Year 4 Supplemental Project Plans.docx

Attachment 1 – Project Areas Appendix A. Public Health Laboratory Strengthening and Leadership N/A

Appendix B. Public Health Preparedness and Response

#1 Project Name: Continuity of Operations Plans for Public Health Laboratories Project Activity Contact Information: Jasmine Chaitram, zoa6@cdc.gov Approximate Amount of Supplemental Funding Available: $150,000 Project Description:

Most state public health laboratories have Continuity of Operations Plans (COOP) in the event that a laboratory loses some or all of its operations due to a number of hazards (e.g. fire, power outage, natural weather). It’s unclear if all states and US territories with public health laboratories have these plans formally documented and how comprehensive they are to include all tests/services performed by the laboratory. CSELS/DLS would like to collaborate with APHL to develop an inventory of state COOPs as well as an inventory any state/local legal and/or jurisdictional requirements that would complicate testing being performed by another state or additional staff coming onsite to perform testing (e.g. state licensing). The plans should also be reviewed or updated to include testing agreements with clinical and commercial laboratories in advance of the next event. CSEL DLS would also like to work with APHL to develop drills and exercise to test the effectiveness of these COOPs in select states or regions.

Mid-Term Outcome

· Increases laboratory effectiveness in response to public health needs, including emergencies Long-Term Outcome

· Creates sustainable and resilient PHLs that effectively and efficiently adapt to evolving public health needs

#2 Project Name: Tenth National Laboratory Training Conference (NLTC 10) Project Activity Contact Information: Yescenia Wilkins, exq6@cdc.gov Approximate Amount of Supplemental Funding Available: $200,000

Project Description:

This funding is to support the next National Laboratory Training Conference (NLTC), which typically occurs every 2-3 years and is sponsored by CDC and APHL. The conference uniquely brings together the laboratory training coordinators from each state/local public health laboratory, DC, Puerto Rico and Guam. Spanning three days, the meeting features innovative demonstration models of training; skill building sessions; the sharing of existing resources (toolkits, templates, training outlines, resources, etc.), model practices, and lessons learned with the training community; strategic planning discussions with regional laboratory representatives to identify priority training needs; review of activities and products from the training partners community; and, engagement in both formal and informal networking events. The conference also provides the opportunity for subject matter experts, training coordinators, and APHL and CDC leadership and team members to gather in order to standardize and coordinate training approaches, models, and activities. It also provides an opportunity to identify needs, discuss challenges, share successes, and make joint recommendations. The last conference in June 2017 also included the biosafety officers (BSOs) from each state, as well as selected Preparedness Coordinators, Bioterrorism Coordinators, and Chemical Terrorism coordinators. Having the BSOs and training coordinators attend from each state/jurisdiction aided in strengthening their collaboration.

Mid-Term Outcome

· Promotes competent, collaborative, and practice-ready PHL workforce

· Improves laboratory methods, systems, and informatics capacity

· Increases laboratory effectiveness in response to public health needs, including emergencies Long-Term Outcome

· Protects the public from public health threats

· Creates sustainable and resilient PHLs that effectively and efficiently adapt to evolving public health needs

Appendix C. Global Health N/A

Appendix D. Laboratory Systems and Standards #3 Project Name: State-directed regional networks of PHLs Project Activity Contact Information: John Ridderhof, jcr0@cdc.gov Approximate Amount of Supplemental Funding Available: $200,000 Project Description:

State-directed regional networks have been identified as a key sustainability strategy to increase resilience of public health laboratories (PHLs). Collaborative networks enable the sharing of testing services, technical protocols and materials, and workforce development efforts across a spectrum of technical areas. APHL has provided assistance through SharePoint sites for information sharing among and between regional networks, meeting logistics, recording and facilitation, and mini-grants that incentivize networks to work collectively to improve processes and practices. New priority activities for regional networks will involve grants to incentivize efforts to improve preparedness with a specific emphasis on COOP following the lessons learned from last year’s hurricanes, Puerto Rico, and other emergencies. Additionally CDC programs are increasingly embracing regional approaches to workforce and testing service capacity and consultation between states, CDC programs and APHL will help further strategies for service sharing. Last is that APHL will provide some travel assistance and support directly to the regions, especially to incentivize states to meet to form regions.

Mid-Term Outcome

· Improves laboratory methods, systems, and informatics capacity

· Increases laboratory effectiveness in response to public health needs, including emergencies Long-Term Outcome

· Protects the public from public health threats

· Creates sustainable and resilient PHLs that effectively and efficiently adapt to evolving public health needs

#4 Project Name: Public Health Laboratory System Database (PHLSD) Project Activity Contact Information: John Ridderhof, jcr0@cdc.gov Approximate Amount of Supplemental Funding Available: $150,000 Project Description:

