The Dark Report

Alert! Changes to CLIA Accreditation, CLIA Revisions

MEDICAL LABORATORIES HAVE LIVED WITH THE REGULATIONS FOR THE CLINICAL LABORATORY IMPROVEMENTS AMENDMENTS (CLIA) since they were first implemented in 1992. Over the past 30 years there has been no major revision or updating of CLIA regulations. Nor has there been much change in the long-standing status quo associated with how labs choose which deeming …

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Joint Commission Will Not Accept COLA Accreditation

CEO SUMMARY: This may be a first in the 40-year history of CLIA accreditation of clinical laboratories. The Joint Commission (TJC) announced it will no longer recognize COLA’s laboratory accreditation program within “TJC-accredited facilities,” effective Jan 1, 2023. COLA-accredited labs within TJC-inspected facilities have two years to switch their CLIA accreditation provider. The reasons behind …

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What’s Behind Joint Commission Move to Not Accept COLA Labs?

DURING THE NEXT TWO YEARS, a substantial number of hospitals and healthcare facilities will need to respond to The Joint Commission’s (TJC) decision to no longer recognize CLIA accreditations issued by COLA in “TJC-accredited facilities.” In the 30-year history of the current Clinical Laboratory Improvement Amendments (CLIA) regulation, it is believed that there is no …

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Labcorp Selects Oracle Cerner to Streamline Lab Workflows

THERE IS A UNIQUE CORPORATE COLLABORATION unfolding that involves Labcorp and Oracle Cerner. Announced in November, Labcorp will use Oracle Cerner’s lab information systems to update clinical laboratory workflow processes and support the sharing of patient data across healthcare organizations.  The Labcorp/Oracle Cerner arrangement also intends to demonstrate that the collected health data from hospital …

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National Lab Says It Will Help with Supply Chain Services

RECOGNIZING THAT SUPPLY CHAIN ISSUES are troublesome to some of its clinical laboratory customers, one national lab company has announced it would like to help solve those issues.  In September, Quest Diagnostics issued a press release describing a novel relationship in which it will act as a supply chain partner for one of its clinical …

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Use Histology Laboratory Data to Illustrate Specimen ‘Life Cycle’

BECAUSE OF THE CHALLENGING LABOR MARKET, pathology labs need ways to boost staff productivity. To help identify workflow bottlenecks, one approach is to examine lab data and encourage bench teams to think holistically about specimen movement in the lab. Clinical laboratory managers and pathologists should not simply trust their eyes to catch these logjams, said …

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CLIA on Path to Recognize Lab Data As a Specimen

CEO SUMMARY: Discussions within the federal Clinical Laboratory Improvement Advisory Committee (CLIAC) are focusing on digital diagnostic data and clinical laboratory testing conducted remotely. CLIAC recommendations about these important topics may eventually be part of updates to CLIA, whose language has remained largely untouched since its inception in 1988. SWEEPING RECOMMENDATIONS ARE BEFORE FEDERAL CLINICAL …

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January 23, 2023, Intelligence: Late-Breaking Lab News

New data from the Association of American Medical Colleges (AAMC) offers further evidence of a decreasing talent pool of pathologists in the United States. Active physicians in anatomic and clinical pathology dropped from 13,201 in 2016 to 12,180 in 2021—a 7.7% decrease, according to the AAMC’s Physician Specialty Data Report. Only pulmonary disease doctors had …

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PAMA Cuts Have Simply Been Kicked Down the Road

PAYMENT RATE CUTS FOR CLINICAL LABORATORY TESTS, called for under the Protecting Access to Medicare Act of 2014 (PAMA), have been avoided temporarily—again.  A down-to-the-wire bill in Congress to keep the federal government funded into the new year included a provision to delay PAMA cuts to the Clinical Laboratory Fee Schedule (CLFS) for 2023. This …

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