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Employers, Others Looking to Build New Clinical Labs

Clinical Laboratory Trends / Robert Michel

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 these entities seek to provide a safe work environment and limit their legal liability associated with COVID-19, and they want their own clinical laboratories to ensure adequate […]

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In Just 13 Days, Lab Buys, Validates & Uses Analyzer

Laboratory Equipment / Robert Michel

CEO SUMMARY: In response to the nationwide outbreak of SARS-CoV-2, clinical labs are introducing new analyzers whenever possible to boost testing capacity. Pre-pandemic, buying and installing new instruments could take at least two months, and that timeline can go longer now. But because of advance planning, working closely with its instrument vendor, and adjusting on the fly when needed, a 161-bed

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Volume XXVII No. 10 – July 13, 2020

Mary Van Doren

IS POOLED TESTING the answer to COVID-19 testing shortages? Yes and no. THE DARK REPORT analyzes the pros and cons of this suddenly-popular old idea, with experts from across the industry offering their input. Also in this issue is the case for why local labs should be getting more testing supplies, and how the government has damaged the supply chain.

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It’s a Clinical Lab Moment … But No Advocates!

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

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 event that could be quite favorable to the clinical lab profession. Unfortunately,

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Government Officials Intensify Broad Chaos In Clinical Lab Supply Chain

Clinical Laboratory / Robert Michel

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 officials at all levels. This is particularly true of ongoing disruptions to the supply chain of the

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Labs Still Confront New Supply Shortages Daily

Laboratory Equipment / Robert Michel

CEO SUMMARY: For three lab directors in the Midwest, a seemingly endless cycle of COVID-19 lab-supply shortages crops up almost daily. These labs might not have enough test kits one day, and be short of reagents, transport vials, or specimen collection swabs the next. To address these problems, the lab directors have cobbled together a variety of solutions, but they

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July 13, 2020 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

On July 9, eight national laboratory associations sent a letter to Vice President Mike Pence to request that the White House Coronavirus Task Force take action to resolve major obstacles that constrain the ability of their member laboratories to perform molecular and serological tests for COVID-19. Specifically, the lab associations want action and resolution on supply chain issues. The letter noted that “At times, our members have even received faulty

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Volume XXVII No. 9 – June 22, 2020

Mary Van Doren

THE NEWS ON THE SEROLOGICAL TEST FRONT is discouraging, even bleak, as THE DARK REPORT analyzes the outcome of the FDA’s own review of 11 tests previously listed as marketable. Only three tests passed the review, and yet a quality control expert consulted by THE DARK REPORT has dim views of the FDA’s testing operation, leading to even more doubts. Also, health insurers are scraping away at mandated COVID-19 test reimbursements, leaving lab revenues once again at their mercy.

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FDA Says 8 of 11 Tests Fail in Serology Test Review

TDR Insider / Robert Michel

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, as of this writing

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Where Is the FDA When Labs Need It Most?

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

LET’S START WITH AN ESSENTIAL FACT: in the management of almost every outbreak of a novel infectious disease, clinical laboratory tests will be essential in diagnosis of the disease, in monitoring the progress of an infected patient, and in determining if, once cured, a patient has immunity to that disease. Next, let’s recognize another basic fact: clinical lab

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