Draft PWS_Electronic Database Subscription Services.pdf

PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS

Veterans’ Health Administration (VHA) National Office of Sterile Processing Services (12OSP)

Electronic Database Subscription Services

Date: April 17, 2025

VA-25-00054117

PWS Version Number: 1.0

Contents

1.0 BACKGROUND

2.0 APPLICABLE DOCUMENTS

3.0 SCOPE OF WORK

4.0 PERFORMANCE DETAILS

4.1 PERFORMANCE PERIOD

4.2 PLACE OF PERFORMANCE

4.3 TRAVEL

5.0 SPECIFIC TASKS AND DELIVERABLES

5.1 PROJECT MANAGEMENT

5.1.1 CONTRACTOR PROJECT MANAGEMENT PLAN

5.1.2 REPORTING REQUIREMENTS

5.1.3 PROJECT KICKOFF MEETING

5.2 TASK TWO: DATA MATCH

5.2.1 INITIAL DATASET OF MATCHED RECORDS

5.2.2 ONGOING DATASET OF MATCHED RECORDS

5.3 Task three: data match

6.0 GENERAL REQUIREMENTS

6.1 ENTERPRISE AND IT FRAMEWORK

6.1.1 VA TECHNICAL REFERENCE MODEL

6.1.2 FEDERAL IDENTITY, CREDENTIAL, AND ACCESS MANAGEMENT

(FICAM) 13

6.1.3 INTERNET PROTOCOL VERSION 6 (IPV6)

6.1.4 TRUSTED INTERNET CONNECTION (TIC)

6.1.5 STANDARD COMPUTER CONFIGURATION

6.1.6 VETERAN FOCUSED INTEGRATION PROCESS (VIP) AND PRODUCT

LINE MANAGEMENT (PLM)

6.1.7 PROCESS ASSET LIBRARY (PAL)

6.1.8 AUTHORITATIVE DATA SOURCES

6.1.9 SOCIAL SECURITY NUMBER (SSN) REDUCTION

6.2 SECURITY AND PRIVACY REQUIREMENTS

6.2.1 POSITION/TASK RISK DESIGNATION LEVEL(S)

6.2.2 CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

6.3 METHOD AND DISTRIBUTION OF DELIVERABLES

6.4 PERFORMANCE METRICS

6.5 FACILITY/RESOURCE PROVISIONS

6.6 GOVERNMENT FURNISHED PROPERTY

6.7 SHIPMENT OF HARDWARE OR EQUIPMENT

ADDENDUM A – ADDITIONAL VA REQUIREMENTS, CONSOLIDATED

1.0 BACKGROUND

The Department of Veteran’s Affairs Office for Sterile Processing (OSP) and Healthcare Technology Management (HTM) requires the services of a contractor to provide a comprehensive electronic database of manufacturer’s instructions for the cleaning/reprocessing, sterilization/disinfection/preventive maintenance of Medical/Surgical instrumentation and Equipment, as well as Instructions for Use (IFU’s) for Dental, Tissue/Implants Biomedical Equipment Preventive Maintenance Service Manuals, Consumables, Non-Medical Equipment and Medical Safety Data Sheets (MSDS). The Government requires a subscription set of services as described below.

The Veterans Health Administration (VHA) provides sterile processing and biomedical preventive maintenance for all medical and surgical equipment. OSP and the HTM Program Office are committed to ensuring the safety of Veterans through the development of national level policies, along with oversight of all sterile and high-level disinfection processing of critical and semi-critical reusable medical equipment.

Currently the VHA is subscribed to a web-based subscription service to the field that provides VHA with web-based access to a comprehensive electronic database of manufacturer’s instructions for the cleaning/reprocessing, sterilization, and disinfection.

