TABLE 1.

Roles of the medical microbiologist

Role	Valuesa
Clinical consultation	Provides guidance on test selection and appropriate specimen collection Assists with interpretation of test and antimicrobial susceptibility results
Scientific oversight and vision	Monitors developments in the field to ensure that laboratory testing meets current needs (e.g., emergence of novel antimicrobial resistance factors, syndromes and/or pathogens)
Test evaluation, verification, implementation, and oversight	Evaluates and verifies clinical utility and performance of FDA cleared/approved laboratory tests in the local setting Establishes impact of testing options and algorithms on patient care Ensures that test results are reported in an accurate and clear manner, with addition of appropriate interpretative guidance as applicable Ensures cost effective selection and implementation of tests Creates protocols for laboratory testing practices Develops test menus and guidelines for optimal laboratory test utilization in collaboration with clinical colleagues Establishes and monitors quality indicators to ensure maintenance of test performance standards after implementation Selects and evaluates external laboratories to which specimens are referred for testing Monitors referral lab testing to ensure appropriate use
Test modification, development and validation	Validates performance of off-label usage of FDA-approved/cleared assays Develops and validates laboratory developed tests as required to support the populations served by the laboratory
Regulatory and administrative oversight	Ensures compliance with regulatory/accrediting bodies (e.g., CMS, Joint Commission, CAP) Establishes and enforces safe laboratory practices Complies with institutional guidelines (e.g., Institutional Review Board, Biosafety committee)
Institutional leadership	Represents the laboratory on institutional committees, including infection prevention and control, and antimicrobial stewardship Serves on ad hoc committees in outbreak settings (e.g., outbreaks of Ebola virus infection, pandemic influenza)
Education	Trains residents and fellows from pathology, infectious diseases, pharmacy and other relevant specialties in the field of clinical microbiology Provides education to physicians, nurses and allied health staff on appropriate specimen collection, test utilization and interpretation Communicates test updates to the local healthcare system
Research	Participates in clinically relevant research; examples may include (i) evaluating test performance in comparative and outcome studies, (ii) assessing cost-benefit and clinical impact of testing protocols, and (iii) contributing to the development of best-practice guidelines

^aCAP, College of American Pathologists; CMS, Centers for Medicare and Medicaid Services; CLIA, Clinical Laboratory Improvement Amendments; FDA, United States Food and Drug Administration.