Source: Rollins Animal Disease Diagnostic Laboratory submitted to NRP
NAHLN: NC
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
COMPLETE
Funding Source
Reporting Frequency
Annual
Accession No.
1010791
Grant No.
2016-37620-25771
Cumulative Award Amt.
$1,339,247.00
Proposal No.
2016-08616
Multistate No.
(N/A)
Project Start Date
Sep 1, 2016
Project End Date
Aug 31, 2021
Grant Year
2019
Program Code
[AA-G]- Homeland Security
Recipient Organization
Rollins Animal Disease Diagnostic Laboratory
2101 Blue Ridge Road
Raleigh,NC 27607
Performing Department
(N/A)
Non Technical Summary
The laboratory continues HL7 messaging of test results. Currently we are messaging CSF, FMDV, ASF, SECD and AI. AI messaging is turned off at the request of NAHLN for the NPIP surveillance testing conducted in North Carolina. The diagnostic CSF testing services for Puerto Rico and the Virgin Islands will continue as needed and requested. The CSF domestic slaughter surveillance and surveillance of submitted diagnostic cases will continue through the new budget period as provided. The laboratory is actively conducting surveillance for Highly Pathogenic Avian Influenza (HPAI) and Exotic Newcastle Disease (END) in domestic poultry. Additionally, surveillance testing on client submitted avian necropsy cases are routinely tested for HPAI, END and other clinically significant diseases affecting poultry. The laboratory will continue to investigate and pursue opportunities to assist the swine industry with testing for Senecavirus A. Senecavirus A PCR testing is done as companion testing for suspect Foot and Mouth disease investigations. This testing is conducted with tests also being performed at NVSL-FADDL and as initiated by State and Federal authorities. The laboratory will continue Pseudorabies serology testing program by actively recruiting routine surveillance along with samples from locations with potential for feral swine exposure. Funding will be used for maintenance agreements on thermocyclers and robotics equipment. Funding will also be used for maintenance and monitoring of the air handling systems in the BSL-3 laboratories. Additional funds will be utilized for the purchase of a Quality System Document control program and LIMS enhancements.
Animal Health Component
100%
Research Effort Categories
Basic
0%
Applied
100%
Developmental
0%
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
31135101101100%
Knowledge Area
311 - Animal Diseases;

Subject Of Investigation
3510 - Swine, live animal;

Field Of Science
1101 - Virology;
Keywords
Goals / Objectives
The laboratory continues HL7 messaging for Classical Swine Fever (CSF) PCR, Foot and Mouth Disease (FMD) PCR, African Swine Fever (ASF) PCR, and Avian Influenza (AI) PCR for HPAI Matrix, H7, and H5. The AI messaging is turned off for routine NPIP surveillance testing at the request o NAHLN. Messaging of Porcine Epidemic Diarrhea Virus (PEDV) and Swine Delta Coronavirus continues as testing is performed.As a continuation of the NAHLN FMD testing exercise in August 2014, the accessioning exercise in March 2015, and through the NCVDLS HPAI working group planning and exercise efforts, the laboratory was able to increase the data accuracy and sample processing for laboratory submissions. The refined process increased the use of barcodes that reduced the time required to enter accessions in LIMS and improved the accuracy of information captured.The planning and exercise efforts involved:Enabled HL7 messaging for HPAI matrix, H7 and H5 test results to the USDA.Developed a prepopulated and barcode enabled NCDA&CS HPAI submission form for both premise and specimen identification; scanned premise barcodes ensure the proper premise locations are associated with incoming submissions. The HPAI submission form incorporates USDA issued specimen barcode labels scanned into our LIMS identifying each unique specimen tested for internal tracking and HL7 messaging to the USDA.Updated the data in the NCVDLS LIMS so premises have both State and Federal premise identifiers (PINS) when they have been assigned.Process Improvements included:Created standardized templates in LIMS that allow laboratory receiving staff to quickly create HPAI accessions with the proper specimen tree and test assignments.Created an electronic plate map worksheet in which specimen barcodes are scanned. The worksheet is uploaded into the PCR machine where testing can be performed quickly since the worksheet captures the specimen ids, their well locations and which assays the PCR machine is to execute. Once testing is complete, the plate map with results, is downloaded from the PCR machine and electronically uploaded into our LIMS for a second tier of technician review.HPAI accessions are now mass reviewed and reported in batches by case coordinators. Mass reviewing accessions reduces the amount of time laboratory staff spends doing administrative functions; allowing them to perform the tasks of testing specimens.HL7 Messages are automatically created and sent to the USDA NAHLN LMS for each accession once the test results have been reviewed by approved laboratory staff.In an effort to improve time required for entering accessions in LIMS, we will investigate an online mobile accessioning application. This will be pursued through our LIMS provider and incorporate some of the enhancements that are currently being developed.
Project Methods
Nothing to report

