This Call for solutions is for Shipboard Isolation Systems (SIS)

Statement of Objectives (SOO)

This document outlines the government's objectives for procuring a Shipboard Isolation System (SIS) designed to rapidly test and evaluate solutions for mitigating, containing, and preventing the spread of communicable diseases, particularly biological warfare agents. The SIS aims to provide temporary isolation or quarantine capabilities for individuals experiencing symptoms or who have been exposed to such threats, aligning with U.S. Navy and U.S. Air Force priorities.

• The system will encapsulate a patient on an ICU or Acute Care Ward bed, providing a physical barrier and maintaining negative pressure to contain airborne pathogens.

• It will minimize equipment contamination and reduce the need for extensive disinfection by allowing external connections for auxiliary equipment and supplies.

• Contractors must provide test plans, reports, and documentation supporting claimed performance characteristics, including negative pressure, filtration, patient/equipment access, and size/weight.

• Contractors will use this SOO to prepare a draft Statement of Work (SOW), including a proposed delivery schedule, logistics details, packaging, handling, storage, and shelf-life estimates.

• Key Performance Parameters (KPPs), Key System Attributes (KSAs), and Additional Performance Attributes (APAs) are detailed in Attachment 1.

• Key requirements include maintaining negative pressure (threshold -2.5 Pa, objective -12.5 Pa), air exchange rates (threshold ≥12 ACH, objective ≥25 ACH), filtration efficiency (threshold 99.97% at 0.3 micron, objective 99.999% at 0.1 micron), patient access methods, and operational parameters like mission length (2-week threshold, 4-week objective).

• The system must also meet regulatory compliance requirements for FDA marketing authorization.

• Prototype development will be conducted at the contractor's facilities.

• Phase I prototypes are to be delivered within 90 days of award, with Phase II prototypes (if authorized) within 60 days of downselect.

• Delivery locations are expected to be within CONUS.

• The government seeks Government Purpose Rights (GPR) for technical data and software, with specific data deliverables and IP licenses to be negotiated.

• Contractors must provide cost estimates including production costs, Life-Cycle Cost Estimate (LCCE), and additional costs.

• The government intends to make up to three prototype awards under Title 10 Section 4022, with a downselect to up to two for Phase II and potential follow-on production.

• Evaluation factors for Phase I include Performance, Technical Maturity, and Item Cost.

• Data deliverables include an Integrated Master Schedule (IMS), Technical Data Package (TDP), Safety and Environmental Documentation, Berry Amendment compliance verification, manufacturing capability overview, Regulatory Strategy, Quality Assurance Program Plan (QAPP), Sponsor Authorization Letter, FDA Communications, Testing Documentation, and Regulatory Audits and Inspections Data.

Solicitation / RFP / RFQ

This Call for Solutions (CFS) seeks "Solution Briefs" for a prototype Shipboard Isolation System (SIS). The SIS is intended to rapidly test and evaluate solutions to mitigate, contain, and prevent the spread of communicable diseases on United States Navy (USN) and United States Air Force (USAF) vessels. The system will provide temporary isolation or quarantine capabilities for personnel, particularly in response to biological warfare agents or infectious diseases.

• The primary deliverable is a "Solution Brief" detailing the technical approach, innovation, capabilities, IP strategy, and a Rough Order of Magnitude (ROM) cost estimate.

• Offerors must demonstrate how their solution meets specific prototype criteria, including operational size, weight, patient access, biocontainment, air filtration, shipboard adaptability, packaging, storage, and protection during storage.

• Key Performance Parameters (KPPs), Key System Attributes (KSAs), and Additional Performance Attributes (APAs) will be evaluated.

• Solutions must align with Modular Open System Approach (MOSA) requirements.

• FDA authorization for marketing is required for follow-on production.

• The government intends to award multiple Prototype Other Transaction (OT) Agreements.

• The effort is phased: Phase I (prototype development and testing), Phase II (further testing and downselect), and potential follow-on production.

• The anticipated timeframe for Phase I and Phase II testing is up to one year each.

• A follow-on production contract may be awarded without further competition, potentially for up to 150 systems.

• Submission Deadline: 19 MAY 2026, 1600 EST.

• Submission Method: Email to christine.m.halamoutis.civ@army.mil and peter.w.stahley.civ@army.mil.

• Submission Format: Two separate PDF files: "Solution Brief" (max 15 pages) and "Supporting Data Package" (no page limit).

• Evaluation: Solution Briefs will be evaluated based on demonstrated ability to meet prototype criteria, supported by documentation. The government will also assess participation from non-traditional defense contractors and/or small businesses.

