36D79724D0020 36C26125A0015 Signed.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

36C261-24-AP-4152

36D79724D0020 36C26125A0015

AWARDED:

EFFECTIVE: 02-01-2025

36C26124Q0945 10-22-2024

Mohammed Hussain 916-923-4534 11-08-2024

15:00 PDT

Department of Veterans Affairs

Network Contracting Office (NCO 21)

X

334516

1000 Employees

N/A

"See Delivery Schedule"

Network Contracting Office (NCO 21)

4S002

BIOMERIEUX INC

515 S COLOROW DR

SALT LAKE CITY UT 84108

HCNVCMEG9NL6

FMS-VA-2(101) Financial Services Center

PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

VISN 21 Wide VISN 21 Wide Film Array Laboratory Test System Cost Per test (CPT) Federal Supply Schedule (FSS) Single Award Blanket Purchase Agreement (BPA) – all-inclusive of equipment, service, training, reagents.

BPA Ceiling Limit: $13 Million

The PoP is Base Plus Four (4) Option Years:

Base Period: 02/01/2025 - 01/31/2026 Option 1 : 02/01/2026 - 01/31/2027 Option 2 : 02/01/2027 - 01/31/2028 Option 3 : 02/01/2028 - 01/31/2029 Option 4 : 02/01/2029 - 01/31/2030

VA Contracting POC: Mohammed Hussain Mohammed.Hussain2@va.gov

$0.00 See CONTINUATION Page

X 1

David J. Alvarez

Docusign Envelope ID: 9C565820-2403-4AEE-8428-DB534312C905

Ben W Andrews

VP, US Clin Ops Sales, bioMérieux 1/7/2025

36D79724D0020 36C26125A0015

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 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

B.4 STATEMENT OF WORK (SOW) / DESCRIPTION / SPECIFICATIONS

B.5 INTRODUCTION

B.6 TERMS AND CONDITIONS

B.7 ADMINISTRATIVE DATA

B.8 PRICING DATA

B.9 OPTION TO EXTEND THE TERM OF THE BPA

B.10 GENERAL SUPPLY ORDERS

B.11 AUTHORIZED LIMITS

B.12 OBLIGATION OF FUNDS

B.13 PERIOD OF PERFORMANCE

B.14 AUTHORIZED INDIVIDUALS

B.15 ORDER FORMAT

B.16 AUTHORIZED REPRESENTATIVES

B.17 FEDERAL HOLIDAYS

B.18 BPA EMPLOYEE IDENTIFICATION

B.19 MANAGEMENT CONTROL

B.20 INVOICES

B.21 PRECEDENCE

SECTION C - CONTRACT CLAUSES

C.1 FSS-BPA CLAUSE CONTENT

C.2 52.216-18 ORDERING (AUG 2020)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.6 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.7 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.8 VAAR 852.208-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS – ORDERS or BPAs (JAN 2023)

(DEVIATION)

C.9 VAAR 852.208-71 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTOR COMMITMENTS-ORDERS AND

BPAS (JAN 2023) (DEVIATION)

C.10 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023)

C.11 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 55

C.12 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.13 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.14 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.15 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.16 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.17 MANDATORY WRITTEN DISCLOSURES

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

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: Kate Gomm (385) 770-2833 Kate.Gomm@biomerieux.com

515 S. Colorow Drive, Salt Lake City, UT 84104

b. GOVERNMENT: Contracting Officer 36C261: Mohammed F Hussain

Network Contracting Office 21

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 IAW issued Call Order(s).

