Attention Lab Directors: Four CLIA Updates from the Past Year to Examine
CMS tweaked its CE, documentation, and on-site visit requirements for directors
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Articles and Reports
Clinical Lab Training Documentation Becomes More Important with CMS Revision
Third-party verification of lab personnel experience is now a CLIA requirement
FDA Watch: Mass Spectrometry Test Receives First Moderate Complexity Designation
Roche’s vitamin D assay includes internal quality controls that allowed it to obtain the CLIA designation
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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More FDA Workshops Focus on NGS Technology
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FDA Looks Back at Successes and Details Plans for 2016, Including LDTs
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FDA Report Asserts Case Studies Support Need for More Oversight of LDTs
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AMP Offers Proposal for Regulation of Laboratory-Developed Tests
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CMS Releases New CLIA-Waived Tests, Billing Codes
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CMS Offers Physicians and Providers Help Prepping for ICD-10
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Proposed Legislation Aids Personalized Medicine Agenda
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