Sources Sought Notice Sources Sought Notice Page 6 of 6 Sources Sought Notice *= Required Field Sources Sought Notice Page 1 of 6 THIS REQUEST FOR INFORMATION (RFI) IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI IN ACCORDANCE WITH (IAW) FAR 15.201(e). DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), 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 RFI. SOURCES SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is a sources sought/RFI only. The purpose of this sources sought/RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 334510 (size standard 1,250). Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses for a solicitation announcement. The Department of Veterans Affairs (VA), VISN 22 Network Contracting Office, is seeking sources that can provide an ISTAT System that meets the following Statement of Work and specifications for the VA San Diego Healthcare System. This contract will be a Blanket Purchase Agreement (BPA) with a Base + 4 option years (5 years). **Abbott Laboratories** CONTRACT LINE ITEM & DESCRIPTION Quantity EG7+ iSTAT CARTRIDGE / 03P76-25 9000 CHEM8+ iSTAT CARTRIDGE / 09P31-26 4000 ACTk iSTAT CARTRIDGE / 03P87-25 2000 cTnl iSTAT CARTRIDGE / 03P90-25 2000 Statement of Work IStat Point of Care 1. SCOPE: 1.1 Contractor shall provide all equipment, reagents, standards, controls and any other item required for the proper operation of its contractor owned analyzers and peripherals necessary for the generation of a combination of the following test results: blood gas (arterial, venous, mixed venous), chemistry testing (glucose, creatinine, Sodium, Potassium, chloride, BUN, ionized calcium), Hemoglobin/hematocrit, Troponin, Kaolin Activated Clotting Time cost per test (CPT) services on behalf of the VA San Diego Health Care System (VAHCS), 3155 La Jolla Village Dr, San Diego, CA, 92161. Services shall be required for a base one year period with four one-year options for renewal. 1.2 Analyzers are specialized instruments for the testing of specific parameters of whole blood for therapeutic monitoring and routine screening. The analyzer(s) offered by the contractor shall be portable, bedside units for use primarily in the clinical areas of the hospital. Services shall be provided to the VA San Diego Pathology & Laboratory Medicine Service (P&LMS) in San Diego CA, 92161. 2. DEFINITION/ACRONYMS: 1. Cost Per Test (CPT): The loaded cost charged to the VA by the contractor each time the equipment is used by the VA. The loaded cost shall be all inclusive and incorporate, as a minimum, the following: (a) Equipment use (b) All reagents, standards, controls, supplies, parts, accessories and any other item required for the proper operation of the contractor s equipment (c) Any software or program necessary for data management (d) Any middleware necessary for the generation and reporting of a test result in VISTA. This middleware must be capable of supporting other instrumentation in the resulting of tests at the Point of Care (e.g. glucometers, blood gas coox analyzers, etc.) (e) All necessary maintenance to keep the equipment in good operation condition (this element includes both preventive maintenance and emergency repairs) (f) Training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge. 2. San Diego Health Care VA System 3. CAP - College of America Pathologists 4. JC Joint Commission 5. QC Quality Control 3. GENERAL REQUIREMENTS: 3.1 Offered models of clinical laboratory analyzers shall be capable of producing accurate and reproducible assays on blood by established in vitro diagnostic methods. Models shall provide accurate test assay results for sample specimens up to the manufacturer s defined maximum test per hour without excessive malfunctions, breakdowns, or service calls. 3.1.1 Offered equipment shall be current state-of-the-art equipment. Remanufactured and discontinued models will not be accepted. 3.1.2 The awarded contractor shall provide all upgrades to the equipment hardware and operating system software, at no additional cost to the Government. The contractor shall provide or include in the Cost per Test technical support for the software programs required for data management and interfacing results into VISTA. These enhancements shall be delivered and installed at each participating VISN 22 medical facility within 60 days of issuance to the commercial market. 3.1.3 The models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, current production shall mean that the clinical laboratory analyzer model is being manufactured as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. 3.1.4 An operator s manual shall be furnished with each instrument supplied to VA and updates to the manual shall be provided in a timely manner. 3.1.5 Contractors offered analyzer shall conform to all facilities existing space constraints. The hand held portable point of care unit, capable of being used at the bedside, provided by the contractor shall fit within an approximate 12 X 12 X 12 space. 3.3 In the event that the consumables 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 shall deliver the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the contractor shall deliver to all participating facilities 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 will be honored by the contractor until the arrival at the Government site of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory may result in default. 3.4 Inventory Control Reagents, Supplies and Disposable: The contractor shall maintain on Government provided space a continuously stocked inventory of reagents, standards, controls, supplies, and any other material required to properly perform tests on the offered equipment. These items shall be of the highest quality ensuring sensitivity, specificity and tested to assure precision and accuracy. The quality of the products shall be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission (TJC). 3.5 Maintenance and Repairs: 3.5.1 With the exception of the specific maintenance and repair requirements stated herein, which shall have precedence; preventive maintenance, emergency repair, maintenance credit for equipment malfunction, and replacement laboratory equipment shall be performed and provided in accordance with the terms, conditions, and provision of contactor s existing Federal Supply Service Contract for performance of CPT services as stated in Subsection III of the VA National Acquisition Center contract requirements Solicitation (RFP 797-FSS-03-0001). 