Clinical Laboratory Management

Name: Clinical Laboratory Management
Brand: Wiley
Price: 200.99 EUR
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Lynne Shore Garcia Alice S. Weissfeld Donna M. Wolk Timothy C. Allen Vickie S. Baselski Deirdre L. Church Donald S. Karcher Michael R. Lewis Andrea J. Linscott Melinda D. Poulter Gary W. Procop(Editor)

Wiley (Publisher)

3rd Edition

Published on 7. March 2024

816 pages

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978-1-68367-392-7 (ISBN)

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Clinical Laboratory Management

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

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

Topics covered include:

* an introduction to the basics of clinical laboratory management, the regulatory landscape, and evolving practices in the modern healthcare environment

* the essence of managerial leadership, with insights into employee needs and motivation, effective communication, and personnel management, including the lack of qualified position applicants, burnout, and more

* financial management, budgeting, and strategic planning, including outreach

* up-to-date resources for laboratory coding, reimbursement, and compliance, reflecting current requirements, standards, and challenges
* benchmarking methods to define and measure success

* the importance of test utilization and clinical relevance

* future trends in pathology and laboratory science, including developments in test systems, human resources and workforce development, and future directions in laboratory instrumentation and information technology
* an entirely new section devoted to pandemic planning, collaboration, and response, lessons learned from COVID-19, and a look towards the future of laboratory preparedness

