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Responses must be received no later than Friday, November 28, 2025, at 10:00AM EST. THIS SOURCES SOUGHT NOTICE IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOL... Responses must be received no later than Friday, November 28, 2025, at 10:00AM EST. THIS SOURCES SOUGHT NOTICE IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS SOURCES SOUGHT NOTICE IN ACCORDANCE WITH (IAW) FAR 15.201(e). DISCLAIMER: This Sources Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Sources Sought Notice that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Sources Sought Notice. SOURCES SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is a sources sought notice only. The purpose of this sources sought notice is to gain knowledge of potential qualified sources and their size classification relative to NAICS 334516. Responses to this sources sought notice will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought notice, a solicitation announcement may be published. Responses to this sources sought notice are not considered adequate responses for a solicitation announcement. The Department of Veterans Affairs (VA), VISN 5 Network Contracting Office, is seeking sources that can provide Hematology for the Washington DC VA Medical Center. ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 1.00 YR __________________ __________________ Procurement of a base plus four option year renewals for hematology testing on a cost per test basis. The Contractor shall provide to the laboratory full instrumentation, installation, correlation studies, reagents, maintenance and preventive services and a quality control program to provide routine and stat Hematology assays. GRAND TOTAL __________________ DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK SCOPE OF PROCUREMENT: The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). Equipment must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory. If Contractor offers a family of analyzers, the Washington, DC VAMC technical evaluation panel will determine if instrumentation proposed meets needs of using facility. Equipment must meet the test volume and turnaround time requirements of the facility. STATs are typically 60 minutes from receipt in lab to verification in lab computer. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables, and any other materials required to properly perform and report tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Sigma performance may be included to support test quality. Expiration date must be clearly marked on reagent, standards, and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award. The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America in the proposal. Special handling for emergency orders of supplies: 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 for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. 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). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery. DEFINITIONS: Cost per Patient Reportable Result (CPRR)- as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (1) installation of new equipment and 5-year equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, printer paper, printer toner cartridges, printer imaging units, printer maintenance kits, parts, 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. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single 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. Parameter definitions- CBC- Complete Blood Count WBC- White Blood Cell Count Diff- Automated Differential RBC- Red Blood Cell Count MCH- Mean Corpuscular Hemoglobin MCV- Mean Corpuscular Volume MCHC-Mean Corpuscular Hemoglobin Concentration RDW- Red Cell Distribution Width MPV-Mean Platelet Volume MDW-Monocyte Distribution Width Complete Blood Count (CBC) and White Blood Cell (WBC) Automated Differential (DIFF) and Reticulocyte- CBC with five-part WBC Diff shall include the following parameters at a minimum: hemoglobin, hematocrit, WBC, RBC, platelet, MCH, MCV, MCHC, RDW, MPV, and MDW (for select patient population). Five-part WBC Diff shall include at a minimum: % neutrophils, % lymphocytes, % monocytes, % eosinophils, and % basophils. CBC with three-part WBC Diff shall include the following parameters at a minimum: hemoglobin, hematocrit, WBC, RBC, platelet, MCH, MCV, MCHC. Three-part WBC Diff shall include at a minimum: % granulocytes, % lymphocytes, and % monocytes. Accepts body fluid samples for analysis, body fluid analysis with diff preferred. Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule. TEST MENU: Refer to Attachment A for desired test menu and estimated annual volumes. GENERAL REQUIREMENTS: Primary analyzer(s) Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer shall be equivalent to a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment. (Applies only if selected) Back-up Analyzer; equipment required in support of operations for the VA laboratories in the event the primary analyzer(s) becomes non-operational/non-functional. This category of equipment shall only be operated during periods of time when the primary instrumentation is not available for use. As such, the requirements for consumable supplies, i.e., reagents, quality control material, calibrators, etc., shall be minimal and corollary to the successful operation of the primary instrumentation. Specific tests that require back-up performance are listed in Attachment A. Operational Features- The instrumentation offered shall have the following: The capability of performing analysis on 100% of the tests listed in Attachment A. Sufficient capacity and throughput to meet the volume/ service demands as defined in Attachment A. Safety features to avoid unnecessary exposure to biohazardous and chemical material. 