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Notice of Intent to Sole Source *=Required Field Presolicitation Notice Page 1 of 4 Introduction: The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 09, hereby provides notice o... Notice of Intent to Sole Source *=Required Field Presolicitation Notice Page 1 of 4 Introduction: The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 09, hereby provides notice of its intent to award a brand name only sole source, firm-fixed price contract for the supplies and services listed below to a large business, Biomerieux, Inc. with its U.S. headquarters located at Salt Lake City, Utah. The contract is expected to be awarded under the authority of 41 U.S.C. 1901, as implemented by FAR 13.501(a) Sole Source (including brand name) acquisitions. A Sole Source Justification for Other Than Full and Open Competition will be prepared. The anticipated award date is before 9/30/2024, with an effective date of 10/1/2024, and period of performance through 9/30/2025 with four 12-month options. The anticipated total combined cost for all five years is expected to be less than $750,000.00. Background: Both campuses are using BACTEC leased blood culture equipment from Becton Dickinson (BD) under a cost-per-test (CPT) type contract that ends 9/30/2024. Government aggregated volume at the Nashville Campus and Murfreesboro campus is 9,600 bottles/year & 1,440 bottles/year, respectively. Nashville also performs stem cell cultures with an average volume of 1,430 bottles/year. Murfreesboro campus does not handle or perform stem cell cultures. Murfreesboro blood culture cabinet daily hold volume is 40-50 bottles. Nashville s daily hold volume is 250-260 bottles. Current workflow using the BD instrument is: Patient demographics and test accession number for each blood culture set (one aerobic bottle and one anaerobic bottle) is entered into the instrument computer by the Technologist. The computer keyboard is used to input full patient name and full social security number. The handheld barcode scanner is used to scan the patient accession barcode label to input the unique test number. The specimen type, hospital ward, time of specimen collection, and time of lab receipt are entered by using the computer mouse to select the appropriate response from the preprogrammed dropdown boxes for each entry parameter. The blood culture set is entered into the instrument incubator by the Technologist. The following steps must be performed for each bottle in the blood culture set. The instrument drawer is opened by the Technologist, which activates the barcode scanner built into the front of the instrument and identifies the available incubation wells in the instrument with green LEDs. The Technologist scans the bottle barcode label, this identifies the bottle and the bottle type. The Technologist then scans the patient accession barcode label, which links the unique test number to the bottle. This information is automatically saved by the instrument database. The Technologist selects an available incubation well for the bottle and places it in the well. Once the desired number of blood culture sets have been scanned and loaded into the instrument, the drawer is closed signaling the instrument that the loading process is complete. The instrument monitors the bottles for five days. If a bottle becomes positive (microorganism growth detected inside the bottle) during the five-day culture period, the instrument alerts staff with an audible alarm and red LEDs on the instrument drawer containing the positive bottle and a flashing red LED on the incubation well inside the drawer where the bottle was placed. The Technologist opens the drawer containing the positive bottle and removes it for further testing outside of the instrument. Bottles that remain in the instrument for five days without going positive are considered negative (no microorganism growth detected inside the bottle) and are ready for removal. The instrument alerts staff that negative bottles are ready for removal with green LEDs on the drawer containing negative bottles and flashing green LEDs on the incubation wells inside the drawer where the bottles were placed. The Technologist opens the drawer containing the negative bottles and removes them for disposal in the biohazard waste bin. Issue with Current Workflow: Patient Safety Concerns & High Work Demand placed on Staff. The current blood culture instrumentation in use requires hands-on input of patient information, the patient s name and social security number are entered with the computer keyboard. Clerical errors such as misspelled patient names, incorrect patient names, incorrect social security numbers, name and social security number linked to a different patient s bottles, etc. do occur. These errors are time consuming to correct and a serious patient safety concern if test results are reported on the wrong patient. Lab Service is currently severely