36C25820R0041_1.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 148

36C25820R0041

Sheri Eiri, Contract Specialist (602) 795-4362 07-07-2020

12:00 pm

Department of Veterans Affairs

NCO22-Gilbert Network Contracting

777 E. Missouri, Suite 300

Phoenix AZ 85014

X 100

X

541611

$16.5 Million

N/A

X

VA Cooperative Studies Program Clinical

2401 Centre Avenue

Albuquerque NM 87106

NCO22-Gilbert Network Contracting

777 E. Missouri, Suite 300

Phoenix AZ 85014

This is accomplished through the

Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp

This is mandatory and the sole method for submitting invoices.

See CONTINUATION Page

The VA Cooperative Studies Program Clinical Research

Pharmacy Coordinating Center (CSPCRPCC) has a requirement to provide auditing Good Clinical Practice (GCP) services for the clinical trials conducted by the VA Cooperative

Program (CSP).

This acquisition will be an Indefinite Delivery, Indefinite

Quantity (IDIQ) contract to acquire the services of experienced Contractors to serve as providers of clinical trial site auditing services.

All work shall be performed in accordance with the enclosed

Statement of Work.

This is a 100% Total Small Business Set Aside.

$0.00

See CONTINUATION Page

X X

James J. Moran, CO

VA-VHA-RPOW-2019-2C91E4DD

Table of Contents

SECTION A

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

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.3 STATEMENT OF WORK

B.2 DELIVERY SCHEDULE

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

SECTION C - CONTRACT CLAUSES

C.1 IT CONTRACT SECURITY

C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

C.3 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.4 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.5 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS

(DEC 2013)

C.6 52.216-18 ORDERING (OCT 1995)

C.7 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.8 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.9 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF

COMMERCIAL ITEMS (APR 2020)

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

C.11 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

ATTACHMENT A – BUSINESS ASSOCIATE AGREEMENT

ATTACHMENT B-EXPENSE WORKSHEET TRAINING

ATTACHMENT C – TRAVEL / EXPENSE REIMBURSEMENT CLAIM

ATTACHMENT D QUALITY ASSURANCE SURVEILLANCE PLAN

ATTACHMENT E-WHEN REQUESTING ANY TYPE OF ANNOUNCEMENT LETTER

ATTACHMENT F-FOLLOW UP LETTER

WAGE DETERMINATION

SECTION E - SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

E.2 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.3 52.216-1 TYPE OF CONTRACT (APR 1984)

E.4 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.5 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018) .. 125

E.6 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.7 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED BY REFERENCE

(JAN 2008)

E.8 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.9 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (DEC

2019)

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 36C258

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

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

[X] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

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.

This is accomplished through the

Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp

This is mandatory and the sole method for submitting invoices.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the

Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.3 STATEMENT OF WORK

Performance Work Statement Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Auditing Services

New Mexico Veterans Affairs Health Care System (NMVAHCS)

Introduction:

This requirement is for Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Auditing Services.

1. Background:

The New Mexico VA Cooperative Studies Program has a requirement to provide auditing Good Clinical Practice (GCP) CRQA services for the clinical trials conducted by or requested by the VA Cooperative Studies Program (CSP). These trials are conducted at VA facilities and associated non-VA facilities throughout the United States. CSP clinical trials vary over time in number, size and design, but typically consist of 5 to 10 trials that are actively audited each fiscal year.

The SMART mandate is to ensure that the clinical trials of the VA CSP are conducted in compliance with the scientific and ethical principles embodied in the GCP regulations and guidelines. SMART accomplishes this task by assuring that VA personnel conducting or supporting clinical trials are trained in GCP and that any compliance problems at participating research sites are identified and resolved through a program of site CRQA visits.

2. Scope

The Contractor shall provide Clinical Research Quality Associate (CRQA) and provide services to the VA CSP through the Site Monitoring, Auditing and Resource Team (SMART) co-located with the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center located in Albuquerque, New Mexico. The tasks include performing site visits, providing post-visit reports, and providing GCP quality assurance support.

3. Services:

The contractor shall provide Clinical Research Quality Associate visits and associated services.