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

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Content

Cover
Title Page
Copyright Page
Contents
Contributors
Preface
Acknowledgments
Section I Basic Concepts and the Current Healthcare Environment (section editor: Donald S. Karcher)
Chapter 1 Clinical Laboratory Management: Basic Principles and Practices
Management, Leadership, and Administration
A Brief History of Management Concepts
Classical Theory
Behavioral Theory
Quantitative Theory
Operations Management and the Integrated Theory
Decision Making and Problem Solving
What Is Decision Making?
Types of Decisions
Individual versus Group Decision Making
The Problem-Solving/Decision-Making Process
Management Functions
Planning
Organizing
Directing
Controlling
Summary
The Evolving Models of Clinical Laboratories
Centralized Testing
Decentralized Testing
The Basics of Financial Management
Costs
Revenue
Gross versus Net Revenue
Medicare
Managed Care
Budgeting
Operating Budget
Capital Budget
Revenue Cycle: Billing and Collecting
A Brief History of Clinical Laboratory Finances
Management Ethics
SUMMARY
KEY POINTS
GLOSSARY
ACKNOWLEDGMENTS
REFERENCES
APPENDIX
Appendix 1.1 Laboratory Strategic Plan
Appendix 1.2 Laboratory Organizational Chart
Chapter 2 Regulatory Issues in Laboratory Medicine
Introduction
Brief History of Regulation of the Clinical Laboratory
Department of Health and Human Services and CLIA
FDA and Medical Devices
Overview of the Current Clinical Laboratory Regulatory Environment
CLIA and the Regulation of Quality
CLIA Framework
Quality Control
Accreditation and Licensure
Laboratory Inspection and Accreditation
Personnel Certification and Licensure
FDA Regulation of In Vitro Diagnostic Tests
Current Overview
Laboratory-Developed Tests
Regulations Affecting Transfusion Medicine
Introduction
Framework of FDA Regulations
Blood Collection and Component Production
Transfusion Services
Reporting Requirements
Cellular Therapies
Current and Future Regulatory Challenges
Clinical Laboratory Workplace Safety
Risk Assessments
Chemical Hazards
Biological Hazards
Other Infectious Hazards
Transportation of Clinical Specimens
Physical Hazards
Additional Safety Regulatory Resources
Overview of Laboratory Reimbursement Regulation
U.S. Healthcare
Medicare
Pathology and Laboratory Services in Medicare
Claims Processing
Reimbursement for Physician Services
Laboratory Test Reimbursement
Patient Privacy: HIPAA and Related Regulations
HIPAA Introduction
Protected Health Information
Patient Informed Rights
Consent and Authorization
Privacy Rule
Security Rule
HITECH and Omnibus Rule
Breach Notification Rule
Enforcement Rule
Current Topics in HIPAA Compliance
Summary of Laboratory Responsibilities
SUMMARY
KEY POINTS
GLOSSARY
ACKNOWLEDGMENTS
REFERENCES
Chapter 3 The Changing Practice of Medicine
Introduction
Staffing Shortages
Pathology Pipeline
Consolidation of Hospital Systems, Hospitals, and Physician Practices
Health Disparities
The Impact of Technology
Electronic Health Records
Patient Access to Information: Recent Changes to the HIPAA Rules
Molecular Testing
Stewardship of Limited Resources
Supply Chain Instability
Laboratory Utilization
Blood Products
Medicolegal Issues
Malpractice Pre-COVID-19
Malpractice in the Age of COVID-19
Public Readiness and Emergency Preparedness Act
Climate of Medical Training
Trainee and Physician Well-Being
SUMMARY
KEY POINTS
GLOSSARY
ACKNOWLEDGMENTS
REFERENCES
Chapter 4 The Changing Healthcare Environment
Introduction
Changing Provider Payment Models
Overview of Reimbursement Methods
Types of Managed Care Organizations
Managed Care and the Clinical Laboratory
Impact of Healthcare Reform
Patient Protection and Affordable Care Act
Payment Reform and Provider Reimbursement Strategies
Medicare Shared Savings Program
Value-Based Purchasing (VBP)
Other Payment Reforms
Hospitals and Laboratories: Concerns in Healthcare Reform
The Changing Legal Environment
HIPAA
False Claims Act
Technological Advances
Changing Testing Modalities
Pathology Informatics
Meaningful and Relevant Information
Impact of Bioinformatics on Pathology
Direct Consumer Access
Direct Access Testing
Direct-to-Consumer Testing
Consolidation in the Healthcare Industry
Consolidation of Practices
Integrated Delivery Systems
Internal Consolidation in Hospital Laboratories
Regional Integrated Laboratory Networks
STRATEGIES FOR FUTURE SUCCESS
Strategic Redesign
Supply Chain
Laboratory Design
Developing System-Wide Thinking and a Common Culture
Training Adequate, High-Quality Laboratory Professionals for the Future Workforce
Pathologist Shortage
Moving from Top-Down Management to Bottom-Up Customer Focus
Evidence-Based Medicine
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
Section II Managerial Leadership (section editor: Deirdre L. Church)
Chapter 5 The Foundations of Leadership
Introduction
Distinguishing Management from Leadership
What Is "Leadership" and How Do You Become a Leader?
Management
Leadership
The First Foundational Factor Is Integrity
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
The Definition of Authentic
Knowing Yourself
How Do You Respond in Various Situations?
The Importance of Context
The Path to Authenticity
The Third Foundational Factor Is Commitment to Something Bigger than Yourself
Succeeding as a Leader
What Happens Next?
SUMMARY
KEY POINTS
ACKNOWLEDGMENTS
REFERENCES
APPENDIX
APPENDIX 5.1 Resources
APPENDIX 5.2 Further Information
Chapter 6 Employee Needs
Introduction
Definitions and Background
Special Challenges from the Pandemic
Strategies for Assessing and Reducing Burnout
Additional Trends and Needs of Laboratory Employees
The Role of Generational Differences
SUMMARY
KEY POINTS
GLOSSARY
ACKNOWLEDGMENTS
REFERENCES
Chapter 7 Motivating through Intelligent Leadership
What Is Motivation?
Leadership as a Conduit of Motivation
Knowledge of Self
