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Lean Used to Lay Groundwork for Lab’s 15189 Accreditation
CEO SUMMARY: Henry Ford Health System’s laboratory organization has become first in the nation to have all its laboratory sites “standardized under one source of leadership†and accredited to the standards of ISO 15189: Medical Laboratories. The journey to achieve this current state…
When Should Labs Become ‘Patient-centric?’
AS THE AMERICAN HEALTHCARE SYSTEM MOVES FORWARD with its transformation, several trends make it advisable that clinical labs and pathology groups consider the importance of becoming “patient-centric.†First, patients are being incentivized to become price shoppers and select their providers—in…
Sonora Quest Builds EMPI To Serve Patients and ACOs
CEO SUMMARY: Probably no state has seen a faster transition to ACOs, medical homes, and other types of integrated clinical care organizations than Arizona. Recognizing that this change created a new opportunity to add more value with clinical lab testing services, Sonora Quest Laboratorie…
Claritas Is Example of New Lab Business Model
CEO SUMMARY: One by one, new business models for clinical laboratory testing are popping up. Each is a response to healthcare’s rapid evolution, the ongoing decline in lab test reimbursement, and the growing role for molecular diagnostics and genetic testing. In Cambridge, Massachusetts…
CMS Cuts BRCA Price by 49% in Response to Competition
IN THE FINAL WEEKS OF 2013, the federal Centers for Medicare & Medicaid Services (CMS) announced that it would reduce the price it pays for the BRCA genetic test by 49%, to $1,438, effective on January 1, 2014. For Myriad Genetics, Inc., this wa…
2013’s Top Ten Lab Stories Point to Tougher Times
CEO SUMMARY: For 2013, the big story was money—or, more accurately, less money for providers. This was not limited to clinical labs and pathology groups, but was equally true of hospitals and physicians. In THE DARK REPORT’S annual lookback at the year’s 10…
December 2, 2013 “Intelligence: Late-Breaking Lab News”
Despite the continuing cutbacks in reimbursement for lab testing, some professional investors still see opportunity in this market sector. On November 13, Genova Diagnostics, Inc., of Asheville, North Carolina, was acquired by Levine Leichtman Capital Partners and  
Lab’s Patient-Centric Approach Collects Overdue Money in PSCs
CEO SUMMARY: At Sonora Quest Laboratories (SQL), the ‘Voice of the Customer’ is guiding the organization’s evolution from physician-centric to patient-centric. It was quickly recognized that an effective enterprise master patient index (EMPI) was essential. One patient-centric servi…
ACLA, CAP Comment on Final 2014 Medicare Rules
CEO SUMMARY: On November 27, as the nation prepared for the Thanksgiving holiday, the federal Centers for Medicare & Medicaid Services (CMS) announced the long-awaited final rules for 2014. Early analysis of the 1,300 pages of rules CMS released indicates that the agency moderated one…
MedLab CEO Discusses Changes in Lab Market
CEO SUMMARY: Two factors combined to cause executives at Laboratory Partners and its MedLab business division to file a Chapter 11 bankruptcy petition on October 25. One was the sustained and continuing cuts to lab test reimbursement. The other was the reluctance of Wall Street investors …
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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