Progress 09/01/16 to 08/31/21

Outputs
Target Audience:Our Target audience consists of the USDA, Animal Industry, veterinarians, and citizens of NC that we serve. Changes/Problems:The COVID pandemic continues to make staffing and obtaining laboratory testing supplies problematic. What opportunities for training and professional development has the project provided?The COVID pandemic continues to limit the ability for training and educational activities although multiple professional staff members participate in the AAVLD quality symposium and AAVLD annual meeting. How have the results been disseminated to communities of interest? Nothing Reported What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

Impacts
What was accomplished under these goals? The laboratory continues to work to enhance our surveillance and diagnostic capabilities overall and in particular as they relate to high consequence and foreign animal diseases. We remain active in NAHLN activities that serve this purpose and enhance the National Animal Health Laboratory Network as a whole. We participated in offered NAHLN projects/exercises. The laboratory, in particular our IT staff, participate in bimonthly NAHLN IT core and all members meetings.

Publications


    Progress 09/01/19 to 08/31/20

    Outputs
    Target Audience:Our Target audience consists of the USDA, animal industry, veterinarians, and citizens of North Carolina that we serve. Our goal is to provide timely and accurate diagnostic servcie for high consequence and foreign animal diseases. We continue to enhance our quality system, testing capabiliites and capacity, and disease reporting with this support. Changes/Problems:The COVID-19 pancemic has made staffing difficult. Safeguarding employee health has driven split shifts within laboratory sections to promote social distancing. Maintaining our increasing work-load, which has maintained through-out the pandemic, has proved challenging. The COVID pandemic has also coincided with our LPAI event which further challenged lab staffing/capabilities. The world wide need for PCR testing supplies has made it difficult at times to purchase and maintain testing supplies. What opportunities for training and professional development has the project provided? The COVID-19 pandemic has limited the invovlement of staff regarding training/educational activities during this progress cycle although our Director and Assistant Director participated in AAVLD and NAHLN activities (validation exercises). How have the results been disseminated to communities of interest? Nothing Reported What do you plan to do during the next reporting period to accomplish the goals? We will move into a new state-of-the-art laboratory that will provide increased capacity and capabilities. The laboratory will continue to maintain testing equipment to accommodate surveillance and surge/outbreak testing. We will maintain and monitor the BSL-3 laboratory air handling systems to ensure appropriate environmental and biosecurity testing conditions. We will continue to seek enhancements of our LIMS system to support remote accessioning through the use of mobile devices We will purchase needed equipment (tissuelyzer, thermocycler) directly involved with NAHLN testing that will maintain and enhance our PCR surge capacity for avian influenza and other high consequence diseases. We will send employees to applicable training

    Impacts
    What was accomplished under these goals? We continue to served as a Tier 1 member of NAHLN and in this role actively participated and engaged in a LPAI event involving NC, and to a lesser extentSC, during the progress reporting period. We also particiated in the ASF Oral Fluids Emergency Validation Exercies, FMD Bulk-Takn Milk Validation excercises and approved to participate in the validation pilot involving Oral Fluids as an Unapproved Ancillary Sample for FADIs. Our laboratorycompleted and received certification for the NAHLN HL7 messaging competency exercises for the all the tests we perform that have a NAHLN messaging guide; as required by being a NAHLN Level 1 laboratory. Our IT staff continue to serve as members on both the NAHLN IT Core Committee and the NAHLN IT General Committee. Our Assistant Director is a member of the Methods Technical Working Group. The laboratory continues to perform active surveillance for Foreign Animal Diseases and high consequence diseases insupport of animal agriculture. During the grant cycle we performed 25,507 AI Matrix PCRs. We also performed 359 ASF, 348 CSF, 202FMD, and 1198PRV tests. The laboratory was also involved in 38 Foreign Animal Disease Investigations.

