Laboratory Quality Standards Webinar

When: December 7, 2017 (2:00 PM Eastern)

Topics Biomedical and Health Research, Quality and Patient Safety
Activity: Return of Individual-Specific Research Results Generated in Research Laboratories
Board: Board on Health Sciences Policy

Public Webinar of the Committee on Return of Individual-Specific Results Generated in Research Laboratories

 December 7, 2017

2:00–3:30PM ET

90 Minute Webinar


Quality Standards for Regulated and Non-regulated Biomedical Research Laboratories


Session Objectives:

  • Explore current standards used in research laboratories to assure the reproducibility of research results or to ensure tests are analytically or clinically valid.
    • Identify challenges researchers may encounter when determining whether or how to return results if certain standards are not met (e.g. challenges of interpretation and translation, contextualization, or communication).
  • Consider how the innovative culture of a research laboratory does or does not align with the required practices of clinical laboratories to ensure specimen control, assay validity, and reproducibility.
  • Discuss the process of CLIA accreditation and explore the barriers or perceived barriers that lead research laboratories to refrain from taking the steps necessary to become certified under CLIA
    • Examine the technical and operational requirements and costs (including opportunity costs) of asking research labs to produce at clinical or near clinical laboratory level results (for example, obtaining CLIA certification or getting results confirmed in a CLIA laboratory).
  • Discuss the potential utility of more codified guidelines for quality standards that could be used in non-regulated biomedical research laboratories and identify what should be included in such guidelines if they were to be produced.

Moderator: Debra Leonard, Chair and Professor of Pathology and Laboratory Medicine, University of Vermont

Speakers: (10 minute opening remarks followed by discussion and Q&A)

  • Rebecca Davies, Associate Professor, University of Minnesota 
  • Randy Querry, Accreditation Manager, American Association for Laboratory Accreditation

Register for the webinar using the link at the top right of this page. 

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