Call for Solutions (CFS) SIS - Final DRAFT 11MAR2026...docx

DRAFT: CALL FOR SOLUTIONS

Call for Solutions (CFS) Number: W911QY-26-S-SBIS-01 Issuing Office: U.S. Army Contracting Command-Aberdeen Proving Ground (ACC-APG), Natick Contracting Division (NCD) Date Issued: TBD

TITLE: Shipboard Isolation System (SIS)

SECTION A: GENERAL INFORMATION

1. This Call for Solutions (CFS) is issued under the authority of 10 U.S.C. § 4022, “Authority of the Department of Defense to carry out certain prototype projects,” against the Army Open Solicitation (AOS) W9128Z-25-S-A002.

2. The Government intends to award multiple Prototype Other Transaction (OT) Agreements to the offerors whose Solution Briefs are determined to be most advantageous to the Government based on the evaluation criteria outlined in Section D.

3. This CFS invites interested parties to submit a “Solution Brief” for a prototype SIS.

SECTION B: PROBLEM STATEMENT / CAPABILITY GAP

The Department of War has an urgent need for a Shipboard Isolation System (SIS) to rapidly test and evaluate viable solutions to mitigate, contain, and prevent the spread of communicable disease on United States Navy (USN) vessels. SIS will provide the capability to temporarily isolate or quarantine personnel aboard multiple USN ship classes, effectively preventing the spread of biological threats. The system must align with the USN priorities of enabling isolation capabilities for individuals who are experiencing symptoms of a communicable disease (i.e., biological warfare agent (BWA) or infectious disease) and/or have been exposed, or presumed to have been exposed, but are asymptomatic. Key objectives are outlined in the attached Statement of Objectives (SOO), to include biocontainment specifications and successful completion achievement of FDA 510(k) clearance.

SECTION C: SUBMISSION INSTRUCTIONS

1. Interested offerors shall submit a Solution Brief in accordance with (IAW) the procedures outlined in the parent AOS, W9128Z-25-S-A002 and IAW 10 U.S.C. 4022.

· Initial Submission: Solution Brief

· Submission Format: The total submission shall consist of two (2) separate files:

1. File 1: Solution Brief

2. File 2: Supporting Data Package

· File 1: Solution Brief

. The Solution Brief is the core of the offeror's proposal. In accordance with the parent Army Open Solicitation (AOS), the Solution Brief is limited to fifteen (15) pages.

. The Solution Brief should provide a concise narrative addressing the technical approach, innovation, IP strategy, and business information. File 2 This submission will only count as a one (1) page portion. of submission within the solution brief submission.

· File 2: Supporting Data Package

. The Supporting Data Package contains all the evidence and verifiable data referenced in the Solution brief.

. There is no page limit for the Supporting Data Package.

. This package should be clearly organized (e.g., with a table of contents and bookmarks) to allow for easy navigation and verification of claims.

. Acceptable supporting data includes but is not limited to: third-party test reports from accredited laboratories, detailed engineering analyses, modeling and simulation data, white papers with supporting calculations, videos of internal testing, or existing commercial/government certifications. The burden of proof rests with the offeror.

· Submission Deadline & Method:

. Both files shall be submitted in PDF format no later than [DATE TBD] at 1600 EST.

. Submissions shall be sent via email to [TBD email address]. The email subject line shall be: " CFS W911QY-26-S-SIS-01 Submission - [Offeror Name]".

· The two files shall be named as follows:

. [Offeror Name]_Solution_Brief.pdf . [Offeror Name]_Supporting_Data.pdf

Call for solution briefs should include:

Contractors shall include test plans and reports and any other relevant documentation to support claimed performance characteristics including maintaining negative pressure, filtration, patient and equipment access, and operational size and weight. In addition, contractors shall disclose any unique test methods required to assess the performance of their solution.

The contractor will use the SIS SOO as a basis for preparing a draft Statement of Work (SOW), which will be included as an integral part of the proposal. The contractor shall propose a delivery schedule in the SOW to include the number of systems that can be produced per month. The contractor shall also provide logistic details including packaging, handling, storage, and transportation requirements, as well as logistical footprints and shelf-life estimates.

The Government requires sufficient data rights to operate, maintain, and sustain the SIS. The Government's preference is for Government Purpose Rights for all technical data and software developed with Government funding under this effort, for technical data related to interfaces (physical, electrical) necessary to comply with Modular Open System Approach (MOSA) requirements including to connect the SIS to shipboard and medical systems, and also for technical data related to form, fit and function (FFF) and operation, maintenance, installation, and training (OMIT). The specific data deliverables (e.g., as-built drawings, operations manuals, specifications) and IP licenses will be negotiated for each phase.

