Inactive

The West Texas VA Health Care System (WTVAHCS) in Big Spring, Texas is seeking Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), and other small business sou... The West Texas VA Health Care System (WTVAHCS) in Big Spring, Texas is seeking Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), and other small business sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 12. NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE. The North American Industry Classification System (NAICS) is 334516. Any SDVOSB, VOSB, or small business firms who wish to identify their interests and capability to provide this product must provide product specifications, performance and delivery information by notifying the Contract Specialist no later than NOON PM Central Time, April 12, 2019. Notification shall be e-mailed to Robyn Nussbaum, at robyn.nussbaum@va.gov. Any vendor who responds to this Notice must provide credentials to perform the requirement as outlined in the below scope. DISCLAIMER This Sources Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Notice that is marked as proprietary will be handled accordingly. In accordance with the Federal Acquisition Regulation, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Notice. SCOPE: The West Texas VA Health Care System is requesting a Cost per test (CPT)/ Cost per Reportable (CPRR) lease contract for an automated blood cell analyzer and an automated cell image analyzer for performing Complete Blood Counts with differentials (CBC) and automated slide reviews/ differentials. The contract will be for one base year plus four option years. GENERAL REQUIREMENTS Contractor shall provide all labor, material, maintenance, tools, equipment, technical/maintenance manuals, training, travel, delivery, and accessories necessary to furnish the equipment defined herein. The contract proposal will include the equipment, preventative maintenance, and service. It will also include all reagents, supplies, consumables, (other than ink and paper), assay controls, calibrators, and parts necessary for the performance of complete performance of tests listed below. REQUIRED: Tests Estimated Volume Annually Complete blood count/w Differential 28000 Reticulocytes 800 OPTIONAL: Tests Estimated Annual Volume Reticulocyte Hemoglobin Content 700 Body Fluid Testing 25 The agreement includes reagents, controls, calibrators, buffer, M-F 8-5pm service, consumables and maintenance parts, and other supplies needed, all analyzers and printers for all instruments and as needed replace printer at no cost. The analyzers will be installed and assist with validation by the vendor. Vendor will ship the required reagents, calibrators, controls and other consumable supplies to the facility described above on scheduled monthly basis. Vendor will provide support for interface connectivity to all facilities. Vendor will provide support with calibration of the instruments through secure connectivity. DEFINITIONS/ACRONYMS: A. CO - Contracting Officer C. Contractor and/or Supplier/Installer - Company performing work under this contract. D. NFPA - National Fire Protection Association. E. VAMC - Department of Veterans Affairs Medical Center F.. VAH - Department of Veterans Affairs Hospital G. JACHO - Joint Commission On Accreditation Of Healthcare Organizations H. FSE - Field Service Engineer/Technician I. UL -Underwriters Laboratories J. OSHA Occupational, Safety and Health Administration K. OEM Original Equipment Manufacturer EQUIPMENT REQUIREMENTS 1. Specifications of component equipment as set forth in this section are minimum specifications, unless otherwise stated, and shall not be construed as limiting the overall quality, quantity or performance characteristics of items furnished in the system. The Contractor Furnished Equipment (CFE) shall meet or exceed the minimum requirements and shall be held responsible for the supply, performance and overall quality of the contractor s furnished equipment. 2. All equipment to be supplied under this specification shall be the newest and the most current model of a standard product of a manufacturer of record. A manufacturer of record shall be defined as a company whose main occupation is the manufacture for sale of the items of equipment and which: a) Maintains a factory production line. b) Maintains a stock of replacement parts for the item. c) Maintains engineering drawings, specifications, operating manuals and maintenance manuals. d) Has published and distributed descriptive literature and equipment specifications on the equipment. 3. Automated blood counters and differential equipment must meet the following specifications: The vendor will provide the facility with Food and Drug Administration (FDA) approved analyzer/equipment, software, reagents, controls, calibration materials, disposables, and any consumable parts necessary for analyzing/testing. Tests shall be vendor supported. The analyzer must be able to perform all assays listed in number 17. The vendor shall provide state of the art technology that shall include flow cytometry to measure and differentiate cell types. Equipment shall have accurate capability of monitoring reagent usage. The vendor shall provide/install any routine and special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to: printers, UPS, interface boxes and surge suppressors. Any items excluded by the vendor shall be delineated in their technical proposal. The cost of the excluded items shall be incorporated in the price proposal. Must meet performance and characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). Sufficient capacity to meet the volume and service demands of a minimum of 1650 samples/month for Blood Counter. The analyzer must be able to perform testing on low volume specimens down to 1 ml of sample. Bi-directional, bar coded computer interface. The fully operational interface (both hardware and software) must be immediately available for implementation to the VA Vista hospital information system/and or Cerner LIS system for real time data transmissions. Interfacing requirements to be provided by the vendor: Instrument LIS physical connection and translation (drivers). Must be compatible with Vista, and Cerner Information systems. Any additional hardware and software needed to interface the analyzer and technical assistance with interfacing the analyzer The total equipment footprint, when installed, must not negatively impact the functionality/ operations of the Pathology & Laboratory Service nor will it require significant and/or costly infrastructure changes. (The department counter tops are modular and can be adapted without constituting a major infrastructure change.) Printer with capability of printing a chartable patient report. Uninterruptible power supply for each analyzer. Automated sampling system. All analyzers must have cap piercing sampling capability for vacutainer tubes of various sizes with no sample preparation necessary. Analyzer shall have diluting capability with the analyzer calculating the final result. System shall accept blood, and other body fluids. System shall have positive sample identification to reduce possible sources of error/delay and to improve laboratory efficiency. System shall have a design that removes the possibility of reagent or sample carryover. Carryover studies shall be performed, as applicable, as part of the initial evaluation of the instrument. Vendor shall provide interpretation of the raw data as part the install. Vendor shall also provide documented evidence confirming the system design removes the possibility of any reagent or sample carryover. System must have documented evidence that there is no reagent carryover interference with other onboard assays. The analyzers must have a comprehensive QC Program which includes at a minimum the following options: QC files with automatic calculations of mean and standard deviation of individual lots with data storage. The ability to view and print daily and monthly QC results The ability to view and print Levy Jennings graphs On-line documentation of out of range QC QC acceptance criteria built in Equipment shall be able to store and retransmit records (24 hours of maximal instrument throughput) in case of interface downtime. Must have ability to backup and store patient data on external media. Must be able to perform assays listed below. Blood Counter Assays Complete Blood Count with automated 5-part differential and platelet count Reticulocyte count required; immature reticulocyte fraction CBC without differential Nucleated red blood cell count Flagging for immature white blood cells and immature granulocyte count Vendor shall list the reagents and calibrators that require any additional preparation prior to use such as warming/mixing/reconstitution. Vendor shall list the reagents/waste receptacles requiring treatment before disposal. Vendor shall also list all reagents/waste that is considered above normal toxicity and/or hazard. Vendor cannot be including remotely monitored maintenance/troubleshooting software program that electronically transmits critical operational and administrative information from instruments to our internal systems via a secure Internet connection. This secure, encrypted technology will enable transfer of key logs, report generation, and remote services developments. It should also offer the potential to improve inventory management by enhanced troubleshooting information made available to a technical support group, a portal to access instrument logs, files, maintenance information, software version, proactive instrument operations monitoring, predictive instrument maintenance, and QC data collection for peer review. INSTALLATION AND VALIDATION Throughout the life of the agreement, the vendor shall provide assistance to the user in setting up and maintaining/trouble shooting user-defined assays as additional tests are brought in-house. TRAINING Throughout the life of the agreement, the vendor shall provide assistance the user in setting up any new assays and/or software revisions. SERVICE AND MAINTENANCE Instrument support service shall provide assistance with troubleshooting and repair of the analyzers. On-site service shall be available Monday through Friday during regular business hours (8am-5pm). The support service shall follow-up all down time calls within 1 hour. The vendor shall provide a twenty-four hour/seven-day service hotline with technical support. The vendor shall provide a preventative maintenance schedule to include timely scheduled vendor preventative maintenance visits as required. The vendor shall supply engineering controls if necessary for any heat, humidity, or noise issues that may result from use of the proposed system. Vendor shall provide standard and routine software and hardware upgrades to the equipment hardware and operating systems, without additional charge to the Government (e.g. upgrades that correct or improve either the mechanical operations or software of the system and would keep the instrument performing optimally). Vendor shall define daily, weekly, monthly, and as needed maintenance and the time required to perform each maintenance task. Vendor shall indicate which tasks are user level and which are service level. For reagents with hazardous constituents, vendor shall provide a mechanism for the Laboratory to meet local discharge requirements. The vendor shall supply information regarding any hazardous chemicals OTHER Request for instrumentation upgrades or replacement due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls shall be evaluated as needed/annually by the laboratory with communication to the vendor for modification of the contract. A high incidence of such 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 another analyzer(s) that can produce the required criteria satisfactorily to the user. The vendor shall remove all equipment within 90 days after notification of the expiration of the terms of this agreement but not until the completion of new vendor's equipment installation inclusive of completed cross over studies. Vendor shall be responsible for removing the hard drive and turning it over to the VA for destruction prior to removal of any analyzer. The vendor shall reimburse the facility for any costs/supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, or other vendor related factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction. In the event that the any consumable, reagent, or other necessary item are found to be defective and unsuitable for use with the vendor's equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of 24 hours after receipt of the verbal order for priority delivery from the facility. If either circumstance has occurred, the vendor shall deliver to the facility, in the most expeditious manner possible, without additional cost to the facility, the necessary consumables in sufficient quantity so testing is not delayed. This contract should assist the West Texas VA Health Care System to pursue the goal of being a good steward in our community by eliminating, minimizing or mitigating adverse environmental impacts. The following chemicals have been targeted by the EPA specifically for reductions and feasible elimination. Please list any reagents (and in what concentration) that contain the following chemicals: Benzene Carbon tetrachloride Chloroform Dischloromethane Methyl ethyl ketone Toluene Methyl isobutyl ketone Xylenes Tetrachloro-ethylene Cadmium 1,1,1-Trichloro-ethane Chromium Trichloro-ethylene Cyanide Lead Mercury Nickel PAST PERFORMANCE The following will be reviewed: Quality of Service (to include timeliness of service, documentation and communication of work/repairs at time of service, does service repair/fix the problem on the first site visit or does service have to return to repair/fix the problem again, are parts/tools available when service is performed or is service delayed due to ordering replacement parts), and technical support including method validation, Ability of the vendor to supply accurate data for annual contract renewal by required time frames and timeliness of billing reconciliation. Customer satisfaction: meets or exceeds expected turnaround time with negligible downtime. Vendor shall list reagent recalls/bulletins and within the last five years. Vendor shall also list reagent unavailability due to manufacturing issues within the last five years. INTERFACE Transfer of data is bidirectional and will occur in the following manner: INSTRUMENT DATA INNOVATIONS VISTA (LIS) The following data fields will be collected: Prime ID Specimen ID Patient ID Priority Action code Sample type Collect date Collect time Creation date Creation time Last name First name Middle name Sex Birthday Location Analyzer Station Test name Data is transferred from VISTA to a Data Innovations Secure Network Interface (SNI) device which is then sent to the instrument, using the appropriate format. Once testing is complete, the instrument sends the result back to the SNI which then sends the result back to VISTA in the appropriate format. All testing is performed by Pathology & Laboratory Medicine Service staff using appropriate procedures, access and verify codes. VA sensitive information is stored in the VISTA/LIS database and all records are backed up on disk and stored in a secure, location, (disks in locked drawers behind locked doors ) per regulations. Data will be available to providers using CPRS system. The above ppi will stay on the instrument s hard drive for about one month and then will be written over by new patient data. At the end of the contract the hard drive and any other data storing devices will be removed from the instrument and be taken to IRM for disposal.