Collaboration with other program management offices will allow increased quality assurance programs and technology solutions to automate several processes, thereby decreasing risk and errors while increasing emphasis on patient safety. These initiatives include software management tools for document management and control of Sterile Processing Service (SPS) policies incorporating current guidance through national standardization. Procuring additional advancements in software technology for asset management and instrument tracking will allow SPS to expand quality management programs with increased benchmarking capabilities. Increased emphasis on continuing educational programs for all specialties within SPS is imperative, so that new and innovative programs are developed to minimize the differences associated with generational gaps within the SPS workforce. OSP will strive to improve the integrity, quality, and value of SPS clinical services at VHA facilities.

The Joint Commission (TJC), the Association for the Advancement of Medical Instrumentation (AAMI), and Centers for Medicare and Medicaid Services (CMS) guidelines require that Biomedical Engineering have current Preventive Maintenance (PM) manuals for biomedical equipment used at a healthcare facility be available on site for the technicians who need them as well as the Original Equipment Manufacturers (OEM) Maintenance frequency recommendations. A Biomedical Equipment PM Document Database subscription service would make all VHA Healthcare Systems compliant with the new regulations.

Specifically, VHA DIRECTIVE 1116 (2) STERILE PROCESSING SERVICES: Provides procedures for the decontamination, high-level disinfection (HLD), and/or sterilization of critical and semi-critical reusable medical instruments and equipment and storage of items reprocessed in the VA medical facilities. The VA medical facility must ensure manufacturer’s instructions for use (MIFU) are available for all Reusable Medical

Devices (RMD) including consigned and loaned devices, reprocessing equipment and expandable products used in reprocessing.

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 2006

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

9. Public Law 109-461, Veterans Benefits, Health Care, and Information

Technology Act of 2006, Title IX, Information Security Matters

10. 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”

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

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

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

14. 36 C.F.R. Part 1194 “Information and Communication Technology Standards and Guidelines,” January 18, 2017

15. Office of Management and Budget (OMB) Circular A-130, “Managing Federal

Information as a Strategic Resource,” July 28, 2016

16. 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed

Services (CHAMPUS)”

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

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

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

20. VA Directive 6500, “VA Cybersecurity Program,” February 24, 2021

21. VA Handbook 6500, “Risk Management Framework for VA Information

Systems VA Information Security Program,” February 24, 2021 https://www.va.gov/vapubs/index.cfm https://www.va.gov/vapubs/index.cfm http://www.va.gov/vapubs http://www.va.gov/vapubs

22. VA Handbook 6500.2, “Management of Breaches Involving Sensitive Personal Information (SPI),” March 12, 2019

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

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

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

26. VA Handbook 6500.10, “Mobile Device Security Policy,” February 15, 2018

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

28. OIT 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

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

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

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

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

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

34. VA Directive 6300, “Records and Information Management,” September 21,

35. VA Handbook, 6300.1, “Records Management Procedures,“ March 24, 2010

36. NIST SP 800-37 Rev 2, “Risk Management Framework for Information

Systems and Organizations: A System Life Cycle Approach for Security and Privacy,” December 2018

37. NIST SP 800-53 Rev. 5, “Security and Privacy Controls for Federal Information Systems and Organizations,” September 23, 2020 (includes updates as of 12/10/2020)

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

39. VA Handbook 0735, “Homeland Security Presidential Directive 12 (HSPD-

12) Program,” March 24, 2014

40. 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

41. OMB Memorandum M-19-17, “Enabling Mission Delivery Through Improved Identity, Credential, and Access Management,” May 21, 2019

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

43. Federal Identity, Credential, and Access Management (FICAM) Roadmap and Implementation Guidance, December 2, 2011, (NOTE: Part A of the FICAM Roadmap and Implementation Guidance, v2.0, was replaced in 2015 https://www.va.gov/process/ https://www.va.gov/process/maps.asp https://www.va.gov/process/artifacts.asp https://www.va.gov/trm/TRMHomePage.aspx with an updated Architecture (https://arch.idmanagement.gov/#what-is-the-ficam-architecture)

