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-SOURCES SOUGHT NOTICE- 36C24921Q0034 New Base + Options - Blood Gas Analyzer Lexington VA Medical Center, KY **This is not a request for proposals, bids, or quotes. This notice is purely to find capa... -SOURCES SOUGHT NOTICE- 36C24921Q0034 New Base + Options - Blood Gas Analyzer Lexington VA Medical Center, KY **This is not a request for proposals, bids, or quotes. This notice is purely to find capable contractors who can meet this requirement, what their business size is, and to assess whether a set-aside is warranted. This notice does not represent a commitment by the Government to issue a solicitation or award a contract. The Government is not obligated to and will not pay for information received because of this announcement. ** BACKGROUND: This is a new requirement for Lexington VAMC [facility], which requires two identical Blood Gas Analyzer Instrument Systems to conduct a variety of tests for arterial, capillary, venous and mixed venous whole blood specimens. The NAICS code is 334516 with a small business size standard of 1000 employees. VAAR 819.7003 states that the nonmanufacturer rule (NMR) and the Limitations On Subcontracting (LoS) rule apply to ALL SD/VOSB set-aside and sole source contracts. The LoS and NMR applies to all small businesses above the simplified acquisition threshold, which for commodities is set at $250,000.00. Any SDVOSB or VOSB proposing an end product it did not manufacture must meet requirements in 13 C.F.R. 121.406 to be considered a nonmanufacturer and small business under the VA Rule of Two. For example, provide an item manufactured by another small business For example, provide an item manufactured by a large business under a Small Business Administration (SBA) class waiver No SBA class waiver exists for the given NAICS, PSC (6550), and requirement description (Optical instruments, Test Equipment, Components and Accessories). Any interested contractor needs to provide an authorized distributor letter (if not a manufacturer), Manufacturer Disclosure Statement for Medical Device Security (MDS2 ) form from the manufacturer, and answer the following questions: Do you manufacture any of the like, kind, and quality products sought in this notice? If yes, what is your business size? To fall under the definition of a non-manufacturer for set-aside purposes, answer the following: How many employees do you have? Do you primarily engage in the retail or wholesale trade, normally selling the type of item sought it in this requirement? How do you take ownership or possession of those normally procured items? Are the items you selling produced by other small businesses? troubleshoot, repair, or generally work on the system? f. Do you keep any of these products in your own inventory/stock? Do you offer all the products and services under existing Federal Government contracting vehicles? if yes, please provide the contract number/identifier. list the contract line items (CLINs) or schedule items (SINs) that would most match the products and services in the Requirement paragraph below. What is your product 510k premarket Notice reference? What is normal/standard delivery period including installation once an order is made? If not a manufacturer, can you provide an authorized distributor/reseller letter from the original equipment manufacturer (OEM)? Note: The SD/VOSB cannot simply be a middle-man or pass-through, which places an order on behalf of the VA with a small business (or large business if class waiver is available), for something the SD/VOSB does not routinely sell, that the subcontracted small or large business delivers directly to the VA, without the SDVOSB taking either ownership or possession of the item. SCOPE The Lexington VA Healthcare System requires two identical Blood Gas Analyzer Instrument Systems to conduct a variety of tests for arterial, capillary, venous and mixed venous whole blood specimens. Measured tests include pH, pCO2, pO2, Oxygen Saturation (SO2%), Total Hemoglobin or Hematocrit, Oxyhemoglobin (O2Hb,) Carboxyhemoglobin (CO Hb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb). This contract will be for one base year and four option years. The contractor shall provide the analyzers, service, and all supplies/ reagents needed to provide testing. The contractor shall perform to the standards in this contract. The contract is to lease through cost per test, cost per reportable or monthly invoice, not a purchase of equipment. The purpose of this Statement of Work (SOW) is for the Government to obtain the greatest overall benefits in response to the requirements. GENERAL REQUIREMENT The contractor shall provide the facility with analyzer/equipment and printer, (on board instrument or interfaced to a printer), reagents, control, calibrators, linearity material, disposables, any consumable parts or supplies necessary for analyzing/testing, and printing results from analyzer for the life of the contract. Vendor shall list the consumable parts provided. Contractor shall state any parameter/function that is pending FDA approval at the time of submission. The Contractor must provide all necessary training to support the installation and implementation (including operation, cleaning, and troubleshooting) of the equipment. SYSTEM REQUIREMENTS Tests required to be included in Analyzer provide