While many areas of health care are still struggling with the issue of patient safety, laboratory diagnostics has always been a forerunner in pursuing this issue. Significant progress has been made since the release of “To Err is Human.”1 This article briefly reviews laboratory quality assessment and looks at recent statistics concerning laboratory errors.
It has been 12 years since the Institute of Medicine [IOM] reported the alarming data on the cause and impact of medical errors in the United States.1 Besides causing serious harm to patients, medical errors translate into huge costs for the national economy. In 1999, Berwick and Leape published that the estimated cost of medical errors in the United States was between $17 billion-$29 billion a year.2 In 2006, Null and colleagues published an article indicating the overall estimated annual economic cost of improper medical intervention was much higher, approaching $282 billion.3 While many areas of health care are still struggling with the issue of patient safety, laboratory diagnostics has always been a forerunner in pursuing this issue. The concepts and practices of quality assessment programs have long been routine in laboratory medicine, and error rates in laboratory activities are far lower than those seen in overall clinical health care.4 This article briefly reviews laboratory quality assessment and looks at recent statistics concerning laboratory errors.
Quality Standards
Laboratory medicine sets high quality standards. Regulation of quality in the health care sector is based on accreditation, certification, quality monitoring, patient’s rights, standard operation processes, and standards of health care quality.5 The Centers for Medicare and Medicaid Services [CMS] regulates all laboratory testing [except research] performed on humans in the United States through the Clinical Laboratory Improvement Amendments [CLIA]. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations [CMSO], has the responsibility for implementing the CLIA program. The objective of the CLIA program is to ensure quality laboratory testing.6
In order for a health care organization to participate in and receive payment from Medicare or Medicaid programs, it must be certified as complying with the Conditions of Participation [CoP], or standards, set forth in federal regulations. This certification is based on a survey conducted by a state agency on behalf of CMS. However, if a national accrediting organization, such as The Joint Commission [TJC], formerly known as the Joint Commission on Accreditation of Health Care Organizations, has and enforces standards meeting the federal CoP, CMS may grant the accrediting organization “deeming” authority and “deem” each accredited health care organization as meeting the Medicare and Medicaid certification requirements. The health care organization is then considered to have “deemed status” and is not subject to the Medicare survey and certification process. Laboratories can also be accredited by the College of American Pathologists [CAP] and the Commission on Office Laboratory Accreditation [COLA], both of which also have deemed status with CMS.7,8,9
Sources of Laboratory Error
Traditionally, laboratory practice can be divided into 3 phases [pre-analytical, analytical, and post-analytical]. All 3 phases of the total testing process can be targeted individually for improving quality, although it is well published that most errors occur in the pre- and post-analytical phases [Table 1].10 In the field of laboratory medicine, Lippi and colleagues published that the total testing process error rate ranges widely from 0.1% to 3.0%.11 In studies done by Plebani and Carraro, laboratory error rates declined over 10 years from 0.47% in 1977 to 0.33% in 2007.12,13 A similar declining trend has been seen specifically in analytical errors. The analytical variability is now frequently less than 1/20th of what it was 40 years ago.14 Analytical mistakes now count for