P09 Responder Enterprise SOW.docx

Oklahoma City VA Healthcare System Initial Outfitting & Transition Support Services

Statement of Work

Hospital Comm Systems / Nurse Call Information Data Management Software System

Statement of Work Hospital Comm Systems / Nurse Call Information Data Management Software System

Introduction Oklahoma City Veteran Affairs Health Care System (OKC VAHCS) wishes to enter into an agreement to purchase Hospital Communication System / Nurse Call Information Data Management Software System with an authorized vendor for supply and delivery of the items identified below, and subsequent services required to assemble, test, install, integrate, warranty, and/or maintain new items for the Oklahoma City VA Medical Center Hospital at 921 NE 13th St, Oklahoma City OK, 73104.

The nurse call hospital communication software solution includes systems for connectivity to OKC’s Rauland Responder 5 (R5) nurse call hardware. The software shall provide a robust full disclosure archive of hospital trends (including safety, call volume, and response times, unit-based trends, nurse call events (by room, over time, and staff visits to rooms), hourly and daily event trends with drill-down performance metrics, and event trackers showing real time events. The software shall also provide validating software releases and functions for OKC’s specific environment, SIP integration with Engage for sharing staff assignments and delivering alerts to Vocera with support for dial back audio to patient rooms, and interface with Oklahoma City’s Electronic Health Record (CPRS, VistA, Oracle Health (Cerner)), Patient Monitoring (Philips), Virtual Care Platform (AvaSure), Communication System (Vocera), CISCO Call Manager, and Device Location System (Centrak - RTLS).

The vendor will use the Enterprise Risk Assessment, Memorandum of Understanding, Interconnection Security Agreement, and Business Associate Agreement provided by the VA to use the existing nurse call infrastructure network to communicate all components of the hospital comm system. The network will include secured wired and wireless information technology (IT).

Further information and details about each item and any services required is provided in section 3. The vendor is required to provide fully functional system(s) for all items listed.

Table 1 – Package Items Summary

Test System

Dashboards (Professional Services)

Subscriptions

2 General Conditions

2.1 General Operation

On-Site assembly, installation of items, and performance of services identified in this document will take place during normal business hours which are defined as 0700-1600 (i.e. 7:00am-4:00pm Central Standard Time) Monday through Friday, excluding Federal Holidays.

The vendor will protect all finished spaces and surfaces at no additional cost to the facility. The vendor will be responsible for paying for, and repairing, any damage or noted deficiencies to finished spaces and surfaces resulting from the vendor’s (or subcontractors) installation.

Prior to starting work, the vendor and associated personnel (including subcontractors) will be required to attend a general contractor’s site safety training program and adhere to its Personal Protective Equipment (PPE) requirements. The length of the training is approximately 2 hours. A minimum of 10 hours of OSHA Safety Training is required prior to taking on-site safety training.

There are no dumpsters available for vendor use. Vendor shall be responsible for removal of all trash generated from installation. Vendor shall provide an electronic copy of the User and Service manuals for each equipment model and network hardware device or system.

Vendor shall be in compliance with VA network security regulations according to VA Directive 6500 and 6550. Additionally, the vendor shall comply with Appendix B and C of this document.

2.2 Drawing Documents and Specifications

OKC VAHCS will have the right to use all final system architecture drawings, specifications, and any other documentation submitted by the winning vendor at no additional cost to the facility. Documentation should include locations of all access points, network nurse call equipment, nurse call hardware equipment, storage and servers, and major components.

Vendor shall provide the Manufacturer Disclosure Statement (MDS2) and fill out form VA 6550.

