TAG:
clia
Eight Macro Trends for Clinical Labs in 2023
CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…
Holmes, Balwani Get Lengthy Prison Terms for Theranos Fraud
SENTENCING OF ELIZABETH HOLMES AND RAMESH “SUNNY” BALWANI in federal court caps the strange, yet captivating, saga of Theranos and its flawed blood testing technology. For laboratory professionals, the four years of legal wranglings that surrounded the Theranos fraud case may be remembered …
VALID and SALSA Acts Still Pending in Congress
CEO SUMMARY: Both the pending VALID Act and SALSA Act continue to push ahead as 2022 comes to an end. Meanwhile, a new bill centered on the Physician Fee Schedule may protect pathologist payments. These three different proposals share something in common:…
November 21, 2022, Intelligence: Late-Breaking Lab News
In yet another employment ripple from the pandemic, a group of more than 75 pathologists penned a letter to Congress urging lawmakers to retain the option for remote diagnostic work. In the letter, which appeared in the Oct. 20 issue of Nature, the pathologists wrote, “During the COVID-19 pa…
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…
Clinical Laboratories Face 20% Increase in CLIA Fees
CHANGES HAVE BEEN PROPOSED to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that would raise fees by 20% for clinical laboratories and amend certain testing personnel qualifications. The American Hospital Association (AHA) has obj…
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’…
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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