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Aperio ScanScope XT instrument, parts, and accessories

Solicitation Number: RFQ-NCI-90084-NG
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Cancer Institute, Office of Acquisitions
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RFQ-NCI-90084-NG
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Combined Synopsis/Solicitation
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Added: Apr 08, 2009 12:44 pm
The National Cancer Institute (NCI) plans to procure the brand name ScanScope XT instrument, parts, and accessories; manufactured by Aperio Technologies Inc.; to be used to create digital slides of tissue and other specimens for pathology applications that require magnification up to 40x.



This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice.



This is a 100 percent small business set aside.



This announcement constitutes the only solicitation and a separate written solicitation will not be issued.



This solicitation: No. RFQ-NCI-90084-NG includes all applicable provisions and clauses in effect through FAR FAC 2005-31 (March 2009) simplified procedures for commercial items.



The North American Industry Classification System Code is 333314 and the business size standard is 500 employees.



Only one award will be made as a result of this solicitation.



DESCRIPTION:



APERIO SCANSCOPE SYSTEM

CLIN-001: Product Number: XT100-P-H-0

Description: ScanScope XT (Standalone Scanner)

Quantity: One each



CLIN-002: Product Number: IMPHWXT100-P-H-0

Description: ScanScope XT – Hardware Implementation

Quantity: One each



CLIN-003: Product Number: S+XT-P-S-0

Description: ScanScope XT – Spectrum Plus Device License

Quantity: One each



CLIN-004 Product Number: IMPSWS+XT-P-S-0

Description: ScanScope XT – Spectrum Plus Device License – Software Implementation

Quantity: One each



APERIO APPLICATION SOFTWARE

CLIN-005: Product Number: S9152S-P-S-0

Description: Cell Quantification - General purpose image analysis algorithms for cell quantification (Nuclear Membrane)

Quantity: One each



APERIO HARDWARE

CLIN-006: Product Number: HS9007XT-P-H-0

Description: 2” by 3” Slide Tray (Must be on site installation: For XT)

Quantity: One each



APERIO INSTALLATION:

CLIN-007: Standard set-up and configuration (installation of a single Spectrum software suite onto a single sever/DSR):

Quantity: One each



SHIPPING and HANDLING

CLIN-008: Shipping and Handling charge

Quantity: One each





STATEMENT OF WORK:



Contractor shall provide the Aperio ScanScope XT System, parts, and accessories:



The scanner and software must have the ability to create high-resolution 40x digital slides image files. Multiple image file formats must be supported. Appropriate file management and image viewing software that allows annotation of the images shall be provided. The annotations must be separate from, and not modify the original images; however appropriate security to prevent miss-match of annotation file and image file is required. Tools for file management must include data tables, and auto populated fields with barcode data and be user friendly. The scanner must meet or exceed the following specifications to satisfy the digital slide imaging needs of NCI:



The following salient characteristics apply:



1) Imaging capabilities: The scanner must:



1.1. be capable of fully scanning both 1x3 and 2x3 slides, inches

1.2. produce images with no discernible “stitching” artifacts,

1.3. produce “high” quality images at 20x and 40x optical resolutions, 40x

1.4. produce images with an appropriate numeric aperture (at least 0.75),

1.5. be able to produce z-stack images, and





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 slide(s) failed to scan properly. The expected failure rate should be less than 5%,

2.4. The scanner shall 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 be able 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 on the NIH/NCI network with a published schema such that the database may be read from an outside application,

4.2. All images generated shall be the property of the NCI 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, password protected, 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 cameras), 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 supplementing our current pathology database (Softpath) and shared space on the NCI network with the ability to store slide images locally. 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 shall 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. must allow the collaborative sharing of the digital image in real time from various locations, and

5.5. Images shall 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 digital slide management software shall have an optional automatic TMA segmentation module,

6.4) The digital slide management software should offer an optional compliance module to track user activity and generate reports thereof,

6.5) The digital slide management software must offer GLP-compliance and HIPAA-compliance capability, and provide full update and access auditing capabilities,

6.6) The digital slide management software shall 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 digital slide management software shall be provided 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.





DELIVERY: Contractor shall deliver the item within 45 days after award to: NIH/NCI Bethesda, Maryland 20892. Complete mailing address and point of contact information shall be provided upon award. Upon delivery, contractor must notify the NCI Project Officer to schedule the delivery date and time.



INSTALLATION: Contractor shall install the equipment and have ready to use within seven (7) days after delivery.



