Special Notice RFI 36C25626Q0666.pdf

Special Notice

Special Notice 36C25626Q666

SUBJECT* Stryker Endoscopy ProCare for GI Equipment Service & Preventative Maintenance

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 77056

SOLICITATION NUMBER* 36C25626Q0666

RESPONSE DATE/TIME/ZONE 04-20-2026 3:00 PM CENTRAL TIME, CHICAGO,

USA

ARCHIVE 7 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

PRODUCT SERVICE CODE* J065

NAICS CODE* 811210

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs Network Contracting Office 16 Galleria Financial Center 5075 Westheimer Road Suite 750 Houston TX77056-5643

POINT OF CONTACT*

Contract Specialist Tiffany Burks tiffany.burks@va.gov 601-362-4471 X56338

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov

URL DESCRIPTION Department of Veterans Affairs

AGENCY CONTACT’S EMAIL ADDRESS tiffany.burks@va.gov

EMAIL DESCRIPTION Special Notice 36C25626Q0666

Special Notice

Special Notice 36C25626Q0666

DESCRIPTION

NOTICE OF INTENT TO SOLE SOURCE

The Department of Veterans Affairs (VA), Veterans Health Administration, Network Contracting Office (NCO) 16, Houston, Texas 77056, intends to award a sole-source contract under the authority of 41 U.S.C. 253(c)(1), FAR 6.302-1, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements,” to Stryker, located at 5900 Optical Ct., San Jose, CA 95138.

The contractor shall provide support services including on-site repairs, telephone response, preventive maintenance, updates, hardware and firmware support, installation, parts, and labor for the Stryker Endoscopy ProCare system supporting GI equipment.

This Notice of Intent is not a request for quotations. Due to the unique characteristics and proprietary nature of the equipment and required servicing, Stryker is the only responsible source capable of meeting the Government’s requirements.

Interested parties may submit a capabilities statement no later than April 20, 2026, at 3:00 PM CST to tiffany.burks@va.gov. Please include “Notice of Intent – STRYKER” in the subject line. Capabilities statements must provide clear and unambiguous evidence demonstrating the ability to provide the required services.

Responding as an interested party on www.beta.sam.gov does not constitute sufficient evidence of capability. A determination not to compete this requirement based on responses received is solely at the discretion of the Government. Verbal and faxed responses will not be accepted. All interested parties must be registered in the System for Award Management (SAM) at https://sam.gov to be eligible for any Government contract award. No telephone inquiries will be accepted.

If no viable responses are received by the deadline, NCO 16 intends to proceed with negotiations solely with Stryker.

ANNUAL MAINTENANCE SOW

Stryker Endoscopy ProCare for GI Equipment

I) EQUIPMENT IDENTIFICATION AND COVERAGE

A) Support, Services, & Maintenance for the below listed equipment. Detailed list in section

XXVI.

Equipment Quantity

Stryker Connected OR IP NEW ProCare 9

Stryker LIVE VIDEO CONFERENCING

CISCO PROCARE

Stryker CHROMO EXAM LIGHT NEW ProCare

Stryker S Series Standard Boom NEW ProCare 15

Stryker FPVPALEAD SHIELD NEW ProCare 18

Stryker SLX 682 New ProCare 4

Stryker 32" 4K SURGICAL DISPLAY 16

Stryker CONNECTED OR HUB BASE

SYSTEM

B) Service means the following with respect to equipment:

1) On-site field service preventative maintenance visit, which includes a thorough inspection/performance test per year to ensure the Equipment meets specifications.

2) Working hours of 8 A.M. to 5 P.M. Monday through Friday.

3) All labor, parts, materials, travel expenses, and ancillary costs required for the

Equipment Services are included.

II) GENERAL REQUIREMENT

A) Michael E. Debakey Medical Center is requesting a contractor to provide support services including on-site repairs, telephone response, preventative maintenance, and updates for all hardware, firmware, installation, parts, labor, and preventive maintenance on the Stryker Endoscopy ProCare for GI equipment at the Michael E. Debakey Medical

Center located at 2002 Holcombe Blvd, Houston, TX 77030. The Contractor shall furnish all labor, materials, parts, equipment, tools to service and perform yearly preventative maintenance on the Stryker Endoscopy ProCare for GI equipment. The full listing of the clinic equipment can be found in the Equipment Identification section.

