36C24E21R0022.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. DUNS: DUNS+4:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C24E21R0022 07-21-2021

Michael Haydo 4128223158 08-25-2021 10:00 am EDT

00240E US Department of Veterans Affairs Veterans Health Administration Regional Procurement Office (RPO) East 323 North Shore Drive, Suite 500 Pittsburgh PA 15212-5319

X

541611

$16.5 Million

N/A

US Department of Veterans Affairs

VA ORD ORPP&E

810 Vermont Ave, NW Washington DC 20420

00240E

US Department of Veterans Affairs Veterans Health Administration Regional Procurement Office (RPO) East 323 North Shore Drive, Suite 500 Pittsburgh PA 15212-5319

00240E

Financial Services Center (FSC)

P.O. Box 149971 Austin TX 78714-8971

See CONTINUATION Page

See schedule

See CONTINUATION Page

X X

X 1

Michael D. Haydo

PCOE14L3-67579

36C24E21R0022

Table of Contents

SECTION A .................................................................................... Error! Bookmark not defined.

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS.. Error!

Bookmark not defined.

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT

2018)

C.2 52.216-18 ORDERING (AUG 2020)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.6 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ...40

C.7 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.8 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.9 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.10 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.11 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.12 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.13 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) (JUL 2020)

(DEVIATION)

C.14 MANDATORY WRITTEN DISCLOSURES

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUN 2020) 55

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.7 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (FEB 2021) (JUL 2020) (DEVIATION)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C24E Michael Haydo

Veterans Health Administration

Regional Procurement Office (RPO) East

323 North Shore Drive, Suite 500

Pittsburgh PA 15212-5319

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Upon receipt and acceptance by the VA.

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Financial Services Center (FSC)

P.O. Box 149971

Austin TX 78714-8971

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

AMENDMENT NO DATE

Statement of Work Administrative and Technical Support Services Contract

1.0 BACKGROUND

The Department of Veterans Affairs’ (VA) conducts an array of research on some of the most difficult challenges facing medical science today. VA Office of Research and Development (ORD) oversees thousands of research projects in such research areas as aging, women’s health, post-traumatic stress disorder, cancer, genomics, ischemic heart disease, diabetes, mental health, spinal cord injury, traumatic brain injury, regenerative medicine, engineering prosthetics/orthotics, substance abuse disorders, obesity and hypertension. More than 7,500 research projects are currently conducted at 108 VA medical centers in the areas of biomedical, clinical, rehabilitation and health services research.

ORD is the research arm of the Veterans Health Administration (VHA). The major emphasis of ORD is to advance VA medical research and development programs that address Veterans’ needs, with an emphasis on service-connected injuries and illnesses, and that contribute to the Nation’s knowledge of disease and disability. A secondary benefit of these research endeavors is the transfer to the healthcare delivery system of new and beneficial technologies resulting from research conducted throughout the VA medical centers. ORD consists of four research services that together form a cohesive whole to explore all phases of Veterans' health care needs: Biomedical Laboratory Research & Development (BLRD); Clinical Science Research & Development (CSRD);

Health Services Research & Development (HSRD) and Rehabilitation Research & Development (RRD). Additional Research Programs within ORD include the Quality Enhancement Research Initiative (QUERI), the Office of Research Protection, Policy and Education (ORPP&E), the Million Veteran Program (MVP), Technology Transfer Program (TTP) and the Cooperative Studies Program (CSP).

The mission of the Office of Research Protections, Policy, and Education (ORPP&E) is to protect participants in VA human research. ORPP&E is responsible for: all policy development and guidance for human research protection in the VA; all training and education in human research protection throughout the VA; and oversight of the administrative operation of the VA Central Institutional Review Board (VA CIRB), which reviews and has oversight of designated VA multi-site and single site projects.

ORPP&E's vision is to make VA human research as safe as possible.

Additional information about ORPP&E can be found at https://www.research.va.gov/programs/orppe/default.cfm.

The proposed contract seeks to acquire technical and administrative support for the following functions:

ORPP&E’s regulatory policy team is responsible for developing policy and guidance for the 108 VA facilities engaged in human subjects research. As part of this effort, ORPP&E maintains a total of five mailboxes and one database to manage the receipt of questions from VA facilities. In 2020, an estimated 800 questions were received in the various mailboxes ORPP&E manages. ORPP&E also manages five listservs to facilitate the sharing of information and best practices amongst VA facilities engaged in human subjects research.

