6630--Blood Bank Analyzer & Reagents

2 | Page 36C25026Q0042 This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ, and the solicitation number is 36C25026Q0042. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular #2025-06 (Oct 01, 2025). The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 (Analytical Laboratory Instrument Manufacturing), with a small business size standard of 1000 employees. The FSC/PSC is 6630 (Chemical Analysis Instruments). The Richard L. Roudebush VA Medical Center, Indianapolis IN, FOB destination, is seeking the procurement, delivery, and installation of Blood Bank item (s). Supply necessary materials and/or parts for Blood Bank Analyzer, Reagents, Supplies, and Services, Cost Per Reportable Result (CPRR), per the requirements listed below. The Richard L. Roudebush VA Medical Center anticipates the award of a firm fixed-price, 5-year ordering period, Indefinite Delivery/Indefinite Quantity (IDIQ) contract to a single offeror. All interested offerors shall provide quotes for the following: Requirements: CPRR and Assays Volumes and Costing Test Name Annual Test Volumes ABO/Rh and Type and Screen 3073 ABO/Rh Forward and Reverse 426 Weak D Testing 10 DAT Poly 301 DAT IgG 60 DAT - Complement 60 Immediate Spin Crossmatch 12 Electronic Crossmatch 2457 AHG (IgG) Crossmatch 306 Antibody Identifications 142 Antigen Testing Patient 25 Antigen Testing Donor 663 C Typing 60 E Typing 110 c Typing 35 e Typing 4 K Typing 110 Rh Phenotype 25 Fy(a) 50 Jk(a) 15 Donor Retypes O 800 A 642 AB 6 B 112 O Negative 200 A Negative 135 B Negative 25 Additional items: (When applicable or if not an available on analyzer) Antisera for Retypes in Tube testing Anti-A 100 Anti-B 100 Anti-A,B 100 Anti-D 50 AB Positive Control 25 Red Cells for Retypes Tube testing A1 Cells 50 B Cells 50 A2 Cells 10 Reagents Tube testing Poly (IgG and Complement) 60 IgG 60 Complement 60 LISS 50 Red Cells Tube testing Check Cells 50 Complement Check Cells 60 Please see attached APPENDIX C VA INFORMATION AND INFORMATION SYSTEM SECURITY AND PRIVACY LANGUAGE FOR INCLUSION IN CONTRACTS, AS APPROPRIATE The guaranteed minimum only applies to the Federal Government Fiscal Year in which the contract is awarded. The guaranteed minimum is $10,000.00. The Government does not guarantee, nor is it obligated, to place any orders under this contract in excess of the guaranteed minimum. The maximum total value of the contract, inclusive all option periods, shall not exceed $750,000.00. Individual task orders will be funded annually. The Contracting Officer is the only authorized individual that can place annual task orders against this contract for the estimated amount of services for the specific timeframe, and the task orders will be issued to the contractor. STATEMENT OF WORK Blood Bank Analyzer & Reagents 1. Scope: Contractor shall provide all FDA approved walk away/automated transfusion service analyzer and corresponding automated and manual tube reagents, standards, controls, supplies, consumable/disposable items, parts, accessories; middleware management system, high performance server rack, software, hardware, UPS (uninterrupted power supply), all parts and materials, technical manuals, reagents, consumable supplies, shipping and handling costs associated with receipt of reagents, preventative and repair maintenance agreement, operator training in the operation of and performance of preventive maintenance and any other item required for the proper operation of its' contractor owned Blood Bank equipment necessary for open market contract agreement. However, as requirements change, additional tests/reagents/instrumentation/software upgrades may be added to the contract as new technology becomes available on the market and added to the base contract. The fully automated analyzer must be able to analyze multiple specimens (including STATs) automatically, reduce technician errors and standardize blood bank reporting. The equipment must maintain, reduce the number of workstations, or reduce the overall labor required to accomplish all testing. Automation will provide a more efficient workflow and decrease variables for error in performing critical testing. Definitions: Cost per Test (CPT) contract as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers: Over a base year plus 4 option year contract, the contractor, via federal supply schedule, shall provide all necessary accessorial equipment parts, disposables, control tests, reagents and supplies to complete patient testing. The contract will include one (1) analyzer and one (1) manual gel benchtop stations. The cost per test contract pricing shall include costs covering (a) equipment use, (b) all reagents, (c) service agreement for the life of the contract, calibrators, standards, quality controls, supplies, consumable/disposable items, parts, probes, printers, needles, accessories, and any other item required for the proper operation of the contractor s equipment and necessary for the generation of a patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI) (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors shall provide delivery, installation, and removal of equipment at no additional charge. If any