S02 36C24623Q0642 Attachment I - Statement of Objectives 24 Aug 2023.pdf

STATEMENT OF OBJECTIVE

Asheville OR Lighting Project

24 Aug 2023

1.0 Description of Requirement

The Department of Veterans Affairs (VHA), VISN 6, Asheville VA Medical Center has a requirement for Operating Room Lighting Systems and Interactive Wall Panels. Currently the Operating Room Suite is under construction and this equipment is necessary to outfit its newly renovated and expanded Operating Room Suite.

1.1 Definitions and Acronyms

1.1.1 Contracting Officer (CO) - The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

1.1.2 Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance.

The COR shall keep a quality assurance file. At the conclusion of the contract or when requested by the CO, the COR shall provide documentation to the CO. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the CO for action. shall be appointed via separate letter for this contract. The COR shall be responsible for the effective oversight of this contract to ensure satisfactory contractor performance and protect the public trust. A copy of the COR Appointment letter shall be provided to the Contractor after contract award and shall contain detailed information in regards to the COR and their associated duties, responsibilities and authorities.

1.1.3 Contractor Performance Assessment Reporting System (CPARS) - CPARS is a web-enabled application that collects and manages the library of automated Contractor Performance Assessment Reports (CPARs). A CPAR assesses a contractor's performance and provides a record, both positive and negative, on a given contractor during a specific period of time. Each assessment is based on objective facts and supported by program and contract management data, such as cost performance reports, customer comments, quality reviews, technical interchange meetings, financial solvency assessments, construction/production management reviews, contractor operations reviews, functional performance evaluations, and earned contract incentives

1.1.4 Equipment - means a tangible item that is functionally complete for its intended purpose, durable, nonexpendable, and needed for the performance of a contract. Equipment is not intended for sale, and does not ordinarily lose its identity or become a component part of another article when put into use. Equipment does not include material, real property, special test equipment or special tooling.

1.1.5 Government-furnished property (GFP) - means property in the possession of, or directly acquired by, the Government and subsequently furnished to the contractor for performance of a contract.

Government-furnished property includes, but is not limited to, spares and property furnished for repair, maintenance, overhaul, or modification. Government-furnished property also includes contractor-acquired property if the contractor-acquired property is a deliverable under a cost contract when accepted by the Government for continued use under the contract.

1.1.6 Government Property - Means all property owned or leased by the Government. Government property includes both Government-furnished property and contractor-acquired property.

Government property includes material, equipment, special tooling, special test equipment, and real property. Government property does not include intellectual property and software.

1.1.7 Statement of Objectives (SOO) - A Government-prepared document incorporated into the solicitation that states the overall performance objectives. It is used in solicitations when the Government intends to provide the maximum flexibility to each offeror to propose an innovative approach.

1.2 Acronyms

This section lists acronyms that may be used in this Statement of Work and other parts of the solicitation.

CO Contracting Officer COR Contracting Officer Representative CPARS Contractor Performance Assessment Rating System FAR Federal Acquisition Regulation OR Operating Room SOO Statement of Objectives VA Veteran Affairs VAMC Veteran Affairs Medical Center

2.0 Scope of Requirement

At a minimum the contractor shall be responsible for providing all (to include, but not limited to) equipment, labor, materials, training, hardware, software, licenses’, travel, project management and any incidentals required for the successful installation of a complete turn-key solution that shall ultimately replace the existing Operating Room Lighting Systems and install the required new Operating Room Lighting Systems at the Asheville VAMC.

3.0 Summary of Objective

The Contractor shall be responsible for successful installation of a turnkey solution that will ultimately replace the existing Steris Lighting System at the Asheville VAMC and install new lighting and panels in the newly constructed ORs. The new Lighting System shall be required to integrate and be functional at the completion of install with the following equipment in VA inventory:

- Stryker 1588 AIM – 1588010000 x7

- Olympus CV-190 x2

- Olympus Viscera Elite II – OTV-S300 x1

- Storz TC300 x1

- Storz TC301 x1

- iPad Air – 3rd gen – Model MUUJ2LL/A

- Intuitive Ion System – IF1000

- Medtronic Illumisite – ILS-1000-CS

- Arthrex – AR-3200-0021

- Change Healthcare Mckesson PACS

A. The contractor shall be responsible for providing separate technical and price volumes.

B. Maintenance and Support Services for a Base plus four Option Years, priced to begin post installation and Government Acceptance (contract level) of the installed solution which may or may not lead to the award of a separate contract which would begin post acceptance of the OR Lighting System solution. 24 hr response time is critical

