STATEMENT OF WORK 1.1. SCOPE OF PROCUREMENT: 1.1.1. The instruments shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile for VA Puget Sound Healthcare System with locations in Seattle and Tacoma/American Lake VA as described in Attachment A; 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). 1.1.2. The Contractor is required to provide a continuously stocked inventory of reagents, standards, vendor provided Controls, supplies, disposables, validation materials, CAP proficiency testing, linearity materials, printers, scanners, computers 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. 1.1.3. Contractor is required to provide quality controls for troubleshooting and/or routine use as needed. 1.1.4. 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 Cost Per Reportable Result (CPRR) contract. 1.1.5. 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. 1.2. DEFINITIONS: The per patient reportable result price shall include costs covering: five-year equipment use, all reagents, validation materials, CAP survey materials, linearity materials, standards, contractor provided quality controls, supplies, consumable/disposable items, parts, printers, scanners, computers 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). All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge. 1.2.2. Contractors are required to provide a price for each test that can be performed on its equipment. The CPRR price shall include costs covering five-year equipment use including the following: All reagents, standards, quality Contractor provided Controls, linearity materials, calibration verification materials, supplies, consumable/disposable items, parts, accessories. Including any other item required for the proper operation of the Contractor s equipment and necessary for the generation and reporting of a test result. All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge. 1.2.3. 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 protected health information (PHI), or that provides certain services involving the disclosure of (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. 1.2.4. Specimen Processing Automation Line Pre-analytical processing and archival processing equipment offered to the Seattle VA laboratory providing automation of specimen processing functions, as indicated in the general requirements section. 1.2.5. 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. 1.2.6. Contractor Middleware Management System - A server installed with software that interfaces the testing instrumentation to the VA Laboratory Information System (LIS) or VA Middleware and can receive, process and send data following CLSI guidelines. 1.2.7. Throughput The speed that the equipment processes and/or operates reported in units per hour. GENERAL REQUIREMENTS: 1.2.8. 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 shall provide sufficient capacity and throughput to meet the volume and service demands 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. 1.2.8.1. (Applies only if selected) 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. Additional primary analyzers required for the performance of daily workload are not considered back-ups for the purposes of consumables, reagents, etc. 1.2.8.2. Installation (applies only if selected): 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. 1.2.9. Operational and Technical Features- The instrumentation offered shall be approved by the Food and Drug Administration (FDA): 1.2.9.1. Primary Processing Automation Line Instrumentation and Integrated Clinical Laboratory Chemistry/Immunochemistry Instrumentation and Robotics System (Automated track or line) for Seattle location only. The offerings for the Seattle location shall be in accordance with requirements listed below. Please include a clear description regarding how samples are transported on the rack. NOTE: American Lake location will not have Primary Processing Automation Line Instrumentation or need an Integrated Clinical Laboratory Chemistry/Immunochemistry Instrumentation and Robotics System (Automated track or line). 1.2.9.1.1. Sufficient capacity and throughput to meet the volume and service demands. 1.2.9.1.2. Includes a specimen management system to manage and track sample progress and position. 1.2.9.1.3. Seattle location only: Specimen archival through mapping of specimen location; for easy retrieval once moved off-line. (Specimen Management System). 1.2.9.1.4. Seattle location only: The ability, based on test requests, to sort and route specimens. (Line/track system/ Specimen Management System) 1.2.9.1.5. Seattle location only: 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) 1.2.9.1.6. Minimal operator intervention to introduce STAT specimens or to change a routine specimen priority. 1.2.9.1.7. The ability to detect processing errors and provide error notification. (Specimen Management System) 1.2.9.1.8. Seattle location only: The ability to separate the serum/plasma from the blood cells through the process of centrifugation. (Centrifuge) 1.2.9.1.9. Seattle location only: Ability to detect short samples and clots (Alliquoter) 1.2.9.1.10. Seattle location only: The ability to remove caps from blood collection tubes. (Decapper) 1.2.9.1.11. Seattle location only: The ability to recap and/or reseal - tubes. (Recapper) 1.2.9.1.12. Seattle location only: 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) 1.2.9.1.13. Seattle location only: The ability to print bar code labels and label daughter (aliquot) tubes to maintain positive specimen identification. 1.2.9.1.14. Seattle location only: The ability to connect all primary and back-up testing analyzers. 