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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 1... 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 ea...