S02 36C24622Q0119 Next Generation Testing1.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 58

36C24622Q0119

Tiara White 757-251-5762

EST

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

X

$35 Million

N/A

X

Richmond VAMC Pathology and Lab Building 500-3A134 Richmond VA 23249

100 Emancipation Drive Hampton VA 23667

Financial Services Center

PO BOX 149971

Austin TX 78714-9971 x

See CONTINUATION Page

This is a solicitation for the services of Genetic Testing Panels for the Richmond VA Medical Center.

The offeror shall submit its offer IAW all clauses, provisions within this solicitation, the SOW as well as the instructions to offerors.

The offeror shall complete pricing data in both the Schedule of Items and the Price/Cost Schedule.

The offeror shall indicate any and all discounts offered to the VA.

Offeror shall be registered and current in the System for Award Management (SAM) database at the time of award.

www.sam.gov/SAM/.

See CONTINUATION Page

X X x 1

Cherisse A. Hall Contracting Officer

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 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 22

C.3 52.223-99 Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors.

C.4 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.5 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.6 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 27

C.7 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 INSTRUCTIONS TO OFFERORS

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.3 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

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

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer Cherisse A. Hall

100 Emancipation Drive

Hampton VA 23667

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] monthly 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.

Department of Veterans Affairs

Financial Services Center

PO 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

B.2 STATEMENT OF WORK

Genetic Testing

I. Introduction Central Virginia VA Health Care System Department of Pathology and Laboratory Medicine Services has a need to acquire genetic testing services for patients with prostate cancer and other malignancies. Results of this testing will provide information to guide treatment, as well as provide the possible risk of developing cancer again in the future. Genetics testing also provides information on gene mutations that may be passed to future generations. The estimated volume of tests needed for fiscal year 2022 and 4 options years will be provided in the IGCE.

Contractor shall provide genetic testing services to include: specimen requirements, means of transport for specimens from VA laboratories to contractor’s laboratory; processing and analysis of the specimen. Consultation regarding selection, collection, transportation and result interpretation shall also be provided when required.

II. Contractor Responsibilities

(a) Provide all supplies necessary to transport the specimens to include:

(1) Lab test request forms

(2) Specimen shipping containers

(3) Special instructions for handling of specimen

(4) Transportation envelopes or packs with tracking air bills

(b) A Laboratory User’s Manual or similar documentation will be provided to the Central Virginia VA Healthcare System Laboratory. The manual shall include the testing methodology used for each test, test reference ranges, and specimen requirements and any special handling required.

(c) Transport samples in such a manner as to ensure the integrity of the specimen.

Contractor will supply any special preservatives required for specimen preservation. All specimens shall be shipped in containers provided by contractor.

(d) Analyze samples. The contractor shall return the test results to the Central Virginia VA Healthcare System Laboratory within established time-frames.

(e) Contractor shall provide the VA laboratories with a means of communication to permit immediate inquiry regarding the status of pending test.

(f) Contractor shall consult with VA Laboratories on test results by telephone when urgency of situation requires.

(g) The VA Laboratories reserves the right to request the results of any proficiency testing that the contractor subscribes.

(h) Contractor shall provide monthly billing for tests provided by the 20th of each month following the month in which the service was delivered.

III. Reporting of Test Results A report is defined as a printed final copy of laboratory testing results. Each test report shall at a minimum indicate the following information:

(a) Patient’s name and identification code or last 4 digits of Social Security Number

(b) Physician’s name (if supplied)

(c) Medical Center or VA facility name

(d) Patient’s location, e.g. clinic, ward (if supplied)

(e) Test ordered

(g) Date/time of specimen collection (when available)

(h) Date/time specimen received in Reference Lab

(i) Date test completed

(j) Test result

(k) Flag abnormal results

(l) Reference Range

(m) Toxic and/or therapeutic range where applicable

(n) Name of testing laboratory (contractor and/or subcontractor)

(o) Testing laboratory specimen number

(p) Type of specimen

(q) Comments related to the test provided by the submitting lab

(r) Information that may indicate a questionable validity of test results

(s) Unsatisfactory specimen shall be reported with reason as to its unsuitability for testing

Reports shall be faxed to the number provided in the laboratory. The use of an online portal for ordering and obtaining results can only be used if VA security requirements are met.