ORPP&E’s regulatory policy team is also responsible for managing VA’s national implementation of the Cooperative Research Provision/Single IRB Requirement found in 38 CFR 16.114. Programmatic responsibilities include managing the process by which study teams request exceptions to the single IRB requirement and facilitating the process by which study team’s obtain ORD approval to rely on ORD approved commercial IRBs for industry-sponsored multisite non-exempt research. A total of 200 single IRB exception requests and 153 applications to rely on a commercial IRB were processed in 2020.

ORPP&E’s education and training team is responsible for conducting training and education for the 108 VA facilities and their university affiliates that are engaged in human subject research. A total of 35 education and training sessions were offered in FY20 to over 12,343 attendees. The team is responsible for hosting both in-person and remote educational training sessions on issues pertaining to the conduct and oversight of research involving human subjects. The team is also responsible for the dissemination of guidance and tools to VA facilities involved in the conduct and oversight of VA research involving human subjects.

The VA Innovation and Research Review System (VAIRRS) is the VA's enterprise instance of IRBNet. VAIRRS is the research committee software management platform for all VA medical centers with research programs and is uniquely positioned to withstand the changing pressures of research needs, including:

• oversight needs of the research programs and institutions

• collaborative needs of dually appointed VHA investigators

• regulatory changes of the new Common Rule (2019).

As of November 2020, a total of 48 VA facilities have transitioned to the VAIRRS platform, with the remaining facilities scheduled to transition onto the platform by the end of FY21. The VAIRRS platform houses a library of over 60 forms and templates that are used by VA facilities in the conduct and oversight of research involving human subjects.

The VA Central IRB has been in existence for over 12 years and is responsible for providing IRB oversight of human subject research for VA facilities nationwide. The VA about:blank

CIRB currently has Memorandums of Understanding (MOUs) with 108 VA facilities for which it serves as an IRB of record. The VA CIRB is currently comprised of two IRB panels, with a third panel scheduled to begin operation in 2021. As of December 31, 2018, the two panels had oversight of 228 studies involving 1,490 local sites. In 2019, the VA Central IRB received 35 new studies and approximately 44 new protocol applications, which includes 199 associated LSI applications. With the implementation of the single IRB requirement in 2020, this number is expected to only increase. The two existing panels review, approve, and provide continuing oversight of human subject research for which more than one VA facility is engaged in human subjects research.

The third panel will be responsible for reviewing single site human subjects research conducted at smaller VA facilities that do not have a primary IRB of record.

2.0 PURPOSE AND SCOPE

The purpose of this contract is to obtain administrative and technical assistance in support of the Office of Research Protections, Policy, and Education. To support the tasks identified below requires an experienced and cohesive team of technical and administrative professionals who can demonstrate a comprehensive understanding of the regulatory and policy requirements governing the conduct and oversight of human subjects research and the infrastructure needed to support these activities for approximately 108 VA facilities nationwide.

Support to ORPP&E’s regulatory policy team shall include (1) providing administrative support to maintain the five mailboxes and FAQ database, to include updating the database with questions and responses received and (2) providing administrative support to track and process single IRB exception requests and applications to rely on commercial IRB’s for multisite non-exempt research.

Support to ORPP&E’s education and training team includes providing administrative assistance with educational trainings to include assisting with pre-and post-event activities and assisting with the administration of webinars using platforms available to ORPP&E (e.g. gotowebinar, CISCO Webex, Microsoft Teams).

Support to the VAIRRS team includes providing administrative support with the planning and hosting of meetings pertaining to the VAIRRS program and providing administrative support with managing the document review process for the creation and revision of templates and forms related to the VAIRRS program.

Support to the VA CIRB shall include providing both technical and administrative assistance in managing the receipt and processing of human subject research applications, to include new submissions as well as post-approval monitoring (i.e.

amendments/modifications, continuing reviews, and reportable events). Additional duties of the Contractor shall include (1) providing meeting support to include scheduling panel meetings, ensuring distribution of meeting materials electronically to IRB panel members and staff, and preparing meeting agendas and minutes for VA CIRB panel meetings; (2) assisting in the preparation and review of Standard Operating Procedures and related forms for the VA CIRB; and (3) conducting annual file audits of a select number of VA CIRB study folders.

3.0 PLACE OF PERFORMANCE

The contract services and activities will take place primarily at the VA ORD in Washington D.C. or at approved Contractor facilities mutually agreed to by the Contractor and the VA, to include the option of telework.

4.0 PERIOD OF PERFORMANCE

The period of performance shall be one base period of twelve months and three option periods of twelve months each. Only the VA under authority of the VA Contracting Officer has the authority to exercise an option under this Agreement.

5.0 GENERAL REQUIREMENTS

1. The Contractor shall contact the Contracting Officer and Contracting Officer

Representative (COR) to set up a contract award kick-off meeting within the first 15 calendar days of the contract award date.

2. The Contractor will provide a plan, the “Project Management Plan (PMP)”, as to how tasks will be successfully completed.

a. The PMP shall include a narrative and graphic format displaying schedule, specifically defined milestones, risks, communications, and resource support.

The PMP shall explain how the Contractor will coordinate and execute planned, routine, and ad hoc requirements as identified in the PWS. A list of staff assignments supporting each task shall be included once they are determined.

b. The PMP will be submitted within 30 calendar days of contract award.

c. Upon acceptance, the initial PMP will be considered baseline and shall be updated as needed.

3. The Contractor will contact the COR to set up semi-annual evaluation meetings to discuss the status of the contract, deliverables, contract performance and results of the Quality Assurance Surveillance Plan (QASP) evaluation. Prior to meeting, the VA COR will coordinate schedules for VA staff to receive input for the evaluation of the performance of the Contractor.

4. The Contractor will prepare agendas and minutes for the semi-annual contract meetings. At the request of the VA COR, the Contractor shall take minutes of conference calls and/or meetings held with the Contractor management, VA COR, and Stakeholders. Copies of these minutes shall be provided to the COR.

5. Hours of Operation: the hours of operation will be specified in the approved Project

Management Plan.

6. Travel: Travel is not anticipated under this contract.

6.0 SPECIFIC TASKS AND DELIVERABLES

Contractor personnel shall provide all administrative and technical support for the tasks outlined below:

Task 1: Administrative Helpdesk Support

The Contractor shall provide administrative helpdesk support to ORPP&E.

Deliverable 1.1 The Contractor shall have experience working with Microsoft Access Databases. The Contractor shall transfer questions and responses received from the five mailboxes managed by ORPP&E as well as questions and responses from newly published FAQs and guidance documents into the FAQ database monthly.

Deliverable 1.2 The Contractor shall be responsible for maintaining ORPP&E mailboxes, to include organizing and collating questions and responses and purging redundant questions monthly.

Deliverable 1.3 The Contractor shall add VA email addresses of individuals to the various listservs that ORPP&E manages (e.g. IRB Chairs, IRB Administrators, Training and Education, R&D Committee, and Small Research Programs) on an ongoing basis.

Task 2: Meeting and Training Support: Education and Training

The Contractor shall provide administrative support to ORPP&E’s education and training program.

Deliverable 2.1 The Contractor shall be responsible for scheduling and conducting tech walks with first time webinar presenters, to include all individuals granted open mics, prior to ORPP&E scheduled webinars. The Contractor shall send emails requesting availability for a tech walk a minimum of one week before the webinar to ensure tech walks occur for all presenters before the day of the scheduled webinar.

Deliverable 2.2 The Contractor shall assist with administering/hosting webinars using the platform available to ORPP&E. Activities will include adding requisite information to the webinar platform, to include the title and duration of the webinar; speakers names, titles and email addresses; handouts, polls and surveys; opening the webinar platform at the designated time; managing questions received during the webinar to include displaying questions on the screen for viewers at the appropriate time; displaying presenter slides when necessary; and helping to resolve any issues that may come up during the course of the webinar.

Deliverable 2.3 The Contractor shall assist with post webinar activities, to include preparing survey and data analytics generated from the webinar platform, to include attendee registration information, attendance records, questions submitted, response to post-webinar evaluation surveys and sending webinar recordings, associated handouts, presenter information, key words used to tag each webinar for search functionality, and transcripts to ORPP&E’s webmaster for posting to the webpage.

Task 3: Meeting and Training Support: VAIRRS Program

The Contractor shall provide administrative support to the VAIRRS Program.

Deliverable 3.1 The Contractor shall be responsible for scheduling project management and workgroup session meetings for the VAIRRS program. The Contractor shall maintain workgroup rosters and coordinate availability of workgroup members and meeting participants for workgroup and project management meetings, respectively.

The Contractor shall coordinate availability of meeting participants and set up in-person and remote meetings using approved meeting platform. The Contractor shall solicit agenda topics from meeting participants; prepare and disseminate meeting agendas;

attend meetings, track open tasks and action items; and prepare meeting minutes.

Deliverable 3.2 The Contractor shall be responsible for scheduling monthly webinars, obtaining webinar materials from presenters and attending webinars and managing presentations as necessary.

Deliverable 3.3 The Contractor shall be responsible for assisting with VAIRRS program communication efforts to include the following: Drafting monthly program updates for posting on the VAIRRS external webpage or the internal SharePoint site; monitoring and responding to questions received in the VAIRRS program mailbox; and elevating questions to the VAIRRS Program Manager as appropriate.

Deliverable 3.4 The Contractor shall be responsible for drafting revisions to the VAIRRS library of forms and templates based on input received during document review sessions, tracking changes made to forms and templates, and maintaining a list of the most current versions of all forms.

