FY 24 NAHLN Infrastructure Agreement (Farm Bill)

FISCAL YEAR 2024 TARI Digitally signed NAHLN Level 2 Laboratory Work Plan by TARI MOODY MOODY Date: 2024.04.29 13:00:23 -05''00'' INTRODUCTION In compliance with the Cooperative Agreement between the University of Kentucky Research Foundation and the United States Department of Agriculture (USDA), Animal and Plant Health Inspection Services (APHIS), Veterinary Services (VS) this Work Plan sets forth the objectives, roles, responsibilities, and activities for your laboratory to maintain Level 2 Laboratory designation within the structure of the National Animal Health Laboratory Network (NAHLN) beginning in Fiscal Year (FY) 2024. The APHIS, VS, National Veterinary Services Laboratories (NVSL), will provide funding in support of the cooperative endeavor outlined in this Work Plan. I. NEED FOR ASSISTANCE The Nation’s public health and food supply is at constant risk from accidental or malicious introduction of exotic animal diseases. In 2002, Congress recognized the severity of these threats and provided funding to USDA to enhance early detection of foreign animal disease agents and newly emerging diseases and to better respond to animal health emergencies (including bioterrorist events) that threaten the Nation’s food supply and public health. The NAHLN was formed to coordinate Federal laboratory capacity with the extensive infrastructure (facilities, professional expertise, and support) of State supported laboratories. The NVSL serves as the National Reference Laboratory for the NAHLN and provides training, test procedures, proficiency testing, assay controls, and equipment while the laboratories of the NAHLN provide the laboratory space and personnel necessary to ensure that the U.S. has the capacity and capability to detect and respond to an animal disease outbreak. To allow the Network to achieve its surveillance and response goals and to expand its capability and capacity for detecting emerging and zoonotic diseases to protect animal health, public health, and the nation’s food supply, the NAHLN is structured into five laboratory designations: Level 1, Level 2, Level 3, Affiliate and Specialty. The NAHLN Agreement for Participation defines each designation’s roles and responsibilities within the Network. Level 1, Level 2, and Level 3 Laboratories within the NAHLN will receive annual infrastructure support from the USDA to help laboratories maintain the requirements necessary to remain approved within each designation and to support an overall increase in NAHLN capacity and capabilities to meet the needs faced during an adverse animal health event caused by the presence of an emerging disease or foreign animal disease. II. OBJECTIVES AND APPROACH A. Objectives x Meet all responsibilities of a Level 2 laboratory as outlined in the 2024 Agreement for Participation in the National Animal Health Laboratory Network (NAHLN) As a Level 2 Laboratory. x Increase NAHLN capabilities and capacity in addressing an adverse animal health event such as may occur with an emerging disease detection or foreign animal disease outbreak. These objectives will be supported with a base amount of infrastructure funding that will, at some level, recur annually. B. Plan of Action 1. The Cooperator will take the necessary actions to conduct the following NAHLN activities to meet the responsibilities of a Level 2 laboratory: Page 1 of 4 a. Support and/or hire IT personnel to- x Actively and consistently electronically message diagnostic test results, using HL7 standards, to the Laboratory Messaging System (LMS) or other VS systems for all laboratory approved NAHLN assays able to be messaged; x Maintain the ability to use HL7 standards to electronically transmit test result data to APHIS databases by participating in appropriate/available messaging competency events; x Develop new messages for diagnostic test results in a timeframe prescribed by NAHLN; x Comply with IT system access and connectivity requirements: i.e. Information Security Awareness & Acknowledgement of Rules of Behavior training, e-authentication enrollment and submission of APHIS 513 forms as applicable; x Provide diagnostic data per the specified timelines and reporting requirements. b. Support a quality system by - x Maintaining full accreditation by AAVLD or by an accrediting body according to OIE/ISO 17025 standard and provide documentation of such. c. Support laboratory and administrative personnel to - x Accept and rapidly test samples in support of disease investigations, surveillance and outbreak situations; x Assist other laboratories during emergency situations as able; x Utilize the APHIS Laboratory Portal; x Maintain the ability to fulfill the administrative requirements related to federal funding received for various NAHLN activities. 2. The Cooperator will choose from any, or all, of the following categories and perform the necessary procedures to conduct activities to increase NAHLN capabilities and capacity: a. Equipment - x Purchase equipment that directly increases the Cooperator’s laboratory capacity. (Equipment must be identified in the financial plan) x Purchase equipment to support emerging disease diagnostics, such as Metagenomics/ Next Generation sequencing equipment. (Equipment must be identified in the financial plan) b. Electronic messaging enhancement - x Contract with LIMS specific experts to help with LIMS integration of HL7 or modification to commercial LIMS to encompass HL7 requirements. x Attend training for new/existing IT personnel in NAHLN laboratories. x Obtain or support electronic accessioning capability. c. Quality management support - x Attend quality management training that can include NAHLN QMS training, AAVLD Quality Symposium, ISO 17025 training, QA software training, etc. x Purchase software to support the quality system. d. Technical support to increase FAD and/or emerging disease diagnostic capabilities and capacity, such as - x Complete additional proficiency tests for FADs that are not reimbursed through other NAHLN