STATEMENT OF WORK (SOW) PROJECT: MOBILE PET/CT SERVICES AT BALTIMORE LOCH RAVEN MEDICAL CENTER 1. Background: The Baltimore VA Medical Center (hereafter referred to as BT VAMC ) has identified a need for Positron Emission Tomography - Computed Tomography (PET/CT) imaging services to enhance their medical offerings. The BT VAMC seeks to locate this mobile PET/CT unit at the Loch Raven VA Medical Center facility. The BT VAMC seeks to contract a service provider for the provision, operation, and maintenance of a mobile PET/CT unit. While the Baltimore VA will provide technologists, the contractor is expected to deliver comprehensive training for the operation of the unit and ongoing maintenance support. 2. Scope of Services: A. Equipment Provision: The contractor shall provide a fully operational mobile PET/CT unit that meets the clinical requirements of The BT VAMC. This unit should be compliant with all applicable health, safety, and environmental regulations. The system shall meet or exceed the technical requirements listed below: a. PET Axial Field of View (FOV): 25 cm or larger b. PET detector: Digital SiPM c. PET crystal: Lutetium-based (Lu) scintillator d. PET Hardware Time of Flight (ToF) resolution: 300 psec or faster e. PET Air Cooled System f. CT solid-state detector coverage per rotation: 4 cm or greater g. CT native slice count per rotation: 64 or greater h. CT slice minimum slice thickness: 0.5mm or smaller i. CT generator: 72 kW or greater j. CT Metal Artifact Reduction software k. CT Iterative dose reduction software l. CT low contrast resolution @ 0.3%: 2 mm or better m. CT spatial resolution at cut-off: 21 lp/cm or better n. PET OSEM and Point Spread Function reconstruction. o. PET Ai Deep Learning reconstruction p. CT Ai Deep Learning reconstruction q. PET NEMA system sensitivity: 13 kcps/MBq or greater r. PET NEMA resolution (axial and transverse @1cm): 5 mm or less s. PET PSF reconstruction resolution (axial and transverse @1cm): 2 mm or less t. Dual PET/CT console configuration for acquisition and display u. Calcium Scoring capability on console v. PET/CT Console UPS w. Cardiac Gating capability for PET x. Device-less Respiratory Gating for PET y. Wide bore PET/CT gantry opening: 78 cm or greater z. Patient table movement from console in the X (sagittal), Y (coronal) and Z (axial) direction aa. Patient table maximum scan range: 199 cm or greater bb. Patient maximum table weight limit: 220 kg or greater cc. PET calibration sources and CT QC phantom dd. MEDRAD Stellant Flex CT Injector (medium dual flow) ee. On-site application training ff. 12' x 60' Transportable coach with proper lead shield for radiation safety gg. Transportable coach to include sink and patient restroom hh. Transportable coach to include 3 separate patient incubation rooms ii. Transportable coach to include PET Hot Lab equipment jj. Transportable coach to include protective patient entry canopy B. Training Services Provision Statement This agreement stipulates that the contractor shall provide comprehensive training services to the technologists of the BT Veterans Affairs Medical Center (VAMC). The scope of training encompasses the following key areas: 1. Operation of PET-CT Camera: A. Detailed instruction on the operational mechanics and protocols of the PET-CT camera. B. Hands-on training sessions to ensure proficiency in utilizing the camera for various diagnostic procedures. 2. Safety Protocols: A. Comprehensive guidance on safety measures and protocols specific to the PET-CT camera and its environment. B. Training on the proper use of protective equipment and adherence to radiation safety standards. 3. Quality Control Procedures: A. Instruction on routine quality control checks to ensure optimal functioning of the PET-CT camera. B. Training in identifying and addressing common technical issues to maintain high-quality imaging standards. 4. Emergency Procedures for Equipment Failure: A. Detailed procedures to follow in the event of equipment malfunction or failure.  B. Strategies for maintaining operational continuity and ensuring patient safety during equipment downtimes. 5. Operation of the Mobile Unit: A. Instruction on the setup, operation, and management of the mobile PET-CT unit. B. Training in navigating the unit s specific operational challenges, including mobility, space constraints, and remote operation. 6. Comprehensive Understanding of All Functions: A. Thorough training on all aspects of the PET-CT system, including software, hardware, and ancillary equipment. B. Instructions on routine maintenance, troubleshooting, and efficient operation of the entire system. The contractor commits to delivering this training in a manner that ensures the technologists at BT VAMC are fully equipped with the knowledge and skills required for the proficient operation of the PET-CT camera and the mobile unit, adhering to all relevant safety and quality standards. The training will be conducted by qualified professionals with expertise in PET-CT technology and will be tailored to meet the specific needs of the BT VAMC staff and patients. C. Maintenance and Servicing Responsibility Statement This agreement confirms that the contractor is fully responsible for the maintenance and servicing of the mobile PET/CT unit operated by the BT Veterans Affairs Medical Center (VAMC). The contractor's responsibilities under this agreement include, but are not limited to, the following: 1. Regular Scheduled Maintenance: A. The contractor will conduct regular, scheduled maintenance of the mobile PET/CT unit to ensure its optimal functioning and longevity. These maintenance activities will adhere to the manufacturer's guidelines and industry best practices. B. A maintenance schedule will be provided to BT VAMC, detailing the frequency and scope of regular maintenance checks. 