Description
STATEMENT OF WORK Vitrea Advance Software I. GENERAL REQUIREMENT Contractor shall provide all software updates travel, and supervision for corrective maintenance services to all government-owned software listed below: " VitreaAdvanced, Vitrea Concurrent User Pkg 6 Concurrent Users " VitreaAdvanced, VitreaCore 8 Concurrent User Pkg " VitreaAdvanced, CT SUREPlaque Software 1 Concurrent User " VitreaAdvanced, CT Transcatheter Aortic Valve Replacement (TAVR) Planning App 2 Concurrent Users II. EQUIPMENT: Software will be in good operating condition upon the effective date of this contract. This contract will not apply to any instrument damaged through negligence, misuse, abuse, fire, or explosion or any act of God. III. UPDATES,SOFTWARE MAINTENANCE AND SERVICE: The Contractor shall provide software maintenance, beginning in February. Software maintenance shall be scheduled with the Contracting Officer' Representative (COR). Service also includes all necessary intervening service calls required to troubleshoot any software maintenance needs. The VA will provide first call service, which includes trying to resolve any problem first before calling the Contractor. IV. ADDITIONAL SERVICES: Contractor guarantees all software covered in this contract shall be in optimum working condition at the contract expiration date provided that the Contractor is notified of any deficiencies at least one (1) day before the contract expiration date. Any changes, updates or retrofits made on any component or system shall be reported to the COR for annotation on station equipment manuals and records. For any service call made during normal working hours, the Contractor's repairman shall report their arrival and departure to the COR. Contractor shall include, at no extra charge, any engineering and software update necessary for continued optimum operation of the equipment listed in this contract. The Contractor 's repairman shall complete a full service report, in writing, after each service call (emergency or scheduled) and submit either a hard copy or an electronic version of this report to the COR within 5 days after the service day. V. PERFORMANCE AND RESPONSE TIME 1. The Contractor shall respond to service calls, within one (1) hour for telephonic response, and on-site within four (4) hours. This requirement for response time shall be the same for both services calls during the VA normal business hours and after-hour service calls. Corrective work shall be completed within forty-eight (48) hours from telephone contact time. 2. All work shall be performed by competent, experienced and factory-trained to work on the specific software. All work performed shall be first-class and accomplished in accordance with manufacturer's instructions. All work shall be performed to the satisfaction of the COR who will inspect the repairman's work and indicate his approval on a signed statement prior to the repairman's departure from the premises. 3. Service calls during the VA normal business hours and related to malfuctions not successfully preempted by software maintenance services shall be at no additional cost to the Government. 4. Emergency service or repairs authorized by the COR, which occur after the VA normal business hours of operation, shall be accomplished at the overtime-hourly rates specified in the pricing schedule. The VA will be responsible for premium portion of the overtime rate only. All overtime service calls shall be handled by one repairman only unless approved in advance by the COR. If regular timework must be carried over and the Contractor wishes to continue to work beyond the VA normal business hours of operation, authorization for overtime work must be obtained from the COR before proceeding. 5. The Government shall not be responsible for incidental charges including, but not limited to, parking, tolls, mileage, phone, etc., on straight time or overtime work. VI. OTHER WORK 1. Maintenance problems discovered on equipment covered by this contract which the Contractor believes exceed the scope of contract provisions, shall not be worked on without concurrence and specific authorization from the BIOMED COR to perform repairs. The Contractor shall immediately notify the BIOMED COR of any equipment or environmental conditions which impair or jeopardize the functioning of the equipment. 2. In any case, the VA shall be explicitly notified in advance that additional charges will be incurred, prior to beginning such work. In such instances that the VA agrees the work is not within the scope of the contract, and the VA desires the Contractor to perform repairs, a separate purchase order will be issued to the Contractor for the work. Any service required which the Contractor believes to be in excess of the contract provisions and require additional payment (e.g., work beyond normal work hours) shall not be performed without prior authorization from the BIOMED COR, who will arrange a separate purchase order to pay for the additional service if desired by the VA. 3. In addition to covered services, Contractor shall provide equally responsive, competent service for additional work on covered equipment when requested by the VA, during regular business hours or after-hours, which will be paid via separate purchase order at a pre-determined cost if unrelated to maintenance