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The CLIA regulations require that all laboratories retain certan records for a designated period of time. The following table lists the CLIA record keeping requirements of laboratory records.
|Calibration and Calibration Verification||2 years|
|Discontinued Procedures||2 years|
|Equipment Maintenance and Function Checks
|Method Performance Validation and Specifications||2 years after discontinuation method|
|Proficiency Testing Evaluations and Corrective Action
|Proficiency Testing Results (lab worksheets, instrument printouts, data submission reports)
|PT Attestation Statement
|Quality Control Records and Reports (daily QC records)||2 years|
|Remedial Action - errors in reported patient results (both the original and corrected report)
According to CLIA, the Laboratory Medical Director, as stated on the CLIA license, is responsible for the overall operation of the laboratory. The Laboratory Medical Director is ultimately responsible even if responsibilities are delegated. He/She must ensure that all the duties are properly performed, staff competencies are met, and applicable CLIA regulations are followed. It is the Director’s responsibility to ensure that the laboratory develops and uses a quality system approach to laboratory testing that provides accurate and reliable patient test results.
The Medical Director's duties include, but are not limited to:
For further information, visit CMS CLIA website and see “The Interpretative Guidelines for Laboratories.”