was defeated. The 28th of March, however, was highly honorable to the Republican arms, and to the Italian Legion. The movement was directed by General Pacheco. The enemy were besieging the Cerro, under the orders of General Nuñez, who had shamefully deserted to the enemy's files, in the beginning of the siege. They showed much boldness, and several times came up under the heavy ramparts of the fortress, threatening to cut off the communications with the city and destroying with musket shots the light-house erected on the upper part of the edifices. General Pacheco ordered several corps to be transported to the Cerro, among which was the Italian Legion. That movement took place during the night; and at the first light it was in ambush in a powder manufactory, half a mile from the battery. That edifice, although in ruins, had the walls standing, and afforded sufficient space to contain the entire Italian Legion, though in a somewhat confined situation. Skirmishing was commenced, and afterwards something more serious. The enemy stood boldly against their opponents, and got possession of a strong position called the Quadrado, or the Square, at the distance of a short cannon-shot from the Powder-house. A number of men had already been wounded among the Republicans, and, among others, Colonel Cajes and Estivao, in my opinion the best of the officers. Such was the state of things, when the signal was given for the Legion to make a sortie, and the conflict became serious, under the command of Colonel Carceres, who had charge of the force engaged. I shall always feel proud of having belonged to that handful of brave men, having always seen them on the high road of victory. It was proposed to attack the enemy on an eminence, behind the shelter of a ditch and parapet. The space which it was necessary to pass, in order to assault it, was unobstructed by any obstacle, and therefore the enterprise was by no means an easy one. But the Legion, that day, would have faced fiends, if they could have been conjured upon the field; and they marched on against the enemy, without firing a shot and without hesitating for a moment, except to throw themselves into the Pantanoso, three miles distant from the
- 34. field of battle.Nuñez was killed, and many prisoners were taken. The Oriental corps, in company with the Italians, fought very bravely; and, though the above-mentioned movement was somewhat retarded, the order was given to the column on the right to advance and place itself between the river and the enemy. And certainly not one of the enemy's infantry was saved. That battle reflects great honor on the skill of General Pacheco. During the first years of the siege of Montevideo, the Italian Legion sustained innumerable conflicts. They suffered the loss of many killed and wounded; but in no engagement did they disgrace themselves. General Rivera was defeated at India Muerta; but the capital was not conquered with him. The corps belonging to it were trained to war by daily fighting, and also gained moral advantage over the besiegers. The English and French intervention took place, and then all parties anticipated a happy result of the war. A project for operations, combined by the government and the admirals of the two allied nations, was an expedition in the Uruguay; and it was placed under my command. In the period now past, the national flotilla had been increased by the addition of several vessels, some of which were chartered, like the first, and others sequestrated from certain enemies of the Republic, and others still were prizes made from the enemy, who sent their vessels to the Bucco and other places on the coast in possession of the forces of Ourives. Then, between the acquisition of the above-mentioned vessels, and of two others of the Argentine squadron, sequestered by the English and French, and placed at the disposition of the Oriental government, the expedition for the Uruguay was composed of about fifteen vessels, the largest of which was the Cagancha, a brig of sixteen guns, and the smallest were several boats. The landing corps was thus composed: the Italian Legion of about two hundred men, about two hundred Nationals, under command of Colonel Battle, and about a hundred cavalry, with two four pounders and six horses in all.
