Creating a Molecular Environment, Phase 4

Abstract

When implementing molecular testing in the microbiology laboratory at OSF Saint Francis Medical Center, we started with the more difficult laboratory-developed testing and then moved to the United States Food and Drug Administration (FDA)–approved assays, which are equally important but require a less rigorous evaluation process. FDA-approved molecular testing can be less difficult because the assays in question have already been developed and validated. Our responsibility is to make sure that these assays work for our laboratory, write up the protocol with our specifications, and perform training before we turn out results on patients. Using FDA-approved testing usually involves following certain guidelines, which takes most of the guesswork out of the evaluation process. In 2007, the Illinois legislature passed a law known as the MRSA Screening and Report Act, which required all hospitals in Illinois to implement screening criteria for patients to determine whether they are carriers of methicillin-resistant Staphylococcus aureus (MRSA) on admission. This did not involve all patients but included those that were, according to the MRSA Screening and Report Act, “in all intensive care units, and other at-risk patients identified by the hospital”. OSF established guidelines for screening that have change slightly over the years. The most current screening criteria are as follows: [↵][1]* To whom correspondence should be addressed. E-mail: stephanie.e.wallace{at}osfhealthcare.org [1]: #xref-corresp-1-1