Creating the Vision
Humility
Work-Life Balance and Basic Needs
Knowing What Others See in You
Factors of Motivation
The Right People Need the Right Leader
Actually Fix the Problems
Knowing the Emotions of Leading
Emotional Intelligence
The Need for Purpose
Human Motivation Theory
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
Chapter 8 Effective Communication
Introduction
Channels of Communication
Formal Channels of Communication
Informal Channels of Communication
Types of Communication
Oral Communication
Telephone Communication
Written Communication
Online Presentations
Electronic Communication
Visual Communication
Body Language and Other Nonverbal Communication
Barriers to Effective Communication
Physical Barriers
Nonverbal Barriers
Verbal Barriers
Psychological Barriers
The Importance of Listening
Effective Listening
Ineffective Listening
Stages of Listening
Types of Listening
Elements of Effective Face-to-Face Communication
Skills for Effective Face-to-Face Communication
Organizational Climate
Using Body Language
Using Positive Language
Leadership Essentials for Improving Communication
The Interaction Process
Adapting Communication Styles
SUMMARY
KEY POINTS
GLOSSARY
ACKNOWLEDGMENT
REFERENCES
Chapter 9 Effective Meetings
Introduction
Things To Do before a Meeting
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 a Meeting
Things To Do after a Meeting
Calculating the Cost of a Meeting
Recurrent Meetings
How To Be an Effective Participant in a Meeting
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
Chapter 10 Conflict Management
Conflict Is Natural and Inevitable
Origins of Conflict
Conflict Resolution Styles
Conflict Management
Equity, Diversity, and Inclusion Considerations
When Conflict Resolution Fails
What the Organization Can Do
SUMMARY
KEY POINTS
REFERENCES
Chapter 11 Leading People Through Change in Pathology and Laboratory Medicine
Introduction
The Case for Change Management
Definition of Change
The Psychology of Change
Why Change Management Is Important
Sources of Change
The Need for Change
Models of Change Management
The Kotter Model
The ADKAR Model
Supporting Laboratory Staff Through Change
Actions Leading to Successful Change
Managing Resistance
Auditing and Reinforcing the Change
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
APPENDIX
APPENDIX 11.1 Case Study
The Problem That Drove the Change
The Actions Taken
Results
Section III Personnel Management (section editor: Melinda D. Poulter)
Chapter 12 Employee Selection
Introduction
Diversity, Equity, and Inclusion (DEI) in the Workplace
Criteria-Based Job Descriptions (CBJD)
Basic CBJD Requirements
Criteria-Based Job Description Review
Minimal Personnel Requirements
Search Process
Search Committee
Advertising
Interview Process
Screening Résumés
Interview Formats
Interview Questions
Interview "Do's and Don'ts"
Hiring Process
Candidate Selection
Orientation and Onboarding
Documentation
Separation from Service
Retention
Losing an Employee
Progressive Discipline
Termination
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
Chapter 13 Performance Appraisals and Competency Assessment
Introduction
Performance Appraisals
Definition and History of Performance Appraisals
Purpose of Performance Appraisals
Advantages of Performance Appraisals
Trends Beyond the Traditional Performance Appraisal
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
Regulatory Foundation for Competency Assessment
Timing of Competency Assessment
Methods for Assessment of Competency
Practices
Personnel Excellence
SUMMARY
KEY POINTS
REFERENCES
APPENDIX
APPENDIX 13.1 Web-Based Software Products and Websites
Performance Appraisal Software
Performance Appraisal Websites
Competency Assessment Programs
Employee Performance Appraisal Forms
Clinical Laboratory Job Descriptions
Chapter 14 Staffing and Scheduling
Introduction
Laboratory Personnel: Current Dynamics Affecting Staffing
Labor Shortage
Business Need
Increasing Opportunities for Medical Technologists
Personnel Requirements
Education
Training and Competence Assessment
Functional Definitions
Generalist versus Specialist
Laboratory Staffing
Staffing Requirements
Basis for Determination: Workload Recording
Staff Scheduling
Key Success Factors
Metrics for Success
Alternatives
Special Considerations
Flexible Staffing
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
APPENDIX
Appendix 14.1 Further Information
Chapter 15 Teams, Team Process, and Team Building
Introduction
Definition of a Team
Types and Classifications of Teams
Why Define "Team" So Precisely?
Guidelines for Choosing Whether To Have Teams
Common Purpose
Interdependent Tasks
Costs: a Cautionary Note
Group Process and Teams
Selecting Team Members
Task- and Process-Related Training
Leading Teams
General Ideas about Leadership: a Brief Review
Leadership in a Team Environment
Team Leader Selection
Goal Setting, Performance, and Rewards
Goal Setting and Performance
Goal Setting and Teams
Evaluating Teams and Team Members
Rewarding Team Members
Virtual Teams and Remote Work
Global Teams (a Special Case of Virtual Teams)
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
APPENDIX
APPENDIX 15.1 Representative Websites
Chapter 16 Labor Relations
Introduction
Labor Law
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
Labor Law Updates
National Labor Relations Board (NLRB)
Description
Function
Structure
Processing of Cases
Authority To Secure Injunctive Relief from a Court
Issues Related to the NLRB
Union Structure
Formal Structure
Union Membership
Function of the Union Steward
Unionization Process
Individual, Group, and Union Image: Reasons Why Employees Join a Union
Relevance for Healthcare Workers
Organizing Campaign
Authorization Cards
The Bargaining Unit
Information Distribution and Solicitation
Election
Certification
Collective Bargaining
Issues for Bargaining
Preparation Phase
Negotiation Phase
