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The Veterans Integrated Service Network 20 (VISN 20) is seeking a manufacturer that can provide High Complexity Immunochemistry Analyzers for facilities Alaska VA Healthcare System (AVAHS). Please see... The Veterans Integrated Service Network 20 (VISN 20) is seeking a manufacturer that can provide High Complexity Immunochemistry Analyzers for facilities Alaska VA Healthcare System (AVAHS). Please see the STATEMENT OF WORK below for details. Potential contractors shall provide, at a minimum, the following information to José Ronstadt, at jose.ronstadt@va.gov, no later than 02/02/2021: 1) Offeror s name, address, point of contact, phone number, and e-mail address. 2) Business type, size, and company's DUNS number. Small and Veteran owned manufacturers are encouraged to respond. 3) Offeror s interest in quoting on the solicitation when it is issued, based on the requirements detailed within the STATEMENT OF WORK. This is not a Request for Quote (RFQ), or Invitation for Bid (IFB); nor does it restrict the Government to an ultimate acquisition approach. 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 the Alaska VA Healthcare System (AVAHS) to establish a Blanket Purchase Agreement (BPA) for Automated Chemistry Immunochemistry Instrumentation. The BPA shall be under the FSS Contract, Federal Supply Class (FSC) Group 66 III Cost Per Test (CPT)/ Cost Per Reportable Result (CPRR), Clinical Laboratory Analyzers. 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 the AVAHS and awarded in the final BPA. However, as requirements change, 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: The AVAHS has provided an estimated annual volume by test as reflected in Chemistry Test List SOW Attachment . Pricing is based on the AVERAGE annual test volume. The Government estimates the volumes as listed in Chemistry Test List SOW Attachment , but does not guarantee volumes as listed; they are estimates ONLY. TERM OF AGREEMENT: This will be a single award, firm-fixed price BPA with one base year and four, one year option renewals 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 30 days notification to the CO. This BPA shall be reviewed annually. 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 insert identification numbers of the BPA and FSS. ORDERING METHOD: The AVAHS 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 and reporting the clinical parameters as defined in the Technical Evaluation Plan [P09 SSEP a separate document]. The instrument shall have random access capability and be able to simultaneously perform analysis of tests listed in Chemistry Test List SOW Attachment . Must 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 an integrated family of analyzers, the technical evaluation panel will determine if instrumentation proposed meets needs of using facility 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 (along with their prices) that are to be purchased by the facility and are not included in the CPRR contract 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. 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 Chemistry Test List SOW Attachment for desired test menu and estimated annual volumes required by the laboratory. Special testing requirements: IDMS traceable Creatinine Reagent is available NGSP Traceable Hemoglobin A1c CDC HoSt Program standardized Testosterone [analytical performance meets criteria of mean bias within +/-6.4%] 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 should be required to meet the productivity specifications defined herein. Analyzers offered shall provide capacity and throughput to meet the volume and service demands as defined in Chemistry Test List SOW Attachment . The primary analyzer must be the same chemistry/immunochemistry analyzers as one of the Alaska Federal partner Laboratory analyzers. This requirement supports the commitment of the Alaska Federal Laboratory partnership reliance on members to share expertise, parts, reagents, and supplies in times of need. Alaska can be vulnerable to delays in reagent/supply transportation and in travel of out-of-state field service engineers. The Alaska Federal partners cooperate to assure that facility laboratory operations are continuous and not disrupted. 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 Testing Instrumentation/Integrated Platform Analyzer: The analyzer shall be flexible and have components that can be upgraded or reconfigured on site The capability of performing analysis on 100% of the tests listed in Chemistry Test List SOW Attachment . The capability of performing analysis with no more than 10% repeats of CPRR Sufficient capacity to meet the volume as defined in Chemistry Test List SOW Attachment and has throughput of no less than 1,000 tests per hour. 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 [reasonable time-limit no less than 7 days] in case of interface outage Capability to record, store and print the following information: Quality control data and statistics Instrument maintenance information and records Patient identification and specimen identification data Specimen analysis results On board reagent inventory system A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system - VistA. The fully operational interface (both hardware and software) shall be immediately available for implementation to VistA. The analyzer interface must be capable of connectivity with the CERNER laboratory/hospital information system. The eventuality of the laboratory information system changeover will take place within the base year plus 4 option years. 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 all reagent containers and the ability to track reagent location and volume throughout the on-board lifetime of each reagent. 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 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 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 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 a variety of patient specimens with varying tests The ability to detect insufficient samples The ability to measure the following indices on each specimen: hemolysis, lipemia, and icterus The ability to detected clotted specimens and provide alert notification Primary tube sampling from various manufacturers and sizes of evacuated tubes The instrumentation shall be capable of handling all routine sample collection tube sizes: 13x75, 13x100, 16x100, as well as sample cups (0.5, 1.0, and 2.0 mL) 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 Calibration stability must adhere to manufacture s specifications Contractor Middleware Management System The Contractor shall provide middleware that is compatible with VistA/Cerner The middleware shall be able to communicate via current HL7 message protocol Middleware for clinical chemistry systems should have capacity for interfacing other vendor s analyzers The Contractor shall provide the server(s) and Data Innovations Instrument Manager Middleware software that is compatible with VistA/Cerner. The Contractor shall assist in the provision of the appropriate software drivers, development of drivers, and interfaces for effective data transmitting features. All driver development shall be provided by the vendor without additional charge. The middleware should have the ability to interface and transmit data with regulatory agency web based applications, such as the College of American Pathologists (CAP). 