P02 RFI Draft PWS.docx

Veterans Health Administration Enterprise Mammography Tracking System Draft Performance Work Statement

A. INTRODUCTION

This document outlines the Veterans Health Administration (VHA) requirements for the vendor to furnish and install an enterprise Mammography Tracking System and services. The proposed Mammography Tracking System will enable radiologists and clinical staff to better manage the VHA Mammography programs.

VHA has substantial interface requirements between the proposed Mammography Tracking System and the Veterans Health Information and Systems Technology Architecture (VistA) and Oracle Health (OH) Millenium. Facilities and Veterans Integrated Service Networks (VISNs) throughout VHA may utilize a variety of Radiology Information Systems in addition to the Electronic Health Record.

The proposed Mammography Tracking System shall provide functionality as described in this document to every VHA Facility providing in house Mammography solutions, in addition to the National Teleradiology Program, and oversight/analytics capabilities for the National Radiology Program Office. The solution needs to be capable of expanding to provide for future in-house Mammography program. Implementation of the proposed Mammography Tracking System will be managed through a phased deployment to maximize organizational learning and project management resources. Each phase of the project must be coordinated with the assigned VISN Primary Contracting Officer’s Representative (COR) and will be discussed in detail with the vendor during the pre-work orientation.

The vendor shall be responsible for providing all services associated with the furnishing and installation of the proposed Mammography Tracking System. The vendor shall provide training, system maintenance, and data exchange throughout each facility. Upon completion of the installation, testing, and training, VHA will have a state-of-the-art Mammography Tracking System.

B. LOCATION OF VHA FACILITIES

Currently, VHA has 88 in-house Mammography Programs across 56 VAMC/Healthcare Systems in addition to the National Teleradiology Program (NTP) and National Radiology Program Office.

C. PROJECT MANAGEMENT

1. The proposed solution shall provide a single service account manager for VHA.

2. The proposed solution shall provide project management to include:

a. Software, network, and implementation planning

b. Timeline

c. On-site installation and implementation

d. Hand off fully functioning Mammography Tracking System

D. CLINICAL FUNCTIONALITY

1. Patient Registration

a. The proposed solution shall include patient/family history features.

1. Describe the proposed solutions Patient/Family History features including:

a. Provide example of forms provided to the patient for collecting Patient/Family History information

i. Can these forms be pre-populated with information from the proposed solution?

b. Provide screenshots of the Patient/Family History section from the proposed solution

b. The proposed solution shall have the capability to allow Radiologist Technologist comments to be entered.

1. Describe how Radiologist Technologist comments can be entered and communicated with the proposed solution

c. The proposed solution shall have the ability to auto update patient demographics upon registration.

d. Ability to receive demographic updates from DEERS and other external systems.

e. Ability to utilize a tablet to gather patient history and automatically import this into the system

2. Reporting

a. The proposed solution will be capable of:

1. Generating the Radiology Report

2. Transmitting the Radiology Report to VistA/CPRS

3. Utilize the voice recognition component of PowerScribe 360 or PowerScribe One 2019

4. Creating Radiology Report Addendums

b. Archive the lay letters into VISTA/CPRS & OH

c. The proposed solution shall have the capability of providing a radiologist worklist

1. Describe the proposed solutions Radiologist Worklist capabilities.

2. Provide screenshots of the proposed solutions Radiologist Worklist.

d. The proposed solution shall integrate with Hologic and GE Mammography workstations.

1. Describe the proposed solutions integration with Mammography Workstations

2. Describe any recurring annual integration, licensing, or other cost associated with maintaining the integrating with third (3rd) party vendors such as GE or Hologic Mammography Workstations.

e. The proposed solution shall integration with PowerScribe 360 or PowerScribe One 2019

1. Describe how the proposed solution utilizes the voice recognition component of PowerScribe 360 or PowerScribe One 2019

2. Describe any recurring annual integration, licensing, or other cost associated with maintaining the integrating with PowerScribe.

f. The proposed solution shall integration with VistA/CPRS and Oracle Health (OH) Millenium

1. Describe how Radiology Reports are transmitted to VistA/CPRS & OH

g. The proposed solution shall include diagnostic BI-RADS Codes in the HL7 report message

h. The proposed solution shall have reporting template capabilities

1. Describe creating a negative screening mammography report

2. How many steps are required to complete this report?

i. The proposed solution shall be used to support the following breast examinations

