6635--Intent to Sole Source to OEM and authorized SB distributor AeroFit Respiratory Fit Testing System (2)

Page 1 of 3 Page 1 of INTENT TO SOLE SOURCE: AeroFit Respiratory Fit Testing Systems THIS IS NOTICE OF INTENT TO SOLE SOURCE FOR AEROFIT RESPIRATORY FIT TESTING SYSTEMS: VAMC TOGUS, ME. INTENT TO SOLE SOURCE FOR PURCHASE REQUISITION: This is not a request for competitive offers. This is not a solicitation or request for offers. No solicitation package is available, and telephone requests will not be honored. The Department of Veterans Affairs VA Medical Center intends to award a one-time, Firm Fixed Price, Sole Source contract for the AeroFit Respiratory Fit Testing Systems. Technology, knowledge, technical expertise, and servicing capabilities for the AeroFit Respiratory Fit Testing Systems are proprietary and peculiar to OHD LLLP. Government distribution of this equipment is available only through OHD LLLP, the OEM and SB Distributor for the specific product being procured. A Sole Source Letter has been provided by the OEM describing the proprietary nature of the AeroFit Respiratory Fit Testing Systems, establishing this product as being peculiar to OHD LLLP as the OEM. The letter states that only the OEM is the authorized SB government Distributor: Only OHD LLLP., can distribute this product to the Government. No other vendors in any class aside from the OEM are authorized to distribute this product. An additional sole source letter indicates that service and maintenance are proprietary to the Small Business (SB) OEM. The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901. This statute is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(1)(i). The intent is to procure these services on a sole source basis. No solicitation will be posted to Contract Opportunities. The primary North American Classification System Code (NAICS) is 334519: Other Measuring and Controlling Device Manufacturing. The most current Business Size Rating for this NAICS is 600 employees. Capable parties may identify their interests and authorization to respond to this requirement by September 12th, 2025, at 16:30 (EDT). A determination by the Government not to compete this requirement upon response to this notice is solely within the discretion of the Contracting Officer. Department of Veterans Affairs VAMC Togus, ME Safety Service Line Statement of Work (SOW) AeroFit Respiratory Fit Testing Systems 1. Introduction This Statement of Work (SOW) outlines the requirements for the procurement of two AeroFit Respiratory Fit Testing Systems for the Department of Veterans Affairs (VA) Togus Maine Medical Center Safety Service Line. The equipment is intended to replace existing Portacount Fit Testers that are at the end of their lifecycle and are no longer supported by the manufacturer. 2. Scope of Work The contractor shall provide two AeroFit Respiratory Fit Testing Systems that meet the specifications outlined herein. The systems shall be capable of standalone operation without the need for software installation or internet connectivity, ensuring compliance with VA operational standards. 3. Requirements The vendor shall supply the following equipment and accessories for each unit: 4. Functional and Performance Requirements The AeroFit Respiratory Fit Testing System shall operate as a standalone device, requiring no external software downloads or internet connection. The system shall be capable of performing fit testing procedures in accordance with OSHA and VA standards. The equipment shall be compatible with existing VA respiratory safety protocols. The system shall be suitable for routine use in a clinical environment and meet all applicable safety and performance standards. 5. Background and Justification This procurement is necessary to replace the existing Portacount Fit Testers, which are no longer supported by the manufacturer (TSI). The existing equipment has reached the end of its lifecycle, and updates or repairs are no longer available. The AeroFit Respiratory Fit Testing System was recommended at recent professional conferences, including the Industrial Hygiene Conference and OSHA Respiratory Course, as a reliable and compliant alternative. 6. Delivery and Installation The contractor shall deliver the equipment to the Togus Maine Medical Center within the agreed timeline. Installation, if required, shall be coordinated with VA Safety Service personnel to ensure proper setup and operation. 7. Acceptance Criteria All equipment shall be new, unused, and in accordance with the specifications outlined. Equipment shall be free from defects and fully operational upon delivery. All accessories and consumables shall be included as specified. 8. Period of Performance The contractor shall deliver the equipment within [insert specific timeframe] from contract award. 9. Contractor Responsibilities Provide all equipment and accessories specified. Ensure equipment meets all applicable standards and specifications. Provide any necessary training materials or support documentation. Coordinate delivery and installation with VA personnel. 