Clarification Regarding Fine Needle Aspiration (FNA) Specimen Adequacy Assessment, Rapid On-site Evaluations (ROSE) and Workload Limits

Summary

• The Centers for Medicare & Medicaid Services (CMS) is providing clarification related to FNA and ROSE under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
• A slide assessment that provides only a determination of specimen adequacy is not considered to be a slide examination for purposes of determining workload limits in accordance with 42 CFR 493.1274(d).
• Thus, when establishing workload limits for qualified individuals during specimen adequacy assessment or during diagnostic slide examination, workload limits should be determined as described herein.