TAG:
the clinical laboratory
October 5, 2020 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXVII, No. 14 – October 5, 2020 Issue
Guess who will be partnering with the US Department of Veterans Affairs to support its wider use of digital pathology? It’s Google! Last month, it was announced that the Defense Innovation Unit (DIU) of the Department of Defense (DoD) had selected Google …
COVID-19 Changes Lab and Pathology Profession
By R. Lewis Dark | From the Volume XXVII, No. 11 – August 3, 2020 Issue
WE ARE ENTERING THE SEVENTH MONTH OF THE SARS-COV-2 OUTBREAK and some public health authorities predict that new cases of COVID-19 will continue through the fall and into 2021. If true, this will not be auspicious for the nation’s clinical laboratories and anatomic pathology groups. The curren…
UHC Ready to Implement New Lab Test Registry
By Robert Michel | From the Volume XXVII, No. 11 – August 3, 2020 Issue
CEO SUMMARY: UnitedHealthcare announced that its new Test-Registry Protocol will become effective on Jan. 1, 2021, creating a major billing hurdle for labs and pathology groups. By that date, a lab must register each type of test before it can submit claims for these tests to the nati…
Employers, Others Looking to Build New Clinical Labs
By Robert Michel | From the Volume XXVII, No. 11 – August 3, 2020 Issue
CEO SUMMARY: Employers, universities, municipalities, and other large organizations are interested in building their own clinical laboratories. In addition, entrepreneurs—many with no prior experience in laboratory medicine—want to make money providing COVID-19 testing. Many of th…
Is COVID-19 Pooled Testing Good for Labs, Bad for IVDs?
By Robert Michel | From the Volume XXVII No. 10 – July 13, 2020 Issue
This is an excerpt of a 1,420-word article in the July 13, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Pooled testing for COVID-19 could be a double-edged sword for clinical labs and in vitro diagnos…
It’s a Clinical Lab Moment … But No Advocates!
By R. Lewis Dark | From the Volume XXVII No. 10 – July 13, 2020 Issue
Nearly every day since the onset of the SARS-C0V-2 outbreak, there have been stories in the national news about clinical laboratory testing for COVID-19. No laboratory professional alive today has seen such an endless stream of news stories about clinical lab testing. This is a once-in-a-lifetime …
COVID-19 Pooled Testing: Good for Labs? Not IVDs?
By Robert Michel | From the Volume XXVII No. 10 – July 13, 2020 Issue
CEO SUMMARY: Pooled testing for COVID-19 could be a double-edged sword for clinical labs and in vitro diagnostics companies. Offering the advantage of reducing the number of standard tests for SARS-CoV-2, this testing method would cut lab spending on tests and testing supplie…
Why Local Labs Deserve More COVID-19 Supplies
By Robert Michel | From the Volume XXVII No. 10 – July 13, 2020 Issue
CEO SUMMARY: As government officials and IVD firms divert the lion’s share of COVID-19 tests to a handful of billion-dollar labs, in thousands of hospitals across the nation COVID-19 patients languish days longer before discharge because their hospital lab must send COVID-19 tests t…
Government Officials Intensify Broad Chaos In Clinical Lab Supply Chain
By Robert Michel | From the Volume XXVII No. 10 – July 13, 2020 Issue
CEO SUMMARY: Clinical labs throughout the United States are ready to meet the challenges of the COVID-19 pandemic. At the same time, there is widespread recognition that many barriers to increasing labs’ COVID-19 testing capacity are caused by the inappropriate actions of government…
FDA Says 8 of 11 Tests Fail in Serology Test Review
By Robert Michel | From the Volume XXVII No. 9 – June 22, 2020 Issue
This is an excerpt of a 1,970-word article in the June 22, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: After introducing some 200 serological assays onto the market in March and April with little or no review,…
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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