Timeliness of Biodetection RFI.pdf

REQUEST FOR INFORMATION

Biodetection and Bioidentification Timeliness Study Department of Homeland Security

Countering Weapons of Mass Destruction Office (CWMD)

A. Description The United States Department of Homeland Security Countering Weapons of Mass Destruction Research & Development Division is requesting information from potential vendors that can conduct a study that analyzes the relationship between time and the effectiveness of mitigation enabled by the level of potential biothreat characterization and response. The study is to define the metrics and criteria of timeliness for a response to an intentional release of a biothreat across various operational environments. The goal is to provide a comprehensive, independent analysis of factors and aspects affecting the timeline of characterization from detection through identification and confirmation, which drives government response. Therefore, the study needs to provide metrics for measuring the effectiveness and timeliness of responding to the release.

This work will be the basis of additional work in determining an effective mitigation process for intentional biological releases as well as costs and benefits of associated biothreat detection, characterization, identification, and/or confirmation of an intentional biothreat release. The work should enable the analysis of various attributes, within a set of environmental factors, threat scenarios, threat types, release modes, and sampling modes. The work will need to incorporate all of a biological terrorism event and utilize measures that compare the rate of detection and response against various agents’ factors, including infection and transmission.

In the context of this Request For Information (RFI), the Government will be examining timeliness as the relationship between time to enable various responses and the consequences of an intentional biological threat release. Understanding this relationship will allow users to define and optimize the response. The relationship will enable the Government to produce criteria, thresholds, and objectives for future government efforts. Timeliness as a concept needs to incorporate the basic steps of detection, presumptive identification, identification, confirmation, characterization, and the government actions they enable. It is these government actions that minimize infections/casualties, minimize economic impacts, and improve the response time for law enforcement and first responder actions. The study will be used to investigate how changes in the timeliness window enables opportunities for minimizing the spread of infection, enables more effective treatment, affects law enforcement, and first responder operations. A major consideration of the study should be how timeliness metrics are affected by the specific biological threat agent (e.g., toxin, virus, vegetative bacteria, fungi, spore forming bacteria), venue/population (e.g. airport, outdoor stadium, indoor stadium, railroad hub, office building, mall, open air public event) and response-consequence of agents. Other considerations should include mean time to signs, symptoms, incapacitation, death, recovery, and how the route of exposure (e.g. ingestion, inhalation, direct contact) impacts illness severity, threat release mode, sampling mode, environmental factors, and the effective windows for medical countermeasures.

Analysis should also include acceptable level of recovery confidence to enable a response from the relevant stakeholders (SLTT, law enforcement, operational users, etc.) to minimize the impact of a biothreat agent (e.g., toxin, virus, vegetative and spore forming bacteria and fungi) release’s associated incubation times for infectious agents. The analysis will need to factor in the time for state and local leaders to both make an informed decision and implement response activities to occur.

THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. This RFI is issued solely for information and planning purposes – it does not constitute a Request For Proposal (RFP) or a promise to issue an RFP in the future. This RFI does not commit the Government to contract for any supply or service whatsoever. Respondents are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party’s expense. Not responding to this RFI does not preclude participation in any future RFP, if any is issued.

B. Background Recognizing opportunities for improvements in the current U.S. system that monitors for biological threats, CWMD is leading an effort to understand the current capabilities of biodetection, characterization and agent identification of biological materials, and how the timeline of those events affects the effectiveness of FSLTT government response. CWMD is committed to protecting the American people from biological threats by understanding how current and future technological advancements and collaborations with partners across the homeland security enterprise has, and can, improve the ability to detect, identify, and effectively respond to a biological incident. Understanding the complex relationship between the timeline of the biological processes, the levels of characterization enabling government response, and the effectiveness of those responses, enables CWMD to evaluate current capabilities and timeliness to inform future capability and timeliness requirements.

C. Scope The CWMD Office seeks to understand the capability and interest of industry partners in the performance of a study focused on developing and evaluating the timeliness metrics for measuring how timely and effective a process and or system is to detection and response against a wide scale of potential intentional biothreat releases. For example, how should CWMD measure the timeframes between alternative means of detection and characterization against a wide scale release? Understanding the complex relationship between the timeline of the biological processes; the levels of characterization enabling government response; and the effectiveness of those responses will enable CWMD to evaluate current capabilities and timeliness to inform future capability and timeliness requirements. This measurement should consider the limitation of spread and minimization of casualties to determine a recommended set of capabilities that can be used across various scenarios and specific locations. The CWMD Office requires that the metrics incorporate a range of response measures including diagnosis, effective treatment windows, and decontamination.

Desired Study Product:

The DHS CWMD office intends to utilize this study to understand the relationship between biological timeline, levels of characterization, and overall consequences, to identify goals for both near term and long-term efforts. However, it is recognized that many factors contribute to biodetection and bioidentification, and therefore how timeliness is defined. Some of the factors that CWMD staff and experts have already identified and should be incorporated into this study are discussed below in the detailed research and development requirements. The period of study is not expected to exceed 12 months but will be left up to the discretion of CWMD Office and will vary depending on the depth of the proposed research and any potential follow-on requests.

It is critical that the offeror provides a plan of actions and milestones with estimated costs to justify their proposed period of performance.