3 Functional and Technical Specifications

3.1 Test System – Qty 1

The vendor shall provide all required hardware (including mounts and rails), software, and user interface requirements necessary to provide a fully functioning nurse call hospital communication software test solution. At a minimum, the vendor shall provide the following Rauland Responder components:

Single Patient Station – Qty 1 Duty Station – Qty 1 Code Station – Qty 1 Audio Pull-Cord Station – Qty 1 Waterproof Pull-Cord Station – Qty 1 2-Jack Station – Qty 1 Domeless Controller – Qty 1 Branch Regional Controller – Qty 1 Power Supply w/ Battery Backup – Qty 2 Nurse Console – Qty 1 Staff Terminal – Qty 1 Bed Control Module – Qty 1 Corridor Light – Qty 1 Pillow Speaker – Qty 1 Wall Mounting Cabinet – Qty 1 8-Port Ethernet Switch – Qty 1

3.2 Dashboards (Professional Services) – Qty 1 (Ea.)

The vendor shall provide all software and user interface requirements necessary to provide a fully functioning nurse call software solution. The dashboards need to interface with appropriate informatics and systems based on their care area. This includes Philips Patient Monitoring, AvaSure, Vocera, CISCO Call Manager, and RTLS. All dashboards should be accessible via an authorized web browser, displayed in multiple locations, and customizable. This includes the PBX display for code notifications, labels, and locations. The vendor shall provide dashboards with the following characteristics:

3.2.1 Hospital Trends

Provides high level insights into the following:

Safety Call Volume Response Times

3.2.2 Unit-Based Trends

Provides quick overview of the following:

Nurse call events by room and over time Staff visits to rooms

3.2.3 Hourly and Daily Trends

Summarizes hourly and daily event trends Contains drill-down performance metrics

3.2.4 Real Time Events

Contains an event tracker showing real time events Supports fall reduction strategies Focuses on the following safety events:

Bed and chair exits Toilet and shower emergencies

3.3 Subscriptions – Qty 198

The vendor shall provide all required hardware (including mounts and rails), software, and user interface requirements necessary to provide a fully functioning nurse call hospital communication software solution. The subscriptions will need to interface with appropriate informatics and charting systems based on their care area. This includes EHR, Philips Patient Monitoring, AvaSure, Vocera, CISCO Call Manager, and RTLS. The selected software must be on the Philips, AvaSure, Vocera, CISCO, and RTLS pre-approval list of interfaces prior to contract award. At a minimum, the vendor shall provide subscriptions with the following characteristics:

Includes 70-200 beds Software updates Renewal cost of no more than $70,000 Features Automated staff-to-patient assignments Status boards Support for staffing, evidence-based protocols, and care quality Maintenance support and Corrective maintenance repair 24x7 emergency phone support Service and modification as required due to safety or reliability Guaranteed 95% uptime

3.4 Digital Door Signage

The vendor shall provide all required hardware (including mounts and rails), software, and user interface requirements necessary to provide a fully functioning nurse call hospital communication software solution. Digital door signage will need to interface with appropriate informatics and charting systems based on their care area. This includes EHR, Philips Patient Monitoring, AvaSure, Vocera, CISCO Call Manager, and RTLS and the associated pre-approval list of interfaces. At a minimum, the vendor shall provide digital door signage with the following characteristics:

3.4.1 Hardware

Magnetic Bed connectivity cables LED feedback lights/panels Badge reader

3.4.2 Software

Customizable configuration for the following:

Contextual Illumination Isolation Status Assigned Care Team Patient Requests Bed Safety Display Patient Precautions

3.5 Nurse Call Management System

The Nurse Call Management System shall include the network infrastructure, database server, and management software for the communication among equipment described in Section 3.1-3.8 and to other VA systems such as EHR, Patient Monitoring, AvaSure, Vocera, CISCO Call Manager, and RTLS. It must monitor 24/7 within the developed nurse call infrastructure.

3.5.1 Equipment Features and Characteristics

Allow intercommunication among equipment described in Section 3.1-3.8 Communicate on both the nurse call and VA network Must integrate with the following systems:

Electronic Health Record (EHR) VistA

CPRS

Cerner Philips Patient Monitoring AvaSure Virtual Care Platform Vocera Engage CISCO Call Manager Centrak RTLS Must be VA TRM approved

3.5.2 Nurse Call Network Infrastructure

Wired network (includes to all equipment described in Section 3.1-3.8).

Wired network to all stations, terminals, and modules described in Section 3.5. The vendor shall provide Cat6 cable for all components.

Room 5F100, and determination of IT closet and room number can be changed as needed.

The contractor shall provide all hardware, conduit, cabling, and hangers necessary for a complete and functional system that meets industry standard installation guidelines.

The system shall support the limiting and control of traffic shaping policies based on the type of device and the associated user account.

