LabReflex
For People Running Labs
What's really happening in the lab and how to make it better
Practical insights on inspections, operations, and performance.
Latest Episodes
Pulse: Who’s Counting the Labs?
May 25, 2026
This episode looks at new pressure points in lab medicine: payment reporting, LDT oversight, liquid biopsy expansion, supplier stability, and compliance risk. PAMA reporting: CMS is collecting private-payer data for the Clinical Laboratory Fee Schedule, but Laboratory Economics reports CMS may not know exactly which labs qualify as “applicable laboratories.” That raises questions about data quality, enforcement, and future Medicare lab rates. Enhancing CLIA Act of 2026: A new bill from Rep. Neal Dunn would keep LDT oversight centered in CLIA/CMS rather than FDA device regulation. It proposes a public LDT database, more transparency around validation and performance, third-party validity confirmation, centralized error reporting, and stronger CMS authority when LDT validity is questioned. Guardant360 Liquid CDx: Guardant received FDA approval for an expanded liquid biopsy panel. The story highlights the growing role of blood-based genomic profiling in oncology, along with challenges around interpretation, limitations, and reimbursement. Bio-Rad and Elliott: Elliott reportedly built a stake in Bio-Rad. For labs, this is a reminder that vendor strategy and financial pressure can affect reagents, QC materials, instruments, service, and validated workflows. Key Takeaway Labs are being asked to support payment policy, regulatory oversight, precision medicine, supply chains, and compliance systems. The big question: are the people designing these systems accounting for how labs actually work?
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Pulse: Who Controls the Diagnostic Front Door?
May 19, 2026
This week on LabReflex Pulse, Dr. Chris Zahner and Dr. Aakash Bhatia dive into a series of stories that all point toward a bigger shift happening inside laboratory medicine: diagnostics are becoming infrastructure. From Nebraska rapidly validating an Andes virus PCR assay during a hantavirus scare… to Epic and Labcorp deepening diagnostic workflow integration… to AI pathology consolidation and real-time infectious disease surveillance dashboards — the organizations controlling diagnostic workflows may increasingly shape the future of healthcare itself. This week’s topics: Nebraska’s rapid Andes virus PCR response Following a hantavirus outbreak aboard the MV Hondius cruise ship, the Nebraska Public Health Laboratory rapidly validated an Andes virus PCR assay before exposed passengers arrived in the United States. The story raises major questions about rare-pathogen preparedness and rapid assay deployment in the post-COVID era. WIRED coverage: https://www.wired.com/story/race-to-develop-andes-hantavirus-test/ CDC Health Alert: https://www.cdc.gov/han/php/notices/han00528.html WHO outbreak notice: https://www.who.int/emergencies/disease-outbreak-news/item/2026-DON600 Epic + Labcorp integration: interoperability or market positioning? Labcorp announced expanded integration with Epic Aura, giving Epic users broader access to Labcorp’s testing menu and specialty diagnostics workflows. Chris and Aakash discuss whether EHR workflow design may increasingly influence diagnostic utilization — and whether hospital outreach laboratories should be paying closer attention. Labcorp announcement: https://ir.labcorp.com/news-releases/news-release-details/labcorp-and-epic-expand-collaboration-advance-diagnostic ARUP launches infectious disease positivity dashboard ARUP introduced a national infectious disease positivity trends dashboard using deidentified laboratory data to help identify emerging patterns and seasonal shifts. The episode explores whether large reference laboratories are quietly becoming real-time public health surveillance networks. ARUP announcement: https://www.aruplab.com/news/05-13-2026/arup-launches-national-infectious-disease-test-positivity-trends Roche acquires PathAI Roche announced plans to acquire digital pathology company PathAI in a major move signaling that AI pathology is transitioning from experimental technology to enterprise infrastructure. Roche announcement: https://www.roche.com/media/releases/med-cor-2026-05-07 Reuters coverage: https://www.reuters.com/legal/litigation/switzerlands-roche-agrees-acquire-us-based-pathai-2026-05-07/ Quick Hit: Cepheid Xpert GI Panel Cepheid received IVDR CE marking for its multiplex GI PCR panel, capable of detecting 11 gastrointestinal pathogens in approximately 75 minutes. The conversation touches on the continued expansion of rapid syndromic molecular testing and what it may mean for the future of microbiology workflows. FDA summary: https://www.accessdata.fda.gov/cdrh_docs/reviews/K251721.pdf Cepheid announcement: https://www.morningstar.com/news/pr-newswire/20260513la58308/cepheid-receives-ce-marking-under-ivdr-for-xpert-gi-panel Subscribe to LabReflex! For more conversations at the intersection of laboratory medicine, diagnostics, pathology, and healthcare strategy, subscribe wherever you get your podcasts.
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Deep Dive: Your Quality Plan Is Not Your Quality System
May 13, 2026
Your Quality Plan Is Not Your Quality System In this LabReflex deep dive, we break down a simple but important inspection-readiness idea: A quality plan is what the lab says it does. A quality system is what actually happens when something goes wrong. Many labs prepare for inspection by trying to show that failures never happen. But real quality is not about pretending the lab is perfect. It is about having a consistent, repeatable system for detecting problems, documenting them, reviewing them, correcting them, verifying the fix, and improving over time. Key framework Detect → Document → Review → Correct → Verify → Improve A strong quality system makes follow-up obvious. It helps the lab answer: How did we know there was a problem? Where was it documented? Who reviewed it? What changed? Did the fix work? What improved because of it? Main example We use critical value notification delays as an example. A weak response is: “Staff were reminded.” A stronger response asks: Why were the calls delayed? Was there a shift-specific pattern? Were contact numbers correct? Was the escalation process clear? Did the lab audit afterward to prove improvement? Big takeaway The strongest labs are not the ones that claim they never have problems. They are the ones that can show their quality system in action. The goal is not perfection. The goal is control, learning, and consistent improvement.
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Short updates on operations, inspections, and lab leadership.
About LabReflex
Diagnostics drive nearly every decision in medicine, but most people only see the numbers. LabReflex gives those numbers context -- what matters, what doesn't, and what to do about it.
Direct, practical, and grounded in actual work. Hosted by Dr. Christopher Zahner, a clinical pathologist and former NASA engineer, alongside Dr. Aakash Bhatia, a hematopathologist focused on diagnostic precision and the future of pathology.
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