Apr 20, 2016 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing
Latest news follows reports that Theranos was facing sanctions that include revoking its CLIA license and a two-year ban on its executives Holmes and Balwani and its former medical director, Dhawan
Federal prosecutors began a criminal investigation into whether Theranos misled investors about its medical laboratory technology and operations, The Wall Street Journal (WSJ) reported on Monday evening.
Investigators recently sent subpoenas to Walgreens Boots Alliance Inc. (NASDAQ: WBA) and the New York State Department of Health (NYSDOH) seeking documents and testimony about statements Theranos made, according to WSJ reporters Christopher Weaver, John Carreyrou, and Senior Editor Michael Siconolfi. As sources, the WSJ cited unnamed people familiar with the matter. (more…)
Apr 18, 2016 | Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Human genome pioneer J. Craig Venter’s newest project seeks to ‘change the way medicine is practiced’ by creating genomic-based medicine model
With little fanfare or public notice, a start-up company in San Diego is busy sequencing the largest number of whole human genome sequences in the world. The knowledge expected to result from this effort promises to revolutionize healthcare, as well as clinical laboratory testing.
Human Longevity Inc. (HLI) is a genomics and cell therapy company that has assembled the largest human genome sequencing operation in the world. It’s goal is to use whole genome sequencing and cell-based therapeutics to redefine aging and “meaningfully extend the human lifespan.”
“HLI’s mission is to identify the therapeutically targetable mechanisms responsible for age-related human biological decline, and to apply this intelligence to develop innovative solutions to interrupt or block these processes, meaningfully extending the human lifespan,” HLI states on its website. “We are trying to tackle some of the most vexing diseases like cancer, heart disease, and diabetes … we are working to change the way medicine is practiced through our genomic-focused, preventive model.” (more…)
Apr 16, 2016 | Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
As independent and hospital-based medical laboratories navigate against the headwinds of shrinking reimbursement levels, it is critical for labs to not only strengthen their relationships with current clientele, but also to grow their client base
A monumental shift is underway within the medical laboratory industry. Given today’s healthcare landscape, accurate testing is no longer enough for labs to remain competitive—fierce competition, falling reimbursement rates, and new quality-based care mandates make excellence in client service and long-term, profitable relationships essential to a laboratory’s survival.
DarkDaily.com is pleased to offer a recently published free White Paper that shares essential information every lab needs in order to achieve the highest level of performance, generate and maintain strong, reliable client relations, and deliver superior, consistent service that bolsters relationships across the continuum of care. (more…)
Apr 14, 2016 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Hiring & Human Resources, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Managed Care Contracts & Payer Reimbursement
Wall Street Journal obtained copy of letter sent by CMS to Theranos, dated March 18, 2016, that notified its executives of sanctions that include revocation of Theranos’ CLIA license and a process by which the medical lab company can appeal
Theranos, the high-profile clinical laboratory company, had a day of reckoning yesterday. That’s when The Wall Street Journal (WSJ) published a story revealing that Theranos was sent a letter by the federal Centers for Medicare & Medicaid Services (CMS) providing notice of sanctions.
In a letter to Theranos executives, CMS said it is prepared to:
• revoke the company’s CLIA certificate;
• impose a fine of $10,000 per day;
• suspend and cancel the lab’s approval to receive Medicare payments; and
• impose a two-year ban on the owner, operator, and laboratory director for owning or operating a clinical laboratory.
Dated March 18, the letter is addressed to Sunil Dhawan, MD, Director; Elizabeth Holmes, Owner; and Ramesh Balwani, Owner. (more…)
Apr 11, 2016 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
A 1999 case involving California phlebotomist charged with reusing needles resulted in similar widespread testing of thousands of patients
Because of possible exposure to HIV, hepatitis B, and hepatitis C from a healthcare worker, thousands of patients treated in multiple hospitals in different states are being offered free clinical laboratory testing. This situation is attracting national media attention and is a reminder to pathologists and medical laboratory professionals of the increased transparency that is being given to different types of medical errors that expose patients to risk.
A surgical technologist who allegedly stole the drug fentanyl from multiple hospitals provides an example of how the healthcare system can miss systematic misconduct by individual employees that can put thousands of patients at risk. (more…)
Apr 8, 2016 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing, Laboratory Testing, Management & Operations
New technology from researchers at the University of Texas Southwestern Medical Center enables the ability to study cancer cells in their native microenvironments
Imaging research is one step closer to giving clinicians a way to do high-resolution scans of malignant cells in order to diagnose cancer and help identify useful therapies. If this technology were to prove successful in clinical studies, it might change how anatomic pathologists and radiologists diagnose and treat cancer.
Researchers at the University of Texas Southwestern Medical Center developed a way to create near-isotropic, high-resolution scans of cells within their microenvironments. The process involves utilizing a combination of two-photon Bessel beams and specialized filtering. (more…)
