Quality assurance Clinical Laboratory Improvement

The Clinical Laboratory Improvement Amendments (CLIA) set standards designed to improve the quality of all laboratory testing. In the first portion of this chapter, we discuss the CLIA requirements that apply to most Immunohistochemistry laboratories, and explain topics such as certification, test complexity, patient test management, proficiency testing, personnel, quality control, quality assurance, and compliance. 

With the introduction of quality assurance in the diagnostic laboratory 56 years ago [6], a kind of educational and benchmarking process started forcing laboratories, national and international organizations, and the IVD industry to improve the methods applied in clinical laboratories. Comparison of the measurements of enzyme activity demonstrate that the analytical performance of the methods applied 30 years ago were far beyond the biological variation and most probably insufficient for medical needs. Interlaboratory comparisons show that with the new routine methods based on recommendations of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) (Table 5) comparable results can be obtained irrespective of time and space and thus small individual variations can now be detected. Similar improvements in the analytical process in clinical laboratories can be reported generally for homogenous measurands. 

In general, the results of these proficiency testing programs indicate a considerable improvement in the performance of PbB determination in most laboratories (for review see Parsons, 1992). According to the practice in clinical chemistry, quality assurance including internal and external quality control should, therefore, be an integrated part of PbB measurements. 

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