AOS Statement of Objectives PPTS_Final Draft (2026-03-12)..docx

STATEMENT OF OBJECTIVE (SOO)

DISTRIBUTION A. Authorized for public release; distribution unlimited.

Project Title: Portable Patient Transport System (PPTS) Background The Capability Program Executive Chemical, Biological, Radiological, and Nuclear Defense (CPE-CBRND) and Joint Project Manager for CBRN Protection are seeking readily available systems for a single, non-ambulatory patient system to support the Biocontainment, Isolation, and Quarantine (BIQ) PPTS program. This man-portable system will control and prevent the spread of biological threats (biothreats) while transporting a single, non-ambulatory infectious patient by air, rail, ground, or sea.

The desired solution is a complete system consisting of a patient containment enclosure with an integrated, battery-powered air filtration system. This system must generate negative pressure, provide sufficient air changes per hour (ACH), and filter all exhaust air. Essential features include glove ports, pass-through interfaces, and windows to allow for continuous patient care.

ACQUISITION STRATEGY & PROGRAM OVERVIEW

This Statement of Objectives (SOO) defines the goals for a multi-phased prototype project awarded under the authority of 10 U.S.C. § 4022

Phased Acquisition and Success Criteria The program consists of two Segments. Segment I contains one phase, and Segment II contains two phases (Phase II and III). The Government intends to make up to five (5) Other Transaction Agreements for Segment I (Phase I). Down-selections will be conducted only at the conclusion of each Segment. Following the completion of Segment I, the Government will evaluate performers and down-select up to two solutions to proceed to the Segment II option (Phase II and III). Evaluation criteria for potential selection for the Segment II option will be based on the affordability of the prototype, availability of funds and the prototypes ability to meet the threshold requirements and user feedback in Segment I testing as described in Attachment 1, Table 2 and 3. Comment by Wojciechowski, Amanda N CIV USARMY CECOM (USA): See comment in call. This language should be incorporated into call. Comment by Halamoutis, Christine M CIV USARMY ACC (USA): This was added to the call

To be considered successful and eligible for a non-competitive follow-on production award, a prototype must meet the following criteria.

Table 1: Minimum criteria for a successful prototype.

Head to foot airflow

12 Air Changes per Hour (ACH)

99.97% at 0.3-micron particle diameter

System shall provide a low battery warning

During battery hot swap, power interruption shall be less than or equal to 1 minute

System will have pass-through interfaces from the system exterior to the system interior

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

The System must meet all military, federal, and international airworthiness and transport requirements for airlift in accordance with: MIL-HDBK-516 for C-17, C-130, KC-135 and HH-60.

•The PPTS shall have restraint straps for safe physical patient restraint inside the containment enclosure appropriate to the manner of movement regardless of state of attachment to a vehicle.

•The PPTS restraint straps shall accommodate 90% of personnel for all key sizing dimensions (5th to 95th percentile, male and female body dimensions).

•The PPTS restraint straps shall be in the vicinity of the patient’s chest, waist, and legs.

Follow-on Production Authority In accordance with 10 U.S.C. 4022, and upon a determination that the project for this transaction has been successfully completed, any competitively awarded system Other Transaction Authority (OTA) because of this Call for Solutions may result in the award of a follow-on production agreement or transaction without the use of competitive procedures for up to 400 units over four years.

PROPOSAL SUBMISSION REQUIREMENTS:

This Statement of Objectives (SOO) outlines the overall goals of the effort. Performers shall use this SOO as the basis for preparing a comprehensive proposal that addresses all project segments and phases. The proposal must be submitted in response to the Request for Solution Proposal as set forth in the associated Call for Solutions.

Performers are encouraged to propose novel and innovative concepts. The proposal must include the maturity level (TRL/MRL), production lead time, and total cost for the proposed solution.

The proposal must contain the following distinct elements:

· A draft Statement of Work (SOW).

· A detailed Master Delivery Schedule for all hardware and data deliverables.

· The total firm-fixed-price for all prototypes and associated deliverables.

· The Performer’s projected unit cost and maximum monthly production rate for a potential Full Rate Production (FRP) quantity.

· A complete Bill of Materials (BOM) down to the raw material level.

· A table detailing the Performer’s data rights assertions for any technical data or software with less than Government Purpose Rights. The Government’s preference is for GPR.

· Supporting documentation for all performance claims, including but not limited to: test plans and reports, biological protection data, patient care (e.g., glove ports, visibility, waste storage, patient restraint) maintainability/reliability data, and platform integration analysis.

· Disclosure of any unique or non-standard test methods required to assess the proposed solution.

