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June 2019

Lab Quality Management Consulting Services

Pinnacle Lab Quality

Pinnacle Lab Quality offers consulting services covering clinical laboratory quality and regulatory affairs, including compliance with CLIA, CAP, and state licensure requirements, and in the establishment and maintenance of clinical laboratory quality management systems. Services are available for established clinical laboratories and startups alike, with recent work spent consulting with genetic testing and reference lab companies to implement quality management systems, lead licensure and accreditation efforts, develop and implement regulatory strategies, and serve as an advisor and auditor for quality and regulatory affairs. Practice expertise includes ISO 15189, QMS establishment, Lean/Six Sigma applications, assessing and revamping existing quality programs, implementation of electronic nonconforming event management programs, cost of poor quality (CoPQ) tracking, and creating and benchmarking a culture of quality in the clinical lab.

Pinnacle Lab Quality

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