6515--Minneapolis VAMC Notice of Intent to Sole Source BD FACS Lyric IVD Flow Cytometer

The Department of Veterans Affairs, Network Contracting Office 23 intends to award a sole source contract under the authority of FAR 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements, to Becton, Dickinson and Company (BD Sciences). Contractor shall provide all equipment and accessories, installation services, and project management support for a Flow Cytometer and accessories at the Minneapolis VAMC. This is a brand specific procurement for BD FACS Lyric IVD Flow Cytometer and accessories. This is a sole source supply purchase to BD Sciences as they are the only provider of the BD FACS Lyric IVD Flow Cytometer per a memo from BD Sciences. The place of performance is the Minneapolis VAMC. The NAICS code is 334516 with a size standard of 1000 employees. The solicitation number is 36C26323Q0909 This action will result in a Firm-Fixed Price contract with a period of performance of a Base period with no option years. This notice of

intent is not a request for quotations; interested parties may express their interest by providing a capabilities statement no later than August 2nd at 17:00 CDT. The capabilities statement must provide clear and unambiguous evidence to substantiate the capability of the party to provide the required services. A determination not to compete this proposed contract upon responses to this notice is solely within the discretion of the Government. Verbal responses are not acceptable and will not be considered. When responding to this announcement, respondents should refer to Announcement, Notice of Intent. If after August 2nd at 17:00 CDT no viable responses have been received in response to this announcement, Department of Veterans Affairs shall negotiate solely with BD Sciences. This notice of intent to award a sole source contract is not a request for competitive quotes. There will be no solicitation available for competitive quotes. Phone calls will not be accepted. The point of contact for this action is Contract Specialist Jeffrey Brown, who can be reached at Jeffrey.Brown8@va.gov. STATEMENT OF WORK Special Hematology - Flow Cytometer 1. SCOPE: Contractor shall provide Minneapolis VA Health Care System Special Hematology Laboratory (MVAHCS), 1 Veterans Drive, Minneapolis, MN 55417, a benchtop flow cytometer system for lymphocyte enumeration and multicolor flow cytometric immunophenotyping testing. This shall specifically include all the items referenced in the Contract Line Items, instrument setup (including installation, validation, training and technical support) and a one-year warranty for the items listed in the Contract Line Items. All equipment provided must be new. This is a sole-source or brand name only procurement request. 2. TECHNICAL SPECIFICATIONS: The MVAHCS is requesting a sole source or brand name only procurement of a benchtop flow cytometer for immunophenotyping testing, as detailed in the schedule of items. All items are to be shipped FOB Destination. The instrumentation shall perform all analyses for the required tests with precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the National Committee for Clinical Laboratory Standards (NCCLS). The system provided must include the following: Schedule of Items: FACSLyric 3L10C Instrument US-IVD (part #: 662878) Computer Bundle Z2MiniG5 FACSLyric USIVD (part #: 665062) Microsoft Office 2019 (part #: 664314) Assy Printer HP Color LaserJet Pro (part #: 665425) Monitor Desktop NEC Display 27 Inch LED (part #: 664872) Scanner Barcode GD4400-B 2D (part #: 663058) BD FACSLyric Extended Use Tanks (part #:651158) FACSLyric Universal Auto Loader USIVD (part #: 662879) Assembly Tube Rack 30 (part #: 651314) Assembly Tube Rack 40 (part #: 651319) CST beads 50T IVD (part #: 662413) Custom FC Bead Dilution Buffer (part #: 661614) BD FACS Clean Solution 5L (part #: 340345) BD FACSflow Sheath Fluid 20L (part #: 99-30211-00) BD FC Beads 7-Color Kit (US-IVD) (part #: 662961) BD FC Beads BV605 (part #: 661626) BD FC Beads APC-R700 (part #: 661625) BD FC Beads APC-H7 (part #: 661621) BD FC Beads V500-C (part #: 661624) BD FC Beads V450 (part #: 661623) Trucount Absolute Counting Tubes IVD (part #: 340334) Software Assurity Linc RSS (part #: 664017) Module FACSuiteMultitest 4c Assay US IVD (part #: 664236) Module FACSuiteMultitest 6c Assay US IVD (part #: 664237) Methodology: Multicolor immunofluorescence flow cytometry Optics: Capable of 10 color option with 3 lasers Solid-state lasers: 488 nm, 640 nm, 405 nm Auto optical alignment on demand Fluidics: Automated