SCM-Functional_Requirements-PRJ_-2094-_PACS-3D_Medical_Imaging_0425.xlsx

XLSX spreadsheet 50 KB Posted

Attached to
PACS-3D Medical Imaging
Solicitation number
2025-RFP-00358
Issued by
San Mateo County, California

About this file

The document is a detailed Functional Requirements Specification for a Picture Archiving and Communication System (PACS) and 3D Medical Imaging solution for San Mateo County Health in California. The procurement seeks a comprehensive PACS system that must integrate seamlessly with Epic Electronic Health Record (EHR) and support multiple medical departments including Radiology, Cardiology, and potentially expanding to Neurology, Dentistry, Endoscopy, Laboratory, and Surgery. The system requirements span extensive functional specifications across worklist management, image viewing, clinical documentation, technologist and physician workflow tools, 3D imaging capabilities, mammography and cardiology-specific features, and enterprise-level archive and administration functions.

The project emphasizes critical integration requirements, particularly with Epic EHR, and seeks a vendor with proven expertise in healthcare PACS implementations. Key objectives include enhancing system reliability, ensuring full HIPAA compliance, and improving overall usability across multiple medical disciplines. The county is looking for a solution that can migrate existing studies, consolidate imaging applications, and provide advanced visualization tools. While specific budget details are not explicitly outlined, the comprehensive functional requirements suggest a complex, enterprise-level imaging system that will require significant technical capabilities and a demonstrated track record of successful Epic integrations in healthcare settings.

