36C25625Q1257.docx

SUBJECT*

Brand Name or Equal to LUMENIS DIGITAL TRIO INCLUDING SMARTPULSE Sources Sought

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 16 5075 Westheimer Road, Suite 750

Houston TX 77056-5643

POINT OF CONTACT*

Contacting Officer Le Kisha Douglas, MPA LeKisha.Douglas@va.gov N/A N/A N/A

PLACE OF PERFORMANCE

2495 Shreveport Hwy #71N

Pineville LA

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Sources Sought Notice Sources Sought Notice

DESCRIPTION

Sources Sought Notice

1. Title: BRAND NAME OR EQUAL LUMENIS DIGITAL TRIO LASER SYSTEM INCLUDING SMARTPULSE

2. Purpose: The Network Contracting Office (NCO) 16 located at 5075 Westheimer Road, Galleria Financial Center, Suite 750, Houston, Texas, hereby issues the following Sources Sought to Request Information (RFI) with the intent of determining the contractor interest, capabilities, qualifications of potential businesses, nonmanufacturer rule compliance, Buy American Act compliance, Trade Agreement compliance and estimated industry pricing information for market research and estimated budgetary purpose for the name brand or equal product for Lumenis Digital Trio Laser System including Smartpulse (for ophthalmology services) that must use a digital platform, allowing it to take images and videos of the treatment, generate digital treatment reports and connect/be compatible to the local (Zeiss Forum) EMR. The current equipment being utilized is the former Lumenis Laser model, that ha reached end of life.

Contractor shall provide all shipping, installation (if required), equipment, personnel, labor and testing for name brand or equal product, as well as conducting on-site training for equipment acclimation and proper usage. This Sources Sought is published for market research purposes. This Sources Sought will be used to determine if a set-aside for any small business program is appropriate. Government anticipates competitive, firm fixed price contract. Please review this announcement, respond to questions below and review all attachments in their entirety.

Government request that interested offerors complete all questions below, provide required documentation, descriptive literature and authorization letter as described below. The Government is in no way obligated to do business with or to enter into any form of contract with any person, firm or other entity that receives or responds to this announcement.

3. Objective: To find qualified and certified contractors with the capability to with the capability to provide the following:

a. One (1) name brand or equal product equivalent to Lumenis Digital Trio Laser System including Smartpulse (for ophthalmology services) that must use a digital platform, allowing it to take images and videos of the treatment, generate digital treatment reports and connect/be compatible to the local (Zeiss Forum) EMR. (as prescribed in the included draft of the Statement of Work).

4. Place of Performance:

Alexandria VA Medical Center (AVAMC) 2495 Shreveport Hwy 71N Pineville, Louisiana 71360

5. Responses Requested: The MEDVAMC requires all the following information and questions answered in this RFI/SS: Questions and information that is not provided shall be considered nonresponsive to the Request for Information and contractor shall not be considered as part of the market research.

a. Contractors shall provide their point(s) of contact name, address, telephone number, and email address; and the company's business size, and SAM Unique Entity Identification Number.

b. Is your company a small business, SDBs, HUBZone, or 8A concern? Please provide proof of qualifications.

c. Does your company meet all required four prong factors for the Nonmanufacturer Rule (NMR) per guidance of SBA and 13 C.F.R. § 121.406 Offer must answer all questions below.

1. Does your company exceed the 1000 employee alternative size standard for nonmanufacturers?

2. Is your company primarily engaged in the retail or wholesale trade and normally sells the type of products being supplied? __________

3. Does your company must take ownership or possession of the item(s) with its personnel, equipment, or facilities in a manner consistent with industry practice? __________

4. Does your company supply the end products of a small business manufacturer or processor made in the United States? _____________

d. Is your company considered small under the NAICS code 339112.

e. Do you (offer) manufacture the product yourself or a distributor of the items being researched above?

f. Are you an authorized distributor/reseller? Provide evidence from original equipment manufacturer (OEM).

g. Do you (offer) supply a product manufactured by another domestic small business, if it is a nonmanufacturer?

h. Do you (offer) supply the product of any sized manufacturer if SBA has granted a waiver to the nonmanufacturer rule?

i. Is your (offer) Buy American Certificate completed in SAM? Please provide evidence with response.

