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5. PROJECT NUMBER (if applicable)
CODE
7. ADMINISTERED BY
2. AMENDMENT/MODIFICATION NUMBER
CODE
6. ISSUED BY
8. NAME AND ADDRESS OF CONTRACTOR
4. REQUISITION/PURCHASE REQ. NUMBER
3. EFFECTIVE DATE
9A. AMENDMENT OF SOLICITATION NUMBER
9B. DATED
PAGE OF PAGES
10A. MODIFICATION OF CONTRACT/ORDER NUMBER
10B. DATED
BPA NO.
1. CONTRACT ID CODE
FACILITY CODE
CODE
Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:
The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers
E. IMPORTANT:
is extended,
(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.
12. ACCOUNTING AND APPROPRIATION DATA
(REV. 11/2016)
is required to sign this document and return ___________ copies to the issuing office.
is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO:
Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.
15C. DATE SIGNED
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
D. OTHER
Contractor
16C. DATE SIGNED
14. DESCRIPTION OF AMENDMENT/MODIFICATION
16B. UNITED STATES OF AMERICA
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.
15A. NAME AND TITLE OF SIGNER
16A. NAME AND TITLE OF CONTRACTING OFFICER
15B. CONTRACTOR/OFFEROR
STANDARD FORM 30
PREVIOUS EDITION NOT USABLE
Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)
(If required)
(SEE ITEM 11)
(SEE ITEM 13)
(X)
CHECK
ONE
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
(Signature of person authorized to sign) (Signature of Contracting Officer) Department of Veterans Affairs Technology Acquisition Center 23 Christopher Way Eatontown NJ 07724 Department of Veterans Affairs Technology Acquisition Center 23 Christopher Way Eatontown NJ 07724 To all Offerors/Bidders
36C10B21R0031 07-28-2021
X X
X Title: A Survey of Veterans Experiences with and Preferences for Modalities of PTSD
Kindly find enclosed Responses to Questions and Answers associated with this effort. As a result of the responses, Section B.4, Performance Work Statement has been revised accordingly. All changes have been captured in red font.
All responses are due no later than August 10, 2021 at 12 PM EST in accordance with E.6 Quote Submission Instructions.
Matthew Newell Contracting Officer Responses to Questions and Answers A Survey of Veterans Experiences with and Preferences for Modalities of PTSD 36C10B21R0031
| Item |
| Reference |
| Question |
| Answer |
| 1 |
| Section 3.0 Scope of Work |
| Will the survey and study protocol already have been developed by the VA prior to the project kick-off? We would appreciate clarification on whether the contractor will be responsible for survey development, We respectfully recommend providing clarification about how much of the survey and protocol development will already be completed by the VA prior to project kick-off. |
| Both will be done by VA. |
| 2 |
| Section 3.0 Scope of Work |
| The RFP implies that the VA wants the selected contractor to utilize the VA's RedCap account (p. 21-22 of RFP), yet it also mentions the contractor developing a recruitment and engagement platform with a landing page for recruitment and pre-screening (p. 22). Could you please clarify whether this platform is expected to be within RedCap, or a separate platform that ultimately leads to the RedCap for respondents who meet the screening criteria? |
| VA expects the contractor to utilize a separate platform that leads to Redcap. |
| Page 24 of the RFP states that the contractor will provide technical information for the Institutional Review Board (IRB) application. Will the contractor be responsible for developing the full IRB application, or supplement existing IRB materials previously developed by the VA? |
| VA will complete the majority of the IRB but will need to consult with the contractor on a few components. |
| 4 |
| Section 5.0 Mandatory Tasks and Deliverables |
| The RFP does not mention analysis of the survey data as part of the scope of work. Please confirm that data analysis is not part of the project deliverables. |
| Data analysis is not part of the scope or a deliverable. |
| 5 |
| Section E.6 Quote Submission Instructions |
| Are there specific requirements/limitations for proposal page length? |
| Review Section E.6 Quote Submission Instructions for specific requirements/limitations including 5-page limitation. |
| 6 |
| Section 3.0 Scope of Work |
| The contractor is to recruit 400 Veterans and "Veteran status in neither an inclusion nor an exclusion criterion for this study." What do you mean by Veteran status and is the study restricted to Veterans? |
| This may have been an error. Self-reported Veteran status shall be an inclusion criterion. This is revised in the attached PWS. |
| 7 |
| Section 3.0 Scope of Work |
| Participants will be sent an electronic gift card as compensation. Q: What is the value and nature of the gift card, that may determine how hard it is to recruit participants. Q: Is the contractor authorized to propose/include additional participant compensation in our proposal? Q: Will the electronic gift cards be sent by text or email? |
| Participants shall be emailed an electronic gift card valued at $20.00. |
Contractor is not authorized to include additional participant compensation.