The contractor shall inspect for compliance with the following standards:

• VHA Directive 1200.05

• VHA Handbooks – 1108.04, 1058.01, 1907.01, 1200.01, 6500 - VA Information Security Program

• 45 CFR 46 – Protection of Human Subjects

• 38 CFR 16 (VA Common Rule) – Protection of Human Subjects

• E6 (R2) – International Conference on Harmonization (ICH) Guidelines – Good Clinical Practice

• FDA 1572 Guidance

• FDA Regulations

• CSP Investigator Guidelines

• Program level Global SOPs

• CSP Study Protocol and Operations Manuals

• SMART SOPs and Approved Methods and Procedures (AMPs)

• VHA Handbook 1605.05 Business Associate Agreements

• VA Directive 6500.6 Contract Security

• VA Directive 6502 Enterprise Privacy Program

The contractor will be required to travel when conducting site visits [CLIN 2] Travel Arrangements and Reimbursement - Travel arrangements shall be the responsibility of the contractor. Travel costs will be reimbursed in accordance with Federal Travel Regulations (Chapter 300 through 304) utilizing Government rates. Contractors will be reimbursed for actual travel expenses, but the contractor will use the most economical method of travel available, including non-refundable airfares and mid-range hotels matching government per diem whenever possible.

Reimbursable costs include airfare, car rental, hotel, taxis, and meals and incidentals (M&IE). M&IE expenses are included only at the Federal Per Diem Rate. To receive reimbursement, the Contractor shall submit his/her invoices along with travel expense worksheet (which is supplied at the time of award), receipts and all other supporting documents. Documentation to support lowest cost available are required for reimbursement. Travel time is not reimbursable. For site visits requiring travel, port-to-portal travel time should be considered as part of the overall cost of the visit.

Contractor (PRIME if there are Subcontractors) will submit all required documents noted above.

If travel dates or location are changed at the request of the program, the change fee for new date and/or location will be reimbursed. No costs will be reimbursed for the convenience of the CRA.

Changes for convenience are the responsibility of the contractor. Documentation supporting change in location or date/s must come from CSP program officials and /or site staff and must be submitted when invoicing.

Task 1 – CRQA visits with pre and post work, (INCLUDES PORTAL-TO-PORTALTRAVEL TIME) [CLIN 1 & 2]

Subtask 1a – Conduct focused GCP or specialized For Cause Quality Associate Visits - one to four days (INCLUDES TRAVEL TIME) [CLIN 1 & 2]

The contractor shall conduct focused or specialized For Cause QA visits per the SMART Standard Operating Procedures (SOPs) to inspect VA investigators for compliance with GCP and with VA and CSP Research policies. These visits may require travel with less than 24-hour notice. In the case of For Cause visits the site is not notified of the visit. The contractor must be able to conduct these visits in the timeframe required by CSP Director or Program Leadership. The contractor may be required to lead a team of CSP staff that assist in conducting the site visit.

The contractor shall conduct focused or For Cause site visits per SMART SOPs to inspect VA investigators research study for compliance with GCP and with VA and CSP research policies. In conducting these sites visits, the contractor shall:

• Provide CSP Director and SMART leadership staff immediate feedback of significant discoveries made during site visits

• Assess site for key area/s of focused audit

• Assess site for key area/s of For Cause Audit

• Assess effectiveness of interactions between the investigator site study team and the contractor and other representatives of CSP

• Provide guidance during site visits on study conduct and use of GCP tools to improve study site practices

• Know and comply with VA Privacy and Data Security Policy during site visits

• Prepare reports after each inspection for CSP Director and SMART, citing opportunities for improvement (OFIs) and providing recommendations for correcting problems and improving practice in the time required by the CSP Director

Subtask 1b – Conduct routine Quality Associate Visits - one to four days (with pre and post work, (INCLUDES TRAVEL TIME) [CLIN 1 & 2]

The contractor shall conduct periodic routine contractor visits per the SMART Standard Operating Procedures (SOPs) to inspect VA investigators for compliance with GCP and with VA and CSP Research policies.

• Frequency of Visits – The frequency and timing of contractor visits will be determined by SMART Staff Leadership for each site based on the following:

o Lead CRA and Study Team recommendations o Subject accrual rate at the site o Total number of subjects to be enrolled at the site o Complexity and risk level of the study protocol o Data collection and record keeping proficiency at the site o Observations and corrective actions from previous monitoring visits

Subtask 1c – Preparing for site visits [CLIN 1]

Scheduling –After approval of planned visit by auditing study Lead, the contractor shall coordinate visit dates with site Study Coordinator and Site Investigator. The contractor will request current contact information and mailing address.

