RFQ 36C24822Q0164.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 37

36C24822Q0164 12-01-2021

Jessica Kiser 407-646-4017 12-07-2021

12:00 EST

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

X

621511

$35 Million

N/A

X

36C672

Department of Veterans Affairs VA Caribbean Healthcare System 10 Casia Street

San Juan PR 00921-3201

36C248

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

Department of Veterans Affairs Financial Services Center

P.O. Box 149971 Austin TX 78714-9971

(877) 353-9791 (512) 460-5429

See CONTINUATION Page

Solicitation for Lung Blood Test Nodify - Cost Per Tests for the VA Caribbean Healthcare System in San Juan, PR.

See section B.2 to quote items.

See CONTINUATION Page

X X

X 1

36C24822Q0164

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.2 PRICE/COST SCHEDULE/ITEM INFORMATION

B.3 DELIVERY SCHEDULE

B.4 STATEMENT OF WORK

SECTION C - CONTRACT CLAUSES

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

2018)

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

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-21 REQUIREMENTS (OCT 1995)

C.6 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

C.7 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.8 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

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

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.10 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.11 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.12 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

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

(DEVIATION)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

1998)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

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

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: 36C248- Contracting Officer: Norbert Reed, Norbert.Reed@va.gov Contract Specialist: Jessica Kiser, Jessica.Kiser@va.gov

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or [] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Annually

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.

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971

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

AMENDMENT NO DATE

mailto:Norbert.Reed@va.gov mailto:Jessica.Kiser@va.gov

B.2 PRICE/COST SCHEDULE/ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES

ESTIMATED

QUANTITY UNIT UNIT PRICE

ESTIMATED

AMOUNT

15.00 EA __________________ __________________

Lung Blood Test-NODIFY CDT TESTING

Contract Period: Base POP Begin: 12-15-2021 POP End: 12-14-2022 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Laboratory Testing

MANUFACTURER PART NUMBER (MPN): CDT

Lung Blood Test-NODIFY XL2 TESTING

Contract Period: Base POP Begin: 12-15-2021 POP End: 12-14-2022 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

MANUFACTURER PART NUMBER (MPN): XL2

Contract Period: Option 1 POP Begin: 12-15-2022 POP End: 12-14-2023 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Contract Period: Option 1 POP Begin: 12-15-2022 POP End: 12-14-2023 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Contract Period: Option 2 POP Begin: 12-15-2023 POP End: 12-14-2024 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Contract Period: Option 2 POP Begin: 12-15-2023 POP End: 12-14-2024 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Lung Blood Test-NODIFY CDT TESTING Contract Period: Option 3 POP Begin: 12-15-2024 POP End: 12-14-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Contract Period: Option 3 POP Begin: 12-15-2024 POP End: 12-14-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Contract Period: Option 4 POP Begin: 12-15-2025 POP End: 12-14-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Contract Period: Option 4 POP Begin: 12-15-2025 POP End: 12-14-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

GRAND TOTAL __________________

B.3 DELIVERY SCHEDULE

ITEM NUMBER

ESTIMATED

QUANTITY

PERIOD OF

PERFORMANCE

0001-

SHIP TO: Department of Veterans Affairs VA Caribbean Healthcare System 10 Casia Street San Juan, PR 00921 3201

USA

As shown in Section B.2

12/15/2021- 12/14/2022

MARK

FOR:

To Be Deternined

B.4 STATEMENT OF WORK

Nodify Lung Molecular Testing

1.0 Purpose

Veterans Affairs Caribbean Healthcare System (VACHS) in San Juan, Puerto Rico has a requirement for the molecular test Nodify Lung. The Pathology and Laboratory Medicine Service (P&LMS) is a clinical laboratory that does a wide menu of laboratory testing to include Anatomic Pathology service and Clinical Laboratory services. The P&LMS in accordance with Federal Regulations, following accreditation agencies requirements and improving services to the veteran’s population is requesting a base plus four-year option in order to provide expertise and exclusive reference laboratory services to those patients with lung nodules for the detection of lung cancer, one of the most common cancer found in our veteran’s population. Nodify Lung is a blood-based biomarker in patients with pulmonary nodules.

2.0 Scope

VACHS, Pathology and Laboratory Medicine Service requires Cost Per Test base 12 Months and four one-year options contract for the testing of lung cancer risk assessment thru genomic profile.

Nodify Lung is composed of CDT, and the XL2 test helps pneumologists identify patients with a high risk of developing lung cancer. In addition, it keeps in surveillance those with low genomic profile, avoiding and reducing unnecessary biopsy or surgery procedures, and ensuring the patient gets the right surgery at the right time, reducing the waste of resources.

