W065--Two (2) RAPIDPoint® 500e Blood Gas Systems and Associated Reagents

THIS IS A BRAND NAME OR EQUAL SOURCES SOUGHT NOTICE ONLY. This is not a solicitation for bids, proposals, proposal abstracts, or quotations. The purpose of this Sources Sought Notice is for market research to obtain information regarding the potential availability and capability of qualified Service Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), Small Business Manufacturers, other Small Businesses interested and capable of providing items requested, as well as any large businesses. This source sought is UNRESTRICTED and seeks providers capable of fulfilling the requirement in accordance with the Statement of Work and Salient Characteristics. The responses received from interested contractors will assist the Government in determining the appropriate set-aside and the appropriate acquisition method. The intended contract is a firm-fixed price supply purchase. The SBA Non-Manufacturer Rule is not applicable as a class waiver exists under NAICS code 334516 -Analytical Laboratory Instrument Manufacturing under which this requirement will be procured. The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 20, Puget Sound VA Health Care System (VAHCS) is conducting market research to identify potential contractor sources which can provide Brand Name or Equal for the following: Two (2) RAPIDPoint® 500e Blood Gas Systems and Associated Reagents on a Base + 4 Option Years contract for the Department of Veterans Affairs VISN 20 in accordance with the attached Salient Characteristics and Statement of Work. Potential sources having the capabilities necessary to provide the above commodities which meet all the requirements outlined in the attached statement of work are invited to respond to this Sources Sought Notice via e-mail to Dane.Gift@VA.Gov no later than noted in the RFI. No telephone inquiries will be accepted. Appropriate responses shall include the following information: Company name, address, and business size; point of contact name, phone number, and e-mail address; A capability statement addressing the requirements in the attached Salient Characteristics to include: References for similar commodities currently being provided or previously provided (if any) at the required service levels as outlined in the Statement of Work and Salient Characteristics Capability Statement Capability to provide required supplies at VISN 20 in accordance with the Statement of Work and Salient Characteristics NAICS Code 334516 is applicable to determine business size standard. Disclaimer and Important Notes: This Sources Sought 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. The Government will treat any information received as proprietary and will not share such information with other companies. Any organization responding to this Sources Sought Notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to supply the required commodities. 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 submitted. The Government may or may not issue a solicitation as a result of this announcement. There is no solicitation available at this time. The Department of Veterans Affairs, NCO20 is looking for BRAND NAME or EQUAL sources of the following (Base+4 OYs): Items (Per Year) Qty RP500e BLOOD GAS ANALYZER 2 UPS STANDARD 120V 2 Warranty Service RAPIDPOINT 500e PLUS 2 Years 2 Extended Service RAPIDPOINT 500e PLUS 3 Years 2 MCART LAC 250 Test 1 MCART LAC 400 Test 1 MCART LAC 750 Test 24 Salient Characteristics: The Chemistry Department of Puget Sound Health Care Systems requires two (2) new blood gas analyzers that provide the following attributes: The blood gas platform selected is a comprehensive, whole blood critical care analyzer that combines blood gases, electrolytes, metabolites, co-oximetry, and calculated results in a simple, compact device. The platform combines maintenance-free, replaceable cartridge technology for sensors and reagents The analyzer uses non-lysing whole blood co-oximetry technology. The analyzer must produce very rapid and complete testing within one minute. The analyzer will provide bidirectional connectivity and an onboard data management system. The platform menu must include, but not limited to, the following: pH PCO2 TCO2 PO2 Hct Na+ K+ Cl- Ca++ Mg++ Glucose Lactate HHb O2Hb MetHb COHb SO2 O2 tBil HbF tHb BarP The platform will have a mechanism to prevent clots from entering the sample path. The platform will use liquid QC to meet CLIA guidelines Samples can be aspirated directly from the syringe Proficiency samples will not require adaptors Foot print of analyzer will not exceed 14.2 inches wide, 15.5 inches deep, and 18.2 inches tall to meet laboratory countertop restrictions. The platform will have an onboard thermal printer and a back up battery source. The platform will have the capacity to provide the following reports: - Calibration Report - Cartridge Log Report - Daily Sample Log Report - Edit Log Report - Error Log Report - Maintenance Log Report - Operator Setup Report - Patient Report - Levey-Jennings QC Report - QC Corrective Actions Report - QC Data Report - QC Statistics Report - QC Setup Report - Sample Audit Log Report . Statement of Work Scope of Work VA Puget Sound Health Care System is in need of two (2) Whole Blood/Arterial Blood Gas/Critical Care Metabolites Analytical Instrument Systems to conduct a variety of tests on our patient population. These analyzers and supplies must be provided to both Seattle and/or American Lake and/or any VAPSHCS campuses per the estimate given in the Statement of Work. The purpose of this Statement of Work (SOW) is for the Government to obtain the greatest overall benefit in response to the requirements. I 1.0 REQUIREMENTS/SERVICES