Progress 08/15/12 to 08/14/16
Outputs
Target Audience:Clients and stakeholders of the Texas A&M Veterinary Medical Diagnostic Laboratory. Changes/Problems:
Nothing Reported
What opportunities for training and professional development has the project provided?1. Rhapsody and HL7 messaging training 2. NAHLN IT development 3. African Swine Fever PCR How have the results been disseminated to communities of interest?Worked with USDA and Texas Animal Health Commission to set up the sampling stream for the African Swine Fever pilot project. Worked with USDA, Texas Animal Health Commission and Texas Parks and Wildlife Department to provide testing support for a Chronic Wasting Disease outbreak in captive deer herds in Texas. What do you plan to do during the next reporting period to accomplish the goals?
Nothing Reported
Impacts
What was accomplished under these goals?
Quality System Succesfully completed accreditation of the Drug Testing Laboratory by the Racing Medication Testing Consortium (RMTC). Prepared for the 5 year AAVLD accreditation site review. Continued to expand use of the Qualtrax document managment system, specifically for QA training and workflow. Training additional staff for foreign and emerging animal diseases: Maintained proficiency tested, certified staff for NAHLN-related surveilland and response testing. Laboratory information management system (including NAHLN messaging) Continue work on implementation of new LIMS and expanding HL7 messaging capabilities. Completed implementation of NAHLN HL7 messaging protocol and procedure. Added messaging for African Swine Fever pilot project. Staff attended NAHLN IT Committee meetings and conference calls. Staff attended Rhapsody training NAHLN sample handling, processing, and testing capacities (including enhancement of biocontainment capabilities) Continued construction of a new College Station Laboratory. The new facility features enhanced BSL-3 capabilities and capacity including a BSL3 necropsy and BSL3 space for bench diagnostics, research and development. Successfully completed all NAHLN Proficiency Panels Enhancing inter-laboratory activities in support of the goals of the NAHLN: TVMDL continued participation in a USDA funded enhanced passive surveillance (EPS) project. Through this project,TVMDL supports activities such as automated data inquiries and diagnostic testing. Participated in validation of of new NAHLN assays, specifically for ASF. Offered to send staff to other NAHLN labs in support of the HPAI response effort, or to take samples from other states for this testing. Dr. Bruce Akey served as Co-Chair of the NAHLN Methods Technical Working Group and also served on the NAHLN IT Workgroup Other integrated activities (research, education, and/or outreach/service) in support of the goals of the NAHLN and agricultural security Participated in expansion of the enhanced passive surveillance (EPS) project. Collaborated with IIAD on defining pre-order data and post-test data as well as HL7 messaging standards. Provided training or assistance for other NAHLN laboratories as requested.
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Progress 08/15/14 to 08/14/15
Outputs
Target Audience:Clients and stakeholders of the Texas A&M Veterinary Medical Diagnostic Laboratory. Changes/Problems:
Nothing Reported
What opportunities for training and professional development has the project provided?1. Rhapsody and HL7 messaging training 2. NAHLN IT development 3. African Swine Fever PCR 4. Participated in NAHLN Coordinating Council and NAHLN Methods Technical Working Group How have the results been disseminated to communities of interest?Worked with USDA and Texas Animal Health Commission to set up the sampling stream for the African Swine Fever pilot project. What do you plan to do during the next reporting period to accomplish the goals?
Nothing Reported
Impacts
What was accomplished under these goals?
Quality System Continued to refine the TVMDL Quality System during preparation for and successful completion of ISO 17025 accreditation for testing in the Drug Testing section. Also reviewed requirements and began harmonizing the QA system to meet GLP standards. Continued to expand use of the Qualtrax document managment system, specifically for QA training and workflow. Training additional staff for foreign and emerging animal diseases: Maintained proficiency tested, certified staff for NAHLN-related surveilland and response testing. Laboratory information management system (including NAHLN messaging) Continue work on implementation of new LIMS and expanding HL7 messaging capabilities. Completed implementation of NAHLN HL7 messaging protocol and procedure. Added messaging for African Swine Fever pilot project. Staff attended NAHLN IT Committee meetings and conference calls. Staff attended Rhapsody training NAHLN sample handling, processing, and testing capacities (including enhancement of biocontainment capabilities) Continued construction of a new College Station Laboratory. The new facility features enhanced BSL-3 capabilities and capacity including a BSL3 necropsy and BSL3 space for bench diagnostics, research and development. Purchased two Kingfisher 96-flex machines to replace aging, unsupported equipment and maintain throughput capacity. Participated in a NAHLN tabletop exercise of FAD sample receiving and accessioning. Enhancing inter-laboratory activities in support of the goals of the NAHLN: TVMDL continued participation in a USDA funded enhanced passive surveillance (EPS) project. Through this project, TVMDL supports activities such as automated data inquiries and diagnostic testing. Participated in validation of of new NAHLN assays, specifically for ASF. Offered to send staff to other NAHLN labs in support of the HPAI response effort, or to take samples from other states for this testing. Other integrated activities (research, education, and/or outreach/service) in support of the goals of the NAHLN and agricultural security Participated in expansion of the enhanced passive surveillance (EPS) project. Collaborated with IIAD on defining Pre-order data and post-test data as well as HL7 messaging standards. Provided training or assistance for other NAHLN laboratories as requested.