The PHLSD online application was rolled out by APHL in September 2017 with a series of webinars and communications. The database has a section for equipment listing roughly 400 instruments and this is priority activity to inform CDC development of EUAs with data on existing instrumentation in PHLs. There are 2800 clinical and environmental tests that will create a national test directory, intended to inform PHL decision making and replace many duplicative surveys (from CDC programs). Key priorities for year 4 include convening a task force of PHL and CDC representatives to guide continual development of reports, addition of tests and instruments, and promote full participation by the 51 state PHLs and continuing participation from local PHLs. Specific activities will include technical assistance for full reporting of PHL instrumentation to improve the EUA development process (discussions of Clinical Partners forum), active mentoring and twinning between PHLs to increase participation, refine and improve automated reports such as the CLIA reports for CMS surveyors (PHLSD modeled after OID laboratory database). Fund demonstration projects of developing test lists among state-directed regional networks that directly improve COOP for natural disasters (e.g. hurricane and PR) and emergency response. A key component of supporting the PHLSD is using SMEs to continually revise and update the tests and instrument lists in addition to providing technical assistance to PHLs for inputting information and understanding functionality.

Mid-Term Outcome

· Improves laboratory methods, systems, and informatics capacity

· Increases laboratory effectiveness in response to public health needs, including emergencies Long-Term Outcome

· Creates sustainable and resilient PHLs that effectively and efficiently adapt to evolving public health needs

· Revises standards for the PHL system resulting in a more efficient, higher quality, and safe PHL system #5 Project Name: Clinical Laboratory Partners Workgroup Meeting Project Activity Contact Information: Jasmine Chaitram, zoa6@cdc.gov Approximate Amount of Supplemental Funding Available: $40,000 Project Description:

CDC has done a great job of outreach to public health laboratories and has many options and programs to directly support public health laboratories during emergencies. The Division of Laboratory Systems (DLS) is focused on helping clinical laboratories improve their quality systems, advance interoperability of laboratory data, and improve response to public health emergencies. There are approximately 250,000 clinical and private laboratories in the United States. Having direct relationships with each of these laboratories would be impossible. DLS is working with professional laboratory organizations to provide information, communication and guidance to clinical laboratories during emergencies. APHL can help DLS to bring together these partner organizations during one day meetings to discuss challenges, gaps and ways to engage clinical and private laboratories during a public health response.

Mid-Term Outcome

· Increases laboratory effectiveness in response to public health needs, including emergencies Long-Term Outcome

· Improves response to public health emergencies Appendix E. Workforce Development #6 Project Name: Preparedness Training for the Public Health Laboratory Workforce Project Activity Contact Information: Yescenia Wilkins, exq6@cdc.gov Approximate Amount of Supplemental Funding Available: $75,000

Project Description:

This funding is to provide relevant and timely training on biosafety, biosecurity, and emergency response laboratory procedures to the public health and clinical laboratory communities. This project builds on previous supplemental-funded activities with APHL that provided in-person workshops and virtual training exercises.

Specific Activities:

· Implement a minimum of two in-person Conventional Methods courses focused on biothreat agents at BSL3 laboratories

· Develop a fifth virtual knowledge exercise to complete the series of five. These exercises assess retention of rule-out-or-refer skills. Exercises one through four were completed with previous funding.

· Deliver a minimum of two webinars focused on laboratory emergency preparedness and response topics.

Mid-Term Outcome

· Promotes competent, collaborative, and practice-ready PHL workforce

· Increases laboratory effectiveness in response to public health needs, including emergencies

· Improves public health laboratory detection and response programs

Long-Term Outcome

#7 Project Name: Public Health Lab Biosafety Officials (BSO) Evaluation Project Activity Contact Information: Anja Minnick mty5@cdc.gov Approximate Amount of Supplemental Funding Available: $200,000 Project Description:

Biosafety Officials (BSOs) are integral in ensuring a safe work environment for many laboratory professionals across the country. Biosafety Officials identify effective risk mitigation strategies and provide biosafety training to reduce potential biological hazards or threats faced by public health, sentinel, and clinical laboratories within states. The role of Biosafety Officials is relatively new, and the Division of Laboratory Systems is well positioned to help key stakeholders better understand the benefits of Biosafety Officials. To do so, it is important for DLS to understand how effective BSOs have been in establishing risk mitigation strategies that adequately protect laboratory professionals and the barriers biosafety Officials encounter. An evaluation that assesses how biosafety Officials establish risk mitigation strategies, how well those strategies are implemented throughout states, and whether laboratory professionals are safer as a result would be of great value to DLS and the CDC.

Mid-Term Outcome

· Promotes competent, collaborative, and practice-ready PHL workforce

· Increases laboratory effectiveness in response to public health needs, including emergencies

· Develops model policies and tools for quality and safe PHL practice

· Creates sustainable and resilient PHLs that effectively and efficiently adapt to evolving public health needs

#8 Project Name: APHL-MicrobeNet Training Partnership/Development of training materials and videos for MicrobeNet Project Activity Contact Information: Lisa Angel/John McQuiston, vin3@cdc.gov/zje8@cdc.gov Approximate Amount of Supplemental Funding Available: $20,000 Project Description:

APHL has consistently assisted CDC and the MicrobeNet Team in providing training to the State Public Health laboratories for utilizing the MicrobeNet system. Both benefits and hurdles to implementing MicrobeNet in the public health laboratories have been identified and the training has become more efficient over time. The highest reasons for laboratories to either not implement the MicrobeNet system or to stop using it has been identified as a lack of training on how to use MicrobeNet or the specific recommended techniques.

