6440 Fargo/BHHCS Chemistry Immunochemistry Base+4 - VISN

1. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK
   1. SCOPE OF PROCUREMENT:
      1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work.  The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).
      2. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. Equipment must maintain or, preferably, reduce the number of workstations or overall labor required to accomplish the required testing by the laboratory.
      3. If Contractor offers a family of analyzers, the technical evaluation panel will determine if instrumentation proposed meets needs of using facility.
      4. New equipment shall be provided.
      5. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted.  These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor.  Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts, should be forwarded to the designated individuals determined at contract award.
      6. 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 regularly scheduled standing order/routine supplies delivery. 
   2. DEFINITIONS:
      1. Cost per Patient Reportable Result (CPRR) - Contractors are required to provide a price for a reportable patient result. The Contractor should provide multiple CPRR options to include one CPRR for all fours sites combined; one CPRR for Fargo volume only, and one CPRR for the VA Black Hills Healthcare System (Fort Meade, Hot Spring, and Rapid City combined).  The per patient reportable result price shall include costs covering: (1) 5 year equipment use; (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation of a patient reportable result.  The per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required to produce a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI);  (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel.  Contractors shall provide delivery, installation and removal of equipment at no additional charge.

NOTES:

Vendors not having the ability (for manufacturing reasons) to supply a component(s) included in the CPRR and/or CPT as defined in the statement of work and evaluation factors must individually specify the item(s) so that effective comparisons can be made between offers.

Vendors offering third party products (reagents or consumables) must individually specify the product, source, reference information, and indicate whether the third-party reagents will be procured by the offeror and if the costs are included in the quoted CPRR. Offeror should certify their technical support of the third-party method on the equipment systems.

1. 1. 1. Contractor Middleware Management System - For the purposes of this solicitation, this is a separate component or module that electronically connects the testing instrumentation to manage data, results and workflow of 2 or more pieces of instrumentation.  (Not to be confused with middleware for interfacing equipment with the hospital/laboratory information system.)
      2. Throughput – The speed that the equipment processes and/or operates reported in units per hour.
   2. Test Menu – Refer to Attachment A CLIN Schedule for desired test menu and estimated annual volumes by laboratory. Preference will be given to the vendor with the most advantageous test platform.
   3. GENERAL REQUIREMENTS
      1. Primary analyzer(s) – Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein.  In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation.  For the purpose of this solicitation, the combination (if required) of a chemistry and immunochemistry analyzer will be considered one primary analyzer.
      2. Operational and Technical Features- The instrumentation offered shall be approved by the Food and Drug Administration (FDA) and be available at the time of proposal submission and have the following:
         1. Testing Instrumentation: The testing instrumentation must be approved by the Food and Drug Administration (FDA) and be available at the time of proposal submission and shall have the following:
            1. The capability of performing analysis on the tests listed in Attachment A CLIN Schedule
            2. Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A CLIN Schedule
            3. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system (Fargo interface manager in use is Data Innovations). The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.
               1. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.
               2. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alphanumeric that may be enabled concurrently.
               3. A barcode reading accuracy rate of 99% or greater.
            4. An instrument management system (internal to testing instrumentation) that provides/maintains the following:
               1. On-board QC data management system with the ability to capture, store and electronically transfer QC data.
               2. Ability to monitor instrument performance.
            5. Continuous monitoring of vital instrument functions with immediate operator notification of failure(s).  A record(s) of the vital instrument function failure(s) must be maintained and stored electronically on-board the equipment.
            6. 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.
            7. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage is not required, but highly desirable.  
            8. Capability to capture, store and print the following information:
               1. 1. Instrument maintenance information.
                  2. Patient demographic information.
                  3. Specimen results.
            9. On board reagent inventory management system must have:
               1. A system that provides reagent data to include but not limited to lot number, expiration date, and the number of remaining tests available for use on the analyzer (per analyte).
               2. Bar coding of reagents and the ability to track reagent containers throughout the testing process using bar code technology. 
               3. A barcode reading accuracy rate of 99% or greater.
            10. Minimal operator intervention when introducing a STAT specimen or when changing a routine specimen to a STAT specimen.  The introduction of a STAT specimen must not compromise existing programmed testing.  
            11. On board reagent stability sufficient to accommodate both high and low volume use.
            12. The ability to detect and alert operator of low liquid levels and the potential of depletion.
            13. The ability to unload/remove and load/add reagent containers from the equipment during operation without interrupting testing in progress is not required, but highly desirable.
            14. The ability to calibrate and support more than one (1) reagent lot of the same reagent on the equipment at the same time.
            15. The capability to calibrate assays during test run without aborting the run.
            16. The capabilities to store, print, and retrieve calibration data.
            17. The ability to continuously load patient specimens.
            18. The ability to detect short samples.
            19. Clot detection with alert notification.
            20. Hemolysis, icterus, and lipemia (HIL) detection with alert notification.
            21. Primary tube sampling from evacuated collection tubes of various sizes and from various manufacturers.
            22. Capable of handling all routine sample collection tubes plus other various sized sample containers, e.g. sample cups (0.5, 1.0, and 2.0 ml), carrier tubes and tube inserts.
            23. The capability to auto dilute a test when defined limits are exceeded. (Contractor shall indicate on Attachment B Chem IC Workbook each analyte that can be set to auto dilute on each instrument model offered.)
            24. The capability to program a test to perform a repeat analysis.  The repeat test result must be able to cross the interface and overlay the initial result. 
            25. 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.
            26. IDMS traceable Creatinine reagent.
            27. Minimal requirements for sample pre-treatment.
            28. Minimal carryover.
            29. Long calibration stability.
            30. The capability of incorporating other manufacturer’s reagents.
         2. Contractor Middleware Management System must have