The contractor shall contact the site coordinator to set up a date/time for the visit and to discuss:

o Tentative Agenda o Estimated time needed on site with the Site Investigator/Coordinator o Specific documents needed for review

After the contractor has set up a date/time for the visit, the contractor shall submit a request to the SMART Program Manager (PM) email group for a site announcement letter using the provided email template. See Attachment D-Announcement Letter.

Documents and resources – Prior to the contractor visits, the contractor shall assemble all documents and resource materials needed to conduct the visit (i.e., correspondence, previously completed monitoring documents, etc.). Visit will be conducted following the SMART Routine Audit Plan.

Subtask 1d – Conducting site visits [CLIN 1]

In conducting these sites visits, the contractor shall:

• Review subject and investigator study records for compliance with GCP, VA and CSP research policy

• Check for study protocol compliance

• Review Essential Documents Binder (EDB)

• Conduct Informed Consent and HIPPA review

• Conduct participant data review

• Verify Case Report From (CRF) data against Source documents

• Review source documents for Adverse Events (AE)/Serious Adverse Events (SAE)

• Review electronic medical record for unidentified SAEs

• Review CRFs for accuracy and legibility

• Check for CRF submission to Data Coordinating Center

• Know and comply with VA Privacy and Data Security Policy during site visits

• Provide CSP Director and SMART Staff Leadership immediate feedback of significant discoveries made during site visits

• Provide guidance during site visits on study conduct and use of GCP tools to improve study site practices

• Assess effectiveness of interactions between the investigator site study team and the contractor and other representatives of CSP

• Determine follow-up actions to be taken

• Provide relevant GCP training and re-education as needed

• Conduct exit interview with study team to discuss site status

Subtask 1e – Prepare site visit reports and summary letters [CLIN 1]

Study specific templates are provided to the auditor upon assignment of study training and visit.

Within fourteen calendar days (or current SOP requirement) of last day on site of site visit, the contractor shall complete a site visit report, Summary for Investigator and applicable attachments (using provided templates) and provide these documents to the SMART PM group by posting to SMART SharePoint site or other location as directed by SMART leadership.

See Section 4. Deliverable Schedule.

Provide all QA visit logs and scanned documents related to site visit to SMART and Auditing contractor study lead for review, follow-up and finalization. QA activities performed include:

• Summary of findings, conclusions, and any actions taken or planned to correct any deficiencies noted during the visit

• All documents must be submitted in the specified electronic format using the required templates. Content must be understandable by SMART staff, site staff and CSP study personnel. Content shall be grammatically correct, and content verified for accuracy.

• Inform the SMART Lead contractor of recurrent and/or serious compliance deficiencies

• Assist with development and implementation of Corrective Actions and/or Preventive Actions (CAPAs) in order to mitigate recurrence of compliance deficiency

The contractor shall communicate with and provide follow up with the study lead contractor to answer all questions and issues prior to visit report approval and Summary for Investigator distribution to the intended recipients within current SOP/AMP requirement.

Subtask 1f – Audit Report Follow-up and Resolution [CLIN 1]

Once the investigator correction action response has been received from the site the Sponsor’s Designated Representative (SDR) evaluates the corrective action response for acceptability and completeness. The SDR ensure the Site Investigator response is acceptable and complete by:

• Reviewing and evaluating the Site Investigator’s written response

• Discussing the findings and specified actions with site personnel and Study Leadership as needed

• Maintaining the secure CSP audit file of documents and correspondence.

• Consulting, as needed, with the appropriate CSP Coordinating Center Project Manager, QA Nurse Specialist or designee to assist site personnel in resolving issues raised in the SMART audit report.

• Documents resolution and closeout of site visit

Task 2 – CRQA Visits without pre and post work (INCLUDES PORTAL-TO-PORTAL TRAVEL TIME)

[CLIN 1 & 2]

Subtask 2a – Support of another contractor conducting contractor visits - one to four days on site

The CRQA may support another CRQA in conducting site auditing visits at the request of the Lead

CRQA or SMART Leadership. For example, this may include providing support to the lead auditor during a site visit, most often during a for cause audit, or training as a new auditor on conducting site visits.

The supporting auditor is not responsible for the pre work such as scheduling visits, pre visit log reviews, developing special tools for the For-Cause audit, or any of the post work such as visit summary, visit report, summary attachments or post audit communication between site and lead.

