6550--VISN 15- (POC) Creatinine -eGFR Testing (VA-25-00017406)

Sources Sought Notice Sources Sought Notice Page 15 of 15 Sources Sought Notice *= Required Field Sources Sought Notice Page 1 of 2 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) UIE number (f) Cage Code (g) Tax ID Number (h) Type of small business, e.g. Services Disabled Veteran Owned small Business, Veteran-owned small business, 8(a), HUBZone, Women Owned Small Business, Small disadvantaged business, or Small Business HUBZone business and (i) must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below Work to be performed: INTENT: It is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 15) to establish an Indefinite Delivery Indefinite Quantity (IDIQ) agreement for Point of Care testing for Creatinine with eGFR (Estimated Glomerular Filtration Rate). The contract shall be under open market Cost Per Reportable (CPRR). The Government will award a CPRR contract to a Contractor for point of care testing reagents and analyzer service. The Vendor will also supply a CPRR price for reagent, service, and data manager support for existing analyzers in select VISN 15 Laboratory Sites. Contractor agrees to the following terms of the contract exclusively with the VISN facilities listed by Attachment A herein and awarded in the final contract. However, as requirements change, facilities within VISN 15 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the contract as new technology becomes available on the market. ORDERS: The Government is obligated only to the extent of authorized orders actually issued under the contract by authorized individuals. PRICES AND TERMS: VISN will provide an estimated volume by test as reflected in Attachment A for each individual medical center and outpatient clinic laboratory. Pricing is based on the AVERAGE daily test volume for each facility. The Government estimates the volumes per facility as listed in Attachment A but does not guarantee volumes as listed; they are estimates ONLY. TERM OF AGREEMENT: This will be a single vendor award, firm-fixed price contract with one base year and four, one-year options. If the Contractor fails to perform in a manner satisfactory to the CO, this contract may be canceled with thirty (30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. This contract shall be reviewed annually. VISN intends to establish the Base Year plus three Ordering periods 09/01/2025 through 08/31/2029. IDENTIFICATION: Delivery Orders issued shall be identified by their applicable contract Number. contract identification numbers are assigned through the VHA ORDERING METHOD: The participating facilities in Attachment A 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. 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 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). If Contractor offers a family of analyzers, VISN technical evaluation panel will determine if instrumentation proposed meets needs of using facility. 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. 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 (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 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) System should be FDA approved that allows for reading of the following: Creatinine eGFR (Calculated using MDRD Equation) pH Carbon Dioxide, Partial Pressure (pCO2) Oxygen, Partial Pressure (pO2) Sodium Potassium Ionized Calcium Chloride Glucose Lactate Creatinine Actual Bicarbonate (cTCO2 calculated) Total Carbon Dioxide (cHCO3 calculated) Base Excess of Extra Cellular Fluid (BE(b) calculated) Oxygen Saturation (cSO2 calculated) Hemoglobin (cHgb calculated) Estimated Glomerular Filtration Rate (eGFR calculated) Estimated Glomerular Filtration Rate if African American (eGFR-a calculated) Anion Gap (AGAP calculated) Anion Gap, Potassium (AGapK calculated) GENERAL REQUIREMENTS: Contractor should provide CPRR pricing for sites with existing equipment. CPRR pricing will include reagents, service and maintenance of analyzers and data manager systems. CPRR pricing would provide 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. Operational Features- The instrumentation offered shall have the capability to perform; Creatinine testing. eGFR result must be calculated on board the analyzer at the time of testing Calculation for eGFR must be performed using MDRD Equation. Creatinine testing must 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. Cards must allow for testing of both venous and arterial blood sources. 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 (CBOC). Meters must be portable or singlehanded use Technical Features The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following: Testing cannot be High Complexity testing by CLIA definitions. Operator and patient identification tracking. Products must be compatible with the wireless EPOC point of care analyzers in place at Kansas City VAMC. 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. Capability to add user configurable comments. Maintenance for end users should be minimal and easily documented. Vendor should supply documentation detailing maintenance requirements. Ability to correlate Creatinine values with main laboratory instrumentation within +/- 20%. 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. 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 A. 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. Hardware Features- The instrumentation shall have the following: Downloader and rechargers must be provided if required as part of the testing system. Existing equipment as specified in Attachment A. 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. All parts used must be new or factory rebuilt 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 ant 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 wear the VA issued ID badge above the waistline at all times while on the premises. Rechargeable batteries should be included. 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 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 specialist 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 (may be 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. The Contractor shall provide all start up reagents required to establish instruments for operation for performance of acceptance testing. 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 as long as 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 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, 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 of 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-Test Clinical Laboratory Analyzers contract. This shall include training on the operation of the system, maintenance, quality control, limitations of the test, data manipulation, and basic trouble shooting and repair, as applicable, to nursing, pharmacy and/or laboratory personnel. Service Requirements 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: A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with maximum call back response time of 1 hour. The contractor shall provide the necessary information to replace an inoperable device. This replacement shall include meters, charging bases, and rechargeable batteries at no additional cost. A minimum acceptable service shall also include replacement delivery of items to be replaced with overnight service, but no longer than one (1) business day from the time of service ticket confirmation. Upgrades - The Contractor shall provide upgrades to the equipment hardware, bidirectional interface and software in order to maintain the integrity of the system and the state-of the art technology, at no additional charge to the Government if sites are interested. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of equipment being offered, i.e., new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the contract; however, it does refer to significant changes in the hardware operational capability. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the contract, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. rechargeable batteries. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g., starter kits. 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. Any response to this source selection from Interested parties must be received NLT 08/05/2025, 3:00 PM CST. Attention: Michael Murphy, Contract Officer Email: contact@example.gov Additional Important Information: Interested persons shall reference 36C25525Q0262 in the subject line of all emails. Only organizations with an active SAM.GOV account can be considered. Utilize this link to either start a new registration or to renew the organization s registration. https://sam.gov/content/home