The system must provide all needed core networking services: DHCP, DNS, SNMP, SMS, and HTTP(s).

If the vendor solution requires an Active Directory or other LDAP directory services for client authentication (RADIUS 802.1x), then the vendor must provide all hardware and software necessary for said methods.

The system must support the blocking of access to and from networks by way of IP subnet address ranges, CIDR, or country designations.

The contractor shall adhere to the standards outlined by the National Fire Protection Association (NFPA-101 Life Safety Code).

3.5.3 Wireless Network

The estimated wireless network coverage area, including all pathways between these departments, is approximately 600,000 sq ft.

Table 2 – Department Locations

The network bandwidth shall be capable of handling all devices simultaneously, excluding Biomedical Engineering spares.

It is the responsibility of the contractor to determine a proper network topology and an appropriate amount of switches, wireless access points to provide a fully functional system that meets the requirements of this procurement.

The contractor shall provide all required managed wireless access points (WAP), controllers, switches, firewalls and routers supporting industry standard wireless and network protocols needed to provide a functional system. The system is to be based on the connection of managed wireless access points to contractor provided aggregation and edge Power over Ethernet (PoE) Ethernet switches.

Cabling of WAP shall be installed using GREEN Cat6. The system shall support AES and TKIP encryption modes in WEP, WPA, or WPA2 modes.

Contractor shall perform heat mapping before the system is installed. Contractor shall be caution with potential interference for other VA wireless systems such as OI&T Wi-Fi, Guest Wi-Fi, in-building wireless for Radio on frequencies 7/800Mhz and 380-450Mhz, and cellular phone.

The contractor shall provide a site survey to include the effective range boundary and the minimum signal to noise ratio needed to support the wireless system. The VA will review the site survey with the ability to approve or reject prior to commencement of the project. It is the intent that the wireless signal survey will only be focused on the area outlined in the coverage drawings.

The system must provide a central accessible dashboard for monitoring system health, usage, configuration, reporting, logging, and alerts. The system must display location of every access point on an interactive map representing the plan view of the campus and the provided floor plans of each building.

WAP location shall not be located within 18” from the sprinkler head.

3.5.4 Network Switches

Edge switches must be capable of at least 1 GB to each edge device and have dual power supply (120V preferable). Edge switches greater than 8 ports must support 10 GB uplinks to an aggregation switch via SFP+ GBICS. The contractor must determine the needed uplink bandwidth and appropriate physical media necessary for connection to the aggregation switch in the Prime TR to ensure adequate throughput.

A maximum of 2 stands of Multi-Mode or Single Mode fiber, depending on distance, will be allocated for use by this network to connect each Prime TR aggregation and core switches are properly provisioned to support this minimal fiber usage in terms of uplink bandwidth to the core switch.

Layer 2 switch integration between VA OIT and nurse call switch. Each switch must be capable of providing sufficient power to each WAP.

Devices have no special environmental concerns and are expected to operate within normal commercial environmental conditions.

3.5.5 Software Infrastructure

Software shall utilize FIPS 140-3 compliant encryption algorithms and/or in progress of certifying the encryption protocol. Vendor shall provide evidence and proof of active certifying process if not FIPS 140-3 certified at the time of contract award. FIPS 140-3 Security Requirements for Cryptographic Modules can be found at: https://csrc.nist.gov/publications/detail/fips/140/2/final The software shall be TRM approved prior to bid [http://trm.oit.va.gov]. This is due to time constraints of ensuring compatibility and interoperability with the Electronic Health Record modernization efforts.

Database is time stamped and cannot be altered through the user interface.

User Access Management:

System Administration Capable to manage all configuration of the VAMC database Department/Superuser Capable to manage all alarm configuration, notification, user management, and data analytic report of the department Alarm Management User Capable to acknowledge an alarm/notification but not to clear alarms View Only User Capable to view data/reports/alarms but cannot make changes or manage alarms

3.5.6 Operating Systems

Windows OS workstations must be approved for use on the VA network (Windows 10 LTSC or newer).

Server must be capable of operating on the VA server virtual environment. If windows, server OS must be Windows OS 2019 or newer, SQL 2019 or newer. The Oklahoma City VAHCS highly desires the ability to split the SQL database and host it on the OIT Enterprise SQL instance.

