BACKGROUND: Since 2013, FDA has approved several culture-independent syndrome-based, multi-analyte nucleic acid panels for enteric pathogens. These culture-independent diagnostic tests (CIDTs) allow a clinical laboratory to simultaneously and rapidly detect a wide range of enteric pathogens. CIDTs offer faster turnaround time in the clinical laboratory setting, among other benefits. Use of these tests has implications on isolate-based public health surveillance systems, such as PulseNet. The Association of Public Health Laboratories (APHL) commissioned an analysis of current state legal requirements for the submission of isolates or other clinical materials from clinical to public health laboratories in the United States. Additionally, a checklist was developed to assist public health departments in revising and strengthening their requirements for submission of isolates or other clinical material from clinical laboratories.
METHODS: A review of state statutes and regulations among the 50 states and the District of Columbia was compiled from electronic research databases and state publications from June 9-26, 2015. A total of 8 enteric pathogens were included in the analysis: Campylobacter species, Clostridium botulinum, Cryptosporidium, E. coli (O157 and non-O157 STEC)/Shiga toxin producing E. coli, Listeria monocytogenes, Salmonella species (Typhi and non-Typhi), Shigella species and Vibrio species. A checklist was then developed citing examples of strong legal frameworks and language which supports mandatory submission of isolates or other clinical materials by clinical laboratories.
RESULTS: Among the regulations and statutes analyzed, several approaches were used by states in mandating submission of isolates or other clinical materials from clinical laboratories. Forty-three state jurisdictions mandate submission of isolates or other clinical materials for at least three of the eight pathogens analyzed. Of the remaining jurisdictions, four do not require routine submission of isolates or other clinical materials and others only require submission under certain circumstances (upon request or suspicion of bioterrorism or outbreaks).
CONCLUSIONS: While some states have robust laws mandating isolate submission, a need still exists for improvement in many states, given the increasing challenges of CIDTs. States should consider using the checklist that was developed to strengthen their legal framework for mandatory isolate submission. Isolate submission is critical to maintaining the nation’s foodborne disease surveillance and response system.