3.1 Existing Conditions/Configuration and Magnitude of Existing System

In an effort for offeror to understand the total magnitude of this project the government is making the disclosure below of what the existing system is comprised of. Additionally, the Asheville VAMC will make the area of work available for interested parties prior to offer submission by offering a Site Visit (refer to Page 1 of the SF1449 for date, time & location).

3.1.1. The existing system is comprised of:

3.2 Operating Room - 1

Integration required for:

Stryker 1588 AIM – 1588010000

Olympus CV-190

Change Healthcare Mckesson PACS

Arthrex – AR-3200-0021

3.3 Operating Room - 2.

Integration required for:

Stryker 1588 AIM – 1588010000

Olympus CV-190

Change Healthcare Mckesson PACS

3.4 Operating Room - 5

Integration required for:

Stryker 1588 AIM – 1588010000

Olympus Viscera Elite II – OTV-S300 iPad Air – 3rd gen – Model MUUJ2LL/A

Change Healthcare Mckesson PACS

3.5 Operating Room – 6

Integration required for:

Stryker 1588 AIM – 1588010000

Olympus CV-190

Storz TC300 x1

Storz TC301 x1

Change Healthcare Mckesson PACS

3.6 Operation Room – 7

Integration required for:

Stryker 1588 AIM – 1588010000

Olympus CV-190

Medtronic Illumisite – ILS-1000-CS iPad Air – 3rd gen – Model MUUJ2LL/A

Change Healthcare Mckesson PACS

4.0 Minimum Performance Requirements (Salient Characteristics)

The OR Lighting Systems minimum technical performance requirements to meet the minimum needs to the Government are as follows:

All lights are required to have the following:

Lights shall be LED

360 degree rotation

4 color temperature options between 3600 to 5000 kelvin

Integration system must have the following components:

Complete control of lights

Internet Protocol (IP) connectivity

Equipment Management Boom

Full electric brake system with touch capabilities

Powered and manual vertical articulating arm options

Ability to combine an all-electric brake system with vertical articulation

Meet all regulations and standards to include: NFPA70, NFPA 99, UL 60601-1

Footprint to be no larger than 12 inches on each side

No less than 176 lbs shelf weight capacity

KEZR and KEXS isolated power

Triple Redundant ground system Multiple shelving options (minimum of 3 shelves) Adjustable arms (ability to move back & out of the way)

Universal Display mount

360 degrees of rotation

Ability to accommodate between 19” – 32” monitors

Ability to allow displays to be rotated laterally and lifted (must be capable of being moved from the field when not in use and easily moved back into the field when needed)

Contains a protective cover that shields monitor cables

Integration System

Integrated platform to specifically control all operating system rooms

Contains a centralized touch panel that allows a centralized command for remote device control from Nursing Station

Has the ability to integrate with Electronic Health Records (HER)

Contains Uncompressed true 4K capability

Contains Analog and Digital encoders without third-party scalers

Contains the ability to display no less than four video signals at one monitor simultaneously

Ability to route an image to any monitor using a touch panel

Ability to connect multiple room speakers to provide audio from multiple sources

No less than 48- Port Switch for scalability Used to provide IT switch for network capable medical equipment.

Compatible with all signal type

Composite (Fluoro)

S-Video (Microscope)

RGBHV( Hemo, PACS)

3G-SDI (Competitor Devices, DaVinci)

DVI (DaVinci Robot)

HDMI

HD, 4K, 3D

OR Hub

Must displays critical devices status on monitors for light sources, insufflators, arthroscopy pump, shaver, etc.

4K image compression

Captures, records, streams and prints with 4K or HD

No less than 8” multi-touch capacities touchscreen

Ability to integrate with the patient record via EHRM (cerner), Vista imaging systems or Change Healthcare Mckesson PACS system

Contains at least one USB 3.0

Ability to use a barcode or similar technology to scan importing patient information directly to the patient records

Surgical Display

No less than 4X the resolution of a 1080p image

No less than two input options

5.0 Desired Functionality

The ideal system would be comprised of the following. However, the Government is open to an alternative solution that addresses the intent of the following functionality/capabilities.

