6640--New Long Term Procurement - Base 2 CPRR reagents and consumables for Laboratory Tests.
BPA LANGUAGE INTENT: Pursuant to Federal Supply Schedule (FSS) and FSS Contract Clause I-FSS-646, it is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VHAPORHCS to... BPA LANGUAGE INTENT: Pursuant to Federal Supply Schedule (FSS) and FSS Contract Clause I-FSS-646, it is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VHAPORHCS to establish a Three-year procurement for Automated Chemistry Immunochemistry Instrumentation or continuation of current Automated Chemistry Immunochemistry Instrumentation. The Government will award a CPRR BPA to a single Contractor for Automated Chemistry Immunochemistry Instrumentation. Contractor agrees to the following terms of the BPA exclusively with VAPORHCS awarded in the final BPA. Additional tests/reagents/instrumentation may be added to the BPA as new technology becomes available on the market and added to the base FSS contract. ORDERS: All products ordered under this BPA, placed against the Federal Supply Schedule Award Contract(s), are subject to the terms and conditions of the FSS contract. This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by authorized individuals. PRICES AND TERMS: VAPORHCS will provide an estimated annual volume by test as reflected in Attachment D.1. The Government estimates the volumes at VAPORHCS as listed in Attachment D.1, but does not guarantee volumes as listed; they are estimates ONLY. The facility will fax, email or upload their test counts from the chemistry analyzers. By the 10th of the following month to the contractor. TERM OF AGREEMENT: This will be a single award, firm-fixed price BPA with one base year and two, one year options and shall be effective for the term of the FSS Contract including additional FSS extensions. The Contractor is required to immediately notify the CO (Government Contracting Officer), in writing, if at any time the FSS contract upon which this BPA is based, is no longer in force. The resulting BPA shall be automatically extended for the remaining term of the BPA without modification upon any extensions of the Contractor s FSS contract. In addition, where a new FSS contract replaces Contractor s current FSS contract, the resulting BPA may be reassigned under the new FSS contract for the remaining term of the BPA with written agreement between Contractor and the contracting officer. This BPA is not a contract. If the Contractor fails to perform in a manner satisfactory to the CO, this BPA 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 60 days notification to the CO. This BPA shall be reviewed annually. VAPORHCS intends to establish the base year of the agreement for the period of 6/16/2025 through 6/15/2026. IDENTIFICATION: Delivery Orders issued shall be identified by their applicable FSS Contract Number and BPA Number. FSS & BPA identification numbers are assigned through the VHA Procurement Activity; CO: click here to insert identification numbers (BPA & FSS). 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/TECHNICAL EVALUATION PLAN SCOPE OF PROCUREMENT: The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the Technical Evaluation Plan. The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below meeting 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 an integrated family of analyzers, the 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 VAPORHCS. The Contractor is required to provide a continuously stocked inventory of reagents, standards, Vendor provided Controls, supplies, disposables and any other materials, to include replacement parts, 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. Contractor is required to provide vendor controls for troubleshooting and/or routine use as needed. The Contractor will provide a detailed list of all parts and supplies that are to be purchased by the facility and are not included in the CPRR contract. 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, Vendor provided 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 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 Vendor provided Controls, linearity material, calibration verification material, 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. Specimen Processing Automation Line Pre-analytical processing and archival processing equipment that will automate these specimen processing functions, as indicated in the general requirements section. Specimen Management System - A component of the Processing Automation Line that directs and manages the operation and components of the pre-analytical processing/automation system. Contractor Middleware Management System - A server installed with software that interfaces the testing instrumentation to the Laboratory Information system and is able to receive, process and send data following CLSI guidelines. Throughput The speed that the equipment processes and/or operates reported in units per hour. TEST MENU: Refer to Attachment D.1 for desired test menu and estimated annual volumes by laboratory. Special testing requirements: HIV Methodology shall be 4th generation or higher to meet the CDC requirement for HIV testing. Rapid testing for cardiac marker High Sensitive Troponin T, 10 minutes or less. IDMS traceable Creatinine Reagent is available. Rapid testing for intraoperative PTH. 10 minute or less. GENERAL REQUIREMENTS: Primary analyzer(s) Base equipment offered shall be new and 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. Analyzers offered per facility shall provide sufficient capacity and throughput to meet the volume and service demands as defined in Attachment D.1. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer may serve as a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment. 