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

45. NIST SP 800-63-3, 800-63A, 800-63B, 800-63C, “Digital Identity Guidelines,” updated March 02, 2020

46. NIST SP 800-157, “Guidelines for Derived PIV Credentials,” December 2014

47. NIST SP 800-164, “Guidelines on Hardware-Rooted Security in Mobile

Devices (Draft),” October 2012

48. Draft National Institute of Standards and Technology Interagency Report

(NISTIR) 7981, “Mobile, PIV, and Authentication,” March 2014

49. 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)

50. 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)

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

52. Trusted Internet Connections (TIC) 3.0 Core Guidance Documents, https://www.cisa.gov/publication/tic-30-core-guidance-documents

53. OMB Memorandum M-19-26, “Update to the Trusted Internet Connections (TIC) Initiative,” September 12, 2019

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

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

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

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

58. Executive Order 13221, “Energy-Efficient Standby Power Devices,” August

2, 2001

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

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

61. Office of Information Security (OIS) VAIQ #7424808 Memorandum, “Remote

Access,” January 15, 2014, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

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

63. “Veteran Focused Integration Process (VIP) Guide 4.0,” January 2021, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371

64. VA Memorandum “Proper Use of Email and Other Messaging Services,”

January 2, 2018, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

65. “DevSecOps Product Line Management Playbook” version 2.0, May 2021, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946 https://arch.idmanagement.gov/#what-is-the-ficam-architecture https://arch.idmanagement.gov/#what-is-the-ficam-architecture https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514 https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514 https://www.voa.va.gov/DocumentView.aspx?DocumentID=4896 https://www.cisa.gov/publication/tic-30-core-guidance-documents https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28 https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371 https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28 https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946

66. NIST SP 500-267B Revision 1, “USGv6 Profile,” November 2020

67. OMB Memorandum M-21-07, “Completing the Transition to Internet Protocol

Version 6 (IPv6),” November 19, 2020

68. Social Security Number (SSN) Fraud Prevention Act of 2017

69. Section 240 of the Consolidated Appropriations Act (CAA) 2018, March 23,

70. VA Directive 1116 (2) Management of Critical and Semi Critical reusable

Medical Devices.

3.0 SCOPE OF WORK

The Contractor shall provide comprehensive web-based electronic database of manufacturer’s instructions for the cleaning/reprocessing, sterilization/ disinfection / preventive maintenance of medical/surgical instrumentation and equipment, as well as IFU’s for Dental instruments, Tissue and implant, Non-Medical Equipment, Consumables, and Safety Data Sheets to 190 VA facilities and all satellite clinics with the capability to save frequently used and favorite IFU documents for immediate access. The contractor must be able to provide a continuation of the current VA document library, currently in use by the field, in its entirety with no interruption in current services. The contactor must provide URL linkage to allow easy access to the subscription service and must allow direct access to IFU documents within an Instrument Tracking System program. The contractor must be ISO 9001:2015 registered and maintain status as an ISO 9001:2015 registered company. The contractor shall provide planning, facilitation, communication, technical support and training for the use of the subscription-based service. The contractor will provide monthly status reports. The scope of Services is for both Sterile Processing and the Biomedical Equipment PM Document Database subscription service is for all VHA Healthcare Systems.

4.0 PERFORMANCE DETAILS

4.1 PERFORMANCE PERIOD

The PoP shall consist of one (1) 12-month Base Period, with four (4) 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 eleven (11) Federal holidays set by law (USC Title 5 Section 6103) that VA follows:

Under current definitions, four are set by date:

New Year's Day January 1 https://dvagov.sharepoint.com/sites/NPOSP/Operational%20Memos/Forms/AllItems.aspx?id=%2Fsites%2FNPOSP%2FOperational%20Memos%2F1116%282%29%20Management%20of%20Critical%20Semi%2DCritical%20Reusable%20Medical%20Devices%20Amended%20992024%2Epdf&parent=%2Fsites%2FNPOSP%2FOperational%20Memos https://dvagov.sharepoint.com/sites/NPOSP/Operational%20Memos/Forms/AllItems.aspx?id=%2Fsites%2FNPOSP%2FOperational%20Memos%2F1116%282%29%20Management%20of%20Critical%20Semi%2DCritical%20Reusable%20Medical%20Devices%20Amended%20992024%2Epdf&parent=%2Fsites%2FNPOSP%2FOperational%20Memos

Juneteenth June 19 Independence Day July 4 Veterans Day November 11 Christmas Day December 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 Birthday Third Monday in January Washington's Birthday Third Monday in February Memorial Day Last Monday in May Labor Day First Monday in September Columbus Day Second Monday in October Thanksgiving Fourth 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.

