08/22/2013

CMS has announced the implementation of an optional risk based Quality Control (QC) plan called Individualized Quality Control Plan (IQCP).  IQCP will provide laboratories with flexibility in customizing their QC program.  This plan will begin with an educational phase beginning January 1, 2014.   The educational phase will terminate January 1, 2016. 

Following  are several important points regarding the IQCP. 

  • The option to implement IQCP is available to laboratories inspected by state inspectors only.  Those laboratories in CLIA exempt states or accredited by CMS accreditation organizations (e.g. CAP and Joint Commission) will NOT have the option of using IQCP.   It is unknown at this time if exempt states and accreditation organizations will implement the use of IQCP at some point in the future.  
  • Not all specialties within the laboratory have the option of using IQCP.  Pathology, Histopathology, Oral Pathology and Cytology may not use IQCP.   In addition, not all CLIA specialties and subspecialties may completely implement IQCP.   Each specialty section of a laboratory should check the eligible IQCP for each CLIA regulation with regards to the specialty used
  • The option of implementing IQCP is voluntary.   Laboratories have the option to use the QC requirements as written in CLIA (2003).
  • During the educational period (1/1/2014 - 1/1/2016) laboratories will have three (3) acceptable QC options available.
    • Follow the CLIA regulatory requirements as written
    • Continue to follow the Equivalent Quality Control (EQC) procedures as described in the current Interpretive Guidelines in Appendix C of the state office manual
    • Implement IQCP as described
  •  Following the educational period, laboratories will have only two (2) acceptable QC options available. 
    • Follow the CLIA regulatory requirements as written
    • Implement IQCP as described

The EQC option will be phased out after this time.  Laboratories currently using EQC will need to choose one of the two remaining acceptable QC options. The educational period is designed to allow these laboratories to transition into one of the acceptable QC systems.  

Educational materials for laboratories are under development and announcements will be made as material becomes available.

Click here to view the August 16, 2013, CMS Letter to State Survey Agency Directors.

Click here for more information regarding the IQCP.
 

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