1.2.9.1.15. Seattle location only: Ensure immediate availability of primary tube after initial testing is completed. 1.2.9.1.16. Seattle location only: The ability to auto-archive, store and retrieve specimens. 1.2.9.1.17. Barcode reader stations must have the following capabilities: 1.2.9.1.17.1. The accuracy of the barcode reading must have less than a 1.0 % failure rate. 1.2.9.1.17.2. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. 1.2.9.1.17.3. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha, numeric, and/or alphanumeric concurrently. 1.2.9.1.18. Seattle location only: The ability to connect instrumentation from other vendors to the processing line. Offer must state what other instrumentation can be connected. 1.2.9.2. Seattle location only: 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) at the time of proposal submission and shall have the following: 1.2.9.2.1. Sufficient capacity and throughput to meet the volume and service demands. 1.2.9.2.2. An instrument management system (internal to testing instrumentation) that provides/maintains the following: 1.2.9.2.3. Ability to monitor instrument performance. 1.2.9.2.3.1. Continuous monitoring of vital functions with immediate operator notification of failure(s) and on-board storage of these records. 1.2.9.2.3.2. 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. 1.2.9.2.3.3. Ability to store and retransmit patient records to the VA Laboratory Information system for a minimum 48 hours in case of interface outage. 1.2.9.2.3.4. Capability to record, store and print the following information: 1.2.9.2.3.4.1. Required quality control and instrument maintenance information. 1.2.9.2.3.4.2. Patient demographic information and specimen results. 1.2.9.2.3.5. On board reagent inventory system. 1.2.9.2.4. 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. 1.2.9.2.4.1. The accuracy of the barcode reading must have less than a 1.0 % failure rate. 1.2.9.2.4.2. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. 1.2.9.2.4.3. 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. 1.2.9.3. Bar coding of reagents and the ability to track reagent containers throughout the testing process using bar code technology. 1.2.9.4. Ability to prioritize STAT testing without compromising existing programmed testing. 1.2.9.5. 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. Contractor will outline STAT procedure. 1.2.9.6. On board reagent stability, sufficient to accommodate both high and low volume use. See ATT A. 1.2.9.7. The ability to detect and alert operator of low reagent levels and the potential of depletion. 1.2.9.8. The ability to load and unload all reagents from the equipment during operation without interrupting testing in progress or have sufficient capacity to complete 24 hours of testing. 1.2.9.9. The ability to support multiple reagent lots of the same reagent on the equipment at the same time with active, valid calibrations. 1.2.9.10. The ability to maintain multiple calibrations per analyte. 1.2.9.11. The capability to calibrate assays during test run without aborting the run. 1.2.9.12. The capabilities to store, print, and retrieve calibration data. 1.2.9.13. 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): 1.2.9.13.1. Facility shall be notified if a new lot number is about to be run to ensure that quality control material is performed. 1.2.9.13.2. Quality control results will be easily distinguishable i.e., identified by reagent lot number or similar mechanism, on instrument printout or display monitor. 1.2.9.13.3. Operator may select to run a test on only a specified lot of reagent even though more than one lot has a valid calibration. 1.2.9.14. The ability to continuously load patient specimens. 1.2.9.15. The ability to detect short samples. 1.2.9.16. Clot detection with alert notification. 1.2.9.17. Primary tube sampling from various manufacturers and sizes of evacuated tubes. 1.2.9.18. The instrumentation shall be capable of handling all routine sample collection tubes e.g.: 13x75, 13x100, 16x100. plus, other various sized sample containers i.e., sample cups (0.5, 1.0, and 2.0 ml), carrier tubes and tube inserts. 1.2.9.19. Automatically repeat testing when defined limits are exceeded via auto dilution or sample volume adjustment. 1.2.9.20. The capability to program a test as a repeat with interfacing of results to overlay initial result. 1.2.9.21. 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. 1.2.9.22. The backup analyzer will be a mirror image or have the same reagent requirement as the primary analyzer. 1.2.9.23. Calibration stability adheres to manufacture s specifications. 1.2.9.24. 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. 1.2.10 Inventory Management System 1.2.10.1 The contractor shall provide an automated Inventory Management system to track and provide real time inventory of reagents and supplies. 1.2.11. Contractor Middleware Management System 1.2.11.1. The Contractor shall provide instrumentation and middleware that is compatible with VA LIS or interfaces directly with Data Innovations Middleware. 1.2.11.2. The Middleware shall be able to communicate via HL7 messages version 1.6 or later. 1.2.11.3. Middleware for clinical chemistry systems must be bidirectional interfaceable to include front end automation, laboratory /clinical information systems, third party middleware applications, laboratory instrumentation, current and future generations, for all other laboratory sections at no additional cost. 1.2.11.4. The Contractor shall provide the server(s) and Data Innovations Instrument Manager Middleware software, to include wrapper rules for Auto Verification, or other middleware that is compatible with VA LIS/middleware, and provide technical support for both the hardware and software for the duration of the contract. 