6640--ASI Karyotyping upgrade & Controller

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 firm fixed price, Sole Source Award.
The intended Contractor is a small vendor Applied Spectral Imaging Inc. located at 6160 Innovation Way, Carlsbad, CA 92009.
The VA Greater Los Angeles Healthcare System Cytogenetics Laboratory requires a software and hardware upgrade to its existing Applied Spectral Imaging (ASI) GenASIs imaging systems to add automated (Aided) Karyotyping capability. The upgrade adds ASI s Aided Karyotyping software licenses, which provide automatic chromosome segmentation and classification, together with the GenASIs version 8.0 software update and the supporting hardware (high-end PCs, NVIDIA T1000 8GB graphics cards, and memory upgrades) required to run it, plus a Gen 2 stage controller and on-site installation and calibration.
The upgrade covers six existing installed systems: two 9-slide scanning platforms (S/N SC230006 and SC160015), three capture stations (S/N FV110030, ASIINC0045, and BV240012), and one review station (S/N RV160046).
The upgraded systems will be used in the clinical Cytogenetics Laboratory to perform automated metaphase karyotype analysis on patient specimens, reducing manual analysis time, standardizing karyotype interpretation, and improving turnaround time for chromosome studies that support Veteran diagnostic care.
Applied Spectral Imaging, Inc. (ASI) is the Original Equipment Manufacturer (OEM) and the sole developer, owner, and licensor of the proprietary GenASIs imaging platform and the Aided Karyotyping software module. This requirement is not the purchase of a new, stand-alone karyotyping system; it is an upgrade to the laboratory s six existing, ASI-manufactured GenASIs systems that are already installed and in clinical production use. The following characteristics limit availability to ASI as the only source:
Proprietary software and hardware. The Aided Karyotyping license, the GenASIs version 8.0 software update, and the matched hardware upgrades are proprietary to ASI and can only be licensed, installed, and integrated on ASI s own GenASIs systems. No other vendor can provide, install, or integrate this software on ASI equipment.
Native integration with the installed base. The upgrade must operate on the laboratory s existing installed ASI scanning, capture, and review stations without replacing the installed microscopes, cameras, and imaging hardware. No competing product performs automatic chromosome segmentation and classification directly on the installed ASI GenASIs platform.
Active Platinum Service Contract and warranty integrity. The systems are covered under an active ASI Platinum Service Contract, and the quoted upgrade pricing and discounts are tied to that contract. Only the OEM can perform these software and hardware upgrades without voiding the existing warranty and service coverage.
Avoidance of duplicative cost and clinical disruption. The installed ASI systems are already validated and in clinical use under CAP and CLIA requirements. Obtaining an equivalent capability from another manufacturer would require purchasing entirely new imaging systems, full clinical revalidation, and staff retraining at duplicate capital expense; it would not be a like-for-like alternative and would interrupt patient diagnostic testing.
For these reasons, no other supplier s supplies or services can meet the Government s requirement, and the requirement can be satisfied only by Applied Spectral Imaging, Inc.
Place of Performance
Department of Veteran Affairs VA Greater Los Angeles Healthcare System 11301 Wilshire Blvd Los Angeles, CA 90073
DRAFT STATEMENT OF WORK 1. Introduction
The purpose of this Statement of Work (SOW) is to obtain ASI Karyotyping Software and Controller for the cytology department in Pathology & Laboratory Medicine Department at VA Greater Los Angeles Healthcare System. 2. Background The VAGLAHS at 11301 Wilshire Blvd, CA 90073 is part of the Desert Pacific Healthcare Network (VISN 22), and is one of the most diversified tertiary health care providers in the VA. It is a teaching hospital, providing a full range of patient services, with state-of-the art technology as well as education and research. It also boosts one of the largest and most diverse patient populations in the VA system.
3. Scope Manual metaphase organization is labor-intensive and slow. By automating chromosome segmentation and classification, the lab instantly recaptures countless hours of technologist time. This empowers staff to shift their focus away from tedious manual sorting and toward high-level clinical interpretation.
