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 Laboratory Medicine: A National Status Report Executive Summary CHAPTER V - QUALITY SYSTEMS AND PERFORMANCE MEASUREMENT 197 Approaches to Quality Systems in Laboratory Medicine ........................................................ 197 Performance Measurement........................................................................................................... 210 Conclusions..................................................................................................................................... 228 Reference List.................................................................................................................................. 230 CHAPTER VI - LABORATORY INFORMATION SYSTEMS 243 Structure of LIS............................................................................................................................... 243 Advanced Applications for Comprehensive Systems .............................................................. 250 Unresolved Issues Related to Advanced Applications............................................................. 250 Data Standards for Comprehensive Systems............................................................................. 259 Conclusions..................................................................................................................................... 261 Reference List.................................................................................................................................