36C26126Q0619_2.docx

36C26126Q0619

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

36C261-27-AP-0216

662-27-1-045-0001

06-26-2026 Tawnya Krommenhoek tawnya.krommenhoek@va.gov 07-02-2026

10AM

MDT

36C261 Department of Veterans Affairs Network Contracting Office 21

X

541512 $34 Million

N/A

See Delivery Schedule

36C261

Financial Services Center P.O. Box 149971

Austin TX 78714-9971

See CONTINUATION Page VA San Francisco Health Care System Remote Automated Laboratory System Software and Support ** Please see Schedule of Supplies for full description **

This RFQ is a sole source procurement to Abbott Rapid Diagnostics Informatic, Inc., for the procurement of Remote Automated Laboratory System Software and Support IAW RFO 6.103-1. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency.

Quotation shall be submitted to Tawnya Krommenhoek, Contracting Officer, by the date/time listed in box 8.

tawnya.krommenhoek@va.gov

See CONTINUATION Page

Tawnya Krommenhoek

VA-VHA-RPOW-2025-0057

Table of Contents

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 36C261 Tawnya Krommenhoek

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

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

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

All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests. VA's Electronic Invoice Presentment and Payment System - The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website:

http://www.tungsten-network.com/US/en/veterans-affairs/ to register and begin submitting electronic invoices, free of charge. The Department of Veterans Affairs Tungsten Number is: AAA544240062 (this allows you to file invoices online for free.)

More information on the VA Financial Services Center is available at:

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

Vendor e-Invoice Set-Up Information:

If you have questions about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

• Tungsten e-Invoice Setup Information: 1-877-489-6135

• Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

• FSC e-Invoice Contact Information: 1-877-353-9791

• FSC e-invoice email: vafsccshd@va.gov

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

StatStrip GLU (Glucose) Module Includes up to 3 Institutions (54 Instruments) HL7 Interface ADT In-Unit Patient Verification with Positive Patient Identification Contract Period: Base POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW) MANUFACTURER PART NUMBER (MPN): StatStrip GLU (Glucose) Module LOCAL STOCK NUMBER: StatStrip GLU (Glucose) Module

i-STAT Module Includes up to 3 Institutions (21 instruments)

Contract Period: Base POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW) MANUFACTURER PART NUMBER (MPN): i-STAT Module LOCAL STOCK NUMBER: i-STAT Module

Clinitek Status Module Includes up to 3 Institutions (7 instruments)

Contract Period: Base POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW) MANUFACTURER PART NUMBER (MPN): Clinitek Status Module LOCAL STOCK NUMBER: Clinitek Status Module

Clinitek Status Module Add One time configuration fee Base year only

Contract Period: Base POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW) MANUFACTURER PART NUMBER (MPN): Clinitek Status Module Add One time LOCAL STOCK NUMBER: Clinitek Status Module Add One time

HemoSonics Quantra Module Includes up to 3 Institutions (1 instrument)

Contract Period: Base POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW) MANUFACTURER PART NUMBER (MPN): HemoSonics Quantra Module LOCAL STOCK NUMBER: HemoSonics Quantra Module

RALS -MTE Includes up to 3 Institutions

Contract Period: Base POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

MANUFACTURER PART NUMBER (MPN): RALS -MTE

LOCAL STOCK NUMBER: RALS -MTE

RALS eQuiz LICENSE Institution 1 Number of Operators - 1000 Contract Period: Base POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW) MANUFACTURER PART NUMBER (MPN): RALS eQuiz LOCAL STOCK NUMBER: RALS eQuiz

Test System Configuration Fee - One Time Cost, Base Year Only

POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW) MANUFACTURER PART NUMBER (MPN): Test System Configuration LOCAL STOCK NUMBER: Test System Configuration

Test System Annual License Fee

POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW) MANUFACTURER PART NUMBER (MPN): Test System Annual LOCAL STOCK NUMBER: Test System Annual

StatStrip GLU (Glucose) Module Includes up to 3 Institutions (54 Instruments)

ADT In-Unit Patient Verification with Positive Patient Identification Contract Period: Option 1 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

i-STAT Module Includes up to 3 Institutions (21 instruments)

Contract Period: Option 1 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

Clinitek Status Module Includes up to 3 Institutions (7 instruments)

Contract Period: Option 1 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

HemoSonics Quantra Module Includes up to 3 Institutions (1 instrument)

Contract Period: Option 1 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

RALS -MTE Includes up to 3 Institutions

Contract Period: Option 1 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

RALS eQuiz LICENSE Institution 1 Number of Operators - 1000 Contract Period: Option 1 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

