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Medical Coding SaaS TAC Number: VA-20-00053119 Contract Opportunity Sources Sought Notice

PRODUCT SERVICE CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE

DATE/TIME/ZONE

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

Required Field Contract Opportunity Sources Sought Notice

AN91

MedCodr Software as a Service 07724 36C10B20Q0381 06-25 -2020

12:00PM

EASTERN TIME, NEW YORK, USA

N 541519 Department of Veterans Affairs Technology Acquisition Center 23 Christopher Way Eatontown NJ 07724 Rene Brown, rene.brown1@va.gov Debra Clayton, debra.clayton2@va.gov Joseph Jones, joseph.jones6@va.gov

Department of Veterans Affairs (VA) Technology Acquisition Center (TAC) is seeking information concerning the availability of capable contractors to provide a server-based software to perform medical coding related to clinical studies, Adverse Events and Serious Adverse Events reporting. This reporting is a Food and Drug Administration (FDA) requirement as specified in 21 CFR 312 and reporting requires Coding (converting verbatim terms into Preferred Terms) to standardize reporting information.

Additional NAICS: 541511 – Custom Computer Programing Services.

This is a request for information (RFI) only and is limited to 5 pages (excluding PWS if your response includes PWS recommended changes). Do not submit a proposal or quote. There is no obligation on the part of the Government to acquire any products or services described in this RFI. Your response to this RFI will be treated only as information for the Government to consider. You will not be entitled to payment for direct or indirect costs that you incur in responding to this RFI. This request does not constitute a solicitation for proposals or the authority to enter into negotiations to award a contract. No funds have been authorized, appropriated or received for this effort. Interested parties are responsible for adequately marking proprietary, restricted or competition sensitive information contained in their response. The Government does not intend to pay for the information submitted in response to this RFI.

If interested, please provide the following:

1. A capabilities statement that addresses the questions below and draft PWS. If additional information is required by VA to determine a contractor’s capability to provide the full requirement and the economic feasibility of the information provided, additional information may be requested at a later date. Technical questions may be submitted as part of your response. A draft version of the requirement is below. Please direct all responses to Rene Brown, rene.brown1@va.gov and Debra Clayton, debra.clayton2@va.gov .

2. Please address the following questions in your RFI response:

a. Describe your understanding of the FEDRAMP approval process.

b. If you do not have FEDRAMP approval currently provide a timeline in which you anticipate obtaining?

c. Provide a Rough Order of Magnitude (ROM) estimate to include pricing models that would be most advantageous to the Government.

d. Provide a breakout of any software and services necessary for the Web service subscription.

e. Describe how your system is hosted.

f. With respect to training on your solution, provide your recommendations as to when training should occur; format (i.e., virtual or face to face); frequency; and identify for which functional roles training is recommended;

3. Has the draft PWS provided sufficient detail to describe the technical requirements that encompass the services to be performed under this effort?

______ YES _______ NO (if No, answer question below) If “NO”, please provide your technical comments/recommendations on elements of the draft PWS that may contribute to a more accurate proposal submission and efficient, cost effective effort.

4. Any Contract Vehicle of which you are a part that can be used to acquire your solution as well as the company business size and status for each vehicle as designated by the NAICS 541519 and the U.S. Small Business Administration (i.e., Large Business, Small Business, Service-Disabled Veteran Owned Small Business, Small Disadvantaged Business, Women-Owned Small Business, Hub Zone Small Business, etc.)

PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS

Veterans Health Administration (VHA) Office of Research & Development (ORD)

Medical Coding SaaS

Date: May 20, 2020

VA-20-00053119

PWS Version Number: 1.3

Contents

1.0BACKGROUND7
2.0APPLICABLE DOCUMENTS8
3.0SCOPE OF WORK12
4.0PERFORMANCE DETAILS12
4.1PERFORMANCE PERIOD12
4.2PLACE OF PERFORMANCE13
5.0SPECIFIC TASKS AND DELIVERABLES13
5.1PROJECT MANAGEMENT13
5.1.1CONTRACTOR PROJECT MANAGEMENT PLAN13
5.1.2REPORTING REQUIREMENTS13
5.1.3PROJECT COORDINATION14
5.1.4PROJECT ADMINISTRATION14
5.1.5SUBCONTRACT MANAGEMENT14
5.2ASSESSMENT, AUTHORIZATION, AND CONTINUOUS MONITORING14
5.3RESEARCH MEDICAL CODING SaaS REQUIREMENT15
5.4SUPPORT AND SUBSCRIPTION15
5.5DATA MIGRATION16
5.6USER TRAINING17
5.7OPTION PERIOD ONE to FOUR17
6.0GENERAL REQUIREMENTS18
6.1ENTERPRISE AND IT FRAMEWORK18
6.1.1VA TECHNICAL REFERENCE MODEL18
6.1.2FEDERAL IDENTITY, CREDENTIAL, AND ACCESS MANAGEMENT (FICAM)18
6.1.3INTERNET PROTOCOL VERSION 6 (IPV6)19
6.1.4TRUSTED INTERNET CONNECTION (TIC)20
6.1.5STANDARD COMPUTER CONFIGURATION20
6.1.6VETERAN FOCUSED INTEGRATION PROCESS (VIP)20
6.1.7PROCESS ASSET LIBRARY (PAL)21
6.1.8AUTHORITATIVE DATA SOURCES21
6.2METHOD AND DISTRIBUTION OF DELIVERABLES22
6.3PERFORMANCE METRICS22
6.4GOVERNMENT FURNISHED INFORMATION23
ADDENDUM A – ADDITIONAL VA REQUIREMENTS, CONSOLIDATED24
ADDENDUM B – VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE31

1.0 BACKGROUND

The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Office of Research & Development (ORD) strives to provide high quality, effective, and efficient Information Technology (IT) services to those responsible for providing care to the Veterans at the point-of-care as well as throughout all the points of the Veterans’ health care in an effective, timely and compassionate manner. VA depends on Information Management/Information Technology (IM/IT) systems to meet mission goals.

