COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS General Information Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C24220Q1057 Posted Date: 08/13/2020 Original Response Date: 08/19/2020 Current Response Date: 08/19/2020 Product or Service Code: 6505 Set Aside (SDVOSB/VOSB): Unrestricted Set-Aside NAICS Code: 325412 Contracting Office Address Department of Veterans Affairs, Northport VAMC, 79 Middleville Rd., Northport, NY 11768-2200. Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. This solicitation is a "request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-05. The associated North American Industrial Classification System (NAICS) code for this procurement is 325412, with a small business size standard of 1,250 Employees. This procurement is being issued as Unrestricted Set-Aside. It is the Government s intent to issue a firm fixed price, single award as a result of this solicitation. The North American Industry Classification System (NAICS) code is 325412, Pharmaceutical Preparation Manufacturing, with a business size standard of 1250 Employees. All interested companies shall provide quotation(s), for the following: VA Department of Veterans Affairs, Northport VAMC, 79 Middleville Rd., Northport, NY 11768-2200, is seeking to purchase a Brand-Name or Equal of Amyvid (F18 florbetapir intravenous) or a similar beta amyloid PET tracer for the evaluation of veterans with dementia in the Radiology/Nuclear Medicine Service at four VA Medical Centers (VAMC) as listed below. Supplies: Brand Name or Equal for PET Radiopharmaceutical (Amyvid) Item # Description/Part Number* 1 Amyvid, East Orange 2 Amyvid, NYH, Brooklyn 3 Amyvid, Bronx 4 Amyvid, Northport *** Vendor covers all shipping and handling costs *** Requirements: This is a Brand Name or Equal procurement. The contractor shall deliver Amvvid (F18 florbetapir intravenous) or a similar beta amyloid PET tracer on an as needed basis to each of the participating VAMCs. The beta amyloid PET tracer must: Require imaging to begin within 30 minutes Require an imaging time of no more than 10 minutes. The contractor shall provide all labor, supervision and transportation necessary to meets the needs of deliveries for the various Radiology/Nuclear Medicine Services at the participating VAMCs. The contactor shall have an adequate supply of Amyvid (F18 florbetapir intravenous) or a similar beta amyloid PET tracer to meet the requirements of the participating VAMCs. Due to the critical need of these supplies in a timely manner, only vendors within a 60-mile radius of any given participating VAMCs need to respond. Technology Requirements All technology that transmits VA sensitive information must be FIPS 140-2 compliant. Contractor Contact Information: The contractor will provide with their proposal, the following information: The contractor s regular daily work hours. Instructions for placing orders over the phone, by fax and through a web-based ordering system. No veteran specific information will be transmitted through any web-based ordering system. Orders that are placed through any web-based system will not include veteran specific information. Veteran specific information will only be transmitted over the phone. The contractor s telephone number for phone orders during regular work hours. The contractor s telephone number for placing emergency orders after the contractor s regular working hours including weekends and holidays, 24 hours a day, 7 days a week, 365 days a year. The contractor s telephone number for expert advice about awarded products. The contractor s fax number for radiopharmaceutical orders. If there are any changes to the above, the contractor will immediately provide updates to each participating medical center in writing. Contractors shall provide copies of licenses and certifications along with their proposals. Package Inserts: The contractor will ship current a package inserts for the PET radiopharmaceutical to each participating veterans administration medical center at the inception of the contract. Any new or updated additions to the package inserts will be sent by the contractor to each participating medical center promptly. Available Product: The contractor must be able to supply the selected PET radiopharmaceutical. Orders and Delivery Delivery Locations: James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx, NY 10468 Veterans Administration New Jersey Health Care System 385 Tremont Avenue East Orange, NJ 07018 Northport VAMC 79 Middleville Road Northport, NY 11768 VA New York Harbor Health Care System Brooklyn Campus 800 Poly Place Brooklyn, NY 11209 Orders will be placed by 5:00 pm for delivery by the following workday. Orders can be placed orally by telephone, through a web-based system and/or fax transmission. Due to the demands of the VMACs patient care requirements, there shall be no restriction on the number of orders which may be placed by a participating VAMC, nor the number of deliveries required per day. Deliveries must be available Monday through Friday. Time of delivery specified or mutually agreed to at the time of receipt of telephone orders shall become mandatory upon the contractor s acceptance to the commitment. Delivery of supplies by the scheduled time will be complete except as otherwise authorized by ordering personnel. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. Invoice shall include period covered, billing date, name of preparation, quantity, and amount. The contractor is responsible for on time delivery of radiopharmaceuticals and must have back-up facilities/production options to maintain greater than 95% on time delivery or risk penalties that include no charge doses that, at a minimum, equal the amount of missed doses. The contractor must provide an emergency plan for deliveries during inclement weather. Deliveries of radioactive products must incorporate sufficient lead or other high-density material shielding to comply with applicable Federal and or State standards relating to shipment of radioactive material. Deliveries are to be made to Nuclear Medicine Hot Labs in each of the participating VAMCs. If the medical center has 2 Hot Labs, deliveries are to be made to the specified PET Hot Lab. Access to the Nuclear Medicine Hot Labs during non-business hours shall be obtained by contacting the VA Police Service. Drivers who make deliveries must present acceptable photographic identification to the VA Police Service. Drivers must have documentation of radiation safety training that is available to the receiving facility upon request. There will be no surcharges for any deliveries. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. Labeling Doses: The contractor shall label all unit doses delivered radiopharmaceuticals with the amounts, preparation time, expiration time and date, etc., and provide a bar code labeled insert to allow scanning data into the VAMC s nuclear medicine information management system (NMIS). If the contractor s system varies from the current NMIS information system in use at the participating medical centers, the contractor shall provide their system as well as data migration, technical support, and training to staff on its use at no additional cost to the government. A label must be affixed to each syringe, vial, or other container that is used to hold a radioactive radiopharmaceutical to be transferred for commercial distribution. The label must include a radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial or other container can be correlated with the information on the transport radiation shield label. Shipping and Radioactive Labels: All packaging of radioactive materials must be clearly labeled Caution, Radioactive Material and contain a radioactive symbol with the proper Transportation Class and exposure levels, preparation time, expiration time and date and order number on the outside of the shipping container in order to comply with specific regulatory requirements. All shipping containers must be free of radioactive contamination both inside and outside and adequately packaged to prevent damage during handling, shipment and storage. The contractor must supply with each shipment/order/delivery a system for spent (used) syringes, which meets OSHA s Biohazard Policy/Regulations and is needless. Nuclear Regulatory Commission License: The contractor must be licensed by the Nuclear Regulatory Commission (NRC) and must be in the business of delivering radiopharmaceuticals. Additionally, the contractor shall meet the Department of Transportation, NHPP, FDA, OSHA, and all other agency rules and regulations (Federal and State) including USP 797. Contractors shall provide copies of licenses and certifications along with their proposals. CFR10: The contactor shall abide by the Title Code of Federal Regulations (CFR 10). Sales Representative: The contractor shall assign to each participating VAMC an individual sales representative to (1) aid in the facilitation of a smooth coordination between each participating VAMC and the contractor and to (2) aide in the prompt resolution of discrepancies. Quality Control Manual: The contractor shall provide a copy of their laboratory s current quality control manual and shall be willing to discuss discrepancies in lab results which do not fit the clinical picture. The contractor shall test all products for quality control periodically and only those products that pass quality control may be sent to each participating medical center. The testing and the detailed report shall be furnished to each participating medical center at no additional cost. All contractor quality control testing/procedures shall be performed as required by Federal and State regulatory agencies. USP 797: The contractor must validate that they are in compliance with USP 797. Each vendor must provide clean room reports and evidence of satisfactory air quality in the clean rooms. Canceling orders and returned products: Each participating medical center may cancel ordered doses within a ten-hour (10) notice to contractor. The contractor shall accept returns for credit under the following conditions: Product(s) shipped in error. Product(s) damaged in shipment. Recalled product(s). Unused, unopened doses of product for patients who fail to keep their appointments. Unused, unopened nonradioactive products prior to expiration. The contractor will pick up radioactive and non-radioactive products to be returned for proper disposal at no cost to the government. Credit for the returned product will be reflected in the current month s invoice. The contractor shall not add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at cost of the contractor. Replacements shall be received within 48 hours of notification. All charges for delivery shall be included in the fee schedule. Additional fuel surcharges will not apply. MSDS Sheets: When the contract is awarded, the contractor must provide MSDS sheets (Material Safety Data Sheets) for the contract radiopharmaceutical to each participating VAMC. Invoicing