SPECIAL NOTICE
J -- Intent to Sole Source Abbott Optis and Coroflow Service Plan
- Notice Date
- 7/23/2024 3:44:16 AM
- Notice Type
- Special Notice
- NAICS
- 811210
—
- Contracting Office
- 241-NETWORK CONTRACT OFFICE 01 (36C241) TOGUS ME 04330 USA
- ZIP Code
- 04330
- Solicitation Number
- 36C24124Q0763
- Response Due
- 7/29/2024 5:00:00 AM
- Archive Date
- 08/28/2024
- Point of Contact
- Manases Cabrera, Contracting Specialist, Phone: 781-687-4418
- E-Mail Address
-
manases.cabrera@va.gov
(manases.cabrera@va.gov)
- Awardee
- null
- Description
- 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 950 Campbell Ave, West Haven, CT 06516 has a requirement for full-service support for the OPTIS Mobile Next and CoroFlow Cardiovascular systems located at the VA Connecticut Healthcare System 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 Manases Cabrera, Contracting Specialist with the responses or questions regarding this requirement at manases.cabrera@va.gov. This notice will close on July 29, 2024, at 8:00 AM Eastern Standard Time (EST) Statement of Work (SOW) Transaction #: 689-24-4-7441-0629 General: The contractor shall provide full-service support for the OPTIS Mobile Next and CoroFlow Cardiovascular systems located at the VA Connecticut Healthcare System which includes the main West Haven Medical Center and surrounding Community Based Outpatient Clinics (CBOCs). The OPTIS Mobile Next imaging system is a transportable system designed for cath labs to provide better insights to optimize patient outcomes through automation and an improved workflow. The CoroFlow Cardiovascular System is an advanced platform to measure physiological indices such as FFR, RFR, CFR, and IMR to provide physiology data for vessel characteristics through the entire coronary vasculature. Both will be utilized to advance the vascular care that the veteran population receives at VA Connecticut Healthcare System. Description of Work: The contractor shall provide all required service including emergency service, repairs, preventative and corrective maintenance, labor, travel, unlimited parts, technical support, application support, and factory authorized updates/modifications/upgrades for the VA Optis Mobile Next and CoroFlow Cardiovascular systems. All services performed shall be in accordance with the original equipment manufacturer (OEM) specifications. Field service engineers must be licensed or contracted with the original manufacturer in order to work on the equipment. All parts and software must be certified new from the original manufacturer. Reference below for equipment type and the required service: Summary of Service & Equipment Description: Service Coverage for Abbott Systems including but not limited to the below model names and serial numbers. OPTIS Mobile Next SN: 19608482 Base Year Extended Product Warranty: Parts Replacement Coverage Software Upgrades/Revisions Annual Preventative Maintenance including parts Corrective Maintenance and Repair Service Calls to include parts, travel, and labor to return equipment to standard operating condition On-site Service, Priority Response Level 2 (within two business days) Shipping Level 2: Priority next business day morning 24/7/365 Telephone Technical Support: 1-855-478-5833, option 2 Remote System Diagnostics and Maintenance Loaner systems/components/equipment/modules availability to include shipping fees Technical User Training Course Credits Advanced Training Package 10% Parts and Services Discount Option to extend for an additional year for up to two additional option years CoroFlow Cardiovascular SN: 2126, 2183 (Base Year) Extended Product Warranty: Parts Replacement Coverage Software Upgrades/Revisions Annual Preventative Maintenance including parts Corrective Maintenance and Repair Service Calls to include parts, travel, and labor to return equipment to standard operating condition On-site Service, Priority Response Level 2 (within two business days) Shipping Level 2: Priority next business day morning 24/7/365 Telephone Technical Support: 1-855-478-5833, option 2 Remote System Diagnostics and Maintenance Loaner systems/components/equipment/modules availability to include shipping fees Technical User Training Course Credits Advanced Training Package 10% Parts and Services Discount Option to extend for an additional year for up to two additional option years Hours of Performance: Normal hours of coverage are Monday through Friday 8:00 AM to 6:00 PM EST excluding federal holidays. All service/repairs will be performed during normal hours of coverage unless requested or approved by the Contracting Officer s Representative (COR). Preventative periodic maintenance will be performed Monday through Friday 8:00 AM to 6:00 PM EST or as agreed to by the user and the COR in accordance with manufacturer s recommendations. There will be 24/7 telephone support. Federal Holidays observed by the VAMC are: New Year s Day Martin Luther King Day Presidents Day Memorial Day Juneteenth Day Independence Day Labor Day Columbus/Indigenous People s Day Veterans Day Thanksgiving Day Christmas Day NOTE: Hardware/software update/upgrade installations will be scheduled and performed at a mutually agreed upon time at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the COR or designated representatives. Government