- 36. CHAPTER XXII. THE EXPEDITIONPROCEEDS FOR THE URUGUAY— COLONIA TAKEN BY IT—BURNED—PAGE, A SUSPICIOUS FRENCHMAN—MARTIN GARCIA TAKEN. It was near the close of the year 1845 when the expedition left Montevideo for the Uruguay, beginning an honorable campaign with brilliant but fruitless results, for the generous but unfortunate Oriental nation. We arrived at Colonia, where the English and French squadrons were awaiting us, to assail the city. It was not a very arduous enterprise, under the protection of the superfluous guns of the vessels. I landed with my Legionaries; and the enemy opposed no resistance under the walls: but, on getting outside of them, they were found ready for battle. The allies then debarked, and requested their commanders to support me in driving the enemy away. A force of each of the two nations accordingly came out for my assistance. But the Italians had hardly begun to fight, and obtained some advantage, when the allies retired within the city walls. The reason for this unexpected movement was never explained to me; but I was compelled to follow their example, in consequence of the great inferiority of my force compared with that of the enemy. When the other party proposed to abandon the city, they obliged the inhabitants to evacuate it, and then endeavored to give it to the flames. From that time, therefore, many of the houses presented the sad spectacle of the effects of conflagration, the furniture having been broken, and everything lying in confusion. When the Legion landed, and the Nationals, they had immediately followed the enemy who were retreating; and the allies, landing afterwards, occupied the empty city, sending out a part of their forces to support them. Now it
- 37. was difficult, betweenthe obstacles presented by the ruins and the fire, to maintain the discipline necessary to prevent some depredations; and the English and French soldiers, in spite of the severe injunctions of the Admirals, did not fail to take the clothes which were scattered about the streets and in the deserted houses. The Italians followed their example, and, in spite of every exertion made by me and my officers to prevent them, some of them persisted in the work for a time; and I have the mortification of acknowledging that I did not entirely succeed in my efforts to prevent them. The most important articles taken by the Italians, however, were eatables; and this afforded some consolation, as the fact was less discreditable to my countrymen than if they had chosen objects of lasting pecuniary value. I feel also most confident in saying, that nothing of that disgraceful conduct would have happened, but for the beginning made by the allied troops. A Frenchman, named Page, who then resided in Montevideo, published a description of the scene of plunder. It was said by his contemporaries, that Page was a creature of Guizot, sent out as a fiscal, and to take account of what happened. I could not ascertain whether he was a diplomatic spy or not. It is certain that, in consequence of the French sympathy, I was obliged, on landing on the shore of Colonia, to send the men below, as their ship was thundering, with its cannon well pointed towards us. We had several men wounded, receiving contusions from splinters and fragments of rock. Besides, Page's elegant "Narrative of Facts," as he entitled a report which he published, called the Italian Legion "Condoltreri," a term of contempt, in his opinion, but which they were farthest from deserving. In Colonia I and my troops might have coöperated in an attack on the city; but they were sent elsewhere, to restore the authority of the Republic on the banks of the Uruguay. The Island of Martin Garcia, where I arrived before Anzani with a small force, yielded without resistance. There I obtained a number of oxen and a few horses.
- 39. CHAPTER XXIII. FIRST MEETINGWITH A "MARTRERO"— DESCRIPTION OF HIS HABITS AND CHARACTER— ANOTHER MARTRERO, JUAN DE LA CRUZ—THE RIO NEGRO—JOSEPH MUNDELL—THE SEVERITY OF THE ENEMY DROVE THE MARTREROS AND PEOPLE TO US. At Colonia I met with the first "Martrero" I ever saw. He was named Sivoriña, and was one of the remarkable men known by that title who belonged to the patriot party. The services of that class of brave adventurers were of great value to that expedition. The "Martrero" is a type of independent man. One of them often rules over an immense extent of country in that part of South America, with the authority of a government, yet without laying taxes, or raising tribute: but he asks and receives from the inhabitants their good will, and what is needful to his wandering life. He demands nothing but what is necessary; and his wants are limited. A good horse is the first element of a Martrero. His arms, usually consisting of a carbine, a pistol, a sword, and his knife, which are his inseparable companions, are things without which he would think he could not exist. If it is considered that from the ox he obtains the furniture of his saddle; the "Mancador," with which to bind his companion to the pasture; "Mancas," to accustom him to remaining bound and not to stray; the "Bolas," which stop the bagual, or wild horse, in the midst of his fury, and throw him down, by entangling his legs: the "Lazo," not the least useful of his auxiliaries, and which hangs perennially on the right haunch of his steed; and finally the meat, which is the only food of the Martrero;— if all these are borne in mind, in the forming and use of which the
