CMS Releases Updated State Operations Manual for Laboratories

The Centers for Medicare and Medicaid Services (CMS) recently released an updated advance copy of the State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services under the Clinical Laboratory Improvement Amendments (CLIA). The manual provides guidance to help laboratories comply with CLIA regulations and incorporates feedback received from the laboratory community since 2017.

The manual’s key revisions clarify frequently asked questions from stakeholders and surveyors related to quality assessment, temperature and humidity monitoring, calibration verification, alternative control materials for provider-performed microscopy procedures, cytology annual statistical laboratory evaluation, test reports and other areas.

AABB reminds accredited facilities that CLIA requirements are minimal requirements and that they must follow all standards of their accreditation organizations.

Laboratories can sign up to receive CMS-CLIA email communications online. Individuals may also sign up to receive email updates directly from CMS-CLIA by submitting their email addresses at the bottom of the CMS-CLIA website. 

Additional CLIA updates are available through the Clinical Laboratory Improvement Advisory Committee (CLIAC).