36C25522Q0345.docx

SUBJECT*

PSG & EEG Replacement VISN

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

POINT OF CONTACT*

Denise Maynard denise.maynard@va.gov 913-946-1978

PLACE OF PERFORMANCE

VA Medical Centers

Topeka, KS and Leavenworth, KS

DESCRIPTION: This is a SOURCES SOUGHT announcement only. It is neither a solicitation announcement nor a request for proposal or quote and does no obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this Sources Sought must be in writing. The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified businesses.

Responses to this notice shall include:

1. Company Name

2. Address

3. Point of Contact

4. Phone, Fax, and Email

5. DUNS number

6. Must provide a capability statement that addresses the organizations qualifications and ability to perform the work in the Statement of Requirements.

See Attached:

1. Statement of Requirements

Please respond if you can.

All responses due by 9:00 am CST, Thursday, June 16, 2022 Denise Maynard Contract Specialist denise.maynard@va.gov 913-946-1978 Network Contracting Office 15

See attached document: Statement of Requirements

Statement of Work – VISN 15 EK Sleep/EEG

*Brand Name Only* Objective Veterans Integrated Services Network (VISN) 15, Heartland Network’s Eastern Kansas (EK) Health Care System (HCS) is in need of purchasing new polysomnography (PSG) and electroencephalogram (EEG) equipment to replace their legacy equipment located at the Colmery-O’Neil and Dwight D. Eisenhower Veterans Affairs Medical Centers (VAMC) locations in Topeka and Leavenworth, Kansas. Current PSG and EEG equipment are no longer supported by the manufacturer and are in need or replacement. The system required by the EK HCS is the Cadwell Easy III PSG 54 Channel and Arc Essentia E3 32 Channel EEG systems to fit their clinical and Veterans needs. The PSG and EEG equipment will be interfaced using existing Cadwell CadLink interfacing software currently installed.

Equipment Specifications Requirements

Reader Stations for PSG for Leavenworth

Clinical EEG system for Leavenworth

Networking for Leavenworth

PSG Systems for Topeka

Reader Stations for PSG for Topeka

Clinical EEG system for Topeka

Reader Station for EEG for Topeka

Networking for Topeka

Software

· Vendor shall ensure all software operating on the device provided is supported by the original manufacturer at time of delivery.

· For example, vendor shall not provide VISN 15 a device/workstation utilizing the Windows XP or Windows 7 operating system as they are no longer Microsoft supported.

· Proprietary software systems are acceptable so long as vendor supports the version provided to VISN 15 and it is the newest version at time of delivery.

· Access to all software shall be provided to VISN 15 in situations where re-installation is necessary.

· Software shall be provided to VISN 15 with unlimited perpetual licensing for the supported life of the device.

· In cases where vendor insists on utilizing a licensing fee model this should be noted in the bid provided for VISN 15 consideration.

Network Security The vendor is required to fill out the five attached VA Security Forms if their equipment can be connected to the VA network. If these forms are not completed and submitted with the bid package the vendor can be disqualified from the bidding process.

Cerner Compatibility

· All vendors providing a bid to this requirement shall provide a Cerner compatibility statement from the OEM of the equipment that they are proposing to the VISN 15 Office.

· This statement will include an OEM attestation that the product proposed is Cerner verified and provide a list of healthcare organizations that have deployed the project with the Cerner EHR.

· The statement will also include any relevant information as to what data can be transmitted to Cerner.

· This statement will be dated within 60 days of the quote being provided to ensure it is recent and accurate.

· The statement will provide an OEM point of contact who can be reached to further discuss any questions or concerns over Cerner compatibility.

· If the device/system being proposed does not connect to the network or medical record the vendor shall note this in their proposal.

· Vendor bids that do not include a Cerner compatibility statement directly from the OEM will be discarded from consideration.

Installation and Assembly

· Vendor shall be responsible for assembly and installation of systems after notification from VISN 15 Biomedical Engineering that it has been delivered to station.

· Installation shall include implementation and testing of all purchased interfaces to VA electronic systems in coordination with Clinical Staff, Biomedical Engineering staff, OIT staff, and others identified as needed.

· Install shall include unboxing and transportation of equipment to final use location.

· Assembly and install shall occur within 30 days of delivery to station.

· Vendor shall provide all necessary accessories, cables, adaptors, etc. to deliver a fully functional clinical device.

Training

· Vendor shall provide on-site clinical/applications training for relevant VISN 15 site staff members. Training shall consist of five (5) days onsite at Topeka and four (4) days onsite at Leavenworth.

· Vendor shall provide introductory system/maintenance training to VISN 15 Biomedical Engineering staff or local site Biomedical Engineering during installation.

· Three (3) Easy III Biomedical training two-day trainings at OEM site shall be included in vendor proposal.

· Three (3) Arc Essentia Biomedical training two-day trainings at OEM site shall be included in vendor proposal.

