The term “point-of-care test” (POCT) is defined, and the associated benefits and challenges are described. There are many possible test locations, which are defined. The importance of addressing potential operator errors, training and education is emphasized. A hypothetical example of a detailed cost analysis is presented showing the importance of proper healthcare cost:benefit analysis. The differences in the requirements for quality assurance programs between point-of-care and laboratory tests are explained, from a management and regulatory perspective, based on US regulations. This section includes an explanation of the key CLIA ’88 regulations in the US. Data management is addressed, a significant challenge for POCTs. The practical aspects of validation and quality control are also explained. Finally, advice is provided on POCT administration.

James H. Nichols, Ph.D., DABCC, FACB is a Professor of Pathology, Microbiology, and Immunology and Medical Director of Clinical Chemistry at Vanderbilt University School of Medicine. Dr. Nichols received his B.A. in General Biology/Premedicine from Revelle College, University of California at San Diego. He went on to complete a Masters and Doctorate in Biochemistry from the University of Illinois, Urbana-Champaign. Jim was a fellow in the Postdoctoral Training Program in Clinical Chemistry at the Mayo Clinic, Rochester, MN. He is board certified in both Clinical Chemistry and Toxicological Chemistry by the American Board of Clinical Chemistry. Dr. Nichols spent several years as Associate Director of Clinical Chemistry, Director of Point-of-Care Testing, and an Associate Professor of Pathology at Johns Hopkins Medical Institutions. Jim later served as Medical Director of Clinical Chemistry for Baystate Health in Springfield, MA and was a Professor of Pathology at Tufts University School of Medicine. Dr. Nichols’ research interests span evidence-based medicine, information management, laboratory automation, point-of-care testing and toxicology.

Point-of-care, cost analysis, cost:benefit, economics, quality control, quality assurance, good laboratory practice, regulations, Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88), accreditation, moderate complexity, validation.