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Clinical Laboratory Improvement Amendments of 1988
Newsmaker Interview: Director of CDC’s Division of Laboratory Systems Talks COVID-19, CLIA, and More
CEO SUMMARY: In this exclusive interview, Reynolds Salerno, PhD, the Director of the Division of Laboratory Systems at the CDC, offers insightful comments about the federal agency’s response to the SARS-CoV-2 pandemic, what went right during public health efforts, and lesson…
Ex-Theranos CEO Elizabeth Holmes Awaits Ruling on New Trial Request
Keeping with the unexpected and odd circumstances surrounding Theranos, a federal judge heard arguments on Oct. 17 about whether convicted company founder Elizabeth Holmes’ should get a new trial. That hearing stemmed from the government’s star witness in Holmes’ 2021 tr…
Consumer Trends, Quality Management, and Labs
TODAY’S HEALTHCARE SYSTEM IS MARKED by uncertainty and unprecedented pressures. Every clinical laboratory and pathology group faces the triple whammy of shrinking budgets, staff shortages, and a rate of inflation that drives up the cost of supplies and salaries. …
Texas Lab Details Dual Accreditation Journey
CEO SUMMARY: In seeking dual accreditation for CLIA and ISO 15189, Advanced Diagnostic Laboratory of San Antonio adapted existing processes to meet accreditor expectations. The result was stronger staff empowerment to suggest improvements in quality, combined with increased recognit…
Hospital Lab Outreach Taps On-Demand Testing
CEO SUMMARY: In this case study, clinical laboratory managers from Bryan Health in Nebraska explain how they expanded their lab outreach program to include direct-to-consumer tests. The project involved researching what tests were most appropriate without the need for a physician’…
COLA Re-enters CLIA Accreditation for Pathology
CEO SUMMARY: COLA again h…
New Trends Reshaping Healthcare, Lab Testing
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February 22, 2022 Intelligence: Late-Breaking Lab News
Scopio Labs, a medical imaging company in Tel Aviv, recently landed $50 million in Series C venture capital funding as it moves to more fully enter the clinical laboratory market, TechCrunch reported on Feb. 9. Scopio has developed a scanner that can magnify a whole blood sample by 100 …
In Theranos’ Trial, CLIA Laboratory Director Has a Starring Role
CEO SUMMARY: Most clinical lab directors understand the risks that come with running a CLIA-licensed lab. Such risks are at the forefront of the criminal trial of Elizabeth Holmes, founder of now-defunct Theranos. During the trial, federal prosecutors and defense attorneys question…
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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