2. Unscheduled Emergency Repairs and Downtime:  A. In the event of unscheduled breakdowns or malfunctions, the contractor will provide prompt and efficient repair services to minimize downtime. B. The contractor will ensure the availability of a dedicated team for emergency responses to address and resolve any unexpected issues with the mobile PET/CT unit. 3. Provision of Necessary Maintenance Supplies and Parts: A. All necessary supplies, replacement parts, and materials required for the maintenance and repair of the mobile PET/CT unit will be provided by the contractor. B. The contractor guarantees the use of high-quality, compatible parts and supplies that meet or exceed industry standards for the maintenance of the mobile PET/CT unit. The contractor commits to maintaining the mobile PET/CT unit in a state of readiness and optimal operational condition, ensuring uninterrupted service for the BT VAMC. This commitment includes rapid response to any issues that may arise, ensuring minimal impact on the services provided by BT VAMC and the welfare of its patients. All maintenance and repair work will be performed by qualified and experienced technicians, in accordance with the highest standards of service and professionalism. D. Site Preparation The contractor hereby agrees to provide complete site preparation services for the Baltimore VA. This includes, but is not limited to, clearing excavation, grading, and any necessary soil stabilization. Provision of suitable power hookups for the unit and water if necessary. Installation of appropriate data connections for the operation of the PET/CT unit. The contractor will ensure all work complies with relevant regulations and standards and will adapt to any unforeseen circumstances or changes in project scope to maintain the project timeline and quality standards. All necessary adjustments or additional services required for the successful preparation of the site will be communicated promptly and effectively, ensuring transparency and collaboration throughout the project duration. 3. Performance Period: The period of performance for the contract will commence upon contract award and will be specified in the terms and conditions negotiated between The BT VAMC and the contractor. Option Year Extension Clause This contract includes the provision for The BT VAMC to exercise option years beyond the initial term as specified herein. In accordance with the Federal Acquisition Regulation (FAR), The BT VAMC reserves the right to extend the duration of this contract for three-month increments, not to exceed a total of one additional year. The decision to exercise each option year is at the sole discretion of The BT VAMC and must be communicated in writing to the contractor no later than 10 days prior to the expiration of the current contract term. Each exercised option period shall be subject to the same terms and conditions of this contract unless otherwise agreed upon by both parties in writing. 4. Performance Standards: The contractor must ensure that the mobile PET/CT unit is operational and available for use according to the schedule agreed upon with The BT VAMC. All maintenance and repairs must be carried out with minimal disruption to The BT VAMCs services. 5. Contractor Requirements: - The contractor must have a proven track record of providing mobile PET/CT units and services. - The contractor must ensure the unit is operational within the agreed timeframe upon deployment at The Baltimore VA. - The contractor must provide a dedicated point of contact for scheduling maintenance and service. 6. Reporting and Documentation: The contractor shall provide The BT VAMC with Quarterly reports detailing the unit s usage, any maintenance performed, and any issues encountered and resolved. Preventive maintenance should be performed on the unit at recommended scheduled intervals. This will be performed and covered under the contract by the vendor. 7. Compliance: The contractor shall ensure that all services provided under this SOW comply with federal, state, and local regulations, as well as any specific requirements of The Center. 8. Security Training Due to the increased emphasis on privacy and information security, the following special contract requirements are established and hereby made part of the contract entered into with the Department of Veterans Affairs. a. Privacy Training: Contractor and their sub-contractors assigned work under the contract are required to receive annual training on patient privacy as established by HIPAA statues. Training must meet VHA s and the Department of Health and Human Services Standards (HSS) for Privacy of Individually identifiable health information. Contractor shall provide documented proof to the contracting officer that all employees assigned work and/or having access to protected health information have received annual training. Proof of training is to be forwarded to the COR. Training can be obtained through http://www.insidelms.va.gov/index.shtm. An account must be set up in order to access the training site by visiting https://www.tms.va.gov/plateau/user/login.jsp. page and contacting the local LMS Administrator or contacting the VA TMS Help Desk by phone at 1-866-496-0463 or via e-mail at vatmshelp@va.gov. For contractors and sub-contractors who do not have access to VHA computer systems, this requirement is met by receiving VHA National Privacy Training, other VHA approved privacy training or contract furnished training that meets the requirements of the HHS standards. b. Rules of Behavior for Automated Information Systems: Contractor personnel having access to VA Information Systems are required to read and sign a Rules of Behavior statement which outlines rules of behavior related to VA Automated Information Systems. The COR will provide, through the facility Information Security Officer (ISO), the Rules of Behavior to the contractor for the respective facility. c. VA Information Security Awareness Training: Each contractor assigned work under the contract is required to receive and document completion of VA training on Information Security. Training can be obtained through http://www.insidetms.va.gov/index.shtm. An account must be set up in order to access the training site by visiting https://www.tms.va.gov/plateau/user/login.jsp. page and contacting the local LMS Administrator or contacting the VA TMS Help Desk by phone at 1-866-496-0463 or via e-mail at vatmshelp@va.gov. Contractor shall provide documented proof to the COR that all contractor employees servicing a VA contract have received annual training. 