start-up and shutdown capability Compatibility with 20 L BD FACSFLOW cubitainer Performance: Sample acquisition rate of 35,000 events/second Sample carryover 0.10% with default SIT flush Sample carryover 0.05% with 3 or more SIT flushes Throughput 50 minutes for a 40-tube rack Noise levels of 55 dBA Automated loader can accommodate 30 or 40 tubes Simplified workflow including automated performance QC BD CS&T Beads, automated optimization with precise and stable compensation for up to 2 months with BD FC beads. Software/Data Management: BD FACSuite Clinical Application BD FACSuiteTM Application The PC must be configured with a Microsoft Windows 10 operating system or above. Featuring a graphical user interface with multiple windows, pull down menus and toolbars. Bidirectional transfer of information between Data Innovations interface (LIS connectivity) and the BD FACSLyric using BD FACSLinkTM interface solution. Desired Instrument Dimensions: Cytometer no larger than 25 W x 23 D by 23 H Electrical Requirements: Vendor provides UPS or surge protector if the system requires it. Vendor must ensure compatible electrical power with the VAMC outlets in the laboratory. Sample Type: Peripheral Blood, Body Fluids, Tissue Installation and Validation Contractor shall provide installation of all equipment, including labor and travel. Contractor shall provide validation of the instrument, including labor and travel. Instrument validation includes verifying pneumatic pressures, sheath flow rates, sample flow rates, laser powers, laser alignment, loader performance, and instrument performance with calibration alignment beads and CS&T beads. MVAHCS clinical staff will confirm functionality of the equipment before full acceptance is provided. Training and Technical Support Contractor shall provide either virtual or on-site training. This shall include training on the operation of the system, maintenance, data manipulation, applications specialist and basic troubleshooting and repair. Contractor shall provide 2 training provisions to instructor-led operator training in San Jose, CA. Contractor will provide transportation, lodging, hotel breakfast and lunch during the training course. Technical support available Monday Friday 8 am 4:30 pm. Warranty Contractor shall provide a warranty of, at a minimum, one (1) year on the equipment. 3. HARDWARE: If needed, prior to any purchase award, the Vendor may consult with the Laboratory and Facilities Engineering staff at each site to ensure that existing lab space and existing lab utilities will accommodate vendor's proposed equipment. If needed, the Vendor will furnish written documentation to the contracting office certifying equipment is compatible with site. 4. MAINTENANCE/SERVICE CALL: Service calls may be placed Monday through Friday, 8 am to 5 pm. Most service/maintenance problems can be handled over the telephone. Telephone response time shall be within four (4) hours of notification. During standard response hours, the contractor will make reasonable efforts to provide on-site engineering support within 48 hours of determination that on-site is necessary. Contractor s Service Phone Number is: 331-240-0251 5. SUPPORT FEATURES: The vendor shall provide software upgrades in order to maintain the integrity of the system and state-of-the art technology at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. 6. SDS, HAZARDOUS MATERIALS AND WASTE STREAM ANALYSIS: The contractor shall provide VA medical facilities in Minneapolis, with a listing of the vendor s products used with this analyzer(s) that are considered hazardous. The listing should also include a determination as to what can be considered harmless to be disposed of by normal methods, such as disposing down the sink or disposing in the trash and what has to be specially handled for disposal and how it is handled. The contractor is required to provide a list identifying any hazardous materials that may be provided as part of this contract that are defined as hazardous under the latest version of Federal Standard No. 313. Safety Data Sheets (SDS) shall be available upon request. 7. ORDERING/DELIVERY: The MVAHCS Contracting Office will issue contract award to the contractor referencing the awarded contract and purchase order number. The contractor will make arrangements with the MVAHCS for installation of equipment and training of key operators. Installation of equipment and training will be scheduled as soon as possible after receipt of equipment at the VA facility. Delivery/Installation Times: Between 8 am to 4:30 pm Monday Friday, except Federal holidays.