Task 4: VA Central IRB Support – Protocol Review and Processing

The Contractor shall support the VA CIRB by processing new study submissions and managing post-approval monitoring (amendments, continuing review, and reportable events) for all assigned human subjects research studies. The Contractor shall ensure that all documents produced by and in support of the VA CIRB are written clearly, concisely, and incorporate all required regulatory and VA policy requirements.

Deliverable 4.1 The Contractor shall use the approved IRB platform for managing research studies (e.g. IRBNet and VA CIRB database). All protocol actions must be processed in accordance with VA CIRB SOPs.

Deliverable 4.2 The Contractor manages both PI applications and Local Site Applications from all local participating sites for the assigned study (which can involve anywhere from 1 site to over 50 sites per study nationwide), notifying all sites of the requirement for local review, collecting all comments and summarizing them for review by the IRB, and highlighting any problems or concerns that may require additional required changes or modifications to the study for review by the IRB.

Deliverable 4.3 The Contractor shall perform administrative and technical reviews of assigned study applications to identify missing or incomplete documentation and to highlight areas that may be deficient or require clarification. The contractor will complete required review forms and communicate findings to the study team and/or assigned IRB members as necessary.

Deliverable 4.4 The Contractor shall coordinate review of the study submission among the study team and assigned IRB members to include information security, regulatory, privacy, and VA Central IRB voting primary, secondary, and informed consent reviewers, ensuring that all reviews are completed in a timely manner, summarizing comments, and contacting the study team to request additional information and/or changes to the project or forms.

Deliverable 4.5 The Contractor shall maintain a complete file of all submitted study documents, results of all reviews by assigned reviewers, and all correspondence in accordance with VA CIRB SOPS and other regulatory requirements. The Contractor shall ensure strict document and version control to preserve the integrity of approved documents.

Deliverable 4.6 The Contractor shall prepare interim and final letters to the study team for actions eligible for expedited review, notifying all relevant parties, including but not limited to the national study team, all local participating sites, local participating research offices, and coordinating centers, of the results of each review and the regulatory basis for requested changes, until the study team has satisfied all identified reviewer and regulatory concerns and a final approval letter from the IRB is issued. The Contractor is responsible for ensuring that all expedited actions are appropriately reported to the next convened meeting of the IRB.

Deliverable 4.7 The Contractor shall ensure all databases and tracking logs are kept up to date, so the exact status of a given project is known at all times.

Deliverable 4.8 The Contractor shall manage communication with, and provides advice and guidance to Principal Investigators, Study Chairs, and Study Teams, throughout all stages of the study, from application submission to conclusion of the study.

Deliverable 4.9 The contractor shall manage all post-approval monitoring activities as assigned by VA Central IRB Management staff to include the processing of modifications to approved studies, continuing review or annual reports as required, and the processing of reportable event reports to include unanticipated problems, protocol deviation and violations, local RCO and other audit reports, and complaints. In managing these actions, the tasks delineating in deliverables 4.1 through 4.8 also apply.

Task 5: VA Central IRB Support – Meeting Support

The Contractor shall provide pre-meeting, meeting, and post-meeting support to all panels of the VA CIRB. The Contractor shall ensure that all documents produced by and in support of the VA CIRB are written clearly, concisely, and incorporate all required regulatory and VA policy requirements.

Deliverable 5.1 The Contractor shall assist with generating agendas for VA CIRB meetings, to include coordinating schedules with VA CIRB members to ensure both quorum and appropriate placement of items on the agenda with sufficient allocation of time to agenda items.

Deliverable 5.2 The Contractor shall ensure that actions that require review by the convened IRB are placed on the appropriate meeting agenda for review and that all project documents are received from the study and available to IRB members for review. The Contractor is responsible for alerting the IRB Panel Manager if experts are needed for the review of the protocol and ensuring the study team’s availability at the meeting when necessary.

Deliverable 5.3 The Contractor shall attend IRB meetings where his/her assigned protocol will be reviewed and shall be responsible for taking accurate, detailed, and comprehensive notes during the meeting and drafting letters that accurately capture required changes and recommendations made by the convened IRB, ensuring that all letters are clear and reflect the regulatory basis for the actions and determinations by the IRB during the meeting.

Deliverable 5.4 The Contractor shall provide support to the VA CIRB panel administrator during meetings by attending meetings, tracking attendance throughout the duration of the meeting, and taking detailed notes during the meeting.

Deliverable 5.5 The Contractor shall prepare accurate, detailed, and complete meeting minutes of VA CIRB meetings, ensuring that meeting minutes are compliant with VA and other federal requirements as well as VA CIRB SOPs. The Contractor will assist with publishing final minutes to IRBNet and the VA CIRB SharePoint site as necessary.

