Provider-Performed Microscopy Procedures

Background

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulates U.S. facilities that perform laboratory tests on human specimens for health assessment, disease diagnosis, prevention, or treatment. CLIA allows facilities with a CLIA Certificate for PPM procedures to perform a limited number of moderate complexity tests using a bright-field or phase-contrast microscope and any waived tests.

Overview of PPM procedures

PPM procedures are moderately complex microscopic tests that do not qualify for waiver because they are not simple procedures. PPM procedures require training and specific skills for test performance and must meet certain other criteria. Controls are generally not available to monitor the complete testing process for these procedures.

A CLIA certificate is required and the laboratory or testing site must meet the CLIA quality standards for moderate complexity testing. The laboratory or testing site performing PPM procedures under a CLIA Certificate for PPM procedures is not subject to routine biennial inspections.

Educational materials

Digital copies of our resources are available for download ensuring immediate and unlimited use for the laboratory community. Access the link below to download a copy.

CLIA and PPM: An Introduction eLearning course

This course focuses on the CLIA requirements for laboratories and testing sites conducting PPM procedures. This course emphasizes quality practices to prepare licensed physicians, midlevel practitioners, and dentists who perform patient testing under a CLIA Certificate for PPM procedures, as well as those who serve as laboratory directors at laboratories or testing sites that perform PPM procedures.

This booklet describes regulatory requirements and recommended practices for licensed physicians, midlevel practitioners, and dentists who perform patient testing under a CLIA Certificate for PPM procedures or those who serve as laboratory directors at laboratories or testing sites that perform PPM procedures. The booklet includes:

• An overview of the regulatory requirements for PPM procedures
• Resources including forms and examples
• Common microscopic findings for the nine specific microscopic examinations that may be performed under a Certificate of PPM Procedures, including images

CLIA Resources

Contact

For questions or comments, please email the Division of Laboratory Systems at dlsinquiries@cdc.gov.