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CLIA News and Announcements Archive

  • The final rule to amend Fecal Occult Blood (FOB) Testing was approved on October 20, 2017, and will go into effect on December 19, 2017. This rule amends the existing Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood (FOB) tests. This change excludes the more complex automated FOB analyzers from the list of waived tests in the CLIA regulations.

     — 12/19/2017
  • The Division of Laboratory Systems (DLS) in CDC’s Center for Surveillance, Epidemiology, and Laboratory Services (CSELS) has two new tools now freely available for use by sites that perform testing under a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver or Certificate of Provider-performed Microscopy Procedures. Both tools were developed by DLS as a result of the recommendation and input from the Clinical Laboratory Improvement Advisory Committee (CLIAC).

    • Waived Testing Checklist:

      This self-assessment checklist emphasizes recommended practices for physicians, nurses, medical assistants, pharmacists, and others who perform patient testing under a CLIA Certificate of Waiver. It can be used as a voluntary tool to help assure good testing practices and reliable, high quality test results. Please view the Self Assessment Checklist under Educational Materials here.

      In November 2014, CLIAC emphasized the need to develop a non-punitive and non-regulatory self-assessment checklist-type tool and recommended it for biennial use by all Certificate of Waiver testing sites. The tool could also be used prior to or at the time a site first applies for a CLIA Certificate. Please view past CLIAC meetings here.

    • Provider-Performed Microscopy (PPM) Procedures Booklet:

      This booklet describes recommended practices for physicians, midlevel practitioners (nurse midwife, nurse practitioner, or physician assistant), and dentists who perform patient testing under a CLIA Certificate for PPM procedures. The booklet contains an overview of the regulatory requirements, resources including forms and examples, and an overview with images of common microscopic findings for the nine specific microscopic examinations that may be performed under a Certificate of PPM Procedures. Please view the Provider-Performed Microscopy Procedures booklet under Educational Materials here.

     — 07/18/2016
  • The Centers for Disease Control and Prevention (CDC), Center for Surveillance, Epidemiology, and Laboratory Services (CSELS), Division of Laboratory Systems (DLS) would like to announce the publication of the following 2 Funding Opportunity Announcements (FOAs) in www.grants.gov:

    CDC-RFA-OE16-1602 Use of a Medical Data Warehouse in a Laboratory Quality Improvement Initiative that Links to Patient and System Outcomes.
    The purpose of this project is to support a collaborative opportunity to develop, implement, and evaluate a process to assess the usefulness of data contained within a medical data warehouse to document and address quality gaps in the pre-, intra-, and/or post-analytic phases of clinical laboratory medicine that can be linked to patient and/or system outcomes.
    Please go to http://www.grants.gov/web/grants/search-grants.html, for more information and an application.  Application are due April 22, 2016.

     CDC-RFA-OE16-1603 Improving Waived Testing Performance and Outcomes through Partnerships.
    The purpose of the project is to support and expand the efforts of the laboratory and stakeholder organizations to instill quality practices, including applicable minimum Clinical Laboratory Improvement Amendments of 1988 (CLIA) requirements and good laboratory practice recommendations, in Certificate of Waiver (CW) sites nationwide to improve patient safety and health outcomes.
    Please go to http://www.grants.gov/web/grants/search-grants.html, for more information and an application. Applications are due April 22, 2016.

     — 03/14/2016
  • The April 12-13, 2017 CLIAC meeting will be postponed due to administrative factors. Updated information will be provided once available.

     — 03/08/2017
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