All components in their respective areas listed in this Statement of Objectives will be networked together to communication between the acquisition devices, servers and review workstations.

5.0.1 System is desired to have an Internet Protocol (IP) for transmitting data across a secured network. This will allow for expandability without significantly altering conduits and wiring for future expansion. In addition to allowing for ease in troubleshooting and diagnosing the system.

5.0.2 Ability to Control Room lights from supplied Control Panel to maintain a sterile environment.

5.0.3 Smaller Booms are preferable

5.0.4 Ultraviolet & Infrared Imaging Camera Functionality display both images at the same time Image-by-Image.

5.0.5 Room temp controls integrated into control panels

5.0.6 Universal integration to towers & light sources from a variety of manufacturer’s

5.0.7 Touch and voice control capabilities

5.0.8 Contains a One Touch Button for turning the system On/ Off

5.0.9 Contains a Picture-in-Picture (PIP) and Picture -by-Picture (PBP)

5.1 OR Lighting System Software Platform

5.1.1 The Offeror shall disclose the software platform operating system by providing a completed Manufacturer Disclosure Statement for Medical Device Security (MDS2) and Pre-Procurement Risk Assessment (PPA) in accordance with VHA Directive 6550. This will be used in the determination of technical acceptability of offered software solution to ensure allowability on VA Networks. All servers are required to be no version earlier than Windows Server 2016 and all workstations must be a Microsoft version no earlier than Windows 10. In addition, all equipment must have already an approved ERA (Enterprise Risk Analysis).

5.1.2 The offeror shall disclose the offered systems support/upgradability (such as if is Microsoft Widows based Platform Windows 10 to Windows 11).

5.1.3 The Offeror shall include in their offer the expandability of the platform that they are offering.

5.2 Brand Name References

Any and all references to a brand name, model, marketing language or functionality pursuant to a particular manufacturer does not constitute a preference/desire of the Government for any one make or model over any other. The intent of the language contained herein is merely to communicate to industry as to the minimum needs of the Government in the most efficient means possible and does not represent the Governments preference.

5.3 Brand Name “or Equal” Submission Instructions

For consideration and evaluation of technical acceptability of any product proposed as an “or Equal”, the Offeror shall submit, with its offer, all technical data pertaining to the proposed as an equivalent, for consideration of technical acceptability. Offerors shall be responsible for demonstrating equivalency in a side by side comparison of technical data and shall address how each of the salient characteristics/minimum needs of the Government, as identified in this solicitation, have been met and/or exceeded. Any Offeror, failing to submit such supporting documentation, as required for an “or Equal” in accordance with this solicitation, shall not be considered. The Government will only review documentation as submitted by Offerors to determine technical acceptance and shall not be held responsible for researching any additional information beyond that information submitted by the Offeror.

6.0 Site Prep

Five of the Asheville VAMC Operating Rooms are currently newly under construction Room 2010, 2020, 2030, 2040 and 2070, the other five are existing OR rooms 1, 2, 5, 6 and

7. The new 5 OR Rooms are new and awaiting buildout while other existing 5 rooms are currently scheduled for upgrade renovation of the surgical lighting. It is anticipated that some of the manufacturer data, materials, and other critical information shall be required ahead of the equipment delivery. The Contractor shall be required to make these critical components available and/or shipped to the Medical Center within 30 calendar days of Contract award.