The VA, VHA, ORD Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center, Regulatory Affairs and Clinical Compliance Section (RACC) currently uses an obsoleting server-based software to perform medical coding related to clinical studies Adverse Events/Serious Adverse Events reporting requirements. This reporting is a Food and Drug Administration (FDA) requirement as specified in 21 CFR 312 and reporting requires Coding (converting verbatim terms into Preferred Terms) to standardize reporting information.

Software as a Service (SaaS) is the requirement for this procurement due to VA software validation requirements for software physically installed on a VA server. Using the SaaS model puts the requirements on the vendor to meet Federal guidelines for the product to be used by Federal agencies. This eliminates the need for the VA to manage software (such as installation and performing updates) and keeps the expertise with the vendor.

Software as a Service (SaaS) is an application delivery model in which the application is hosted on a cloud infrastructure outside the security boundary of VA and is provided to the Cloud Service Customer (CSC) over the internet. (Software hosted in VAEC does not meet this definition of SaaS). The CSC uses the SaaS offering via a thin-client interface, such as a web-browser or a program interface. The CSC subscribes to the SaaS offering and is only responsible for limited application configuration settings. The Cloud Service Provider (CSP) offering the application is responsible for management of the application, safeguarding of data stored or processed by the application, and all elements of the underlying infrastructure.

In order to qualify as SaaS for use at VA, and to align with Federal Risk and Authorization Management Program (FedRAMP) requirements, the hosting for the offering must conform to the NIST 800-145 definition of Cloud Computing and thus contain following key characteristics:

· On-Demand Self-Service: The CSP fully automates the provisioning of both the customer interface and the underlying cloud components of the SaaS offering. In some cases, the CSP may provision internal resources manually, while providing the CSC an automated interface to request and track the service.

· Broad Network Access: The SaaS capabilities are available over the internet or over a network that is available from all access points the CSC requires. The SaaS offering is accessible through common platforms (e.g., mobile phones, tablets, laptops, and workstations).

· Resource Pooling: The computing infrastructure supporting the SaaS offering is shared among more than one CSC using a multi-tenant model, and resources are dynamically assigned depending on customer demand.

· Rapid Elasticity: Computing capabilities are automatically provisioned and released in a manner that scales with customer demand. In some cases, the scaling of resources may not be fully automated, but it should be fast enough to support the needs of the CSC, which the CSC would have to define.

· Measured Service: Resource usage, such as storage, processing, bandwidth, and user activity are measured and reported on in a manner that is relevant to the SaaS offering.

The SaaS offering must be hosted within the United States and data stored / processed / transmitted within the offering must remain within the United States.

CSPs should be aware of FedRAMP and ready to partner with VA through the SaaS FedRAMP Authorization process.

The Federal Chief Information Officer (CIO) has confirmed that for SaaS, agencies have the option of: (1) leveraging a Provisional Authority to Operate (P-ATO) completed by the Joint Authorization Board (JAB); (2) leveraging an Authority to Operate (ATO) completed by another agency, or (3) conducting their own ATO. However, if either the JAB or another agency has already gone through the Risk Management Framework (RMF) process with the cloud service provider then we encourage the agency to leverage the work already done. This is less burdensome for both the agencies and the service providers.

Regardless of the approach, VA will be using the Federal Risk and Authorization Management Program (FedRAMP) baselines as a starting point, since they are specifically tailored for cloud services.

2.0 APPLICABLE DOCUMENTS

In the performance of the tasks associated with this Performance Work Statement, the Contractor shall comply with the following:

1. 44 U.S.C. § 3541-3549, “Federal Information Security Management Act (FISMA) of 2002”

2. “Federal Information Security Modernization Act of 2014”

3. Federal Information Processing Standards (FIPS) Publication 140-2, “Security Requirements For Cryptographic Modules”

4. FIPS Pub 199. Standards for Security Categorization of Federal Information and Information Systems, February 2004

5. FIPS Pub 200, Minimum Security Requirements for Federal Information and Information Systems, March 2016

6. FIPS Pub 201-2, “Personal Identity Verification of Federal Employees and Contractors,” August 2013

7. 10 U.S.C. § 2224, "Defense Information Assurance Program"

8. Carnegie Mellon Software Engineering Institute, Capability Maturity Model® Integration for Development (CMMI-DEV), Version 1.3 November 2010; and Carnegie Mellon Software Engineering Institute, Capability Maturity Model® Integration for Acquisition (CMMI-ACQ), Version 1.3 November 2010

9. 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974”

10. Public Law 109-461, Veterans Benefits, Health Care, and Information Technology Act of 2006, Title IX, Information Security Matters

