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Notification for MIC.21835

This update is to provide clarification on a new Microbiology Checklist requirement, MIC.21835, published in the 2019 Checklist Edition, MIC.21835 (Direct Testing for Organism Identification and Susceptibility), based on inquires that the CAP has received on the applicability of this requirement to different organisms and test systems. 

Which methods does MIC.21835 apply to? 

MIC.21835 applies to:

  • Methods such as molecular blood culture systems where correlation of phenotypic culture results with molecular identification and purity assessment is critical for proper result interpretation.

MIC.21835 does not apply to:

  • Nucleic acid amplification testing for more targeted assays, such as gonorrhea and chlamydia screening tests (GC/CT) and multiplex respiratory pathogen panels.

For the 2019 edition, an additional revision to add the phrase “as applicable” was made to the checklist to clarify that MIC.21835 does not apply to all identification and susceptibility testing performed directly from patient specimens (see below).  MIC.21835 will be revised further in the 2020 Checklist Edition to more fully clarify the intent.  

**NEW** 09/17/2019
MIC.21835 Direct Testing for Organism Identification and Susceptibility Phase II

If organism identification (ID) and/or antimicrobial susceptibility testing (AST) (phenotypic or genotypic) is performed directly from patient specimens (as applicable) or directly from positive blood culture broths, the specimen/blood culture is inoculated onto solid media to assess for purity, and the growth examined for consistency with the ID and AST.

NOTE: It is the responsibility of the laboratory director to determine the extent of confirmatory testing necessary. Such testing may be limited to confirmation that colony growth morphology is consistent with organism identification results obtained from the direct test.

This requirement applies only to testing performed for patient care/management, not to infection control or epidemiology testing.

Evidence of Compliance: 
Written procedure describing the use of culture to confirm isolation of organism(s) that are morphologically consistent with the ID and/or AST results.

Please share this eAlert with appropriate personnel at your laboratory as needed. 

Questions? Contact us at 800-323-4040 or accred@cap.org.