SPECIAL NOTICE
65 -- Intent to Sole Source SudoScan system
- Notice Date
- 3/11/2024 11:41:43 AM
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- 241-NETWORK CONTRACT OFFICE 01 (36C241) TOGUS ME 04330 USA
- ZIP Code
- 04330
- Solicitation Number
- 36C24124Q0359
- Response Due
- 3/13/2024 7:00:00 AM
- Archive Date
- 05/12/2024
- Point of Contact
- Fred Revah, Contract Specialist, Phone: 207-623-8411 x7992
- E-Mail Address
-
frederic.revah1@va.gov
(frederic.revah1@va.gov)
- Awardee
- null
- Description
- INTENT TO SOLE SOURCE: SUDOSCAN SYSTEM to Anchors Away, LLC THIS IS NOTICE OF INTENT TO SOLE SOURCE FOR THE SUDOSCAN SYSTEM FOR PURCHASE REQUISITION#: 523-24-2-7821-0048. 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, VA Boston Healthcare System, Boston MA intends to award a Firm Fixed Price, Sole Source Contract for the Sudoscan System to the Service Disabled Veteran Owned Small Business (SDVOSB) OEM (Original Equipment Manufacturer) Distributor Anchors Away LLC. The Sudoscan System is proprietary to Sudoscan Inc. Anchors Away LLC has provided a Sole Source Letter indicating that they are the only company that is authorized to distribute this product. No other company has the rights or expertise to distribute the Sudoscan System. The authority for applying the Simplified 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 13.106-1(b)(1). The intent is to procure the services mentioned above on a sole source basis. No solicitation will be posted to Contract Opportunities. The primary North American Classification System Code (NAICS) is 339112: Surgical and Medical Instrument Manufacturing. The most current Business Size Rating for this NAICS is 1000 Employees. Capable parties may identify their interests and authorization to respond to this requirement by March 13th, 2024 at 10:00 AM (EST). Please contact Fred Revah, Contracting Specialist with the responses or questions regarding this requirement at Frederic.revah1@va.gov. 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. VA Boston Healthcare System SudoScan Performance Work Statement 523-24-2-7821-0048 Introduction VA Boston Healthcare System is looking to make an emergency purchase of a SudoScan to replace the QSART function test of the existing Autonomic Testing Lab within the Neurology Department. The current QSART test relies on pharmaceuticals that are extremely difficult to obtain and are in short supply. Therefore, the diagnostic test can no longer be offered by the VA under the current circumstances. Purchase of the SudoScan would allow VA Boston to keep service in-house and prevent sending out care into the community. Background This emergency purchase will replace a piece of equipment that performs a particular test in VA Boston s Neurology department. Currently, it is no longer possible to obtain the materials necessary to perform the QSART test as the pharmaceutical required to run the test has very limited availability. The SudoScan does not require such pharmaceuticals and performs the same diagnostic function as the QSART test. Until a SudoScan is purchased, VA Boston will need to refer care into the community. Scope The scope of this emergency purchase will improve service provided to the veterans at VA Boston. The purchase includes the SudoScan which contains one set of hand/foot electrodes, a control touch panel computer and display unit with power cable, license to one executable copy of the SudoScan diagnostic software and one copy of technical documentation. It also includes a mobile kit, which contains a cart/stand and magnetic spray holder and wipe box holder, disposable smart electrodes, and two-year warranty. This purchase shall also include on-site installation and training. The scope also includes all work required for installation such as mounting equipment, successfully connecting the device to the network/printer/file share, and training for users, technicians, physicians, clinical engineering, and nurses. The system and all hardware components shall come with a standard 2-year warranty and OEM preventative maintenance during the warranty period. The vendor shall also provide extended operating system support or no cost upgrades if extended support is not available. The vendor shall provide the following documentation for the proposed configuration and setup: o Hard and soft copy of operator s manual o Hard and soft copy of technical service manuals including troubleshooting guides, necessary diagnostic software and equipment, schematic diagrams, and parts lists o Hard and soft copy of cleaning procedures and approved cleaning agents list o DVD or web-based training if available Performance Requirements The system shall be able to do the following things: Interface to the current network of VA Boston Connect and successfully send/receive data to/from the Neurology File Share Connect with network printers to print PDF reports Deliverables The contractor shall be able to deliver and install all hardware, peripherals, software, and support for the installation and proper functioning of this SudoScan. 6.0 Applicable Directives Appendix B The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. Appendix C 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 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. 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. 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. RECORDS MANAGEMENT OBLIGATIONS A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists. B. Definitions Federal record as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them. The term Federal record: includes VHA records. does not include personal materials. applies to records created, received, or maintained by Contractors pursuant to their VHA contract. may include deliverables and documentation associated with deliverables. C. Requirements Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. In accordance with 36 CFR 1222.32, the Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. VHA and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VHA or destroyed except in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage, or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the Contractor must report to VHA. The agency must report promptly to NARA in accordance with 36 CFR 1230. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records, and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records, and/or equipment is no longer required, it shall be returned to VHA control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand-carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4). The 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, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VHA guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VHA policy. The Contractor shall not create or maintain any records containing any non-public VHA information that is not specifically tied to or authorized by the contract. The 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 from public disclosure by an exemption to the Freedom of Information Act. The VHA owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VHA shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20. Training. All Contractor employees assigned to this contract who create, work with or otherwise handle records are required to take VHA-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. ** VHA training for contractors is available in Talent Management System (TMS): Records Management for Records Officers and Liaisons, Item #3873736 D. Flow down of requirements to subcontractors The Contractor shall incorporate the substance of this clause, its terms, and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.
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