6515--Software/Hardware - Optis Integrated Next System - Cinci (07/06)
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation for quote to be requested with no other form of written solicitation to be issued. This solicitation RFQ-36C25023Q0874 is issued as a request for quote. This solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular (FAC)  2023-01. The North American Industry Classification System (NAICS) number is 334510 and the business size standard is 1250 in number of employees. This is a solicitation only pertaining to brand name item (s). Manufacturer: Abbott. Supply necessary materials and/or parts for Optis Integrated Next System and Upgrade Kit per the attached requirements. Materials and parts will be delivered to: Cincinnati VA Medical Center, 3200 Vine St., Cincinnati, OH 45220, FOB destination. Requirement 1: OPTIS Integrated Next System Item # Mfg. Part Number Description Qty 1 1014933 Ultreon 1.0 Software: RFR, FFR, Physiology Pullback, OCT: automatic measurements (diameter, length, expansion, apposition), angiography co registration with OCT image, cybersecurity features (Personally Identifiable Information Security) 1 2 System Cabinet (SC): Contains PC, engine and power supply. Resides in control room or technical closet. 1 3 Tableside Controller (TC): Provides OCT/FFR control at tableside. Clamps to table rail in procedure room. 1 4 DOC Holster: Holds the DOC when not in use. Interfaces the SC with the TC, DOC, FFR PressureWire and Wi-Box unit 1 5 Drive-motor and Optical Controller (DOC): Drives the OCT imaging catheter. Provides OCT acquisition control. 1 6 Control Room Monitor, Keyboard, and Mouse: Provides OPTIS system functionality from the control room. Resides in control room. 1 7 Remoting Cable: Resides in the floor, ceiling or wall conduit. 1 8 USB Extender: Used to connect SC to control room keyboard and mouse when SC is in the technical closet. 1 9 DVI Extender: Used to connect SC to control room keyboard and mouse when SC is in the technical closet. Can also be used to connect SC to monitor boom video interface that requires a long distance to connect. 1 10 One (1) Wi-Box Transmitter and two (2) Wi-Box cables. 1 11 ILUMIEN OPTISi Project Management: PM010-108 1 12 ILUMIEN OPTISi Networking Service: NET-108 1 13 ILUMIEN OPTISi Professional Installation: PIP-108 1 14 OPTIS Integrated Pre-Install Kit: C408654: - OPTISi Fiber DVI Ext. Cbl. 30M: Used to connect SC to control room keyboard and mouse when SC is in the technical closet. Can also be used to connect SC to monitor boom video interface that requires a long distance to connect. - OPTISi Fiber USB Ext. Cbl. 30M: Used to connect SC to control room keyboard and mouse when SC is in the technical closet. - OPTISi Remoting Cbl. 27M: Resides in the floor, ceiling or wall conduit - OPITSi Cbl. Pull Eye 1 15 Service Coverage: Includes initial one year manufacturer s warranty 1 Requirement 2: OPTIS Integrated Next Upgrade Kit Item # Mfg. Part Number Description Qty 1 1014935 OPTIS Next AI PC 1 2 OPTIS Next Tableside Controller 1 3 Ultreon 1.0 Software: RFR, FFR, Physiology Pullback, OCT: automatic measurements (diameter, length, expansion, apposition), angiography co-registration with OCT image, cybersecurity features (Personally Identifiable Information Security) 1 4 Service Coverage: Includes 90 days parts and labor warranty for the upgraded hardware parts. If the original unit is covered under a separate service plan that extends beyond this 90 day period, the upgraded hardware shall be covered under such service plan. 1 Offerors must comply with all instructions contained in provision 52.212-1, Instructions to Offerors-Commercial, applies to this acquisition. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. The following additional provisions apply: 52.212-2, Evaluation-Commercial Items, the Government will award a contract/purchase order resulting from this solicitation to the responsible offeror whose offer conforms to the solicitation and is determined to be the most advantageous to the government, technical, price and past performance considered. 52.212-3, Offeror Representations and Certifications-Commercial Items, a completed copy of this provision shall be submitted with the offer unless SAM registered which must be noted in the quote. 52.212-4, Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. 52.212-5, Contract Terms and Conditions-Commercial Items. The following additional clauses apply: Purchase order (SF 1449) will be awarded to the winning bid with submission of Invoice tough Tungsten upon delivery of ALL items listed on spreadsheet. From the VAAR the following apply: 852.232-72, Electronic submission of payment requests. All invoices must be submitted to Tungsten for payment processing. The PO number must appear on all invoices, packing slips, shipping labels, and/or correspondences to the contracting officer. 