provides software/hardware upgrade/update. There shall be no additional charge for time spent at the site during or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts. Conformance Standards: Contractor shall provide service and ensure that the equipment functions in accordance with the equipment manufacturer s technical performance specifications. Contractor shall conform to all regulations to include but not be limited to federal, state, and local governing any chemicals, equipment or work which may be used or performed in the work under this contract. Operational Uptime Requirements: The medical equipment/system shall be operable and available for use 98% of the normal operating hours of the equipment. Downtime will be computed from notification of problem during normal work hours. Guaranteed Response Time: The OEM certified Field Service Engineer (FSE) will use commercially reasonable efforts to respond to Customer s requests within 24 hours of notification to the vendor s service support team. Live Phone Support: Service shall include phone support with vendor technical support engineers 24 hours, 7 days a week. After Hours Phone Support: Service for after hour phone support shall include 24 hours, 7 days a week, and 365 days a year for technical assistance when required. Software Enhancements: Periodic software enhancements shall be provided as part of the firm fixed price contract and shall be considered within scope. Preventative Maintenance: Perform system scheduled maintenance inspections as outlined in the user s manual developed by the manufacturer. Parts Exchange: All parts required for the repair of the system (excludes instruments and accessories) are covered. Part Protection: Preferred pricing on repairs or replacement due to accidental damage. Labor & Travel Expenses: All labor and travel conducted during normal business hours: Monday through Friday, 8:00 AM to 6:00PM EST (excludes vendor company holidays) are covered. Certified Trained Technicians and Key Personnel: The scheduled maintenance and service calls shall be performed by OEM trained personnel in accordance with the agreement. Technicians shall include fully qualified Facility Service Engineers (FSE) and a fully qualified FSE who will serve as the backup and show proof of competency, as shown by training conducted on said system. ""Fully Qualified"" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program, for the equipment identified in this statement of work. For field experience, the FSE(s) has a minimum of two years of experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive and remedial maintenance. Proof of training shall be provided upon demand and be immediately sent via fax, upon demand to the COR. All FSE s and technicians shall be authorized by the Contractor to perform the maintenance services. All work shall be performed by ""Fully Qualified"" competent FSE's. The COR and/or designated representative specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the VAMC equipment. It is anticipated that any hospital regulatory inspections (TJC, etc.) will have the vendor providing proof that they meet industry standards of quality, and traceable standards, as used to calibrate this device- system, at the time of the maintenance event. Period of Performance: Base year: 08/20/2024 08/20/2025 Option year 1: 08/202025 08/20/2026 Option year 2: 08/20/2026 08/20/2027 Dates as specified unless contract award passes these dates. Then the first date of performance will start the day of award. Unscheduled Maintenance (Emergency Repair Service): Contractor shall maintain the equipment in accordance with the manufacturer s specifications. The Contractor shall provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations. All required parts shall be furnished. The COR or government designated representatives are authorized to request and approve service calls from the Contractor. Response Time: Contractor's FSE must respond with a phone call to the COR or designated representative within 1 hour after receipt of telephoned notification during normal hours of coverage. Scheduled Maintenance: All labor and travel conducted during normal business hours: Monday through Friday, 8:00 AM to 6:00PM EST (excludes vendor company holidays) are covered. Parts: All needed parts for repairs and maintenance conducted are covered. Parts and Services Not Covered or Excluded by Contract: All parts and service not covered or are excluded by contract but may be purchased separately include and are limited to: Technology Performance Package Software Expansion Modules Hardware upgrades/revisions Coverage for Capital Items: Ampere RF ablation generator Cool Point irrigation pump TactiSys Quartz System WorkMate Scribe module, EP-4 cardiac stimulator Any transducers ORW OPTIS Mobile additional labs Service Manuals/Tools/Equipment: All required manuals, tools, and equipment for repairs and maintenance conducted are covered and are the responsibility of the vendor. Check in Requirements: The Field Service Engineer must report to the Biomedical Engineering Department to obtain a badge and sign in with the Biomedical Engineering Service before work begins. Submit any mobile media devices that would be used on the system to a virus scan. Upon completion