December 7, 2015 Intelligence: Late Breaking Lab News

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Last week, a joint laboratory accreditation agreement was announced by AABB and the American Association for Laboratory Accreditation (A2LA). The two associations will now collaborate to allow labs to obtain three assessments under one effort, including AABB accreditation, ISO 15189 accreditation, and CLIA requirements. In their statement about the benefits of the new arrangement, the two associations said that the assessment will be “against an ISO standard that is not prescriptive and can be imple- mented based on the [lab] organization’s work culture and processes.”


One “behind the scenes” element in this agreement to offer a three-standard accreditation service is that both AABB and A2LA recognize the role that a quality management system (QMS) such as ISO 15189 can play in helping labs better manage costs while simultaneously identifying and reducing systemic errors in ways that improve patient safety. At a time when the public and the media are starting to hold clinical labs to a higher standard of quality and patient safety, this new accreditation service may find a ready welcome with lab administrators wanting to keep their lab organizations at the front edge of innovation and clinical excellence.


Last month, the FDA sent letters to three genetic testing companies. The federal agency said they were marketing unapproved tests directly to consumers. The three companies were: DNA4Life DNACardioCheck, Inc. and Interleukin Genetics, Inc. The letter requested that the lab companies either show that the tests have been cleared, or provide their rationale for why the tests do not need to be cleared. Last September, the FDA sent a similar letter to Pathway Genomics, questioning the clinical validation of its cancer detection test. Independent of the FDA’s efforts to regulate LDTs, the agency is demonstrating that it intends to assert its authority to regulate genetic tests.


  • Edward D. Dooling, Jr., recently founded and is now the CEO of Vanguard Healthcare Staffing, based in Sparta, New Jersey. He has held executive positions at American Pathology Partners, Asterand, AmeriPath, and Dianon Systems.

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That’s all the insider intelligence for this report. Look for the next briefing on Monday, January 4, 2016.


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