· Vendor shall include all costs for travel to provide this training in their proposal.

· Vendor shall coordinate all installation and training dates with VISN 15 specified Biomedical Engineering POC who will communicate internally with clinical staff.

Warranty and Service

· Service and Operator Manuals – The vendor shall provide the following documentation for the proposed system:

· Two (2) copies of operator's instruction manuals per unit purchased

· Two (2) copies of complete technical service manuals including detailed troubleshooting guides, necessary diagnostic software, service keys, schematic diagrams, parts lists, and any other resources available to the manufacturer’s service technicians.

· Two (2) copies of a system manager’s manual outlining back-up procedures, managing privilege group limits, routine tasks, etc.

· Warranty – The system, all accessories, and all software shall be covered under the manufacturer’s warranty and shall include all parts and labor for at least one year following acceptance by the VAMC.

· A manufacturer’s factory-trained Field Service Engineer shall perform installation and maintenance during the warranty period.

· The warranty period shall not begin until after the VISN 15 Biomedical Engineering POC has accepted the products delivery, installation, and functionality.

· The warranty shall include all manufacturer recommended Preventive Maintenance procedures for its duration.

· All available software updates and security patches will be made available to the VISN 15 during the warranty period.

· Vendor shall provide response to applications and technical calls within 8 hours.

· Vendor shall ship replacement parts within 48 hours of identifying necessity by VISN 15 Biomedical Engineering staff.

Other Features Value added features in the vendor’s proposal that will be considered include but are not limited to:

· Options for Trade-in of existing equipment shall be proposed in bid package

· Extended Warranty options shall be outlined in bid package

· Service and Biomedical training options shall be outlined in bid package

· Options for this training should include all registration, travel, and lodging costs when possible

Hours of Operation

· Normal hours of coverage are Monday through Friday, 7:00 AM to 3:30 PM Central Standard Time excluding national holidays.

· Vendor on-site visits will be coordinated with the VISN 15 Biomedical Engineering POC before being scheduled or conducted.

· Vendor representatives will check in with the VISN 15 Biomedical Engineering POC when they arrive on-site and check out upon completion of work each day.

· All services shall be performed during normal hours unless otherwise scheduled with the VISN 15 Biomedical Engineering POC.

· Vendor staff shall always be professional and shall take all necessary precautions to maintain a safe environment for the occupants. This includes, as necessary, coordinating access and closures for sensitive areas of the Medical Center.

· Vendor shall be responsible for cleaning all work areas after completion of tasks. This includes removal of packaging and a clean sweep/mop of the area as required by work type.

· Vendor staff shall minimize noise as much as possible while working in all buildings.

· Vendor is responsible for providing all PPE necessary for their work.

Note: Hardware/software update/upgrade installations, where applicable, may be scheduled and performed outside normal hours of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the VISN 15 Biomedical Engineering POC).

Federal Holidays observed by VISN 15 are:

Independence Day

Delivery

· Vendor shall deliver purchased equipment within 30 business days of receiving completed Contracting package from the VISN 15 Contracting Officer. If delivery delays occur vendor shall notify the Contracting Officer and the VISN 15 Biomedical Engineering POC.

· Delivery will be to the two (2) VISN 15 main campuses listed below. Vendor shall coordinate exact delivery location with the Contracting Officer and VISN 15 Biomedical Engineering POC at the time of the purchase.

· Vendor will ensure that equipment is sent to the Attention of Biomedical Engineering and will include the VISN 15 PO Number on the shipping label.

· Delivery of oversized, palletized orders or orders that contain a large number of components will be coordinated with the appropriate VISN 15 site Biomedical Engineering POC who will communicate internally with Warehouse Staff.

VISN 15 Medical Center Delivery Locations

Dwight D. Eisenhower VA Medical Center 4101 S. 4th Street Leavenworth, KS 66048 ATTN: Biomedical Engineering PO Number for Order Colmery-O’Neil VA Medical Center 2200 SW Gage Boulevard Topeka, KS 67218 ATTN: Biomedical Engineering PO Number for Order

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS

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.

1. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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.

1. VA INFORMATION CUSTODIAL Language

1. 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 in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

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 140-2 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 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 the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

1. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

1. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

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

1. 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.

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

1. 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.

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

g. The contractor/subcontractor agrees to:

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

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

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

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

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than _30___ days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within __30__ days.

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

1. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

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

1. 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.

1. 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.

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

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

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

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

1. 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;

1. 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

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

1. 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;

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 sanitization specifications need to be pre-approved 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.

1. SECURITY INCIDENT INVESTIGATION

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

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

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.

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

1. LIQUIDATED DAMAGES FOR DATA BREACH

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

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

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

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

1. 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) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $__35__ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

1. SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day’s notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

1. TRAINING

1. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

1. Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

1. Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

1. Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

1. Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access

The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

1. equipment requirements

1. If this device connects to the VA secure wireless network then the unit must utilize a FIPS 140-2 certified compliant connection compatible with the VA network.