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. Contractor must provide a mechanism and documentation for the Clinical Laboratory to meet local discharge requirements (i.e., mercury and formaldehyde SDS sheets must be provided in advance for review). A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system. The accuracy of the barcode reading must have less than a 1% failure rate. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Equipment must accept, at a minimum, BCBC characters in specimen identifier that is alphanumeric. Ability to prioritize STAT testing without compromising existing programmed testing. Menu flexibility to accommodate batch testing. Minimal daily, monthly, and periodic maintenance. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. On board reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least three (3) months for reagents when available. No requirements for sample pre-treatment. Capability to detect out of range quality control and flag patient results if the quality control is out of range. Ability to accept various types of sample containers. Must have accurate metering capability for monitoring reagent usage or accept DVAMC s monthly LMIP statistics generated from VistA computer system. Technical Features- The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following: On-board QC data management system with a minimum storage capacity of three QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data. Ability to monitor instrument performance, preferably using a secure, direct data connection to a technical support center so instrument performance can be managed in real time. On board reagent inventory system. Ability to calibrate in all sample modes. Minimal carryover, no carryover preferred. Minimal reagent preparation, preferably no reconstitution required. Acceptability of various sample containers. Ability to change reagents while instrument is in operation. Onboard calibration and lot (calibrator and reagent) tracking. Long calibration stability. Minimal specimen volume. Adequacy of sample detection. Equipment performance evaluations will be based on at least the following: 2.4.4.13.1 Quality and accuracy of testing, 2.4.4.13.2 Amount of downtime of each analyzer, 2.4.4.13.3 Competence of service personnel, and 2.4.4.13.4 Number of times the service engineer must return to fix the same instrument issue. Other performance categories can be added or removed as needed. Hardware Features- The instrumentation shall have the following: A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. All construction or alteration of the current space is the responsibility of the Contractor in conjunction with local Facilities Management Services. An on-board monitor/screen that is easily readable. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient s name and accession or unique identifier number (UID). An uninterruptible power supply with line conditioner for each instrument provided. Service and replacement of the unit shall be the responsibility of the Contractor. An auto sampling system that includes cap piercing closed tube aspiration, auto-loader, and auto-mixing. Primary tube sampling. Clot detection. Manual sampling mode that reads barcode label; ideally both closed and open manual sampling modes is desirable. Modem to technical support to monitor instrument/QC performance. Specific Equipment Requirements A quality control user group comparison program. The following are specifications for the automation system: Provision of a data manager, Single inlet and single outlet, Automated repeat and/or reflex testing based on established rules developed by the Laboratory, Ability to auto-verify results, Specimen archival through mapping of specimens to racks; for easy retrieval once moved off-line. For those sites requiring back up analyzers, it would be desirable for the backup analyzer to be a mirror image or have the same reagent requirement as the primary analyzer. Method Performance/Validation Requirements Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations. Correlation studies for each analyte: A minimum of 30 samples spanning the reportable range, shall be run by the present and the proposed method. In systems where multiple sampling modes exist, mode to mode correlation studies must also be performed. Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, ROC analysis, and meet current standards defined by CLSI. Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method. A minimum 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire range shall be performed as a minimum. Precision study using normal and abnormal control material. This shall consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal controls and abnormal controls for 10 days (may be run twice a day) for a total of 20 values per level of control. Sensitivity. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate, and false negative rate 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 studies shall be completed by the contractor on all analyzers during installation. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge. Reference Range- A reference range must be determined for each test following CLSI/regulatory guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each analyte. One of the following protocols shall be used: A verification of the manufacturer s suggested reference range may be performed if the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 50 reference individuals shall be used to verify the manufacturer s range. Any apparent outliers should be discarded, and new specimens obtained to provide a statistically valid verification. If the suggested manufacturer s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method. If a laboratory is currently using the proposed instrument/reagent system, the in-use reference range can be transferred to the new system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed. Reports-The Contractor shall provide to the Contracting Officer a copy of a quarterly report of sales within 30 calendar days after the close of each quarter s business. Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of the facility, reporting the savings realized and shall be shared with personnel associated with acquiring the products, and respective laboratory personnel. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge (per FSS awarded contract) shall not be accepted. There will be no additional charges for any reports required by the task order. 2.4.9.1 All reports shall be submitted in accordance with the following schedule: Time Period Date Report Due January- March April 20th April- June July 20th July- September October 20th October- December January 20th The contractor shall provide a list of customers and using locations within a reasonable distance from the Washington, DC VAMC for potential site visits. Customer references should include those that are using the instrument models that are proposed for the Washington, DC VAMC. 2.4.9.2 Ordering/Billing: Orders will be placed by Washington, DC VAMC via I.M.P.A.C. purchase card or purchase order via telephone, mail, fax, or online. Billing will be monthly in arrears for the level of tests by the facility. Monthly payments include equipment, service, and reagents necessary to perform tests provided to the contractor. Deliveries will be F.O.B. destination. Support Features- Commercial marketing. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, current production shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, linearity kits, consumable/disposable items, parts, accessories, and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all the statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format. Training. 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 defined in the Contractor s Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Reportable-Test Clinical Laboratory Analyzers contract. 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 one operator 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. The Contractor shall provide all necessary procedures manuals, troubleshooting manuals, operator manuals (also available on computer disc format). Procedures should be in Clinical and Laboratory Standards Institute (CLSI) format. The Contractor shall assist with the transcribing of the generic procedure manual template into local format. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g., water system, offered according to the following terms: Service Requirements A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 30 minutes. Equipment repair service shall be provided 7 day/ 8 hour, 0800 1600, on-site service as needed. All arrangements shall be coordinated between the Contractor and VA laboratory personnel. In the event both the Primary and Back-up analyzers are down, Equipment repair service shall provide 7 day/24-hour on-site service. Equipment repair response time at the site shall be no more than 2 hours for service personnel. Preventative maintenance will be performed as frequently as published in manufacturer s operator s manual and within 2 weeks of the scheduled due date. Scheduled maintenance times should be flexible to minimize interruptions during peak workload times. 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, and 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. Assist the user in setting up and maintaining/troubleshooting user-defined assays. If the equipment provided by the contractor is requiring repair and is down more than 24 hours and/or no functional back-up analyzer is provided, the Contractor is to bear the cost of testing at an alternative location until the equipment is returned to a fully functional level. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software 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 agreement; 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 agreement, as indicated, 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 sold or provided with the model of equipment proposed, e.g., starter kits, tables/stands, etc. The Contractor will notify, within 24 hours of any recalled reagents or equipment components. This must be accomplished by telephone, email, and/or certified mail. The contractor will provide sufficient replacement items to resolve the problem so no break in service is realized. In the case of a company merger and/or acquisition, the contractor will immediately notify the Contracting Officer for this agreement and provide a contingency plan of services to assure that no break in services is realized by the facility. The Contractor shall provide a directory with the names and telephone numbers of all contact persons to be used by the facility to inquire about billing issues, reagent shipments, service concerns, etc. The contractor is encouraged to quote a spectrum of value-added incentives. Such incentives may include customer and professional service programs (i.e., PACE approved continuing education programs for clinical laboratory staff) and new innovations to assist the VA facility with the usage of the contractor s products/services in the most efficient manner. 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 (see Attachment A). 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. If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g., licenses, ports/cards, cables, software, etc.) to the universal interfacing system. If a site does not have 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 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 and/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), 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 determine 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 re...