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Progress 08/15/13 to 08/14/14
Outputs
Target Audience: TVMDL is currently working and leading several efforts to enhance the nation’s ability to respond to a HCD event. TVMDL personnel are working with other NAHLN partners and Plum Island to develop, commercialize, and validate new serological tests for FMD. Also, in coordination with the USDA CEAH and the FAZD Center, TVMDLis participating in expansion of the enhanced passive surveillance (EPS) project. This project is designed to explore the utility of integrating & aggregating multiple data sources for syndromic surveillance. The diagnostic laboratory is an essential component of this study. Pre-order data and post-test data will be integrated into this system for poultry and equine. Linking of this data into the system will require additional work on the IT side to ensure appropriate messaging of test order results with the AgConnect suite of tools and the Biosurveillance Field Entry System (BFES).TVMDL continues to foster joint diagnostic development/validation projects/collaborations with Texas A&M AgriLife Research and the Texas A&M University College of Veterinary Medicine. (CVM). Changes/Problems:
Nothing Reported
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? Project Plan for FY’14 Quality System Review assays currently in use and determine their relevancy with respect to new technologies and new diagnostic testing capabilities. As new technologies evolve, continue to ensure that our clients are offered the most relevant and accurate testing capabilities. In addition, these assays must be affordable and timely. Ensure new state-of-the art capabilities that will allow for acquisition of novel diagnostic technologies that can be used for high-consequence disease (HCD) testing. Enhance the agency’s document control system through implementation of new document control software and training on this software. In FY’14, TVMDL will continue to implement a new quality document tracking system that will provide increased capabilities for document management, to include training records. Training additional staff for foreign and emerging animal diseases: Identify, train, and proficiency test additional staff at TVMDL to serve as part of a high consequence disease response. Laboratory information management system (including NAHLN messaging) Continue work on implementation of new LIMS and expanding HL7 messaging capabilities. NAHLN sample handling, processing, and testing capacities (including enhancement of biocontainment capabilities) Continue planning and preparations for breaking ground on a new College Station Laboratory. In 2013 funding was secured to support a new laboratory in College Station. We will continue design of the new facility and anticipate breaking ground before September 2014 on a new College Station laboratory. Purchase of an additional ABI 7500 quantitative PCR machine to expand testing capacity. Enhancing inter-laboratory activities in support of the goals of the NAHLN: TVMDL will continue participation in a USDA funded enhanced passive surveillance (EPS) project. Through this project, TVMDL supports activities such as automated data inquiries and diagnostic testing. Participating in validation of serological assays for foot and mouth disease (FMD) virus. Participating in CBPP and LSD negative cohort testing. Other integrated activities (research, education, and/or outreach/service) in support of the goals of the NAHLN and agricultural security TVMDL is currently working and leading several efforts to enhance the nation’s ability to respond to a HCD event. TVMDL personnel are working with other NAHLN partners and Plum Island to develop, commercialize, and validate new serological tests for FMD. In addition, TVMDL is working with multiple partners to develop assays for high consequence swine diseases. These are only two of many projects TVMDL personnel are funded for and are participating in and/or leading for the development of HCD assays. During FY’14, in coordination with the USDA CEAH and the IIAD Center, TVMDL will participate in expansion of the enhanced passive surveillance (EPS) project. This project is designed to explore the utility of integrating & aggregating multiple data sources for syndromic surveillance. The diagnostic laboratory will be an essential component of this study. Pre-order data and post-test data will be integrated into this system for poultry and equine. Linking of this data into the system will require additional work on the IT side to ensure appropriate messaging of test order results with the AgConnect suite of tools and the Biosurveillance Field Entry System (BFES). Continue to foster joint diagnostic development/validation projects/collaborations with Texas A&M AgriLife Research and the Texas A&M University College of Veterinary Medicine. (CVM). Seek state funding for an additional residency in veterinary microbiology in partnership with CVM. TVMDL continues to create joint appointments with our system partners to enhance our outreach capabilities and our diagnostic development, validation, and applied research capacity.