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. In the instance that the mirror imaged analyzers become unavailable the back-up analyzer will be used. 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 D.1. Additional primary analyzers required for the performance of daily workload are not considered back-ups for the purposes of consumables, reagents, etc. Installation Contractor will provide an alternate site for validation of the instrumentation if space is not available for side-by-side validation with existing instrumentation. Contractor will perform, at their cost, new validation studies as defined by the customer when instrumentation is installed in the final workspace. Operational and Technical Features- The instrumentation offered shall be approved by the Food and Drug Administration (FDA) and Contractor s FSS Contract at the time of proposal submission and have the following: Primary Processing Automation Line Instrumentation. Offering for an Integrated Clinical Laboratory Chemistry/Immunochemistry Instrumentation and Robotics System (Automated track or line) in accordance with the requirements of each respective laboratory, as listed in Attachment D.2, shall have the following listed below. Please include a clear description regarding how samples are transported on the rack. Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment D.1. Includes a specimen management system to manage and track sample progress and position. Specimen archival through mapping of specimen location; for easy retrieval once moved off-line. (Specimen Management System). The ability, based on test requests, to sort and route specimens. (Line/track system/ Specimen Management System) The ability to send the primary tube or processed aliquots by means of a tracking system to the proper testing instrumentation to maximize efficiency and to maintain and standardize turnaround times of results. (Line/track system/ Specimen Management System) Minimal operator intervention to introduce STAT specimens or to change a routine specimen priorities. The ability to detect processing errors and provide error notification. (Specimen Management System) The ability to separate the serum/plasma from the blood cells through the process of centrifugation. (Centrifuge) Ability to detect short samples and clots (Aliquotter) The ability to remove caps from blood collection tubes. (Decapper) The ability to recap and/or reseal - tubes. (Recapper) The ability to remove an aliquot of serum/plasma using disposable pipette tips to prevent contamination and move into another specimen tube or cup for analysis. (Aliquotter) The ability to print bar code labels and label daughter (aliquot) tubes to maintain positive specimen identification. The ability to connect all primary and back-up testing analyzers offered in accordance with Attachment D.2 Ensure immediate availability of primary tube after initial testing is completed. The ability to auto-archive, store and retrieve specimens. Capacity to be determined by Attachment D.2. Barcode reader stations must have the following capabilities: The accuracy of the barcode reading must have less than a 1.0 % 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, 10 characters in specimen identifier that is alpha, numeric, and/or alphanumeric concurrently. Testing Instrumentation The testing instrumentation must be an integrated platform with flexible, components that can be upgraded and or reconfigured on site and is approved by the Food and Drug Administration (FDA) and on Contractors FSS Contract at the time of proposal submission and shall have the following: The capability of performing analysis on 100% of the tests listed in Attachment D.1. with no more than 10% repeats of CPRR. Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment D.1. An instrument management system (internal to testing instrumentation) that provides/maintains the following: Ability to monitor instrument performance. Continuous monitoring of vital functions with immediate operator notification of failure(s) and on-board storage of these records. Capability to detect and alert operator of out of range quality control results via flagged results on QC printout and visual alerts on display monitor. Ability to store and retransmit patient records to the VA Laboratory Information system for a minimum 48 hours in case of interface outage. Capability to record, store and print the following information: Required quality control and instrument maintenance information. Patient demographic information and specimen results. On board reagent inventory system. 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 1.0 % 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, 10 characters in specimen identifier that is alpha and/or numeric depending on site that may be enabled concurrently. Bar coding of reagents and the ability to track reagent containers throughout the testing process using bar code technology. Ability to prioritize STAT testing without compromising existing programmed testing. Minimal operator intervention to introduce STAT specimens or to change a routine specimen to a STAT specimen, as well as introduce STAT specimens during a test run without aborting a run. Vendor will outline STAT procedure. On board reagent stability, sufficient to accommodate both high and low volume use. See ATT D.1 The ability to detect and alert operator of low reagent levels and the potential of depletion. The ability to load and unload all reagents from the equipment during operation without interrupting testing in progress or have sufficient capacity to enable a complete 24 hours of testing. The ability to support multiple reagent lots of the same reagent on the equipment at the same time with active, valid