Justification and Need: Because turnover rate is high within the state public health laboratories and the ability to have continuity in system knowledge is key to both success and consistency in using systems like MicrobeNet, this Cooperative agreement should be continued, and enhanced with the development of online training modules. Goals and Activities: The goal is to provide sustainable training to state public health laboratories for successful adoption of the MicrobeNet platform to enhance pathogen identification and surveillance. Continuing activities will include providing training to identified State Public Health Laboratory scientist. Enhanced activities will include developing short online training modules for sustainability.

Appendix F. Laboratory Informatics Capacity

9. Project Name: Enhancing support for messaging for multiple surveillance systems Project Activity Contact Information: Jason Hall, zfr9@cdc.gov Approximate Amount of Supplemental Funding Available: $600,000 Project Description:

To submit disease data (NND and other programs) to CDC, jurisdictions often are required to send their data, which are housed in a single system, through a number of separate, often duplicative, data streams. Implementing HL7 messaging for transmitting surveillance data will reduce this burden on state public health departments by eliminating redundant data collection systems, will increase interoperability and standardization of electronic data exchange, and will improve data quality for national disease surveillance. This project will build upon current investments in HL7 data message exchange to serve multiple programs across CDC and reduce state burden. This is an enhancement to existing work to support improvements to continuous integration and dev ops on AIMS as well as adding support for nine more diseases.

10. Project Name: Enhancing support for technical assistance Project Activity Contact Information: Jason Hall, zfr9@cdc.gov Approximate Amount of Supplemental Funding Available: $700,000

Project Description:

State often need assistance with setting up, modifying and receiving and consuming standards-based electronic data exchange. APHL provides staff and contractors to states for specific projects to help with ELR, NMI, eCR, CDC ELR, Quest ELR, Animal Rabies, and other activities. This project will build upon current investments in technical assistance to serve multiple programs across CDC and reduce state burden. This is an enhancement to add additional support to advance data exchange for ELR, NMI, and eCR so more states can simultaneously be supported.

11. Project Name: Enhancing support for sending Electronic Disease Notification Data (EDN) for Vaccinated Refugees Using HL7 Messages Project Activity Contact Information: Yoni Haber, dlv8@cdc.gov Approximate Amount of Supplemental Funding Available: $100,000

Project Description:

Since inception of this program, more than 100,000 U.S.-bound refugees have been vaccinated, accounting for more than 700,000 documented vaccine doses. These refugees are then settled into different states where the public health agencies need to have access to medical history data, including vaccination history. The goal of the project is to send vaccination information into state immunization registries by using HL7 messages, making refugee vaccination information available to a wider medical community and limiting revaccination

12. Project Name: Laboratory Informatics Curriculum and Training Project Activity Contact Information: Jasmine Chaitram, zoa6@cdc.gov Approximate Amount of Supplemental Funding Available: $300,000 Project Description:

This funding is to develop a curriculum and supporting training courses that present laboratory informatics in the context of public health. This project builds on previous supplemental-funded activities with APHL that gauged gaps in laboratory informatics knowledge and skills, produced a roadmap for building a curriculum, and developed three introductory eLearning courses.

Specific Activities:

· Develop a laboratory informatics curriculum, building on previous environmental scanning that identified gaps and needed competencies and produced a roadmap for the curriculum.

· Complete a training series through the development of 2-3 introductory- and/or intermediate-level courses as part of the curriculum and that build on the three introductory courses already created: 1) “Introduction to Laboratory Informatics: Life of a Specimen”; 2) “Introduction to Laboratory Informatics: Life of a Result”; and 3) “Laboratory Information Management Systems (LIMS) and other Informatics Systems”. Possible additional topics include Data Quality, Data Standards, Data Systems Integration, and Project Management and the Systems Life Cycle.

13. Project Name: Enhancement of Electronic Case Reporting Project Activity Contact Information: Laura Conn, lconn@cdc.gov Approximate Amount of Supplemental Funding Available: $2,500,000 Project Description:

This project will be completed in three phases. During each phase up to 10 clinical care organizations will be supported for the submission of electronic case reports to the appropriate Public Health Agency. This includes setting up technical connectivity for receiving and sending eICRs and Reportability Responses between the clinical care organizations and public health agencies. It also includes the execution of the necessary legal agreements. Enhancements to the HL7 standards will be made as necessary.

