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ehi
DNV Offers Accreditation For Both CMS and ISO
CEO SUMMARY: For about a year, hospitals and health systems have had a new choice for meeting the Medicare Conditions of Participation. This new choice is Det Norske Veritas (DNV). Because DNV offers a dual process for achieving Medicare accreditation and ISO 9001 certification, it brings…
2009’s Top Ten Lab Stories Reflect Some Good, Bad
CEO SUMMARY: As the closing year of the first decade of the new century and the new millennium, 2009 brought neither disruption nor upheaval to the majority of laboratories in the United States. Rather, it was marked by at least two themes. One was how public disclosure of problems with l…
Geisinger’s Use of EHR Creates Opportunity for Lab to Add Value
CEO SUMMARY: Every health reform proposal makes it a high priority to implement a universal electronic medical record (EHR). Because lab test data is the essential component of a successful EHR, laboratory managers and pathologists may soon have a once-in-a-lifetime opportunity to use EHR…
Health Info Exchange (HIE) Helps South Bend Lab
CEO SUMMARY: Across the country, there are many efforts to create Regional Health Information Exchanges (HIEs). This has the potential to change the way laboratories connect electronically with referring physicians. This is true in South Bend, Indiana, where the Michiana Health I…
Catholic Health Initiatives Signs Pact with PAML
CEO SUMMARY: In concept, it is a simple deal. Catholic Health Initiatives (CHI), the nation’s second largest Catholic health system, is taking a 25% equity position in Pathology Associates Medical Laboratories (PAML). However, the consequences may be significant. PAML now has a…
FDA Advisory Panel Convenes To Assess Whole Slide Imaging
Editor’s Note: Guest writer Martin Perry attended the FDA’s advisory panel on digital pathology conducted earlier this month. He is CEO of The Perry Group and has extensive experience in imaging and healthcare. He offers his insights from the FDA proceedings on digital pathology imaging….
GSK and Abbott Team up For Companion Diagnostic
CEO SUMMARY: Although GlaxoSmithKline PLC is several years away from having a deliverable product from its Antigen Specific Cancer Immunoassay (ASCI) Program, it has a development deal with Abbott Laboratories to produce a companion diagnostic test for ASCI-based products. The in…
Lab M&A Deals in June Show Market Direction
CEO SUMMARY: Despite a dismal economy, the month of June spawned two interesting merger/acquisition transactions in the lab testing industry. In one case, a blood brother gobbled up a specialty diagnostics company. In another transaction, two cross-town neighbors in Kansas City m…
Elevating Lab Testing At Policymaking Table
CEO SUMMARY: With the help of contributing clinical laboratories, the CDC has launched an ambitious effort to gather data, apply evidence review methods used in clinical studies, then identify and publish best practices in laboratory medicine. The goal is to advance the value of …
Educated Consumers Buying 250-Bioassay Lab Test Panel
CEO SUMMARY: Biophysical Corporation is creating a new, direct-to-consumer market for laboratory testing. Its unique approach is to offer 250-bioassay test panels—along with a staff physician review of results—to the educated, informed consumer. Testing multiple biomarkers ma…
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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