and Payments: The contractor must submit an invoice at least once per month that shows the period covered, the billing date, the name of each product delivered, the quantity delivered, the amount delivered, the date each product was delivered and the correct Veterans Administration purchase order number. All invoices are to be sent to (1) Austin vial electronic invoicing and (2) each participating medical center via secure e-mail. Payments shall be made in the arrears via Tungsten Network or government purchase credit card. HIPAA COMPLIANCE: The Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs. Employees of the vendor who accept orders must complete two on-line courses on the VHA TMS System: VA Privacy and Information Security Awareness and Rules of Behavior Privacy and HIPAA Requirement The vendor must send copies of each involved employee to the COR for this contract. VA ACQUISITION REGULATION SOLICITATION PROVISION AND CONTRACT CLAUSE NOTE: This clause will undergo official rule making by the Office of Acquisitions and Logistics. The below language will be submitted for public review through the Federal Register. The final wording of the clause may be changed from what is outlined below based on public review and comment. Once approved, the final language in the clause can be obtained from the Office of Acquisitions and Logistics Programs and Policy. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE 1. 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. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS 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. VA HANDBOOK 6500.6 MARCH 12, 2010 APPENDIX C C-2 3. 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. MARCH 12, 2010 VA HANDBOOK 6500.6 APPENDIX C C-3 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 VA HANDBOOK 6500.6 MARCH 12, 2010 APPENDIX C C-4 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 COTR. 4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy MARCH 12, 2010 VA HANDBOOK 6500.6 APPENDIX C C-5 Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment. b. The contractor/subcontractor shall certify to the COTR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required. c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default program files directory and silently install and uninstall. d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges. e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle. f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties. g. The contractor/subcontractor agrees to: (1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies: (a) The Systems of Records (SOR); and (b) The design, development, or operation work that the contractor/subcontractor is to perform; (2) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and VA HANDBOOK 6500.6 MARCH 12, 2010 APPENDIX C C-6 (3) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR. h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency. (1) Operation of a System of Records means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records. (2) Record means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person s name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph. (3) System of Records means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as Systems ), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems. j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than ____ days. k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within ____ days. MARCH 12, 2010 VA HANDBOOK 6500.6 APPENDIX C C-7 l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology. 5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA s network involving VA information must be reviewed and approved by VA prior to implementation. b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII. c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks. d. The contractor/subcontractor s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA s POA&M management process. The contractor/subcontractor must use VA s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may VA HANDBOOK 6500.6 MARCH 12, 2010 APPENDIX C C-8 affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary. e. The contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost. f. VA prohibits the installation and use of personally owned or contractor/subcontractor owned equipment or software on VA s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE. g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract. h. 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: (1) Vendor must accept the system without the drive; (2) 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 (3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. MARCH 12, 2010 VA HANDBOOK 6500.6 APPENDIX C C-9 (4) 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; (a) 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 (b) 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. (c) 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. 6. 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 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. 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 VA information, obtain monetary or other VA HANDBOOK 6500.6 MARCH 12, 2010 APPENDIX C C-10 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. 7. LIQUIDATED DAMAGES FOR DATA BREACH 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); MARCH 12, 2010 VA HANDBOOK 6500.6 APPENDIX C C-11 (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 $______ 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. 