short-staffed, particularly on the evening and midnight shifts. During heavy workload on these shifts, patient demographic input is often (2-3 times/week) saved for the next shift to enter. This often creates confusion with identification of the blood culture bottles entered in the instrument without patient identifiers and also creates the potential for incorrect test results to be reported. Market Research: Market research looked at three manufacturers of this type of equipment: BD (BACTEC), Fisher Scientific (Versatrek), and Biomerieux (Virtuo). Government found Biomerieux s Virtuo system and its integration with existing blood culture systems to be more self-functioning, requiring the least amount of lab technician oversight and input, and yielding greater efficiency in the overall lab operational workflow than the BD and Fisher Scientific units. Intent: Government seeks a replacement system offering less human interaction to improve the lab service s operational workflow as the service is severely short-staffed with high workload demands. Government seeks purchase credits during the CPT leasing period so that at the end of the five years, ownership of the equipment to transferred to the government. Blood culture unit that communicates with existing government-owned bioMerieux Vitek Mass Spectrometer and Vitek2 identification and susceptibility testing (ID/AST) systems. Nashville campus has both systems while Murfreesboro only requires and uses the Vitek 2 system. The contractor will provide the supplies and services listed below to Tennessee Valley Healthcare System (TVHS) covering both Nashville, Tennessee (TN) campus and Alvin C. York, Murfreesboro, TN campus. Supply/Services: Create a capital equipment purchase agreement with supplies and equipment maintenance service using the CPT model covering a total of five years to procure the following: Qty: 2, BACT/Alert Virtuo blood culture incubators. One for Murfreesboro and one for Nashville. Qty: The minimum annual average required anaerobic and aerobic culture bottles for Murfreesboro and Nashville as described in the background section. Qty: 2, Annual Equipment Maintenance Service detailed in the salient characteristics section. Qty: 2, BACT/Alert Virtuo blood culture incubators connected to/integrated with Biomerieux s MYLA data management platform which was acquired from government s past purchase for both campuses of Biomerieux Vitek2 system used in identification and susceptibility testing (ID/AST) of bacteria and yeast. Salient Characteristics: The Blood Culture instrumentation required must be fully automated, possessing motion-activated Load and Go loading where the bottles are simply placed onto the loading bay and no further action is required by the lab tech. The instrument must include smart scanning technology that moves the bottles into the scanning station and images the entire bottle, recognizing bottle ID s and accession labels. The instrument must include a blood level detection system that senses fill level in real time with immediate notification of improper fill. The instrument must be able to perform Pre-Programmed reports (Positive, Negative, Negative to date, Orphan & Anonymous), Instrument Reports (Temperature, Calibration), and Bottle Fill Volume Reports. The instrument must include audible and visual on-screen alerts for positive bottles with automated positive bottle removal including retrieval chutes for the bottles to be placed to free space in the incubation area for any new samples for incubation. The instrument must include automated unloading of negative bottles with visual on-screen alerts for negative bottles. The instrument must have the ability to fully integrate with current bioMerieux s MYLA (formerly Maestra) middleware software enabling connection to hospital laboratory information system (LIS). The instrument must include remote connectivity for instrument troubleshooting and software updates. The instrument must have a primary incubator capacity of at least 400 cells to meet the daily average of bottle usage to include those bottles that remain for 30-days or longer for stem cell cultures. The contractor shall provide all upgrades to the equipment hardware and operating system software, without additional charge to the Government (e.g., upgrades that corrects either a mechanical or software deficiency of the system). These enhancements to the Contractor s equipment shall be delivered to the Government site and installed within sixty (60) days of the issuance or date of first commercial availability. Any upgrade that is supplemental and retrofitted to the initial contracted features of the model (e.g., connection with another piece of equipment, new specimen tracking system, new module that adds new tests and/or different methodologies to their instrument, expansion of their reagent storage capabilities etc.) AND is being marketed to their commercial customer at a cost, would not