1. Hospital Construction contractor will be responsible for the following :

a. Rough-in box 60” minimum above finished floor to comply with NFPA requirement for flammable anesthetics

b. Provide an opening in the wall to receive rough-in box per installation requirements.

c. Provide complete room schematics including electrical, mechanical, and equipment location details structural steel supports locations and mounting to building existing structural steel support for lighting/boom and or systems equipment proposed in solicitation to match the rooms layout per the drawings and specifications.

d. Install cable conduit, junction boxes, electrical outlets, and mounting brackets according to lighting package requirements to align with project drawings and specifications.

e. Ensure that all electrical requirements comply with local code.

f. Ensure space, structural, and heat load requirements are met according to project specs and plan.

g. Receive shipment and safely, securely store equipment if shipment arrives prior to requested installation date.

h. Provide adequate access from delivery/storage area to installation site.

i. Relocate equipment from on-site storage/delivery area to installation site.

j. Run all cables outside the OR- Including conduit, J-hooks, penetrations through firewall, video cables, radio antennae cables, or fiber optics to networking hubs and video conferencing hubs, communications closets, conference rooms, centralized nurse desks, rooftop, or other departments.

k. Ensure that site preparations and construction are complete and ready for final integration installation - including electrical and network connections, finished floor and paint.

l. Proactively schedule the installation in conjunction with the STERIS project manager.

m. Provide a minimum of two (2) weeks advance notice for requested changes to the installation schedule.

n. Provide a clean, dry, dust free environment for equipment storage and installation.

o. Provide easy access to all rooms involved in the installation during normal business hours and upon request after hours.

p. Participate in a final walk-through evaluation of the system followed by a sign-off of the certificate of completion.

2. Equipment manufacturer will be responsible for the following:

a. Remove all old lighting equipment

b. Installing a rough-in box

c. Label all ends of all wires for future identification

d. Provide cable conduit drawings, electrical requirements, and mounting requirements for the room

e. Provide space, structural, and heat load requirements for the base unit

f. Deliver all custom back boxes, mounting brackets, and construction-related items to the hospital in accordance with the mutually agreed upon construction and renovation schedule

g. Pull and terminate non-plenum cabling inside the OR through specified conduits and junction boxes as specified per the project

h. Provide external cables and detailed specifications for the interconnections if cables are necessary for the equipment to be fully functional

i. Provide a pre-installation checklist to verify site preparation is complete

j. Mount, install, and connect integration equipment, to include video, audio, and control cables, cable terminations, wall cameras, wall monitors, base unit, touch screen controls, surgical monitors and other applicable equipment to the project

k. Complete a test and validation of the integration system to complete customer satisfaction

l. Adjust surgical light brakes as necessary after installation of monitors

7.0 Phasing – Delivery/Installation

Delivery & installation of this project will be required to be phased due to the area being actively under construction. Above-Ceiling Mounting plates will be required to be received by the VA Medical Center within 2 weeks of the date of the Contract Award to minimize delays to the active Construction Project in which this equipment is to be installed within. The Contractor shall be required to provide support and communicate with the VA’s Construction Contractor and Identified COR/COR’s to finalize their Phasing strategies. It is anticipated that there will be at least two (2) phases for this project. Phases are envisioned as detailed below.

Phase 1. Install new OR lighting systems including booms and equipment and interactive wall panels in 4 general ORs and 1 hybrid OR in new construction area.

Phase 2. Begins after phase 1. Remove existing and replace with new OR lighting systems including booms and equipment and interactive wall panels in 4 general ORs and 1 Hybrid.

8.0 Training

The Government requires the training of various Engineering staff, Biomedical Engineering staff, and applicable Nursing staff. When Training is required by the contract or its subsequent attachments the vendor shall provide training to applicable personnel with no less than 3 organized classes for multiple tours of duty. Two additional training shall be provided for the particular equipment or system as required in each associated specification. A training schedule shall be developed and submitted by the contractor and approved by the COR at least 30 days prior to the planned training. The Contractor shall be responsible for providing all training materials (handouts, visual aids, user assessment, etc.).

9.0 Project Management Plan

The contractor shall be responsible for developing a project management plan for submission with their offer. This plan is required minimalize downtime while transitioning between systems, key personnel of the contractor, potential resources that the Asheville VAMC may need to proffer for successful completion, and a projected timeline for the total project forecasted in days from contract award. The contractor shall provide in their offer a project plan defining delivery, phasing, set-up, project management, and on-site support during implementation and deployment as necessary/applicable. Gant Charts highlighting critical detailed milestones identify critical path milestones.