1. Contractor to provide information for VA Form 6550 appendix “A” below.

VA 6550 A

VA DIRECTIVE 6550 Appendix A – To be completed for all procurements of network-connected medical devices and non-network-connected medical devices that store sensitive information. For client/server systems, a separate 6550 Appendix A is required for each the client and the medical server.

1.1 Equipment Category (VA-MDNS)

1.2 Manufacturer

1.3 Model

1.4 Application Name and Software Version #

1.5 Requesting Service

1.6 VISN

1.7 Facility Name

1.8 Facility Number

1.9 Manufacturer Point of Contact

Phone Number E-mail address

1.10 Biomedical Engineering Point of Contact

Phone Number E-mail address

1.11 Responsible Service if Biomedical Engineering is NOT the Primary System Manager for system maintenance, support and lifecycle management

1.12 Medical Device Type ☐ Discrete device ☐ Software

☐ Client ☐ Application server

1.13 Equipment Description (i.e. equipment function and systems it communicates with)

1.14 MDIA VLAN Number for installation (if known)

1.15 Installation Location (Room, Building, Division)

1.16 Is there an existing Enterprise Risk Analysis (ERA) for this device/system? ☐ Yes ☐ No

If yes, what is the ERA number?

**Note that the ERA must be for the same make, model, and application software version to apply to the requested system. A new ERA is required for major software or operating system updates (e.g. version 2.0 to 3.0) but is not required for minor updates (e.g. version 2.0 to version 2.1).

If an ERA exists for the requested system, completion of the 6550 Appendix A is not required beyond this point. Please sign to certify that an existing ERA is available for the requested system and forward the document to either the Area Manager or

ISSO for signature, as appropriate.

2.1 Device Operating System (OS)

Can the OS be automatically patched? ☐ Yes ☐ No **Note that systems that do not support automated patching via the VHA MD Update Server or via vendor channels impose a significantly higher risk to the VA network.

If patching is not automated, what is the patching process and/or limitations?

Procurement of systems with unsupported operating systems is prohibited. Unsupported operating systems are OSs that are not supported by the manufacturer and have reached the end of the OS lifecycle as published by the OS manufacturer (i.e. no further security patches will be released for the OS by the manufacturer after the OS end-of-life nor will be available by other methods such as extended warranty purchases from the OS manufacture).

2.2 Is the network connection wireless? ☐ Yes ☐ No

If yes, what is the FIPS 140-2 certification number?

Procurement of systems using 802.11 wireless networking that are not FIPS 140-2 compliant is prohibited.

2.3 Does the device include a database? ☐ Yes ☐ No

If yes, what is the database version?

2.4 Can the device run McAfee antivirus? ☐ Yes ☐ No

**Note that systems that do not support VA-approved antivirus scanning or an antivirus scanning solution managed by the vendor impose a significantly-higher risk to the VA network.

If antivirus is not supported, what are the AV processes and/or the limitations?

2.5 For Windows-based devices, can the VHA SMAK toolkit be installed? ☐ Yes ☐ No ☐ Non-Windows-based system

If no, has the vendor agreed to provide a complete software and application inventory for all system components as per FISMA requirements?

☐ Yes ☐ No

**Note that systems that do not support SMAK installation or for which the vendor does not agree to provide a complete software inventory impose a significantly higher risk to the VA network.

2.6 Does the system support the use of two-factor authentication (please review the VA’s requirements for two-factor authentication here)? ☐ Yes ☐ No

2.7 Is the device required to be joined to the VA domain? ☐ Yes ☐ No

2.8 Does the device allow for encryption of the data drive or OS drives? ☐ Yes ☐ No

2.9 Is sensitive data stored at rest on the device? ☐ Yes ☐ No

If yes, how many records can be stored on the device? ☐ <500 ☐ >500 If yes, does the device support on demand purging of data from the local hard drive? ☐ Yes ☐ No

2.10 Will sensitive data be stored outside of the VA network (e.g. cloud-based service provider – excludes Electronic Medical Record connection)? ☐ Yes ☐ No

2.11 Is connectivity external to the VA required for system operation? ☐ Yes ☐ No

2.12 Is connectivity external to the VA required for system support? ☐ No ☐ Yes - VA S2S VPN

☐ Yes – Other ☐ Yes - VA Citrix Describe remote access method and ports required if access is not via VA site-to-site VPN or VA Citrix.

2.13 How many IP addresses are required?

2.14 What kind of IPs does the system use? ☐ Static IP ☐ DHCP

**Systems should be deployed with static IPs unless DHCP is required.

2.15 If server-based, select one of the following: ☐ Vendor-provided physical server

☐ Vendor-provided virtual host ☐ Biomedical Engineering-provided physical server ☐ Biomedical Engineering-provided virtual host ☐ OIT-provided virtual host ☐ Other – describe

2.16 If…