Administration of the Agreement
Management Rights Clause
Labor Actions and Disputes
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
APPENDIX
Appendix 16.1 Helpful Websites Related to Unions and Collective Bargaininga
Appendix 16.2 Do's and Don'ts for Management Regarding Union Activity
Chapter 17 Workplace Drug Testing and the Clinical Laboratory
Introduction
Regulated and Nonregulated Testing
Whom To Test
Preemployment Testing
For-Cause or Reasonable Suspicion
Random Testing
Posttreatment Testing
Urine Drug Testing Protocol
Specimen Collection
Specimen Testing
Specimen Validity
Urine Drug Screening
Urine Drug Confirmation
Reporting Results
Alternative Specimen Types
Managing Clinical and Forensic Drug Testing
SUMMARY
KEY POINTS
GLOSSARY
ACKNOWLEDGMENTS
REFERENCES
APPENDIX
APPENDIX 17.1 Websites
Collection Site Manual
American Presidency Project
The Council on Alcohol and Drugs
Federal Register
National Archives, Office of the Federal Register
Section IV Requirements for Effective Laboratory Management (section editor: Andrea J. Linscott)
Chapter 18 Quality Management
Introduction
Quality Management of Preanalytical Processes
Test Selection and Ordering
Quality of Specimen Collection
Patient and Client Satisfaction
Specimen Transport, Storage, and Receipt and Preanalytical Processing
Quality Management of Analytical Processes
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
Turnaround Time
Corrected and Incomplete Reports
Document Control
SUMMARY
KEY POINTS
GLOSSARY
ACKNOWLEDGMENTS
REFERENCES
APPENDIX
APPENDIX 18.1 Regulations, Guidelines, and Information with Application to a Clinical Laboratory
REGULATIONS GROUPED BY ISSUING AGENCY
MISCELLANEOUS SOURCES
APPENDIX 18.2 CAP Laboratory Inspection Checklist Associated with Quality Management
Chapter 19 International Organization for Standardization
Introduction
ISO Background
ISO Certification versus ISO Accreditation
"Shall"/"Should"/"May"/"Can" Explained
ISO 9001
Seven Principles of ISO 9001
Standards Related to ISO 9001
ISO 15189
Structure of ISO 15189
Important Principles of ISO 15189
Documents Related to ISO 15189
ISO 15189 versus ISO 9001
CLIA '88 and ISO 15189
International Requirements for ISO 15189 Accreditation
Considerations for the Laboratory Management Team
Approaching ISO 15189 Accreditation
Accreditation Bodies for ISO 15189
CAP as an Accreditation Body
SUMMARY
KEY POINTS
REFERENCES
Chapter 20 Effective Communication in Laboratory Management
Introduction
Delivering the Message
Communicating to Diverse Audiences
Means and Mechanics of Effective Communication
Spoken Word
Written Word
Intradepartmental Communication
Interdepartmental Communication
External Communication
SUMMARY
KEY POINTS
ACKNOWLEDGMENT
REFERENCES
Chapter 21 Laboratory Information Systems
Introduction
A Primer on Computers
Hardware
Software
Networking
Cloud Computing
Healthcare Information Systems
Laboratory Information System Fundamentals
LIS Architecture
LIS Interfaces
LIS Administration
LIS Selection and Implementation
Specialty Considerations
Microbiology
Blood Banking
Point-of-Care Testing
Molecular Diagnostics
SUMMARY
KEY POINTS
GLOSSARY
ACKNOWLEDGMENTS
REFERENCES
Chapter 22 Management of Point-of-Care Testing
Introduction
Organizational Management of POCT
Administrative Considerations
Setting Goals for POCT Management
Laboratory Certification and Accreditation
Developing Management Structures for POCT
Operational Management of POCT
Determining the Scope of POCT Services
Weighing POCT versus Alternatives
Analyzing Costs of POCT
Assessing the Benefits of POCT Services
Quality Management of a POCT Program
Technological Management of POCT
POCT Innovation
Pandemics, Mass Casualties, and Humanitarian Emergencies Driving POCT Innovation
New Monitoring Technologies
SUMMARY
KEY POINTS
GLOSSARY
ACKNOWLEDGMENTS
REFERENCES
Chapter 23 Principles of Preanalytic and Postanalytic Test Management
Introduction
Preanalytic Activities
Test Selection and Implementation
Appropriate Test Utilization
Specimen Acquisition, Transport, and Storage
Test Ordering
Postanalytic Activities
Storage and Retention
Assessment of Test Results on Patient Outcomes
SUMMARY
KEY POINTS
GLOSSARY
ACKNOWLEDGMENTS
REFERENCES
Chapter 24 Selection and Implementation of New Equipment and Procedures
Introduction
Defining the Laboratory's Requirements
Technical/Performance Considerations
Specimen Type
Specimen Volume
Test Menu
Testing Volumes
Turnaround Time/Batch Size
Operational Throughput
Automation and Digitalization
Open versus Closed Platform
Available Interface
Assay Performance
Regulatory Clearance/Approval
Reagent Availability
Control Availability
Physical and Technology Requirements
Space Requirement
Power
Data
Plumbing/Water
Temperature/Humidity
Supply Chain Logistics
Human Resources
Staffing
Workflow
Ease of Use
Training Requirements
Financial
Instrument Cost
Cost of Operation
Cost per Result
Warranty
Maintenance Contract
Consumable Costs
Disposable and Consumable Cost
Software Requirements
Evaluation and Validation
Personnel Costs
Prioritization of Requirements
Confidentiality and Conflict of Interest
Information Review
Implementation and Product Placement
Verification and Validation
Verification
Validation
Personnel Competency Assessment and Training
Proficiency Testing
SUMMARY
KEY POINTS
REFERENCES
Chapter 25 Laboratory Safety
Introduction
Safety Management Plan and Responsibilities
Laboratory Hazards
Biological Hazards
Chemical Hazards
Physical Hazards
Radiation Hazards
Mental Hazards
Standard Precautions
Hazard Prevention and Containment
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
Spill Management
Biological
Chemical
Fire Safety
Disaster Preparedness
Waste Management
Regulatory Oversight
Management Program
Packaging and Shipping Infectious Substances
Infectious Substances Classification
Packaging, Labeling, and Shipping Regulated Material