The Nodify XL2 tests patients with incidental lung nodules:

• ≥40 years old

• 8-30 mm nodule

• ≤50% risk of malignancy (Solitary Pulmonary Nodule calculator (Mayo Model)

• No history of non-lung cancer within five years

• No lung cancer history

Nodify CDT tests patients with incidental lung nodules:

• ≥40 years old

• 8-30 mm nodule

• ≤65% risk of malignancy (Solitary Pulmonary Nodule Calculator (Mayo Model)

• No previous diagnosis of cancer

The contractor shall perform tests per the guidelines established by Federal, State, and local ordinances, with the Federal Drug Administration (FDA) and manufacturer’s policies, and with all terms, conditions, provisions, schedules, and specifications provided herein.

3.0 Requirement

The contractor shall provide the following material:

CPT code: 88291- 15 XL2 and CDT, each, plus all shipment material required to ship the specimens back to the contractor for testing.

4.0 Period of Performance and Delivery

This requirement shall be effective from the date of award.

https://nodulerisk.biodesix.com/nodulerisk https://nodulerisk.biodesix.com/nodulerisk

Estimated Period of Performance dates subject to change after award.

Base: 01/01/2021 to 12/31/2022 Option 1: 01/01//2022 to 12/31/2023 Option 2: 01/01/2023 to 12/31/2024 Option 3: 01/01/2024 to 12/31/2025 Option 4: 01/01/2025 to 12/31/2026

Deliver to Veterans Affairs Caribbean Healthcare System, Attn: Pathology & Laboratory Medicine Services (113), 10 Casia Street, San Juan, PR 00921

5.0 Responsibilities of Contractor’s Laboratory

The contractor shall provide personnel to perform the following test referred by Veterans Affairs Caribbean Healthcare System, 10 Casia Street, San Juan, PR 00921 as required:

1. Contractor shall perform tests as required by the VACHS.

2. Test will be shipped to Contractor via vendor’s required shipping service.

3. VACHS will be responsible for sending specimens to contractor.

5.1 Turnaround Time

Testing will be performed within the published turnaround times established by contractor’s Laboratory Test Directory. Contractor shall consistently meet its published turnaround times and closely monitor its ability to meet published turnaround times as an indirect measure of testing capacity. As testing demand warrants, vendor may initiate additional runs, hire additional employees, and/or purchase additional equipment to meet the needs of new, guaranteed, or anticipated business.

1. The contractor may fax, mail or email results.

(a) Fax Information:

ATTN: Pathology & Laboratory Medicine Services (113) Telephone number: (787) 641-7582 ext. 10136 Fax number: (787)-641-5339

(b) Caribbean VA Healthcare System ATTN: Pathology/Laboratory (113) 10 Casia Street San Juan, PR 00921-3201

(c) Encrypted electronic email:

Laura.vega-vazquez@va.gov and to the ordering provider email that are provided in the test requisition.

2. Laboratory tests shall be performed Monday through Friday 08:00 AM to 4:30 PM, excluding federal holidays.

6.0 Responsibilities of the VACHS:

Contact point for the VA Caribbean Healthcare System is Pathology & Laboratory Medicine Services (787) 641-7582 ext. 10136. Pathology & Laboratory Medicine Services will be responsible for coordination with CBL Path. Ms. Laura Vega, Anatomic Pathology Supervisor will be the Contracting Officer Representative (COR) for this contract and is responsible for the record keeping and certification of payment.

7.0 Procedures

1. The test is requested thru Computer Patient Record System (CPRS) pathology requisition section. The pneumologist will place an electronic order thru patient electronic record system.

After test is completed and reported to the pathology laboratory the completed report will be uploaded to VISTA Imaging at CPRS and a Molecular Pathology notification will be generated to ordering provider.

2. P&LMS staff will ship the company the specimens within the established timeframe and following collection instruction provided in the contract. The specimens must be correctly identified patient information and laboratory accession number when required, accompanied with the test requisition form filed and copy of the pathology report when applicable.

2. The contractor is responsible to perform the genomic profile on the peripheral blood specimen submitted as requested by physician. The material is collected in the specified collection tubes provided by the contractor.

3. The contractor is responsible to perform Nodify Lung test using a blood-based antibody assay, one to determine the likelihood of a pulmonary nodule to be malignant or benign therefore re-classifying risk for patients at the VACHS.

4. The contractor is responsible for handling, transporting and delivering packing and shipping materials required to ship samples for testing according federal regulations.

5. The contractor is responsible to cover shipping expenses when material is sent for testing.

6. The contractor is responsible to include instructions for shipping as well as any other specific instructions as required.

7. The complete package must include:

i. Test requisitions, Collection Tubes, Shipping Box with ice pack for specimen packaging, FEDEX international airway bill form pre-printed with company FEDEX account number and required information and FEDEX bag for shipping.

