36C24E18R0002-001.docx

36C24E18R0002

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

501-18-2-283-0005 36C24E18R0002 02-13-2018 Michael Haydo 4128223158 02-28-2018

10:00 AM

00240E US Department of Veterans Affairs Veterans Health Administration Service Area Office (SAO) East 323 North Shore Drive, Suite 500 Pittsburgh

PA

15212-5319 X X 541611 $15 Million X N/A X Department of Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy 2401 Centre Ave, SE Albuquerque

NM

87108 00240E US Department of Veterans Affairs Veterans Health Administration Service Area Office (SAO) East 323 North Shore Drive, Suite 500 Pittsburgh

PA

15212-5319

00240E See electronic invoicing instructions.

X See CONTINUATION Page See schedule X X Michael D. Haydo

PCOE14L3-67579

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED

INSPECTED

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: _______________________________________________________ 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

33. SHIP NUMBER

34. VOUCHER NUMBER

35. AMOUNT VERIFIED CORRECT

36. PAYMENT

37. CHECK NUMBER

FOR

PARTIAL

FINAL

COMPLETE

PARTIAL

FINAL

38. S/R ACCOUNT NUMBER

39. S/R VOUCHER NUMBER

40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT 42a. RECEIVED BY (Print) 41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE 42b. RECEIVED AT (Location) 42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C24E Michael Haydo US Department of Veterans Affairs Veterans Health Administration Service Area Office (SAO) 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:

3. INVOICES: Invoices shall be submitted in arrears:

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.

See electronic invoicing instructions.

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

B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes FAR 52.219-14 Limitations on Subcontracting. Accordingly, any contract resulting from this solicitation will include this clause. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

B.3 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, and VAAR 852.215-71, Evaluation Factor Commitments. Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) to assist in assessing contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor compliance with the subcontracting commitments.

STATEMENT OF WORK (SOW)

NIDA MONITORING

1. CONTRACT TITLE

Monitoring IDIQ contract for Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) services

2. BACKGROUND

The VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) and the National Institute on Drug Abuse (NIDA) have partnered to fill a requirement to provide monitoring GCP CRQA services for the clinical trials conducted by NIDA. These trials are conducted at non-VA facilities throughout the United States. NIDA clinical trials vary over time in number, size and design, but typically consist of two to three trials conducted at 10 – 20 investigative sites.

The purpose of this request is to establish an Indefinite Delivery, Indefinite Quantity (IDIQ) contract to acquire the services of an experienced Contractor to serve as a provider of clinical trial site monitoring CRQA services for the NIDA studies. The Contractor shall serve as a study CRQA and shall provide services to the VA CSP through a division of the CSPCRPCC called the Site Monitoring, Auditing and Resource Team (SMART) located in Albuquerque, New Mexico.

3. SCOPE

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. The SMART accomplishes this task by ensuring that NIDA 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.

4. SPECIFIC TASKS

CRQA visits and associated services required:

CRQAs will have access to PHI/PII data during performance of the tasks stated in this Statement of Work.

CRQAs shall meet the minimum requirements stated below. Vendor shall provide the SMART PM group (ABQCSPSMART-PM@va.gov) documentation on any CRQAs performing services under the contract to include any future CRQAs added by the vendor. SMART PM will provide response back to vendor accepting CRQAs by name.

Qualifications/Technical Abilities/Capabilities:

· Degree/Professional Certifications required:

· Bachelor’s Degree or Licensed Health Care Professional

· Five years or more clinical research monitoring experience

· Technical Abilities/Capabilities:

· Software knowledge in Microsoft Office products (Word, PowerPoint, Excel, etc.)