852.246-71, Inspection of all parts will be held. If goods are rejected, they will be held for 15 days, if not replaced, the rejected merchandise will be returned to the contractor at their risk and expense. Payment of invoice will be delayed. Contractor shall provide an authorized distribution letter. The Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized Contractor reseller for the proposed equipment/system such that the OEM warranty and service are provided and maintained by the OEM. All warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. The Contractor shall provide new items ONLY; no remanufactured or "gray market" items. All items must be covered by the manufacturer's warranty. Contact: Rachel MacRae, Contracting Specialist, via email at Rachel.MacRae@va.gov. No telephone inquiries will be accepted. Only written inquires received directly for the offeror are acceptable. All quotes must be received by 7/11/2023 by 4:00pm EST to Rachel MacRae (Rachel.MacRae@va.gov). STATEMENT OF WORK (SOW)  1. Contract Title. Optis Integrated Next System 2. Background. One Cardiac Catheterization room has integrated OPTIS technology, and the other procedure does not. The lack of the technology in one procedure has caused delays in patient care due to technology not being available. When Optical Coherence Tomography (OCT) technology is essential and not available, patients will be transported to the other procedure rooms, or have procedural imaging delays to another procedure day. By incorporating the Optis Next system into a secondary procedural room, this will work to maximize patient flow and standardize available technologies to both procedural rooms. In the event of a breakdown, the secondary system will create a back-up system to ensure the technology would be available at all times. New Ultreon 1.0 software will upgrade the current technology in both Cath lab procedure rooms to incorporate technology to enhance morphology by auto detecting calcification within coronary arteries to accurately prescribed and direct treatments. Ultreon 1.0 automatically detects vessels diameter measurements, helps to measure the length of stenotic coronary lesions and assists with the optimal stent landing zones. Ultreon 1.0 software incorporates Optical Coherence Tomography (OCT) to investigate coronary disease and helps to reduces the amounts of contrast used during cardiology procedures. In additional to the benefits of OCT, the Ultreon 1.0 software upgrade supports the continual use of Fractional Flow Reserve (FFR) and Resting Full-cycle Ration (RFR) technology for advanced measuring diagnostic tools for the evaluation of coronary stenosis.  3. Scope. To procure one (1) Optis Integrated Next System for the IR/Cath Lab department at the Cincinnati VA Medical Center. Building 1, Room C216 H To procure one (1) Optis Integrated Next Upgrade Kit for the IR/Cath Lab department at the Cincinnati VA Medical Center. Buliding 1, Room C216O 4. Specific Tasks. The contractor shall provide equipment with the following requirements: Ultreon 1.0 Software: RFR, FFR, Physiology Pullback, OCT: automatic measurements (diameter, length, expansion, apposition), angiography co-registration with OCT image, cybersecurity features (Personally Identifiable Information Security) o System Cabinet (SC): Contains PC, engine and power supply. Resides in control room or technical closet. o Tableside Controller (TC): Provides OCT/FFR control at tableside. Clamps to table rail in procedure room. o DOC Holster: Holds the DOC when not in use. Interfaces the SC with the TC, DOC, FFR PressureWire and Wi-Box unit o Drive-motor and Optical Controller (DOC): Drives the OCT imaging catheter. Provides OCT acquisition control. o Control Room Monitor, Keyboard, and Mouse: Provides OPTIS system functionality from the control room. Resides in control room. o Remoting Cable: Resides in the floor, ceiling or wall conduit o USB Extender: Used to connect SC to control room keyboard and mouse when SC is in the technical closet. o DVI Extender: Used to connect SC to control room keyboard and mouse when SC is in the technical closet. Can also be used to connect SC to monitor boom video interface that requires a long distance to connect. o One (1) Wi-Box Transmitter and two (2) Wi-Box cables o ILUMIEN OPTISi Project Management: PM010-108 o ILUMIEN OPTISi Networking Service: NET-108 o ILUMIEN OPTISi Professional Installation: PIP-108 o OPTIS Integrated Pre-Install Kit: C408654 OPTISi Fiber DVI Ext. Cbl. 30M: Used to connect SC to control room keyboard and mouse when SC is in the technical closet. Can also be used to connect SC to monitor boom video interface that requires a long distance to connect. OPTISi Fiber USB Ext. Cbl. 30M: Used to connect SC to control room keyboard and mouse when SC is in the technical closet. OPTISi Remoting Cbl. 27M: Resides in the floor, ceiling or wall conduit OPITSi Cbl. Pull Eye o Service Coverage: Includes initial one year manufacturer s warranty o OPTISTM Next AI PC o OPTIS Next Tableside Controller o Ultreon 1.0 Software: RFR, FFR, Physiology Pullback, OCT: automatic measurements (diameter, length, expansion, apposition), angiography co-registration with OCT image o Service Coverage: Includes 90 days parts and labor warranty for the upgraded hardware parts. If the original unit is covered under a separate service plan that extends beyond this 90 day period, the upgraded hardware shall be covered under such service plan. 5. Performance Monitoring. Once the equipment is procured, the contract will be complete with the exception of exercising use of the warranty.  6. Security Requirements. Contractor shall have access to the space for installation and calibration of equipment when staff is available to escort them to the space. As the space is currently in use, there should be no unescorted access for either of these procedures. Patient information will be stored on the system. The system does have capability to integrate. Our current system has the capability to be integrated and connected to the network however Biomed has not integrated it. Our current system is operating stand alone and this new system is planned to be operated the same way. No VA network connection is needed. The software does store patient information therefore the security clause is included. Service & Maintenance will follow the security requirements as per VA s Medical Device Protection Program (MDPP) which protects VA s medical devices tough a comprehensive security initiative that encompasses pre-procurement assessments, medical device isolation architecture (MDIA), communication, validation, scanning, access control list remediation, patching, and secure remote connectivity. General Security 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. Access to VA Information and VA Information Systems A 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. The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured. 