Personnel Training
Training Program
Methods
Documentation
Monitoring and Evaluation
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
APPENDIX
APPENDIX 25.1 Sample Form for Declination of Hepatitis B Vaccinationaa See reference 41.
APPENDIX 25.2 Important Information Resourcesa
APPENDIX 25.3 Common Safety Compliance Failures
APPENDIX 25.4 Biohazard Spill Kit Sample
APPENDIX 25.5 Biological Spill Cleanup Procedure (possible aerosol)
APPENDIX 25.6 Minor Chemical Spill Cleanup Procedurea
APPENDIX 25.7 Shipping Containersa
APPENDIX 25.8 Shipping Label Examplesa
APPENDIX 25.9 Shipper's Declaration for Category A, Infectious Substances
APPENDIX 25.10 Employee Accident and Exposure Report
Chapter 26 Emergency Management
Introduction
Emergency Management Plan
Purpose or Policy
Hazard Analysis
Incident Management System
Elements of an EMP
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
Fire
Hazardous Materials
Radioactive Material
Utility Failure
Bomb Threat
Active Shooter/Hostage Response
Natural Disasters
Pandemics
Terrorism Threats
Civil Disorder
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
APPENDIX
APPENDIX 26.1 List of Selected Emergency Preparedness Agencies and Organizations
APPENDIX 26.2 Emergency Operations Center (EOC) Checklist
APPENDIX 26.3 Operating Status Report Form
APPENDIX 26.4 Selected Information Resources on the Internet
Section V Financial Management (section editor: Michael R. Lewis)
Chapter 27 Financial Management: Setting the Stage
Introduction
The Hospital Environment
Financial Challenges Created by the COVID-19 Pandemic
Operating in the Inpatient Hospital Setting
Operating in the Outpatient Hospital Setting
The Non-Hospital Environment
SUMMARY
KEY POINTS
GLOSSARY
ACKNOWLEDGMENT
REFERENCES
Chapter 28 Strategic Planning
Introduction
Business Strategy and Operational Efficiency
Developing and Maintaining a Business Strategy: The Strategic Planning Process
Structure of the Clinical Laboratory Industry
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
Competitors' Goals
Competitors' Assumptions
Competitors' Capabilities
Interactions of Competitors
Conclusions
Strategic Positions in the Clinical Laboratory Industry
What Are Strategic Positions?
Types of Strategic Positions
Strategic Positions of Clinical Laboratories
Conclusions
Implementing the Strategy: Activity Fit
What Is Activity Fit?
Activity Fit Involves Trade-Offs
Failure of Strategy
Straddling
Growth Trap
Profitability Trap
Hubris
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
Chapter 29 Human Resource Management in the Laboratory: An Important Component of Financial Management
Introduction
Constraints on Managerial Function
The Cardinal Rules for Optimizing Performance
Get It Right at the Outset
Expect High 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 Promptly and Decisively When Necessary
When Problems Surface, Involve Laboratory Leaders and Human Resources as Appropriate
Classic Situations That May Interfere with Optimal Performance (Table 29.4)
The Underperforming Employee
The Overperforming Employee
The Intrusion of Interpersonal Issues
Individual and/or Group Troublemakers
Weakness of the Supervisory Staff
Practical Issues in the Utilization of Human Resources
Skill Mix of Staff
Cross-Training and Rotation
Mix of Employment Arrangements
Coverage of Vacations, Holidays, and Routine Shifts
Use of Overtime or External Contract Labor
SUMMARY
KEY POINTS
GLOSSARY
ACKNOWLEDGMENT
REFERENCES
Chapter 30 Costs, Budgeting, and Financial Decision Making
Introduction
Cost Accounting
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
Equipment Purchase
Capitation Contract
Capital Acquisition Concepts
Time Value of Money
Depreciation
Budgeting
Types of Budgets
The Budgeting Process
Budget Examples
Variance Analysis
Financial Statements
Financial Ratios
Applications of Financial Tools in the Evolving Laboratory Landscape
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
Section VI Coding, Billing, and Charges for Laboratory Services (section editors: Vickie S. Baselski and Alice S. Weissfeld)
Chapter 31 Correct Coding of Billable Services in the Clinical Laboratory
Introduction
Procedure Coding: What Test Procedures Have Been Performed?
The CPT System
Description
Types of CPT Codes
Modifiers
The Process for Change
Procedure Coding Guidance: The Impact on Reimbursement
Procedure Coding Alternatives
Capitated Services
Diagnosis Coding: Why Is the Service Being Performed?
Inpatient Diagnosis Coding
Outpatient Diagnosis Coding
Other Unique Patient Groups
ICD-CM
SNOMED CT
Service Location
Role of CLIA and State Licensing
Revenue Codes
Documentation of Codes
Requisition
Claims
Code Mapping
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
APPENDIX
APPENDIX 31.1 General References and Resources
APPENDIX 31.2 Websites
Chapter 32 Approaches to Billing Laboratory Services
Introduction
Interactions in the Billing Process
Provider Mix
Payor Mix
Terms of Coverage
Types of Services
Payment for Services
Logistics of the Billing Process
Claim versus Invoice Submission
Invoice Billing
Claim Billing
Fee-for-Service Arrangement Billing
Capitated Arrangement Billing
Value-Based Pay for Performance
SUMMARY
KEY POINTS
GLOSSARY AND APPENDIXES
REFERENCES
Chapter 33 Charges and Fees for Laboratory Services
Introduction
Calculating Costs and Charges
Determining Costs
Setting Charges
Determining Payment Amounts
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
Retrospective Payment
Prospective Payment
Value-Based Payment
SUMMARY
KEY POINTS
GLOSSARY AND APPENDIXES
REFERENCES
Section VII Reimbursement, Compliance, and Profitability (section editors: Vickie S. Baselski and Alice S. Weissfeld)
Chapter 34 Rules and Regulations in Reimbursement
Introduction
General Criteria
Basic Rules
Procedure Code Edits
Basic Edits
National Correct Coding Initiative
Mutually Exclusive Codes
Comprehensive/Component Edits