4.1 Task 1 – CRQA visits (with pre and post work)

4.1.1 Subtask 1 – Site Initiation Visits - one to two days

[CLIN 1 & 2]

The CRQA shall conduct site initiation visits as defined by the Monitoring Plan with the support of a Lead CRQA from the SMART. The visits shall be scheduled after the Investigator’s Meeting. When conducting a site initiation visit, the CRQA shall perform an evaluation of all of the following, as relevant to the design of the trial:

· Protocol procedures including inclusion/exclusion criteria

· Subject informed consent process

· Screening procedure

· Randomization procedure

· Investigational Product Accountability

· Unanticipated Adverse Event reporting and Serious Adverse Event Reports

· Source document requirements and availability

· Case Report Form (CRF) completion, correction, QA procedures

· Institutional Review Board (IRB) policies and procedures (i.e., adverse events and protocol deviations)

· Regulatory and other study document completion and maintenance

· Site correspondence with sponsor, CRQA and maintenance

· Un-blinding procedures of a blinded study

· Other related protocol procedures

The CRQA shall assure the following regulatory information is present in the site files:

· Current IRB approval – protocol/amendments

· Current IRB approval – consents(s)

· Current IRB membership list or documentation of IRB compliance

· Investigator agreements

· Financial disclosures

· Investigator curriculum vitae (CV)

· Research and indemnity (if applicable) agreement

· All training requirements – GCP, Health Insurance Portability and Accountability Act (HIPAA) and Human Subjects Protections (HSP)

Additionally, the CRQA shall ensure the following Study Management Documents are completed (if applicable) and appropriately filed in the Essential Document Binder (Regulatory Binder):

· Delegation of Authority Form or CRF Authorization Log

· IRB policy and procedures (i.e., adverse event and protocol deviation reporting)

· IRB correspondence

· Sponsor correspondence

· Study contact list

· Subject list

· Site Visit Log

· CRFs (all versions)

· CVs

· Medical license(s)

4.1.2 Subtask 2 – Conduct routine CRQA visit for assigned site - one to three days

[CLIN 1 & 2]

The CRQA shall conduct the routine CRQA visits as defined by the CRQA Plan with the support of a Lead CRQA from the SMART. When conducting a routine CRQA visit, the CRQA shall perform an evaluation of the following tasks, if appropriate:

· Check for protocol compliance

· Review Essential Document Binder

· Conduct subject data review

· Verify CRF data against Source Documents

· Review timeliness of Query resolution

· Review Source Documents for Adverse Events (AE)/Serious Adverse Events (SAE)

· Review CRFs for accuracy and legibility

· Check for CRF submission to Data Coordinating Center

· Perform investigational product accountability

· Determine follow-up actions to be taken

· Provide relevant GCP Training

· Hold exit interviews with study teams to discuss site status

4.1.3 Subtask 3 – Conduct study final visit for assigned site - one to four days

[CLIN 1 & 2]

The CRQA shall conduct study final visits as defined by the CRQA Plan with the support of a NIDA Lead CRQA from the SMART. Timing of final visit shall be directed by the SMART NIDA Lead, Monitoring. During the visit the CRQA shall:

· Discuss site close-out procedures with staff

· Ensure submission of data and query resolution

· Review Essential Document Binder for completeness

· Check for final disposition of investigational product

· Retrieve documents for Sponsor files

· Discuss record retention with investigator

4.1.4 Subtask 4 - Prepare site visit reports and summary letters [CLIN 1]

Within seven (7) calendar days of site visit, the CRQA shall:

· Complete a site visit report (using a pre-approved template provided by the Lead) and prepare a follow-up QA summary letter, if applicable, that includes:

· Date(s) of visit

· Name of the CRQA who conducted the visit

· Name and address of the Investigator

· Identification of person(s) participating during the visit

· QA activities performed

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

· Provide QA documents, which may include reports and follow-up summary letter, to the SMART

· All reports and letters will be grammatically correct and sent to the SMART in the specified electronic format

4.1.5 Subtask 5 – Additional notes for preparing and conducting site visits [CLIN 1 & 2]

· Scheduling – The CRQA shall schedule all site visits through the SMART Program Manager (PM). The CRQA shall complete an announcement letter template request, a site visit report and follow up letter from each site visit. The CRQA shall forward to the SMART NIDA Lead CRQA for their review. Periodic conference call participation with multi-center clinical trial personnel and telephone contact with site staff shall be required.

