Proficiency Testing and Laboratory Accreditation

The initial CLIA 88 regulations focused primarily on the analytical process. However, it was later stressed that the quahty of the total testing process must be monitored in addition to the precision and accuracy of the analytical phase. Thus as mentioned earlier in this chapter, 

The CLIA requirements cover several broad classes (1) Subpart J. Facility Administration (2) Subpart K. Quality Systems (3) Subpart M. Personnel and (4) Subpart Q. Inspection. The final rule dealt mainly with changes to the subpart on Quality Systems, with particular attention to preanalytical, analytical, and postanalytical systems. It places increased emphasis on having quality systems to monitor preanalytical and postanalytical processes, yet the biggest impact of the final rule is on analytical quahty assessment and analytical quality systems.  

TABLE 19-8 HCFA/CLIA ProftcieneyTestingvC 1 for Acceptable Performance 

Blood gas PCO2 Target value 55mmHg or 8% (greater) 

Cholesterol, high-density lipoprotein Target value 30% 

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