6640--INTENT TO SOLE SOURCE: TO SOLE OEM-AUTHORIZED SB (SDVOSB) HISTOSMATE MODEL 65281 WAX CLEANING STATION

Page 1 of 3 Page 1 of INTENT TO SOLE SOURCE: TO SOLE OEM-AUTHORIZED SB (SDVOSB) DISTRIBUTOR THIS IS NOTICE OF INTENT TO SOLE SOURCE: HISTOSMATE MODEL #65281 LABORATORY EQUIPMENT WAS CLEANING SYSTEM: VAMC WEST HAVEN, CT. INTENT TO SOLE SOURCE FOR PURCHASE REQUISITION: This is not a request for competitive proposals. 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 HistosMATE Model #65281. Technology, knowledge, technical expertise, and servicing capabilities for the HistosMATE Model #65281 are proprietary and peculiar to Milestone Medical Technologies, Inc. Government distribution for this equipment is available only through: Branch Medical LLC., the SD/VOSB Distributor for the specific product being procured. A Sole Source Letter has been provided by the OEM describing the proprietary nature of the HistosMATE Model #65281, establishing this product as being peculiar to the OEM and that the only OEM authorized government Distributor is Branch Medical LLC. No other vendors in any class aside from the OEM are authorized to distribute this product to the government. 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 restricting competition for this procurement via FAR 19.1406. 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 339113: Surgical Appliance and Supplies Manufacturing. The most current Business Size Rating for this NAICS is 800 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 proposed award upon response to this notice is solely within the discretion of the Contracting Officer. VA Connecticut Healthcare System West Haven Campus Pathology & Laboratory Medicine Service Salient Characteristics Benchtop placement with no construction or installation required. No connection to the VA Network is needed for this equipment. FMS delivery from warehouse to laboratory will be needed. Cabinet: Heavy duty industrial grade external chassis "HistosMATE" software, intuitive, user-friendly Software controlled temperature and time Cabinet coating resistant to acid and organic solvents Cavity: All stainless steel Powered with 1 resistance heating element (2x200 W) controlled by PID technology Magnetic stirrer with speed control (200-600 RPM) Built-in PT100 Temperature sensors Tube for paraffin draining. Accessories included (P/N: HMS01): Exhaust tube (2.5 m) feet (P/N 50332) Stainless steel basket for automatic removal of wax traces from metal molds, forceps Dimensions: cm 30 W x 46.5 H x 51.5 D - 11.81" x 18.30" x 20.27" Total Weight: 35 Kg - 77.16 lb. 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-2433__________________ Contracting Activity: Department of Veterans Affairs, Regional Procurement Office East (VISN 1), VAMC West Haven, CT. PR: 689-25-3-7821-0053 Brief Description of Supplies/ Services required and the intended use/Estimated Amount: HistosMATE Laboratory Wax Cleaning System Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The HistosMATE equipment is designed by Milestone Medical to clean laboratory racks. The HistoMATE is specifically configured to integrate with the Milestone Medical Logos Processor already in place at VAMC West Haven. However, HistosMATE will also clean laboratory racks for other conventional processors. HistosMATE is peculiar in the market due to its use of its MileGREEN solution as a cleaning reagent. The HistosMATE cleaning process is a Xylene-free process; this distinguishes HistosMATE from known competitors in the market. MileGREEN has low toxicity and is non-carcinogenic. The West Haven VAMC facility uses the Milestone Medical Logos Processor and has indicated that the Milestone brand is more effective in cleaning the Logos laboratory racks. HistosMATE will also clean the other brands of processors in use at VAMC West Haven that were procured before the Logos. The ability to clean multiple types of racks efficiently makes the HistosMATE indispensable for VAMC West Haven laboratory operations. The HistosMATE will provide both operational and economic efficiency by replacing manual cleaning techniques previously employed at VAMC West Haven. Historically, cleaning molds, forceps, and racks were either cleaned manually or utilized