NOTICE OF AWARD Justification and Approval (J&A) FAR Subpart FAR 8.405-6(a)(1)(i)(B) -- Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized. Title: INO Therapy Services, Naval Medical Center Portsmouth (NMCP) J&A Number: JA-23-0193 Awardee: INO Therapeutics Award: VA FSS Contract V797D-60737 Order: HT940623F0133 1. Identification of the agency and contracting activity: Defense Health Agency - Tidewater Contracting Division 2. Nature and/or Description of Action being Approved: New order on GSA schedule 65IB, Category 42-2A, Pharmaceuticals and Drugs 3. Description of Supplies/ Services: This is a non-personal services contract to provide INO Therapy Services that consists of delivery of gases, exchange of machines, preventive maintenance, and cylinder/machine pick up. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to provide the INO Inhaled Nitric Oxide and affiliated machines at Naval Medical Center Portsmouth (NMCP) as defined in the Performance Work Statement (PWS). TOTAL Contract Value: $732,512.00 Period of Performance: Base plus 4 options Base - From 1 October 2023 through 30 September 2024 Option 1 - From 1 October 2024 through 30 September 2025 Option 2 - From 1 October 2025 through 30 September 2026 Option 3 - From 1 October 2026 through 30 September 2027 Option 4 - From 1 October 2027 through 30 September 2028 Type of Contract (Primary): FAR 16.202 Firm-Fixed Price Funding Type: Operations & Maintenance (O&M) 4. Statutory and Regulatory Authority Permitting Other Than Full and Open Competition (see FAR 6.302), FAR 8.405-6(a)(1)(i)(B) -- Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized. 5. Rationale Justifying Use of the Statutory Authority Cited: NMCP requires INO therapy for patient care in Neonatal, Pediatric, and Adult intensive care units. Market research confirms (see MRM) INO Therapeutics, LLC is the only manufacturer on the Federal Supply Schedule (FSS) which provides an INO Therapy Service and the attendant requirements (e.g. (a) the pharmaceutical drug nitric oxide for inhalation, (b) a delivery device meeting the criteria for the administration of nitric oxide set forth in the product label for nitric oxide delivery, (c) various maintenance, pick-up and delivery, and other services. Additionally, INO Therapeutics manufactures the INOmax machine, which is currently the INO therapy device at use at NMCP. The staff to include nurses, corpsman, and respiratory therapist have received extensive training using this piece of equipment; therefore, the amount of time in becoming familiar with use (vs. for a new system) is greatly reduced or eliminated. The INOmax is also used in the PICU, ICU, OR and cardiac Cath lab environments allowing for standardized care, education, supply use, and maintenance throughout the facility. This enhances patient safety and quality of care and greatly increases competency with an intricate specialized piece of equipment. The cost and time required to recompete for a new INO Therapy System outside of the FSS (which is a preferred source over open market commercial sources (FAR 8.004)) from a different manufacturer/vendor, the extensive re-training of a large staff, and the time necessary for staff to acclimate to the new system would not be effective to the Government and would potentially impact patient care. INO Therapeutics is the Original Equipment Manufacturer (OEM), and only OEM technicians may provide the maintenance and services required quarterly to the INOmax machines, and only INOmax specific INO may be used. 6. Efforts to Obtain Competition: All future requirements will be handled on a case-by-case basis. As the barriers that preclude the agency from the requirements of section 8.405-2 (SUPPLIES) are due to limited vendors on schedule, no actions can be taken by this agency to remove those barriers. If additional vendors are added to the FSS for this equipment, they will be considered as applicable. 7. Determination that Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer has determined the anticipated cost to the Government for the requirement covered by this J&A will be fair and reasonable. The proposed price will be compared to historical prices, prices obtained through market research, and an Independent Government Cost Estimate. A contract will not be awarded unless the prices is determined to be fair and reasonable. 8. Market Research: Market research was conducted between Jan and June 2023. The market research conducted included research conducted on the internet, review of mandatory sources, review of various companies' product literature, review of available sources on the FSS Schedule, and discussion with subject matter expert. The internet search was done using Google, Bing, and GSA Advantage. It was found that INO Therapeutics is the only manufacturer which can provide an INO Therapy services which meets the Essential Characteristics and is on Federal Supply Schedule. INO Therapeutics also requires the exclusive use of gases they provide, and OEM certified technicians only perform maintenance and service. Other possible sources such as Noxivent by Lindeand & Vero biotech also provide INO Therapy Services; however, they are not schedule holders on Federal Supply Schedule.
