RFQ 36C25723Q1106.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. UEI: EFT:

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. NOV 2021)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C25723Q1106 07-24-2023

Marcellus Jackson 210-694-6376 08-08-2023

13:00 EDT

36C257

Department Of Veterans Affairs

Network Contracting Office 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

X

334516

1000 Employees

N/A

X

36C549

Department of Veterans Affairs

VA North Texas Healthcare System

Laboratory

4500 S. Lancaster Rd.

Dallas TX 75216

36C257

Network Contracting Office 17

This is accomplished through the

Tungsten Network located at:

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

This is mandatory and the sole method for submitting invoices.

(877) 353-9791 (512) 460-5540

See CONTINUATION Page

This solicitation is for an immunoassay analyzer, reagents, consumables, supplies and maintenance services IDIQ for the

VA North Texas Healthcare System (VANTHCS) in Dallas, TX.

Any questions must be submitted in writing to the POC at marcellus.jackson@va.gov no later than 7/31/2023, 13:00 ET.

IDIQ Ordering Periods:

Ordering Period 1: 9/19/2023 - 9/18/2024

Ordering Period 2: 9/19/2024 - 9/18/2025

Ordering Period 3: 9/19/2025 - 9/18/2026

Ordering Period 4: 9/19/2026 - 9/18/2027

Ordering Period 5: 9/19/2027 - 9/18/2028

See CONTINUATION Page

X X

X 1

Vance Wayne Farrell

Contracting Officer

36C25723Q1106

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

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.4 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

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

C.2 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS (NOV 2021)

C.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JUN 2023)

C.4 52.216-18 ORDERING (AUG 2020)

C.5 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.6 52.216-22 INDEFINITE QUANTITY (OCT 1995)

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

C.8 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.9 52.237-2 PROTECTION OF GOVERNMENT BUILDINGS, EQUIPMENT, AND

VEGETATION (APR 1984)

C.10 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.11 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.12 VAAR 852.204-71 INFORMATION AND INFORMATION SYSTEMS SECURITY

(FEB 2023)

C.13 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023) ... 57

C.14 VAAR 852.219-70 VA SMALL BUSINESS SUBCONTRACTING PLAN MINIMUM

REQUIREMENTS (JAN 2023) (DEVIATION)

C.15 VAAR 852.223-71 SAFETY AND HEALTH (SEP 2019)

C.16 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.17 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 61

C.18 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.19 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.20 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

SECTION E - SOLICITATION PROVISIONS

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

1998)

E.2 INSTRUCTIONS TO OFFERORS

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.6 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

E.7 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.8 52.237-1 SITE VISIT (APR 1984)

E.9 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.10 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE

RESOLUTION (OCT 2018)

E.11 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

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 36C257

Network Contracting Office 17

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]

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.

Tungsten Network http://www.fsc.va.gov/einvoices.asp

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

AMENDMENT NO DATE

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

B.2 STATEMENT OF WORK

Reagent Rental Purchase Agreement for EIA/IFA automated instrumentation for autoimmune testing.

1. Purpose: Requesting the procurement of immunoassay analyzer(s), reagents, consumables, supplies, maintenance, and customer training for testing of antibodies for ANA, ANCA, ENA screen, dsDNA, Jo-1, RNP, Sm, SS-A, SS-B, Scl-70, H pylori (IgG), Mitochondrial, Smooth muscle, CCP, RF (IgA, IgM, IgG) and Tissue Transglutaminase (IgA, and IgG) through reagent rental agreement for the

Immunology testing area at the VA North Texas Health Care System (VANTHCS), Dallas, TX.

2. Scope: The Contractor will provide the analyzer(s) with designated options, all system software, UPS, monitor, scanner, printer, technical support, customer training, and business hours service plan.

Test menu

Assay Est Annual Usage

ANA 3500

ANCA 500

ENA screen 1700 dsDNA 2200

Jo- 1 375

RNP 375

Sm 375

SS-A 375

SS-B 375

Scl-70 375

H pylori IgG 400

Mitochondrial 430

Smooth muscle 460

CCP 900

RF (IgA, IgM, IgG) 1850

Tissue Transglutaminase

(IgA, IgG)

The Contractor shall:

A. Deliver, install, and set up the instrument(s) and components.

B. Provide test validation guidance and validation supplies.

C. Provide technical support and guidance.

D. Provide reagents, consumables, and supplies as requested by VANTHCS staff.

E. Provide set up for interfaced result reporting, which includes LIS physical connection and translation (drivers), and any required (additional) interface connection license(s).