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 analytic processes and the generation of summary reports for quality improvement and monitoring. Summary reports shall be interactive, customizable, real-time, 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 and identify problematic data 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 logical rule writing applications and vendor developed drivers or functionality that enable the use auto-validation/auto-verification in accordance with 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 Technology to automatically direct additional specimen testing based on customer-configurable testing criteria (reflex technology). A backup plan for the server functionality capable of taking over 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. 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. 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 AVAHS. 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 to optimize the utility of the middleware 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 software rules writing and programming prior to implementation, annually thereafter, and anytime there is an upgrade where additional training would be beneficial. Hardware Features The equipment model being offered shall be in current production as of the date this offer is submitted A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. 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 An uninterruptible power supply (UPS) with line conditioner for each instrument provided. 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 Immunochemistry sampling shall be accomplished using single-use tips and cups to avoid carryover of the antibody molecules. Method Performance/Validation Requirements Method validation shall be at the expense of and performed by the Contractor and 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, whole blood, and urine. All studies must be approved by the Laboratory 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 (analysis on current method and correlated to new method) for each analyte with minimum number of samples spanning the reportable range. Contractor shall provide statistical data and graphic representations to support acceptance of the new method for above studies. Statistics shall consist of mean, bias, slope, y-intercept, correlation coefficient, and receiver operating characteristics (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. Precision studies using normal and abnormal material shall include 10 replications within run on 2 levels of vendor provided materials Sensitivity may be validated concurrently with correlation studies and calculations to determine efficiency, sensitivity, false positive/false negative rate must be applied Specificity/interference assessment for all analytes to determine adverse effects for level of bilirubin, hemolysis, lipemia, or other interfering substances Carryover studies shall be completed by the contractor on all analytes during installation to prove there are no probe washing defects. A reference range must be determined for each test according to CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. The Contractor shall provide to the Contracting Officer and the COR a copy of a monthly invoice/usage report within 30 days of the end of the billing month. The Contractor shall provide all reagents, calibrators, quality control materials, linearity materials, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the FSS contract and required to validate instruments for operation and validation The Contractor shall provide instrument training coordinated with and timely to the equipment installation 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 key operator training for 2 operators shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair for each system. Thereafter, the Contractor shall provide training for minimally one operator per system 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 AVAHS and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant for the duration of the training. In addition, basic operator training shall be provided by Contractor on-site for all operators on all shifts, as applicable The Contractor shall be able to provide, at no additional cost to the Contractee, regular scheduled preventive maintenance and emergency equipment repair the analyzer. The Contractor shall be responsible for regular maintenance and emergency repair of associated equipment: water system, printer, and UPS. Service Requirements A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 1 hour Location for Alaska [Station 463]: Alaska VA Healthcare System - Laboratory, 1201 North Muldoon Rd, Anchorage, AK 99504, and hours of operation are Mon-Fri 07:30am - 17:00pm Equipment repair service shall be provided during operational hours listed in line above. Most repairs will take place during normal business hours, 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. A Field Service Engineer must reside within the State of Alaska due to dependence on airline transportation and unreliable conditions for air travel. Remote Access diagnostic trouble shooting capabilities available with a national ISO Internet Security agreement may be implemented 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, within 24 hours of the repair. 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 description of the malfunction or repair findings proof of repair including documentation verifying acceptable performance Each notification for an emergency repair service call shall be treated as a separate and new service call The vendor agrees that all equipment provided shall be operable no less than 99% of operational time. Downtime is defined as the inability to produce clinically acceptable results for any given parameters and will be computed from the time of initial notification until the instrument is operational and produces clinically acceptable results Scheduled maintenance is excluded from downtime Vendor will provide a Downtime Summary report of instrumentation prior to the award of contract. The report should be specific to the analyzer proposed for the AVAHS and include: Average frequency of downtime per month Average hours of downtime per month Average number of downtime calls from customers per year. Number of recalls for reagents or parts in a year The Contractor shall provide upgrades to both the equipment hardware 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. These shall be provided as they become commercially available. This does not refer to replacing the original piece of equipment provided under the BPA; however, it does refer to significant changes in the hardware operational capability. The Contractor shall provide linearity material for on-going regulatory requirement for 6-month AMR validation of the manufacturer s published AMRs. All analytes calibrated with less than 3 calibrators require semi-annual linearity testing. The Contractor must share this responsibility by supplying materials to meet the regulatory requirement. The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by the proposed analyzer system in accordance with the requirements of the Code of Federa...