4.3 TRAVEL

Not applicable.

5.0 SPECIFIC TASKS AND DELIVERABLES

The Contractor shall provide online access to major manufacturers IFU documents for decontamination, assembly, and sterilization of reusable instruments and supplemental guides.

• Provide online access to major manufacturers’ IFU documents for cleaning equipment outside of the sterile field, such as compression sleeves and pumps, etc.;

• Provides online access to major manufacturers’ IFU documents for decontamination, assembly, and sterilization of reusable instruments, Safety Data Sheets (SDS) / MSDS sheets, and information needed for dental consumables;

• Provides online access to major manufacturers’ preventive maintenance manuals

/documents for all hospital equipment to include clinical as well as capital equipment use for the processing of reusable medical Devices (RMD);

• Provide online access to major manufacturers’ IFU documents for implantable biological and non-biological materials and devices;

• Provide online access to Non-Medical Equipment operator, user, instructions, and service manual with Instruction for use documents;

• Provide online access to Consumables instruction for use documents, packing inserts, prescribing information for single use, disposable devices;

• Provide online access to SDS and/or MSDS sheets that contain information about safe handling of chemicals found within a healthcare setting and the appropriate protocol for spills and/or leaks.

• Provide customizable data storage and access to the PM service manuals;

• Provide linkage with Nuvolo. Nuvolo is the VA current Cloud Management

System (CMS) - a cloud based workspace (service now) computerized maintenance management system used throughout the VA;

• Provide Instrument Tracking System linkage allowing direct access to IFU documents;

• Contractor shall poll the manufacturers at least quarterly for updates and post these to the electronic database within 30 calendar days of receipt;

• Contractor shall send weekly updates and change reports each Monday no later than 3:00 pm eastern time to OSP and HTM of any changes to the database;

• Contractor will be international standards organization (ISO) 9001:2015 Registered and maintain status as an ISO 9001:2015 registered company the duration of the contract;

• Contractor shall provide initial onboarding and ongoing training for all end users and the OSP staff. Unlimited virtual site training sessions, training videos, tip sheets and up to four (4) annual virtual or in-person training sessions on a national platform.

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.

Deliverable:

A. Contractor Project Management Plan

5.1.2 REPORTING REQUIREMENTS

The Contractor shall provide the COR 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 report shall include status of deliverables, accomplishments, planned activity for the next month, risks; recommendations for future activities; changes to plans, milestones, schedules, and resources; organization accomplishments and relevant statistics; and lessons learned.

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.

Formal acceptance or rejection of deliverables. The VA shall have 5 business days to review each document and provide feedback and comments. The contractor shall have five business days to incorporate comments. A final review shall be conducted with the COR and 10NC6 National Program Office for Sterile Processing. Delivery of the post-final review document with incorporated comments from the final review meeting shall constitute acceptance by the VA with COR’s written approval.

Deliverable:

