Clinical Laboratory Management E-Book

• Herausgeber: John Wiley & Sons
• Kategorie: Fachliteratur
• Serie: ASM
• Sprache: Englisch

Seitenzahl: 3221

Veröffentlichungsjahr: 2013

Beschreibung

This totally revised second edition is a comprehensive volume presenting authoritative information on the management challenges facing today's clinical laboratories. * Provides thorough coverage of management topics such as managerial leadership, personnel, business planning, information management, regulatory management, reimbursement, generation of revenue, and more. * Includes valuable administrative resources, including checklists, worksheets, forms, and online resources. * Serves as an essential resource for all clinical laboratories, from the physician's office to hospital clinical labs to the largest commercial reference laboratories, providing practical information in the fields of medicine and healthcare, clinical pathology, and clinical laboratory management, for practitioners, managers, and individuals training to enter these fields. If you are looking for online access to the latest clinical microbiology content, please visit www.wiley.com/learn/clinmicronow.

Leseprobe

Clinical Laboratory Management

Clinical Laboratory Management

SECOND EDITION

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

Copyright © 2014 American 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 978-1-68367-345-3 (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: [phone]. Fax: [phone].

E-mail: [email protected]

Online: http://www.asmscience.org

Contents

Contributors

Preface

Acknowledgments

SECTIONI

Basic Concepts and the Current Healthcare Environment

1 Principles of Management

Jeffrey Casterline and John R. Snyder

IntroductionLeadership, Management, and AdministrationLeadership • Management • AdministrationManagement ConceptsCultural Lag • Review of Management ThoughtDecision MakingWhat Is Decision Making? • Types of Decisions • Individual versus Group Decision Making • The Problem-Solving/Decision-Making Process • RiskManagement EthicsDefinitions • Characteristics of High-Ethics Organizations • Benefits of Strong Workplace Ethics • Management Roles and ResponsibilitiesSummaryKEY POINTSGLOSSARYREFERENCESOTHER READINGAPPENDIX

2 Management Functions

Laurence P. Vetter

IntroductionPlanningStrategic Planning • Selecting a Planning Group • Environmental Analysis • SWOT Analysis • Vision and Mission Statements • Goals and Strategies • Prioritization • Accountability • Measuring Success (Metrics)OrganizingOrganizational Chart • Time Management • Policies • Procedures • Workflow • StaffingDirectingCommunicating • Delegating • Motivating • Managing Change • CoachingControllingSetting Performance Standards • Evaluating Employee Performance • Problem Solving • Decision MakingSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIXES

3 Relevant Economic and Business Concepts

Roxanne Mercer and Ann L. Harris

IntroductionOverview of Laboratory Industry Trends during the Past Decade • Forecast for the FutureStrategic Business Planning OverviewMarket Assessment • Key StrategiesCompetitive EnvironmentClinical Laboratory Competitive Market • Business Entities, Strategic Alliances, Joint Ventures, Mergers and Acquisitions, and Integrated NetworksThe Economic EnvironmentFour Stages of the Business Cycle • The National Economy: Fiscal and Monetary Policies • Assess Infrastructure and Develop Production Strategies • Cost Accounting Principles • System-Wide Approach to Establishing a Fee Schedule • Consumer Price Index • Pricing StrategiesPromotional (Marketing and Sales) StrategiesMarket Research • Marketing Strategies • Sales Strategies • Advertising StrategiesCustomer-Focused Concepts and Service StrategiesWho Is the Customer? • Understanding Customer Behavior • Key Concepts and Recognized Customer Service Strategies • Service Delivery StrategiesSummaryKEY POINTSGLOSSARYREFERENCESADDITIONAL READINGAPPENDIX

4 Current Challenges to Financial Stability within the Diagnostic Laboratory

Roxanne Mercer and David S. Wilkinson

IntroductionWorkforceAvailability of Personnel • Training Programs • On-the-Job Training • Recruitment and Retention • Generational DiversityWorkplaceCentralized versus Decentralized Operations • Local and Regional Integration of Laboratory ServicesWork FlowNew Technology • Testing Site OptionsDoing More with LessSystematic Approaches to Managing Change • RightsizingShrinking ReimbursementGross versus Net Revenue • Medicare • Managed Care • BillingRegulations and Unfunded MandatesRegulations • Unfunded MandatesSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIX

5 The Impact of Regulatory Requirements

Susan D. Roseff, Denise E. Russell, Christina E. Anderson, and Roxanne Mercer

IntroductionBrief History • Overview of the Current State of Laboratory RegulationsRegulation of Workplace Safety and Human Resource ManagementOccupational 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 DiscriminationAccreditation and LicensureBrief History • Laboratory Inspection and Accreditation • Personnel Certification and LicensureRegulations Affecting Transfusion MedicineOverview 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 OversightRegulation of Laboratory Business PracticesNegotiated Rule-Making Process • Corporate Compliance • Key Elements of a Model Compliance Plan for Hospitals • The Legal EnvironmentLaboratory Reimbursement and Medical NecessityMedicare • 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 MonitorsCompliance—the Next Generation: HIPAACovered 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 EnforcementSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIXES

6 The Changing Practice of Medicine

Susan D. Roseff, Denise E. Russell, and Margaret M. Grimes

IntroductionOverview of Major ChangesShift 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 NeedsThe Impact of TechnologyThe Electronic Medical Record • Meaningful Use/Value-Based Purchasing • Patient Access to Information • Patient Confidentiality • Advances in Diagnostic TestingThe Emergence of Clinical Practice GuidelinesThe 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 GuidelinesMedicolegal IssuesMalpractice 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 LiabilityTraining Physicians for Practice in the 21st CenturyThe 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 EnvironmentExternal Forces Impacting Undergraduate and Graduate Medical EducationFinding the Right Mix: How Many Physicians Do We Need? • Current Challenges to Academic CentersSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIX

7 The Changing Healthcare Environment

Ann Harris and David S. Wilkinson

IntroductionChanging Reimbursement ModelsChange 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 MarketImpact of Healthcare ReformPatient Protection and Affordable Care Act • Payment Reform and Provider Reimbursement Strategies • Current Trends and Issues with Healthcare Reform • Hospitals and Laboratories: Concerns in Healthcare ReformChanging Emphasis on Quality and ValueHealth Maintenance Organization Network Management • Patient Management • Disease Management • Healthcare Reform: Demonstration ProjectsThe Educated ConsumerBaby Boomers and Generation Xers: The Educated and Savvy Consumer • Consumer-Driven Healthcare • The Increasingly Litigious EnvironmentChanging TechnologyTechnological 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 UseConsolidation in the Healthcare IndustryOverview: 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 NetworksStrategies for Success in the 21st CenturyStrategic 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 InformationSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIXES

SECTIONII

Managerial Leadership

8 The Foundations of Leadership

David S. Hefner and Katharine R. Becker

IntroductionDistinguishing Management from LeadershipWhat Is “Leadership” and How Do You Become a Leader? • Management • LeadershipThe First Foundational Factor Is IntegrityThe 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 WordThe Second Foundational Factor Is AuthenticityThe Definition of Authentic • Knowing Yourself • How Do You Respond in Various Situations? • The Importance of Context • The Path to AuthenticityThe Third Foundational Factor Is Commitment to Something Bigger than YourselfSucceeding as a Leader • What Happens Next?SummaryKEY POINTSACKNOWLEDGMENTSREFERENCESAPPENDIXES

9 Employee Needs

John C. H. Steele, Jr.