It is anticipated that the study will require an examination of timeliness from both an operational and consequence perspective. A breakdown of the expected requirements is provided below:

Detailed Requirements:

I. An analysis of the timeline of events between wide scale intentional release of an infectious biological agent, the disposition of the release, the infection of those exposed, the incubation time, and the time to first symptoms, potential window of successful intervention, and final consequence. The study should incorporate developing a metric of consequence that enables capturing the variations caused by environmental factors, infectious pathways, and various operational environments (e.g., transportation hubs, urban centers, and stadiums).

a. The measure of consequence/timeliness: what constitutes the most effective measure and why?

b. Consideration of the timeline for Federal response assets to be authorized and deployed to include but not be limited to:

i. Activation of the National Disaster Medical System and deployment of response teams.

ii. Activation of the Strategic National Stockpile including time to arrive at airport and time to unload and distribute the medical countermeasures.

c. Types of event samples available (aerosol, water, ground, soil, etc.) and their longevity and suitability for biological pathogen characterization (detection, preliminary identification, identification, confirmation etc.)

II. A methodology for investigating potential benefits and/or reduction in consequence by implementing various interdiction capabilities; allowing for the evaluation of various technologies, techniques, and monitoring methods. Effectively looking at how the timeline (in minutes, hours, days, etc.) of various proposed process steps can affect the overall impact of the release of an infectious biological agent.

III. The methodology must include logistical factors such as movement of personnel and transport of samples, etc. that affect the time to response.

a. Examination of the various levels of notification/characterization, detection, preliminary identification, identification, and confirmation that enable response to a biological emergency, including public health and law enforcement, in terms of timeliness as compared to the baseline (i.e., no early warning capability).

b. Other response pathways and technical concepts conceived during the analysis.

c. Including methods to examine utilizing various sampling methods such as from air, water, soil, etc.

d. Enabling studies of evaluating timeliness and response measures in different operational environments and with different pathogen types.

IV. Demonstration of the developed methodology by conducting several permutations of the capability through different pathogens, environments, type, and level of actionable response pathways, and technologies.

V. Developing a universal confidence metric(s), to cover different levels and types of pathogen characterization that enable effective evaluation and discussion of alternative pathways and technologies for biological release response. The goal is to define what ‘high confidence’ capabilities are for first responders, and decision makers.

a. Incorporates the risk of false positive based on available threat information from detection and, identification, i.e., false alarms and incorrect identifications and characterization.

b. Examine the consequence of various allowable false detection and identification rates to understand the downsides of non-confidence in biological characterization.

c. Providing detection, identification, and/or examine the impact tradeoffs to SLTT partners between no early warning detection and commensurate or acceptable response to early detection, identification, and characterization in terms of:

i. Resources

ii. Economic Impact

iii. Morbidity/Mortality

D. Responses Interested parties should submit electronic responses to the point(s) of contact identified below:

Kevin Schwertfeger Contract Specialist kevin.schwertfeger@hq.dhs.gov

And

Darnell Griffin Contracting Officer darnell.griffin@hq.dhs.gov

RFI responses should be Calibri font size 12, with 1-inch margins, in *.docx format. Figure legends, labels, and table contents may be no smaller than font size 8 as presented in Microsoft Word. Responses shall be limited to 10 pages inclusive of cover page containing respondent information. Proprietary information, if any, should be minimized and MUST BE CLEARLY MARKED. The subject line of the email should contain the RFI number.

mailto:kevin.schwertfeger@hq.dhs.gov mailto:darnell.griffin@hq.dhs.gov

At a minimum, responses should include:

● Company information: (name, phone number, Unique Entity Identifier (UEI), CAGE

Code, POC information, website, etc.).

● GSA contract(s): contract numbers and contractor’s socioeconomic status.

● Description of your company’s capabilities as they relate to the services described in this notice.

● A description of your company’s previous experience providing the services described in this notice, including independent testing that substantiates your capabilities, and/or published and government reports that summarize your previous activities.

● A description of any teaming/subcontracting your company anticipates utilizing in support of this requirement.

● A statement indicating the ability of your company to meet the proposed Period Of Performance (POP) OR a detailed explanation of what a feasible POP to complete this effort would look like.

● A proposed method, timeline and cost estimate to complete the above-described research and development effort.

● Any other relevant information that is not listed above which the Government should consider in finalizing its market research and acquisition strategy.

Glossary A: Terms and Definitions

• Biodetection: Recognition of a biological agent that could be a threat or is otherwise unexpected in each area, Biodetection requires additional analysis to determine the specific agent, if it is a threat and what response actions should be taken.

• Bioidentification: Discernment of the specific threat agent involved to the species level that can enable immediate response including the use of Medical Countermeasures.

• Casualty: a person who is killed, wounded or incapacitated by some event; the term is usually used to describe multiple deaths and injuries due to violent incidents or disasters.

• Confidence: The degree of quality information, trust in the equipment and analysis process that is required to enable policy makers to take high regret actions.

• Confirmation: A method or technology that provides confirmatory identification, and additional discernment, (such as species) of a biological entity such as a pathogen that the likelihood of an incorrect identification is very low.

• Characterization: A term to cover the broad methods and/or steps used to determine that a biological pathogen is present to knowing what biological pathogens are present.

This includes terms such as: detection, preliminary identification, identification, confirmation, detection via identification.

• Detection: A method or technology that determines the potential presence of a biological agent and/or pathogen without necessarily knowing what the biological agent or pathogen is.

• Detection through identification: A method or technology that determines the presence of a biological pathogen by identifying it against all other materials within a sample such that the nature of the biological pathogen is anticipated or known.

• Effectiveness: A measure of the change in exposed, spread, infected, and casualty numbers based on the timeliness of a detection and identification capability.

• FSLTT: Federal, State, Local, Tribal, and Territorial

• Identification: A method or technology that provides the identify of a biological entity with low risk of being incorrect, or such that those using the data can assume it is known.

• Preliminary identification: A method or technology that provides the presumed identity of a biological entity either with high risk of being incorrect, or only to the point that the presence of the biological entity is considered ‘anticipated’ but not known.

• SLTT: State, Local, Tribal, Territorial

• Timeliness: The relationship between the biological timeline, the steps of the response pathway, and the consequence of the response.