36C25024Q1091.docx

36C25024Q1091

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

506-25-1-1527-0003 36C25024Q1091 11-0 -2024 Morgan Stein (Morgan.Stein@va.gov) 11-1 -2024 12:00

EST

Department of Veterans Affairs Network Contracting Office (NCO) 10 3140 Governor’s Place Blvd. Suite 210 Kettering OH 45409-1337 X 811210 $34 Million N/A X 36C250 Department of Veterans Affairs Ann Arbor VA Medical Center 2215 Fuller Road Ann Arbor MI 48105 36C250 Department of Veterans Affairs Network Contracting Office (NCO) 10 3140 Governors Place Blvd. Suite 210 Kettering OH 45409-1337

Department of Veterans Affairs Financial Services Center Invoices To Be Submitted Electronically https://www.ob10.com/us/en/veterans-affairs// Invoice Setup Info Phone 877 353 9791 512 460 5429 X See CONTINUATION Page

THIS IS A REQUIREMENT TO PROVIDE SOFTWARE MANAGEMENT SERVICES

FOR THE EXISTING ALARIS INFUSION SYSTEM INSTALLED AT THE

ANN

ARBOR VAMC.

WHILE THE VAMC DEVELOPS ITS ACQUISITION

STRATEGY

FOR A REPLACEMENT INFUSION SYSTEM.

Vendor shall provide all Personnel, management, and maintenance necessary to provide Carefusion Alaris Infusion Pump Software Management Services for the Ann Arbor VAMC IAW the PWS herein.

Vendor shall be issued a Firm-Fixed-Price Purchase Order for a b ase (one) year contract to be exercised at the Government s convenience.

All questions relating to this RFQ must be submitted by email only to Morgan.Stein@va.gov. Question deadline is November at 12:00 PM NOON EDT.

This procurement is being conducted under FAR 13.106.

See CONTINUATION Page X X Lisa Bailey Contracting Officer 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: Contract Specialist Morgan Stein Department of Veterans Affairs Network Contracting Office (NCO) 10 3140 Governor’s Place Blvd. Suite 210 Kettering OH 45409-1337

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.

https://www.tungsten-network.com/customer-campaigns/veteransaffairs/

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

B.2 REVIEW REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT SYSTEM (CPARS)

(a) as prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed $250,000 and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Seal Logistics Center in Portsmouth, Virginia. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for contractor responsibility determination information.

(b) Each contractor whose contract award is estimated to exceed $250,000 is required to register with CPARS database at the following web address: www.cpars.csd.disa.mil. Help in registering can be obtained by contacting Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690. Registration should occur no later than thirty days after contract award and must be kept current should there be any change to the contractor’s registered representative.

(c) For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the contractor’s designated representative for comment. The contractor representative will have thirty days to submit any comments and re-assign the report to the VA contracting officer.

(d) Failure to have a current registration in the CPARS database, or to re-assign the report to the VA contracting officer within those thirty days, will result in the Government’s evaluation being placed on file in the database with a statement that the contractor failed to respond.”

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Carefusion Alaris Infusion Pump Software Management Services Contract Period: Base POP Begin: 12-01-2024 POP End: 11-30-2025 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance PRODUCT/SERVICE CODE: J065 - Maintenance, Repair, and Rebuilding of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

36C25024Q1091

B.4 SOFTWARE MANAGEMENT SERVICES - PERFORMANCE WORK STATEMENT

The purpose of this procurement is to acquire infusion pump software management services (SMS) for use in Ann Arbor VA Medical Center. The Contractor shall provide all software management services required to maintain and operate the Alaris Infusion System from BD (formerly CareFusion) currently located at 2215 Fuller Rd, Ann Arbor MI.

1. BACKGROUND

Software management services for the Alaris Infusion System includes software enhancements to server-based Alaris Infusion System software components; services that include internet, webinar and on-site training and clinical education; support ranging from remote monitoring of the Alaris Systems Manager to technical support for the Alaris Infusion System; and includes collection of data and providing analytics tools and services. Software enhancements do not include software updates or version upgrades to infusion device hardware.

The following components comprise the Alaris Infusion System located at Ann Arbor VA Medical Center for this requirement.

Table 1. Alaris Infusion System Components

Alaris Infusion System Description. Infusion system modules connect to an infusion controller (PCU). The PCU connects wirelessly to the VA enterprise network to transmit and receive data to and from the Alaris Systems Manager server. The Alaris Systems Manager resides on a server (virtual or physical) in a VA data center. Users will access the Alaris Systems Manager server to manage system configuration, retrieve pump connectivity data, capture data analytics, and upload infusion drug libraries. Users will also access software applications such as Guardrails Editor and CQI Reporter to manage drug library configuration and analyze reports collected from infusion data. Care Coordination Engines run on another server (virtual or physical) residing in a VA data center that allow for the infusion devices to wirelessly communicate interoperability parameters to the EHR. The Alaris System Maintenance software is utilized during performance of Alaris Infusion System maintenance. This is a part of the VISN 10 centric solution that covers just one site in VISN 10 the Ann Arbor VAMC. This site has 247 8015 Pc Units, 464 8100 modules, 33 8110 Modules, 25 8120 modules, and 29 8300 modules. The PC unit connects to the network and reports directly to the Cleveland VAMCs hosted virtual servers.

