CMS: Advanced Notification: Revisions to State Operations Manual

Angie SzumlinskiUncategorized

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


Read the full release here: