Inactive

THIS IS A SOURCES SOUGHT ANNOUNCEMENT FOR INFORMATION ONLY. THIS IS NOT A SOLICITATION FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. In preparation for a future procurement, th... THIS IS A SOURCES SOUGHT ANNOUNCEMENT FOR INFORMATION ONLY. THIS IS NOT A SOLICITATION FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. In preparation for a future procurement, the VA Medical Center Buffalo, is performing market research to gain knowledge of potential qualified sources and their size classification (service disabled veteran owned small business, veteran owned small business, hub zone, 8(a), small disadvantage business, woman-owned, small business, or large business) relative to NACIS 334516 (size standard 500 employees) that can offer IHC instrumentation for staining surgical pathology slides cut from tissue biopsies and Surgical Specimens. The Government is seeking a system consisting of an instrumentation system, reagent test kits, quality control reagents, and training and technical support in a Cost-Per-Test (CPT) or Cost-Per-Slide (CPS) arrangement for a base year plus 4 (four) option years. Instrument Service: CPT/CPS must include unlimited on-site service and repairs 8 am to 5 pm Monday through Friday except observed holidays. Required preventative maintenance must also be included with all labor, travel, and parts included. Interested companies should submit an electronic statement outlining their company's capability and capacity to provide the product, the specifications of their units, and the delivery time to deliver the product to each facility. Also, firms should provide their business size status in accordance with the small business administration guidelines (www.sba.gov) for the NAICS code they fall within. This Sources sought is for informational purposes and all businesses able to provide these supplies are encouraged to submit information regardless of Business size. Please email statements of capabilities to Sam DeMuzio no later than Friday, June 5, 2020 at 4:00PM Eastern time to sam.demuzio@va.gov. This notice is to assist the VA in determining sources only. A solicitation is not currently available. If a solicitation is issued it will be announced later, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. Responses to this sources sought announcement are not considered adequate responses to any future solicitation announcements. Statement of Work Immunohistochemical (IHC) Instrument with Fluorescence In-situ hybridization (FISH) and In-situ hybridization (ISH) Testing 1.0 Background Immunohistochemistry (IHC) is a key diagnostic tool in tissue pathology. Once the slides have been prepared using the IHC system they are sent to a pathologist for diagnosis. IHC stains are used to visualize antigens and proteins in a tissue with the help of enzymatically or fluorescently labeled antibodies. The Clinical Laboratory Immunohistochemistry Stainer needs to be an automated system for drying, dewaxing, cell conditioning, application of antibodies, detection, and counterstain chemistry. The instrument platform must include In-situ hybridization (ISH) testing and Fluorescence in situ hybridization. (FISH) The automated IHC instrument must be FDA approved and must process an average minimum of ninety (90) slides in less than 10 hours. Clarity and consistency of staining is paramount for proper patient diagnosis. The instrument must utilize a flexible open system which can employ any available primary antibody or detection system which is commercially available. An open system has the ability to accept third party reagents. The open system must be compatible to creating custom staining protocols and run multiple detection systems and chromogens in a single run while retaining optimal staining results. The VAWNY Healthcare system at Buffalo estimates a test volume of 500 slides per month. Cost per Test (CPT) - The Contractor is required to provide a price for each test that can be performed on their equipment. The per test price shall include costs covering the following: (1) Five-year equipment use. (2) All reagents, standards, quality controls, supplies, consumables and disposable items, parts, accessories, and any other items required for the proper operation of the Contractor s equipment and necessary for the generation and reporting of a test result. 3) Printer and print cartridges /toner as needed. All products to be shipped FOB Destination without any exceptions. (3) All necessary maintenance to keep the equipment fully operational to include emergency repairs. Daily, weekly, and monthly Preventive Maintenance is the responsibility of the Laboratory Technicians. (4) Training for Government personnel. (5) The Contractor is required to provide delivery, installation, and removal of their equipment upon contract completion at no additional charge. (6) Fully automated or semi-automated system that requires minimal hands on technician time to complete testing of all parameters. Clinical Laboratory Immunohistochemistry (IHC and ISH) System - - Automated system for drying, dewaxing, cell conditioning, application of antibodies, detection, and counterstain chemistry. 2 Description/Specifications 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. All products to be shipped FOB Destination without any exceptions. All reagents supplied must have expiration date of at least six months. All pricing must be provided on an excel spreadsheet for all items which are required to produce a satisfactory test result. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Unexpected changes in methodology/technology/product 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 Buffalo Laboratory Contracting Officer Representative (COR), lab chiefs, and the VISN program office. These individuals shall be identified upon award of the contract. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the SOW. The equipment must maintain or preferably reduce the overall labor (technologist time) required to accomplish the required testing. Test menu Refer to Attachment A for desired test menu and estimated annual volumes. Industry Standards Unless otherwise stated, all equipment shall be held to current industry standards for such equipment as present within the current market for Immunohistochemistry (IHC) equipment, supplies and services. 