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College of American Pathologists
Passage of FDA Regulation of LDTs Inches Closer in the Senate
By Robert Michel | From the Volume XXIX, No. 8 – June 6, 2022 Issue
CONGRESSIONAL LAWMAKERS ARE MOVING A BILL FORWARD that would give the federal Food and Drug Administration (FDA) the power to regulate laboratory-developed tests. There are many in the clinical laboratory profession who oppose any proposal to give the FDA regulatory oversight of LDTs. …
California Agency Problems Deepened Valencia Branch Laboratory Saga
By Robert Michel | From the Volume XXIX, No. 5 – April 4, 2022 Issue
CEO SUMMARY: Adding a new twist in the ongoing saga of the CLIA compliance failures at the Valencia Branch Laboratory in California are insights from a former clinical laboratory director familiar with the industry in California. He observed that problems at California’s Laborator…
COLA Re-enters CLIA Accreditation for Pathology
By Robert Michel | From the Volume XXIX, No. 5 – April 4, 2022 Issue
CEO SUMMARY: COLA again h…
Questions Remain about California COVID-19 Lab
By Robert Michel | From the Volume XXIX, No. 4 – March 14, 2022 Issue
This is an excerpt of a 2,058-word article in the March 14, 2022 issue of  THE DARK REPORT. The full article is available to members of The Dark Intelligence Group CEO SUMMARY: Despite multiple investigations citing more than 60 deficiencies, including some that caused immediate j…
New Trends Reshaping Healthcare, Lab Testing
By Robert Michel | From the Volume XXIX, No. 4 – March 14, 2022 Issue
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Questions Remain about California’s Valencia Lab
By Robert Michel | From the Volume XXIX, No. 4 – March 14, 2022 Issue
CEO SUMMARY: Despite multiple investigations citing more than 60 deficiencies, including some that caused immediate jeopardy to patient safety according to state inspectors, the Valencia Branch Laboratory never closed. The California Department of Public health said the state lab no…
2021’s Top 10 Lab Stories Highlight Important Trends
By Robert Michel | From the Volume XXVIII, No. 17 – December 20, 2021 Issue
This is an excerpt of a 3,075-word article in the December 20, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Much like 2020, the pandemic dominated our new list of the top 10 lab stories for 2021. Beyond…
2021’s Top 10 Lab Stories Confirm Important Trends
By Robert Michel | From the Volume XXVIII, No. 17 – December 20, 2021 Issue
CEO SUMMARY: Much like 2020, the pandemic dominated our new list of the top 10 lab industry stories for 2021. Beyond COVID-19 testing, the virus crept its way into long-term trends, such as pathology jobs and technology innovation. New ways of delivering healthcare will need respons…
Federal Rule to Revise Out-of-Network Billing
By Robert Michel | From the Volume XXVIII, No. 14 – October 18, 2021 Issue
CEO SUMMARY: Remaining out of network with health insurance companies may boost revenue for providers, including anatomic pathologists and emergency room physicians. But the good times may soon end. Last month four federal agencies issued rules that implement new requirements under …
CAP Introduces Features to Aid CLIA Inspections
By Robert Michel | From the Volume XXVIII, No. 14 – October 18, 2021 Issue
CEO SUMMARY: Clinical labs are changing in multiple ways and the College of American Pathologists regularly revises its CLIA accreditation processes in response to these changes. One such change is the growth in the number of integrated delivery networks that operate multiple hospit…
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