36C24623Q0817.docx

36C24623Q0817

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. SIGNAT

URE 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

558-23-3-122-0261 36C24623Q0817 06-08-2023 Charlsi Brooker 757-728-7014 06-15-2023 8:00am

EDT

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667 X 334510 1250 Employees N/A X Department of Veterans Affairs Durham Medical Center Att: Christopher Lester 508 Fulton Street Durham NC 27705 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin TX 78714-9971 512-460-5049 512-460-5221 X See CONTINUATION Page Please see price/cost schedule and attachments for item descriptions and quantities, and complete all requirements as directed in section E.1.

Please reference RFQ# 36C24623Q0817 on all correspondence.

See CONTINUATION Page X X X

ONE

John Summers Contract 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: Contracting Officer 36C246 John Summers Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

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.

http://www.tungsten-network.com/us/en/veterans-affairs/ ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 STATEMENT OF WORK

1. Introduction of Required Specifications:

1.1.1 Purpose: The purpose of this Statement of Work (SOW) is to outline the tasks and responsibilities of the awarded contractor in relation to provisions, installation, integration in relation to an upgrade of the Polysmith equipment, software, and HL7 integration/implementation at the Durham VAMC, Durham, NC.

1.1.2 Contractor must provide all necessary tools, equipment/hardware, software, licenses, installation, maintenance, warranty, and training in accordance with this SOW.

1.1.3 Primary Goals: This procurement will provide an upgrade to current Government-owned sleep equipment and software, as well as implementation of HL7 interface from Government-owned Polysmith 12 systems to the third-party web-based application maintained and operated by Somnoware when deployed at the facility. The Polysmith system will receive HL7 messages in the form of ADT and ORM feeds from Somnoware. After the given patient study collection is completed, an ORU results message will be generated from the Polysmith system and will be sent to Somnoware HL7 interface. Discrete data points are sent to Somnoware from Polysmith via HL7 ORU messages. The discrete data capabilities of Polysmith allows Somnoware to populate the patient's record in Somnoware with relevant clinical data. Nihon Kohden is responsible for the patient data generated by the Polysmith applications and the accuracy of the data transmitted via the Polysmith HL7 interface. It is the responsibility of Somnoware to validate the information generated by their application for patient reports with the variables being received from Polysmith HL7 messages and that the data displayed by Somnoware is properly stored/maintained within the Somnoware cloud.

1.1.4 Equipment: All equipment must be new, state of the art, and not recertified nor refurbished. All equipment must be compliant with current VA requirements for allowable operating system platforms.

1.1.5 Industry Standards: Unless otherwise stated, all equipment must be held to current industry standards for such equipment as present within the current market for polysomnography system equipment, supplies, and related services.

1.1.6 Contractor must meet all minimum requirements contained in section 1.3.

1.2 Definitions:

1.2.1 Polysmith Sleep System: Polysomnography equipment used to diagnose sleep apnea disorders with combined EEG and PSG multi-modality tools, data management, and IT compatible solutions. This system must include amplifiers, PCs, software, and hardware necessary to diagnose and treat sleep disorders.

1.2.2 Clinical acceptance: Initial Clinical use means the delivered equipment as determined by the Government performs the basic intended clinical function of the system in a safe manner for the purpose for which it was designed, with most or all system functionality, allowing the equipment to be used clinically for the diagnosis of sleep disorders. This begins the initial Contractor warranty period.

1.2.2.1 Initial Clinical acceptance for HL7 third party interface means the contractor has delivered an HL7 interface that sends discrete HL7 clinical data (as determined by the government) to the Somnoware HL7 interface. The contractor is responsible for the accuracy of the data generated by the Polysmith equipment and for the information being sent via the Polysmith HL7 interface. Delivery of the Polysmith HL7 interface that transmits data and can be received by Somnoware HL7 interface begins the initial Contractor warranty period.

1.2.3 HL7: Health Level Seven or HL7 refers to a set of international standards for the transfer of clinical and administrative data between software applications used by various healthcare providers.

1.2.4 Polysmith Software: Sophisticated and easy-to-use software for data acquisition and analysis of sleep. Automated analysis of sleep stages, respiratory events, desaturations.

1.2.5 Warranty: Equipment has one year of parts and depot support. Supply items are warranted for 90 days from the date of shipment. The products are warranted to be free from material defects in workmanship or material under normal use and service for the warranty period.

