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Services | Carrot Clinical
Services

REGULATORY

  • Complete regulatory applications for CLIA, CAP, California state, New York state, and other agencies

  • Assess regulatory inspection readiness through onsite audits and mock inspections, and assist with corrective actions

  • Support inspection preparation activities

QUALITY

  • Design, develop, establish, and maintain a quality management system that complies with applicable regulations

  • Identify and support quality monitoring and improvement projects

  • Assist in development and review of test method validations

LABORATORY OPERATIONS

  • Develop and review policies and procedures for pre-analytical, analytical, post-analytical, and general laboratory functions

  • Evaluate operational and technical workflows

  • Assist with laboratory space design, build-out, and moves

  • Appraise the qualifications of clinical laboratory personnel for regulatory compliance

TRAINING

  • Train personnel on clinical laboratory regulatory and quality management system requirements and preparation for inspections

GENERAL AND STRATEGIC CONSULTING

  • Advise on general clinical laboratory regulatory compliance, quality management system, and operational matters

  • Provide strategic input on laboratory and laboratory-developed test (LDTs) timelines and activities

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