In summary – support of another auditor - requires no pre or post work but does include travel and actions conducted at the site.

o Subtask 2b – Support of study kickoff, annual, program meetings or training - one to four days on site

• The contractor may be required to attend or present at study kickoff meetings, annual meetings or other meetings at the direction of the Lead contractor or SMART Leadership

• The contractor may be required to attend in house training or perform QA tasks at the direction of the SMART Leadership.

Task 3 - GCP Quality Assurance (QA) support to the VA Cooperative Studies Program, Hourly; no travel required [CLIN 3]

Subtask 3a – Create site visit tools o Subtask 3b – Develop GCP tools for use by participating sites

Subtask 3c – Design data from casebooks for organizing patient files at investigative sites

Subtask 3d – Develop requirements, procedures and guidance for source documentation of key study data within each trial o Subtask 3e – Remote Records Review (not related to the review required for visits with pre and post activities) o Subtask 3f – Study Orientation o Subtask 3g – Completion of training required by the Department of Veterans Affairs, VA CSP and

SMART

o Subtask 3h – Other QA activities as assigned (i.e., Serve as the Sponsor’s Designated Representative (SDR) for the review of reports received from the site auditors

• The SDR shall finalize and approve reports prior to distribution.

• The SDR shall complete the site visit portion of the SDR form.

• The SDR shall submit a request to the SMART Program Manager (PM) email group for a site visit follow up letter using the provided email template (see Attachment E-Follow Up Letter).

• The SDR shall review site visit response, verify actions, communicate with site staff and site auditor prior to approving response and submitting response and SDR form to close out study visit. Lead contractor will submit a request to the SMART Program Manager (PM) email group and provide documentation of completion using current business process and forms.

4. Deliverable Schedule

The contractor shall deliver the following as stated in the table below:

PWS Task Deliverable Description Due Date Electronic submission to:

Task 1 See subtasks See subtasks See subtasks

Subtask 1a Focused or For Cause Audit completed

Focused Audit – final report, investigator summary and supporting documents

For Cause Audit-Final report and supporting documents

Focused Audit –14 calendar days from last day of visit unless otherwise required by CSP

Director

For Cause Audit-Due in the number of days required by VA

CSP Director

VA CSP Director and

SMART Leadership, SMART PM (COR)

Subtask 1b Routine audit completed– final report, investigator summary and supporting documents

14 calendar days from last day of visit

SMART SharePoint site, URL https://www.csp.va.g ov/smart/SitePages/

Home.aspx

SMART PM (COR)

Subtask 1c Schedule as directed by

SMART Leadership and submit a request to the

SMART Program Manager

(PM) email group for a site announcement letter (See

Attachment D-

Announcement Letter)

30 days prior to visit but no later than 14 days.

SMART Auditing Lead and

SMART PM email group

ABQCSPSMART-

PM@va.gov

Subtask 1c Contractor shall assemble all documents and resource materials needed to conduct the visit according to audit plan and save documents received from site coordinator

Prior to first day of visit

SMART SharePoint site, URL https://www.csp.va.g ov/smart/SitePages/

Home.aspx https://www.csp.va.gov/smart/SitePages/Home.aspx https://www.csp.va.gov/smart/SitePages/Home.aspx mailto:ABQCSPSMART-PM@va.gov mailto:ABQCSPSMART-PM@va.gov https://www.csp.va.gov/smart/SitePages/Home.aspx

Subtask 1d

Perform audit by completing audit plan

During visit dates SMART SharePoint site, URL https://www.csp.va.g ov/smart/SitePages/

Home.aspx

Subtask 1e

The contractor shall finalize and provide logs, site visit report, Summary for

Investigator and applicable attachments

Within fourteen calendar days

(or current SOP requirement) of last day on site of site visit

SMART Auditing Lead

SMART PM (COR)

SMART SharePoint site, URL https://www.csp.va.g ov/smart/SitePages/

Home.aspx

Subtask 1f Documented response to follow up.

