J065--Intent to Sole Source Excimer Laser Maintenance

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 located at 150 South Huntington Avenue, Boston, MA 02301 has a requirement for a CVX-300 Excimer Laser Maintenance Agreement. The Government intends to award a firm-fixed-price sole source contract. 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 Governments 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 be advantageous to the Government. Please contact Manasés Cabrera, Contracting Specialist with the responses or questions regarding this requirement at manases.cabrera@va.gov. This notice will close on November 6, 2023, at 8:00 AM Eastern Standard Time (EST) STATEMENT OF WORK SPECTRANETICS CVX-300 EXCIMER LASER 523-24-1-7441-0003 REQUESTING SERVICE: Clinical Engineering OBJECTIVE: Using a sole source Vendor, BHS requests to renew a five-year Rightfit Uptime preventive maintenance, repair and support service contract for one BHS owned, Spectranetics, CVX-300 Excimer Laser, EE 179435, located at West Roxbury. 1.2 Performance Period: BHS VA requests a base and four option year contract: Base 12/1/2023 11/30/2024 Option 1 12/1/2024 11/30/2025 Option 2 12/1/2025 11/30/2026 Option 3 12/1/2026 11/30/2027 Option 4 12/1/2027 11/30/2028 1.3 Type of Contract: Firm Fixed Price 1.4 Contract Award Meeting: The contractor shall not commence performance on the tasks in this SOW until the CO has conducted a kick-off meeting or has advised the contractor that a kick-off meeting is waived. 2.0 BACKGROUND: BHS owns this device, which is located at VA Medical Center, West Roxbury, MA. This service contract is for preventive maintenance and repair of this equipment. The laser uses a coronary laser with an atherectomy catheter for the treatment of peripheral and coronary arterial disease. 3.0 SCOPE: The Vendor shall provide all labor, personnel, equipment, tools, materials, parts, supervision and other items necessary to accomplish the deliverables and perform onsite preventive maintenance (PM), repairs and support on the BHS CVX-300 Excimer laser system, EE 179435. 3.1 RESPONSE TIME: A two (2) hour call back response time for any non-PM service-related issues that are communicated to the contractor. 3.2 Contractor on site: When required by BHS, requested and authorized by a BHS purchase order (PO) an FSA must be on-site within 24 hours. to address any service calls. 3.3 PROFESSIONAL QUALIFICATIONS: The assigned field service agent (FSA) must have the appropriate training, experience, expertise and certification by the OEM to work on the equipment. 4.0 SCHEDULING A VISIT: Contact the BHS CE department at (857) 203-5517 to schedule a visit at a mutually agreed upon date and time. 4.1 SECURITY REQUIREMENTS: FSA shall report to Clinical Engineering (CE) point of contact 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 GB112 (next to Hanscom Credit Union) where the FSA 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 Clinical Engineering 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 GOVERNMENT RULES AND REGULATIONS: 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: Work outside the scope of this agreement is not authorized. Purchase of parts is not authorized. 7.0 AUTHORIZED SERVICE: Preventative maintenance (PM) and repair on the CVX-300 Excimer laser system, EE 179435. Service must meet the manufacturer s required service frequency and must include all steps detailed in the OEM service manual. 7.1 EQUIPMENT TO BE SERVICED: Spectranetics CVX-300 Excimer Laser system, serial number 81093, EE number 179435. 8.0 Emergency work: If emergency work is needed, FSA must provide a written estimate of repairs. CE staff member will then request a purchase order (PO). Only when the FSA has these two documents can work outside of this contract begin. 9.0 DELIVABLES: 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 9.1 Parts and subsystems: that need to be replaced containing PHI will be performed as follows: a. All media (e.g., hard drives) containing PHI will remain property of the VA. b. They will be removed from subsystem with Clinical Engineering staff member present and secured by Clinical Engineering. c. Clinical Engineering will identify media with equipment ID number for documentation. d. Clinical Engineering will transport Media to Field Ops for disposal. e. Vendor Personnel exposed to PHI will abide to signed BAA with the Department of Veterans Affairs Veterans Health Administration. 9.2 Hours of Coverage: twenty-four-hour, 7 day per week, Helpline for software, hardware, and user questions. 9.3 Guaranteed Uptime: A guaranteed uptime of 95% shall be maintained during hours of coverage to date: Uptime % = productive time down time divided by productive time times 100. Productive time is planned time of use of equipment. Downtime begins at time of first service call until equipment is returned to proper operating conditions. 9.3 Response time: On-site service technician will be dispatched within 24 hours if required (all costs included) 9.4 Preventive maintenance (PM): Preventative maintenance (PM) and repair on the Script Pro equipment must meet the manufacturer s required service frequency and must include all steps detailed in the OEM service manual. 10.0 VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE: 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 security. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS: 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. 11.1 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. 11.2 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. 11.3 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. 12.0 VA INFORMATION CUSTODIAL LANGUAGE: 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). 12.1 VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems 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 must follow VA directives. 12.2 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. 12.3 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 security laws, regulations and policies in this contract. 12.5 The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor media storage 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. 13.0 SECURITY: Information System Security The contractor shall ensure adequate LAN/Internet, data, information, and system security in accordance with VA standard operating procedures and standard contract language, conditions laws, and regulations. The contractor s firewall and web server shall meet or exceed the government minimum requirements for security. All government data shall be protected behind an approved firewall. Any security violations or attempted violations shall be reported to the VA project manager and the VBA Headquarters Information Security Officer as soon as possible. The contractor shall follow all applicable VA policies and procedures governing information security, especially those that pertain to certification accreditation. 13.1 Security Training: All contractor employees and subcontractors under this contract or order are required to complete the VA's on-line Security Awareness Training Course and the Privacy Awareness Training Course annually. Contractors must provide signed certifications of completion to the CO during each year of the contract. This requirement is in addition to any other training that may be required of the contractor and subcontractor(s).