3.0 Instrumentation Specifications: 3.1 Operational/Technical Features - The instrumentation offered shall provide the capabilities detailed below. Equipment shall be new, state of the art, and not used, recertified nor refurbished. Equipment shall be acquired for Clinical Laboratory located at the Veteran Administration Western New York Healthcare System (VAWNYHCS) at Buffalo. The system must be an open system which allows use of reagents from third party vendors, and ability to create custom protocols. Use of third-party reagents must include acceptable value of cost per test to the government. Sufficient capacity and throughput of an average minimum 90 slides in ten hours or less to enhance turnaround time and allow for maximum productivity and service demands as defined in the Test Menu. Provided instrument shall be able to accommodate a 20% increase in workload during the period of this agreement. The IHC system must consistently deliver only the amount of reagent required with no cross-contamination between slides. Fresh reagents must be applied to each slide. A reagent capacity of a minimum of 35 reagents. Positive identification of slides and reagents to minimize errors. Must have the ability and flexibility to add and remove reagents without interrupting cases in process or impacting workflow including capability to prioritize the stains in process. Ease of use with reagent handling, i.e., barcoded reagents to prevent or reduce reagent mix up, ability to load reagents on as needed basis in an expeditious manner. Pre-packaged bulk solution reagent kits with no mixing and continuous access to bulks and waste for improved workflow. Techs must be able to access waste with minimal delay for slide processing. The system must perform IHC, ISH and FISH, and have capability for fully automated overnight runs. Technician intervention not required once slides and reagents have been loaded onto instrument, once daily maintenance has been completed. ALK FISH method must be FDA approved and provide quality results as interpreted by VAWNY healthcare system at Buffalo pathologists. See attachment A for list of specific Antibodies and Companion diagnostics which must be included in cost per slide. The system must be fully automated and provide slide pretreatment, baking , deparaffinization, and cell conditioning . Optimal quality of slide staining as determined by VA WNY Healthcare system at Buffalo Staff pathologists. Method of performance, comparison, and equipment validation shall be at the expense of the Contractor and shall include all lab supplies and reagents. The IHC instrument shall not be connected to the VA Lab Vista computer system. Once the Buffalo VA Converts to the Cerner Information system, we may want to interface the instrument. Data Management and Software capabilities must provide services to interface with laboratories computer system, reports and workload reports. Vendor will provide server, hardware and software and printer with toner and printer supplies as needed by Buffalo Lab. Sufficient safety features to avoid unnecessary exposure to bio-hazardous and chemical material. The exposure to and the volume of bio-hazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling. Vendor must provide information of Average waste generated per slide VA Safety regulations require strict control of chemical waste disposal. The system must separate hazardous waste from non-hazardous waste for GEMS and EPA compliance: 40 Code of Federal Regulations (CFR) Title 40: Protection of the Environment Part 261- Identification of Hazardous Waste. Provided analyzers shall be able to accommodate a 20% increase in workload during the period of this agreement. Minimal maintenance required, Vendor must specify time required for daily, weekly and monthly maintenance. There shall be easy access to the instrument for the technical operator to perform maintenance. 3.2 Hardware/Software Features Instrumentation, reagents, consumables and all other provided equipment shall have a total footprint that, when installed/stored in the laboratory shall save space and shall not negatively impact the functionality/operations of that laboratory. This footprint shall not require significant and/or costly infrastructure changes. The physical system must have a footprint in order to meet the confined space of the existing laboratory space. Hardware should include a 2D compatible digital barcode reader to provide positive identification for all specimen IDs. The equipment must also support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Accuracy of bar code reading must have a 1% failure rate. Equipment must accept, at a minimum, a 10-character, alphanumeric specimen identifier (letters and numbers). Easy slide insertion with minimal handling of slides. Ability to store and retransmit records in case of interface outage. Have independently functioning slide staining chambers, or equivalent solution, to preserve sample integrity. Have the ability to add short turnaround time (STAT) slides with no interruption to routine runs. The instrument must be continuous processing and have the ability and flexibility to add/remove reagents without interrupting cases in process or impacting workflow including capability to prioritize the stains in process. Ability to load slides with delayed start time, and fully automated overnight runs. Pre-packaged bulk solution reagent kits with no mixing and continuous access to bulks and waste for improved workflow. Optimized protocols with flexible options including variable incubation times and temperatures. An on-board, adjustable monitor/screen that is easily readable. The system includes a printer that has the capability of printing clear, legible and easy to read reports, printer toner and printer supplies included in price of contract. Replacement printer provided as needed. An uninterruptible power supply with line conditioner for each instrument will be provided. Instruments will be evaluated for ease of use by VAWNY at Buffalo pathologists and Lab supervisor. The software must be user-friendly, easy to navigate, and provide reliable programs to manage testing, slides, reagents, workflow and chemical waste. Equipment shall have accurate metering capability for monitoring reagent usage and reagent level detection. Reagent tracking must include product code, LOT number and expiration date. The Contractor may in the alternative provide another means of tracking reagent usage and reagent level detection if the metering capability is not practical. System will have an effective automatic detection and tracking of insufficient reagent quantities and alert for tests remaining. The instrument shall include buttons and barcodes that automatically register and locate staining kits and slides. Barcoded reagents in which the Instruments must have capability to ensure that one can't use reagents if they are expired or if the volume of the reagents is insufficient to complete the run. Information must be provided regarding waste capacity and how often bulk waste and hazardous waste must be emptied. Waste volume report must be provided by vendor. Provide instrument Operation Manual printed copy at each facility and electronic procedure manual in the instrument software. The procedure manual shall be formatted in accordance with current approved CLSI guidelines. 4.0 Test and Data Management: Method/Performance of Testing Method of performance/comparison shall be at the expense of the Contractor, shall include all reagents, be approved by the Food and Drug Administration (FDA) to perform the services/requirements as described and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act and related documents, College of American Pathologists (CAP) Standards and federal regulations and via validation of the VA. Instrument must be FDA approved. 5.0 Support Features: 5.1 Installation/Site Preparation: Site preparation specifications shall be furnished in writing by the Contractor as a Site Preparation Report after award. The report shall be provided to the CO at least ninety (90) days before installation. The Contractor shall visit each site and propose the location of equipment and determine specific site prep requirements including but not limited to: Space availability Power availability Availability of waste drainage systems Increase heat load affecting air conditioning Specialized ventilation if required Special finishes required Carts for non-floor standing instrumentation Equipment shall be new, state of the art, and not be used, recertified or refurbished. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies and required to establish instruments for operation for performance of acceptance testing. The Contractor shall provide technical support for the performance of the instrument to the satisfaction of the Government, all validation studies including: stain quality precision, method comparison with current instrument , accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no additional cost to the Government. Validation must be performed to the satisfaction of the Lab medical director. The Contractor shall perform all the statistical analysis as stated in 4.0 and report data in an organized, clearly comprehensible format. The Contractor shall visit each facility at minimum one (1) time per quarter to review the account, provide product information, answer questions, provide Customer Service, handle any defective merchandise, and take care of any other issues that have not been resolved. The schedule shall be created post-award directly with the point of contacts provided at the time of award. 5.2 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 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 (1) 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. 5.3 Service and Maintenance Plan - The Contractor shall provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation (or equivalent solution or better), as applies, and any incremental support equipment, e.g. water system, offered according to the following terms: The Contractor shall provide remote support for trouble shooting. A technical assistance center shall be available by telephone Monday through Friday from 6 am until 6 pm with a maximum call back response time of two hours. Equipment repair service shall be provided at minimum of Monday through Friday from 8- 5 pm. 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. Equipment repair service response time shall be no more than twenty-four (24) hours. If an instrument cannot be repaired within 4 days, a replacement instrument will be provided. A minimum of two (2) scheduled preventative maintenance calls per year at each facility, once every six (6) months unless otherwise stated within a deviation document. A deviation shall be granted if this deviation is in the best interest of VISN under CO discretion. 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: 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. Each notification for an emergency repair service call shall be treated as a separate and new service call. A copy of each service/maintenance record shall be provided to the corresponding VA facility COR within five (5) working days of service/maintenance completion. The Contractor will immediately notify the CO and Contracting Officer s Representative (COR) of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled/defective products at no cost to the Government. The Contractor may be liable for costs processing recalls, i.e. administrative and clinical services to replace recalled/defective products. 5.4 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. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide on-site training by support specialists for minimally one (1) operator 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 included in the Blended CPRR/CPT price. In addition, remote training shall be included. 5.5 Upgrade/Updates - The Contractor shall provide updates 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 updates that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, update 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. Should the facility decide to upgrade their current equipment, e.g., replace existing equipment with newer models, the CO and Contractor may do so under a signed supplemental agreement. 5.6 Information Technology Considerations - Ancillary support equipment - The Contractor shall provide, install and maintain, as indicated, any and all ancillary support equipment to fully operate the instrument as defined in these specifications, e.g. cabinetry to support/house the instrument (if necessary), water systems (including consumable polishers, filters, etc.), 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. The Contractor shall be 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 In the event the VA Buffalo lab needs to interface the instrument, The Contractor shall provide any and 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. 