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?.## Statement of Work AGREEMENT LANGUAGE It is the intent of the Department of Veterans Affairs, VA Heartland Network (herein afterward referred as VISN 15) to establish a Cost-Per Reportable Result ... ?.## Statement of Work AGREEMENT LANGUAGE It is the intent of the Department of Veterans Affairs, VA Heartland Network (herein afterward referred as VISN 15) to establish a Cost-Per Reportable Result (CPRR) IDIQ Contract for PT/PTT Coagulation equipment, and Cost per Test (CPT) for esoteric testing supplies. It is the intent of the Government to award this agreement to a single Contractor for the Coagulation equipment. 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 AGREEMENT as new technology becomes available on the market. Prices and Terms VISN 15 will provide an estimated volume of tests performed as reflected in Attachment 1 for each individual medical center and/or outpatient clinic laboratory. Pricing is based on the AVERAGE daily test volume per instrument/analyzer for each facility. The Government estimates the volumes listed in the attached spreadsheet per facility but does not guarantee volumes as listed; they are estimates ONLY. TERM OF AGREEMENT: This will be a single award, Indefinite Delivery Indefinite Quantity (IDIQ) firm-fixed price award with five, one-year ordering periods, VISN 15 intends to establish the first ordering period of the agreement for the period of May 1, 2025, through April 30, 2026. Current contract expires on 04/30/2025. New equipment must be delivered by April 1, 2025 to complete required validation and correlation studies and comply with Laboratory Standards. ORDERING METHOD: 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. 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 be able to simultaneously perform the complete profile 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 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, VISN 15 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 in Attachment Reference 2. 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. The Contractor will assist with a holding tank for sites that use on demand orders. Contractor will work with the laboratory to determine adequate reagent volumes for contracted period. Volumes must allow for use of the same lot number of product for the contracted period. 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) - 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. 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. Cost per Test (CPT) – 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 (a) equipment use, (b) 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, (c) all necessary maintenance to keep the equipment in good 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. Parameter Definitions PT – Prothrombin Time APTT- Activated Partial Thromboplastin Time INR- International Normalized Ratio SI- International Sensitivity Index 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 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/REAGENTS CPPR: PT/PTT CPT: Fibrinogen, Thrombin Time, D-Dimer, Anti-Xa, controls and calibrators for esoteric testing. Refer to Attachment Reference 1 for desired CPRR and CPT 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 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. Back-up analyzer – Equipment required to support the operations of the VA laboratories in those cases when the primary analyzer(s) is not operational/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 Reference 1. Contractor shall provide quality control material at a minimum of two levels: normal and elevated. All reagents, controls, calibrators, and normal donor plasma (for annual lot changes) will be of the same lot number for all users. Lot numbers will be in use at least twelve (12) months. All sites covered under this AGREEMENT will convert to the new yearly lot number within 2 months of each other. Assayed control plasma for PT and APTT are the preferred products to assess test quality. If assayed controls are not offered/available, the Contractor shall: Furnish assayed control plasmas to be run concurrently until a range can be established for the unassayed material. Provide documented peer review of unassayed control data. The product information must specify an appropriate ISI for the instrument and reagent lot number combination. The ISI value for PT reagents must be between 1.0 - 1.3. The variance of the ISI value between reagent lots must not exceed 0.2. Ability to electronically enter the ISI value using bar code technology. Documentation must be provided regarding the effect of lupus anticoagulants in the therapeutic monitoring of warfarin. Operational Features - The instrumentation offered shall have the following: The capability of performing simultaneous analysis on 100% of the tests listed in Attachment Reference 1. Sufficient capacity and continuous throughput to meet the volume and service demands as defined in Attachment Reference 1 for laboratories that must meet 30 minutes’ turnaround time from accession to result verification. 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. 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, refer to section 2.4.16.6. The accuracy of the bar code reading must have less than a 1% failure rate. The equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Equipment must accept, at a minimum, 10-character specimen identifier that is configurable such as alphanumeric (letters and numbers). For those sites requiring back up analyzers, the backup analyzer should be a mirror image of the primary analyzer. Ability to prioritize STAT testing without compromising existing programmed testing. Minimal daily, weekly, and monthly maintenance. Equipment must be able to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. Capability to store at least 1000 patient results in a database for immediate recall. Ability to automatically identify and manage potentially hemolyzed, lipemic or icteric samples prior to analysis. Ability to accept various types of sample containers. Ability to locate patient samples using patient name, SSN, or unique ID, and determine when results will be available. Equipment must have the capacity to cap pierce sample tubes. Equipment must have the ability to continue operating when loading reagents and disposing of waste. Technical Features – The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following: The following products should be available: D-Dimer D-Dimer HS D-Dimer controls Thrombin Time QFA Thrombin, 2 ml Low Fibrinogen Control Anti-X Anti-Xa Calibrator LMW Heparin Controls Low Abnormal Control UF Heparin Control Calibration Plasma Heparin Cuvettes Sample Cups Cuvette Waste Bin On-board quality control (QC) data management system. Stores a minimum of 2 quality control files for each level of control for a given analyte. Displays Levy-Jennings graphs of quality control data. Electronically transfers and stores QC data. Stores individual QC results on multiple lot numbers. Ability to evaluate QC against others in peer group, using a Quality Assurance Program. Ability to automatically program the performance of QC testing by time, new bottle, and reagent. Ability to monitor instrument performance. On-board reagent inventory system. Minimal carryover. Long calibration stability. Minimal reagent, calibrator, and control preparation. No specimen pre-treatment required for PT and PTT testing. Primary tube sampling with clot detection. Ability to perform calibration curves on other assays during test run without aborting the run. Ability to store, print and retrieve multiple calibration curves where applicable. The instrument must store, print and retrieve curves for Fibrinogen and D-dimer, such that using same lot numbers and patient specimens may be run rapidly and on a STAT basis. Ability for the curve dilutions to be defined by the operator and the curves should be stable for a minimum of six months. D-Dimer testing must be FDA approved for exclusion of PE and DVT. Must have the ability to perform Heparin Xa testing for establishment of Heparin therapeutic ranges. The ability to accommodate the use of third-party reagents for specialized testing The ability to trace reagents lot, calibration, and QC with results. An on-board refrigeration system for reagents. Minimum 24-hour on-board stability of PT and APTT reagents. Minimum eight (8) hour stability of quality control material. Equipment must have the capability to detect out of range quality control and alert the operator of the occurrence. The system must be able to obtain approval to connect the VA computer system. The vendor must provide MDS2 form, MOU (if applicable) and VA form 6550. 