or APHIS agreements. x Training in advanced diagnostics in support of emerging disease detection – new technology training such as that to acquire expertise for whole genome sequencing operation and analysis. x Emerging disease case work up: develop and implement a diagnostic plan for samples that remain undiagnosed following routine workups. x Support NAHLN and APHIS related activities in the establishment of technical aspects of emerging disease detection and reporting protocols, such as- Participate in validation, proficiency testing, standard operating procedures development and review, development of data transfer mechanism, etc. x The Cooperator will maintain awareness of IT capabilities within the facility in which their laboratory is housed and assess and mitigate any impacts to messaging capability as they arise. Page 2 of 4 3. USDA, APHIS, VS, NVSL personnel will: a. Serve as the responsible Federal agency on behalf of the USDA. b. Provide training and expertise as needed to personnel from cooperating laboratories to increase understanding of quality systems, electronic messaging requirements, and technical training on diagnostic assays that fall under the scope of NAHLN. c. Provide guidelines and assistance to the Cooperator in the implementation phase of the project. d. Provide guidelines and assistance to the Cooperator in ensuring full compliance with Federal regulations. e. Assist in ensuring there is effective communication among all participants contributing to the objectives of the agreement. C. Resources Required 1. The Cooperator will: a. Provide a Quality Manager to support the Cooperator laboratory’s quality system. b. Provide laboratory information management system capable of capturing and electronically messaging test results data to APHIS databases. c. Provide personnel necessary to complete the activities chosen from the categories above in II.B. 2. USDA, APHIS, VS, NVSL will provide the following: a. Funding for/to support the above objectives. III. QUANTITATIVE PROJECTION OF ACCOMPLISHMENTS TO BE ACHIEVED A. Reporting Quarterly Performance and Financial Reports are required to be submitted into ezFedGrants (eFG) as outlined on the Award Face Sheet. The reports template becomes available for submission in eFG on the last day of each quarter and are named according to the calendar year quarter instead of the agreement quarter. When the reports generate in eFG, they are available in the Actionable Items tile for the GAO and Recipient Administrative Contact. Reports are due 30 days after the end of the calendar year quarter and final reports are due no later than 120 days following the expiration or termination of the award. 1. Financial Reporting x The Recipient must maintain complete, accurate and current records which disclose the Federal funds for the program. x The Federal Financial Report, SF-425, is cumulative and used to report the status of funds for the award. 2. Performance Reporting x Performance Reports outline the accomplishments that have been achieved by the Recipient to meet the proposed Work Plan goals and objectives. It is recommended that in the performance narrative section, Block 10 of the generated form, you state, “See Attached” and upload your Accomplishment Report (template will be provided by NAHLN). Prior data remains on your Accomplishment Report to assist in tracking progress. x The Accomplishment Report will document a list of accomplishments of agreed upon work functions, including the progress and activities related to electronic messaging of required disease testing, electronic messaging of all laboratory-approved NAHLN assays, participation in messaging competency events, quality management system activities (internal audit, management reviews, etc.), equipment purchases that enhance capacity and/or capability, Quality Management and/or technical support training and Quality Management software purchase and use. The report will contain narrative explanations for any deviations from projected norms. When accomplishments Page 3 of 4 cannot be quantified by activity or function the Cooperator will provide the target date for each function and an estimate of what the capabilities will be. B. Claims Claims are submitted and processed through eFG to receive reimbursement for work performed. Claims should be broken down by cost category using the “Requested Amount by Cost Element” section of the claim or included as an attachment. IV. DATA COLLECTION AND MAINTENANCE A. Establish Criteria to Evaluate Project 1. Results: Quarterly progress reports will validate the presence of requirements needed to maintain current laboratory designation and confirm progress in meeting the category requirements chosen by the laboratory to increase laboratory capabilities and capacity. 2. Successes: Laboratories will meet the requirements necessary to maintain current laboratory designation and provide evidence of enhanced capability and capacity. B. Methodology Used to Determine If 1. Identified needs are met: The NAHLN Annual Assessment will be used to identify if the requirements necessary to maintain current laboratory designation are maintained and capability and capacity are enhanced. 2. Results and benefits are achieved: The final report will be used to determine if results and benefits are achieved. V. RESULTS OR BENEFITS EXPECTED Successful completion of these efforts will result in the laboratory meeting key responsibilities that are required to maintain Level 2 Laboratory designation and enhancing the overall capacity and capability of the Network. Laboratories with accredited quality management systems, trained personnel, ability to electronically message test results with Health Level 7 (HL7) standards and active participation in routine surveillance and emerging disease and foreign animal disease investigations are critical to maintaining our preparedness and strength as a Network. VI. GEOGRAPHIC LOCATION IN WHICH PROJECT IS TO TAKE PLACE This project will take place in the Cooperator’s laboratory. Page 4 of 4