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Page 7 of 7 DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK Pathology and Laboratory Medicine Service VA WNY Healthcare System at Buffalo Cost Per Test (CPT) and Cost Per Reportable Result (CPRR) A. SCOP... Page 7 of 7 DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK Pathology and Laboratory Medicine Service VA WNY Healthcare System at Buffalo Cost Per Test (CPT) and Cost Per Reportable Result (CPRR) A. SCOPE OF PROCUREMENT This solicitation is for the procurement of ten (10) color Configuration flow Cytometer. and maintenance service, must have the capability of performing or reporting the clinical parameters as defined in the statement of work. The intent is to establish an indefinite Delivery, Indefinite Quantity (IDIQ) contract for a flow cytometer to perform a cost per reportable. The flow cytometer will be utilized for immunophenotyping to aid in the diagnosis of malignancies and perform lymphocyte subset panels. Brand Name only Beckman Coulter s Navios Tetra System B. DEFINITIONS a. 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 controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor s equipment and necessary for the generation and reporting of a test result; (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. b. Cost per Reportable Result (CPRR)- )- are for intermittent or unknown volume tests and will be based upon the intermittent needs of the service for testing availability on the testing platform. The contractor is required to furnish all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor s equipment and necessary for the generation and reporting of a test result. c. Flow cytometer testing analyzer(s) Base equipment that fully supports the scope of their operations (minimal requirements) as defined in this solicitation. 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. The contractor agrees to the following terms of the awarded Contract exclusively with VA WY Healthcare system at Buffalo and is responsible for executing 100 percent of the IDIQ. Additional tests reagents, and instrumentation may be added to the awarded Contract as new technology becomes available on the market and added to the awarded contract. C. TEST MENU Ability to perform the following Tests 10 color panel leukemia/lymphoma panel testing Lymphocyte Subset testing (CD4/CD8 testing) Annual need estimate 1200 tests per year These are estimates only derived from previous and expected future patient care numbers. The list of desired tests is also in Attachment A. D. GENERAL REQUIREMENTS 1. Operational Features - The Flow cytometer instrumentation must have: The desired instrumentation shall have the capability of performing and reporting the clinical parameters as defined in this statement of work. The instrument shall be able to perform the complete profile and meet performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act and the clinical and Laboratory Standards institute. (CLSI). Equipment must maintain or preferably reduce the number of workstations or overall labor required to accomplish the required testing. Sufficient capacity and throughput to meet the volume and service demands as defined in the Test Menu. c) Sufficient 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. An SDS sheet must be provided for each product which is potentially hazardous. d ) Ability to provide remote access for monitoring and troubleshooting instrument problems. e.) A total equipment footprint that when installed in the Laboratory shall not impact the functionality and or operations of the Laboratory. 2. Hardware Features - The Flow cytometer testing instrumentation must have the following: Fully automated system that has been on the market for at least one year and is FDA approved. sufficient capacity and demand to meet the service demands as described in section C Equipment must maintain or preferably reduce the number of workstations or overall labor required to accomplish the required testing. Data archive feature reduces time for administrative tasks Contractor is responsible for any licensing or hardware used to connect to Data Innovations and the Network. Minimal daily maintenance such that analyzer is not required to be down for more than 60 minutes per day The ability to store and retransmit records twenty-four (24) hours of maximal instrument throughput in case of interface outage Accuracy of barcode reading must have less than 1 percent failure rate. The contractor to supply printer and replacement printers when required at no additional cost. The Contractor to supply data display widescreen, flat panel LCD monitor, twenty-two (22) inches or twenty-four (24) inches diagonal. The ability to store and retransmit records in case of interface outage. The ability to read barcode labels on individual tubes. A quality control package used for daily monitoring of system performance and operator notification upon quality control failure. A total equipment footprint that when installed in the laboratory shall not impact the operations or Safety of the Laboratory. 3. Technical Features- The instrumentation must be a fully Automated System that has been on the market for at least one year and is approved by the Food and Drug Administration (FDA). The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this SOW, current production shall mean that the laboratory analyzer model being offered is new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. The Contractor shall clearly identify the primary analyzer being offered with their cost per reportable pricing. Analyzer identification shall include all the following: Analyzer full model name, Year of the analyzer, Analyzer Manufacturer, and the version of Microsoft SQL that will be run on the Analyzer. The Contractor shall be required to complete VA Directive 6550 and the Manufacturer Disclosure Statement for Medical Device Security. These two forms are mandatory as part of the Contractor s proposal package. The Contractor is also required to identify specifically which year of the awarded BPA their Analyzer will be upgraded. If an upgrade of the analyzer will not take place during the period of performance of