Proficiency testing (PT) is a regulatory requirement published by the Centers for Medicare and Medicaid Services (CMS) in the Clinical Laboratory Improvement Amendments (CLIA) regulations. Proficiency testing is required for all regulated analytes and provider performed microscopy procedures (PPMPs). The purpose of PT is to verify the accuracy and reliability of patient testing. This verification indicates peer comparison of outcomes with laboratories performing like testing. Required participation and scored results are monitored by CMS and voluntary accreditation organizations.
For subscribed laboratories, samples are sent three times per calendar year. Five challenges (samples) are provided for all regulated analytes while fewer samples are provided for non-regulated analytes and waived test methods. The comprehensive process includes testing of provided samples in the same manner as patient samples, results are submitted to the provider for scoring.
The PT plan is included as an aspect of the quality assessment (QA) plan and overall quality program. The regulatory requirements of states and accreditation agencies may require PT for additional analytes or waived kits. Laboratory staff participation in PT sample evaluation may be incorporated into the laboratory's competency assessment program.
Alternative assessment procedures (AAPs) are acceptable for non-regulated analytes and special circumstances, which can include external PT, split sample analysis with other laboratories or in-house methods, or other special processes developed or approved by the laboratory director.
