S02 - Final Product Description - DataFaxv.2 3.3.23.pdf

PRODUCT DESCRIPTION (PD)

DEPARTMENT OF VETERANS AFFAIRS

Office of Information & Technology Cooperative Studies Program Coordinating Centers

DFdiscover (as known as DataFax or iDataFax) Servers Software Licenses, Maintenance, Support and User Seats

Date: 03/03/2023

VA-23-00036295

PD Version Number: 1.2

DFdiscover (as known as DataFax or iDataFax) Servers Software Licenses and Maintenance

FORCE Number: VA-23-00036295

1.0 PRODUCT REQUIREMENTS

All parties hereby acknowledge and understand that the Government’s Schedule of Supplies/Services is comprised of the following documents, without exception:

Attachment 1, Product Description, DFdiscover (as known as DataFax or iDataFax) Servers Software Licenses, Maintenance, Support and User Seats, dated March 3, 2023. Accordingly, regardless of their placement during the negotiation phase of this action (e.g., as an attachment or addenda), and if there are any inconsistencies in the Solicitation or Final Contract, the parties hereby agree that the aforementioned documents are incorporated into the Government’s Schedule of Supplies/Services and therefore, deemed first in the order of precedence as defined by the applicable Federal Acquisition Regulation.

The Department of Veterans Affairs (VA), Office of Information and Technology, Cooperative Studies Program Coordinating Centers (CSPCC) has a requirement for the renewal of DFdiscover Software Server licenses, maintenance, support and user seats.

DFdiscover is a clinical trials management software currently being used by the CSPCCs to conduct multi-site research studies. These multi-site clinical research studies follow strict scientific/regulatory guidelines comparing different treatment methods to determine cost benefits of treatment, efficacy of treatments and determine new standards of care/treatment for Veterans. The software allows the centers to collect clinical data for current ongoing multisite clinical trials by electronic data entry. In addition, DFdiscover provides a rich, programmable edit check language to detect problems, display warnings and request corrections when filling out forms. It has remote site monitoring capabilities as well.

Period of Performance:

Base Year: March 9, 2023 – March 8, 2024 Option Year 1: March 9, 2024 – March 8, 2025

The software delivery, maintenance and support shall be within 30 days after contract award.

Base Period: March 9, 2023 through March 8, 2024 Description Licenses # of Seats

1 DFdiscover Software Enterprise License for all VA Cooperative Studies Programs Up to 100 server licenses for the VA to distribute as needed for use within the Cooperative Studies Program. Up to 400 concurrent users per server. Up to 255 paper CRF studies per server, with a total of 999 studies maximum. Server includes:

• Production servers

• Test servers

• Development servers

Up to 100 server licenses

Up to 400 concurrent users per server

• UAT/Validation servers

• Training servers

• Archive servers, including previous versions of the software

• Sandbox servers

• Replication / disaster recovery servers

Access to all desktop, tablet, and web versions of the software, including:

• DFexplore data management

• Randomization edit check module

• DFadmin study and server administration

• DFsetup study setup

• DFsend drag-and-drop scanned CRF upload

• DFATK User Acceptance Test Kit

• DFweb

• DFcollect Android/iOS tablet app

Access to DFws API.

2 DF Toolkit

DFtoolkit is a suite of utilities that provide enhanced reports and information for studies using the DataFax and DFdiscover systems. The tools produce:

annotated CRFs/eCRFs with corresponding data dictionary information; PDFs of participant binders for study closeout; DF edit check listings; QC database data in a spreadsheet format with charts; schema data in spreadsheet format; data quality reports with color-coded charts; study version comparison report.

Contractor shall deliver the DF Toolkit within 45 days from award

• annotatedCRF a tool for generating annotated CRFs and eCRFs with filled numbers and major field attributes like name, alias, modules, type, length, formats legal ranges, coding and priority

• closeoutPDF a tool for generating subject binders (generally for closeout purposes) including data laid out in CRF/eCRF view, a data field value listing (useful for longer values that don’t fit in the boxes), attached images (primary and optionally secondary) and field audit history in chronological and by field order. Can include deleted and/or lost (missing) records.

