SOLICITATION NOTICE
66 -- Aperio ScanScope XT
- Notice Date
- 2/17/2009
- Notice Type
- Presolicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-90058-NG
- Archive Date
- 3/18/2009
- Point of Contact
- Malinda L Holdcraft,, Phone: (301) 402-4509
- E-Mail Address
-
holdcram@exchange.nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute Laboratory of Pathology (NCILP) plans to procure the brand name Aperio ScanScope XT instrument to be used to create digital slides of tissue and other specimens for pathology applications that require magnification up to 40x. This acquisition will be processed under FAR Part 12 – Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1(b)(2) and 13.501-(a)(1) to use simplified acquisition procedures for commercial item. The North American Industry Classification System Code is 334516 and the business size standard is 500 employees. Only one award will be made as a result of this solicitation. Facts and Reasons to Justify Other than Full and Open Competition 1.Statute Statute: 41 U.S.C. 253 (1) as set forth in FAR 13.106-(b)(2) and 13.501-(a)(1) (b) Solicitation from a single source. (2)For Sole source acquisition of commercial items in excess of the simplified acquisition threshold conducted pursuant to subpart 13.5, the requirements at 13.501(a) apply. No other requirement and/or type for supply or service will satisfy agency need. 2. Sole Source Justification: This Aperio XT Scanner is a new purchase and will not be replacing old equipment. The use of this equipment will improve quality assurance of slide scanning; improve file sharing for research and clinical use; and demonstrate significant benefits to the academic endeavors. This technology offers the ability to view, analyze, and manage patient and research cases as digital images, and store the images in a virtual library for future retrieval. The software (Spectrum Plus) will create an electronic teaching file for medical residents and researchers will have access to specific cases electronically, rather than the laborious task of retrieving and reviewing individual paraffin blocks and slides. As expert pathology consultants for abnormal pathology cases from medical centers throughout the country and internationally, electronic images of cases reviewed from submitted hospitals can be returned to the originating facility. Imaging slide sets for clinical trials allows investigators ease of access to their protocols (i.e. molecular profiling core currently uses this process for their case sets). This scanner will also increase the efficiency of the NCILP through a reduction in sharing traditional glass slides, as well as collaborative uses. The XT will offer the continuity with previous equipment, database interoperability, file structure and existing images in the Laboratory of Pathology (approximately 7,000 images to date). Images stored in virtual library will have same file format as existing images in LP Tissue MicroArray Lab and by the NCI Molecular Profile Core. The XT is the only platform that offers a single non-tiff image that is non-proprietary and can be analyzed by other commercially available packages. The XT is the only scanning system with a real 20x objective and 40x objective. It contains a web-based database (Spectrum Plus) and server capacity to share images, and it provides operator control of embedded meta-data including slide label images. Other systems allow the collection of this information but do not have the capacity to block it from users and this is critical for confidentiality issues. The instrument satisfying NCILP’s requirements must meet the following salient characteristics: 1) Imaging capabilities: The scanner must: 1.1.be capable of fully scanning both 1x3 and 2x3 slides, 1.2.produce images with no discernible “stitching” artifacts, 1.3.produce “high” quality images at 20x and 40x optical resolutions, 1.4.produce images with an appropriate numeric aperture (at least 0.75), 1.5.be able to produce z-stack images, and 1.6.produce self contained images in an accepted ISO format. 2) High throughput: The scanner must have the following characteristics: 2.1.High capacity: the scanner must be able to hold at least 120 slides in a given processing batch, 2.2. Hands free operation: The scanner must be able to scan an entire batch of slides without user intervention, including finding the appropriate tissue area's and full multi-point auto-focus, 2.3.Fault tolerant: The scanner must be fault tolerant in its ability to handle “difficult slides”. Should the scanner fail to scan a given slide in a processing batch, the scanner must be able to recover gracefully and complete the remainder of the batch without user interventions. Additionally, once a batch is complete it should be clear to the operator which slides/s failed to scan properly. The expected failure rate should be less than 5%, 2.4.The scanner should be able to scan and have ready for viewing an area of 1.5cmx1.5cm in less than 2 minutes, and 2.5.Random access: Once a batch of slides has been scanned, the instrument must be capable of accessing the slides in a random access manner so that slides can be rescanned if needed. 