8. The contractor will not charge a QNS “QUANTITY NOT SUFICIENT” test and will notify laboratory in written form for proper action and addendum to pathology report.

9. The contractor must have a completed report with a turnaround time of 10-14 business days.

10. The contractor will not accept a specimen for testing with more than 48 hours upon collected.

11. The contractor is responsible to send all final report to the pathology department via mail, encrypted electronic mail or fax, following all Privacy/HIPPA regulations to safeguard patient sensitive information to the following address:

12. The contractor will provide VACHS with a monthly statement of services performed. The Contractor will be paid monthly, in areas, upon receipt of a proper invoice for the services furnished in the previous months. Inclusion on your invoice should be your Company's name, tax ID number, funding obligation number (purchase order number), description of services, period of services, amount, and remit to address. See section B.2 for invoicing information. Payment will be made upon written certification from the COR that the services have been performed.

13. The contractor shall be held responsible for any fines/penalties assessed due to state, local or federal laws being violated by the contractor.

14. The laboratory is responsible to provide the company, the specimens within the established timeframe and following collection instructions provided by the contractor. The specimens must be correctly identified patient information and laboratory accession number when required, accompanied with the test requisition form filled and a copy of the pathology report when applicable.

With Sensitive Data and Training

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

LANGUAGE

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. 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.

b. A contractor/subcontractor 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.

c. 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.

d. 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.

Contractor Personnel 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 Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start date of the contract the contractor will be responsible for the actions of those individuals that provide or perform work for the VA.

1. Position Sensitivity – The position sensitivity has been designated as __ low __ risk.

2. Background Investigation – The level of background investigation commensurate with the required level of access is National Agency Check (NACI) with written inquiries.

3. Contractor Responsibilities

a. The contractor shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM), the contractor shall reimburse the VA within 30 days.

The web site which provides information on the cost of the security investigation is:

www.opm.gov\extra\investigate – Select Federal Investigations Notices (FIN 01-01)

b. The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and are able to read, write, speak, and understand the English language.

c. The contractor will provide to the Contracting Officer prior to award the following: (1) List of names of contract personnel. (2) Social security numbers of contractor personnel. (3) Home address of contractor personnel or the contractor address.

The Contracting Officer will submit the above information to the Office of Security and Law Enforcement, Washington, D.C. The Office of Security and Law Enforcement will provide the necessary investigative forms (these forms are indicated in paragraph 3.d. below) to the contractor’s personnel, coordinate the background investigations with OPM and notify the Contracting Officer and contractor of the results of the investigation.

d. The contractor shall submit or have their employees submit the following required forms to the VA Office of Security and Law Enforcement within 30 days of receipt:

(i) Standard From 85P, Questionnaire for Public Trust Positions

(ii) Standard Form 85P-S, Supplemental Questionnaire for Selected Positions

(iii) FD 258, U.S. Department of Justice Fingerprint Applicant Chart

(iv) VA Form 0710, Authority for Release of Information Form

(v) Optional Form 306, Declaration for Federal Employment

(vi) Optional Form 612, Optional Application for Federal Employment

d. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract.

e. Failure to comply with the contractor personnel security requirements may result in termination of the contract for default.

http://www.opm.gov/extra/investigate

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 onsite 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 accordance with VHA Handbook 1600.1, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

SECURITY INCIDENT INVESTIGATION

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. 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.

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

1) Nature of the event (loss, theft, unauthorized access);

2) Description of the event, including:

a. date of occurrence;

3) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

4) Number of individuals affected or potentially affected;

5) Names of individuals or groups affected or potentially affected;

6) 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;

7) Amount of time the data has been out of VA control;

8) The likelihood that the sensitive personal information will or has been compromised

(made accessible to and usable by unauthorized persons);

9) Known misuses of data containing sensitive personal information, if any;

10) Assessment of the potential harm to the affected individuals;

11) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

12) 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.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 for affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

1) Notification;

2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

3) Data breach analysis;

1) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

2) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

3) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days’ notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

TRAINING

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete VA Privacy and Information Security Awareness and Rules of Behavior Training and Privacy and HIPAA Training and HIPAA Training before being granted access to VA information and its systems.

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Rules of Behavior before being granted access to VA information and its systems.

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

c. 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 as the training and documents are complete.

RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS (NARA)

The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

1. Citations 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.

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.

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. 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.

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

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

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.

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.].

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.

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.

The Certification and Accreditation (C&A) requirements do not apply and a Security Accreditation Package is not required for this SOW.

SECTION C - CONTRACT CLAUSES

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

ITEMS (OCT 2018)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line-item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of persons to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by

EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractors point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts;

18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C.