    Publications


      Progress 09/01/18 to 08/31/19

      Outputs
      Target Audience:Our target audience consists of the animal industry, veterinarians, and citizens of North Carolina that we serve. Our goal is provide timely and accurate diagnostic services for high consequence and foreign animal disease. We continue to enhance our quality system, capabilities and reporting with this support. HL7 messaging for 11 diagnostic tests conducted by the laboratory is available and currently in use and/or available for reporting to the USDA. The laboratory has conducted and passed the available competency/proficiency testing for all the tests we perform. The laboratory continues to perform active surveillance for Foreign Animal Diseases and high consequence diseases in in support of animal agriculture. During the grant cycle we performed 13,719 AI Matrix PCRs and 213,251 AI serology tests. We had 32 positive AI samples that were sent to NVSL for confirmation. They were all H5H7 negative and when further characterization successful are typically identified as swine origin. We also performed 369, 135 FMD, and 1135 PRV tests. The laboratory was also involved in investigating 21 cases of vesicular disease lesions in swine. All the cases were FMD negative (tested here and duplicate sample confirmed at NVSL). Seneca Valley Virus suspected and identified when further characterization is successful. The laboratory remains active in NAHLN activities that enhance our preparedness and response to high consequence disease and outbreak testing. We have 10 PT techs for AI, 5 for CSF and FMD, 7 for ASF, and 7 for APMV-1. We participated in the Newcastle Disease table top exercise in August, the barcoding exercise in November, and was one of the major testing laboratories in support of the swine oral fluids study titled "Negative cohort study plan for the estimation of diagnostic specificity of Two PCR assays for the detection of Classical Swine Fever, African Swine Fever and Foot and Mouth disease viruses in oral fluid samples". Utilizing funds available in the NIFA grant we were able to maintain and enhance laboratory capabilities with the purchase of needed equipment directly supporting NAHLN's mission. The electronic Quality Managing System (Qualtrax) purchased last year is being phased in and implemented and our two servers have been replaced. Changes/Problems:The surveillance and diagnostic case load in the molecular department continues to increase substantially. This laboratory discipline is directly involved in NAHLN testing and FAD investigations. FAD investigations involving vesicular lesions in swine populations and our influenza PCR testing for surveillance and disease investigations to continue increase annually. Maintenance of the aging BSL-3 laboratory remains a challenge at times ensuring appropriate environment and testing conditions. What opportunities for training and professional development has the project provided?The project has allowed several supporting staff members (professional staff directly involved in NAHLN testing and Information Technology staff involved in overall laboratory support) to attend relevant, national meetings (AAVLD, Quality, and Incident Command/ASF meetings). How have the results been disseminated to communities of interest?Testing results are reported timely and accurately to approrpiate parties. Process enhancements and pertinent disease information is reported to internal and external partners. What do you plan to do during the next reporting period to accomplish the goals? The laboratory will continue to maintain testing equipment to accommodate surveillance and surge/outbreak testing. We will maintain and monitor the BSL-3 laboratory air handling systems to ensure appropriate environmental and biosecurity testing conditions. The laboratory will fully integrate our quality system into the recently purchased Qualtrax Electronic Quality Management System. We will continue to seek enhancements of our LIMS system to support remote accessioning through the use of mobile devices We will purchase needed equipment (freezer, pipettes) directly involved with NAHLN testing that will maintain and enhance our PCR surge capacity for avian influenza and other high consequence diseases. We will send employees to applicable training

