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Laboratory medicine-associated diagnostic services are an essential component of the quality of the healthcare system in U.S. in the 21st century. In fact, Clinical Laboratory Improvement Amendment (CLIA)-certified laboratories exceeded 200,000 in 2008.¹

With the volume of tests performed, quality and safety are of utmost importance. In a Laboratory Medicine National Status Report prepared by Battelle Memorial Institute for the Centers for Disease Control and Prevention (CDC), it is estimated approximately 6.8 billion laboratory tests are performed annually in the U.S. with revenue of $52 billion in 2007.² Over 4,000 laboratory tests are available for clinical use and around 500 are performed regularly.

Tests considered within the "traditional" realm of laboratory medicine-chemistry, hematology and coagulation-account for approximately 66 percent of all laboratory tests performed with $32 billion in revenue. This is close to double the cumulated revenue of anatomic pathology, cytology, molecular, esoteric and drugs-of-abuse testing combined.

Spending Statistics
Despite the vital role laboratory testing plays in the national healthcare system, spending on laboratory services accounts for only 2.3 percent of U.S. healthcare expenditures and 2 percent of Medicare expenditures.² These statistics do not reflect the essential role these tests and services have in the vast majority of medical decisions.^3,4

The contribution the clinical laboratory provides to the U.S. healthcare system is undervalued, despite the fact diagnostic laboratory tests have a decisive role in patient safety, public health, clinical medical decisions and research.

Emphasis on Safety
In reality, laboratory test results have a major impact in the vast majority of clinical decisions. Meanwhile, laboratory professionals are facing challenges to find ways to reduce laboratory-related error rates and optimize the use of laboratory testing.⁵ Patient safety is imperative in diagnostic testing; it has, in fact, emerged as a major public health issue in recent years with the promotion of a patient-centered quality care.

The College of American Pathologists (CAP) has been addressing the issue of errors in laboratory medicine since 1946 and has developed Q-Probes and Q-Tracks programs, designed to provide data regarding the error rates and their significance in laboratory testing.^5,6 CAP also has developed programs and resources to reduce these errors by improving the analytic performance of each laboratory test through establishing daily quality control (Quality Assurance Service), proficiency programs (Surveys) and by providing reagents and documents for use as standards.^6,7,8 Additionally, CAP developed a program of accreditation of clinical laboratories (Laboratory Accreditation Program), and introduced a system of terminology for the electronic health records (SNOMED).^9,10

And the laboratory is not alone with its efforts. Patient safety emerged as a major public health issue with the December 1999 Institute of Medicine (IOM) report, To Err is Human followed in 2001 by Crossing the Quality Chasm: A New Health System for the 21st Century.^11,12 These sentinel studies have focused national attention on improving the quality and safety of healthcare. The immediate effect has been a significant growth in interest in the problem of medical error and patient safety from media and the medical literature. Organizations such as the American Hospital Association, the National Quality Forum and the U.S. Agency for Healthcare Research and Quality have issued "best practice" recommendations for patient safety.

The Joint Commission has outlined patient safety requirements for hospital accreditation, including patient identity checking. A medical error, according to the IOM definition, could mean '"a healthcare provider chose an inappropriate method of care," or it could mean "the health provider chose the right course of care but carried it out incorrectly."

Alternatively, a medical error is "the failure to complete a planned action as intended or the use of a wrong plan to achieve an aim." An adequate definition of "laboratory error" acknowledged by the International Organization for Standardization is "any defect from ordering tests to reporting results and appropriately interpreting and reacting on these."¹³ Using data from the current literature, the laboratory error probability spans from 1 in 8,300 laboratory results (or 2,000 patients) to 1 in 33-50 laboratory results.^14,15 As these two limits probably do not reflect the situation completely accurately, a more probable error rate might range from 1 in 164 to 1 in 330 events or laboratory results.^16-18

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