The contractor shall include in a table form, its data rights assertions for all technical data and computer software (including non-commercial technical data and non-commercial computer software as well as commercial technical data and commercial computer software) being provided to the Government with less than an unlimited or unrestricted rights license and explain how the approach will result in the best approach, considering life cycle costs. The Government will consider the impact of the data rights assertions in making selection decision(s). Please note that the Government reserves the right to evaluate any proposed approach that provides less than Government Purpose Rights (GPR) for the prototype design documentation and/or does not facilitate competitive procurement of hardware maintenance/sustainment services for SIS, described herein, negatively and use that information as part of its selection decision(s).

Please provide the cost estimate in a format that allows for clear evaluation and comparison, ensuring completeness and accuracy. If possible, include assumptions, methodologies, and any relevant supporting documentation used to derive the estimate.

1. Production Costs

a. Estimated costs for full-scale production, including materials, labor, and compliance with FDA 510(k) clearance and Berry Amendment requirements.

2. Life-Cycle Cost Estimate (LCCE)

a. A comprehensive assessment of the system's affordability and long-term sustainment costs, including maintenance, operational support, and disposal.

3. Additional Costs

a. Any other costs associated with meeting the requirements outlined in the Statement of Objectives (SOO) and achieving successful completion criteria for follow-on production.

Technical maturity, item cost and performance will be assessed during submission evaluation.

SECTION D: EVALUATION PROCESS & CRITERIA

The initial solution briefs MUST assert to meeting or exceeding the stated Threshold Requirement to be considered for a request for proposal submission for Phase 1. Support of assertions may be included in Supporting Data file, to be excluded from the page limitation within the Solution brief.

Table 1 Minimum Threshold Requirements

System will include glove ports located near patient head and torso to enable proper patient care.

Utility ports for cables/hoses.

Airflow into containment and exhausted out through HEPA filter

12 air changes per hour (ACH)

99.97% at 0.3-micron particle diameter.

Table 2: Additional Requirements

· The SIS isolation area interior shall be no less than 70 inches tall in standing/useable area.

· The SIS shall be no more than 54 inches wide.

· The SIS shall be no more than 118 inches long.

· The SIS shall be large enough to encapsulate an intensive care unit (ICU) bed with a clearance of at least 6 inches on all four sides of the ICU bed. The National Stock Numbers (NSN) for ICU beds are: 6530-01-690-8324 and NSN 6530-01-527-3820

· The SIS shall not have any individual component that exceeds the maximum weight limit in MIL-STD-1472 for two-person carry.

· The SIS shall not have any individual sub-assembly that exceeds the maximum weight limit in MIL-STD-1472 for two-person lifting.

· The SIS shall not have any individual sub-assembly that exceeds the maximum weight limit in MIL-STD-1472 for two-person carry.

· The SIS shall be stored in storage containers that are as small as practicable.

· The SIS shall be stored in the minimum number of storage containers as practicable.

· The SIS shall have individual storage containers that, when packed, are less than or equal to the maximum weight limit in MIL-STD-1472 for two-person lifting.

· The SIS shall have individual storage containers that, when packed, are less than or equal to the maximum weight limit in MIL-STD-1472 for two-person carry.

The SIS shall use National Institute for Occupational Safety and Health (NIOSH) P-100 certified filters.

· Same as Threshold.

· The SIS shall remain fully operational and meet all functional performance requirements while being subjected to the dynamic ship motion environment defined in Table 3: Ship Motion Parameters below.

· The SIS shall be provided with all necessary provisions to secure the ICU bed to the ship.

· The SIS shall maintain a negative pressure differential greater than or equal to 0.006 inches of water gauge inside the isolation space for 2 minutes with the largest utility port open and the transfer pouches closed, if applicable.

· The SIS inlet filter shall be removable from outside of the isolation space.

· The SIS shall have an exhaust air filter with filtration efficiency of 99.97% at 0.3-micron particle diameter

· The SIS exhaust filter shall be removable from outside of the isolation space.

· The SIS exhaust filter shall be upstream of the blower.

· The SIS shall have directional airflow inside the isolation area that flows from high to low and along the length of the isolation area.

· The SIS shall have one pair of glove ports located on the end of the isolation space at the patient’s head.

· The SIS shall have one pair of glove ports located on either side of the isolation space near the patient’s head/chest.