Electronic gift cards shall be distributed via email.
| 8 |
| Section 3.0 Scope of Work |
| Portal will allow study participants to sign up online or download an application form. Q: Is the application on RedCap or on the contractor portal? Q: If participants download a form, does it need to be uploaded to the contractor's portal and routed to the VA? |
| Sign up shall be completed online. I don’t think we will need a download option but if we did it would all be through contractor portal. |
| 9 |
| Section 3.0 Scope of Work |
| Will the contractor portal collect or store any clinical data? If yes, please describe |
| The contractor portal shall not collect or store any clinical data. |
| 10 |
| Page 22 |
| Clinical data will be...connected to a non-identifiable participant username. If contact information is included to support the text messaging requirement, is the actual email and phone number to be invisible to the VA? i.e. will all communication be bridged through the portal? |
| Ideally, yes, all communication will be bridged through the portal. |
| 11 |
| Section 3.0 Scope of Work |
| The place of performance is marked as remote, yet the RFP states "The contractor will be local to NCPTSD to permit in person meetings." Q: What is considered local? Will the Government remove this requirement and allow the use of virtual meetings such as MS TEAMS or Zoom? If in-person meetings are required it is acceptable for us to travel at our own expense (within the FFP amount)? |
| All work shall be performed remotely as outlined in Section 4.2 Place of Performance. |
| 12 |
| General |
| Will the Government provide an extension of the due date to 13 Aug 21? |
| Extension will be granted for 48 hours at this time. RFP responses due no later than Tuesday August 10, 2021 at 12PM EST. |
| 13 |
| Section 4.2 Place of Performance |
| The RFP mentions the job is "remote" however it also states the contractor should be local to the National Center for Posttraumatic Stress Disorder. Is the center located in Menlo Park, California or New Jersey? Does the vendor's company have to be based in either of those areas or can we work with a contractor/sub local to the center who can be available for project meetings etc? |
| Offeror can be anywhere if performance can be done remotely. The center is located in California. RFP is revised to remove this language. |
| 14 |
| Section 3.0 Scope of Work |
| You would like a company with experience recruiting clinical samples with PTSD which is strongly preferred. Would you strongly consider a company with experience recruiting clinical samples of people with other conditions/illnesses/ or specific targeted audiences as well? |
| If there is no PTSD recruitment experience, offerors can share experience recruiting other clinical populations. |
| 15 |
| Section 3.0 Scope of Work |
| Have other vendors done a similar recruitment campaign such as this for the VA in recent years? If so, can you provide the vendor's company name? |
| Vendor’s name will not be disclosed. |
| 16 |
| Section 3.0 Scope of Work |
| Is the contractor developing the PTSD study or receiving the study from the VA and turning it into an interactive experience? |
| The VA is developing the study design and procedures. Contractor is recruiting participants and implementing the study. |
| 17 |
| Section 3.0 Scope of Work |
| How many unique VA users need access to the recruitment portal? |
| 2-4 VA users shall access recruitment portal. |
B4. PERFORMANCE WORK STATEMENT
PERFORMANCE WORK STATEMENT (PWS)
DEPARTMENT OF VETERANS AFFAIRS
Office of Information & Technology National Center for Posttraumatic Stress Disorder (NC-PTSD), Dissemination and Implementation Science Division at the VAPAHCS Menlo Park Division
A Survey of Veterans Experiences with and Preferences for Modalities of PTSD Treatment
Date: August 5, 2021
VA-21-00066853
PWS Version Number: 1.5
1.0 BACKGROUND
The rapid growth and diffusion of digital mental health interventions is changing the landscape of PTSD care. Beyond traditional face-to-face psychotherapy, veterans may now choose evidence-based services through telemental health (both video and phone), web-based programs, or mobile apps (either as part of therapist-delivered treatment or as a self-management tool). Given the many barriers to accessing effective in-person PTSD treatment, providing patients with a choice of modality for receiving effective services is a promising advancement, both in terms of increasing overall access to care and increasing engagement by involving patients in determining how they want to receive care. However, successful dissemination and implementation of health interventions requires a clear understanding of the demand for each type of service and the segmentation of this demand across customers (veterans). There has been some research on the use (e.g., Connolly et al., 2020) and acceptability (Goetter, Blackburn, Bui, Laifer, & Simon, 2019) of video telemental health. In addition, usage data can offer insights into the demand for specific mobile mental health apps among the general population. However, almost nothing is known about the demand for the different types of digital mental health interventions among veterans specifically, or how geographic, demographic, or psychological factors may moderate this demand.