IntroductionThe Laboratory Workforce—Is There an Approaching Crisis?Theories of Human NeedsMaslow’s Hierarchy of Needs • Alternative TheoriesMeeting Employee NeedsLevel 1 and 2 Needs • Level 3, 4, and 5 Needs • Higher-Level NeedsThe Role of Generational DifferencesCharacteristics of the Generations • Meeting the Needs and Wants of the Four GenerationsSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIX

10 Motivating through Intelligent Leadership

Christa Pardue

What Is Motivation?Knowledge of SelfCreating the Vision • Humility • Basic NeedsKnowing What Others See in YouFactors of Motivation • The Right People Need the Right Leader • Actually Fix the ProblemsKnowing the Emotions of LeadingEmotional Intelligence • The Need for Purpose • Human Motivation TheorySummaryKEY POINTSGLOSSARYREFERENCES

11 Successful Communication

Diane C. Turnbull

IntroductionChannels of CommunicationFormal Channels of Communication • Informal Channels of CommunicationTypes (Methods) of CommunicationOral (Face-to-Face) Communication • Telephone Communication • Written Communication • PowerPoint Presentation • Electronic Communication • Visual Communication • Body Language and Other Nonverbal CommunicationBarriers to CommunicationPhysical Barriers • Nonverbal Barriers • Verbal Barriers • Psychological BarriersThe Importance of ListeningEffective Listening • Ineffective Listening • Stages of ListeningTypes of ListeningNonlistener • Marginal Listener • Evaluative Listener • Active ListenerElements of Effective CommunicationSkills for Effective Communication • Organizational Climate • Using Body Language • Using Positive LanguageLeadership Essentials for Improving CommunicationThe Interaction Process • Adapting Communication StylesSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIX

12 Effective Meetings

Mark G. Hanly

IntroductionThings To Do before the MeetingDetermine 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 MeetingThings To Do during the MeetingThings To Do after the MeetingCalculating the Cost of MeetingsRecurrent MeetingsHow To Be an Effective Participant in a MeetingSummaryKEY POINTSGLOSSARYREFERENCES

13 Conflict Management

Jean Egan

IntroductionConflict DefinedWhat Conflict Is and Is NotConstructive ConflictDestructive ConflictCommon Causes of ConflictInternal and External Origins of ConflictInternal Sources of Conflict • External Sources of ConflictPower Is the Underlying IssueTwo Basic Beliefs about Handling a ConflictFive Conflict Resolution StylesWorking with Each Style To Resolve ConflictCreating an Environment Where Conflict Is Addressed and ResolvedThe Role of the Manager • The Role of the Staff • Creating the Right Environment To Resolve ConflictA Communication Model To Manage and Resolve ConflictThe GGMG ModelA Seven-Step Plan for Resolving ConflictWhen Conflict Resolution FailsKey Steps in Resolving ConflictWhat the Organization Can DoSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIX

14 Managing Change

Kellie Gibbs

IntroductionKey Concepts of ChangeTypes of ChangeFactors Affecting ChangeThe Change CurveLaboratory Change RolesHow To Become an Agent of ChangeWhy People Resist ChangeFear • Lack of Trust • Comfort • Perception of Need • Lack of Knowledge/Competence • Poor Communication • Exhaustion/SaturationForms of Resistance to ChangeSteps to Managing ChangePrepare • Implement • Monitor • Sustain • ReevaluateChanges that Are Common TodayLooking AheadParadigm Shifts in Today’s Healthcare IndustryTrends and ChangesCompeting in the Future in the Healthcare ArenaSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIX

SECTIONIII

Personnel Management

15 Employee Selection

Anthony S. Kurec

IntroductionDiversity in the WorkplaceCriterion-Based Job Description RequirementsJob Description Review • Minimal Personnel RequirementsSearch ProcessSearch Committee • AdvertisingInterview ProcessScreening Résumés • Interview Formats • Interview Questions • Interview “Do’s and Don’ts”Hiring ProcessOrientationDocumentationRetentionResignation and TerminationProgressive DisciplineSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIX

16 Performance Appraisals and Competency Assessment

Kari Jones, Diane C. Halstead, and Donna L. Oblack

IntroductionPerformance AppraisalsDefinition 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 WebsitesCompetency AssessmentRegulatory Foundation for Competency Assessment • Timing of Competency Assessment • Methods for Assessment of Competency • Practices • Personnel ExcellenceSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIXES

17 Staffing and Scheduling

Patti Medvescek

IntroductionLaboratory Personnel: Current Dynamics Affecting StaffingLabor Shortage • Business Need • Increasing Opportunities for Medical TechnologistsPersonnel RequirementsEducation • Training and Competence Assessment • Functional Definitions • Generalist versus SpecialistLaboratory StaffingStaffing Requirements • Basis for Determination: Workload RecordingStaff SchedulingKey Success Factors • Metrics for Success • Alternatives • Special Considerations • Flexible StaffingSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIX

18 Teams, Team Process, and Team Building

James W. Bishop, K. Dow Scott, Stephanie Maynard-Patrick, and Lei Wang

IntroductionDefinition of a TeamDistinguishing Teams from Work Groups • Types and Classifications of Teams • Why Define a “Team” So Precisely?Group Process and TeamsGuidelines for Choosing Whether To Have TeamsCommon Purpose • Interdependent Tasks • Summary • A Cautionary NoteSelecting Team MembersTask-Related Training • Team-Related TrainingLeading TeamsGeneral Ideas about Leadership: A Brief Review • Leadership in a Team Environment • Team Leader SelectionMotivating Team PerformanceGoal Setting and Performance • Goal Setting and Teams • Evaluating Teams and Team Members • Pros and Cons of Rewarding Team MembersVirtual TeamsGlobal TeamsSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIXES

19 Labor Relations

Lynne S. Garcia

IntroductionLabor LawNational 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 NLRANational Labor Relations BoardDescription • Function • Structure • Processing of Cases • Authority To Secure Injunctive Relief from a Court • Current Issues Related to the NLRBUnion StructureFormal Structure • Union Membership • Function of the Union StewardUnionization ProcessIndividual, Group, and Union Image: Reasons Why Employees Join a Union • Relevance for Healthcare EmployeesOrganizing CampaignAuthorization Cards • The Bargaining Unit • Information Distribution and Solicitation • Election • CertificationCollective BargainingIssues for Bargaining • Preparation Phase • Negotiation Phase • Administration of the Agreement • Management Rights ClauseSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIXES

20 Workplace Drug Testing and the Clinical Laboratory

Jimmy R. Lea

IntroductionRegulated and Nonregulated TestingWhom To TestPreemployment Testing • For Cause/Reasonable Suspicion • Random Testing • Return to DutyDrug Testing ProtocolSpecimen Collection • Specimen Testing • Cutoff Concentrations • Drug Confirmation • Reporting ResultsManaging Clinical and Forensic Drug TestingSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIXES

SECTIONIV

Requirements for Effective Laboratory Management

21 Quality Management

Ron B. Schifman, George S. Cembrowski, Donna M. Wolk, and Joanne I. Brisbois

IntroductionQuality Management of Preanalytical ProcessesTest Selection and Ordering • Quality of Specimen Collection • Patient and Client Satisfaction • Specimen Transport, Storage, Receipt, and Preanalytical ProcessingQuality Management of Analytical ProcessesMethod 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 ProcessesTurnaround TimeCorrected and Incomplete ReportsDocument ControlSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIXES

22 International Organization for Standardization

Anne Marsden and Amy Shahtout

IntroductionISO BackgroundBenefits of the ISO StandardsISO 9000 FamilyISO 15189ISO Certification ProcessISO 15189 and the CAPSummaryKEY POINTSREFERENCES

23 Effective Communication in Laboratory Management

Elissa Passiment and Andrea J. Linscott

IntroductionDelivering the MessageCommunicating to Diverse AudiencesMeans and Mechanics of Effective CommunicationSpoken Word • Written Word • Intradepartmental Communication • Interdepartmental Communication • External CommunicationSummaryKEY POINTSGLOSSARYREFERENCES

24 The Laboratory Information System: Making the Most of It in the Clinical Microbiology Laboratory

Joseph M. Campos

IntroductionThe Microbiology Laboratory in the 21st CenturyA Primer on Information System Terminology and ArchitectureA Primer on the LISLIS InterfacesAdmission/Discharge/Transfer (ADT) Interface • Order-Entry Interface • Results-Entry Interface • Instrument Interface • Billing Interface • Reference Laboratory Interface • Peripheral HardwareLaboratory InformaticsLaboratory Data Repository • Data-Mining Tools • ConnectivityMiscellaneous ApplicationsPreparation of a Periodic Antibiogram • Electronic Surveillance for Clusters of Hospital-Associated Infections • Unique Device IdentifiersSummaryKEY POINTSGLOSSARYREFERENCES

25 Management of Point-of-Care Testing

Glen L. Hortin and Christopher D. Doern

IntroductionOrganizational ChallengesPolitical Challenges • Setting Goals for POCT Management • Developing Management Structures for POCT • Laboratory Licensure and AccreditationOperational ChallengesDetermining 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 BillingPOCT in Developing Countries and Rural SettingsChallenges • Organizing POCT in Resource-Limited SettingsTechnological ChallengesRapid Changes of Menu, Devices, and Technology • Lack of Equivalence between POCT and Central Laboratory Tests • New Monitoring TechnologiesSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIX

26 Principles of Preanalytic and Postanalytic Test Management

Adarsh K. Khalsa, Michael Santa Cruz, and Michael A. Saubolle

IntroductionPreanalytic ActivitiesTest Selection and Implementation • Appropriate Test Utilization • Specimen Acquisition, Transport, and Storage • Test OrderingPostanalytic ActivitiesThe Report • Storage and Retention • Assessment of Test Results on Patient OutcomesSummaryKEY POINTSGLOSSARYREFERENCES

27 Selection and Implementation of New Equipment and Procedures

Paula Revell and Lakshmi Chandramohan

IntroductionDefining the Laboratory’s RequirementsTechnical/Performance ConsiderationsPhysical/Technology RequirementsHuman ResourcesFinancialConfidentiality and Conflict of InterestInformation ReviewImplementation and Product PlacementVerification and ValidationVerification • ValidationPersonnel Competency Assessment and TrainingProficiency TestingSummaryKEY POINTSGLOSSARYREFERENCES

28 Laboratory Safety

James J. Dunn and David L. Sewell

IntroductionSafety Management Plan and ResponsibilitiesLaboratory HazardsBiological Hazards • Chemical Hazards • Physical Hazards • Radiation HazardsStandard PrecautionsHazard Prevention and ContainmentRisk Assessment • Handwashing • Barrier Protection • Engineering Controls • Work Practices • Respiratory Protection • Immunization • Warning Signs and Labels • Biological Safety Cabinets and Chemical Fume HoodsSterilization and DecontaminationSpill ManagementBiological • ChemicalFire SafetyWaste ManagementRegulatory Oversight • Management ProgramPackaging and Shipping Infectious SubstancesInfectious Substances Classification • Packaging, Labeling, and Shipping Regulated MaterialPersonnel TrainingTraining Program • Methods • Documentation • Monitoring and EvaluationSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIXES

29 Emergency Management

Andrea J. Linscott, Patti Medvescek, and David L. Sewell

IntroductionEmergency Management PlanPurpose or Policy • Hazard Analysis • Incident Management SystemElements of an EMPEmergency Operations Center • Communications • Medical Treatment Areas • Decision To Shut Down Laboratory • Damage Assessment • Evacuation • Personnel Pool • Personnel Care • Locator System • Security • Training • Monitoring and EvaluationDisastersFire • Hazardous Materials • Radioactive Material • Utility Failure • Bomb Threat • Natural Disasters • Terrorism Threats • Civil DisorderSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIXES

SECTIONV

Financial Management

30 Financial Management: Setting the Stage

Ronald B. Lepoff

IntroductionThe Hospital EnvironmentOperating in the Inpatient Hospital Setting • Operating in the Outpatient Hospital SettingThe Non-Hospital EnvironmentSummaryKEY POINTSGLOSSARYREFERENCES

31 Strategic Planning

Paul Valenstein

Introduction: What Is Strategy?Evidence To Recommend Strategic PlanningRandomized Controlled Trials • Case Studies • Economic TheoryDeveloping and Maintaining a Business Strategy: The Strategic Planning ProcessStructure of the Clinical Laboratory IndustrySize 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 • ConclusionsCompetitor AnalysisCompetitors’ Goals • Competitors’ Assumptions • Competitors’ Capabilities • Interactions of Competitors • ConclusionsStrategic Positions in the Laboratory IndustryWhat Are Strategic Positions? • Types of Strategic Positions • Strategic Positions of Clinical Laboratories • ConclusionsImplementing the Strategy: Activity FitWhat Is Activity Fit? • Activity Fit Involves Trade-OffsFailure of StrategyStraddling • Growth Trap • Profitability Trap • HubrisSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIXES

32 Human Resources at the Local Level: An Important Component of Financial Management

Washington C. Winn, Jr., Fred Westenfeld, and Michael R. Lewis

IntroductionConstraints on Managerial FunctionThe Cardinal Rules for Optimizing PerformanceGet 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 AppropriateClassic Situations that May Interfere with Optimal PerformanceThe Underperforming Employee • The Overperforming Employee • The Intrusion of Personal Issues • The Underground Troublemaker • The Cabal • Weakness at thePractical Issues in Utilization of Personnel ResourcesSkill Mix of Personnel • Cross-Training and Rotation • Mix of Employment Arrangements • Coverage of Vacations, Holidays, and Routine Shifts • Use of OvertimeSummaryKEY POINTSGLOSSARYREFERENCES

33 Costs, Budgeting, and Financial Decision Making

Geoffrey C. Tolzmann and Richard J. Vincent

IntroductionCost AccountingClassification 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 ExamplesBreak-Even AnalysisEquipment Purchase • Capitation ContractCapital Acquisition ConceptsTime Value of Money • DepreciationBudgetingTypes of Budgets • The Budgeting Process • Budget ExamplesVariance AnalysisFinancial StatementsFinancial RatiosSummaryKEY POINTSGLOSSARYREFERENCES

34 Financial Decision Making: Putting the Pieces Together

Ronald J. Bryant and Michael R. Lewis

IntroductionContextual ConsiderationsAnalytical Underpinnings of a DecisionExecuting the PlanSummaryKEY POINTS

SECTIONVI

Generation of Revenue

35 Correct Coding of Billable Services in the Clinical Laboratory

Vickie S. Baselski, Alice S. Weissfeld, and Fran Sorrell

IntroductionProcedure Coding: What Test Procedures Have Been Performed?The CPT SystemDescription • Types of CPT Codes • Modifiers • The Process for Change • Procedure Coding GuidanceProcedure Coding AlternativesCapitated ServicesDiagnosis Coding: Why Is the Service Being Performed?Inpatient Diagnosis Coding • Outpatient Diagnosis Coding • Other Unique Patient Groups . ICD-CM . SNOWMED CTService LocationRole of CLIA and State Licensing • Revenue CodesDocumentation of CodesRequisition • Claims • Code MappingSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIX

36 Approaches to Billing Laboratory Services

Vickie S. Baselski, Alice S. Weissfeld, and Fran Sorrell

IntroductionInteractions in the Billing ProcessProvider Mix • Payor MixTerms of CoverageTypes of Services • Payment for ServicesLogistics of the Billing ProcessClaim versus Invoice Submission • Invoice Billing • Claim BillingCapitated Arrangement BillingPay for PerformanceSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIX

37 Charges and Fees for Laboratory Services

Vickie S. Baselski, Alice S. Weissfeld, and Fran Sorrell

IntroductionCalculating Costs and ChargesSetting Costs • Setting ChargesDetermining Payment AmountsFee Schedules • Medicare Clinical Laboratory Fee Schedule • Fee Setting for New Codes on the CLFS • The Medicare Physician Fee Schedule • Other Fee Schedules • Capitated PaymentsKeys to Success in ReimbursementRetrospective Payment • Prospective PaymentSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIX

SECTIONVII

Profitability, Contribution, and Reimbursement

38 Rules and Regulations in Reimbursement

Vickie S. Baselski, Alice S. Weissfeld, and Fran Sorrell

IntroductionGeneral CriteriaBasic RulesProcedure Code EditsBasic Edits • National Correct Coding Initiative • Mutually Exclusive Codes • Comprehensive/Component Edits • Medically Unlikely EditsConditions of CoverageMedical Necessity • National Coverage Determination • Local Coverage Determination • Screening Tests • Experimental Testing • Administrative PoliciesSpecial Coverage ConditionsEnd-Stage Renal Disease • Skilled-Nursing Facility • Ambulatory Payment Classifications • Inpatients • Three-Day Window • Date of Service Rule • Other Private-Payor RulesRemittance Advice ReviewBeneficiary Documents • Provider Documents • Auditing Remittance AdviceSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIXES

39 Reimbursement Compliance

Vickie S. Baselski, Alice S. Weissfeld, and Fran Sorrell

IntroductionImproper PaymentsProgram IntegrityAuthority for Program Integrity • Activities in Program IntegrityPayor IntegrityPrepayment Review • Postpayment ReviewLaboratory Provider IntegrityThe Seven Essential Elements • Specific Areas of ConcernCoding and Billing IssuesCPT Coding • Modifiers • ICD-CM Coding • The Requisition • Special Ordering SituationsMedical-Necessity IssuesRecord RetentionMarketing PracticesPricing and Inducements • Ordering Provider and Patient CommunicationFraud Alerts and Advisory OpinionsAuditing and MonitoringResponse to Possible Fraud or AbuseLaboratory Examples of Fraud and AbuseSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIXES

40 Determination of Profitability

Vickie S. Baselski, Alice S. Weissfeld, and Fran Sorrell

IntroductionPitfalls in Cost AccountingLaboratory ProfitabilityBalance Sheets • Income Statements • Cash Flow StatementsKey IndicatorsKey Income Indicators • Key Expense IndicatorsInstitutional ProfitabilityHuman ProfitabilityLaboratory ValueSummaryKEY POINTSGLOSSARYREFERENCES

SECTIONVIII

Outside Marketing and Expansion

41 Outreach Considerations and Overall Goals

Charlene H. Harris

IntroductionConsidering an Outreach ProgramAdministrative Interest • Exploring the Market • Strategic Plan • Business Plan • Sales PlanCommitment from All Relevant PartiesFeasibility Report • Philosophical Understanding • Service and Financial SupportImplementing the Outreach ProgramPeople • Processes • Facilities • Equipment • SuppliesOutreach IndicatorsGrowing the Outreach ProgramMarket Assessment • Client NeedsSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIXES

42 Outreach Implementation Requirements: A Case Study

Frederick L. Kiechle, Jack Shaw, and Joseph E. Skrisson

IntroductionOutreach Plan Approval ProcessBarriers to the Plan’s Approval • Consultants to the Rescue • Bureaucratic Simplification Equals SuccessRequirements for Outreach ImplementationSales and Marketing Program • Courier Services: Basics and LogisticsBeaumont Reference Laboratory: 1993 to 2004Annual Growth and Its Implications • Projecting Future Volume • Send-Out Tests • Monitoring Financial OutcomeJoint Venture Hospital LaboratoriesHistory of JVHL . Benefits of BRL’s Affiliation with JVHLSummaryKEY POINTSGLOSSARYREFERENCES

43 Finance and Decision Making in Outreach

Michael G. Bissell and Harry E. Pukay-Martin

IntroductionThe Clinical Laboratory as a Business • The Phases of the Growth CurveDecision Making in Laboratory Outreach ManagementTypes of CostsDirect and Indirect Costs • Fixed, Variable, and Mixed Costs • Unit Costs • Additional Cost Concepts for Decision Making • Characteristics of Laboratory Costs • MicrocostingLevels of Decision Making in Outreach OperationsMenu: 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 EquipmentSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIXES

44 Outreach: Obstacles to Hospital Outreach and Enhancing Customer Satisfaction

Beth H. Deaton

IntroductionMaking Organizational ChangesCentralize Work • Place Laboratory Management on Off ShiftsGive Outreach Its DueMake Outreach High-Profile • Manage Outreach as a Business, Not a DepartmentInformation Technology ChangesHospital Systems versus Separate Systems • Nonstaff Physicians • Data Interface • Patient Registration and Accounting Concerns • Populating the Patient Record • Physician Office ConnectivityMeeting the NeedsCapital • FTEsHospital versus Outreach ContractingDefining Insurance Plans • Contracting • Acceptance of PayorsFailure To Understand Financial Implications and RequirementsUnrelated Business Income Tax • Other TaxesUnderstanding the Hospital’s Point of ViewLower Cost per Test • Make MoneyTranslating Hospital and Laboratory Compliance for an Outreach OperationPhysician 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 CooperationEnhancing Customer Satisfaction: CommunicationNewsletter • Marketing and Sales Team • Laboratory Guidebook • Website • Focus GroupCustomer Satisfaction AssessmentSurveys • Problem Reporting and ResolutionCouriers: The First LineClient ServicesAccess to Draw Sites and Patient Service CentersBuilding and Retaining Your Client BaseLeverage the Continuum of Care • Keep Asking Why • Follow Up When Clients LeaveProfessional Marketing and Sales PersonnelCommission Plans • Reports • Prepackaged InformationTechnical Expertise AccessibilityAccounts That Require Special CareNursing Homes • Drug Accounts • Home Health Agencies • Veterinary Lab ServicesDefine Service Area and ServicesRange of Services • The Importance of StandardizationSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIXES

SECTIONIX

Clinical Trials and Evidence-Based Laboratory Medicine

45 The Current State of the U.S. Food and Drug Administration Process and Regulations for Diagnostic Laboratory Assays

Donna M. Wolk, Natalie N. Whitfield, Elizabeth M. Marlowe, and Marilyn M. Marshall

IntroductionBackground: The FDA Processes for Classification and Assessment of New IVDsPremarket Approval (PMA) • Premarket Notification [510(k)] and 510(k) Review • Alternative Application Submission Approaches • The Pre-IDE Process • The Expedited ReviewMiscellaneous FDA RequirementsEstablishment Registration • Medical Device Listing • Good Manufacturing Practices and Quality System Regulations • Quality ControlAutomated Laboratory AssaysPostmarket ReviewLimitations Inherent to Current FDA ProcessesSummaryKEY POINTSGLOSSARYREFERENCES

46 The Clinical Trial Laboratory: Research Compliance for Clinical Research Microbiologists

Donna M. Wolk and Marilyn M. Marshall

IntroductionFunded Clinical Research in Laboratory MedicineSponsored Projects • Office of Research and Contract Analysis (ORCA)Compliance with Human Subject RegulationsBackground 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 HSPPsCompliance with HIPAACompliance with Conflict of Interest PoliciesIntellectual Property ConsiderationsGLP and GCP RegulationsSponsor 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 ReportsSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIX

47 Clinical and Evidence-Based Research in the Clinical Laboratory

Donna M. Wolk

IntroductionTypes of StudiesObservational Studies • Mechanistic Studies • Therapeutic Studies • Large-Scale Clinical Trials • Meta-AnalysisTranslational ResearchSequence of Investigation • Literature Search • Hypothesis Generation • Designing the Study To Test the HypothesisBiostatisticsDescriptive Statistics • Inferential Statistics: General Issues for Medical Devices • Other Issues for Diagnostic StudiesOther Research ConsiderationsSystematic Reviews and Laboratory Medicine Best PracticesEvidence-Based Laboratory Medicine • Laboratory Medicine Best Practices InitiativeSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIX

SECTIONX

Defining and Measuring Standards for Success

48 Benchmarking and Performance Monitoring for the Clinical Laboratory

Lionelle D. Wells, Washington C. Winn, Jr., and Michael R. Lewis

IntroductionWhy Benchmark?The Payoff from BenchmarkingThe Basic StepsPrioritization • Data Collection and Analysis • Development and Implementation of PlansWhere Do We Find Information about Benchmarks?Quality Benchmarks • Financial BenchmarksGeneral Approach to Financial Benchmarking and Performance MonitoringThe 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 EnvironmentMeasuring Laboratory Financial PerformancePerformance Monitoring • External BenchmarkingInterpretation of Performance Monitoring DataSummary Measure as Unifying Force • Prerequisites for Effective Use of a Summary MeasureInterpretation of External Benchmarking DataMeasuring Laboratory Performance in the Broader Clinical SettingEffect of Accountable Care Organizations • Linkage of Payment to Measures of Quality • Laboratory-Related Standards in Broader Accreditation ProgramsSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIXES

49 Test Utilization and Clinical Relevance

Michael L. Wilson, Gary W. Procop, and L. Barth Reller

IntroductionEvaluating Potential and Real ProblemsClinical Relevance • Cost-Effectiveness Analysis, Cost-Benefit Analysis, and Cost-Utility AnalysisDocumenting the Extent of the ProblemLiterature Review • Centralized Studies • Local DataLaboratory-Based Approaches to ControlNewsletters • Policy Changes • Personal and Ad Hoc Communication • LIS/HIS-Based Controls on Test Ordering • LIS-Based Feedback in ReportsInstitution-Based Approaches to ControlWorking 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 StepsPutting It All TogetherBase Policy Approaches and LIS/HIS-Based Controls on Evidence-Based Medicine • Track Results • The Plan, Do, Study, Act Model • The Future: Better Teaching and TrainingSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIX

50 Benchmarking and Performance Monitoring: What Is Appropriate for Your Laboratory?

Ronald J. Bryant and Michael R. Lewis

IntroductionStarting at the Beginning: What To Measure?Where Can We Get Help?How Will I Fund This?Evaluation of Data and Monitoring of PerformanceSummaryKEY POINTSGLOSSARY

SECTIONXI

The Future of Clinical Laboratories

51 The Future of Pathology and Laboratory Medicine: Political, Social, Economic, and Regulatory Impacts

Paul Bachner

IntroductionThe Current Environment of HealthcareCurrent RegulationsCLIA ’88 • HIPAA • OSHA Standards for Occupational Exposure to Blood-Borne Pathogens • The Stark LawsLiability ConsiderationsThe Future Regulatory Climate under CLIA ’88Personnel Standards and Quality Control Standards • Complexity Categories • Waived Testing • Changes to CLIA and Alternative ApproachesThe Impact of HIPAALaboratory Requirements • The Future of HIPAABioterrorismRecent History • Future ImpactLong-Term Effects: Legislation, Regulation, AccreditationQuality, Value, and Patient Safety • The Patient Safety MovementIssues Affecting Research and Academic LaboratoriesStem Cell Research • BiorepositoriesRestrictive Patents and Restraints on Use of Human TissuesSummaryKEY POINTSGLOSSARYREFERENCESAPPENDIX