3.5.2 Emergency repairs shall be performed after initial telephone notification that the equipment fails any parameters. The contractor shall provide the Government with a designated point of contact and telephone number and shall make arrangement to enable his maintenance representative to receive such notification. 3.5.3 The contractor shall repair or replace (replace defined as in place and functioning in the facility), at any/all locations specified in the Statement of Work, any malfunctioning equipment within forty eight (48) hours after receipt of initial telephone notification of a malfunction. Contractor shall provide maintenance coverage 24-hours per day, seven days per week including all Federal holidays for VA Health Care System in San Diego. Contractor shall provide technical support service to assist in troubleshooting 24-hours per day, seven days per week including Federal holidays. 3.5.4 In-addition to above the contractor shall furnish a malfunction incident report to the installation 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(s) of equipment Time spent for repair Description of malfunction and repair, and Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. 3.5.5 During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflect a downtime of 5% of greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government at the using facility to replace the initial laboratory equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer s instruction, shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 95% in each month of the term of the agreement. 3.5.6 Training: With the exception of the specific training requirements states herein, which shall have precedence; contractor shall provide training in accordance with the terms, conditions, and provisions of contractor s existing Federal Supply Service Contract for performance of CPT services as stated in Subsection IV of the VA National Acquisition Center contract V797P-7322A. 4. SPECIAL REQUIREMENTS: In addition to the general requirements for the Cost-Per- Test requirements states above, the contractor shall meet the following special requirements: 4.1 The contractor s unit shall have software/middleware that is fully VISTA compatible, capable of simultaneous data transfer from the unit to the VISTA system (without upgrade or other software modification), and all hardware /software necessary to transfer data into patient files in VISTA shall be provided at no additional cost to VA. 4.2. System shall provide appropriate quality control analysis system and all components necessary to interface with VISTA. 4.3 Shall have auto quality control to meet CAP standards (1 level per 8 hour shift) 4.4 Provide QC lock out and operator lock out 4.5 QC shall be available in Levy Jennings format, or statistical reporting available 4.7 Shall have ability to run venous, mixed-venous and arterial samples for blood gases 4.8 Shall provide a two (2) to three (3) minutes turnaround time for samples on most tests (Shall provide <5 minute turnaround for tests other than Troponin, ACT which should be <15 minutes.) 4.9 Shall provide data management of patient and QC results included with remote access 4.10 Shall be capable of operating at high altitudes with no interferences 4.11 Shall provide calibrations per CAP requirements 4.12 Require minimal maintenance 4.13 Shall provide ease of use 4.14 Shall have ability to correct for patient temperature, if required for ABG 4.15 Shall be easy to troubleshoot 4.16 All controls and calibrators shall be included in the CPT 4.17 Instruments shall be moveable for transport to bedside without recalibration 5. TRANSITION PERIOD: Upon award, the transition period for the awarded contractor to have all required analyzers, peripherals, consumables, training, correlation studies, reagents, controls, interfaces, etc., installed and fully operational shall be within 30 calendar days after award. Offerors shall provide with their proposal a plan for transitioning services from the incumbent contractor to the new awarded contractor. The contractor s submitted transition plan shall not exceed the required 30-day period contained herein. Failure of the contractor to conform to the transition period shall be considered as sufficient cause to terminate the contract for cause under the Termination for Cause clause of the contract. The VA shall have sole discretion in the decision to terminate for failure to comply. 6. TERMS AND CONDITIONS: With the exception of terms and conditions as stated herein, the contractor shall provide all equipment and service in accordance with the terms, conditions, provisions and schedule of the contractor s existing and future FSS Contract for performance of blood gas, blood chemistry, Troponin, ACT cost per test service for the VA San Diego Palms located at 3350 La Jolla Village Drive, San Diego, CA, 92161. 7. INFORMATION SECURITY AND PRIVACY: The C&A requirements do not apply, and a Security Accreditation Package is not required. The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications. If you are interested and are capable of providing the sought out supplies/services, please provide the requested information as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) Please indicate the size status and representations of your business, such as but not limited to: Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? (2) Is your company considered small under the NAICS code identified under this RFI? (3) Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? (4) If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). (5) If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (6) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract? If so, please provide the contract number. (7) If you are an FSS GSA/NAC or NASA SEWP contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? (8) Please provide general pricing of your products/solution for market research purposes. (9) Please submit your capabilities in regards to the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes? (10) Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. (11) Please provide your SAM Identification Number. (12) Please provide a list of detail requirements and drawings. *** Submissions addressing Section (8) should show clear, compelling and convincing*** evidence that all equal to items" meet all required salient characteristics. Responses to this notice shall be submitted via email to Carlo.manuel@va.gov. Telephone responses shall not be accepted. Responses must be received no later than Monday, November 11, 2024, at 1:00 PM PST. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this request for information. Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation.
