TAG:
lab industry
Understanding Key Parts of New AKS, Stark Law Rules
CEO SUMMARY: Both the federal Stark Law and Anti-Kickback Statute have been revised and the final rules became effective on Jan. 19. The good news for clinical laboratories and anatomic pathology groups is that federal regulators from the Centers for Medicare and Medicaid Services a…
What Comes Next? Predictions on COVID-19 Test Volumes in 2021-22
CEO SUMMARY: Incoming data show that the number of referrals for both COVID-19 tests and routine tests is in a decline that started in October and is continuing. This complicates the strategic planning for hospital/health system labs, independent labs, and pathology groups. They nee…
COVID-19 Variant Sequencing Offers Clinical Opportunities
This is an excerpt of a 2,987-word article in the March 1, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: In Wisconsin, an oncology research lab started sequencing variants of the SARS-CoV-2 virus and fou…
SARS-CoV-2 Variant Sequencing Offers Clinical Opportunities
CEO SUMMARY: In Wisconsin, an oncology research lab started sequencing variants of the SARS-CoV-2 virus and found multiple uses for such test results to help hospitals, health systems, schools, and municipalities identify infection sources and track the virus’ spread. In one case,…
Pathologist’s Prison Term Is a Warning for AP Groups
CEO SUMMARY: In January, a former VA pathologist was sentenced to 20 years in federal prison following his conviction on charges of involuntary manslaughter and mail fraud. The facts in this case show why leaders of clinical labs and pathology groups need to be aware of individuals …
CAP Loses Accreditation Clients to Joint Commission
CEO SUMMARY: Over the past 18 months, several prominent national health systems decided to shift their CLIA laboratory accreditation services away from the College of American Pathologists and to The Joint Commission. These shifts from one accrediting body to another will involve hun…
SARS-CoV-2 Variant Sequencing Creates New Opportunities for Labs
This is an excerpt of a 2,964-word article in the February 8, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Variants of the COVID-19 virus are appearing across the world. Recent data show the same variants wil…
Variant Sequencing of SARS-CoV-2 Creates Opportunities for Labs
CEO SUMMARY: Variants of the COVID-19 virus are appearing across the world. Recent data show the same variants will infect people in several different countries. Here in the United States, interest is growing in having clinical laboratories sequence specimens from patients who test pos…
Top 10 2020 Lab Stories Are about More than Just COVID-19
This is an excerpt of a 3,689-word article in the December 28, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: There are several surprises in The Dark R…
Managing Labs in Two Dimensions in 2021
EXPECT 2021 TO BE JUST AS CHALLENGING A YEAR for lab management as was 2020. This will be true not only because of the SARS-CoV-2 pandemic. Other important factors will complicate the operation of clinical laboratories and anatomic pathology groups in the new year….
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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