36C25626Q0527-Data Innovations- Instrument Manager-Brand Name- License-Software.pdf

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36C25626Q0527
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This is a Combined Synopsis/Solicitation for commercial items issued by the Department of Veterans Affairs (VA) for maintenance and support services for a Data Innovations Instrument Manager middleware system at Central Arkansas Veterans Healthcare System (CAVHS). The solicitation number is 36C25626Q0527, with quotes due by March 31, 2026 at 10:00 A.M. Central Time, submitted electronically to Contracting Officer Anthony Marion at anthony.marion2@va.gov. Questions must be submitted by March 25, 2026. The requirement is unrestricted with a NAICS code of 541519 and size standard of $34 million. The contract will be awarded on a Lowest Price Technical Acceptable (LPTA) basis with a firm-fixed-price structure for a five-year base period (August 1, 2026 through July 31, 2027) plus four one-year option periods exercisable at the government's sole discretion.

The Statement of Work requires the contractor to provide comprehensive maintenance and support for the Instrument Manager system, including 24/7/365 technical support, auto-verification system continuation, laboratory intelligence implementation for key performance indicator monitoring, system configuration and enhancement, professional services, and training. Deliverables include ongoing software patches, updates, security fixes, workflow rule development, specimen management support, and quality assurance monitoring with a minimum 95 percent customer satisfaction target and 24-hour initial response time to support inquiries. The place of performance is CAVHS at 4300 West 7th Street, Room 2E-155-LR, Little Rock, Arkansas 72205, with delivery required within 60 calendar days after receipt of order. Invoices are submitted monthly in arrears via electronic submission to VA's Financial Services Center. The contractor must be the original equipment manufacturer (OEM) or hold current OEM authorization and provide evidence of such authorization with the technical quote, with failure to provide complete OEM certification resulting in quote rejection.

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A.1 COMBINED SYNOPSIS/SOLICITATION

1.This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Part 12, Simplified Acquisition Procedures for

Certain Commercial Items as supplemented with additional information included in this notice.

This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This requirement will be evaluated using LPTA (Lowest Price

Technical Acceptable) evaluation process.

2. The combined synopsis/solicitation number is 36C25626Q0527.

3. Solicitation documents and incorporated provisions and clauses are those in effect through

Federal Acquisition Circular FAC 2026-01 (eff. 03/13/2026) FAR Deviation JAN 2026 (eff.

01/22/2026) VAAR DEVIATION FEB 2026 (eff. 03/17/2026) VAAM Alert 26-02 (eff.

10/28/2025) Acquisition Policy Flash 26-26 eff. 03/17/2026)

4. This requirement is unrestricted. The North American Industry Classification System number is 541519 with a size standard of $34M.

5. Place of Performance: John L. McClellan Memorial Veterans' Hospital

4300 W. 7th St.

Little Rock, AR 72205

6. Period of Performance: 5 (five) Years

7. All questions regarding this solicitation shall be submitted via email to Contracting Officer, Anthony Marion at anthony.marion2@va.gov no later than 10:00A.M. Central Time by March

25, 2026.

8. Quotes are due no later than March 31, 2026 at 10:00A.M. Central Time and shall be submitted electronically via e-mail to the Contracting Officer, Anthony Marion at anthony.marion2@va.gov

COMBINE SYNOPSIS/SOLICTATION APPLICABLE Provisions and Clauses

The provision at 52.212-1 Introduction to Offerors – Commercial, applies to this acquisition.

The provision at 52.212-2 EVALUATION – COMMERCIAL ITEMS (NOV 2021) applies to this acquisition.

The clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition and a statement. The addendum to FAR 52.212-4 also applies to this acquisition.

Addendum to FAR 52.212-4 Show FAR clauses followed by VAAR clauses in numeric order.

Solicitation contains a list of all clauses incorporated by reference in numeric order under

52.252-2 (see below), starting first with FAR and followed by VAAR.