By requested date Lead Auditor, SMART

Director, COR

Task 2 See subtasks See subtasks See subtasks

Subtask 2a

Services provided to support another contractor – visit completion

By requested date Lead Auditor, SMART

Director, COR

Subtask 2b Support services provided By requested date Lead Auditor, SMART

Director, COR

Task 3 See subtasks See subtasks See subtasks

Subtask 3a Site tools submitted By requested date Lead Auditor, SMART

Director, COR

Subtask 3b GCP tool/s submitted By requested date Lead Auditor, SMART

Director, COR

Subtask 3c Design data submitted By requested date Lead Auditor, SMART

Director, COR

Subtask 3d

Documents submitted By requested date Lead Auditor, SMART

Director, COR

Subtask 3e

Documentation of review log

By requested date Lead Auditor, COR

Subtask 3f

Documentation of Upon completion of training, no later than due date of training

SMART PM email https://www.csp.va.gov/smart/SitePages/Home.aspx https://www.csp.va.gov/smart/SitePages/Home.aspx https://www.csp.va.gov/smart/SitePages/Home.aspx https://www.csp.va.gov/smart/SitePages/Home.aspx completed study orientation requirement. group

ABQCSPSMART-

PM@va.gov

COR

Subtask 3g Documentation of completed training

Upon completion of training, no later than due date of training requirement.

SMART PM email group

ABQCSPSMART-

PM@va.gov

Subtask 3h

Properly completed and submitted SDR review activities of visit reports and documents – Post Visit

Properly completed and submitted SDR review activities of visit reports and documents – Post Site

Response

Due 30 days from last date of visit or current SOP requirement.

Due as determined by Director of SMART

Director of SMART, COR

SMART PM email group

ABQCSPSMART-

Successfully complete the appropriate training courses in TMS

Before being granted access to

VA info and systems and annually thereafter

ABQCSPSMART-

PM@va.gov

COR

20 Submit expenses incurred utilizing the invoice template, travel expense and professional service worksheets and training supplied at the time of award.

Invoices should be submitted in VIS

Within 30 days of visit or QAS

And after all QA services are complete and all associated QA documents are submitted.

Within 30 days of visit or QAS and after SMART PM approves the invoice, the contractor will submit the final invoice as directed in the contract

ABQCSPSMART-

Note -All communications regarding invoicing from a subcontractor shall be directed through the primary contract holder.

mailto:ABQCSPSMART-PM@va.gov mailto:ABQCSPSMART-PM@va.gov mailto:ABQCSPSMART-PM@va.gov mailto:ABQCSPSMART-PM@va.gov mailto:ABQCSPSMART-PM@va.gov mailto:ABQCSPSMART-PM@va.gov mailto:ABQCSPSMART-PM@va.gov

If for any reason a deliverable cannot be delivered as scheduled, the contractor shall notify the COR three business days prior to the due date. This notice must include the reason(s) for the delay, and the impact on the overall project.

5. Identification, Parking, Smoking, and VA Regulations:

A. The Contractor's FSEs shall wear visible identification issued by VAHCS Police Section at all times while on the premises of VAHCS. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. VAHCS will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at VAHCS.

Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

6. Information Security:

In accordance with Appendix A, Handbook 6500.6 Checklist blocks 7, the C&A requirements do not apply to this requirement, and Security Accreditation Package is not required. The nature of this requirement is technical; however, there is no information to be protected.

7. PHI/PII Protected Health Information/Personally Identifiable Information:

PHI/PII is any information about an individual maintained by an agency, including (1) any information that can be used to distinguish or trace an individual‘s identity, such as name, social security number, date and place of birth, mother‘s maiden name, or biometric records; and (2) any other information that is linked or linkable to an individual, such as medical, educational, financial, and employment information. The contractor will have access to PHI/PII data during performance of the tasks stated in this Statement of Work. CRAs must know and comply with VA Privacy and Data Security Policy during site visits and properly protect this information.

8. Other Pertinent Information or Special Considerations:

Contracting Officer’s Representative

Name: TBD

Section: Site Monitoring, Auditing and Resource Team (SMART)

Address:

VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 2401 Centre Avenue, SE Albuquerque, NM 87106-4180

Phone number: TBD

Fax number: (505) TBD

E-mail address: TBD@va.gov

9. Period of Performance:

Ordering Period 1 September 1, 2020 – August 31, 2021 Ordering Period 2 September 1, 2021 – August 31, 2022 Ordering Period 3 September 1, 2022 – August 31, 2023 Ordering Period 4 September 1, 2023 – August 31, 2024 Ordering Period 5 September 1, 2024 – August 31, 2025

10. Contractor Qualifications:

The contractor, contractor’s employees, sub-contractor and individuals who will perform work under this contractor must meet all the qualifications listed below and submit copies of degree, training certificates, professional certifications, resume, CV, etc. to meet contractor qualifications.

a) Bachelor’s degree (BA/BS) in a scientific or health-related field or licensure as health care provider, (e.g., RPh, RN, MD, DO, PA CNP, etc.) or advanced degree in health-related field (e.g.

