Proficiency Testing

Proficiency Testing

Intellect’s Proficiency Testing application manages workflows and documents related to proficiency testing. It assists in interlaboratory comparison testing and allows labs to investigate and document internal procedures, making audit prep easy and ensuring compliance.

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Proficiency testing software facilitates compliance

What is laboratory proficiency testing?

Proficiency testing (PT) is a critical tool for laboratories to verify the accuracy and reliability of their testing procedures. Intellect’s Proficiency Testing application manages workflows and documents related to proficiency testing and assists in interlaboratory comparison testing that allows labs to investigate internal procedural problems.

This CLIA regulation was effective August 10, 2022, except for amendments to §§ 493.2 and 493.801 through 493.959, effective July 11, 2024.  See the Federal Register for details.

Is record-keeping essential for proficiency testing compliance?

Yes, maintaining thorough records is imperative for a period of two years from the PT event date. This includes documentation of PT sample preparation and handling procedures, testing steps, instrument printouts, PT program results forms (with attestation statements), electronic result entries if applicable, and evaluations of laboratory performance by the PT program. Additionally, corrective actions from unsatisfactory scores must be documented and retained.

How often must labs proficiency test?

Typically, PT samples are dispatched to HHS-participating laboratories several times annually. Then, laboratories report their sample results back to the PT program for evaluation based on CLIA grading criteria. This process is closely monitored by CMS and accreditation organizations to ensure laboratory performance standards are consistently met.

To learn more about approved proficiency testing programs for CLIA, visit the Department of Health & Human Services website.