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What Labs with LDTs Must Do to Comply with FDA’s LDT Rule

By Robert Michel | From the Volume XXXI, No. 10 – July 22, 2024 Issue

CEO SUMMARY: Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This com…

May 30, 2023, Intelligence: Late-Breaking Lab News

By Scott Wallask | From the Volume XXX, No. 8 – May 30, 2023 Issue

Hospital laboratory outreach programs continue to be acquisition targets for national laboratory companies. Earlier this month, Labcorp in Burlington, North Carolina, announce…

VA: 120,000 Cancelled Lab Tests Did Not Route to Physicians

By Scott Wallask | From the Volume XXX, No. 6 – April 17, 2023 Issue

OFFICIALS FROM THE DEPARTMENT OF VETERANS AFFAIRS (VA) AND ORACLE CERNER found themselves on the …

Alert! Changes to CLIA Accreditation, CLIA Revisions

By R. Lewis Dark | From the Volume XXX No. 2 – January 23, 2023 Issue

MEDICAL LABORATORIES HAVE LIVED WITH THE REGULATIONS FOR THE CLINICAL LABORATORY IMPROVEMENTS AMENDMENTS (CLIA) since they were first implemented in 1992. Over the past 30 years there has been no major revision or updating of CLIA regulations. Nor has there been much change in the long-standing statu…

CLIA Accreditation Market: More Competitive Now?

By Robert Michel | From the Volume XXVIII, No. 10 – July 26, 2021 Issue

CEO SUMMARY: It’s been three decades since compliance with the Clinical Laboratory Improvement Amendments (CLIA) became mandatory. During that time, there has been little competition among the major organizations with deeming status by the Medicare Program to accredit labs to CLIA…

Volume XXXI, No. 11 – August 12, 2024

This issue identifies current lab trends as experienced by the two Blood Brothers, Labcorp and Quest Diagnostics, and delves into these trends. Also, a new survey highlights consumer healthcare trends that labs should be aware of.

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