Highlighted SOW.pdf

36C24522Q0235

Invoice Setup Information 1-877-489-6135

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

I. VISN 5 ENTERPRISE MAMMOGRAPHY INFORMATION SOLUTION STATEMENT OF WORK

A. INTRODUCTION

This document outlines the VISN 5 requirements for the vendor to furnish and install a VISN 5 enterprise Mammography Information Solution and services. The proposed Mammography Information Solution will enable radiologists and clinical staff to better manage the VISN 5 Mammography program.

By responding to this solicitation, the vendor acknowledges understanding that VISN 5 has substantial interface requirements between the proposed Mammography Information Solution and the Veterans Health Information and Systems Technology Architecture (VistA).

VistA serves as the radiology information system as well as the electronic medical record provider for VISN 5.

The proposed Mammography Information Solution shall provide functionality as described in this document to every facility in VISN 5. Implementation of the proposed Mammography Information Solution will be managed through a phased deployment to maximize organizational learning and VISN 5 project management resources. Each phase of the project must be coordinated with the assigned VISN 5 Primary Contracting Officer’s Technical Representative (COTR) 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 Information Solution. The vendor shall provide training, system maintenance, and data exchange throughout each facility in VISN 5. Upon completion of the installation, testing, and training, VISN 5 will have a state of the art Mammography Information Solution.

B. LOCATION OF VISN 5 FACILITIES

Sites in VISN 5 that have mammography units on site:

VA Maryland Healthcare System (Baltimore) 10 N Greene St Baltimore, MD 21201

Louis A. Johnson VA Medical Center (Clarksburg) 1 Medical Center Drive Clarksburg WV 26301

Off-site Radiologist Reading location:

Betty Puskar Breast Care Center 1 Medical Center Drive box 8064 Morgantown, WV 26506

Washington DC VA Medical Center (Washington DC) 50 Irving Street, NW Washington DC 20422

C. PROJECT MANAGEMENT

The proposed solution shall provide a single service account manager for VISN 5 The proposed solution shall provide project management to include:

o Software, network, and implementation planning o Timeline o On-site installation and implementation o Hand off fully functioning Mammography Information Solution

D. CLINICAL FUNCTIONALITY

Patient Registration o The proposed solution shall include patient/family history features.

Describe the proposed solutions Patient/Family History features including 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?

Provide screenshots of the Patient/Family History section from the proposed solution o The proposed solution shall have the capability to allow Radiologist

Technologist comments to be entered.

Describe how Radiologist Technologist comments can be entered and communicated with the proposed solution o The proposed solution shall have the ability to auto update patient demographics upon registration

Reporting o The proposed solution will be capable of:

Generating the Radiology Report

Transmitting the Radiology Report to VistA/CPRS Utilize the voice recognition component of PowerScribe 360 Creating Radiology Report Addendums o The proposed solution shall have the capability of providing a radiologist worklist Describe the proposed solutions Radiologist Worklist capabilities Provide screenshots of the proposed solutions Radiologist Worklist o The proposed solution shall integrate with Hologic and GE Mammography workstations.

Describe the proposed solutions integration with Mammography

Workstations Describe any recurring annual integration, licensing, or other cost associated with maintaining the integrating with the GE or Hologic Mammography Workstations.

o The proposed solution shall integration with PowerScribe 360 Describe how the proposed solution utilizes the voice recognition component of PowerScribe 360 Describe any recurring annual integration, licensing, or other cost associated with maintaining the integrating with PowerScribe.

o The proposed solution shall integration with VistA/CPRS

Describe how Radiology Reports are transmitted to VistA/CPRS o The proposed solution shall include diagnostic BI-RADS Codes in the HL7 report message o The proposed solution shall have reporting template capabilities

Describe creating a negative screening mammography report How many steps are required to complete this report?

o The proposed solution shall be used for support for the following breast examinations