· Special Requirements – The CRQA’s reporting requirements will necessitate computer program access and literacy in Microsoft Office Programs, e.g., Word, Excel, PowerPoint, as well as Internet capability to transmit documents and access email and correspondence. The CRQA shall provide all equipment and supplies necessary to perform the contract requirements set forth in the Request for Proposal (RFP) except for a laptop computer which shall be provided by the Government for use in providing the CRQA services. Computer Access must be maintained. Travel arrangements shall be the responsibility of the CRQA. Following the Clinical Research Quality Assurance Plan (CRQAP) – A CRQAP will be provided by the SMART to the CRQA to direct activities during the site visit. The CRQAP is a document developed to ensure the clinical trial (study) is conducted in accordance with applicable laws, regulations, guidelines and VA CSP policies and procedures. To become fully aware of the scope of requirements the CRQA must fully understand the requirements of the CRQAP and can provide all services required by the Plan.

· Frequency of Visits – The frequency and timing of CRQA visits will be determined by SMART for each site based on the following:

· Study Team recommendations

· Subject accrual rate at the site

· Total number of subjects to be enrolled at the site

· Complexity of the study protocol

· Data collection and record keeping proficiency at the site

· Observations and corrective actions from previous monitoring visits

· Preparing for Visits – Prior to the CRQA visits, the CRQA shall assemble all documents and resource materials needed to conduct the visit (i.e., correspondence, previously completed monitoring documents, etc.) The CRQA shall contact the site coordinator to set up a date/time for the visit and to discuss:

· Tentative Agenda

· Estimated time needed on site with the Site Investigator/Coordinator

· Specific documents needed for review

· Excess hours – for studies with high complexity or for activities not initially required, the CRQA may be required to provide services beyond that were originally planned. In such cases, the CRQA shall contact the Lead or Chief, NIDA Monitoring for authorization to bill for these excess hours.

The CRQA shall contact the SMART to confirm the schedule and to initiate an announcement letter for a scheduled site visit. The SMART is responsible for sending the announcement letters to the Principal Investigator (PI), Study Coordinator, Data Coordinating Center (DCC), the Clinical Research Associate and GCPMG study File.

4.2 Task 2 – CRQA Visits (without pre and post work) and other Clinical Trials related activities [CLIN 1 & 2]

4.2.1 Subtask 1 – Meeting or other visits - one to four days

1. Pre-Kickoff Meeting

2. Kickoff Meeting

3. Investigator’s Meeting

4. SMART Annual CRQA training

5. Other The CRQA may be required to attend the Kickoff Meeting held prior to the clinical trial start where all trial participants will receive training for specific study procedures and requirements. The CRQA shall attend the Kickoff Meetings to receive training on study protocol and procedures. Training will be provided by the Study Chairman, Sponsor, and other study personnel. In addition to attending the meeting, the CRQA may be required to provide training to site personnel on the requirements of the monitoring plan. The CRQA may be required to participate in Clinical Trial related conference calls.

b. 4.2.2 Subtask 2 -Support of other the CRQA conducting visits - one to three days on site

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

4.3 Task 3 – GCP QA Support / Hours [CLIN 3]

· Lead activities

· Monitoring Form development

· EDB / Participant Study Binder creation

· Protocol and Operations Manual Review and Editing

· Develop CRQA Plan

· Source Document Plan

· Review and Edit Reports from other CRQAs

· Attend Sponsor Calls

· Address questions from sites and Sponsors

· Other activities as required

· Activities supporting other CRQAs such as training/retraining

· Complete mandatory VHA training (Privacy, HIPAA, Ethics, Information Security, GCP Training and others as assigned)

· All Monitors activities

· Activities supporting other CRQAs such as training/retraining or remote monitoring.

· Complete required study specific training.

· Complete mandatory VHA training (Privacy, HIPAA, Ethics, Information Security, GCP Training, Rules and Behavior and others as assigned - to be completed in TMS prior to start of work).

· Complete SMART and CSP policies and procedure training and orientation

4.4 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, Appendix E 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;

· Successfully complete the appropriate VA privacy training in TMS and annually complete required privacy training; and

· Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access.

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.

4.5 Records Management

4.5.1. 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.

4.5.2. 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.

4.5.3. 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.

4.5.4. 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.

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

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

4.5.7. 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.

4.5.8. 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.].

4.5.9. 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.

4.5.10. 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.

5. TRAVEL EXPENSES

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. The place of performance includes work sites throughout United States and the SMART office which is in Albuquerque, NM. The CRQA shall make his or her own travel arrangements.