• EClist a report detailing which edit checks are on each field (one per line)

• QC2Excel a program for converting the QC database to Excel format complete with charts, priorities and the ability to generate site friendly and specific files that can be easily e-mailed with a single button.

• schema2excel a program for converting the setup into Excel format

• dataquality a program for generating a data quality report showing performance by country, site and patient. Includes breakdowns of number of QCs of each type, QCs/subject, how many are >60 days old, consecutive overdue visits, color coding of best to worst, etc. Can generate site specific report cards based on a user defined template with rules

• schemadiff a program to compare versions of a study definition and highlight their differences.

Base: March 9, 2023 through March 8, 2024 Description Licenses # of Seats

A TECHNICAL SUPPORT

Allowance for ad hoc technical consulting and support for custom software enhancements for the VA environment as needed. This includes custom developed code to be released to the VA for VA projects.

May include time for background and security checks, travel, onsite visits, programming, and documentation as required.

B TRAINING

Allowance for various ad hoc training sessions as needed for new staff as well as rollout of new features.

Option Period One: March 9, 2024 through March 8, 2025

1 DFdiscover Software Enterprise License for all VA Cooperative Studies Programs Up to 100 server licenses for the VA to distribute as needed for use within the Cooperative Studies Program. Up to 400 concurrent users per server. Up to 255 paper CRF studies per server, with a total of 999 studies maximum. Server includes:

Up to 100 server licenses

Up to 400 concurrent users per server

• Production servers

• Test servers

• Development servers

• UAT/Validation servers

• Training servers

• Archive servers, including previous versions of the software

• Sandbox servers

• Replication / disaster recovery servers

Access to all desktop, tablet, and web versions of the software, including:

• DFexplore data management

• Randomization edit check module

• DFadmin study and server administration

• DFsetup study setup

• DFsend drag-and-drop scanned CRF upload

• DFATK User Acceptance Test Kit

• DFweb

• DFcollect Android/iOS tablet app

Access to DFws API 2 DF Toolkit

DFtoolkit is a suite of utilities that provide enhanced reports and information for studies using the DataFax and DFdiscover systems. The tools produce:

annotated CRFs/eCRFs with corresponding data dictionary information; PDFs of participant binders for study closeout; DF edit check listings; QC database data in a spreadsheet format with charts; schema data in spreadsheet format; data quality reports with color-coded charts; study version comparison report.

Contractor shall deliver the DF Toolkit within 45 days from award

• annotatedCRF a tool for generating annotated CRFs and eCRFs with filled numbers and major field attributes like name, alias, modules, type, length, formats legal ranges, coding and priority

• closeoutPDF a tool for generating subject binders (generally for closeout purposes) including data laid out in CRF/eCRF view, a data field value listing (useful for longer values that don’t fit in the boxes), attached images (primary and optionally secondary) and field audit history in chronological and by field order. Can include deleted and/or lost (missing) records.

• EClist a report detailing which edit checks are on each field (one per line)

• QC2Excel a program for converting the QC database to Excel format complete with charts, priorities and the ability to generate site friendly and specific files that can be easily e-mailed with a single button.

• schema2excel a program for converting the setup into Excel format

• dataquality a program for generating a data quality report showing performance by country, site and patient. Includes breakdowns of number of QCs of each type, QCs/subject, how many are >60 days old, consecutive overdue visits, color coding of best to worst, etc. Can generate site specific report cards based on a user defined template with rules

• schemadiff a program to compare versions of a study definition and highlight their differences.

Option Period One: March 9, 2024 through March 8, 2025

A TECHNICAL SUPPORT

Allowance for ad hoc technical consulting and support for custom software enhancements for the VA environment as needed. This includes custom developed code to be released to the VA for VA projects.

May include time for background and security checks, travel, onsite visits, programming, and documentation as required.

