Theranos CEO Elizabeth Holmes Trial Delayed Again, This Time Due to COVID-19 Restrictions, as Lawyers Battle Over Destroyed Clinical Laboratory Test Evidence
Government prosecutors allege destruction of LIS database and point to Holmes’ extravagant lifestyle as evidence of fraud motive There is a new twist in the federal criminal fraud trial of Elizabeth Holmes, co-founder and former CEO of now defunct clinical laboratory...
New Study Shows Protective Immunity Against COVID-19 Is ‘Robust’ and May Last Up to Eight Months or Longer Following Infection
Researchers find declining antibody levels in SARS-CoV-2 patients are offset by T cells and B cells that remain behind to fight off reinfection Questions remain regarding how long antibodies produced by a COVID-19 vaccine or natural infection will provide ongoing...
Researchers in Five Countries Use AI, Deep Learning to Analyze and Monitor the Quality of Donated Red Blood Cells Stored for Transfusions
By training a computer to analyze blood samples, and then automating the expert assessment process, the AI processed months’ worth of blood samples in a single day New technologies and techniques for acquiring and transporting biological samples for clinical...
CMS’ Latest Value-Based Care Reimbursement Model Explores Geographic Direct Contracting for Medicare, Focuses on Costs and Quality
Physicians engaged with CMS in value-based care are asking clinical laboratories to help them close gaps in patient care through testing Clinical laboratories know that any change to how the federal Centers for Medicare and Medicaid Services (CMS) reimburses...
University of Kansas Health System Laboratory Shares Lessons from Assessing Pooled Testing for COVID-19 Patients
Available funds and disease prevalence affect whether pooled testing is feasible and desirable, notes University of Kansas Health System microbiology laboratory director Pooled testing for the SARS-CoV-2 coronavirus has its supporters and its critics. There is no...
ASCP and CAP Support New Legislation That Bars Surprise Medical Billing
The No Surprises Act, passed as part of the COVID-19 relief package, ensures patients do not receive surprise bills after out-of-network care, including hospital-based physicians such as pathologists Consumer demand for price transparency in healthcare has been...
VA’s ‘Million Veterans Program’ Research Study Receives Its 100,000th Human Genome Sequence
With improved genetic sequencing comes larger human genome databases that could lead to new diagnostic and therapeutic biomarkers for clinical laboratories As the COVID-19 pandemic grabbed headlines, the human genome database at the US Department of Veterans Affairs...
Anticipated Influenza/SARS-CoV-2 “Twindemic” Has Not Developed, Says CDC, Much to the Relief of the Nation’s Medical Laboratories
The remarkably low number of influenza diagnoses makes it possible for clinical laboratories to stay focused on COVID-19 One positive note for clinical laboratories this winter is the fact that the number of biological samples being submitted for influenza (flu)...
Do New Strains of SARS-CoV-2 Coronavirus and Inconsistent Distribution of COVID-19 Vaccines Threaten a Return to Normalcy in 2021? McKinsey Weighs In
The latest McKinsey report addresses when the COVID-19 pandemic is “most likely” to end and what needs to happen to get there Clinical laboratory leaders, pathologists, and diagnostics professionals everywhere want to know when the SARS-CoV-2 coronavirus will burn...
New Test Under Development That Detects Breast Cancer within One Hour with 100% Accuracy Has Potential to Help Pathologists Deliver More Value
Such a test, if proved safe and accurate for clinical use, could be a useful diagnostic tool for anatomic pathologists What would it mean to anatomic pathology if breast cancer could be diagnosed in an hour from a fine needle aspiration (FNA) rather than a core...
Autopsies Clearly Help Pathologists Understand COVID-19 and How It Affects the Body, So Why Are More Not Being Performed?
Payers are unwilling to reimburse for autopsies despite the fact that autopsies are a proven way to learn more about new diseases and how they attack the human body Each year, less money is spent by Medicare and private health insurers on autopsies. However, autopsies...
Coveted Blue Horseshoe Crab Blood is Keeping COVID-19 Vaccinations Free of Deadly Endotoxins, But Demand for This Blood Could Have Implications for Supply of Certain Clinical Laboratory Tests
Pathologists may be interested to learn that though a substitute for horseshoe crab blood has been available for nearly 20 years, it has not been widely adopted in the US Since the 1970s, the blue blood of the horseshoe crab has saved countless human lives by...
Walmart Health Opens Two Primary Care Clinics at Retail Supercenters in Chicago with Plans to Open Seven Florida Locations in 2021
Walmart may be the largest, but it is not the only retailer offering clinical laboratory testing and primary care services at conveniently-located retail stores Earlier this month in “How Walmart Plans to Take Over Health Care,” CNBC asked, “Is Walmart the future of...