5.7 Commercial Offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and shall assist in regulatory compliance, electronic copy of the procedure manual and electronic copy of software instructions. 5.8 Characterization of hazardous waste The Contractor shall provide a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations and address the criteria listed in the Code of Federal Regulations (CFR) Title 40 Protection of the Environment Part 261 et al. In addition, the list shall also identify any hazardous materials defined as Hazardous under the latest version of Federal Standard No. 313 that may be provided as a part of this contract. Material Safety Data Sheets (MSDS) shall be submitted for all products. The Contractor will provide a complete chemical analysis of waste, to include mercury, sodium azides, carcinogens, reproductive toxins, acute toxins and all other waste that may be considered ignitable, corrosive, reactive or toxic. Subsequent waste analysis studies for any new test or new test formation introductions shall be provided. Documentation of all analysis will be provided to the CO for review. The description shall address the following: Waste toxicity (Reference 40CFR261.11 and 40CFR261.24) Waste ignitability (Reference 40CFR261.21) Waste corrosivity (Reference 40CFR261.22) Waste reactivity (Reference 40CFR261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40CFR261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40CFR261.33) Solid Waste (Reference 40 CFR261.2) Exclusions (Reference 40 CFR261.4) The Contractor shall provide a written guide describing the proper disposal and care of all reagents, consumables and equipment. The Contractor shall also provide their own reports of effluent studies associated with their instrument. The Contractor will provide written instructions and training material to ensure all required 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 their equipment may discharge so that the Laboratory 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 Laboratories 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 the Contractors proposal: 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 Centers to determine whether the waste from each device can legally be disposed of via the sewerage system. The systems shall be totally self-contained excluding waste and shall not require external water, pressure, or vacuum. The Contractor shall provide a waste stream analysis for each proposed instrument and if any waste requires special handling before disposal. 6.0 National Holidays: The Laboratory is not open on National Holidays ALL Deliveries must arrive before 3pm Federal Holidays consist of: New Year's Day Martin Luther King's Birthday President's Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day 7.0 Designation of Contract Officer Representation COR will be designated in writing. COR will be furnishing technical guidance and advice regarding the work being performed under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer. 8.0 Schedule of Items and Implementation Timeframe The Contractor shall provide with their proposal an implementation plan for installation of their new equipment. The implementation of the requirements described in this Statement of Work shall be completed no later than ninety (90) days after the Contract award date. This ninety-day timeframe is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated ninety-day timeframe. The Contractor shall not be penalized for implementation timeframes that extend beyond the ninety day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government. Upon award of the Contract, the transition period for the awarded Contract to have all equipment and peripherals installed and operational shall be from the date of award through ninety days. During this ninety-day time period all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed. Training will include two operators per instrument at the Contractor s location. Further, training shall include provisions for additional training at the Contractor s location or at the VAWNYHCS Laboratory as agreed upon by the Contractor and the Buffalo Laboratory. During this ninety-day time period all initial validations shall be completed to the satisfaction of the Buffalo Laboratory Manager. The Contractor shall provide with their proposal an implementation plan for installation of their new equipment. The Contractor s submitted plan shall not exceed ninety days for the transition of all requirements under the awarded Contract including installation and training of personnel, transition of all testing materials, reagents and supplies, and performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as enough cause to terminate the awarded Contract for cause under the Termination for Cause clause of the awarded Contract. At the end of ninety days from the award of the Contract, the awarded Contractor shall have full and sole responsibility for all requirements identified in this Statement of Work against the awarded Contract. Total period of performance shall not exceed five years. Each option year exercised shall be funded by a separate delivery/task order for each separate facility. REQUIREMENT: Immunohistochemical (IHC) Stainer Cost Per Test (Cpt) Includes Equipment, Consumables, Service & Maintenance in Accordance with Mfg. Recommendations, Training. Contractor shall provide new equipment, reagents, consumables, preventative maintenance, repairs and training. Equipment shall be installed, configured and validated by the contractor. In the event the workload increases, contractor shall be able to fulfill the Government needs. Dates are dependent upon award date: PART I: Base Year: October 1, 2020 through September 30, 2021 PART II: 1st Option Year: October 1, 2021 through September 30, 2022 PART III: 2nd Option Year: October 1, 2022 through September 30, 2023 PART IV: 3rd Option Year: October 1, 2023 through September 30, 2024 PART V: 4th Option Year: October 1, 2024 through September 30, 2025 Price/Cost Schedule: PART I: Base Year: October 1, 2020 through September 30, 2021 CLIN DESCRIPTION QTY UNIT PRICE/EACH TOTAL 1 IHC Autostainer cost per slide format 5000 ea PART II: 1st Option Year: October 1, 2021 through September 30, 2022 CLIN DESCRIPTION QTY UNIT PRICE/EACH TOTAL 2 IHC Autostainer cost per slide format 5000 ea PART III: 2nd Option Year: October 1, 2022 through September 30, 2023 CLIN DESCRIPTION QTY UNIT PRICE/EACH TOTAL 3 IHC Autostaine...