new FDA approved tests become available during the contract the test shall be offered at contract pricing and in future should be added to the contract upon the yearly estimated number of tests provided to the contractor. This does not include those items approved for exclusion by the government such as printer paper, labels etc. This per patient reportable result contract price shall also encompass all costs associated with repeat and confirmatory testing required to produce a single patient reportable result. It will also include the material to perform as well as all other costs associated with quality control, calibration, validation (to include Installation Qualification, Operation Qualification, Performance Qualification, and Associated Quality Control, as well as correlation study testing that is prescribed by Clinical and Laboratory Standards Institute (CLSI), Joint Commission, and AABB. All necessary maintenance to keep the equipment in optimal operating condition (This element includes both preventive maintenance and emergency repairs and (d) training for Government personnel. Contractors are required to provide delivery, installation, and removal of equipment at no additional charge. Please be advised that this contract will be awarded firm-fixed price, open market. Terms and Conditions: Except for changes, or additions contained within this statement of work, the contractor shall provide all equipment and services in accordance with the terms, conditions, provisions, and schedule of the contractor s existing and future contract for performance of Blood Bank contract services for Richard L. Roudebush Veterans Affair Medical Center in Indiana. 1.1 PRICES AND TERMS: Richard L. Roudebush Veterans Affair Medical Center will provide an estimated volume by test as reflected in requirements table on page one. Pricing is based on the AVERAGE daily test volume per instrument/system. The Government estimates the volumes as listed in requirements table on page one, but does not guarantee volumes as listed; they are estimates ONLY. Control estimates should consider that repeat controls per day are run and extra supplies should be included accordingly. 1.2 Additional Fixed Cost Disclosure: All pieces of equipment required for system operation as requested, including, but not limited to: Instruments, equipment parts, service agreements, maintenance of all equipment, hardware and software including all installation costs, service, maintenance and future software upgrades Requirements: System Capabilities I: Offered models of clinical laboratory blood bank system shall produce accurate and reproducible assays on biological and other specimens by established in vitro diagnostic methods. Model(s) shall provide accurate test assay result for sample(s) up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls. Gel agglutination technology Equipment shall be new state-of-the-art equipment with most up to date technology available by vendor. Remanufactured and discontinued models will not be accepted. If the vendor has a newer model of a blood bank analyzer released for sale, post market research, the VA Blood Bank must be given the option to approve the newer model versus the model observed during market research. One (1) manual gel benchtop workstation as backup that is able to utilize the same reagents as the analyzer. The analyzer and manual gel system must parallel each other in order to allow for interchangeable reagent cells, quality control and consumables that are integrated to where the manual system can be used when the automated analyzer is nonoperational or during periods of maintenance or downtime. Walk away/automated transfusion service analyzer and corresponding automated and manual tube reagents and FDA regulated. Capability of interfaced with VistA, Blood Establishment Software (VBECS) and Cerner. The system shall be capable of producing accurate and reproducible assays on biological samples with FDA approved methods for in vitro diagnostic methods. Model shall provide accurate test assay results up to the manufacturer s defined maximum test per hour without excessive malfunctions, breakdowns, or service calls. turnaround time of 30 minutes regardless of whether the test mix is currently running at the full burdened level for Type and Screen testing. The fully automated analyzer must be able to analyze multiple specimens (including STATS) automatically, reduce technician error and standardized blood bank reporting. Allows multiple specimens, reagents, test cards, and controls to be loaded and scanned in one action. Preference of reports with patient Identifiable information - full name, social security number and specimen identification number. Customizable printouts if available. Replacement computers or printers shall be provided as needed, at no additional charge, for the duration of the contract. A sturdy, moveable cart will be provided for the analyzer. The awarded contractor shall provide all upgrades to the equipment hardware and operating system software, at no additional cost to the Government. These enhancements shall be delivered and installed at Richard L. Roudebush Veterans Affair Medical Center within 60 days of