- 40. knife is indispensable,some idea may be conceived of how much he counts on that instrument, which he also employs, with wonderful dexterity, in wounding and cutting the throat of his enemy. The Martrero is the same as the Gaucho of the Pampas, and the Monarco de la cuchilla, (Monarch of the Knife,) of the Rio Grande, but more free and independent. He will obey, when the system of government is conformed to his own opinions and sympathies. The field and the wood are his halls; and the ground is his bed. To him little appears sufficient. When he enters his house, the Martrero there finds one who truly loves him, and shares with him his toils and dangers, with courage and fortitude equal to his own. Woman as the more perfect being, appears to me to be naturally more adventurous and chivalrous than man; and the servile education to which in that country she is condemned, probably prevents the examples from being more common. Vivoriña was the first of the Martreros who joined my troops: but he was not the best. On the banks of the channel of Inferno, the eastern one, between the island of Martin Garcia and the continent, he had seized a boat, and put his pistol to the breast of its master, and compelled him to transport him to the Island, whither he came and presented himself to me. Many other Martreros afterwards came in, and rendered much service in the ulterior operations; but the man on whom I love to bestow a high title, and who joined to the courage and audacity of a Martrero, the valor, integrity and coolness of a good captain, was Juan de la Cruz Ledesma, of whom mention will often be made in this narrative. Juan de la Cruz, with his black head-dress, his eagle eyes, noble mien, and beautiful person, was my intrepid and faithful companion in that Uruguay expedition, which I consider the most brilliant in which I was ever engaged; and he, and Joseph Mundell, equally brave and better educated, are impressed upon my mind for life. In Colonia were assembled Colonel Battle, and the Nationals of the garrison. In Martin Garcia we had left some men, and raised the Republican standard. The expedition then continued the voyage along the river. Anzani had the vanguard, with some of the smaller vessels, and took possession of a number of merchantmen under the
- 41. enemy's flag. Wethus reached the Yaguary, a confluent of the Rio Negro with the Uruguay. The Rio Negro, which empties into the Uruguay at that place, forms several islands of considerable size, covered with woods and pasture-grounds in ordinary times; but in winter, when the rivers are swollen by the rains, they are almost entirely flooded, so that only animals are able to live there. The troops, however, found enough oxen and some wild horses. The greatest benefit to the expedition there was the landing of the horses, and allowing them relief from the evils of the voyage. Beyond those islands towards the east, and bathed by the Rio Negro on the south, by the Uruguay on the north, is the Rincon de las Gallinas. This is a part of the main land, of considerable extent, joined to the neighboring country by an Isthmus; and it abounded with an immense number of animals, of various kinds, not excepting horses. It was, therefore, one of the favorite spots of the Martreros. One of my first cares was to march, with a part of the landing force, and take a position on the shore of the Rincon, from which I sent out Vivoriña, with Miranda, one of his companions, on horseback. They soon met with several of the Martreros of the place, who joined the expedition, and were soon followed by others; and, from that time, a beginning was made in forming a body of cavalry, which increased very fast. Meat was abundant; and in that same night an operation was undertaken against a party of the enemy, which had the most successful issue. A Lieutenant Gallegos, who had accompanied the troops from Montevideo, was intrusted with the command. He surprised the enemy, in number about twenty; but few were able to escape, and he brought in six prisoners, some of whom were wounded. The affair gained for us several horses, which were a very important acquisition in our circumstances. The system adopted by the enemy was, to send the inhabitants into the interior, in order to cut off their communications with the troops; and this induced many of those unfortunate people to join us, among whom they found a kind reception and a safe retreat, in the largest of the islands, to which the soldiers carried a great number of animals, and chiefly sheep, for their subsistence. Thus, in
- 42. different ways, theexpedition gained strength and was favored by circumstances, especially by the arrival of Juan de la Cruz, whose discovery deserves to be mentioned. The Martreros of the Rincon, who were assembled with me at the time, informed me that Juan de la Cruz, at the head of a few parties of his friends, had fought several bands of the enemy on previous days; but, overcome by numbers, had been obliged to scatter his men, and take to the woods alone, in the thickest bushes, and even to abandon his horse, and to set off in a canoe, for the most obscure islands of the Uruguay. There he was still an object of the chief persecution to the enemy, who, after the battle of India Muerta, when there were no longer any national corps in the country, could pursue the Martreros at their pleasure. In such a painful situation was he found at that time; and I intrusted one Saldana, an old companion of Juan de la Cruz, with a few Martreros, to visit his retreat and bring him away. The undertaking was successful; and after a few days spent in the search, they found him, on an island, in a tree, and his canoe tied at its root, floating in the water, it being the time of inundation, and the little island being flooded. He had so placed himself that he could at once have retreated into the woods, if enemies had appeared, instead of friends. The young Italians in the expedition at that time, learned a lesson of the life they will be called to lead, when they shall see their country redeemed. Juan de la Cruz was an important acquisition to the expedition. From that day forward, we had with us all the Martreros of the surrounding district, and a force of excellent cavalry, without which little or nothing could have been undertaken in those countries. The Isla del Biscaino, (or the Island of the Biscayan,) the largest in the Yaguary, soon became a colony, peopled by the families which fled from the barbarity of the enemy, and various others, from the capital. Many animals were sent over to it, a number of horses were left there, and an officer was entrusted with the care of everything.
