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More Labs Recognize Big Changes Are Coming
By R. Lewis Dark | From the Volume XXXI, No. 3 – February 26, 2024 Issue
ONE WAY TO DISCERN THE NEAR FUTURE FOR THE CLINICAL LABO…
Online Exclusive: Robert Michel Discusses Three Notable Items from AACC Meeting
By Scott Wallask | From the Volume XXX, No. 11 – July 31, 2023 Issue
ROBERT MICHEL, EDITOR-IN-CHIEF OF THE DARK REPORT, attended July’s American Association for Clinical Chemistry (AACC) Annual Scientific Meeting in Anaheim, California. In this video from the exhibit hall, Michel noted three important changes at the confer…
The Next Theranos News Could See More Criminal Charges
By Mary Van Doren | From the Volume XXV No. 15 – October 22, 2018 Issue
CEO SUMMARY: THE DARK REPORT has learned – before any other lab news resource – that in the latest in a long line of Theranos news stories, the U.S. Attorney is making statements ab…
How Many Patients Were Harmed at Theranos?
By Joseph Burns | From the Volume XXV No. 8 – May 29, 2018 Issue
CEO SUMMARY: Reporting in The Wall Street Journal shows that some physicians in Arizona were concerned about the harm from erroneous test results from Theranos Inc. But those physicians who expressed concern may have been only a small set of the …
PAMA Data Projections Led to Decision to Sell Lab
By Joseph Burns | From the Volume XXIV No. 3 – February 21, 2017 Issue
CEO SUMMARY: Following passage of the Protecting Access to Medicare Act of 2014, officials at PeaceHealth and PeaceHealth Laboratories began to model the financial effect this law would have on this long-established hospital lab outreach program. Based on projections of a 20% cut in reven…
Labs Share Successes in Delivering More Value
By Robert Michel | From the Volume XXI No.16 – November 24, 2014 Issue
CEO SUMMARY: As the number of accountable care organizations and patient-centered medical homes grows monthly, a handful of innovative labs are seizing the opportunity to develop and deliver lab testing services that add more value to physicians and patients. These early-adopter labs reco…
Mass Spectrometry Is Finding Larger Role in Clinical Labs
By Joseph Burns | From the Volume XX No. 4 – March 25, 2013 Issue
CEO SUMMARY: Mass spectrometry is a diagnostic technology that is transforming clinical labs and improving care at a rapid pace. The current generation of instruments is capable of supporting a faster time-to-answer and provides improved accuracy and specificity over many existing methods…
More IVD Consolidation as Danaher Acquires Iris
By Joseph Burns | From the Volume XIX No. – October 8, 2012 Issue
CEO SUMMARY: Danaher Corporation continues to fuel growth by continually acquiring in vitro diagnostics (IVD) companies. Its latest purchase is Iris International, which manufactures automated urine microscopy systems. Danaher also has $5 billion available that it could spend in the next …
Time for Congress to Properly Fix CLIA PT Issue
By R. Lewis Dark | From the Volume XIX No. 11 – August 6, 2012 Issue
THIS TIME, THE PROVERBIAL CAT MAY BE OUT OF THE BAG when it comes to long-standing dissatisfaction with how federal regulators interpret and enforce CLIA (Clinical Laboratory Improvement Amendments) regulations as they relate to inadvertent errors in the referral of proficiency tests (PT). For many …
Sarasota Hospital Lab Reduces Number of Hemolyzed Specimens
By Joseph Burns | From the Volume XIX No. 7 – May 14, 2012 Issue
CEO SUMMARY: Seeking to improve turnaround time for stat lab tests, the laboratory at Sarasota Memorial Health Care System identified high rates of hemolysis as the chief reason for less than ideal TAT. Because 32% of blood draws were handled by the lab’s phlebotomy staff while 68% of b…
CURRENT ISSUE
Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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