6515--629-22-2-7024-0094, Endo software (VA-22-00037892)

Southeast Louisiana Veterans Health Care System Associate Director, Patient/Nursing Services STATEMENT OF WORK: EndoVault Electronic Nursing Record Software License BACKGROUND: Nurses are currently logging into three different programs to gather information for each case. Vital signs are manually entered. Specimen labels are handwritten. Providers are currently using Endosoft for documentation and nursing staff uses CPRS and VISTA for assessment and documentation. The process is not efficient and increases the risk for error which impacts patient safety. OBJECTIVES: Integrated on the same database as procedure documentation to reduce duplication by sharing clinical data between physicians and nursing staff. ONC meaningful use certified Electronic Health Record (EHR). Fully customizable history, pre, intra, post, and discharge nursing documentation templates meeting Joint Commision (JC), Association of Operating Room Nurses (AORN,) and Society of Gastroenterology Nurses and Associates (SGNA) requirements. Allows for electronic signatures, patient education material, inventory management, and scope sterilization. Includes ability to interface with GE physiological monitors. SCOPE: Software must have: Customize templates to manage endoscopy workflow Customize fields and data sets specific to endoscopy Ability to create standardized workflows based on similar diagnoses Pre-built reports built into the system to track patient care and quality indicators Ability to allow the user to build ad-hoc reports as needed Automated label printing for pathology Interface with Vista to gather ADT information using the HL7 Interface to gather real-time patient information. HL7 ADT (Admit, Discharge and Transfer) messages are used to communicate patient demographics, visit information and patient state at a healthcare facility. ADT messages are one of the most widely-used and high volume HL7 message types, as it provides information for many trigger events including patient admissions, registrations, cancellations, updates, discharges, patient data merges, etc. Document compliance with The Joint Commission A variety of reports that describe the overall system performance for quality measurement, e.g. Timeliness of Care, Number of Cases, etc. Store the actual files securely in a secure server in the Southeast Louisiana Veterans Health Care System (SLVHCS) Ensure that no data goes beyond the VA firewall Store historical data Provide technical support at a minimum of daily by phone in CST and by E-mail 24 hours daily Protect against cyber threats and meet VA IT standards for software. Twelve (12) licenses to be installed on Six (6) non-networked label printers MAINTENANCE TASKS: Database support services System issues annual updates. Updates consist of new features and program enhancements. Handle routine help requests from the site. Assure the full operational status of the system hardware. Assure the full operational status of the system software. Handle required OS and server system software updates. Help manage the repair of any hardware malfunctions. SETUP AND ACTIVATION: Newest release of the software Consultation service for implementation and system configuration Software maintenance and support (unlimited access to toll free line and web support, software updates and user workshops) Interface manager module HL7 ADT or PDF interface Onsite training to end users prior to go-live Onsite training to administrative users prior to go-live Follow up with any required meetings or technical documentation. Ensure functionality Supply site end users with User Manual and participate in training. 3. Delivery 3.1 Contractor shall deliver, install and configure all equipment to the Southeast Louisiana Veterans Health Care System (SLVHCS), 2400 Canal St, Loading Dock (entrance Tulane Avenue) New Orleans, LA 70119 on or before 03/20/2022. 3.2 Deliver materials to job in manufacturer's original sealed containers with brand name marked thereon. 3.3 Package to prevent damage or deterioration during shipment, handling, and storage. 3.4 Maintain protective covering in place and in good repair until delivery is necessary. 3.5 Any government requested delayed delivery up to 90 days after initial award delivery date, shall be at no additional cost to the Government. 3.6 A pre-delivery meeting will be conducted 60 days prior to initial award delivery date for verification of delivery. 4. INSPECTION AND ACCEPTANCE: 4.1 The Contractor shall conduct a joint inspection with the COR upon delivery of tools. 4.2 Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s). 5. DELIVERABLES 5.1 Operation and Maintenance Manuals 5.1.1 Binders - Quantity (2) each for items 2.1 5.1.2 Digital Copies- Quantity (1) each for items 2.1 5.2 Deliver compilation of all manufacturer recommended maintenance schedule and operation materials packaged in binder(s) to COR upon completion of installation. 6. SECURITY REQUIREMENTS SECURITY AND HIPPA COMPLIANCE CONSIDERATIONS: In reference to VHA Handbook 6500.6 Appendix A, Block 6, the equipment (or service) included in this contract involves connection of IT devices to a VA network. Therefore, C&A and SAP apply, and the following from Appendix B & C applies. An interconnection between contractor and SLVHCS will exist with interfaces to VistA: Census data, patient movement data, and clinical information using Health Level 7 interfaces. All interfaces will feed contractors system to eliminate points of double data entry and improve efficiencies. All data from these feeds will be compliant with protections for PHI. (Appendix B) The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information protection, patient privacy, and information system security as delineated in this contract. During contract performance, contractor may require access to VA facility, equipment, information systems, or sensitive data; to provide services, install, train, maintain or repair equipment. Contractor will provide evidence of training to the COR, if requested. If contracted staff have access to the VA network, Information Technology Network, protected health information (PHI) or access to VA systems they are also required to take the VA Privacy & Information Security Awareness Training (VA10176) prior to being given access to VA network. During equipment install, warranty repair or maintenance, the contractor may have physical or administrative access, to the equipment included in this contract, that capture, store, and process VHA sensitive information. If warranty repair is done off-site, all hard drives or other data storage devices will be removed, and if done on-site will be purged of data, prior to contractor access. ePHI stored in equipment will be transferred to either VistA Imaging/Information systems or to a dedicated file server for long-term retention and incorporation into patient records. 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. 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. 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. 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 SecurityAwareness 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. 7. REFERENCE (S): 1. VA Affairs Handbook 6500, Risk Management Framework for VA Information Systems Tier 3: VA Information Security Program, 10 Mar 2015. 2. Veterans Health Administration Procurement Manual (VHA PM) 11/3/2014. 3. VA Handbook 1901.01, Health Information Management and Health Records 19 Mar 15. 4. VHA Handbook 1605.5, Business Associate Agreements 22 July 2014 5. Privacy Act of 1974 (5 U.S.C. 552a). 6. Memo: VA Maintenance/Installation (Warranty) Contracts (VAIQ 7058822), 24 Mar 2011. 7. Veterans Affairs Handbook 6500.6 Contract Security, 12 Mar 2010. 8. HIPPA Privacy Rule (See 45 CRF 164, 502(a)(1) 9. VA Directive 6512, Secure Wireless Technology, dated 4 Nov 2009 10. Memo: Contractors Excepted from Background Investigations and Screenings, 8 Feb 2007 7. WARRANTY: 7.1 The contractor shall provide all manufacturers warranty with products upon delivery.