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This Sources Sought Notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Gover... This Sources Sought Notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Government to acquire any products or services. Your response to this Sources Sought Notice will be treated as information only. No entitlement to payment of direct or indirect costs or charges by the Government will arise because of contractor submission of responses to this announcement or the Government use of such information. This request does not constitute a solicitation for proposals or the authority to enter negotiations to award a contract. No funds have been authorized, appropriated, or received for this effort. The information provided may be used by the Department of Veterans Affairs in developing its acquisition approach, statement of work/statement of objectives and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained in their response. The Government does not intend to award a contract based on this Sources Sought Notice or to otherwise pay for the information submitted in response to this Sources Sought Notice. The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the services described below. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) Company Name (b) Address (c) Point of Contact (d) Phone, Fax, and Email (e) UEI number (f) Cage Code (g) Tax ID Number (h) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? (i) Is your company considered small under the NAICS code identified under this SSN/RFI? (j) Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? (k) If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). (l) If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (m) If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to subcontracted work. (n) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract? If so, please provide the contract number. (o) If you are an FSS GSA/NAC or NASA SEWP contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? (p) Please provide general pricing of your products/solution for market research purposes (q) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract? If so, please provide the contract number. (r) Please provide general pricing of your products/solution for market research purposes (s) Must provide a capability statement that clearly addresses the organizations qualifications and ability to perform as a contractor for the work described below. Requirement: The VA Heartland Network 15 Contracting Office located at 3450 South 4th Street, Leavenworth, KS, 66048-5055 is seeking a potential qualified contractor to provide a BPA agreement for Point of Care testing reagents and analyzer service. Vendor will also supply a Cost Per Test (CPT) for reagent, service and data manager support for existing analyzers in select VISN 15 Laboratory Sites. Please see the Statement of Work for more specifics, including brand name and details. The North American Industry Classification System Code (NAICS Code) is 325413 (In Vitro Diagnostic Substance Manufacturing), size standard 1,250. Based on this information, please indicate whether your company would be a Large or Small Business and have a socio-economic designation as a Small Business, VOSB or SDVOSB. Important Information: The Government is not obligated to, nor will it pay for or reimburse any costs associated with responding to this source sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to an acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Currently a total set-aside for Service-Disabled Veteran Owned Small Business firms is anticipated based on the Veterans Administration requirement with Public Law 109-461, Section 8127 Veterans Benefit Act. However, if response by Service-Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open may be used. Responses to this notice shall be submitted via email to Lisa A Buchanan at lisa.buchanan1@va.gov. Telephone responses will not be accepted. Responses must be received no later than Friday, September 12, 2025, at 3:00PM CST. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this sources sought. Responses to this sources sought notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation. DESCRIPTION/SPECIFICATIONS/STATEMENT OF REQUIREMENTS SCOPE OF PROCUREMENT: It is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 15) to establish an agreement for Point of Care testing. The BPA shall be under open market Cost Per Reportable (CPRR). The Government will award an agreement for Point of Care testing reagents and analyzer service. Vendor will also supply a Cost Per Test (CPT) price for reagent, service and data manager support for existing analyzers in select VISN 15 Laboratory Sites. The contractor agrees to the following terms of the BPA exclusively with the VISN facilities listed by Attachment A herein and awarded in the final BPA. However, as requirements change, facilities within VISN 15 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional reagents may be added to the BPA as new technology becomes available on the market. VISN 15 will provide an estimated volume by reagent as reflected in Attachment A for each individual medical center and outpatient clinic laboratory. The Government estimates the volumes per facility as listed in Attachment A but does not guarantee volumes as listed; they are estimates ONLY. This will be a single vendor award with five ordering periods. VISN 15 intends to establish the BPA starting on 12/01/2025, with contract completion 11/30/2030. This agreement shall not exceed five years from the date of award. This BPA shall be reviewed annually. The participating facilities may order products via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions. The delivery terms for all items ordered under the BPA will be FOB Destination. The contractor will make shipping arrangements and prepay all shipping and handling costs. Contractor will promptly replace all Products lost or damaged in shipment. Contractor will be responsible for all disputes with the shipper and all insurance claims related to the shipment. GENERAL REQUIREMENTS 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 the capability to perform testing as described below and 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 shall be acquired for each of the clinical laboratories located at the VISN facilities listed in Attachment A. The Contractor is required to provide a continuously 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. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. The 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. Estimated volumes of testing can be found in Attachment A. 