1. MRI

2. Ultrasound

3. Mammography

4. Contrast Enhanced Mammography (CEM)

5. Various Image guided breast biopsies & tumor localizations

6. Molecular Breast Imaging (MBI)

j. The proposed solution shall include Breast Cancer Risk Assessment

1. Must include the Tyrer Cuzick risk management module

a. List any additional risk management modules that are sources utilized for the Breast Cancer Risk Assessment

b. List the sources included with the proposed solution

c. List the sources that are optional and any associated licensing cost

d. Provide screenshots of how these risk models are visualized by the techs and radiologists, i.e., is it just a list in black and white? or is it an easy-to-read color diagram?

k. The proposed solution shall have the ability to turn on and off the different risk management modules

l. The proposed solution shall provide a dashboard of the Breast Cancer Risk Assessment that is customizable (i.e. different risk modules can be turned off and on

1. Describe how the Radiologist is informed of the Breast Cancer Risk

2. Provide screenshots of how the Radiologist would view the Breast Cancer Risk

m. Ability for the product to integrate with third (3rd) party AI software systems

n. The proposed solution shall have the ability to document physical findings

1. Describe how physical findings can be documented in the proposed solution

2. Describe the proposed solutions ability to import and view scanned documents (e.g., Radiology Reports, Pathology reports for biopsies).

3. Tracking

a. The proposed solution shall have the ability to create a patient follow-up report.

1. Describe the proposed solutions ability to create a patient follow-up report

a. Describe the different actions that can be driven from the follow-up report

b. Describe the different actions that will remove the patient from the follow-up report

b. The proposed solution shall have a method for sending results letter to patients.

1. Describe the proposed solutions method for sending a results letter to Patients

a. Describe the different triggers that can be utilized to initiate sending the results letter

b. Can the results letters be turned off for example by facility?

c. Can the results letter be customized by facility?

d. Can the results letters be edited by the facility “on the go’?

c. The proposed solution shall have the ability to send the results letter to CPRS via HL7.

d. The proposed solution shall have the ability to track patient complaints

1. Describe the proposed solutions ability to track patient complaints

4. QA and QC The proposed solution shall have the capability for quality assurance and compliance.

1. Describe the proposed solution capabilities for assisting VISN 5 to be in compliance with the Mammography Quality Standards Act and Program (MQSA)

2. Are second reads allowed to maintain Radiologist credentialing?

5. Analytics and Reports

a. The proposed solution shall have the ability to provide analytics and reports

1. Provide samples of all supported reports

2. Provide information on the types of business analytics tools available for data mining

b. The proposed solution shall include a minimum of the following report types:

1. Medical Audit data

a. Please provide screenshots of how these reports will look.

1. High risk patient follow-up report

b. Performing clinician workload report

c. Pathology outcomes profile

d. Risk factor reports sent to clinicians

e. Anonymize the false negative /positive list

f. BIRAD 0/Recall report and follow up

c. All reports should be limited to a group of users on a need-to-know basis

d. The proposed solution shall include an automated tissue density integration package

e. The proposed solution shall include an interface with EQUIP

1. Provide references of where the proposed solution is installed with EQUIP at a VA

E. TECHNICAL FUNCTIONALITY

The proposed solution should be an enterprise deployment with the ability to manage at the facility, VISN, and/or VHA level.

1. The proposed Mammography Tracking System being offered shall be non- developmental, i.e. commercially available, in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the proposed Mammography Tracking System is deployed in several VA sites.

a. Specify the proposed server and client software versions.

b. List the actual major and minor releases, including dates, for the past two years for the proposed Mammography Tracking System.

c. List any third (3rd) party software components included in the proposed Mammography Tracking System and whether the cost is included in the proposed licensing models.

1. For any third (3rd) party software components, describe the business and technical agreements that are in place to ensure ongoing support and development.

2. List all database(s) that are used for the proposed Mammography Tracking System.

2. Requirements for upgrading the client software:

a. Can this be performed in the background without user intervention?

b. All user preferences must be retained during upgrades.

3. VHA requires a comprehensive disaster recovery plan to ensure data integrity and restoration.

a. There shall be a process for performing automated system backups.

b. There shall be a process for restoring system backups.

4. The proposed Mammography Tracking System shall include a test system that replicates the production environment. This test system will be used for validating software upgrades, new modalities, and integrated applications. The physical location for the test system will be in Baltimore.

