SOW_CO2_Sensor_5-11-2026.docx

STATEMENT OF WORK

Department of Veterans Affairs – Miniaturized CO2 Sensor Prototype Development and Novel Physiologic Gas Monitoring Research

1.0 BACKGROUND

1.1 Carbon dioxide (CO2) is a byproduct of normal metabolism and a direct marker of an individual's capacity to sufficiently ventilate. Retention of CO2 occurs in patients who have a decreased drive to breathe (e.g., following anesthesia or administration of opioids), reduced ability for gas exchange in the lungs (e.g., advanced COPD), neuromuscular disease (e.g., ALS, spinal cord injuries), and chest wall disorders (e.g., significant obesity, kyphoscoliosis). All hypoventilation disorders manifest first with sleep-related hypoventilation -- well before daytime hypercapnia appears -- making early detection critical.

1.2 Current noninvasive CO2 monitoring methods remain limited for the desired use case. End-tidal CO2 monitoring (capnometry/capnography) measures CO2 in exhaled breath and is clinically useful but is an indirect breath-based measurement affected by airway sampling, ventilation/perfusion mismatch, nasal obstruction, mouth breathing, supplemental oxygen, or lack of a valid end-tidal waveform. Skin-based transcutaneous CO2 monitors estimate arterial CO2 by heating the skin and measuring CO2 diffusing through the skin surface; however, these devices require calibration, carry heating-related considerations, and exhibit a response lag -- the American Academy of Sleep Medicine notes that transcutaneous CO2 readings typically lag behind arterial CO2 changes by two minutes or more. None of the current technologies are miniaturized to enable the addition of CO2 sensing to remote monitoring devices, home-based medical diagnostics (sleep testing devices), or portable sensors for facility-based monitoring outside of the ICU, PACU, and other continuous monitoring step-down units.

1.3 Additionally, current pulse oximeters perform differently across skin pigmentation levels. The FDA has identified that pulse oximeter oxygen saturation is often overestimated in darker-skinned patients compared with arterial oxygen saturation by blood gas analysis, creating a risk of missed hypoxemia. Pulse oximetry alone is insufficient to identify hypoventilation, particularly when supplemental oxygen is used.

1.4 The VA Sleep Medicine Program Office (SMPO) has identified a technology gap that, if addressed, would markedly expand the utility of home sleep apnea testing devices to diagnose patients with sleep-related hypoventilation, reduce the need for in-laboratory sleep studies, alleviate the need for bulky cabled sensors, and enable in-home diagnosis and remote monitoring pathways. Additionally, this technology expands in-hospital, emergency department, and outpatient surgical center capabilities to monitor for respiratory depression before adverse patient outcomes including death, cardiac arrest, respiratory arrest, intubation, or ICU transfer occur.

2.0 SCOPE

2.1 The contractor shall design, execute, and analyze the experimental approaches as defined in the approved Project Work Plan. Required deliverables include, at a minimum:

2.1.1 Deliverable 1 -- Carbon Dioxide Sensing:

2.1.1.1 The contractor shall investigate and experimentally evaluate novel noninvasive approaches for carbon dioxide sensing that could be miniaturized for home-use and portable ward monitoring devices.

2.1.1.1.1 Approaches may include, but are not limited to, spectroscopic sensing targeting hemoglobin-bound CO2 or carbamate spectral features, active resonator-based detection, and signal modulation techniques with lock-in extraction.

2.1.1.2 The contractor shall propose and justify the specific technical approaches in the Project Work Plan (Deliverable 1) for VA COR review and approval.

2.1.2 Deliverable 2 -- Improved Oxygen Saturation Sensing:

2.1.2.1 The contractor shall investigate and experimentally evaluate approaches for improving oxygen saturation sensing accuracy across diverse skin pigmentation levels, with the objective of reducing melanin-related measurement bias consistent with current FDA guidance.

2.1.2.1.1 Approaches may include narrow-band or targeted optical sources, multi-wavelength sensing, and skin-pigment correction algorithms.

2.1.2.2 The contractor shall propose and justify the specific technical approaches in the Project Work Plan (Deliverable 1) for VA COR review and approval.