11. 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”

12. VA Directive 0710, “Personnel Security and Suitability Program,” June 4, 2010, https://www.va.gov/vapubs/index.cfm

13. VA Handbook 0710, Personnel Security and Suitability Program, May 2, 2016, https://www.va.gov/vapubs/index.cfm

14. VA Directive and Handbook 6102, “Internet/Intranet Services,” August 5, 2019

15. 36 C.F.R. Part 1194 “Information and Communication Technology Standards and Guidelines,” January 18, 2017

16. Office of Management and Budget (OMB) Circular A-130, “Managing Federal Information as a Strategic Resource,” July 28, 2016

17. 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)”

18. NIST SP 800-66 Rev. 1, An Introductory Resource Guide for Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, October 2008

19. Sections 504 and 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended, January 18, 2017

20. Homeland Security Presidential Directive (12) (HSPD-12), August 27, 2004

21. VA Directive 6500, “VA Cybersecurity Program,” January 24, 2019

22. VA Handbook 6500, “Risk Management Framework for VA Information Systems – Tier 3: VA Information Security Program,” March 10, 2015

23. VA Handbook 6500.2, “Management of Breaches Involving Sensitive Personal Information (SPI)”, July 28, 2016

24. VA Handbook 6500.3, “Assessment, Authorization, And Continuous Monitoring Of VA Information Systems,” February 3, 2014

25. VA Handbook 6500.5, “Incorporating Security and Privacy into the System Development Lifecycle”, March 22, 2010

26. VA Handbook 6500.6, “Contract Security,” March 12, 2010

27. VA Handbook 6500.8, “Information System Contingency Planning”, April 6, 2011

28. VA Handbook 6500.11, “VA Firewall Configuration”, August 22, 2017

29. OI&T Process Asset Library (PAL), https://www.va.gov/process/ . Reference Process Maps at https://www.va.gov/process/maps.asp and Artifact templates at https://www.va.gov/process/artifacts.asp

30. One-VA Technical Reference Model (TRM) (reference at https://www.va.gov/trm/TRMHomePage.aspx)

31. VA Directive 6508, “Implementation of Privacy Threshold Analysis and Privacy Impact Assessment,” October 15, 2014

32. VA Handbook 6508.1, “Procedures for Privacy Threshold Analysis and Privacy Impact Assessment,” July 30, 2015

33. VA Handbook 6510, “VA Identity and Access Management”, January 15, 2016

34. VA Directive and Handbook 6513, “Secure External Connections”, October 12, 2017

35. VA Directive 6300, Records and Information Management, September 21, 2018

36. VA Handbook, 6300.1, Records Management Procedures, March 24, 2010

37. NIST SP 800-37 Rev 1, Risk Management Framework for Information Systems and Organizations: A System Life Cycle Approach for Security and Privacy, December 2018

38. NIST SP 800-53 Rev. 4, Security and Privacy Controls for Federal Information Systems and Organizations, January 22, 2015

39. OMB Memorandum, “Transition to IPv6”, September 28, 2010

40. VA Directive 0735, Homeland Security Presidential Directive 12 (HSPD-12) Program, October 26, 2015

41. VA Handbook 0735, Homeland Security Presidential Directive 12 (HSPD-12) Program, March 24, 2014

42. OMB Memorandum M-06-18, Acquisition of Products and Services for Implementation of HSPD-12, June 30, 2006

43. OMB Memorandum 04-04, E-Authentication Guidance for Federal Agencies, December 16, 2003

44. OMB Memorandum 05-24, Implementation of Homeland Security Presidential Directive (HSPD) 12 – Policy for a Common Identification Standard for Federal Employees and Contractors, August 5, 2005

45. OMB memorandum M-11-11, “Continued Implementation of Homeland Security Presidential Directive (HSPD) 12 – Policy for a Common Identification Standard for Federal Employees and Contractors, February 3, 2011

46. OMB Memorandum, Guidance for Homeland Security Presidential Directive (HSPD) 12 Implementation, May 23, 2008

47. Federal Identity, Credential, and Access Management (FICAM) Roadmap and Implementation Guidance, December 2, 2011

48. NIST SP 800-116 Rev 1, Guidelines for the Use of Personal Identity Verification (PIV) Credentials in Facility Access, June 2018

49. OMB Memorandum M-07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information, May 22, 2007

50. NIST SP 800-63-3, 800-63A, 800-63B, 800-63C, Digital Identity Guidelines, December 2017

51. NIST SP 800-157, Guidelines for Derived PIV Credentials, December 2014

52. NIST SP 800-164, Guidelines on Hardware-Rooted Security in Mobile Devices (Draft), October 2012

53. Draft National Institute of Standards and Technology Interagency Report (NISTIR) 7981 Mobile, PIV, and Authentication, March 2014

54. VA Memorandum, VAIQ #7100147, Continued Implementation of Homeland Security Presidential Directive 12 (HSPD-12), April 29, 2011 (reference https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514)

55. IAM Identity Management Business Requirements Guidance document, May 2013, (reference Enterprise Architecture Section, PIV/IAM (reference https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514)

56. VA Memorandum “Personal Identity Verification (PIV) Logical Access Policy Clarification,” July 17, 2019, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4896

