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The US Regulatory Requirements for Point-of-Care Testing

Ehrmeyer, Sharon S. PhD, MT(ASCP)

Point of Care: The Journal of Near-Patient Testing & Technology: June 2011 - Volume 10 - Issue 2 - p 59-62
doi: 10.1097/POC.0b013e31821bd6af
Special Feature Article

Conceptually, all patients are entitled to quality laboratory results, regardless of where, when and who does the testing. In the United States, under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), all clinical laboratory testing including point-of-care testing (POCT) examining "materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease..."is regulated. These CLIA mandates are based on test complexity-waived and nonwaived-and focus on the 3 phases of testing: preanalytical, analytical, and postanalytical. As such, all POCTs must be conducted under a current CLIA certificate and meet the minimum requirements specified in the CLIA regulations. The Centers for Medicare & Medicaid Services (CMS) serves as the inspection agency for CLIA compliance. Many testing sites, however, choose to comply with CLIA through meeting the testing standards and being inspected by a CMS "deemed" professional organizations. The 3 primary organizations are the Joint Commission, the College of American Pathologists, and COLA. Each of these agencies' requirements consider the unique nature of POCT and vary as to what test sites need to do be in compliance with its standards and, in essence, the CLIA regulations. The POCT coordinator or committee overseeing POCT sites must, in addition to ensuring that patients' needs are met, be cognizant of the minimum CLIA requirements as well as the applicable professional guidelines, checklists, and professional standards.

From the Pathology and Laboratory Medicine and Clinical Laboratory Science/Medical Technology Program, Department of Pathology and Laboratory Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI.

Reprints: Sharon S. Ehrmeyer, PhD, MT(ASCP), Clinical Laboratory Science/Medical Technology Program, 6175 MSC, 1300 University Avenue, Madison, WI 53706. E-mail:

© 2011 Lippincott Williams & Wilkins, Inc.