Advanced Notification: Revisions to State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines
for Laboratories and Laboratory Services
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/