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JUN 08, 2016 9:00 AM PDT

Individualized Quality Control Plan (IQCP) Training

Speaker
  • Product Manager, Culture Media Americas
    Biography
      Stephanie Dean is the Product Manager Culture Media Americas for Thermo Fisher Scientific focusing on the Voice of the Customer by enhancing product offerings that lead the world in serving science.

      After receiving a Bachelor's of Science degree in Biology, pre-med at University of Houston, Houston Texas, she began her career as a microbiologist for Bayer Animal Health, Shawnee, Kansas, in the Quality Control lab. During her eleven years at Bayer she quickly became the Supervisor of Quality Control, leading several teams earning the Bayer Continuous Improvement Process (CIP) awards for Antimicrobial Preservative Effectiveness and Sterility Testing.

      Her next discipline in the field of microbiology involved managing the production of Remel brand microbiological diagnostics at Thermo Fisher Scientific in Lenexa, Kansas. Her Integrity was pivotal in managing eleven assembly lines and over 40 hourly employees manufacturing products used in the diagnosis of patients.
      She currently lives in Kansas City, Missouri with her three children. She enjoys watching sports, cooking, and reading.

    Abstract

    This presentation covers the "Individualized Quality Control Plan” (IQCP) implemented by The Centers for Medicare & Medicaid Services (CMS) on January 1, 2016. The guidance and concepts for IQCP are a formal representation and compilation of many of the activities currently undertaken in laboratories to ensure quality test results for patients.  The three main parts of IQCP are Risk Assessment, Quality Control Plan, and Quality Assessment.  IQCP permits the laboratory to customize its QC plan according to test method, environment, patient population, and personnel competency. 
    Upon completion of this presentation, participants should be able to:

    • Identify eligible test for IQCP
    • Identify the three sections of an IQCP
    • Prepare a plan for implementation of IQCP

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