Laboratory Medicine and the Health Care System

Per capita and as a percentage of gross domestic product (GDP) health care expenditures in the United States are the highest in the world. Most analysts expect that health care costs will continue to rise above the rate of inflation as the nation’s population ages and technology advances. Increased spending on health care has not produced commensurate improvements in access to health care, health outcomes, or the quality of services delivered by the health care system. Several sentinel studies, including two reports from the Institute of Medicine (1,2), highlighted the need for improvements in the safety and quality of American health care. These studies spurred government agencies, professional associations, private insurers, foundations, academic institutions, and others to initiate quality improvement efforts in almost every arena of health care. In a newly issued report, the IOM recommends systematic reviews of evidence on the effectiveness of health services as the central link between evidence and clinical decision making, as individual studies rarely provide definitive answers to clinical questions (3).

Laboratory testing is an integral part of modern medical practice, and laboratory medicine confronts the same challenges of quality, cost, and access as the larger health care system. Over 200,000 clinical laboratories are certified to operate in the United States by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which set minimum standards for clinical laboratory testing. These laboratories conduct more than 7 billion tests per year (4). Although laboratory testing accounts for only about 2.3% of annual health care costs in the United States (5), the influence of laboratory medicine on the quality and cost of health care as a whole is much greater because laboratory test results influence the majority of patient care decisions. Thus, practices that reduce laboratory-related error rates or optimize use of laboratory testing can have a substantial effect on patient safety, clinical decision making about treatments and interventions, health outcomes, and costs.

1. Institute of Medicine. To Err is Human: Building a Safer Health System (1999). NAS Press
2. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century (2001). NAS Press
3. Institute of Medicine. Knowing What Works in Health Care: A Roadmap for the Nation (2008). NAS Press
4. The value of clinical laboratory services. Washington, DC: American Clinical Laboratory Association, 2007. (Accessed May 15, 2007, at American Clinical Laboratory Association
5. Terry M. Lab industry strategic outlook: market trends and analysis 2007. New York, NY: Washington G-2 Reports, 2007.