SPECIFIC TASKS & DELIVERABLES

The contractor shall design, execute, and analyze the experimental approaches described above. All month references in this SOW mean calendar months from the date of contract award unless otherwise specified. Where a task spans a range of months, the associated deliverable is due no later than the last day of the final month in the stated range, unless a specific date is negotiated at contract award and documented in the Project Work Plan. Any rework of deliverables will not be done at government expense. Required deliverables include:

1. Project Work Plan -- TASK: Develop detailed technical plan, timeline, experimental design, equipment list, risk matrix, and decision gates. DELIVERABLE: Written project work plan submitted to VA COR (Deliverables 1 and 2). Due: End of Month 1.

2. Literature and Market Update -- TASK: Review existing CO2 and oxygen sensing approaches. DELIVERABLE: Written summary of current technologies, limitations, and technical distinctiveness of proposed approaches (Deliverables 1 and 2). Due: End of Month 2.

3. CO2 Sensing Testbed -- Task: Design, build, and document an experimental testbed capable of evaluating novel noninvasive CO2 sensing approaches as defined in the approved Project Work Plan. The testbed shall support collection of quantifiable sensor performance data against reference comparator measurements. DELIVERABLE: Operational testbed with technical documentation, including design rationale, equipment specifications, and operating procedures (Deliverable 1). Due: Months 3-5.

4. CO2 Modulation Protocol -- TASK: Develop and document an experimental protocol for controlled CO2 stimulation or modulation to evaluate sensor response. The protocol shall include methods for synchronizing the known CO2 stimulus with sensor output and for isolating the sensing signal from background noise. Signal extraction methods (e.g., lock-in amplification or equivalent) shall be proposed by the contractor and documented in the Project Work Plan. DELIVERABLE: Written experimental protocol including stimulation methodology, synchronization approach, and signal extraction rationale. (Deliverable 1) Due: Months 6-9.

5. Oxygen/Melanin Sensing Testbed -- TASK: Design, build, and document an experimental testbed capable of evaluating noninvasive oxygen saturation sensing approaches across skin pigmentation levels, as defined in the approved Project Work Plan. The testbed shall support collection of quantifiable performance data stratified by skin pigmentation against reference comparator measurements. DELIVERABLE: Operational testbed with technical documentation. (Deliverable 2) Due: Months 4-7.

6. Reference Measurement Plan -- TASK: Define comparator measurements. DELIVERABLE: Written plan for comparison against arterial blood gas, transcutaneous CO2, end-tidal CO2, co-oximetry, standard pulse oximetry, and skin pigmentation assessment. (Deliverables 1 and 2) Due: End of Month 2.

7. Experimental Data Package -- TASK: Collect, process, and document all experimental data. DELIVERABLE: Raw and processed data, metadata, calibration records, and quality-control documentation. (Deliverables 1 and 2) Due: Months 9-11.

8. Statistical Analysis Report -- TASK: Analyze accuracy, bias, precision, repeatability, response time, signal-to-noise ratio, limits of agreement, and oxygen performance stratified by skin pigmentation. DELIVERABLE: Written statistical analysis report. (Deliverable 2) Due: Month 11.

9. Quarterly Progress Reports -- TASK: Summarize work completed each quarter. DELIVERABLE: Written quarterly report covering work completed, problems encountered, corrective actions, next-quarter plan, and updated milestone status. (Deliverables 1 and 2) Due: End of each quarter.

10. Final Technical Report -- TASK: Synthesize all findings. DELIVERABLE: Comprehensive final report including feasibility determination, technical results, failed and successful approaches, limitations, recommended next steps, and recommendation on whether further prototype development is warranted. (Deliverables 1 and 2) Due: Month 12.

11. Final Briefing -- TASK: Present findings to VA stakeholders. DELIVERABLE: Slide deck and oral presentation for VA program office. (Deliverables 1 and 2) Due: Month 12.

12. Technical Artifacts -- TASK: Compile all technical products generated under the effort. DELIVERABLE: Code, algorithms, model assumptions, prototype design files, SOPs, and data dictionaries. (Deliverables 1 and 2) Due: Month 12.

Contractor Qualification Requirements The contractor shall demonstrate the technical capability to design, build, and experimentally evaluate novel noninvasive physiologic sensing systems operating at advanced electromagnetic frequencies or optical wavelengths, including the ability to perform signal extraction, sensor characterization, and quantitative comparison against clinical reference measurements.

The contractor must comply with all applicable VA research compliance requirements, including IRB/IACUC approvals if human subjects or animal research is involved (to be confirmed by the program office prior to award).

The contractor must maintain research records in accordance with VA Records Management requirements.

