The Food and Drug Administration’s plan to subject many laboratory-developed tests to a new layer of regulatory requirements over the course of the next decade is drawing sharply contrasting reactions from stakeholders who view it as either an essential step to improve patient safety or a hindrance that will stifle diagnostic innovation and test improvement.

Despite that fundamental disagreement on the policy’s substance, there does seem to be consensus among informed observers that the FDA is determined to take action, that legislative intervention to block the agency faces long odds, and that the agency’s final guidance will create a regulatory challenge for labs unrivaled by anything out of Washington since CLIA ’88.

My feature article in the October edition of CAP TODAY. Read the whole shebang.

Leading pathologists and the CAP are encouraging laboratory professionals to use the social media website Twitter as a way to amplify lab medicine’s voice among clinicians, policymakers, news organizations, patients, and the public. It is advice that at least one prominent social media expert and nonpathology physician says lab professionals ought to heed.

“Pathologists have a problem being recognized by society because we don’t see patients directly. This is an opportunity for us to get out there in society and to contribute value in that regard,” says Timothy Craig Allen, MD, JD, a newly elected member of the CAP’s Board of Governors and director of anatomic pathology at the University of Texas Medical Branch, Galveston.

My latest in CAP TODAY’s Put It on the Board section. Read the whole shebang.