1.2.11.5. All driver development shall be provided by the respective contractor, free-of-charge. 1.2.11.6. The middleware should have the ability to interface with regulatory agency applications. i.e. CAP. 1.2.11.7. The Contractor shall assist in the provision of the appropriate software drivers and interfaces for effective use of automated regulatory agency reporting features. 1.2.11.8. The Contractor shall assist in the establishment, testing, deployment, and troubleshooting of the full capacity of the Middleware before implementation date. 1.2.11.9. 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. 1.2.11.10. Summary reports shall be interactive, customizable, and accessible on-demand. 1.2.11.11. 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. 1.2.11.12. 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. 1.2.11.13. The Middleware shall include moving averages system. The Contractor shall establish, test, deploy and troubleshoot the functionality of the moving averages system. 1.2.11.14. The patient 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. 1.2.11.15. The Middleware shall include Boolean logic rule writing applications and contractor developed drivers or functionality that enable the use auto-validation/auto-verification in accordance with CAP regulations. 1.2.11.16. The Middleware shall facilitate the development of compound, nested rules with multiple event actions. 1.2.11.17. 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. 1.2.11.18. The Middleware shall be able to query incoming orders and outgoing results and hold either for user review and action. 1.2.11.19. The Middleware shall contain a specimen management system that allows the user to quickly locate any specimen in the system. 1.2.11.20. 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 vendor will assist with set up and mapping between the analyzers and the Quality Control program. 1.2.11.21. 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. If required, management system is available on board the analyzer, and in the storage of room temperature and refrigerated reagents. 1.2.11.22. 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. 1.2.11.23. The contractor shall provide an accessible 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. 1.2.11.24. Patient status display for technologist review and workflow management for all integrated (linked) testing instrumentation. 1.2.11.25. Ability to retransmit patient records to VA LIS in case of interface outage. 1.2.11.26. Technology to automatically repeat testing based on customer configurable testing criteria (repeat testing) 1.2.11.27. Technology to automatically direct additional specimen testing based on customer-configurable testing criteria (reflex technology). 1.2.11.28. Contractor shall provide middleware and a virtual server with hot backup server capable of taking over system functionality automatically in the event of primary server failure at no additional cost. 1.2.11.29. 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. 1.2.11.30. It is preferable that the contractor 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. 1.2.11.31. Provide a completed copy of the Manufacturer Disclosure Statement for Medical Device Security (MDS2) and VA Form 6550. 1.2.11.32. Contractor shall collaborate with each lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity. Contractors will define level and type of support offered. 1.2.11.33. 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. 1.2.11.34. The Contractor shall provide all hardware, software, lines, adapters, sample scanners, printers for hard copy results, and devices required to connect all Laboratory instruments to the Middleware, including, but not limited to, Lantronix devices or equivalent that can convert DB9 serial to RJ45 Ethernet following RS232 protocols. 1.2.11.35. The Contractor shall provide 24/7 technical support for all hardware and software of the Middleware and its connections. 1.2.11.36. The Contractor shall provide all updates, upgrades, revisions, patches, and fixes at no cost. 1.2.11.37. 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. 1.2.11.38. The Contractor shall provide all necessary licenses and support for licenses for the Laboratory to optimize the utility of the Middleware; i.e. licenses for connections and Thin Client licenses. 1.2.11.39. If required, remote access to server for multiple VA users, either with dedicated thin client terminals or via Windows Remote Desktop Connection 1.2.11.40. 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. 1.2.12. Hardware Features- The instrumentation shall have the following: 1.2.12.1. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. 1.2.12.2. All monitors/screens will clearly display information in all light conditions. 1.2.12.4. An Always On uninterruptible power supply (UPS) with line conditioner for each instrument provided as needed. (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. 1.2.12.5. If the proposed instrument system requires an independent water system to operate, the contractor will offer the option to include the water system and all maintenance of the system as part of the CPRR package. 1.2.13. Specific Equipment Requirements- - 1.2.13.1. Single lot of reagent for each test/analyte per shipment with a minimum dating of 90 days. 1.2.13.2. User defined option for patient testing to be disabled if QC failure occurs. 1.2.13.3. The printer should be user defined to print the results real-time or on demand as well as option to print exceptions reports held in the middleware for auto verification purposes. 