NAHLN:WA-WASHINGTON ANIMAL DISEASE DIAGNOSTIC LABORATORY PARTICIPATION AS A LEVEL 1 LABORATORY IN THE NATIONAL ANIMAL HEALTH LABORATORY NETWORK

<b>Project Methods</b><br> Methods for laboratory testing for foregin animal diseases in the NAHLN must meet multiple requirements set forth by USDA and include: (1) Standard operating procedures are provided to the laboratories for all NAHLN assays to ensure appropriate and standardized testing, flow of samples, and reporting of assay results across the network; (2) NAHLN laboratories must agree to use protocols and reagents that are provided by the NAHLN Program Office only in accordance with published agent-specific USDA surveillance and/or response plans, VS Guidance (such as 12001) and current versions of SOPs when conducting NAHLN assays for suspected high consequence livestock pathogens and other bio-threat agents; (3) NAHLN laboratories are trained and proficiency tested for a variety of FAD assays, and may be asked to conduct screening tests on samples collected during an animal disease investigation. These assays must be used in accordance with the procedures and timeframes defined in the current version of the Veterinary Services Guidance 12001: Policy for the Investigation of Potential Foreign Animal Disease/Emerging Disease Incidents (FAD/EDI), Surveillance Manuals and SOPs; (4) Laboratories are expected to follow the procedures for reporting results and notifications to appropriate State and Federal officials that are detailed in the appropriate VS Guidance, Surveillance Manuals, and/or Standard Operation Procedures; (5) Laboratories are expected to have developed and/or reviewed their sample receiving and handling activities, guidelines and standard operating procedures (SOP) to ensure consistency with agent-specific issues of laboratory safety, sample and specimen handling, worker training, select agent materials and facility requirements associated with the agent-specific functional designations; (6) NAHLN laboratories may be involved with the use, transfer, and possession of high consequence livestock pathogens and toxins and select agent materials. Whether or not the NAHLN laboratory is registered to possess Select Agents, they will be required to follow notification and transfer processes and be compliant with all current regulations of the Federal Select Agent Program for the receipt, possession, use, storage, shipping, and transfer of select agents and toxins in Title 9 Code of Federal Regulations (CFR) Part 121, 7 CFR Part 331, and 42 CFR Part 73); (7) NAHLN laboratories will be expected to ship and receive samples containing hazardous materials. There are specific requirements for shipment of dangerous goods (International Air Transport Association) and shipment of organisms (Title 9 CFR, Part 122). NAHLN laboratories are expected to have personnel trained and qualified in shipping requirements for hazardous materials, and to have and maintain the permits necessary to appropriately ship and receive these samples; (8) NAHLN laboratories perform regulatory testing for a variety of purposes. Laboratories are expected to provide results for this testing through the appropriate mechanisms and according to the timelines specified in the applicable program standards, surveillance manuals, NAHLN standard operation procedures and/or VS guidance documents.