- 44. CHAPTER XXIV. THE EXPEDITIONPROCEEDS—SURPRISE GUALEGUAYECHU— REACH THE HERVIDERO— ACCOMPANIED BY AN ENGLISH AND A FRENCH OFFICER—A LARGE ESTANCIA, AND ITS NUMEROUS HORSES AND OTHER ANIMALS—I LEAVE THE VESSELS IN CHARGE OF ANZANI—GO WITH THE MARTREROS—LA CRUZ AND MUNDELL—ATTACK ON THE HERVIDERO— BATTLE OF ARROYO GRANDE. The expedition then proceeded by the river, and arrived at a place on its banks named Fray Bento, where the vessels cast anchor. About eight miles below, on the opposite bank, in the Province of Entre Rios, is the mouth of the River Gualeguayechu. The place is distant about six miles from its mouth. That province belonged to the enemy. The expedition was in want of horses for the operation; and good ones were to be found in that region, as well as materials needed to make clothing for the troops, and other necessary articles, with which the province was well provided. An expedition was therefore formed, to obtain supplies. I went up the river further, expressly for the purpose of preventing suspicion; and then, in the night, the small vessels and boats embarked the Italian Legionaries, and the cavalry with a few horses, and proceeded towards the landing-place. At the mouth of the little river lived a family, and it was known that several merchant vessels and a small war-vessel were there, which it was necessary to surprise; and this was effected. The troops were so successful, that they reached the very house of the commandant of Gualeguayechu, while he was asleep in his bed. The Colonel commandant of the country was named
- 45. Villagra. All theauthorities, with the National Guards, were soon in our hands; and we garrisoned the strongest places with Republican troops. The expedition then proceeded to recruit horses and obtain other things of the most importance. We obtained many excellent horses in Gualeguayechu, with articles necessary to clothe the men, harnesses for the cavalry, and some money, which was distributed among the sailors and soldiers. All the prisoners were released at our departure. A party of the enemy's cavalry, in garrison in the town, were found to be absent, on the arrival of the expedition, and returned during our stay. Being seen by the sentinels, a few of the best mounted and equipped of the cavalry were sent out, and an encounter took place, in which the enemy were repulsed. This little affair greatly encouraged the Republicans, especially as it took place in view of all. We had one man badly wounded. At the mouth of the river was a peninsula, formed by it and a small stream, and there was the residence of the family before mentioned. The infantry embarked in the small vessels in which they had sailed; the cavalry marched by land to the peninsula, leading the horses they had taken; and there they again remained. The labor of embarking and disembarking horses was not new to them; and in a few days everything was carried away—some to the island of the Biscaino, and some to the other island in the upper part of the river, to serve in future operations. The expedition then proceeded into the interior, as far as Paysandù, with the occurrence of little or nothing worthy of notice. In that city was a large guard, and the enemy had constructed some batteries and sunk a number of vessels, in different parts of the channel of the river, to obstruct the passage. All obstacles were overcome; and a few shot in the vessels, and a few wounded men, were the only consequences of a heavy cannonade with the batteries. Two officers deserved my particular notice: one a Frenchman, and the other an Englishman, who commanded two small vessels of war of their nations, and accompanied me in almost the whole of that expedition, although their instructions were not to fight. The English Lieutenant was named Tench; and he remained
- 46. but a shorttime; the French officer was Hypolite Marier, commander of the schooner L'Eclair. The latter was with me the whole time, and became very dear to me, being an officer of great merit. We reached Hervidero, formerly a most beautiful establishment, then abandoned and deserted, but still very rich in animals, which were highly valuable to the expedition all the time of our stay. That point of the Uruguay was named Hervidero, from the Spanish word Hervir, which means to boil; and indeed it looks like a boiling cauldron under all circumstances, but especially when the river is low, abounding in whirlpools formed by the numerous rocks lying under water, over which a very rapid current pours all the year. The passage is very dangerous. A very spacious house stands on an eminence, built with a terrace on the roof, called Azotea, and overlooks all the left bank of