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Generalization

The Proposed Solution shall initiate the majority of clinical activities including:Required or Optional RequirementMeets Requirement? (Y/N & Comments)
WorklistsRequired
F-001Default site level worklists that must be customizable and available for all usersRequiredOptional
F-002Level of Worklist customization shall be availableRequired
F-003−available to individual usersOptional
F-004−available to site administrators to customizeOptional
F-005-Site administrators for site wide worklistsOptional
F-006-Site administrators for user groups or individualsOptional
Worklist searching
F-007-Various search criteria available to usersRequired
F-008-Method to save frequently used worklist search criteria by users, like a worklist shortcutRequired
Viewing Studies
F-009When opening a study, the first image must be displayed within 5 secRequired
F-010User is able to open more than 1 study at a time, such as current and prior studiesRequired
F-011Comparison or prior studies can automatically open, such as in a continuous reading workflowOptional
F-012View prior studies while viewing current studyRequired
F-013There must be obvious markings to distinguish between current study and prior studiesRequired
F-014Easy to identify if an image is compressedOptional
F-015Easily identifiable Image orientation markersRequired
F-016Able to view report(s) for current and/or prior exam(s)Optional
F-017Able to view note(s) for study(ies)Optional
F-018Able to view Key ImagesRequired
F-019Able to view associated scanned documentsOptional
F-020Able to view Image Overlay textRequired
F-021Image Overlay text is editable system wideRequired
F-022Image Overlay can be edited -For user groupsOptional
F-023Image Overlay can be edited -For individual usersOptional
Hanging Protocols (Display Protocols)
F-024There must be site level display protocols that can be edited by site administratorsRequired
F-025Hanging protocols must be editable by usersRequired
F-026Hanging protocol customization should be available to non reading usersRequired
F-027Hanging protocols can be customized by modalityRequired
F-028Hanging protocols can be customized by body partRequired
F-029Hanging protocols specific to breast imaging should be availableOptional
F-030There should be tools for site administrators to review and clean up a users hanging protocolsOptional
F-031There may be methods or tools for a user to clean up their own protocols, if user is skilled enough and comfortable with the toolOptional
Keyboard Shortcuts
F-032Options for keyboard shortcuts may be customizableOptional
F-033If so, are they customizable globally, or for each userOptional
Mouse Settings/Options
F-034Options for different mouse actions should be customizableOptional
F-035If so, are they customizable globally, or for each userOptional
Image Viewing Tools - GeneralClinical Care - Clinical Documentation
Image selection
F-036A single image can be selectedRequired
F-037Multiple images can be selectedRequired
F-038Images can be stackedRequired
F-039Series can be stackedRequired
F-040Entire study can be stacked as a single seriesRequired
Paging/Scrolling and Cine
F-041Users must have multiple methods to scroll through images and series, including with a mouseRequired
F-042Shortcuts and adjustments for scrolling and scroll speedOptional
F-043User accessible cine controls and settingsOptional
F-044Cardiac cine controlsRequired
F-045Non-cardiac exam cine controlsRequired
Window/Level and VOI LUT
F-046Shortcuts and mouse settings to adjust W/L and LUT must be availableRequired
F-047W/L and LUT presets must be availableRequired
F-048W/L and LUT settings are customizable globallyOptional
F-049For each userRequired
F-050W/L settings must include various NM and PT specific optionsRequired
F-051W/L may be adjusted inside a selected area or ROIOptional
F-052W/L may be adjusted inside a zoom window or magnifying glassOptional
Image Manipulation
F-053Image(s) can be flippedRequired
F-054Image(s) can be rotatedRequired
F-055Image(s) can be zoomedRequired
F-056by stepped factors or continuous zoom or bothOptional
F-057A "Magnifying Glass" tool is available to magnify a portion of an imageOptional
F-058The "Magnifying Glass" zoom factor should be adjustableOptional
F-059W/L within the "Magnifying Glass" should be adjustableOptional
F-060Image(s) can be panned when zoomed or the entire image isn't viewable in the image windowRequired
F-061Image(s) may be be sharpenedOptional
F-062Image(s) may be enhancedOptional
F-063Image adjustments must be able to be reset to original state without having to close and reopen the studyRequired
Annotations and Measurements
F-064Annotations must be able to be added to imagesRequired
F-065-Text annotationsRequired
F-066-Regions of InterestRequired
F-067-ArrowsRequired
F-068-Spine labelingOptional
F-069Annotations must be able to be edited and/or deletedRequired
F-070Images may be calibratedRequired
F-071-To a scaleOptional
F-072-To a calibration device within the imageOptional
F-073Distances must be able to be measuredRequired
F-074Angles must be able to be measuredRequired
F-075-Including Cobb angle measurementsRequired
F-076Ultrasound image(s) can be measured in metric unitsOptional
F-077Measurements can be taken on ultrasound cine clipsOptional
Syncing and Cross Reference
F-078Series and images must be able to be synced within a studyRequired
F-079Series and images must be able to be synched between different studiesRequired
F-080Synching across different studies should be able to adjust to align anatomy. This can be a manual or automated process.Optional
F-081Synching can be enabled/disabled while viewing as part of normal workflow by userOptional
F-082Cross reference lines must be available when synchedRequired
F-083Cross referrence lines must be able to be enabled/disabled by userRequired
F-084Cross reference lines and syncing must be possible across series in a studyRequired
F-085Cross reference lines and syncing must be possible with both current and comparison studiesRequired
F-086All displayed series must be able to be localized to a single point in a studyRequired
F-087All displayed series must be able to be localized to a single point across studiesOptional
Technologist Tools and WorkflowClinical Care - Clinical Content
F-088Technologist must be able to re-order images and save for other usersRequired
F-089Technologist must be able to add anotations and measurements and save for other usersRequired
F-090Technologist should be able to scan appropriate documents into a studyOptional
F-091This can be Forms and eFormsOptional
F-092This can also be Measurement forms from modalities, eg, ultrasound worksheetsOptional
F-093Technologist must be able to save changes in a single stepRequired
F-094Technologist must be able to Copy or Move an image to another studyRequired
F-095Technologist must be able to Copy or Move an single series to another studyRequired
F-096Technologist must be able to Delete a single image from a studyRequired
F-097Technologist must be able to Delete a single series from a studyRequired
F-098Technologist or appropriate privileged user should be able to un-Delete an image or seriesOptional
F-099Technologist or appropriate privileged user should be able to un-Delete a studyOptional
F-100Technologist or appropriate privileged user must be able to Merge studiesRequired
F-101Technologist or appropriate privileged user must be able to Unmerge or Split studiesRequired
F-102Technologist must be able to Mark a study as Verified or similar statusRequired
F-103Technologist must be able to Unverify a studyRequired
F-104A QC option is availble to identify images or QC studies used with a QC processesOptional
F-105If available can the process be used for marking images for QC review such as MQSA EQUIPOptional
F-106Studies should be able to be marked as Stat or UrgentOptional
F-107Studies should be able to be unmarked as Stat or UrgentOptional
F-108Studies should be able to be marked as VIP / ConfidentialOptional
F-109Patient should be able to be unmarked as VIP / ConfidentialOptional
F-110Studies or images should be able to be bookmarked or marked as Interesting cases or for teaching purposesOptional
Reading Physician Tools and WorkflowClinical Care - User Interface and Display
First Login
F-111At first login or when opening a study should autologin the radiologist to PowerScribeRequired
F-112At first login or when opening a study should autologin the radiologist to EpicRequired
F-113At first login or when opening a study should autologin the radiologist to PACS-EI ViewerRequired
F-114When study is opened from viewer, report shell is opened in PowerScribe and Patient page or Mammo module is opened in EpicRequired
F-115There must be syncing of patient/study between viewer and Nuance PowerScribeRequired
F-116There must be syncing of patient/study between viewer and EpicRequired
F-117Signing a study in PowerScribe should update the status of a study in the viewer to FinalOptional
F-118Auto reading workflow should be available where once initiated, after a report is signed, the study will be marked Final, the study closed and the next study opened, ready for review and interpretationOptional
F-119Previous saved changes by technologists, reading physicians, or other privileged users must be viewable upon study opening without additional actionsRequired
F-120Changes are saved in a single step by priviledgd usersRequired
F-121Changes by radiologists, such as measurements and annotations, Key Image Notes (KIN) must be auto-saved when study is closed, marked as read, or savedRequired
F-122When interrupted by a referring physician to review another case, there is a simple mechanism to review another case and when finshed and return to the interrupted study. Any changes or annotations are still present in the original studyOptional
F-123Reading physician should be able to mark a study as Read, Dictated, or FinalOptional
F-124Reading physician can un finalize a studyOptional
F-125Reading physicians should be able to mark or bookmark a study or image as an interesting case or for teaching purposesOptional
F-126Reading physicians should be able to mark or bookmark a study or image for QC reviewOptional
F-127Reading physicians should be able to mark or bookmark a study or image as interesting for referring physician reviewOptional
F-128Reading physicians should be able to mark or bookmark a study or image as interesting for conference presentation (Cancer, Surgery,etc…)Optional
Inherent Basic 3D ToolsClinical Care - Workflow
F-129The viewer should be able to generate MultiPlanar Reformats (MPR)Optional
F-130The viewer should be able to generate Maximum Intesity Projections (MIP)Optional
F-131The viewer should be able to perform some 3D rendering or advanced imaging analysisOptional
F-132The viewer may be able to perform some additional advanced analysis directlyOptional
F-133A 3D Advanced Image Analysis solution may be able to be launched from the viewerOptional
F-134Images generated on an external 3D module or system must be able to be saved back to the studyRequired
Conferencing Tools and AnonymizationClinical Care - Decision Support (CDS)
F-135Can a reading physician and referring physician review a study in a live online conferenceOptional
F-136Is it collaborative, can both user see actions in the conferenceOptional
F-137Can the reading physician move the curser in the conference so the referring physician can seeOptional
F-138For general conferences such as Tumor board or other such, can studies be identified for the conference ahead of timeOptional
F-139Is it simple to view the identified conference patients/examsOptional
F-140Can the patients be anonymized for the conference, as neededOptional
Import ExportClinical Care - Therapies
F-141External studies can be imported into the systemRequired
F-142From disc either within the system or using a 3rd party applicationOptional
F-143Online via image exchangeOptional
F-144From another systemOptional
F-145Studies can be exportedRequired
F-146Online via image exchangeOptional
F-147To disc either within the system or using a 4rd party applicationOptional
F-148To another systemOptional
F-149Exported studies or images should be able to be anonymized during export if being used for academic purposesRequired