All OS and database versions must NOT be end of life within two (2) years of installation.

3.5.7 One Patient Record

The OKC VA needs patient record documentation such that one record is created and updated throughout the hospital stay to ensure completeness, patient safety, and continuity of care.

A system that creates multiple patient records depending on which unit a patient is admitted to will not meet this requirement.

3.5.8 Installation Requirement

The contractor shall perform all installation and configuration necessary to complete the work. All installation activities shall be executed in accordance with the project plan and schedule. The contractor shall perform the installation in accordance with the technical requirements outlined.

The Contractor shall install, verify, and validate the technical requirements identified in this document. COR will inspect and approve Contractor performance prior to VA acceptance for the Nurse Call network.

The Contractor shall be responsible for the design, configuration and installation of all cabling, access points, cradle points, switches and other equipment needed for the Nurse Call network. All cable and fibers used for this shall become the property of the VA at the end of the contract.

The Contractor shall submit a plan for approval by VA of all hardware and fasteners, as well as cable routing pathways. Plan will be submitted within 30 days of the contract award.

All access points will be installed using standard horizontal cabling methods. Patch cables only between switch and patch panel and between horizontal termination block and access point.

VA has no decommission scope of work for removing the incumbent’s access points, cables, wireless infrastructure components, and tenting for dust containment. If vendor can use existing cable and AP layout, VA is amenable.

All UTP patch panels, horizontal cabling and patch cables will be CAT6. The vendor shall be responsible for cable management including the labeling of all network cables, cables, ports, etc. associated with guest wireless installation.

Existing cable trays may be used for cable distribution. For locations where cable trays are not available, cabling shall be fastened with appropriate fasteners. Where cable penetrates fire and smoke walls that do not have existing cable trays, metal sleeve shall be installed in accordance with NFPA-101 using approved fire stop material to seal all penetrations. Any cable to be installed in an inaccessible area must be installed in conduit. All cable must be plenum rated.

Laying of wiring on suspended ceilings will not be permitted. Contractors shall be responsible for identifying any architectural deficiencies prior to installation and shall be responsible for correcting any broken ceiling tiles and penetrations in accordance with approved ANSI/UL (e.g. UL1479) Fire stop requirements. Inspections will be conducted and enforced post installation.

The Contractor shall take digital photographs before and after action activities to all disruption of smoke or fire wall. Activity includes core drill, breakage or removal of fire stop, and broken ceiling tiles. The Government will not sign off on the final invoice until this task is completed.

The Contractor must comply with all relevant standards and building codes including:

The Joint Commission (TJC) on Manual for Health Care Facilities, all necessary Life Safety and/or Support guidelines American Society of Testing Material (ASTM): D2301-04 Standard Specification for Vinyl Chloride Plastic Pressure Sensitive Electrical Insulating Tape Federal Specifications: A-A-59544-00 Cable Wire, Electrical (Power, Fixed Installation) National Fire Protection Association (NFPA):

70-05 National Electrical Code (NEC) Underwriters Laboratories, Inc. (UL): 44-02. Thermoset-Insulated Wires & Cables 83-03, 467-01 Electrical Grounding & Bonding Equipment 486A-01 Wire Connectors and Soldering Lugs for Use with Copper Conductors 486C-02 Splicing Wire Connectors 486D-02 Insulated Wire Connector Systems for Underground Use or Damp Locations 486E-00 Equipment Wiring Terminals for Use with Aluminum and/or Copper Conductors 493-01 Thermoplastic-Insulated Underground Feeder and Branch Circuit Cable 514B-02 Fittings for Cable and Conduit 1479-03 Fire Tests of Through-Penetration Fire Stops NFPA 70: National Electric Code NFPA 101: Life Safety Code.

Occupational Safety and Health Act (OSHA).

UL Listing of Communications Cabling and Hardware Building Industry Consulting Services; Telecom Distribution Methods Manual ANSI/TIA/EIA-569-B – “Commercial Building Standard for Telecommunications Pathways and Spaces”.

ANSI/EIA/TIA-526-14 “Method B: Optical Power Loss Measurements of Installed Multimode Fiber Cable Plant”.

