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Quality Strategy Earns Honor for SD Laboratory
CEO SUMMARY: Hereās 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 nationās first clinical lab to offer the ass…
ISO 15189 Accreditation Requires Specific Steps For Global Recognition
CEO SUMMARY: This intelligence briefing is the third in an ongoing series about quality management systems (QMS) and their role in advancing the performance of clinical laboratories and improving the quality of the testing services they provide. ISO 15189 is a set of standards for medical…
ISO 15189 Accreditation Program Offered by CAP
CEO SUMMARY: Two strong trends in laboratory management can be seen in the College of American Pathologistsā (CAP) move to offer accreditation to ISO 15189:2007. The first trend is the movement toward quality management systems such as Lean and Six Sigma. The second trend is the global …
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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