Automated Analysis: Upgrades all scanning, capture, and review platforms to Version 8.0, integrating an Aided Karyotyping license for "automatic chromosome segmentation and classification". Massive Processing Power: Replaces obsolete hardware by deploying High-End PCs to scanning systems and equipping manual capture stations with dedicated Nvidia T1000 8GB graphics cards and 8GB of memory. Precision Hardware: Installs a Gen 2 ASI Stage Controller to guarantee highly responsive, accurate slide navigation. Aggressive Cost Savings: Leverages the Platinum Service Contract to secure heavy price reductions, including a completely waived installation and calibration visit fee. Must perform automated metaphase scanning, capture, and analysis for clinical cytogenetic specimens. Must natively integrate with and upgrade the laboratory s existing installed ASI GenASIs imaging systems (scanning, capture, and review stations) without requiring replacement of the installed microscopes, cameras, or imaging hardware. Must operate on the GenASIs software platform, version 8.0, and be deliverable as a software license upgrade to systems currently under an active service contract. Must support a shared, networked karyotyping workflow across capture, scanning, and review stations so that images acquired on one station can be analyzed and reviewed on another. Must include the hardware required to run the aided karyotyping software at clinical performance, including a high-end PC, an NVIDIA T1000 8GB (or equivalent) graphics card, and a memory upgrade, where applicable to the upgraded system
The scope includes delivery, installation, configuration, testing, training (as required), and support of the following items:
Products: Part Code Part Name Qty CPQUGPF-S Upgrade for a Pathology Scanning System Includes: GenASIs Software Update - applicable for system(s) with 8 software version (under service contract) platinum Aided Karyotyping Scanning & Analysis software license, for automatic chromosome segmentation and classification High-End PC Upgrade Pathology Scanning PL -System Number: SC230006 & SC160015 2 CPQUGHA-R Upgrade for Review System to Software Version 8.0 Includes: GenASIs Software Update - applicable for system(s) with 8 software version (under service contract) platinum Aided Karyotyping Analysis software license, for automatic chromosome segmentation and classification Upgrade Review PL (All PL) -System Number: RV160046 1 CPQUGHA-M Upgrade for Cyto Manual System to Software Version 8.0 Includes: GenASIs Software Update - applicable for system(s) with 8 software version (under service contract) platinum Aided Karyotyping Capture & Analysis software license, for automatic chromosome segmentation and classification Graphic Card Nvidia T1000 8GB Memory 8GB Upgrade Cytogenetic Manual PL -System Number: FV110030 3 FPRSP0069 Stage Controller Gen.2 1 FPRSV0050 Visit fee (support, system move or installation) for an ASI Engineer - for up to 2 working day, out of Warranty and Service. 1
Salient Characteristics Aided Karyotyping Software Upgrade: Must provide fully automatic chromosome segmentation and classification (aided karyotyping) to reduce manual analysis time and improve consistency of clinical karyotype results. Must perform automated metaphase scanning, capture, and analysis for clinical cytogenetic specimens. Must natively integrate with and upgrade the laboratory s existing installed ASI GenASIs imaging systems (scanning, capture, and review stations) without requiring replacement of the installed microscopes, cameras, or imaging hardware. Must operate on the GenASIs software platform, version 8.0, and be deliverable as a software license upgrade to systems currently under an active service contract. Must support a shared, networked karyotyping workflow across capture, scanning, and review stations so that images acquired on one station can be analyzed and reviewed on another. Must include the hardware required to run the aided karyotyping software at clinical performance, including a high-end PC, an NVIDIA T1000 8GB (or equivalent) graphics card, and a memory upgrade, where applicable to the upgraded system. Must be validated for clinical in vitro diagnostic use (IVDR compliant / FDA-cleared product family) consistent with CAP and Joint Commission requirements for a clinical cytogenetics laboratory. Must support automatic chromosome segmentation and classification on both scanning/capture platforms and review-only platforms.
Compatibility Existing ASI GenASIs systems currently installed in the VA Greater Los Angeles Cytogenetics Laboratory under an active Platinum Service Contract (System Serial Numbers: Scanning SC230006, SC160015; Capture FV110030, ASIINC0045, BV240012; Review RV160046).
Hours of Operation Normal tour-of-duty hours at VAGLAHS is 7:30 am to 5:00 pm, Monday through Friday, excluding Federal holidays. However, the service is operating 24/7 and as such there may be instances in which the vendor s workday may be outside of this period. The vendor is required to coordinate these times with the designated Program Manager.
In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as Legal Federal official holidays
When a holiday falls on a Sunday, the following Monday will be observed as a National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government Agencies.
