Impact of Delays between Clinical and Laboratory Standards Institute and Food and Drug Administration Revisions of Interpretive Criteria for Carbapenem-Resistant Enterobacteriaceae

Sarah M Bartsch; Susan S Huang; Kim F Wong; Rachel B Slayton; James A McKinnell; Daniel F Sahm; Krystyna Kazmierczak; Leslie E Mueller; John A Jernigan; Bruce Y Lee

doi:10.1128/JCM.00635-16

Impact of Delays between Clinical and Laboratory Standards Institute and Food and Drug Administration Revisions of Interpretive Criteria for Carbapenem-Resistant Enterobacteriaceae

J Clin Microbiol. 2016 Nov;54(11):2757-2762. doi: 10.1128/JCM.00635-16. Epub 2016 Aug 31.

Authors

Affiliations

¹ Public Health Computational and Operations Research (PHICOR), Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
² Division of Infectious Diseases and Health Policy Research Institute, University of California-Irvine School of Medicine, Orange, California, USA.
³ Center for Simulation and Modeling, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
⁴ Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
⁵ Infectious Disease Clinical Outcomes Research Unit (ID-CORE), Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center, Torrance, California, USA.
⁶ Torrance Memorial Medical Center, Torrance, California, USA.
⁷ International Health Management Associates, Inc., Schaumburg, Illinois, USA.
⁸ Public Health Computational and Operations Research (PHICOR), Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA brucelee@jhu.edu.

Abstract

Delays often occur between CLSI and FDA revisions of antimicrobial interpretive criteria. Using our Regional Healthcare Ecosystem Analyst (RHEA) simulation model, we found that the 32-month delay in changing carbapenem-resistant Enterobacteriaceae (CRE) breakpoints might have resulted in 1,821 additional carriers in Orange County, CA, an outcome that could have been avoided by identifying CRE and initiating contact precautions. Policy makers should aim to minimize the delay in the adoption of new breakpoints for antimicrobials against emerging pathogens when containment of spread is paramount; delays of <1.5 years are ideal.

Publication types

Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, P.H.S.

MeSH terms

Anti-Bacterial Agents / pharmacology*
Carbapenems / pharmacology*
Carrier State / diagnosis*
Carrier State / microbiology
Clinical Laboratory Services / standards
Disease Transmission, Infectious / prevention & control
Enterobacteriaceae / drug effects*
Enterobacteriaceae / isolation & purification
Enterobacteriaceae Infections / diagnosis*
Enterobacteriaceae Infections / microbiology
Humans
Infection Control / methods
Microbial Sensitivity Tests / methods*
Microbial Sensitivity Tests / standards*
Time
United States
United States Government Agencies
beta-Lactam Resistance

Substances

Anti-Bacterial Agents
Carbapenems

Abstract

Publication types

MeSH terms

Substances

Grants and funding