· The SIS shall have one pair of glove ports located on either side of the isolation space near the patient’s waist/legs.

· The SIS glove ports that comprise a glove port pair shall have a center-to-center distance of no less than 33 cm and no greater than 43 cm.

· The SIS glove port gloves shall be ambidextrous.

· The SIS I2Q glove port gloves shall meet or exceed the requirements of ASTM F1671.

· The SIS gloves port gloves shall provide sufficient dexterity for caregivers to perform clinical tasks such as operating medical equipment, administering medication, and adjusting patient monitoring devices.

· The SIS glove port gloves shall be non-porous.

· The SIS glove ports shall have removable covers on the interior.

· The SIS glove ports shall have removable covers on the exterior.

· The SIS shall allow for the glove port gloves to be replaced.

· The SIS shall be provided with one complete set of size small glove port gloves.

· The SIS shall be provided with one complete set of size medium glove port gloves.

· The SIS shall be provided with one complete set of size large glove port gloves.

· The SIS shall be provided with one complete set of size extra-large glove port gloves.

· The SIS glove port gloves shall be commercially available.

· The SIS glove port gloves shall all be at least 32 inches long and no more than 34 inches long.

· The SIS isolation area walls shall be transparent starting no more than 30 inches above the floor.

· The SIS I2Q floor shall be strong enough to prevent tearing/ripping/wear-through that compromises liquid leak containment when the bed is secured to the deck for the minimum mission duration.

· The SIS shall have a visual indicator that illuminates green when the negative pressure differential is greater than or equal to 0.01 inches of water gauge.

· The SIS shall have a visual indicator that illuminates yellow when the negative pressure differential is less than 0.01 inches of water gauge.

· The SIS shall have a visual indicator that illuminates red when the negative pressure differential is less than or equal to 0 inches of water gauge.

· The SIS utility ports shall be sized to allow cables/hoses to pass through into the isolation space.

· The SIS utility ports shall be able to be sealed with cables/hoses passing through them

· The SIS utility ports shall be able to be sealed after the cables/hoses have been removed.

· The SIS transfer pouches shall allow items to be passed into the isolation space while maintaining a negative pressure differential greater than or equal to 0.01 inches of water gauge inside the isolation space during the transfer.

· The SIS transfer pouch shall be located between the two glove port pairs on one of the long sides.

· The SIS transfer pouch shall be sized to accommodate the passing of items up to 8 inches by 12 inches.

· The SIS shall be compatible with 100-240 VAC, 50/60 Hz, 15 A power using a NEMA 5-15 plug.

· The SIS I2Q shall meet the EMI requirements necessary for shipboard medical equipment when powered by 100-240 VAC, 50/60 Hz, 15 A, single-phase power.

· The SIS shall meet the EMI requirements necessary for shipboard medical equipment when powered by 120 VAC, 60 Hz, 15 A power.

· The SIS shall be provided with all tools, supplies, and materials required to setup the system.

· The SIS shall be provided with all tools, supplies, and materials required to operate the system.

· The SIS shall be provided with all tools, supplies, and materials required to breakdown and store system.

· The SIS shall be provided with all tools, supplies, and materials required to perform corrective maintenance actions during system operation (e.g., repair hole/tear, replace a glove, change power source)

· The SIS tools, supplies, and materials shall all be stored in the system storage containers.

· The SIS shall be fully operable after being stored in the "Salt Fog / Corrosive Environments" environmental condition per MIL-STD-810.

· The SIS shall be fully operable after being stored in the "Basic Cold, Hot Dry, Dust, Sand, Fungal Growth, " environmental condition in accordance with MIL-STD-810.

· The SIS shall be packaged in accordance with MIL-STD-2073-1.

· The SIS shall be fully operable after being stored in the "Immersion" environmental condition per MIL-STD-810.

· The SIS storage container(s) shall be corrosion-resistant when tested in accordance with Method 509.8 ("Salt Fog / Corrosive Environments") of MIL-STD-810.

· The SIS I2Q storage container(s) shall be stackable without damaging the contents or the storage containers.

· The SIS shall be fully operable after Type I (Environmental) vibration testing in accordance with MIL-STD-167-1 when packed in its storage container(s).

The Government will evaluate Solution Briefs and subsequent performance using the following phased, qualitative criteria:

Submissions will be evaluated based on the merit of the proposed solution in addressing the Call, not against other submission in response to this Call.

