Clinical Laboratory Improvement Advisory Committee (CLIAC) | DLS |CDC

Clinical Laboratory Improvement Advisory Committee (CLIAC) | DLS |CDC

Participate in Public Comment on Emerging Technologies and the Clinical Laboratory

At the November 6-7, 2019 meeting, CLIAC is specifically soliciting public comments to address the questions below. Information provided via public comments will not be considered advice directly addressed to HHS. Rather, it will be used by CLIAC to inform their deliberations and recommendations to HHS and to help focus a CLIAC workgroup that will be convened in response to an April 2019 CLIAC recommendation that such a workgroup be charged with providing input to CLIAC in advising how CLIA might be updated.

1. Are bioinformaticists needed in clinical and public health laboratories? If so, what are the current roles, responsibilities, and competencies of bioinformaticists in these settings?
2. What areas exist in CLIA where specific requirements or guidance might be needed to ensure the accuracy and reliability of new and emerging laboratory technologies and nontraditional testing workflow models, including next generation sequencing, biomarker testing, metagenomics, and others?
3. What data are available that could assist in answering how CLIA may need to be revised or where guidance may be needed to ensure the accuracy and reliability of emerging technologies?

In general, each individual or group requesting to make oral comments will be limited to a total time of ten minutes (unless otherwise indicated). Written comments can also be provided up to the first day of the meeting. Send comments to CLIAC@cdc.gov.

Register for the Meeting