Mid-Term Outcome

· Advances an electronic reporting infrastructure to reduce burden on clinical care providers and provides more timely and complete reports to public health Long-Term Outcome

· Reduces incidence and prevalence of preventable diseases and public health threat

· Protects the public from public health threats

14. Project Name: Supporting Continuation and Expansion of Electronic Data Exchange between State Newborn Screening Programs and Birth Hospitals Project Activity Contact Information: Jasmine Chaitraim, zoa6@cdc.gov Approximate Amount of Supplemental Funding Available: $200,000 Project Description:

Atlanta Hospital uses. GPHL hopes to extend the data exchange with the other 6 Piedmont Hospitals by the end of next year. Meanwhile GPHL is exploring the possibility to expand this project to other major hospital systems in Georgia aiming at covering at least 50% of Georgia newborns by the end of 2020. Therefore supplemental funding is requested to support this expansion with the overall goal to reduce medical/laboratory errors and improve quality, efficiency, and timeliness of NBS. This project is considered a demonstration project that will produce applications generalizable nationwide.

In addition, we are supporting the Colorado NBS Program to collect data for 3 new diseases being considered for the state NBS panel using a similar ETOR system. However, the current support utilized the carryover funds from 2017 resulting in CO having to divide their initial project plan over 2 years. Therefore supplemental funding is requested to support CO for the second year in order to complete their project and NBS ETOR between GPHL and additional hospital systems in Georgia (in additional to Piedmont hospitals).

Specific Activities:

· For the Colorado project, complete ETOR data collection and evaluation for the 3 new diseases.

· Develop reports, presentations, and/or publications to disseminate findings, lessons learned and success stories.

· Develop NBS ETOR applications that can be used or adapted for other state programs.

15. Project Name: VPD Reference Centers -Informatics Project Activity Contact Information: Paul Rota, par1@cdc.gov Approximate Amount of Supplemental Funding Available: $166,380 Project Description:

The VPD RC project is currently very stable with HL7 data flowing from the RCs to the CDC with only intermittent issues. A new PCR assay that specifically detects measles vaccine viruses (MeVA) was evaluated and validated at the 4 RCs. Vocabulary was developed and test messages created in an effort to transmit test results for this new assay by HL7 transport. The move of Strep Pneumo to the ARLN project will require support to assure the data is properly tagged so that it gets to the ARLN group not VPD.

Proposed Activities:

· Continue to monitor the VPD HL7 data stream for issues that need addressing.

· Support the onboarding of the MeVA assay by facilitating incorporation of the vocabulary into RCs LIMS systems and resulting HL7 feed.

· Provide technical support and guidance to assure the Strep Pneumo ARLN data is properly identified.

· Revisit the incorporation of embedded data into the HL7 feed to allow incorporation of sequencing results into the message.

Expected Outputs:

· HL7 data stream monitored closely to assure technical issues are quickly identified and addressed.

· MeVA assay test messages completed by each RC and capability to consume those messages evaluated by CDC.

· Strep Pneumo data properly tagged for consumption by ARLN not VPD

· Work with CA, MN, NYS to incorporate embedded data into HL7 message Expected Outcomes:

· MeVA assay results are incorporated into HL7 data flow to allow for a complete test record in the VPD database.

· Strep Pneumo testing realigned to ARLN on all fronts including HL7 messaging.

· Sequencing data incorporated into the HL7 message to allow for a complete digital testing record in one database

16. Project Name: Laboratory Based Surveillance Network: Opioids Project Activity Contact Information: Jasmine Chaitram, ZOA6@CDC.GOV Approximate Amount of Supplemental Funding Available: $350,000 Project Description:

The capacity of Laboratory Response Network- Chemical (LRN-C) will be expanded by CDC National Center for Environment Health (NCEH) to include testing opioids analogues for population surveillance. De-identified results will be hosted on the AIMS platform, and then used by public health communities at local, state and federal levels, but not shared back with clinicians.

CDC DLS will work with APHL informatics to create a data repository and facilitate the data exchange between clinical labs, LRN-C labs and storage of data on APHL Informatics Messaging Services (AIMS).

This will occur in 2 phases:

Phase I – Discovery, approximately 6 months

· Requirements gathering, design, documentation, develop level of effort and cost estimates Phase II – Development and Implementation

· CDC DLS in collaboration with APHL will select one or more jurisdictions to pilot test new analytical approaches for using LabCorp and LRN-C definitive testing data for Opioids.

· (a) Identify 1-2 states to receive data from clinical labs

· (b) Work with LRN C labs to develop content and message

· (c) Provide Technical support for LRN-C lab to process the test order from clinical labs and sending the results to AIMS

· (d) Provide technical support for clinical labs to send the opioid test order to LRN-C lab This project will provide evidence and define best practices for the potential utility of non-fatal opioid surveillance using APHL-administered mini-grants to build capacity for jurisdiction-based opioid surveillance. Initially, a small number of public health laboratories that currently have instrumentation capable of definitive drug testing would be supported by APHL for specific projects that build laboratory technical capabilities to support jurisdictional opioid surveillance. The selected public health laboratories, with support of APHL, will identify methods and sources for samples as the basis for monitoring of non-fatal opioid OD within the jurisdiction.