      Impacts
      What was accomplished under these goals? We continue HL7 messaging of test results for Avian Influenza (AI) PCR (Matrix, H7, and H5), African Swine Fever (ASF) PCR, Classical Swine Fever (CSF) PCR, and Foot and Mouth (FMD) PCR, Porcine Epidemic Diarrhea Virus (PEDV) PCR, Swine Delta Coronavirus PCR, Pseudorabies (PRV) gB and g1 ELISA. We completed and received certification for the NAHLN HL7 messaging competency exercises for the all the tests we perform that have a NAHLN messaging guide; as required by being a NAHLN Level 1 laboratory. Our IT staff continue to serve as members on both the NAHLN IT Core Committee and the NAHLN IT General Committee. Our laboratory serves as one of the ASF approved testing laboratories and participate in the active surveillance of CSF and ASF. Testing is completed for appropriate cases, based on the NAHLN guidelines, and CSF and ASF both tested on appropriate submitted samples. HL7 messaging for 11 diagnostic tests conducted by the laboratory is available and currently in use and/or available for reporting to the USDA. The laboratory has conducted and passed the available competency/proficiency testing for all the tests we perform. The laboratory continues to perform active surveillance for Foreign Animal Diseases and high consequence diseases in in support of animal agriculture. During the grant cycle we performed 13,719 AI Matrix PCRs and 213,251 AI serology tests. We had 32 positive AI samples that were sent to NVSL for confirmation. They were all H5H7 negative and when further characterization successful are typically identified as swine origin. We also performed 369, 135 FMD, and 1135 PRV tests. The laboratory was also involved in investigating 21 cases of vesicular disease lesions in swine. All the cases were FMD negative (tested here and duplicate sample confirmed at NVSL). Seneca Valley Virus suspected and identified when further characterization is successful. The laboratory remains active in NAHLN activities that enhance our preparedness and response to high consequence disease and outbreak testing. We have 10 PT techs for AI, 5 for CSF and FMD, 7 for ASF, and 7 for APMV-1. We participated in the Newcastle Disease table top exercise in August, the barcoding exercise in November, and was one of the major testing laboratories in support of the swine oral fluids study titled "Negative cohort study plan for the estimation of diagnostic specificity of Two PCR assays for the detection of Classical Swine Fever, African Swine Fever and Foot and Mouth disease viruses in oral fluid samples". Utilizing funds available in the NIFA grant we were able to maintain and enhance laboratory capabilities with the purchase of needed equipment directly supporting NAHLN's mission. The electronic Quality Managing System (Qualtrax) purchased last year is being phased in and implemented and our two servers have been replaced.

      Publications


        Progress 09/01/17 to 08/31/18

        Outputs
        Target Audience: Nothing Reported Changes/Problems:Dr. Richard Mock, the previous program director, retired. Oversight and responsibility of the program now is the responsibility of the Laboratory Director, Dr. James Trybus. The surveillance and diagnostic case load in the molecular department continues to increase substantially. This laboratory discipline is directly involved in NAHLN testing and FAD investigations. FAD investigations involving vesicular lesions in swine populations increased from 8 cases last program cycle to 19 this cycle. Also, our influenza PCR testing for surveillance and disease investigations increased from 5,375 to 7,138. Maintenance of the aging BSL-3 laboratory remains a challenge at times ensuring appropriate environment and testing conditions. What opportunities for training and professional development has the project provided? THe project has allowed several supporting staff members (professional staff directly involved in NAHLN testing and Information Technology staff involved in overall laboratory support) to attend relevant, national meetings (AAVLD and USALIMS user group meetings). How have the results been disseminated to communities of interest? Nothing Reported What do you plan to do during the next reporting period to accomplish the goals? The laboratory will continue to maintain testing equipment to accommodate surveillance and surge/outbreak testing. We will maintain and monitor the BSL-3 laboratory air handling systems to ensure appropriate environmental and biosecurity testing conditions. The laboratory will fully integrate our quality system into the recently purchased Qualtrax Electronic Quality Management System. We will continue to seek enhancements of our LIMS system to support remote accessioning through the use of mobile devices. We will purchase needed equipment (freezer, pipettes) directly involved with NAHLN testing that will maintain and enhance our PCR surge capacity for avian influenza and other high consequence diseases. We will send employees to applicable training.