processors that were not as efficient due to their lengthy cleaning cycles. The other brands of processors used reagents such as xylene for the cleaning process; xylene is a toxic reagent and is a carcinogenic solution. These previous cleaning methods required extensive processing time and were costly; they created clogging issues within the equipment. These clogs prompted additional maintenance, increasing operational costs and adversely impacted healthcare by delaying patient care due to prolonged downtime during cleaning cycles. The Milestone HistosMATE is more efficient; it completes its cleaning cycle in seven minutes. This rapid turnaround minimizes equipment downtime. The equipment configuration and the MileGREEN cleaning solution prevent clogging issues previously experienced with historical cleaning methods. The increased efficiency and directly contributes to improved patient care. The peculiar technology of the HistosMATE system, and its direct integration and compatibility with the Milestone Medical Logis Processor, and due to the health benefits offered by the MileGREEN cleaning solution, HistosMATE will reduce costs, increase operational efficiency, and will improve healthcare at VAMC West Haven, CT due to the reduction in cleaning cycle duration. Other VISN 1 sites have also purchased the HistosMATE systems due to safety and efficiency. There are no known brands that can meet the specific needs as effectively as the Milestone Medical HistosMATE. A single source award for the HistoMATE equipment is recommended IAW FAR 13.106-1(b)(1). Description of market research conducted and results or statement why it was not conducted: Market Research Findings: Mandatory Sources: No VA agency or other agency has excess supplies of this nature. AbilityOne cannot fulfill this requirement. SAC (Strategic Acquisition Center): The SCMC (Supply Chain Master Catalog) was searched. The requirement listed is not available via any SAC Contract on the SAC website. VAAR 813.003-70(c) VFCP: There is no NMR waiver for NAICS 339113: Ultrasonic Medical Cleaning equipment manufacturing. Therefore, IAW VAAR 819.7003(d) VFCP (Veteran s First Contracting Program) cannot be applied; the NMR is not satisfied. There is one (1) capable and OEM-authorized SD/VOSB distributor for the Government market; but a SDVOSB single source cannot be leveraged without the NMR Waiver. GSA NAC (National Acquisition Center) FSS (Federal Supply Schedule): The GSA e-Library does not list any contracts under Schedule 65 II A: Medical Equipment for the Histosmate. A GSA Advantage search yielded no results. ADDS Up: An ADDS UP search has indicated that the Department of Veterans Affairs (VA) has issued only one award for the procurement of a Histosmate. This award was granted by the Regional Procurement Office East (VISN 1), located at the VAMC in Providence, RI, on December 15, 2022, and made to Branch Medical LLC, the Single Source SDVOSB Distributor for the OEM, Milestone Medical Technologies, Inc. FAR 19.202: PREFERENCE FOR SMALL BUSINESS: SBA DSBS Search produced two (2) SB result for NAICS 339113 and Keywords: Ultrasonic. Although the SBA NMR Exception would apply, there is only one (1) SB, SDVOSB vendor authorized to supply the HistosMATE. Market Research Summary: Currently, there are no known brand products that are equal to the HistosMATE on the market. Recommendation: The recommended strategy is for a single source award to the sole, OEM-authorized SB (SD/VOSB) distributor: Branch Medical LLC, IAW FAR 13.106-1(b)(1)(i): one source. There is no NMR Waiver; this requirement is not eligible for a SD/VOSB set-aside. There is an SBA NMR Exception IAW FAR 19.502-2(a); however, the SB Rule of (2) cannot be met as there is only (1) OEM-authorized SB class distributor. The HistosMATE is proprietary and exclusive to the LB OEM, Milestone Medical Technologies, Inc. Milestone has provided a Letter of Authorization (LOA) designating Branch Medical LLC as the sole distributor to the Government. There are no mandatory sources capable of supplying HistosMATE. 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. ____________________________ ________________________ Deidra Thomas Date Contracting Officer VAMC White River Junction VT, NC01 RPOE