After Nearly 3 Decades, CMS Proposes Updates to Proficiency Testing Rules

When the CLIA (the Clinical Laboratory Improvement Amendments of 1988) proficiency testing (PT) regulations were first implemented in 1992, George H.W. Bush was President, gas cost about $1.05 per … [Read more...]


CLIA: CMS Proposes 20% Fee Increase—and Further Increases Could Follow

As if Year 2 of PAMA lab fees wasn't enough, CMS dished out another dose of agita to the lab industry: CLIA fees will be going up 20%, effective this year. Background For those of you who are new to … [Read more...]


Top of the News: ANDE Rapid DNA Platform First to Win FBI Approval

"Great news! The FBI just called." --Extremely rare phrase almost never uttered except sarcastically One of the very few exceptions to the above principle is ANDE (previously known as NetBio), a … [Read more...]


Lab Quality & Safety: JCAHO to Crack Down on Handwashing Shortcuts

You can preach hygiene until the cows come home but it may not be enough to get busy and distracted lab employees to wash their hands properly. In addition to undermining test integrity, effective … [Read more...]


Brief Your CEO: After 36 Years, CLIA Comes Under CMS Review

Brace yourself—and your C-suite—for more sweeping legal changes. Even as your lab makes the transition to the new, supposedly market-based PAMA Medicare Part B fee schedule for tests, big changes may … [Read more...]


CLIA: After 36 Years, CMS Gives Lab Accreditation a Good Hard Look

"May you live in interesting times." If you've been in the clinical labs business for a while, you probably appreciate the wisdom behind this ancient Chinese curse. 2018 is shaping up to be a very … [Read more...]


“Applicable Labs”: The Fly in the PAMA Market-Based Pricing Ointment

The lab industry has no objection to basing Medicare payments for lab tests on the actual rates charged to payors in the private market. What has the industry so upset is how CMS has executed the … [Read more...]


Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

Lab Charged in Kickback Scheme Fights to Keep Its CLIA License Case: Next Health is in a legal fight for its life. Earlier this year, the feds indicted two officials of the Dallas lab company for … [Read more...]


Alert Emphasizes Leadership Sets Tone for Safety and Quality

"Tone at the top" is a frequent refrain in compliance. It's also the message of a Sentinel Event Alert (Alert) issued March 1 by The Joint Commission. According to the Joint Commission's Sentinel … [Read more...]


Lab Accreditation Updates

Two of the main accreditation organizations for laboratories, the Joint Commission and the College of American Pathologists, have issued some updates that labs need to be aware of for 2017: The … [Read more...]