TAG:
California COVID-19 test lab
Whistleblower Lab Manager Files Response to PerkinElmer Lawsuit
By Robert Michel | From the Volume XXVIII, No. 8 – June 14, 2021 Issue
IN A DAVID-VERSUS-GOLIATH-LIKE BATTLE, perhaps the most unusual lawsuit in decades involving clinical laboratory operations and compliance is unfolding in a federal courthouse in California. In this case, a multi-billion-dollar in vitro diagnostics (IVD) company is suing a laboratory manager w…
Might Politics Sway California Lab’s CLIA Compliance?
By R. Lewis Dark | From the Volume XXVIII No. 3 – March 1, 2021 Issue
IS IT A CONFLICT FOR A STATE GOVERNMENT TO BUILD AND OPERATE A CLIA high-complexity clinical laboratory and have the same department that manages this lab facility also conduct the CLIA-mandated inspections and oversight of the lab’s compliance, as required by the federal Clinical Laboratory Improv…
Whistleblowers Disclose Issues in California’s COVID Lab
By Robert Michel | From the Volume XXVIII No. 3 – March 1, 2021 Issue
SUMMARY: Whistleblowers at the State of California’s brand-new COVID-19 Valencia Branch Laboratory are telling reporters about staff sleeping on the job, unlicensed staff handling specimens, and other significant issues. Given the reports of several news outlets, one relevant ques…
State of California’s COVID Lab Producing Inconclusive Results
By Robert Michel | From the Volume XXVII, No. 17 – December 7, 2020 Issue
Inconclusive COVID-19 test results and delays in reporting results continue to plague the state of California’s brand new clinical laboratory, located in Valencia. That’s according to reports by several news outlets in the Golden State. On Nov. 20, …
California Builds Its Own COVID Lab: $25 Million or $1.7 Billion?
By Robert Michel | From the Volume XXVII, No. 16 – November 16, 2020 Issue
CEO SUMMARY: California dropped a bomb on the state’s existing network of hospital labs and independent clinical labs when, on Oct. 30, it announced it had built and opened a new laboratory facility in Valencia designed to perform 150,000 COVID-19 tests per day. Now, existing labs…
CURRENT ISSUE
Volume XXXII, No. 1 – January 6, 2025
The Dark Report examines how AI is being used to predict the outcomes of FDA LDT lawsuits. Also, this issue is Part Two of a series about boosting pathology compensation in different settings, including hospitals. Two experienced pathology consultants identify the most effective approaches when negotiating Part A pathology agreements with hospitals and health systems, along with how to use data to bolster these negotiations.
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