Services
REGULATORY
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Complete regulatory applications for CLIA, CAP, California state, New York state, and other agencies
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Assess regulatory inspection readiness through onsite audits and mock inspections, and assist with corrective actions
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Support inspection preparation activities
QUALITY
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Design, develop, establish, and maintain a quality management system that complies with applicable regulations
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Identify and support quality monitoring and improvement projects
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Assist in development and review of test method validations
LABORATORY OPERATIONS
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Develop and review policies and procedures for pre-analytical, analytical, post-analytical, and general laboratory functions
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Evaluate operational and technical workflows
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Assist with laboratory space design, build-out, and moves
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Appraise the qualifications of clinical laboratory personnel for regulatory compliance
TRAINING
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Train personnel on clinical laboratory regulatory and quality management system requirements and preparation for inspections
GENERAL AND STRATEGIC CONSULTING
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Advise on general clinical laboratory regulatory compliance, quality management system, and operational matters
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Provide strategic input on laboratory and laboratory-developed test (LDTs) timelines and activities