ANSI/EIA/TIA-526-7 “Method 1: Optical Power Loss Measurements of Installed Single mode Fiber Cable Plant”.

ANSI/TIA/EIA-606-A – “Administration Standard for the Telecommunications Infrastructure of Commercial Buildings”.

ANSI/J-STD-607 – “Commercial Building Grounding and Bonding Requirements for Telecommunications”.

FCC – Part 67, for Communications Interconnection Devices

3.6 Area Specific Requirement

All specifications and quantities shall adhere to Table 1: Package Items Summary in the Introduction.

3.7 Project Management Plan

3.7.1 Contractor Project Management Plan

The Contractor shall draft a Contractor Project Management Plan (CPMP) that lays out the Contractor’s approach, timeline, and tools to be used in execution of the contract. The PMP should take the form of both a narrative and graphic format displaying the schedule, milestones, risks, and resource support. The CPMP shall include the contractor’s plans for managing all subcontractors. Topic areas to be addressed shall include oversight and communications with subcontractors while onsite at VA locations, as well as executing the timely distribution and delivery of all materials to subcontractor personnel. The CPMP shall also include how the Contractor shall coordinate and execute planned, routine, and ad hoc data collection reporting requests as identified. The initial baseline CPMP shall be concurred upon and updated monthly thereafter. The Contractor shall update and maintain the VA Contracting Officer’s Representative (COR) approved CPMP throughout the period of performance.

The CPMP includes but is not limited to:

Project Schedule to include Milestones, Deliverables, and Critical Path Verification & Validation (V&V) Plan Training Plan (System Administrator and Guest Training material)

3.7.2 Reporting Requirements

The Contractor shall provide weekly progress reports, to include schedule updates, to the VA COR and shall cover all work completed during the reporting period and work planned for the subsequent reporting period. The reports shall also identify any problems that arose and provide a description of how the problems were resolved. If problems have not been completely resolved, the Contractor shall provide an explanation. The Contractor shall monitor performance against the CPMP and report any deviations. It is expected the Contractor will remain in communication with the VA accordingly, so issues are transparent to both parties to prevent the escalation of outstanding issues.

The Contractor shall provide the COR with Weekly Installation Progress Reports in electronic form in Microsoft Word, Project formats or PDF. The report shall include detailed instructions/ explanations for each required data element, to ensure that data is accurate and consistent. These reports shall reflect data as of the last day of the preceding Month. These reports shall include a summary of the task order deliverables.

3.7.3 Verification and Validation Requirement (Testing)

The Contractor shall perform testing following installation to ensure access points and wireless service are functioning at a data rate acceptable to the site as determined during the site survey and with signal to noise ratio acceptable to the site as determined during the site survey. The Contractor shall discuss and confirm suggested speed test criteria in Testing Requirement 1 with the VA COR.

The Contractor shall provide a Pre-Installation Survey Heat Map, which will show where the access points are located and that they are functioning. The Contractor shall test for interference with existing medical center systems. The Contractor shall provide a final test plan that includes updates addressing any comments provided by the VA to the draft test plan.

Contractor shall test the integration to EHR (CPRS, VistA, Cerner), Philips Patient Monitoring, AvaSure, Vocera Engage, CISCO Call Manager, and RTLS.

3.7.4 Project Estimate Timeline

Phase I:

System Design.

Expected Start Date:

As soon as contract Award.

Phase II:

Installation of cables Expect Start Date:

As soon as Phase I is completed.

Phase III:

Installation of Network gear and WAP.

Phase IV:

Deliver and install all patient monitor equipment Expected Start Date:

As soon as Phase III is completed.

Phase V:

Validation, Verification:

Expected Start Date:

Immediately after Phase IV Phase VI:

End User Training.

Expected Start Date:

Immediately after Phase V Phase VII:

GO-Live Expected date is To Be Determined

3.8 Training Requirements

The vendor shall provide training for the OKC VAHCS Clinical and Non-Clinical staff.