1.2.6 Somnoware Cloud: The Somnoware Cloud is a web hosted application provided by Somnoware.

1.3 Equipment Minimum Requirements:

1.3.1 Polysmith 12:

· Computer hardware must be compatible with Polysmith 12 software.

· Must have a minimum of a two-port NIC for use in SFF PCs.

· Must include Live View Panel Observer software and license.

· Must be compatible with existing Government-owned equipment currently in place.

1.3.2 PSG-1100:

• Must have Axis SD camera with pan, tilt, zoom.

· Must be compatible with Polysmith software.

· Must have microphone system.

· Must have integrated pressure transducer.

· Must be compatible with existing Government equipment currently in place.

1.3.3 ETCO2:

• Must have bleed off cannula for pressure transducer.

· Must have instantaneous, mainstream ETCO2 waveform and values.

· Must not have water traps or condensation issues.

1.4 HL7 Third Party Interface Customization:

1.4.1 Server and Storage Locations: SQL Server instances that support the Polysmith system are stored on VA provided virtual servers on VA premises. Polysmith HL7 Interfaces (Inbound ADT/ORM) are hosted on VA provided virtual servers on VA premises. Polysmith is configured to store sleep study data on VA provided storage on VA premises.

1.4.2 Third-party communication with Polysmith: Polysmith uses HL7 for communication with third party systems.

1.4.2.1 Hospitals and clinics use complex systems, incorporating many different technologies including medical devices, electronic medical records (EMRs), and Medical Device Data Systems (MDDS). To maintain the best experience, reliability, and security, Polysmith software interfaces with these different medical systems using HL7 to exchange data.

1.4.2.2 The use of HL7 as the standard for data exchange between digital systems provides a common interface to ensure compatibility, interoperability, and interchangeability. Each digital system used in a healthcare environment is developed by different organizations under different quality and regulatory requirements to ensure safety and effectiveness. HL7 allows these systems to remain independent under their own regulatory regimes.

1.4.2.3 Data standards, such as HL7, provide the common language that lets different digital systems work together. A key benefit of the HL7 data standard is that it provides secure access to the right health information when and where it is needed. This reduces data exchange errors between systems. Using the HL7 protocol ensures that Polysmith understands what data needs to be exchanged with other HL7 compatible digital systems.

1.4.2.4 Adhering to the HL7 protocol gives integrators a high level of confidence that their systems can communicate safely and effectively. This avoids custom protocols that would require extensive testing to validate the integration between different digital systems. Furthermore, any changes to a custom protocol require regression testing and continuous development to adhere to the changes. This places a significant burden on both healthcare institutions and their vendors since the likelihood of compatibility errors increases exponentially over time as the systems are updated. The transparency of the HL7 data standard also minimizes the potential for errors, resulting in improved patient care.

1.4.2.5 Lastly, the use of HL7 avoids disruption when a new digital system replaces an existing one. For example, the VA’s migration from Vista Electronic Health Record (EHR) to Cerner’s MHS Genesis EHR is streamlined since vendors can rapidly implement updates to HL7 messages. Polysmith’s HL7 messaging has full customization which does not require customers to wait for a new version of Polysmith.

1.4.3 Polysmith Study Review: Data collected using the Polysmith system requires the use of the Polysmith application to review and score polysomnography data in accordance with contractor Software License Agreement. Scoring and clinical interpretation by VA staff will be done within the Polysmith application as hosted by VA owned IT resources and licensing. Upon completion of scoring and clinical interpretation, the VA staff will initiate HL7 transfer of discrete variables of Polysmith data by initiating the HL7 button within Polysmith. The contractor will provide the discrete data as determined by the VA clinical staff to be sent to the Somnoware via Polysmith HL7. No clinical reports for official use or as determined as official diagnosis will be generated within the Polysmith application.

1.4.3.1 Clinical reports as generated within the Somnoware cloud are the responsibility of the VA clinical staff and Somnoware. The VA has contracted the Somnoware system to store will store Polysmith sleep study data in the Somnoware cloud. Somnoware will use a manual or automated process of their making to perform the action of storing the PSG data collected by Polysmith action. However, this method will bypass the Polysmith DMS database in SQL Server which will prevent any further use of Polysmith DMS features as a result. In context of this paragraph, Polysmith and Polysmith DMS should be considered separate components of the same application.