are; pH, pCO2, pO2, SO2, THb, O2Hb, COHb, MetHb, HHb and various calculated values (Base Excess, TCO2, etc) Annual volume is estimated to be 3500 patients. The instruments shall be able to perform the complete profile described above discretely by either direct or indirect (calculated) measurement and meet the performance characteristic for accuracy and precision as defined by the 1988 Amendments to the Clinical Laboratory Improvement Act (CLIA) and the Clinical Laboratory Standards Institute (CLSI) The instruments shall have: -Effective Clot Detection to avoid instrumentation malfunction and inaccurate analysis. In addition, the sampling system must immediately alert the operator that a sample is not positioned properly or if insufficient sample quantity is found. -Direct sampling from blood gas syringes and other blood collection tubes, without adaptor. Sample size should be indicated. -continuous sensor status/ sample monitoring with corrective actions. -Measurement cartridge based or sensor cassette analyzers must offer multiple test size cartridges to meet the needs of the laboratory. Reagent / solution packs should be storable at room temperature. -start up time of no more than one hour. -minimal maintenance required. -the ability to be move cartridges/reagents/consumables from analyzer to analyzer to optimize usable life. -On Board internal Quality control sampling that follows the same pathway as patient samples, three levels for blood gas and co-oximetry. Quality control must run automatically without operator intervention and automated corrective actions. -On board data management system to include Levy-Jennings graphs, calculating mean and SD. -necessary safeguards/ monitoring to ensure Individualized Quality Control Plan (IQCP) is not required for use. - Calibration that is automatic yet programmable at appropriate required intervals. The system must alert the operator of a calibration failure. - built in printer or a contractor suppled printer. -barcode scanner, allowing multiple scanning options The contractor shall supply: -Initial method validation along with correlation studies done by the contractor with VA personnel (precision, accuracy, initial linearity /calibration verification with AMR, carryover) -all necessary training to support the installation and implementation, including use, cleaning, troubleshooting of equipment. - definition of the actual hands on maintenance time required for daily, weekly, monthly, and as needed maintenance. - supply specification of calibration frequency of one point, two point, and system calibrations in accordance with regulatory requirements. -an electronic copy of the blood gas equipment procedure/operator manual and online procedure manual in the instrumentation software. -Uninterruptible power supply for analyzers. The instrument must have the ability to function for at least 45 minutes on a battery backup. -Service engineer available within reasonable distance. Service coverage available minimally Monday through Friday, 8am -5pm.Telephone technical assistance available 24 hours per day, 365 days per year. Preventative maintenance performed by contractor once per year. -replacement parts if found not functioning properly by contractor or customer per warranty. Contractor must provide list of items/parts with cost that would not be covered under contract/ warranty. -Bidirectional computer interface. The fully operational interface must be immediately available for implementation to the VA system and Data Innovations (DI) middleware system for real time data transmissions, including instrument LIS physical connection and translation (drivers) compatible with DI and VISTA; any additional interface connection (hardware/software) and contractor technical assistance with interfacing analyzers. -upgrades, hardware and software, to equipment at no additional cost. -if required, the contractor is to complete with their proposal the Medical Equipment Pro procurement Assessment (VA Directive 6550 Appendix A) for the Office of Information Technology (OI & T) for the facility for any medical devices that will be connected to the VA information network. Delivery The awarded contractor must provide an implementation plan for delivery, installation, set-up, training and connectivity within 30 days of award. Invoices and Payments The contractor shall invoice orders, with payments made by the VA Finance Center, Austin, Texas. Security and Privacy of VA Sensitive Information All media (hard drives, DVD s, Floppies, etc.) that contains sensitive data must be surrendered to the Medical Center (Biomedical Engineering) any may not leave VA property. All Contractor-owned media (USB drives, DVD s, CD s, Floppy disk) that is to be inserted into a medical device must be scanned by Biomedical Engineering prior to being placed in the medical device Interested parties may identify their interest and capability to respond to the requirement and submit pertinent documentation (e.g. brochures, written responses to questions, OEM letters, MSD2, etc.) supporting capability by Friday, November 6, 2020 at 11:59pm CST to: Daniel.Tibitoski@va.gov. Responses received will be reviewed; however, a determination by the Government not to compete the proposed procurement based upon responses received to this notice is solely within the discretion of the Government. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.