CMS Clarification on Fine Needle Aspiration Specimen Adequacy Assessment, Rapid On-site Evaluation (ROSE) and Workload Limits

PUBLISHED: Mar 22, 2018
Relevant to: Clinical Lab

The Centers for Medicare and Medicaid Services has issued a memorandum to state survey agencies clarifying Fine Needle Aspiration (FNA) and Rapid On-site Evaluation (ROSE) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

In the memorandum, CMS:

  • Clarifies that 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).
  • Outlines the methodology for establishing workload limits for qualified individuals during specimen adequacy assessment or during diagnostic slide examination.
  • Specimen adequacy assessments are not counted toward the individual’s daily slide workload limit. However, the time spent by the individual performing such specimen adequacy assessments must be used to prorate the maximum number of slides the individual can examine in a 24-hour period.
  • To determine how the remaining time is used to prorate the maximum number of slides that can be examined during an individual’s workday, please refer to the formula described in 42 CFR 493.1274(d)(2)(ii). This prorating formula is also listed in the CMS memorandum, link is provided below.
  • During diagnostic slide examination, if a pathologist or a cytologist performs the primary examination/evaluation of a slide, each slide is counted toward their daily slide workload limit. If a pathologist performs a secondary examination of a cytology slide after a previous cytologist or pathologist has performed the primary examination/evaluation, the slide is NOT counted toward the secondary pathologist daily slide workload limit. As per 42 CFR 49.1274(d)(2)(iv), previously examined cytology slides are not required to be counted in the 100-slide workload limit.

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