Evaluation Area How Assessed

The Government will utilize a phased approach where testing and evaluation will be conducted in two (2) phases. The Government intends to make up to three (3) prototype awards, all of which will undergo Phase I prototype performance testing. After testing on the Phase I prototypes is complete, the Government will downselect contractors to continue to Phase II. This decision will be based on final Phase I test results, early user feedback, affordability of the prototype, and the availability of funds. The evaluation criteria for prototype selection, as outlined in Table 1.

Table 1 Evaluation Criteria for Prototype Selection will guide the downselect process. Upon completion of testing on the Phase II prototypes, one solution will be selected to move forward into production based on all test results, user feedback, and affordability of the prototype.

Phase I Objective (15 prototypes)

The contractor shall deliver up to 15 prototypes for Phase I testing within 90 days of award. Following verification of biocontainment requirements, a user touch point will be conducted as soon as a ship is available to help down select prototypes to continue on to Phase II. Table 3 below outlines the test objectives and methodologies and the criteria for downselect.

Table 3: Phase I Criteria

(CFM x 60)/Volume

Evaluate Patient Visibility

Head to foot visibility

Evaluate Equipment ports

≥5 cable/hoses; equipment/food

MIL-STD-2073-1

Smaller is best with the fewest storage containers

Phase II Objective (Up to 15 prototypes):

Contractors selected for Phase II shall deliver up to fifteen (15) prototype systems for testing within 60 days after notification of successful downselect. Phase II testing will include a logistics and maintenance demonstration conducted during an operational evaluation by the designated Lead Operational Test Agency (LOTA). While specific testing activities for the operational demonstration have not yet been finalized, the Government will provide detailed evaluation criteria and testing requirements to contractors at the time of Phase II award. All testing conducted during Phase II will focus on verifying that the prototype systems meet the requirements outlined in Attachment 1 of this solicitation, specifically those requirements that were not tested during Phase I. The requirements in Attachment 1 will remain unchanged throughout the duration of the effort. The Government reserves the right to update or refine evaluation criteria prior to Phase II award to ensure alignment with program objectives and operational needs, provided such updates do not alter the requirements specified in Attachment 1.

SECTION E: ANTICIPATED CONTRACTING PHASED EFFORT

1. Phase I: Award of up to three (3) prototype OT Agreements. Performers will develop their initial system designs and demonstrate progress towards key performance objectives; with a specific focus on the proposed path for meeting criteria in SOO Table 1: Protype Criteria. The anticipated time frame for Phase I testing may take up to one (1) year. After testing on Phase I prototypes is complete, the Government will downselect contractors to continue to Phase II.

2. Phase II: Downselect up to two (2) prototypes. All testing conducted in Phase II will focus on verifying the prototype systems meet the requirements outlined in SOO Attachment 1 – Threshold Requirements. Considerations for downselect include, but aren’t limited to, test results, affordability of the prototype, and the availability of funds. The anticipated time frame for Phase II testing may take up to one (1) year. Upon completion of testing on Phase II prototypes, one solution may be selected to move forward to Follow-on Production contract.

3. Follow-on Production: IAW 10 U.S.C. 4022, and upon a determination that the prototype project for this transaction has been successfully completed, any competitively awarded prototype Other Transaction Authority (OTA) as a result of this CFS may result in the award of a follow-on production contract, or transaction without the use of competitive procedures.

SECTION F: INTELLECTUAL PROPERTY

The Government desires, at a minimum, Government Purpose Rights for all technical data and computer software developed with Government funding under this effort, for technical data related to interfaces (physical, electrical) necessary to comply with MOSA requirements and to connect the SIS to shipboard and medical systems and also for technical data related to form, fit and function (FFF) and operation, maintenance, installation, and training (OMIT). Special consideration will be given to IP strategies that facilitate the rapid and affordable achievement of biocontainment requirements. The path for intellectual property will be assessed during submission evaluation, including the impact of the offeror’s data rights assertions and how they may affect initial deployment, maintenance and sustainment efforts.

SECTION G: SUCCESSFUL COMPLETION CRITERIA FOR FOLLOW-ON PRODUCTION

To be eligible for a non-competitive follow-on production award, the final selected prototype must be determined by the Government to have “successfully completed” the project. A prototype is considered successful if it meet the criteria outlined above in Table 2 Additional Requirements.

SECTION H: POINT OF CONTACT (POC)

Agreements Officer (AO): Pete Stahley Email: peter.w.stahley.civ@army.mil Agreements Specialist: Christine Halamoutis Email: christine.m.halamoutis.civ@army.mil