Task 6: VA Central IRB Support – Administrative Support

Deliverable 6.1 The Contractor shall assist with revising VA CIRB SOPs as requested by VA Central IRB management personnel.

Deliverable 6.2 The Contractor shall assist with updating forms, checklists, templates, and reports used by the VA CIRB as requested by VA Central IRB Management personnel.

Deliverable 6.3 The Contractor shall perform file audits of up to 20 VA CIRB Principal Investigator protocols on an annual basis. Protocols to be audited will be designated by VA Central IRB Management personnel.

Deliverable 6.4 The Contractor shall assist with preparing for oversight inspections and site visits as necessary.

Deliverable 6.5 In rotation with other VA CIRB staff, the Contractor shall be responsible for answering calls received on the national VA Central IRB toll free line, logging in the calls, and providing and appropriate response or forwarding the call to VA Central IRB staff if indicated.

Task 7: Regulatory and Policy Support – Implementation of the Cooperative Research Provision/Single IRB Requirement

The contractor shall provide administrative support to ORPPE’s cooperative research provision/single IRB program.

Deliverable 7.1 The Contractor shall ensure that all checklists and other required documents for the Non-VA Institutional Review Board Application Process are included in the application process, entering applications into the tracking system, and routing documents appropriately to required reviewers.

Deliverable 7.2 The Contractor shall maintain and track records of the status of IRB reliance agreements and Federal Wide Assurance (FWA) for non-VA Institutional Review Board including maintaining a database of when IRB reliance agreements are executed, modified, renewed, suspended, or terminated.

Deliverable 7.3 The Contractor shall maintain a database of the status of Federal Wide Assurances for any non-VA IRB used by a VA Facility, including when it is executed with an Office of Research Oversight addendum, modified, suspended, or terminated.

6.1 DELIVERABLES TABLE

TASK DELIVERABLE PLANNED

COMPLETION

DATE

Task 1:

Administrative Help Desk Support

1.1 The Contractor shall have experience

working with Microsoft Access Databases.

The Contractor shall transfer questions and responses received from the five mailboxes managed by ORPP&E as well as questions and responses from newly published FAQs and guidance documents into the FAQ database on a monthly basis.

As outlined in task order.

Task 1:

Administrative Help Desk Support

1.2 The Contractor shall be responsible for

maintaining ORPP&E mailboxes, to include organizing and collating questions and responses and purging redundant questions on a monthly basis.

Task 1:

Administrative Help Desk Support

1.3 The Contractor shall add VA email

addresses of individuals to the various listservs that ORPP&E manages (e.g. IRB Chairs, IRB Administrators, Training and Education, R&D Committee, and Small Research Programs) on an ongoing basis.

task order..

Task 2: Meeting and Training Support – Education and Training Program

2.1 The Contractor shall be responsible for

scheduling and conducting tech walks with first time webinar presenters, to include all individuals granted open mics, prior to ORPP&E scheduled webinars.

Task 2: Meeting and Training Support – Education and Training Program

2.2 The Contractor shall assist with

administering/hosting webinars using the platform available to ORPP&E.

As outlined in task order.

Task 2: Meeting and Training Support – Education and Training Program

2.3 The Contractor shall assist with post

webinar activities.

Task 3: Meeting and Training Support – VAIRRS Program

3.1 The Contractor shall be responsible for

scheduling project management and workgroup session meetings for the VAIRRS program.

Task 3: Meeting and Training Support – VAIRRS Program

3.2 The Contractor shall be responsible for

scheduling monthly webinars, obtaining webinar materials from presenters and attending webinars and managing presentations as necessary.

Task 3: Meeting and Training Support – VAIRRS Program

3.3 The Contractor shall be responsible for

assisting with VAIRRS program communication efforts.

Task 3: Meeting and Training Support – VAIRRS Program

3.4 The Contractor shall be responsible for

drafting revisions to the VAIRRS library of forms and templates.

Task 4: VA CIRB Support – Protocol Review and Processing

4.1 The Contractor shall use the approved

IRB platform for processing research applications (e.g. IRBNet and VA CIRB database). All protocol actions must be processed in accordance with VA CIRB SOPs.

Task 4: VA CIRB Support – Protocol Review and Processing

4.2 The Contractor manages both PI

applications and Local Site Applications from all local participating sites for the assigned study

As outlined in task order.

Task 4: VA CIRB Support – Protocol Review and Processing

4.3 The Contractor shall perform

administrative and technical reviews of assigned study applications.

