Enhanced Pulse Oximetry System Prototype Development and Delivery

J&A Number: 17-10190 JUSTIFICATION AND APPROVAL FOR USE OF OTHER THAN FULL AND OPEN COMPETITION 1. Contracting Activity. The Naval Medical Logistics Command (NMLC), Fort Detrick, MD is the contracting activity and the Naval Medical Research Unit Dayton (NAMRU-D), located at Wright-Patterson Air Force Base, Ohio, is the requiring activity. 2. Description of the Action Being Approved. NMLC contemplates award of a firm fixed price contract on a sole source basis to Thera Tactics to provide an enhanced pulse oximetry capability that will provide accurate, real time monitoring in a tactical aviation environment. This capability is needed to understand and address the significant increase in hypoxia-like physiologic episodes (HL-PEs) that have been experienced in Naval Aviation. In essence, the air crew member experiences oxygen deprivation during high gravity maneuvers, leading to diminished consciousness. Since 2010, there have been 346 such episodes, which represents a 350% increase over the past decade. HL-PEs are believed to be caused by failures in the oxygen delivery systems on older air frames, particularly the F/A-18; however, the sensors currently being used are not able to detect when and why these failures occur. The need to understand HL-PEs through in-cockpit operator physiological monitoring has been identified by senior Navy leadership. Specifically, the Commander, Naval Air Forces, has asked the Chief, Bureau of Medicine and Surgery, to develop an enhanced pulse oximetry capability as quickly as possible. 3. Description of Supplies/Services. The contractor will develop a pulse oximetry system with the following characteristics: 1. The pulse oximetry system shall be fully integrated into the F-18 flight helmet and be able to measure blood oxygen saturation (SpO2) at the capillary bed that is supplied by the supraorbital artery. This is the only site that directly conveys the oxygen state of the central nervous system. This is also the only site that does not possess vasoconstrictive effects when in the presence of low temperatures or extreme gravitational forces. 2. The pulse oximetry system shall include a method to quickly identify the correct placement of the pulse oximeter to accommodate the location of the supraorbital artery for each operator. 3. The pulse oximetry system shall include state of the art noise reduction algorithms to accommodate the harsh vibration forces present in tactical aviation. 4. The system must include the ideal data averaging strategy to maximize accuracy and responsiveness. 5. The pulse oximetry system shall employ an altimeter into the system to identify and record significant deviations from scheduled cabin pressurization. 6. The pulse oximetry system shall employ an accelerometer to de-conflict normal blood oxygen desaturations that are associated with high gravitational forces (9Gx) from those associated with malfunctions in life support. The oximeters algorithm shall integrate this G information to provide automated data validity information to eliminate false alarms associated with G stress. 7. The pulse oximetry system shall employ an algorithm that will enable the system to identify when a significant exposure to carbon monoxide has occurred. 8. The contractor shall conduct a hypoxia pulse oximetry verification and validation (V&V) study from 100% blood oxygen saturation to 70 % blood oxygen saturation that will establish the pulse oximetry systems margin of error when compared to arterial blood hemoximetry (the FDA standard). This study will provide preliminary V&V information in advance of delivering the prototypes. Estimated Dollar Value $1,685,000.00 4. Statutory Authority Permitting Other Than Full and Open Competition. 10 U.S.C. 2304(c)(1), (as implemented by FAR 6.302-1); Only one responsible source and no other supplies or services will satisfy agency requirements. 5. Rationale Justifying Use of Cited Statutory Authority. HL-PEs, potentially caused by oxygen delivery system failures, have been linked to 4 F/A-18 pilot deaths. Investigators believe crashes of the Navy's T-45 trainer may also be linked to HL- PEs. The Navy's current operational tempo dictates continued reliance on these older air frames, even as the risks associated with HL-PEs are better understood. The Navy risks more pilot deaths as these airframes continue to fly without fully understanding the causes of HL-PEs. The Navy has attempted to mitigate the risks by emphasizing early recognition of hypoxia symptoms to air crew members. While helpful, this mitigation strategy is not a solution. A solution can only come from a complete understanding of the root causes of the problem, and the enhanced pulse oximetry capability envisioned by this effort is required to enable that solution. The gravity of this problem is expressed in the letter from Commander, Naval Air Forces to Chief, BUMED. Admiral Shoemaker writes, "I cannot overstate the importance of aggressively pursuing research in these areas. Our aircrew members are depending on Navy Medicine, including the Navy Medical Research Enterprise commands, to address and overcome these important safety issues necessary to maintain optimum operational warfighting readiness." Thera Tactics is the only source that can develop a pulse oximetry system that meets the Governments requirements (as outlined in section 3 of this