j. Is your (offer) Trade Agreement Certificate completed in SAM? Please provide evidence with response.

k. Information for the name brand or equal product being requested, is it manufactured outside the US-Domestic non-available?

l. Information for the name brand or equal product being requested, is it a foreign manufactured end product under the trade agreement?

m. What is your schedule of delivery after receipt of order for the name brand or equal product?

n. For the name brand or equal product required, Is your company available under any;

Government Wide Agency Contract (GWAC) General Services Administration Schedules (GSA) Indefinite Delivery Indefinite Quantity (IDIQ) Blanket Purchase Agreement (BPA)

If so, please list the contract number for name brand or equal product.

o. Provide descriptive literature demonstrating ability to meet all of the requirement/salient characteristics listed if other than brand name product is being offered. Please provide list of contracts for commercial, federal, state, and local governments. Listed contracts shall provide communication on the government requirement illustrating the capability for comparison. to the name brand or equal product meeting the specific requirements per the draft Statement of Work.

p. Contractors shall provide an estimated industry pricing for name brand or equal product for market research and budgetary purpose.

6. Opportunity: NCO 16, is seeking information from potential contractors on their ability to provide this service. THIS IS A SOURCES SOUGHT FOR REQUEST INFORMATION (RFI) ONLY. Small Business Concerns are encouraged to provide responses to this Sources Sought in order to assist the MEDVAMC in determining potential levels of competition available in the industry. Contractor shall possess the capability to provide all requirements and objectives.

7. Instructions and Response Guidelines: Sources Sought responses are due by August 1, 2025 at 1630 (CST) via email to LeKisha.Douglas@va.gov .

All Questions shall be submitted by July 30, 2025 at 1200 (CST) via email to LeKisha.Douglas@va.gov.

Telephone requests or inquires will not be accepted.

Public Information will not be provided and shall be utilized to the full extent possible.

This a New Requirement.

The subject line shall read: 36C25625Q1257 -RFI-Sources Sought- One (1) Brand Name or Equal to Lumenis Digital Trio including Smartpulse. NO SOLICITATION EXISTS AT THIS TIME. There is no page limitation on subparagraphs 5(a) - 5(o).

Please provide the information you deem relevant in order to respond to the specific inquiries of the Sources Sought. Information provided will be used solely by MEDVAMC as "market research" and will not be released outside of the MEDVAMC Purchasing and Contract Team.

This Sources Sought notice does not constitute a Request for Proposal (RFP), Invitation for Bid (IFB), or Request for Quotation (RFQ), and it is not to be construed as a commitment by the Government to enter into a contract, nor will the Government pay for the information submitted in response to this request. All information contained in this Sources Sought is preliminary as well as subject to modification and is in no way binding on the Government.

In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract. If a solicitation is released, it is will be synopsized on Contracting Opportunities (https://beta.sam.gov/) website or GSA. It is the responsibility of the interested parties to monitor these sites for additional information pertaining to this Sources Sought, or future RFP/RFQ.

8. Contact Information:

Contracting Officer, Le Kisha Douglas, MPA Email address: LeKisha.Douglas@va.gov

Your responses to this notice are appreciated.

THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE QUOTES/PROPOSALS; however, any firm that believes it can meet the requirements may provide answers, responses and give written notification prior to the response due date and time. Supporting evidence and responses

Sources Sought Notice Sources Sought Notice

Page 1 of

Sources Sought Notice

STATEMENT OF WORK

BRAND NAME OR EQUAL LUMENIS DIGITAL TRIO LASER SYSTEM

ALEXANDRIA VA MEDICAL CENTER, ALEXANDRIA, LOUISIANA

1. SCOPE

The overall scope is to procure a Brand name or Equal system, equivalent to the Lumenis Digital Trio Laser System for the ophthalmology service at the Alexandria VA Medical Center (AVAMC) located at 2495 Shreveport Hwy 71N, Pineville, Louisiana. The Contractor shall provide all necessary tools, interfaces, equipment/hardware, software, licenses, delivery, installation, warranty, and training. The Lumenis digital trio laser system or equivalent will allow fast and effective treatment of the anterior segment that includes procedures of SLT, Iridotomy, Capsulotomy and Posterior Membranectomy (including vitreous opacities ‘illumination) using clinically proven technology, while offering physicians the option of keeping their current slit lamp set up. The laser system must use a digital platform, allowing it to take images and videos of the treatment, generate digital treatment reports and connect to the local (Zeiss Forum) EMR.

