36C26219Q0831-002.docx

SALIENT CHARACTERISTICS OF FORUM DATA MANAGEMENT

Image and Data Management /PACS System must be listed in the VistA Approved DICOM Modality Interfaces, 15 June 2014, or later page 17. A DICOM modality is considered “Supported” if it passes the VA’s internet validation test suite listed in the Joint VA/DoD DICOM Modality Conformance Requirements (Rev 3.0) document (see http//www.va.gov/imaging).

PACS system must be able to integrate with the VA VistA system and accept New/Updated Consults/Orders created from CPRS/VistA that contains Patient demographic data, and send these as a DICOM Modality Work-lists to a single/multi DICOM compliant instruments within the eye-clinics network.

Image and Data Management/PACS System must be FDA 510k approved and listed as a Medical Device.

Image and Data Management System/ PACS must provide “Post Processing Analysis, Dynamic Review/Manipulation of RAW data” functionality for ZEISS Cirrus HD-OCT. This allows to manipulation of the raw patient files down to the algorithmic level. Change Baselines test in the Doctor’s lane for GPA and Macular Change Analysis.

Image and Data Management System/ PACS must provide “Post Processing Analysis, Dynamic Review/ Manipulation of Raw data functionality for Zeiss Humphrey Field Analyzer. This allows to manipulation of the raw patient files down to the algorithmic level. Change Baselines test in the Doctor’s lane for GPA (Guided Progression Analysis).

Image and Data Management/PACS System must be able to store and access raw instrument data from ZEISS Field Analyzer, ZEISS Cirrus HD-OCT, ZEISS Visucam Fundus Camera and ZEISS FF450/Visupac Fundus Camera systems.

Image and Data Management/PACS System must have functionality to enable real-time and dynamic editing/manipulation of all prior Visual Field Test data for all Glaucoma patients and allow for Baseline changes, real-time report generation for any VFI date, display RelEYE images and data from the new ZEISS HFA 3. This is done by the Doctor in their respective lane.

Image and Data Management System must support DICOM standards and Work-List functionality in order to create and send patient demographics to a specific or all instrument’s via a DICOM work-list within the eye clinic’s network.

Combined Report: HFA-Cirrus reports for Structure Function analyses in Single Display with OD-OS on one (1) page print out from data of Cirrus HD OCT and a Humphrey Visual Field.

Image and Data Management System must have Bi-directional DICOM capabilities to send both DICOM Modality Work-lists containing Consult/Order details to instrument’s within the eye-clinics network and receive back the diagnostic test results and RAW data for storage within the Image and Data Management System for access.

The image management system must have the ability to do VNA (Vedor Neutral Archive, LDAP, PKI which is single sign enterprise authentication.

Image and Data Management/PACS System must connect to any brand of non-DICOM diagnostic instrument with export capabilities, and convert the diagnostic test results into a DICOM compatible file containing all patient demographical information, UID’s, Accession number, Device name and type, laterality and other key pieces of data with the least amount of user interaction. This must be then stored within the Image and Data Management/PACS System and also forwarded to the VA VistA Image and Data Management/PACS System must not require the use of an external PC or import computer for a DICOM compatible modality.

Image and Data Management/PACS System must be able to download all past RAW data from one or more ZEISS Field Analyzers, ZEISS Cirrus HD-OCT’s, ZEISS Visucam Fundus Camera and ZEISS FF450/Visupac Fundus Cameras acquired within the main clinic and all satellite clinics upon installation of the Image and Data Management/PACS System.

Image and Data Management/PACS System must be able to display ZEISS Field Analyzer Glaucoma Progression Analysis (GPA) and enable the clinician to manipulate data and store baseline changes at the workstation within the Image and Data Management System if Glaucoma Workplace is procured as a part of FORUM Image and Data Management /PACS System must be able to present VFI Index, Mean Deviation, Pattern Standard Deviation and Global Indices at a glance summary of all past and present tests.

Image and Data Management /PACS must be able to display and allow the clinician to scroll through the various ZEISS Cirrus Macula Cube B-scan slices, within in the Image and Data Management System viewer.

Image and Data Management /PACS System must be able to display all Cirrus HD-OCT past and present test data from one or more ZEISS Cirrus instruments located in one or more VA clinics. This date must be accessible to enable viewing and manipulation at the workstation.

Image and Data Management /PACS System must be able to automatically label images and reports coming from the instruments DICOM Header to enable the clinician to sort test data by visit date/s, modality type/s, right eye, left eye or both eyes.

Image and Data Management /PACS System must be able to tag individual test reports/images as Favorites to enable easy access on future patient visits Image and Data Management System must be able to display images in pre-formatted clinical display groupings for Glaucoma, Retina and Cataract cases.

Image and Data Management System must be able combine multiple databases of the Zeiss Humphrey Visual Field Analyzers and remove and store on the respective “Pacs Server”.

Image and Data Management System must be able combine multiple databases of the Zeiss Cirrus OCT Instrument remove and store on the respective “Pacs Server”.

Image and Data Management System must be able to accept the raw data of the IOL Master Biometer and inject that data (without using a thumb drive), into the Lumera Microscope and Callisto Eye for use during Cataract Surgery with Markerless technology for Toric IOL Patients.