APHL 2022 POSTER ABSTRACTS and completeness of ELR data collection and the processing from healthcare facilities and reporting jurisdictions to PHAs , ultimately resulting in enhanced data reporting to both the CDC and to HHS .
Presenter : Michelle Schmitz , Booz Allen Hamilton , Schmitz _ Michelle @ bah . com
Office of Regulatory Affairs Data Exchange : Sample Data Sharing
O Fennell , US Food and Drug Administration
The ORA Data Exchange ( DX ) enables FDA and regulatory partners to securely share sample collection , receipt and analysis data on selected microbiological , chemical and radiological analytes . This real-time data sharing initiative allows for rapid review of analysis data to improve food safety testing efforts , assist in risk assessment analysis , increase efficiencies and aid in timely and accurate regulatory decision making . The ORA DX allows for multiple regulatory information sharing capabilities via the ORA Partners Portal ( ORAPP ) and the System-to-System Services ( a . k . a . NFSDX ). ORAPP is a web portal that provides a user interface for data sharing between FDA and regulatory partners . The System-to-System Services provide an interface to submit data directly from the LIMS / regulatory partner system to FDA system , which reduces manual data entry . Also , the ORA DX includes the Enhanced DX Client , a desktop client application , which also supports the submission of sample data to FDA . There are labs that have come onboard for all available sample data sharing options ( ORAPP , System-to-System Services and Enhanced DX Client ). Maryland Department of Health ( MDH ) Laboratories Administration is a noteworthy example of System-to-System Services onboarding funded by the Laboratory Flexible Funding Model ( LFFM ). The agency completed system integration development in only three weeks . Such fast-paced system integration was the result of a long-standing partnership between the agency and their IT vendor on a series of projects including a largescale LIMS upgrade that preceded System-to- System integration . ORA Office of Regulatory Science has initiated state lab production usage of sample data sharing capabilities . So far , Connecticut Agricultural Experiment Station , Michigan Department of Agriculture and Rural Development and MDH have electronically sent sample data via ORA DX .
Presenter : Omari Fennell , US Food and Drug Administration , omari . fennell @ fda . hhs . gov
A Standardized Approach to Electronic Test Orders and Results ( ETOR )
J Kondamuri , . Park , T Hardin , E Jordanov and S Downer , J Michael Consulting , LLC
Background : The ability to exchange electronic test orders and results ( ETOR ) streamlines a laboratory ’ s workflow , improves data quality and completeness , reduces turnaround time and enhances forecasting . Yet due to the challenges of implementation , ETOR adoption remains low among public health laboratories ( PHLs ). J Michael Consulting ( JMC ) has developed standardized and scalable tools and processes to help PHLs efficiently onboard trading partners and maintain production-level ETOR interfaces with many clients with minimal overhead . This poster describes JMC ’ s ETOR solution and toolkit .
Methods : JMC leverages a LIMS-agnostic , table-driven Rhapsody route as the cornerstone of its ETOR solution . As many PHLs already use the Rhapsody integration engine for other use cases , this solution builds on existing infrastructure and expertise within the PHL . The ETOR solution connects all clients via web service , rather than onerous point-to-point connections . JMC recommends basing the ETOR message specification on the HL7 LOI and LRI Implementation Guides and has developed tools to facilitate the gap analysis and validation process for both the hospital and the PHL . JMC has a suite of test scenarios for communicable disease testing and newborn screening that can be modified based on use case and the PHL ’ s test catalogue .
Results : JMC has partnered with multiple PHLs , hospitals and other trading partners to implement an agile ETOR solution that is easy to maintain and reuse across laboratories and laboratory systems .
Conclusions : The JMC ETOR solution is driving adoption of ETOR between PHLs and their clients .
Presenter : Jyothi Kondamuri , J Michael Consulting , jkondamuri @ jmichael-consulting . com
LIMS Lite : A Public Health Informatics Ecosystem for Implementing Sequencing Workflows , Bioinformatics Analyses and Data Sharing in Public Health Laboratories
M Marshall 1 , C Dominguez 1 , B Lewis Van 1 , J Smagala 2 , G Peterson 3 , E Neuhaus 4 ; 1 J Michael Consulting , 2 Revolutionary Informatics ,
3
Yahara Software , 4 Centers for Disease Control and Prevention
Public health agencies are expanding genomic sequencing capacity to improve surveillance and epidemiological investigations . While sequencing data adds valuable information to aid in metabolic disorders , outbreak detection , transmission chain tracing and understanding large-scale dynamics of pathogen evolution , it also poses new challenges for public health laboratories ( PHLs ). For example , performing sequencing workflows requires new laboratory processes and new biostatistical expertise . Presently , a lack of standardization in sample processing into sequencing libraries , implementation of bioinformatics pipelines and result reporting makes it difficult to reliably reproduce and share results . This presents an urgent need for a unified informatic ecosystem to support standardized pathogen sequencing workflows and analyses and to facilitate efficient data sharing for public health . This session will introduce participants to the innovative LIMS Lite platform that CDC and J Michael Consulting are building to bridge this informatics gap . LIMS Lite is an open source unified informatic ecosystem designed to facilitate the execution of standardized laboratory workflows and bioinformatics analyses , to ease reporting of genomic attributes and to simplify efficient data sharing among public health agencies . Currently being built to support multiple pathogens , including Influenza , SARS-CoV-2 and Anthrax , LIMS Lite aims to unify the sequencing methodologies used among public health laboratories . Uniting laboratory analysis and reporting will improve process validation , reproducibility and traceability of sequencing data , advancing our ability to monitor and understand outbreaks . Several key features of LIMS Lite are designed to increase accessibility and auditability of sequencing to public health laboratories . A user-friendly interface implements click-through protocols for conducting sample workflow , execution of bioinformatics pipelines , viewing of results and data sharing . This
Informatics