requirements of the contract. (See WARRANTY) VII. DOCUMENTING The contractor shall supply certification of tuberculosis testing completion prior to commencing any work located on the MEDVAMC campus. a) The Contractor shall maintain a separate maintenance record on each Radiology Modality that is using the Vitrea Software covered under this contract,. All maintenance records shall be readily available anytime upon request for inspection by the Contracting Officer, COR or designee. The maintenance record is the property of the government and shall be turned over to the Government at the end of the contract. The maintenance record shall be a chronological file that includes the following information: look at this (1) Date. (2) Nature of work (i.e. Software maintenance services). (3) Description of work performed (contractor should be brief and concise). (4) Any indication of problems experienced. (5) Initial or signature of repairman performing work. VIII. PROCEDURE FOR REPORTING OF ARRIVAL AND DEPARTURE FOR ONSITE WORK The Contractor's representative shall report his arrival and departure for onsite work in accordance with the following procedure: 1. Upon arrival at the station, the Contractor shall check in with the BIOMED shop to sign in on response log, so that the VAMC will be aware of the Contractor's presence at the facility at all times. Response time shall be determined by the first appearance of a service representative at the appropriate office in response to a particular call. 2. Upon each departure, Contractor shall serve notice of disposition of work to the COR or designee. In addition the contractor shall furnish the BIOMED COR or his designee a copy of a work order, service sheet or other such written notification of services performed. Such reports shall include at a minimum the following information: " Name and address of contractor " Name of contractor employee(s) performing the work " Date(s) work performed and hours spent. " Brief description of work performed, including preventive maintenance services and identification of equipment worked on. " Signature of contractor's employee(s) and signature of COR or his designee. " If the report is not submitted, it will indicate to the Government that no inspection or maintenance was performed and payment may be withheld and/or delayed. IX. UNIFORMS The Contractor shall require all employees, including supervisors, to wear distinctive uniform clothing for ready identification, and assure that every employee is in uniform no later than the time specified by the COR, or otherwise no later than 10 working days from the date an employee first enters on duty. The uniform shall have the Contractor's name, easily identifiable, affixed thereon in a permanent manner such as a badge or monograms. X. HOURS OF WORK: Services shall be performed during the VA normal business hours, 8:00 a.m. through 5:00 p.m., Monday through Friday, excluding Government holidays. XI. UPDATES: " The Contractor shall furnish new updates and software patches. All new updates and software patches that are installed become the property of the Government. XII. SAFETY REQUIREMENTS: In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer, or his/her designee, may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contractor shall have one supervisory employee, who will disseminate requirements to those who work at our facility, report to the Safety Manager's office for a one- (1) time training class before working on-site. The Contracting Officer or his/her designee will notify the Contractor of any noncompliance with the foregoing provisions and the action to be taken. The Contractor shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. Such notice, when served on the Contractor or his representative at the site of work, shall be deemed sufficient for the purpose aforesaid. If the Contractor fails or refuses to comply promptly with such notice, the contracting Officer may issue an order stopping all or any part of the work and hold the Contractor in default. XIII. ORDERS: All orders for service will be placed by the COTR or his deisgnees, and the Contractor's service representatives shall report to the COTR or his designees prior to the commencement of work and after completing the services. Services to be rendered will be as directed by the COTR, and any changes must receive concurrence of that. XIV. OTHER REQUIREMENTS a) The Contractor shall require his employees to comply with all VA rules and regulations pertaining to the conduct of his employees while on station. Particular attention is drawn to the fact that the VAMC is a NO SMOKING Facility. Smoking is not permitted in any building. b) Contractor shall have use of station telephones to make business calls related to Medical Center's equipment. Misuse of this privilege will necessitate the need to require the contractor to use public telephones. c) UNAUTHORIZED USE OF GOVERNMENT EQUIPMENT (1). The Contractor shall not allow his/her employees, including Subcontractors' employees, to open desk drawers, cabinets, or to use office equipment, including the use of non-pay telephones for any purpose other than a local emergency call. (2). The Contractor shall be responsible to provide all necessary equipment, tools, parts, and materials to perform the work. The Government shall