Case Study

National Institutes of Allergies and Infectious Diseases (NIAID); Leidos Biomedical Research, Inc.: Planning for Development of Medical Countermeasures for Biodefense

Key Findings

  1. Designing for a successful bio-defense research infrastructure blends together subject matter expertise in the science domain and strong technical and management capabilities (Capability Maturity Model Integration and the Project Management Body of Knowledge).
  2. Architecting a forward thinking design that can support research for up to 30 years takes creative dialogue with a wide variety of current and potential future stakeholders.
  3. Strong program and research data governance from a range of medical devices and information systems yield cost savings and accelerates success.
  4. Working in a changing environment requires IT agility and a significant depth and breadth of skills to meet challenges from unexpected directions.
    By maintaining a project risk log that is updated and regularly submitted to the client risks are minimized, ensuring project stability.

Customer

National Institutes of Health, National Institute of Allergies and Infectious Diseases: Integrated Research Facility (IRF) Frederick

Challenge

In 2004, NIAID initiated the design and build of a maximum-containment research facility, the Integrated Research Facility (IRF), to speed the discovery and delivery of interventions targeting high consequence viral pathogens. The building was designed in accordance with the Centers for Disease Control and Prevention and NIH biosafety standards, and includes unique Biosafety Level 4 (BSL-4) medical imaging capabilities –the highest level in biosafety standards. Vital to the nation’s efforts to protect the public’s health against emerging biological threats, the IRF applies clinical tools and concepts and medical imaging in the study of disease progression in experimentally infected animals.

From 2005-2017, Leidos Biomedical subcontracted with TCG to create the high-level computing, administrative, and scientific design for this 144,000 ft building which is comprised of 32,000 ft of laboratory space for six core lab groups: Clinical, Anatomic Pathology, Cell Culture, Medical Imaging, Comparative Medicine and Aerobiology. TCG went on to supply subject matter expertise in a wide range of areas over the years.

Solution

Initially, TCG met with NIAID stakeholder and research scientists to elicit use cases for research envisioned 5-10 years into the future, as similar facilities have taken that long to be fully up and running. We developed high level network architecture and conceptual and logical designs for administrative and scientific work considering state-of-the-art technologies at the time such as Voice Over Internet Protocol (VoIP), thin client, and in-suit communications devices. We worked directly with the building architecture and general contractor teams to ensure the final design and construction took those designs into account. Once building construction was underway, we transitioned our work into developing technical statements of work (SOWs), requests for proposal evaluation, and quality assurance testing to acquire hardware and software that supported a multitude of solutions, including, but not limited to:

  • Communications including: VOIP, Emergency Plain Old Telephone Service (POTS) and satellite backup communications. Guest, administrative, laboratory wireless networks
  • Compute Infrastructure including: server room design, server architecture, Multi-network Wireless Intrusion Detection System, audio/video systems
  • Research systems including: Electronic Health Record (EHR), Biospecimen Collection and Management systems, Laboratory Information systems (LIMS), Electronic laboratory notebook systems (eLN)

We then transitioned into supporting the Office of Cyber Infrastructure and Computational Biology (OCICB) in deploying the communications and informatics solution for the scientific work of the organization. We focused on data management and governance in areas including data architecture, modeling, integration, metadata development, and data quality.

Results

The Division of Select Agents and Toxins of the Centers for Disease Control and Prevention (CDC) approved the start of BSL-4 research in October, 2014, nine years after TCG’s high level systems and network architecture and design role was initiated. Our role transitioned as the IRF’s needs evolved, developing technical Statements of Work. We used our CMMI Level 3 Decision Analysis and Resolution (DAR) analysis framework to review and compare products addressing wireless and in-suit communications, Picture Archiving and Communication Systems (PACS), Laboratory Information Management System (LIMS), Electronic Laboratory Notebook (ELN), confocal microscopy, telemetry, scientific equipment monitoring, lab cameras, VoIP telephony, and satellite backup. After installation of the interconnecting systems, TCG defined research core workflows, architected the research data repository, and ensured that the research data generated is governed in a way that best achieves the IRF scientific mission. TCG played a mission critical role in planning for NIAID’s ability to conduct experiments which will advance the understanding of emerging diseases such as Ebola and the development of countermeasures and clinical care paradigms such as the Idylla™ prototype Ebola virus test of Zaire ebolavirus (EBOV) and Sudan ebolavirus (SUDV) in order to protect the nation from high consequence pathogens.

Taxpayer Savings: $375,000

Pulling in subject matter experts for short term, part-time assignments for specific skill sets from TCG’s deep bench of IT and scientific domain experts resulted in a cost effective approach. Of the many systems ultimately selected that generated cost savings, designing a cutting-edge VoIP communications network saved taxpayers $375K over a 20 year research period by avoiding the rerunning and rewiring of telephony as moves, adds, and changes would need to occur.

Finally, total cost for the research facility was stated at a 2014 Conference on Biocontainment Facilities as over $180 million. In 2005, TCG’s role started before ground breaking in order to have a forward thinking IT architecture to support BSL-4 research ultimately authorized in 2014. Due to construction techniques necessary to support this mission-critical scope, retrofitting would be cost prohibitive if TCG’s designs did not properly anticipate the needs of its user base. So, we view our role as one of cost avoidance.