FDA Pushes Forward with Plans to Regulate Laboratory-Developed Tests, in a Move that Will Impact Many Clinical Laboratory Companies and Pathology Groups

It was national news when the FDA sent notice to Congress on July 31 that it planned to issue draft guidance on regulation of LDTs After sitting in a state of suspended animation for several years, the Food & Drug Administration’s (FDA) plans to regulate laboratory-developed tests are now front and center. On July 31, the FDA served the required 60-day legal notice to Congress that it was ready to move forward to issue rules for regulation of LDTs. If the federal agency wanted to get the...

Why More Clinical Laboratory Sales Managers Are Failing in Today’s Fast-Evolving Healthcare Marketplace

Sales managers at top-performing medical labs and pathology groups are directing the lab sales reps to develop new clients who can refer lab tests that are still adequately reimbursed In today’s rough-and-tumble healthcare marketplace, every clinical laboratory and pathology group needs a sales manager or sales vice president who is at that top of the game in managing productive sales reps, achieving growth targets, and strengthening their lab’s financial stability. Labs with strong sales...

Innovative Clinical Pathology Laboratories Raise Analytical Test Quality with Lean and Process Improvement

Lab Quality Confab showcases the next paradigm shift for clinical laboratory QA/QC Can Lean, Six Sigma, and process improvement techniques measurably improve the quality of analytical test results produced by clinical pathology laboratories? A handful of innovative pathologists and laboratory scientists say the answer is “yes”! The outcomes from their pioneering efforts to deliberately attack and improve the quality of the analytical test results in their medical laboratories provide early...
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