6525--Small Animal DXA System

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This is a Request for Quote (RFQ) and the solicitation number is 36C24E23Q0107. The government anticipates awarding a firm-fixed price contract resulting from this combined synopsis/solicitation. This solicitation is issued as a 100% set aside for small business concerns. It is the responsibility of the contractor to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at www.acquisition.gov. STATEMENT OF NEED (SON) CONTRACT DESCRIPTION AND REQUIREMENTS The Regional Procurement Office (RPO) - East has a requirement to purchase to purchase an OsteoSys iNSiGHT Small Animal Dual Energy X-Ray Absorptiometry (DXA) System for the Ralph H. Johnson VA Medical Center (Charleston). This system will allow for simultaneous high-resolution imaging and DXA analysis in preclinical research. The new system will operate as part of the VA Small Animal Imaging Core, providing a much-needed resource for animal models of bone disease, cardiovascular disease, and metabolic disease in both mice and rats. A firm-fixed price contract will be awarded for the purchase of Brand Name or Equal equipment in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Quotes shall contain the Offeror s best terms for cost/price and technical capabilities of the required OsteoSys or equivalent equipment. The government reserves the right to award without discussions. 1.1 PRICING The Offeror shall submit price quotes for the required brand name or equal equipment, to the specifications listed in Section 1.2 below. Please enclose the established price list and description of capabilities and product specifications for the required equipment. The Offeror shall submit a separate price sheet for equal items to include Manufacturer Name, Stock/Part #, Unit of Issue and Price. Items offered that are brand name or equal shall identify items as being on GSA schedule and reference the contract number for each item. Note: The Offeror should include a description of any support services or warranty information in the technical quote. 1.2 REQUIRED PRODUCTS & SPECIFICATIONS OsteoSys iNSiGHT Small Animal Dual Energy X-Ray Absorptiometry (DXA) System, or equal, equipment. ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT 0001 SHARED RESOURCE - EQUIPMENT iNSiGHT Small Animal Dual Energy X-Ray Absorptiometry (DXA) System The iNSiGHT is a small animal DXA system used to study body composition in a wide variety of animal models and tissues. Includes a 1-year warranty and a preventative maintenance visit in year 2. LOCAL STOCK NUMBER: OsInDXA-Sys 1.00 EA 0002 iNSiGHT Digital Radiography (DR) Mode Digital radiography (DR) is an available mode on the iNsIGHT system, different from the dual-energy x-ray absorptiometry (DXA) mode. This mode takes advantage of the digital x-ray detector within the system to provide an x-ray image from a single energy source. Settings can range from energies of 40\R\80 KeV, currents of 0.1\R\0.8 mA, and acquisition times of 5\R\60 seconds. LOCAL STOCK NUMBER: OsInDXA-DR mode 1.00 EA 0003 iNSiGHT Offline Analysis Viewing and analysis for data acquired on the iNsIGHT system. LOCAL STOCK NUMBER: OsInDXA-Offline 2.00 EA 0004 iNSiGHT Installation Installation on the purchased iNSiGHT system with basic safety requirements discussed, and system operation. LOCAL STOCK NUMBER: OsInDXA-Inst 1.00 EA 0005 iNSiGHT Training Training and on the purchased iNSiGHT system. LOCAL STOCK NUMBER: OsInDXA-Trn 1.00 EA 0006 Free Shipping and Handling iNSiGHT DXA LOCAL STOCK NUMBER: Shipping iNSiGHT 1.3 Product Capabilities & Salient Characteristics or equal High resolution imaging and DXA system shall meet or exceed the following specifications and salient characteristics: Scan time of 25 seconds or less per animal, which generates a whole animal x-ray attenuated image, bone mineral density map and lean vs. fat mass color map, as well as the following calculations automatically for whole animal or region of interest (ROI): Bone Mineral Content (BMC) (g/cm2), Bone Mineral Density (BMD) (g), Bone area (cm2), Tissue area (cm2), Fat tissue (mass and percentage) (g & %), Lean tissue (mass and percentage) (g & %), Total mass (g). This is a critical feature, as it allows for high-throughput scanning of live animals and rapid bone/tissue analyses in animal studies. This instrument will be part of a Shared Resource Facility and utilized by many research groups, therefore it is essential that the scans and accompanying data outputs listed above be provided as rapidly as possible. This 25-second scan time not only makes workflow very efficient, but also means that minimal radiation is delivered to the animal per scan, allowing for a single animal to be scanned many times over the course of a study without concern for radiation toxicity. Integrated software that allows for unlimited region of interest (ROI), exclusion ROI, and length measurements, built-in comparison of individual animals/ ROIs over longitudinal study timepoints, ability to copy and paste ROIs from one image to another, and body composition images with color editing. These software features are essential because they allow for consistency in measurements from one sample to