1. PURPOSE

The purpose is to purchase the Lumenis Digital Trio Laser System or an equivalent laser system for the Ophthalmology Department at the Alexandria VA Medical Center to replace current laser that is beyond end of life.

1. QUANTITY

1Brand name or equal to Lumenis Digital Trio ALL in one laser system (Part Number: GA-0001700DIGBE-OM) 1 Professional Installation and on-site training session

1. SPECIFICATIONS AND SALIENT CHARACTERISTICS:

Brand Name or Equal to Lumenis Digital Trio ALL in one laser system

YAG PHOTODISRUPTOR MODE AND SLT MODE

Laser Source Q-Switched Nd:YAG SLT mode: Q-Switched, frequency doubled Nd:YAG Wavelength 1064 nm SLT mode: 532 nm Energy (power) 0.3 - 10 mJ per pulse SLT mode: 0.3 - 2.0 mJ per pulse, continuously variable in 0.1 mJ increments Pulse Duration 3 ns SLT mode: 3 ns Burst Mode 1, 2, or 3 pulses per burst (selectable) SLT mode: Single pulse Spot Size 8 μm SLT mode 400 μm Cone Angle 16 degrees Slt mode < 3 degrees Posterior Offset 0 - 350 μm (continuously variable) SLT mode: Not applicable Repetition Rate 3 Hz (in single burst) SLT mode: 3 Hz Aiming Beam Red diode, continuously variable red diode, continuously variable with adjustable intensity with adjustable intensity Cooling Air cooled SLT mode: Air cooled Electrical Requirements 100 -240 VAC, 50/60 Hz, 3.15 Amps 100 -240 VAC, 50/60 Hz, 3.15 Amps CDRH Classification FDA IIIb SLT mode: FDA IIIb Digital Camera High Definition (HD) Camera SLT mode: High Definition (HD) Camera Smart Selecta Duet Table Wheelchair accessible; Table height, 945 mm max, 695 mm min; travel ~250 mm (37.8 in max, 27.4 in min, travel ~10.4 in); Table width Small: 630 mm (24.8 in) Medium: 880 mm (34.5 in); Table depth Small: 400 mm (15.7 in) Medium: 450 mm (17.8 in); Table wheelbase Small: 520 mm x 440 mm (20.4 in x 17.2 in); Medium:

460 mm x 830 mm (18.1 in x 32.7 in); Total system weight <60 kg

Additional Tro Specs (Smart 532) Wavelength 532 nm green Weight 4 kg (8.82 lbs) Dimensions 26.3 cm L x 29.5 m W x 13.7 cm H (10.4 in x 11.6 in x 5.4 in) Dual Port FC and SMA connectors, resistor type Power Requirements 100-240 VAC, 50/60 Hz, single phase Cooling System Air/TEC cooled CW Pulse Duration 5 ms - 3,000 ms CW Pulse Interval Derived from duration and duty cycle configurations and cannot be adjusted directly SmartPulse™ Duration 10 ms - 1,500 ms or single pulse SmartPulse™ Interval 0.05 ms - 0.5 ms SmartPulse™ 0.3 ms - 10 ms or single pulse Duty Cycle 5% / 10% / 15% Aiming Beam Laser Diode laser, 635 nm nominal; Intensity: 5 levels up to 1 mW System Power Output 0 - 2,000 mW Wheelchair accessible; Table height, 945 mm max, 695 mm min; travel ~250 mm (37.8 in max, 27.4 in min, travel ~10.4 in); Table width Small: 630 mm (24.8 in) Medium: 880 mm (34.5 in); Table depth Small: 400 mm (15.7 in) Medium: 450 mm (17.8 in); Table wheelbase Small: 520 mm x 440 mm (20.4 in x 17.2 in); Medium:

460 mm x 830 mm (18.1 in x 32.7 in); Total system weight <60 kg

1. SYSTEM REQUIREMENTS

1. The equipment shall be compatible with the equipment, infrastructure, and supplies and Zeiss Forum.

1. Contractor shall provide a projected schedule in terms of days from the time of award addressing (at a minimum) the following milestones: verification that all system quantities and configurations are accurate; manufacture/assembly of all parts and/or equipment; delivery to identified location; and complete installation of hardware.