document). The Government requires that the pulse oximetry system be able to measure blood oxygen saturation (SpO2) at the capillary bed that is supplied by the supraorbital artery. The Thera Tactics pulse oximeter (TTPO) is specifically designed for high performance tactical aviators, as it uses a forehead sensor that is placed over the microcirculation fed by the supraorbital artery that arises from the internal carotid artery and lacks vasoconstrictor properties. The Government requires that the pulse oximetry system to include a method to quickly identify the correct placement of the pulse oximeter to accommodate the location of the supraorbital artery for each operator. Thera Tactics has a patent pending for an infrared photometric technique to locate this microcirculatory bed (Bebout, D.E. and W.L, Bednarski, Method for Monitoring Non-Invasive Arterial Oxygen Saturation, Pulse Rate and Detection of Carboxyhemoglobin. United States Patent 15612933 (pending), 2016.). Because this method is pending intellectual property of Thera Tactics, no other pulse oximeter (PO) can offer this technique which is integral to the research protocol. Similarly, the Government is unaware of any other potential offeror with a similar capability. The Government requires that the pulse oximetry system to include state of the art noise reduction algorithms to accommodate the harsh vibration forces present in tactical aviation. The TTPO has an integrated three dimensional accelerometer that will be used to quantify vibrations in all three directions simultaneously to be used for algorithm development to improve performance under these extreme conditions. Studies will be conducted on a vibration table that simulates the high frequency vibrations of high performance tactical aircraft. There are no commercial POs that have a three dimensional accelerometer for this purpose, and the Government is unaware of any non-commercial potential offerors with this capability. The Government requires that the pulse oximetry system employ an altimeter into the system to identify and record significant deviations from scheduled cabin pressurization. The TTPO contains an altimeter to measure cabin pressure and enhance performance and accuracy. Studies will be conducted in a hypobaric chamber up to 20,000 ft and data will be submitted to FDA in a 510k for clearance and use under these conditions. No commercial PO has claims or indications for use during reduced atmospheric pressures. The Government requires that the pulse oximetry system employ an algorithm that will enable the system to identify when a significant exposure to carbon monoxide has occurred. The TTPO has a patented algorithm to detect carboxyhemoglobin using the forehead sensor with two wavelengths of light (Bebout and Bednarski, patent 15612933, pending, 2016). No other commercial PO has this capability, and the Government is unaware of any non-commercial potential offerors with this capability. The TTPO is designed with sufficient battery capacity to last three hours and record data at 80- 100 Hz. Commercial pulse oximeters only save data at 1 Hz because of limited memory and battery life and cannot fulfill the objectives of our research protocol. Furthermore the TTPO is designed with sufficient battery capacity to last three hours and record data at 80-100 Hz. Commercial pulse oximeters only save data at 1 Hz because of limited memory and battery life and cannot fulfill the objectives of our research protocol. Finally, Thera Tactics has an original equipment manufacturer agreement with Nellcor (Medtronic) that allows them to incorporate a FDA cleared Nellcor pulse oximeter board into their monitoring system. For these reasons, Thera Tactics is the only company that can meet the Governments requirement. 6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable. A sources sought notice (posted for 5 days) and a notice of intent to sole source (posted for 15 days) will be synopsized on FBO.gov. If another company submits a written interest in this requirement as a result of the announcement, the company's information will be evaluated before the contract is signed with Thera Tactics. 7. Determination of Fair and Reasonable Cost. The Contracting Officer will perform a cost analysis in order to determine that the anticipated cost to the Government of the services covered by this J&A will be fair and reasonable. 8. Actions to Remove Barriers to Future Competition. For the reasons set forth in Paragraph 5, the Naval Medical Logistics Command has no plans at this time to compete future requirements, if any, for an enhanced pulse oximetry capability. If another potential source emerges, the Naval Medical Logistics Command will assess whether competition for future requirements is feasible. 9. Contracting Point of Contact. The point of contact at Naval Medical Logistics Command is Jennifer Reed, Code 05, at DSN 343-1200, commercial (301) 619-1200 or by e-mail at jennifer.m.reed20.civ@mail.mil. 10. Other Information The following documents were used in the preparation of this J&A and are attached for reference: Letter from Commander, Naval Air Forces, to Chief, BUMED, dated 30 May 17, subj: PHYSIOLOGIC EPISODES NAMRU-D report 16-90, Mitigation of Hypoxia-like Physiological Episodes Through Commercial Off-The-Shelf Technologies On-line article, "4 F/A-18 pilot deaths could be tied to oxygen system failures," www.stripes.com, June 16, 2016.