calibrations. The ability to maintain multiple calibrations per analyte. The capability to calibrate assays during test run without aborting the run. The capabilities to store, print, and retrieve calibration data. For routine (general) chemistry tests, when more than one lot of a given reagent has a valid calibration and quality control material is programmed to run as a control (in the control mode): Operatory shall be notified if a new lot number is about to be run to ensure that quality control material is performed. Quality control results will be easily distinguishable i.e., identified by reagent lot number or similar mechanism, on instrument printout or display monitor. Operator may select to run a test on only a specified lot of reagent even though more than one lot has a valid calibration The ability to continuously load patient specimens. The ability to detect short samples and interfering indices i.e. hemolysis, lipemia, and icterus, on all systems including Chemistry, Immunochemistry and pre-analytics. Clot detection with alert notification. Primary tube sampling from various manufacturers and sizes of evacuated tubes. Automatically repeat testing when defined limits are exceeded via auto dilution or sample volume adjustment. The capability to program a test as a repeat with interfacing of results to overlay initial result. 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. For those sites requiring back up analyzers, it is desirable for the backup analyzer to be a mirror image or have the same reagent requirement as the primary analyzer. Ability to store and retransmit records (48 hours of maximal instrument throughput) in case of interface outage. Calibration stability adheres to manufacture s specifications. User defined/Open Channel test capability. In the event that the contractor cannot provide desired assays, the contractor will provide application development support for open channel test implementation. Contractor Middleware Management System The Contractor shall provide instrumentation and middleware that is compatible with VistA or interfaces directly with Data Innovations Middleware. The Middleware shall be able to communicate via HL7 messages version 1.5 or later. Middleware for clinical chemistry systems should be open for bidirectional interfacing of front end automation, reference laboratories, and laboratory /clinical information systems, third party middleware applications, and laboratory instrumentation, current and future generations, for all other vendors and/or laboratory sections at no additional cost. The Contractor shall provide the server(s) and Data Innovations Instrument Manager Middleware software or other middleware that is compatible with VistA, and provide technical support for both the hardware and software for the duration of the contract. All driver development shall be provided by the respective vender, free-of-charge. The middleware should have the ability to interface with regulatory agency applications. i.e. CAP. The Contractor shall assist in the provision of the appropriate software drivers and interfaces for effective use of automated regulatory agency reporting features. The Contractor shall assist in the establishment, testing, deployment, and troubleshooting of the full capacity of the Middleware before implementation date. The Middleware shall contain systems that facilitate the analysis of laboratory pre-analytic, analytic, and post-analytic processes and the generation of summary reports for quality improvement and monitoring efforts. Summary reports shall be interactive, customizable, and accessible on-demand. Reports shall have, at a minimum, the flexibility to display information organized by department, workflow unit, desired time frame, production phase and priority. Software shall have the capability to drill down within the summary reports, identify problematic data and generate corrective action plans. Canned summary reports shall include, at a minimum: Turnaround time, specimen and test volumes, instrument quality control, specimen quality indicators, and % auto-verification, % (and number) repeat tests. The Middleware shall include moving averages system. The Contractor shall establish, test, deploy and troubleshoot the functionality of the moving averages system. The moving average system should have real-time, failure notification capability and an auto verification interrupt function at the analyte, specimen, and patient or instrument level. The Middleware shall include Boolean logic rule writing applications and vendor developed drivers or functionality that enable the use auto-validation/auto-verification in accordance with CAP regulations. The Middleware shall facilitate the development of compound, nested rules with multiple event actions. The middleware rule-writing application should have a visual (point-&-click) graphical user interface consistent with Microsoft Windows application and not require complex programming or coding. It should provide sufficient data elements & granularity so criteria can be defined for patient, specimen and test-level conditions. The Middleware shall be able to query incoming orders and outgoing results and hold either for user review and action. The Middleware shall contain a specimen management system that allows the user to quickly locate any specimen in the system. The Middleware shall have the ability to transmit QC data directly to Bio-Rad Unity Real Time or any other comparable online Quality Control program. The software shall have a system for inventory management that facilitates the tracking of consumables and ordering of supplies, and include pertinent information about the consumables, including, lot numbers, expiration dates, and item numbers. The