In addition to advice from APHL members stakeholders should be involved in the support of demonstration projects, such as CSTE, state epidemiologists. Criteria for determining whether demonstration projects or other approaches of support for this testing service will be decided by an appropriate body, such as the Opioid Task Force.

17. Project Name: Cancer Pathology Reporting Pilot with Nevada Department of Health Project Activity Contact Information: Sandy Jones, sft1@cdc.gov Approximate Amount of Supplemental Funding Available: $200,000 Project Description:

Quest will have a cancer pathology HL7 2.5.1 message format developed soon for transmission to state cancer registries. Quest has requested that the cancer registry be able to receive the cancer pathology laboratory messages from the Departments of Health that were received through the AIMS platform. Nevada Department of Health, Nevada Cancer Registry, and Quest have all discussed the interest in piloting this.

We would like to propose a pilot project to implementation transmission of cancer pathology data through AIMS to the Nevada Department of Health that would then route the data to the Nevada Cancer Registry. This pilot project with Quest and Nevada will allow the cancer registry community to have a better understanding of the requirements to implement cancer pathology laboratory data to states through the AIMS platform. Quest believes that the cancer HL7 2.5.1 messages could be sent in a single file with ELR data, then the data could be parsed out into separate files for routing to the different Department of Health programs. The cancer registry community has a core ICD-10-CM code list that all cancer registries have agreed to receive cases from laboratories based on and there is an expanded ICD-10-CM code list that a subset of cancer registries (10 states) that have requested additional cases be sent based on.

If this pilot proves successful, then the CDC’s National Program of Cancer Registries will look at expanding this project to a national implementation project.

Appendix G. Newborn Screening and Genetics

18. Project Name: Newborn Screening and Genetics/Improving the Interpretation of Newborn Screening Test Results Project Activity Contact Information: Amy Mowbray, htm3@cdc.gov Approximate Amount of Supplemental Funding Available: $700,000 Project Description:

Newborn screening laboratories increasingly use molecular techniques to better identify and improve treatment for babies with heritable diseases. As laboratories adopt next generation sequencing technologies, they produce large amounts of valuable data. At the same time, newborn screening programs are working to implement screening for an expanding number of new conditions. Laboratories need additional resources and expertise to adequately analyze and interpret ever more complex data from both biochemical and molecular tests. This project will expand the Newborn Screening and Genetics Program’s activities to support up to 5 new bioinformatics fellows. These fellows will help develop bioinformatics capability in the newborn screening system. In addition, this project will convene newborn screening stakeholders to assess necessary processes and tools for enhancing interpretation of test results. This effort will inform activities to reduce false positives and improve the predictive value of newborn screening tests.

Mid-Term Outcome

· Promotes competent, collaborative, and practice-ready PHL workforce

· Improves laboratory methods, systems, and informatics capacity

· Increases laboratory effectiveness in response to public health needs, including emergencies

· Improves public health laboratory detection and response programs

Long-Term Outcome

· Reduces incidence and prevalence of preventable diseases and public health threats

· Reduces morbidity and mortality equitably delivered throughout the United States and the world

· Creates sustainable and resilient PHLs that effectively and efficiently adapt to evolving public health needs

Appendix H. Food Safety

19. Project Name: PulseNet Project Activity Contact Information: Peter Gerner-Smidt, plg5@cdc.gov Approximate Amount of Supplemental Funding Available: $253,500 Project Description:

Existing; Support for up to three PulseNet International (PNI) trainings/workshops: $100,000 (one steering committee, two WGS curator trainings), one PulseNet WGS workshop for state participants in Atlanta for 10 participants: $15,000, one APHL staff traveling to one PNI: $3,500 New: one regional PulseNet meeting to support coordination and optimization of regional PulseNet activities: $30,000 New: support states facing internal procurement problems procuring WGS supplies through APHL for real-time surveillance: $75,000 supplies & $30,000 salary/fringes/overhead support for APHL

Mid-Term Outcome

Long-Term Outcome

20. Project Name: Implementation of Global Hepatitis Outbreak and Surveillance Technology (GHOST) at State Public Health Laboratories Project Activity Contact Information: Yury Khudyakov, hee9@cdc.gov;

Approximate Amount of Supplemental Funding Available: $200,000 Project Description:

Need: GHOST developed at DVH enables all users to perform state-of-the-art surveillance and outbreak investigation activities. Implementation of GHOST among State Public Health Laboratories gives access to States Departments of Health to the novel technology and assists in guiding local public health interventions. The GHOST pilot project has been launched in 2016 to evaluate the quality assurance system and analytical tools for the detection of HCV transmission clusters and transmission networks. Currently, seven state laboratories are engaged in piloting this technology targeting HCV. During the pilot, state laboratories were able to apply GHOST to detect and investigate HCV outbreaks in their jurisdictions, indicating transition of the project from piloting to implementation in state surveillance programs. Recently, GHOST was updated to include tools for the detection of HAV outbreaks. Several new functionalities for detection of HBV outbreaks and recent HCV infections are to be added in FY18.

