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FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 09, 2017 FBO #5557
DOCUMENT

65 -- RFI for Lab Telepathology and Digital Slide Scanning Systems - Attachment

Notice Date

2/7/2017
 

Notice Type

Attachment
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

Department of Veterans Affairs;VAMC Manchester;718 Smyth Road;Manchester NH 03104
 

ZIP Code

03104
 

Solicitation Number

VA24117N0181
 

Response Due

2/14/2017
 

Archive Date

4/15/2017
 

Point of Contact

Craig Harris
 

E-Mail Address

4-4366<br
 

Small Business Set-Aside

N/A
 

Description

STATEMENT OF WORK (SOW) Anatomic Pathology Digital Pathology REVISION: April 28, 2016 Page 1 of 11 INTENT: it is the intent of the Department of Veterans Affairs, VA New England Healthcare System, VISN1 (herein afterwards referred to as VISN (1) to purchase for Whole Slide Imaging, scanning, and digital pathology system for VISN1 laboratories to include: VA Maine, VA White River Junction, VA Manchester, VA Boston Healthcare System (West Roxbury and Jamaica Plain), VA Providence, and VA Connecticut. PURPOSE: The tissue slide scanners, image analysis software, storage servers, and compatible operating system permits large scale archived collections of histopathology specimens that require an image library for historical archives, remote consultation, and digital preservation of patient specimens that have been referred for outside consultation. These specimens would be irreplaceable if lost. This system would allow VISN1 laboratories to evaluate specimens and generate data from multiple specimens concurrently. Functionality will include whole slide digital scanning, documentation, remote consultation, specialty consultation and computer assisted digital image analysis. The products contracted for through this statement of work will facilitate a model of care that delivers Tele-pathology services, both hardware and software, to participating laboratories in VISN1. The quality of the product must be suitable for basic surgical and cytopathology functions including, but not limited to the following: consultative services; second review for newly diagnosed malignancies; coverage for pathologist absences; quality assurance review, Joint Pathology Center consultations, and support for tumor board. In addition, the system should be in consistent with the Federal Drug Administration (FDA) draft guidance, Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices issued February 25, 2015. Additional features such as software for image analysis, automated walk-away scanning and ability to add a fluorescent module at a later date will be considered an additional benefit. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The vendor shall provide necessary equipment and upgradable digital slide image viewing software with capacity for networked based inter-facility tele-pathology for VISN1. A unit will be deployed at each of the listed sites in section 8. The vendor will provide the necessary hardware, computer workstations, driver software, servers and displays required to operate scanners as well as all necessary cables to connect and power unit components. The scanner software should allow for appropriate unique identification/accessioning of case images that will allow accurate assignment of images to the patient of origin, file storage and retrieval. The work station should permit image preview by the scanner operator to assess image quality and accurate identifying information before upload to servers for remote access. Software should include a simple means to correct clerical entry errors and replace suboptimal scans. The software should be integrated with viewer software to allow the scanner operator to assign individual cases to one or more local or remote pathologists for viewing. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. New equipment shall be acquired for each of the clinical laboratories located at the VISN facilities listed in this SOW. System must be scalable for future changes. DEFINITIONS: Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule. GENERAL the contractor will provide narrative descriptions of the following: Describe configuration of the slide feed mechanism including: physical description, number of slides in the queue/carrier, class of automation (e.g., robotics, pneumatics, etc.). Describe user interaction with the slide feeder, options through which the user operates the whole slide imaging system (software menu options, physical controls, connectors and connections, information presented to the user through visual displays, sounds/alarms, etc. Describe Slide Feeder used to introduce slides to the scanner - including hardware, (e.g., loading of slides into carrier), software (how does the system recognize number of slides), can slides be loaded and scanned without further user interaction ( walk-away ), what is required at the time of loading? Configuration (physical description, number of slides in carrier, class of automation (robotics, pneumatics) Describe device ability to read barcoded slides and interface with a whole slide manager. Describe the light source lamp characteristics to include: bulb type manufacturer and model wattage spectral power distribution or color temperature expected lifetime output adjustment control (electrical/electronic/mechanical) optical filters (heat blocking, polarization, neutral density, diffusing) expected intensity variation (coefficient of variation (CV) as a percentage); over the duration of scanning a single slide over the course of a single workday expected spectral variation over the duration of scanning a single slide over the course of a single workday over the lifetime of the device capability of tracking intensity and spectral degradation with lifetime Describe Condenser characteristics illumination format (e.g., Kohler, critical) manufacturer and model numerical aperature focal length working distance Describe calibration test method Describe imaging optics- number of lenses, types, plan acrhromatic Ray-trace from slide (object plane) to digital image sensor (image plane) Microscope object Manufacturer Type (Plan, Plan APO) Magnification Numerical aperature (NA) Focal length Working distance Auxiliary lens(es) Manufacturer Lens type Focal length Magnification of imaging optics, per ISO 8039:1997 Optics and optical instruments microscopes-magnification Describe test methods in conformance with the International Standards, if applicable Relative irradiance of imaging optics at image plane per ISO 13653:1996 Optics and optical instruments General optical test methods - Measurement of relative irradiance in the image field Distortion per ISO 9039:2008 Optics and photonics Quality evaluation of optical systems Determination of distortion Chromatic aberrations per ISO 15795:2002 Optics and optical instruments Quality evaluation of optical systems Assessing the image quality degradation due to chromatic aberrations For mechanical scanner movement describe configuration of the stage to include: stage size, stage manufacturer, stage material, single multi-axis or multiple stacked linear stages (manufacturer and model), type of guides or ways, sample retention mechanism (slide holder). Describe method of movement of the stage (e.g., stepper motor, piezomotor, etc.), movement resolution for XY axes, movement in Z-axis, speed range, travel distance, maximum scanning area, localization and reading of barcode labels. Describe control of movement of the stage (open or closed loop, positional accuracy, and repeatability, physical control, selection of area to be scanned (whole slide automatically determined area with tissue content) Describe digital image sensor including: type, manufacturer, pixel information (number and dimensions of pixels), design of color filter array (configuration and spectral transmittance of color filter mask), responsivity specification (quantum efficiency versus wavelength, linearity, and spatial uniformity), noise specifications (dark current level, read noise), readout rate, and digital output format. Including testing of opto-electric conversion function per ISO 14524:2009 Photography Electronic still picture cameras- methods for measuring opto-electric conversion functions (OECFs) and noise measurements per ISO 15739:2003 Photography electronic still picture imaging noise measurements. Describe Image processing software to include where applicable: exposure control, white balance, color correction, sub-sampling, pixel-offset correction, pixel-gain or flat-field correction, and pixel-defect correction. Describe Image composition features to include: scanning method, single objective or multiple miniature objectives in an array pattern, scanning pattern, overlap between scanned regions, merging algorithms that stitch aligned images together into a composite image file, automation background correction functions, scanning speed (time to scan the whole slide), and number of planes at the Z-axis to be digitized. Include test methods for images of digitized calibration slides, analysis of focus quality metrics and analysis of coverage of the image acquisition for the entire tissue slide. Describe if applicable how the system interacts with DICOM compliant software and hardware (a compatibility report should be submitted with documentation) as mandated by the Veterans Health Administration. Describe how saved files are named and organized; are images compressed? (Images should rarely exceed 1GB) Describe file organization: single file with multi-resolution information, stack of files at different magnification Describe instrument image review manipulation software to include: continuous panning and pre-fetching, continuous zooming (magnification), discrete Z-axis displacement, ability to compare multiple slides simultaneously on multiple windows, ability to perform annotations, color manipulation and color filters, annotation tools, tracking of visited areas and annotations, digital bookmarks, virtual multi-head microscope (remote simultaneous image review) Describe computer hardware Describe computer operating system, encryption and anti-virus capabilities Describe data backup system, software and process to safeguard data Describe contingency process when system may be unusable, if applicable Describe graphics card, graphics card driver, color management settings, color profile, and display interface Describe the device multi-layer support (dimensional applications Z stack, extended focus) Describe viewer functionality and compatibility with MAC and Microsoft Windows Describe scan success rate and scan time. Include scan times which may differ depending on objective and success rate for first time scan Describe the display (optoelectric device that converts the digital image signals in the RGB space into optical image signals for the human reader. Describe entire display system, display technology, physical size of the display for image visualization, backlight type for liquid crystal displays, pixel array, pitch and pattern, video bandwidth, on-screen display controls, ambient light sensing, touch screen technology, color calibration tools and QC procedures. Describe scan resolution for each magnification (uM/Pixel) Describe the following system level assessments Color reproducibility Spatial resolution Focusing tests Whole slide tissue coverage Stitching error Describe any human factors/usability validation testing performed on the scanner. Describe required server, network, work station, monitor size and resolution specifications for optimal image viewing. Describe interface requirements include ability to interface with VHA Vista Imaging applications (ORL messaging, HL7 ORU messaging). Must be HIPPA compliant and meet VHA IT security standards. Describe vendor support and vendor performed maintenance options for a five (5) year period. Include ability to remotely access systems for troubleshooting purposes. Describe end user daily, weekly, etc., maintenance. Include time to perform. Instrumentation and Software: If applicable, equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. For potential integration with laboratory information systems (LIS) scanners should be able to perform automated bar code reading from slide labels with the capacity to read at minimum 1-D and 2-D bar code formats. However, automated scanning should not be dependent on bar code reading when slides lack bar codes or there is not integration with the local LIS. If applicable, equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha and numeric concurrently that may be enabled concurrently. A barcode reading accuracy rate of 99% or greater. The software should permit remote viewing by only VA approved users accessing secure network servers by unique password logging. The software should not be limited to any proprietary image formats but permit viewing of digital slides generated on other platforms. The vendor will provide software upgrades as needed to correct or improve functionality in accordance with warranty and service agreements. If viewing software requires a license then licensing should preferably be service specific and not user specific as viewing may need to be performed from multiple workstations in a department. If applicable, all monitors/screens will clearly display information in all light conditions. An uninterruptible power supply (UPS) with line conditioner for each instrument provided. Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records. Servers of acceptable sizing provided for each site in VISN1listedwith appropriate software Turn-in for credit old equipmentWe would like the option of turning in the WX equipment for credit, if possible ??? Scan whole tissue slides, providing images with infinite focus (Z stacks) from 0 to 40x Resolution must be at least 0.75 m/pixel for a 20x image and 0.25 m/pixel for a 40x image. Provide slide overview image as well as slide label image. Images must be sent automatically from scanner to database seamlessly on contractor provided server Provide high quality images at both 20X and 40X optical resolutions. Must produce images with no discernible stitching artifact. Ability to reduce file size by skipping blank stripes LED light source to reduce need for bulb replacement is preferred It is preferable the scanner 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. Should the scanner fail to scan a given slide in a processing batch, the scanner must be able to recover and complete the remainder of the batch without user interventions. Scan speed must be least 60 seconds or less for a 20x scan (15x15mm) or 155 seconds or less for a 40x scan (15x15mm). Digital images created must be compatible with multiple types of analysis software. Capacity to do whole slide imaging as well as regions of interest. Report whole image data as well as individual cell data and maintain an interactive link between cell metrics and cell imagery. Ability to set RGB values during an algorithm configuration by clicking on desired color on image. Ability to move annotation lines once drawn by dragging and without having to erase and redraw. Ability to continue the same annotation line after stopping and starting again. Figure maker capabilities that automatically format presentation, number images, add correct scale bars and reference frames for each image with a click of a button; and include up to 9 images Systems must be able to save, review, and display file formats to include: JPG, JPEG, TIFF, JPEG2000 compression standard or TIFF Operating system software shall be currently sold and supported by its original manufacturer. Instrumentation with operating systems such as Windows XP and Windows Server 2003, that are no longer supported, shall not be proposed and are unacceptable. If a Windows operating system is applicable, Windows 7 64-bit or newer and Windows server 2008 or newer will be considered. Operating systems must meet all security requirements of the Veterans Health Administration. Ability