· Details on any special logistical requirements (e.g., decontaminability, maintainability, reliability, size, weight, power, operating environmental conditions, setup time, platform integration, and storage) and estimated shelf-life/service-life.

This project is UNCLASSIFIED. Multiple submissions per performer are acceptable.

The Government desires the following objectives for each phase; the objectives for each phase are cumulative.

Segment I: Initial System Delivery & Evaluation Phase I Objectives:

· Deliver thirty (30) prototype systems.

· Provide evidence demonstrating a minimum Technology Readiness Level (TRL) of 5 and Manufacturing Readiness Level (MRL) of 5.

· Support Government-led testing to demonstrate the effectiveness and performance of the solution against the initial test criteria outlined in Attachment 1, Table 2 and 3.

The government will select two performers to proceed to Segment II, which consists of Phases II and III. This downselect decision will be based on the following criteria:

· User feedback

· Affordability of the prototype

· Availability of funds

· A government evaluation the test results from Phase I test requirements outlined in Attachment 1, Tables 2 and 3.

Only performers who participated in Phase I will be eligible for consideration in subsequent phases. Performers are permitted to iterate on their current designs to meet the requirements specified in Attachment 1, Tables 2 and 3, as long as the anticipated delivery timelines for Phase I can still be met.

Segment II: Advanced Integration & Certification Phase II Objectives (Platform Integration & Environmental Testing):

· Demonstrate a minimum TRL of 6 and MRL of 6.

· Support Government-led testing focused on platform integration, environmental resilience, and Reliability, Availability, and Maintainability (RAM) data collection as detailed in Attachment 1, Table 2 and 3.

Phase III Objectives (Airworthiness and Operational Flight Testing):

· Achieve a minimum TRL of 8 and MRL of 8.

· Support Government-led flight testing on operational aircraft to validate performance in an aeromedical evacuation mission profile as detailed in Attachment 1, Table 2 and 3.

· Provide all necessary data and support to achieve a formal Airworthiness Certification.

All prototypes must achieve Airworthiness certification and acquire FDA 510(k) clearance by the end of Phase III.

At the end of all Segment II activities (which includes the completion of both Phase II and Phase III), the Government will perform a final, comprehensive evaluation. This evaluation will lead to a formal, unilateral decision on whether the prototype meets the Phase III Objectives, whether the prototype has been "successfully completed" as required by 10 U.S.C. § 4022(f), and will determine which candidate has performed best when assessed against the key technical goals in the evaluation areas below. This evaluation will determine the final candidate for any non-competitive follow-on production award.

This "successful completion" determination is a mandatory prerequisite for awarding any non-competitive follow-on production contract

DELIVERABLE(S):

The Contractor shall deliver all data in formats to be negotiated and agreed upon with the AOR.

System (Hardware) Deliverables

· Segment I: Thirty (30) prototype systems delivered within 90 days after project award.

· Segment II (for Phases II & III): Ten (10) additional prototypes delivered within 90 days of Segment II authorization.

Data Deliverables

1.1.1 Start of Work Meeting and Minutes

Within 30 days of award, the Contractor shall host a Start of Work meeting to establish the project baseline, schedule, and risks. The Contractor shall deliver meeting minutes.

1.1.2 Test Support

The Contractor shall provide on-site technical support for test events as required. Assume two (2) travel days and two (2) days of support for each phase.

1.1.3 Delivery Schedule

The Government expects to manage the program using an integrated master schedule. The Performer shall propose the creation, maintenance, update, and an execution plan based upon a Master Delivery Schedule (MDS). The SOW shall address this requirement fully.

1.1.4 Technical Data, Intellectual Property Rights, and Software The Government requires sufficient data rights to operate, maintain, and sustain the PPTS for its entire lifecycle.

Government Preference: The Government’s strong preference is for Unlimited Rights for all technical data, software, and associated intellectual property developed under this effort.

Offeror Assertions: The Offeror must include a table detailing any data rights assertions for technical data or software being provided with less than an unlimited/unrestricted license. This includes both commercial and non-commercial items. The Offeror must explain how this approach provides the best value to the Government over the system's lifecycle.

Evaluation Impact: The Government will evaluate the impact of any proposed data rights restrictions. Proposals that provide less than Government Purpose Rights (GPR) for the prototype design, or which hinder the competitive procurement of future sustainment services, may be evaluated negatively and could be a deciding factor in the selection decision.

1.1.5 Berry Amendment Compliance

The Contractor shall provide documentation verifying compliance with the Berry Amendment and detail the sourcing of any non-compliant items.