Medically Unlikely Edits
Add-On Code Edits
Appropriate Use Edits
Conditions of Coverage
Medical Necessity
National Coverage Determination
Local Coverage Determination
Medicare Coverage Database
Screening Tests
Experimental Testing
Administrative Policies
Special Coverage Conditions
End-Stage Renal Disease
Skilled-Nursing Facility
Ambulatory Payment Classifications
Inpatient Payment Classifications
Three-Day Window
Date of Service Rule
Other Private-Payor Rules
Remittance Advice Review
Beneficiary Documents
Provider Documents
Auditing Remittance Advice
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
APPENDIX
APPENDIX 34.1 General References and Resources
APPENDIX 34.2 Websites
Chapter 35 Reimbursement Compliance
Introduction
Improper Payments
Program Integrity
Authority for Program Integrity
Activities in Program Integrity
Payor Integrity
Prepayment Review
Postpayment Review
Laboratory Provider Integrity
The Seven Essential Elements
Specific Areas of Concern
Coding and Billing Issues
CPT Coding
Modifiers
ICD-CM Coding
The Requisition
Special Ordering Situations
Medical-Necessity Issues
Record Retention
Marketing Practices
Pricing and Inducements
Ordering Provider and Patient Communication
Fraud Alerts and Advisory Opinions
Auditing and Monitoring
Response to Possible Fraud or Abuse
Laboratory Examples of Fraud and Abuse
SUMMARY
KEY POINTS
GLOSSARY AND APPENDIXES
REFERENCES
Chapter 36 Determination of Profitability
Introduction
Pitfalls in Cost Accounting
Laboratory Profitability
Balance Sheets
Income Statements
Cash Flow Statements
Key Indicators
Key Income Indicators
Key Expense Indicators
Institutional Profitability
Human Profitability
Laboratory Value
SUMMARY
KEY POINTS
GLOSSARY AND APPENDIXES
REFERENCES
Section VIII Outside Marketing and Expansion (section editor: Gary W. Procop)
Chapter 37 Hospital-Based Laboratory Outreach
Introduction
Considering an Outreach Program
Administrative Interest
Exploring the Market
Strategic Plan
Business Plan
Sales Plan
Commitment from All Relevant Parties
Feasibility Report
Philosophical Understanding
Service and Financial Support
Implementing the Outreach Program
People
Processes
Facilities
Equipment
Supplies
Outreach Indicators
Growing the Outreach Program
Assessment
Client Needs
SUMMARY
KEY POINTS
GLOSSARY
ACKNOWLEDGMENTS
REFERENCES
Chapter 38 Finance and Decision Making in Outreach
Introduction
The Clinical Laboratory as a Business
The Phases of the Growth Curve
Decision Making in Laboratory Outreach Management
Types of Costs
Direct and Indirect Costs
Fixed, Variable, and Semifixed Costs
Unit Costs
Additional Cost Concepts for Decision Making
Characteristics of Laboratory Costs
Microcosting
Beyond the Laboratory Test Cost
Levels of Decision Making in Outreach Operations
Menu: To Test or Not To Test
Operation: To Perform In-House or Send Out
Capital: Whether To Acquire New Equipment
Financing Capital: To Lease or Buy Equipment
Financial Considerations in Outreach
Role of Metrics-Based Decision Making
Realization Rate
Direct Client Billing and Accounts Receivable
SUMMARY
KEY POINTS
GLOSSARY
ACKNOWLEDGMENT
REFERENCES
APPENDIX
APPENDIX 38.1 Microcosting
LABOR
TEST
APPENDIX 38.2 ROI Calculation Methods
PAYBACK METHOD
DEPRECIATION
AVERAGE RATE OF RETURN
TIME VALUE OF MONEY (PRESENT VALUE)
APPENDIX 38.3 Financing Alternatives
PURCHASE
LEASE
Chapter 39 Outreach: Obstacles to Hospital Outreach and Enhancing Customer Satisfaction
Introduction
Making Organizational Changes
Centralize Work
Place Laboratory Management on Off Shifts
Give Outreach Its Due
Make Outreach High-Profile
Manage Outreach as a Business, Not a Department
Information Technology Changes
Hospital Systems versus Separate Systems
Non-Staff Physicians
Connectivity
Patient Registration and Accounting
Populating the Patient Record
Physician Office Connectivity
Meeting the Needs
Capital
FTEs
Hospital versus Outreach Contracting
Defining Insurance Plans
Contracting
Acceptance of Payors
Failure to Understand Financial Implications and Requirements
Unrelated Business Income Tax
Other Taxes
Understanding the Hospital's Point of View
Lower Cost per Test
Make Money
Translating Hospital and Laboratory Compliance for an Outreach Operation
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
PAMA-Protecting Access to Medicare Act
Free Lunch and Giveaways
Enhancing Customer Satisfaction: Communication
Newsletter
Marketing and Sales Team
Website
Social Media and System-Developed Communication
Customer Satisfaction Assessment
Surveys
Problem Reporting and Resolution
Couriers: The First Line
Insource versus Outsource for Couriers
Client Services
Access to Draw Sites and Patient Service Centers
Building and Retaining Your Client Base
Leverage the Continuum of Care
Keep Asking Why
Follow Up When Clients Leave
Professional Marketing and Sales Personnel
Commission Plans
Reports
Prepackaged Information
Technical Expertise Accessibility
Accounts That Require Special Care
Nursing Homes
Drug Accounts
Home Health Agencies
Veterinary Laboratory Services
Define Service Area and Services
Range of Services
The Importance of Standardization
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
APPENDIX
APPENDIX 39.1 Sample Physician Letter
APPENDIX 39.2 Sales Report
APPENDIX 39.3 Monthly Call Review
Section IX Clinical Trials and Evidence-Based Laboratory Medicine (section editor: Donna M. Wolk)
Chapter 40 The Current State of the U.S. Food and Drug Administration Process and Regulations for Diagnostic Laboratory Assays
Introduction
Background: The FDA Processes for Classification and Assessment of New IVDs
Premarket Approval
Premarket Notification 510(k) and 510(k) Review
Alternate Application Submission Approaches
The "Presubmission (Q-Sub)" Process
The Expedited Review
The Emergency Use Authorization Act
Miscellaneous FDA Requirements
Establishment Registration
Medical Device Listing