Mammography

IDMammography RequirementsRequired or Optional RequirementMeets Requirement? (Y/N & Comments)
The Proposed Solution shall have the ability to support Mammography as existing internal features, add-on module or license, or additional integrated system:Required
F-150Is the system validated for mammmography interpretationOptionalOptional
Mammmography features are inherent to the proposed systemOptional
Mammmography functions are an add-on module or licenseOptional
Mammmography is an additional integrated systemOptional
Mammmography functions can be integrated from a third-party systemOptional
F-151The system should support mammo specific hanging protocolsOptional
F-152If system supports Mammography interpretation, Mammo hanging protocols must allow for required CAD to only be visible after initial image viewingRequired
F-153If system supports Mammography interpretation, Mammo hanging protocols should have a simple mechanism for viewing sequential historical studiesOptional
F-154If system supports Mammography interpretation, Mammo hanging protocols should have multiple steps or settings to view images and comparisons in sequenceOptional
F-155If system supports Mammography interpretation, Mammo hanging protocols should be capable of skipping protocol views that aren't present in the current or viewed prior studyOptional
F-156If system supports Mammography interpretation, the system must have mammo specific toolsRequired
F-157If system supports Mammography interpretation, the radiologist must be able to mark images with mammo specific annotation, eg ROIs, clips, etc…Required
F-158If system supports Mammography interpretation, True size scaling must be an included featureRequired
F-159The system may offer mammo specialized hardware devices, such as a customized keypadOptional
F-160The system must support mammo tomographyRequired
F-161The system must support Hologic CAD and CAD markingsRequired
F-162The system must display breast ultrasound imagesRequired
F-163The system should display imported breast MRI and associated analysesOptional