57. Trusted Internet Connections (TIC) Reference Architecture Document, Version 2.2, Federal Interagency Technical Reference Architectures, Department of Homeland Security, June 19, 2017, https://www.dhs.gov/sites/default/files/publications/TIC_Ref_Arch_v2.2_2017.pdf

58. OMB Memorandum M-08-05, “Implementation of Trusted Internet Connections (TIC), November 20, 2007

59. OMB Memorandum M-08-23, Securing the Federal Government’s Domain Name System Infrastructure, August 22, 2008

60. VA Memorandum, VAIQ #7497987, Compliance – Electronic Product Environmental Assessment Tool (EPEAT) – IT Electronic Equipment, August 11, 2014 (reference Document Libraries, EPEAT/Green Purchasing Section, https://www.voa.va.gov/documentlistpublic.aspx?NodeID=552)

61. Sections 524 and 525 of the Energy Independence and Security Act of 2007, (Public Law 110–140), December 19, 2007

62. Section 104 of the Energy Policy Act of 2005, (Public Law 109–58), August 8, 2005

63. Executive Order 13834, “Efficient Federal Operations”, dated May 17, 2018

64. Executive Order 13221, “Energy-Efficient Standby Power Devices,” August 2, 2001

65. VA Directive 0058, “VA Green Purchasing Program”, July 19, 2013

66. VA Handbook 0058, “VA Green Purchasing Program”, July 19, 2013

67. Office of Information Security (OIS) VAIQ #7424808 Memorandum, “Remote Access”, January 15, 2014, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

68. Clinger-Cohen Act of 1996, 40 U.S.C. §11101 and §11103

69. “Veteran Focused Integration Process (VIP) Guide 3.2”, December 2018, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371

70. VA Memorandum “Proper Use of Email and Other Messaging Services”, January 2, 2018, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

3.0 SCOPE OF WORK

The Contractor shall provide VA with subscription/support for six users - of Research Medical Coding Software as a Service (SaaS) with capabilities to maintain coding consistency for patient safety and regulatory activities and migrate coded data to the newer medical coding format. The Contractor shall provide VA with user training for the Research Medical Coding Software. The Contractor shall host the Research Medical Coding Software and all data pertaining to the software in FedRamp certificated cloud environment.

4.0 PERFORMANCE DETAILS

4.1 PERFORMANCE PERIOD

The PoP shall be 12 months from date of award, with four 12-month option periods.

Any work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO).

There are ten (10) Federal holidays set by law (USC Title 5 Section 6103) that VA follows:

Under current definitions, four are set by date:

New Year's DayJanuary 1
Independence DayJuly 4
Veterans DayNovember 11
Christmas DayDecember 25

If any of the above falls on a Saturday, then Friday shall be observed as a holiday. Similarly, if one falls on a Sunday, then Monday shall be observed as a holiday.

The other six are set by a day of the week and month:

Martin Luther King's BirthdayThird Monday in January
Washington's BirthdayThird Monday in February
Memorial DayLast Monday in May
Labor DayFirst Monday in September
Columbus DaySecond Monday in October
ThanksgivingFourth Thursday in November

4.2 PLACE OF PERFORMANCE

Tasks under this PWS shall be performed at Contractor facilities. The Contractor shall identify the Contractor’s place of performance in their proposal submission.

5.0 SPECIFIC TASKS AND DELIVERABLES

The Contractor shall perform the following:

5.1 PROJECT MANAGEMENT

5.1.1 CONTRACTOR PROJECT MANAGEMENT PLAN

The Contractor shall deliver a Contractor Project Management Plan (CPMP) that lays out the Contractor’s approach, timeline and tools to be used in execution of the contract. The CPMP should take the form of both a narrative and graphic format that displays the schedule, milestones, risks and resource support. The CPMP shall also include how the Contractor shall coordinate and execute planned, routine, and ad hoc data collection reporting requests as identified within the PWS. The initial baseline CPMP shall be concurred upon and updated in accordance with Section B of the contract. The Contractor shall update and maintain the VA PM approved CPMP throughout the PoP. The Contractor shall provide the necessary resources and infrastructure to manage, perform, and administer the contract.

Deliverable:

A. Contractor Project Management Plan

5.1.2 REPORTING REQUIREMENTS

The Contractor shall provide the VA with Monthly Progress Reports in electronic form in Microsoft Word and Project formats. The report shall include detailed instructions/explanations for each required data element, to ensure that data is accurate and consistent. These reports shall reflect data as of the last day of the preceding Month.

The Monthly Progress Reports shall cover all work completed during the reporting period and work planned for the subsequent reporting period. The report shall also identify any problems that arose and a description of how the problems were resolved. If problems have not been completely resolved, the Contractor shall provide an explanation including their plan and timeframe for resolving the issue. The report shall also include an itemized list of all Information and Communication Technology (ICT) deliverables and their current Section 508 conformance status. The Contractor shall monitor performance against the CPMP and report any deviations. It is expected that the Contractor will keep in communication with VA accordingly so that issues that arise are transparent to both parties to prevent escalation of outstanding issues.

The Contractor shall participate in teleconference progress meetings to discuss the status of the project and any issue or concern. The frequency of the progress meetings will be determined during the Kickoff Meeting and can be adjusted based on the progress of the project.

Deliverable:

A. Monthly Progress Report

5.1.3 PROJECT COORDINATION

The Contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The Contractor shall maintain continuity with VA Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center.

