Health Sciences

We specialize in assessing laboratory biosafety, biosecurity, and capability/capacity to respond to public health emergencies such as a natural disaster, disease outbreaks (see our white paper, Pandemic Avian Influenza: The Role of the Laboratory), or terrorist events. Our diverse team of experienced laboratory scientists include clinical chemists, medical technologists, microbiologists, immunologists, molecular geneticists, toxicologists, and specialists in veterinary medicine. Our laboratory scientists are intimately familiar with government and professional guidelines for conducting laboratory operations as well as with laboratory regulations and requirements for conducting laboratory work in a safe and secure manner.

Our reach extends beyond the laboratory. We can assist your facility with providing effective Institutional Biosafety Committee (IBC) oversight of laboratory work involving recombinant DNA research, and with ensuring that the laboratory is integrated with relevant organizational emergency response and communications plans. We also provide training and exercises in these areas.

Specific offerings that Constella provides include:

• Laboratory Assessment
• Laboratory Proficiency Training
• Research Laboratory Information Management Systems
• Risk Communications

Selected Projects

• Select Agent Program Services
• Integrating Public Health Laboratories with State Emergency Response Readiness
• Institutional Biosafety Committee Educational Site Visits

Select Agent Program Services

Client: Centers for Disease Control and Prevention

In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 the CDC must continuously track the Possession, Use, and Transfer of Select Agents and Toxins in the United States. Select Agents are those biological agents and toxins that have the potential to pose a severe threat to public health and safety. Constella provides the CDC Division of Select Agents and Toxins and USDA Animal and Plant Health Inspection Service (APHIS) with teams of highly trained laboratory scientists and support personnel from a variety of scientific disciplines to:

• Register all facilities in the United States that possess select agents.
• Inspect all registered laboratories working with select agents in the United States to certify that proper biosafety measures are in place to protect laboratory workers and the public from exposure to these agents, and to ensure that proper biosecurity measures are in place to prevent accidental or intentional release of these agents.
• Inspect all international laboratories working with select agents that receive NIH funding to certify that proper biosafety measures are in place to protect laboratory workers and the public from exposure to these agents, and to ensure that proper biosecurity measures are in place to prevent accidental or intentional release of these agents.
• Authorize and track all shipments of select agents between registered facilities within the United States.
• Monitor and assist CDC with investigating all incidents of theft, loss, or release of select agents in the United States.
• Manage Etiologic Agent Import Permit Program, which issues permits for the United States Public Health Service import to facilities wishing to import into the United States any agents or vectors of human disease, particularly if these are select agents.

In support of this initiative, Constella personnel have conducted nearly 1,000 on-site laboratory inspections. Additionally, Constella processes approximately 50 Select Agent Transfer Requests per month and nearly 200 Import Permit applications per month.

Integrating Public Health Laboratories with State Emergency Response Readiness

Client: Public Health Foundation Enterprises (PHFE) Management Solutions and the State Public Health Laboratory LRN Coordinator

In 2005, the State of California took measures to better integrate its public health laboratory system into state-wide emergency management system. Key public health officials recognized that, to accommodate this integration, the best approach was work with established laboratory partners and stakeholders across jurisdictional boundaries. However, the composition of this laboratory partnership was not just limited to different types of laboratories. It also included stakeholders from throughout the state from disciplines such as emergency operations, planning and communication, occupational safety, public safety, and law enforcement. California Public health officials also recognized the importance of assessing existing public health laboratory systems to identify strengths and weaknesses in procedures, training, equipment, and safety protocols. Constella's assessment of these laboratories provided State leaders with the framework to identify laboratory response capability and capacity already in place and an assessment of how well laboratory and non-laboratory communication systems work together during a public health emergency. This enabled state officials to implement emergency response standards across the state’s public health laboratory system.

Institutional Biosafety Committee Educational Site Visits

Client: NIH Office of Biotechnology Activities

Constella is assisting the National Institutes of Health (NIH) Office of Biotechnology Activities with assessing institutional programs for the oversight of recombinant DNA research subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines). These assessments are focused on evaluating current Institutional Biosafety Committee (IBC) practices as well as the interactions between IBCs, Principal Investigators (PIs), and other institutional oversight committees.

As part of the assessment, Constella is conducting not-for-cause site visits at OBA-selected institutions. These site visits include both an in-depth review of institutional policies and procedures for recombinant DNA research oversight and interviews with institutional personnel to assess their compliance with the NIH Guidelines. Information collected on-site is reported to the OBA who makes recommendations to the institutions in remediation of observed compliance challenges.