10. Government Responsibilities Provide access to installation sites. Facilitate inspection and acceptance procedures. This Statement of Work is issued in accordance with the applicable federal procurement regulations and VA policies. The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract: Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. DEPARTMENT OF VETERANS AFFAIRS Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K) Acquisition Plan Action ID: 36C241-25-AP-4119 Contracting Activity: Department of Veterans Affairs, VISN 01, VAMC 402, 1 VA Center, Augusta, Maine Funding document: 402-25-3-4837-0216 Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The procurement involves the purchase of two AeroFit Respiratory Fit Testing Systems to replace existing Portacount Fit Testers at the Togus VA Medical Center. The systems will be used for respiratory fit testing of VA personnel, ensuring compliance with OSHA and VA standards, and maintaining respiratory safety protocols. Estimated Amount $41,120.00 Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The existing Portacount Testers used for fit testing at the Togus VAMC are past their life cycle, requiring imminent replacement to meet safety OSHA requirements. The Original Equipment Manufacturer (OEM) no longer supports the current system. The AeroFit Respiratory Fit Testing System is required for its standalone capability. It does not rely on software downloads or a connection to a network. Use of any other Portacount Tester would require an additional administrative burden to integrate it into the IT infrastructure that would result in additional costs and unacceptable delays in fulfilling the Agency s requirements. In addition, there would be additional equipment and life cycle costs for the Government to integrate any other Portacount product. Additional equipment such as iPads and IT equipment will be required to support Portacount Fit testers that do not have standalone capability. This would result in unnecessary software and hardware costs over the product s life cycle to the detriment of the Government. The AeroFit Respiratory Fit Testing System is the only product with a standalone capability that can meet the Government s requirements without resulting in additional costs and unacceptable delays. This product can only be procured through the OEM, OHD LLLP. Description of market research conducted and results or statement why it was not conducted: Market research was conducted IAW FAR 10. 001.Market research revealed that there are no mandatory sources of supply: Government Agency or VA Inventories, no AbilityOne supply source. There are no mandatory contracts: SAC, NAC, or other National/Government-wide (GWAC) contracts, that carry the AeroFit testers. AeroFit Respiratory Fit Testing Systems are commercial off-the-shelf (COTS) equipment procured direct from the Small Business OEM: OHD LLLP, via Open Market. A search was conducted at SBA DSBS IAW VAAR 810.001-70(c) using NAICS 334519 to locate potentially capable VIP-Verified suppliers. Despite a thorough search, no results were found in the SBA DSBS for this NAICS, other than the OEM, a SB distributor: OHD LLLP. This supports the Sole Source letter form OHD indicating that distribution is exclusive to OHD. OHD is unique in their capability to distribute the AeroFit testers There is no NMR waiver for NAICS 334519: Other Measuring and Controlling Device Manufacturing. The requirement will fall below SAT (Simplified Acquisition Threshold) Typically, the SBA NMR Exception FAR 19.502-2(a) could be applied, if (2) or more responsible and capable SBs were available and authorized to compete. Additionally, a Market Research Survey for the VAMC Togus AeroFit Quote. The information provided by the OEM OHD LLLP supports a sole source. Market research conducted coupled with recommendations from the professional conferences support that there are no other brands nor sources that can provide a comparable standalone respiratory fit testing system, that comply with the VA s specifications while assessing respiratory fit at high levels of accuracy and speed, to the high degree of the AeroFit System. The recommended strategy is to award a single source contract to OHD LLLP, the sole OEM and authorized SB distributor, in accordance with FAR 13.106-1(b)(1)(i). This procurement at $41,120.00 falls below SAT. The requirement is not eligible for a SDVOSB set-aside, due to the absence of an NMR Waiver. The SB "Rule of Two" cannot be applied; there is no expectation of receiving two (2) fair and reasonable quotes from (2) capable and responsible SB distributors. Therefore, a sole source award is recommended. OHD LLLP, the SB OEM, is unique in their ability to provide the required AeroFit testers. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. ____________________________ ________________________ David Valenzuela Date Contracting Officer NC01 RPOE