Non Technical Summary
This project will help the South Dakota Animal Disease Research and Diagnostics Laboratory (ADRDL) continue to be a top-level partner with National Animal Health Laboratory Network (NAHLN) in providing a solid defense to the American agriculture system. In this capacity, ADRDL will ensure that it is prepared to support the NAHLN mission to monitor, detect, and respond in a timely manner to potential emergencies related to animal disease outbreaks (e.g., bird flu or swine flu or foot and mouth disease, etc.). ADRDL will achieve this goal and objective by using and sharing its current diagnostic capabilities, quality system, IT system, financial system, and administrative resources for NAHLN activities related to ensuring employee competencies, test method validation, real time data communication with stakeholders, emergency preparedness exercises, disease monitoring activities, and other NAHLN support activities as required. We believe that ADRDL's collaboration with NAHLN will help our nation to be ever prepared to deal with emerging or existing threats to animal health, agriculture, and food supply in a timely manner.

Classification

Knowledge Area (KA)	Subject of Investigation (SOI)	Field of Science (FOS)	Percent
311	3910	1040	100%

Knowledge Area
311 - Animal Diseases;

Subject Of Investigation
3910 - Cross-commodity research--multiple animal species;

Field Of Science
1040 - Molecular biology;

Goals / Objectives
Maintain capacity and provide surge testing for the following diseases. ASF/CSF RT PCR, Antimicrobial Susceptibility Testing (AST) and Antimicrobial Resistance (Whole Genome Sequencing), AI/NDV RT PCR, CWD ELISA, FMD RT PCR, PRV gB and g1 ELISA, Spring Viremia of Carp VI, IAS RT PCR (Matix and Subtyping), IAS VI, IAS sequencing, and VHSV RT PCR, and VI.Maintain full AAVLD accreditation.Follow APHIS-VS procedures (and approved manuals and guidance documents) provided for NAHLN testing and reporting (submit a planned deviation, if required), and adhere to the NAHLN standards for use of NAHLN reagents and controls.Ensure that ADRDL personnel will not use NAHLN materials for research, nor distribute any NAHLN materials outside of the laboratory unless approved in advance by the NAHLN Program Office and NVSL Reference Laboratory.Participate in disease investigations, surveillance, and outbreak situations; communicate expected timeframes, priority, and limitations for testing.Comply with the notification guidelines, as outlined in the current NAHLN agreement. ADRDL will also follow appropriate reporting guidelines for accredited veterinarians.Provide assistance, including testing samples or temporarily sending personnel from ADRDL to other laboratories or field operation centers during emergency outbreak situations if required. (As long as South Dakota is not impacted by the outbreak),Comply with the personnel quarantine policy stating that persons working in or visiting the NAHLN facility where high risk animal pathogens from an FAD/ED investigation or outbreak area may have been present are restricted from contact with susceptible animals for a period of five (5) days, and follow the recommended decontamination procedures upon positive laboratory findings.Follow BMBL guidelines to ensure consistency with agent-specific issues of bio safety, sample handling, worker training, select agent materials, and facility requirements associated with the agent- specific including BSL3 spaceAbide by the International Air Transportation Association and all other Federal/state requirements for shipment of dangerous goods and agents, and will have trained personnel to ship these materials, and maintain all permits necessary to appropriately ship samples.Be in compliance with current Federal Select Agent Program regulations regarding the receipt, possession, use, storage, shipping, transfer, and notification processes for Select Agents.Maintain contact with FBI/WMD Coordinator to determine how and when the FBI wants to be notified about pertinent issues.Maintain a fully functional LIMS and competency to electronically message results for approved program diseases, and for which there is a messaging guide.Ensure that employees comply with APHIS-VS security and IT training requirements, or Federal equivalent, and restrict access to samples and results only to approved personnel.Maintain current laboratory information in the APHIS Laboratory Portal by updating at least quarterly and providing capacity information when requested. Participate in NAHLN exercise programs as requested by the NAHLN Program Office, as resources allow.Fulfill the administrative requirements related to Federal funding received for various NAHLN activities and will invoice monthly for reimbursable activities.Participate in NAHLN-related activities, such as working groups, subcommittees, or scenario testing exercises.

Project Methods
Objective 1. Meet all responsibilities of a Level 1 laboratory as outlined in the FY23 agreement. As a Cooperator, ADRDL at SDSU, will take following actions to meet the responsibilities of a Level 1 laboratory leading to increase in NAHLN capabilities and capacity. NAHLN will determine if ADRDL meets the requirements of a Level 1 Laboratory.IT system:Contract with LIMS specific experts to help with LIMS integration of HL7 or modification to commercial LIMS to encompass HL7 requirements, attend training for existing IT personnel in NAHLN laboratories, and obtain or support electronic accessioning capability.Message diagnostic test results, using HL7 standards, to the Laboratory Messaging System (LMS) or other VS systems for all laboratory-approved NAHLN tests.Participate in available messaging competency events.Develop new messages for diagnostic test results in a timeframe prescribed by NAHLN.Comply with IT system access and connectivity requirements, i.e. Information Security Awareness and Acknowledgement of Rules of Behavior training, e-authentication enrollment, and submission of APHIS 513 forms as applicable.Provide diagnostic data per the specified timelines and reporting requirements.Quality system:Maintain full accreditation by AAVLD and provide documentation of such.Attend quality management trainings and maintain software to support the quality system.Laboratory and administrative personnel:Accept and test samples to support disease investigations, surveillance and outbreak events.Assist other laboratories during emergency situations as able.Maintain ADRDL portion on APHIS Laboratory Portal.Maintain the ability to fulfill the administrative requirements related to federal funding received for various NAHLN activities.Purchase and maintain equipment that directly increases the Cooperator's laboratory capacity and support emerging disease diagnostics, e.g. Metagenomics/ Next Generation sequencing equipment.Quarterly reports will be submitted to NAHLN summarizing outcomes of the actions described above.