TO BE PROVIDED: General Requirement The vendor shall furnish all clinical laboratory supplies and services as described herein to the participating VAMC facility in accordance with the applicable Federal Supply Schedule contract. Attachment 1 (Test Volumes) can be utilized by interested contractors to submit their cost proposal. A listing of the estimated yearly quantity is provided under this agreement located in Attachment 1 (Test Volume). Quantities listed in the attachment to this RFQ are estimates based upon prior history of actual volumes and are intended to provide the potential contractor a basis for calculating their pricing. They are not a guaranteed minimum. The pricing shall be based on new equipment. Remanufactured or used models will not be accepted. The vendors offered blood gas analyzer/system(s) must conform to the facility s existing space. The dimensions of this space are 7 X 2.5 in Seattle and 16 X 24 in American Lake. The analyzer/equipment must meet the test volume in Attachment 1 and match or improve the turnaround time requirements. The system should streamline all aspects of testing, thereby improving efficiency and productivity of the using facility. The vendor shall provide the facility with Food and Drug Administration (FDA) approved analyzer/equipment, reagents, controls, calibrators, linearity material, disposables, any consumable part necessary for analyzing/testing on the analyzer. Vendor shall list the consumable parts provided. Vendor shall state any parameter/function that is pending FDA approval at the time of the submission. B. System Requirements: The desired blood gas/critical care metabolite instrumentation must have the capability of performing and/or reporting the following parameters on arterial, venous, or mixed venous whole blood specimens: pH pO2 pCO2 Hemoglobin Hematocrit Sodium Potassium Chloride Ionized calcium Glucose Lactic Acid Base excess Bicarbonate Total carbon dioxide (TCO2) Oxygen saturation Co-oximetry (or similar technology to fractionate hemoglobin species) In addition, the analyses must take place on a single instrument and a single specimen. The instrument shall be able to perform the complete profile described above discretely by either direct or indirect (calculated) measurement and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the National Committee for Clinical Laboratory Standards (NCCLS). The system must have standardization of software, hardware, reagents, and consumables between the primary and back-up analyzers throughout the facility (mirror image redundancy). The vendor shall provide the facility, for the duration of the contract, with all reagents, controls (both blood gas, chemistry, and co-oximetry), calibrators, disposables, any consumable part (inclusive of replacement parts per manufacturers maintenance guidelines, aspiration devices, etc.), necessary for analyzing/testing on both the primary and back-up analyzers to produce a patient result. All linearity material and any commercial system correlation samples needed may be provided to meet CAP requirements. Vendor must provide a printer and all thermal paper for generating paper copy of results, and provide a replacement printer as needed. Vendor shall specify calibration frequency of one point, two point, and system calibrations in accordance with regulatory requirements. The system must alert the operator of a calibration drift. Vendor must provide on-board commercial quality control for every twenty-four hours of operation to include: three levels for blood gases, at least two levels for chemistry, and three levels for co-oximetry to be analyzed on each analyzer at the facility. The system must have a sampling system that can aspirate directly from a syringe or an evacuated blood collection tube and can accommodate any sample type without any additional adapter devices. The sampling system must have the capability of walk away processing that negates the need for additional instrument prompting. The vendor must also state the sample size required for patient testing. The sampling system must immediately alert the operator that a sample is not positioned properly, there is insufficient sample quantity, and have early clot detection that alerts the operator to the suspected existence of a fibrin clot in the specimen. The vendor must define the methodology for clot detection. The system must have ready to use reagents that have on board stability greater than or equal to 30 days. Vendor shall list all reagents needed for blood gas/chemistry/co-oximetry analysis, the format/size of the reagents, and if the supplies are stored at room temperature or refrigerated. Vendor may state if reagents and controls are color-coded. Packaging should be maximized to accommodate the specimen volume at the facility and not require a frequent exchange of inventory on the equipment. The system may provide reagent inventory, in real time that can be printed at selected time intervals for reagent documentation. The system must be programmed to perform and execute auto quality control without operator intervention. Perform automatic corrective action on the system if the results of the quality control testing are not acceptable and have the ability to lock out/suppress a test if there are QC failures. The vendor is to define the actual hands-on maintenance time required for daily, weekly, monthly, and as needed maintenance. The vendor is to include the analyzer time required to perform each maintenance task. Vendor must list which tasks are user level and which tasks are service level. Systems that use electrodes must have minimal maintenance, electrode replacement must be accomplished easily, and the new electrode must be operational