TAG:
clia inspection
Proficiency Testing Ranks High as a CLIA Violation
CEO SUMMARY: Proficiency testing (PT) deficiencies are consistently cited by clinical laboratory accreditors during CLIA inspections. Surveyors and inspectors note that labs may mistakenly believe that an 80% score on a PT event is satisfactory. To the contrary, experts advise labs to scr…
February 21, 2017 Intelligence: Late Breaking Lab News
Theranos, Inc., was in the news again recently. On Feb. 16, The Wall Street Journal reported that Theranos had just $200 million in cash. The information came from a conference call the discredited lab testing company conducted with its investors. During the call, Theranos officials …
Much Disruption for Labs In 2016’s Top 10 Stories
CEO SUMMARY: Within THE DARK REPORT’S list of the Top 10 Lab Industry Stories for 2016 is one story of disruption that might have been one story of disruption about to happen. The disintegration of Theranos during 2016 is the big story about a self-proclaimed disruptor of the lab indust…
Theranos Now Scrambling To Save What It Can
CEO SUMMARY: On July 7, CMS imposed severe sanctions on Theranos for CLIA violations. Included is a two-year ban on owning and operating a clinical laboratory for Theranos, CEO Elizabeth Holmes, the former COO, and the former medical director. Theranos appears to be pivoting away from a c…
CMS CLIA Sanction Letter Sent To Theranos Raises Questions
CITING PRACTICES THAT JEOPARDIZE PATIENT SAFETY, the federal Centers for Medicare & Medicaid Services decided earlier this month to revoke the CLIA certificate that it granted to Theranos Inc. to operate a clinical laboratory in Newark, Calif., and to ban the lab…
Theranos in the News, for Better and Worse
IT’S BEEN AN EVENTFUL COUPLE OF MONTHS for Theranos, the lab testing company that says its goal is to disrupt the clinical laboratory industry. Novelists cannot write fiction as compelling as the unfolding real story about this controversial company. During March and April, The Wall Street Jou…
Pathologists Benefit from Hospital Lab Consulting
CEO SUMMARY: Deteriorating finances at many rural hospitals and smaller community hospitals is a growing trend. It is also a new consulting opportunity for local pathologists because financially-strapped hospitals often give their labs inadequate working capital and lack the staff needed …
November 7, 2011 “Intelligence: Late Breaking Lab News”
Many experts were impressed when General Electric Co. ponied up $587 million to acquire pathology testing company Clarient, Inc., in October 2010. Now comes further insight behind this transaction. At an investment conference in Boston on November 3, John Dineen, CEO…
How In-Clinic Path Lab Benefits GI Practice
CEO SUMMARY: In Manassas, Virginia, a five-physician gastroenterology group is using its in-clinic anatomic pathology laboratory to advance patient care, while boosting revenue associated with this ancillary service. In this exclusive interview, the group’s physician business l…
Seven Deadly Sins of Lab Management Are Much Too Common
CEO SUMMARY: Pity the poor laboratory manager of today. Lab budgets are shrinking. It is difficult to staff adequate numbers of skilled medical technologists. Baby boomers are now retiring. At the same time, accreditation and licensure inspections are becoming tougher. Recently, …
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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