The Contractor shall provide the SMS required under this contract for the following Alaris Infusion System equipment covered under this contract. All services performed shall support compatibility with the current infusion equipment.

Table 2. Supported Alaris Equipment and Software

2. SCOPE OF WORK

The Contractor shall provide software management services for the Alaris Infusion System server and software components identified in Table 2 above. The services shall be in accordance with the tasks and deliverables as described in this Performance Work Statement (PWS). For those components of the system subject to software updates, the Contractor shall complete all system enhancements and patching with clear communication and preparation. The Contractor shall communicate all enhancements and support activations required to keep the system running effectively to the primary point of contact (POC) or the contracting officer representative (COR). All maintenance and updates shall be scheduled at least three (3) days in advance with the COR.

Information Security Considerations All VA sensitive information shall be protected at all times, in accordance with VA Local site guidelines. The Contractor shall report any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information to the COR.

a. Any wireless connectivity to the VA network must be compatible with 802.11b/g/n and FIPS 140-2 compliant.

b. Any remote service support requires a Memorandum of Understanding/Interconnection Security Agreement (MOU/ISA) with the VA.

3. DELIVERABLES

The Contractor shall perform/provide the following services:

Training

a. The Contractor shall include on-site nursing clinical support training for practice reinforcement that can be used for compliance rounds and hospital best practices.

i. One time during the base year of the contract period and any subsequent option year, the Contractor must provide one eight (8) hour day of on-site clinical consulting at each facility for every 500 infusion devices installed at that facility. The training must include nursing staff interactions with the devices and recommending improved practices for medication safety. The COR will provide the Contractor with requested training dates for each facility during the base year of the contract and any subsequent option year. The Contractor will work with the COR in good faith to reasonably accommodate the requested training dates.

ii. The Contractor shall provide a written report to each facility for each practice reinforcement visit.

b. The Contractor shall include a workshop with clinical peers to support customer adoption of CQI Reporter software and enhance interpretation skills of CQI data.

i. Workshop shall be for a period of 2 days and hosted by the Contractor at Ann Arbor VA Medical Center 2215 Fuller Rd, Ann Arbor, MI 48105 once during the base year of the contract and each subsequent option year (annually). The COR will provide the Contractor with requested workshop dates for each facility during the base year of the contract and any subsequent option year. The Contractor will work with the COR in good faith to reasonably accommodate the requested workshop dates.

ii. Workshop shall cover defining and creating a systematic approach to analyzing Guardrails Reporter software alerts and refine drug libraries, dose limits, and clinical advisories to achieve maximum impact for the organization.

c. The Contractor shall provide access to online education. Video content must be made available, upon request, to VA education staff and allowed to be uploaded by the VA to internal learning management systems.

d. The Contractor shall include Suite training sessions with clinical peers to refresh skills on the use of CQI Reporter and Editor training. The training sessions shall be available monthly and can be used as needed.

e. The Contractor shall provide tuition annually for up to two (2) VA representatives to attend the System Data Workshop.

Support

a. The Contractor shall provide phone or email access to highly qualified Pharmacy Consultants and Clinical Infusion Data Consultants to address customer data set questions and concerns and assist with the interpretation of CQI data. The Contractor shall provide a resolution turnaround time of 48 hours from the initial phone call or email communicating a customer issue.

iii. The Contractor shall provide access to qualified Pharmacy Consultants who hold the RPh credential and have at least 3 years’ experience working with BD Continuous Quality Improvement (CQI) information to make recommendations for improved safety limits on specific pharmaceutical products.

iv. The Contractor shall provide access to Clinical Infusion Data Consultants (formerly CQI Managers) who must have at least 3 years’ experience working with BD CQI information to make recommendations for improved safety limits on specific pharmaceutical products and other data set parameters.

b. The Contractor shall provide live technical telephone support with BD authorized support professionals who are based in the United States. The team must be ready to assist and provide support for equipment covered in this contract from 8:00am to 7:00pm in the Eastern Time Zone, Monday through Friday.

The Contractor shall provide Clinical Infusion Data Consultant data support via phone or email from 8:00am to 7:00pm in the Eastern Time zone Monday through Friday, for questions related to the use of the software and interpretation, review, and consulting of data.