issuance to the commercial market. Contractor offered equipment shall perform satisfactorily at any laboratory temperature between 50 - 90 degrees Fahrenheit and relative humidity between 15 - 85 percent. Contractor offered blood bank systems shall conform to existing spaces at the Richard L. Roudebush Veterans Affair Medical Center. The vendor shall provide/install any routine and special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to: printer cartridges, consumable equipment parts, required replacement parts for maintenance or service, etc. Any items excluded by the vendor but required for operation of the system at any time, must be delineated in their technical proposal. The cost of any excluded items must be disclosed in the cost proposal. Sufficient safety features to avoid unnecessary exposure to biohazards and chemical materials. The exposure by the equipment must be minimal and require a minimum amount of handling. Able to perform quality control, interpret quality control and documented all lot numbers and expiration dates of the reagents on board. Reagent QC performance must meet vendor established average expected results, and if not, new lots will be supplied at no charge. Have minimal maintenance required with no need for the operator to clean the sample probe or camera lens. System Capabilities II: Contractor Blood Bank system (Automated and backup system) shall be capable of performing 100% of the tests listed for the following clinical Blood Bank assays. ABO/Rh forward and reverse Antibody Screen (3 cell screening panel required) Antibody Identification (minimum of 2 antibody panels) Antigen Testing patient and donor units (minimum of Rh and K) Donor ABO/Rh - forward typing AHG Crossmatching donor units with patient samples Immediate Spin Crossmatch - preferred DAT Poly, IgG, and Complement - Preferred Testing Instrumentation/Requirements: The testing instrumentation must be approved by the Food and Drug Administration (FDA) and be available on the contractor s contract at the time of proposal submission and shall have the following blood bank systems criteria: Provide broad test menu, with reliable methodologies Provide bar-code and/or manual operation mode for samples Provide bar-code and/or manual operation mode for reagents, and controls. Provide bi-directional or uni-directional interface for Data Innovations with VISTA, VBECS (VistA Blood Establishment Computer Software), and Cerner. Minimum host query All bar code readers must be capable of reading and decoding any label when manually applied to the specimen tube in accordance CLSI and NCCLS. Bar code reader must be able to read ISBT, Codabar, and Code 39 Accommodate user-defined tests Analyzer must be able display temperature records. Provide Quality Control material within the contract Customer changeable parts must be provided by vendor the length of the contract. Comprehensive Integrated onboard QC Program with includes the following options: QC files that can be edited or corrected for errors Have on-board quality control data storage and reporting capabilities Data Archive Ability to alert operator of QC failures Daily QC performance within 15 of less minutes if no incubation is required Provide assay procedures in CLSI format on CD or online. Provide a printed and/or digital Operators Manual Current, clear, concise and easily attainable package insert without deviation from the CLSI documents. Package inserts reflect regulatory recommendations for processing and testing practices of specimens The analyzer and manual gel system must parallel each other to allow for interchangeable reagent cells, quality control and consumables that are integrated to where the manual system can be used when the automated analyzer is nonoperational or during periods of maintenance or downtime. Provide/sequester sufficient volume of controls, reagents, and consumables to run controls a minimum of 1 time a day and patient testing 24/7. Primary tube and cup/tube sampling No cardboard dust Level detect for adequate sample volume Ease of interface and patient loading when the Interface is down Ability to easily run patients when the host computer system is down and easily retransmit results when the host computer system is back online. Visually and/or audible warning user when testing has stopped, never started as expected, or other analyzer/testing problems causing a delay in patient/donor testing. Provide the ability to re-transmit test results to the host computer Multiple drawers for continual access and true walk away capability. Multiple independent centrifuges and incubators Provide on board reagent inventory Analyzer shall have transparent casing with a clear view of the internal system for visual inspections without disrupting the instrument. The system camera shall inspect the gel cards for integrity and gel level prior to use for test reliability. Consumables must have a minimum of 3 month outdate when received at using facility. The system shall have random access, batch processing, continuous sample loading, and STAT capabilities without delay in workflow or analyses already in progress. The user shall have access at any time for loading cards, and reagents