1. TRAINING

1. Contractor shall provide comprehensive training on the use of the equipment for the operating clinicians. This training program shall include at the minimum the following: (i) Technical Training, (ii) Operational Training, and (iii) Hardware and Software Troubleshooting. Training shall occur onsite during normal business hours, 8:00am-4:30pm, Monday through Friday. Competency assessments shall be provided with the training.

1. TESTING AND CERTIFICATION

Upon delivery of each piece of equipment in the system, the Contractor shall notify the COR in writing that the system is ready for acceptance testing, and that it meets all requirements as specified. Submission of this notification of system readiness shall be accomplished by the contractor prior to the beginning of the scheduled Government Acceptance Test.

1. GOVERNMENT ACCEPTANCE TEST

Contractor shall perform the Government Acceptance Test in the presence of the COR and designated Ophthalmology Staff for proof-of-performance. Upon completing the Government Acceptance Test successfully, Contractor shall document the success of this Government Acceptance Test on Contractor’s company form which will be certified by the COR’s signature as evidence of Government Acceptance of the referenced piece of equipment. A copy of this document shall be furnished to the COR and the Contracting Officer before Contractor’s Representative at the end of each testing.

1. INSTALLATION

1. Contractor shall provide all labor, materials, tools, equipment etc. to prepare for the installation of the equipment in an operating room on the fourth floor to the Eye Clinic at the Alexandria VA Medical Center by 03/01/2024

1. Contractor shall be responsible for removing all packing materials and related waste and dispose of offsite.

Section 1. GENERAL. This entire section applies to all acquisitions requiring any Information Security and Privacy language. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

Section 2. VA INFORMATION CUSTODIAL LANGUAGE. This entire section applies to all acquisitions requiring any Information Security and Privacy language. a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG)

VA HANDBOOK 6500.6 April 22, 2024 APPENDIX C C-2 and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

h. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations.

i. The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

k. Notwithstanding the provision above, the contractor shall not release VA records protected by Title 38 U.S.C. § 5705, Confidentiality of medical quality-assurance records and/or Title 38 U.S.C. § 7332, Confidentiality of certain VA HANDBOOK 6500.6 April 22, 2024 APPENDIX C C-3 medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above-mentioned information, the contractor shall immediately refer such court order or other request to the VA CO for response.

l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA.The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO.

Section 3. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS. This section applies when any person requires access to information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract.

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor.

b. Contractors and subcontractors shall sign the VA Information Security Rule of Behavior (ROB) before access is provided to VA information and information systems (see Section 4, Training, below). The ROB contains the minimum user compliance requirements and does not supersede any policies of VA facilities or other agency components which provide higher levels of protection to VA’s information or information systems. Users who require privileged access shall complete the VA elevated privilege access request processes before privileged access is granted.

c. All contractors and subcontractors working with VA information are subject to the same security investigative and clearance 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 shall be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office of Human Resources and Administration/Operations, Security and Preparedness (HRA/OSP) is responsible for these policies and procedures. Contract personnel who require access to classified information or information systems shall have an appropriate security clearance. Verification of a Security Clearance shall be processed through the Special Security Officer located in HRA/OSP. Contractors shall conform to all requirements stated in the National Industrial Security Program Operating Manual (NISPOM).

d. All contractors and subcontractors shall comply with conditions specified in VAAR 852.204-71(d); Contractor operations required to be in United States. All contractors and subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S. services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR/CO in writing prior to access being granted.

e. The contractor shall notify the COR/CO in writing immediately (no later than 24 hours) after personnel separation or occurrence of other causes. Causes may include the following:

(1) Contractor/subcontractor personnel no longer has a need for access to VA information or VA information systems.

(2) Contractor/subcontractor personnel are terminated, suspended, or otherwise has their work on a VA project discontinued for any reason.

(3) Contractor believes their own personnel or subcontractor personnel may pose a threat to their company’s working environment or to any company-owned property. This includes contractor-owned assets, buildings, confidential data, customers, employees, networks, systems, trade secrets and/or VA data.

