Sep 10, 2014 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Donor screening assays and in vitro diagnostic tests, including laboratory-developed tests, are now classified as IVDs and require a UDI label Later this month, a new Food and Drug Administration (FDA) rule will take effect that requires unique device identifiers (UDIs) on most medical devices. This will include analyzers, instruments, and automated systems used by clinical laboratories and anatomic pathology labs. UDIs also will apply to certain combinations of products that contain devices...
Feb 19, 2014 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Analysis of almost 3 million newborn blood samples found that tens of thousands of specimens were not screened promptly for rare but deadly disorders, leading to patient harm in some cases State-mandated newborn testing has come under increased media scrutiny following the discovery that delays in reporting the clinical laboratory test results had resulted in harm to some children with genetic diseases. One source of problems is some hospitals fail to promptly submit specimens from babies to...
Mar 13, 2013 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Pathology
Lots of controversy is associated with this new tax levy that was mandated by the Affordable Care Act Will it be medical device manufacturers or their customers—including medical laboratories—who pay the new 2.3% medical device tax that became effective on January 1, 2013? That question is being asked by healthcare policymakers and experts, as well as pathologists and clinical laboratory administrators. This new tax is mandated by the Affordable Care Act on medical device sales to healthcare...
Feb 20, 2013 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory News, Laboratory Operations, Laboratory Pathology
Medical laboratory continues to operate, retains its CLIA certificate, and maintains that the PT violations at heart of CMS case were inadvertent One nationally prominent clinical laboratory organization closed its chapter in the ongoing story of CLIA enforcement of the regulations governing the inadvertent referral of proficiency testing specimens. But this chapter ended with an unexpected twist for the Ohio State University Wexner Medical Center (OSUWMC), which was given severe sanctions by...
Dec 10, 2012 | Coding, Billing, and Collections, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Pathologists will welcome this law, which provides more latitude for federal regulators should a medical laboratory inadvertently refer a proficiency testing specimen Last Tuesday, the clinical laboratory testing industry gained an important measure of regulatory relief after President Obama signed into law the Taking Essential Steps for Testing (TEST) Act of 2012. This law removes severe penalties for medical laboratories that inadvertently violate proficiency testing (PT) requirements. More...