1.2.13.4. 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. 1.2.14. 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 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. 1.2.14.1. Correlation studies for each analyte. A minimum of 20 samples spanning the reportable range shall be run by the present and the proposed method. In systems where multiple sampling modes exist, mode to mode correlation studies must also be performed. Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall minimally include mean, bias, slope, y-intercept, correlation coefficient, ROC analysis. 1.2.14.2. Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the manufacturer s published measurement range. The material must have values which are within the facility s total allowable error at 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. 1.2.14.3. Precision study using normal and abnormal control material. This shall include, at a minimum, within run and day to day precision studies of 10 normal and 10 abnormal Contractor provided Controls. 1.2.14.4. Sensitivity. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate and false negative rate are applied. 1.2.14.5. Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, biotin or other interfering substances. Validation of serum indices for lipemia, Bilirubin and Hemolysis is required. 1.2.14.6. 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. 1.2.15. 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: 1.2.15.1. 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. 1.2.15.2. 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. 1.2.15.3. If the laboratory is currently using the proposed instrument/reagent system, the in-use reference range can be transferred to the new system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed. 1.2.16. Reports- The Contractor shall provide to the Contracting Officer and other individuals (designated post-award) 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, at 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 contract. These reports will be in an Excel spreadsheet, multiple tabs may be used, to include a summary tab. 1.2.17. Support Features- 1.2.17.1. 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. 1.2.17.2. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, Contractor provided Controls, linearity materials, 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 validate instruments for operation for performance of acceptance testing. This applies to all equipment as well as additional or replacement equipment placed under the terms and conditions of this contract. The Contractor shall perform/assist, 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 the Method Performance/Validation section above and provide a hard-copy and electronic copy of data in an organized, clearly comprehensible format. 1.2.17.3 Go Live: The Contractor shall remain onsite during go-live implementation for a minimum of 72 hours to ensure that all systems and interfaces are functioning. 1.2.17.4 Training: The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility s services and minimally equivalent to the terms and conditions for training defined in the Contractor s Federal Supply Schedule FSC Group 66, Part III, Clinical Laboratory Analyzers contract. This training will include key operator training for 1 operator per system or system line, 1 operator for the preanalytical processor and 1 operator for the middleware. Training shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair for each platform. Thereafter, the Contractor shall provide training for minimally one operator per platform per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant. In addition, basic operator training shall be provided by Contractor on-site for all operators on all shifts, as applicable. 1.2.17.5 Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide, at no cost, emergency equipment repair and preventative maintenance on all primary and back-up instrumentation, primary processing automation line instrumentation and any incremental support/ancillary equipment, e.g. water system, printers, UPS, etc. offered according to the following terms: 1.2.18. Service Requirements 1.2.18.1 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 1.2.18.2 Equipment repair service shall be provided for each facility during operational hours. 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. Onsite equipment repair response time shall be no more than 24 hours for Seattle Campus and no more than one business day for American Lake Campus. 1.2.18.3 Remote Access diagnostic trouble shooting capabilities available with a national ISO Internet Security agreement. 1.2.18.4 Preventative maintenance will be performed as frequently as published in manufacturer s operator s manual and within 2 weeks of the scheduled due date. 1.2.18.5 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: 1.2.18.5.1 Date and time notified 1.2.18.5.2 Date and time of arrival 1.2.18.5.3 Serial number, type and model number of equipment 1.2.18.5.4 Time spent for repair, and 1.2.18.5.5 Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. 1.2.18.6 Each notification for an emergency repair service call shall be treated as a separate and new service call. 1.2.18.7. Uptime Guarantee: The contractor agrees that all equipment provided shall be operable no less than 98% of operational time. Each instrument at each site shall be computed separately. 1.2.18.8 Scheduled maintenance is excluded from downtime. 1.2.19 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 contract; however, it does refer to significant changes in the hardware operational capability. 