1. 1. 1. 1. 1. Sufficient memory to store patient information and test records with downloading capability to an external medium for long term storage of patient records and other information.
            2. Patient status display for technologist review.
            3. Supports workflow management that supports all integrated (linked) testing instrumentation.
            4. Technology to automatically repeat testing based on customer configurable testing criteria (repeat testing).
            5. Technology to automatically direct additional specimen testing based on customer configurable testing criteria (reflex technology). 
            6. Contractor shall collaborate with each lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity.
            7. 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. 1. 1. Hardware Features- The instrumentation shall have the following:
         1. 1. All monitors/screens will clearly display information in all light conditions. 
            2. 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). 
            3. 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 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.
      2. Specific Equipment Requirements-
         1. The technology to electronically transmit quality control and instrument function checks and maintenance information to the Contractor Middleware Management System.
         2. The technology to print results in real time or on demand.
         3. Option to print exception reports held in the middleware for autoverification purposes if the facility is using Contractor Middleware for autoverification.
         4. Equipment relocation and possible reinstallation should the equipment need to be moved due to construction or laboratory redesign at no additional cost for one (1) relocation within each site.
         5. CPRR price shall include assayed control products if available.

1. 1. 1. Method Performance/Validation Requirements-

1. 1. 1. 1. Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards, The Joint Commission (TJC), 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.   These validation requirements are applicable to all new testing analyzers.
         2. Correlation studies for each analyte.  A minimum of 20 samples spanning the reportable range, shall be run comparing the present and the proposed method. In systems where multiple sampling modes exist, mode to mode correlation studies must also be performed. Correlation for hard to collect specimens must consist of a minimum of 10 samples. 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, and meet current standards defined by CLSI. 
         3. 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. 
         4. Precision study using normal and abnormal control material.  This shall include, at a minimum, within run precision study of 10 normal and 10 abnormal controls.
         5. Sensitivity.  Sensitivity may be validated concurrently with correlation studies.  Mathematical calculations to determine efficiency, sensitivity, false positive rate and false negative rate are applied.
         6. Specificity Studies.  A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances.
         7. Carryover Studies. Successful carryover studies shall be completed by the contractor on all analyzers during installation.  These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/TJC/CLSI).  The programs shall be provided to each laboratory at no charge.

1. 1. 1. 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.  One of the following protocols shall be used:
         1. A verification of the manufacturer’s suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects.  The manufacturer shall provide specific information defining how the suggested range was determined.  A minimum of 20 reference individuals shall be used to verify the manufacturer’s range.  Any apparent outliers should be discarded and new specimens obtained to provide a statistically valid verification.
         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.
         3. If a laboratory is currently using the proposed instrument/reagent system, the “in-use” reference range can be transferred to the “new” system if a method comparison study between the two systems proves to be acceptable.  If comparison studies are not acceptable, one of the two above items must be performed.
      2. 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 shall not be accepted. There will be no additional charges for any reports required as part of the BPA. These reports will be in an Excel spreadsheet.
      3. Support Features-
         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. 
         2. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item required to establish 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 BPA. 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 of the statistical analysis as stated in the Method Performance/Validation section above and provide a hard copy of data in an organized, clearly comprehensible format.
         3. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services and minimally equivalent to the terms and conditions for training defined in the Contractor’s Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers contract. Initial training to include two operators per analyzer and shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator 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.
         4. In addition to the training above the following shall be provided:
            1. Basic operator training shall be provided by Contractor on-site for all operators on all shifts, as applicable.
            2. Advanced training shall be provided on instrument troubleshooting, advanced middleware rules writing, data analytics, report writing and customization.
         5. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all instrumentation, primary processing automation line instrumentation and any incremental support/ancillary equipment, e.g. water system, printers, etc. offered according to the following terms:
         6. Service Requirements