be included in the contracted cost of the equipment. The vendor will provide a Preventive Maintenance schedule that includes quarterly, semi-annual, annual (or any other maintenance interval beyond monthly) to be performed by the vendor s Field Service Representatives. The Maintenance schedule must comply with the Joint Commission Date Guidelines listed below: Quarterly = every 3 months, plus or minus 10 days Every 6 months = 6 months from the last event, plus or minus 20 days Annually/every 12 months/once a year/every year = 1 year from the last event, plus or minus 30 days. For proposed equipment, the operation manual and training instructions must be provided in paper format as well as digital format by vendor. Training videos should be provided as a resource, and on-site training should be provided for 90% VA staff who will be operating the instruments, on all three shifts, at the convenience of the VA facility. Vendor should provide specialized advanced key operator training at the vendor facility. The training would be provided at the vendor expense, for a minimum of two key staff per analyzer, initially from each facility. And then one key staff, per analyzer annually. This training should be available for each year of the contract. If all analyzer(s) are inoperable, emergency service will be provided at no charge to the government on a 24 hrs./day 7 day/week basis for the hospital facilities and during regular business hours on a 5 day/week basis for the clinic facilities. The contractor will provide all parts and labor needed to repair the malfunction. Travel, per diem and other expenses associated with the repair will be borne by the contractor. Operator technical support service with troubleshooting and repair of the analyzer(s) must be provided on a 24 hrs./day 7 day/week basis for the hospitals and during regular business hours on a 5 day/week basis for the clinics. A secure VPN connection can be utilized for vendor to remote in for troubleshooting purposes. Contractor will include at least two Preventive Maintenances (PM) annually and provide all replacement parts at no charge to the government. High wear and tear components will be replaced by contractor on a regular basis at no additional charge to the government and these necessary replacements may or may not coincide with scheduled preventive maintenances. Location of Equipment/Service: Facility Street City State, Zip TVHS 1310 24th Avenue South Nashville TN, 37212 TVHS- Alvin C. York 3400 Lebanon Rd., Murfreesboro, TN 37129 Murfreesboro TN, 37129 NAICS code: 334516, Analytical Laboratory Instrument Manufacturing NAICS Small Business Size Standard: 1000 employees) PSC: W066, Lease or Rental of Equipment Instruments and Laboratory Equipment THIS NOTICE OF INTENT IS NOT A SOLICITATION OR REQUEST FOR COMPETITIVE QUOTES. However, interested parties may identify their interest and capability to respond to this requirement and may submit a bid, proposal, or quotation (as appropriate) that the agency shall consider within the given closing/due date of this notice. All Service-Disabled Veteran Owned and Veteran Owned Small Businesses must submit a self-certifying statement that their company meets all criteria established IAW 13 CFR 125.6, thus demonstrating compliance with the SBA Limitations on Subcontracting Rule. Interested parties are encouraged to furnish clear and convincing documentation to satisfy the requirements listed above by email only to the POCs and no later than the close date and time listed in the cover sheet of this notice. All documents submitted will not be returned. The capability documentation should include general information and technical background describing in detail the prospective contractor's capabilities and experience that will demonstrate the ability to support these requirements. Additional questions concerning this requirement before intending to submit a response, please contact the affected program office representatives before the close of this notice: TVHS, Nashville B. Teemus Hayes at 615-873-6982, or email burney.hayes@va.gov TVHS, Murfreesboro (York) Allen Veazey at 615-225-4703, or email allen.veazey@va.gov. Final Disclaimer: A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Information received will normally be considered solely for determining whether to conduct a competitive procurement. The Department of Veterans Affairs will NOT be responsible for any costs incurred by interested parties in responding to this notice of intent. Only written responses will be considered. All responses from responsible sources will be fully considered. As a result of analyzing responses to this notice of intent, the Government shall determine if a solicitation will be issued. Any prospective contractor must be registered in the System for Award Management (SAM) to be eligible for award and, if not a manufacturer, must submit a current authorized distributor letter from the manufacturer.