in addition to samples. No waiting for the system to finish a task so user can access. Use of donor segments for confirmation and crossmatching without the need of spinning for packing red cells. Must have ability to detect clots in patient samples and donor segments. Minimal Maintenance time : Daily preferred to not exceed 15 minutes Weekly preferred to not exceed 30 minutes Monthly preferred to not exceed 1.5 hour Shall have ability for operator to replace the sample probe and a system that will automatically home itself with no additional manual alignment or recalibration (dilutions) required. User Manual available electronically for easy access. Analyzer shall have a design where unused wells in the gel card are not pierced and system will automatically use the partial card wells without user intervention. Partially used cards are good until the expiration of the gel card on the analyzer. No wastage of cards. The QC material included in the contract shall provide quality control testing for the following tests: ABO/Rh Antibody Screen Antibody Identification Antigen Testing patient and donor units Donor ABO/Rh DAT as applicable Must be able to use plasma (CPD, CPDA-1, Na Citrate, K2 EDTA) and serum for testing. Traceability of patient results, traceability of testing process and traceability of reagent lot numbers. Traceability of result transmission. Traceability of result modification. Able to perform testing with same sensitivity and specificity using automated and manual back up method. Software for operation of the system must be user friendly, with touchscreen or point and click icons for easy operations (desirable). Windows must be compliant with a minimum of Windows 11 Override or halt in testing if expired reagents/supplies are placed on analyzer. Flexible and scalable to automation (provide list of third-party vendors it connects to) Must be compatible with Data Innovations The analyzer shall have audible/visual alarm/alerts when reagents are low/needs replenished Audible/visual alerts when Quality Control is due or fails Audible/visual alerts when Maintenance is due or past due Audible/visual alert for missing reagents to perform test Control and Reagent Volume Detection Include test volume amounts and remaining volumes of reagents. Require minimal clearance from to wall to front of analyzer/movable table (i.e. no more than 12 from wall) due to spatial constraints according to Install Qualifications for analyzer. Ability to add test from Middleware if applicable Easily accommodate/prioritize STAT tests during routine/batch testing without interruption with no longer than a 30 minute TAT. Manual Backup System One manual gel benchtop workstations that utilize the same reagents at the analyzer. Able to load multiple reaction media at one time and have on board reagent stability with the ability to leave reagents on the instrument for multiple days. Ability to analyze small volume samples Simple (minimal time) maintenance procedures Provide UPS Adequate uninterruptible power system (UPS) to support each system in the event of a power surge or power failure. UPS must be enough to allow the operator to complete testing and perform a controlled shutdown if necessary. UPS will be maintained by the contractor to include battery replacement and replacement units in the event of a failure of the UPS unit itself for the duration of the contract. Provide long shelf life for reagents, card, and controls, provide chart of shelf life of each reagent, control, cards, etc. as applicable. Provide long on-board stability for both reagents and controls Ability to sequester reagent and control lots for the life of the lot Provide what HIL detection is available, if applicable per methodology. Must have ability to detect clots in patient samples and donor segments. Sufficient safety features to avoid unnecessary exposure to biohazardous and chemical materials. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling. Able to perform quality control, interpret quality control and document all lot numbers and expiration dates of the reagents on board. Shall have ability for operator to replace the sample probe and a system that will automatically home itself with no additional manual alignment or recalibration (dilutions) required. Analyzer must save reactions or photographic evidence of reaction for up to 72 hours for review by supervisor when test is run during off hours. Analyzer must have intuitive user interface-touchscreen monitor with color imaging. Cellular reagents must have a minimum of 4 week outdate when received at using facility. Prices and Terms for Cost-per Test (CPT): Offerors shall provide pricing and quantities according to the listed requirements on page one (1) table. The contract for the analyzer and 1 manual gel workstation in accordance with the contract pricing that can be performed on the quoted equipment (analyzer and 1 manual tabletop gel workstation. The contract shall include all costs for Equipment use All consumables, reagents, standards, controls, and supplies All necessary maintenance to keep the equipment in manufacturers operating conditions, both preventative maintenance and emergency repairs. Service contract