January 2023

Alert! Changes to CLIA Accreditation, CLIA Revisions

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

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

Clinical Laboratory Trends, Lab Intelligence, Laboratory Compliance, Laboratory Management / Scott Wallask

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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Joint Commission Will No Longer Accept COLA Accreditation

TDR Insider / Robert Michel

The Dark Report reports on the provocative move by The Joint Commission (TJC) to no longer recognize COLA’s accreditation program for laboratories within TJC-accredited facilities. The decision was effective Jan 1, 2023. COLA-accredited labs within TJC-inspected facilities have two years to switch their CLIA accreditation provider. The reasons behind The Joint Commission’s decision remain unclear.

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

Clinical Laboratory Trends, Lab Intelligence, Laboratory Compliance, Laboratory Management / Scott Wallask

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

Laboratory Information Systems, Laboratory Management / Scott Wallask

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

Clinical Laboratory, Clinical Laboratory Trends, In Vitro Diagnostics, IVD/Lab Informatics, Laboratory Management / Robert Michel

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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New CPT Codes Debut for Digital Pathology Services

Digital Pathology, Pathology Trends / Scott Wallask

CEO SUMMARY: New digital pathology CPT codes took effect Jan. 1. Because the new codes are designated as Category III, they are not subject to Medicare and private payer reimbursement yet. Instead, federal health officials will monitor the use of the new codes in 2023 to determine how often they are used in diagnosis and

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Use Histology Laboratory Data to Illustrate Specimen ‘Life Cycle’

IVD/Lab Informatics, Laboratory Management / Scott Wallask

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

Clinical Laboratory, Clinical Laboratory Trends, Lab Risk & Compliance, Laboratory Compliance / Scott Wallask

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

Late Breaking Lab News / Scott Wallask

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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