Good Manufacturing Practices (GMPs) and Quality System Regulations (QSRs)
Quality Control
Automated Laboratory Assays
Postmarket Review
Limitations Inherent to Current FDA Processes
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
Chapter 41 The Clinical Trial Laboratory: Research Compliance for Clinical Microbiologists
Introduction
Organizational Resources for Funded Clinical Research in Laboratory Medicine
Office of Sponsored Projects
Office of Research and Contract Analysis
Compliance with Human Subject Regulations
Background for Human Subject Regulations
Regulatory Requirements for HSPPs
Human Subject Research: Classifications Based on Risk
Human Subject Training Requirements and Site Authorization
Informed Consent
Special Populations
Continuing Review by the IRB
Record Retention for HSPPs
Compliance with HIPAA
Compliance with Conflict-of-Interest Policies
Intellectual Property Considerations
GLP and GCP Regulations
Sponsor Responsibilities
Study Director Responsibilities
Quality Assurance Office: Organization, SOPs, Inspections, and Reporting Data
GLP Background
Equipment and Validation of Equipment
Standard Operating Procedures
Reagents and Solutions for Tests and Controls
Final Research Reports
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
APPENDIX
APPENDIX 41.1 Useful Websites
Chapter 42 Clinical Trials and Evidence-Based Research in the Clinical Laboratory
Introduction
Types of Research Studies
Observational Studies
Mechanistic Studies
Therapeutic Studies
Large-Scale Clinical Trials
Meta-Analyses and Systematic Reviews
Translational Research
Sequence of Investigation
Study Design
Hypothesis Generation
Sampling the Population
Deciding on Sample Size, Measurements, and Endpoints
Feasibility
Confounding Variables and Bias
Human Subject Protection
Collecting and Storing Data
Data Analysis and Conclusion Formulation
Traditional Biostatistics
Descriptive Statistics
Inferential Statistics: Issues for Medical Devices
Challenges for Diagnostic Studies
Other Research Considerations
Systematic Reviews and Laboratory Medicine Best Practices
Evidence-Based Laboratory Medicine
Laboratory Medicine Best Practices Initiative
Using Machine Learning for Prediction
SUMMARY
KEY POINTS
SUMMARY
REFERENCES
APPENDIX
APPENDIX 42.1 LMBP Study Quality Appraisal Checklist
STUDY SETTING
PRACTICE
SAMPLE SIZE
COMPARATOR PRACTICE (original or usual practice)
OUTCOME MEASURES
RESULTS
APPENDIX 42.2 Resources for Professional Guidelines and Systematic Reviews
Section X Defining and Measuring Standards for Success (section editor: Michael R. Lewis)
Chapter 43 Benchmarking and Performance Monitoring for the Clinical Laboratory
Introduction
Why Benchmark?
Types of Benchmarking
General Approach to Benchmarking and Performance Monitoring
Prioritization
Metrics Selection
Data Collection and Analysis
Development and Implementation of Plans
Interpretation of Benchmarking and Performance Monitoring Data
Interpretation of External Benchmarking Data
Interpretation of Internal Benchmarking Data
Data Interpretation in the Context of the Laboratory's QMS and Specific Quality Indicators That Are Evaluated
Challenges in Executing Benchmarking and Performance Monitoring
The Problems of Comparability and Selection Bias
The Problem of Cost Accounting
Selection of Indicators for Benchmarking and Performance Monitoring
Effects of the COVID-19 Pandemic Render Many Data from 2020-2021 Unhelpful for Comparisons
Measuring Laboratory Performance in the Broader Clinical Setting
Assessments for Patient Safety
Effect of Value-Based Payment Models (and Other Contemporary Influences)
Linkage of Payment to Measures of Quality
Laboratory-Related Standards in Broader Accreditation Programs
The Unattained Ideal: A Global Laboratory Benchmarking Scorecard Spanning Cost, Quality, and Operational Measures
SUMMARY
KEY POINTS
GLOSSARY
ACKNOWLEDGMENTS
REFERENCES
APPENDIX
APPENDIX 43.1
NOTES
Chapter 44 Test Utilization and Clinical Relevance
Introduction
Evaluating Potential and Real Problems
Clinical Relevance
Cost-Effectiveness Analysis, Cost-Benefit Analysis, and Cost-Utility Analysis
Documenting the Extent of the Problem
Literature Review
Centralized Studies
Local Data
Laboratory-Based Approaches to Control
Newsletters
Policy Changes
Personal and Ad Hoc Communication
EMR-Based Limits and Restrictions on Test Ordering
EMR-Based Feedback in Reports
Institution-Based Approaches to Control
Working with Providers
Formal Protocols Validated by Provider Leadership
The Concept of a Test Formulary
Using Major Events to Effect Change
What Works and Doesn't Work: How To Take the First Steps
Putting It All Together
Base Policy Approaches and EMR-Based Controls on Evidence-Based Medicine
Track Results
The Plan, Do, Study, Act Model
The Future: Better Teaching and Training
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
Section XI The Future of Clinical Laboratories (section editor: Timothy C. Allen)
Chapter 45 The Future of Pathology and Laboratory Medicine: Political, Social, Economic, and Regulatory Impacts
Introduction
The Current Environment of Healthcare
Current Regulations
CLIA '88
HIPAA
OSHA Standards for Occupational Exposure to Blood-Borne Pathogens
Physician Self-Referral Law (Stark Law)
Liability Considerations
Bioterrorism and Emerging Highly Infectious Diseases
Recent History
Future Impact
Long-Term Effects: Legislation, Regulation, and Accreditation
Quality, Value, and Patient Safety
Financial Considerations of the Patient Safety Movement
The "No Surprises" Act
Issues Affecting Academic Laboratories and Research
Financial, Regulatory, and Staffing Concerns
Biorepositories, Restrictions on Use of Human Tissues, and Stem Cell Research
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
APPENDIX
APPENDIX 45.1 Websites
College of American Pathologists
Federal Select Agent Program
U.S. Department of Health and Human Services
