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The practice of laboratory medicine is undergoing rapid change, both leading as well as reflecting changes in our healthcare system.  These changes are driven by new technologies, specialties, digital data coll...

We are rapidly approaching Medical Laboratory Professionals Week, (MLPW), the  annual celebration of the medical laboratory profession, and those who play such a vital role in the delivery of quality healthcare...

In Laboratory Developed Tests: Greater Role Leads to Increased Federal Oversight – PART 1, I discussed both the historical perspective of regulation of LDTs, the current landscape and the relationship between d...

In today’s healthcare environment, constant change is the new “normal.” The entire allied healthcare team, including laboratorians, must keep pace with the latest developments in technology, regulatory requirem...

Historical Perspective The 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FD&CA) gave the FDA authority to regulate medical devices, including in vitro diagnostic devices (IVDs)...

The practice of laboratory medicine is undergoing rapid change, both leading as well as reflecting changes in our healthcare system. These changes are driven by new technologies that now enable molecular and ge...

The National Academies of Medicine, formerly the Institute of Medicine, recently published a report that concludes that “diagnostic errors – inaccurate or delayed diagnoses – persist throughout all settings of ...

According to CMS, in 2012 there were 229,815 laboratories in the U.S., of which 150,256 were Certificate of Waiver sites.  Stated another way, this means that some 65% of laboratories in the U.S. do not have an...

In July, the House of Representatives passed H. R. 6, the 21st Century Cures Act, by a bipartisan margin of 344 – 77. Prior to House passage, the bill was passed out of the House Energy and Commerce Committee b...

Quality Systems Management In the past, when the clinical diagnostic world was less complicated than today, primary care physicians could easily keep up with the handful of key lab tests needed to diagnose mos...