52 The Future of the Clinical Scientist Workforce

Diana Mass and John R. Snyder

IntroductionEssential Role in Healthcare • Other Continuing Imperatives • A New Workforce • Laboratory Paradigms • The Old Laboratory • The New Laboratory • The Changing Workforce • Creating Conditions of Good WorkThe Changing Nature of WorkThe Consultation Role and Process • Consultant Skills • The Internal ConsultantSummaryKEY POINTSGLOSSARYREFERENCES

53 Electronic Health Records and Their Implications and Opportunities for Laboratories

Walter H. Henricks

IntroductionElectronic Health RecordsDefinition and Components • Status of EHR UseFederal Regulations Related to EHRs and Their Implications for LaboratoriesMeaningful Use: The EHR Incentive Program • Meaningful Use Requirements Directly Relevant to Laboratories • EHR Certification Program: Functional Criteria and Data Standards • Certification Criteria and Standards Most Relevant to LaboratoriesConcerns/Implications for Laboratories Related to Increased Use of EHR SystemsResults Management • Test Result Management when Multiple Laboratories Serve a Single EHR System • Computerized Provider Order Entry • EHR-LIS Interfaces • Technical Aspects of Interfaces: HL7 and LOINC • Operational Challenges for Laboratories with LIS-EHR InterfacesStrategies for Laboratories To Succeed in Laboratory Information Management in the EHR EraSteps To Increase Involvement and Influence in EHR Processes Related to the Laboratory • Tactics for Working with EHR Support Staff • Laboratory Involvement in EHR Selection and ImplementationSummaryKEY POINTSGLOSSARYREFERENCES

54 Current Trends in Instrumentation and Technology: Outlook for the Future

Sheshadri Narayanan and Audrey N. Schuetz

IntroductionChemistryCore Laboratory • Rapid-Response Laboratory and Point-of-Care Testing • Noninvasive TestingHematologyAutomation in the Routine LaboratoryCoagulation LaboratoryRoutine Coagulation • Point-of-Care Testing • Molecular TestingMicrobiologyMolecular TestingBlood BankAutomation • Molecular TestingOutlook for the FutureDriving Forces • Miniaturization and Microfluidics • Biochips • DNA SensorsSummaryKEY POINTSGLOSSARYACKNOWLEDGMENTSREFERENCESAPPENDIXES

55 The Future Practice of Laboratory Medicine

Paul Bachner and M. Desmond Burke

IntroductionLaboratory Medicine: Origins and Historic DevelopmentClinical PathologyRecent Trends in Clinical PracticeIncreasing Utilization of Laboratory Services • Growth of Point-of-Care Testing • Increasing Autonomy of Nonphysician Healthcare Providers • The Electronic Revolution and Clinical PracticeReaction to Recent TrendsClinical Laboratory Consultation • Teaching Test Strategy and Interpretation of Results • Future Role of Pathologists and the Laboratory in Emerging Economic Models • Evidence-Based Medicine and Medical InformaticsPredictions for the 21st CenturySummaryKEY POINTSGLOSSARYREFERENCES

Master Glossary

Index

Contributors

Christina E. Anderson

Department of Pathology, Virginia Commonwealth University Health System, Richmond, VA 23298

Paul Bachner

Department of Pathology and Laboratory Medicine, University of Kentucky Chandler Medical Center, 800 Rose St., Room MS 112, Lexington, KY 40536-0298

Vickie S. Baselski

University of Tennessee Health Science Center at Memphis, Clinical Microbiology, 349 Riverbluff Place, Memphis, TN 38103-4132

Katharine R. Becker

PLB Ventures and Consulting, 9502 Roe Circle, Franktown, CO 80116

James W. Bishop

Department of Management, New Mexico State University, Las Cruces, NM 88003

Michael G. Bissell

Ohio State University Medical Center, Room 4173 Graves Hall, 333 W. 10th Ave., Columbus, OH 43210-1239

Joanne I. Brisbois

Geisinger Health System, 100 N. Academy Avenue, MC 01-31, Danville, PA 17822-0131

Ronald J. Bryant

University of Vermont Medical Group, Fletcher Allen Health Care, 111 Colchester Avenue, Mailstop 233MP1, Burlington, VT 05401

M. Desmond Burke

Emeritus Professor of Pathology & Laboratory Medicine, Cornell University Medical College, New York, NY 10021

Joseph M. Campos

Children’s National Medical Center and Georgetown University Medical Center, Washington, DC

Jeffrey Casterline

Department of Pathology and Laboratory Medicine, Drexel University College of Medicine, 245 N 15th Street / MS 435, Philadelphia, PA 19102

George S. Cembrowski

Medical Biochemistry, University of Alberta Hospital, Edmonton, Alberta, Canada

Lakshmi Chandramohan

Department of Pathology, Baylor College of Medicine, Molecular Microbiology Laboratory, Texas Children’s Hospital, 6621 Fannin St., MC2-2271, Houston, TX 77030

Beth H. Deaton

Consolidated Lab Services, 600 Gresham Dr., Norfolk, VA 23507

Christopher Doern

Children’s Medical Center of Dallas, University of Texas Southwestern Medical Center, Dallas, TX

James J. Dunn

Department of Pathology, Cook Children’s Medical Center, Fort Worth, TX 76104

Jean Egan

Jean Egan Associates, LLC, 33 Woods Hollow Road, West Suffield, CT 06093

Lynne S. Garcia

LSG & Associates, 512 – 12th St., Santa Monica, CA 90402

Kellie A. Gibbs

MCG Health, Inc. dba Georgia Regents Medical Center, BI-2008B, 1120 15th Street, Augusta, GA 30912

Margaret M. Grimes

Department of Pathology, Virginia Commonwealth University Health System, Richmond, VA 23298

Diane C. Halstead

North Florida Pathology, P.A., and Clinical Laboratory Services, Baptist Medical Center, Jacksonville, FL 32207

Mark G. Hanly

SEPALabs, Brunswick, GA 31525, and Department of Pathology, Southeast Georgia Health System, Brunswick, GA 31520

Ann L. Harris

Department of Pathology, VCU Medical Center, PO Box 980258, Richmond, VA 23298-0258

Charlene H. Harris

System Director, Laboratory Services, Sarasota Memorial Health Care System, 1700 South Tamiami Trail, Sarasota, FL 34239

David S. Hefner

Georgia Regents Medical Center and Georgia Regents University, 1120 15th Street, Augusta, GA 30912

Walter H. Henricks

Center for Pathology Informatics and Pathology and Laboratory Medicine Institute, Cleveland Clinic, 9500 Euclid Avenue, L21, Cleveland, OH 44195