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

FMS VA-9(101) Financial Services Center

PO Box 149971

Austin TX 78714-9971 mailto:Kate.Gomm@biomerieux.com

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

AMENDMENT NO DATE

0001 11/19/2024

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 EA $4,635.000000 $4,635.00

BCID2 VERIFICATION KIT - 423640

Open Market Contract Period: Base POP Begin: 02-01-2025 POP End: 01-31-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

MANUFACTURER PART NUMBER (MPN): 423640

82.00 EA $4,183.720000 $343,065.04

BIOFIRE BCID2 PANEL, 30 TESTS, RFIT-ASY-0147

Contract Period: Base POP Begin: 02-01-2025 POP End: 01-31-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

MANUFACTURER PART NUMBER (MPN): RFIT-ASY-0147

6.00 EA $8,338.800000 $50,032.80

BIOFIRE JOINT INFECTION (JI) PANEL, RFIT-ASY-0138

Open Market

POP End: 01-31-2026

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

MANUFACTURER PART NUMBER (MPN): RFIT-ASY-0138

1.00 EA $5,098.500000 $5,098.50

BIOFIRE JOINT INFECTION VERIFICATION KIT, 424181

POP End: 01-31-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

MANUFACTURER PART NUMBER (MPN): 424181

162.00 EA $4,183.720000 $677,762.64

BIOFIRE RP2.1 PANEL, 30 TESTS, 423742

POP End: 01-31-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

MANUFACTURER PART NUMBER (MPN): 423742

95.00 EA $4,951.360000 $470,379.20

KIT GI PANEL IVD 30 TESTS, RFIT-ASY-0116

POP End: 01-31-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

MANUFACTURER PART NUMBER (MPN): RFIT-ASY-0116

9.00 EA $5,959.600000 $53,636.40

KIT ME PANEL IVD 30 TESTS, RFIT-ASY-0118

POP Begin: 02-01-2025 POP End: 01-31-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

MANUFACTURER PART NUMBER (MPN): RFIT-ASY-0118

ME VERIFICATION KIT, FLM1-ASY-0145

Open Market Contract Period: Base POP Begin: 02-01-2025 POP End: 01-31-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

MANUFACTURER PART NUMBER (MPN): FLM1-ASY-0145

16.00 EA $6,659.400000 $106,550.40

PNEUMONIA PANEL, 30 TESTS, RFIT-ASY-0144

POP End: 01-31-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

MANUFACTURER PART NUMBER (MPN): RFIT-ASY-0144

RP2.1 VERIFICATION KIT - 423743

POP End: 01-31-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

MANUFACTURER PART NUMBER (MPN): 423743

PNEUMONIA START-UP VERIFICATION KIT, FLM1-ASY-0150

Open Market

POP End: 01-31-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

MANUFACTURER PART NUMBER (MPN): FLM1-ASY-0150

BIOFIRE GI VERIFICATION KIT, FLM1-ASY-0130

POP End: 01-31-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

MANUFACTURER PART NUMBER (MPN): FLM1-ASY-0130

7.00 EA $0.000000 $0.00

BIOFIRE TORCH BASE MFG WARRANTY

POP End: 01-31-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

MANUFACTURER PART NUMBER (MPN): 4706469

7.00 EA $0.000000 $0.00

BIOFIRE TORCH MFG WARRANTY

POP End: 01-31-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

MANUFACTURER PART NUMBER (MPN): 4706471

7.00 EA $2,163.000000 $15,141.00

BIOFIRE TORCH BASE EXTENDED WARRANTY, 4706468

Open Market Contract Period: Option 1 POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

MANUFACTURER PART NUMBER (MPN): 4706468

40.00 EA $4,635.000000 $185,400.00

BIOFIRE TORCH EXTENDED WARRANTY, 4706470

Open Market Contract Period: Option 1 POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

MANUFACTURER PART NUMBER (MPN): 4706470

Contract Period: Option 1 POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

Open Market Contract Period: Option 1 POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

BIOFIRE RP2.1 PANEL, 30 TESTS IVD, 423742

POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

POP End: 01-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

POP End: 01-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

POP End: 01-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

BIOFIRE TORCH BASE EXTENDED WARRANTY

Contract Period: Option 2 POP Begin: 02-01-2027 POP End: 01-31-2028

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

BIOFIRE TORCH EXTENDED WARRANTY

Open Market

Contract Period: Option 2 POP Begin: 02-01-2027 POP End: 01-31-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

