Laboratory Medicine:   
        A National Status Report 
         
         
         
         
         
        Prepared for: 
        Division of Laboratory Systems 
        National Center for Preparedness, Detection, and 
         Control of Infectious Diseases 
        Centers for Disease Control and Prevention 
         
         
         
        Prepared by: 
        The Lewin Group 
        Under subcontract to Battelle Memorial Institute 
         
         
         
         
        May 2008 
           
           
                                           
                       Laboratory Medicine:   
                    A National Status Report 
                                           
                                           
                                           
                                           
                                           
                                           
                                   Prepared for: 
                        Division of Laboratory Systems 
             National Center for Preparedness, Detection, and 
                         Control of Infectious Diseases 
                 Centers for Disease Control and Prevention 
                                           
                                           
                                           
                                   Prepared by: 
                                The Lewin Group 
                                 Julie Wolcott, MA 
                                 Amanda Schwartz 
                              Clifford Goodman, PhD 
                                           
                                           
                                           
                                           
                                     May 2008 
                  Laboratory Medicine: A National Status Report                                              Executive Summary 
                                                         TABLE OF CONTENTS 
                  ACKNOWLEDGMENTS v 
                  EXECUTIVE SUMMARY                                                                                            1 
                       The Value of Laboratory Medicine to Health Care.......................................................................2 
                       Market Profile of the Laboratory Medicine Sector........................................................................3 
                       Laboratory Medicine Workforce...................................................................................................... 4 
                       Quality and the Total Testing Process............................................................................................. 4 
                       Quality Systems and Performance Measurement.........................................................................6 
                       Laboratory Information Systems..................................................................................................... 6 
                       Federal Regulatory Oversight Of Laboratory Medicine...............................................................7 
                       Reimbursement for Laboratory Medicine...................................................................................... 8 
                  INTRODUCTION                                                                                                11 
                       Context of the Report....................................................................................................................... 12 
                       Scope of Report................................................................................................................................. 12 
                       Reference List.................................................................................................................................... 14 
                  METHODS AND LIMITATIONS                                                                                     15 
                       Methods............................................................................................................................................. 15 
                       Limitations........................................................................................................................................ 17 
                  CHAPTER I - THE VALUE OF LABORATORY MEDICINE TO HEALTH CARE                                                 19 
                       Value to the Quality of Patient Care.............................................................................................. 19 
                       Value to Evidence-based Medicine................................................................................................ 22 
                       Value to Clinical Practice Guidelines for Patient Care ...............................................................22 
                       Value of Laboratory Tests and Services Across Patient Care Continuum...............................24 
                       Protecting the Blood Supply and Transplant Recipients............................................................33 
                       Detecting Exposure to Illegal or Toxic Drugs.............................................................................. 34 
                       Value to the Measurement of Quality of Care.............................................................................35 
                       Value to Public Health and Surveillance...................................................................................... 38 
                       Quantifying Value Using Cost-effectiveness Analysis...............................................................42 
                       Conclusions....................................................................................................................................... 48 
                       Reference List.................................................................................................................................... 50 
                  May 2008                                                                                                     i 
                  Laboratory Medicine: A National Status Report                                              Executive Summary 
                  CHAPTER II - MARKET PROFILE OF THE LABORATORY MEDICINE SECTOR                                               67 
                       U.S. Market Size................................................................................................................................ 67 
                       Market by Laboratory Type and Setting....................................................................................... 69 
                       Market for Laboratory Tests........................................................................................................... 81 
                       Research-support Testing ............................................................................................................... 94 
                       Conclusions....................................................................................................................................... 95 
                       Reference List.................................................................................................................................... 97 
                  CHAPTER III - LABORATORY MEDICINE WORKFORCE                                                                105 
                       Types of Professionals................................................................................................................... 105 
                       Workforce Demographics............................................................................................................. 109 
                       Vacancy Rates................................................................................................................................. 111 
                       Wages............................................................................................................................................... 113 
                       Education, Training, and Recruitment........................................................................................ 116 
                       Licensing and Certification........................................................................................................... 124 
                       Conclusions..................................................................................................................................... 129 
                       Reference List.................................................................................................................................. 131 
                  CHAPTER IV - QUALITY AND THE TOTAL TESTING PROCESS                                                         139 
                       Definition of the Total Testing Process....................................................................................... 139 
                       Quality and Errors ......................................................................................................................... 141 
                       Preanalytic Phase ........................................................................................................................... 142 
                       Clinical Pathology Transitional Preanalytic............................................................................... 151 
                       Clinical Pathology Analytic Phase............................................................................................... 153 
                       Anatomic Pathology Transitional Preanalyic............................................................................. 157 
                       Anatomic Pathology Analytic Phase........................................................................................... 159 
                       Postanalytic Phase.......................................................................................................................... 162 
                       Point-of-Care Testing..................................................................................................................... 168 
                       Preanalytic Phase ........................................................................................................................... 169 
                       Analytic Phase................................................................................................................................ 171 
                       Postanalytic Phase.......................................................................................................................... 175 
                       Conclusions..................................................................................................................................... 177 
                       Reference List.................................................................................................................................. 180 
                  May 2008                                                                                                     ii