Thursday, February 25, 2016

The ACP 86 Page Free Guide to CLIA (For Physicians)

A freebie on the net, American College of Physicians offers an 86 page overview of CLIA, written in 2014.   Details after the break.  Find also some links to CLIA history.

CLIA is a complex regulatory system that monitors essentially all clinical laboratories in the US.  Originally, in the 1967 version, it applied to "interstate labs" (under the interstate commerce clause, one might think) and Medicare hospital labs.  When CLIA '88 was created, it expanded the umbrella to all hospital, independent, and physician office laboratories.

The actual law and the actual implementing regulations are amazingly dry (appropriate records kept...appropriate controls run...assure validity...and so on.)   Much apparently must come into being in the implementation of the regulations, not their text.

The American College of Physicians in 2014 produced an 86-page guide to CLIA.  It's free online here.  While designed foremost for physician labs, it overviews the whole CLIA program and even includes a few pages of interesting history and background.

A few other sources on the history of CLIA.

  • From the anti-government Association of American Physicians and Surgeons (here).
  • From a CDC meeting in 2008, by Boone, a PowerPoint view "down memory lane," here.
  • A nine page article by Peddecord & Hammon in Clinical Chemistry from
  • A 1999 article in Medical Laboratory Observer by Darlene Berger, here.
  • PowerPoint from Boone: