Description
4 STATEMENT OF WORK Procurement of Amyvid and 18FDG in Shielded Delivery and Administration System Ralph H. Johnson VA Medical Center Radiology Nuclear Medicine Department 109 Bee Street Charleston, SC 29401 Part 1: General Information Introduction The Ralph H. Johnson VA Medical Center (RHJVAMC) administers fluorine-18 labelled fluorodeoxyglucose (FDG) radioisotopes for Positron Emission Tomography (PET) imaging on a daily basis for clinical nuclear medicine procedures. In addition, RHJVAMC also provides PET imaging studies utilizing Amyvid (Florbetapir), a radioactive diagnostic agent for Alzheimer s disease (AD). FDG and Amyvid are United States Food and Drug Administration (FDA) approved drugs for use in PET and are essential to insure our veterans are provided with optimal patient care. Background Since its development in 1976, FDG has had a profound influence on research in neurosciences. After injection of the FDG, the radioisotope will travel to areas that use glucose for energy, which closely correlates with certain types of tissue metabolism. The PET scanner will then form two-dimensional or three-dimensional images of FDG distribution within the body. In this way, it demonstrates body physiology and not simply body anatomy such as x-rays, CT s or MRIs. The subsequent discovery in 1980 that it accumulates in tumors underpins the evolution of PET as a major clinical tool in cancer diagnosis. FDG is now the standard radiotracer used for PET neuroimaging and cancer patient management. The images can be assessed by a Nuclear Medicine physician or radiologist to provide diagnoses of various medical conditions. Amyvid is used to produce PET scans that estimate the brain -amyloid neuritic plaque density in patients with cognitive impairment. -amyloid protein is a type of protein that forms in patients with AD and some other cognitive disorders. Neuritic plaques, also called amyloid plaques, are abnormal clumps of brain cells mixed with -amyloid protein. A negative Amyvid scan indicates few to no neuritic plaques and reduces the likelihood that any cognitive impairment is due to AD. A positive scan indicates moderate to frequent plaques. This amount of -amyloid plaque can be found in patients with AD, in patients with other types of cognitive impairment, and in older people with normal cognition. Amyvid and FDG are regulated by the United States Nuclear Regulatory Commission (USNRC) through RHJVAMC s radioactive material license (RAM) and administered under the supervision of the Radiation Safety Office (RSO) and Radiologist. Accordingly, procurement and use of these radiopharmaceutical drugs must meet federal regulations to ensure safety and minimize health risks to both the staff and patients. Hence, only qualified vendors that meet the FDA and USNRC regulations can provide these radiopharmaceuticals to the RHJVAMC. Scope Contractor shall provide all single-unit doses of FDG and Amyvid used for routine PET/CT studies and evaluation of Alzheimer s Disease, respectively, in Radiology s PET/CT department of the RHJVAMC located in Charleston, SC. The purpose of the SOW is to identify the vendor requirements necessary for procurement of unit doses of Amyvid and FDG Dose delivery must meet DOT regulations, USNRC ALARA, and Government weight guidelines. The deliveries must come from an FDA and USNRC licensed supplier. In turn, the radioisotopes delivered shall allow the RHJVAMC Department of Radiology to perform clinical imaging studies as required by necessary patient care protocols. D. Applicable Documents 10 Code of Federal Regulations Part 35: United States Nuclear Regulatory Commission- Medical Use of Byproduct Material 49 Code of Federal Regulations Part 173 Subpart I: Class 7 (Radioactive) Materials Department of Veteran Affairs Materials Permit: Reference # 030-01212 Amendment # 61 Part II: Requirements E. Ordering Requirements The contractor shall provide personnel for orders of FDG and Amyvid to be placed by RSO certified Nuclear Medicine personnel during standard hours of care Monday through Friday between the hours of 0700 (7:00 AM EST) and 1700 (5:00 PM EST). Orders will be placed almost exclusively on the business day prior to the scheduled delivery date. The contractor shall calibrate all radiopharmaceutical doses to ensure proper activity ranges ± 10% of the specified ordered dose per specific requirements provided by RHJVAMC personnel based on guidelines outlined in 10 CFR Part 35. The FDG dose activities shall be calibrated for either 7 mCi or 12 mCi ± 10% of activity, or as specified by RHJVAMC. The calibrated Amyvid dose activities shall be calibrated for 10 mCi ± 10% of activity, or as specified by RHJVAMC. The Contractor shall notify the RHJVAMC s PET/CT Department immediately should the inability arise to provide FDG and Amyvid doses by the required date and time. Notification shall be made within two (2) hours of the Contractor becoming aware of the inability to provide the required doses. F. Delivery Requirements In complying with ALARA (as low as reasonably achievable) requirements as well as USNRC recommendations for achieving and maintaining a safe work environment, RHJVAMC requires the qualified vendor to deliver each unit dose of FDG in a shielded dose administration container (referred to as a pig ), which is stored inside a shielded shipping container. This configuration provides the lowest reasonably achievable radiation exposure to the staff and patients at RHJVAMC. Each radiopharmaceutical must be properly compounded, dispensed, calibrated and delivered for a specific patient at a specific time on a specific date by the approved vendor. The dose activity (radioactivity) of Amyvid and FDG has a short half-life (110 minutes), which requires that the dose be delivered at a specific time and at the required dose activity in order for the imaging/therapy study to be properly performed. The contractor shall provide Monday to Friday deliveries at the times specified by the PET/CT technologist, provided RHJVAMC placed a sought order sometime during the business day prior to the required delivery day. Each dose shall be delivered and received by RHJVAMC no later than 30 minutes before the dose calibration time. Doses are to be delivered to the PET/CT department Hot Lab of RHJVAMC, located on the second floor of the hospital in Room B212E. A radiopharmaceutical shall not be considered delivered unless: (1) it is delivered in a proper dose administration and shipping system; (2) the radiopharmaceutical arrives at the specified point of destination; (3) the contractor/contractor s agent has placed the radiopharmaceutical in the custody of a RSO certified personnel; and (4) the radiopharmaceutical is delivered on time and at the specified dose activity. Other Requirements The production facility of the Amyvid and FDG must be approved by the FDA (or the approval request pending and on file with the FDA), with registration in good standing, to produce Amyvid and FDG for human use. The offeror must be licensed, with the license in good standing, by either the USNRC, or the relevant State Radioactive Materials Licensing Agency (provided that the State has an agreement with the USNRC which makes its approval a sufficient alternative to USNRC approval), for the production and/or distribution of FDG and Amyvid . This requirement may also be applied to any subcontractor, sub-subcontractor, manufacturer, carrier, or other entity which the offeror is relying upon to create or handle the FDG, depending on the offeror s performance approach. The packaging and transport of all deliveries shall meet relevant U.S. Department of Transportation requirements for radioactive materials. CREDIT: Contractor shall offer credit for unit doses that are not to be used or cancelled. The Ralph H. Johnson VAMC shall require credit statements (itemized returned doses) and monthly invoices. An electronic daily dose tracking system should be available for the Medical Center s use in certifying and tracking per patient doses delivered. There will be no additional fees added to the invoices outside of the schedule/ price list that is provided by the vendor. This includes delivery fees, daily fees, service fees, dose prep fees and dose disposal fees. Contractor shall accept returns for credit under the following conditions: Product(s) ordered or shipped in error Product(s) damaged in shipment Concealed shipping damages Recalled product(s) Outdated products in unopened, original container (specifically authorized for return by manufacturer) Unused doses of patients who fail to keep their appointments. Incorrectly delivered dose for any reason shall be credited for the full amount. Incorrectly delivered doses shall not exceed one per month. Recalled dose(s) for any reason shall be credited for the full amount. It is the offeror s responsibility to provide the Ralph H. Johnson VAMC with recall notices on any product that has been delivered to the Nuclear Medicine Department that may be defective. Notification shall be made to the Contracting Officer Representative (COR) via the most expedient method. Any doses deemed below standard by the facility shall be credited toward the account and shall not exceed one (1) per quarter; four (4) per year, from date of award. Emergency call back fees shall not be charged for regular work hours (Monday Friday 7:00 am-5:00 pm) on days not observed as a holiday by the VA, i.e. Christmas Eve, Good Friday, etc. The contractor shall not add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at the contractors expense. Replacements shall be received within forty-eight (48) hours of notification from the Ralph H. Johnson VAMC. Cold kits shall be returned to vendor for credit or replacement if expiration date is exceeded. INVOICING: Invoices shall be paid monthly in arrears. Invoices shall show period covered, billing date, name of preparation, quantity and amount. Contractor shall submit certified invoices monthly within 15 days after the end of billing month to the Contracting Officer s Representative (COR) via e-mail to be reviewed for accuracy prior to submission to the Department of Veteran Affairs Financial Services Center for processing. Should the COR find discrepancies, contractor shall correct any discrepancies identified within two (2) business days and provide the Contracting Officer s Representative (COR) with the revised invoice. MARCH 12, 2010, VA HANDBOOK 6500.6 APPENDIX B B-1 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. 1. SUBPART 839.2 INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS 839.201 Contract clause for Information and Information Technology Security: a. 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). b. 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. 2. 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. MARCH 12, 2010, VA HANDBOOK 6500.6 APPENDIX C C-1 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/subcontrator 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 onsite 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 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 VA HANDBOOK 6500.6 MARCH 12, 2010 APPENDIX C C-4 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 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 (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. 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. MARCH 12, 2010, VA HANDBOOK 6500.6 APPENDIX C C-5 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 vulnerability 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 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 /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 VAapproved 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. (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 VA HANDBOOK 6500.6 MARCH 12, 2010 APPENDIX C C-6 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 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 MARCH 12, 2010, VA HANDBOOK 6500.6 APPENDIX C C-7 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); (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 VA HANDBOOK 6500.6 MARCH 12, 2010 APPENDIX C C-8 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 RECORDS MANAGEMENT OBLIGATIONS A.  Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.  B.  Definitions Federal Record as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.  The term Federal record: 1. includes [Agency] records. 2. does not include personal materials. 3. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract. 4. may include deliverables and documentation associated with deliverables. C.  Requirements 1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. 2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. 3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. 4. RHJ VAHCS and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of RHJ VAHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to RHJ VAHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230. 5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to RHJ VAHCS control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4). 6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [FACILITY] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. 7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with RHJ VAHCS policy. 8. The Contractor shall not create or maintain any records containing any non-public RHJ VAHCS information that are not specifically tied to or authorized by the contract. 9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act. 10. The RHJ VAHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which [FACILITY] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20. 11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take RHJVAHCS-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. D.  Flow-down of requirements to Subcontractors 1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same. 2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.