5.1.4 PROJECT ADMINISTRATION

The Contractor shall establish processes and assign appropriate resources to effectively administer the requirement. The Contractor shall respond to Government requests for contractual actions in a timely fashion. The Contractor shall have a single point of contact between the Government and Contractor personnel assigned to support contracts.

5.1.5 SUBCONTRACT MANAGEMENT

The Contractor shall be responsible for any subcontract management necessary to integrate work performed on this requirement and shall be responsible and accountable for subcontractor performance on this requirement. The prime Contractor shall manage work distribution to ensure there are no Organizational Conflict of Interest (OCI) considerations.

5.2 ASSESSMENT, AUTHORIZATION, AND CONTINUOUS MONITORING

The Contractor shall provide Assessment, Authorization, and Continuous Monitoring support of Research Medical Coding SaaS that meet the following requirements:

1. The information system solution selected by the Contractor shall comply with the Federal Information Security Management Act (FISMA).

2. The Contractor shall comply with FedRAMP (https://www.fedramp.gov/agency-authorization/) requirements as mandated by Federal laws and policies, including making available any documentation, physical access, and logical access needed to support this requirement.

3. Following guidance from the Federal CIO, VA will utilize existing JAB ATO or agency ATO issued by another agency as a starting point for FedRAMP requirements. If neither of those exist, VA will sponsor FedRAMP ATO. VA will be using the FedRAMP baselines as a starting point, since they are specifically tailored for cloud services.

4. The Contractor shall, where applicable, assist with the VA Authority to Operate (ATO) Process to help achieve agency authorization of the cloud service or migrated application.

5. The Contractor shall afford VA access to the Contractor’s and Cloud Service Provider’s (CSP) facilities, installations, technical capabilities, operations, documentation, records, and databases.

6. If new or unanticipated threats or hazards are discovered by either VA or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party in accordance with Addendum B.

7. The Contractor shall not release any data without the consent of VA in writing. All requests for release must be submitted in writing to the Contracting Officer’s Representative (COR)/Contracting Officer (CO).

5.3 RESEARCH MEDICAL CODING SaaS REQUIREMENT

The Research Medical Coding SaaS shall include the following Salient Characteristics:

1. The Software shall be certified within the WHODrug Software Certification for handling B3/C3 format data.

2. Data Import

a. Use delimited text and csv (comma-separated values) file formats

b. Coded data validity can be checked by system during import against dictionary

c. Import all records, retaining previously coded records and appending any new records

d. Update status for previously coded records if changed from previous status.

3. Auto and manual coding

4. Coding workflow allowing custom statuses to be created

5. Multi-step verification process

6. Synonym list management

7. Query and comment management

8. Do not code list capabilities

9. Custom search support

10. Data Export

a. User delimited text and csv

11. Report generation

12. Clinical and Safety data - Ability to segregate clinical safety data based on user groups

13. Dictionary version management

5.4 SUPPORT AND SUBSCRIPTION

The Contractor shall provide annual support/subscription for use of software.

The Contractor shall provide Annual software subscription.

The Contractor shall provide user subscription to support 6 users.

The Contractor shall perform Dictionary Load - MedDRA and WHODrug (2 dictionary versions per year).

The Contractor shall perform software maintenance to include software update or upgrade and helpdesk assistance to the users.

· The Contractor shall provide 24/7 website access for self-initiated troubleshooting procedure and information on Research Medical Coding Software

· The Contractor shall provide a toll-free phone number where VA user can reach the technical helpdesk assistance during normal business hour (7am – 5pm mountain time) and meet the following respond time:

Severity Code
User Impact
Response to User
Resolution Time
1 - Important
Individual Impacted (Inability to perform job) Important Service Request
1 business hour
10 business hours
2 - Non-critical
Low/No Impact (Able to perform work functions) Non-critical Service Request
16 business hours
40 business hours
3 - Request
New Service, Scheduled/Planned Work
24 business hours
As scheduled

The SaaS shall be hosted within the United States and data stored/processed/transmitted within the offering must remain within the United States.

VA Data: No personal health information/personally identifiable information (PHI/PII) or patient/study participant identifiable information) is provided or uploaded to this Research Medical Coding software or applications

5.5 DATA MIGRATION

The Contractor shall complete data migrate of the existing dsNavigator data provided by VA in text-based flat file format (e.g. CSV, TXT) 21 business days after the Research Medical Coding software become available to VA.

The Contractor shall demonstrate that VA provided dsNavigator data has been transferred and translated completely as evidence of successful data migration to the Research Medical Coding software.

5.6 USER TRAINING

The Contractor shall coordinate with VA to plan and conduct a virtual User Level Training session for the licensed users. The Contractor shall provide Training Plan to include training schedule and training objective, and curriculum. The Contractor shall provide the user with knowledge, procedure and process to operate the Research Medical Coding Software. The Contractor shall provide a detailed overview of the content, strategy, approach, and organization of the Research Medical Coding Software. The Contractor shall deliver Training Materials, in the form of presentation slides. The Contractor shall coordinate the training date with VA within 10 business days of acceptance of the Training Plan and Materials.

The Contractor shall provide VA with User Guide detailing actual use of software. The User Guide shall clearly outline the use of Research Medical Coding Software for the User Level.

Deliverables:

A. Training Plan B. Training Materials C. User Guide

5.7 OPTION PERIOD ONE to FOUR

The Contractor shall continue provide VA with support/subscription of Research Medical Coding Software as a Service (SaaS) that has capabilities to maintain coding consistency for patient safety and regulatory activities and migrate coded data to the newer medical coding format. The Contractor shall maintain annual FedRamp recertification. The Contractor shall provide Refresher Training to for licensed users. The Refresher Training shall include overview of the Research Medical Coding Software and any enhancement that pertain to the user level operation of the Software.

6.0 GENERAL REQUIREMENTS

6.1 ENTERPRISE AND IT FRAMEWORK

6.1.1 VA TECHNICAL REFERENCE MODEL

The Contractor shall support the VA enterprise management framework. In association with the framework, the Contractor shall comply with OI&T 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 OI&T. Architecture & Engineering Services (AES) has overall responsibility for the VA TRM.

6.1.2 FEDERAL IDENTITY, CREDENTIAL, AND ACCESS MANAGEMENT (FICAM)

The Contractor shall ensure Commercial Off-The-Shelf (COTS) product(s), software configuration and customization, and/or new software are Personal Identity Verification (PIV) card-enabled by accepting HSPD-12 PIV credentials using VA Enterprise Technical Architecture (ETA), https://www.ea.oit.va.gov/EAOIT/VA_EA/Enterprise_Technical_Architecture.asp, and VA Identity and Access Management (IAM) approved enterprise design and integration patterns, https://www.oit.va.gov/library/recurring/edp/index.cfm. The Contractor shall ensure all Contractor delivered applications and systems comply with the VA Identity, Credential, and Access Management policies and guidelines set forth in the VA Handbook 6510 and align with the Federal Identity, Credential, and Access Management Roadmap and Implementation Guidance v2.0.

The Contractor shall ensure all Contractor delivered applications and systems provide user authentication services compliant with the National Institute of Standards and Technology (NIST) Special Publication (SP) 800-63-3, VA Handbook 6500 Appendix F, “VA System Security Controls”, and VA IAM enterprise requirements for direct, assertion based authentication, and/or trust based authentication, as determined by the design and integration patterns. Direct authentication at a minimum must include Public Key Infrastructure (PKI) based authentication supportive of PIV card and/or Common Access Card (CAC), as determined by the business need.

The Contractor shall ensure all Contractor delivered applications and systems conform to the specific Identity and Access Management PIV requirements set forth in the Office of Management and Budget (OMB) Memoranda M-04-04, M-05-24, M-11-11, and NIST Federal Information Processing Standard (FIPS) 201-2. OMB Memoranda M-04-04, M-05-24, and M-11-11 can be found at: https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/omb/memoranda/fy04/m04-04.pdf, https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/omb/memoranda/fy2005/m05-24.pdf, and https://obamawhitehouse.archives.gov/sites/default/files/omb/memoranda/2011/m11-11.pdf respectively. Contractor delivered applications and systems shall be on the FIPS 201-2 Approved Product List (APL). If the Contractor delivered application and system is not on the APL, the Contractor shall be responsible for taking the application and system through the FIPS 201 Evaluation Program.

The Contractor shall ensure all Contractor delivered applications and systems support:

1. Automated provisioning and are able to use enterprise provisioning service.

2. Interfacing with VA’s Master Veteran Index (MVI) to provision identity attributes, if the solution relies on VA user identities. MVI is the authoritative source for VA user identity data.

3. The VA defined unique identity (Secure Identifier [SEC ID] / Integrated Control Number [ICN]).

4. Multiple authenticators for a given identity and authenticators at every Authenticator Assurance Level (AAL) appropriate for the solution.

5. Identity proofing for each Identity Assurance Level (IAL) appropriate for the solution.

6. Federation for each Federation Assurance Level (FAL) appropriate for the solution, if applicable.

7. Two-factor authentication (2FA) through an applicable design pattern as outlined in VA Enterprise Design Patterns.

8. A Security Assertion Markup Language (SAML) implementation if the solution relies on assertion based authentication. Additional assertion implementations, besides the required SAML assertion, may be provided as long as they are compliant with NIST SP 800-63-3 guidelines.

9. Authentication/account binding based on trusted Hypertext Transfer Protocol (HTTP) headers if the solution relies on Trust based authentication.

10. Role Based Access Control.

11. Auditing and reporting capabilities.

12. Compliance with VIEWS 00155984, PIV Logical Access Policy Clarification https://www.voa.va.gov/DocumentView.aspx?DocumentID=4896.

The required Assurance Levels for this specific effort are Identity Assurance Level 3, Authenticator Assurance Level 3, and Federation Assurance Level 3.

6.1.3 INTERNET PROTOCOL VERSION 6 (IPV6)

The Contractor solution shall support the latest Internet Protocol Version 6 (IPv6) based upon the directives issued by the Office of Management and Budget (OMB) on August 2, 2005 (https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/omb/memoranda/fy2005/m05-22.pdf) and September 28, 2010 (https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/egov_docs/transition-to-ipv6.pdf). IPv6 technology, in accordance with the USGv6 Profile, NIST Special Publication (SP) 500-267 (https://nvlpubs.nist.gov/nistpubs/Legacy/SP/nistspecialpublication500-267.pdf), the Technical Infrastructure for USGv6 Adoption (https://www.nist.gov/programs-projects/usgv6-program), and the NIST SP 800 series applicable compliance (https://csrc.nist.gov/publications/sp) 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/or 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/or dual stack (IPv6/ IPv4) users and all internal infrastructure and applications shall communicate using native IPv6 and/or dual stack (IPv6/ IPv4) operations. Guidance and support of improved methodologies which ensure interoperability with legacy protocol and services in dual stack solutions, in addition to OMB/VA memoranda, can be found at: https://www.voa.va.gov/documentlistpublic.aspx?NodeID=282.

6.1.4 TRUSTED INTERNET CONNECTION (TIC)

The Contractor solution shall meet the requirements outlined in Office of Management and Budget Memorandum M08-05 mandating Trusted Internet Connections (TIC) (https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/omb/memoranda/fy2008/m08-05.pdf), M08-23 mandating Domain Name System Security (NSSEC) (https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/omb/memoranda/fy2008/m08-23.pdf), and shall comply with the Trusted Internet Connections (TIC) Reference Architecture Document, Version 2.0 https://www.dhs.gov/sites/default/files/publications/TIC_Ref_Arch_v2.2_2017.pdf.

6.1.5 STANDARD COMPUTER CONFIGURATION

The Contractor IT end user solution that is developed for use on standard VA computers shall be compatible with and be supported on the standard VA operating system, currently Windows 10 (64bit), Internet Explorer 11 and Office 365 ProPlus. Applications delivered to VA and intended to be deployed to Windows 10 workstations shall be delivered as a signed .msi package with switches for silent and unattended installation and updates shall be delivered in signed .msp file formats for easy deployment using System Center Configuration Manager (SCCM) VA’s current desktop application deployment tool. Signing of the software code shall be through a vendor provided certificate that is trusted by VA using a code signing authority such as Verizon/Cybertrust or Symantec/VeriSign. The Contractor shall also ensure and certify that their solution functions as expected when used from a standard VA computer, with non-admin, standard user rights that have been configured using the United States Government Configuration Baseline (USGCB) and Defense Information Systems Agency (DISA) Secure Technical Implementation Guide (STIG) specific to the particular client operating system being used.

6.1.6 VETERAN FOCUSED INTEGRATION PROCESS (VIP)

The Contractor shall support VA efforts IAW the Veteran Focused Integration Process (VIP). VIP is a Lean-Agile framework that services the interest of Veterans through the efficient streamlining of activities that occur within the enterprise. The VIP Guide can be found at https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371. The VIP framework creates an environment delivering more frequent releases through a deeper application of Agile practices. In parallel with a single integrated release process, VIP will increase cross-organizational and business stakeholder engagement, provide greater visibility into projects, increase Agile adoption and institute a predictive delivery cadence. VIP is now the single authoritative process that IT projects must follow to ensure development and delivery of IT products

6.1.7 PROCESS ASSET LIBRARY (PAL)

The Contractor shall perform their duties consistent with the processes defined in the OIT Process Asset Library (PAL). The PAL scope includes the full spectrum of OIT functions and activities, such as VIP project management, operations, service delivery, communications, acquisition, and resource management. PAL serves as an authoritative and informative repository of searchable processes, activities or tasks, roles, artifacts, tools and applicable standards and guides to assist the OIT workforce, Government and Contractor personnel. The Contractor shall follow the PAL processes to ensure compliance with policies and regulations and to meet VA quality standards. The PAL includes the contractor onboarding process consistent with Section 6.2.2 and can be found at https://www.va.gov/PROCESS/artifacts/maps/process_CONB_ext.pdf. The main PAL can be accessed at www.va.gov/process.

6.1.8 AUTHORITATIVE DATA SOURCES

The VA Enterprise Architecture Repository (VEAR) is one component within the overall Enterprise Architecture (EA) that establishes the common framework for data taxonomy for describing the data architecture used to develop, operate, and maintain enterprise applications. The Contractor shall comply with the department’s Authoritative Data Source (ADS) requirement that VA systems, services, and processes throughout the enterprise shall access VA data solely through official VA ADSs where applicable, see below. The Information Classes which compose each ADS are located in the VEAR, in the Data & Information domain. The Contractor shall ensure that all delivered applications and system solutions support:

1. Interfacing with VA’s Master Veteran Index (MVI) to provision identity attributes, if the solution relies on VA user identities. MVI is the authoritative source for VA user identity data.

2. Interfacing with Capital Asset Inventory (CAI) to conduct real property record management actions, if the solution relies on real property records data. CAI is the authoritative source for VA real property record management data.

3. Interfacing with electronic Contract Management System (eCMS) for access to contract, contract line item, purchase requisition, offering vendor and vendor, and solicitation information above the micro-purchase threshold, if the solution relies on procurement data. ECMS is the authoritative source for VA procurement actions data.

4. Interfacing with HRSmart Human Resources Information System to conduct personnel action processing, on-boarding, benefits management, and compensation management, if the solution relies on personnel data. HRSmart is the authoritative source for VA personnel information data.

5. Interfacing with Vet360 to access personal contact information, if the solution relies on VA Veteran personal contact information data. Vet360 is the authoritative source for VA Veteran Personal Contact Data.

6. Interfacing with VA/Department of Defense (DoD) Identity Repository (VADIR) for determining eligibility for VA benefits under Title 38, if the solution relies on qualifying active duty military service data. VADIR is the authoritative source for Qualifying Active Duty military service in VA.

