The Division of Laboratory Systems (DLS) is leading a national effort to improve laboratory practice and quality of service to clinicians and patients.
The Division of Laboratory Systems’ initiative includes:
- A report on the current status of laboratory medicine in the United States, which provides a detailed overview of the key factors affecting the field of laboratory medicine today and those that will shape the field in the coming decades.
- Development of methods to review, evaluate and make evidence–based recommendations for best practices in laboratory medicine.
- Pilot testing the feasibility of a laboratory network to identify evidence based practices.
Laboratory Medicine and the Health Care System
Health care expenditures per capita and as a percentage of gross domestic product (GDP)
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 (IOM) (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 (6,7). 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.
References
Laboratory Medicine: A National Status Report, 2007
CDC commissioned The Lewin Group, under subcontract to Battelle Memorial Institute, to produce a
comprehensive overview of the current state of laboratory medicine. The report provides a detailed
overview of the key factors affecting laboratory medicine, including
- Value of laboratory medicine to the U.S. health care system
- Market profile of the laboratory medicine sector
- Development of a network of laboratories and partnerships with key stakeholders in laboratory medicine to support identification and foster adoption of evidence-based Best Practices
- A report reviewing proficiency testing (PT) and the regulatory, educational, and quality improvement objectives of the Clinical Laboratory Improvement Amendments of 1988 (CLIA ′88)
- Quality and the total testing process in the clinical laboratory
- Quality systems and performance measurement
- Laboratory information systems
- Federal regulatory oversight of laboratory medicine
- Reimbursement for laboratory medicine
To read the complete report, visit Laboratory Medicine: A National Status Report, 2007
Supplements to the report for 2008 will focus on:
- Role of laboratory testing in patient-centered care
- Impact of emerging testing technologies on clinical laboratory practice
- Policy issues and their implications for stakeholders in laboratory medicine
Identifying and Evaluating Laboratory Medicine Best Practices (LMBP)
The objective of LMBP project is to develop and test methods for making evidence based recommendations for best practices in laboratory medicine. For more information about this work visit
Laboratory Medicine Best Practices Initiative.
2007 Proficiency Test Report