36C26225Q1188 NOTICE OF INTENT TO SOLE SOURCE The Department of Veterans Affairs, Network Contracting Office (NCO) 22, located at 4811 Airport Plaza Drive, Long Beach, CA 90815 is issuing this Notice of Intent (NOI) to inform industry contractors of the Government s intent to execute a Sole Source Award under FAR Part 13 Simplified Acquisition Procedures (SAP), specifically FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items. The intended Contractor is Diasorin, Inc., a large business, headquartered at 1951 Northwestern Ave S Stillwater, MN. 55082 VISN 22 site PhoenixVA Healthcare System (PVAHCS), requires the purchase of a Diasorin, Liaison XL analyzer. This requirement is for a one-time purchase for one (1) instrument for testing purposes only. There is a new separate services contract being implemented VISN wide that will cover the required QuantiFERON Gold Plus (QFT-G) Tuberculosis (TB) testing. This equipment must be able to use the supplies as-is from the OEM without modification. This will allow the PVAHCS test for TB on site and not have to send samples to a reference lab. This will provide a faster response time for continued veteran healthcare services. (See Attachment A - Statement of Work (SOW) herein for further details). Diasorin, Inc., is the only known source that is capable of providing the necessary equipment/instrument fully compatible with QuantiFERON Gold Plus (QFT-G) Tuberculosis (TB) testing. This procurement is being conducted using commercial item procedures pursuant to FAR Part 12 and FAR Part 13, specifically FAR Subpart13.106-1(b)(1)(i) allowing the Contracting Officer (CO) to solicit from one source. The North American Industry Classification System (NAICS) for this requirement is, 334516 Analytical Laboratory Instrument Manufacturing. Product/Service Code for this requirement is 6515 medical and surgical instruments, equipment, and supplies. The Small Business Administration (SBA) size standard for this sector is 1,000 employees. This notice of intent is neither a formal solicitation nor a request for competitive proposals. No solicitation document is available and telephone requests will not be honored. No award will be made on the basis of unsolicited quotations or offers received in response to this notice. Any response to this notice must show clear, compelling and convincing evidence that competition will be advantageous to the Government. The intent of this synopsis is for informational purposes only. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this action based on this notice is solely within the discretion of the Government. All inquiries and concerns must be addressed in writing via e-mail to Marcos Diaz at Marcos.Diaz@va.gov with the following information referenced in the subject line, 36C26225Q1188 Liaison XL Analyzer. A determination by the Government not to compete this proposed procurement based on the responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. All interested parties who are responsible, certified, and capable may identify their interest and may submit capability statement which shall be considered by the agency no later than 7:00 AM Pacific Time (PT) on July 21, 2025 to Marcos Diaz at Marcos.Diaz@va.gov. The interested parties bear full responsibility to ensure complete transmission and timely receipt. SDVOSB/VOSB respondents. If respondent is or SDVOSB or VOSB, respondent is encouraged to provide proof of https://veterans.certify.sba.gov certification. In addition, SDVOSB/VOSB Contractors are asked to acknowledge that they understand the limitations on sub-contracting pursuant to FAR clause 52.219-14, Limitations on Sub-Contracting, which will be included in the impending solicitation. Further SDVOSB/VOSB contractors are asked to respond that they are capable of providing the requested services keeping within the parameters of this clause. Please provide the information below: Company Name: UEI Number: Address: Point of Contact Name: Phone No: Email: Business size information Select all that applies: o Small Business o Emerging Small Business o Small Disadvantaged Business o Certified under Section 8(a) of the Small Business Act o HubZone o Woman Owned o Certified Service-Disabled Veteran Owned Small Business (registered in VetBiz.gov) o Veteran Owned Small Business (registered in VetBiz.gov) FSS/ GSA Contract Holder Yes No FSS/ GSA Contract Number Effective Date / Expiration Date NASA SEWP Contract Holder Yes No NASA SEWP Contract Number Effective Date / Expiration Date STATEMENT OF WORK DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK SCOPE OF PROCUREMENT: The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined within this statement of work. The instrument will be able to simultaneously perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). Equipment shall maintain or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory. If Contractor offers a family of analyzers, Phoenix VAMC technical evaluation panel will determine if instrumentation proposed meets needs of using facility. DEFINITIONS: Capital Equipment Purchase: Capital purchases, also known as capital expenditure or capex, are used to make a substantial investment in long-term fixed assets. This can include purchasing machinery and equipment, land, buildings or other infrastructure, and furniture and fixtures. For the purposes of this acquisition, the Liaison XL Analyzer is Capital Equipment. Business Associate Agreement (BAA) - A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of protected health information (PHI), or that provides certain services involving the disclosure of PHI. VHA is a covered entity under the HIPAA Privacy Rule. HIPAA regulations require VHA to execute HIPAA- compliant BAAs with certain entities that receives, uses, or discloses VHA PHI to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule. Parameter definitions High throughput immunoassay analyzer SALIENT CHARACTERISTICS AND GENERAL REQUIREMENTS TEST MENU: The capability of performing QuantiFERON Gold Plus (QFT-G) Tuberculosis (TB) testing QFT testing is FDA Cleared with the following characteristics: Primary screening Sample specimens Interferon gamma release assay (IGRA) General Requirements: Technical Features - The instrumentation shall be approved by the Food and Drug Administration (FDA) and shall have the following: Due to limited space, instrument dimensions must fit within the following: Footprint less than or equal to: 60 x 80 x 48 (W x H x D), dimensions in inches. Ability to monitor instrument performance. On board reagent inventory system. The vendor shall have the capability to provide limited carryover or disposable tips. Ready to use reagents allow Medical Laboratory Technicians in the operation and testing instead of Medical Technologists which helps relieve the impact on staffing. Ability to load sufficient reagents to complete a run, with the ability to load/add reagents while the instrument is running. On board reagent stability sufficient to accommodate both high volume (>100 per shift) and low volume (1 sample plus required controls per 24-hour period). Reagents able to be directly loaded with tracking performed by RFID chips. On board reagent refrigeration or temperature-controlled environment. Walkaway time at least 5 hrs. when running at full capacity. Limited daily maintenance. Ability to perform partial or full runs without significant wasting of reagents. Ability to run more than 2 different tests simultaneously. Capability to detect out of range quality control. Ability to automatically program the performance of QC testing. Hardware Features - Instrumentation to include the following: Moderate complexity CLIA designation. An on-board monitor/screen. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the accession or unique identifier number (UID). An uninterruptible power supply with line conditioner for each instrument provided. Primary tube sampling. OPERATION - The instrumentation offered shall have the following: Direct loading of wide variety of different tube types without presorting requirements or need to sort by assay type. Ability to view on-board reagent and consumable inventory. The instrument must have a visual notification of instrument status (example i.e., if supplies are missing, if immediate action is required to avoid sample loss, or if an instrument hardware error has occurred). The instrument must have both built in physical and chemical contamination control measures. Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment shall be minimal and require a minimum amount of handling. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system. The accuracy of the barcode reading shall have less than a 1% failure rate. Equipment shall be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Equipment shall accept, at a minimum, 13 characters in specimen identifier that is alphanumeric. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. Support Features Commercial marketing. The equipment models being offered shall be in current production and FDA cleared for testing, 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 offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. 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. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally two (2) operators per facility per year at the discretion of the VA 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.  Contractor may offer two (2) classroom training slots for each participating VA location (base year only) in lieu of in-depth on-site or virtual training, for which the Contractor shall cover the cost of airfare, room and board for each participant traveling off-site. Follow up to classroom training in the base year and any subsequent option years (if requested) will occur on-site with a Field Application Specialist (FAS) in a train-the-trainer model for a minimum of 2 operator) or virtual training.  Training paths may be unique to each VA location. Interface Requirements The contractor shall have and maintain a current Memorandum of Understanding/Information Security Agreement (MOU/ISA) with the VA to provide remote support assistance, diagnostics and systems monitoring capabilities. Vendors not having a current agreement shall agree to completing an MOU/ISA for this purpose at the vendor s expense. The MOU/ISA shall become Attachment E of the contract. 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. 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. Information necessary to make the determination for type and amount of interfacing equipment is supplied. The Contractor is responsible for everything leading up to the middleware including any incremental fee required to add additional equipment (e.g., licenses, ports/cards, cables, software, etc.) to the universal interfacing system. The vendor hardware and software proposed solution meets all VA Information Security, Hardware, Software and Network requirements (VA 6500) The Contractor supplies responses to required documents in order to add systems to the VA network including but not limited to the VA Form 6550, Access Control List (ACL) Communication Protocol, MSD2, and the Risk Analysis Tool. The Contractor will provide written instructions and training material to ensure VHA laboratory staff 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 shall fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor s submitted plan shall not exceed 90 days for the transition of all services under the awarded BPA including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate BPA for cause under the Termination for Cause clause of the BPA. Standard and Quality of Performance This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order or BPA is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor s technical specification or as quoted in any BPA at an effectiveness level of 90% or more. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled Termination for cause. (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.) Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes. During the term of the BPA, shall the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. Government s Responsibility - The user will perform routine maintenance and cleaning as required in the manufacturer s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph. Ownership of Equipment This acquisition is for a purchase of equipment where the purchased equipment is owned outright, completely and wholly by the Phoenix VAMC and not to be considered a Cost Per Test or other contract that includes services along with equipment. This purchased equipment shall include all standard market warranties. The Contractor shall identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason shall purge all patient sensitive information prior to departure from the facility. Prior to termination or completion of this BPA, Contractor/subcontractor shall not destroy information received from VA, or gathered/created by the Contractor in the course of performing this BPA without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met shall be sent to the VA Contracting Officer within 30 days of termination or completion of the BPA. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information shall be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the BPA or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information shall be returned to the VA for sanitization or destruction or the Contractor/subcontractor shall self- certify that the media has been disposed of per 6500.1 requirements. This shall be completed within 30 days of termination or completion of the BPA or disposal or return of the IT equipment, whichever is earlier. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information shall not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are: Contractor shall accept the system without the drive. VA s initial medical device procurement includes a spare drive which shall be installed in place of the original drive at time of turn-in; or VA shall reimburse the company for media at a reasonable open market replacement cost at time of purchase. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; The equipment Contractor shall have an existing BAA if the device being traded in has PHI stored on it and hard drive(s) from the system are being returned physically intact; and Any fixed hard drive on the device shall be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or BPA. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation. The contractor will provide evidence of training to the COR, upon request. Privacy & Confidentiality statement: In reference to VHA Handbook 6500.6 Appendix (App) A, Block 6, the equipment included in this contractor does involve connection of IT devices to a VA network. Therefore, C&A, SAP, & the following from App C apply. In reference to VHA Handbook 6500.6 Appendix A, Block 7, the equipment does involve storing, generating, transmitting, or exchanging VA sensitive information. Therefore, the following from App C apply. The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information protection, patient privacy, and information system security as delineated in this contract. During contract performance, the contractor may require access to VA facility, equipment, information systems or sensitive data to provide services, install, train, maintain or repair equipment. VA Course No. VA10176 is privacy training required for VA contractors requiring access to VA facilities for more than 2 consecutive days or any access to VA information systems. Training will be completed. Prior to being granted access to facilities, equipment, or to the data therein. Training is available on VA TMS website at https://www.tms.va.gov/SecureAuth35/.