1.4.4 Customers are notified of new release versions of Polysmith through the DrawBridge licensing system. It is the responsibility of the customer to ensure other third-party systems are aware of new software releases and performing due diligence for compatibility if they choose to install the new Polysmith release.

1.5 Installation Considerations:

1.5.1 IT systems configuration and implementation, including travel time, training for a 2-4 acquisition systems.

1.5.2 Contractor must comply with all VA mandated and local permitted/safety requirements.

1.5.3 Contractor will dispose of all boxes, trash and debris resulting from installation IAW hospital policy.

1.6 Support Features:

1.6.1 Telephone Support: Must include 24x7x365 Unlimited Telephone Support, 24x7 Go-Live Clinical Support by Telephone per Department, 24x7 Ongoing Clinical Support by Telephone per Department for the life of the system. This support must be at no additional cost to the Government.

1.6.2 Remote Support: The contractor will ensure they understand and implement the IT security requirements for system interconnection documents required per the Memorandum of Understanding or Interconnection Agreement (MOU-ISA). The standard operating procedure (SOP) and a template for a MOU-ISA are located on the Information Protection Risk Management (IPRM) Portal and can be provided to the contractor. The facility will work with the contractor to establish a MOU-ISA for this requirement/equipment.

1.6.3 Moving data/archiving, software performance in the Somnoware Cloud and IT issues related to the Somnoware system will be directed to Somnoware. Contactor support is limited to the local Polysmith acquisition system at the facility and HL7 communication between Polysmith and any third-party system that utilizes a Polysmith HL7 interface.

1.7 Warranty:

1.7.1 Equipment Warranty: Equipment has one year of parts and depot support. Supply items are warranted for 90 days from the date of shipment. The products are warranted to be free from material defects in workmanship or material under normal use and service for the warranty period. Third party equipment and/or supplies comes with OEM warranty.

1.8 Licensing:

1.8.1 All Polysmith licensing shall be the property of the facility. Instances of Polysmith hosted in the Somnoware cloud will connect to Polysmith Drawbridge Cloud License Server to register and will use VA licensing.

1.9 Cybersecurity:

1.9.1 Facility will sponsor and submit necessary paperwork thru appropriate channels in order for equipment contained in this contract to obtain TRM and/or RMF and/or any other necessary cybersecurity approvals, if applicable.

1.10 Exclusions:

1.10.1 Contractor will not provide support for services, hardware, or software provided by Somnoware.

1.10.5 Somnoware is responsible for any Windows patching and any security and critical updates for systems owned and operated by Somnoware.

1.10.6 Nihon Kohden is not responsible for reports, branding, etc that does not belong to Nihon Kohden and/or is generated directly from Nihon Kohden equipment.

1.10.7 Nihon Kohden is not responsible for maintaining any file or document which lists variables and maps data between the Polysmith system and Somnoware. It is the responsibility of the VA and/or Somnoware to maintain this document and its contents.

End Statement of Work

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

PSG-1100 IP Camera Kit - Capital Contract Period: Base POP Begin: 06-19-2023 POP End: 06-30-2023 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): PSG1100-C-IPC/ZA

LOCAL STOCK NUMBER: PSG1100-C-IPC/ZA

APC SMART UPS 750VA AME-SUA750

POP Begin: 06-19-2023 POP End: 06-30-2023 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): A/APCUPS

LOCAL STOCK NUMBER: A/APCUPS

TRIPP OMNI SMART 350HG(478087)

POP Begin: 06-19-2023 POP End: 06-30-2023 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): A/TL350HG

LOCAL STOCK NUMBER: A/TL350HG

WALL MOUNT, UNIVERSAL

POP Begin: 06-19-2023 POP End: 06-30-2023 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): A/WM-0030-02

LOCAL STOCK NUMBER: A/WM-0030-02

24 Inch Monitor w/ Speakers

POP Begin: 06-19-2023 POP End: 06-30-2023 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): A/FLTSCREEN-XB3

LOCAL STOCK NUMBER: A/FLTSCREEN-XB3

SLP adult In-lab DSP starter kit

POP Begin: 06-19-2023 POP End: 06-30-2023 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): A/IL-D1