another, and from one animal to another. The ability to draw unlimited ROIs, and copy these over to multiple images, allows for the most accurate comparison of BMD, BMC, and body composition data from one animal to another, and from one animal to itself over time. Further, a built-in comparison tool is essential because it allows for BMD and body composition of a single animal to be tracked easily over time, and visualized in graphical format, without needing to export or analyze further on another device. Ability to color edit body composition images is necessary for customizing scan images for publication in specific journals. Ability to scan tissue samples (such as bone or liver) in 25 seconds or less, generating an x-ray attenuated image, bone mineral density map and lean vs. fat mass color map, as well as the following calculations automatically: Bone Mineral Content (BMC) (g/cm2), Bone Mineral Density (BMD) (g), Bone area (cm2), Tissue area (cm2), Fat tissue (mass and percentage) (g & %), Lean tissue (mass and percentage) (g & %), Total mass (g). This is a critical feature, as it allows for high-throughput scanning of ex vivo samples and rapid bone/tissue analyses. This instrument will be part of a Shared Resource Facility and utilized by many research groups, therefore it is essential that the scans and accompanying data outputs listed above be provided as rapidly as possible. Large DXA scan area (at least 16.5 cm x 25.5 cm), providing both digital radiography and DXA measurements automatically for mice, rats, and other small animals. Provision of digital x-ray images as well as automated DXA measurements (as listed above) for mice, rats, as well as other small animals is essential because this instrument will be utilized by several different research groups studying disease models in a variety of small animals. Flexibility in scan size is key. The following system characteristics are required: Capability to perform high-resolution imaging and dual-energy x-ray absorptiometry (DXA) analysis simultaneously Compact frame with wheels Large Imaging area: 16.5 cm by 25.5 cm Cone beam scan method Ability to scan live animals, including both mice and rats: whole body or region of interest Capability to integrate with isoflurane-based anesthesia system for delivery to animal via nose cone during imaging/analysis Ability to scan ex vivo samples (excised bone, etc.) Ability to draw specific regions of interest for DXA analysis Ability to perform automatic calibration on a daily basis Ability to select both whole body and regions of interest for imaging and analyses Ability to generate separate x-ray attenuation image, bone, and colorimetric tissue map for fat and lean mass automatically Fully shielded unit that meets or exceeds FDA radiation safety standards, with no additional x ray shielding required Lead shielded glass viewing window for animal subjects 4 additional magnification levels for digital radioautography mode Radiation dose per DXA scan is less than or equal to 0.66 mGy Spatial resolution: 31 µm at 4X geometric magnification in digital radiography mode Measurement precision of: In vitro Reproducibility: 0.7%; BMD Reproducibility: 1.0%; and Fat Reproducibility: 1.0%; CV <1% and R² > 0.9 Energy range: 10 100 kV, configurable in digital radioautography mode Max energy for DXA Scan: 60/80 KV at 0.8mA Exposure range: 0.1 s 20.0 s, configurable in digital radioautography mode Stainless steel inner chamber for easy cleaning Access port for safe and efficient delivery of anesthesia into the chamber Dimensions equal or near to 26 in W x 24 in D x 44.5 in H Exposure control: fixed or pre-programmed in DXA mode, with option for fully automatic or manual voltage, amps, time, and stage height in digital radioautography mode Standard image acquisition time: average 10 seconds DXA image acquisition and analysis time: average 25 seconds Automated calibration for DXA analysis on daily basis Input power: 110/240 VAC + 10%, 50/60 Hz, 200 VA Line connection: standard line cord and plug medical grade Integrated high-power Workstation for high-resolution imaging and DXA analyses with the following features: Processor: Intel Core i5-9500 3.0 2666 USB 2.0 Ability to display imaging and measurement results on an integrated monitor Ability to record and process data for both mice and rats Capability to switch observations methods (high-resolution imaging, DXA mode) with a single touch Integrated software with the following characteristics: Provides high-resolution imaging and DXA analyses, generating DXA tissue composition statistics, as well as bone, lean and fat tissue maps of whole body automatically and/or regions of interest of animal subject or scanned ex vivo material Ability to obtain measurements from an image and annotate acquired images Ability to save data and export both images and statistical data Ability to draw unlimited region of interest (ROI), exclusion ROI, and length measurements Ability to acquire body composition images with color editing Ability to compare individual ROIs over longitudinal study timepoints with copy and paste function of ROIs from one image to another. Offline Analysis Keys/Dongles to allow analysis on computers that are directly