Goals: In an effort to enable more wide-spread use of GHOST and to continue implementation of GHOST among State Public Health Laboratories in order to build local capacity for conducting independent outbreak investigation and molecular surveillance to track HAV, HBV and HCV infections.

Specific Activities to be undertaken: Using the existing funding mechanism, continue support of 7 state laboratories currently participating in the GHOST Pilot project and add 3 additional state laboratories. It is planned to announce the funding opportunity to identify the additional 3 sites. New laboratories will need to participate in the annual GHOST Workshop to be trained in GHOST NGS. All participating laboratories will be testing locally acquired specimens from cases infected with viral hepatitis. If specimens for certain pathogens are not available, CDC plans to help. Additionally, CDC plans to evaluate and implement a high-throughput NGS protocol, which would allow for testing up to 100 specimens in a single run. A panel of specimens for this activity will be provided by CDC. Each site will establish a fully operational GHOST laboratory capable of supporting local HAV, HBV and HCV outbreak investigations.

Mid-Term Outcome:

· Promotes competent, collaborative, and practice-ready PHL workforce

· Improves laboratory methods, systems, and informatics capacity

· Increases laboratory effectiveness in response to public health needs, including emergencies

· Improves public health laboratory detection and response programs

Long-Term Outcome:

· Reduces incidence and prevalence of preventable diseases and public health threats

· Reduces morbidity and mortality equitably delivered throughout the United States and the world

· Protects the public from public health threats

· Creates sustainable and resilient PHLs that effectively and efficiently adapt to evolving public health needs

21. Project Name: Regional GHOST-based Surveillance for detection of HAV outbreaks and for HBV and HCV Elimination Project Activity Contact Information: Yury Khudyakov, yek0@cdc.gov Approximate Amount of Supplemental Funding Available: $1,000,000

Project Description: Justification: Recent HAV outbreaks in the United States tend to be large and spread across several jurisdictions. Genetic testing and analyses became important for linking clusters of cases in different states into a single outbreak, facilitating tracking HAV strains and detection of transmission networks for development of most efficient public health interventions to contain HAV outbreaks. Massive multiple state outbreaks of HAV infections associated with hospitalization and even death of infected individuals indicate a significant public health threat posed by this infection in the United States. In addition, HBV and HCV infections are a major public health problem in the United States. The number of deaths associated with HCV has now surpassed 60 other nationally notifiable infectious conditions combined. Outbreaks of HBV and HCV infections associated with unsafe injection practices, drug diversion, and other exposures to blood are difficult to detect and investigate. Availability of the HBV vaccine and novel therapeutics against HBV and HCV provides opportunities for elimination of HBV and HCV infections in the United States.

Need: The effective HAV, HBV and HCV outbreak investigations require comprehensive surveillance. Implementation of strong local surveillance programs to track infections is fundamental for the development and assessment of public health interventions to control HAV, HBV and HCV infections. However, application of molecular surveillance tools is complex and require substantial expertise to implement. Division of Viral Hepatitis, CDC has developed and validated a laboratory and computational methodology for the rapid and cost-effective identification of HAV, HBV and HCV transmission clusters using next-generation sequencing (NGS) data and novel computational tools to control quality of the data and information and to identify transmission clusters and transmission networks. These novel approaches are currently adapted to the Illumina MiSeq platform and developed into Global Health Outbreak and Surveillance Technology (GHOST), a cloud-based system that integrates bioinformatics, information and web-based technologies with NGS, and enables all users, regardless of their computational expertise, to conduct independent, cost-effective, accurate and reproducible hepatitis molecular surveillance. The GHOST pilot project was rolled out to the State Department Public Health Laboratories (SDPHL) in 2016 to evaluate the quality assurance system and analytical tools for detection of HCV transmission clusters and transmission networks. GHOST developed at DVH enables all users to perform state-of-the-art surveillance and outbreak investigation activities. Implementation of GHOST among State Public Health Laboratories gives access to State Departments of Health to the novel technology and assists in guiding local public health interventions.

Specific Activities to be undertaken: Using the current available funding mechanism, announce funding opportunity and select 3-5 sites, which would demonstrate - a strong support from SDPH, well established laboratory facility, availability of highly trained laboratory personnel, access to epidemiologically defined high-risk communities with known or expected high incidence or prevalence of HBV and HCV infections, and capacity to collect and test serum specimens for HBV and HCV infections and conduct follow-up testing in targeted communities. The sites should be in geographic regions with high prevalence of HBV and HCV infections. It is expected that the sites have minimal laboratory equipment for conducting next-generation sequencing using MiSeq. Each site will receive funding to purchase MiSeq sequencer dedicated to GHOST testing, automated workstation to generate MiSeq libraries, specimen collection supplies and reagents for PCR and sequencing, as well as to cover collection of specimens, shipping, travel and training expenses to attend the annual GHOST Workshop.