F. Provide instrument repairs and scheduled preventive maintenance for the instrument and system components.

G. Provide basic and advanced operator training.

3. Location: The analyzer(s) shall be located at, and testing will be performed in the Immunology section of Client Services & Immunopathology, Room 1B-406, Pathology & Laboratory Medicine

Service, VA North Texas Health Care System, 4500 S. Lancaster Rd., Dallas, TX 75216.

4. Performance Requirements: The following are required:

A. Testing Requirements:

1) The test menu must include assays listed in Section 2, Scope.

2) Enhanced specificity with Crithidia assay via IFA

B. System Requirements:

1) The system must be an automated EIA and IFA combo processor.

2) Have open platform capabilities to add additional testing.

3) Ability to create and utilize an atlas of IFA images to compare and review.

4) Ability to store historical patient results and archive images for review if necessary.

5) Automated pattern recognition for IFA assay, and titer to reduce reflex testing.

6) Automated mounting media for IFA slides

7) Positive patient tracking for IFA and EIA with 2D barcode verification.

8) Ability to provide QC data displayed in Levy-Jennings format.

C. Connectivity Requirements: (Note: Does not use the following software: Windows XP

Embedded Service Pack 3, Windows Server 2003 or Windows XP.)

1) System is fully interfaced with VistA via Data Innovations: System accommodates automated

(interfaced) reporting through Data Innovations (DI) to eliminate the need for manual interpretation and manual data entry.

D. Maintenance:

1) The Contractor shall perform preventive maintenance at intervals specified by the manufacturer to ensure proper equipment performance. Preventive Maintenance includes the following:

a) Delivery of parts or materials for Preventive Maintenance.

b) Testing all components for proper test performance. Equipment shall reproduce results according to manufacturer’s specifications.

c) After Preventative Maintenance, the Contractor shall submit a detailed work report for notice at no additional cost.

d) The Contractor shall provide all preventive service materials at no additional cost to the government.

E. Technical Support:

1) Support Personnel will be available during business hours each business day, and live representatives via the Contractor’s message center will be available by telephone at all other times.

2) Technical support shall be available via telephone during business days (and by message center after hours) to provide troubleshooting assistance or to answer testing inquiries.

3) On-site technical support shall be available for escalations within 48 hours.

F. On-site Repairs:

1) For issues that the Contractor determines to require on-site support, the Contractor shall dispatch one or more Support Personnel, normally within 48 business hours after documentation.

2) The Contractor shall submit a detailed work report to include all required materials.

3) The Contractor shall provide all parts and materials at no additional cost to the government.

4) The Contractor shall remove all parts, equipment or materials replaced, or upgraded by the

Contractor due to and not limited to repairs, replacements, recall, and upgrades without any cost to the government.

G. Training: The contractor shall provide the following:

1) Initial on-site operator training for analyzer.

2) One additional on-site or off-site Basic Operator class per year.

3) Handouts and training materials in sufficient quantity for each participant. These are off-the-shelf courses. The contractor shall provide lesson plan, course materials and media (DVD’s, CD’s, videos, etc. if required), and editable procedures at no additional cost.

4) Additional on-site training as requested by VANTHCS at no additional charge.

H. Safety:

1) The Contractor shall immediately notify VANTHCS of any changes in reagent kit composition, procedure modification, recall notification, or any changes that will affect the performance of the test or procedure according to FDA regulations.

I. Test Performance:

1) All tests, procedures, and equipment must perform at manufacturer’s specifications.

Deviations from the performance specifications shall be corrected by the Contractor.

2) Test performance will be evaluated by and not limited for performance thru peer comparison, quality control and proficiency testing peer evaluation.

3) The vendor shall reimburse VANTHCS for any costs and/or supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, instrumentation failure, or other factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction.