To address this gap, we propose to examine attitudes toward different modalities of PTSD interventions and the facilitators and barriers to their use among a diverse sample of veterans with PTSD symptoms. Identifying the sub-groups of veterans who are most receptive to certain intervention types would facilitate tailoring of outreach and marketing efforts so that they meet veterans’ needs and preferences and thereby have the best chance of successful uptake.
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
National Center for Posttraumatic Stress Disorder (NCPTSD) will develop all procedures for the study design, including participant inclusion and exclusion criteria, the assessment, and the procedures. NCPTSD will oversee participant consent and enrollment, data collection, and participant compensation for completing assessments. NCPTSD will analyze study data and report study findings.
The goal of the study is to understand attitudes toward different modalities of PTSD interventions and the facilitators and barriers to their use among 400 veterans with clinically significant PTSD symptoms (as determined by a PCL-5 score ≥ 31) who are fluent in English. Participants will be recruited online and invited to complete a one-time survey. Data will be collected through Redcap (behind VA firewall).
Participants will be recruited using online advertisements. After screening and consent, they will complete a survey administered online via RedCap. Participants will be sent an electronic gift card as compensation. The clinical data collected as part of the proposed research studies (to be reviewed by the Institutional Review Board) will be connected to a non-identifiable participant username only and as they are not accessing VA system or our data. Selected NCPTSD staff will have access to a research dashboard where limited and agreed upon data will be available. All staff who access these data will have completed CITI training.
Participant Requirements:
The participants shall consist of four hundred veterans who, have significant PTSD symptoms (as determined by a PCL-5 score ≥ 31), who are fluent in English, and who own a mobile device. Participants must reside in the continental US and not be engaged in treatment for PTSD during the study period. Veteran status shall be an inclusion criterion for this study.
The contractor will be responsible for recruiting and enrolling the 400 participants that meet the study inclusion/exclusion criteria noted above. Targeted outreach ad campaigns should be used to reach the target population using social media and/or search engine advertising platforms. Contractor must have experience using social media sites, such as Facebook, to target advertising. Experience recruiting clinical samples with PTSD strongly preferred. The contractor will provide advanced analytics on the recruitment campaign performance with views, clicks, surveys, signups. The contractor will provide advanced analytics on the recruitment campaign performance with views, clicks, surveys, signups.
The contractor will develop a user-friendly, interactive study-specific participant recruitment and engagement platform (i.e., a study landing page) that is linked to the advertisements where potential participants can read more about the study, share with others, save the link for future reference, or take the next step towards study participation by signing up online or being redirected to download the study application. This landing page will be integrated with the study pre-screening questions that will determine participant eligibility with branching logic, counting, etc. seamlessly integrated. The contractor will provide a portal for NCPTSD study staff to manage potential participants (e.g., notes, status updates) and connect with potential participants via text messaging. The contractor shall support virtual meetings in accordance with Section 4.0. The contractor will be local to NCPTSD to permit in person meetings.
4.0 PERFORMANCE DETAILS
4.1 PERFORMANCE PERIOD
The PoP shall be on or about September 1, 2021 to August 31, 2022. The PoP shall consist of a 12-month base period including three 12-month option periods. The overall Period of Performance shall not exceed 48 months.
