DISTRIBUTION A. Authorized for public release; distribution is unlimited.

1.0 PROJECT TITLE: Shipboard Isolation System (SIS)

2.0 BACKGROUND/DESCRIPTION:

The SIS program on behalf of the Capability Program Executive Chemical, Biological, Radiological, and Nuclear Defense (CPE-CBRND) and Joint Project Manager for CBRN Protection is seeking prototypes 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 SIS will 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. Isolation and/or quarantine in the SIS will commence based on intelligence and warning, or upon detection for presence of a biological agent and in accordance with (IAW) guidelines defined in NTRP 4-02.10 para 4.3.3.

Recognizing the diverse needs of various ship classes and potential scenarios, it is anticipated a Family of Systems (FoS) may be required to address the USN’s requirement for individual personnel isolation and quarantine. This SIS project will focus on delivering a rapid, readily available solution to address the Navy’s requirement for an Individual Isolation and Quarantine capability. This initial effort will pave the way for the broader FoS development, ensuring comprehensive shipboard protection against biological threats.

The SIS program will develop performance specifications based on the Pre-decisional Concept of Employment requirements expected to be evaluated during the course of the program. The Government intends on making multiple awards for SIS solutions based on availability of Government funding.

A prototype is considered successful if it meets the following criteria outlined below and in Attachment 1:

Table 1: Prototype Criteria

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.

The Government intends on making multiple prototype awards under Title 10 Section 4022 for readily available SIS solutions based on availability of Government funding.

Follow on Production Authority

In accordance with 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 Call for Solutions may result in a single award of a follow-on production contract, or transaction without the use of competitive procedures. If follow-on production is pursued, the potential magnitude could include up to 150 systems in support of operations and sustainment.

3.0 STATEMENT OF OBJECTIVES (SOO):

This Statement of Objectives will lead to the procurement of a system for assessment that will facilitate isolation and quarantine by encapsulating a patient on a shipboard ICU hospital bed or Acute Care Ward bed, or encapsulating the patient and bed, while allowing for provider care via access ports/windows. The system will maintain negative pressure to contain airborne pathogens as well as provide a physical barrier between the medical provider and any fluid-borne pathogens.

SIS will minimize medical equipment contamination, and the requirement for extensive disinfection, by providing cable/wire access through ports while allowing auxiliary equipment to remain external to the set up. The system will allow for the quick and secure delivery of food or other personal items for the patient as well as materials for routine procedures and the removal of waste or other items without breaking the airborne isolation precautions.

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 this 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).

The Contractor shall 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.

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. Upon completion of Phase I testing, 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.

The following objectives are required by the Government for each delivery:

Phase I Objective (15 prototypes)

The contractor shall deliver up to 15 prototypes for Phase I testing within 90 days after award. Following verification of biocontainment requirements and a user touch point to down select prototypes to continue on to Phase II. Table 2 below outlines the test objectives and methodologies and the criteria for downselect.

Table 2: 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

*EUT – Early User Touchpoint

DISTRIBUTION: DoD COMMUNITY ONLY

DISTRIBUTION: DoD COMMUNITY ONLY

2DISTRIBUTION: DoD COMMUNITY ONLY

Unclassified

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.

4.0 DATA DELIVERABLE(S):

The contractor will submit all reports to the Agreement Officer's Representative (AOR) in the final negotiated formats. The Government and contractor will agree on format and content.

4.1 Start of Work Meeting and Meeting Minutes.

The contractor shall conduct a Start of Work meeting that includes a technology and system overview at the contractor facility one month after award. The start of work meeting will include technology and system overview, establishment of baseline, schedule, and ss. Meeting minutes will also be provided as a deliverable.

4.2 Integrated Master Schedule (IMS)

The contractor is expected to manage the prototype delivery using a shared IMS. The contractor should propose the creation, maintenance and update of an IMS. The IMS is expected to detail the durations of project tasks/sub-tasks. The Government anticipates that the IMS will be updated monthly. The contractor’s SOW should address this requirement fully.

4.3 Technical Data Package (TDP)

The contractor will develop and deliver a TDP, that includes detailed drawings, Cage Code, user manual, detailed information on the components, sub-assemblies, and materials upon delivery of the manufactured prototypes. The TDP will be IAW MIL-STD-31000B. The final TDP shall be delivered with the prototypes in Phase II.

4.4 Safety and Environmental Documentation

The SOW will address the provisions of the Safety Assessment Report (SAR), Safety Data Sheets, and Storage/Disposal criteria. The SAR will summarize safety and health hazard data, provide a comprehensive evaluation of the safety and health risks, and identify procedures/precautions required for safe use of the system/subsystem and prototypes. All Safety and Environmental Documentation shall be delivered with the prototypes in Phase 1.

4.5 Berry Amendment Compliance

The contractor shall verify that they meet the specified domestic sourcing standards outlined in the Berry Amendment. Contractors will provide detailed information on all items manufactured or sourced from outside of the United States, per the Call for Solutions.

4.6 Manufacturing Capability

The contractor shall provide an overview of their manufacturing capabilities and quality system, current production rates, as well as ability to scale production for higher demands.

5.0 PROTOTYPE DELIVERABLE(S):

The contractor shall deliver Phase I prototypes and associated data deliverables within 90 days of project award, unless an alternate timeframe is agreed upon with the Government. If authorized to proceed to Phase II, the contractor shall deliver Phase II prototypes and associated data deliverables within 60 days of authorization, or as otherwise agreed upon with the Government. Delivery locations for each phase are expected to be within CONUS.

6.0 PERIOD AND PLACE OF PERFORMANCE:

The contractor will propose a delivery schedule in its SOW to include prototype and data delivery. Prototype development will be conducted at the contractor’s facilities.

7.0 AGREEMENTS OFFICER REPRESENTATIVE (AOR):

Katrina Jewell

SIS

katrina.jewell@usmc.mil 703-617-2424

ATTACHMENT 1 – 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 1 Minimum Threshold Requirements

The additional requirements listed below in Table 2 carry equal weight, and any necessary trade‑offs will be assessed accordingly.

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).

Table 3 details the stability requirements the system must satisfy in maritime environments.

Table 3: Ship Motion Parameters