within two hours of replacement. The analyzer may have on-board integrated maintenance and trouble-shooting procedures. The vendor must provide a comprehensive QC program, provide QC for all tests listed in Attachment 1 and must provide the following options: QC files may be edited or corrected for errors manually with/without password Protection Have on-board quality control data storage (for at least 90 days) and reporting Capabilities Ability to view/print daily, monthly QC results and Levy-Jennings graphs. Ability to visually alert the operator of QC (Westgard/user defined rules) failures. Electronic transfer of QC Data to vendor without the need for manual entry Automatic enrollment in a Quality Assurance program that has peer participation of at least 50 participants that are not part of VISN 20 network. Reports of peer data will be current and available within 2-4 weeks of the data submission for hard copy review. The vendor must supply equipment that performs satisfactorily at any laboratory relative humidity between 15 to 85 percent and any laboratory temperature between 50 to 100 degrees Fahrenheit. Instrumentation and Software: The vendor is to complete with their proposal the Medical Equipment Pre-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. The vendor will provide evidence of VA approved remote network communication system that continuously collects and monitors performance data of the analytical systems following all the policies and procedures outlined in the VA Directive 6500, Information Security Program, and its handbooks to ensure appropriate security controls are in place (see Appendix A in Section D). The system may have the ability to manage patient information through a data manager. Including the acceptance of test ordering information, transmittal of patient laboratory patient results, storage and retrieval of patient laboratory results. Retrieval of patient or instrument data must be in a Microsoft Windows compatible format. The equipment shall include 120-volt UPS that has a 2 3-hour back-up capability for all analyzers. The vendor will be responsible for replacing the UPS should it become dysfunctional and provide battery replacement as needed. The system will support multiple barcode formats including but not limited to Code 39, Code 128 and Coda bar that may be enabled concurrently. The system must accept at a minimum, a 10-character specimen identifier that is alphanumeric (letters and numbers). The vendor must provide the following interfacing requirements: Instrument LIS physical connection and translation (drivers) Routing must be fully supported by all laboratory instrument interface partners, especially Data Innovations, Inc. Any additional hardware and software needed to interface the analyzer and technical assistance with interfacing the analyzer. Any required (additional) interface connection license(s) Instrument-LIS interface must be bi-directional. Provide documentation of successful interfacing with other VA facilities (provide two VAMC references) Interface must use automatic host query to download sample IDs, test requests, and patient demographics. Automatic host query must seamlessly integrate with onboard patient sample barcode scanning and translation. Instrument interface must transmit test results to the host computer system via automatic upload. The system shall have computer capabilities that are compatible with customer LIS software, provide CD-ROM/DVD player, minimum 17-inch flat screen panel LCD display monitor with built-in speakers, optical mouse, and laser jet printer. The blood gas instrumentation must have a printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient s name, social security number, order number, and phlebotomy site. Vendor may list programmable options for patient demographic report. The system shall have an automatic back-up function to store all data from the hard drive. Vendor must describe the back-up option in submitted proposal. Would prefer if data back-up was exportable by USB flash or CD-DVD drive and in a Microsoft Windows compatible format. The system must be able to store and retransmit records (24 hours of maximum instrument throughput) in case of interface downtime. The system may have the ability to edit sample/patient identifier after interface downtime and then be able to resend the sample/patient information to the host for verification. The vendor must provide all upgrades to the equipment hardware, software, and operating systems without additional charge to the Government (e.g., upgrades that correct either a mechanical or software deficiency of the system). These enhancements to the vendor s equipment shall be delivered and installed at the site within two months of their issuance or date of first commercial availability. The vendor will always maintain compatibility of systems with whatever host LIS is in place, especially when vendor software is upgraded. The vendor must remove all equipment within 90 days of the expiration of the terms of this BPA but not until the completion of the new vendor s equipment installation inclusive of completed cross over studies. The facility, per their protocol, will be responsible for the removal/erasing of the hard drive at analyzer removal/upgrade. Installation: The vendor shall list analyzer/utility requirements (electrical, water, plumbing, reagent and bio-hazardous disposal, temperature, humidity, etc.). The vendor shall provide weight and dimensions of proposed analyzers. The vendor must indicate any routine and /or special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to: paper, printer cartridges, drainage systems, surge suppressors, etc. Any items excluded by the vendor shall be delineated in their