Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics
ANY PATHOLOGIST OR LABORATORY MANAGER who considers this to be a quiet time in the laboratory testing industry is setting themselves up for a rude awakening in the not too distant future. Several stories in this issue are written specifically to call attention to major developments in the profession of laboratory testing. First is the …
Early Warning on LDTs and Pre-Authorization Read More »
CEO SUMMARY: News stories about the FDA’s stated intention to regulate laboratory-developed tests (LDTs) generally play up the agency’s comments about the need to assert regulatory oversight of genetic tests and direct consumer access testing. But what has gone unremarked by the lab industry press is the simple fact that, if the FDA were to …
Lab Industry Unprepared For FDA Action on LDTs Read More »
CEO SUMMARY: Ask most pathologists and laboratory administrators about the FDA’s intent to regulate laboratory-developed tests (LDTs), and they will likely answer that it is to control web-based direct-to-consumer lab testing companies and the rapidly- growing number of proprietary tests. Although that is true, any move to regulate LDTs also has the potential to cover …
Many Questions About FDA Regulation of LDTs Read More »
IT’S WIDELY KNOWN BY PATHOLOGISTS and laboratory administrators that hospitals and health systems are buying up private medical practices at an accelerating rate. This is a trend that favors hospital laboratory outreach programs, but may not be auspicious for the national laboratories. For this reason, certain findings in the Medical Group Management Association’s (MGMA) latest …
Hospital-Owned Medical Groups Serving More Patients Per Doc Read More »
CEO Summary: Pre-authorization of expensive genetic and molecular tests is a threat to local clinical laboratories and pathology groups if payers exclude them from provider networks in favor of labs which bid the lowest prices. But one major healthcare corporation believes there is now an opportunity for clinical labs and pathology groups to deliver added …
Systems Approach For Pre-Authorization Of Genetic Tests Read More »
CEO SUMMARY: Here’s a new lab product launch with a surprise twist. Upon earning FDA clearance for its new HIV Ag/Ab Combo Assay this spring, Abbott Diagnostics selected a hospital laboratory in Sioux Falls, South Dakota, to be the nation’s first clinical lab to offer the assay. The honor was recognition of the Avera McKennan …
Quality Strategy Earns Honor for SD Laboratory Read More »
In Hawaii, two competing clinical laboratory companies have joined forces to save a medical technologist (MT) training program from closure. Together, Clinical Laboratories of Hawaii, LLP (CLH–owned by Sonic Healthcare), and Diagnostic Laboratory Services, Inc. (DLS), contributed more than $100,000 to the John A. Burns School of Medicine (JABSOM) at the University of Hawaii at …
October 4, 2010 “Intelligence: Late Breaking Lab News” Read More »
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