LOCAL STOCK NUMBER: A/IL-D1

SLP adult In-lab DSP refill kit

POP Begin: 06-19-2023 POP End: 06-30-2023 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): A/IL-DR1

LOCAL STOCK NUMBER: A/IL-DR1

PS12 OnDemand Review Analysis lic.(Qty1)

POP Begin: 06-19-2023 POP End: 06-30-2023 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): A/PS12-RA-OD1

LOCAL STOCK NUMBER: A/PS12-RA-OD1

PSG PC WITH QUAD NIC

POP Begin: 06-19-2023 POP End: 06-30-2023 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): PSGPC-XE3/ZA

LOCAL STOCK NUMBER: PSGPC-XE3/ZA

Polysmith Review &Analysis PC Upgrade 2

POP Begin: 06-19-2023 POP End: 06-30-2023 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): PS-RA-PCLS-UP2/ZA

LOCAL STOCK NUMBER: PS-RA-PCLS-UP2/ZA

WALL CHANNEL 13" WITH HARDWARE

POP Begin: 06-19-2023 POP End: 06-30-2023 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): A/WC-0002-02

LOCAL STOCK NUMBER: A/WC-0002-02

Adult EtCO2 Kit for PSG-1100 with probes

POP Begin: 06-19-2023 POP End: 06-30-2023 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): TG-980P-ADULT/ZA

LOCAL STOCK NUMBER: TG-980P-ADULT/ZA

LABOR FOR HL7 CUSTOMIZATION

POP Begin: 06-19-2023 POP End: 06-30-2023 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): #NK-HL7-CUSTOM

LOCAL STOCK NUMBER: #NK-HL7-CUSTOM

PS12 HL7 OnDemand lic. (Qty1)

POP Begin: 06-19-2023 POP End: 06-30-2023 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): A/PS12-HL-OD1

LOCAL STOCK NUMBER: A/PS12-HL-OD1

** REPORT CUSTOM PSG, PAGE (V58713)

POP Begin: 06-19-2023 POP End: 06-30-2023 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): #NK-CUSTOM-RPT

LOCAL STOCK NUMBER: #NK-CUSTOM-RPT

Install Solution

POP Begin: 06-19-2023 POP End: 06-30-2023 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies MANUFACTURER PART NUMBER (MPN): Install-Solution-N LOCAL STOCK NUMBER: Install-Solution-N

B.4 DELIVERY SCHEDULE

Durham VAMC 508 Fulton Street Durham, NC 27705 United States

919-286-0411 x178329 christopher.lester@va.gov

Durham VAMC 508 Fulton Street Durham, NC 27705 United States

Durham VAMC 508 Fulton Street Durham, NC 27705 United States

Durham VAMC 508 Fulton Street Durham, NC 27705 United States

Durham VAMC 508 Fulton Street Durham, NC 27705 United States

Durham VAMC 508 Fulton Street Durham, NC 27705 United States

Durham VAMC 508 Fulton Street Durham, NC 27705 United States

Durham VAMC 508 Fulton Street Durham, NC 27705 United States

Durham VAMC 508 Fulton Street Durham, NC 27705 United States

Durham VAMC 508 Fulton Street Durham, NC 27705 United States

Durham VAMC 508 Fulton Street Durham, NC 27705 United States

Durham VAMC 508 Fulton Street Durham, NC 27705 United States

Durham VAMC 508 Fulton Street Durham, NC 27705 United States

Durham VAMC 508 Fulton Street Durham, NC 27705 United States

Durham VAMC 508 Fulton Street Durham, NC 27705 United States

Durham VAMC 508 Fulton Street Durham, NC 27705 United States

B.5 IT SECURITY CLAUSES

VA Handbook 6500.6, Appendix C – Clauses

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/subcontrator 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 COTR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R.

Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COTR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

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

Information technology staff must also use the Windows Installer Service for installation to the default “program files” directory and silently install and uninstall.

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

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

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

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

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

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

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

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

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

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

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

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

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within ____ days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

5. INFORMATION SYSETM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA’s network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor’s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor’s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA’s POA&M management process. The contractor/subcontractor must use VA’s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

f. VA prohibits the installation and use of personally-owned or contractor/subcontractor-owned equipment or software on VA’s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

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

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

(2) VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

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

(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not…