9. Access to VA Information and VA Information Systems 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. a. 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. b. 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. c. 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. d. 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. e. 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. 10. VA information Custodial Language a. 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). b. 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. c. 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. d. 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. e. 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. f. 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. g. 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. h. 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. i. 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. j. 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. k. 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. l. 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 COR. 11. Security incident investigation a. 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 COR 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. b. 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. c. 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. d. 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. 12. Liquidated Damages for Breach of Contract a. 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. b. 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. c. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access). (2) Description of the event, including: (a) Date of occurrence. (b) Data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code. (3) Number of individuals affected or potentially affected. (4) Names of individuals or groups affected or potentially affected. (5) 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. (6) Amount of time the data has been out of VA control. (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); VA information, obtain monetary or other (8) Known misuses of data containing sensitive personal information, if any. (9) Assessment of the potential harm to the affected individuals. (10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and (11) 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. d. 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: (1) Notification. (2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; (3) Data breach analysis. (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution. (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and (6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. 13. Confidentiality and Non-Disclosure It is agreed that: a. The preliminary and final deliverables and all associated working papers, application source code, and other material deemed relevant by the VA which have been generated by the contractor in the performance of this task order are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order. b. The CO will be the sole authorized official to release verbally or in writing, any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order presented to the contractor shall be submitted to the CO for response. c. Press releases, marketing material or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO. 14. Insurance: The contractor shall maintain all necessary insurance coverages, including but not limited to liability, property, and workers' compensation insurance. 15. Payment The terms of payment for the services provided under this SOW shall be detailed in the contract agreement. This Statement of Work is subject to the terms and conditions of the contract agreement entered into between The BT VAMC and the contractor. All services must be performed to the satisfaction of The BT VAMC, in accordance with the standards and timelines established in the agreement. **Required** ALL RESPONDENTS SHALL INCLUDE and SUBMIT THE FOLLOWING: Responses to this Request for Proposal (RFP) shall include company name, address, point of contact, phone number, point of contact e-mail, DUNS Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 532490, (size standard of $40M, per SBA Table of Small Business Size Standards JANUARY 1, 2022) AND whether your company is a special socio-economic status (i.e., SDVOSB, VOSB, Small Business, HUBZone, etc.) Respondents shall answer the following questions: Size, status, and representations of your business, such as but not limited to: VENDOR SHALL BE Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB). Is your company considered small under the NAICS code identified under this RFI? (Size standard of = or < $30M, per SBA Table of Small Business Size Standards August 19, 2019) Is your company a large business? Does your company have an FSS contract with GSA or the VA NAC or a GWAC contract holder with any other federal agency? If so, please provide the contract number. If your company holds a FSS GSA/VA NAC contract other federal GWAC contract holder, are the services requested available on your schedule/contract? General pricing of your products is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. Information provided by potential sources will be utilized by the Government to determine market availability and procurement strategy. **A contract award will not result from this RFI Notice. Vendors who can meet the requirements listed above shall provide the following information: Business Name Business Address Business Point of Contact, including phone number and email address Business size Business Socioeconomic Status Federal Supply Scheduling (FSS) number, if the items required by the Government are available for purchase on an FSS contract. Any other pertinent capability information that relates to the above stated requirement. ***WILL YOUR COMPANY BE DOING ALL OF THE WORK? IF NOT, WILL YOUR COMPANY BE SUB-CONTRACTING OUT THE WORK?***SHALL ANSWER*** SUBMIT ALL Questions FOR INFORMATION TO AMY.WALTER1@VA.GOV.
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