1. 1. 1. 1. 1. Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.
            2. 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 2 hour(s).
            3. Equipment repair service shall be provided during business hours five days per week (8X5). 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.
            4. Equipment repair response time shall be no more than 24 hours.
            5. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call.  The report shall include, as a minimum, the following:
               1. date and time notified
               2. date and time of arrival
               3. serial number, type and model number of equipment
               4. time spent for repair, and
               5. proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.
            6. Each notification for an emergency repair service call shall be treated as a separate and new service call.

1. 1. 1. 1. Upgrades - 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 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 BPA; however, it does refer to significant changes in the hardware operational capability.
         2. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the BPA, as indicated, any and 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, 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.
         3. Interface Requirements-

1. 1. 1. 1. 1. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.
            2. The Contractor is responsible for successful interfacing and help defining and interpreting the data streams/communication to the VA computerized hospital information system.
            3. Equipment must be configured with keep alive for the connection to the current laboratory interface.

• 1. 1. 1. Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software. 
        2. 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, including wastes that remain in the equipment, such as cartridges, as well as wastes that leave the equipment in the form of water, 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 all 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 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 is otherwise regulated as a waste. 
           1. The determination and description shall address the following:
              1. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)
              2. Waste ignitability (Reference 40 CFR §261.21)
              3. Waste corrosivity (Reference 40 CFR §261.22)
              4. Waste reactivity (Reference 40 CFR §261.23) 
              5. Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31)
              6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33)
              7. Solid Waste (Reference 40 CFR §261.2)
              8. Exclusions (Reference 40 CFR §261.4)
           2. The contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis on 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. 
           3. Contractor will 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, including collection for proper disposal in coordination with the medical center GEMS Program Manager or other POC.  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 vendor response:
• Barium                              (Total)
• Cadmium             (Total)
• Chromium            (Total)
• Copper                (Total)
• Cyanide               (Total)
• Lead                                 (Total)
• Mercury                (Total)
• Nickel                               (Total)
• Silver                                 (Total)
• Zinc                                               (Total)
• Arsenic                             (Total)
• Selenium               (Total)
• Tin                                     (Total)
• Nitrogen               (Total)
• Phosphorus           (Total)
• pH
• Flash point            (to higher than 200°F)
• BOD5; biochemical oxygen demand
  1. 1. 1. 1. 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 whether or not the waste from each device can legally be disposed of via the sewer system.
              1. Documentation requires the manufacturer’s technical staff complete a Manufacturer Waste Evaluation Form (Attachment B). The Chemical Evaluation Form seeks information on the chemical product as applicable in an unused or partially used state and as it exists in use per manufacturer’s instructions.  All ingredients at any concentration must be taken into account as you respond to the questions on the form.
              2. Documentation must include Toxicity Characteristic Leaching Procedure (TCLP) with results reported in mg/L from a representative sample(s) of each individual waste. When determining the representative sample, the vendor must take into account calibrations, cleanings and number and types of tests specific to the analyzer and its use specific to each facility.
              3. If the vendor has all required information prepared in a similar format, this may be submitted in lieu of Attachment B.
              4. The vendor must provide Safety Data Sheets for all products. A hyperlink to access this data would also be acceptable.
        2. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 120 days after the award of the BPA. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe.  Contractor shall not be penalized for implementation timelines that extend beyond the 120 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.
           1. Upon award of the BPA, the transition period for the awarded BPA to have all equipment and peripherals installed and operational shall be from date of award through 120 days.  During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.
           2. Contractor shall provide with its quotation an implementation plan for installation of new equipment.  Contractor’s submitted plan shall not exceed 120 days for the transition of all services under the awarded BPA including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations.  Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate BPA for cause under the Termination for Cause clause of the BPA.

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 BPA Call or BPA.