Table 3 – Training Details by Audience

All shifts

@ minimum 600 clinical staff

Superuser: @ minimum 50 staff

6 staff

3 staff

Minimum of 1-week clinical user training for all shifts

4 Information Security The vendor shall comply with all VA information security regulations from VA Directive 6500 and 6550. Additionally, the vendor shall comply with Appendix B and C of this document.

APPENDIX B: VA Acquisition Regulation Solicitation Provision and Contract Clause

1. SUBPART 839.2 – Information and Information Technology Security Requirements

839.201 Contract Clause for Information and Information Technology Security Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media.

In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources.

2. 852.273-75 - Security Requirements for Unclassified Information Technology Resources The contractor, their personnel, and their subcontractor shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

APPENDIX C: VA Information and Information System Security/ Privacy Language for Inclusion into Contracts, as Appropriate

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 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.

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.

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.

Custom software development and outsourced operations must be 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.

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 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).

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.

Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor while 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.

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.

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.

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.

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.

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 140-3 validated.

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.

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 to all requests for demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

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.

For service that involves 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 Information systems 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 VA security privacy control requirements for Federal information systems. This includes standards for 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. During the development cycle, a Privacy Impact Assessment must be completed, provided to COTR, and approved by the VA Privacy Service in accordance with Directive 6507.

The (sub)contractor shall certify, to the COTR, applications are fully functional and operate as intended on systems using the VA Federal Desktop Core Configuration (FDCC) and the common security configuration guidelines provided by NIST or VA, including internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode) and future versions.

The standard installation, operation, maintenance, updating, and patching of software shall not alter configuration settings from the VA approved and FDCC configuration. Information technology staff must also use Windows Installer Service for installation to the default “program files” directory and silently install and uninstall.

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

The security controls must be designed, developed, VA approved, and implemented in accordance with the VA security system development life cycle outlined in NIST Special Publication 800-37 and VA Handbook 6500, Information Security Program and VA Handbook 6500.5.

The (sub)contractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals subject to the Privacy Act of 1974, Public Law 93-579, December 31, 1974 (5 U.S.C. 552a). Violation may involve the imposition of criminal and civil penalties.

The contractor/subcontractor agrees to:

Comply with Privacy Act of 1974 and agency rules and regulations issues in the design, development, or operation of system records on individuals when the contract identifies:

The Systems of Records (SOR) The design, development, or operation work the (sub)contractor is to perform Include Privacy Act notification contained in this contract in every solicitation resulting subcontract and subcontract awarded without solicitation when the work statement in the proposed subcontract requires redesign, development, or operation of a SOR on individuals subject to the Privacy Act.

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.

In the event of violations, civil action may be brought against the agency involved when 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 an employee of the agency.

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

“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 assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

“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 assigned to the individual.

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

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 __3__ days

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 _3___ days.

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 System Hosting, Operation, Maintenance, or Use 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 vulnerability 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.

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.

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.

The (sub)contractor’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 (sub)contractor 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 (sub)contractor activities must also be subject to such assessments. If major changes are made to the system 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 the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

The (sub)contractor must conduct an annual self-assessment on systems and outsourced services. 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 (sub)contractor. The contractor must take appropriate and timely action to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

VA prohibits installation and use of personally owned or (sub)contractor 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 SOW or contract. All security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and funded by the equipment owner. Remote systems must be equipped with, and use, VA-approved antivirus (AV) software and a personal (host or enclave based) firewall that is configured with VA approved configuration. Software must be kept current, including critical updates and patches. OE owners are responsible for providing and maintaining AV software and firewall on non-VA owned OE.

All electronic storage media used on non-VA leased or non-VA owned IT equipment 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 (sub)contractor. Media used by the (sub)contractors that contain VA information must be returned to the VA for sanitization or destruction, or the (sub)contractor must self-certify the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

Biomedical devices, and other equipment or systems, containing media 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:

Vendor must accept the system without the drive.

VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at turn-in VA must reimburse the company for media at a replacement cost at time of purchase.

Due to the specialized, and sometimes proprietary, hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive:

The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media nitization specifications need to be preapproved and described in the purchase order or contract.

A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

6. Security Incident Investigation 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 subcontractor shall immediately notify the COTR, 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.

To the extent known by the (sub)contractor, the (sub)contractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident, and any other information that the (sub)contractor considers relevant.

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.