proposal. The cost of the excluded items must be incorporated in the price proposal. The vendor shall provide the facility with all reagents, calibrators, control, and any cross-over supplies needed at installation and during training of staff. The vendor must pay all shipping costs for the analyzers and all supplies needed for the installation, correlation studies and training of staff. Test counts for billing will begin after all CAP required studies, performed at installation of new equipment, are reviewed and approved. At installation/set-up the vendor/technical support specialist shall perform all validation studies including installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy CAP standards), reference range studies, staff training, in-services to laboratory personnel and clinicians, and assist with any methodology problems and questions. The service must be available during regular office hours on a 5 days/week basis. The vendor must provide equipment installation and possible reinstallation costs if the equipment is required to be moved due to construction or laboratory redesign. The vendor will work with the facility to adjust reagent supply to match workload changes and to provide the option annually for the facility to adjust the shipment table. The vendor shall state what their policy is in regard to adjusting a standing order or ordering an additional shipment of supplies. Training/Procedures: The vendor shall provide all necessary procedure manuals, troubleshooting manuals, operator manuals, technical manuals for computer interfacing, MSDSs, etc. (also available on computer disc). Procedures must be in the Clinical and Laboratory Standards Institute (CLSI) format. The vendor must provide primary user training for a minimum of two users per instrument with on-site training available to the remaining users on all tours (or shifts) with competency assessment performed and documented. Primary user training is to include all costs of off-site training, i.e., transportation (air and ground), room and board, etc. Support Services: The vendor must provide a preventative maintenance schedule to include a minimum of two scheduled preventative visits per year for the duration of the contract. The vendor shall replace any analyzer/equipment that is provided during the terms of this BPA that has not been repaired to the workable satisfaction of the facility. Should the repair record of any individual analyzer/equipment reflect a downtime of 5% or greater of the normal working days in one calendar month, a determination will be made by the designated representative of the using facility/clinic to replace the initial laboratory analyzer/equipment with new analyzer/equipment. Each analyzer/equipment provided by the vendor shall maintain an uptime of 95% in each month during the terms of the agreement. The vendor shall provide instrument support service sufficient to aid with troubleshooting and repair of the analyzers. The vendor may list their service options available. Or the following service options may be available: 24 hours/day, 7 days/week or from 08:00 17:00, 7 days/week. For any site that may encounter the rare occasion when both analyzers are inoperable (service has now escalated to emergency status), service shall immediately dispatch a field service engineer for repair. Vendor is to explain their policy in relation to service if the occasion should occur when all analyzers are inoperable. The support service must follow-up all down calls within 1 hour. The FSR will always keep the facility informed of the timeline for when repairs are to be completed. All repairs on instrument must be completed (at no cost to the facility/clinic) within 24 hours from the time the field service engineer arrives. The vendor will provide twenty-four hour/seven-day service hotline with technical support. All calls will be answered within one hour via telephone. Service is to include all travel, parts for repair or replacement, and labor. The vendor will pay all routine shipping fees for supplies, consumables, and equipment to perform testing at initial installation and with routine supply delivery. If all instruments are inoperable: The vendor shall pay for the laboratory testing at a reference facility if the equipment requiring repair is inoperative due to malfunction through no fault or negligence of the facility for a total of more than 24 hours. The cost incurred from the reference facility testing, packaging and shipping will be applied to the invoice in the form of a credit or deduction. Downtime for each incident will start from the time the facility makes a bona fide attempt to contact the vendor s designated representative until the analyzer is returned to good operating order. If the consumables are found to be defective and unsuitable for use with the vendor s equipment, or the vendor has failed to comply with the requirements for routine supply delivery, the vendor shall deliver the consumable supplies within a period of 24 hours after receipt of the verbal order for priority delivery from the facility/clinic. If either circumstance has occurred, the vendor will deliver to the facility, in the most expeditious manner possible, without additional costs to the facility, the necessary consumable in sufficient quantity until the arrival of the standing order/routine supplies delivery. The vendor must provide replacement parts and any components necessary for the operation of the instrument(s) to produce patient results. Past Performance/Technical Excellence: Availability of four (4) references (two VA and two from the private sector) which can validate past experience within the last three (3) years regarding: a. Quality of Service (to include timeliness