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) 5 year equipment use; (2) all reagents, standards, quality controls, supplies, consumable/disposable items, 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. The per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required to produce 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. Cost per Test (CPT)- 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 each test that can be performed on its equipment. The per test price shall include costs covering (1) 5 year equipment use; (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor s equipment and necessary for the generation and reporting of a test result; (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 are required to provide delivery, installation and removal of equipment at no additional charge. 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. MOU - The VA utilizes a Memorandum of Understanding (MOU) to document the terms and conditions for sharing data and information resources in a secure manner. The following supporting information within the MOU will define the purpose of the interconnection, identify relative authorities, specify the responsibilities of both organizations, and define the terms of the agreement. Additionally, the MOU provides details pertaining to apportionment of cost and timeline for terminating or reauthorizing the interconnection. ISA -Technical details on how the interconnection is established or maintained are included within the Interconnection Security Agreement (ISA). A system interconnection is a direct connection between two or more information technology (IT) systems for the purpose of sharing data and other information resources. The VA uses the ISA to formally document the reasons, methodology, and approvals for interconnecting IT systems; to identify the basic components of an interconnection; to identify methods and levels of interconnectivity; and to discuss potential security risks associated with the interconnections. Parameter definitions- (Name Brand or Equivalent references used) Each participating location will have varied assay requirements. Refer to Attachment A for desired test menu and estimated annual volumes specific to each location. The equipment offered must, at minimum, be able to report the following measured assays. ACT Activated Clotting Time (Kaolin) hs-Tnl Creatinine EGFR (Calculated using CKD-EPI Creatinine Equation 2021) CG8+ Sodium Potassium Ionized Calcium Glucose Hematocrit Hemoglobin (Calculated) pH pCO2 pO2 TCO2 (Calculated) HCO3 (Calculated) Base Excess (Calculated) sO2 (Calculated) CHEM 8+ Sodium Potassium Chloride TCO2 (Total Carbon Dioxide) Anion Gap (Calculated) Ionized Calcium Glucose BUN Creatinine Hematocrit Hemoglobin (calculated Troponin I D-Dimer G3+ pH PCO2 (Carbon Dioxide, Partial Pressure) PO2 (Oxygen, Partial Pressure) TCO2 (Total Carbon Dioxide) BE(b) (Base Excess of Blood) SO2 (Oxygen Saturation) Ionized Calcium Sodium Potassium GENERAL REQUIREMENTS: Primary Analyzer(s): Base equipment offered shall fully support the scope of operations. Depending upon the technical functionality and the capabilities of the individual manufacturer s instrumentation, two mirror-image analyzers to act equally as primary analyzers are required to meet the productivity specifications defined herein. Capability of performing 100% of the tests defined by each location in attachment A on one analyzer Contractor should provide CPT pricing for sites with existing equipment. CPT pricing will include reagents, service and maintenance of analyzers and data manager systems. CPRR pricing will be provided if the solution presented does not allow for use of existing equipment. CPRR will include all components (reagent, equipment, data manager system, service, etc.) necessary to allow for release of a test result into the VISTA computer system. Each participating location will have varied assay requirements. Equipment offered shall provide all reportable assays listed in the prior section. Refer to Attachment A for desired test menu and estimated annual volumes specific to each location. Technical Features: The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following: Enough capacity and throughput to meet the volume and service demands as defined in Attachment A Ability to perform testing at locations that are remote from the laboratory. This may include hospital clinic, emergency department, operating room or Community Based Outpatient Clinic locations. Testing cannot be High Complexity testing by CLIA definitions Creatinine testing Preference is given when eGFR result is calculated by the analyzer and sent with Creatine result to Data Manager and/or Laboratory Information System. Preference is given to analyzers that Calculate eGFR using the MDRD Equation. Creatinine testing must utilize a method that has calibration traceable to an IDMS reference measurement procedure. Methods based on either enzymatic or Jaffe method principles should have calibration traceable to IDMS. Operator and patient identification tracking. Expired operator, failed quality control and invalid lot number instrument lock out. Ability to detect poor reagent or strip integrity. Capillary, arterial and venous sample options. No requirement for micropipette for application of blood for capillary test option. Barcode scanner for entry of patient, operator, and reagent information. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Capability to add user configurable comments. Maintenance shall be minimal and easily documented in analyzer/data management system. The contractor shall supply documentation detailing maintenance requirements. Ability to store, retrieve and retransmit test records in case of interface outage. Error detection and prevention, including but not limited to: Detects clots and/or prevent clots from entering the instrument Ensures proper specimen mixing Detects and prevents errors related to bubbles Detects when interferences are present Quality Control Assayed quality control and linearity solutions will be provided. Analyzer must have the ability to lock out operators from patient testing if quality control fails. Analyzer must have the ability to schedule and perform internal or electronic automatic Quality Controls. Preferably, quality controls should be processed using the same pathway as patient samples. Preferably, automated QC processes will allow for parallel testing of old and new lot of QC material. Data Manager Features: The contractor shall be responsible for providing middleware connectivity for the meters using RALS. The cost for middleware must be included in reagents price. The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface being utilized at VISN 15 VA Medical Centers. The Contractor shall provide 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 in Attachment B. 