Data & Analytics

a. The Contractor shall provide real-time monitoring of the Alaris Systems Manager to ensure system uptime, functionality, optimization, and health in accordance with the national MOU/ISA between the Contractor and VA which is made part of this contract and is incorporated by reference herein.

b. The Contractor shall provide concise, actionable information on the hospital’s infusion management practices, without requiring analytical or reporting software installation or in-house technical resources. This includes unlimited access to a web-based portal defined by hospital with benchmarking tools and the ability to view all infusions. The Government can request a quarterly phone call or report with the data analyst to review the findings in this report.

c. The Contractor shall provide benchmarking tools and the ability to view all infusions (not just those outside of prescribed ranges). This information must be web-based and be accessible to an unlimited number of users per hospital. These services would require hosting on a vendor platform but must not contain any sensitive information, in accordance with the national MOU/ISA.

Software Updates & Maintenance If the Contractor releases updates to the applications or server identified in Table 2 to enhance the security or operation of the software, the Contractor shall deliver the enhancement to the Government in machine-readable form with instructions to assist the Government with installing the enhancement. These enhancements will be provided to the Government within 60 days of their issuance or data of first commercial availability, with no additional charge to the Government, for installed instances of the software. As applicable, the Contractor will install updates remotely through the Contractor’s remote access solution. The Contractor shall use commercially reasonable efforts to correct errors in the software that materially affect the functionality of the software.

All labor, time, materials, equipment, travel, service manuals, and supplies necessary to provide the services required under this contract shall be included in the contract price. One time during each annual period, the Contractor will perform one (1) on-site technical service visit for up to eight (8) hours for each 80 PC units to download CQI data and upload the Government’s drug library data set onto the licensed units. The Contractor shall provide telephone support to the Government regarding the operation of and potential errors in the software.

a. The Contractor shall provide enhancements to the Guardrails Suite MX and Guardrails Editor software when commercially available. This includes providing any updates to the Alaris Systems Manager that are required to install the newest version of Suite MX software.

b. The Contractor shall provide Alaris Systems Manager service patch management of the operating system, Systems Manager application, and other software components. The Contractor shall provide rigorous testing before deployment of software patches and updates, including customized patch cycles and notifications options. All software patches and updates shall be provided at no additional cost to the Government. Remote management of the server shall be delivered in accordance with the most current version of the national MOU/ISA between VA and the Contractor.

c. The Contractor shall provide CareFusion Coordination Engine (CCE) service patch management of the operating system, CCE application, and other software components. The Contractor shall provide rigorous testing before deployment of software patches and updates, including customized patch cycles and notifications options. All software patches and updates shall be provided at no additional cost to the Government. Remote management of the server shall be delivered in accordance with the most current version of the national MOU/ISA between VA and the Contractor.

d. The Contractor shall provide remote installation of server system patches, including the operating system, Alaris Systems Manager, and other system components which will be patched regularly.

e. Software update/enhancement installations shall normally be scheduled and performed outside normal business hours, 8:00am to 7:00pm in the Eastern Time zone Monday through Friday, of coverage at no additional charge to the Government. The COR may approve software installations outside of these hours to meet facility needs.

Unscheduled Maintenance (Emergency Repair Service)

a. The Contractor’s Field Service Engineer (FSE) shall respond via phone call to the COR or his/her designee immediately after receipt of telephoned emergency repair service notification twenty-four (24) hours per day. If the problem cannot be corrected by phone, the FSE will commence work (on-site or remote desktop response) within two (2) hours after receipt of the notification and will proceed progressively to completion without undue delay. This requirement for response time shall be the same for both service calls during the VA normal business hours and after-hour service calls. The COR will provide the Contractor with (a) an accurate description of the software error; (b) the steps necessary to reproduce the software error, if available; (c) if required, the data being processed at the time of the software error and associated log files; and (d) the severity of the software error, including the circumstances that lead to the software error. The COR and the Contractor will communicate and mutually agree on the severity level of the software error in writing.

Scheduled Maintenance

a. The Contractor shall perform patches and enhancements to the software components identified in Table 2 to ensure the Alaris Infusion System equipment and software perform in accordance with the latest OEM maintenance procedures and protocols. Patching shall be provided for all environments: pre-production, production, and training environments. Scheduled software maintenance shall be scheduled at least three (3) days in advance with the COR. An outline of the scheduled software maintenance procedures shall be provided to the COR. The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed, as applicable. This documentation shall be provided to the COR at the completion of the scheduled software maintenance. The Contractor shall provide written description of scheduled software maintenance. This description shall include an itemized list of the procedures performed.

b. Scheduled software maintenance services shall include, but need not be limited to, the following:

i. Reviewing operating system software diagnostics to ensure that the system is operating in accordance with the manufacturer’s specifications

ii. Performing remedial software maintenance of non-emergent nature

iii. Returning the equipment to the operating condition, per OEM standards

iv. Providing documentation of services performed

c. The Contractor shall perform scheduled maintenance services from8:00am to 7:00pm in the Eastern Time zone Monday through Friday. All exceptions to the scheduled software maintenance schedule shall be arranged and approved in advance with the COR.

