7B22--614-26-3-560-0221 - IVX Omnicell Workflows Equipment

Page 4 of 25 Page 1 of This is not a request for quotes; the Government is seeking information for market research purposes only. VA Network Contracting Office (NCO) 9 is seeking sources interested and capable of providing the items as described in the attached Product Description. The North American Industry Classification System (NAICS) is 339112 The Service Code (PSC) is 6515 - Medical and Surgical Instruments, Equipment, And Supplies Responses to this notice shall include company/individual name, size status for the above reference NAICS code, a service capability statement, SAM Entity Unique Identifier (EUI), address, point of contact, and examples of similar facilities to which similar items have been provided. Contractors must provide information on whether they are certified SDVOSB, VOSB, Hub zone, 8(a), women-owned concern. If standard company brochures will be provided as a response to this Source Sought ensure that additional information tailored to this notice is included. This is not a solicitation for quotes. If a solicitation is issued, it will be announced on the Contract Opportunities website https: respond to that solicitation announcement separately from the response to this announcement. Contractors must be registered in System for Award Management (SAM), see internet site: https://www.sam.gov for information about registration. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each. Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner? If you are in GSA, please provide schedule and contract number. Responses to this notice must be submitted via email to daymeion.brantley@va.gov. No telephone inquiries will be accepted. DISCLAIMER This Sources Sought is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Sources Sought that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Sources Sought. Veterans Affairs, NCO-9, is seeking information for vendors interested and capable of providing the service below: STATEMENT OF WORK Automated Sterile Compounding Workflow Solution BACKGROUND: The Memphis VA Medical Center s (VAMC) Pharmacy Service manually compounds sterile non-hazardous and hazardous intravenous (IV) compounds for patient administration. Pharmacy Service currently follows USP 797 standards. However, USP 800 standards have been published and must be implemented by December 2019. In addition, new USP 797 guidelines are projected to be published by June 2020. To remain compliant with these USP standards as well as look at new opportunities to prevent medication errors, the Pharmacy Service is looking at automation to help improve patient safety by reducing medication errors and ensure all documentation is obtained for compounded products as required by new standards. OBJECTIVE: To install sterile compounding workflow solutions that can be placed inside laminar airflow hoods and biological safety cabinets to improve patient safety and reduce potential medication errors when manual compounding is required. SCOPE OF WORK SCOPE OF WORK: Vendor shall provide five IV workflow solutions for laminar airflow hoods and biological safety cabinets. Vendor shall furnish all accessories, parts and expertise necessary to provide shared maintenance of all equipment at the Memphis VAMC. Equipment Requirements Provides an ISO Class 5 environment and/or can be used within an ISO Class 5 environment Can be used in a negative pressure environment Compatible with closed-system transfer devices Uses integrated barcode scanning for verification of ingredients Uses image recognition for verification of ingredients Uses gravimetric verification Uses cameras to visually document compounding of sterile IV medications Allows for remote pharmacist verification Provides compounding instructions for pharmacy technicians when manual compounding is required Print labels for compounded items Alert to destroy items that do not meet accuracy verification Maintains photo documentation of all compounded items Tracks all medications, lot numbers and expiration dates for items used in compounded medications for recall purposes Flexibility with use of different manufacturers and supplies during times of medication/supply shortages Small footprint that can be used in current spaces Ability to interface with VA software (VistA) via HL7 interface Ability to interface with Simplifi797® software Customized reporting system Ability to log into the automation with username and unique PIN Customer support with remote virtual private network (VPN) ability and onsite repairs available 24 hours per day/7 days per week SCHEDULE: Installation estimated to be completed by January 2026. TERM OF CONTRACT AND PRICING: The VA anticipates the award of a single contract for a one-year lease with four option years. The solicitation will be conducted in accordance with FAR 12 and 15. HOURS OF OPERATION: Not applicable. MAINTENANCE AND TECHNICAL SUPPORT: Provide maintenance on all contractor-provided equipment and installed systems. Contractor shall make provisions for the proper maintenance and functioning of associated equipment, facilities and fixtures as may reasonably be required by pharmacists to perform services hereunder. Provide after-hours support for problems with call-pack periods not to exceed 30 minutes from the placement of a call for assistance PLANNING AND INSTALLATION: Contractor shall develop a project implementation strategy with Memphis VAMC to include the preparation of buildings, establishing telecommunications etc. if necessary The service provider should utilize a point-to-point VPN between themselves and Memphis VAMC, if necessary, to dial into the system for diagnostic or upgrading purposes. All security requirements need to be met. Contractors should provide a system