6. INVOICING

The CRQA will invoice for services rendered and expenses incurred utilizing the invoice template, travel expense and professional service worksheets and training supplied at the time of award (See Attachment A & B). When the CRQA is a subcontractor, the primary contract holder is responsible for the review, approval and submission for payment of all invoices submitted to the SMART PM group (ABQCSPSMART-PM@va.gov) under their contract. All communications regarding invoicing from a subcontractor shall be directed through the primary contract holder. Invoices should be submitted only after all QA services are complete and all associated QA documents are submitted. After SMART (NIDA) PM approves the invoice, the contractor will submit the final invoice as directed in the contract (typically via Tungsten Network).

7. PAYMENT

Invoice(s) will be paid in arrears. Invoice amount(s) must match the agreed – upon contract pricing. Invoices listing incorrect information, such as incorrect amounts, will be returned to the Contractor. The Contractor shall submit a properly prepared invoice that shall contain at a minimum:

· Name and address of business

· Invoice date

· Invoice number

· Dates of services completed

· Contract and Purchase Order numbers

· Description, price, quantity or goods/services provided

· Total dollar due

· Other information as required by contract

Verify all required receipts used to claim reimbursement are inclusive of VA travel dates and allowable reimbursement per GSA and federal regulations

8. 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).

9. GOVERNMENT-FURNISHED EQUIPMENT (GFE) AND/OR GOVERNMENT-FURNISHED INFORMATION (GFI)

The Contractor will be assigned a government issued laptop computer & Broadband Modem.

10. CONTRACTOR EQUIPMENT

The Contractor and/or subcontractor will be responsible for acquiring a phone and fax machine or any other equipment necessary to perform their duties.

11. PLACE OF PERFORMANCE

The Contractor will be required to perform work at various sites (hospitals and/or clinics) throughout the United States, at the Contractor’s place of business and at the SMART office in Albuquerque, New Mexico. The Contractor must be available by pager or 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. It is essential that the Contractor can promptly respond to the needs of the SMART, i.e., can report within 24 hours to the SMART Office or to the VA research facility reporting a problem.

SMART 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.

12. PERIOD OF PERFORMANCE

Base Year -April 1, 2018 through March 31, 2019 Option Year One - April 1, 2019 through March 31, 2020 Option Year Two - April 1, 2020 through March 31, 2021 Option Year Three - April 1, 2021 through March 31, 2022

13. DELIVERY SCHEDULE

BASE YEAR (POP: April 1, 2018 through March 31, 2019)

OPTION YEAR ONE (POP: April 1, 2019 through March 31, 2020)

OPTION YEAR TWO (POP: April 1, 2020 through March 31, 2021)

OPTION YEAR THREE (POP: April 1, 2021 through March 31, 2022)

14. DEFINITIONS/ACRONYMS

VA CSP/VA CSPCRPCC – VA Cooperative Studies Program or VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center

VA CSP (or CSP) – VA Cooperative Studies Program

VA – Department of Veterans Affairs

NMVAHCS – New Mexico VA Health Care System

NIDA – National Institute on Drug Abuse

CRQA – Clinical Research Quality Associate

CRQAP – Clinical Research Quality Assurance Plan – Study specific Monitoring plan or Auditing Plan

GCP – Good clinical practices as presented in the International Conference on Harmonization (ICH 6) and adopted by the VA CSP

GSA – Government Services Administration

FAR – Federal Acquisition Regulation

QA – Quality Assurance; those actions taken by the Government to assure services meet the requirements of the Statement of Work (SOW)

QC – Quality control; those actions taken by the contractor to satisfy the requirements of the Statement of Work (SOW)

SMART – Site Monitoring, Auditing and Resource Team

SUBCONTRACT – A contract entered into by the contractor with another organization or person in which an agreement is reached to perform any administrative function or service the contractor specifically related to securing or fulfilling the Contractor’s obligation to the NMVAHCS under the terms of the contract.

36C24E18R0002 SUBCONTRACTOR – any organization or person that provides any function or service for the Contractor specifically related to securing or fulfilling the Contractor’s obligations to the NMVAHCS (VA CSP) under the terms of the contract.

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VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR

INCLUSION INTO CONTRACTS, AS APPROPRIATE

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

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3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data

- General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in…