B TRAINING

Allowance for various ad hoc training sessions as needed for new staff as well as rollout of new features.

1.1 MAINTENANCE /SUPPORT SERVICES:

The Contractor’s software technical service support shall provide unlimited phone/email technical support for standard use of software and technical issues and include the following:

A. Phone support during normal business hours from 9:00 AM to 5:00 PM EST.

B. Email support during normal business hours from 9:00 AM to 5:00 PM EST within

4 hours.

C. Access to online DataFax self-service portal with documentation, Frequently

Asked Questions and Manuals.

D. Latest software and patch updates.

2.0 NOTICE OF THE FEDERAL ACCESSIBILITY LAW AFFECTING ALL

INFORMATION AND COMMUNICATION TECHNOLOGY (ICT)

PROCUREMENTS (SECTION 508)

On January 18, 2017, the Architectural and Transportation Barriers Compliance Board (Access Board) revised and updated, in a single rulemaking, standards for electronic and information technology developed, procured, maintained, or used by Federal agencies covered by Section 508 of the Rehabilitation Act of 1973, as well as our guidelines for telecommunications equipment and customer premises equipment covered by Section 255 of the Communications Act of 1934. The revisions and updates to the Section 508-based standards and Section 255-based guidelines are intended to ensure that information and communication technology (ICT) covered by the respective statutes is accessible to and usable by individuals with disabilities.

2.1 SECTION 508 – INFORMATION AND COMMUNICATION TECHNOLOGY (ICT)

STANDARDS

The Section 508 standards established by the Access Board are incorporated into, and made part of all VA orders, solicitations and purchase orders developed to procure ICT.

These standards are found in their entirety at: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines. A printed copy of the standards will be supplied upon request.

Federal agencies must comply with the updated Section 508 Standards beginning on January 18, 2018. The Final Rule as published in the Federal Register is available from the Access Board: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule.

https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule

The Contractor shall comply with “508 Chapter 2: Scoping Requirements” for all electronic ICT and content delivered under this contract. Specifically, as appropriate for the technology and its functionality, the Contractor shall comply with the technical standards marked here:

E205 Electronic Content – (Accessibility Standard -WCAG 2.0 Level A and AA Guidelines)

E204 Functional Performance Criteria E206 Hardware Requirements E207 Software Requirements E208 Support Documentation and Services Requirements

2.2 COMPATABILITY WITH ASSISTIVE TECHNOLOGY

The standards do not require installation of specific accessibility-related software or attachment of an assistive technology device. Section 508 requires that ICT be compatible with such software and devices so that ICT can be accessible to and usable by individuals using assistive technology, including but not limited to screen readers, screen magnifiers, and speech recognition software.

2.3 ACCEPTANCE AND ACCEPTANCE TESTING

Deliverables resulting from this solicitation will be accepted based in part on satisfaction of the Section 508 Chapter 2: Scoping Requirements standards identified above.

The Government reserves the right to test for Section 508 Compliance before delivery.

The Contractor shall be able to demonstrate Section 508 Compliance upon delivery.

3.0 INFORMATION TECHNOLOGY USING ENERGY-EFFICIENT PRODUCTS

Not Applicable (N/A)

3.1 EPEAT

EPEAT product compliance is not required in this acquisition.

3.2 ENERGY STAR

Energy Star compliance is not required in this acquisition.

3.3 FEMP

FEMP or FEMP low standby power product compliance is not required in this acquisition.

4.0 SYSTEM ACCEPTANCE (PRE-PRODUCTION) TESTING

N/A

5.0 SHIPMENT OF HARDWARE OR EQUIPMENT

Inspection: Destination Acceptance: Destination Free on Board (FOB): Destination

Ship To and Mark For:

Primary Name: Tanya Ammermann Address: N/A Voice: (806) 365-9020 Email: Tanya.Ammermann@va.gov

5.1 SPECIAL SHIPPING INSTRUCTIONS

The software shall be delivered via download from a website. Delivery or provision of the download address shall be made to Tanya Ammermann (Tanya.Ammermann@va.gov), Cooperative Studies Program Coordinating Center.

5.2 NATIONAL ACQUISITIONS

6.0 GENERAL REQUIREMENTS

6.1 VA TECHNICAL REFERENCE MODEL

The Contractor shall support the VA enterprise management framework. In association with the framework, the Contractor shall comply with OIT Technical Reference Model (VA TRM). The VA TRM is one component within the overall Enterprise Architecture (EA) that establishes a common vocabulary and structure for describing the information technology used to develop, operate, and maintain enterprise applications. Moreover, the VA TRM, which includes the Standards Profile and Product List, serves as a technology roadmap and tool for supporting OIT. Architecture & Engineering Services (AES) has overall responsibility for the VA TRM.

6.2 SOCIAL SECURITY NUMBER (SSN) REDUCTION

The Contractor solution shall support the Social Security Number (SSN) Fraud Prevention Act (FPA) of 2017 which prohibits the inclusion of SSNs on any document sent by mail. The Contractor support shall also be performed in accordance with Section 240 of the Consolidated Appropriations Act (CAA) 2018, enacted March 23, 2018, which mandates VA to discontinue using SSNs to identify individuals in all VA mailto:Tanya.Ammermann@va.gov information systems as the Primary Identifier. The Contractor shall ensure that any new IT solution discontinues the use of SSN as the Primary Identifier to replace the SSN with the Integrated Control Number (ICN) in all VA information systems for all individuals. The Contractor shall ensure that all Contractor delivered applications and systems integrate with the VA Master Person Index (MPI) for identity traits to include the use of the ICN as the Primary Identifier. The Contractor solution may only use a Social Security Number to identify an individual in an information system if and only if the use of such number is required to obtain information VA requires from an information system that is not under the jurisdiction of VA.

6.3 INTERNET PROTOCOL VERSION 6 (IPV6)

The Contractor solution shall support Internet Protocol Version 6 (IPv6) based upon the memo issued by the Office of Management and Budget (OMB) on November 19, 2020 (https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf). IPv6 technology, in accordance with the USGv6 Program (https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1), NIST Special Publication (SP) 500-267B Revision 1 “USGv6 Profile” (https://doi.org/10.6028/NIST.SP.500-267Br1), and NIST SP 800-119 “Guidelines for the Secure Deployment of IPv6” (https://doi.org/10.6028/NIST.SP.800-119), compliance shall be included in all IT infrastructures, application designs, application development, operational systems and sub-systems, and their integration. In addition to the above requirements, all devices shall support native IPv6 and dual stack (IPv6 / IPv4) connectivity without additional memory or other resources being provided by the Government, so that they can function in a mixed environment. All public/external facing servers and services (e.g.

web, email, DNS, ISP services, etc.) shall support native IPv6 and dual stack (IPv6 / IPv4) users and all internal infrastructure and applications shall communicate using native IPv6 and dual stack (IPv6 / IPv4) operations.

6.4 SOFTWARE AND LICENSING REQUIREMENTS

6.5 POSITION/TASK RISK DESIGNATION LEVEL(S)

https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf file://R04.med.va.gov/V03/EAS/Users/vhaeasWymbsk/TEMPLATES--NEW%20TAC%20PROCESS/PWS%20TEMPLATE%20(DO%20NOT%20TOUCH)%20-%20In%20Process%20Revisions/DO%20NOT%20TOUCH%20(next%20version/IPv6/(https:/www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1 file://R04.med.va.gov/V03/EAS/Users/vhaeasWymbsk/TEMPLATES--NEW%20TAC%20PROCESS/PWS%20TEMPLATE%20(DO%20NOT%20TOUCH)%20-%20In%20Process%20Revisions/DO%20NOT%20TOUCH%20(next%20version/IPv6/(https:/www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1 https://doi.org/10.6028/NIST.SP.500-267Br1 https://doi.org/10.6028/NIST.SP.800-119