the river. Around it was a multitude of Ranchos, or barracks, with roofs of straw, which attested the great number of slaves possessed by the masters in more quiet times. When I first approached the house, I found herds of the Ganado manso, or domestic oxen, near the deserted habitations, in search of their exiled masters; and with them a majada, or flock of sheep, amounting to about forty thousand, while the ganado cuero or alzado,—that is, the wild cattle,—of about the same number, were scattered over the fields. Besides these there were innumerable horses, ginetes and Poledres, chiefly wild, and many quadrupeds of various kinds. These few lines may give some idea of the aspect of that kind of immense estates in South America, called Estancias. The Hervidero, however, a Saladero, or place for salting meat for exportation, as well as for preparing hides, tallow, and, in short, everything furnished by the animals slaughtered in their country. The depth of the river did not permit them to take any other in larger vessels. Anzani, with the infantry, lodged in the establishment, occupying it in a military manner. The measures taken were very useful in repressing an unexpected attack, arranged between the enemies of Entre Rios, under the command of General Garzon, and those of the Oriental State, under Colonel Lavalleja. That was undertaken while I was not at the Hervidero.
- 47. And, in thefirst place, as for the reason of my absence. Among the cares of Juan de la Cruz, was that of sending some of his martreros to inform the others, who were scattered along the left bank of the river, and those of the Gueguay, who were quite numerous. A certain Magellano, and one José Dominguez were among the most famous of them all. They were then in the neighborhood of the Gueguay. José Mundell had come to that country when a child, and had become identified with the inhabitants and accustomed to their habits. He had a present of an estancia, one of the best in that part of the country. Mundell was one of those privileged persons, who seem to have come into the world to govern all around them. With nothing extraordinary in his physical nature, he was strong and active, "a free cavalier," and of a most generous disposition; he had gained the hearts of all, on whom he bestowed benefits whenever they were in want, thus securing their love and tempering their natures. He was above all things adventurous. It may be added that Mundell, although he had spent the most of his life in the desert, had, from his own taste, cultivated his mind and acquired by study more than an ordinary share of information. He had never taken any part in political affairs, beyond those connected with the choice of men for the Presidency, etc. But when the foreigners, under the orders of Ourives, invaded the territory of the Republic, he regarded indifference as a crime, and threw himself into the ranks of the defenders. With the influence which he had acquired among his brave neighbors, he soon collected several hundred men, and then sent me word that he was going to join me with them. The bold fellows, commanded by Juan de la Cruz, had brought in that news to the Hervidero; and I immediately resolved to meet with Mundell in the Arroyo Malo, about thirty miles below the Salto, or Falls. On the first night after my departure the attack was made on the Hervidero. Hearing the cannon and musketry while I was near Arroyo Malo, I was thrown into the greatest anxiety, as was very natural; but I confided much in the capacity of Anzani, whom I had left in charge of everything. The attack on the Hervidero had been conceived and planned in such a manner that, if the execution had corresponded, its results
- 48. must have beenfatal. Garzon, whose forces were not fewer than two thousand men, most of them infantry, was to have approached the right bank of the river, while Lavalleja was to attack the Hervidero. In order that they might strike at the same moment, they had placed two fireships in the Yuy, a small river of Entre Rios, a few miles above, intended, if not to burn the flotilla, at least to occupy the sailors, and render it impossible for them to give any assistance by land. The courage and coolness of Anzani, and the bravery of the troops, rendered all the efforts of the active enemy unavailing. Garzon effected nothing by his steady fire of musketry, because it was too distant, and the side of the river's bank was commanded by the cannon of the flotilla, which opened upon it. The fireships, being abandoned to the current, passed at a distance from the vessels, and were destroyed by their guns. Lavalleja pressed his troops against the brave Legionaries in vain, they