A. Monthly Status Report

5.1.3 PROJECT KICKOFF MEETING

A technical kickoff meeting shall be held within ten (10) days after contract award. The Contractor shall coordinate the date, time, and location (can be virtual) with the Contracting Officer (CO), as the as the Post-Award Conference Chairperson, the VA PM, as the Co-Chairperson, the Contract Specialist (CS), and the COR. The Contractor shall provide a draft agenda to the CO and VA PM at least five (5) calendar days prior to the meeting. Upon Government approval of a final agenda, the Contractor shall distribute to all meeting attendees. During the kickoff-meeting, the Contractor shall present, for review and approval by the Government, the details of the intended approach, work plan, and project schedule for each effort via a Microsoft Office PowerPoint presentation. At the conclusion of the meeting, the Contractor shall update the presentation with a final slide entitled “Summary Report” which shall include notes on any major issues, agreements, or disagreements discussed during the kickoff meeting and the following statement As the Post-Award Conference Chairperson, I have reviewed the entirety of this presentation and assert that it is an accurate representation and summary of the discussions held during the Technical Kickoff Meeting. The Contractor shall submit the final kickoff presentation to the CO for review and signature within three (3) calendar days after the meeting. The Contractor shall also work with the CS, the Government’s designated note taker, to prepare and distribute the meeting minutes of the kickoff meeting to the CO, COR and all attendees within three

(3) calendar days after the meeting. The Contractor shall obtain concurrence from the CS on the content of the meeting minutes prior to distribution of the document.

Deliverable:

A. Kickoff Summary Report B. Final Kickoff Presentation/Meeting Minutes

5.2 TASK TWO: DATA MATCH

The contractor shall provide a weekly update of any manufacturer updates and notify the COR of such updates so that the updates may be distributed to the various VA Facilities.

The contractor shall protect their electronic database with up-to-date software to prevent spread of malware and malicious viruses, etc.

5.2.1 INITIAL DATASET OF MATCHED RECORDS

The contractor shall provide access to written standard operating procedures/technical documents for the cleaning/reprocessing and sterilization/disinfection / preventive and corrective maintenance of reusable medical equipment/instrumentation based on the manufacturer’s written instructions. The contractor shall sequester old standard operating procedure (SOP)/technical documents so that only the current SOP/technical document is available for general use. Sequestered old SOP/technical documents shall be available for reference purposes.

The contractor shall provide documentation that is at a minimum consistent with the Joint Commission, Association of Operating Room Nurses (AORN), Association for the Advancement of Medical Instrumentation and Society of Gastroenterology Nurses and Associates (SGNA) guidelines for reprocessing of reusable medical equipment/instrumentation.

The contractor shall provide all information and instructions for VA departmental employees to access the database online via web URL connection between the current instrument tracking system subscription service, and VA intranet. The Government will notify the contractor of access problems.

5.2.2 ONGOING DATASET OF MATCHED RECORDS

Shall promptly resolve access issues that are within its purview and will work with VA officials to resolve any additional problems within 24 hours of notification of issue. This shall include 24 hour a day, seven days a week, 365 days per year coverage. The contractor will continue to provide technical assistance and training to key government users of the contractor’s subscription service. Continue to provide annually training to the field of use of the software and as requested by COR. User complaints will be tracked and reviewed, noting errors due to data conversion, improper software function, programming problems, and/or user inexperience.

5.3 TASK THREE: DATA MATCH

The contractor shall continue to provide electronic database access to various VA Facilities including Community Based Outpatient Clinics, Hospitals and VA Central Office for the database of manufacturer’s instructions for cleaning/reprocessing, sterilization/disinfection/ preventive maintenance of medical/surgical instrumentation and equipment, as well as IFU’s for Dental, Tissue/Implants, Biomedical equipment Preventive Maintenance Service Manuals, Consumables, Non-Medical Equipment and Safety Data Sheets.

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 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.

6.1.2 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 VA Handbook 6510 VA Identity and Access Management, VA Handbook 0735 Homeland Security Presidential Directive 12 (HSPD-12) Program, 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-05-24, M-19-17, and NIST Federal Information Processing Standard (FIPS) 201-2. OMB Memoranda M-05-24 and M-19- 17 can be found at:

https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2005/m05- 24.pdf, and https://www.whitehouse.gov/wp-content/uploads/2019/05/M-19-17.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 Person Index (MPI) to provision identity attributes, if the solution relies on VA user identities. MPI 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.

https://www.ea.oit.va.gov/EAOIT/VA_EA/Enterprise_Technical_Architecture.asp https://www.oit.va.gov/library/recurring/edp/index.cfm https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2005/m05-24.pdf https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2005/m05-24.pdf https://www.whitehouse.gov/wp-content/uploads/2019/05/M-19-17.pdf

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 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.