MRI

Ultrasound o The proposed solution shall include Breast Cancer Risk Assessment Must include the Tyrer Cuzick risk management module

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

List the sources included with the proposed solution List the sources that are optional and any associated licensing cost o The proposed solution shall have the ability to turn on and off the different risk management modules o 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 Describe how the Radiologist is informed of the Breast Cancer Risk Provide screenshots of how the Radiologist would view the Breast

Cancer Risk o The proposed solution shall have the ability to document physical findings

Describe how physical findings can be documented in the proposed solution

Describe the proposed solutions ability to import and view scanned documents

i. For example:

1. Radiology Reports

2. Pathology reports for biopsies

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

Describe the proposed solutions ability to create a patient follow-up report Describe the different actions that can be driven from the follow-up report Describe the different actions that will remove the patient from the follow-up report o The proposed solution shall have a method for sending results letter to

Patients.

Describe the proposed solutions method for sending a results letter to

Patients Describe the different triggers that can be utilized to initiate sending the results letter Can the results letters be turned off for example by facility?

Can the results letter be customized by facility?

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

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

o The proposed solution shall have the ability to track patient complaints Describe the proposed solutions ability to track patient complaints

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

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

Are second reads allowed to maintain Radiologist credentialing?

Analytics and Reports o The proposed solution shall have the ability to provide analytics and reports

Provide samples of all supported reports Provide information on the types of business analytics tools available for data mining o The proposed solution shall include a minimum of the following report types:

Medical Audit data High risk patient follow up report Performing clinician workload report Pathology outcomes profile Risk factors reports sent to clinicians

Anonymize the false negative /positive list BIRAD 0/Recall report and follow up o All reports should be limited to a group of users on a need to know basis o The proposed solution shall include an automated tissue density integration package o The proposed solution shall include an interface with EQUIP

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 level.

The proposed Mammography Information Solution 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 Information Solution is deployed in several customer clinical production environments similar to VISN 5 (i.e. VA sites).

o Specify the proposed server and client software versions.

o List the actual major and minor releases, including dates, for the past two years for the proposed Mammography Information Solution.

o List any 3rd party software components included in the proposed Mammography Information Solution and whether the cost is included in the proposed licensing models.

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

o List all database(s) that are used for the proposed Mammography Information Solution.

Requirements for upgrading the client software:

o Can this be performed in the background without user intervention?

o All user preferences must be retained during upgrades.

VISN 5 requires a comprehensive disaster recovery plan to ensure data integrity and restoration.

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

o There shall be a process for restoring system backups.

The proposed Mammography Information Solution 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.

Provide recommended hardware specifications and network requirements for the following:

o Main production system o Workstation, including specifications regarding graphic cards and monitors o Test server

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

Provide a completed copy of the VA Form 6550.

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

F. LICENSING MODELS

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

VISN 5

station

Admi n User

QC

Tech s

Techs Rad s

Mammo Equipment

Radiologist Reading Workstation s

Radiologist reading at one time

Baltimore 3 1 3 4 1 2 – one PACS and one Hologic workstation

Washington

DC

4 1 4 2 2 4 – two PACS and two Hologic workstation

Clarksburg 2 1 2 2 1 1 – GE workstation (located at

WVU)

o Provide cost for adding 1 concurrent user

G. IMAGING ORDERS AND REPORTS

Imaging orders are entered into the VistA Radiology Package.

Within VISN 5, there are six separate instances of VistA HL7 feeds.

The VistA Radiology Package will be the source for all orders, patient and study information.

H. VISN 5 ENTERPRISE RADIOLOGIST WORKLIST

The VISN 5 Enterprise Radiologist Worklist, herein referred to as Radiologist Worklist, is to provide any radiologist a single view of VISN 5 mammography studies in need of interpretation.

