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

Attention: Clinical Laboratories, Acute Care Hospitals, Critical Access Hospitals

Please share this announcement with the following:

  • Medical Director, Laboratory Services
  • Administrative Director and Managers, Laboratory Services

This CMS Quality, Safety and Oversight memo was issued on March 16, 2018.

Key Points:

The Centers for Medicare & Medicaid Services (CMS) is providing clarification related to adequacy assessment or Rapid On-Site Evaluation (ROSE) on material aspirated during a Fine Needle Aspiration (FNA) procedure, 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.

During a Fine Needle Aspiration (FNA) procedure, material is aspirated from a suspicious site, and then an adequacy assessment or a Rapid On-site Evaluation (ROSE) is performed microscopically by a qualified individual to assure that diagnostic material is present. This adequacy assessment helps to ensure that the aspiration will not need to be repeated for the diagnostic slide examination. These slides are not fully screened at this time. Once specimen adequacy has been determined, laboratories, including physician office laboratories, that perform diagnostic examination of FNA or ROSE slides must comply with CLIA regulations, including, but not limited to, 42 CFR 493.20 and 493.25, as applicable.

In this memorandum, CMS also addresses:

Determination of Workload Limits during Specimen Adequacy Assessments and Diagnostic Slide Examinations

During Adequacy Assessment

  • Slide assessments that provide only a determination of specimen adequacy are not to be counted toward individual daily slide workload limit.
  • The maximum number of slides the individual can examine in a 24 hour period should be prorated when performing specimen adequacy assessments, by using the formula described in 42 CFR 493.1274(d)(2)(ii).

During Diagnostic Slide Examination

  • For Pathologist or Cytologist who performs the primary evaluation/examination each slide is counted toward their daily slide workload limit.
  • For a Pathologist who performs the secondary examination of a cytology slide after a Pathologist or Cytologist performed the primary examination/evaluation, the slide is not counted toward the secondary Pathologist daily slide workload limit. This is per 42 CFR 49.1274(d)(2)(iv), previously examined cytology slides are not required to be counted in the 100 slide workload limit.

Are any AOA/HFAP Standards affected by this change?

Standards 09.03.12, 09.03.13, 09.03.14, 09.03.15, 09.03.16, 09.03.17, and 09.03.18 of the Accreditation Requirements for Clinical Laboratories are relevant to this CLIA update.

Effective date: Immediately

Click here to read CMS QSO 18-14:

Questions? Contact us at info@hfap.org.