Impacts
What was accomplished under these goals?
Quality System TVMDL invested in a new electronic document control system, Qualtrax. This software provides a platform for secure electronic management of our quality assurance documents. The system has the capability to predetermine required training, develop associated tests and maintain training records associated with SOP revisions. These updates will eventually allow us to replace manual files, while improving on the accuracy and retrievability of all quality assurance records. The agency’s Test Relevancy Committee continues to consider proposals to develop new tests and works to ensure appropriate validation prior to adding a new test to the agency’s offerings. Considerations include benefit to the client, cost, turn-around time, and equipment. Test retirement requests must also be processed through this committee for recommendation to the Director. The review process/approval process has now been implemented as a workflow within the Qualtrax system. This should improve the efficiency of this process. Training additional staff for foreign and emerging animal diseases Dr. Terry Hensley, TVMDL’s Assistant Agency Director for Diagnostic Services, attended the FAD training course offered at Plum Island for university faculty. Dr. Hensley also participated in a real-time training to diagnose foot-and-mouth disease, organized by the European Commission for the Control of Foot-and-Mouth Disease (EuFMD). Dr. Hensley traveled to Nakuru, Kenya. Hensley took part in a three-hour web induction course that included an overview on FMD, aging of FMD lesions, outbreak investigation, and on-farm biosecurity protocols. Following the online training, participants traveled to Nakuru, for four days of field training. The group conducted field training at an FMD-infected commercial dairy farm and small holder farm. A new laboratory supervisor was hired in the Molecular Diagnostics Section at College Station. Her experience and focus on advanced techniques will increase the agency’s preparedness in the event of a high consequence disease outbreak. Laboratory information management system (including NAHLN messaging) TVMDL implemented a new LIMS system in November 2013. The agency continues to work with the software manufacturer to make improvements and upgrades to the system. NAHLN sample handling, processing, and testing capacities (including enhancement of biocontainment capabilities) TVMDL received an increase of $3 million per year in its state appropriated budget to help construct a $50 million, state-of-the-art facility in College Station that will sustain the state agency for the next several decades. A laboratory at our Amarillo location was renovated to serve as a dedicated culture room for infectious materials. Additional upgrades, repairs and improvements were made to ensure life safety at all four locations. The laboratory at Gonzales is now receiving routine samples for avian influenza from Texas Animal Health Commission monitoring of premises that provide birds to live bird markets throughout the State. Enhancing inter-laboratory activities in support of the goals of the NAHLN. TVMDL continued to participate in USDA-funded projects, including enhanced passive surveillance and assay development. Other integrated activities (research, education, and/or outreach/service) in support of the goals of the NAHLN and agricultural security. TVMDL continued to support two joint appointments (Extension Veterinarians) with the Texas A&M AgriLife Extension Service. In addition, the agency continued collaborations with the Texas A&M University College of Veterinary Medicine (CVM) by continuing to offer a third-year veterinary student elective course, titled “Veterinary Diagnostic Medicine”. TVMDL also hosts all 4th year veterinary students from Texas A&M University for a diagnostic lab briefing and tour.
