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Article: CLIA 2003's new concept: equivalent quality control.(Clinical Laboratory Improvement Amendments)
- Article from:
- Medical Laboratory Observer
- Article date:
- January 1, 2005
- Author:
CopyrightCOPYRIGHT 2005 Nelson Publishing. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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On Jan. 24, 2003, the Centers for Medicare and Medicaid Services (CMS) released the latest version of the Clinical Laboratory Improvement Amendments (CLIA), termed the "Final Rules." (1) In section [section]493.1256 of Subpart K, CMS quietly introduced a new quality-control (QC) concept--equivalent quality control (EQC). The Jan. 12, 2004, CMS Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (Appendix C in the State Operations Manual [SOM]) provides detailed implementation procedures for EQC, which include three evaluation options. (2) To implement EQC for daily use, test sites first must demonstrate that a method's internal checks ...