United States Department of Labor
Chapter 46 The Future of the Clinical Scientist Workforce
Introduction
A Profession Defined by a Pandemic
Educating the Workforce: Challenges and Opportunities
Emerging Roles of the Clinical Scientist
Emerging Laboratory Management Considerations with the Clinical Scientist
SUMMARY
KEY POINTS
GLOSSARY
ACKNOWLEDGMENTS
REFERENCES
Chapter 47 Electronic Health Records and Their Implications and Opportunities for Laboratories
Introduction
Electronic Health Records
Definition and Components
Status of EHR Use
Federal Regulations Related to EHRs and Their Implications for Laboratories
Meaningful-Use Requirements Directly Relevant to Laboratories
EHR Certification
Certification Criteria and Standards Most Relevant to Laboratories
Concerns and Implications for Laboratories Related to Increased Use of EHR Systems
Potential Consequences
Laboratory Reports
"Order Set" Challenges
Information Overload
Formatting Incompatibilities
Results Management
Laboratory Report Components
Laboratory Report Retrieval
Cumulative Laboratory Results
Laboratory Data Display Issues
Validation of EHR Laboratory Report Displays
Physician Alerts
Laboratory Test Result Delivery in an Integrated Healthcare Network
Computerized Provider Order Entry
Introduction
CLIA '88 Required Laboratory Test Request Elements
Appropriate Choice of Individual Laboratory Test Names
EHR-LIS Interfaces
Technical Aspects of Interfaces: HL7 and LOINC
Operational Challenges for Laboratories with LIS-EHR Interfaces
Tactics for Working with EHR Support Staff
Laboratory Involvement in EHR Selection and Implementation
SUMMARY
KEY POINTS
GLOSSARY
ACKNOWLEDGMENT
REFERENCES
Chapter 48 Current Trends in Instrumentation and Technology: A Look toward the Future
Introduction
Hematology
Automated Enumeration of Cell Populations
Molecular Testing
Chemistry
Advances
Laboratory Computerization
Laboratory Automation
Microbiology
Advances
Microorganism Identification
Molecular Microbiology
Blood Transfusion and Coagulation
Coagulation and Thromboelastography
Inventory Tracking and Use
Point-of-Care Testing
Computerization
Rapid Assays
Developments during COVID-19
Molecular Diagnostics
Real-Time PCR
Outlook for the Future
Driving Forces
Device Miniaturization
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
Chapter 49 The Future Practice of Laboratory Medicine
Introduction
Trends Impacting the Field of Clinical Pathology
Difficulty in Finding Laboratory Staff Workforce
Computation
Increasing Patient Access
Going Remote
Response of the Pathology Department to Recent Trends
Informatics and Artificial Intelligence
Automation
Laboratory Consultation
Remote Ready
Laboratory Principles To Live By
Accuracy and Reliability
Scalability
Coordination
Flexibility
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
Section XII Pandemics and Healthcare Institutions (section editor: Deirdre L. Church)
Chapter 50 Epidemics and Pandemics: Lessons from the Past, Concerns for the Future
Introduction
Some Basics of Epidemiology
The Importance of Zoonoses
Epidemics and Pandemics as Four-Act Plays
Act One: Progressive Revelation
Act Two: Management of Randomness
Act Three: Negotiation of a Public Response
Act Four: Subsidence and Retrospection
Lessons from Selected Epidemics and Pandemics from Antiquity through HIV/AIDS
Epidemics of Antiquity
Plague
Smallpox
Yellow Fever
Cholera
Influenza
HIV/AIDS
Coronaviruses and COVID-19
Coronaviruses
Severe Acute Respiratory Syndrome
Middle East Respiratory Syndrome
COVID-19 as a Four-Act Play
The Anthropocene and Future Epidemics and Pandemics
The Anthropocene Epoch
Threats Posed by Currently Known Infectious Agents
Potential Threats from Novel Pathogens
Roles of Laboratories
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
Chapter 51 One Health in Pandemic Planning, Prevention, and Response
Introduction
Pandemics in the Anthropocene: the Call for Transformative Change
What Is One Health?
One Health Thinking for Pandemic Risk Management
One Health Intelligence
Operational Impediment and Opportunities
Confronting the Reality of Complexity
Being Multifaceted
Being Multisolving
Being Adaptive
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
Chapter 52 Pandemic Planning: Roles of Clinical and Public Health Laboratories
Introduction
Perspectives from Previous Pandemics and COVID-19
Investments in Novel Therapeutics
A Progression in Understanding the Evolution of Pandemics
Pandemic Fatigue
Role for Immunology-Based Diagnostics
Early Recognition-SARS-CoV-2 and Its Global Spread
Emergence of COVID-19 and the Response of Taiwan
Effective Mitigative Solutions for COVID-19 in Taiwan
Paradigm Shift: Roles for Big Data in Pandemic Management
Challenges Facing Clinical and Public Health Laboratories
Roles of Laboratories
Advances in Diagnostic Technology
Genomics and Its Role in Mitigating Pandemics
Microbes to Pandemic Agents: Laboratory Mobilization
Pandemic Planning: Partnerships for the Future
Collaboration between Clinical and Public Health Laboratories
Global Surveillance
Economic Costs
Vaccines
Vaccine Hesitancy
Collaboration and Linkage of Laboratories to Incident Commands
The Next Pandemic for Humankind
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
Chapter 53 Laboratory Preparedness
Introduction
Lessons Learned from the Laboratory Response to COVID-19
Organization of Healthcare and Laboratory Systems
Implementing New Tests and Surge Capacity
Supply Chains
Appropriate Outbreak Testing
Quality and Staffing
Regulatory Requirements
Framework for Laboratory System Preparedness
Manufacturing and Distribution
Executive Plan
Human Resources Development
Health Informatics
Specimen Logistics and Transportation
mHealth
Laboratory Networks and Biosafety
Future Directions
SUMMARY
KEY POINTS
GLOSSARY
REFERENCES
Index
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