News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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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It was national news when the FDA sent notice to Congress on July 31 that it planned to issue draft guidance on regulation of LDTs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 full attention of the clinical laboratory industry, it certainly succeeded. In the four weeks since the FDA alerted Congress of its plans for LDT regulation, there has been a flood of national news stories about this development. (more…)

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 leaders are doing much better financially at a time when payers are slashing the prices they pay for medical laboratory tests. (more…)

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 evidence that Lean, Six Sigma, and similar performance improvement methods can play a role in reducing patient risk while significantly increasing the analytical integrity of the lab tests produced by their organizations.