Each site will establish a fully operational GHOST laboratory capable of supporting HAV, HBV and HCV outbreak investigations, and large-scale surveillance projects for the identification of transmission networks among high-risk populations, as well as will identify opportunities for surveillance in support of local HBV and HCV elimination programs. Each site will be available to serve as a regional GHOST Center to assist in HAV, HBV and HCV outbreak investigations and surveillance programs to other local and state programs.

Mid-Term Outcome

· Promotes competent, collaborative, and practice-ready PHL workforce

· Improves laboratory methods, systems, and informatics capacity

· Increases laboratory effectiveness in response to public health needs, including emergencies

· Improves public health laboratory detection and response programs

Long-Term Outcome

· Reduces incidence and prevalence of preventable diseases and public health threats

· Reduces morbidity and mortality equitably delivered throughout the United States and the world

· Creates sustainable and resilient PHLs that effectively and efficiently adapt to evolving public health needs

22. Project Name: The 3rd Annual GHOST Workshop - 2018 Project Activity Contact Information: Yury Khudyakov, yek0@cdc.gov Approximate Amount of Supplemental Funding Available: $50,000

Project Description:

Justification: The effective HAV, HBV and HCV outbreak investigations require comprehensive surveillance. Implementation of strong local surveillance programs to track infections is fundamental for the development and assessment of public health interventions to control HAV, HBV and HCV infections. However, application of molecular surveillance tools is complex, and require substantial expertise to implement. Global Hepatitis Outbreak and Surveillance Technology (GHOST) developed at DVH enables all users to perform state-of-the-art surveillance and outbreak investigation activities.

Need: Implementation of GHOST among State Department Public Health Laboratories (SDPHL) enables SDPH to access the novel technology and assists in local outbreak investigation and guiding public health interventions. Considering novelty of the technology, it is important to educate local epidemiologists in application of GHOST to local public health programs, and state public health laboratorians to conduct next-generation sequencing of HAV, HBV and HCV.

Goals: To educate SDPH in GHOST applications and train SPHL in conducting next-generation sequencing in support of local GHOST-based outbreak investigations and surveillance for HAV, HBV and HCV infections.

Specific Activities to be undertaken: Using the currently available funding mechanism, convene the 3rd Annual GHOST Workshop at CDC, Atlanta, GA in October 2018. Eligible candidates for training will be identified among persons who respond to the announcement. Aditionally, representatives of the state laboratories currently participating in the GHOST Pilot project will be invited to share their experieces. Funding will be used as well to invite faculty and state epidemiologists for discussion of opportunities offered by GHOST application in different epidemiological settings.

Mid-Term Outcome

· Promotes competent, collaborative, and practice-ready PHL workforce

· Improves laboratory methods, systems, and informatics capacity

· Increases laboratory effectiveness in response to public health needs, including emergencies

· Improves public health laboratory detection and response programs

Long-Term Outcome

· Reduces incidence and prevalence of preventable diseases and public health threats

· Reduces morbidity and mortality equitably delivered throughout the United States and the world

· Protects the public from public health threats

· Creates sustainable and resilient PHLs that effectively and efficiently adapt to evolving public health needs

23. Project Name: Integration of genotypic and epidemiological data in support of outbreak investigations for TB Activity Contact Information: Angela Starks, eog0@cdc.gov Approximate Amount of Supplemental Funding Available: $50,000 Project Description:

In collaboration with a DTBE Bioinformatician, local data and expertise are needed to ensure local program utility for proper integration of whole genome sequencing and epidemiological data in support of outbreak investigations. The most effective methods and tools to support the National TB Genotyping Service and Molecular Epidemiologic Activities have yet to be identified. To facilitate this endeavor an expansion of current activities is needed to collaborate with additional state or large city TB Programs with sufficient incidence of TB. This collaboration will help define the most meaningful approaches for data integration and utility of subsequent project tools, methods and data sources. Outcome measures will be defined using historical and prospectively collected data from a variety of genotype-matched cluster and outbreak investigations. The collaboration is best served by a program performing a range of public health activities addressing different epidemiologic challenges with distinct programmatic structures, staffing, and capacities.

Mid-Term Outcome

· Improves laboratory methods, systems, and informatics capacity

· Improves public health laboratory detection and response programs Long-Term Outcome

· Reduces incidence and prevalence of preventable diseases and public health threats

· Reduces morbidity and mortality equitably delivered throughout the United States and the world

· Protects the public from public health threats

24. Project Name: Evaluation of validation protocols, test algorithms, or procedures associated with newer generation IGRA for detection of infection with Mycobacterium tuberculosis Project Activity Contact Information: Angela Starks, eog0@cdc.gov;

Approximate Amount of Supplemental Funding Available: $150,000

Project Description:

In the United States, an estimated 13 million people are infected with M. tuberculosis and are at risk of the development of active TB. However, the identification and treatment of these individuals can prevent future TB cases and aid CDC efforts to eliminate TB in the United States. Newer generation IGRA, specifically the QFT gold plus, are replacing older tests and this requires laboratories to have robust validation protocols in place. Additionally, work with TB programs must be done to evaluate test algorithms and any potential logistical challenges regarding blood collection, transport, and processing. In collaboration with APHL, we aim to identify 3-5 competively selected awardees to develop and evaluate validation protocols, assess 1 vs. 4 blood draws, or assess test algorithms during a 1 year period. Participants would be able to develop proposals based on their experience and patient populations served.

