CMS Provides New Guidance on When International Labs Must Seek CLIA Certification
Recently released Centers for Medicare and Medicaid Services guidance shares when CLIA regulations apply to international labs.
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Staffing Special Report: CMS Proposes Changes to CLIA Laboratory Personnel Requirements
An overview and analysis of the recently proposed changes and how they could affect your medical laboratory.
CMS Proposes CLIA Fee Increases and Nurses Doing High-Complexity Testing
In addition to increasing and imposing new user fees, the proposed rule would allow nurses to perform high and moderate complexity testing, essentially placing nursing degrees on the same level as degrees in clinical laboratory science, biology, and chemistry. Here's what lab managers need to know about the proposed rule.
FDA Watch: Agency Moves to Boost CLIA Waiver Transparency
From - National Intelligence Report
The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it…
Theranos Settles with CMS and Arizona Attorney General
From - National Intelligence Report
After facing federal and state government scrutiny for more than a year, Theranos has reached agreements with the Centers for Medicare & Medicaid Services (CMS) and the Arizona Attorney General to…
Labs Stop VA from Allowing APRNs to Perform Lab Tests
From - National Intelligence Report
The laboratory sector has successfully fought a Department of Veterans Affairs (VA) rule that would have allowed advance practice registered nurses (APRNs) to "perform and supervise" lab testing. Numerous organizations, including…
CMS Grants International CLIA Certificate to ImmunID for Laboratory in France
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CLIA Certificate Granted for Laboratory in France
From - National Intelligence Report
As recently reported in Laboratory Industry Report (see "Inside the Laboratory Industry," Laboratory Industry Report, p. 4, 3/17/16), the diagnostics industry is going…
Government Scrutiny of Theranos Increases
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CMS Releases New CLIA-Waived Tests, Billing Codes
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ACMG and AMA Coalition Make LDT Oversight Recommendations to Congress
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FDA and CMS Address LDT Regulation Before Energy and Commerce Committee
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