• Up to three offerors will be invited to submit a full proposal in response to a Request for Solution Proposal (RSP).

• Full proposals will be evaluated based on performance, technical maturity, and item cost.

• The government is particularly interested in significant participation from non-traditional defense contractors and/or small businesses.

• The government may use AI tools to assist in proposal evaluation, but final decisions remain with government personnel.

• Offerors must provide sufficient data rights for the government to operate, maintain, and sustain the SIS.

• Specific contact information for Agreements Officer Pete Stahley and Agreements Specialist Christine Halamoutis is provided.

Questions & Answers / Clarifications

This document provides responses to vendor questions regarding the SIS (System for Integrated Sterilization) opportunity, clarifying various technical, logistical, and contractual aspects.

• Arm Port Covers: Interior and exterior removable arm port covers have no additional requirements beyond what is stated.
• Sizing Specs: Sizing specifications for utility ports (cables/hoses) will be provided in the final Statement of Objectives (SOO).
• Berry Amendment: Compliance refers to 10 U.S.C. § 4862. Initial non-compliant deliverables with a promise of final compliance are discouraged due to testing replication costs.
• Filtration: The exhaust filter requires HEPA-equivalent performance (99.97% at 0.3 microns). Inlet filters need a minimum MERV rating of 5. Preference is for filters in the DoW inventory; carbon filters are not preferred.
• Watertight Requirements: Only the storage containers must be watertight; the system itself must pass liquid containment requirements.
• Integration: The SIS must attach to D-rings embedded in ship decks. D-ring spacing is not standardized, requiring a flexible vendor solution. ICU bed types and sizes are detailed in the SOO.
• Weight Limits: Individual components must not exceed 50 lbs, with the total system (including storage containers) not exceeding 200 lbs in its stored configuration.
• Power: A 60-minute battery backup is a threshold requirement.
• Funding: The SIS program is considered funded but could be impacted by continuing resolutions. Costs are evaluated as part of the best-value determination under the Other Transaction (OT) agreement, which is not subject to FAR cost principles.
• Partnering: Partnering is preferred, especially with Non-Traditional Defense Contractors (NDCs) and small businesses, as it's a foundational element of the acquisition authority.
• Testing: MIL-STD testing will be conducted by the Government post-delivery. Vendors may submit their own test data, which will undergo government validation.

These clarifications refine requirements related to filtration, integration, size/weight, power, and testing, which bidders should consider when preparing their proposals. Specific due dates for questions and submissions will be detailed in the final Call for Solutions.

Questions & Answers / Clarifications

This document provides responses to vendor questions regarding the SIS (System Integration Specification) opportunity, clarifying requirements and procurement details.

• Arm Port Covers: Interior and exterior removable arm port covers have no additional requirements beyond what is stated.
• Utility Ports: Sizing specifications with min/max requirements for utility ports will be provided in the final Statement of Objectives (SOO).
• Berry Amendment: Compliance refers to the statute 10 U.S.C. § 4862. Initial non-compliance with a promise of final compliance is not acceptable due to the cost and time required for re-testing.
• Filter Specification: The exhaust filter requires HEPA-equivalent filtration (99.97% at 0.3 microns). Inlet filters need a minimum MERV rating of 5. Preference is for filters in the DoW inventory; carbon filters are not preferred.
• Watertight Requirements: Only storage containers must be watertight; the system itself must pass liquid containment requirements but is not required to be watertight.
• Funding: Projects are funded as they can be. Costs are a factor in evaluation, and proposals must be reasonable and allocable to the SOO.
• Integration: SIS will integrate with BCIS and be deployable on a ship, attaching to D-rings on the ship deck. The solution must be flexible for various D-ring configurations.
• Weight: Individual components must not exceed 50 lbs, with the total system weight (including containers) not exceeding 200 lbs in its stored configuration.
• Power & Battery: Battery backup is a threshold requirement with a 60-minute duration. The system has a 200 lb weight limit.
• System Encapsulation: The solution should encapsulate an entire hospital bed, including the patient.
• Testing: A risk-based assessment will be used for vendor-provided test results, including MIL-STD testing.

This Q&A document clarifies several technical and contractual aspects, influencing how vendors should prepare their proposals and technical solutions. Key deadlines for questions and submissions are also detailed, with final Calls for Solutions to be posted after April 1st, and submissions due mid-May.

Other / Unclassified

This document provides the schedule for a "JPM CBRN Protection Industry Day" focusing on Biological Containment Isolation System (BCIS), Portable Patient Transport System (PPTS), and Shipboard Isolation System (SIS).

It details a 1-1 schedule divided into two groups, with specific time slots allocated for meetings with various companies.