5. Period of Performance: Cost per Test Purchase Agreement for the analyzer will be in effect for a contract year, with options to extend contract for four (4) additional one (1) year periods:

Ordering Period 1 - 9/19/2023 – 9/18/2024

Ordering Period 2 - 9/19/2024 – 9/18/2025

Ordering Period 3 - 9/19/2025 – 9/18/2026

Ordering Period 4 - 9/19/2026 – 9/18/2027

Ordering Period 5 - 9/19/2027 – 9/18/2028

The vendor shall remove all equipment within 90 days after notification of the expiration of the terms of this agreement but not until the completion of new vendor's equipment installation inclusive of completed cross over studies. Vendor shall be responsible for removing the hard drive and turning it over to the VANTHCS for destruction prior to removal of any analyzer.

6. Deliverables and Supplies: This order is for the cost per test procurement of an instrument/system for testing. Reagents and supplies will be purchased under the terms of the reagent rental purchase agreement.

A. The Contractor shall deliver all supplies necessary for test performance at no Government cost.

B. The Contractor shall deliver all and not limited to operational, maintenance, troubleshooting, small repairs, equipment specifications, and test manuals.

C. The Contractor shall install the equipment and perform test verification according to manufacturer specification and regulatory requirements.

D. The Contractor shall provide supplies: reagents and consumables for test menu. Additional testing may be added at the discretion of VANTHCS. Any additional testing shall be negotiated between the Contractor and VANTHCS.

E. In the event that requested supplies are on back-order, Contractor is to provide information as to the estimated time of availability.

F. The Contractor shall deliver all invoices for review according to the established contract at the end of each billing cycle.

G. All items not contracted shall be specifically detailed on the invoice including description, quantity acquired, and government cost.

H. Any changes in reagents or equipment modifications shall be immediately disclosed by the

Contractor electronically as well as by postal mail with supporting documentation of the change, and detailed guidance for implementation within twenty-four hours of its application.

I. Additional charges incurred by the government to provide the continuity of contracted tests to patients and not limited to out sourcing, transportation, and or any other additional cost shall be covered by the Contractor at no additional charge to the government.

7. Contractor Security Contract Requirements: This Contractor requires no access to VANTHCS or any VA information system. The analyzer will be interfaced to the VANTHCS information system through Data Innovations. There will be supervised access when the Contractor is physically present for technical support, service calls, and scheduled preventative maintenance.

NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.

NARA Records Management Language for Contracts (May 2017)

1. Contractor shall comply with all applicable records management laws and regulations, as well as

National Archives and Records Administration (NARA) records policies, including but not limited to the

Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII

Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C.

chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the

Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the

Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. [FACILITY] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [FACILITY] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18

U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [FACILITY]. The agency must report promptly to NARA in accordance with

36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [FACILITY] control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The 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, contracts. The

Contractor (and any sub-contractor) is required to abide by Government and [FACILITY] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [FACILITY] policy.

8. The Contractor shall not create or maintain any records containing any non-public [FACILITY] information that are not specifically tied to or authorized by the contract.

9. The 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 from public disclosure by an exemption to the Freedom of Information Act.

10. The [FACILITY] owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which [FACILITY] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by

FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management

System (TMS) Item #3873736, Records Management for Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

Contractor-owned Information Technology (IT) System or Computer Assests

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/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.

b. All contractors, subcontractors, and third-party servicers and associates working with

VA information is 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.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference

Appendix D of VA Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COTR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet

Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration.

Information technology staff must also use the Windows Installer Service for installation to the default

“program files” directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication

800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA

Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and

Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of

Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of

1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the

Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/subcontractor is to perform;

(2) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

(3) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

(1) “Operation of a System of Records” means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) “Record” means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person’s name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) “System of Records” means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as “Systems”), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than _30_ days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe

Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within _10_ days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within _60_ days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant

Secretary for Office of Information and Technology.

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 vulnerability 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, and 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:

(1) Vendor must accept the system without the drive;

(2) 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

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

(4) 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;

(a) 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

(b) 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 preapproved and described in the purchase order or contract.

(c) 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:

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

(2) Description of the event, including:

(a) Date of occurrence;

(b) 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;

(4) Names of individuals or groups affected or potentially affected;

(5) 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;

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

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

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

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy

Incidents, as appropriate; and

(11) 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:

(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;

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

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

(6) Necessary legal expenses the subjects may incur to repair falsified or…