Pharm.D.) OR Certified as a Clinical Research Associate (CRA) by the Association of Clinical Research Professionals (ACRP) or by an equivalent certifying body.

b) GCP trained with documentation of completed courses provided by nationally recognized training providers (e.g., Barnett International, ACRP, CITI, CFPA).

c) Specific training or certification in auditing or monitoring of clinical research, human subjects protection or clinical trial quality assurance (documentation of completed a courses or certification (Clinical Research Associate, (CRA) provided by nationally recognized training providers, e.g., Barnett International, University of North Carolina, etc.) Contractor shall provide copy of relevant experience (on the job training and/or Training Certificate.

d) A Minimum of ten (10) years providing Good Clinical Practice (GCP) Human Subjects Protection (HSP) specific research monitoring or auditing of Clinical Research sites and Quality Assurance (QA) services with multi-site clinical trials.

e) A minimum of seven (7) years’ experience delivering GCP HSP QA service for federally funded research with special consideration given to actual experience monitoring or auditing at VA research sites including documented ability to work accurately with various Government computer systems to retrieve veterans’ records for analysis. Contractor to submit at least three

(3) references with experience delivering GCP HSP QA service for federally funded research.

Indicate project location, amount, whether you were prime or subcontractor and dates of performance.

f) Current Curriculum Vitae (CV) or detailed resume.

g) Experience in medical record and clinical chart review. Resume or CV must demonstrate experience.

mailto:TBD@va.gov https://www.thebalancecareers.com/cv-vs-resume-2058495

h) Computer knowledge - Skilled in Microsoft Office Programs (e.g., Outlook Email, Word, PowerPoint, Excel and SharePoint), and Adobe Acrobat. Resume or CV must demonstrate experience.

11. Quality Assurance:

The contractor shall develop and provide a copy of their management and quality assurance approach for the following:

a) Assignment of personnel to the meet timelines and quality for performing required services to include report submission.

b) Ensure personnel that might be assigned meet the individual technical requirements.

c) Evaluate individual performance if you have multiple employees performing auditing functions.

d) How you intend to interface between the customer and auditors (ex: customer must go through central focal point to communicate/schedule auditor(s), customer directly schedules auditor(s) and informs central focal point, etc.).

12. Performance Monitoring:

Refer to Attachment C-Quality Assurance Surveillance Plan.

13. Security Requirements:

All Contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Law Enforcement Training Center/SIC. The level of background security investigation will be in accordance with VA Directive 0710 dated June 4, 2010 and is available at:

http://vaww.va.gov/vapubs (VA Handbook 0710, Appendix A, Tables 1 and 2). Appropriate Background Investigation (BI) forms will be provided upon contract (or task order) award and are to be completed and returned to the VA Law Enforcement Training Center/SIC within 30 days for processing. Contractors will be notified by VA Law Enforcement Training Center/SIC when the BI has been completed and adjudicated. These requirements are applicable to all Contractor personnel requiring the VA computer access. If the security clearance investigation is not completed prior to the start date of the contract, the employee may work on the contract while the security clearance is being processed. However, the investigation must be completed / approved before any site visits are conducted. The Contractor shall be responsible for the actions of those individuals they provide to perform work for the VA. If damage arises from work performed by Contractor personnel, under the auspices of the contract, the Contractor shall be responsible for resources necessary to remedy the incident.

The investigative history for Contractor personnel working under this contract shall be maintained in the databases of either the Office of Personnel Management (OPM) or the Defense Industrial Security Clearance Organization (DISCO). Should the Contractor use a vendor other than OPM or Defense Security Service (DSS) to conduct investigations, the investigative company must be certified by OPM/DSS to conduct Contractor investigations.

The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non- Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

Each risk analysis shall address all relevant information concerning the data breach, including the following:

• Nature of the event (loss, theft, unauthorized access); Description of the event, including date of occurrence and data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code.

• Number of individuals affected or potentially affected; Names of individuals or groups affected or potentially affected.

• Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text.

• Amount of time the data has been out of VA control.

• The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons).

• Known misuses of data containing sensitive personal information, if any.

• Assessment of the potential harm to the affected individuals.

• Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

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

Notification, one year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports, data breach analysis, fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution, one year of identity theft insurance with $20,000.00 coverage at $0 deductible; and necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

The contractor is required to report any Information Security or privacy breach, loss of data, inappropriate access immediately to contracting officer representative for this contract (COR), relevant facility Information Security Officer relevant facility Privacy Officer - noting details of breach circumstances, necessary remediation/corrective action as required under HIPAA regulations.

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

Position Sensitivity: The position sensitivity impact for this effort has been designated as LOW RISK.

Background Investigation: The level of background investigation commensurate with the required level of access is NATIONAL AGENCY CHECK WITH WRITTEN INQUIRIES (NACI) (cost is approximately $230).

14. Government-Furnished Equipment (GFE) AND/OR Government-Furnished Information (GFI)

Contractor furnished:

The contractor shall provide all equipment and supplies necessary to perform the contract requirements as set forth in the Request for Proposal (RFP). The contractor’s reporting requirements will necessitate literacy in Microsoft Office Programs, e.g., Word, Excel, PowerPoint, SharePoint, as well as Internet capability to send and receive faxes, electronically transmit documents, access email and correspondence, ability to communicate during travel and securely access, store and destroy sensitive documents. Computer access must be maintained following VA regulations.

The contractor shall maintain VA Computer access and ensure computer and program functionality prior to audit.

15. Government furnished:

A laptop computer with Microsoft Office Programs, e.g., Word, Excel, PowerPoint, SharePoint pre-installed and PIV card shall be provided by the Government for use in providing the contractor services (use of this government-furnished laptop for all work for SMART contract services is mandatory).

16. Place and hours of Performance

The Contractor will be required to perform work at different sites (hospitals and/or clinics) throughout the United States and territories, at the Contractor’s place of business and at the SMART office in Albuquerque, New Mexico. The Contractor must be available by phone during business hours (8:00 am to 5:00 pm/MST) Monday through Friday. There may be times when the Contractor will need to be available beyond business hours in the case of a For Cause, special circumstance or unannounced audit. It is essential that the Contractor be able to promptly respond to the needs of the SMART, i.e., be able to report within 24 hours to the SMART Office or to the VA research facility where visit will be conducted.

SMART and CSP program leadership reserves the right to accompany the Contractor on site visits or to visit and inspect the Contractor’s place of business at reasonable times during normal business hours.

Federal Holidays observed are:

New Years' Day Labor Day Martin Luther King Day Columbus Day Presidents' Day Veterans' Day Memorial Day Thanksgiving Day Independence Day Christmas Day And any other day the United States Presidents designates as a federal holiday.

17. Training & Additional Guidance

All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

• Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior relating to access to VA information and information systems;

• Successfully complete the VA Privacy and Information Security and Rules of Behavior training in TMS and annually complete required security training; before being granted access to VA information and systems and annually thereafter, URL:

https://www.tms.va.gov/SecureAuth35 course name and course code: VA Privacy and Information Security Awareness and Rules of Behavior VA 10176; and https://www.tms.va.gov/SecureAuth35

• Successfully complete the appropriate VA privacy training in TMS and annually complete required privacy training; before being granted access to VA information and systems and annually thereafter, URL https://www.tms.vagov/SecureAuth35 and course name and course code: Privacy and HIPAA Training VA 10203; and

• Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access. Course requirement may change, and the COR will inform the contractor, when applicable.

The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time the training and documents are complete.

18. Records Management

Contractor will adhere to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

The Government Agency owns the rights to all data/records produced as part of this contract.

The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

https://www.tms.vagov/SecureAuth35

No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract.

The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

19. Multi-Sites The following cities are examples of those with VA sites or sites with 75 miles that may be used for VA Clinical Trials for ordering period 1 through ordering period 5.

These sites apply to 1 – 4-day visits with or without pre and post work.