B) The Contractor shall provide all hardware, firmware, installation, parts, labor, calibration and preventive maintenance inspections per the OEM recommendations and guidelines.

The Contractor shall provide calibration and preventive maintenance services by authorized Service providers of the equipment listed in the Equipment Identification section. The calibration procedure will consist of calibrating the entire instrument to traceable calibration standards. The instrument shall be cleaned. Worn or defective parts shall be replaced when necessary, as per manufacturer’s specifications. Preventive maintenance inspections shall be scheduled at least three (3) days in advance with the

Contracting Officer Representative (COR). Service also includes all necessary intervening service calls required to replace any worn or defective part needed due to instrument failure.

III) DEFINITIONS/ACRONYMS

A) Acceptance Signature - VAMC employee who is authorized to sign-off on the ESR which indicates that the PMI has been concluded or is still pending completion, or that the Emergency Repair has been accomplished or is still in a pending status.

B) Authorization Signature - COR's signature; indicates COR accepts work status as stated in ESR.

C) Biomedical Engineer(ing) - Supervisor or designee.

D) CDRH - Center for Devices and Radiological Health.

E) CO - Contracting Officer

F) COR - Contracting Officer's Representative

G) ESR - Vendor Engineering Service Report. Documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

H) FAR – Federal Acquisition Regulation.

I) FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VAMC premises.

J) NFPA - National Fire Protection Association.

K) OEM - Original Equipment Manufacture

L) PMI - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions.

M) VAMC - Department of Veterans Affairs Medical Center

N) VAH - Department of Veterans Affairs Hospital

IV) CONFORMANCE STANDARDS

A) Contract service shall ensure that the equipment functions in conformance with the specifications used when the equipment was procured by the VAMC, and any upgrades/updates, as well as following most current published standards/ specifications/regulations by:

1) Manufacturer’s specifications, Association for the Advancement of Medical

Instrumentation (AAMI), Joint Commission for the Accreditation of Healthcare

Organizations (JCAHO), National Fire Protection Agency 99 (NFPA-99), Center for

Device and Radiological Health (CDRH), Original Equipment Manufacturer (OEM), American Hospital Association (AHA), Institute of Electrical And Electronic

Engineers (IEEE), Underwriters Laboratories (UL), Occupational Safety and Health

Administration (OSHA), College of American Pathologists (CAP), VAMC standard operating procedures, and any other Federal, State, and Local regulations pertaining to the equipment listed for this contract.

V) HOURS OF COVERAGE

A) Normal hours of coverage are Monday through Friday from 8:00 a.m. to 5:00 p.m., excluding holidays. All service/repairs will be performed during normal hours of coverage unless requested or approved by COR or the designee assigned by the COR.

B) Any necessary hardware/software update/upgrade installations as deemed by the OEM will be scheduled at least three (3) days in advance and shall be performed at no additional charge to the Government (unless it is detrimental to equipment up-time; to be determined by the COR).

C) Work performed outside the normal hours of coverage at the request of COR or designee assigned by the COR will be billed at the price listed in Vendor Contract. Billing will include service time and exclude parts, as they are included in this contract. The COR or

COR designee will provide a credit card purchase order to cover charges outside of the scope of this contract. PO number must be included on invoice for payment. Work performed outside the normal hours of coverage at the request of FSE will be considered service during normal hours of coverage.

D) Federal Holidays observed by the VAMC are:

- New Years' Day

- Martin Luther King Day

- Presidents' Day

- Memorial Day

- Juneteenth

- Independence Day

- Labor Day

- Columbus Day

- Veterans' Day

- Thanksgiving Day

- Christmas Day

In addition to the days designated as holidays, the Government observes the following days:

- Any other day designated by Federal Statute

- Any other day designated by Executive Order

- Any other day designated by the President’s Proclamation

E) Preventive maintenance will be performed yearly.

VI) UNSCHEDULED MAINTENANCE (Emergency Repair Service)

A) Contractor shall maintain the equipment in accordance with the manufacturer's latest specifications. The Contractor will provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations. All required parts shall be furnished.

B) The CO, COR or the designee assigned by CO or COR has the authority to approve/request a service call from the Contractor.

