36C24124Q0624_1.docx

SUBJECT*

Intent to sole source PenVasc Vascular Information System - Secondary Site Server License-

GENERAL INFORMATION

VA Connecticut

950 Campbell Avenue West Haven CT 06516-2770

POINT OF CONTACT*

Contract Specialist Chadwin Walker chadwin.walker@va.gov 203-932-5711

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

Intent to sole source PenVasc Vascular Information System - Secondary Site Server License- INTENT TO SOLE SOURCE: PenVasc Vascular Information System (VIS) - Secondary Site Server License

This is not a request for competitive proposals. This is not a solicitation or request for offers. No solicitation package is available and telephone requests will not be honored.

The Department of Veterans Affairs Providence Medical Center intends to award a one-time, Firm Fixed Price, Sole Source contract for the PenVasc Vascular Information System (VIS) - Secondary Site Server Licenset to be delivered to VAMC Providence. Original Equipment Manufacturer is PenVasc.

Technology, knowledge, technical expertise, and servicing capabilities for the PenVasc Vascular Information System (VIS) - Secondary Site Server License are proprietary to PenVasc.

A Sole Source Letter was provided by the Original Equipment Manufacturer (OEM) describing the proprietary nature of the PenVasc Vascular Information System (VIS) - Secondary Site Server License establishing this requirement as being peculiar in distribution to the OEM. The letter states that only Pulcir is authorized to distribute the PenVasc Vascular Information System (VIS) - Secondary Site Server License software.

The authority for applying the Simplified Acquisition Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901. This statute is implemented by for restricting competition on this procurement via FAR 8.405-6(a)(1)(i)(B).

The intent is to procure these products on a sole source basis. No solicitation will be posted to Contract Opportunities. The primary North American Classification System Code (NAICS) is 513210: Software Publishers. The most current Business Size Rating for this NAICS is $47 million.

Capable parties may identify their interests and authorization to respond to this requirement by July 2nd, 2024, at 12:00 PM (EDT).

A determination by the Government not to compete this proposed award upon response to this notice is solely within the discretion of the Contracting Officer.

Special Notice Special Notice

Special Notice

STATEMENT OF WORK

SCOPE OF WORK: The Contractor shall provide all labor, personnel, equipment, tools, materials, supervision and other items and services necessary to perform the following:

Installation and implementation of a fully functional PVASC-RTMS PenVasc Vascular Information System (VIS) - Secondary Site Server License for PVAMC CBOC located in New Bedford and Hyannis.

1. EQUIPMENT

The following equipment shall be provided and installed by the Contractor in the space determined by the Government. All equipment installed by the Contractor shall be FDA approved for use, in new condition, and fully operational in accordance with manufacturer literature specifications. A minimum of two (2) copies of any associated operational and/or service manuals shall be provided for all equipment listed below as applicable.

(VIS) - Secondary Site Server License Includes license fee for one year. Annual Renewal of secondary site license with relevant modules is available as

PVASC-RTMS(R).

Department of Veterans Affairs Providence VA Medical Center CBOC Hyannis and New Bedford 830 Chalkstone Ave Providence, RI 02908

Import Module) for Secondary Site

The Contractor shall provide all tools and equipment necessary to properly and safely perform the services set forth within this statement of work. This shall include, but is not limited, to all Personal Protective Equipment (PPE) which may be required for the work to be completed in a safe manner. The Contractor shall provide any equipment necessary for proper infection control measures during installation.

2. SALIENT CHARACTERISTICS

The Contractor shall provide a fully functional system that meets the following characteristics:

Salient Characteristics PVASC-RTMS PenVasc Vascular Information System (VIS) - Secondary Site Server License Includes license fee for one year.

These licenses are proprietary to PenVasc and can only be issued by and used within the PenVasc system.

2. DELIVERY LOCATION

(One or all as necessary and appropriate to this contract) Department of Veterans Affairs Providence VA Medical Center CBOC Hyannis and New Bedford 830 Chalkstone Ave Providence, RI 02908 ATTN: Brenden Wood

3. INSTALLATION

a) The Contractor shall provide all labor, materials, tools, equipment etc. to prepare for and complete the installation of the equipment in the space determined by the Government.

b) Project implementation meetings, if necessary, shall be coordinated with the COR.

c) Installation and implementation dates are to be coordinated in advance with the Contractor and the COR.

d) All employees of the Contractor and subcontractors shall comply with VA security management program and obtain the permission of the VA police, be identified by project and employer, and restricted from unauthorized access.

e) All installation personnel shall be trained by the manufacturer on how to properly install the equipment. Resumes and certifications shall be submitted for review upon request by the Government.

f) All installation personnel shall be trained by the manufacturer on safe and proper Personal Protective Equipment (PPE) usage and general infection control regulations and requirements relevant to the work outlined in the Scope of Work.

g) The Contractor shall communicate to the Government the estimated downtime required to complete full installation and testing PenVasc Vascular Information System Secondary Site Server License. If the Contractor is unable to install the equipment to its normal operational state within 24 hours, the Contractor shall compensate the Government for the downtime by extending the warranty service in a period equivalent to the downtime of the equipment.

h) The Contractor shall be responsible for the safe removal and disposal of all trade-in equipment as applicable.

i) The Contractor shall be responsible for the safe removal and disposal of all packing materials and related waste generated during installation.