of work, the Field Service Engineer must report to the Biomedical Engineering Service to sign out and brief Biomedical Staff or Supervisor if Biomedical Staff is unavailable concerning completion of service. At the end of briefing Field Service Engineer will return the badge and sign out in the Biomedical Engineering Department. Documentation: Contractor shall furnish a detailed field service report upon completion of work to Biomedical Staff in the Biomed Department. Payment will not be processed until a properly completed service report is received. The service report shall contain, at a minimum, the following information: Identification of equipment to be serviced: VA EE Number Vendor Inventory ID number Manufacturer Name Device Name Model Number Serial Number System ID Name of contractor and contract number Name of FSE who performed services Contractor service ESR number/log number Date, time (starting and ending), equipment downtime and hours on-site for service call VA purchase order number(s) covering the call if outside normal working hours Total time spent performing maintenance. Detailed narrative and itemized description of the services required and performed including: Labor and travel Parts (with part numbers) Materials Location Corrective Action Copies of all test reports Complete list of parts replaced (when applicable) Date and time the repair/support was completed Total Cost to be billed (if applicable i.e., part(s) not covered, or service rendered after normal hours of coverage). Signatures: FSE performing services described Authorized VA employee who witnessed service described NOTE: - Any additional charges claimed must be approved by the COR or designated representative before service is completed! The service report shall itemize every item in the specification. Each item shall state the ""as found"" condition or values, the ""calibrated to"" or ""adjusted to"" values, the factory design tolerances, and a complete description of all work performed concerning the items. Included will be a list of new parts used and recommended future repairs. Reporting Requirements: The Contractor shall be required to report to the Clinical Engineering Department to log in. This check- in is mandatory. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall be required to log out with Biomedical Engineering and submit the ESR(s) to the COR or designated representative. ALL ESRs shall be submitted to the equipment user for an ""acceptance signature"" and to the COR or designated representative for an ""authorization signature"". If COR or designated representative is unavailable, a signed, authorized copy of the ESR will be left with the user. Place of Performance: Department of Veterans Affairs VA Connecticut Healthcare System West Haven VA Medical Center 950 Campbell Avenue West Haven, CT 06516 Contracting Officer Representatives: Prior to contract award, the Contracting Officer shall designate a VA Medical Center employee as the COR. All work coordination shall be made through the COR. The Contractor shall be provided a copy of the letter of delegation authorizing the COR at the commencement of the term of the contract. No other person shall be authorized to act in such capacity unless appointed in writing by the Contracting Officer. Safety Requirements: In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contracting Officer shall notify the Contractor of any safety issues and the action necessary to correct these issues. Such notice, when served to the Contractor or his representative at the work site shall be deemed sufficient for the corrective actions to be taken. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or part of the work and hold the Contractor in default. Invoicing: Payment to be made monthly in arrears by certified invoices and must contain the contract number in addition to the requirements detailed in 52.212-4 (G) to be considered valid. All invoices shall be submitted to the VA Financial Service Center and emailed to the COTR. All invoices will reference the purchase order number assigned to the contract. Additional Charges: There shall be no additional charge for time spent at the site (during, or after the normal hours of coverage) awaiting the arrival of additional FSE and/or delivery of parts. Reporting Required Services Beyond the Contract Scope: The Contractor shall immediately, but no later than 24 (twenty-four) consecutive hours after discovery, notify the COR and/or designated representative (in writing) of the existence or the development of any defects in, or repairs required, to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The Contractor shall furnish to the COR or designated representative a written estimate of the cost to make necessary repairs. Condition of Equipment: The Contractor shall accept responsibility for the equipment. Failure to inspect the equipment prior to contract award will not relieve the Contractor from performance of the requirements of this contract. Test Equipment: Prior to commencement of work on this contract, the Contractor shall provide the VAMC with a copy of the current calibration certification of all test equipment which is to be used by the Contractor on VAMC's equipment. This certification shall also be provided on a periodic basis when requested by the VAMC. Test equipment calibration shall be traceable to the Original Equipment Manufacture s standard. Identification, Parking, Smoking, and VA Regulations: The Contractor's FSE's shall always wear visible identification while on the premises of the VAMC. The Contractor shall park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The VAMC will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at the VAMC. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court. Training: The Contractor shall provide first call Clinical Engineering training for current qualified technicians at the VAMC, CT during regular service hours of Monday through Friday from 8:00am 6:00 PM EST. This is not an ongoing training and will only be provided on an annual basis as required. All training for upgrades to equipment shall be considered within scope throughout the life of the contract. All service and repairs are performed by OEM factory certified technicians. Transportation Charges: All costs associated with transportation, from shipping point to the destination specified above, and all costs of removal after contract completion, shall be paid by the Contractor and incorporated in the price proposal. The Contractor shall be responsible for all damage in transit including any transportation costs for replacement. Compliance with OSHA Bloodborne Pathogens Standard: The Contractor shall comply with the Federal/California OSHA Bloodborne Pathogens Standard. The Contractor shall: Have methods by which all employees are educated as to risks associated with bloodborne pathogens. Have policies and procedures which reduce the risk of employee exposure to bloodborne pathogens. Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract. Miscellaneous: Additional equipment may be added and/or removed throughout the life of this contract and shall be considered within scope. Contractor Personnel Security Requirements: Security Requirements: All contractor personnel shall obtain a short-term identification badge issued by the COR or government designated representative. Such badge shall be worn by the individual and prominently always displayed while on VA Property. No employee of the contractor shall enter the project site without a valid identification badge issued by the VA. To obtain a short-term identification badge, contractor personnel shall present to the COR a valid (non-expired) photo identification issued by a US federal, state, or local government agency. Escort will be provided as required in sensitive work areas. The C&A requirements do not apply, and the security accreditation package is not required. The identified Sole Source Vendor shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in standard acquisition guidelines. Per the VA handbook 6500.6, no VA sensitive information will be transferred, shared, or stored with vendor. As such, no additional mechanisms will be needed to ensure the protection of information. Records Management Statement: 1. 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. 2. 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. 3. In accordance with 36 CFR 1222.32, 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. 4. VA Medical Center West Haven 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 the VA Medical Center West Haven or destroyed except for 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, Contractor must report to VA Medical Center West Haven. The agency must report promptly to NARA in accordance with 36 CFR 1230. 5. 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 VA Medical Center West Haven 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). 6. 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 VA Medical Center West Haven guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. 7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VA Medical Center West Haven policy. 8. The Contractor shall not create or maintain any records containing any non-public VA Medical Center West Haven information that are not specifically tied to or authorized by the contract. 9. 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. 10. The VA Medical Center West Haven 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 VA Medical Center West Haven 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. 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, Talent Management System (TMS) Item #3873736, Records Management for Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors Contractor employees who work in or travel to VHA locations must comply with the following: Documentation requirements: If fully vaccinated, shall show proof of vaccination NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination If unvaccinated and granted a medical or religious exception, shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor s order or an FDA approved over-the-counter test. Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel. Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the following website: COVID-19 Screening Tool. Regularly check the website for updates. Contractor employees who work away from VA locations, but who will have direct patient contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.
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