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. 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. The vendor shall provide assistance with setting up Autoverification through Data Innovations. Work with the Laboratory LIMs to interface VISTA LIS with vendor provided instruments. Provide remote or onsite guidance on validation techniques and assist troubleshooting. Provide support and guidance during modifications of final Autoverification build. For example, modifying rules logic cutoff based on evolving SOP’s. 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. 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. Method Validation - 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. Acceptable accuracy and precision for PT, aPTT, Xa and Fibrinogen will be < 10% CV and D-Dimer will be < 5% CV. The method validation will include the following: Correlation studies for each analyte. A minimum of 40 samples spanning the reportable range, shall be run by the present and the proposed method. Contractor shall analyze results and provide statistical data to support acceptance of the new method. 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 when applicable. 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. Intra-VISN facility variations should be kept at an absolute minimum. 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 interrupting 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 program(s) shall be provided to each laboratory at no charge. 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. Studies will be performed at all testing sites and common range will be established for use in VISN 15. 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, the 2.4.13.7.2 above must be performed. FDA Approved D-Dimer, vendor established cut-off for Venous Thromboembolism (VTE) and Pulmonary Embolism (PE). Reportable Range PT, aPTT, Fibrinogen, Thrombin Time, D-Dimer, and heparin assays. Contractor shall provide accurate high and low reportable range limits for all clotting assays (i.e., PT, aPTT and fibrinogen), particle agglutination (immunological) assays (i.e., D-dimer) and chromogenic assays (i.e., heparin anti-factor Xa). Chromogenic Assays (if applicable) – Contractor shall determine a reportable range for chromogenic assays. This study should define the lowest level to the highest level that can be accurately reported. The material used to calibrate the instrument must not be used to determine the reportable range. The sample material used must have a known reference value. A linearity study, if applicable, must be performed to verify the reportable range. Therapeutic Range An ex vivo range must be established. The therapeutic aPTT range must be determined using plasma from patients on unfractionated heparin therapy. Slightly, moderately, and very prolonged aPTT values must be used. Anti-Xa results must be performed to quantify the amount of heparin present relative to the aPTT. A minimum of 50 patient samples must be used. A more detailed explanation of this protocol may be found in the CLSI guideline H47-A2, One Stage PT and APTT Tests. In changing activated partial thromboplastin time (aPTT) methods, preference is given to a reagent system that will provide the same (or nearly the same) heparin responsiveness as the one currently in use. 2.4.17 Reports: The Contractor shall provide to the Contracting Officer and the Contracting Officer Representative (COR) at VISN 15 a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter’s business. Reports are to reflect, as a minimum, total net sales, amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized and shall be shared with each participating facility, 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 as part of the AGREEMENT. Contractor will provide either a web-based or an electronic workload reporting capability to assist with monthly workload reporting. 2.4.18 Support Features 2.4.18.1 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, 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 Paragraph 2.4.13, and report data in an organized, clearly comprehensible format. Training. Upon Installation - the Contractor shall provide an instrument training program for two operating personnel at no charge to the Government that is coordinated with and timely with 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 Cost Per Reportable Result 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, data manipulation, and basic trouble shooting and repair. Additional Training in years 2 through 5 - the Contractor shall provide advanced training for one operator per year per facility. The requested training resources should be flexible; this is the ability to share or combine training resources within the VISN sites. Training shall be provided 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. 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 a maximum call back response time of one hour. Equipment repair service shall be provided during core business hours. See Attachment Reference 3 defining core business hours of each facility included in this solicitation. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel. Equipment response time shall be no more than 24 hours. Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following: date and time notified. date and time of arrival. serial number, type, and model number of equipment. time spent for repair, 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. Equipment relocation: In the event of moving the new equipment to a new location (such as a new laboratory), the contractor shall move contracted lab equipment from the current location to the new lab space. Contractor will perform necessary equipment function checks to include but not limited to calibrations, precision checks and quality controls as needed for the equipment. Function checks will be performed after equipment is placed in the new space. Any damage incurred during the move by the Contractor is the responsibility of the Contractor. Contractor moving the equipment must be approved by the Contractor that provided the equipment or risk voiding warranties or other contract provisions. 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.), etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc. Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and shall assist in regulatory compliance, e.g., Computer disc containing their procedure manual in CSLI format or an on-line procedure manual in the instrument software. Characterization of hazardous waste – The Contractor shall provide a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations and address the criteria listed in the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et al. The description shall address the following: Waste toxicity (Reference 40CFR261.11 and 40CFR261.24) Waste ignitability (Reference 40CFR261.21) Waste corrosivity (Reference 40CFR261.22) Waste reactivity (Reference 40CFR261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40CFR261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40CFR261.33) 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, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and...