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...]
CMS
CLIA: CMS Proposes 20% Fee Increase—and Further Increases Could Follow
January 28, 2019
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...]
ACCREDITATION
Top of the News: ANDE Rapid DNA Platform First to Win FBI Approval
June 25, 2018
"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...]
ACCREDITATION
Lab Quality & Safety: JCAHO to Crack Down on Handwashing Shortcuts
March 12, 2018
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...]
ACCREDITATION
Brief Your CEO: After 36 Years, CLIA Comes Under CMS Review
January 22, 2018
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...]
FOCUS ON
CLIA: After 36 Years, CMS Gives Lab Accreditation a Good Hard Look
January 16, 2018
"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...]
MEDICARE COVERAGE
“Applicable Labs”: The Fly in the PAMA Market-Based Pricing Ointment
October 23, 2017
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...]
ENFORCEMENT
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
September 26, 2017
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...]
PATIENT SAFETY
Alert Emphasizes Leadership Sets Tone for Safety and Quality
March 7, 2017
"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...]
ACCREDITATION
Lab Accreditation Updates
December 6, 2016
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...]