All publications arising from this work must be reviewed and approved by the VA prior to submission, consistent with VA research publication policy.

The contractor must comply with the VA Invention Disclosure Process for any new inventions arising from work performed under this contract (reference: VA Disclosure No. 2026-270; Submission OI2026-08287).

The contractor's designated Principal Investigator (PI) is identified in the contract award as a key person. The PI shall promptly notify the VA COR in writing of any proposed changes in key personnel, major deviations from the approved technical approach, or material budget realignments. Substitution of key personnel requires prior written approval of the Contracting Officer.

PERIOD OF PERFORMANCE

Base Year: Twelve (12) months from the date of contract award.

Estimated Start Date: September 25, 2026 Estimated End Date: September 24, 2027 Option Periods: None Total Period of Performance: One twelve-month base period.

PLACE OF PERFORMANCE

Primary place of performance shall be the contractor's laboratory facilities, which must be equipped to conduct the experimental work described herein and approved in the Project Work Plan. The contractor shall identify the primary laboratory location in the Project Work Plan for VA COR approval. Any changes to the primary place of performance require prior written approval of the Contracting Officer. Remote data analysis, project meetings, and report preparation may occur at the contractor's place of business unless otherwise directed.

RESEARCH-SPECIFIC REQUIREMENTS

Patent Rights / Invention Disclosure:

A VA invention disclosure has been filed: VA Disclosure No. 2026-270 (Submission OI2026-08287), 'Miniaturizing CO2 Sensing to Improve Patient Safety in Unmonitored Environments,' accepted February 24, 2026, San Francisco VA Health Care System, inventor Kathleen Sarmiento, MD. Patent rights disposition is undecided but likely. This disclosure may need to be updated as prototype development progresses. Any new inventions conceived or reduced to practice under this contract shall be subject to the VA's invention disclosure process and applicable federal patent statutes.

Publications:

The contractor shall obtain VA review and approval prior to submitting any publication, conference abstract, or presentation arising from work performed under this contract. As of the contract start date, no work or research has been submitted for publication.

Human Subjects / IRB Approval:

Human-subject testing or IRB approval requirement: To be determined by the program office prior to award. If human subjects research is required, the contractor shall not commence that portion of the work until all required approvals are obtained.

CONTRACT TYPE

The proposed contract type will be a Firm-Fixed-Price (FFP) research and development services contract, or such other contract type as determined appropriate by the Contracting Officer based on the nature of the work and responses to pre-award questions. [CO WILL COMPLETE BASED ON HOW YOU ANSWER QUESTIONS FROM EMAIL]

ACCEPTANCE CRITERIA

Acceptance will require completion of the approved experimental plan, provision of complete data and analysis, quantification of accuracy and response characteristics against reference/comparator measurements, identification of limitations, and a recommendation on whether the approach warrants further development. Acceptance does not require production of a finished FDA-cleared clinical device.

Accuracy: Bias and error versus reference comparators (arterial blood gas PaCO2, EtCO2, TcCO2, co-oximetry) Precision: Repeatability across repeated trials Response Time: Time to detect change compared with transcutaneous and end-tidal methods Skin Tone Performance: Oxygen measurement bias and error stratified by skin pigmentation Signal Quality: Signal-to-noise ratio and artifact sensitivity Feasibility: Whether the approach can plausibly support a future wearable or point-of-care device Measurable acceptance thresholds for accuracy, precision, and response time shall be proposed by the contractor in the Project Work Plan (Deliverable 1) and approved by the VA COR before experimentation begins. Thresholds shall reference applicable published standards where available (e.g., ISO 80601-2-61 for pulse oximeters; AASM guidelines for transcutaneous CO2 monitoring). Deliverables will be accepted when (a) required experiments are completed per the approved plan, (b) usable data are delivered with complete quality-control documentation, and (c) the Final Technical Report includes a clear feasibility assessment supported by quantitative comparison against reference measurements. The COR shall provide written acceptance or rejection within 15 calendar days of receipt of each deliverable.

SECURITY

No VA sensitive information will be provided under this contract. Contractor personnel are not required to access VA networks or computer systems.

INVOICES

Invoices will be submitted against the task order purchase order number (PO#) to Tungsten Network (or the VA's designated invoice processing platform). The COR will validate the costs associated with each invoice in accordance with the contract prior to certifying payment. Invoices shall include sufficient detail to verify alignment with approved deliverables and milestones.