3) Research considerations: Because the scanner will be used for both high throughput pathology material and research material, the following criteria must be met: 3.1.Image analysis: An import aspect of research pathology is image analysis. The Instrument must ship with at least the ability to analyze histological material for nuclear, membranous and cytoplasmic staining, 3.2.Image analysis must be able to be performed on the image server and be initiated by a remote user, 3.3.Image analysis must be able to be initiated in a batch analysis fashion by a remote user, and 3.4.Analysis results must be able to be exported for an entire project or batch in a group fashion by a remote user. 4) Server considerations: 4.1.The scanner must store all its annotations on an external database with a published schema such that the database may be read from an outside application, 4.2.All images generated must be the property of the NCILP and have no restrictions or requirement for annual licensing fees or any other fees in order to be viewed across the network, published or reproduced, 4.3.New images must be able to be added to the server and cataloged into the database without the need of any operator intervention, 4.4.The database (server) must be able to control individual access rights to images and data so that unauthorized access and changes are prevented, 4.5.The database (server) must be able to organize and manage other image types (such as standalone camera’s), documents, and data from other sources, 4.6.The scanner must store all its annotations on an external database with a publish schema such that the database may be read from an outside application, 4.7.New images must be able to be added to the server without the need of any operator intervention, 4.8.The scanner must come with a full database management system capable of replacing our current pathology database. To accomplish this, the system must at a minimum be capable of: a)organizing images into a hierarchy system representing our current pathology case system (multiple slides /case), b)handling multiple users with multiple user permissions based on passwords, and c)producing custom pathology reports. 5)Digital Slide Viewing: 5.1.The scanned image must be immediately available for viewing following scanning without additional rendering or file conversion time, 5.2.Image format should be industry standard TIFF/JPEG or TIFF/JPEG2000 compliant with TIFF6.0 standard, 5.3.The digital image created by the scanner must allow the following functions: a. Smooth tracking and zoom, b. Smart Synchronization, c. Grid overlay, d. Efficient serving of the image over the web, e. Automatic color correction to standard using ICC profile, f. Image Quality enhancement for digital stain separation, adjustment, and recombination, 5.4.The proposed solution must allow the collaborative sharing of the digital image in real time from various locations, and 5.5.Images should be viewable locally and remotely utilizing a web-based browser system anywhere, anytime on any computer with such a web-browser. 6)Digital Slide Management: 6.1)The proposed solution must offer integrated image file management software that allows for logical digital slide organization, searching, and report creation, 6.2)The digital image management software must be role-based to allow specific user profiles for access to certain functions only as appropriate, 6.3)The proposed digital slide management software should offer an optional automatic TMA segmentation module, 6.4)The proposed digital slide management software should offer an optional compliance module to track user activity and generate reports thereof, 6.5)The proposed digital slide management software must offer GLP-compliance and HIPAA-compliance capability, and provide full update and access auditing capabilities, 6.6)The proposed digital slide management software should use an industry-standard SQL database (e.g. Microsoft SQLServer) and should support a multi-site configuration, including the following attributes: a.The option for a single central database shared among all sites, b.Single database with authentication profiles and centralized auditing, c.Capability for digital slides to be scanned at multiple locations and cataloged into the central system automatically, d.Capability for digital slides optionally to be transferred from remote locations to central location for long-term storage and archival, e.Capability for remote sites to connect to central site with outbound connections only, requiring no firewall configuration changes, f.Industry-standard encryption of all PHI (protected health information) transmitted between remote sites and central server, and 6.7)The proposed digital slide management software should be developed under FDA Quality System Regulations (QSRs) and should be part of an FDA-cleared system for one or more clinical indications. 7) Image Analysis Capability: The digital pathology solution proposed must offer automated image analysis capability that includes the following attributes: a.FDA cleared HER2, ER, and PR algorithms for immunohistochemical quantification, b.TMA parallel cell analysis, c.Open platform for the development of 3rd party algorithms, d.Direct interface to the management software for report generation, and e.An algorithm to automatically exclude unwanted areas. The Aperio Scanner XT the only known instrument that meets all of the characteristics required above. The scanner XT is a proprietary product of Aperio Technologies Inc. and is not available elsewhere. This is not a solicitation for competitive quotations. However, if any interested party believes they can meet the above requirement, they may submit a statement of capabilities. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received in the NCI contracting office on or before 11:00 AM ET March 3, 2009. All questions must be in writing and can be faxed (301) 402-4513 or emailed to Malinda Holdcraft, Contract Specialist at holdcram@mail.nih.gov. A determination by the Government not to compete this proposed acquisition based upon 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. In order to receive an award, contractors must have valid registration and certification in the Central Contractor Registration (CCR) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference pre-solicitation number NCI-90058-NG on all correspondence.
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