City Sta te

City State City State City State

Birmingham AL Des Moines IA Fargo ND Charleston SC

Montgomery AL Iowa City IA Omaha NE Columbia SC

Little Rock AR Boise ID Manchester NH Hot Springs SD

Phoenix AZ Chicago IL New Brunswick

NJ Sioux Falls SD

Prescott AZ Indianapolis IN Newark NJ Memphis TN

Tucson AZ Topeka KS Albuquerqu e

NM Nashville TN

Fresno CA Wichita KS Reno NV Amarillo TX

San Diego CA Lexington KY Las Vegas NV Big Springs TX

Los Angeles CA Louisville KY Albany NY Dallas TX

San Francisco CA Alexandria LA Buffalo NY Houston TX

Denver CO New Orleans LA New York NY San Antonio TX

New Haven CT Boston MA Syracuse NY Salt Lake City UT

Washington DC Northampton MA Cincinnati OH Charlottesville VA

Wilmington DE Baltimore MD Cleveland OH Hampton VA

Bay Pines FL Detroit MI Columbus OH Richmond VA

Gainesville FL Minneapolis MN Dayton OH White River Junction

VT

Lake City FL St. Louis MO Muskogee OK Seattle WA

Miami FL Kansas City MO Oklahoma City

OK Spokane WA

Tampa FL Biloxi MS Portland OR Madison WI

Atlanta GA Jackson MS Philadelphia PA Milwaukee WI

Augusta GA Asheville NC Pittsburgh PA Clarksburg WV

Decatur GA Durham NC San Juan PR Martinsburg WV

Honolulu HI Salisbury NC Providence RI Sheridan WY

B.2 DELIVERY SCHEDULE

The government does not guarantee an award of any amount in any year of the contract period with the exception of the guaranteed minimum amount that will be issued during ordering period 1.

The guaranteed minimum award amount for this contract is $ 1,000.00. The maximum aggregate value of orders that can be placed under this contract is $4,000,000.00. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

This is the only guaranteed minimum amount to be issued under this IDIQ procurement and represents the minimum dollar value as defined by and referenced in FAR 16.504 and 52.216- 22, and in other clauses contained in this contract either in full text or by reference. The first task order will be issued will be issued on or after the IDIQ contract award date. All other quantities represented are estimates only and do not bind the government in any way.

Offerors must submit their proposed pricing using the table below. Offers submitted which do not use this table may not be considered for award.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0.00

Auditing Services - Contractor/CRQA shall conduct site visits at VA facilities and associated non-VA facilities in accordance with contract specifications.

Price items: 0001A-0001H.

Contract Period: Base POP Begin: 09-01-2020 POP End: 08-31-2021

Auditing Services - Reimbursable Travel Costs (in accordance with Federal Travel Regulations) Price to be determined based on travel location and in accordance with the Federal Regulations.

Contract Period: Base POP Begin: 09-01-2020

Do Not Provide Pricing.

0.00 HR __________________ __________________

Auditing Services Provide hourly rate for GCP QA Support to the VA CSP in accordance with contract specifications.

Contract Period: Base facilities and associated non-VA facilities in accordance with contract specifications.

Provide Pricing for Items: 1002A-1002H.

Contract Period: Option 1 POP Begin: 09-01-2021 POP End: 08-31-2022

Federal Travel Regulations) Price to be determined based on travel location and in accordance with the Federal Regulations.

Contract Period: Option 1 POP Begin: 09-01-2021

CSP in accordance with contract specifications.

Contract Period: Option 1 facilities and associated non-VA facilities in accordance with contract specifications.

Price items: 2001A-2001H.

Contract Period: Option 2 POP Begin: 09-01-2022 POP End: 08-31-2023

Federal Travel Regulations) Price to be determined based on travel location and in accordance with the Federal Regulations.

Contract Period: Option 2 POP Begin: 09-01-2022

CSP in accordance with contract specifications.

Contract Period: Option 2 facilities and associated non-VA facilities in accordance with contract specifications.

Price items: 3001A-3001H.

Contract Period: Option 3 POP Begin: 09-01-2023 POP End: 08-31-2024

Federal Travel Regulations) Price to be determined based on travel location and in accordance with the Federal Regulations.

Contract Period: Option 3 POP Begin: 09-01-2023

CSP in accordance with contract specifications.

Contract Period: Option 3 facilities and associated non-VA facilities in accordance with contract specifications.

Price items: 4001A-4001H.

Contract Period: Option 4 POP Begin: 09-01-2024 POP End: 08-31-2025

Federal Travel Regulations) Price to be determined based on travel location and in accordance with the Federal Regulations.

Contract Period: Option 4

Do Not Provide Pricing

CSP in accordance with contract specifications.

Contract Period: Option 4

0001A

1.00 DY __________________ __________________

Clinical Research Quality Assurance Visits-(price includes time on site, pre & post work, and portal-to-portal travel time).

1 Day Visit Contract Period: Base

0001B

2.00 DY __________________ __________________

site, pre & post work, and portal-to-portal travel time).

2 Day Visit Contract Period: Base

0001C

3.00 DY __________________ __________________

site, pre & post work,…