The Centers for Medicare & Medicaid Services (CMS) has updated the memo “Clarification Regarding Fine Needle Aspiration (FNA) Specimen Adequacy Assessment, Rapid On-site Evaluation (ROSE) and Workload Limits” as of October 16, 2026.

The memo was originally published on March 16, 2018. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) addresses many problems in laboratories and includes FNA and ROSE. One of the challenges it addresses is cytotechnologist workload. High slide volume can heighten the risk of improper diagnosis, so 42 CFR 493.1274(d) was established, regulating the amount of slides a cytotechnologist can process in 24 hours. The 2018 memo clarifies FNA and ROSE procedures and states that specimen adequacy assessments do not count towards workload limits.

The 2026 update to the memo answers the following question:

• Do adequacy assessments or a ROSE need to be performed on the premises of a CLIA-certified laboratory? -Yes, CMS says specimen adequacy assessment must be done on the premises of a CLIA-certified laboratory in accordance with 42 U.S.C. 263(f)(4)(B)(vi) and 42 CFR 493.1274(a).

The revision also reminds leaders that workload limits must be established in compliance with 42 CFR 493.1274(d) and provides guidance for determining them.