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  1. FHIR Specification Feedback
  2. FHIR-33375

A root cause analysis should be done to determine why detection and reporting are not done

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    • Icon: Change Request Change Request
    • Resolution: Not Persuasive
    • Icon: Highest Highest
    • US ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (FHIR)
    • 0.1.0
    • Biomedical Research & Regulation
    • Overview
    • 1.2
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      The reason for underreporting is generally understood to be a combination of unrecognized adverse events, and provider burden to manually report already clinically-recognized adverse events. Our implementation guides helps facilitate the automation of recognizing adverse events and populating ICSRs for reporting (since currently electronic reporting mechanisms are manual).

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      The reason for underreporting is generally understood to be a combination of unrecognized adverse events, and provider burden to manually report already clinically-recognized adverse events. Our implementation guides helps facilitate the automation of recognizing adverse events and populating ICSRs for reporting (since currently electronic reporting mechanisms are manual).
    • Jean Duteau / Norman Gregory : 16-0-0

    Description

      What is the cause for underreporting-is it the burden of generating a report by busy clinicians, lack of awareness of reporting criteria? Has a root cause analysis been done to address the sources so that automated detection is not just adding more tasks for a clinician that is not reporting for whatever reason?

      Existing Wording:

      …may be underreported and the data reported may not always contain adequate information for decision-making.

      Proposed Wording:

      NA

      (Comment 1 - imported by: Chris Shawn)

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            klsalzman Keith Salzman
            Keith Salzman
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              Updated:
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