NIH's drug lab is shut down after FDA finds quality failures Bloomberg
A U.S.-run laboratory that makes drugs for the National Institutes of Health's clinical trials failed a government quality inspection and will be temporarily shut down. The U.S. Food and Drug Administration, the government regulator that spends much of its time making sure drug companies follow exacting quality standards, inspected the NIH's Pharmaceutical Development Section. The lab makes drugs that are used in government-sponsored clinical trials at the NIH hospital in Bethesda, Maryland. Operations at the lab have been suspended.
Has the time come for integration of radiology and pathology? Dark Daily
For years, certain pathologists and radiologists have floated the idea that an integrated diagnostic service involving both medical specialties could improve patient safety and contribute to improved patient outcomes. Now that the U.S. healthcare system is encouraging tighter integration of clinical services, advocates of an integrated diagnostic service involving radiology and pathology believe that the era of integrated diagnostics may be soon upon us.
Florida State Legislative Session Recap FSP
As of April 28, 2015, the Florida Legislature adjourned sine die in a historic way. Due to a bitter impasse between House Republicans and the Senate over Medicaid expansion, the House packed up their bags and went home three days early before the official May 1 adjournment. This was an unprecedented and historic end to a contentious session. As a result of the surprise shut-down, every piece of legislation relating to healthcare, with the exception of a clinical laboratory bill that we amended and supported (see SB 738), failed passage. We worked hard on so many issues for over six months including prohibition against balance billing, a potential fix to the Beacon/United issue, telemedicine, prohibiting reimbursement tied to a Medicare standard, and many others.
6 hours of sleep: Is it enough for some patients? Medscape
Obtaining sufficient sleep is a crucial component of proper health maintenance. Some authors have gone so far as to recommend that sleep be considered an additional "vital sign" to be assessed at each healthcare provider visit. There are multiple facets to a comprehensive sleep evaluation for an individual patient; however, one of the most important measures is average sleep duration each night. Although all might agree on the importance of total sleep time, it isn't clear what the nightly target should be. In other words, how much sleep is enough for your patient? Before providing an answer to this surprisingly complex question, it's worth taking the time to review the science of health outcomes as they relate to sleep.
2 American diagnostics labs get hit with a $48.5 million fine for providing unnecessary medical tests The Standard Daily
Two U.S. companies have been slammed with a joint $48.5 million fine for conducting unnecessary medical tests in affinity with doctors that refer patients to them for a commission. The companies are Health Diagnostics Laboratory (HDL) and Singulex, two cardiovascular disease testing labs. HDL is fined the sum of $47 and Singulex is to pay back $1.5 million; but then, neither of the companies admitted any guilt or liability in the lawsuit brought against them.
CAP response: JAMA breast biopsy study College of American Pathologists
On March 17, the Journal of the American Medical Association published a study, "Diagnostic Concordance Among Pathologists Interpreting Breast Biopsy Specimens," which examined pathologists' interpretations of breast biopsies. As the world's largest organization of board-certified pathologists, the CAP believes this article may lead to unnecessary worry for patients.
The FSP at work this legislative session FSP
Here are a list of bills currently being presented during the Florida state legislative session with potential impact on our profession. We will continue to monitor their progress and report developments in the coming weeks. Please note that the links will continuously update. Stay tuned!
Florida rheumatologist says UnitedHealthcare's management program for clinical lab tests could jeopardize patient care Dark Daily
In Florida, the confrontation between one of the nation's largest health insurance corporations and physicians, clinical laboratory managers, and pathologists continues. The source of this confrontation are the restrictive and burdensome requirements for medical laboratory test ordering imposed last fall by UnitedHealthcare and administered by BeaconLBS, a business division of Laboratory Corporation of America. For Florida rheumatologist Olga Kromo, M.D., UnitedHealthcare's new decision-support system that physicians are required to use when ordering clinical laboratory tests is highly flawed.
Growing wave of hospital, health system mega-mergers means changing dynamics for pathology, clinical lab medicine Dark Daily
Large and financially-stable multi-hospital health systems are racing to form regional mega-systems. It's a strategy to get ahead of the Affordable Care Act's mandate to improve quality and increase efficiency through coordinated care across the entire care continuum. This growing national trend means further consolidation of clinical laboratory testing services within the merging organizations.
CDC installing cameras in labs in agency-wide safety push Reuters
The U.S. Centers for Disease Control and Prevention has introduced camera monitoring of workers in its highest-level biosafety laboratories as it seeks to restore public faith in its procedures after a series of mishaps, agency officials tell Reuters.