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Request for Quote (RFQ) #: 36C25922Q0247 (Brand Name or Equal) ExactVu Micro-Ultrasound This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subp... Request for Quote (RFQ) #: 36C25922Q0247 (Brand Name or Equal) ExactVu Micro-Ultrasound 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; quotes are being requested and a written solicitation will not be issued. The Government reserves the right to make no award from this solicitation. * The deadline for all questions is 4:00pm EST, 3/25/2022 All questions must be submitted in writing no later than the question cut-off date marked above. All questions will be answered officially through an amendment to the solicitation. ** Quotes are to be provided to Sunnie.Germaine-Pickett@va.gov no later than 4:00pm ET, 3/29/2022. Quotes shall not be hand carried. Faxed quotes shall not be accepted. Emailed quotes are the only method of submitted quotes (4MB email limit). The Government reserves the right to make award solely on initial Quotes received. Offerors bear the burden of ensuring that all portions of the offer (and any authorized amendments) reach the designated office before the deadline specified in the solicitation. This RFQ shall be completed in its entirety, and signed and dated, failure shall not be considered for award. This is a Request for Quote (RFQ) and the solicitation number is 36C25922Q0247. The government anticipates awarding a firm-fixed price contract resulting from this solicitation. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-06 effective July 12, 2021. The North American Industrial Classification System (NAICS) code for this procurement is 334510. This solicitation is unrestricted. List of Line Items; Line Item Description Qty Unit of Measure Unit Price Total Price 0001 Micro-Ultrasound Imaging System (120V) with Single 29L Transducer 1 EA $ $ 0002 Micro-US/MRI Fusion Application 1 EA $ $ 0003 UP-X898MD B&W Thermal Printer 1 EA $ $ Grand Total $ Description of Requirements for the items to be acquired Must provide letter of being an authorized distributor/supplier/ reseller Must be capable of treating the following: Prostate biopsies Abdominal imaging (kidney and bladder) Large prostate procedures Visualize old and new biopsy needle tracks to guide new biopsies, small hypoechoic significant lesions to target new biopsies at suspicious regions Cognitive fusion w/ benefit of 70 micron real-time resolution Must be capable of performing or have the following: Rolling cart w/ all multi-frequency architecture electronics supporting conventional and high-resolution probes 24 LCD monitor on a swiveled base 10 LCD touch-panel mini-display w/ trackball for advanced functionality User interface (10,1 touch screen display 1HM1) 3-probe receptacles One (1) EV29L 29 MHz high resolution transrectal sidefire transducer (linear)+ Real-time fusion alignment of MR images w/ real-time micro-ultrasound b-mode image for micro-US/MRI fusion biopsy procedures. Must meet the following: DICOM-compatible Quick importing and aligning of MRI-annotated images in standard DICOM formats Real-time alignment and synchronization of the real-time micro-ultrasound B-mode image w/ MRI-identified sectors from an MRI report for cognitive fusion procedures Compatible with: 9 MHz end-fire prostate endocavity transducer (curved) 5 MHz abdominal transducer (curved) including color doppler and power doppler Compatible with single-use needle guide kits for transrectal or transperineal configurations Includes prostate risk identification using micro-ultrasound capabilities, which provides evidence-based scale protocol to help quickly identify low risk or suspicious regions and target biopsies accordingly General: Currently, the Oklahoma City Veterans Affairs Health Care System (herein after referred to as OKC VAHCS) Surgery Service requires 1 replacement micro-ultrasound system. To expand and facilitate clinical research in prostate cancer diagnoses, the facility is looking to acquire an Micro-Ultrasound system. Delivery Times: Delivery times shall be Monday through Friday from 07:00 to 16:00 (7:00AM to 4:00PM). Definitions/Acronyms OKC VAHCS: Oklahoma City Veterans Affairs Health Care System Scope: The Contractor will provide the necessary equipment and accompanying software to the OKC VAHCS for one (1) micro-ultrasound system. The system must be an Micro-Ultrasound Imaging System (120V) with Single 29L Transducer. Additionally, the requirement is for a comprehensive and whole solution to the requirement. The Contractor is required to be an expert in the field of micro-ultrasound imaging systems, specifically within the field of urology. As such, the Contractor is required to include any items not specifically listed in the pricing schedule but is necessary to enable the equipment or accompanying software to function. Examples include installation expenses, VA staff training, equipment mounts, display charts, cables, connectors, plugs, and special equipment wiring requirements. The company will be responsible for replacing any machines that malfunction, break, or are not adequately operating at no additional cost to the VA within the first 12 months of purchase. The company will work with OKC VAHCS Biomedical Engineering Department to coordinate any preventive maintenance or replacement of any machine. Training for VA Employees: Comprehensive training or VA staff is required. Examples include: Physicians, Nurses, Surgical Technicians, and Biomedical Engineers. Security Requirements: Contractor Security Requirements (Handbook 6500.6) SUBPART 839.2 INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS 839.201 Contract clause for Information and Information Technology Security: Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media). In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008) As prescribed in 839.201, insert the following clause: 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. 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. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. 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. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. Each risk analysis shall address all relevant information concerning the data breach, including the following: Nature of the event (loss, theft, unauthorized access); Description of the event, including: date of occurrence; data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; Number of individuals affected or potentially affected; Names of individuals or groups affected or potentially affected; Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; Amount of time the data has been out of VA control; The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); Known misuses of data containing sensitive personal information, if any; Assessment of the potential harm to the affected individuals; Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. 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. 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 Privacy and 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. 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. 