The Dark Report

Primary Care’s Shift to Telehealth and Pharmacies

Primary care patients are a major source of lab test referrals to the nation’s clinical laboratories. Until recent years, the typical primary care clinic was located in or near the medical campus of the local hospital and was probably owned by the doctors who staffed the clinic.  Three things are changing this traditional model of …

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Pathologist Makes News at Elizabeth Holmes Trial

CEO SUMMARY: During the trial, a pathologist who formerly was CLIA lab director at Theranos testified about the little regard Theranos executives had for federal proficiency testing regulations labs must follow to retain their CLIA license. Another point of contention was how this pathologist had sent himself copies of emails to document management decisions designed …

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By 2027, Walgreens Wants 1,000 Primary Care Clinics

PRIMARY CARE IS COMING TO A RETAIL CLINIC NEAR YOU! It may not happen overnight, but it will happen. Walgreens Boots Alliance just announced its goal of building 1,000 primary care clinics at its retail pharmacies by 2027. CVS and Walmart have similar plans. These plans were announced last week, when Walgreens disclosed that it …

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Federal Rule to Revise Out-of-Network Billing

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 the No Surprises Act. Data on how much certain specialists charge for out-of-network care …

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UnitedHealth’s Lab Test Registry Implementation Delayed Again

ANOTHER DELAY WAS ANNOUNCED FOR IMPLEMENTATION of UnitedHealthcare’s Laboratory Test Registry Protocol, which requires clinical laboratories to register each of their tests with the health insurer. This latest delay likely is the result of operational issues on behalf of the managed care company and does not spell an end to the test registry altogether. “It’s …

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SUNY Hospital Uses Drones to Move COVID Test Kits

CEO SUMMARY: One healthcare trend accelerated by the SARS-CoV-2 pandemic is the use of drones to move COVID-19 test kits, specimens, and medical supplies. Earlier this year, the SUNY Upstate Medical University Hospital in Syracuse tested the reliability of drones to move unused COVID-19 test kits between locations on its campus. In Scotland and Ghana, …

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CAP Introduces Features to Aid CLIA Inspections

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 hospitals and multiple medical clinics, creating a multi-site clinical lab service. To meet …

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October 18, 2021 Intelligence: Late-Breaking Lab News

One interesting development from the SARS-CoV-2 outbreak is a new ability to collect genetic data on the virus and its variants from a growing number of countries across the globe. The World reported that “In March, the one millionth genomic sequence for the new coronavirus came from Chile; in late May, the two millionth from …

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Artificial Intelligence: Coming at Light Speed!

YOU HAVE PROBABLY  NOTICED THAT THE TERM “ARTIFICIAL INTELLIGENCE” is now part of the description for a growing proportion of the new products and services being offered to your clinical laboratory or anatomic pathology group. Regardless of whether it is automation, analyzers, or software, the claim is that artificial intelligence (AI) is integral to the …

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First Digital Path AI Tool Cleared for Market by FDA

CEO SUMMARY: In a first for the anatomic pathology profession, the Food and Drug Administration (FDA) has cleared for market a digital pathology image analysis product intended to aid pathologists in the diagnosis of prostate cancer. Developed by New York City-based Paige, the Paige Prostate system was determined by the FDA to improve diagnostic accuracy …

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