included. Training for key operating personnel in Richard L. Roudebush Veterans Affair Medical Center. Offerors shall provide in the contract the pricing for tests identified in the site-specific requirements. That pricing shall contain sufficient information to allow Richard L. Roudebush Veterans Affair Medical Center the ability to calculate the actual number of tests performed per kit, including controls, calibrations, CAP surveys, patient test, etc. Annual test volumes provided with this contract are based upon prior history and re not a guaranteed minimum. New tests will be added as requested to the menu with all the reagents for test validation supplied at no additional cost. If at any time during the contract period, tests are not available on this list, the vendor shall reimburse RLR VAMC any additional costs associated with procurement of another source of test performance. This information shall include, at a minimum, the expected out-dating and open vial stability of the kits and controls, etc. The CPRR pricing for the kits shall include. Equipment use. All consumables, reagents, standards, controls, and supplies. All necessary maintenance to keep the equipment in manufacturers operating conditions, both preventative maintenance and emergency repairs. Service contract. On occasion, some site requirements may exceed the Offeror s supply/reagents estimate and necessitate an additional purchase of reagents and/or supplies. Offerors shall provide a price list of all supplies, reagents or other materials required to perform testing for this possibility. Inventory Control Reagents, Supplies and Disposables: The contractor shall maintain on Government provided space a continuously stocked inventory of reagents, calibrators, standards, controls, supplies, required consumable supplies including all routinely replaced parts, disposables and any other material required to properly perform tests or perform maintenance or scheduled cleaning activities on the offered equipment. These items shall be of the highest quality ensuring sensitivity, specificity and tested to assure precision and accuracy. The quality of the products shall be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP), AABB, FDA, and The Joint Commission. Contractor shall provide the list of consumables not covered in the contract but required for successful reportable results. In the event that the supplies are found to be defective and unsuitable for use with the contractor s equipment or the contractor has failed to comply with the requirements herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order, if verbal order is received by 1pm EST time, for priority delivery from the government activity. This shall be done at no cost to the government, in sufficient quantity as required to allow operation of the contractor s equipment for one month (under normal government test load volume). The vendor shall reimburse the RLR VAMC for any costs/supplies related to tests performed by another vendor or sent to a referral laboratory when reagents were not available due to product issues or instrumentation failure. The Contractor is required to provide a continuously and timely stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. Special Handling for Emergency Orders of Supplies: If additional requests for emergency supply deliver are required by the government, the contractor shall honor them until the arrival at the government site of the monthly standing order or routine supply delivery. In the event that the consumables are found to be defective and unsuitable for use with the contractor s equipment, or the contractor has failed to comply with the requirement for routing supply delivery or inventory management, the contractor is required to deliver the consumable supplies within 24 hours of receipt of a verbal order for priority delivery from the government activity. If either circumstance has occurred, the contractor shall deliver to the government site, in the most expeditious manner possible, without additional cost to the government, the necessary consumables in sufficient quantity as required to allow operation of the contractor s equipment for one week (under normal government test load volume). Minimal reagent preparation time/steps prior to use. Validation/Install/Method Performance/Comparison: Start-Up Reagents - The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories, and any other item included on the list of supplies defined in the contract and required to establish instruments for operation for performance of acceptance testing. This applies to all equipment as well as additional or replacement equipment placed under the terms and conditions of this SOW. The Contractor shall perform, to the satisfaction of the Government, all validation studies including: precision, method comparison with current testing methods, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity (where applicable). All materials and reagents needed for such studies are at no cost to the government. The contractor shall provide 100% assistance upon install and validation via a vendor service trained representative. Equipment Installation/Validation Qualification: Confirms