C) Response Time: Contractor’s FSE must respond with a phone call to the COR or the designee assigned by the COR within two (2) hours after receipt of telephone notification twenty-four (24) hours per day. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) within twenty-four (24) hours and will proceed progressively to completion without undue delay. This requirement for response time shall be the same for both services and calls during the VAMC normal business hours and after-hour service calls. Corrective work shall be completed within forty-eight

(48) hours from telephone contact time. When repairs exceed forty-eight (48) hours and at the request of the COR, loaner equipment shall be provided at no additional cost to the

VAMC.

D) Any charges for parts, services, labor, travel, manuals, tools, installation, firmware, or software required to successfully complete unscheduled maintenance are included within this contract unless specifically stated in writing otherwise and approved by the COR.

E) The Contractor shall provide mandatory safety and performance-related updates to covered equipment and software.

F) The Contractor must have the ability to concurrently address multiple emergency calls and unscheduled maintenance on different equipment.

VII) SCHEDULED MAINTENANCE

A) The Contractor shall perform PMI service to ensure that the equipment listed in the schedule performs in accordance with the Conformance Standards. Preventive maintenance inspections shall be scheduled at least three (3) days in advance with the

Contracting Officer Representative (COR). The PMI must be done in accordance with the latest OEM maintenance procedures and protocols. (An outline of the PMI procedures and schedule shall be provided to the COR). The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable). This documentation shall be provided to the COR at the completion of the PMI. The contractor shall provide written description of Preventive

Maintenance Inspections (PMI). This description shall include an itemized list of the procedures performed, including electrical safety. PMI services shall include, but need not be limited to, the following:

1) Cleaning of equipment.

2) Reviewing operating system software diagnostics to ensure that the system is operating in accordance with the Conformance Standards or the manufacturer's specifications.

3) Calibrating and lubricating the equipment.

4) Performing remedial maintenance of non-emergent nature.

5) Testing and replacing faulty and worn parts and/or parts likely to become faulty, fail, or become worn.

6) Inspecting and replacing where indicated, electrical wiring and cables for wear and fraying.

7) Inspecting, and replacing where indicated, all mechanical components which may include, but is not limited to: mounting hardware, support devices, cables, chains, belts, bearings and tracks, interlocks, clutches, motors, keyboards, and patient couches for mechanical integrity, safety, and performance.

8) Returning the equipment to the operating condition defined in the Conformance

Standards.

9) Providing documentation of services performed.

10) Inspecting and calibrating the hard copy image device.

B) PMI services shall be performed in accordance with, and during the hours defined in the

"Hours of Coverage" section and the preventive maintenance schedule established herein.

All exceptions to the PMI schedule shall be arranged and approved in advance with the

COR.

C) Any charges for parts, services, labor, travel, manuals, tools, installation, firmware or software required to successfully complete scheduled PMI are included within this contract, and its agreed upon price, unless specifically stated in writing otherwise and approved by the COR.

VIII) PARTS

A) Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or service for maintenance of medical equipment (i.e. replacement parts) for VAMCs. No re-manufactures or gray market items will be acceptable.

B) The delivery of gray market items to the VAMC in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VAMC reserves the right to enforce any of its contractual remedies. This includes termination of the contract or, solely at the

VAMC’s election, allowing the Contractor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VAMC facility upon discovery of such items.

C) The Contractor shall furnish and replace parts in accordance with the manufacturer's specifications. The Contractor has ready access to all parts, including unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment. The contract shall include all parts. The contractor shall use new original equipment manufacturer (OEM) parts. All parts shall be of current manufacture and have complete versatility with the presently installed equipment. All parts shall perform identically to the original equipment specifications. Rebuilt parts, used parts, or parts removed from other equipment, shall not be installed without specific approval by the CO or the COR.

IX) SERVICE MANUALS/TOOLS/EQUIPMENT

A) The VAMC shall not provide travel, tools, test equipment, service manuals, or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSE's all travel, operational and technical documentation (such as operational and service manuals, schematics, and parts list) which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name and/or the manuals themselves, shall be provided to the CO upon request.

X) TEST EQUIPMENT

A) Should the COR request it, prior to commencement of work on this contract, the

Contractor shall provide the VAMC with a copy of the current calibration certification of all test equipment which is to be used by the Contractor on VAMC's equipment. This certification shall also be provided on a periodic basis when requested by the VAMC.