1.1.6 Safety Documentation

The Contractor shall deliver a Safety Assessment Report (SAR), Safety Data Sheets, and all necessary documentation for safe storage and disposal. At a minimum, the SAR shall 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 systems.

1.1.7 Manuals

The Contractor shall deliver all commercial or newly developed operator and maintenance manuals, updating them as the system baseline changes.

1.1.8 System Support Documentation

The Contractor shall deliver documentation specifying system size, weight, materials, operating limits, and storage/transportation constraints.

PERIOD AND PLACE OF PERFORMANCE:

System development will occur at the Performer’s facilities. Demonstrations and testing will occur at CONUS Government facilities designated after award.

AGREEMENTS OFFICER REPRESENTATIVE (AOR):

The AOR will be designated by the Agreements Officer at the time of award.

ATTACHMENT 1 – PERFORMANCE REQUIREMENTS:

Note. The Government encourages solutions, even if they do not meet all requirements. All proposals will be considered. Requirements (Table 2) are listed in order of priority. Additional criteria are detailed in Table 3 and will also be taken into consideration.

Table 2: Evaluation Criteria

· The PPTS shall maintain a negative pressure differential of 0.01 inches of water gauge or more inside the containment enclosure for 2 minutes with one large pass-through port open and the transfer pouches closed, if applicable.

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

· The PPTS intake filters shall have a removable device to prevent ingestion of rain.

· The PPTS intake filter shall be located outside of the containment enclosure.

· The PPTS exhaust filter shall be located outside of the containment enclosure.

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

· The PPTS air filtration system shall be able to operate in rain conditions without performance degradation.

· The PPTS large pass-through ports shall each be sized to accommodate the passing of items up to 4 inches in diameter.

· The PPTS large pass-through ports shall be sealable.

· The PPTS shall have two small pass-through ports on each side of the containment enclosure in the vicinity of the patient’s head.

· The PPTS small pass-through ports shall each be sized to accommodate the passing of items up to 1.3 inches in diameter.

· The PPTS small pass-through ports shall be sealable.

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· The PPTS transfer pouch shall be located in the vicinity of the patient’s waist.

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

· The PPTS shall have fourteen total individual glove ports that are arranged in pairs.

· The PPTS shall have one pair of glove ports located on the end of the containment enclosure at the patient’s head.

· The PPTS shall have one pair of glove ports located on either side of the containment enclosure near the patient’s head.

· The PPTS shall have one pair of glove ports located on either side of the containment enclosure near the patient’s torso.

· The PPTS shall have one pair of glove ports located on either side of the containment enclosure near the patient’s feet.

· The PPTS glove port diameters shall be sized to accommodate small, medium, large, and extra-large glove sizes.

· The PPTS gloves shall be attached to the glove ports using gussets and O-rings, as necessary.

· The PPTS 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 PPTS glove port gloves shall be ambidextrous.

· The PPTS glove port gloves shall be at least 8 mils thick and no more than 12 mils thick.

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

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

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

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

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

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

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

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

· The PPTS glove port gloves shall be commercially available.

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· The PPTS waste storage system shall consist of two collapsible waste storage receptacles.

· The PPTS waste storage receptacles shall have the ability to be secured when not in use (i.e., in the collapsed state).

· The PPTS waste storage receptacles shall be located near the patient’s feet, one on each side of the containment enclosure.

· The PPTS waste storage receptacles shall each be able to hold at least 5 liters of waste.

· The PPTS waste storage receptacles shall each have a diameter of at least 6 inches.

· The PPTS waste storage receptacles shall each be able to hold at least 10 kilograms of waste.

· The PPTS waste storage system shall not occupy the interior of the containment enclosure.

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· The PPTS shall have restraint straps for safe physical patient restraint inside the containment enclosure appropriate to the manner of movement regardless of state of attachment to a vehicle.

· The PPTS restraint straps shall accommodate 90% of personnel for all key sizing dimensions (5th to 95th percentile, male and female body dimensions).

· The PPTS restraint straps shall be in the vicinity of the patient’s chest, waist, and legs.

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· The PPTS shall include a quick-start guide for operation.

· The PPTS shall include a quick-start guide for breakdown and storage.

· The PPTS shall include instruction labels for system operation.

· The PPTS shall have an attached pouch for storing the quick start guides and the technical manual.

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System Interruption Alert. The system must be able to indicate system interruption via visible alarms.

· The PPTS shall provide a continuous flashing visible alarm when there is a problem with the air filtration system (e.g., low negative pressure differential, low airflow).

· The PPTS air filtration system alarm shall automatically deactivate when the air filtration system problem is resolved.