Cardiology

IDCardiology RequirementsRequired or Optional RequirementMeets Requirement? (Y/N & Comments)
The Proposed Solution shall have the ability to support Cardiology as existing internal features, add-on module or license, or additional integrated system:
F-164Cardiology features are inherent to the proposed systemOptionalRequired
F-165Cardiology functions are an add-on module or licenseOptionalOptional
F-166Cardiology is an additional integrated systemOptional
F-167Cardiology functions can be integrated from a third-party systemOptional
F-168System must support Adult echo including TEERequired
F-169System should support Pediatric echoOptional
General User Actions
F-170Measurements must be able to be added and savedRequired
F-171Measurements must be able to be edited or deletedRequired
F-172Measurements must be able to be assigned to a fieldRequired
F-173Measurements must include:Required
F-174--DistanceOptional
F-175--Area using pointsOptional
F-176--Area inside an ellipseOptional
F-177--Angle between 2 linesOptional
Echocardiography ReportsOptional
F-178System must provide an echo reporting environmentRequired
F-179cardiologists use industry normalized standard reporting phrases. These must be available and have an update mechanismRequired
F-180Standard Reporting (SR) language should be updated periodically. Either as an automated update or an install fileOptional
F-181SR Phrases can be edited or customizedOptional
F-182New or customized SR phrases must be able to be addedRequired
F-183Report templates should require comments on a consistent set of specific anatomy or functionsOptional
F-184Selected phrases should be auto-added to the Conclusion with a simple method not requiring copying and pastingOptional
F-185Report must be able to be reviewed prior to signingRequired
F-186Reports must be able to be unsigned to make changes or additionsRequired
F-187Reports must be able to be edited or addendedRequired
AdministrationRevenue Cycle Management
Study Administration and System CustomizationOptional
F-188Worklists can be customized and filtered to cardiology studiesOptional
F-189There is an echocardiographer worklistOptional
F-190There is a cardiologist reading worklistOptional
F-191Studies must be able to be associated to, or moved to the correct orderRequired
F-192Studies must be able to be associated with, or moved to the correct patientRequired
F-193QC or QA studies should be able to be marked as suchOptional
F-194Studies or images should be able to be anonymized during export for academic purposesOptional
F-195Studies should be able to be marked for Cardiac ConferenceOptional
F-196Sudies must be able to be unlocked, if exam locking occurs, when an exam is opened by another userRequired
Patient AnalyticsOptional
F-197Studies can be queried for specific patient or disease parametersOptional
Advanced Cardiac AnalysisPatient Engagement
F-198The system or module includes advanced cardiac image analysisOptional
F-199The system integrates with a third-party advanced image analysis add-on module or systemOptional
F-200The system must support GE EchoPAC Plug-in v206.xRequired
F-201The system shall support TomTec ArenaOptional
F-202The system shall support Philips QLABOptional
F-203The system may support other advanced image analysis packagesOptional
F-204The system must be able to calculate the following, but is not limited to:Required
F-205−AutoEFOptional
F-206−LVQOptional
F-207−RVQOptional
F-208−MVQOptional
F-209−AVQOptional
F-210−LAQOptional
F-211−TVQOptional
F-212--3DQOptional
F-213−AFI StressOptional
F-214−Quantitative TVIOptional
F-215−AutoStrainOptional
F-216−Vessel measurementsOptional
Optional

3D

ID3D Advanced Image AnalysisRequired or Optional RequirementMeets Requirement? (Y/N & Comments)
The Proposed Solution shall have the ability to provide 3D Advanced Image Analysis as existing internal features, add-on module or license, or additional integrated system. This is separate from Echocardiography specific 3D and Advanced Image Analysis and targeted for general Radiology:Required
F-216Is the 3D solution inherent to the systemOptionalOptional
F-217Is the 3D solution an add-on module or licenseOptional
F-218Is the 3D solution an additional integrated system or third-party systemOptional
The system must be able to accept images from 3DR Labs back into the original studyRequired
F-219Can the 3D component be launched from the studyOptional
F-220Required FunctionsOptional
F-221--Cardiac CT analysisOptional
F-222--Cerebrovascular and stroke analysisOptional
F-223--Vessel analysisOptional
F-224--CT colonographyOptional
F-225--Lung perfusion and nodule analysisOptional
F-226--Tissue perfusion and analysisOptional
F-227--3D fracture modelingOptional
F-228The generated images saved back to the original examOptional

