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by IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

There may be circumstances when laboratories consider the option to modify an FDA-cleared or approved test system. These may be due to the specific needs of the population served, or based on cost/benefit analyses of instrumentation and reagent use; or based on the logistics of in-house testing capabilities.  CLIA allows clinical laboratories to modify their FDA-approved tests, and even to develop their own tests, known as laboratory-developed tests (LDTs), as long as they follow the requirements to validate the performance characteristics of their modified or in-house developed tests.

by IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

The 21st-century challenge is to redesign healthcare systems to be safe, efficient, effective, timely, equitable and patient-centered. Laboratory medicine is integral to many of these objectives, involving disease prevention, diagnosis, treatment, and management. 

by DYLAN J. CHADWICK

We all laughed at Casey, bright-eyed and eager, when we started our hike. He'd seemingly bought out an entire military surplus store in preparation, while we'd opted (through a heady combination of laziness and daring) to pack as little as possible. Most curiously was Casey's hand-pump micron water filter. Roughly the size of a cinder-block and forged from heavy metal, we snorted incredulously as he clipped the device to his pack, hiked up his shorts and started his journey, clattering like an old Buick.