being intrenched in the buildings, and terrifying the enemy with their silence and proud resistance. Anzani had given orders that not a musket should be fired, until the enemy were near enough to have their clothes burnt by the powder; and this plan succeeded well, for, supposing the houses to have been evacuated, they advanced without apprehension: but a general discharge of musketry, when close at hand, from all quarters, put them immediately to flight, making it impossible to rally again. Having arranged with Mundell about his entering Salto when occupied by the Republicans, I returned to the Hervidero. I received notice, about that time, from Colonel Baez, who was making arrangements to join me with some men. The only vessel of the enemy stationed in the Yuy deserted to us, with a portion of the crew. Thus everything smiled on the expedition.
- 50. CHAPTER XXV. THE PROVINCEOF CORRIENTES CALLS GENERAL PAZ FROM MONTEVIDEO—ALLIANCE WITH PARAGUAY—I GO TO SALTO WITH THE FLOTILLA, TO RELIEVE IT FROM A SIEGE—WITH LA CRUZ AND MUNDELL, ATTACK LAVALLEJA—RETURN TO SALTO. The Province of Corrientes, after the battle of Arroyo Grande, had fallen again under the dominion of Rosas: but the admirable resistance of Montevideo, and some other favorable circumstances, called the people again to independence; and Madariaga and the principal authorities in that revolution had invited General Paz from Montevideo, to take command of the army. That old and virtuous chief, by his own fame and capacity, induced Paraguay to make an offensive and defensive alliance; and that state collected at Corrientes a respectable contingent for the army. Things thus proceeded wonderfully well for that part of the country; and not the least important object was the opening of communications with those interior provinces, to collect in the Department of Salto the Oriental emigrants who were in Corrientes and Brazil. I then sent from the Hervidero a balenera, on a mission to General Paz: but, being observed and pursued by the enemy, the men in it were obliged to abandon the boat, and take refuge in the woods. I was obliged to repeat the same thing three times; when at length a brave officer of the Italians, Giacomo Casella, taking advantage of a strong flood in the river, succeeded in overcoming every obstacle, and arrived in the Province of Corrientes. During the same flood I arrived at Salto with the flotilla.
- 51. The city wasgoverned by Lavalleja, who attacked the Hervidero with a force of about three hundred men, infantry and cavalry. He had been engaged for some days in making the inhabitants evacuate the town; and for them and his troops he formed a camp on the left bank of the Capebi, at the distance of twenty-one miles from Salto. The Republicans took the town, without any resistance, and designed to make some fortifications. That point being occupied, they remained there, but, of course, besieged on the land-side, as the enemy were superior in cavalry. One of the principal inconveniences which they suffered was the want of meat, all the animals having been driven away. But that evil did not last long. Mundell, having collected about a hundred and fifty men, drove back a corps of the enemy who were pressing upon him, and arrived safe at Salto. From that moment the Republicans began to make sorties, and to bring in animals enough for the subsistence of the troops. With Mundell's horsemen, and those of Juan de la Cruz, we were able to take the field; and one fine day we went to seek Lavalleja in his own camp. Some deserters from the enemy had given me exact information of his position and the number of his forces; and I determined to attack him. One evening I drew out two hundred of the cavalry and a hundred of the Italian Legionaries, and moved from Salto, intending to surprise the enemy before daybreak. My guides were the deserters; and, although they were acquainted with the country, yet, as there were no roads leading in the direction they took, they got astray, and daylight found us at the distance of three miles from the camp we were seeking. Perhaps it was not prudent to attack an enemy at least equal in force, entrenched, and in their own camp, and which might receive reinforcements, which they had asked for, at any moment; but to turn back would not only have been disgraceful, but would have had a very bad effect on the feelings of the new troops. I was a little troubled by the idea of retreating, and determined to attack. I reached an eminence where the enemy had an advance post. They retired on my approach. I could then see their camp, and observed several groups returning towards it, from various directions. They were detachments which had been sent out in the night to different points, to observe the