Test System Annual License Fee Contract Period: Option 1 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

StatStrip GLU (Glucose) Module Includes up to 3 Institutions (54 Instruments)

ADT In-Unit Patient Verification with Positive Patient Identification Contract Period: Option 2 POP Begin: 10-01-2028 POP End: 09-30-2029 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

i-STAT Module Includes up to 3 Institutions (21 instruments)

Contract Period: Option 2 POP Begin: 10-01-2028 POP End: 09-30-2029 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

Clinitek Status Module Includes up to 3 Institutions (7 instruments)

Contract Period: Option 2 POP Begin: 10-01-2028 POP End: 09-30-2029 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

HemoSonics Quantra Module Includes up to 3 Institutions (1 instrument)

Contract Period: Option 2 POP Begin: 10-01-2028 POP End: 09-30-2029 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

RALS -MTE Includes up to 3 Institutions

Contract Period: Option 2 POP Begin: 10-01-2028 POP End: 09-30-2029 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

RALS eQuiz LICENSE Institution 1 Number of Operators - 1000 Contract Period: Option 2 POP Begin: 10-01-2028 POP End: 09-30-2029 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

Test System Annual License Fee Contract Period: Option 2 POP Begin: 10-01-2028 POP End: 09-30-2029 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

StatStrip GLU (Glucose) Module Includes up to 3 Institutions (54 Instruments)

ADT In-Unit Patient Verification with Positive Patient Identification Contract Period: Option 3 POP Begin: 10-01-2029 POP End: 09-30-2030 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

i-STAT Module Includes up to 3 Institutions (21 instruments)

Contract Period: Option 3 POP Begin: 10-01-2029 POP End: 09-30-2030 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

Clinitek Status Module Includes up to 3 Institutions (7 instruments)

Contract Period: Option 3 POP Begin: 10-01-2029 POP End: 09-30-2030 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

HemoSonics Quantra Module Includes up to 3 Institutions (1 instrument)

Contract Period: Option 3 POP Begin: 10-01-2029 POP End: 09-30-2030 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

RALS -MTE Includes up to 3 Institutions

Contract Period: Option 3 POP Begin: 10-01-2029 POP End: 09-30-2030 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

RALS eQuiz LICENSE Institution 1 Number of Operators - 1000 Contract Period: Option 3 POP Begin: 10-01-2029 POP End: 09-30-2030 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

Test System Annual License Fee Contract Period: Option 3 POP Begin: 10-01-2029 POP End: 09-30-2030 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

StatStrip GLU (Glucose) Module Includes up to 3 Institutions (54 Instruments)

ADT In-Unit Patient Verification with Positive Patient Identification Contract Period: Option 4 POP Begin: 10-01-2030 POP End: 09-30-2031 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

i-STAT Module Includes up to 3 Institutions (21 instruments)

Contract Period: Option 4 POP Begin: 10-01-2030 POP End: 09-30-2031 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

Clinitek Status Module Includes up to 3 Institutions (7 instruments)

Contract Period: Option 4 POP Begin: 10-01-2030 POP End: 09-30-2031 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

HemoSonics Quantra Module Includes up to 3 Institutions (1 instrument)

Contract Period: Option 4 POP Begin: 10-01-2030 POP End: 09-30-2031 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

RALS -MTE Includes up to 3 Institutions

Contract Period: Option 4 POP Begin: 10-01-2030 POP End: 09-30-2031 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

RALS eQuiz LICENSE Institution 1 Number of Operators - 1000 Contract Period: Option 4 POP Begin: 10-01-2030 POP End: 09-30-2031 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

Test System Annual License Fee Contract Period: Option 4 POP Begin: 10-01-2030 POP End: 09-30-2031 PRINCIPAL NAICS CODE: 541512 - Computer Systems Design Services PRODUCT/SERVICE CODE: 7E20 - IT and Telecom - End User: Help Desk; Tier 1-2, Workspace, Print, Output, Productivity Tools (HW/Perp SW)

B.3 DELIVERY SCHEDULE

Attn: PATHOLOGY & LABORATORY MEDICINE SERVICE 4150 Clement Street, Bldg 203 San Francisco, CA 94121 1563

USA

Attn: PATHOLOGY & LABORATORY MEDICINE SERVICE 4150 Clement Street, Bldg 203 San Francisco, CA 94121 1563

USA

Attn: PATHOLOGY & LABORATORY MEDICINE SERVICE 4150 Clement Street, Bldg 203 San Francisco, CA 94121 1563