10.0 Meetings and Conferences

The Contractor shall attend and support meetings and teleconferences to discuss technical requirements, issues, and project progress and status as required. The Contractor shall prepare, and submit for review, presentation materials for meetings and an agenda. The Contractor shall be responsible for taking meeting minutes prepare and submit minutes for all meetings attended no later than 3 business days after the meeting has occurred. The minutes shall be sent to the Contracting Officer and COR for coordination and approval prior to distribution.

11.0 Progress Meetings

The Contractor shall attend Progress Meetings after contract award. These meetings will include the COR, CO, Project Manager, and other relevant personnel on an as needed basis. Leading up to & during installation the PM shall attend Weekly construction, Progress Meetings shall be held bi-monthly at a minimum. These meetings shall cover the progress made in the past period and shall include any pertinent issues which could affect future Contract progress/performance. The Contractor shall record and provide meeting minutes for all meetings. The following items shall be covered, at a minimum:

Attendees and contact information; project percent complete (Actual and Scheduled); RFI’s and statuses;

submittals and statuses; three-week look ahead; Project Schedule; safety; resolution of existing issues;

New Business.

12.0 Project Organization Chart

The Contractor shall provide an organizational chart of its management staff for the Contract. The project organization chart shall depict project team members (government and Contractor), contact information, and each member’s responsibilities.

13.0 Status Reporting

The Contractor shall provide Monthly Progress Reports for the Contract. Monthly Progress Reports shall be submitted NLT the 15th calendar day of the following month and shall contain information about contract, contract performance, schedule, and deliverables. The Progress Reports shall also describe progress of activities necessary to achieve the project objectives and shall contain a description of activities accomplished during the month, activities forecasted for the future months, and problems and issues associated with the performance of the SOR. The biweekly and monthly report shall be used to review and evaluate the overall progress of the project, along with any existing or potential problem areas. The report shall include a summary of the events that occurred during the reporting period, discussion of performance, identification of problems, proposed solutions, corrective actions taken and outstanding issues. The progress report shall depict projected percent complete and actual percent complete for the Contract.

14.0 Site Access

The Contractor shall obtain and monitor assigned security badges, passes, and/or identification (used by prime contractor, designer, and/or subcontractor staff) used during the duration of the Contract. All security badges or passes shall be returned to the base POC upon expiration of the badge, upon completion of the project, or when possession of the badge is no longer necessary (e.g., upon removal of contracted personnel from specific projects). The Contractor shall ensure access is authorized to the appropriate construction site and routes/areas required to complete the Contract. All personnel shall comply with base security rules and procedures.

15.0 Mobilization

The Contractor shall perform mobilization activities as necessary to prepare the construction site for construction activities. The Contractor shall establish a construction management location via temporary trailers. The Contractor shall obtain appropriate approvals and shall provide electric generators and water tanks/deliveries, as required, to accomplish the activities specified in the Contract. The Contractor shall also erect or install support buildings, equipment enclosures, and storage facilities, as required, for construction materials and/or waste materials awaiting disposal.

16.0 Hours of Work

The normal hours of work on installations are from 8:00 a.m. to 4:30 p.m., Monday through Friday, excluding holidays. Construction hours of work and access to work sites are from 7:30 a.m. to 4:30 p.m., Saturday through Thursday, excluding holidays. For work during other than these hours of work, the Contractor shall submit, in writing, for the Contracting Officer's approval, a notice of any period of scheduled work other than the normal hours of work specified above. This notice shall be submitted not less than two weeks prior to each period of work scheduled at times other than normal hours of work including holidays.

US Government holidays. When any of the US Government Holidays fall on a non-work day, the holiday will be observed on either the preceding or succeeding workday. The choice of any such preceding or succeeding workday shall be coordinated with the COR and the CO.

17.0 Activities Coordination

The Contractor shall coordinate worksite activities with applicable personnel to ensure the protection of human health and the environment; the prevention of damage to property, utilities, materials, supplies, and equipment; and the avoidance of work interruptions. The Contractor shall provide physical security to work areas with security equipment and personnel. The Contractor must comply with Occupational Safety and Health Administration (OSHA) safety and health regulations, local national safety and health laws and regulations, local safety office requirements. The Contractor is required to provide copies of OSHA and all other applicable safety and health reports submitted during the duration of the Contract.