the awarded BPA, then the Contractor is required to clearly state that their analyzer will not be upgraded at any time during the period of performance of the awarded BPA. One instrument with 2nd workstation included base equipment offered that shall fully support the scope of operations FDA approved software for data management of CD4/CD8 analysis and leukemia/lymphoma testing, manipulation, and interpretation by technologists and Hematopathologists. Laser requirement for ten (10) color configuration and fixed optical system. Two (2) custom panels for leukemia/lymphoma with thirty (30) markers per panel. An uninterruptible power supply. Automatic and manual system compensation to include real time compensation, data analysis, and gating. Fully digital electronics for linear and log for all corrected parameters with post acquisition electronics. The ability to create custom test panels. The ability to provide on board incubation, lysing, and fixing of samples. Minimal sample carryover five percent (5%) for sample pipetting. Reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least six (6) months for reagents. 4. Support Features Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable and disposable items, parts, accessories, and any other item included on the list of supplies defined in the Federal Supply Schedule Contract and required to establish instruments for operation for performance of acceptance testing Supplies - The vendor must provide continuously stocked inventory of reagents, standards, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the contract and required to establish instrument operation such that equipment operations are not interrupted. Testing Method should include antibody coated tubes, if available and precoated tubes with Quality Control, if available. Expiration dates must be clearly marked on reagents, standards, and control containers. Unexpected changes in methodology and technology shall be at the expense of the Contractor. Notify of any delays in shipment as well as any or all technical advisory recalls and alerts, prior to or simultaneously with field alerts should be forwarded to the Contracting Officer Representative. The shipping of all reagents, consumables and supplies shall be FOB Destination, no exceptions. Emergency Orders of Supplies -Special handling for emergency orders of supplies: If 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 twenty-four (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 and or routine supplies delivery. Quality Control Failure/Instrument failure in the event of Quality Control failure, or if equipment operations are interrupted, the vendor will be responsible to pay for emergency Lab specimen testing sent to a Local Pathology Laboratory for testing. All invoices will be forwarded by the COR to the Contractor for payment. The Buffalo VA Laboratory COR will inform the Contractor and Contracting Officer when QC or equipment failure has occurred, and the date specimens will be sent out to local pathology lab for testing. The vendor will perform, to the satisfaction of the Government, all Method performance and validation studies which will include 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 vendor will perform all of the statistical analysis and report data in an organized, clearly comprehensible format. Results shall be consistent with current CLSI guidelines and related documents and Federal regulations. Carryover studies demonstrating absence of any clinically significant carryover shall be completed the Contractor on the analyzer during installation. These studies shall be performed using either Contractor dev eloped programs or developed by CLSI/CAP. The program will be provided to the lab at no charge. Training - The vendor must 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 vendor s Cost Per Reportable Result Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers contract. This will include training on the operation of the system, data manipulation, and basic trouble shooting and repair. The vendor will provide training for two operators for each model of instrumentation placed. Utilization of the training slots will be mutually agreed upon between the VA WNY Healthcare system at Buffalo facility laboratory and the vendor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant. Equipment Preventative Maintenance/Repair Service - The vendor must be able to provide emergency equipment repair and preventative maintenance on all instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms: A technical assistance center must be available by telephone 7am to 10pm EST with a maximum call back response time of 2 hours. Remote access for monitoring and troubleshooting instrument problems must be provided. Equipment repair service must be provided during routine business hours. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements will be coordinated between the contractor and VA laboratory personnel. Equipment response time will be no more than 12 hours. A minimum of two scheduled preventative maintenance calls per year. A malfunction incident report shall be furnished to the installed site upon completion of each repair call. The report shall include, as a minimum, the following: date and time notified date and time of arrival serial number, type and model number of equipment time spent for repair, and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflect a downtime of 2% or greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer s instructions, shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 98% in each month of the term of the agreement. Each notification for an emergency repair service call will be treated as a separate and new service call. Upgrades or Replacement: Request for instrumentation upgrades or replacement, due to workload increase, menu changes, technological upgrades, excessive instrumentation failures/malfunctions, breakdowns, or service calls will be evaluated as needed/annually with communication to the vendor for modification of the contract. A high incidence of problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with other analyzer(s) that can produce the required criteria of this