Mid-Term Outcome

· Promotes competent, collaborative, and practice-ready PHL workforce

· Improves laboratory methods, systems, and informatics capacity

· Improves public health laboratory detection and response programs

· Develops model policies and tools for quality and safe PHL practice

Long-Term Outcome

· Reduces incidence and prevalence of preventable diseases and public health threats

· Revises standards for the PHL system resulting in a more efficient, higher quality, and safe PHL system

25. Project Name: Evaluation of WGS versus phenotypic drug susceptibility test results for M. tuberculosis to determine predictive value for the purposes of potentially decreasing the amount of growth-based testing performed in public health laboratories Project Activity Contact Information: Angela Starks, eog0@cdc.gov Approximate Amount of Supplemental Funding Available: $250,000

Project Description: Growth-based drug susceptibility testing for M. tuberculosis is resource intensive and requires special expertise. Current practice includes DST for all patients by growth-based methods. However, increasingly programs are interested in faster and perhaps more accurate methods, including whole genome sequencing, to provide results for patient management and surveillance. The Wadsworth Center in NYS and Public Health England are planning to implement programs with WGS as the primary DST method that could potentially eliminate >85% of growth-based testing. CDC is currently assessing the predictive value of WGS results through an evaluation of samples received for the Molecular Detection of Drug Resistance Service. However, the number of isolates being evaluated is limited (~800) and is biased toward resistance. In collaboration with APHL, we aim to identify 3-5 competively selected awardees to perform WGS for all samples received over a 3-6 month period and compare these results to the growth-based results. CDC is planning universal WGS in the near future but is limited by the need to wait for the submission of drug susceptibility test data to our surveillance system. This project will allow CDC to quickly aggregate in-house versus state PHL data to determine if moving forward with a broader guidance development process is worthwhile.

Mid-Term Outcome

· Promotes competent, collaborative, and practice-ready PHL workforce

· Improves laboratory methods, systems, and informatics capacity

· Improves public health laboratory detection and response programs

· Develops model policies and tools for quality and safe PHL practice

Long-Term Outcome

· Reduces incidence and prevalence of preventable diseases and public health threats

· Revises standards for the PHL system resulting in a more efficient, higher quality, and safe PHL system

26. Project Name: Assessing incidence and risk factors for false positive cultures of Mycobacterium tuberculosis Project Activity Contact Information: Angela Starks, eog0@cdc.gov Approximate Amount of Supplemental Funding Available: $75,000 Project Description:

False positive cultures for Mycobacterium tuberculosis can occur due to pre-analytical mistakes, aerosol production and cross contamination during the analytical phase, or through errors in the post analytical phase of laboratory testing. A better understanding of the incidence and risk factors associated with false-positive cultures in U.S. laboratories is needed to help guide policies and procedures to reduce their occurrence. False positive cultures can result in the unnecessary treatment of patients and expenditure of healthcare and public health resources. In collaboration with APHL, this project aims to assess the occurrence of false-positive cultures in 5-7 public health or clinical laboratories using criteria that includes genotyping, drug resistance profile, only one positive culture, and programmatic/clinical information (e.g., call from clinician because patient does not have symptoms consistent with TB) to define potential false positive cases for further evaluation. The project would assess all AFB cultures over a 6 month to 1 year period, depending on the test volume of the laboratory. Cultures identified as potentially false positive would be evaluated by participating laboratories in collaboration with programmatic/ healthcare counterparts for confirmation. Participating laboratories would provide information relative to testing volume, facilities, and specimen processing procedures to assess potential risk factors associated with false positives. All participants would engage as part of a larger workgroup to assess outcomes and develop potential resources/tools to address this issue.

Mid-Term Outcome

· Promotes competent, collaborative, and practice-ready PHL workforce

· Improves laboratory methods, systems, and informatics capacity

· Improves public health laboratory detection and response programs

· Develops model policies and tools for quality and safe PHL practice Long-Term Outcome

· Reduces incidence and prevalence of preventable diseases and public health threats

· Revises standards for the PHL system resulting in a more efficient, higher quality, and safe PHL system

27. Project Name: Influenza Laboratory Strengthening and Pandemic Preparedness Project Activity Contact Information: Chris Duggar, cnd8@cdc.gov Approximate Amount of Supplemental Funding Available: $2,000,000 Project Description:

Influenza Laboratory Strengthening –

· During the 2017-18 Influenza Season we identified a weakness in surveillance operations and will address CLAW and National Surveillance Accessioning maintenance; further efforts will be made to gather business requirements and needed enhancements.

· Re-establish the working group to review and update the laboratory capability and capacity assessment tool following WHO new Terms of References.

· Training session (either in person or via webinar) to make sure that all APHL staff as well as CDC staff are aware of the implemented…