(4) Any previously undisclosed changes to contractor/subcontractor background history are brought to light, including but not limited to changes to background investigation or employee record.

(5) Contractor/subcontractor personnel have their authorization to work in the United States revoked.

(6) Agreement by which contractor provides products and services to VA has either been fulfilled or terminated, such that VA can cut off electronic and/or physical access for contractor personnel.

f. In such cases of contract fulfillment, termination, or other causes; the contractor shall take the necessary measures to immediately revoke access to VA network, property, information, and information systems (logical and physical) by contractor/subcontractor personnel. These measures include (but are not limited to): removing and then securing Personal Identity Verification (PIV) badges and PIV – Interoperable (PIV-I) access badges, VA-issued photo badges, credentials for VA facilities and devices, VA-issued laptops, and authentication tokens. Contractors shall notify the appropriate VA COR/CO immediately to initiate access removal.

g. Contractors/subcontractors who no longer require VA accesses will return VA-issued property to VA. This property includes (but is not limited to): documents, electronic equipment, keys, and parking passes. PIV and PIV-I access badges shall be returned to the nearest VA PIV Badge Issuance Office. Once they have had access to VA information, information systems, networks and VA property in their possessions removed, contractors shall notify the appropriate VA COR/CO.

4. TRAINING. This entire section applies to all acquisitions which include section 3. a. All contractors and subcontractors requiring access to VA information and VA information systems shall successfully complete the following before being granted access to VA information and its systems: (1) VA Privacy and Information Security Awareness and Rules of Behavior course ( (Talent Management System (TMS) #10176) initially and annually thereafter.

VA Handbook 6500.6 April 22, 2024 APPEND IX C C-6

(2) Sign and acknowledge (electronically through TMS #10176) understanding of and responsibilities for compliance with the Organizational Rules of Behavior, relating to access to VA information and information systems initially and annually thereafter; and

(3) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system or information access [to be defined by the VA program official and provided to the VA CO for inclusion in the solicitation document – i.e., any role-based information security training].

b. The contractor shall provide to the COR/CO a copy of the training certificates and certification of signing the Organizational Rules of Behavior for each applicable employee within five days of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training 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 required training is complete.

5. SECURITY INCIDENT INVESTIGATION. This entire section applies to all acquisitions requiring any Information Security and Privacy language. a. The contractor, subcontractor, their employees, or business associates shall immediately (within one hour) report suspected security / privacy incidents to the VA OIT’s Enterprise Service Desk (ESD) by calling (855) 673-4357 (TTY: 711). The ESD is OIT’s 24/7/365 single point of contact for IT-related issues. After reporting to the ESD, the contractor, subcontractor, their employees, or business associates shall, within one hour, provide the COR/CO the incident number received from the ESD.

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved and the circumstances surrounding the incident, including the following: (1) The date and time (or approximation of) the Security Incident occurred.

(2) The names of individuals involved (when applicable).

(3) The physical and logical (if applicable) location of the incident.

(4) Why the Security Incident took place (i.e., catalyst for the failure).

(5) The amount of data belonging to VA believed to have been compromised.

(6) The remediation measures the contractor is taking to ensure no future incidents of a similar nature.

c. After the contractor has provided the initial detailed incident summary to VA, they will continue to provide written updates on any new and relevant circumstances or facts they discover. The contractor, subcontractor, and their employes shall fully cooperate with VA or third-party entity performing an independent risk analysis on behalf of VA. Failure to cooperate may be deemed a material breach and grounds for contract termination.

d. VA IT contractors shall follow VA Handbook 6500, Risk Management Framework for VA Information Systems VA Information Security Program, and VA Information Security Knowledge Service guidance for implementing an Incident Response Plan or integrating with an existing VA implementation.

e. 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 the VA Office of 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.

f. The contractor shall comply with VA Handbook 6500.2, Management of Breaches Involving Sensitive Personal Information, which establishes the breach management policies and assigns responsibilities for the oversight, management and reporting procedures associated with managing of breaches.

g. With respect to unsecured Protected Health Information (PHI), the contractor is deemed to have discovered a data breach when the contractor knew or should have known of breach of such information. When a business associate is part of VHA contract, notification to the covered entity (VHA) shall be made in accordance with the executed BAA.

h. If the contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach involving any VA sensitive personal information the contractor/subcontractor processes or maintains under the contract; the contractor shall pay liquidated damages to the VA as set forth in clause 852.211-76, Liquidated Damages—Reimbursement for Data Breach Costs.

