TAG:
clia license
Congress May Respond to Tough CLIA PT Penalties
CEO SUMMARY: For years, severe penalties in cases where a laboratory has inadvertently erred in handling proficiency testing (PT) specimens have been a point of contention between the Centers for Medicare & Medicaid Services (CMS) and the clinical laboratory profession. Two bills prop…
June 25, 2012 “Intelligence: Late Breaking Lab News”
Earlier this month, the clinical laboratory at Ohio State University Wexner Medical Center (OSUWMC) was sent a letter by federal CLIA (Clinical Laboratory Improvement Act) officials declaring that the laboratory was in violation of proficiency testing (PT) regulation…
CLIA’s Catch-22 Involving Proficiency Testing
THERE’S A REGULATORY TRAP awaiting the unwary laboratory organization. It involves language in CLIA rules for proficiency testing (PT). All medical directors and lab administrators will want to fully understand the implications of what appears to be an emerging trend in CLIA laboratory enforcement….
Inadvertent PT “Errors” Trigger CLIA Sanctions
CEO SUMMARY: Despite taking appropriate steps to complete proficiency testing (PT), in recent years an unknown number of labs were determined to be in violation of CLIA requirements. Federal regulators are enforcing penalties ranging from suspension of the labs’ licenses to transition t…
Baylor Pathologists Form Lab with US Oncology
CEO SUMMARY: In Dallas, Pathologists Bio-Medical Laboratories is part of a new laboratory partnership that includes Baylor Health Care System, Texas Oncology, and US Oncology. The four partners ponied up a total of $40 million in cash and debt to build a state-of-the art laboratory in a 1…
First U.S. Labs Nearing ISO:15189 Accreditation
CEO SUMMARY: Laboratories, hospitals, and other health-care providers in the United States will increasingly be required to adopt quality management systems (QMS) as part of their regular operational routine. This is consistent with trends in other developed countries. Several U.S. labora…
Labs Should Prepare for Tighter CLIA Enforcement
CEO SUMMARY: Lab directors and pathologists should take notice of disturbing new developments in enforcement of CLIA regulations. During the past year, CMS officials have revoked the CLIA certification of several hospital laboratories for what are, essentially, inadvertent violations of p…
Hospital Lab Takes CMS To Court in CLIA Case
CEO SUMMARY: A California hospital challenged CMS in federal court over the threatened loss of its lab’s CLIA certificate. CMS threatened to revoke the certificate in 2007 and stop paying the hospital’s Medicare and Medi-Cal lab bills. In January, Victor Valley Community Hospital won …
California Medicaid Prepares To Issue Lab Contracts
CEO SUMMARY: California Medi-Cal officials may be creating more problems than they solve with their latest scheme to have independent laboratories sign contracts with their Medicaid program—while excluding hospital laboratory outreach programs and labs operated from physicians’ clinic…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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