Facilities in the United States that perform laboratory testing on human specimens for health assessment or disease diagnosis, prevention, or treatment are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). A CLIA Certificate for Provider-Performed Microscopy (PPM) procedures permits physicians and midlevel practitioners to perform a limited list of moderate complexity microscopic tests, as well as waived tests, as part of a patient’s visit.
PPM procedures are a select group of moderately complex microscopic tests that do not meet the criteria for waiver because they are not simple procedures; they require training and specific skills for test performance and they must meet certain other criteria. Controls are generally not available to monitor the complete testing process for these procedures. Therefore, only limited activities are suitable for inspection. The laboratory or testing site performing PPM procedures is not subject to routine biennial inspections. However, a CLIA certificate is required and the laboratory or testing site must meet the CLIA quality standards for moderate complexity testing.
The Center for Disease Control and Prevention (CDC) recently published an educational booklet for PPM testing. This booklet describes recommended practices for physicians, midlevel practitioners (nurse midwife, nurse practitioner, or physician assistant), and dentists who perform patient testing under a CLIA Certificate for PPM procedures.
The booklet contains an overview of the regulatory requirements, resources including forms and examples, and an overview with images of common microscopic findings for the nine specific microscopic examinations that may be performed under a Certificate of PPM Procedures. The following is a link to the CDC educational booklet: http://wwwn.cdc.gov/clia/resources/ppmp/pdf/15_258020-A_Stang_PPMP_Booklet_FINAL.pdf
|