Task 4: VA CIRB Support – Protocol Review and Processing

4.4 The Contractor shall coordinate review of

the study submission among the study team and assigned IRB members.

Task 4: VA CIRB Support – Protocol Review and Processing

4.5 The Contractor shall maintain a complete

file of all submitted study documents, results of all reviews by assigned reviewers, and all correspondence

As outlined in task order.

Task 4: VA CIRB Support – Protocol Review and Processing

4.6 The Contractor shall prepare interim and

final letters to the study team for actions eligible for expedited review.

Task 4: VA CIRB Support – Protocol Review and Processing

4.7 The Contractor shall ensure all databases

and tracking logs are kept up to date.

As outlined in task order.

Task 4: VA CIRB Support – Protocol Review and Processing

4.8 The Contractor shall manage

communication with, and provides advice and guidance to Principal Investigators, Study Chairs, and Study Teams.

As outlined in task order.

Task 4: VA CIRB Support – Protocol Review and Processing

4.9 The contractor shall manage all post-

approval monitoring activities as assigned by VA Central IRB Management staff.

As outlined in task order.

Task 5: VA CIRB Support – Meeting Support

5.1 The Contractor shall assist with

generating agendas for VA CIRB meetings.

Task 5: VA CIRB Support – Meeting Support

5.2 The Contractor shall ensure that actions

that require review by the convened IRB are placed on the appropriate meeting agenda and reviewed by the convened IRB.

Task 5: VA CIRB Support – Meeting Support

5.3 The Contractor shall attend IRB meetings

where his/her assigned protocol will be reviewed and shall be responsible for taking accurate, detailed, and comprehensive notes during the meeting and drafting letters.

As outlined in task order.

Task 5: VA CIRB Support – Meeting Support

5.4 The Contractor shall provide support to

the VA CIRB panel administrator during meetings.

As outlined in task order.

Task 5: VA CIRB Support – Meeting Support

5.5 The Contractor shall prepare accurate, detailed, and complete meeting minutes of VA CIRB meetings

Task 6: VA CIRB Support – Administrative Support

6.1 The Contractor shall assist with revising

VA CIRB SOPs as requested.

Task 6: VA CIRB Support – Administrative Support

6.2 The Contractor shall assist with updating

forms, checklists, templates, and reports used by the VA CIRB as requested.

As outlined in task order.

Task 6: VA CIRB Support – Administrative Support

6.3 The Contractor shall perform file audits of

up to 20 VA CIRB Principal Investigator protocols on an annual basis.

Task 6: VA CIRB Support – Administrative Support

6.4 The Contractor shall assist with preparing

for oversight inspections and site visits as necessary.

As outlined in task order.

Task 6: VA CIRB Support – Administrative Support

6.5 In rotation with other VA CIRB staff, the

Contractor shall be responsible for answering calls received on the national VA Central IRB toll free line, logging them in, and providing an appropriate response and forwarding the question or problem to another VA Central IRB staff member.

As outlined in task order.

Task 7:

Regulatory and Policy Support – Implementation of the Cooperative Research Provision/Single IRB Requirement

7.1 The Contractor shall ensure that all checklists

and other required documents for the Non-VA Institutional Review Board Application Process are included in the application process.

As outlined in task order.

Task 7:

Regulatory and Policy Support – Implementation of the Cooperative Research Provision/Single IRB Requirement

7.2 The Contractor shall maintain and track

records of the status of IRB reliance agreements and Federal Wide Assurance (FWA) for non-VA Institutional Review Board.

As outlined in task order.

Task 7:

Regulatory and Policy Support – Implementation of the Cooperative Research Provision/Single

7.3 The Contractor shall maintain a database of

the status of Federal Wide Assurances for any non-VA IRB used by a VA Facility

IRB Requirement

Table 1: Task/Deliverable Summary

Indicator/Task/Deliverable Performance

Standard Min

Leve l

Review Method(s)

Frequency

The Contractor shall contact the Contracting Officer and COR to set up a contract award kick-off meeting within the first 15 calendar days of the contract award date

The kick-off meeting was held within 15 days of award

100% Inspection

Once

The Contractor shall provide project management support. A Project Management Plan (PMP) that lays out the Contractor’s approach, timeline and tools shall be provided.

A quality PMP is provided and updated annually.

95% Contractor-provided data

Annually

The Contractor shall contact the COR to set up semiannual evaluation meetings

Semi-annual meetings are held

90% 100% Inspection

Semi-annually

The Contractor shall prepare agendas and minutes for semi-annual contract meetings

Agendas and minutes for semi-annual meetings are prepared

85% Contractor-provided Data

Semi-annually

The Contractor will complete all government-mandated training as required

All required training for all contract staff is completed

100% Inspection

Annually before an over-due report is generated

1. Administrative Help Desk Support: The Contractor will provide administrative support to ORPP&E.

All deliverables completed according to timeline and standards in the approved PMP

90% Random Sampling;

100% Inspection

In accordance with the approved

PMP

2. Meeting and Training Support – Education and Training: The Contractor shall provide administrative support to ORPP&E’s education and training program.