POP End: 01-31-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

POP End: 01-31-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

POP End: 01-31-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory

Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

POP End: 01-31-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

FILMARRAY ME PANEL, IVD 30 TESTS, RFIT-ASY-0118

POP End: 01-31-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

POP End: 01-31-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

Open Market

Contract Period: Option 3 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

Open Market Contract Period: Option 3 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

Contract Period: Option 3 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

Open Market Contract Period: Option 3 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

POP End: 01-31-2029 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

KIT GI PANEL IVD 30 TESTS, RFIT-ASY-0116

Contract Period: Option 3 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

POP End: 01-31-2029 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

POP End: 01-31-2029 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

Contract Period: Option 4 POP Begin: 02-01-2029 POP End: 12-31-2029 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

Contract Period: Option 4 POP Begin: 02-01-2029 POP End: 12-31-2029 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

POP End: 01-31-2030 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

Open Market

Contract Period: Option 4 POP Begin: 02-01-2029 POP End: 01-31-2030 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

POP End: 01-31-2030 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

POP End: 01-31-2030

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

POP End: 01-31-2030 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

Contract Period: Option 4 POP Begin: 02-01-2029 POP End: 01-31-2030 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic

GRAND

TOTAL

$9,338,496.90

B.3 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

0001-

FOB:

DESTINATION 1.00 02/01/2025 -

01/31/2026

1001-

FOB: DESTINATION 1.00 02/01/2026 -

01/31/2027

2001-

FOB: DESTINATION 1.00 02/01/2027 -

01/31/2028

3001-

FOB: DESTINATION 1.00 02/01/2028 -

01/31/2029

4001-

FOB: DESTINATION 1.00 02/01/2029 -

01/31/2030

B.4 STATEMENT OF WORK (SOW) / DESCRIPTION / SPECIFICATIONS

1. INTENT:

a. In the spirit of the Federal Acquisition Streamlining Act and pursuant to Federal Acquisition Regulation (FAR) Part 12 – Acquisition of Commercial Items and FAR Part 08 – Required Sources of Supplies and Services, it is the intent of the Department of Veterans Affairs (VA), Veterans Integrated Service Network (VISN) 21 to establish Blanket Purchase Agreement (BPA) with a Base Year period and four one-year Option Periods for a microbiology organism identification. Antimicrobial resistance mechanism analyzer, service, training, reagents, and supplies to meet the requirement described within this statement of work. Syndromic testing is a method that enables highly sensitive and specific detection of multiple pathogens related to an infectious disease. Multiplex PCR panels target a comprehensive grouping of pathogens and can be used to identify bacteria, viruses, fungi, parasites, and antimicrobial resistance genes.

b. This contract shall have a Base Year period and four one-year Option Periods and will be reviewed at least annually to ensure the terms are met, to assess current market conditions and to determine price reasonableness. Additional discounts maybe requested by NCO 21 at any time.

2. SCOPE OF PROCUREMENT:

a. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in this Statement of Work (SOW), perform all the required tests described within this solicitation, and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

b. Equipment shall maintain, or preferably reduce the number of workstations and/or overall labor required to accomplish the required testing by each laboratory.

c. If a Contractor offers a family of analyzers, the VISN 21 technical evaluation panel shall determine if instrumentation proposed meets needs of using facility.

d. The Contractor shall provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables, and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity, and tested to assure precision and accuracy.

Expiration dates shall be clearly marked on reagents, standards, and control containers.

Unexpected changes in methodology/technology shall be at the expense of the Contractor.

Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

e. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

3. DEFINITIONS:

a. Cost per Test (CPT) - as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers – Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) five year equipment use, (2) all reagents, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result, (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors are required to provide delivery, installation, and removal of equipment at no additional charge.

b. Business Associate Agreement (BAA) - A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI).

VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

4. TEST MENU: Refer to Attachment A for required test menu and estimated annual volumes.

5. GENERAL REQUIREMENTS:

a. Primary analyzer(s) – Base equipment offered shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. If a back-up analyzer is required, the back-up analyzer shall meet the technical functionality and the capabilities of the primary analyzer, to include additional analyzer(s) that meet the definition of a primary analyzer.

i. The instrument shall have capabilities of identifying organisms directly from blood culture specimens.

ii. The instrument shall include an FDA-approved broad library of gram positive, gram negative, anaerobic bacterial organisms as well as yeast and fungi to limit the amount of work needed on self-validation/verification studies.

iii. The instrument shall have bench side accessibility.

iv. The instrument shall be FDA 21 CFR Part 11 Compliant.

v. A preparatory apparatus (pouch loading block) shall be provided for specimen preparation.

vi. The instrument shall have capabilities of identifying organisms straight from blood culture specimens.

vii. The instrument shall be fully integrated with the antimicrobial resistance mechanism testing platform in place with automatic linking of organism ID to sensitivity.

b. The system shall provide self-contained, automated identification and antibiotic susceptibility testing system for minimally aerobic, facultative, and fastidious microorganisms, yeast, and anaerobes.

c. Operational Features - The instrumentation offered shall have the following, at a minimum:

i. The capability of performing analysis on 100% of the test panels listed in Section d.

ii. Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A.

iii. Safety features to avoid unnecessary exposure to biohazardous and chemical material.

The exposure to and the volume of biohazardous and chemical material generated by the equipment shall be minimal and require a minimum amount of handling.

iv. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (including only hardware) shall be available for implementation to the VA computerized hospital information system.

(1) The accuracy of the barcode reading shall have less than a 1% failure rate.

(2) Equipment shall be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

v. Equipment shall accept, at a minimum, BCBC characters in specimen identifier that is alpha and/or numeric, depending on the facility.

vi. Minimal periodic maintenance.

vii. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

d. Technical Features - The instrumentation shall be approved by the Food and Drug Administration (FDA) and shall have the following, at a minimum:

i. The capability of accurately and reliably identifying organisms directly from specimens including positive blood cultures, respiratory and stool.

ii. Positive blood cultures target organisms and antibiotic resistance genotypes should include:

a. Positive blood cultures

i. ☒Enterococcus

ii. ☒ Listeria monocytogenes

iii. ☒ K. oxytoca

iv. ☒ K. pneumoniae

v. ☒ Proteus

vi. ☒ S. marcescens

vii. ☒ C. albicans

viii. ☒ C. glabrata

ix. ☒ C. krusei

x. ☒ C. parapsilosis

xi. ☒ C. tropicalis

xii. ☒ S. aureus

xiii. ☒ S. agalactiae

xiv. ☒ S. pyogenes

xv. ☒ S. pneumoniae

xvi. ☒ E. baumannii

xvii. ☒ H. influenza

xviii. ☒ N. meningitidis

xix. ☒ P. aeruginosa

xx. ☒ E. cloacae complex

xxi. ☒ E. coli

xxii. ☒ mecA

xxiii. ☒ vanA/B

xxiv. ☒ SPC

iii. Respiratory specimen target organisms should include:

a. Respitory:

i. ☒ Adenovirus

ii. ☒ Coronavirus

iii. ☒ Influenza A and B

iv. ☒ Metapneumovirus

v. ☒ AParainfluenza

vi. ☒ RSV

vii. ☒ Rhinovirus/Enterovirus

viii. ☒ Bordetella pertussis

ix. ☒ Chlamydophilia pneumonia

x. ☒ Mycoplama pneumonia

iv. Stool specimen target organisms should include:

a. Stool specimen:

i. ☒ Aeromonas

ii. ☒ Campylobacter

iii. ☒ C. difficile (ToxA/B)

iv. ☒ P. shigelloides

v. ☒ Salmonella

vi. ☒ Vibrio

vii. ☒ V. cholera

viii. ☒ Y.enterocolitica

ix. ☒ E. coli 0157

x. ☒ EAEC

xi. ☒ EPEC

xii. ☒ ETEC

xiii. ☒ STEC

xiv. ☒ EIEC

xv. ☒ Adenovirus

xvi. ☒ Astrovirus

xvii. ☒ Norovirus

xviii. ☒ Rotavirus

xix. ☒ Sapovirus

xx. ☒ Cryptosporidium

xxi. ☒ Cyclospora cayetanensis

xxii. ☒ Ciprofloxacin

v. The capability of detecting emerging antimicrobial resistance.