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Progress 08/15/12 to 08/14/13
Outputs
Target Audience:
Nothing Reported
Changes/Problems:
Nothing Reported
What opportunities for training and professional development has the project provided? n/a How have the results been disseminated to communities of interest? Other integrated activities (research, education, and/or outreach/service) in support of the goals of the NAHLN and agricultural security TVMDL is currently working and leading several efforts to enhance the nation’s ability to respond to a HCD event. TVMDL personnel are working with other NAHLN partners and Plum Island to develop, commercialize, and validate new serological tests for FMD. In FY’13 we will participate in the negative cohort studies for these assays. In addition, TVMDL is working with multiple partners to develop assays for high consequence swine diseases. These are only two of many projects TVMDL personnel are funded for and are participating in and/or leading for the development of HCD assays. During FY’13, in coordination with the USDA CEAH and the FAZD Center, TVMDL will participate in expansion of the enhanced passive surveillance (EPS) project. This project is designed to explore the utility of integrating & aggregating multiple data sources for syndromic surveillance. The diagnostic laboratory will be an essential component of this study. Pre-order data and post-test data will be integrated into this system for poultry and equine. Linking of this data into the system will require additional work on the IT side to ensure appropriate messaging of test order results with the AgConnect suite of tools and the Biosurveillance Field Entry System (BFES). Continue to foster joint diagnostic development/validation projects/collaborations with Texas A&M AgriLife Research and the Texas A&M University College of Veterinary Medicine. (CVM). Add an additional residency in veterinary microbiology in partnership with CVM. TVMDL continues to create joint appointments with our system partners to enhance our outreach capabilities and our diagnostic development, validation, and applied research capacity. What do you plan to do during the next reporting period to accomplish the goals? Project Plan for FY’13 Quality System Review assays currently in use and determine their relevancy with respect to new technologies and new diagnostic testing capabilities. As new technologies evolve, continue to ensure that our clients are offered the most relevant and accurate testing capabilities. In addition, these assays must be affordable and timely. Ensure new state-of-the art capabilities that will allow for acquisition of novel diagnostic technologies that can be used for high-consequence disease (HCD) testing. Enhance the agency’s document control system through implementation of new document control software and training on this software. In FY’13, TVMDL will invest in and implement a new quality document tracking system that will provide increased capabilities for document management, to include training records. TVMDL is currently in advanced stages of purchasing a system. Training additional staff for foreign and emerging animal diseases: Identify, train, and proficiency test additional staff at TVMDL to serve as part of a high consequence disease response. Laboratory information management system (including NAHLN messaging) Install and implement new laboratory information management system (LIMS). Installation of a new LIMS will allow for more efficient use of resources, increased ability to retrieve valuable epidemiological information during a disease event and the ability to track and monitor disease movement. LIMS to be installed and implemented by September 3st, 2013. NAHLN sample handling, processing, and testing capacities (including enhancement of biocontainment capabilities) Begin planning and preparations for breaking ground on a new College Station Laboratory. In 2013 funding was secured to support a new laboratory in College Station. We will begin design of the new facility early July 2013. The goal is to break ground before September 2014 on a new College Station laboratory. Enhancing inter-laboratory activities in support of the goals of the NAHLN: TVMDL will continue participation in a USDA funded enhanced passive surveillance (EPS) project. Through this project, TVMDL supports activities such as automated data inquiries and diagnostic testing. Participating in validation of serological assays for foot and mouth disease (FMD) virus. Participating in CBPP and LSD negative cohort testing.
Impacts
What was accomplished under these goals?
FY12 Accomplishments Quality System Quality Assurance (QA) and laboratory testing sections have worked hand-in-hand on several continuous improvement projects. The Electronic Quality System (EQS) was reconfigured and now provides more convenient and ready access to information necessary to perform assigned tests, including procedures and validation records for each test method. We continue to align procedures across the Agency to ensure consistency of test results. TVMDL recently established a Test Relevancy Committee. This committee is tasked with reviewing existing tests for relevancy and accuracy. In addition, requests for new tests are submitted to the committee for review and eventual recommendation to the Director. Considerations include benefit to the client, cost, turn-around time, and equipment. The agency has made a concerted effort to enhance documentation of client complaints and client feedback. Over the past year, 39 client feedback forms were submitted to QA. Of those submitted, 27 were positive in nature. The 12 that identified a discrepancy were evaluated and resolved through the corrective action request (CAR) process that involved a root cause analysis, corrective action plan, correction of the deficiency and actions to prevent re-occurrence. Root Cause Analysis and Corrective Action trainings were available to all TVMDL staff. Staff training for foreign and emerging animal diseases During FY12 two additional staff members were trained in molecular diagnostics testing and passed proficiency testing for classical swine fever (CSF), foot and mouth disease (FMD), avian influenza virus (AI), and exotic Newcastle disease virus (END). The