CLIA Requirements–Paraphrased
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Requirement:
Have a record of test system performance.
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- Intralaboratory Reports and Charts:
Point Data Report
Summary Data Report
Supervisor's Report
Operator Report
Data Review Report
Levey-Jennings Chart
- Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Data Rejection Report
Laboratory Performance Overview
Laboratory Comparison Report
Laboratory Histogram Report
Bias and Imprecision Histogram
Statistical Profile Report
Affiliated Data Exception Report
Affiliated Laboratory Comparison Report
- InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart
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Requirement:
Monitor the accuracy of the analytical process.
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- Intralaboratory Reports and Charts:
Levey-Jennings Chart
- Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Laboratory Performance Overview
Laboratory Comparison Report
Laboratory Histogram Report
Bias and Imprecision Histogram
Statistical Profile Report
Affiliated Data Exception Report
Affiliated Laboratory Comparison Report
- InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart
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Requirement:
Monitor the precision of the analytical process.
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- Intralaboratory Reports and Charts:
Levey-Jennings Chart
- Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Laboratory Performance Overview
Laboratory Comparison Report
Laboratory Histogram Report
Bias and Imprecision Histogram
Statistical Profile Report
Affiliated Data Exception Report
Affiliated Laboratory Comparison Report
- InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart
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Requirement:
Detect immediate errors.
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- Intralaboratory Reports and Charts:
Point Data Report
Supervisor's Report
Operator Report
Data Review Report
- InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart
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Requirement:
Establish or verify the criteria for acceptability of all control materials.
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Requirement:
Establish statistical parameters for each batch and lot number of control materials.
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Requirement:
Document all control procedures performed.
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- Intralaboratory Reports and Charts:
Data Review Report
Point Data Report
Supervisor's Report
Levey-Jennings Chart
- InstantQC™ Reports and Charts:
InstantQC™ Chart
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Requirement:
Document that at least once each day patient specimens are assayed or examined, test two control materials of different concentrations.
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- Intralaboratory Reports and Charts:
Data Review Report
Point Data Report
Summary Data Report
Levey-Jennings Chart
- InstantQC™ Reports and Charts:
InstantQC™ Chart
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Requirement:
For blood gas analyses, document that one sample of control material is tested each eight hours of testing using a combination of control materials that include both low and high values on each day of testing.
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- Intralaboratory Reports and Charts:
Data Review Report
Point Data Report
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Requirement:
Evaluate and define the relationship between test results for the same analyte using different methodologies, instruments, or testing sites.
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Requirement:
Document all corrective actions taken as a result of QC.
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Requirement:
Document all analytic systems assessment activities.
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- Intralaboratory Reports and Charts:
Data Review Report
Point Data Report
Supervisor's Report
- Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Laboratory Performance Overview
Laboratory Comparison Report
Laboratory Histogram Report
Bias and Imprecision Histogram
Statistical Profile Report
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Requirement:
Document that, over time, control material testing is rotated among all operators who perform the test.
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- Intralaboratory Reports and Charts:
Data Review Report
Point Data Report
Supervisor's Report
Levey-Jennings Chart
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Requirement:
Document that control material testing is performed after a complete change of reagent, major preventive maintenance, or when any critical part is replaced.
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- Intralaboratory Reports and Charts:
Data Review Report
Point Data Report
Supervisor's Report
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