connected to the DXA Installation of system and comprehensive training to include intensive overview of the system in both imaging and DXA analysis modes, as well as data analysis, experimental design, and maintenance Warranty coverage to include (1) year of the following: Telephone and remote diagnostic repair support, Monday Friday, 8 am 7 pm All replacement parts Travel time and labor for onsite assistance during standard hours (Monday Friday, 8 am 5 pm local time, exclusive of observed holidays) All software updates and enhancements made commercially available All safety and quality updates Warranty coverage to include (1) preventative maintenance visit in year two Background A severe limitation in current in vivo imaging is the inability to image a single animal over multiple time points through disease progression, due in part to the toxicology associated with the delivery of radiation in the form of x-rays, to the subject. The VA Small Animal Imaging Core currently operates a Skyscan 1176 Micro-CT, which provides x-ray imaging and the ability to construct 3-D models of specific hard tissues/regions of interest. However, traditional micro-CT imaging is limited by several factors, including long imaging sessions (>45 minutes per animal/session) to attain resolution of <10 micrometers, restricted ability/inability to image and analyze soft tissues such as adipose (fat) content, time-intensive analysis to obtain basic density measurement of bone tissues, and delivery of high-dose radiation to the animal. Delivery of high-dose radiation for the purpose of imaging, particularly over long imaging sessions and multiple time points for a single animal, can significantly impact biological processes and can ultimately interfere with disease monitoring, discovery of novel disease markers, and measurements of treatment efficacy. Furthermore, analyses of micro-CT images, particularly for density readouts, requires a significant investment of time and resources on the part of the core/laboratory user and are inherently biased due to the multi-step, subjective process. There currently exists a need in our Research Program for a system capable of time-efficient, high-resolution imaging in concert with rapid, automated measurements of bone mineral density (BMD), bone mineral content (BMC) and body composition in small animal models of disease (mice and rats). The iNSiGHT DXA system by OsteoSys provides high-resolution imaging and dual-energy x-ray absorptiometry (DXA) analysis simultaneously. The addition of this system to the VA Small Animal Imaging Core would provide the option for in vivo imaging of whole animal or regions of interest at 100 micrometers pixel size at 1.2x magnification with simultaneous, automatic DXA analysis, providing readouts of bone mineral density (BMD), bone mineral content (BMC), and body composition (adipose), in about 25 seconds per session. This is a significant time and cost advantage over traditional micro-CT imaging, and moreover, allows for multiple imaging sessions/density measurements in a single animal over time, delivering significantly less radiation to the animal in a single imaging session (10 seconds for X-ray imaging and 25 seconds for imaging with automated density measurement readouts) compared to traditional micro-CT imaging (>45 minutes). Using this technology, we will be able to accurately and reproducibly detect changes in both hard and soft tissue density, to include bone and adipose tissue in organs and tissues impacted by disease states, including osteoporosis, fracture, heart disease, liver disease, and obesity, among others. This system will make possible objective monitoring of both hard and soft tissues, including adipose (fat), which is not currently possible with the tools at hand, and will enhance the capabilities of our imaging core. Further, this system will make possible imaging with hard/soft tissue density readouts over time, as animals (both mice and rats) can be scanned multiple times over the course of disease/treatment progression with much lower risk of radiation toxicology, due to significantly shorter scan times. Lastly, with integrated, automatic DXA analysis through Insight analysis software, as well as automatic calibration, this system will allow for objective examination of hard and soft tissue density, with greatly reduced user bias and significantly reduced investment of user/core time dedicated to analysis. This system will greatly strengthen the research capabilities of our station, facilitating basic scientific discovery of mechanisms underlying physiological and pathological processes and translation of these findings to support the rapid implementation of cutting-edge personalized medical treatments. 