Aug 13, 2014 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
It took UCSF physicians just 48 hours to identify the bacteria in cerebrospinal fluid that was causing fourteen-year-old Joshua Osborn’s hydrocephalus and status epilepticus
There’s rich irony in the FDA’s recent announcement that it would move forward with plans to regulate “laboratory-developed tests ” (LDTs) just weeks after the national media published stories about how innovative use of an LDT helped physicians make an accurate diagnosis that saved the life of seriously-ill 14-year old boy.
Pathologists and clinical laboratory managers may be aware of the case of Joshua Osborn. It was a laboratory-developed test that used next-generation gene sequencing in a unique approach that gave his care team the diagnostic information they needed to select the right therapies for his condition.
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Dec 15, 2011 | Coding, Billing, and Collections, Laboratory Management and Operations, Laboratory Operations, Laboratory Pathology
Big changes in how these lab test claims are handled are just 11 weeks away, and most clinical laboratories are not up to speed on this issue
Note: Dark Daily offers this opinion and commentary by Editor Robert L. Michel
Big changes are coming in how payers handle code stacked claims for genetic tests and molecular diagnostic assays! However, few pathologists and clinical laboratory administrators understand why the collective efforts of payers to control utilization and reimbursement of these types of lab tests have the potential to undermine the financial stability of their medical laboratories and anatomic pathology groups.
The year 2012 is about to arrive and, when it does, it will bring the clinical laboratory testing industry to an important crossroads. Payers—both government and private—are ready to take decisive action to rein in an area of genetic and molecular testing that they consider to be on verge of spiraling out of their control.
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Nov 3, 2011 | Laboratory Management and Operations, Laboratory News, Laboratory Pathology, News From Dark Daily
Federal and state laboratory regulators tighten down during inspections of nation’s medical laboratories
Across the United States, medical laboratory accreditation and CLIA compliance is quietly getting tougher. This is a trend which affects every clinical laboratory and anatomic pathology medical group that must comply with CLIA and meet the accreditation requirements of the Medicare program.
One sign that laboratory accreditation and compliance is getting tougher is the increased number of hospital laboratories willing to publicly acknowledge that a recent assessment, survey, or inspection resulted in serious deficiencies.
Federal and state clinical laboratory regulators are backing up tough talk about tighter enforcement of the requirements of the Clinical Laboratory Improvement Act (CLIA) requirements. Over the past 18 months, Dark Daily is aware that two nationally-prominent medical laboratory companies—following CLIA inspections of certain lab facilities—were required to cease certain types of clinical testing until serious deficiencies were corrected. These consequences demonstrate that it is not just hospital laboratories feeling the brunt of more rigorous CLIA inspections.
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