J065--Intent to Sole Source Pulse Laser Service Contract

This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(2) requiring the dissemination of information on proposed contract actions. This is a notice of intent to award a sole-source contract pursuant to 10 U.S.C 2304 (C)(1), as implemented by FAR 6.302-1(a)(2) and 6.301-1(c), only one responsible source and no other supplies or services will satisfy agency requirements and brand-name descriptions. The Department of Veterans Affairs Medical Center at 150 South Huntington Avenue, Boston, MA 02301, requires preventive maintenance (PM), repairs, and support for Lumenis Pulse Holmium laser. The Government intends to award a firm-fixed-price sole source contract with Boston Scientific. A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government. this notice of intent is not a request for competitive proposals. This is a written notice to inform

the public of the Government's intent to award on a sole source basis. Interested parties may identify their interest and capability to respond to the requirement. Any response to this notice must show clear and convincing evidence that competition will benefit the Government. Please contact Manasés Cabrera, Contracting Specialist, with the responses or questions regarding this requirement at manases.cabrera@va.gov. Please respond before April 22, 2024, at 8:00 AM Eastern Standard Time (EST) REQUESTING SERVICE: Clinical Engineering. 1.0 Objective: To provide Original Equipment Manufacturer (OEM) certified technicians for preventive maintenance (PM), repairs, and support for Lumenis Pulse Holmium laser, located at VAMC Jamaica Plain, MA., in accordance with Boston Scientific's quote of 2/21/2024 for EE# 210377, serial number 340. 1.1 Period of Performance: BHS requests a base and four option year contract. Base 6/2/2024 6/1/2025 Option 1 6/2/2025 6/1/2026 Option 2 6/2/2026 6/1/2027 Option 3 6/2/2027 6/1/2028 Option 4 6/2/2028 6/1/2029 1.4 Type of Contract: Firm Fixed Price. 1.5 Contract Award Meeting: The contractor shall not commence performance on the tasks in this SOW until the Contracting Officer has conducted a kick-off meeting or has advised the contractor that a kick-off meeting is waived. 2.0 Background: The Lumenis Pulse Holmium laser is owned by BHS and is utilized for surgical procedures. Due to propriety rights, only technicians certified by Boston Scientific can repair, service and maintain this laser. 2.1 Protected Health Information (PHI), the only records exchanged between VA and vendor are invoices and vendor service reports. Neither contain PHI. 3.0 Scope: The Vendor shall accomplish the deliverables, provide certified technicians, labor, personnel, equipment, tools, materials, parts, supervision, and other items necessary to perform two onsite PM every 12 months, repairs, and support on the BHS Lumenis laser listed in paragraph 7.1 below. Access to Lumenis technicians 24 hours a day, 7 days a week via phone. Spare parts, labor and travel are included. Wear & tear parts, & software updates also included. 3.1 Contractor on Site: When required by BHS, requested, and authorized by BHS and the vendor, a field service agent (FSA) must be on-site in 3 5 days. 3.2 Professional Qualifications: The assigned (FSA) must have the appropriate training, experience, expertise, and current certification by the OEM to work on the equipment identified in paragraph 7.1 below. 4.0 Scheduling a Visit: Contact the BHS CE department at (857) 203-5517 or Dennis Allen (dennis.allen2@va.gov) or another CE staff member to schedule a visit at a mutually agreed upon date and time. 4.1 Security Requirements: FSA shall report to the CE point of contact or another government designated representative to check in and obtain a short-term identification (ID) badge. This must be obtained before any work is performed. 4.2 Identification: FSA must present a current (not expired) Federal ID, PIV card, State or local government ID card/badge before the temporary Federal ID badge is issued. 5.0 Upon Arrival: All contractors can proceed to CE, building 1, (older brick building) ground floor, room GB-112 (next to Hanscom Credit Union) where the ID presented is verified. If deemed official, the CE liaison will have the contractor sign in and will then give the FSA a temporary U. S. Government ID badge. The badge shall be worn prominently by the FSA while on VA Property. 5.1 Work Site: The contractor will be escorted by CE staff or other designated VA employee to the work site and must return to CE to sign out and turn-in said badge along with the documented service report for the service performed. If there is a need to replace any hard drive, hard drives, and all information on them, are the property of the VA and must remain in the control of the VA Clinical Engineering department for proper destruction. 6.0 Federal Law: The FSA must follow all Government laws, rules and regulations regarding National Security, patient privacy, and information security. And must adhere to the privacy Act, HIPAA, and COVID-19 screening requirements. 6.1 Unauthorized Work/Parts: Work outside the scope of this agreement is not authorized. Purchase of parts is not authorized. 7.0 Authorized Service: Two preventive maintenance (PM) services on the laser listed in paragraph 7.1 below. Use of OEM parts/kits required by OEM Periodic Manufacturers certification are included in PM services. Service must meet the manufacturer s required service frequency and must include all steps detailed in the OEM service manual. 7.1 BHS equipment to be serviced: Manufacturer Device Name EE Number Serial number Location Lumenis Pulse Laser EE211349 340 Jamacia Plain 7.2 Emergency work: service outside of scope of this agreement is not authorized. 8.0 Deliverables: Field Service Report (FSR) must be completed by the FSA and a copy given to CE staff. The FSR must include: Name & work phone number of FSA who performed services. Contractor service ESR number/log number. Date, time (starting and ending), equipment downtime and hours on site for service call. Identification of equipment serviced to include: Facility Inventory EE ID number Manufacturer Device name Model number Serial number 8.1 Itemized Description: of Service Performed (including, if authorized by a separate PO, costs associated with after normal working hour services) including: Labor and Travel, parts with part numbers. Materials used. b. Signatures of FSE and BHS employee who verified the work. 8.2 Hours of Coverage: Support is available 24 hours a day 7 days a week. 8.3 Maintenance: PM must be completed following OEM schedule. FSA must follow and complete all steps/part replacement and testing following OEM PM guide. 9.0 VA Information and Information Systems & Privacy: 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. 9.1 Access to VA Information and VA Information Systems: Access to VA information Contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. 9.2 Investigative Requirements: 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. 9.3 Custom software development: and outsourced operations must be 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. 9.4 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. 10.0 VA Information Custody: 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). 10.1 VA Information: should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems 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 follow VA directive requirements. 10.2 Prior to Termination: or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor while 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. 10.3 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 follow security laws, regulations, and policies in this contract. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations, and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and VA Handbook 6500.6, Contract Security APPENDIX C. 3. 11. Records Management: 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. 11.1 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. 11.2 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. 11.3 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. 11.4 In accordance with 36 CFR 1222.32, the Contractor shall maintain all records created for Government use or created while 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. 11.5 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. 11.6 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). 11.7 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. 11.8 The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VHA policy. 11.9 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. 11.10 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. 11.11 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. 11.12 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 11.13  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, and require written subcontractor acknowledgment of same. 11.14 Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.