36C25626Q0527

Table of Contents

A.1 COMBINED SYNOPSIS/SOLICITATION

SECTION B - CONTINUATION OF COMBINED SYNOPSIS/SOLICITATION

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

B.4 STATEMENT OF WORK (SOW)

B.5 CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS) ... 25

SECTION C - CONTRACT CLAUSES

C.1 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

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

C.3 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984) 27

C.4 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025)

(DEVIATION)

C.5 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.6 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

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

SERVICES (NOV 2021)

E.3 52.216-1 TYPE OF CONTRACT (NOV 2025) (DEVIATION)

E.4 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

SECTION B - CONTINUATION OF COMBINED SYNOPSIS

/SOLICITATION

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 36C256 Anthony Marion

Department of Veterans Affairs

Network Contracting Office 16

5075 Westheimer Road, Suite 750

Houston TX 77056-5643

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

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.

FSC e-Invoice Payment/Invoice Setup Information 1-877-489-6135 http://www.fsc.va.gov/fsc/einvoice.asp

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the

Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

Data Innovations Instrument Manager Middleware System with Auto-

Verification, Maintenance & Support.

Instrument Manager Maintenance and Support License# 075984

Contract Period: Base

POP Begin: 07-31-2026

POP End: 07-30-2027

MANUFACTURER PART NUMBER (MPN): CS-MAS-01

Instrument Manager Maintenance and Support

License# 075984

0001AA

1.00 EA __________________ __________________

Instrument Manager Base Software with High Availability

Contract Period: Base

POP Begin: 07-31-2026

POP End: 07-30-2027

MANUFACTURER PART NUMBER (MPN): IM-B07

0001AB

82.00 EA __________________ __________________

Instrument Manager Interface Connection with High Availability

Contract Period: Base

POP Begin: 07-31-2026

POP End: 07-30-2027

MANUFACTURER PART NUMBER (MPN): IM-CX-07

0001AC

10.00 EA __________________ __________________

End User Software Connection with HA/DR

POP End: 07-30-2027

MANUFACTURER PART NUMBER (MPN): IM-EU-07

0001AD

Lab Intelligence

POP End: 07-30-2027

MANUFACTURER PART NUMBER (MPN): IM-IN-01

0001AE

Specimen Management

POP End: 07-30-2027

MANUFACTURER PART NUMBER (MPN): GSA-IM-SM-01

0001AF

Peer & Daily QC Integration for Bio-Rad Unity Real Time

POP End: 07-30-2027

MANUFACTURER PART NUMBER (MPN): GSA-IM-QC-BI

Instrument Manager Base Software for Test License# 347237

Contract Period: Base

POP Begin: 07-31-2026

POP End: 07-30-2027

MANUFACTURER PART NUMBER (MPN): CS-MAS-01-TEST

Instrument Manager Base Software for Test License# 347237

0002AA

5.00 EA __________________ __________________

Instrument Manager Interface Connection for Test

POP End: 07-30-2027

MANUFACTURER PART NUMBER (MPN): IM-CX-01-TEST

0002AB

2.00 EA __________________ __________________

End User Software Connection for Test

POP End: 07-30-2027

MANUFACTURER PART NUMBER (MPN): IM-EU-01-TEST

0002AC

Specimen Management for Test

POP Begin: 07-31-2026

POP End: 07-30-2027

MANUFACTURER PART NUMBER (MPN): IM-SM-01-TEST

0002AD

Peer & Daily QC Integration for Bio-Rad Unity Real Time for Test

Contract Period: Base

POP Begin: 07-31-2026

POP End: 07-30-2027

MANUFACTURER PART NUMBER (MPN): IM-QC-BI-TEST

1.00 YR __________________ __________________

Verification, Maintenance & Support.

Instrument Manager Maintenance and Support License# 075984

Contract Period: Option 1

POP Begin: 07-31-2027

POP End: 07-30-2028

MANUFACTURER PART NUMBER (MPN): CS-MAS-01

Verification, Maintenance & Support.

Instrument Manager Base Software for Test License# 347237

Contract Period: Option 1

POP Begin: 07-31-2027

POP End: 07-30-2028

Verification, Maintenance & Support.

Instrument Manager Maintenance and Support License# 075984

Contract Period: Option 2

POP Begin: 07-31-2028

POP End: 07-30-2029

Verification, Maintenance & Support.