satisfactory installation has been performed and checklist completed and signed by vendor if completed by vendor. Confirms Installation is has been performed and signed/approved by vendor. Installation shall include at a minimum, uncrating and/or unpacking of all equipment, hardware set-up and hook-up of system, and documentation that the analyzer is functioning within the correct specifications. The vendor shall assist 100% in the performance of method validation during the initial setup of analyzer. Operation Qualification: Confirms acceptable results Comparison with current method in use Same ABO/Rh in both methods Comparable Antibody detection results Consistent Performance Test cases by Vendor Include but not limited Type and Screen, DAT, Antibody Identification, Donor/patient antigen testing, Donor/patient crossmatch, etc. Include Validation kits in contract. Based on Standard Operation Procedures Performance Qualification: Function checks of start-up and shut down Maintenance Archiving Alarms and Alerts System Liquid and Volume detection Waste Determination from Vendor for Safety to approve of waste disposal Verify Barcode of handheld and analyzer Correct Reagent card read by analyzer/alarm is not correct card Quality Control: Ensure Quality Control Pass/Fail Past due alert (Dead stop or comment that QC had not been completed) Correlations for each analyte: A minimum of 20 samples, spanning the reportable range, shall be run by the present and proposed method. The results should provide applicable statistical data to support acceptance of the new method. Define criteria of grade of reaction results from tube to automation. Correlation of ABO/Rh from tube to automation True positives and False positives in antibody screens and True negative and False negatives. Antibody identification from tube to automation Precision, method comparison with current method to analyzer, calibration verification, and determination of sensitivity and specificity at no cost to the Government. The precision study shall include at a minimum, within run precision study of 10 positive and 10 negative controls on a day-to-day precision study of positive and negative controls. Sensitivity Studies Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rates and false negative rates are applied. Specificity Studies A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances. Carryover Studies Successful carryover study data shall be provided by the contractor. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The Contractor shall perform statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format. The contractor shall include reagents, calibrators, standards, controls, supplies, disposables and any other material required to properly perform the tests. Maintenance and Repairs: Preventive maintenance, emergency repair, maintenance credit for equipment malfunction, and replacement laboratory equipment shall be performed and provided in accordance with the terms, conditions, and provisions of contractor's existing in contract for performance of contract services. Define the actual hands-on maintenance time required for daily, weekly, monthly, quarterly, yearly, and as needed maintenance. Contractor is to include the analyzer time required to perform each maintenance task and list which tasks are user level and which tasks are service level. Should the repair record of any piece of laboratory equipment reflect a downtime of 5% or greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government at the using facility to replace the initial laboratory equipment with new equipment. The responsibility for maintaining the equipment furnished in operating condition in accordance with manufacturer s instructions, shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 95% in each month of the term of the agreement. A technical assistance center shall be available by telephone 24 hours per day, 7 days a per week, with a maximum call back response within 1 hour. Equipment repair service shall be provided 24 hours per day, 7 days per week including Federal holidays. Equipment repair response call back time shall be no more than 1 hour Preferred Service Engineers available in Indiana or in surrounding states - Ohio, IL, and TN and available in 2-3 hours. Contractor shall provide documentation of maintenance repairs, upgrades, quality control post repair, and reports defining operational status of analyzer prior to use. Preventative maintenance will be performed as frequently as published in manufacturer s operator s manual and within 2 weeks of the scheduled due date. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following: Date and time notified Date and time of arrival Serial number, type and model number of equipment. Time spent for repair. Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. Each notification for an emergency repair service call shall be treated as a separate and new service call. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the 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. This requirement only applies to system upgrades that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the contract; however, it does refer to significant changes in the hardware operational capability. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the contract, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc. Interface Requirements: The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system for the primary and backup system. The Contractor shall provide any and all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied for the primary and backup system. The contractor is responsible for everything leading up to the connection including any incremental fee required to add additional equipment (e.g. licensed, ports/cards, cables, software, etc.) to the universal interfacing system. If there is not a universal interface and one is needed to optimally interface the instrument, then the contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with the VA computerized hospital information system. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system. Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software. Characterization of Waste: The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 Protection of the Environment Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), and the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to decide if the waste is a hazardous waste or otherwise regulated. The determination and description shall address the following: Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24) Waste ignitability (Reference 40 CFR §261.21) Waste corrosivity (Reference 40 CFR §261.22) Waste reactivity (Reference 40 CFR §261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33) Solid Waste (Reference 40 CFR §261.2) Exclusions (Reference 40 CFR §261.4) The Contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the Contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices. Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosal and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with Contractor response: Barium (Total) Cadmium (Total) Chromium (Total) Copper (Total) Cyanide (Total) Lead (Total) Mercury (Total) Nickel (Total) Silver (Total) Zinc (Total) Arsenic (Total) Selenium (Total) Tin (Total) pH Flash point (to higher than 200oF) BOD; biochemical oxygen demand The documentation the Contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether the waste from each device can legally be disposed of via the sewerage system. Training: Contractor shall provide training in accordance with the terms, conditions, and provisions of contractor's existing contract for performance of services. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility s services and minimally equivalent to the terms and conditions for training. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for 2 (two) operators per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant. Contractor shall provide supplemental operating training to the Government personnel, without additional charge to the Government upon installation of any upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished under this solicitation. Additional continual education training is offered to facilities via webinars, etc. TRANSITION/DELIVERY/IMPLEMENTATION: The implementation of the services/requirements described in this solicitation shall be completed no later than 180 calendar days after the award of the contract. This timeframe is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated time frame. Contractor shall not be penalized for implementation timeliness that extend beyond the 180-calendar day timeframe if the extension is through no fault of the contractor. Contractor must include a contingency plan to address the need to exceed the 180-calendar day phase-in-period. The implementation plan will be submitted with the contractor s technical proposal for this agreement. Upon award of a contract, the transition period Contractor shall have all blood bank equipment and peripherals installed and operational at the facilities shall be from date of award through 180 calendar days. During this same period all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor s submitted transition plan shall not exceed 180 calendar days for the transition of all services including installation and training of all services, training of personnel, transition of all testing materials, reagents and supplies, etc. and performance of all correlations and validations. Failure of the contractor to confirm to the transition period shall be considered as sufficient cause to terminate the contract for cause under the Termination for Cause clause. Contractor acknowledges the fact that upon termination of the contract by any means that any components of the system which contain any type of demographics, or personal identifying information (e.g. hard drives or other storage devices) will be removed and destroyed, by the VA prior to removal from VA premises. At the end of the 180 calendar days from award of the contract, the awarded contractor shall have full and sole responsibility for services under the awarded contract. Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the contract is accepted by the Government. This also includes replacement, substitute equipment and equipment that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor s technical specification. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled Termination for cause. (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.) (End of SOW) The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. Offerors must comply with all instructions contained in provision 52.212-1, Instructions to Offerors-Commercial, applies to this acquisition. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Products and Commercial Services (SEPT 2023) FAR 52.212-2, Evaluation Commercial Products and Commercial Services (NOV 2021) FAR 52.212-3, Offerors Representations and Certifications Commercial Products and Commercial Services (MAY 2024) Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Products and Commercial Services. If paragraph (j) of the provision is applicable, a written submission is required. FAR 52.204-7, System for Award Management (NOV 2024) FAR 52.204-16, Commercial and Government Entity Code Reporting (AUG 2020) FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Service or Equipment (NOV 2021) FAR 52.204-29, Federal Acquisition Supply Chain Security Act Orders Representation and Disclosures (DEC 2023) FAR 52.225-2, Buy American Certificate (OCT 2022) FAR 52.252-1, Solicitation Provisions Incorporated by Reference (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://www.acquisition.gov/far/index.html (FAR) and http://www.va.gov/oal/library/vaar/index.asp (VAAR) VAAR 852.252-70, Solicitation Provisions or Clauses Incorporated by Reference (JAN 2008) VAAR 852.273-70, Late Offers (NOV 2021) (End of Addendum to FAR 52.212-1) The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Products and Commercial Services (NOV 2023) FAR 52.204-13, System for Award Management Maintenance (OCT 2018) FAR 52.204-18, Commercial and Government Entity Code Maintenance (AUG 2020) FAR 52.225-1, Buy American Supplies (OCT 2022) VAAR 852.203-70, Commercial Advertising (MAY 2018) VAAR 852.208-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors Orders or PBAs (NOV 2022) VAAR 852.208-71, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factor Commitments Orders and BPAs (NOV 2022) VAAR 852.211-70, Equipment Operation and Maintenance Manuals (NOV 2018) VAAR 852.211-72, Technical Industry Standards (NOV 2018) VAAR 852.212-71, Grey Market and Counterfeit Items (Feb 2023) VAAR 852.215-70 Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors (OCT 2019) VAAR 852.219-70 VA Small Business Subcontracting Plan Minimum Requirements (NOV 2022) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products and Commercial Services (JAN 2025). The following clauses also pertain to 52.212-5 for this solicitation. 52.204 10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109 282) (31 U.S.C. 6101 note) 52.204 27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L. 117 328) 52.204 30, Federal Acquisition Supply Chain Security Act Orders Prohibition. (DEC 2023) (Pub. L. 115 390, title II) 52.209 6, Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded. (JAN 2025) (31 U.S.C. 6101 note) (16) 52.219 4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a) 52.219-28, Postaward Small Business Program Rerepresentation (JAN 2025) (15 U.S.C. 632(a)(2)) 52.222 19, Child Labor Cooperation with Authorities and Remedies (JAN 2025) (E.O. 13126) 52.222 36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627) 52.223-23, Sustainable Products and Services (MAY 2024) (DEVIATION FEB 2025) (7 U.S.C. 8102, 42 U.S.C. 6962, 42 U.S.C. 8259b, and 42 U.S.C. 7671I) Alternate II (JAN 2025) of 52.225-3 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury) 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (MAY 2024) (E.O. 13513) 52.232-33, Payment by Electronic Funds Transfer System for Award Management (OCT 2018) (31 U.S.C. 3332) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332) 52.240 1, Prohibition on Unmanned Aircraft Systems Manufactured or Assembled by American Security Drone Act Covered Foreign Entities (NOV 2024) (Sections 1821 1826, Pub. L. 118 31, 41 U.S.C. 3901 note prec.) Award Basis Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most advantageous/favorable to the Government. Responses should contain your best terms and conditions. The following are the decision factors: Price, sufficient documentation to evaluate the functional and technical specifications compared to Statement of Work, Buy American Act Certificate, copy of OEM s Authorized Distributor letter (if applicable), and estimated schedule for delivery. Warranty/Extended Warrant details and Delivery/Installation Schedule. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoters shall list exception(s) and rationale for the exception(s), if any. Submission of your response shall be received via email not later than 4:00PM EST on Wednesday, November 12, 2025, to [email protected]. No submission received after the above-mentioned date and time will be accepted. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below by 12:00PM EST on Friday, November 7, 2025. Responses will be posted by 3:00PM EST on Monday, November 10, 2025. No telephone calls will be accepted. Point of Contact Lonnelle Jones, Email: [email protected]