VA VISN 2 s intends to negotiate with a sole source manufacturer of Radiology Picture Archiving and Communication System (PACS), Philips Healthcare, to provide on-going use of the current PACS. We believe that Philips Healthcare is the only vendor capable of providing the required maintenance, support and ongoing sustainment services. This service previously competed and/or advertised on GSA and the open market and the only vendor to provide a response was Philips Healthcare. This requirement is to sustain the usage of the currently operational Philips Intellispace PACS for the period of performance identified below at the VA VISN 2 Medical Centers identified in the draft SOW. A competitive solicitation is currently open until October 03, 2018 which will replace this PACS. Vendors interested in submitting offerors to replace the PACS in VISN 2 are encourage to review RFQ 36A79718Q0005. All responsible sources who believe they can furnish the service described in this notice should email
[email protected] with details regarding your firm s capability. Period of Performance: A base year from October 01, 2018 to September 30, 2019 with subsequent option periods through September 30, 2021 DRAFT STATEMENT OF WORK: 1. NYHHS (VA New York Harbor Healthcare System), New Jersey (VA New Jersey Healthcare System), VA Northport, VA Hudson Valley Health Care System and VA James J. Peters (Bronx) Medical Center (hereafter together referred to as VISN 2 South) seek to continue acquiring a Picture Archiving and Communication System (PACS) solution maintaining all current capabilities. The PACS shall utilize a single database, such that any image obtained at ANY VISN 2 South site is easily accessible from any OTHER VISN 2 South site and such that a list of prior imaging exams for any given patient includes imaging exams performed at ALL VISN 2 South facilities. Each entity has its own RIS (VistA). VISN 2 South may wish to regionalize interpretation of imaging studies and therefore needs a PACS that makes this not only possible, but easy to accomplish with minimal advance notice. 2. The proposed PACS shall interface with Vista (via HL7 and/or DICOM) so as to be able to receive patient and exam information, either directly or through imaging equipment as an intermediary. The vendor will continue current support of IHE Integration Profiles and Actors relevant to the iSite PACS platform, and continue to support applicable Actors/Profiles in subsequent releases, if and when available. Under the Service Delivery Model, developed software updates and upgrades for the duration of the contract will be provided at no additional cost, as available to other like/similar customers. 3. The PACS shall be capable of a high degree of integration with a Radiology Voice Recognition System, such as PowerScribe, Commissure or comparable third party vendor. Provided however, VISN 2 South acknowledges that VISN 2 South is solely responsible for its integration of any validated third party vendor(s), such as PowerScribe, Commissure, with the proposed PACS. Integration implies running on the PACS diagnostic workstation and the PACS application passing user authentication and exam information to the voice recognition system, so that users who are already logged into the PACS application and who have selected a specific exam do NOT have to log into the voice recognition application or manually select the exam in the voice recognition application. 4. Since the one PACS will communicate with multiple instances of Vista, the proposed PACS will need to uniquely identify each imaging study, regardless of the site of origin. It shall do this in such a way as to guarantee that the reports are ultimately sent back to the correct Vista system and that any additional site identifiers which might be appended to the accession number are stripped off before the information is sent back to the appropriate Vista system. 5. If the study information is passed from the PACS to the voice recognition system, the PACS shall be able to uniquely identify each study to the voice recognition system as currently functioning. Philips cannot be responsible for the performance of 3rd party functionality. 6.. All imaging studies stored on the iSite PACS shall be available via the work list in under 3 seconds from any Clinical Workstation or Diagnostic Workstation (regardless of age) with 10Mbs LAN (Clinical Workstation) or 100Mbps (Diagnostics Workstation) LAN speed or greater 7. Every user (Diagnostic, Clinical, and Web) shall be presented with a RIS-driven chronological timeline of the patient s complete Radiology history. Images shall be available with a single click and reports shall be easily available, such as with a right click . 8. Images from the PACS shall be viewable throughout the enterprise via a web-based viewer. This viewer shall be interfaced with Vista/CPRS, such that a user who has already selected a given study on a selected patient in CPRS may launch the web-based PACS viewer and view the correct image(s) without the need for additional user authentication or manual selection of the patient or exam. 9. Any study that is work list retrieved using the web access from a standard PC shall be displayed in full fidelity full resolution (in under 3 seconds) with following PC specs: 128MB of RAM, Windows 98 or higher, 350 MHz processor. This performance shall be contractually guaranteed with 1,000 concurrent users. 10. Base cost shall include: Unlimited # of web access licenses at full fidelity, full resolution (no lossy compression) Unlimited # of Diagnostic workstation licenses Unlimited # of Clinical workstation licenses Unlimited # of DICOM associations with scanners 11. Vendor shall warrant per the GSA agreement 99.99% up-time on the system, with financial penalties for non-compliance as outlined in the GSA agreement. System up-time shall be defined as per the GSA agreement. 12. Vendor shall include maintenance and upgrades of all included hardware and software, at no additional cost for the term of the contract. 13. Vendor shall supply, at no additional cost, additional server(s) and storage capacity required to meet the needs of VISN 2 South, for the term of the contract. 14. Vendor shall provide, at no additional cost, 24/7 continuous remote monitoring of the PACS hardware and software, though a VA-approved VPN connection. 15. Vendor shall agree to locate all equipment on VA premises, or other locations as determined by VISN 2 South. 