Instrument Manager Base Software for Test License# 347237

Contract Period: Option 2

POP Begin: 07-31-2028

POP End: 07-30-2029

Instrument Manager Maintenance and Support License# 075984

Contract Period: Option 3

POP Begin: 07-31-2029

POP End: 07-30-2030

Verification, Maintenance & Support.

Instrument Manager Base Software for Test License# 347237

Contract Period: Option 3

POP Begin: 07-31-2029

POP End: 07-30-2030

Verification, Maintenance & Support.

Instrument Manager Maintenance and Support License# 075984

Contract Period: Option 4

POP Begin: 07-31-2030

POP End: 07-30-2031

Verification, Maintenance & Support.

Instrument Manager Base Software for Test License# 347237

Contract Period: Option 4

POP Begin: 07-31-2030

POP End: 07-30-2031

GRAND TOTAL __________________

B.3 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY DELIVERY DATE

0001-

0002AD

SHIP TO: Department of Veteran Affairs

Central Arkansas Veterans

Healthcare Sys

4300 W 7th Street

USA

1 07-31-26-07-30-27

MARK FOR: Sean Whiteman

501-257-6449 sean.whiteman@va.gov

1001-

SHIP TO: Department of Veteran Affairs

Central Arkansas Veterans

Healthcare Sys

1.00 07-31-27-07-30-28

4300 W 7th Street

2001-

SHIP TO: Department of Veteran Affairs

Central Arkansas Veterans

Healthcare Sys

4300 W 7th Street

1.00 07-31-28-07-30-29

3001-

SHIP TO: Department of Veteran Affairs

Central Arkansas Veterans

Healthcare Sys

4300 W 7th Street

1.00 07-31-29-07-30-30

4001-

SHIP TO: Department of Veteran Affairs

Central Arkansas Veterans

Healthcare Sys

4300 W 7th Street

1.00 07-31-30-07-30-31

B.4 STATEMENT OF WORK (SOW)

STATEMENT OF WORK

Data Innovations Instrument Manager and Auto-Verification System

Central Arkansas Veterans Healthcare System (CAVHS)

Little Rock, Arkansas

1. BACKGROUND: The Central Arkansas Veterans Healthcare System (CAVHS), Department of Pathology and Laboratory Medicine Service (PLMS), requires the brand-name Data

Innovations (DI) laboratory management system/license for continued support and enhancement of the laboratory interface middleware system known as Instrument Manager (IM). Data

Innovations' IM middleware allows data transmission between laboratory equipment and the

Veterans Health Information Systems and Technology Architecture (VistA/CPRS).

Current Status: CAVHS operates Instrument Manager with auto-verification capabilities to enable laboratory-defined parameters for acceptable patient results to automatically release to the electronic health record (EHR) without additional staff review. Results outside defined parameters are reviewed by laboratory technologists before reporting.

Requirement: This SOW covers the ongoing maintenance and support of the current IM system, continuation of auto-verification workflow development, and implementation of laboratory intelligence (Lab Intelligence) capabilities to monitor key performance indicators (KPIs) in compliance with Electronic Health Record Modernization (EHRM) initiative requirements.

Data Innovations is the sole-source provider for this specialized middleware system and provides all maintenance, support, and professional services directly.

2. SCOPE OF WORK: The Contractor shall provide all materials, labor, software, hardware, training, and support necessary to maintain and enhance the CAVHS laboratory interface system including:

2.1 System Support and Maintenance

• Ongoing Instrument Manager Maintenance & Support for production systems

• Ongoing Instrument Manager Maintenance & Support for test systems

• Auto-verification license maintenance and support

• Twenty-four (24) hours per day / seven (7) days per week / three hundred sixty-five (365) days per year telephone technical support

• Troubleshooting and resolution of system issues

• Software patches, updates, and security fixes

2.2 Auto-Verification Continuation

• Continuation of existing auto-verification rule sets for high-complexity workflow configurations

• Maintenance of auto-verification parameters and configurations

• Support for specimen management workspace

• Laboratory Intelligence integration with auto-verification workflows

2.3 Laboratory Intelligence Implementation

• Installation and configuration of Lab Intelligence module for KPI visualization

• Configuration and support for key performance indicators including:

• Specimen/test volume metrics

• Turn-around time tracking

• Quality control violation dashboards

• Auto-verification rate monitoring

• Quality indicator dashboards

• Lab Intelligence training and documentation

2.4 System Configuration and Enhancement

• Support for configuration of production and test servers

• Database migration and validation support as needed

• Driver updates and compatibility maintenance

• Mirroring functionality configuration and support

• High availability and disaster recovery support

• Interface connectivity with VistA and all laboratory analyzers

2.5 Professional Services (as needed)

• Implementation support for system upgrades

• Workflow rule development and refinement

• Training on rule writing and maintenance

• Support for specimen management workspace customization

• User security configuration and management

• Technical guidance on laboratory intelligence configuration

2.6 Training and Support

• Initial and ongoing staff training on IM system and auto-verification workflows

• Training on Laboratory Intelligence dashboard usage

• Rules writing and maintenance training

• Documentation and Standard Operating Procedure (SOP) support

• Knowledge transfer and technical guidance

3. SPECIFIC TASKS AND DELIVERABLES

3.1 Customer Service Requirements

The Contractor shall provide:

• 24/7/365 Technical Support: Telephone support availability with reasonable response time to critical issues

• Dedicated Support Contacts: Primary and backup technical contacts for escalation

• Response Times: Initial response to reported issues within 24 hours; critical issues prioritized for same-business-day response

• Issue Resolution: Committed effort to resolve reported technical issues in timely manner

• Performance Tracking: Monthly monitoring of support quality and customer satisfaction

3.2 Product Support and Changes

• Product Notifications: Immediate notification to the COR of any product recalls, security vulnerabilities, or mandatory updates

• Product Substitution: No substitutions without written approval from CAVHS PLMS and the Contracting Officer

• Change Management: All changes to contract terms, pricing, or conditions require written agreement with CAVHS and signature by the VA Contracting Officer

• Defective Products: Contractor shall replace and/or reimburse recalled/defective products at no cost to the Government; Contractor liable for processing costs

3.3 Site Conditions and Access

• All work and delivery shall take place during clinical business hours (Monday-Friday, 8:00 AM - 4:30 PM CST, excluding federal holidays and weekends)

• No smoking, eating, or drinking inside the laboratory at any time

• Contractor staff must comply with all facility security, safety, and infection control procedures

• Cellular phone use only in designated areas; COR approval required for areas of uncertainty

• Smoke-free facility: smoking prohibited inside buildings and grounds; violators subject to removal

3.4 Equipment Protection and Property

• Contractor shall protect all equipment and materials from damage

• Contractor responsible for any damage to facility, grounds, or furnishings resulting from

Contractor actions

• Contractor shall repair or replace any items damaged due to Contractor actions

• Contractor shall exercise precautions against damage during all work activities

3.5 System Security Requirements

• Contractor shall comply with all applicable VA records management laws and regulations including:

• Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33)

• Privacy Act of 1974 (5 U.S.C. 552a)

• Freedom of Information Act (5 U.S.C. 552)

• National Archives and Records Administration (NARA) policies (36 CFR

Chapter XII Subchapter B)

• Data Handling:

• Protected Health Information (PHI) access and handling under secure conditions

• All data created for Government use remains Federal records under Government control

• No removal of memory storage devices, hard drives, or non-volatile memory units from VA control

• All research data provided for Contractor analysis shall be de-identified

• Confidentiality Requirements:

• Immediate notification to COR of any inadvertent or unauthorized disclosures

• Restricted disclosure to authorized personnel with documented need-to-know

• Implementation of administrative, technical, and physical safeguards for information security

• No removal of Government materials or equipment without written COR permission

• Return of all Government materials upon completion or as directed

• Destruction of records prohibited except per agency records schedules with written concurrence of Head of Contracting Activity

• Willful destruction/damage of Federal records subject to penalties per 18 U.S.C.

