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Title
Advanced Notification: Revisions to State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services
Memo #
16-02- CLIA
Posting Date
2015-11-06
Fiscal Year
2016
Summary
The Clinical Laboratory Improvement Amendments (CLIA) Individualized Quality Control Plan (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 http://www.cms.gov/CLIA/

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