6.1.4 TRUSTED INTERNET CONNECTION (TIC)

The Contractor solution shall meet the requirements outlined in Office of Management and Budget Memorandum M-19-26, “Update to the Trusted Internet Connections (TIC) Initiative“ (https://www.whitehouse.gov/wp-content/uploads/2019/09/M-19-26.pdf), VA https://www.voa.va.gov/DocumentView.aspx?DocumentID=4896 https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1 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 https://www.whitehouse.gov/wp-content/uploads/2019/09/M-19-26.pdf

Directive 6513 “Secure External Connections”, and shall comply with the TIC 3.0 Core Guidance Documents, including all Volumes and TIC Use Cases, found at the Cybersecurity & Infrastructure Security Agency (CISA) (https://www.cisa.gov/publication/tic-30-core-guidance-documents). Any deviations must be approved by the VA TIC 3.0 Working Group at vaoisesatic30team@va.gov.

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), Edge (Chromium based), and 365 Apps for enterprise. 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 Microsoft Endpoint Configuration Manager (CM) 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) AND PRODUCT LINE

MANAGEMENT (PLM)

The Contractor shall support VA efforts IAW the updated Veteran Focused Integration Process (VIP) and Product Line Management (PLM). The major focus of the new VIP is on Governance and Reporting and is less prescriptive, with a focus on outcomes and continuous delivery of value. Product Line Management (PLM) is a framework that focuses on delivering functional products that provide the highest priority work to customers while delivering simplified, reliable, and practical solutions to the business, medical staff, and our Veterans. The VIP Guide is a companion guide to the PLM Playbook and can be found at:

https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371 and the PLM Playbook can be found at https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946. The PLM Playbook pivots from project-centric to product-centric delivery and contains descriptive practices that focuses on outcomes. The PLM Playbook contains a set of “plays” that implement Development, Security, and Operations (DevSecOps) principles and processes such as automated development, continuous integration/continuous delivery, and release on demand. The PLM Playbook details how product lines implement Lean-Agile principles, methods, practices, and techniques through levels of https://www.cisa.gov/publication/tic-30-core-guidance-documents mailto:vaoisesatic30team@va.gov https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371 https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946 maturity. VIP and PLM are the authoritative processes 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 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 Person Index (MPI) (formerly the Master Veteran Index (MVI)) to provision identity attributes, if the solution relies on VA user identities. MPI 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 https://www.va.gov/PROCESS/artifacts/maps/process_CONB_ext.pdf http://www.va.gov/process 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.

6.1.9 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 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 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.

6.2 SECURITY AND PRIVACY REQUIREMENTS

6.2.1 POSITION/TASK RISK DESIGNATION LEVEL(S)

In accordance with VA Handbook 0710, Personnel Security and Suitability Program, the position sensitivity and the level of background investigation commensurate with the required level of access for the following tasks within the PWS are:

Position Sensitivity and Background Investigation Requirements by Task

Task Number Tier1 / Low Risk Tier 2 / Moderate Risk

Tier 4 / High Risk

5.1 5.2 5.3

The Tasks identified above and the resulting Position Sensitivity and Background Investigation requirements identify, in effect, the Background Investigation requirements for Contractor individuals, based upon the tasks the particular Contractor individual will be working. The submitted Contractor Staff Roster must indicate the required Background Investigation Level for each Contractor individual based upon the tasks the Contractor individual will be working, in accordance with their submitted proposal.