This document is relevant to potential bidders as it lists the companies that participated in the industry day. This may indicate potential prime contractors, subcontractors, or key industry players involved in the CBRN Protection domain. Understanding who attended could provide insights into the competitive landscape or potential teaming opportunities.

Solicitation / RFP / RFQ

This document outlines a "Call for Solutions" for the Shipboard Isolation System (SIS) program. The U.S. Navy is seeking prototypes to rapidly test and evaluate viable solutions for mitigating, containing, and preventing the spread of communicable diseases on Navy vessels. The SIS aims to provide a capability for temporary isolation or quarantine of personnel, aligning with Navy priorities for managing potential biological threats.

• Prototype Criteria: Solutions must meet specific criteria including operational size (fitting a hospital ICU bed), weight (person-portable), patient access (visibility and glove/utility ports), power (120v), biocontainment (negative pressure, HEPA filtration), airflow (12 ACH), visual/audible system operation indicators, shipboard adaptability (stability, securing provisions), packaging (MIL-STD-2073-1), storage size (fitting through 26"x66" watertight doors), protection during storage (watertight per MIL-STD-810), and FDA 510(k) clearance.

• Phased Approach: The government intends to make multiple prototype awards (up to 3) for a two-phase testing process. Phase I requires delivery of up to 15 prototypes within 90 days for initial performance testing. A downselect will occur, with selected contractors proceeding to Phase II.

• Phase II: Requires delivery of up to 15 prototypes within 60 days after downselect notification for logistics and maintenance demonstrations during operational evaluation.

• Data Deliverables: Include a Start of Work Meeting, Integrated Master Schedule (IMS), Technical Data Package (TDP) IAW MIL-STD-31000B, Safety and Environmental Documentation, Berry Amendment Compliance verification, and Manufacturing Capability overview.

• Awards: Multiple prototype awards are anticipated under Title 10 Section 4022.

• Follow-on Production: Successful completion of prototype projects may lead to a single follow-on production contract award without further competition, potentially for up to 150 systems.

• Proposal Basis: Contractors will use the Statement of Objectives (SOO) to prepare a draft Statement of Work (SOW).

• Evaluation: Technical maturity, item cost, and performance will be assessed. A phased approach with downselection between Phase I and Phase II will occur. Final selection for production will be based on all test results, user feedback, and affordability.

• Data Rights: Government preference is for Government Purpose Rights for technical data and software, especially for interfaces and MOSA compliance.

• Not specified in this document.

• Attachment 1 details specific threshold and additional requirements for the SIS prototypes.

• The Agreement Officer's Representative (AOR) is Katrina Jewell.

Solicitation / RFP / RFQ

This Call for Solutions (CFS) seeks proposals for a prototype Shipboard Isolation System (SIS) to rapidly test and evaluate solutions for mitigating, containing, and preventing the spread of communicable diseases on U.S. Navy vessels. The Government intends to award multiple Prototype Other Transaction (OT) Agreements.

• Develop a Shipboard Isolation System (SIS) capable of temporarily isolating or quarantining personnel.

• System must align with U.S. Navy priorities for preventing the spread of biological threats.

• Key objectives include biocontainment specifications and achieving FDA 510(k) clearance.

• Specific performance requirements cover operational size, weight, patient access, power, biocontainment (negative pressure, airflow, filtration), alarms, equipment access, shipboard adaptability, packaging, storage, disinfection, and shelf life.

• Offerors must include a draft Statement of Work (SOW) with a proposed delivery schedule and logistic details.

• Other Transaction (OT) Agreements under 10 U.S.C. § 4022.

• Phased approach: Phase I (up to 3 awards, ~1 year), Phase II (downselect up to 2, ~1 year), potentially leading to Follow-on Production.

• Submit a "Solution Brief" (max 15 pages) and a "Supporting Data Package" (no page limit).

• Both files must be in PDF format.

• Submission Deadline: [DATE TBD] at 1600 EST via email to [TBD email address].

• Evaluation will be based on Technical Merit, Innovation & IP Strategy, and Non-Traditional/Small Business Participation.

• Phase I requires delivery of up to 15 prototypes within 90 days of award.

• Open to parties capable of developing prototype projects under 10 U.S.C. § 4022.

• Focus on significant participation from non-traditional defense contractors and/or small businesses is encouraged.

• The Government requires sufficient data rights for operation, maintenance, and sustainment, preferring Government Purpose Rights.

• Offerors must disclose data rights assertions.

• Cost estimates for production and life-cycle costs are required.

• Detailed technical and performance requirements are outlined in Section D and Attachment 1 (referenced but not provided).