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Clinical Laboratory Improvement Amendments of 1988
Several Times, Feds Tried to ‘Redirect’ Lab Activities
By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue
CEO SUMMARY: Regulation of laboratory developed tests (LDTs) by the Food and Drug Administration (FDA) may turn out to be one of the most impactful federal laws or regulations ever promulgated, so far as it pertains to clinical laboratories.cThe Dark Report provides this historical look b…
FDA & CMS Issue Letter, Agree on LDT Oversight
By Robert Michel | From the Volume XXXI, No. 2 – February 5, 2024 Issue
CEO SUMMARY: With the release of a public statement about the oversight of LDTs on Jan. 24, 2024, officials at both the Food and Drug Adminstration and the Centers for Medicare and Medicaid Service went on record that both agencies are aligned in the spec…
Proficiency Testing Ranks High as a CLIA Violation
By Robert Michel | From the Volume XXX, Number 15 – October 23, 2023 Issue
CEO SUMMARY: Proficiency testing (PT) deficiencies are consistently cited by clinical laboratory accreditors during CLIA inspections. Surveyors and inspectors note that labs may mistakenly believe that an 80% score on a PT event is satisfactory. To the contrary, experts advise labs to scr…
Two Forces Push for More FDA Oversight of LDTs
By R. Lewis Dark | From the Volume XXX, No. 14 – October 2, 2023 Issue
CLINICAL AND GENETIC TESTING LABS MAY SUDDENLY FEEL THEMSELVES STUCK IN THE MIDDLE of a yin-yang situation when it comes to laboratory developed tests (LDTs). One force, the U.S. Food and Drug Administrati…
FDA Issues Proposed Rule to Further Regulate LDTs
By Scott Wallask | From the Volume XXX, No. 14 – October 2, 2023 Issue
CEO SUMMARY: Publication of the FDA’s draft rule on LDT regulation starts the clock on public comment. The proposal seeks to clearly identify laboratory developed tests (LDTs) as in vitro diagnos…
FDA’s Road to Regulation of Lab Developed Tests
By Robert Michel | From the Volume XXX, No. 14 – October 2, 2023 Issue
CEO SUMMARY: Today’s generation of clinical lab managers and pathologists should understand that the FDA’s efforts to publish a draft rule defining its authority to review laboratory developed tests (LD…
Competency Assessments Prove To Be a Nagging CLIA Deficiency
By Scott Wallask | From the Volume XXX, No. 11 – July 31, 2023 Issue
CEO SUMMARY: Competency assessment problems rank high among frequently cited deficiencies during CLIA inspections. Representatives from the CAP, COLA, and The Joint Commission explain what areas to…
FDA Expected to Publish Proposed LDT Rule in August
By Scott Wallask | From the Volume XXX, No. 10 – July 10, 2023 Issue
CEO SUMMARY: Congressional lawmakers and the federal Food and Drug Administration are again eyeing changes that would bring greater oversight to laboratory-developed tests (LDTs). Leaders at clinical laboratories and pathology groups should monitor these proposals, both of which c…
Atrium Health’s Advice on Epic Beaker Rollouts
By Scott Wallask | From the Volume XXX, No. 9 – June 19, 2023 Issue
CEO SUMMARY: Starting in 2019, Atrium Health began a years-long process to implement Epic Beaker as its laboratory information system. It was an enormous effort, involving dozens of locations across three s…
CMS: TJC Made ‘Business Decision’ to Not Recognize COLA
By Scott Wallask | From the Volume XXX, No. 9 – June 19, 2023 Issue
Following up on a prior briefing, The Dark Report has learned that the Centers for Medicare and Medicaid Services (CMS) does not appear to hav…
CURRENT ISSUE
Volume XXXI, No. 14 – October 14, 2024
For the second time in the past 16 months, respected health systems have taken steps to collaborate specifically to advance value-based care. Also, several statewide pilot programs—each involving tens of thousands of newborns—are publishing studies that demonstrate how exome, whole genome sequencing, and rapid whole genome sequencing can deliver both improved patient outcomes and a return on investment.
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