6.2.2 CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

Contractor Responsibilities:

a. The Contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain the appropriate Background Investigation, and are able to read, write, speak, and understand the English language.

b. Within 3 business days after award, the Contractor shall provide a roster of Contractor and Subcontractor employees to the COR to begin their background investigations in accordance with the PAL template artifact. The Contractor Staff Roster shall contain the Contractor’s Full Name, Date of Birth, Place of Birth, individual background investigation level requirement (based upon Section 6.2 Tasks), etc. The Contractor shall submit full Social Security Numbers either within the Contractor Staff Roster or under separate cover to the COR. The Contractor Staff Roster shall be updated and provided to VA within 1 day of any changes in employee status, training certification completion status, Background Investigation level status, additions/removal of employees, etc. throughout the Period of Performance. The Contractor Staff Roster shall remain a historical document indicating all past information and the Contractor shall indicate in the Comment field, employees no longer supporting this contract. The preferred method to send the Contractor Staff Roster or Social Security Number is by encrypted e-mail. If unable to send encrypted e-mail, other methods which comply with FIPS 140-2 are to encrypt the file, use a secure fax, or use a traceable mail service.

c. The Contractor should coordinate with the location of the nearest VA fingerprinting office through the COR. Only electronic fingerprints are authorized. The Contractor shall bring their completed Security and Investigations Center (SIC) Fingerprint request form with them (see paragraph d.4. below) when getting fingerprints taken.

d. The Contractor shall ensure the following required forms are submitted to the COR within 5 days after contract award:

1) Optional Form 306

2) Self-Certification of Continuous Service

3) VA Form 0710

4) Completed SIC Fingerprint Request Form

e. The Contractor personnel shall submit all required information related to their background investigations (completion of the investigation documents (SF85, SF85P, or SF 86) utilizing the Office of Personnel Management’s (OPM) Electronic Questionnaire for Investigations Processing (e-QIP) after receiving an email notification from the Security and Investigation Center (SIC).

f. The Contractor employee shall certify and release the e-QIP document, print, and sign the signature pages, and send them encrypted to the COR for electronic submission to the SIC. These documents shall be submitted to the COR within 3 business days of receipt of the e-QIP notification email. (Note:

OPM is moving towards a “click to sign” process. If click to sign is used, the Contractor employee should notify the COR within 3 business days that documents were signed via e-QIP).

g. The Contractor shall be responsible for the actions of all personnel provided to work for VA under this contract. In the event that damages arise from work performed by Contractor provided personnel, under the auspices of this contract, the Contractor shall be responsible for all resources necessary to remedy the incident.

h. A Contractor may be granted unescorted access to VA facilities and/or access to VA Information Technology resources (network and/or protected data) with a favorably adjudicated Special Agreement Check (SAC), completed training delineated in VA Handbook 6500.6 (Appendix C, Section 9), signed “Contractor Rules of Behavior”, and with a valid, operational PIV credential for PIV-only logical access to VA’s network. A PIV card credential can be issued once your SAC has been favorably adjudicated and your background investigation has been scheduled by OPM. However, the Contractor will be responsible for the actions of the Contractor personnel they provide to perform work for VA. The investigative history for Contractor personnel working under this contract must be maintained in the database of

OPM.

i. The Contractor, when notified of an unfavorably adjudicated background investigation on a Contractor employee as determined by the Government, shall withdraw the employee from consideration in working under the contract.

j. Failure to comply with the Contractor personnel security investigative requirements may result in loss of physical and/or logical access to VA facilities and systems by Contractor and Subcontractor employees and/or termination of the contract for default.

k. Identity Credential Holders must follow all HSPD-12 policies and procedures as well as use and protect their assigned identity credentials in accordance with VA policies and procedures, displaying their badges at all times, and returning the identity credentials upon termination of their relationship with

VA.

Deliverable:

A. Contractor Staff Roster

6.3 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:

Microsoft 365, MS Word 2000/2003/2007/2010/2019, MS Excel 2000/2003/2007/2010/2019, MS PowerPoint 2000/2003/2007/2010/2019, MS Project

2000/2003/2007/2010/2019, MS Access 2000/2003/2007/2010, MS Visio 2000/2002/2003/2007/2010/2019, AutoCAD 2002/2004/2007/2010, and Adobe Postscript Data Format (PDF).

6.4 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.

6.5 FACILITY/RESOURCE PROVISIONS

The Government will provide office space, telephone service and system access when authorized contract staff work at a Government location as required in order to accomplish the Tasks associated with this PWS.