All deliverables completed according to timeline and standards in the approved PMP.

90% Random Sampling;

100% Inspection

In accordance with the approved

PMP

3. Meeting and Training Support – VAIRRS Program:

The Contractor shall provide administrative support to the VAIRRS Program.

All deliverables completed according to timeline and standards in the approved PMP.

90% Random Sampling;

100% Inspection

In accordance with the approved

PMP

4. VA Central IRB – Protocol Review and Processing:

The Contractor shall support the VA CIRB by processing new study submissions and managing post-approval monitoring.

according to timeline and standards in the approved PMP.

90% Random Sampling;

100% Inspection

In accordance with the approved

PMP

5. VA Central IRB Support – Meeting Support: The Contractor shall provide pre-meeting, meeting and post-meeting support to all panels of the VA CIRB.

according to timeline and standards in the approved PMP.

90% Random Sampling;

100% Inspection

In accordance with the approved

PMP

6. VA Central IRB Support – Administrative Support:

The Contractor shall provide administrative support to the VA CIRB as needed.

All deliverables completed according to timeline and standards in the approved PMP.

90% Random Sampling;

100% Inspection

In accordance with the approved

PMP

7. Regulatory and Policy Support – Implementation of the Cooperative Research Provision/Single IRB Requirement

All deliverables completed according to timeline and standards in the approved PMP.

90% Random Sampling;

100% Inspection

In accordance with the approved

PMP

7.0 TASK REVIEWS

The Contractor shall notify the CO/COR and VA PM as soon as it becomes apparent to the Contractor that a scheduled delivery shall be late. The Contractor shall include in the notification the rationale for late delivery, the expected date for the delivery and the projected impact. The CO/COR will review the proposed schedule and provide guidance to the Contractor; all contract changes will be via written modification signed by the Contracting Officer. Prompt notification of delay does not limit the Government's right to all rights and remedies up to and including termination.

All deliverables will be reviewed for content, completeness, accuracy, and conformance to task order requirements by the CO/COR and/or his/her presentative. Reviews will include validation of information as specified in the contract. All deliverables will be checked to ensure the completeness, quality, and adequacy of all deliverables.

The Government requires a period not to exceed thirty (30) days after receipt of written deliverable items for inspection and acceptance or rejection. Inspection and acceptance of all work performance, reports and other deliverables under this task order shall be performed by the COR. The Government’s written approval of the draft and final documents shall constitute acceptance by the VA.

8.0 KEY PERSONNEL

a. The Contractor will propose labor categories they deem essential for successful contractor accomplishment of the work to be performed under this contract and subsequent task orders and option. These individuals are defined as “Key Personnel” and are those persons whose résumés shall be submitted and marked by the contractor as “Key Personnel” through submission of the Technical Capability. Substitutions shall only be accepted if in compliance with the “Substitution of Key Personnel” provision identified below.

b. Key Personnel shall include as a minimum: one Program Manager, five Protocol Coordinators, and one qualified technical writer/editor. Additional positions may be added by agreement between the government and the contract and outlined on a contract modification.

c. The Program Manager is responsible for direct communication with the VA COR.

She/he shall have a Master’s Degree from a recognized institute of higher education;

shall have a minimum of 5 years’ experience in research administration and oversight and a minimum of 3 years of management and supervisory experience.

d. The Protocol Coordinators shall be assigned to the VA CIRB and may support any of the VA CIRB panels. Protocol Coordinators shall be technically sufficient in written and oral communication and shall have a minimum of 3 years’ experience working in an IRB performing reviews of non-exempt human subject research.

e. The Technical Writer/Editor is responsible for preparing the IRB agenda and meeting minutes and ensuring that all prepared meeting minutes meet all regulatory and policy requirements as well as all requirements specified in VA CIRB SOPs. In addition to the preparation of VA CIRB meeting agenda and meeting minutes, the Technical Writer shall assist the VA CIRB Panel and Network Administrators in the preparation, review and editing of letters, forms, and VA CIRB SOPs. This includes development of document and email templates with periodic review for consistency, accuracy, and as needed personalization based on review/specific situation. The Technical Writer/Editor shall hold at least a Baccalaureate degree in English, Journalism, or other appropriate field of study and have a minimum of 3 years’ experience with an IRB.

f. The Contractor shall demonstrate the appropriate mix and balance of education, academic excellence, training and experience.

g. The proposed Key Personnel shall be familiar with the functions of the Institutional Review Board, the Common Rule, and FDA regulations.

h. The Contractor shall identify the specific responsibilities for each key role within the Management Plan.

i. The Contractor shall be available for consultation with VA from 8 am to 4:30 pm Eastern Time.

j. The Contractor shall notify VA CO in writing within 10 business days of any changes in management plan.

