English: Health care providers use laboratory test results to diagnose disease, determine prognosis, and monitor a patient’s treatment or health status. Current practice shows an increased trend for medical decisions based on tests performed at the point of care. Forethought, planning, and preparation are critical when making decisions to begin testing or when adding a new test to the menu in a laboratory, physician office, or other point-of-care location. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) Certificate for Provider-Performed Microscopy (PPM) procedures issued by the Centers for Medicare & Medicaid Services (CMS) permits a laboratory or testing site to perform a limited list of moderate complexity microscopic tests, as well as any waived tests.

PPM-certified laboratories may perform certain microscopic examinations during the course of a patient visit using specimens that quickly deteriorate or are not easily transportable. PPM-certified laboratories must meet the same CLIA quality standards as laboratories performing moderate complexity tests. 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 CLIA requirements for testing under a Certificate for PPM can be found at http://www.gpo.gov/fdsys/pkg/CFR-2003-title42-vol3/ xml/CFR-2003-title42-vol3-part493.xml#seqnum493.19.

Although some of the recommendations in this booklet exceed CLIA requirements for provider-performed microscopy testing, following these good testing practices will likely lead to reliable, high quality test results.

The findings and conclusions in this booklet are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

CS258020-A

Collection: Stephen B. Thacker CDC Library collection

https://stacks.cdc.gov/view/cdc/38523/cdc_38523_DS1.pdf