16. Vendor shall comply with all applicable VA security and privacy regulations, as well as applicable non-VA laws and regulations, such as HIPAA. 17. Vendor shall provide, at no additional cost, a complete Disaster Recovery solution, to include: Real-time backup of image files Continuous log files are updated Twice daily incremental backup of DB Weekly full back up DB Disaster Recovery. Backup of Image Data. Philips will back up a copy of all image data from the Hardware to a disaster recovery datacenter to enable the restoration of image data in the event of a loss of data on the Hardware.  Backup of Database. Philips shall incrementally backup the database twice per day and perform a full database backup once per week.  Disaster Recovery Warranty. In the event of a loss of data on the Hardware Philips will use reasonable efforts to restore the most recent stack within 96 hours of notice of a loss of data. Philips will use reasonable efforts to make each additional stack available in 96-hour increments thereafter until all data is available. A stack is defined as a logical grouping of data less than 1.6 terabytes. 18. All images shall be stored on line, all the time, in RAID 5. The system shall not use near-line or off-line storage. 19. Work list Failover The PACS shall have multiple databases that can fail over 20. Vendor shall supply, at no additional cost, 24/7 live technical support by telephone. 21. Data Privacy and Confidentiality: 21.12.1 Where appropriate the system shall comply with the Federal Privacy Act. Each party will implement appropriate policies and procedures for purposes of preventing unauthorized access to data, and unauthorized disclosure of data. All information and data relating to DVA's business submitted to the Contractor under this Agreement shall be treated as confidential by the Contractor and shall not, unless otherwise required by law, be disclosed to any third party by the Contractor without DVA's prior written consent. 21.12.2 To the extent required by the provisions of HIPAA and regulations promulgated there under, the Contractor does hereby assure DVA that it will appropriately safeguard protected Patient Health Information (PHI) made available to or obtained by the Contractor. Without limiting the obligations of the Contractor otherwise set forth in this Agreement or imposed by applicable law, the Contractor agrees to comply with applicable requirements of law relating to PHI and with respect to any task or other activity the Contractor performs on behalf of DVA, specifically the Contractor shall: Not use or further disclose data other than as permitted or required by this Agreement or as required by law; Use appropriate safeguards to prevent use or disclosure of data other than as provided for by this Agreement; Report to DVA any use or disclosure of data not provided for by this Agreement of which the Contractor becomes aware; Make available data in accordance with applicable law; Make internal practices, books, and records relating to the use and disclosure of data received from DVA available to the Secretary of the United States Health & Human Services for purposes of determining DVA' compliance with applicable law (in all events, the Contractor shall immediately notify DVA upon receipt by the Contractor of any such request, and shall provide DVA with copies of any such materials); Make available the information required to provide an accounting of disclosures pursuant to applicable law; and At termination of this Agreement, return or destroy all data received from DVA that the Contractor still maintains in any form and retain no copies of data. 21.12.3 Without limiting the rights and remedies of DVA set forth elsewhere in this Agreement or available under applicable law, DVA may terminate this Agreement without penalty or recourse to DVA if DVA determines from substantial and credible evidence that the Contractor has violated a material term of the provisions of this Section of this Agreement and the Contractor has had an opportunity to cure such breach in accordance with the Federal Acquisition Regulations. Contractor agrees that this Agreement may be amended from time to time ,subject to mutual agreement by both parties, if and to the extent required by the provisions of HIPAA and regulations promulgated there under, in order to assure that this Agreement is consistent therewith. All patient data acquired by the Contractor through the PACS remains the sole property of VA. 21.12.4 Contractor as part of the contract shall provide its solution in such a manner that will allow DVA meet all required regulatory deadlines to maintain full HIPPA compliance. An explanation of what the offeror is currently and will be doing to achieve this shall be included in the technical proposal. Proposed PACS shall comply with the latest version of Philips DICOM Conformance, HL7 Standards Requirements and supportive of the IHE Technical Framework with respect to Integration Profiles and Actors where appropriate for Image Acquisition Modalities in Radiology, Cardiology, Dental, Ophthalmology and Other Specialties , Attachment One of this solicitation. Vendor shall provide via Customer Care, (Technical Support), with the individual opening a trouble ticket a follow-up status update within 3 hours of opening a ticket and a resolution within 8 Hrs. If this is not possible and the trouble ticket needs to be escalated, follow-up status needs to be communicated to the Site Customer Advocate to be prioritized with regard to urgency for resolution. 25. Vendor shall provide a Network Diagram and Data Flow Diagram of the VISN 2 South configuration with IP addresses and Host names. 26. Vendor shall provide a Network Diagram of the Disaster Recovery Plan for VISN 2 South. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE Information Security 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. 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. 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. 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. (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 pre-approved 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 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 $__150.00____ 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-day s 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. 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.