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 licensed under the Public Health Service Act (PHSA), such as donor screening assays and in vitro diagnostic (IVD) testing, including laboratory-developed tests (LDTs), noted a document describing the new law on the FDA website. (more…)
Jul 9, 2010 | Laboratory News, Laboratory Pathology
Medicare to do National Demonstration Project Involving Medical Homes
Medical home pilot projects are being closely watched by pathologists and clinical laboratory managers. This is a new model of patient-centered care which has important advocates among primary care practitioners. If the medical home concept catches on, it may require clinical laboratories to provide laboratory testing services in a different way.
In southeastern Pennsylvania, a medical-home pilot project is taking a “do-it-yourself” approach to managing chronic illnesses. This project is viewed by some as a precursor to a national model. The innovative program, which combines the Wagner Chronic Care Model with the patient-centered medical home concept, provides physicians with resources to improve patient–doctor communications. The pilot project is also designed to educate willing patients on how to self-manage their chronic illnesses.
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