Multiple Pathology and Other Healthcare Organizations Request CDC Include Clinical Laboratory Personnel in First Round of COVID-19 Vaccinations
CAP president maintains medical laboratory staff are ‘indispensable’ in pandemic fight and should be in ‘top tier’ for vaccination As COVID-19 vaccinations continue to roll out, the College of American Pathologists (CAP) is lobbying for clinical pathologists and...
Mayo Clinic Laboratories Used Ingenuity, Flexibility, and Teamwork to Fast-Track COVID-19 Testing Capacity, Including Hiring Hundreds of Lab Workers
As coronavirus pandemic emerged, the Minnesota reference laboratory surged its testing capacity from 2,600 to 20,000 samples per day in an effort to meet ever-increasing demand Over the past several years, medical laboratory workforce shortages worldwide have...
Connecticut and Maine to Utilize ‘Episode of Care’ Payment Models for State Employees and Retirees
Also called a ‘bundled payment’ model, under this plan, hospitals and clinical laboratories will receive ‘lump sums’ for certain healthcare procedures Employers and insurers continue to move healthcare providers away from fee-for-service (FFS) payment models and...
Walmart, Quest Diagnostics, and DroneUp Collaborate on Pilot Project to Deliver COVID-19 Laboratory Tests to Consumers in Select Cities
Coronavirus pandemic expected to spur wider acceptance of drone delivery services for clinical laboratory specimens and medical supplies Routine delivery of clinical laboratory specimens and medical supplies by drone moved one step closer to reality with news that...
University of Vermont Microbiology Laboratory Identifies Inefficiencies When Performing Pooled Testing for COVID-19
The key to success with pooled testing, says the lab’s director, is having the right personnel and equipment, and an LIS that supports the added steps Experts believe pooled testing for COVID-19 could reduce the number of standard tests for SARS-CoV-2 by conserving...
Healthcare Companies and Health Systems Continue to Grow Through Mergers and Acquisitions Despite COVID-19 Pandemic
Consolidation of hospitals and health systems means consolidated medical laboratory services as well, and that impacts laboratory revenue and staff Though COVID-19 shifted many healthcare systems’ priorities in 2020—including quite dramatically altering the priorities...
Critical Shortages of Supplies and Qualified Personnel During the COVID-19 Pandemic is Taking a Toll on the Nation’s Clinical Laboratories says CAP
As demand for SARS-CoV-2 coronavirus testing increases, leaders of the College of American Pathologists meet online to brainstorm possible solutions to the crisis In September, the College of American Pathologists (CAP) began its series of “virtual media briefings”...
C₂N Diagnostics Releases PrecivityAD, the First Clinical Laboratory Blood Test for Alzheimer’s Disease
The St. Louis-based in vitro diagnostics (IVD) developer is making PrecivityAD available to physicians while awaiting FDA clearance for the non-invasive test Clinical laboratories have long awaited a test for Alzheimer’s disease and the wait may soon be over. The...
Reporter Who Broke Theranos Scandal Maintains Disgraced Clinical Laboratory Testing Company Could Have Returned Funds to Defrauded Investors Instead of Fighting Lawsuits
Former CEO Elizabeth Holmes now awaits March 9 court date on federal fraud charges that include reporting false medical laboratory test results on some patients Clinical laboratory leaders have watched with keen interest the federal criminal proceedings against...
FDA Authorizes First At-Home COVID-19 Antigen Tests, but Roadblocks Remain for “Fast-and-Frequent” Antigen Testing
Developers of medical laboratory tests had high hopes that cheap saliva-based tests would compete with at-home OTC tests that use nasal swabs, but skepticism among scientists continues Reverse-transcription polymerase chain reaction (RT-PCR) technology has become the...
Workplaces Must Screen Employees for COVID-19, Say Authorities in the US and Ontario, and This Trend Could Mean Big Business for Clinical Laboratories
As mandatory screenings for private industry workers increases, some states launch free COVID-19 testing for state employees, while engaging medical laboratories to provide such testing Amid the SARS-CoV-2 pandemic, welcoming employees back to work is not as simple as...
Google DeepMind’s AlphaFold Wins CASP14 Competition, Helps Solve Mystery of Protein Folding in a Discovery That Might be Used in New Medical Laboratory Tests
The AI protein-structure-prediction system may ‘revolutionize life sciences by enabling researchers to better understand disease,’ researchers say Genomics leaders watched with enthusiasm as artificial intelligence (AI) accelerated discoveries that led to new clinical...
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State of the Genetic Testing Marketplace–Getting Paid for All Your Lab’s Genetic Test Claims: What’s Changing, What’s Not, and What’s Working Best
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Getting Paid for COVID-19 Test Claims: What Every Clinical Lab Needs to Know to Maximize Collected Dollars
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Prepare Your Clinical Lab for Double the Regulatory, Compliance, and Managed Care Risk in 2021: The Simultaneous Need to Deal with COVID-19 and Routine Testing Activities
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COVID-19 Employee Testing and Screening Programs: Essential Guidance on Legal, Risk Management, Regulatory, and Compliance Issues
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