CLIA-88Clinical Laboratory Improvement Amendments of 1988
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Plotting the DCLHb concentration and apparent analyte concentration obtained from the specimen on the interference plot enables one to determine if the measured analyte result can be reported and be within the limits specified under the CLIA-88 rules for clinically significant bias.
The use of the limits for allowable error established under CLIA-88 for judging the presence of clinically significant test interference represented a compromise between the somewhat arbitrary use of the 10% limits applied by some (9,10) and the use of more rigorous approaches for defining acceptable laboratory performance advocated by others, such as use of total variance limits (including analytical and biological variability), loss of diagnostic efficiency, and use of medical-usefulness criteria (13-16).
A separate statement indicating 12 overlapping deficiencies under CLIA-88 was issued by CMS in February 2002 based upon the same inspections.