Security
4.1 Information Security The vendor shall ensure adequate LAN/Internet, data, information, and system security in accordance with VA standard operating procedures and standard contract language, conditions laws, and regulations. The vendor s firewall and web server shall meet or exceed the government minimum requirements for security. All government data shall be protected behind an approved firewall. Any security violations or attempted violations shall be reported to the VA Project Manager and the VBA Headquarters Information Security Officer as soon as possible. The vendor shall follow all applicable VA policies and procedures governing information security, especially those that pertain to certification accreditation. The contractor shall follow The Veterans Affair Acquisition Regulation (VAAR) security clause VAAR- 852.273-75 SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES sited in section C. Contract Clauses (a) The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include, but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce's National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST's Web site at: http://checklists.nist.gov (b) To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in "VA Information and Information System Security/Privacy Requirements for IT Contracts" located at the following Web site: http://www.iprm.oit.va.gov
4.2 Contract Personnel Security
All contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Security and Investigations Center (07C). The level of background security investigation will be in accordance with VA Directive 0710 dated September 10, 2004 and is available at: http://www.va.gov/vapubs/ (VA Handbook 0710, Appendix A, Tables 1 - 3). Appropriate Background Investigation (BI) forms will be provided upon contract (or task order) award, and are to be completed and returned to the VA Security and Investigations Center (07C) within 30 days for processing. Contractors will be notified by 07C when the BI has been completed and adjudicated. These requirements are applicable to all subcontractor personnel requiring the same access. If the security clearance investigation is not completed prior to the start date of the contract, the employee may work on the contract while the security clearance is being processed, but the contractor will be responsible for the actions of those individuals they provide to perform work for the VA. In the event that damage arises from work performed by contractor personnel, under the auspices of the contract, the contractor will be responsible for resources necessary to remedy the incident.
(END OF STATEMENT OF WORK)
This procurement is being conducted using commercial item procedures pursuant to FAR Part 12.
The North American Industry Classification System (NAICS) for this requirement is, 334516 Analytical Laboratory Instrument Manufacturing. Product of Service Code for this requirement is 6640 Laboratory Equipment and Supplies. The Small Business Administration (SBA) size standard for this sector is 1000 Employees.
If your company is interested and capable of providing the required supplies/services, please provide 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) Submit your capabilities statement illustrating how your organization can/cannot meet the list of DRAFT SOW requirements. For instances where your company cannot meet the DRAFT SOW requirement(s), please explain. For instances where your company can meet the DRAFT SOW requirement(s), please show how your company meets/exceeds each requirement. (2) Please review the list of DRAFT SOW requirements and provide any additional feedback or suggestions. If none, please reply as N/A. In the VA s efforts to procure domestic end products, are you able to provide a domestic product or a domestic alternative product? (4) 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. (5) Is your company considered small under the NAICS code identified in this RFI? (6) Are you the manufacturer, authorized distributor, and/or can your company provide a solution to the required supplies/services described in the list of DRAFT SOW? (7) If you are a large business, do you have any designated/authorized distributors? If so, please provide their company name, telephone, point of contact and size status (if available). (8) If you re a small business and you are an authorized distributor/reseller for the items identified above, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified. (9) Limitations on Subcontracting: How does your business ensure compliance with the limitations on subcontracting as outlined in 13 CFR § 125.6? (10) Are the items you are identifying/providing considered Commercial of the Shelf (COTS) items as defined in FAR Part 2.101 under commercial items? (11) Non-Manufacturer Rule: If applicable, can you confirm your business complies with the Non-Manufacturer rule? Specifically, does your company: Provide a product from a small business manufacturer or processor? Not exceed 500 employees? Primarily engage in the retail or wholesale trade and normally sell the type of item being supplied? Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice? (12) What is your lead time to deliver a single unit with all components? Is there scale in lead time with greater quantities? Please elaborate. (13) What is estimated life span of your solution? What support/services does that entail? (14) Does your proposed equipment have FDA clearance? Please specify what FDA clearance(s) have been obtained. (15) Does your organization offer a leasing solution? Please elaborate. (16) Does your company have a Federal Supply Schedule (FSS) GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract? If so, please provide the contract number(s). (17) If you are an FSS GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract holder, are all the items/solutions you are providing information about available on your schedule/contract? Please state if all or some items are available on the contract. (18) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. (19) Please provide your SAM.gov Unique Entity ID/Cage Code number. Buy America Compliance Respondents shall provide sufficient detail to determine compliance with the Buy American Act, including country of origin, domestic content, and availability of domestic alternatives. Responses should be complete and supported with verifiable information. Please identify the country of origin for the end product(s) being offered. Include the location of final assembly/manufacture.
Please provide the percentage of domestic content (by cost) for each product(s). Describe the origin of the major components.
Does your product qualify as a domestic end product in accordance with the Buy American Act?
Please identify the manufacturer name and location for the product(s). Confirm whether the manufacturer is U.S.-based.
Identify the country of origin of each product and indicate whether the product qualifies as a U.S.-made or designated-country end product in accordance with the Trade Agreements Act 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 Clift Domen at •••••@•••••.•••Sign up to see this detail with the following information referenced in the subject line, PR for 691-26-4-2701-0097 ASI Karyotyping upgrade & Controller. 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 1:00 PM Pacific Daylight Time (PDT) on Thursday, July 30th, 2026 to Clift Domen at •••••@•••••.•••Sign up to see this detail. The interested parties bear full responsibility to ensure complete transmission and timely receipt.