4. TRAINING

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

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

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

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

(4) 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.]

b. 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.

c. 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.

5. INSPECTION AND ACCEPTANCE

a) The Contractor shall conduct a joint inspection with the COR upon delivery of equipment.

b) Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s).

c) The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the Contracting Officer.

6. WARRANTY

a) The contractor shall provide a one-year manufacturer’s warranty on all parts and labor.

b) The warranty shall include all travel and shipping costs associated with any warranty repair.

7. TASK FREQUENCY AND INSTRUCTIONS

The work set forth in the Scope of Work shall be completed in a single visit, be it a single day or multiple days as required for appropriate completion. All work is to be scheduled in advance with the COR.

Equipment delivery shall not precede installation by more than 20 days. Installation and implementation must be immediately followed by clinical user training including “go live” support. Implementation and integration with VistA CPRS shall not exceed 90 days from date of award.

8. SPECIAL WORK REQUIREMENTS

The Contractor shall comply with any and all Infection Control Risk Assessment requirements deemed appropriate by the Providence VA Medical Center during all portions of the work set forth in the Scope of Work.

The Contractor must comply with security, privacy, and safety issues in accordance to VA standards, policies, and directives set forth at all times while providing the work outlined in the Scope of Work.

9. PROPERTY DAMAGE

The contractor shall take all necessary precautions to prevent damage to any government property. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the contractor, unless corrective action is taken. Any damaged material (e.g., trees, shrubs, lawn/turf, curbs, gutters, sidewalks, etc.) will be replaced in a timely manner or corrected by the contractor with like materials, at no extra cost to the government, upon approval of the Contracting Officer.

10. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS

The contractor's employees shall wear visible identification at all times while on the premises of the VA property. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. The VA will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the VA. Cellular phones and two-way radios are not to be used within six feet of any medical equipment. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.

11. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD

12. INFORMATION SECURITY LANGUAGE

Records Management Language for Statement of Work (SOW):

The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract:

1. Citations to pertinent laws, codes, and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors–Commercial Products and Commercial Services”

2. FAR 52.212-3, “Offerors Representations and Certifications–Commercial Products and Commercial Services” Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Products and Commercial Services.” If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

· FAR 52.212-4, “Contract Terms and Conditions–Commercial Products and Commercial Services” (Nov 2023)

· FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Products and Commercial Services” (Dec 2023)

· VAAR 852.212-71 “Gray Market and Counterfeit Items (FEB 2023) [sol & contracts for new medical and information technology equipment for VAMCs that include 52.212-1 & 52.212-2]” The following subparagraphs of FAR 52.212-5 are applicable:

52.204-27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub L. 117-328) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (NOV 2021) (31 U.S.C. 6101 note).

52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) (15 U.S.C. 644) 52.222-19, Child Labor--Cooperation with Authorities and Remedies (NOV 2023) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627) 52.232-33, Payment by Electronic Funds Transfer - System for Award Management (OCT 2018) (31 U.S.C. 3332)

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The version of FAR 52.212-1 in the addendum is tailored for Simplified Acquisition Procedures and supersedes the current version of FAR 52.212-1 contained in the FAR.

Appendix C VA Information and Information System Security/Privacy Language for Inclusion into Contracts sections 1, 2, 3, 6, 7, and 9

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

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

b. 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.

c. 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.

d. 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.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. 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).

b. VA information should not be co-mingled, if possible, with any other data on thecontractors/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.

c. 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.

d. 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.

e. 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.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/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.

i. 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.

j. 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.

k. 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.

l. 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.

6. SECURITY INCIDENT INVESTIGATION

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/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.

b. 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.

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

d. In instances of theft or break-in or other criminal activity, the contractor/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.

7. LIQUIDATED DAMAGES FOR DATA BREACH

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

b. 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.

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

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

(2) Description of the event, including:

(a) date of occurrence;

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

(3) Number of individuals affected or potentially affected;

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

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

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

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

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

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

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

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

d. 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:

(1) Notification;

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

(3) Data breach analysis;

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

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

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