of service, documentation and communication of work/repair 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 vendor to supply accurate data for annual contract renewal by required time frames and timeliness of billing reconciliation. Customer satisfaction: meets or exceeds turn-around with negligible downtime. The vendor will include within its proposal the national average of service calls per analyzer per year. The vendor shall list reagent recalls/bulletins within the last five years. The vendor shall list any product unavailability due to manufacturing issues within the last five years. The proposed equipment should have at least one-year proven experience and be available on the Federal Supply Schedule. II 2.0 VALUE ADDED CHARACTERISTICS: The vendor will provide replacement parts and any components necessary for the operation of the instrument(s) to produce patient results. The system may have the ability for the electronic transfer of the manufacturer s QC ranges to the instrument without the need for manual entry. The system may have the ability to have on-board documentation for out-of-range quality control and instrumentation problems. The analyzer may have onboard maintenance records that can be modified for additional user defined maintenance records and printed at selected time intervals for maintenance documentation. The system may have a touch-screen interface in addition to the keyboard and mouse. The vendor may provide on-site refresher training in renewal option years of the contract if so exercised. User also has the option of sending one additional staff member per analyzer for primary off-site training in renewal option years. Renewal option year training is to include all costs of off-site training, i.e., transportation (air and ground), room and board, etc. The system may list additional parameters such as lactic acid, creatinine, blood urea nitrogen, etc. that can be analyzed on a patient sample. The system may have FDA approval for pH of other body fluids. The system may have the ability to have on-board parallel QC lot capability, allowing for old and new lot QC to be run consecutively for validation for effective time management and CAP compliance. III 3.0 OTHER TERMS AND CONDITIONS: Unless otherwise agreed upon by both parties, Terms and Conditions of this BPA will be determined by the vendor s current Federal Supply Schedule contract with the General Services Administration or VA National Contract Center. All pricing will be based on and shall not exceed the vendor s most current FSS contract pricing for supplies offered. This shall be based on Period of Performance: 1 May 2024 to 30 April 2025 Base Year 1 May 2025 to 30 April 2026 Option Year 1 1 May 2026 to 30 April 2027 Option Year 2 1 May 2027 to 30 April 2028 Option Year 3 1 May 2028 to 30 April 2029 Option Year 4 ATTACHMENT 1 ANNUAL VOLUME: TEST VOLUME ABG 6800 GLUCOSE 6800 IONIZED CALCIUM 12,176 CO-OXIMITRY 280 LACTIC ACID 4600 NOTE: VA Puget Sound Health Care System workload increases 2.5% each year, on average. Potential contractors shall provide, at a minimum, the following information to Dane.Gift@va.gov. 1) Company name, address, and point of contact, phone number, e-mail address, and SAM UID. 2) Please identify your company s size in comparison to the anticipated North American Industry Classification System (NAICS) code 334516 Analytical Laboratory Instrument Manufacturing. To be considered a small business your company must have fewer than 1,000 employees. This notice is to determine the marketplace for this specific requirement. Please check one of the following: [ ] yes [ ] no Service Disabled Veteran Owned Small Business (SDVOSB) [ ] yes [ ] no Veteran Owned Small Business (VOSB) [ ] yes [ ] no Small Business Manufacturers [ ] yes [ ] no All other Small Business (SB) [ ] yes [ ] no Other than Small Business 3) The Government is not obligated to, nor will it pay for or reimburse any costs associated with responding to this sources sought notice. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Notice to Potential Offerors: All Offerors who provide goods or services to the United States Federal Government must be registered in the System Award Management (SAM located on the web at www.sam.gov). It is desirable that any Respondent should have completed their business Online Representations and Certifications Application in the System for Award Management (SAM). 4) Any Service Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. 5) If not a manufacturer, only authorized representatives/providers/distributors of the manufacturer will be considered. Equipment must be new, no used or refurbished equipment accepted. Please provide a proof of authorized dealer or reseller letter from manufacturer. 6) This is a brand name or equal requirement. As such, the salient characteristics reflect the physical, functional, or performance characteristics that equal products must meet to satisfy the Government s needs. To be considered for any potential solicitation, offers of equal products, including equal products of the brand name manufacturer, must: (a) Meet the salient physical, functional, or performance characteristic specified in this sources sought; clearly identify the item by Brand name, if any and make/model number. (b) Include descriptive literature such as illustrations, drawings, or a clear reference to descriptive data or information available that identifies that the equal item meets or exceeds the salient characteristics required by the Government. Responses are due by 04/8/2024 5:00 PM EST, to the Point of Contact. Shipping Address: Puget Sound VAHCS 1660 S. Columbian Way Seattle, WA 98108 Point of Contact: Dane Gift Contracting Officer Dane.Gift@va.gov