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. 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. 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. 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. 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. 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). 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. The C&A requirements do not apply, and the Security Accreditation Package is not required: Training certificates are in place, which ensures the contractor and employee(s) will protect VA sensitive information. Delivery and acceptance is to be F.O.B Destination (FAR 52.247-34) at the Veterans Affairs Medical Center, located at Oklahoma City VA Health Care System 921 N.E. 13th Street Oklahoma City, OK 73104 52.212-1, Instructions to Offerors--Commercial Items applies to this acquisition ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL Gray market items are Original Equipment Manufacturer s (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable. Offeror shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions. The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items. Offerors providing an or equal product(s) must adhere to the terms in FAR 52.211-6. If an item in this solicitation is identified as brand name or equal, the purchase description reflects the characteristics and level of quality that will satisfy the Government s needs. The salient physical, functional, or performance characteristics that equal products must meet or exceed are specified in the solicitation. To be considered for award, offers of equal products, including equal products of the brand name manufacturer, must Meet the salient physical, functional, or performance characteristic specified in this solicitation; Clearly identify the item by- Brand name, if any and Make or model number, Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and Clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification. The contracting officer will evaluate equal products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the contracting officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. Unless the offeror clearly indicates in its offer that the product being offered is an equal product, the offeror shall provide the brand name product referenced in the solicitation Any award made as a result of this solicitation will be made on an All or Nothing Basis. State if quoted items are available and priced through offerors existing Government-wide Acquisition Contract (GWAC), GSA Multiple Award Schedule (MAS) contract, or VA-wide Acquisition Contract. Offerors are warned against contacting any VA personnel other than the Contracting Officer and Contract Specialist prior to placement of any award made resulting from this RFQ. If such contact occurs and found to be prejudicial to competing contactors, the offeror making such contact may be excluded from award considerations. All proprietary information shall be clearly and properly marked. If the Offeror submits annexes, documentation, attachments or the like, not specifically required by this solicitation, such will count against the Offeror s page limitations unless otherwise indicated in the specific volume instructions below. All information shall be confined to the appropriate file. The offeror shall confine submissions to essential matters, sufficient to define the quote and provide an adequate basis for evaluation. Offerors are responsible for including sufficient details, in a concise manner, to permit a complete and accurate evaluation of each quote. Submission of quote shall include the following volumes: (I) Technical capability or quality of the item offered to meet the Government requirement; and (II) Price Volume I - Technical capability or quality of the item offered to meet the Government requirement The offeror shall submit specifications, cut sheets, or brochures confirming the equal products, including equal products of the brand name manufacturer submitted, meets or exceeds the salient physical, functional, or performance characteristic specified in this solicitation. The product(s) quoted must be identified by brand name, if any, and make or model number. Volume II Price Price - The offeror shall complete the pricing schedule provided in Section (v) above: Price/Cost Schedule. (End of Addendum to 52.212-1) 52.212-2, Evaluation--Commercial Items applies to this acquisition ADDENDUM to FAR 52.212-2 EVALUATION COMMERCIAL ITEMS: The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government considering price and other factors. The following factors shall be used to evaluate quotations: Factor 1. Technical capability or quality of the item offered to meet the Government requirement Factor 2. Price Evaluation Approach. The Government will evaluate quotations using the comparative evaluation process outlined in FAR 13.106-2(b)(3), where quotations will be compared to one another to determine which provides the best benefit to the Government. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotations may exceed minimum requirements of the solicitation. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation, but is not required to do so. Each response must meet the minimum requirements of the solicitation. The Government is not requesting or accepting alternate quotations. The evaluation will consider the following: Factor 1. Technical capability or quality of the item offered to meet the Government requirement: The quotation will be evaluated to the extent to which it can meet and/or exceed the Government s requirements as outlined in the solicitation and based on the information requested in the instructions to quoters section of the solicitation. Factor 2. Price: The Government will evaluate the price by adding the total of all line item prices. The Government may use various price analysis techniques and procedures to make a price reasonableness determination. Offers that do not meet or exceed the technical capability or quality of the item offered to the Government requirement, as stated in Factor 1, shall not be selected regardless of price. (End of Addendum to 52.212-2) 52.212-3, Offeror Representations and Certifications Commercial Items, applies to this acquisition. Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. Offerors must be registered in SAM at time of offer submission. 52.212-4, Contract Terms and Conditions--Commercial Items applies to this acquisition 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (JUL 2020) applies to this acquisition FAR 52.212-5 applies to this acquisition with the following FAR clauses incorporated by reference; FAR 52.203-6 Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (OCT 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402) FAR 52.204-10 Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) (31 U.S.C. 6101 note) FAR 52.209-6 Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (JUN 2020) (31 U.S.C. 6101 note) FAR 52.219-6 Notice of Total Small Business Set-Aside (NOV 2020) (15 U.S.C. 644) FAR 52.219-8 Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)) FAR 52.219-28 Post Award Small Business Program Representat...