October 2025

CAP Regains Veterans’ Affairs Lab Accreditation Contract

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 organizations and sheds light on how CAP’s inspection process holds value to the federal agency. The deal could […]

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More Signs of Shifting Sands in the Lab World

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

If you feel like the ground is shifting under your feet in the clinical laboratory world, I would agree with you. It’s clear that situations are changing in the diagnostics market. This issue of The Dark Report is stocked with evidence of our observation. Take, for example, the lead briefing, which digs into the College

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CAP Regains VA Lab Accreditation Contract

Laboratory Management / Janette Wider

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 organizations and sheds light on how CAP’s inspection process holds value to the federal agency. The

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Pathology Journals Not Immune to Questionable Studies

Pathology Trends / Stephen Beale

As we recently reported, scientific fraud is more prevalent than many people in the science community would like to admit. The “publish or perish” mindset in academia has led to a proliferation of questionable and even fabricated papers in peer-reviewed journals. But to what extent do these problems apply to pathology and laboratory medicine? Quite

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Accreditors Explain Changes to CLIA Supervisor Qualifications

Laboratory Compliance / Mark Terry

In December 2023, the Centers for Medicare and Medicaid Services (CMS) announced major updates to the Clinical Laboratory Improvement Amendments (CLIA) personnel regulations, which went into effect on December 28, 2024. During a panel discussion at the 2025 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management, four speakers from the major accrediting organizations

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Oracle Hopes to Sway Market with New AI-Assisted EHR

Clinical Laboratory Trends / Jillia Schlingman

W hile it remains to be seen whether it truly pushes boundaries, Oracle Health got attention when recently announcing it had released an immersive, next-generation electronic health records (EHR) platform fueled by artificial intelligence (AI). The system is conversational, contextual, and can achieve complex tasks, according to the tech giant. Clinical laboratory observers will be

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FDA Has Future Avenues to LDT Oversight

In Vitro Diagnostics / Scott Wallask

CEO SUMMARY: Even though a federal court vacated the FDA’s final rule for laboratory developed tests, experts warn that the agency may still be able to regulate some LDTs via its authority over diagnostic software. An attorney notes that software’s central role in modern lab tests could allow FDA oversight. Long-term regulatory clarity is needed

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October 27, 2025, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

In yet another shuffling of the in vitro diagnostics (IVD) space, Hologic announced on Oct. 21 that it was being acquired by private equity firms Blackstone and TPG for $18.3 billion. The deal will take Hologic off the Nasdaq, likely in early 2026. TPG and Blackstone lauded Hologic’s focus on women’s health. Hologic earned approximately

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After Regaining its Outreach Service, Lab Grows It by $10M

TDR Insider / Robert Michel

In this case study, Kootenai Health in Idaho explains how taking back lab outreach services from a commercial lab company can improve physician satisfaction, enhance patient care, and increase revenue. Although the transition was bumpy, within two years of bringing outreach in house, those services contributed $10 million to the health system’s bottom line. This

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Observing a Champion … and Some Antagonists

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

Judging from the briefings we present in this issue, a “cheers and jeers” column seems an appropriate use of my soapbox. First, the well-earned cheers. An in-depth case study traces how Kootenai Health, which had seen its clinical laboratory outreach business outsourced to a national lab, took a series of strategic steps to win back

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