Site Administration

IDSite AdministrationRequired or Optional RequirementMeets Requirement? (Y/N & Comments)
F-229The Proposed Solution must implement event, audit and access logging that conforms with current HIPAA Security Rule.Required
F-230HIPAA logs must be accesible and searchable to site administratorsRequiredRequired
F-231Site administration tool including funcitons:OptionalOptional
F-232--For User administration including user groups configurationOptional
F-233--To add exam matching factors for comparison purposes such as Body Parts, if needed
F-234--To add locations, if necessaryOptional
F-235--For exam procedure maintenance, if necessaryOptional
F-236--Customize site defaults, such as worklists, text overlays, etc…Optional
F-237Site administrators can add/edit/remove DICOM modalitiesOptional
F-238Site administrators can view DICOM store, send, query-retrieve logsOptional
F-239Administrators can restart, reprocess, or clear queues
F-240Site administrators can view overall system statusOptional
F-241System has system reporting functionalityOptional
F-242--Does this require an add-on license, such as Microsoft SSRS or SAP Crystal Reports
F-243Client viewers should be capable of auto identifying and configuring displays without required user interventionOptional
F-244Client should be able to properly identify which monitors should be used for worklilst and which for images, automaticallyOptional
F-245User settings must be automatically configured when a user logs in to any clientRequired
F-246User default hanging protocols must be automatically used without user interaction beyond opening a studyRequired
F-247Each user musn't be required to configure displays for each pc they might useRequired
F-248Each user musn't be required to have to manually download user config files on to each pc they might useRequired
F-249Each user musn't be required to have to manually download hanging protocols to each pc they night useRequired
F-250Study images are only cached on client pc while study is openOptional

VNA Enterprise Archive

Enterprise Archive - Vendor Neutral ArchiveRequired or Optional RequirementMeets Requirement? (Y/N & Comments)
The Proposed Solution shall be able to offer or integrate with an Archive:Required
F-251−Proposer can include or add later, an Archive solutionOptionalOptional
F-252−Proposer can integrate to a third party Archive solutionOptional
Proposer's Archive solution
F-253--Solution must integrate with EpicOptional
F-254--Solution must be committed to support Epic HyperDriveOptional
F-255--Solution must be able to partition or compartmentalize studies/images by discipline, eg, Dentistry vs Endoscopy, as neededOptional
F-256--Solution must support DICOM imagesOptional
F-257--Solution should support non-DICOM imagesOptional
F-258--Solution can integrate with multiple systems if needed
F-259-PACS-Enterprise ImagingOptional
F-260-Cardiology PACSOptional
F-261-Dental PACSOptional
F-262-Surgery including EndoscopyOptional
F-263-Laboratory/PathologyOptional
F-264Proposer solution is or can be on premiseOptional
F-265Proposer solution is or can be cloud hostedOptional
F-266If cloud hosted, data center(s) are located in non disaster prone regionsOptional
F-267If cloud hosted, data center(s) redundancy is in a different regionOptional
Migration
F-268Describe estimated length of time for archive/migration from each existing system -refer to XXXX for current image volumesOptional
F-269-Scimage PACSOptional
F-270-GE ViewPointOptional
F-271-MiPACS DentalOptional
Third-Party Archive integration (Mark SELF in Meets Requirement for Proposers own VNA solution)Optional
F-272--Vendor has successfully integrated with the following VNA vendors with little to no issue. Mark each system with a record of at least 3 or more clients.
F-273-Agfa Enterprise Imaging VNAOptional
F-274-Change Healthcare Image RepositoryOptional
F-275-Fuji Synapse VNAOptional
F-276-GE Healthcare DatalogueOptional
F-277-Hyland Acuo VNAOptional
F-278-Insite One Unified Clinical ArchiveOptional
F-279-Mach7 VNAOptional
F-280-Merative Merge VNAOptional
F-281-Philips Enterprise Repository Vue ArchiveOptional
F-282-Sectra VNAOptional

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