Final AOS Statement of Objectives PPTS (09JUN2026).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 occur, at a minimum, at the conclusion of each segment; however, the Government reserves the right to execute an earlier down selection should circumstances, such as a critical failure, necessitate it. 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 5.

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.

1. The PPTS shall not detach from the NATO litter per SAE J3027.

2. The NATO litter assembly shall not detach from the ambulance gurney per SAE J3027.

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 476 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), production lead time, and total cost for the proposed solution.

The proposal must contain the following distinct elements:

· A draft Statement of Work (SOW).

· The FDA number associated with marketing authorization or a summary Regulatory Strategy that identifies and rationalizes a marketing pathway in alignment with ISO 13485:2016.

· 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 unlimited data rights.

· 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 up to thirty (30) prototype systems

· Provide evidence demonstrating a minimum Technology Readiness Level (TRL) 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 5.

The government will select up to 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 5.

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 5, 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.

· Support Government-led testing focused on platform integration, environmental resilience, and Reliability, Availability, and Maintainability (RAM) data collection as detailed in Attachment 1, Table 3 and 5.

Phase III Objectives (Airworthiness and Operational Flight Testing):

· Achieve a minimum TRL 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 4 and 5.

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

All prototypes must achieve Airworthiness certification and acquire FDA marketing authorization 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: Up to 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 Regulatory Strategy

For systems that do not possess FDA marketing authorization, the Awardee shall deliver a Regulatory Strategy that identifies and rationalizes a marketing pathway in alignment with ISO 13485:2016. It is then expected that the strategy be delivered following each update (for example, following receipt of FDA feedback, analysis of test data, etc.). Following each delivery, the Government will respond with comments and/or acceptance within 10 business days; feedback will be incorporated as appropriate. See attachment 2 for additional FDA-related deliverables.

1.1.3 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.

1.1.4 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.

1.1.5 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.

1.1.6 Berry Amendment Compliance

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

1.1.7 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.

1.1.8 Manuals

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

1.1.9 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 in each phase are listed in order of priority (Table 2-4). Additional criteria are detailed in Table 5 and will also be taken into consideration.

Table 2: Phase I 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.

1. Q: The airflow rate of your filtration system, in cubic feet per minute (ft³/min).

2. V: The interior volume of the containment space, in cubic feet (ft³).

Use the following formula to find the ACH: ACH = (Q × 60) / V

Government Testing (GT) This is a pass/fail criterion

· 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.

· System shall be compatible with ground vehicles UFM 82/83 ambulance and AMBUS.

· The PPTS shall meet all requirements to include Society of Automotive Engineers (SAE) J3027 crash-compliance for Department of Transportation vehicle transport

1. The PPTS, with a patient secured inside, shall not detach, break free, or separate from the NATO litter when tested in accordance with SAE J3027.

2. The NATO litter assembly, with PPTS attached and a patient secured inside, shall not detach, break free, or separate from the ambulance gurney when tested in accordance with SAE J3027.

· The PPTS containment enclosure material shall meet or exceed the requirements of ASTM F1671.

· The PPTS containment enclosure material shall pass Test Method 2 of NFPA 701.

· The PPTS containment enclosure material shall have a minimum tear propagation resistance of 1,000 grams-force in both the machine and transverse directions in accordance with ASTM D1922.

· PPTS containment enclosure material shall have a minimum puncture resistance force of 8 Newtons in accordance with ASTM F1342.

· 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 glove ports to allow simultaneous two-handed access for at least two medical providers.

· The PPTS glove ports shall allow medical providers to reach any part of the patient's body.

· The PPTS glove port gloves shall be ambidextrous.

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

· The PPTS glove port gloves shall meet or exceed the requirements of ASTM D6319.

· The PPTS glove 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 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 waste disposal interface shall be accessible from both sides of the containment enclosure.

· The PPTS waste storage receptacles shall be stowable, allowing it to be securely collapsed, retracted, or tied down when not in use.

· The PPTS waste storage system waste disposal interface shall be located in a low-interference zone (e.g., the lower extremities/foot end).

· The PPTS waste storage receptacle(s) shall hold a total of at least 10 liters of waste.

· The PPTS waste storage receptacle(s) shall have a diameter of at least 6 inches.

· The PPTS waste storage receptacle(s) shall hold a total of at least 20 kilograms of waste.

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

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· The PPTS window material shall have haze less than or equal to 5 percent in accordance with ASTM D1003.

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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 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 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, excluding the weight of the patient, shall be less than or equal to the calculated carrying weight limit in MIL-STD-1472 for two-person carry.

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

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

Demonstration / In-Flight Assessment

Table 3: Phase II Evaluation Criteria

· System shall be compatible with ground vehicles UFM 82/83 ambulance and AMBUS.

· The PPTS shall meet all requirements to include Society of Automotive Engineers (SAE) J3027 crash-compliance for Department of Transportation vehicle transport

1. The PPTS, with a patient secured inside, shall not detach, break free, or separate from the NATO litter when tested in accordance with SAE J3027.