contract satisfactorily to the user. Removal of instrument by the vendor shall be performed within 60 days after request. The vendor must 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 must be provided as they become commercially available and at the same time as they are being provided to commercial customers. Ancillary support equipment - The vendor will provide, install and maintain, as indicated, any and all ancillary support equipment to fully operate the molecular analyzer as defined in these specifications, e.g., installation of telephone lines for modem operations, cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the vendor will include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g., starter kits, tables/stands, etc. Additional testing menu The vendor must provide availability and pricing for additional tests; in the event the VA WNY Healthcare System at Buffalo Clinical Laboratory deems necessary adding new tests/profiles to their in-house menu for the purpose of improving patients care in the future. Invoicing All invoices shall be issued monthly in arrears stating the test name, monthly volume of patient reportable results and the individual cost per reportable price as awarded per contract. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge will not be accepted Computer Interfacing Requirements - The fully operational interface (both hardware and software) must be immediately available for implementation to the VA VistA hospital information system at the time of contract award. The vendor is responsible for providing all hardware required for the connection, implementation and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see requirements below). Likewise, the vendor will provide all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in the chart below. If the site already has a universal interface box, the vendor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g., licenses, ports/cards, cables, software, etc.) to the universal interfacing system. If the site does not have a universal interface and one is needed to optimally interface the instrument, then the vendor is responsible for the acquisition of the universal interface box and everything else needed to connect with VistA. If there are any software upgrades in the instrument during its life, the vendor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VistA. Commercial offerings - The vendor will provide to the VA facility any additional support material that is routinely provided to equivalent commercial customers and will assist in regulatory compliance, e.g., PC computer diskette of their procedure manual or an on-line procedure manual in the instrument software. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 60 days after the award of the contract. This timeline is based on a reasonable attempt of the vendor to complete all the necessary implementation requirements within the stated timeframe. Vendors will not be penalized for implementation timelines that extend beyond the 60-day timeframe, if the extension is through no fault of the vendor and is a result of delays due to the Government. p. 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 decide if the waste is a hazardous waste or otherwise regulated. The determination and description shall address the following: Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24) Waste ignitability (Reference 40 CFR §261.21) Waste corrosivity (Reference 40 CFR §261.22) Waste reactivity (Reference 40 CFR §261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33) Solid Waste (Reference 40 CFR §261.2) Exclusions (Reference 40 CFR §261.4) The Contractor will provide written instructions and training material to ensure VHA laboratory staffs 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. The 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, corrosiveness, 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, thimerosal 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 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) pH Flash point (to higher than 200 F) BOD; biochemical oxygen demand The documentation the Contractor provides will be used to work with the VA Medical Center and the public and/or private organization (e.g., POTW) to determine whether the waste from each device can legally be disposed of via the sewerage system. Upon award of a BPA, the transition period for the awarded contract to have all testing equipment and peripherals installed and operational at the VA WNY Healthcare system at Buffalo facility shall be from date of award through 60 days. During this same period, all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed. Offerors shall provide with its quotation a plan for transitioning services from the incumbent contractor to the newly awarded contractor. Contractor s submitted transition plan shall not exceed 60 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 confirm to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract. At the end of 60 days from award of the contract, the awarded contractor shall have full and sole responsibility for services under the awarded BPA. E. PROPOSALS 1. It is the clear intent of the Government to award this BPA to a single vendor for the VA WNY Healthcare at Buffalo Flowcytometry testing business. 2. The Government will entertain recommendations only for new state-of-the-art equipment. 3. Vendors are asked to submit their base proposals outlining the proposed reagents for the tests included in Attachment A. This configuration should be based on the vendor s best recommendation that meets the operational activities and required efficiencies and productivity of a laboratory of the size and scope defined herein. In addition, the vendors are encouraged to offer alternate equipment configurations (optional proposals/packages) that minimally meet the specifications of this solicitation; yet may enhance the operational activities, efficiencies and the productivity of the laboratory. 4. The Government will make the contract award considering the reagent and/or equipment configuration option that best meets the operational needs of the Buffalo facility and its compliance with the evaluation factors of this solicitation. Optional proposals/packages will be considered once the award is completed. 