TAG:
clia requirements
CMS and CAP Comment On CLIA PT Matters
CEO SUMMARY: Federal regulators rely on interpretations from administrative law judges (ALJ) for guidance in how to apply the Clinical Laboratory Improvement Amendments (CLIA) as they pertain to proficiency testing (PT) and the issue of inadvertent PT referrals. Representatives of the Cen…
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…
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…
Current Review of CLIA Standards Intended to Address Laboratory PT
EFFORTS ARE UNDER WAY TO REVIEW existing requirements for laboratory certification under the federal Clinical Laboratory Improvement Act (CLIA). CLIA legislation was a response by Congress to widely-publicized failings in the quality and performance of certain cytology and office laboratories during …
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…
Market Hesitates to Embrace Automated Screening Products
CEO SUMMARY: Technology to enhance and improve conventional Pap smear screening was introduced into the clinical marketplace almost five years ago. But the clinical laboratory industry has yet to embrace these various technologies in any meaningful way. Like the introduction of liquid pre…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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