TVMDL laboratory at Gonzales was recognized as a member of the NAHLN. There are trained and proficiency tested personnel for AI and END at all four TVMDL laboratories. Laboratory information management system (including NAHLN messaging) In July 2012, TVMDL contracted with CAI to purchase and implement the USALIMS system. In preparation for conversion to USALIMS, the agency formally created a LIMS implementation plan, based on standard project management practices defined by the Project Management Institute. USALIMS will be in place at TVMDL no later than September 3, 2013. TVMDL continues to participate in messaging with the NALHN for BSE. NAHLN sample handling, processing, and testing capacities (including enhancement of biocontainment capabilities) In early January 2013, TVMDL renovated the Necropsy suite at its laboratory located in Center, Texas, to enhance biosafety, biosecurity, life safety, and general work conditions. The project provided the suite with a dedicated HVAC (heating, ventilation, and air conditioning) unit with HEPA (high efficiency particulate air) exhaust to ensure negative differential air pressure to the laboratory. The suite contains a dedicated biosafety cabinet and combination locked entry door to enhance biosafety and biosecurity. Life safety features installed included a new safety shower and eyewash for both the necropsy suite and general laboratory. The project was completed in late February 2013. Improvements to the College Station laboratory’s after-hours receiving process were implemented in late summer 2012. An existing space was renovated and set-up for use as an after-hours receiving room. The after-hours receiving room offers increased security for submissions left overnight and includes a dedicated refrigerator and incubator for a temperature-controlled environment. The room is outfitted with motion sensor lighting for safety. Electricity is supplied on an emergency generator circuit to preserve submissions in case of a general power failure. TVMDL submitted an exceptional item funding request to the Texas Legislature in spring 2013 related to construction of a new facility at College Station. A new facility capable of meeting safety and workflow requirements will ensure TVMDL can continue to operate in support of the livestock, companion animal, and public health industries; remain on the cutting edge of veterinary diagnostics and can advance diagnostic research; and is equipped with the latest technology to enhance diagnostic capabilities for animal owners and veterinarians throughout Texas. Inter-laboratory activities in support of the goals of the NAHLN In FY12, TVMDL continued to participate in the NAHLN/FAZD Center Laboratory Capacity Estimation Model (LCEM) software development project. This project defines NAHLN testing capacity during a high consequence disease event. LCEM allows both the NALHN and participating laboratories to effectively model their laboratory testing capacity.Pilot testing on the LCEM was completed, and the software was released to all NAHLN labs on June 19th, 2012. Over 190 user accounts were created in the system after release, from 67 different facilities. To assist in this release, several training videos, reference guides, and a user FAQ were developed. Both TVMDL and the South Dakota State University Lab participated in pilot exercises and testing. Components that allow for resource cost tracking, cost comparison reporting, and monitoring of consumable laboratory supplies have been built into LCEM in Phase II. Additionally, data elements from LCEM can now be integrated into the NAHLN Portal. Other integrated activities (research, education, and/or outreach/service) in support of the goals of the NAHLN and agricultural security TVMDL actively supported the development of the assay for the nucleic acid purification and detection of FMDV in bulk tank milk samples. TVMDL provided technical expertise and a critical reagent, an internal positive control, to this project. Inclusion of our internal positive control enables monitoring of the nucleic acid purification and detection efficacy and minimizes false negatives. In addition, TVMDL scientists participated and were deemed highly proficient in the FADDL-conducted interlab comparison study to assess proficiency of the nucleic acid and detection methods that will be used for analysis of the milk samples from experimentally infected animals and endemic countries. The samples and results from this experiment will be valuable for utility of the FMDV assay in bulk tank milk testing for FMDV surveillance. Additionally, TVMDL scientists participated in the testing of more than 200 samples for a negative cohort performance evaluation. TVMDL was also funded to assess the use of Next Generation Sequencing (NGS) methods and Bioinformatics tools for high throughput Babesia bovis and Babesia bigemina sequencing. This project is a collaboration with Dr. Charlie Johnson, a Texas A&M AgriLife Research core director. Babesia bovis and Babesia bigemina cause bovine babesiosis (cattle tick fever), which would have a significant economic impact on the state’s livestock economy if re-introduced in Texas. There is no vaccine and lack of genomic sequences for diagnostics and vaccine development. The data generated from this project will provide valuable technical data to demonstrate feasibility of NGS for Babesia genome sequencing. TVMDL also collaborates with Dr. Thomas Hairgrove, Extension Veterinarian with Texas A&M AgriLife Extension Service, on development and validation of new diagnostics tests for large animals. Through the collaboration, a highly sensitivity and specific qPCR test for Anaplasma marginale was developed and implemented for routine diagnostic testing. An abstract describing this work has been submitted for presentation at the 2013 AAVLD national meeting. An additional notable collaboration with Dr. Hairgrove is the development of an improved qPCR test for detection of Trichomonas foetus (a pathogen of significant economic impact) in smegma samples. The improved method provides substantial savings in time and money to cattle producers. An invention disclosure describing the invention enabling the improvements has been filed.
Publications
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