TAG:
qms
Spectra Lab in Milpitas Accredits to ISO 15189
CEO SUMMARY: Spectra Laboratories, Inc., a renal-specific testing services company with labs in New Jersey and California, announced earlier this month that the American Association for Laboratory Accreditation awarded accreditation to ISO 1589 to its laboratory in Milpitas, California. I…
Lab Testing, Pathology Is Fast-Growing in China
CEO SUMMARY: It was record attendance at the major pathology congress which took place in Hangzhou, China, last month. Because of the ongoing growth of China’s economy, the demand for healthcare—and for high-quality clinical lab and pathology testing—is rising at an accelerated pace…
TriCore Earns Multi-Site CAP 15189 Accreditation
CEO SUMMARY: To achieve the goals of continuous improvement and standardization across all facilities within its organization, TriCore Reference Laboratories opted to implement the CAP 15189 quality management system (QMS). Last month, the lab announced its accreditation to CAP 1…
September 6, 2011 “Intelligence: Late Breaking Lab News”
Cleveland Heart Lab closed on a Series B financing round that totals $18.4 million. The money was provided by Excel Venture Management, Healthcare Ventures, and existing investors. Executives at Cleve- land Heart Lab said the new funds will be used t…
Analysis of Lab Test Error Offers Lessons for Labs
CEO SUMMARY: As happens now and again, a rather typical example of an error in lab testing has made the nightly news in Indianapolis because of one justifiably irate patient who got a false positive test report for an STD. One pathologist, asked by THE DARK REPORT to assess the p…
Pennsylvania Lab Earns ISO 15189 Accreditation
CEO SUMMARY: Clinical laboratories often promote themselves as being able to deliver quality results. But simply saying so is not the same as having an outside organization audit the laboratory to accredit its analytical processes and its other operational activities. NMS Labs in Willow G…
Our Top Ten Lab Stories Highlight Major Changes
CEO SUMMARY: What makes 2010 a watershed year for the laboratory testing industry is enactment of the 2,700-page Patient Protection and Affordable Care Act (PPACA). Even if parts of this bill are repealed, the remaining parts of the massive legislation will trigger major changes …
Quality Strategy Earns Honor for SD Laboratory
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 ass…
ISO 15189 Accreditation Earned by Spectra Labs
CEO SUMMARY: Spectra Laboratories Inc., recently announced that it had earned accreditation to the ISO 15189:2007 standard, following an assessment by a team from the Association for Laboratory Accreditation (A2LA). Spectra is a high-volume laboratory that serves renal patients. …
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…
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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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