Any work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO). If required, the CO may designate the Contractor to work during holidays and weekends.
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 Day | January 1 |
| 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 in the Location of Performance: All work shall be performed |X| Remotely |_| On-site
| Hours of Coverage: | Monday through Friday, 8am – 4:30pm, all time zones within the continental United States. |
| 4.3 | TRAVEL |
The Government anticipates NO travel under this effort to perform the tasks associated with the effort, as well as to attend program-related meetings or conferences throughout the PoP. Include all estimated travel costs in your firm-fixed price line items. These costs will not be directly reimbursed by the Government.
5.0 MANDATORY TASKS AND DELIVERABLES
The Contractor shall perform the following:
5.1 PROJECT MANAGEMENT
The contractor shall develop a targeted study recruitment campaign.
5.1.1 CONTRACTOR PROJECT MANAGEMENT PLAN
The contractor shall provide technical information for Institutional Review Board (IRB) application within one month after contract award.
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 ongoing updates. Brief status updates, every two weeks (bi-weekly), conducted by phone will indicate the status of the recruitment campaign and the study-specific participant recruitment and engagement platform.
The Contractor shall provide the COR with Progress Reports every two weeks 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 two weeks.
The Bi-Weekly 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.
Deliverable:
A. Bi-weekly Progress Report.
5.1.3 MONTHLY MEETINGS AND PROGRESS REPORT
The contractor shall provide monthly meetings will be held by phone and will focus on reviewing the projected schedule and the contractor’s recommendations for recovering from any schedule slippage, as well as discussing/reviewing project content in depth. See Reporting Requirements below.
The Contractor shall provide to the contracting officer representative (COR) and the Project Manager with monthly Progress Reports in electronic form in Microsoft Word and maintain a schedule in MS Project format. In addition, verbal reports on progress will be provided at weekly project meetings.
The Monthly Progress Reports shall describe 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 Contractor shall monitor performance against the PMP and report any deviations.
The Contractor shall communicate with VA accordingly so that issues that arise are transparent to both parties to prevent escalation of outstanding issues.
Deliverable:
A. Monthly Progress Report.
5.2 OUTREACH TASKS
5.2.1 SUBMIT MOCKUPS
The contractor shall submit mockups of study advertisements and the recruitment and engagement platform for approval by NCPTSD, with up to 3 iterations at NCPTSD discretion. Mockups will be based on review of available study materials from NCPTSD (protocol, informed consent, etc.) to distill most relevant information and developed using 8th grade language.
Deliverable:
A. Mockups
5.2.2 SUBMIT FINAL STUDY ADVERTISEMENTS
Based on feedback from the mockups and iterations, the contractor shall develop the final advertising materials. The contractor shall submit the final study advertisements and participant screening procedure approval by NCPTSD.
Deliverable:
A. Final Study Advertisements
5.2.3 RECRUIT AND ENROLLMENT
The contractor shall recruit and enroll a minimum of 400 Veteran study participants meeting following inclusion and exclusion criteria and screening procedures provided by NCPTSD. Contractor shall maintain this enrollment and ensure Veteran enrollees are active Deliverable:
Enrollment of 400 Veterans
5.2.4 PROVIDE STUDY PAGE PORTAL
The contractor shall provide, host, and maintain study page portal access to NCPTSD study staff to monitor participants through all stages of study participation, including data collection and participant compensation. Collected patient health information (PHI) will stored within a HIPAA and HITRUST compliant server that can only be accessed by select staff members with limited and controlled access. HIPPA and HITRUST compliance for the portal and system are required at the time of contract onset.
The clinical data collected as part of the proposed research studies (to be reviewed by the IRB) will be connected to a non-identifiable participant username only and as they are not accessing VA system or our data. All communication provided to VA shall be bridged through the portal to remove emails and phone numbers.
Deliverable:
Study page portal
6.0 GENERAL REQUIREMENTS
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 | 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 |
| |X| |
| |_| |
| |_| |
| 5.2 |
| |X| |
| |_| |
| |_| |
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:
1. 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.
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.
1. 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.
b. 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 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).
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).
1. 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.
1. 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.
1. 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.
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.
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.…
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