Documentation & Reports The Contractor shall provide written reports detailing the software management services provided under the contract. The documentation shall include detailed descriptions of the scheduled and unscheduled software maintenance (i.e., emergency software repairs (ESR)) procedures performed, including updates and services required to maintain the software. The ESR shall consist of a separate report for the item(s) covered under this contract. Grouping reports of services performed under this contract with reports of services performed under other contracts on “one” ESR is prohibited. In addition, each ESR shall, at a minimum, document the following data legibly and in complete detail:

a. Contractor information:

i. Name of Contractor

ii. Contract Number

iii. Name of FSE who performed the services

iv. Contractor service ESR number/log number

b. Date and time (starting and ending), software downtime, and hours on-site for service call

c. VA purchase order numbers covering the call

d. Description of problem reported by COR

e. Identification of software to be serviced:

i. Software license and version number

ii. Inventory ID number

iii. Manufacturer name

iv. Device name, model number, and serial number

v. Any other manufacturer identification numbers

f. Itemized description of service performed:

i. Labor and travel

ii. Software patches

iii. Parts (with part numbers)

iv. Location of problem/corrective action

g. Total cost to be billed, if applicable (i.e., service rendered after normal hours of coverage)*

h. Signatures:

i. FSE performing services described

ii. Authorized VA employee who witnessed service described *Any additional charges for work performed outside the scope of this contract shall be coordinated with the CO (Contracting Officer) and COR before service is initiated.

Payments All invoices shall be submitted monthly in arrears. Invoices shall be properly prepared in accordance with FAR 52.212-4, shall contain sufficient detail, shall match with the service tickets for the work rendered, and shall match the contracting line-item numbers (CLINs). Invoices shall be sent electronically to the VA Financial Services Center for payment processing via their electronic e-Invoice system. At a minimum, invoices shall include the following details:

a. Contract number

b. Purchase order number (Correct purchase order number which will be issued by the Contracting Officer after the contract is awarded. Invoices without correct purchase order number shall be rejected and returned to the Contractor.)

c. Item(s) covered (to include License numbers)

d. Description of the services rendered

e. Billing period in which the services were rendered

f. Invoice number and date Competency and Certification of Personnel Servicing Equipment

a. The Contractor shall provide fully qualified FSEs to perform the software maintenance and repair services required under this contract. “Fully qualified” is defined as having successfully completed OEM training required for the software components identified in Table 2 along with any associated equipment.

b. The FSEs shall be authorized by the Contractor to perform the maintenance services. All work shall be performed by fully qualified competent FSEs. Upon request, the Contractor shall provide copies of all OEM training certificates for FSEs showing types of software and equipment and dates of training for all software and equipment identified to be covered. When deemed appropriate, the COR reserves the right to prohibit Contractor personnel from working on VAMC software and equipment.

4. PERFORMANCE STANDARDS

Table 3. Performance Standards Deliverable Reference Paragraph

5. PERFORMANCE PERIOD

The period of performance (POP) shall be for December 1, 2024 – November 30, 2024 (base year) with one option year December 1, 2025 – November 30, 2026.

Normal hours of work are defined as Monday through Friday from 8:00am to 7:00pm in the Eastern Time zone excluding Federal holidays or as otherwise arranged with the COR.

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

Under current definitions, five (5) are set by date:

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

The other six (6) are set by a day of the week and month:

6. PLACE OF PERFORMANCE

Tasks under this PWS shall be performed remotely, when possible. The Contractor shall perform on-site work when required. Work may be performed at remote locations other than the Contractor’s facilities. If a problem requiring service cannot be resolved over the phone or remotely, then an authorized Contractor’s representative shall commence work on-site within the designated time identified and will proceed progressively to rectify the problem without undue delay without any additional cost to the Government with prior approval by the COR.

Table 4. Locations of Performance

7. REFERENCES

National MOU-ISA – CareFusion, LLC (A Becton Dickinson Subsidiary) (Pyxis, Alaris)

B.5 RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS

The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

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

B.6 INFORMATION SECURITY IN ACCORDANCE WITH VA HANDBOOK 6500.6 Appendix C – Paragraphs 1,2,3,6,7,9:

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data

· General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

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6. SECURITY INCIDENT INVESTIGATION

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

7. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a "security incident" as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

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

(2) Description of the event, including:

a. date of occurrence;

b. data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

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

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted,…