All departing key personnel shall be replaced within 60 calendar days from the last date of employment. The Contractor shall make every effort to replace departing personnel as quickly as possible. The Contractor will provide written notification of departure, indicating the last date of employment.

8.1 Substitution of Key Personnel.

Any personnel the contractor offers as substitutes shall have the ability and qualifications equal to or better than the key personnel who are being replaced.

Requests to substitute personnel must be approved by the COR and the CO. All requests for approval of substitutions in personnel shall be submitted to the COR and the CO within 30 calendar days prior to making any change in key personnel. The request shall be written and provide a detailed explanation of the circumstances necessitating the proposed substitution. The contractor shall submit a complete resume for the proposed substitute.

The Contractor shall be responsible for managing and overseeing the activities of all Contractor personnel, as well as subcontractor efforts used in performance of this effort, if applicable. The Contractor’s management responsibilities shall include all activities necessary to ensure the accomplishment of timely, effective, professional and high-quality support, performed in accordance with the requirements contained herein.

9.0 GOVERNMENT-FURNISHED EQUIPMENT (GFE)/GOVERNMENT-FURNISHED

INFORMATION (GFI)

The contractor will be loaned a VA computer, PIV and CAG access.

10.0 SECURITY REQUIREMENTS

The contractor will need access to VA systems to perform work on this contract. The following security requirements apply to the contractor:

10.1 POSITION/TASK RISK DESIGNATION LEVEL(S)

Position Sensitivity

Background Investigation (in accordance with Department of Veterans Affairs 0710 Handbook, “Personnel Suitability and Security Program,” Appendix A)

Low / Tier

Tier 1 / National Agency Check with Written Inquiries (NACI) A Tier 1/NACI is conducted by OPM and covers a 5-year period. It consists of a review of records contained in the OPM Security Investigations Index (SII) and the DOD Defense Central Investigations Index (DCII), Federal Bureau of Investigation (FBI) name check, FBI fingerprint check, and written inquiries to previous employers and references listed on the application for employment. In VA it is used for Non-sensitive or Low Risk positions.

Moderate / Tier 2

Tier 2 / Moderate Background Investigation (MBI) A Tier 2/MBI is conducted by OPM and covers a 5-year period. It consists of a review of National Agency Check (NAC) records [OPM Security Investigations Index (SII), DOD Defense Central Investigations Index (DCII), FBI name check, and a FBI fingerprint check], a credit report covering a period of 5 years, written inquiries to previous employers and references listed on the application for employment; an interview with the subject, law

Position Sensitivity

Background Investigation (in accordance with Department of Veterans Affairs 0710 Handbook, “Personnel Suitability and Security Program,” Appendix A) enforcement check; and a verification of the educational degree.

High / Tier

Tier 4 / Background Investigation (BI) A Tier 4/BI is conducted by OPM and covers a 10-year period. It consists of a review of National Agency Check (NAC) records [OPM Security Investigations Index (SII), DOD Defense Central Investigations Index (DCII), FBI name check, and a FBI fingerprint check report], a credit report covering a period of 10 years, written inquiries to previous employers and references listed on the application for employment; an interview with the subject, spouse, neighbors, supervisor, co-workers; court records, law enforcement check, and a verification of the educational degree.

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 / NACI Tier 2 / Moderate /

MBI

Tier 4 / High / BI

All Tasks 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.

The C&A requirements do not apply, and a Security Accreditation Package is not required.

10.2 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.

b. The Contractor shall bear the expense of obtaining background investigations.

c. 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. The roster shall contain the Contractor’s Full Name, Full Social Security Number, Date of Birth, Place of Birth, and individual background investigation level requirement. 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.

d. The Contractor should coordinate the location of the nearest VA fingerprinting office through the COR. Only electronic fingerprints are authorized.

e. The following forms are required to be completed:

1) Optional Form 306;

2) Self-Certification of Continuous Service;

3) VA Form 0710; and

4) Completed Security and Investigations Center (SIC) Fingerprint Request Form.

f. The Contractor personnel will receive an email notification from the Security and Investigation Center (SIC), through the Electronics Questionnaire for Investigations Processes (e-QIP) identifying the website link that includes detailed instructions regarding completion of the investigation documents (NACI-SF85).