5. Vendors must provide in their offer the following: a) Cost-per-test or cost-per-kit for the test menu defined in Section C for the Buffalo site. b) Cost per Reportable Result for the test defined in Section C for the Buffalo site. c) Commercial literature and other information describing their compliance with the technical specifications. If the commercial literature does not directly address specific specifications identified in this solicitation, the vendor is required to indicate compliance with those specifications in written format. d) documentation and/or certification that the instrumentation offered will perform analyses with a precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical Laboratory Standards Institute (CLSI formerly NCCLS). e) a reference list of all commercially sold systems in the United States. References should include, if possible, references from other VA medical facilities as well as non-VA facilities. Information should include: name of customer; contact person; phone number; brief description of equipment and service provided; beginning and ending dates when service and equipment was provided. e) vendors must provide a description of all ancillary support equipment that is needed to operate the flow cytometer as defined in the specifications and offered as a part of this agreement. f) list of VA references currently using the VistA software interface for instruments offered and certification that there is a commercially available and immediately implementable vendor computer interface to the VA VistA computer system that is deliverable at the same time of equipment receipt. It is the sole responsibility of the vendor to insure successful development of the vendor to VA VistA interface. g) an equipment installation schedule. h) a transition plan describing timeframes for the full implementation of the equipment including installation, training and correlations and validations. i) mean failure rate (in days) of each offered piece of equipment j) summary of operator-performed and vendor-performed maintenance procedures including an estimate of time spent in the performance for each category of maintenance. 1. Operator-performed: Offerors must summarize their maintenance procedures and provide an estimate of time spent in performance for each category, e.g., daily, weekly, monthly, semi-annually, etc. The estimate of time spent on daily maintenance would take into consideration starting the equipment from a cold start-up. 2. Vendor-performed: Offerors must describe the frequency of preventive maintenance and provide an estimate of the time required to perform the maintenance. k) a copy of the Federal Supply Schedule contract, if applicable, for which the offer for equipment is based. This copy shall become part of the BPA file. l) an estimate of the travel costs associated with training by category, i.e. transportation, lodging, and meals. This information is necessary as an employee is required to stipulate this information when requesting authorization/approval to travel. 6. Contractors are required to provide delivery, installation and removal of equipment at no additional charge. 7. Vendors that offer multiple types of repair service packages that are different than the minimum requirements stated in the specifications are encouraged to offer an associated adjusted price per reportable. 8. The quantities listed in Attachment A are the VA s best estimate and will be used to evaluate quotations and select the firm to receive the BPA. However, the VA does not guarantee to order these quantities for the Gainesville site listed above. The unit prices quoted shall be incorporated into the BPA and shall apply to the quantities actually ordered by the VA as long as these quantities are within 20%, plus or minus, of the estimated annual volume. The prices used shall be the prices in the vendor s parent FSS contract, if applicable, unless the vendor quotes a different pricing scheme which is incorporated into the BPA. Extra consideration will be given to vendors who quote pricing schemes advantageous to the VA for total volumes that vary by more than 20%. 9. Vendors offering third party products, instrumentation and (reagents or consumables) where the cost is included in the CPT must individually specify the product, source and reference information, indicate whether the third-party reagents will be procured by the offeror and the costs are included in the quoted CPT and certify their technical support of the third party method on their equipment systems. F. EVALUATION OF OFFERS 1. Minimum Requirements. Each respondent for award shall meet all the minimum specifications as outlined in General Requirements. 2. Evaluation Factors. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: a) Evaluation factors: 1) Equipment footprint/physical characteristics (Technical). Consideration will be given to the number and types of instrumentation and its ability to conform to Gainesville existing space, equipment configuration, scalability, integration, throughput, degree of automation, and data management. 2) Breadth of menu (Technical). Consideration will be given to breadth of menu (by specimen type), number of test channels, proprietary versus third party reagents, consistent availability of reagents and supplies (history of product backorders), method assay performance and specimen handling. 3) Performance reliability and ease/efficiency of operation (Technical). Consideration will be given to equipment reliability, record of maintenance service, operator maintenance requirements, calibration requirements, on-board reagent capacity, reagent handling, inventory control management, quality control maintenance and quality control management. 4) Price. Price means the proposed price or cost as identified in the price schedule of the solicitation. Additional costs incurred that are necessitated to ensure the successful operation of the equipment and that will be borne by the Government will be added to the proposed price to insure a fair and equitable price comparison. b) The satisfaction of the Technic...