• Business Associate Compliance:

• Signed Business Associate Agreement (BAA) required if accessing PHI

• Compliance with VA/VHA Directives regarding Protected Health Information

• Collaboration with Facility Privacy Officer for BAA implementation

• Government Equipment:

• Use of Government IT equipment only for contract-authorized purposes per

CAVHS policy

• No creation or maintenance of records with non-public CAVHS information outside contract scope

• No retention, use, sale, or dissemination of deliverables containing Privacy Act information

• Subcontractor Management:

• Contractor must obtain COR approval prior to engaging any subcontractor

• Subcontractors must execute written acknowledgment of security and confidentiality requirements

• Contractor liable for subcontractor compliance with all security and confidentiality provisions

• Government Ownership:

• CAVHS owns all rights to data and records produced under this contract

• All deliverables are Government property with unlimited rights for use, disposal, or disclosure

• Any Contractor rights in deliverables must be identified per FAR 52.227-11 through FAR 52.227-20

3.6 Compliance and Training Requirements

• Records Management Training: All Contractor employees creating, handling, or accessing records must complete CAVHS-provided records management training per agency policy (including annual refresher training)

• Infection Control: All employees, contractors, and visitors must comply with local infection control procedures

• VA Directives and Policies: Contractor must comply with all applicable VA directives and policies including:

• VA Directive 1106 - Pathology and Laboratory Medicine Service

• VA Directive 6066 - Protected Health Information and BAA Management

• VA Directive 6500 - VA Cybersecurity Program

• VA Directive 6502 - VA Enterprise Privacy Program

• VHA Directive 1605 - VHA Privacy Program

• All related handbooks and amendments

3.7 Delivery and Installation

• Location: Central Arkansas Veterans Healthcare System, Pathology and Laboratory

Medicine Service, 4300 West 7th Street, Room 2E-155-LR, Little Rock, AR 72205

• Delivery Timeline: Within 60 calendar days after receipt of order (ARO)

• Pre-Delivery Meeting: Contractor shall conduct joint pre-delivery meeting with COR 60 days prior to negotiated delivery date to verify delivery and installation dates

• Delivery Requirements:

• Deliver specified items only when facility is ready for installation

• Joint inspection with COR upon delivery

• Provide dates of completion for punch list items

• Provide information on replacement parts or short-shipped items

• Provide all manufacturer recommended maintenance schedules and operation materials in binder(s) or digital format

• Delayed Delivery: Government-requested delays up to 90 days after initial delivery date at no additional cost

4. PLACE OF PERFORMANCE: Central Arkansas Veterans Healthcare System (CAVHS)

Pathology and Laboratory Medicine Service

4300 West 7th Street, Room 2E-155-LR

Little Rock, Arkansas 72205

Primary Contacts:

• Laboratory Manager/COR: Sean Whiteman, 501-257-6449

• Laboratory Information Manager: Jessica German, 501-257-6483

5. PERIOD OF PERFORMANCE: Base Contract: Date of Award August 1st, 2026, through

July 31st, 2027.

Option Years: One (1) year each for a total of four (4) option years, exercisable at sole discretion of the Government and upon availability of funds.

6. PERFORMANCE MONITORING AND ACCEPTANCE

6.1 Acceptance Procedures

• COR shall ensure all work is completed satisfactorily prior to acceptance

• All deliverables must meet specifications outlined in this SOW

• Disputes over work quality shall be resolved by the Contracting Officer

• Vendor credentials shall be reviewed prior to finalization of award

6.2 Performance Monitoring Criteria

Vendor performance shall be monitored by CAVHS PLMS Laboratory Information Manager and

COR based on:

• Ability to consistently provide technical support in timely manner

• Ability to execute deliverables as stated in scope and specific tasks

• Responsiveness to Government requests and inquiries

• Quality of professional services and training delivery

• Maintenance of security and compliance requirements

• System uptime and reliability metrics

6.3 Quality Assurance Metrics

• Response Time Standard: Initial response to support inquiries within 24 hours with minimum 95% compliance rate

• Issue Resolution: Technical issues resolved with minimal system downtime

• Customer Satisfaction: Minimum 95% customer satisfaction on annual survey

• Surveillance Method: Monthly monitoring of support quality; annual evaluation;

CPARS performance evaluation

• Performance Incentive: Exercise of option periods contingent on satisfactory performance

7. GOVERNMENT FURNISHED EQUIPMENT (GFE) / INFORMATION (GFI): No GFE or GFI shall be provided to the Contractor. Contractor shall be responsible for obtaining all necessary tools, resources, and information required to perform contract services.