USA

Attn: PATHOLOGY & LABORATORY MEDICINE SERVICE 4150 Clement Street, Bldg 203 San Francisco, CA 94121 1563

USA

Attn: PATHOLOGY & LABORATORY MEDICINE SERVICE 4150 Clement Street, Bldg 203 San Francisco, CA 94121 1563

USA

Page 1 of

B.4 STATEMENT OF WORK

Statement of Work LICENSING for DATA MANAGEMENT SYSTEM & SUPPORT SERVICE for interfacing Nova Glucometers, Abbott I-Stat, Clinitek Status, Hemosonics Quantra, RALs - MTE, RALs - eQuiz

1.0 General:

The Contractor shall provide the following module to the existing RALS to allow for 54 Nova Glucometers, 21 Abbott I-Stat docking stations, 7 Clinitek Status instruments, 1 Hemosonics Quantra, RALs-MTE, and RALs-eQuiz to be connected/supported to the RALS Data Management System to maintain data management, support and connectivity module:

a) Licensed instrument interface (software) with RALS and individual connection licenses for transmitting laboratory results from remotely connected diagnostic test meters (Nova Glucometers, Abbott I-Stat, Clinitek Status, and Hemosonic Quantra) to the VA VISTA laboratory computer program, and then to the patient VA computer record (CPRS). Also, licensed software with RALs for RALs – MTE and RALs – eQuiz for manual result entry and user training/competency.

b) Licensing for a test system that mirrors the functionality of the production (live) system is also required. This system is needed to be in compliance with the requirements of the Oracle/Cerner interface project within the VA. Only non-live (test data) will be used in this system to test the functionality of patches and updates before they are installed into the production system.

c) The module must be compatible with the existing RALS data management system that is used by San Francisco VA Health Care System. Remote customer service is provided to maintain the interface, connectivity and troubleshooting 7 days per week 24 hours per day.

d) The module addition for the Meters will allow for managing remote test results including quality control and linearity, testing person identity, meter identity, patient results, critical values, flagged records, reference values, new lot reagent records, and hold back results based on pre-determined criteria.

e) Maintain service or upgrade the licensed software using HL7 protocols for the transmission of test results and quality control data from the meter to the patient chart.

f) The module addition must be compatible with the currently installed RALS data management system.

g) System updates are provided at no charge.

The current RALS data management system is installed in a virtual space on the BioMed Virtual Server, located at the San Francisco VAMC, 4150 Clement Street, San Francisco, CA 94121.

2.0 Scope of Work:

The Contractor shall ensure all maintenance meets or exceeds performance standards specified in the manufacturer manual.

3.0 Period of Performance:

4.0 Location and Hours of Operation:

The module will be installed/activated on the current Alere RALS system located on the BioMed Virtual Server. The primary RALS system administrator (Ancillary Test Coordinator) operates the system Monday through Friday 8:00 am to 4:30 pm at this location. Staff using the system are located throughout the hospital and off-site clinics and work 7 days per week, 24 hours per day.

5.0 Contractor Responsibilities and Tasks:

5.1 The Contractor shall provide qualified technicians or IT staff who shall perform in a professional manner in accordance with industry standards and VA local policies.

5.2 At the conclusion of each requested service or scheduled upgrade, the Contractor shall provide a written service report indicating the date of service, name of technician or staff that performed the work and the service performed. The reports shall be delivered to the COR and the Ancillary Test Coordinator by email.

5.3 Software or system updates: will include applicable regulations and manufacturers specifications

5.4 Reviewing operating system and connections to ensure that the equipment and licensed software operate within its specifications.

5.5 Work outside the scope of the contract shall not be performed unless authorized by VAMC San Francisco HCS Biomedical Engineering Department prior to the work being performed.

6.0 Personnel Qualification: The Contractor must be qualified to work on all components of the data management system and the latest revisions of hardware and software as required by the manufacturer (MAS-RALs/Alere).

7.0 Security Consideration. All VA policies shall be followed, and the contractor shall not come into contact with VA sensitive information.

8.0 Point of Contact:

8.1 COR – Contracting Officer Representative – The identity of COR will be provided to the Contractor upon award of Task Order.

8.2 Subject matter experts:

APPENDIX C — VA INFORMATION AND INFORMATION SYSTEM SECURITY AND PRIVACY LANGUAGE FOR INCLUSION IN CONTRACTS, AS APPROPRIATE

1. GENERAL. This entire section applies to all acquisitions requiring any Information Security and Privacy language. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

2. VA INFORMATION CUSTODIAL LANGUAGE. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

h. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations.

i. The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

k. Notwithstanding the provision above, the contractor 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 medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above-mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA. The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO.

3. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS. This section applies when any person requires access to information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract.

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor.

b. Contractors and subcontractors shall sign the VA Information Security Rule of Behavior (ROB) before access is provided to VA information and information systems (see Section 4, Training, below). The ROB contains the minimum user compliance requirements and does not supersede any policies of VA facilities or other agency components which provide higher levels of protection to VA’s information or information systems. Users who require privileged access shall complete the VA elevated privilege access request processes before privileged access is granted.

c. All contractors and subcontractors working with VA information are subject to the same security investigative and clearance 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 shall be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office of Human Resources and Administration/Operations, Security and Preparedness (HRA/OSP) is responsible for these policies and procedures. Contract personnel who require access to classified information or information systems shall have an appropriate security clearance. Verification of a Security Clearance shall be processed through the Special Security Officer located in HRA/OSP. Contractors shall conform to all requirements stated in the National Industrial Security Program Operating Manual (NISPOM).

d. All contractors and subcontractors shall comply with conditions specified in VAAR 852.204-71(d); Contractor operations required to be in United States. All contractors and subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S. services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR/CO in writing prior to access being granted.

e. The contractor shall notify the COR/CO in writing immediately (no later than 24 hours) after personnel separation or occurrence of other causes. Causes may include the following:

(1) Contractor/subcontractor personnel no longer has a need for access to VA information or VA information systems.

(2) Contractor/subcontractor personnel are terminated, suspended, or otherwise has their work on a VA project discontinued for any reason.

(3) Contractor believes their own personnel or subcontractor personnel may pose a threat to their company’s working environment or to any company- owned property. This includes contractor-owned assets, buildings, confidential data, customers, employees, networks, systems, trade secrets and/or VA data.

(4) Any previously undisclosed changes to contractor/subcontractor background history are brought to light, including but not limited to changes to background investigation or employee record.

(5) Contractor/subcontractor personnel have their authorization to work in the United States revoked.

(6) Agreement by which contractor provides products and services to VA has either been fulfilled or terminated, such that VA can cut off electronic and/or physical access for contractor personnel.

f. In such cases of contract fulfillment, termination, or other causes; the contractor shall take the necessary measures to immediately revoke access to VA network, property, information, and information systems (logical and physical) by contractor/subcontractor personnel. These measures include (but are not limited to): removing and then securing Personal Identity Verification (PIV) badges and PIV – Interoperable (PIV-I) access badges, VA-issued photo badges, credentials for VA facilities and devices, VA-issued laptops, and authentication tokens. Contractors shall notify the appropriate VA COR/CO immediately to initiate access removal.

g. Contractors/subcontractors who no longer require VA accesses will return VA- issued property to VA. This property includes (but is not limited to): documents, electronic equipment, keys, and parking passes. PIV and PIV-I access badges shall be returned to the nearest VA PIV Badge Issuance Office. Once they have had access to VA information, information systems, networks and VA property in their possessions removed, contractors shall notify the appropriate VA COR/CO.

4. TRAINING. This entire section applies to all acquisitions which include section 3.

a. All contractors and subcontractors requiring access to VA information and VA information systems shall successfully complete the following before being granted access to VA information and its systems:

(1) VA Privacy and Information Security Awareness and Rules of Behavior course (Talent Management System (TMS) #10176) initially and annually thereafter.

(2) Sign and acknowledge (electronically through TMS #10176) understanding of and responsibilities for compliance with the Organizational Rules of Behavior, relating to access to VA information and information systems initially and annually thereafter; and

(3) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system or information access [to be defined by the VA program official and provided to the VA CO for inclusion in the solicitation document – i.e., any role- based information security training].

b. The contractor shall provide to the COR/CO a copy of the training certificates and certification of signing the Organizational Rules of Behavior for each applicable employee within five days of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the required training is complete.

5. SECURITY INCIDENT INVESTIGATION. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The contractor, subcontractor, their employees, or business associates shall immediately (within one hour) report suspected security / privacy incidents to the VA OIT’s Enterprise Service Desk (ESD) by calling (855) 673-4357 (TTY: 711). The ESD is OIT’s 24/7/365 single point of contact for IT-related issues. After reporting to the ESD, the contractor, subcontractor, their employees, or business associates shall, within one hour, provide the COR/CO the incident number received from the ESD.

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved and the circumstances surrounding the incident, including the following:

(1) The date and time (or approximation of) the Security Incident occurred.

(2) The names of individuals involved (when applicable).

