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Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Important Update: Quality Management Systems’ Growing Role in Clinical Laboratory Accreditation and Licensure



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Media Contact: Ron Martin


AUSTIN, Texas (January 21, 2013) – Each fall, Dark Daily and THE DARK REPORT conduct their annual Lab Quality Confab Process Improvement Institute, a two-day gathering of clinical laboratory stakeholders focused on advancing the knowledge, skills, and effectiveness of process improvement and quality management. At a recent Lab Quality Confab, Judy Yost, MA, MT(ASCP), Director of the Division of Laboratory Services at the Centers for Medicare and Medicaid Services, gave a presentation: “Understanding How Laboratory Certification and Licensure Intersects with the Essentials of Quality Management Systems.”

Ms. Yost’s presentation was followed by a roundtable discussion on a related topic: “Great Debate: Should Labs Complement CMS and CLIA Requirements with a Quality Management System?” The roundtable was moderated by Lucia Berte, MA, MT(ASCP), CMQ/OE(ASQ), and President of Laboratories Made Better! P.C. and joined by James H. Nichols, Ph.D., DABCC, FACB, Medical Director of Baystate Health, Elissa Passiment, Ed.M., CLS(NCA), Executive Vice-President of the American Society for Clinical Laboratory Science, Christine D. Flaherty, MHA, MT(ASCP), CPHQ, Regional Laboratory Director of Sutter Health, and Leo Serrano, FACHE DLM(ASCP), Director of Laboratory Services for the Avera McKennan Hospital & University Health Center.

These two important sessions have been developed into a new Special Report entitled Quality Management Systems’ Growing Role in Clinical Laboratory Accreditation and Licensure: How labs can better meet CMS and CLIA Requirements with more effective use of a Quality Management System. This Special Report, available for purchase at is a distillation of the two presentations, and comprehensively addresses how CLIA laboratory accreditation interacts with Quality Management Systems and other aspects of quality management.

Designed for laboratory managers and clinical diagnostic leaders, the Report provides an enhanced understanding of the differences and similarities between CLIA certification and a Quality Management System (QMS), and describes the various components of quality management and how these components fit into the complicated network of national and international standards.

In addition, the Report provides a greater understanding of how utilizing a CLIA certification as a template for a continual quality process and Quality Management System can lead to a more efficient laboratory operation with positive effects on patient outcomes and laboratory economics, and is in summary an indispensable resource for the information needed to make critical decisions about laboratory processes, quality initiatives, and the adoption of a Quality Management System to achieve Total Quality Management and meet CLIA accreditation standards.

Get more information and order the Special Report here. 

For more information about Lab Quality Confab, visit, or contact Ron Martin at 512-264-7103.


Established in 1995, THE DARK REPORT  is the leading source of exclusive business intelligence for laboratory CEOs, COOs, CFOs, Pathologists and Senior industry executives. It is widely-read by leaders in laboratory medicine and diagnostics. The DARK REPORT produces the famous Executive War College on Laboratory and Pathology Management (every spring, which showcases innovations by the nation’s and globe’s leading laboratory organizations. Dark Daily is an Internet-based e-briefing intelligence service, read worldwide by thought leaders in laboratory and pathology management. Other well-known conferences conducted by THE DARK REPORT are Lab Quality Confab (on the use of Lean and Six Sigma methods in labs and hospitals), Molecular Summit (on the integration of in vivo and in vitro diagnostics). THE DARK REPORT co-produces Frontiers in Laboratory Medicine annually in the United Kingdom; Executive Edge bi-annually in Canada; and The Business of Pathology bi-annually in Australia.