CMS: Advanced Notification: Revisions to State Operations Manual

Angie Szumlinski Uncategorized

Memorandum Summary

The Clinical Laboratory Improvement Amendments (CLIA) Individualized Quality ControlPlan (IQCP) procedure in the revised SOM will supersede the IQCP procedure in S&C 13-54.

” Revisions to Appendix C of the SOM: Revisions include the removal of Equivalent Quality Control (EQC) in the Interpretive Guidelines for §493.1256(d) and the insertion of IQCP in the Interpretive Guidelines for §493.1256(d)
” Education & Transition Period: The IQCP Education and Transition Period will conclude on 12/31/2015.
” Implementation of IQCP: The IQCP effective date will be 01/01/2016.
” Guidance for surveyors after full implementation of IQCP: Surveyors will continue to follow established survey policies and protocols using the Outcome Oriented Survey Process.

” Educational resources: Resources available on the CLIA Webpage at


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