18.0 Notification Requirements

The Contractor is required to notify the CO and COR of critical issues that may affect the contract performance and/or human health and the environment. The types of issues that require notification include, but are not limited to, health risks, spills, unexpected utility crossings, unusual weather conditions, unacceptable materials, changes in critical personnel, unforeseen hazardous material. On critical issues, verbal notification shall be made immediately followed by written notification as soon as practical. For critical issues pertaining to human health and the environment, the Contractor shall immediately notify the CO and stop work. Work shall only resume at the direction of the CO following resolution of the issue.

19.0 Other Contract Requirements

19.1 Shipping and Services

The Contractor shall provide transportation for construction material and equipment to the Asheville VA Medical Center and for movement of the materiel and equipment from its Point of Delivery to the ultimate in-country destinations. The Contractor shall self-insure such shipments or obtain commercial insurance without any right of subrogation of any claim against the United States Government.

19.2 Travel

All United States Government Contractor personnel shall be in economy class or as otherwise directed in the United States Joint Federal Travel Regulations.

19.3 Nicotine Free Campus Effective 1 Oct 2019

As part of the U.S. Department of Veterans Affairs’ (VA) commitment to provide excellent health care for Veterans, the department will implement a new policy restricting smoking by patients, visitors, volunteers, contractors and vendors at its health care facilities by October. VHA’s new smoke-free policy applies to cigarettes, cigars, pipes, any other combustion of tobacco and non-Federal Drug Administration approved electronic nicotine delivery systems (ENDS), including but not limited to electronic or e-cigarettes, vape pens or e-cigars.

19.4 Compliance with Emergency Management Directives

Contractors shall comply with all safety directives and emergency management instructions as directed by the local VA Medical Center site specific policies & procedures, Local Construction Handbook, and any subsequent updates to the handbook directed by policy or law. These directives are to ensure preparedness and safety of all personnel doing business on the VA Medical Center property. Notifications of “Exercise” and Real-World events are typically made via a Public Address/Giant Voice Systems. The contractor shall responsible for the participation of their on-site employees and reasonably respond to these announcements in the safest means practicable.

All employees of the contract are required to participate in mandatory required facility exercises to meet facility accreditation and compliance. The timeframe for these exercises are typically short. Examples include, but not limited, Active Shooter/Active Threat, Tornado, Bomb Threat and Fire Drills. The contractor/subcontractor employees shall be required to respond to any VA Medical Center Drill as if it were a real-world emergency/threat.

All employees of the contractor/subcontractor shall participate in preparations for all VAMC Safety or Emergency Management as directed. All hazards, events, and disasters including inclement weather, earthquakes, mandatory evacuations and also includes site safety and preparations for visits by high profile VIP’s.

20.0 IT Security VA Information and Information System Security/Privacy Language (Some of this language may be omitted in the resultant contract solely based on the system proposed in your companies system disclose within the attached 6550)

20.1 GENERAL

Contractors and contractor 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.

20.2 ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

b. All contractors 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. 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 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.

d. The contractor 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’s employ. The Contracting Officer must also be notified immediately by the contractor prior to an unfriendly termination.

20.3 VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract 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’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 contractor’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 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 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 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 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 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 electronic storage media for restoration in case any electronic equipment or data used by the contractor 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 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’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 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 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 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 is in receipt of a court order or other requests for the above mentioned information, that contractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

20.4 INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. The contractor shall certify to the COR 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.

b. 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.

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

d. 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.

e. The contractor 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.

f. The contractor 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 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.

g. 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 is considered to be an employee of the agency.

(4) “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.

(5) “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.

(6) “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.

h. 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.

i. 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 30 days.

j. 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 30 days.

k. 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.

20.5 Information System Hosting, Operation, Maintenance, Or Use

a. VA prohibits the installation and use of personally-owned or 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 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.

b. 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 or any person acting on behalf of the contractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor 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.

c. 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 possible for the VA to retain the hard drive, then;

a. 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

b. 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 sanitization specifications need to be pre-approved and described in the purchase order or contract.

c. 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.

20.6 Security Incident Investigation

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

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

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

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

20.7 Liquidated Damages For Data Breach

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

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

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

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

(2) Description of the event, including:

(a) date of occurrence;

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

(3) Number of individuals affected or potentially affected;

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

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

(6)…