title: Point-of-care testing: the impact of CLIA regulations on your testing program.
abstract: Competitive pressures drive physician offices toward on-site clinical laboratory testing programs to streamline service, generate revenue, and make better decisions during patient visits. The Clinical Laboratory Improvement Amendments continue to govern all laboratory tests performed for patient diagnosis, monitoring, or treatment. However, new diagnostic tools reduce regulatory hassles previously associated with point-of-care testing. Of course, regulatory consequences are still an important consideration when commencing a testing program or adding to an existing one. Here we focus on the regulatory restraints surrounding physician office laboratories to help you determine whether or not it makes sense to test in your setting.
authors.affiliation: Quality America, Inc., P.O. Box 8787, Asheville, NC 28814, USA. sdunn@quality-america.com
authors.forename: Sheila G
authors.initials: SG
authors.lastname: Dunn
mesh_terms: D002984:Clinical Laboratory Information Systems / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006801:Humans; D007753:Laboratories / Q000592:standards*; D019095:Point-of-Care Systems / Q000331:legislation & jurisprudence*; D011216:Practice Management, Medical / Q000331:legislation & jurisprudence*; D014481:United States