6.2 METHOD AND DISTRIBUTION OF DELIVERABLES

The Contractor shall deliver documentation in electronic format, unless otherwise directed in Section B of the solicitation/contract. Acceptable electronic media include: MS Word 2000/2003/2007/2010, MS Excel 2000/2003/2007/2010, MS PowerPoint 2000/2003/2007/2010, MS Project 2000/2003/2007/2010, MS Access 2000/2003/2007/2010, MS Visio 2000/2002/2003/2007/2010, and Adobe Postscript Data Format (PDF).

6.3 PERFORMANCE METRICS

The table below defines the Performance Standards and Acceptable Levels of Performance associated with this effort.

Performance Objective
Performance Standard
Acceptable Levels of Performance
A. Technical / Quality of Product or Service
1. Demonstrates understanding of requirements

2. Efficient and effective in meeting requirements

3. Meets technical needs and mission requirements

4. Provides quality services/products

5. Incorporates “ease of use” Human Centered Design principles in any software developed.

Satisfactory or higher

B. Project Milestones and Schedule
1. Established milestones and project dates are met

2. Products completed, reviewed, delivered in accordance with the established schedule

3. Notifies customer in advance of potential problems Satisfactory or higher

C. Cost & Staffing
1. Currency of expertise and staffing levels appropriate to perform tasks required

2. Personnel possess necessary knowledge, skills and abilities to perform tasks Satisfactory or higher

D. Management
1. Integration and coordination of all activities to execute effort
Satisfactory or higher

The COR will utilize a Quality Assurance Surveillance Plan (QASP) throughout the life of the contract to ensure that the Contractor is performing the services required by this PWS in an acceptable level of performance. The Government reserves the right to alter or change the surveillance methods in the QASP at its own discretion. A Performance Based Service Assessment will be used by the COR in accordance with the QASP to assess Contractor performance.

6.4 GOVERNMENT FURNISHED INFORMATION

The Government will make available the information required by the contractor to provide requested services/software. Specifically, the government will provide data to be migrated in a text-based flat file format.

ADDENDUM A – ADDITIONAL VA REQUIREMENTS, CONSOLIDATED

Cyber and Information Security Requirements for VA IT Services The Contractor shall ensure adequate LAN/Internet, data, information, and system security in accordance with VA standard operating procedures and standard PWS language, conditions, laws, and regulations. The Contractor’s firewall and web server shall meet or exceed VA minimum requirements for security. All VA data shall be protected behind an approved firewall. Any security violations or attempted violations shall be reported to the VA Program Manager and VA Information Security Officer as soon as possible. The Contractor shall follow all applicable VA policies and procedures governing information security, especially those that pertain to certification and accreditation.

Contractor supplied equipment, PCs of all types, equipment with hard drives, etc. for contract services must meet all security requirements that apply to Government Furnished Equipment (GFE) and Government Owned Equipment (GOE). Security Requirements include: a) VA Approved Encryption Software must be installed on all laptops or mobile devices before placed into operation, b) Bluetooth equipped devices are prohibited within VA; Bluetooth must be permanently disabled or removed from the device, unless the connection uses FIPS 140-2 (or its successor) validated encryption, c) VA approved anti-virus and firewall software, d) Equipment must meet all VA sanitization requirements and procedures before disposal. The COR, CO, the PM, and the Information Security Officer (ISO) must be notified and verify all security requirements have been adhered to.

Each documented initiative under this contract incorporates VA Handbook 6500.6, “Contract Security,” March 12, 2010 by reference as though fully set forth therein. The VA Handbook 6500.6, “Contract Security” shall also be included in every related agreement, contract or order. The VA Handbook 6500.6, Appendix C, is included in this document as Addendum B.

Training requirements: The Contractor shall complete all mandatory training courses on the current VA training site, the VA Talent Management System (TMS) 2.0, and will be tracked therein. The TMS 2.0 may be accessed at https://www.tms.va.gov/SecureAuth35/ . If you do not have a TMS 2.0 profile, go to https://www.tms.va.gov/SecureAuth35/ and click on the “Create New User” link on the TMS 2.0 to gain access.

Contractor employees shall complete a VA Systems Access Agreement if they are provided access privileges as an authorized user of the computer system of VA.

VA Enterprise Architecture Compliance The applications, supplies, and services furnished under this contract must comply with VA Enterprise Architecture (EA), available at http://www.ea.oit.va.gov/index.asp in force at the time of issuance of this contract, including the Program Management Plan and VA's rules, standards, and guidelines in the Technical Reference Model/Standards Profile (TRMSP). VA reserves the right to assess contract deliverables for EA compliance prior to acceptance.

VA Internet and Intranet Standards

The Contractor shall adhere to and comply with VA Directive 6102 and VA Handbook 6102, Internet/Intranet Services, including applicable amendments and changes, if the Contractor’s work includes managing, maintaining, establishing and presenting information on VA’s Internet/Intranet Service Sites. This pertains, but is not limited to: creating announcements; collecting information; databases to be accessed, graphics and links to external sites.

Internet/Intranet Services Directive 6102 is posted at (copy and paste the following URL to browser): https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=1056&FType=2

Internet/Intranet Services Handbook 6102 is posted at (copy and paste following URL to browser): https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=1055&FType=2

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.

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