8. SECURITY CONTROLS COMPLIANCE TESTING On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time. VA HANDBOOK 6500.6 MARCH 12, 2010 APPENDIX C C-12 9. TRAINING a. 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: (1) 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; (2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) 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.] b. 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. c. 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. RECORDS MANAGEMENT: The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract: Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. 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 by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. 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, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. Evaluation Factors and Sub-factors Our Evaluation Factors and Sub-factors are as follows: FACTOR 1: Fair and Reasonable Price. FACTOR 2: Technical Capability (ability to): Deliver the PET radiopharmaceutical on time and when needed. Accept orders by telephone, through a web-based system and/or by fax transmission. Provide deliveries to each participating VAMC by 6:30 am the following business day. Provide sterilized lead containers for doses prior to reuse. Provide full credit for all radiopharmaceuticals not used for scheduled patients who do not show up for their appointment ( no shows ). Accepts returns of unused products prior to expiration date for full credit. Demonstrate an established record of reliability for on time daily deliveries or products on the Products List. FACTOR 3: Past Performance: Show evidence that vendor is reliable and that has been in business for at least 5 years. Technical Capability and Past Performance, when combined (Factor 2 + Factor 3) are equal to or equivalent to Price (Factor 1). Name of Product Dose EO NYH BK Bronx NP   TOTAL Amyvid (florbetapir F18) or similar PET radiopharmaceutical units 12 2 8  2      24 Warranties The Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized 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 vendor shall provide new items ONLY; no remanufactured or "gray market" items. All items must be covered by the manufacturer's warranty. Services The delivery/task order period of performance is 10/01/2020 to 09/30/2021. Delivery shall be provided "no later than 30 days after receipt of order/award of contract . delivery terms FOB destination. The contractor shall deliver all line item(s) to Northport VAMC, 79 Middleville Rd., Warehouse Building 36, Northport, NY 11768-2200. Place of Performance James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx, NY 10468 Veterans Administration New Jersey Health Care System 385 Tremont Avenue East Orange, NJ 07018 Northport VAMC 79 Middleville Road Northport, NY 11768 VA New York Harbor Health Care System Brooklyn Campus 800 Poly Place Brooklyn, NY 11209 Award shall be made to the offeror, whose proposal offers the best value to the government, considering technical capability, past performance, and price. The government will evaluate information based on the following evaluation criteria: Quotes will be evaluated based upon the ability to meet the above exact specifications, technical capability, delivery time, lowest price and the best value to the government with proof of distribution authorization letter. The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Items (Deviation Oct 20018) ADDENDUM to 52.212-1 Instructions to Offerors -Commercial Items FAR 52.212-2, Evaluation-Commercial Items-(Oct 2014) FAR 52.212-3, Offerors Representations and Certifications Commercial Items (Oct 2018) 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. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Items (Oct 2018) ADDENDUM to FAR 52.212-4 Contract Terms and Conditions-Commercial Items FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders (May 2019). The following subparagraphs of FAR 52.212-5 are applicable, along with 52.203-19, 52-204.10, 52.209-10, 52.221-1, 52.219-28, 52.222-3, 52.222-35, 52.222-50, 52.222-36, 52.222-21, 52.222-26, 52.223-18, 52.225-13, 52.233-3, 52.233-4 and 52.247-64 subparagraphs. **Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed Amyvid (F18 florbetapir intravenous) or a similar beta amyloid PET tracer, verified by an authorization letter or other documents from the OEM, such as the OEM s warranty and services associated with the equipment shall be in accordance with the OEM terms and conditions. ** This is an open-market combined synopsis/solicitation for Amyvid (F18 florbetapir intravenous) or a similar beta amyloid PET tracer as defined herein.  The government intends to award a contract as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all proposals, must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" quoters shall list exception(s) and rationale for the exception(s). Submission shall be received not later than 08/19/2020 @ 11 AM at email address listed below for Contracting Officer address for submission of quotes. Late submissions will be treated in accordance with the solicitation provision at FAR 52.212-1(f). Only email quotes will be accepted. Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the [email protected]. Point of Contact Wilmen Joa Email: [email protected] 179-00 Linden Blvd. Jamaica, NY 11425

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