TRAINING: Contractor shall provide training by the manufacturer (at no additional cost to the Government) on proper use of equipment, software and related use for at least three (3) NCI researchers at NCI location within one week of installation – for one and one half (1.5) days.



SERVICE AND SUPPORT: Contractor shall provide service and support for the Scan Scope instrument and other products for a period of one year from date of installation at no additional charge to the government.



WARRANTY: Contractor shall provide and support the manufacturer’s standard commercial warranty for the Scan Scope and it components.



PAYMENT: Payment shall be made after delivery, installation, and training, upon Government acceptance.



BASIS FOR AWARD:



Offerors must provide descriptive literature, or other materials that demonstrate that their offer meets the foregoing requirements. The contract will be awarded to the responsible offeror with the lowest-price offer that fully meets the requirements of the solicitation.





BRAND NAME JUSTIFICATION:



The Aperio XT Scanner (“XT”) will allow NCI the ability to electronically capture and store images from pathology slides at a high volume with improved quality assurance. 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.)





PROVISIONS AND CLAUSES:

The following FAR provisions and clauses apply to this acquisition:



FAR clause 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (June 2008);



FAR clause 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS- (February 2009) WITH DUNS NUMBER ADDENDUM {52.204-6 (April 2008};



FAR Clause 52.212-4 CONTRACT TERMS AND CONDITIONS – COMMERCIAL ITEMS (October 2008);



FAR Clause 52.212-5: CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (February 2009). The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition:



52.203-6, Restrictions on Subcontractor Sales to the Government (SEP 2006), with Alternate I (OCT 1995) (41 U.S.C. 253g and 10 U.S.C. 2402).



52.219-6, Notice of Total Small Business Set-Aside (JUNE 2003) (15 U.S.C. 644); Alternate I (OCT 1995) of 52.219-6 and Alternate II (MAR 2004) of 52.219-6.



52.219-8, Utilization of Small Business Concerns (MAY 2004) (15 U.S.C. 637 (d)(2) and (3)).



52.219-14, Limitations on Subcontracting (DEC 1996) (15 U.S.C. 37(a)(14)).



52.222-3 Convict Labor



52.222-19 Child Labor-Cooperation with Authorities and Remedies



52.222-21 Prohibition of Segregated Facilities



52.222-26 Equal Opportunity



52.222-35 Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans



52.222-36 Affirmative Action for Workers with Disabilities



52.222-37 Employment Reports of Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans



52.222-39 Notification of Employee Rights Concerning Payment of Union Dues or Fees (DEC 2004) (E.O. 13201).



52.223-15 Energy Efficiency in Energy-Consuming Products



52.225-5 Trade Agreements (Nov 2007) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).



52.225-13 Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).



52.232-33 Payment by Electronic Funds Transfer–Central Contractor Registration



52.239-1 Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a)



Full text copies of the representations and certifications for other cited provisions and clauses may be obtained on line at the NCI OA Internet website at http://amb.nci.nih.gov or from Malinda Holdcraft, Contract Specialist at holdcram@exchange.nih.gov.





OFFERORS:

Offers must be submitted on an SF-1449, signed by an authorized representative and shall provide a copy of the valid certification registrations: (a) offeror’s Central Contractor Registration (CCR) and (b) Online Representations and Certifications Applications (ORCA).



ALL QUESTIONS REGARDING THIS SOLICITATION SHALL BE ADDRESSED TO MALINDA HOLDCRAFT, CONTRACT SPECIALIST, VIA ELECTRONIC MAIL AT HOLDCRAM@EXCHANGE.NIH.GOV



Faxed or electronic mail quotations will NOT be accepted.



Quotations shall be mailed or delivered to the following: National Cancer Institute – Office of Acquisition; Attn: Malinda Holdcraft, Contract Specialist; 6120 Executive Boulevard Room 6072; Rockville, Maryland 20852-7194.



Quotations must be received in the NCI-OA contracting office by 11:00 AM ET on April 16, 2009. Please refer to solicitation number RFQ-NCI-90084-NG on all correspondence.





PLEASE NOTE:

In order to receive an award, contractor must be registered in and have valid certifications in the Central Contractor Registration (CCR) (http://www.ccr.gov) and the Online Representations and Certifications Application (ORCA) (http://orca.bpn.gov) AND shall meet all the specifications stated above.





:
6120 Executive Blvd.
EPS Suite 600
Rockville, Maryland 20852
:
Malinda L Holdcraft,
Contract Specialist
Phone: (301) 402-4509
Fax: (301) 402-4513
:
Caren N Rasmussen,
Contracting Officer
Phone: (301) 402-4509
Fax: (301) 402-4513