8. OTHER PERTINENT INFORMATION

8.1 Proprietary Access: Contractor shall have proprietary access codes for Data Innovations IM system at administrator level necessary to perform maintenance and support services.

8.2 Inspection and Acceptance: Vendor credentials shall be reviewed and verified prior to finalization of award for all consumables and services provided.

8.3 Risk Control: All employees, contractors, and visitors are required to abide by local infection control procedures per VA and CAVHS requirements.

8.4 Follow-On Work: No known follow-on work identified at this time.

8.5 Conflict of Interest: A determination has been made that no conflicts of interest exist, nor is there potential for conflicts of interest prior to execution of this contract.

9. GOVERNMENT PERSONNEL OBSERVED HOLIDAYS: The Government hereby provides notice and Contractor hereby acknowledges receipt that Government personnel observe the listed days as holidays:

New Year's Day January 1

Martin Luther King's Birthday Third Monday in January

President's Birthday Third Monday in February

Memorial Day Last Monday in May

Juneteenth June 19

Independence Day July 4

Labor Day First Monday in September

Columbus Day Second Monday in October

Veterans Day November 11

Thanksgiving Day Fourth Thursday in November

Christmas December 25

In addition to the days designated as holidays, the Government observes the following days:

1. Any other day designated by Executive Order;

2. Any other day designated by the President’s Proclamation; and

3. Any other day designated by Federal Statute.

10. PRODUCTS/LICENSES

Product Code Product Name License Qty

CS-MAS-01 Instrument Manager Maintenance and Support 075984 1

CS-MAS-01-

TEST

Instrument Manager Maintenance and Support for Test 347237 1

Supporting Asset Details

Product Code Product Name Qty

IM-B07 Instrument Manager Base Software with High

Availability

IM-CX-07 Instrument Manager Interface Connection with High

Availability

IM-EU-07 End User Software Connection with HA/DR 10

IM-IN-01 Lab Intelligence 1

GSA-IM-SM-

Specimen Management 1

GSA-IM-QC-

BI

Peer & Daily QC Integration for Bio-Rad Unity Real

Time

IM-B02-

TEST

Instrument Manager Base Software for Test 1

IM-CX-01-

TEST

Instrument Manager Interface Connection for Test 5

IM-EU-01-

TEST

End User Software Connection for Test 2

IM-SM-01-

TEST

Specimen Management for Test 1

IM-QC-BI-

TEST

Peer & Daily QC Integration for Bio-Rad Unity Real

Time for Test

11. CONTRACTING OFFICER AND CONTRACTING OFFICER'S

REPRESENTATIVE

Contracting Officer (CO): Anthony Marion

Contracting Officer's Representative (COR): Sean Whiteman, Laboratory Manager, 501-257-

12. RECORDS MANAGEMENT OBLIGATIONS

A. Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions

“Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United

States Government or because of the informational value of data in them.

The term Federal record:

1. includes [Agency] records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their

[Agency] contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

• Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs.

21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of

1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

• In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of

Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5

U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

• In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for

Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

• [Agency] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [Agency] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to

[Agency]. The agency must report promptly to NARA in accordance with 36 CFR

1230.

• The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from

Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the

Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [Agency] control or the

Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the

Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

• The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

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

• The Contractor shall not create or maintain any records containing any non-public

[Agency] information that are not specifically tied to or authorized by the contract.

• The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

• The [Agency] owns the rights to all data and records produced as part of this contract.

All deliverables under the contract are the property of the U.S. Government for which

[Agency] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through

FAR 52.227-20.

• Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

D. Flow down of requirements to subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

13. INFORMATION SECURITY

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.

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

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 of

$37.50.

14. INVOICING AND PAYMENT: Invoices for payment shall be submitted monthly in arrears and the following information shall appear on all invoices:

• Contractor’s name/address/phone number

• Contract XXX

• PO) funding number

• Contract Number: XXXXX, Month and year of service for invoice submitted

• Contract Line Item Number and description of service performed

• Line Item Price(s) being invoiced

• Total invoice amount

• Timeframe of charges included in the invoice

NOTE: Invoices with any incorrect or incomplete information will be returned to the

Contractor for resubmission.

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, Vendor

Electronic Invoice Submission Methods. Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below: VA’s Electronic…

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