(1) MRSA (Methicillin Resistance Staphylococcus aureus, VRE (Vancomycin

Resistant Entercoccus, ESBL (Extended Spectrum Beta Lactamase), KPC (Klebsiella pneumonia Carbapenemase), and others as they arise.

vi. Comprehensive and extensive data base of bacteria and yeast species that is consistent with FDA/CLSI guidelines.

vii. Software or equipment modifications as needed and, when commercially available, to comply with changes in standards for identification or susceptibility testing established by CLSI, Center for Disease Control (CDC) and other governing or authoritative bodies. The platform shall be able to increase throughput by connecting the two machines together.

(1) The platform is capable of expanding throughput by connecting additional

FilmArray system computer.

The BioFire Torch is composed of two to twelve FilmArray Torch Modules connected to a Torch System Base running that runs the software. The BioFire Torch System Base houses two BioFire Torch Modules. Up to five Duplex Module enclosures, each capable of housing two additional BioFire Torch Modules, may be added on top of the BioFire Torch System Base. Each BioFire Torch Module can be randomly and independently accessed to run a reagent pouch. The BioFire Torch software controls the function of each BioFire Torch Module and collects, analyzes, and stores data generated by each BioFire Torch Module.

viii. Comprehensive array of bacterial and resistance mechanism targets which each individual facility may select to meet individual needs.

e. Data Management - The System shall have the following, at a minimum:

i. Capability to connect to the VISTA interface.

a. The Contractor shall supply IT personnel to assist with the implementation of the LIS interface to VISTA. Some instrumentation already onsite and in use, with the exception of an upgrade from FA 2.0 instrumentation at VA Palo Alto Healthcare system New instrumentation will be added at VA Fresno Medical Center and VA Reno Medical Center.

ii. Capability to record, store and print the following information:

(1) Required quality control.

(2) Specimen results

(3) Sufficient memory to store test results with downloading capability to an external medium for long term storage.

f. Hardware Features - The instrumentation shall have the following, at a minimum:

i. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.

ii. An on-board monitor/screen that is easily readable.

g. Support Features –

i. Commercial marketing. The equipment models being quoted shall be in current production as of the date this quote is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being quoted as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Gray market equipment, supplies, reagents are not acceptable.

ii. Start-Up Reagents. The Contractor shall provide all reagents, consumable/disposable items, parts, accessories, and any other item required to establish instruments for operation for performance of acceptance testing. However, required verification and validation products are not offered by Contractor.

iii. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services and equivalent to a training program that the Contractor provides in the commercial market. This shall include, but is not limited to, training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room, and board for each participant.

iv. Service Requirements

(1) A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 2 hour.

(2) A malfunction incident report shall be furnished to each facility upon completion of each repair. The report shall include, as a minimum, the following:

a. date and time notified.

b. serial number, type, and model number of equipment, and

c. proof of repair

v. Ancillary support equipment. The Contractor shall provide, install, and maintain through the life of the BPA, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g., cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g., starter kits, tables/stands, etc.

vi. Commercial offerings. The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g., Computer disc containing their procedure manual in CSLI format or an on-line procedure manual in the instrument software.

vii. Characterization of waste. The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

(1) The determination and description shall address the following:

a. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

b. Waste ignitability (Reference 40 CFR §261.21)

c. Waste corrosivity (Reference 40 CFR §261.22)

d. Waste reactivity (Reference 40 CFR §261.23)

e. Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR

§261.31)

f. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33)

g. Solid Waste (Reference 40 CFR §261.2)

h. Exclusions (Reference 40 CFR §261.4)

(2) The Contractor shall provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the Contractor shall fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