Test equipment calibration shall be traceable to a national standard.

B) Should the CO request it, the Contractor shall submit a sample of calibration certification of all test equipment to be used by the Contractor on VAMC equipment. Failure to submit sample of calibration certification of all test equipment to be used by the

Contractor on VAMC equipment with technical proposal shall result a non-responsive technical proposal.

XI) INFORMATION SYSTEM SECURITY AND PRIVACY

A) 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.

B) ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

2) 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.

3) 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.

4) 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.

5) 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.

C) VA INFORMATION CUSTODIAL RESPONSABILITIES

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).

2) 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.

3) 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.

4) 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.

5) 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.

6) 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.

7) 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.

8) 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.

9) 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.

10) 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.

11) 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.

12) 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.

D) 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 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.

2) 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.

3) 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.

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

5) 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.

6) 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.

7) The contractor/subcontractor agrees to:

(a) 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:

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

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

(b) 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

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

8) 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.

(a) “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.

(b) “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.

(c) “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.

9) 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.

10) The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the

Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than ____ days.

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

12) 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.

E) 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 vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact

Assessment (PIA) must also be provided to the COTR and approved by VA Privacy

Service prior to operational approval. All external Internet connections to VA’s network involving VA information must be reviewed and approved by VA prior to implementation.

2) 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.

3) 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.

4) 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.

5) 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.

6) 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.

7) 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.

8) 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:

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

(b) 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

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

(d) 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;

(i) 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

(ii) 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 preapproved and described in the purchase order or contract.

(iii)A statement must 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.

F) 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.

2) 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.

3) 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.

4) 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.

G) 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.

2) 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.

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

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

(b) Description of the event, including:

(i) date of occurrence;

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

(iii)Number of individuals affected or potentially affected;

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

(v) 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;

(vi)Amount of time the data has been out of VA control;

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

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

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

(x) Data breach analysis as outlined in 6500.2 Handbook, Management of

Security and Privacy Incidents, as appropriate; and

(xi)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.

4) 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 $______ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(a) Notification;

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

(c) Data breach analysis;

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

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

and

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

H) SECURITY CONTROLS COMPLIANCE TESTING

1) 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.

I) INFORMAION SECURITY 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:

(a) 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;

(b) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(c) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(d) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

2) 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.

3) 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.

XII) CONTACT INFORMATION

A) Upon contract award, the Contractor must provide valid and reliable contact information for service, preventative maintenance, emergency, and technical assistance requests.

XIII) REPORTING REQUIREMENTS

A) The Contractor shall be required to report to Biomedical Engineering to log in. This check in is mandatory. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall be required to log out with Biomedical

Engineering and submit the ESR(s) to the COR. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature" unless otherwise stated by the COR. If the COR is unavailable, a signed, authorized copy of the ESR will be sent to the Contractor after the work can be reviewed

(if requested or noted on the ESR).

1) VAMC Biomedical Contact Persons:

2) Location (Building/Room Number):

3) Telephone Number & Extension:

B) The Contractor’s repairman shall complete a full-service report, in writing, after each service call (emergency or scheduled) and submit either a hard copy or an electronic version of this report to the COR within 5 days after the service day.

XIV) DOCUMENTATION/REPORTS

A) The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance (i.e., Emergency repairs) procedures performed, including replaced parts and prices (for services performed outside normal working hours) required to maintain the equipment in accordance with the Conformance Standards section or the manufacturer's specifications. Such documentation shall meet the guidelines as set forth in the Conformance Standards section. The electronic Engineering Service Report (ESR) will consist of a separate PMI report for the item(s) covered under the "specific" contract.

Grouping different equipment from different contracts on "one" ESR is prohibited. In addition, each ESR must, at a minimum, document the following data legibly and in complete detail:

1) Name of Contractor and Contract Number.

2) Name of FSE who performed services.

3) Contractor service ESR number/log number.

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

5) VAMC purchase order numbers covering the call if outside normal working hours.

6) Description of problem reported by COR.

7) Identification of equipment to be serviced:

(a) Inventory ID number,

(b) Manufacturer's name,

(c) Device name,

(d) Model number,

(e) Serial number,

(f) Any other manufacturer's identification numbers.

B) Itemized Description of Service Performed (including, if…