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· The PPTS shall be provided with appropriate warning labels for system operation. Examples of possible warning labels include the number of people required to lift/carry the system, pinch hazards, and trip hazards.

· The PPTS shall be provided with appropriate warning labels for system breakdown and storage. Examples of possible warning labels include the number of people required to lift/carry the system, pinch hazards, and trip hazards.

· The PPTS shall be provided with a Health Hazard Assessment (HHA).

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· The PPTS shall be capable of operating in the Sand environmental condition per MIL-STD-810.

· The PPTS shall be capable of operation after being exposed to the Rain environmental condition per MIL-STD-810.

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· The PPTS shall maintain airborne contamination containment for 12 hours. Field level corrective maintenance actions that do not breach containment are acceptable to meet this requirement.

· The PPTS shall maintain liquid contamination containment for 12 hours. Field level corrective maintenance actions that do not breach containment are acceptable to meet this requirement.

In-Flight Assessment

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Operators. The PPTS non-strenuous receipt, set-up, breakdown and storage shall be completed by no more than two trained operators.

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Time. Once familiarization training has been completed, individuals wearing personal protective equipment should be capable of setting up the enclosure for full use, including function checks, within 15 minutes.

· The PPTS shall be able to be set up from the storage configuration to the patient transport configuration, including functional checks, by no more than two trained operators wearing medical personal protective equipment (PPE) in 15 minutes or less.

· The PPTS shall be able to be set up from the storage configuration to the patient transport configuration, including functional checks, by no more than two trained operators wearing Mission Oriented Protective Posture (MOPP) IV CBRN Individual Protective Equipment (IPE) in 15 minutes or less.

· The PPTS interior surfaces of the containment area shall be compatible with EPA-registered disinfectants for a contact time of 10 minutes. (O)

· The PPTS shall be packaged in accordance with MIL-STD-2073-1 to support ease of transport in the storage configuration.

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· The PPTS shall be capable of operation after being stored in the Sand environmental condition per MIL-STD-810, Method 510.7.

· The PPTS shall be capable of operation after being stored in the Dust environmental condition per MIL-STD-810, Method 510.7.

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· The PPTS low battery warning shall activate when 5 to 15 minutes of power is remaining.

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· The PPTS shall be provided with a battery charger to recharge the rechargeable battery, if applicable.

· The PPTS rechargeable battery charger shall operate using 120VAC, 60Hz, 15A ground power with a National Electrical Manufacturers Association (NEMA) 5-15 plug.

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· The PPTS shall be compatible with the Raven 90C litter (NSN 6530-01-432-5114).

· The PPTS shall be compatible with the Talon II 90C (without collapsible handles) litter (NSN 6530-01-504-9051).

· The PPTS shall be compatible with the Oversized litter (NSN 6530-01-552-7708).

The PPTS weight shall be less than or equal to carrying weight limit in MIL-STD-1472 for two-person carry.

· The PPTS shall be capable of being transported globally by air modes (C-17 A/ER, C-130 H/J, KC-135 R/T, H-60 Black Hawk) in the patient transport configuration.

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GT (MIL-STD-461, Method CE102, CS101, CS114, CS115, CS116, CS118) Less interference is best

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This is a pass/fail criterion

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This is a pass/fail criterion

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· The PPTS shall be secured to the conveyance in accordance with transport platform requirements.

· The PPTS shall be secured to the conveyance without breaking containment.

· The PPTS shall maintain containment when being secured to the conveyance.

· Containment is achieved when the PPTS maintains negative pressure differential, air changes per hour, directional airflow, filtration efficiency, and leak containment. Containment is achieved when the PPTS maintains negative pressure, air changes per hour, directional airflow, filtration efficiency, and leak containment.

· Conveyances are NATO litter, DECON litter, Oversized litter, Raven 90C litter, and Talon II 90C litter.

· The PPTS shall be capable of being transported globally by ground modes in the patient transport configuration.

II

· The PPTS shall be provided with all tools, supplies, and materials required to complete field level corrective maintenance actions.

· The PPTS shall be provided with a separate bag or case to store the tools, supplies, and materials required to complete field level corrective maintenance actions.

Inspection Demonstration Decreased maintainability is better

III

· The PPTS shall allow for safe patient transfer to and from fixed facilities.

Demonstration / In-Flight Assessment

Table 3: Additional Criteria

** After receipt of the lifecycle cost estimate, the Government will perform a detailed analysis of the submitted lifecycle estimated proposal. For purposes of this analysis, the Agreement Officer and/or a representative of the Agreement Officer shall have the right to examine the supporting records and/or request additional information as needed.