1.5 Objectives The iNSiGHT DXA system, manufactured by OsteoSys, will make possible simultaneous high-resolution imaging and dual-energy x-ray absorptiometry (DXA) analysis in preclinical research. This system enables x-ray imaging of whole body and regions of interest (mice, rats), with a 100 micrometers pixel size at 1.2x magnification and 31 micrometers pixel size at 4x magnification, in conjunction with automated readouts of bone mineral density (BMD), bone mineral content (BMC) and body composition (to include adipose tissue). Maps of bone, lean and fat tissue are generated automatically for each subject, with an average imaging session of 25 seconds. Furthermore, the iNSiGHT DXA automatically calibrates daily, making obtained density measurements highly objective and reproducible, both critical elements in research studies in general and particularly those involving animal subjects. Not only will this system increase our ability to perform high-resolution imaging at significantly faster speeds in both mice and rats, but it will overcome several of the drawbacks of traditional x-ray imaging, such as micro-CT, which include higher radiation delivery to the animal, significantly longer scan times (>45 minutes), and inability to detect and analyze soft tissues including adipose due to limitations of the technology, including x ray source, voltage, and available filter sets. DXA analysis, as provided by the iNSiGHT DXA, will allow us to track changes in bone and adipose tissue in several disease states, that cannot be done with our current instrumentation. The new system will operate as part of the VA Small Animal Imaging Core, providing a much-needed resource for animal models of bone disease, cardiovascular disease, and metabolic disease in both mice and rats. OsteoSys has also developed software that accelerates the discovery process, with the ability to quickly and automatically calibrate and generate readouts of BMD, BMC, and body composition. This highly specialized system will allow researchers the opportunity to dissect how changes in bone and soft tissue density correspond with the pathobiology of many diseases, including cancer, heart disease, metabolic disease, liver disease, and osteoporosis, among others. The product capabilities and salient characteristics identified above by a brand name or equal" description are intended to be descriptive, not restrictive, and to indicate the quality and characteristics of the product that will be satisfactory. Quotes offering "equal" products (including products of the brand name manufacturer other than the one described by the brand name) will be considered if such product is clearly identified in the quote and is determined by the VA to meet fully the salient characteristics on above products. If offering an equivalent product, the brand name of the equivalent product shall be clearly identified in the quote. Unless visibly identified as an equivalent product, offered items shall be considered as the brand name product referenced in this announcement. The evaluation of quotes and the determination as to the equality of the products shall be the responsibility of the Government and shall be based on information provided by the Offeror. The Government is not responsible for locating or securing any information not provided in the quotation by the Offeror. To ensure that sufficient information is available, the Offeror must furnish, as a part of the quote, all descriptive material necessary for the purchasing activity to determine whether the products meet the salient characteristics of this requirement. Vendors proposing to modify a product to make it conform to the requirements of this announcement shall include a clear description of the proposed modification and clearly mark any descriptive material to show the proposed modification. Offers that do not have descriptive material will not be considered for award. Instructions to the Offeror Basis for award resulting from this RFQ will made to the Best Value Offer that provides a complete package pursuant to the preparation requirements set forth in 52.212-1. FAR 52.212-2 (Evaluation- Commercial Items) will be incorporated in full text into the RFQ and will be evaluated on the following factors. Evaluations will be in accordance with FAR 13 Simplified procedures. Evaluation Factors for Award Technical capability will be more important than price. The following FAR provision and clauses apply to this solicitation and are incorporated by reference. The solicitation document, incorporated provision and clauses are those in effect through the Federal Acquisition Circular (FAC) 2005-89, Effective July 2, 2015. It is the responsibility of the contractor to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at www.acquistion.gov. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. FAR 52.212-1 Instructions to Offerors Commercial FAR 52.212-2 Evaluation- Commercial Items FAR 52.212-3 Offeror Representations and Certifications FAR 52.212-4 Contract Terms and Conditions FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes Or Executive Orders Commercial Item FAR 52.219-6 Notice of Total Small Business Set-Aside (Nov 2011) FAR 52.219-8 Utilization of Small Business Concerns (Oct 2014) FAR 52.233-3 Protest After Award (Aug 1996) FAR 52.211-6 Brand Name or Equal FAR 52.233-2 Service of Protest Quotes shall be submitted via email to contact@example.gov and Offerors must reference Solicitation 36C24E23Q0107 in the subject line of the email. No telephone request for information will be considered. Incomplete packages will be considered nonresponsive. All offers must be received by the closing date Tuesday, April 11, 2023, no later than 11:59 AM, EST.