server(s) must have sufficient memory to store all middleware records for a minimum of 14 days with downloading capability to an external medium for long term storage of patient records and other information. The vendor shall provide an accessible online medium for long term storage for patient records, results and other information with storage capacity to maintain 2 years worth of information. Information should be stored in a format that is readable by standard software. Patient status display for technologist review and workflow management for all integrated (linked) testing instrumentation. Ability to retransmit patient records to universal interface system in case of interface outage. Technology to automatically repeat testing based on customer configurable testing criteria (repeat testing) Technology to automatically direct additional specimen testing based on customer-configurable testing criteria (reflex technology). If vendor provides middleware and server, a backup server capable of taking over system functionality in event of primary server failure is provided at no cost. Test Environment or Test Instance of the Middleware in order to be utilized as an isolated environment for testing new systems, configuration changes, instrument interfaces, upgrades, etc. Test System should have the ability to interface with VistA and VistA test Account. It is preferable that the vendor utilize the VA national site-to-site VPN or work with the VA Officer of Cyber and Information Security and Information Security Officers to establish a client-based VPN. Provide a completed copy of the Manufacturer Disclosure Statement for Medical Device Security (MDS2) and VA Form 6550. Contractor shall collaborate with each lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity. Vendors will define level and type of support offered. Contractor shall assist customer with optimizing operation and utilization of the data management system to fully integrate desired testing instrumentation enhancing productivity and management of workflow. The Contractor shall provide all hardware, software, lines, adapters, and devices required to connect all Laboratory instruments to the Middleware, including, but not limited to, Lantronix devices or equivalent that are capable of converting DB9 serial to RJ45 Ethernet following RS232 protocols. The Contractor shall provide 24/7 technical support for all hardware and software of the Middleware and its connections. The Contractor shall provide all updates, upgrades, revisions, patches, and fixes at no cost to the Contractee. The Contractor shall provide all necessary information to complete an ISA/MOU, if necessary, to create a VPN for the contractor to directly connect to the Middleware for troubleshooting purposes. The Contractor shall provide all necessary licenses and support for licenses in order for the Laboratory to optimize the utility of the Middleware; i.e. licenses for connections and Thin Client licenses. Remote-access to server for multiple VA users, either with dedicated thin client terminals or via Windows Remote Desktop Connection The Contractor shall provide training for the Middleware prior to implementation, annually thereafter and anytime there is an upgrade where additional training would be beneficial. 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. See Attachment D.3 for current specifications. All monitors/screens will clearly display information in all light conditions. A printer(s) 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 (UPS) with line conditioner for each instrument provided. (This includes UPS units for sites with automation lines, specimen management systems, data management systems, refrigerated archive storage, etc.,) Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records. If the proposed instrument system requires an independent water system to operate, the vendor will include the water system and all maintenance of the system as part of the CPRR package. Specific Equipment Requirements- - Single lot of reagent for each test/analyte per shipment with a minimum dating of 90 days. User defined option for patient testing to be disabled if QC failure occurs. The printer should be user defined to print the results real-time or on demand as well as option to print exceptional reports held in the middleware for auto verification purposes. Equipment installation and possible reinstallation should the equipment need to be moved due to construction or laboratory redesign at no additional cost for one (1) location within each site. Equipment will be compatible with facility based limitation such as, but no limited to HVAC for cooling, size to get through doors to the final install location, water supply, drain for wastes. If applicable. Method Performance/Validation Requirements Method performance/comparison shall be at the expense of and performed by 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. All studies performed will be appropriate for the test menu of the respective laboratory to include serum, plasma, urine and body fluids as applicable. All studies must be approved by the local Laboratory Medicine Medical Director and made electronically available. These requirements shall be in effect during installation and any future changes to the test menu and/or method updates. 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. 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 include, at a minimum, within run precision study of 10 normal and 10 abnormal Vendor provided Controls. 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, if required. 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 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 ...
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