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Whole Genome Sequencing Is Poised for Clinical Use
CEO SUMMARY: Pathologists and clinical lab managers interested in following the advances in use of whole human genome sequencing for clinical purposes should follow the money. Within weeks of obtaining FDA clearance for its MiSeqDx system and reagents, Illumina had inked major agreements …
CMS Gives Deemed Status to A2LA under CLIA Law
CEO SUMMARY: Quietly published in the March 25 issue of the Federal Register was a notice that CMS had granted deeming authority for CLIA to the American Association for Laboratory Accreditation (A2LA). This action gives laboratories in the United States a new choice to meet the accredita…
Congress’ New SGR Law Has Mixed News for Labs
CEO SUMMARY: Once again, the lab industry faces a mixed bag following passage of a new law by Congress last week. Besides the one-year fix for the SGR, H.R. 4302 also has language that may defer adjustments to Medicare Part B lab test fees until 2017 and creates a new procedure for Medica…
Eastern Canada’s Latest Lab Errors Get Attention
CEO SUMMARY: Authorities for Eastern Health in Newfoundland and Labrador province in Canada are conducting a root cause analysis after finding discrepancies in breast cancer testing that affected nine patients. Health officials said these cases were discovered as a result of an improved q…
Maine’s Spectrum Medical Group Offers Multiple Specialties
CEO SUMMARY: Pathologists looking for a viable future in a healthcare system marked by integration of clinical care and value-based reimbursement will be interested to learn about Spectrum Medical Group based in Portland, Maine. This 180-member multispecialist group includes 22 pathologis…
Better Data Needed to Support Pathologists as Consultants
MULTIPLE TRENDS ARE UNFOLDING that mutually reinforce the need for pathologists and PhDs to be experts and consultants in how physicians order and follow up on molecular diagnostics assays and genetic tests. “Healthcare in the United States is approaching a tipping point that can greatly favor pat…
Clinical Labs Spending Money in New Ways
CEO SUMMARY: In response to the many changes now unfolding in the U.S. healthcare system, labs are investing their scarce capital in different ways. Five trends in lab spending can be identified. They range from expanding the informatics capabilities of a lab organization to acquiring the…
Caris Life Sciences Achieves Accreditation to ISO 15189
IN DECIDING TO PURSUE ACCREDITATION TO ISO 15189: Medical Laboratories, Caris Life Sciences considered the international benefits of this designation. It was December when Caris Life Sciences of Irving, Texas, announced that it had earned accreditation to ISO 15189 from the …
Federal Judge Lets Trial Proceed in Case against Quest
CEO SUMMARY: Four California labs have charged that Quest Diagnostics engaged in predatory pricing in a case filed originally in November 2012. After the lawsuit was amended last summer and fall, U.S. District Judge William H. Orrick III heard various motions in the case. On February 6 he…
Physician Group ACO Targets High-Volume Tests for Savings
HERE’S AN EXAMPLE OF HOW an accountable care organization views cost control. Atrius Health sought to control excess costs by focusing on high-priced items. It started with inappropriate hospitalizations and imaging studies and moved on to laboratory testing. Atrius Health is…
CURRENT ISSUE
Volume XXXII, No. 14 – October 6, 2025
The Dark Report examines increasing healthcare costs for employers and how clinical labs can help those employers. Also, an in-depth case study shows how one hospital system regained its outreach program after originally ceding it to a national lab company, adding millions to the system’s bottom line.
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