- 52. Republicans, the enemyhaving heard of our setting out. I then immediately gave orders to Mundell, who had the vanguard, to press on a strong body of cavalry, to prevent their concentration. The enemy did the same, to repel that movement and protect their troops. Mundell, with great bravery, succeeded, and drove and dispersed several of their detachments; but he advanced too far, in the warmth of the pursuit, so that his troops soon found themselves surrounded by the enemy, who, recovering from their first fright, came upon them with their lances, threatening to separate them from the main body, which, although at a distance, was approaching for a battle. In the meantime, seeing all this, I at first designed to have the whole little force of the Republicans proceed in a mass, and give a decisive blow. I therefore hastened the march of the infantry, forming the rear guard and reserve, with the cavalry of Juan de la Cruz: but seeing the position of Mundell, which admitted no delay, I left the infantry behind under the command of Marrocchetti, and pressed forward the reserve of cavalry in échellons. The first échellon, commanded by Gallegas, pushed on, and somewhat restored the resistance of the cavalry. The charge of Juan de la Cruz drove the enemy back; and they retired towards their camp. I had ordered the échellons of the reserve to charge in a compact mass, so that Mundell and his men, who had fought bravely, might recover their order in a moment. Our troops then moved on towards the enemy's camp, in order of battle,—the infantry in the centre by platoons, and under orders not to fire a shot; Mundell on the right, and Juan de la Cruz on the left; while a small échellon of cavalry formed a reserve. The enemy's cavalry, after the first encounter, had formed again behind the infantry, who were covered by a line of carts; but the firmness and resolution of the Republicans, now marching on in a close body and in silence, intimidated them so much that they made but little resistance. In a moment the action was over; or, rather, it was not a fight, but a complete discomfiture and precipitate flight towards the pass of the river. On reaching that point some of the boldest endeavored to make a stand; and they might have been able, but it would have been a very arduous task; although the
- 53. Republican cavalry hadhalted: for the Legionaries, at the command of "Cartridges on the neck!" threw themselves into the water with the greatest fury, and there was no more resistance. The victory was now complete. All the infantry of the enemy were in the power of the conquerors, and some of the cavalry, with all the families of the Salto, who had been dragged from their homes, and a train containing various objects of merchandize, consisting of thirty- four loaded wagons. Above all, we had captured a great number of horses, which were the most valuable of all things in our existing circumstances. A brass cannon, made in Florence, some ages past, by a certain Cenni, fell into our hands. It was the same piece which had been fired upon us at the Hervidero; and being dismounted on that occasion, was undergoing repair in the enemy's camp. After the action, which lasted only a few hours, we collected everything useful, and set off on our return. Our progress to Salto was quite a triumphal march. The population poured blessings on us from their own houses, to which they had been restored by our means; and the victory acquired for the army a reputation which was well merited, proving that all the three classes of troops were able to keep the field. Our celerity was of much importance; for, as has already been mentioned, the enemy were in expectation of a strong reinforcement; and that was the entire force of General Urquiza, which had just before been victorious at India Muerta, and was then on the march for Corrientes, to fight the army of that province. Vergara, who had the vanguard of it, came in sight of Salto the day after our return, and captured a few of our horses, which were dispersed in the neighboring pastures. Being in the presence of those forces, which seemed to overwhelm us, we made every exertion to resist it. A battery, marked out by Anzani, in the centre of the city, made a progress that was quite astonishing. Both soldiers and people worked at it, such houses as were adapted to defence were fortified, and every man had a post assigned him. Several cannon were levelled from the boats, and preparations were made to supply the battery. At that time arrived Colonel Baez, with about sixty cavalry.
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