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. It 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 similar testing. Required participation and scored CMS and voluntary accreditation organizations monitor results.
For subscribed laboratories, samples are sent three times per calendar year. Five challenges (samples) are provided for all regulated analytes, while fewer samples are supplied for non-regulated analytes and waived test methods. The comprehensive process includes testing provided samples in the same manner as patient samples; results are submitted to the provider for scoring.
The PT plan is included in the quality assessment (QA) plan and overall quality program. State regulatory requirements and accreditation agencies may require PT for additional analytes or waived kits. The laboratory's competency assessment program may incorporate staff participation in PT sample evaluation.
Alternative assessment procedures (AAPs) are acceptable for non-regulated analytes and exceptional circumstances, including external PT, split sample analysis with other laboratories or in-house methods, or other unique processes developed or approved by the laboratory director.