(3) The Contractor shall provide a description of all wastes that the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosiveness, reactivity, and toxicity as defined in 40 CFR §261 shall be determined and documented. Any mercury containing reagents shall be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e., mercury, thimerosol and formaldehyde) shall be developed and SDS sheets shall be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and shall be included with Contractor response:

a. Barium (Total)

b. Cadmium (Total)

c. Chromium (Total)

d. Copper (Total)

e. Cyanide (Total)

f. Lead (Total)

g. Mercury (Total)

h. Nickel (Total)

i. Silver (Total)

j. Zinc (Total)

k. Arsenic (Total)

l. Selenium (Total)

m. Tin (Total)

n. pH

o. Flash point (to higher than 200°F)

p. BOD; biochemical oxygen demand

(4) The documentation the Contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system.

viii. Implementation/transition timeframe. The implementation of the services/requirements described in this solicitation shall be completed no later than 60 days after the award of the BPA. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe.

Contractor shall not be penalized for implementation timelines that extend beyond the 60-day timeframe if the extension is through no fault of the Contractor and is a result of delays due to the Government.

(1) Upon award of a BPA, the transition period for the awarded BPA to have all equipment and peripherals installed and operational shall be from date of award through 60 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

(2) Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 60 days for the transition of all services under the awarded BPA including installation and training of personnel, transition of all testing materials, reagents, and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate BPA for cause under the Termination for Cause clause of the BPA.

(3) At the end of 60 days from award of the BPA, the awarded Contractor shall have full and sole responsibility for services under the awarded BPA for new instrumentation.

h. Standard and Quality of Performance - This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or BPA] is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin after the installation date, equipment verification, and after the written acceptance by the VA that the equipment can perform the requirements stated within this solicitation. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any BPA at an effectiveness level of 90% or more.

i. In the event that equipment does not meet the standard of performance during the initial

30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

ii. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled “Termination for Cause.” (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.)

iii. Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

iv. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours.

v. The Government shall maintain daily records to satisfy the requirements of this paragraph and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

vi. During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the POC to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment.

i. Government’s Responsibility - The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

j. Ownership of Equipment - Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

i. Prior to termination or completion of this BPA, the Contractor shall not destroy information received from VA, or gathered/created by the Contractor in the course of performing this BPA without prior written approval by the VA.

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

a. Contractor shall accept the system without the drive;

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

iii. 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 Contractor shall have an existing BAA if the device being traded in has protected health 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 shall 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 BPA.

iv. 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 Information Security Officer (ISO) needs to maintain the documentation.

k. Installation - All contract work at the government sites is to be performed during regular business hours 8:00 am to 4:30 pm Pacific Standard Time, Monday through Friday.

However, at the convenience of the government the COR may request any work that generates additional downtime for our customers be performed afterhours.

Any work at the government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer’ Representative (COR). If required, the COR may designate the Contractor to work during holidays and weekends to resolve equipment failures affecting the end customer.

There are eleven (11) Federal holidays set by law (USC Title 5 Section 6103) that the VA follows:

Under current definitions, five are set by date:

New Year's Day January 1 Juneteenth National Independence Day June 19 Independence Day July 4 Veterans Day November 11 Christmas Day December 25

If any of the above falls on a Saturday, then Friday shall be observed as a holiday. Similarly, if one falls on a Sunday, then Monday shall be observed as a holiday.

The other seven are set by a day of the week and month:

Martin Luther King's Birthday Third Monday in January Washington's Birthday Third Monday in February

Memorial Day Last Monday in May Labor Day First Monday in September Columbus Day Second Monday in October Thanksgiving Fourth Thursday in November

Installation under this SOW shall be performed at any of the facilities listed in Section B.2.5 and shall be coordinated with the designated COR and individual facility POC.

Travel - The Government anticipates local travel under this effort to perform UPS maintenance through the period of performance. Include estimated local travel costs in your firm-fixed price line items. These costs will not be directly reimbursed by the Government.

3. IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

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 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.

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.