Section 6. INFORMATION SYSTEM DESIGN AND DEVELOPMENT. N/A

Section 7: INFORMATION SYSTEM HOSTING, OPERATION, MAINTENACE OR USE. N/A

Section 8: SECURITY AND PRIVACY CONTROLS COMPLIANCE TESTING, ASSESSMENT AND AUDITING. N/A

Section 9: PRODUCT INTEGRITY, AUTHENTICITY, PROVENANCE, ANTI-COUNTERFEIT AND ANTI-TAMPERING. This entire section applies when the acquisition involves any product (application, hardware, or software) or when section 6 or 7 is included. a. The contractor shall comply with Code of Federal Regulations (CFR) Title 15 Part 7, “Securing the Information and Communications Technology and Services (ICTS) Supply Chain”, which prohibits ICTS Transactions from foreign adversaries. ICTS Transactions are defined as any acquisition, importation, transfer, installation, dealing in or use of any information and communications technology or service, including ongoing activities, such as managed services, data transmission, software updates, repairs or the platforming or data hosting of applications for consumer download.

b. When contracting terms require the contractor to procure equipment, the contractor shall purchase or acquire the equipment from an Original Equipment Manufacturer (OEM) or an authorized reseller of the OEM. The contractor shall attest that equipment procured from an OEM or authorized reseller or distributor are authentic. If procurement is unavailable from an OEM or authorized reseller, the contractor shall submit in writing, details of the circumstances prohibiting this from happening and procure a product waiver from the VA COR/CO.

c. All contractors shall establish, implement, and provide documentation for risk management practices for supply chain delivery of hardware, software (to include patches) and firmware provided under this agreement. Documentation will include chain of custody practices, inventory management program, information protection practices, integrity management program for sub-supplier provided components, and replacement parts requests. The contractor shall make spare parts available. All contractor(s) shall specify how digital delivery for procured products, including patches, will be validated and monitored to ensure consistent delivery. The contractor shall apply encryption technology to protect procured products throughout the delivery process.

d. If a contractor provides software or patches to VA, the contractor shall publish or provide a hash conforming to the FIPS Security Requirements for Cryptographic Modules (FIPS 140-2 or successor).

e. The contractor shall provide a software bill of materials (SBOM) for procured (to include license products) and consist of a list of components and associated metadata which make up the product. SBOMs must be generated in one of the data formats defined in the National Telecommunications and Information Administration (NTIA) report “The Minimum Elements for a Software Bill of Materials (SBOM).”

f. Contractors shall use or arrange for the use of trusted channels to ship procured products, such as U.S. registered mail and/or tamper-evident packaging for physical deliveries.

g. Throughout the delivery process, the contractor shall demonstrate a capability for detecting unauthorized access (tampering).

h. The contractor shall demonstrate chain-of-custody documentation for procured products and require tamper-evident packaging for the delivery of this hardware.

Section 10. VIRUSES, FIRMWARE AND MALWARE. This entire section applies when the acquisition involves any product (application, hardware, or software) or when section 6 or 7 is included.

a. The contractor shall execute due diligence to ensure all provided software and patches, including third-party patches, are free of viruses and/or malware before releasing them to or installing them on VA information systems.

b. The contractor warrants it has no knowledge of and did not insert, any malicious virus and/or malware code into any software or patches provided to VA which could potentially harm or disrupt VA information systems. The contractor shall use due diligence, if supplying third-party software or patches, to ensure the third-party has not inserted any malicious code and/or virus which could damage or disrupt VA information systems.

c. The contractor shall provide or arrange for the provision of technical justification as to why any “false positive” hit has taken place to ensure their code’s supply chain has not been compromised. Justification may be required, but is not limited to, when install files, scripts, firmware, or other contractor-delivered software solutions (including third-party install files, scripts, firmware, or other software) are flagged as malicious, infected, or suspicious by an anti-virus vendor.

d. The contractor shall not upload (intentionally or negligently) any virus, worm, malware or any harmful or malicious content, component and/or corrupted data/source code (hereinafter “virus or other malware”) onto VA computer and information systems and/or networks. If introduced (and this clause is violated), upon written request from the VA CO, the contractor shall: (1) Take all necessary action to correct the incident, to include any and all assistance to VA to eliminate the virus or other malware throughout VA’s information networks, computer systems and information systems; and

(2) Use commercially reasonable efforts to restore operational efficiency and remediate damages due to data loss or data integrity damage, if the virus or other malware causes a loss of operational efficiency, data loss, or damage to data integrity.