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. A BI is not required per VA Information and Information System Security/Privacy Requirements for IT Contracts dated August 2008 if the following exception applies: Contract Personnel with limited and intermittent access to equipment connected to facility networks on which limited VA sensitive information may reside, including medical equipment contractors who install, maintain, and repair networked medical equipment such as CT scanners, EKG systems, ICU monitoring, etc. In this case, Veterans Health Administration facilities must have a duly executed VA Business Associate Agreement (BAA) in place with the vendor in accordance with VHA Handbook 1600.1, Business Associates, to assure compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in addition to the contract. Contract personnel, if on site, should be escorted by VA IT Staff. Training 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: 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; Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; Successfully complete the appropriate VA privacy training and annually complete required privacy training; and 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.] 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. 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. 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). 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. Information Systems Hosting, Operations, Maintenance, or Use Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: Vendor must accept the system without the drive; VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation. SECURITY INCIDENT INVESTIGATION 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. 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. LIQUIDATED DAMAGES FOR DATA BREACH 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. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency. 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 $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: Notification. One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports. Data breach analysis. Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution. One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. SYSTEM INTERCONNECTION Any VA External Computer System interconnections between VA Systems on the VA Network and VA Business Partner Systems residing outside the VA Network will require a signed Memorandum of Understanding (MOU) and Interconnection Security Agreement (ISA) collectively known as MOU ISA between the VA and the VA Business Partner. 7. Cincinnati VA Medical Center (CVAMC) Record Management Clause.  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. Cincinnati VA Medical Center (CVAMC) 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 CVAMC 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 CVAMC. 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 Statement of Work. 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 CVAMC 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 Statement of Work. 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 CVAMC 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 CVAMC policy.   8. The Contractor shall not create or maintain any records containing any non-public CVAMC 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 CVAMC 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 CVAMC 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 tough 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. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.   [Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor. TMS Course 10203, VA Privacy & Information Security Awareness will be used to satisfy this requirement.    12. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this Statement of Work and require written subcontractor acknowledgment of same.   13. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.  8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). No GFE/GFI is needed or required for this contract.  9. Other Pertinent Information or Special Considerations.   a. Identification of Possible Follow-on Work. None at this time.   b. Identification of Potential Conflicts of Interest (COI). None at this time.   c. Identification of Non-Disclosure Requirements. None at this time.   d. Packaging, Packing and Shipping Instructions. None at this time.   e. Inspection and Acceptance Criteria. Once the equipment is received, it will be checked in by the Warehouse, inspected by Bio-Med, and tagged by Supply Chain. Supply Chain will notify Cath Lab/IR department for delivery. Upon Delivery, Representative will on site for the integration services and work with biomed department to integrate into fluoroscopy cockpit 10. Risk Control. None at this time.  11. Place of Performance. The equipment will be used in the IR/Cath Lab department at the Cincinnati VA Medical Center. C216H and C216O  12. Period of Performance. N/A 13. Delivery Schedule. Q4, FY23. Â
36C25023Q0874 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 10
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