IV. Quality Control Contractor shall notify the VA Laboratory Director (or designee) immediately by phone or email of any testing errors or defective tests. The notification shall be followed up by a written statement with recommended actions to take to remedy or resolve the situation. If the Contractor has defects or errors in their testing procedure that caused erroneous results, the Contractor shall repeat the test at no charge to the VA or provide a credit to the VA. The choice of which will be discussed between the VA and the Contractor.

For quality purposes, tests routinely performed in duplicate should be indicated.

V. Testing Changes The Contractor shall advise the Central Virginia VA Healthcare System Laboratory Director (or designee) of any changes in assay methodology, procedures, reference ranges and any new tests introduced.

If the contractor changes the assay procedures or a critically important component of an assay (e.g., an antibody, purified antigen, etc.) the contractor shall notify the VA Laboratory Director (or designee) prior to the intended change. The contractor shall provide documentation that the quality and efficacy of the test will remain unchanged or be improved.

VI. VA Laboratory Responsibilities The VA Laboratory will provide laboratory specimens prepared in accordance with the contractor’s Laboratory User’s Manual. All specimens will be properly identified and labeled for testing.

The VA Laboratory will ship clinical specimens to the contractor on the same day of collection, excluding weekends and holidays. If a specimen is drawn on a weekend or holiday and can be preserved, it will be shipped on the next regular business day. Formalin-fixed, paraffin-embedded specimens will be shipped as soon as possible after being requested by the clinician or pathologist. All specimens will be properly stored in accordance with the policies and procedures of the reference lab.

VII. Changes to the Statement of Work

The government may require additional Oncotype testings’ as well as other Oncotype DX testing as patient needs dictate. Any changes to this SOW shall be authorized and approved only through written correspondence from the CO and/or a modification of the contract. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

VIII. CONTRACTOR QUALIFICATIONS

1. The reference laboratory and any subcontractors thereof must be licensed or accredited by the College of American Pathologists, the Nuclear Regulatory Commission, the Center for Disease Control, Medicare and/or other state regulatory agencies as mandated by federal and state statutes. In addition, the laboratory must be certified as meeting the requirements of the Clinical Laboratory Improvement Act of 1988 and comply with the National Standards to Protect the Privacy of Personal Health Information

(HIPPA).

2. 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.

3. The contracted laboratory must meet HIPPA requirements. The contractor shall be required to be in compliance with the Health Insurance Portability and Accountability Act of 1996 regulations and when needed, will be required to sign a Business Associate Agreement with the VA. The signed agreement will be returned to the contracting officer and a signed copy will be returned to the contractor for their files.

4. The contractor shall ensure the confidentiality of all patient information being faxed, mailed or transported and will be held liable in the event of a breach of confidentiality.

The contractor shall comply with the provision of the Federal Privacy Act of 1974 (Public Law 93-579), HIPAA (Public Law 104-191), and the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment and Rehabilitation Act of 1972 (Public Law 93-255), as well as any other statutes regarding confidentiality of patient information during and after the execution of the contract. The contractor shall obtain a signed confidentiality certificate from each employee that may have access to medical record information prior to allowing them to work on this contract. Any information about an individual that is maintained by the VA shall be kept confidential. A copy of a signed certificate shall be provided to the CO upon request.

5. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by the VA which has been generated by the contractor in performance of this task order, are the exclusive property of the U.S.

Government and shall be submitted to the CO at the conclusion of the task order. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response. Press releases, marketing material, or any other printed or electronic documentation related to this contract, shall not be publicized without the written approval of the CO.

6. 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.

A. Position Sensitivity – The position sensitivity has been designated as (low) risk.

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

C. 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.

XII. RECORDS MANAGEMENT CONTRACT LANGUAGE

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.

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

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.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

50.00 EA __________________ __________________

GENETIC TESTING PANELS (EXCLUDING EXOME)

Contract Period: Base POP Begin: 11-24-2021 POP End: 09-30-2022 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Laboratory Testing

Contract Period: Option 1 POP Begin: 10-01-2022 POP End: 09-30-2023

Contract Period: Option 2 POP Begin: 10-01-2023 POP End: 09-30-2024

Contract Period: Option 3 POP Begin: 10-01-2024 POP End: 09-30-2025

Contract Period: Option 4 POP Begin: 10-01-2025 POP End: 09-30-2026

GRAND TOTAL __________________

B.3 DELIVERY SCHEDULE

ITEM NUMBER QUANTITY

DELIVERY

DATE

0001 SHIP TO: DEPARTMENT OF VETERANS

AFFAIRS

RICHMOND VAMC

PATHOLOGY & LAB Bldg. 500- 3A134

RICHMOND, VA 23249

50.00 11/24/2021- 09/30/2022

MARK

FOR:

KARMEN PURDEL

804-675-5163

KARMEN.PURDEL@VA.GOV

1001 SHIP TO: DEPARTMENT OF VETERANS

AFFAIRS

RICHMOND VAMC

PATHOLOGY & LAB Bldg. 500- 3A134

RICHMOND, VA 23249

50.00 10/01/2022- 09/30/2023

MARK

FOR:

KARMEN PURDEL

2001 SHIP TO: DEPARTMENT OF VETERANS

RICHMOND VAMC

PATHOLOGY & LAB Bldg. 500- 3A134

RICHMOND, VA 23249

50.00 10/01/2023- 09/30/2024

MARK

FOR:

KARMEN PURDEL

3001 SHIP TO: DEPARTMENT OF VETERANS

RICHMOND VAMC

PATHOLOGY & LAB Bldg. 500- 3A134

RICHMOND, VA 23249

50.00 10/01/2024- 09/30/2025

MARK

FOR:

KARMEN PURDEL

4001 SHIP TO: DEPARTMENT OF VETERANS

RICHMOND VAMC

50.00 10/01/2025- 09/30/2026

PATHOLOGY & LAB Bldg. 500- 3A134

RICHMOND, VA 23249

MARK

FOR:

KARMEN PURDEL

B.4 SPECIAL CONTRACT REQUIREMENTS

A. WORK HOURS

The services covered by this contract shall be furnished by the contractor as defined herein. The contractor shall not be required, except in case of emergency, to furnish such services on Federal Holidays or during off duty hours as described below.

The following terms have the following meanings:

Normal working hours: Monday through Friday, 8:00 a.m. – 4:30 p.m., excluding federal holidays.

New Year’s Day Martin Luther King’s Day Memorial Day President’s Day Juneteenth Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Christmas

Any other day specifically declared by the President of the United States to be a federal holiday.

When one of the holidays falls on Sunday, the following Monday shall be observed as a Federal Holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday.

B. BILLING AND PAYMENT

Invoices shall be submitted monthly, in arrears to the VA’S Electronic Invoice Presentment and Payment System (see website at http://www.fsc.va.gov/einvoice.asp), and shall include at a minimum:

Date of invoice

Contract Number

Purchase Order Number

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

Invoice Number

CLIN & Date of service

C. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

LANGUAGE FOR INCLUSION INTO CONTRACTS, FOR MEDICAL EQUIPMENT

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.

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 accordance with VHA Handbook 1600.01, 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 COTR.

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA’s network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA.

These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of

PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor’s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor’s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA’s POA&M management process. The contractor/subcontractor must use VA’s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

f. VA prohibits the installation and use of personally-owned or contractor/subcontractor-owned equipment or software on VA’s network. If non- VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non- VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

i. Vendor must accept the system without the drive;

ii. VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

iii. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

iv. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

1. The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

2. Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

3. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

6. 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 COTR 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.

7. 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:

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

ii. Description of the event, including:

1. date of occurrence;

2. data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected;

iii. Names of individuals or groups affected or potentially affected;

iv. 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;

v. Amount of time the data has been out of VA control;

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

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

viii. Assessment of the potential harm to the affected individuals;

ix. Data breach analysis as outlined in 6500.2 Handbook, Management of

Security and Privacy Incidents, as appropriate; and

x. 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 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

i. Notification;

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

iii. Data breach analysis;

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

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

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

8. 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-day’s 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.

9. TRAINING

a. 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:

i. 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;

ii. Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

iii. Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

iv. Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

b. The contractor shall provide to the contracting officer and/or the COTR 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.

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.

SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

ITEMS

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

(End of Clause)

FAR

Number

Title Date

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

DEC 2013

52.217-8 OPTION TO EXTEND SERVICES NOV 1999

C.2 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR

2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

C.3 52.223-99 Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors.

ENSURING ADEQUATE COVID-19 SAFETY PROTOCOLS FOR

FEDERAL CONTRACTORS (OCT 2021) (DEVIATION)

(a) Definition. As used in this clause -

United States or its outlying areas means—

(1) The fifty States;

(2) The District of Columbia;

(3) The commonwealths of Puerto Rico and the Northern Mariana Islands;

(4) The territories of American Samoa, Guam, and the United States Virgin

Islands; and

(5) The minor outlying islands of Baker Island, Howland Island, Jarvis Island, Johnston…