to add Fluorescent technology as an adjunct module at a later date if needed Provide a notification ( work list ) of cases assigned to a pathologist user upon his/her logging into the local or remote server. Cases should be easily opened and all slides associated with a particular case accession number should be grouped and accessible in the viewer window environment. Upon selecting a particular slide from a case group a thumbnail of the whole slide showing label and tissue should be viewable in order to confirm proper identification. The thumbnail should also provide the means to rapidly navigate to selected areas of the slide for viewing in the main examination window. The main examination window will allow free image handling that will include mouse wheel controlled magnification/demagnification and click-drag movement of the image through the viewing area. If configured to specifications, the system should stream images in crisp focus with essentially no image assembly delays or pixelation at all magnifications. The software should provide capacity for creating storable annotations of images. In addition, there should be an image capture feature for capturing and storing secondary images from selected areas of interest. To track and establish stages of case viewing, the software should provide a means to designate cases as complete or still under review. Complete cases would be removed from work lists whereas as incomplete cases would remain as pending. Software should include the ability to search and retrieve cases from the archived image database by various search parameters. Training. The Contractor shall provide on-site instrument training program that is coordinated with and timely to the equipment installation. The vendor will provide at a minimum, initial on-site training for scanner operators, pathologists and clinical engineering staff. Thereafter, the Contractor shall provide training as needed. Supplementary advanced training and continuing educational opportunities provided by the vendor will be considered an additional benefit. VISN 1 Site Requirements: VA Maine one multi-slide scanning system, VA Maine HCS, 1 VA Center, ATTN: Lab Manager, D. Arbour (Lab 113), Augusta, ME 04330 VA White River Junction one multi-slide scanning system, White River Junction VA, 215 North Main Street, ATTN: Lab Manager, L. Cooper (Lab 113), White River Junction, VT 05001 VA Manchester one small slide scanning system; small footprint, Manchester VA, 781 Smyth Road, ATTN: Lab Manager, K. Hall (Lab 113), Manchester, NH 03104 VA Providence one multi-slide scanning system, Providence VA, 830 Chalkstone Avenue, ATTN: Lab Manager, C. Lima (Lab 113), Providence, RI 02908 VA Connecticut - one multi-slide scanning system, West Haven VA, 950 Campbell Avenue, ATTN: Lab Manager, L. Zucker (Lab 113), West Haven, CT 06516 VA Boston West Roxbury one multi-slide scanning system, VA Boston HCS, 1400 VFW Parkway, ATTN: Lab Manager D. McElwee (Lab 113), West Roxbury, MA 02132 VA Boston Jamaica Plain appropriately sized slide scanning system, small footprint, used for live viewing of frozen sections (single or small system) VA Boston HCS, 150 South Huntington Ave, ATTN: Lab Manager D. McElwee (Lab 113)Jamaica Plain, MA 02130 Interface and software Requirements The vendor is required to fill out and submit a VHA form 6550 with their submission package. Current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system Must be HIPPA complaint and meet VHA IT security standards. If a universal interface is needed for the interface, the Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 60 days after the award of the Award. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 60 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government. If a site already has a universal interface system, the Contractor is responsible for everything leading up to the connection to the software system, including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system. The vendor will perform installation of equipment in coordination with designated personnel from VISN 1 Pathology and Laboratory Medicine Service, Clinical Engineering, and the Office of Information and Technology (OI&T). Both parties establish that the network and servers meet required specifications for optimal hardware and software functioning. The vendor will provide an electronic Standard Operating Procedure (SOP) for both the operation of the device and maintenance. The SOP s will be customized at each site. Electronic training manuals and materials will also be provided. Contracting please include: Security Clauses to be included: 1-3, 5F-H, 6-8 Include 6550 Please check with Mary Goulart prior to submitting to ensure you have the latest SOW
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/MaVAMC608/MaVAMC608/VA24117N0181/listing.html)
 

Document(s)

Attachment
 

File Name: VA241-17-N-0181 VA241-17-N-0181_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3259168&FileName=VA241-17-N-0181-003.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3259168&FileName=VA241-17-N-0181-003.docx

 

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Record

SN04394214-W 20170209/170207235437-fa3dc5966ec659a656931264559f32d5 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
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