In a 1999 study, the US Institute of Medicine (IOM) concluded that 44,000 to 98,000 hospitalized Americans die each year from preventable medical errors. While the number of serious medical errors attributable to point of care (point-of-care testing, POCT) is not known, the testing environment (patient bedside) and...

In the U.S. all testing, including decentralized testing, is regulated according to the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88). Congress passed CLIA'88 to ensure accurate, reliable, and timely test results regardless of test site. These quality control, quality assurance, and proficiency tesing...