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Clinical Laboratory Improvement Amendments of 1988
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…
CMS Ends Remote Reading of Pathology Glass Slides
By Scott Wallask | From the Volume XXX, No. 8 – May 30, 2023 Issue
CEO SUMMARY: On the day the federal government ended the public health emergency for SARS-CoV-2, CMS issued an updated FAQ that ended the allowance for remote reviews of glass slides…
Six Important Themes to Help Labs Succeed
By Scott Wallask | From the Volume XXX, No. 5 – March 27, 2023 Issue
CEO SUMMARY: Clinical laboratories face business challenges with day-to-day operations, genetic testing, and evolving care delivery models. The 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management returns on April 25-26 in New Orleans. Participant…
CURRENT ISSUE

Volume XXX, Number 17 – December 4, 2023
In this issue, The Dark Report discusses the impact of artificial intelligence-powered solutions. The Dark Report suggests that it is timely for lab managers at all levels of the organization to begin learning about the field of artificial intelligence. In addition to this topic, discover how labs should be prepared for data to dominate diagnostics, understand that CLIA lab directors must monitor delegated duties, and stay informed about the latest regulatory and IVD updates.
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