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.

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.

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.