Glen L. Hortin

Quest Diagnostics, Tampa, FL 33617

Kari Jones

Anatomic Pathology, MCGHealth, Inc., 1120 15th Street, Augusta, GA 30912

Adarsh K. Khalsa

Laboratory Sciences of Arizona, Banner Good Samaritan Medical Center, Phoenix, AZ 85006

Frederick L. Kiechle

Pathology Consultants of South Broward, Memorial Healthcare System, 3501 Johnson Street, Hollywood, FL 33021

Anthony S. Kurec

Clinical Associate Professor, Emeritus, SUNY Upstate Medical University, 750 East Adams St., Syracuse, NY 13202

Jimmy R. Lea

Forensic Drug Laboratory, Georgia Regents University Medical Center, 1120 15th Street, Augusta, GA 30912

Ronald B. Lepoff

Department of Pathology, University of Colorado School of Medicine, 12401 East 17th Avenue, Mailstop A022, Aurora, CO 80045

Michael R. Lewis

University of Vermont Medical Group, Fletcher Allen Health Care, 111 Colchester Avenue, Mailstop 233MP1, Burlington, VT 05401

Andrea J. Linscott

Dept. of Pathology, Ochsner Healthcare System, 1514 Jefferson Highway, New Orleans, LA 70121

Elizabeth M. Marlowe

Regional Reference Laboratories, Southern California Permanente Medical Group, 11668 Sherman Way, North Hollywood, CA 91605

Anne Marsden

Quality Assurance, Quest Diagnostics Nichols Institute, San Juan Capistrano, CA 92690

Marilyn M. Marshall

Office of Responsible Conduct for Research, University of Arizona, Tucson, AZ 85719

Diana Mass

Clinical Laboratory Sciences Program, School of Life Sciences, Arizona State University, Tempe, AZ 85287-4501, and Associated Laboratory Consultants, 14142 Ridge Canyon Rd., Valley Center, CA 92082

Stephanie Maynard-Patrick

Department of Management, New Mexico State University, Las Cruces, NM 88003

Patti Medvescek

Labor Analytics and Benchmarking, Financial Operations, Indiana University Health, 950 N. Meridian St., Suite 800, Indianapolis, IN 46204

Roxanne Mercer

Department of Pathology, VCU Medical Center, PO Box 980662, Richmond, VA 23298-0662

Sheshadri Narayanan

Dept. of Pathology & Laboratory Medicine, Weill Medical College of Cornell University, 525 East 68th St., Room F-715, New York, NY 10021

Donna Oblack

Cincinnati Department of Veteran Affairs Medical Center, Cincinnati, OH 45220

Christa Pardue

Laboratory Services, University Health Care Systems, 1350 Walton Way, Augusta, GA 30901

Elissa Passiment

ASCLS, 2025 M Street, NW, Suite 800, Washington, DC 20036

Gary W. Procop

Department of Molecular Pathology, Cleveland Clinic, 9500 Euclid Avenue / LL2-2, Cleveland, OH 44195

Harry E. Pukay-Martin

Department of Pathology, The Ohio State University, 121 Hamilton Hall, 1645 Neil Ave., Columbus, OH 43210

L. Barth Reller

Departments of Pathology and Medicine, Duke University School of Medicine, DUMC Box 3938, Research Drive, Durham, NC 27710

Paula Revell

Pathology and Pediatrics, Baylor College of Medicine, and Clinical and Molecular Microbiology Laboratories, Texas Children’s Hospital, 6621 Fannin St., MC1-2261, Houston, TX 77030

Susan D. Roseff

Department of Pathology, Virginia Commonwealth University Health System, PO Box 980662, Richmond, VA 23298-0662

Denise E. Russell

Risk Management, Virginia Commonwealth University Health System, Richmond, VA 23298

Michael Santa Cruz

Laboratory Sciences of Arizona, Banner Gateway Medical Center / MD Anderson Cancer Center, Gilbert, AZ 85234

Michael A. Saubolle

Laboratory Sciences of Arizona, Banner Good Samaritan Medical Center, and University of Arizona College of Medicine, Phoenix, AZ 85006

Ron B. Schifman

Diagnostics Service Line, Southern Arizona VA Healthcare System, 3601 South 6th Ave. (6-113), Tucson, AZ 85723

Audrey N. Schuetz

Dept. of Pathology & Laboratory Medicine, Weill Cornell Medical College/NewYork-Presbyterian Hospital, 525 East 68th St., Room Starr 737C, New York, NY 10065

K. Dow Scott

Institute of Human Resources and Industrial Relations, Loyola University Chicago, Chicago, IL 60611

David L. Sewell

Pathology and Laboratory Medicine Service, Veterans Affairs Medical Center, Department of Pathology, Oregon Health and Sciences University, Portland, OR 97239

Amy Shahtout

Quest Diagnostics, 33608 Ortega Highway, San Juan Capistrano, CA 92690

Jack Shaw

Mednet Services, 1633 Fairlane Circle, Suite 300, Allen Park, MI 48101

Joseph E. Skrisson

Dynacare Laboratories, 9200 W. Wisconsin Avenue, Milwaukee, WI 53226-3596

John R. Snyder

Ohio State University College of Medicine, 4240 Campus Drive, Lima, OH 45804

Fran Sorrell

American Esoteric Laboratories, 1701 Century Center Cove, Memphis, TN 38134

John C. H. Steele, Jr.

Department of Pathology, Georgia Regents University, Room BI-2008A, 1120 15th Street, Augusta, GA 30912-3640

Geoffrey C. Tolzmann

Dahl-Chase Diagnostic Services, 417 State Street, Suite 540, Bangor, ME 04401

Diane C. Turnbull

Georgia Regents University, 1102 15th Street, Augusta, GA 30912

Paul Valenstein

IHA Pathology and Laboratory Management, 5301 East Huron River Dr., Ann Arbor, MI 48106-3058

Laurence P. Vetter

Department of Pathology, Virginia Commonwealth University, P.O. Box 980662, Richmond, VA 23298-0662

Richard J. Vincent

University of Vermont Medical Group, Fletcher Allen Health Care, 111 Colchester Avenue, Mailstop 233MP1, Burlington, VT 05401

Lei Wang

Department of Management, The University of Texas Pan-American, Edinburg, TX 78539

Alice S. Weissfeld

Microbiology Specialists, Inc., 8911 Interchange Drive, Houston, TX 77054

Lionelle D. Wells

Center for Disease Detection, San Antonio, TX 78233

Fred Westenfeld

Department of Pathology and Laboratory Medicine, Fletcher Allen Health Care, 111 Colchester Avenue, Mailstop 233MP1, Burlington, VT 05401

Natalie N. Whitfield

Department of Pathology, University of Arizona Medical Center, 3601 N. Campbell Avenue, Tucson, AZ 85724-5059

David S. Wilkinson

Department of Pathology, VCU Medical Center, 1101 East Marshall Street, P.O. Box 980662, Richmond, VA 23298-0662

Michael L. Wilson

Department of Pathology and Laboratory Services, Denver Health Medical Center, Mail Code #0224, 777 Bannock, Denver, CO 80204-4507

Washington C. Winn

(Deceased)

Donna M. Wolk

Department of Laboratory Medicine, Geisinger Health System, 100 N. Academy Avenue, MC 01-31, Danville, PA 17822-0131

Preface

The current environment for laboratory medicine and pathology continues to undergo dramatic transformation, which is influenced by significant changes in the legislative, regulatory, reimbursement, technologic, sociologic, economic, communication, and business sectors. The practice of all aspects of medicine and allied healthcare requires new approaches and a much broader range of managerial expertise. Areas in which a laboratory director, manager, or supervisor is expected to understand and perform include fiscal and human resources, patient care testing and quality performance issues, and overall accountability to the facility administration.

