SAM #36C26226Q1114

Sole Source Upgrade of ASI GenASIs Imaging Systems for Automated Karyotyping at VA Greater Los Angeles Healthcare System

This opportunity is for a sole source upgrade of ASI GenASIs imaging systems at the VA Greater Los Angeles Healthcare System Cytogenetics Laboratory. - Agency: Department of Veterans Affairs, Network Contracting Office 22 (NCO 22) - Sole source contract to Applied Spectral Imaging Inc. (ASI), the OEM - Upgrade covers six ASI GenASIs imaging systems - Includes proprietary Aided Karyotyping software licenses - GenASIs version 8.0 software update - High-end PCs, NVIDIA T1000 8GB graphics cards, memory upgrades - Gen 2 stage controller - On-site installation and calibration by ASI engineer - Upgrades must integrate natively with existing ASI hardware (microscopes, cameras, imaging systems) - Only ASI can provide, install, and validate these upgrades due to proprietary technology and warranty/service contract requirements - Procurement under NAICS 334516 (Analytical Laboratory Instrument Manufacturing), PSC 6640 (Laboratory Equipment and Supplies) - Interested vendors may submit capability statements to determine if competition is possible

Product Line Items: - 2 ASI GenASIs Scanning System Upgrades (CPQUGPF-S) - 1 ASI GenASIs Review System Upgrade (CPQUGHA-R) - 3 ASI GenASIs Manual Capture System Upgrades (CPQUGHA-M) - 1 ASI Stage Controller Gen.2 (FPRSP0069) - 1 ASI Engineer Installation/Support Visit Fee (FPRSV0050)

Service Line Items: - On-site installation and calibration by ASI engineer

Key Requirements: - Upgrades must maintain compatibility and warranty/service contract coverage - No replacement of existing microscopes, cameras, or imaging hardware - Clinical validation constraints require ASI as sole provider

Description

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 includes ASI's Aided Karyotyping software licenses, which provide automatic chromosome segmentation and classification, along with the GenASIs version 8.0 software update and supporting hardware (high-end PCs, NVIDIA T1000 8GB graphics cards, and memory upgrades), a Gen 2 stage controller, and on-site installation and calibration. The upgrade covers six existing 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 supporting 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 for 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 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 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 upgrades without voiding the existing warranty and service coverage. Avoidance of duplicative cost and clinical disruption. The installed ASI systems are validated and in clinical use under CAP and CLIA requirements. Obtaining equivalent capability from another manufacturer would require purchasing new systems, revalidation, and staff retraining, causing duplication and interruption of patient testing. For these reasons, no other supplier's supplies or services can meet the Government's requirement, and it can only be satisfied 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 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 at VA Greater Los Angeles Healthcare System. 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 healthcare providers in the VA. It is a teaching hospital, providing a full range of patient services, with state-of-the-art technology, education, and research. It also has one of the largest and most diverse patient populations in the VA system. Scope Manual metaphase organization is labor-intensive and slow. Automating chromosome segmentation and classification saves countless hours of technologist time, allowing staff to focus on 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 with high-end PCs for scanning systems and equips manual capture stations with Nvidia T1000 8GB graphics cards and 8GB memory. Precision Hardware: Installs a Gen 2 ASI Stage Controller for responsive, accurate slide navigation. Cost Savings: Uses the Platinum Service Contract to secure discounts, including waived installation and calibration fees. Requirements include performing automated metaphase scanning, capture, and analysis, native integration with existing ASI systems, operation on GenASIs software v8.0, support for networked workflow, and hardware support including high-end PCs, NVIDIA T1000 graphics, and memory upgrades. The scope includes delivery, installation, configuration, testing, training, and support of the following: Part Code Part Name Qty CPQUGPF-S Upgrade for a Pathology Scanning System 2 CPQUGHA-R Upgrade for Review System to Software Version 8.0 1 CPQUGHA-M Upgrade for Cyto Manual System to Software Version 8.0 3 FPRSP0069 Stage Controller Gen.2 1 FPRSV0050 Visit fee (support, system move or installation) 1 Salient Characteristics Aided Karyotyping Software Upgrade: Must provide fully automatic chromosome segmentation and classification, reduce manual analysis time, and improve result consistency. Must perform automated metaphase scanning, capture, and analysis for clinical specimens. Must integrate with existing ASI systems without hardware replacement. Must operate on GenASIs software platform v8.0, as a license upgrade. Must support shared, networked workflow across stations. Must include hardware such as high-end PC, NVIDIA T1000 graphics, and memory upgrades. Must be validated for clinical in vitro diagnostic use (IVDR compliant / FDA-cleared). Must support chromosome segmentation/classification on all platforms. Compatibility Existing ASI GenASIs systems in the VA Greater Los Angeles Cytogenetics Laboratory under active Platinum Service Contract (Serial Numbers: SC230006, SC160015, FV110030, ASIINC0045, BV240012, RV160046). Hours of Operation Normal hours are 7:30 am to 5:00 pm, Monday through Friday, excluding Federal holidays. The service operates 24/7, and vendor work times should be coordinated with the Program Manager. Holidays are observed as per federal law, with Monday or Friday adjustments if holidays fall on weekends. Security 4.1 Information Security The vendor shall ensure system security per VA standards, including firewall and web server requirements, and report violations. Follow VA policies and VAAR-852.273-75 security clause. Contractors and personnel are subject to federal laws and VA policies, including FISMA, OMB Circular A-130, and NIST standards. Use security configurations from NIST's website. 4.2 Contract Personnel Security All contractor employees requiring VA system access must undergo background checks per VA Directive 0710. Forms must be completed within 30 days of contract award. Contractors are responsible for actions of personnel during the security clearance process and for any damages caused by their personnel. (END OF STATEMENT OF WORK) This procurement uses commercial item procedures per FAR Part 12. The NAICS code is 334516 (Analytical Laboratory Instrument Manufacturing). The Product Service Code is 6640 (Laboratory Equipment and Supplies). The SBA size standard is 1000 employees. If interested, provide a capabilities statement addressing the requirements, feedback, and questions about domestic products, business size, and compliance. Include your SAM.gov Unique Entity ID/Cage Code. Buy American Act Compliance Provide details on country of origin, domestic content percentage, and whether the product qualifies under the Act. Confirm manufacturer location and origin for each product, and whether it qualifies as a U.S.-made or Trade Agreements Act product. This notice is not a formal solicitation. No solicitation document exists, and responses are for informational purposes only. The Government may decide whether to conduct a competitive procurement. All inquiries should be sent via email to Clift Domen at Clift.Domen@va.gov, referencing PR for 691-26-4-2701-0097, by 1:00 PM PDT on July 30, 2026. Responses will be considered solely for procurement decision-making. Additional links: Veterans Affairs Website

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