TAG:

medical laboratories

Wisconsin Lab Network Feeds Valuable Data to State Health Lab

CEO SUMMARY: From the earliest days of the COVID-19 pandemic, the 138-member Wisconsin Clinical Laboratory Network has reported to the state health lab the number of COVID-19 tests, the number of positive results, as well as other data that includes data on lab testing supplies and ca…

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In Michigan, Short Supplies Constrain COVID Test Capacity

CEO SUMMARY: Because of a severe shortage of supplies, members of Michigan’s two hospital laboratory networks have been stymied in their ability to respond to the pandemic and operate their SARS-CoV-2 analyzers at full capacity. The lack of primers, reagents, specimen-collec…

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Lab Directors Develop Plans for Return of Routine Hospital Care

CLINICAL LABORATORY DIRECTORS IN MICHIGAN are developing plans to test patients who will return when hospitals reopen for routine care. Included in those plans are strategies to do testing for the novel coronavirus on patients who will return for everyday care and elective procedures, said Bart…

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March, April Patient Visits Drop at Virginia Physician Group and Lab

DURING THE CARONAVIRUS PANDEMIC, gastroenterology and other physician groups with in-house medical laboratories—like most medical practices and clinical laboratories in the United States—have seen a sharp drop in patient visits and specimen volume. That drop occurred at the same time ga…

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Chicago Lab Launches LDT, Finds 20% Positive

CEO SUMMARY: After seeing the novel coronavirus spread quickly in China, staff in the Department of Pathology and Laboratory Medicine developed a test to identify the pathogen in patients in Chicago and its suburbs. With the CDC’s assay in hand, it started work on its ow…

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Veritas Genetics to Close Its Testing Operations in U.S.

MAYBE CHARGING CONSUMERS THE LOW PRICE of $599 for a whole human genome sequence is not a winning financial strategy. That’s one possible reason why closely-watched Veritas Genetics of Cambridge, Mass., will stop operations in the United States. It was in July that Veritas annou…

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Labs May Be Excluded from Revised Stark, AKS Rules

CEO SUMMARY: When CMS and the OIG issued proposed rules last fall to make it easier for providers to participate in value-based and coordinated care arrangements, they considered excluding clinical labs, pharma companies, and DME firms because of concerns that the proposed rules could pro…

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Labs May Be Excluded from Revised Stark Law, AKS Rules

This is an excerpt of a 1,460-word article in the Jan. 6, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Here are early insights about a federal compliance reform that has not gotten much attention among clinical la…

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PGx Testing Labs Concerned by FDA’s Statements, Actions

This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…

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PGx Labs Concerned by FDA’s Statements, Actions

CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…

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