5. Provide recommended hardware specifications and network requirements for the following:

a. Main production system

b. Workstation, including specifications regarding graphic cards and monitors

c. Test server

6. Provide a completed copy of the Manufacturer Disclosure Statement for Medical Device Security (MDS2).

7. Provide a completed copy of the VA Form 6550.

8. The proposed solution shall provide the ability for patient context exchange and synchronization between PACS/Imaging/Radiology/Dictation application and mammography tracking software

F. LICENSING MODELS

1. The proposed solution shall include a licensing model that will accommodate the following users and their functions:

Total VAMC/CBOC Locations (physical addresses of Mammography units)

2. Provide cost for adding 1 concurrent user

G. IMAGING ORDERS AND REPORTS

1. Imaging orders are entered into the VistA Radiology Package or Oracle Health Millenium OpenLink.

2. Within VHA, there are potentially 2 separate instances of VistA HL7 feeds per location and 1 national instance of the OH OpenLink HL7 feed.

H. IMPORTING HISTORICAL RADIOLOGY REPORTS

The proposed solution shall include the migration of studies from the current Mammography information system for all prior studies.

I. PERFORMANCE

1. The proposed solution shall include an uptime guarantee of a minimum uptime of 95%.

a. Provide your uptime guarantee for the proposed Mammography Tracking System.

1. How is uptime defined?

2. How is uptime measured?

3. What is considered downtime?

4. Detail any contractual consequences for failure to meet the uptime guarantee.

2. The proposed solution shall have the performance capability to remain active during database maintenance jobs or other server activities.

J. USER AND GROUP FUNCTIONALITY

1. The proposed solution shall support application authentication using Single Sign-On (SSO) or Lightweight Directory Access Protocol (LDAP) via PIV/CAC cards.

a. Provide the number of government deployments that you currently have that support SSO or LDAP via CAC/PIV.

2. The proposed solution shall provide the capability to develop user groups with distinct privileges/permissions.

a. Describe the available default user groups on the proposed Mammography Tracking System and the privileges/permissions allowed for each group.

b. Can the permissions for the default user groups be modified by a PACS administrator?

c. Can a group be created to limit access to confidential information?

K. HEALTH LEVEL SEVEN (HL7) INTEGRATION

1. The proposed solution shall provide HL7 integration to VistA and OH Millenium.

a. Provide HL7 integration statements for all included components of the proposed Mammography Tracking System.

2. The proposed solution must meet the qualification process for the VA VistA and OH Millenium HL7 interface.

a. Provide documentation in support of this qualification and clarify any issues identified.

L. DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) INTEGRATION

Provide DICOM Conformance Statements for all included products.

M. CUSTOMER TRAINING

1. The proposed solution shall include clinical, technical and PACS administrator training as specified below.

a. Clinical-User Training

1. The vendor shall provide clinical training on the proposed Mammography Tracking System and its operation.

2. Clinical users of the proposed Mammography Tracking System will include, but are not limited to, the following:

a. Radiologic technologist

b. Radiologist

c. Breast imaging nurse navigators/coordinators

3. Upon completion of training, clinical users will be able to successfully utilize all available features with minimal or no assistance from a VA or vendor super user.

b. PACS Administrator Training

1. The vendor shall provide power-user and system administrator training for operational support of the proposed Mammography Tracking System.

2. Upon completion of training, the PACS administrator will be able to:

a. Act as the local super user for the clinical users

b. Act as the local trainer for the clinical users

c. Resolve the top ten most common user questions

d. Create and manage user accounts

e. Install and configure the client application for a new user

f. Monitor system utilization

g. Manage other day to day tasks required for the system

c. Biomedical Engineer Training

1. The vendor shall provide biomedical engineer training for implementation and operational support for the proposed Mammography Tracking System.

2. Upon completion of training the biomedical engineers will:

a. Act as the local system expert

b. Understand the functions of each system’s components

c. Be able to start the system, including the different services that make up the proposed Mammography Tracking System

d. Locate and review application logs

e. Install and configure the client application for a new user

N. CUSTOMER SUPPORT

1. The proposed solution shall provide 24/7 Customer Support including software obsolescence, major upgrades, revisions, patches and fixes for year one.

2. The vendor shall provide remote technical and clinical applications support for year one.

3. The vendor shall utilize the VA national site-to-site VPN.

4. The proposed solution shall include a response time via phone of within 60 mins and on-site service within 24 hours from time of request.

O. REFERENCES

1. Provide a list of multi-hospital implementations with a similar number of facilities as VHA that are current or former users of the proposed Mammography Tracking System.

2. Provide VA reference showing HL7 interface success