The Government is performing inspections and putting physician's office labs under the microscope.
The Department of Health and Human Services and Centers for Medicare and Medicaid Services (CMS) have identified vulnerabilities and quality problems with many waived labs. CMS is recommending agency management for these labs. The Centers for Disease Control (CDC) recently recommended a change to the Clinical Laboratory Improvement Amendments (CLIA) statute that exempts waived labs from regulatory criteria such as quality control, proficiency testing and inspections.1
1 A COLA White Paper: Federal Government Questions Quality in Waived Testing. The Hard Facts and what can Laboratories do now? 2013