(3) The physical and logical (if applicable) location of the incident.

(4) Why the Security Incident took place (i.e., catalyst for the failure).

(5) The amount of data belonging to VA believed to have been compromised.

(6) The remediation measures the contractor is taking to ensure no future incidents of a similar nature.

c. After the contractor has provided the initial detailed incident summary to VA, they will continue to provide written updates on any new and relevant circumstances or facts they discover. The contractor, subcontractor, and their employes shall fully cooperate with VA or third-party entity performing an independent risk analysis on behalf of VA. Failure to cooperate may be deemed a material breach and grounds for contract termination.

d. VA IT contractors shall follow VA Handbook 6500, Risk Management Framework for VA Information Systems VA Information Security Program, and VA Information Security Knowledge Service guidance for implementing an Incident Response Plan or integrating with an existing VA implementation.

e. 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 the VA Office of 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.

f. The contractor shall comply with VA Handbook 6500.2, Management of Breaches Involving Sensitive Personal Information, which establishes the breach management policies and assigns responsibilities for the oversight, management and reporting procedures associated with managing of breaches.

g. With respect to unsecured Protected Health Information (PHI), the contractor is deemed to have discovered a data breach when the contractor knew or should have known of breach of such information. When a business associate is part of VHA contract, notification to the covered entity (VHA) shall be made in accordance with the executed BAA.

h. If the contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach involving any VA sensitive personal information the contractor/subcontractor processes or maintains under the contract; the contractor shall pay liquidated damages to the VA as set forth in clause 852.211-76, Liquidated Damages— Reimbursement for Data Breach Costs.

6. INFORMATION SYSTEM DESIGN AND DEVELOPMENT. This entire section applies to information systems, systems, major applications, minor applications, enclaves, and platform information technologies (to include the subcomponents of each) designed or developed for or on behalf of VA by any non-VA entity

a. Information systems designed or developed on behalf of VA at non-VA facilities shall comply with all applicable Federal law, regulations, and VA policies. This includes standards for the protection of electronic Protected Health Information (PHI), outlined in 45 C.F.R. Part 164, Subpart C and information and system security categorization level designations in accordance with FIPS 199, Standards for Security Categorization of Federal Information and Information Systems and FIPS 200, Minimum Security Requirements for Federal Information Systems. Baseline security controls shall be implemented commensurate with the FIPS 199 system security categorization (reference VA Handbook 6500 and VA Trusted Internet Connections (TIC) Architecture).

b. Contracted new developments require creation, testing, evaluation, and authorization in compliance with VA Assessment and Authorization (A&A) processes in VA Handbook 6500 and VA Information Security Knowledge Service to obtain an Authority to Operate (ATO). VA Directive 6517, Risk Management Framework for Cloud Computing Services, provides the security and privacy requirements for cloud environments.

c. VA IT contractors, subcontractors and third-party service providers shall address and/or integrate applicable VA Handbook 6500, VA Handbook 6517, Risk Management Framework for Cloud Computing Services and Information Security Knowledge Service specifications in delivered IT systems/solutions, products and/or services. If systems/solutions, products and/or services do not directly match VA security requirements, the contractor shall work though the COR/CO to identify the VA organization responsible for governance or resolution. Contractors shall comply with FAR 39.1, specifically the prohibitions referenced.

d. The contractor (including producers and resellers) shall comply with Office of Management and Budget (OMB) M-22-18 and M-23-16 when using third-party software on VA information systems or otherwise affecting the VA information. This includes new software purchases and software renewals for software developed or modified by major version change after the issuance date of M- 22-18 (September 14, 2022). The term “software” includes firmware, operating systems, applications and application services (e.g., cloud-based software), as well as products containing software. The contractor shall provide a self-attestation that secure software development practices are utilized as outlined by Executive Order (EO)14028 and NIST Guidance. A third-party assessment provided by either a certified Federal Risk and Authorization Management Program (FedRAMP) Third Party Assessor Organization (3PAO) or one approved by the agency will be acceptable in lieu of a software producer's self- attestation.

e. The contractor shall ensure all delivered applications, systems and information systems are compliant with Homeland Security Presidential Directive (HSPD) 12 and VA Identity and Access management (IAM) enterprise identity management requirements as set forth in OMB M-19-17, M-05-24, FIPS 201-3, Personal Identity Verification (PIV) of Federal Employees and Contractors (or its successor), M-21-31 and supporting NIST guidance. This applies to Commercial Off-The-Shelf (COTS) product(s) that the contractor did not develop, all software configurations and all customizations.

f. The contractor shall ensure all…