2. The NATO litter assembly, with PPTS attached and a patient secured inside, shall not detach, break free, or separate from the ambulance gurney when tested in accordance with SAE J3027.

· The PPTS containment enclosure material shall meet or exceed the requirements of ASTM F1671.

· The PPTS containment enclosure material shall pass Test Method 2 of NFPA 701.

· The PPTS containment enclosure material shall have a minimum tear propagation resistance of 1,000 grams-force in both the machine and transverse directions in accordance with ASTM D1922.

· PPTS containment enclosure material shall have a minimum puncture resistance force of 8 Newtons in accordance with ASTM F1342.

· 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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This is a pass/fail criterion

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

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· 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

Table 4: Phase III Evaluation Criteria

· System shall be compatible with ground vehicles UFM 82/83 ambulance and AMBUS.

· The PPTS shall meet all requirements to include Society of Automotive Engineers (SAE) J3027 crash-compliance for Department of Transportation vehicle transport

1. The PPTS, with a patient secured inside, shall not detach, break free, or separate from the NATO litter when tested in accordance with SAE J3027.

2. The NATO litter assembly, with PPTS attached and a patient secured inside, shall not detach, break free, or separate from the ambulance gurney when tested in accordance with SAE J3027.

· The PPTS containment enclosure material shall meet or exceed the requirements of ASTM F1671.

· The PPTS containment enclosure material shall pass Test Method 2 of NFPA 701.

· The PPTS containment enclosure material shall have a minimum tear propagation resistance of 1,000 grams-force in both the machine and transverse directions in accordance with ASTM D1922.

PPTS containment enclosure material shall have a minimum puncture resistance force of 8 Newtons in accordance with ASTM F1342.

· 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

· 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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Table 5: Additional Criteria

ATTACHMENT 2 – FDA-RELATED DELIVERABLES:

In addition to the regulatory strategy requirements in Section 2.2.2 the following deliverables are also required.

Quality Assurance Program Plan (QAPP) The Awardee shall provide a QAPP, including the Awardee's Quality Manual, no later than 30 days after award. The QAPP will be updated and submitted when changes occur to the Quality Management Plan. Following each delivery, the Government will respond with comments and/or acceptance within 10 business days; feedback will be incorporated as appropriate.

Sponsor Authorization Letter The Awardee shall include with any Regulatory Submission (Pre-Submission or Marketing Authorization Filing) a fully executed sponsor authorization letter enabling the FDA to disclose information to CPE-CBRND and its government support contractors related to the proposed product under Public Law 115-92.

FDA Communications The Awardee shall provide the Government regulatory representative (ACPE-MRAS) with all communications to and from the FDA or other regulatory authorities regarding regulatory and quality activities relevant to the technology, to include, but not limited to: informal communications, draft and final communications regarding formal meetings (e.g., Pre-Submission) and submissions under review, feedback, minutes, and draft and final submissions for marketing authorization. The Government will respond with comments and/or acceptance within 10 business days of receipt. Government feedback will be incorporated as appropriate.

The Awardee, or regulatory sponsor if not the Awardee, will designate the ACPE-MRAS representative as the co-contact for all such communications.

The Awardee shall ensure that the ACPE-MRAS representative and at least one representative of the Government funding entity receive invitations to FDA meetings and regulatory discussions applicable to this Project.

Testing Documentation If applicable, the Awardee shall deliver documentation of Institutional Animal Care and Use Committee (IACUC) and Animal Care and Use Review Office (ACURO) approval(s) in accordance with DFARS Clause 252.235-7002 prior to the start of any activities that make use of animals.

If applicable, the Awardee shall deliver documentation of Institutional Review Board (IRB) and Office of Human Research Oversight (OHRO) approval(s) in accordance with DFARS Clause 252.235-7004 prior to the start of any activities that make use of human specimens, data, and/or subjects.

Regulatory Audits and Inspections Data In the event of an International Organization for Standardization (ISO) or U.S. Food and Drug Administration (FDA) inspection that occurs at the Contractor facilities or of the Contractor records, the Contractor shall notify the U.S. Government within 48 hours. The Contractor shall provide the U.S. Government with a copy of the FDA Form 483 and the Establishment Inspection Report (EIR), and/or ISO Audit Findings and Non-conformances, upon receipt.

The Contractor shall provide the plan for addressing areas of non-conformance as identified in the report, status updates during the plan's execution, and a copy of all final responses to the FDA within 10 business days of generation.

The Contractor shall provide copies of any ISO or FDA audit or inspection reports received from subcontractors involved in or related to this technology, upon receipt.

For Government audits/site visits, documentation requested by the audit team will be provided prior to the audit.

Upon completion of Government audits/site visits of the Awardee, the Awardee shall provide a report capturing findings or results, to include plans for addressing findings or areas of concern to the Government, within 15 business days of audit completion.

Upon completion of audits/site visits of subcontractors and suppliers, the Contractor shall provide a report capturing the findings, results, and next steps in proceeding with the subcontractor. If action is requested of the subcontractor, concerns for addressing areas of non-conformance will be detailed and provided to the Government within 15 business days of audit completion.