not be obligated to provide any equipment, tools, parts, and materials to assist the Contractor in performing the work. XV. WARRANTY The Contractor shall warrant satisfactory software for maintenance work outside the contract for a period of ninety (90) days immediately following completion of such work. The Contractor shall warrant satisfactory software for covered systems for a period of ninety (90) days immediately following the contract expiration date. Warranty service shall be limited to correcting items discovered to be in poor condition due to insufficient upkeep or failure to replace worn parts during the contract period. The Contractor shall correct these deficiencies upon notification by the Contracting Officer. This warranty shall remain valid while other parties perform service on the overall systems in question, provided the individual items requiring warranty service have not been obviously subjected to unnecessary, detrimental treatment by parties other than the Contractor (qualified service performed which is reasonable and necessary to uncover the deficiency shall not void warranty obligations of the Contractor). When directed to correct any such deficiency, the Contractor shall complete the required repairs with the same responsiveness stipulated in Section V, "Performance and Response Time". Each software update performed in satisfying this warranty clause shall include a ninety-day extension of this warranty for the subject item, from the completion date of the related warranty work, as well. XVI. INVOICES & METHOD OF PAYMENTS All invoices shall be submitted in arrears, properly prepared in accordance with FAR 52.212-4, contain sufficient details, and match with the service tickets for the work rendered. a Quarterly Invoices Invoices for fixed quarterly fee shall be properly prepared and sent to the VA Financial Service Center at: P.O. Box 149971. Austin, Texas 78714-8971. These invoices shall be sent in arrears at the beginning of the first month of each quarter following the quarter in which the PM services were rendered and billed for. At a minimum, all invoices shall include the following details: ¢ Description of the services rendered ¢ Billing period in which the services were rendered ¢ Correct purchase order number which will be issued by the Contracting Officer after the contract is awarded. Invoices without correct purchase order number shall be rejected and returned to the Contractor. ¢ Invoice number and date Payments will be made in accordance with the prompt payment act out of the Government annual appropriated funds obligated in a purchase order which will be issued after the contract is awarded. b Invoices for Repair Services Invoices for repair services shall be properly prepared, contain sufficient details, and include a copy of the repair tickets issued by the repairman who provided the repair services. Invoices for repair services shall be submitted in arrears and sent to the VA Financial Service Center at: P.O. Box 149971. Austin, Texas 78714-8971. The VA reserves the right to pay for repair services either by the government Visa purchase card administered through Citibank Bank, or by a separate purchase order at its own discretion. The contractor shall be able to participate and accept the Government Visa card. Contractor shall use VISA Level II access, which will provide the Purchase Order Number to Citibank when sending the transactions. XVII. GOVERNMENT PARTY TO EXECUTE AND MODIFY THE CONTRACT After the contract has been in force for a period of time, it may be necessary to change and/or modify the operations to provide better service. Pursuant to FAR 43.102, no government personnel other than the Contracting Officer can execute contract modifications on behalf of the government. XVIII. END OF SERVICE PERIOD No service shall be performed under this agreement after the contract expiration date without written authority or direction from the Contracting Officer. The Vendor will need to access VA systems in order to perform software maintenance and patches. PRIVACY/SECURITY The contractor will have electronic connectivity to the devices and will have access to patient databases or receive screenshots with PHI present. Any electronic or magnetic data storage devices such as hard drives, etc. shall be turned into the ISO. Electronic or magnetic data storage devices are not to be removed from VA property. 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. 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 Impact Assessment (PIA) must be completed, provided to the COR, 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 __10__ 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 _10___ 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. 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 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); (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. 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 Member required to complete VA Privacy and Information Security Awareness & Rules of Behavior Training (TMS course #: 10176 "Privacy and INFOSEC & Rules of Behavior and #10203 VA Privacy and HIPAA"). 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. PO BAA requirement: A BAA is required and there is a National BAA with Vital Images. End of Scope of Work