that maintains a minimum of 99% up time performance rate. Failure to provide this may result in a possible contract termination. Contractor shall provide hardware necessary to connect remotely to Memphis VAMC to be utilized at the contractor site. Contractor shall provide facsimile, telephone, computer/laptops, networking and other telecommunication equipment to be utilized at the contractor facility. Contractor shall provide all supplies, services, maintenance, repairs and upgrades required at contractor facility to provide services as described above. Contractor s equipment, hardware, software and supplies shall be compatible with the VA s software and hardware used during performance of this contract, including critical patches and antivirus updates. Contractor shall provide proof of installation of critical patches and/or antivirus updates to the VA upon request. Contractor s network and security system shall be compatible with the VA s network and security system. Contractor shall use any VA furnished items in conjunction with, and exclusively for, performance under this contract. APPENDIX C VA INFORMATION AND INFORMATION SYSTEM SECURITY AND PRIVACY LANGUAGE FOR INCLUSION IN CONTRACTS, AS APPROPRIATE NOTE: Any sections (1-14) which DO NOT apply should not be included in the Statement of Work (SOW), Performance Work Statement (PWS), Product Description (PD) or contract. GENERAL. This entire section applies to all acquisitions requiring any Information Security and Privacy language. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy. VA INFORMATION CUSTODIAL LANGUAGE. This entire section applies to all acquisitions requiring any Information Security and Privacy language. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter contract ) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data General. VA information will not be co-mingled with any other data on the contractor s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies. The contractor shall not make copies of VA information except as specifically authorized and necessary to fulfil the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations. The contractor s firewall and web services security controls, as applicable, shall meet or exceed VA s minimum requirements. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer to all requests for demands for production of or inquiries about VA information and information systems to the VA CO for response. Notwithstanding the provision above, the contractor 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 medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the abovementioned information, the contractor shall immediately refer to such court order or other requests to the VA CO for response. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that are used to store, process, or access VA information that cannot be destroyed shall be returned to VA. The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of VA CO. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS. This section applies when any person requires access to information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor. Contractors and subcontractors shall sign the VA Information Security Rule of Behavior (ROB) before access is provided to VA information and information systems (see Section 4, Training, below). The ROB contains the minimum user compliance requirements and does not supersede any policies of VA facilities or other agency components which provide higher levels of protection to VA s information or information systems. Users who require privileged access shall complete the VA elevated privilege access request processes before privileged access is granted. All contractors and subcontractors working with VA information are subject to the same security investigative and clearance 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 shall be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office of Human Resources and Administration/Operations, Security and Preparedness (HRA/OSP) is responsible for these policies and procedures. Contract personnel who require access to classified information or information systems shall have an appropriate security clearance. Verification of Security Clearance shall be processed through the Special Security Officer located in HRA/OSP. Contractors shall conform to all requirements stated in the National Industrial Security Program Operating Manual (NISPOM). All contractors and subcontractors shall comply with conditions specified in VAAR 852.204-71(d); Contractor operations required to be in United States. All contractors and subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S. services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR/CO in writing prior to access being granted. The contractor shall notify the COR/CO in writing immediately (no later than 24 hours) after personnel separation or occurrence of other causes. Causes may include the following: Contractor/subcontractor personnel no longer have a need for access to VA information or VA information systems. Contractor/subcontractor personnel are terminated, suspended, or otherwise have their work on a VA project discontinued for any reason. Contractors believe their own personnel or subcontractor personnel may pose a threat to their company s working environment or to any company owned property. This includes contractor-owned assets, buildings, confidential data, customers, employees, networks, systems, trade secrets and/or VA data. Any previously undisclosed changes to contractor/subcontractor background history are brought to light, including but not limited to changes to background investigation or employee record. Contractor/subcontractor personnel have their authorization to work in the United States