Section 11. CRYPTOGRAPHIC REQUIREMENT. N/A

Section 12. PATCHING GOVERNANCE. N/A

Section 13. SPECIALIZED DEVICES/SYSTEMS (MEDICAL DEVICES, SPECIAL PURPOSE SYSTEMS, RESEARCH SCIENTIFIC COMPUTING). This entire section applies when the acquisition includes one or more Medical Device, Special Purpose System or Research Scientific Computing Device. If appropriate, ensure selected clauses from section 6 or 7 and 8 through 12 are included. a. Contractor supplies/delivered Medical Devices, Special Purpose Systems-Operational Technology (SPS-OT) and Research Scientific Computing Devices shall comply with all applicable Federal law, regulations, and VA policies. New developments require creation, testing, evaluation, and authorization in compliance with processes specified on the Specialized Device Cybersecurity Department Enterprise Risk Management (SDCD-ERM) Portal, VA Directive 6550, Pre-Procurement Assessment and Implementation of Medical Devices/Systems, VA Handbook 6500, and the VA Information Security Knowledge Service. Deviations from Federal law, regulations, and VA Policy are identified and documented as part of VA Directive 6550 and/or the VA Enterprise Risk Analysis (ERA) processes for Specialized Devices/Systems processes.

b. All contractors and third-party service providers shall address and/or integrate applicable VA Handbook 6500 and Information Security Knowledge Service specifications in delivered IT systems/solutions, products and/or services. If systems/solutions, products and/or services do not directly match VA security requirements, the contractor shall work though the COR/CO for governance or resolution.

c. The contractor shall certify to the COR/CO that devices/systems that have completed the VA Enterprise Risk Analysis (ERA) process for Specialized Devices/Systems are fully functional and operate correctly as intended. Devices/systems must follow the VA ERA authorized configuration prior to acquisition and connection to the VA computing environment. If VA determines a new VA ERA needs to be created, the contractor shall provide required technical support to develop the configuration settings. Major changes to a previously approved device/system will require a new ERA.

d. The contractor shall comply with all practices documented by the Food Drug and Administration (FDA) Premarket Submission for Management of Cybersecurity in Medical Devices and Postmarket Management of Cybersecurity in Medical Devices.

e. The contractor shall design devices capable of accepting all applicable security patches with or without the support of the contractor personnel. If patching can only be completed by the contractor, the contractor shall commit the resources needed to patch all applicable devices at all VA locations. If unique patching instructions or packaging is needed, the contractor shall provide the necessary information in conjunction with the validation/testing of the patch. The contractor shall apply security patches within 30 business days of the patch release and have a formal tracking process for any security patches not implemented to include explanation when a device cannot be patched.

f. The contractor shall provide devices able to install and maintain VA-approved antivirus capabilities with the capability to quarantine files and be updated as needed in response to incidents. Alternatively, a VA-approved whitelisting application may be used when the contractor cannot install an anti-virus / anti-malware application.

g. The contractor shall verify and document all software embedded within the device does not contain any known viruses or malware before delivery to or installation at a VA location.

h. Devices and other equipment or systems containing media (hard drives, optical disks, solid state, and storage via chips/firmware) with VA sensitive information will be returned to the contractor with media removed. When the contract requires return of equipment, the options available to the contractor are the following: (1) The contractor shall accept the system without the drive, firmware and solid state.

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

(3) Due to the highly specialized and sometimes proprietary hardware and software associated with the device, if it is not possible for VA to retain the hard drive, firmware, and solid state, then: (a) The equipment contractor shall 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.

(b) Any fixed hard drive, Complementary Metal-Oxide-Semiconductor (CMOS), Programmable Read-Only Memory (PROM), solid state and firmware 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 solicitation, contract or order.