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. Contractor shall provide copies of current ISA/MOU and BAA that are applicable for remote connection to the interface system used to manage to testing system. Vendor shall include all hardware and software required for data management and interface Capability to detect out of range quality control and omit outliers as needed to reflect accurate quality control statistics. Omission of outliers is preferred over deletion of outliers. In most cases, two servers would be required, one for each separate instance of the laboratory information system, VISTA. (VISN15 Eastern and Western Orbits). All devices running windows must be Windows 10 OS and 11 OS at the time of award. A bi-directional computer interface compatible with the current VA laboratory information system (VISTA). The fully operational interface (both hardware and software) shall be immediately available for interfacing to the VA computerized hospital information system. Vendor must be able to interface results through current Data Manager. Remote monitoring and data management capabilities to include instrument monitoring (and appropriate notification to site of errors/warnings related to analyzer functions) and quality control management. Remote monitoring software must have National MOU/ISA approval with documentation for specific analyzer(s) being proposed. Remote monitoring must be currently in use by other VA facilities. Data Manager will be provided to monitor and evaluate test and quality control results. Data Manager will assist with transmission of results to VISTA for posting in patient records. The Data Manager system should allow coordinators to monitor end user access and/or competency from desktop. The Data Manager will allow coordinators to manage reagent lot numbers as applicable to the system. The Data Manager should have ability to support a virtual environment (Oracle Cerner). Cerner Compatibility Statement Vendors providing a bid to this requirement shall provide a Cerner Compatibility Statement (CCS)from the OEM of the equipment. The CCS must include the following: An OEM attestation that the product proposed is Cerner verified. The statement must be dated within 60 days of the quote to ensure it is recent and accurate. A list of VA healthcare organizations that have deployed the device/system with the Cerner EHR. Details related to any data to be transmitted to Cerner. The statement must provide an OEM point of contact for questions or concerns related to Cerner compatibility. The proposal must declare if the device/system does not connect to the network or electronic medical record. Vendor bids that do not include a CCS directly from the OEM will be disqualified. All devices running windows must be Windows 10 OS at the time of award. Hardware Features The instrumentation shall have the following: Downloader, replacement downloaders and rechargers must be provided if required as part of the testing system. The contractor shall provide full maintenance both remotely and onsite to include all replacement parts, software updates, labor, travel expenses, tools, test equipment and other incidentals necessary to maintain or restore the existing data manager to operating specifications which meet or exceed the manufacturers specifications for existing equipment. If existing equipment malfunctions, the contractor will be contacted by the facility to provide a replacement unit as part of this agreement. Any and all parts used must be new for that model and type of device. If any action requires replacement of a hard drive or other storage media, the contractor shall not remove the hard drive/storage media from the VA premises and must turn over said device to the facility. All services for this contract must meet manufacturers performance and technical specifications, Federal Regulations, FDA device certification and other specifications that may apply such as National Electric Code (NEC), Life Safety Code (LSC), the Joint Commission (JC), and VA Regulations. Contractor must provide the appropriate service documentation at no additional expense. Contractor shall provide hardcopy proof, upon request of COR, that contracting entity is a certified manufacturer service provider and that technicians are current in device certification training. Contractor service representative shall report to the Engineering Offices upon arrival on station to be issued a temporary VA Contractors ID badge and shall always wear the VA issued ID badge above the waistline while on the premises. Rechargeable batteries should be included free of charge, initially with analyzer and/or for troubleshooting. If device functions utilizing wireless technology, the device must have FIPS-140-2 certification. Vendor must supply the following documentation for all analyzers and data management systems proposed to VISN 15: MDS2 - Manufacturer Disclosure Statement for Medical Device Security. VA Directive 6550 Appendix A- Pre-Procurement Assessment FIPS-140-2 Certification for Wireless technology MOU/ISA for Data Management systems that will require vendor access. 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, Joint Commission and Federal regulations. Correlation studies for each analyte. A minimum of 20 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 provide technical support specialists to assist with studies and to 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, 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 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 (maybe run twice a day) for a total of 20 values per level of control. Intra-VISN facility variations should be kept at an absolute minimum. 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. Testing will not be implemented at the individual facilities for the selected system if the validation fails statistical studies as determined by the facility Pathology & Laboratory Service Chief. Reference Range- A reference range must be determined for each test following CLSI 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 lab. 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 20 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. 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, 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 on-site, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), 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 instrument training program that is coordinated with and timely to the equipment installation and appropriate for the size and scope of the facility s services. This shall include detailed, hands-on training on the operation of the system, data management, maintenance, quality control, limitations of tests, data manipulation, and basic troubleshooting and repair. When training occurs on-site, all operators performing testing will be trained by the contractor. When such training occurs off-site, it will include two operators per analyzer in the first year. Thereafter, the Contractor shall provide off-site training for minimally one operator 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. There shall be no difference in the detail of training provided on-site and off-site. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up ...