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Issued to a laboratory once the State Agency or CMS surveyors conduct a survey (inspection) and determine that the laboratory is compliant with the applicable CLIA requirements. This type of certificate is issued to a laboratory that performs nonwaived (moderate and/or high complexity) testing.
The Individualized Quality Control Plan (IQCP) is a quality management system under the US Clinical Laboratory Improvement Amendments (CLIA) federal regulatory standards. It is designed to enable regulated medical laboratories to manage the frequency of their quality control .
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To this end, much of the work done by medical laboratory scientists involves ensuring specimen quality, interpreting test results, data-logging, testing control products, performing calibration, maintenance, validation, and troubleshooting of instrumentation as well as performing statistical analyses to verify the accuracy and repeatability of ...
Closely related terms are the rejectable quality limit and rejectable quality level (RQL). [1] [2] In a quality control procedure, a process is said to be at an acceptable quality level if the appropriate statistic used to construct a control chart does not fall outside the bounds of the acceptable quality limits. Otherwise, the process is said ...
Quality control (QC) is a measure of precision, or how well the measurement system reproduces the same result over time and under varying operating conditions. Laboratory quality control material is usually run at the beginning of each shift, after an instrument is serviced, when reagent lots are changed, after equipment calibration, and ...