1.2.20 Ancillary support equipment: The Contractor shall provide, install and maintain through the life of the CONTRACT, 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, preventative maintenance and repair, etc.), printers and universal interface equipment, UPS, 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. 1.2.21 Characterization of waste: The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 Protection of the Environment Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated. 1.2.21.1 The determination and description shall address the following: 1.2.21.1.1 Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24) 1.2.21.1.2 Waste ignitability (Reference 40 CFR §261.21) 1.2.21.1.3 Waste corrosivity (Reference 40 CFR §261.22) 1.2.21.1.4 Waste reactivity (Reference 40 CFR §261.23) 1.2.21.1.5 Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31) 1.2.21.1.6 Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33) 1.2.21.1.7 Solid Waste (Reference 40 CFR §261.2) 1.2.21.7.8 Exclusions (Reference 40 CFR §261.4) 1.2.22 The contractor shall 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. 1.2.23 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 parameters listed below and must be included with contractor response: 1.2.23.1 Barium (Total) 1.2.23.2 Cadmium (Total) 1.2.23.3 Chromium (Total) 1.2.23.4 Copper (Total) 1.2.23.5 Cyanide (Total) 1.2.23.6 Lead (Total) 1.2.23.7 Mercury (Total) 1.2.23.8 Nickel (Total) 1.2.23.9 Silver (Total) 1.2.23.10 Zinc (Total) 1.2.23.11 Arsenic (Total) 1.2.23.12 Selenium (Total) 1.2.23.13 Tin (Total) 1.2.23.14 pH 1.2.23.15 Flash point (to higher than 200 F) 1.2.23.16 BOD; biochemical oxygen demand 1.2.24 The documentation the contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine if the waste from each device can legally be disposed of via the sewerage system 1.2.25. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed as outlined by Network Medical Facility order. 1.2.26 Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order is accepted by the Government. This also includes replacement, substitute instruments and instruments that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor s technical specification or as quoted at an effectiveness level of 95% or more. 1.2.27 If equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. 1.2.28 If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled Termination for cause. (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.) 1.2.29 Operational use time for performance testing for a system is defined as the accumulated time during which the instrument is in actual use. System failure downtime is that period when any instrument in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor s designated representative at the prearranged contact point until the system or instrument(s) is returned to the Government in proper operating condition. 1.2.30 During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. 1.2.31 The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes. 1.2.32 During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the POC, COR or contracting officer to replace the malfunctioning equipment with new equipment. Each instrument provided by the Contractor shall maintain an uptime of 98% in each month of the term of the agreement for equipment. The same terms and conditions apply to ancillary/support equipment provided under this contract, i.e., water system UPS, etc. 1.2.33. Government s Responsibility- The user will perform routine maintenance and cleaning as required in the manufacturer s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph. 1.2.34. Ownership of Equipment: Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer. 1.2.35. The Contractor will identify if removable media is required to perform their duties. The Biomedical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility. 1.2.36 Prior to termination or completion of this contract, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the contract. 1.2.37 All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the CONTRACT or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be retained by the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the contract or disposal or return of the IT equipment, whichever is earlier 1.2.38 Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are: 1.2.39. Contractor must accept the system without the drive; 1.2.40. VA s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or 1.2.41 The government must reimburse the company for media at a reasonable open market replacement cost at time of purchase. 1.2.42 Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; 1.2.42.1. The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and 1.2.42.2 Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract. 1.2.42.3 A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) Contractor provided Controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation. 2.2.43 Records Management 1.2.43.1 The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract: 1.2.43.2 Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. 1.2.43.3 Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. 1.2.43.4 Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. 1.2.43.5 Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. 1.2.43.6 Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. 1.2.43.7 The Government Agency owns the rights to all data/records produced as part of this contract. 1.2.43.8 The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. 1.2.44 Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. 1.2.45 No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.
