Next Steps: With LDT Final Rule Now Null, Industry Groups Urge Lab Managers and Pathologists to Advocate for Change
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
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LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
Using the IQCP Process to Improve CLIA Compliance and Lab Testing System Quality
Individualized quality control plans offer flexibility and the capacity to seamlessly adopt new nonwaived tests, practices, and technologies.
Five Changes You Need to Know about New CLIA Proficiency Testing Rules
With the final rule on PT published July 11, here are the five things lab managers need to know to keep their labs compliant.
Analytic Systems Account for 5 of Top 10 Most Cited CLIA Deficiencies
CMS has published its list of top 10 most frequently cited Clinical Laboratory Improvement Amendments deficiencies for the previous year.
After Nearly 3 Decades, CMS Proposes Updates to Proficiency Testing Rules
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Brief Your CEO: After 36 Years, CLIA Comes Under CMS Review
From - G2 Compliance Advisor
Even as your lab makes the transition to the new, supposedly market-based PAMA Medicare Part B fee schedule for tests, big changes may be in store for another rock of…
CLIA Corner: FDA Moves to Boost CLIA Waiver Transparency
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Theranos Faces New Challenges and Increasing Federal Scrutiny
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CMS Issues Deficiency Letter to Theranos
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