It is very important that individuals working within the healthcare environment learn to hear, speak, and thoroughly understand the operational language of healthcare administration. During the past few years, the fields of laboratory medicine and pathology management have seen many dramatic changes, including those related to quality assurance, communication, data storage and retrieval, point-of-care testing, test management, automation, safety and emergency preparedness, regulatory requirements, information confidentiality, billing and coding requirements, physical space changes, laboratory consolidation, shortage of training programs and trained personnel, competency testing, specimen handling and shipping requirements, decrease in reimbursement, demand for increased productivity, and increased need for consultation and educational initiatives for clients. Reactions to the changes that have occurred in the healthcare environment in recent years are essentially twofold: increased efforts to contain costs and increased demand for appropriate and error-free medical care.

The purpose of this text is to provide comprehensive, practical information and guidelines for healthcare management in the 21st century to laboratory directors; managers; chief technologists; supervisors; trainees in schools of healthcare administration, medical laboratory technology, and other allied health disciplines; those training for leadership positions; and those studying for board or registry certification in management. This book is designed both for those who are already actively working in clinical pathology and clinical laboratory management and for those who are training to enter these fields. It contains a comprehensive overview of management principles and how they apply to the clinical laboratory. In-depth analysis of the financial challenges facing clinical laboratories is included, as are discussions on good business practices. There is extensive information on the impact of the regulatory environment on every aspect of clinical laboratory practice, as well as personnel management related to all relevant job classifications. Additional discussions include the changing practice of medicine, managerial leadership, the expanding field of point-of-care testing, enhanced information systems and security/confidentiality requirements, reimbursement compliance, outside marketing and expansion, clinical trials and evidence-based medicine, benchmarking, current trends in instrumentation and technology, enhanced consultation though expanded test result reports, and the future of clinical laboratories.

The authors are all practicing laboratorians, many of whom have had extensive “hands-on” experience in all facets of clinical laboratory practice, including both technical and managerial responsibilities. Each section is edited by experienced professionals and includes comprehensive coverage, both didactic and practical, of all issues related to clinical laboratory operations.

Clinical Laboratory Management, Second Edition, offers extensive laboratory management information in one resource. Practical examples and numerous summary tables are provided to serve as guidelines for relevant documentation. Various management tools are discussed, particularly related to personnel, technical, regulatory, and financial responsibilities. This information is relevant for all job levels within the laboratory, as well as for all healthcare management and technical training courses. Each chapter follows the same format, designed to flow easily from one section to another. When relevant, chapters contain checklists, work sheets, forms, abbreviations/acronyms, diagrams, figures, photographs, and specific practical examples of relevant material.

It is important for readers to understand that there are many different laboratory settings; not every laboratory will handle managerial responsibilities the same way, nor will every option be applicable to every situation. The key to quality and clinically relevant laboratory management approaches requires a thorough understanding of the pros and cons of each approach and how various options may or may not be relevant for one’s particular laboratory size and range of expertise, client base, number and type of patients seen, personnel expertise and availability, equipment availability, educational initiatives, and communication requirements.

The use of product or program names is not intended to endorse specific products or programs or to exclude substitute products or programs. Every effort has been made to ensure accuracy; however, ASM Press and the Editors encourage you to submit to us any suggestions, comments, and information on errors found.

Acknowledgments

As editors for the Second Edition of Clinical Laboratory Management, we would like to express our thanks to the many educators, colleagues, and students who have helped shape our perspectives regarding the field of clinical laboratory and pathology management. As with the first edition, the aim was to consolidate this information for the benefit of those working in healthcare and to share our knowledge with individuals currently working in laboratory management positions. However, regardless of your position in the healthcare arena, understanding the management challenges and “rules of the game” is beneficial for everyone.

Our special thanks go to the authors for their outstanding contributions. All of these individuals have extensive work experience in the field and bring this expertise to each chapter. We appreciate the time and energy it took to produce the Second Edition, knowing that all were extremely busy with the day-to-day operations for their current positions.

We would like to thank members of the editorial staff of ASM Press, especially Ellie Tupper, Christine Charlip, and our copyeditors; they are outstanding professionals and contributed extensive support throughout the publication process. With their help, we all managed to complete the task and maintain our sense of humor.

Above all, our special thanks go to our families and colleagues for their support, guidance, and advice during this extensive project. This Second Edition was very much a collaborative effort, and we hope the material will prove beneficial to the overall healthcare community.

Lynne S. Garcia

Paul Bachner, Vickie S. Baselski,

Michael R. Lewis, Andrea J. Linscott,

Dale A. Schwab, John C. H. Steele, Jr.,

Alice S. Weissfeld, David S. Wilkinson,

and Donna M. Wolk

I

Basic Concepts and the Current Healthcare Environment

SECTION EDITOR: David S. Wilkinson

1  Principles of Management

Jeffrey Casterline and John R. Snyder

2  Management Functions

Laurence P. Vetter

3  Relevant Economic and Business Concepts

Roxanne Mercer and Ann L. Harris

4  Current Challenges to Financial Stability within the Diagnostic Laboratory

Roxanne Mercer and David S. Wilkinson

5  The Impact of Regulatory Requirements

Susan D. Roseff, Christina E. Anderson, Roxanne Mercer, and Denise E. Russell

6 The Changing Practice of Medicine

Susan D. Roseff, Denise E. Russell, and Margaret M. Grimes

7 The Changing Healthcare Environment

Ann L. Harris and David S. Wilkinson

1 Principles of Management

Jeffrey Casterline and John R. Snyder

IntroductionLeadership, Management, and AdministrationLeadership • Management • AdministrationManagement ConceptsCultural Lag • Review of Management ThoughtDecision MakingWhat Is Decision Making? • Types of Decisions • Individual versus Group Decision Making • The Problem-Solving/Decision-Making Process • RiskManagement EthicsDefinitions • Characteristics of High-Ethics Organizations • Benefits of Strong Workplace Ethics • Management Roles and ResponsibilitiesSummaryKEY POINTSGLOSSARYREFERENCESOTHER READINGAPPENDIX

OBJECTIVES

To familiarize the reader with the concepts of leadership, management, and administration

To place modern management ideas in their historical context