The proposed solution shall include filter parameters that include at minimum VISN 5 facilities.

o Please list the display columns headings available for the VISN 5 Enterprise Radiologist Worklist

Are the column headings configurable by

User

Groups

Facility(s) o Are VISN 5 Enterprise Radiologist Worklist display filters and display columns changes easily saved by the radiologist?

o Describe the sorting capabilities including multilevel sorts on the VISN 5 Enterprise Radiologist Worklist.

o Provide a screenshot of how a typical VISN 5 Enterprise Radiologist Worklist would appear to a radiologist.

o If a study is sent to an external Teleradiology service for interpretation, is the study automatically removed from the VISN 5 Enterprise Radiologist Worklist?

o After a radiologist completes or closes a study, is it possible for the next study to be displayed automatically or does the radiologist need to return to VISN 5 Enterprise Radiologist Worklist to go to the next study?

The proposed solution shall have the ability to create new worklists in addition to those provided.

I. IMPORTING HISTORICAL RADIOLOGY REPORTS

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

o This includes the migration of studies from the 3 separate MRS databases:

Baltimore - MRS 7 QA+

Washington DC - MRS 7 Standard Clarksburg - MRS 7.3.251.0

J. PERFORMANCE

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

o Provide your uptime guarantee for the proposed Mammography Information Solution.

How is uptime defined?

How is uptime measured?

What is considered downtime?

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

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

K. USER AND GROUP FUNCTIONALITY

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

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

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

o Describe the available default user groups on the proposed Mammography Information Solution and the privileges/permissions allowed for each group.

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

o Can a group be created to limit access to confidential information?

L. HEALTH LEVEL SEVEN (HL7) INTEGRATION

The proposed solution shall provide HL7 integration to VistA.

o Provide HL7 integration statements for all included components of the proposed Mammography Information Solution.

The proposed solution must meet the qualification process for the VA VistA HL7 interface.

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

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

Provide DICOM Conformance Statements for all included products.

N. CUSTOMER TRAINING

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

o Clinical-User Training The vendor shall provide clinical training on the proposed

Mammography Information Solution and its operation.

Clinical users of the proposed Mammography Information Solution will include, but are not limited to, the following:

Radiologic technologist Radiologist

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.

o PACS Administrator Training The vendor shall provide power-user and system administrator training for operational support of the proposed Mammography Information Solution.

PACS administrators are radiologic technologists with PACS, computer and network expertise.

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

Act as the local super user for the clinical users Act as the local trainer for the clinical users Resolve the top ten most common user questions Create and manage user accounts Install and configure the client application for a new user Monitor system utilization Manage other day to day tasks required for the system o Biomedical Engineer Training The vendor shall provide biomedical engineer training for implementation and operational support for the proposed Mammography Information Solution.

Biomedical engineers are technical medical equipment specialists with PACS, hardware, software and network expertise.

Upon completion of training the biomedical engineers will:

Act as the local system expert Understand the functions of each system’s components

Be able to start the system, including the different services that make up the proposed Mammography Information Solution

Locate and review application logs Install and configure the client application for a new user

O. CUSTOMER SUPPORT

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

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

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

The vendor shall work with the VA Office of Cyber and Information Security and VISN 5 Information Security Officers to establish a MOU/ISA.

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.

P. REFERENCES

Provide a list of multi-hospital implementations with a similar number of facilities and annual volumes as VISN 5 that are current or former users of the proposed Mammography Information Solution.

Provide VA reference showing HL7 interface success

Each reference should include the following details:

o Customer contact information

Primary customer contact name

Business title

Address

Phone

Email o Number of facilities o Annual study volume o Licensing model o System architecture o Version of software installed o Number of end users o Original delivery schedule o Final delivery schedule o Contractor’s self-assessment of performance and results

VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors

1. Contractor employees who work in or travel to VHA locations must comply with the following:

a. Documentation requirements:

1) If fully vaccinated, shall show proof of vaccination.

i. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

2) If unvaccinated and granted a medical or religious exception, shall show negative COVID-19 test results dated within three calendar days prior to desired entry date.

Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test.

3) Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

4) Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

a. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in