POINTS OF CONTACT

VA Program Manager POC:

Name: Tanya Ammermann Address: Department of Veterans Affairs

CSPCC

950 Campbell Avenue West Haven, CT 06516

Voice: 860-365-9020 Email: Tanya.Ammermann@va.gov

Contracting Officer Representative:

Name: Rushawn James Address: Department of Veterans Affairs 811 Vermont Avenue Washington DC Voice: (202) 461-6009 Email: Rushawn.James@va.gov

Contracting Officer:

Name: Lori L. Walker Address: Department of Veterans Affairs Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724 Voice: (512) 981-4134 Email: Lori.Walker1@va.gov

Contract Specialist:

Name: Samantha McIntyre Address: Department of Veterans Affairs Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724 Voice: (512) 981-4474 Email: Samantha.McIntyre2@va.gov mailto:Rushawn.James@va.gov mailto:Lori.Walker1@va.gov mailto:Samantha.McIntyre2@va.gov

INFORMATION SECURITY CONSIDERATIONS:

The Assessment and Authorization (A&A) requirements do not apply and a Security Accreditation Package is not required

All VA sensitive information shall be protected at all times in accordance with local security field office System Security Plans (SSP’s) and Authority to Operate (ATO)’s for all systems/LAN’s accessed while performing the tasks detailed in this Product Description.

A prohibition on unauthorized disclosure: “Information made available to the Contractor or Subcontractor by VA for the performance or administration of this contract or information developed by the Contractor/Subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA.” This clause expressly limits the Contractor/Subcontractor’s rights to use data as described in Rights in Data – General, FAR 52.227-14(d).(1).

A requirement for data breach notification: Upon discovery of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the Contractor/Subcontractor has access, the Contractor/Subcontractor shall immediately notify the COR and simultaneously, the designated ISO, and Privacy Officer for the contract. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. See VA Handbook 6500.6, Appendix C, paragraph 6.a.

A requirement to pay liquidated damages in the event of a data breach: “In the event of a data breach or privacy incident involving SPI the contractor processes or maintains under this contract, the contractor shall be liable to VA for liquidated damages for a specified amount per affected individual to cover the cost of providing credit protection services to those individuals.” However, it is the policy of VA to forgo collection of liquidated damages in the event the Contractor provides payment of actual damages in an amount determined to be adequate by the agency.

Based on the determinations of the independent risk analysis, the Contractor shall be responsible for paying to VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

1) Notification;

2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

3) Data breach analysis;

4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs

A requirement for annual security/privacy awareness training: “Before being granted access to VA information or information systems, all Contractor employees and Subcontractor employees requiring such access shall complete on an annual basis either: (i) the VA security/privacy awareness training (contains VA security/privacy requirements) within 1 week of the initiation of the contract, or (ii) security awareness training provided or arranged by the contractor that conforms to VA’s security/privacy requirements as delineated in the hard copy of the VA security awareness training provided to the Contractor. If the Contractor provides their own training that conforms to VA’s requirements, they will provide the COR or CO, a yearly report (due annually on the date of the contract initiation) stating that all applicable employees involved in VA’s contract have received their annual security/privacy training that meets VA’s requirements and the total number of employees trained. See VA Handbook 6500.6, Appendix C, paragraph 9.

A requirement to sign VA’s Rules of Behavior: “Before being granted access to VA information or information systems, all Contractor employees and Subcontractor employees requiring such access shall sign on annual basis an acknowledgement that they have read, understand, and agree to abide by VA’s Contractor Rules of Behavior which is attached to this contract.” See VA Handbook 6500.6, Appendix C, paragraph 9, and Appendix D. Note: If a medical device vendor anticipates that the services under the contract will be performed by 10 or more individuals, the Contractor Rules of Behavior may be signed by the vendor’s designated representative. The contract must reflect by signing the Rules of Behavior on behalf of the vendor that the designated representative agrees to ensure that all such individuals review and understand the Contractor Rules of Behavior when accessing VA’s information and information systems.