Request for Information - RnD Borne Disease Agent Surveillance

Performance Work Statement (PWS)

This PWS outlines a non-personal services contract to develop safe and validated external proficiency testing procedures for the detection of pathogens in arthropods (mosquitoes). The goal is to support reliable diagnostic capabilities through performance-based external quality assurance using non-infectious agents.

• Develop a comprehensive manual/SOP for creating, preparing, and using safe, transportable external quality assurance/proficiency test materials for pathogen detection in arthropods, specifically excluding live or cultured pathogenic organisms. The manual will focus on partial nucleic acid constructs or synthetic/non-infectious materials, using Dengue virus detection via qRT-PCR as a model.

• Validate the developed protocol using standard laboratory validation processes to establish performance specifications (accuracy, precision, sensitivity, specificity).

• Demonstrate proficiency test performance characteristics, including limit of detection (LOD), sensitivity, and specificity, using a minimum of 60 samples.

• Provide an initial analysis of the proficiency test analyte's and protocol's capability for use in field-expedient conditions, evaluating stability, transportability, robustness, and practicality.

• Submit monthly progress reports.

• Deliverables include a draft and final manual/SOP, a validation report, a performance results package, and a field-expedient capability analysis report.

• Quality Control Plan (QCP) required.

• Government will evaluate performance per the Quality Assurance Surveillance Plan (QASP).

• Period of Performance: SEE SCHEDULE

• Place of Performance: All services shall be performed at the contractor’s facility.

• Government will provide limited virus-free mosquito samples for confirmation testing.

• All data, reports, and materials produced are subject to Government unlimited rights.

• Work is unclassified; PII/PHI requirements are not applicable.

Request for Information (RFI)

This notice is for market research, planning, and information gathering only. It is NOT a solicitation, RFP, RFQ, or IFB, and the government will not pay for responses or award a contract based on this RFI. The responses will help the government assess commercial product availability, determine vendor capabilities (including small businesses), and inform acquisition strategy regarding competition.

The RFI addresses the need for a quality assurance program for diagnostic testing related to vector-borne diseases that threaten U.S. military forces. Specifically, it seeks information on developing external quality tests using non-infectious agents to minimize risk while ensuring broad implementation and validation.

The scope is limited to the research, development, validation, and documentation of safe external proficiency testing procedures. Work will be performed at the contractor's facilities, with the government providing limited virus-free mosquito samples for confirmation testing.

1. Develop a Written Manual/Protocol for Safe External Proficiency Testing.
2. Validate the Proficiency Testing Protocol.
3. Demonstrate Proficiency Test Performance Characteristics.
4. Provide Analysis of Field-Expedient Capability.

Vendors with relevant capacity should submit a white paper (max 10 pages) addressing:

1. Company Information: Name, address, contact details, business size/ownership type, UEI, and CAGE code.
2. Capability Details: Past performance on similar requirements (including previous contract numbers and clients), any limitations or unique features, and a description of the organization's ability and knowledge.

• Deadline: Refer to the applicable SAM.gov posting.
• Questions & Responses: Submit via email to Benjamin.t.marcus2.civ@health.mil. Telephone inquiries will not be accepted.
• Review: Responses will be reviewed for planning purposes only. Proprietary or confidential information should be clearly marked.