TAG:
lab intelligence
Cuts to Rural Labs Boost RESULTS Act Support
CEO SUMMARY: Two related legislative concerns should have the sharp attention of clinical laboratory leaders, particularly those in rural areas. On one end, PAMA cuts are scheduled to hit on Jan. 31 short of another reprieve from Congress. Meanwhile, lawmakers at a recent …
Top Stories in 2025 Played Out in Courts, Capitol Hill
CEO SUMMARY: The biggest story of the year for clinical laboratories came in a huge court victory, as a federal judge vacated the FDA’s final rule on laboratory developed tests. Labs breathed a sigh of relief after the court decision, as the FDA rule had promised to incr…
Pathologists Take Images to the Cloud
CEO SUMMARY: Scaled-up operations, streamlined logistics, and potential cybersecurity benefits all present a valid argument for pathology practices to move their data to the cloud. Digital pathology in particular stands to gain from a cloud-based setup that allows remote v…
How Stanford Tackles the Lab Labor Shortage
CEO SUMMARY: Clinical labs nationwide face worsening staffing shortages across all roles. Stanford Health Care’s Jennifer Fralick outlines strategies to retain talent and improve efficiency, such as career ladders and top-of-skills staffing. By aligning tasks with skill …
CAP Regains VA Lab Accreditation Contract
CEO SUMMARY: In a blow to The Joint Commission, the US Department of Veterans Affairs has awarded a new clinical laboratory accreditation contract to the College of American Pathologists (CAP). The decision highlights the competition between the two accrediting organizatio…
New Study Underscores Prevalence of Scientific Fraud
Pathologists and other laboratory professionals rely on peer-reviewed research to keep up with the latest developments in their specialties. They do so with the expectation that medical journals are upholding high standards of scientific rigor and transparency. I…
Labs Directly Attack Upcoming PAMA Cuts
CEO SUMMARY: The clinical laboratory industry once again finds itself advocating on Capitol Hill for proposed legislation to deal with an old problem: test reimbursement rate cuts under PAMA. While Congress has delayed scheduled rate cuts for the last several years, PAMA c…
Profitable Collaboration with Pharma Companies
CEO SUMMARY: Drug discovery efforts by pharmaceutical companies often need a boost from anatomic pathology practices and clinical laboratories. Forward-thinking lab leaders and pathologists can take advantage of their data and expertise to partner with pharma, setting the …
Clinical Labs Battle Complex Claims Denials
CEO SUMMARY: While the number of denials is not going up, the reasons that private payers deny claims are becoming more complex and time-consuming to appeal. After reviewing noteworthy trends among payers, learn a three-level approach to appeals that may lead to greater su…
For AI Regulation, Look to Data Laws, FDA Action
CEO SUMMARY: AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics. Few court cases exist yet that interpret AI use within clinical settings, but labs must watch how HIPAA and state laws wield influence. Vendor soft…
CURRENT ISSUE
Volume XXXIII, No. 1 – January 19, 2026
The Dark Report looks at the FDA’s move to reclassify Oncology companion diagnostics as Class II medical devices and considers how labs can benefit. Also, observers are concerned about the effect of PAMA cuts on rural clinical laboratories.
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