        Impacts
        What was accomplished under these goals? HL7 for 11 diagnostic tests conducted by the laboratory are available andare currently in use and/or available for reporting to the USDA. The Laboratory has conducted and passed the available competency/proficiency testing for AI, FMD, PRV and ASF. The laboratory continues to perform active surveillance for Foreign Animal Diseases and high consequence diseases in support of animal agriculture. During the grant cycle we performed 13,823 AI Matrix PCRs and 220,766 AI serology tests. We had 21 positive AI samples that were sent to NVSL for confirmation. They were all H5H7 negative and whenfurther characterization successful aretypically identified as swine origin. The laboratory was also involved in investigating 19 cases of vesicular disease lesions in swine. All the cases were FMD negative (tested here and duplicate sample confirmed at NVSL). Seneca Valley Virus suspected and identified when further characterization is successful. The laboratory remains active in NAHLN activities that enhance our preparedness and response to high consequence disease and outbreak testing. We have 8 PT techs for AI, 5 for FMD and, 5 for ASF. We participated in the Newcastle Disease table top exercise in August, the barcoding exercise in November, and was one of the major testing laboratories in support of the swine oral fluids study titled "Negative cohort study plan for the estimation of diagnostic specificity of Two PCR assays for the detection of Classical Swine Fever, African Swine Fever and Foot and Mouth disease viruses in oral fluid samples". Utilizing funds available in the NIFA grant, we were able to maintain and enhance laboratory capabilities with the purchase of needed equipment directly supporting NAHLN's mission. Also, wepurchased anelectronic Quality Managing System (Qualtrax) and replaced two aging servers.

        Publications


          Progress 09/01/16 to 08/31/17

          Outputs
          Target Audience: Nothing Reported Changes/Problems:Monitoring of the environment conditions in both BSL suites is becoming more crucial given the age of the buildings. Upgrades to equipment and additional software upgrades/systems will be necessary within the next few years. What opportunities for training and professional development has the project provided? Nothing Reported How have the results been disseminated to communities of interest? Nothing Reported What do you plan to do during the next reporting period to accomplish the goals?The laboratory LIMS has barcode enabled specimen identification and premises entry capabilities. The application of barcoding increases data accuracy and reduces the time for sample data entry related to laboratory submissions. Barcoding increases the efficiency of data entry in the receiving section of the laboratory. The laboratory is implementing a mobile submission application for EIA that will transition into a mobile submission application for general diagnostics that could be utilized in the event of a high consequence disease outbreak. The application is being developed by CAI, our USALIMS provider. During the last 12 months, the laboratory has worked with the Department of Agriculture and State Purchasing Departments to acquire a Quality Management Software application. We are hopeful that the award for the software application will be approved with the next couple of months.

          Impacts
          What was accomplished under these goals? During the last 12 months, the laboratory has worked with the Department of Agriculture and State Purchasing Departments to acquire a Quality Management Software application. We are hopeful that the award for the software application will be approved with the next couple of months. The laboratory continues to utilize the standardized templates within our LIMS that allows the laboratory's receiving staff to quickly create Avian influenza accessions with the proper specimen tree and assay assignments. The technical staff utilize electronic plate map worksheets where specimen barcodes are scanned. The worksheets are uploaded in the PCR thermocycler with the specimen ids, their well locations and assay assignments. Once testing is complete, the plate map with results, is downloaded from the PCR instrument and electronically uploaded into our LIMS for a second tier of review. The refined process with the use of barcodes reduces the time required and decreases the likelihood of errors The reporting of high volume tests results such as Avian influenza PCR, Avian mycoplasma PCR, and Avian influenza ELISA serology results are routinely mass reviewed and reported in LIMS. This LIMS application has dramatically decreased the time needed to report and distribute final results. HL7 messaging allows the laboratory to automatically send the results once they have been reviewed and released in LIMS. This direct messaging of test results to NAHLN has eliminated the need to submit additional excel reports of test numbers. Diagnostic surveillance and routine diagnostic testing for Puerto Rico and the Virgin Islands will continue as requested.

          Publications