revoked. Agreement by which contractor provides products and services to VA has either been fulfilled or terminated, such that VA can cut off electronic and/or physical access for contractor personnel. In such cases of contract fulfillment, termination, or other causes; the contractor shall take the necessary measures to immediately revoke access to VA network, property, information, and information systems (logical and physical) by contractor/subcontractor personnel. These measures include (but are not limited to): removing and then securing Personal Identity Verification (PIV) badges and PIV Interoperable (PIV-I) access badges, VA-issued photo badges, credentials for VA facilities and devices, VA-issued laptops, and authentication tokens. Contractors shall notify the appropriate VA COR/CO immediately to initiate access removal. Contractors/subcontractors who no longer require VA access will return VA issued property to VA. This property includes (but is not limited to) documents, electronic equipment, keys, and parking passes. PIV and PIV-I access badges shall be returned to the nearest VA PIV Badge Issuance Office. Once they have had access to VA information, information systems, networks and VA property in their possessions removed, contractors shall notify the appropriate VA COR/CO. TRAINING. This entire section applies to all acquisitions which include section 3. All contractors and subcontractors requiring access to VA information and VA information systems shall successfully complete the following before being granted access to VA information and its systems: VA Privacy and Information Security Awareness and Rules of Behavior course (Talent Management System (TMS) 10176) initially and annually thereafter. Sign and acknowledge (electronically through TMS #10176) understanding of and responsibilities for compliance with the Organizational Rules of Behavior, relating to access to VA information and information systems initially and annually thereafter; and Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system or information access [to be defined by the VA program official and provided to the VA CO for inclusion in the solicitation document i.e., any role-based information security training]. The contractor shall provide the COR/CO with a copy of the training certificates and certification of signing the Organizational Rules of Behavior for each applicable employee within five days of the initiation of the contract and annually thereafter, as required. Failure to complete the mandatory annual training 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 required training is complete. SECURITY INCIDENT INVESTIGATION. This entire section applies to all acquisitions requiring any Information Security and Privacy language. The contractor, subcontractor, their employees, or business associates shall immediately (within one hour) report suspected security / privacy incidents to the VA OIT s Enterprise Service Desk (ESD) by calling (855) 673-4357 (TTY: 711). The ESD is OIT s 24/7/365 single point of contact for IT-related issues. After reporting to the ESD, the contractor, subcontractor, their employees, or business associates shall, within one hour, provide the COR/CO with the incident number received from the ESD. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved and the circumstances surrounding the incident, including the following: The date and time (or approximation of) the Security Incident occurred. The names of individuals involved (when applicable). The physical and logical (if applicable) location of the incident. Why did the Security Incident take place (i.e., catalyst for the failure). The amount of data belonging to VA was believed to have been compromised. The remediation measures the contractor is taking to ensure no future incidents of a similar nature. After the contractor has provided the initial detailed incident summary to VA, they will continue to provide written updates on any new and relevant circumstances or facts they discover. The contractor, subcontractor, and their employes shall fully cooperate with VA or third-party entity performing an independent risk analysis on behalf of VA. Failure to cooperate may be deemed a material breach and grounds for contract termination. VA IT contractors shall follow VA Handbook 6500, Risk Management Framework for VA Information Systems VA Information Security Program, and VA Information Security Knowledge Service guidance for implementing an Incident Response Plan or integrating with an existing VA implementation. 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 the VA Office of 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 violations 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. The contractor shall comply with VA Handbook 6500.2, Management of Breaches Involving Sensitive Personal Information, which establishes the breach management policies and assigns responsibilities for the oversight, management and reporting procedures associated with managing of breaches. With respect to unsecured Protected Health Information (PHI), the contractor is deemed to have discovered a data breach when the contractor knew or should have known of breach of such information. When a business associate is part of VHA contract, notification to the covered entity (VHA) shall be made in accordance with the executed BAA. If the contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach involving any VA sensitive personal information the contractor/subcontractor processes or maintains under the contract; the contractor shall pay liquidated damages to the VA as set forth in clause 852.211-76, Liquidated Damages Reimbursement for Data Breach Costs. INFORMATION SYSTEM DESIGN AND DEVELOPMENT. This entire section applies to information systems, systems, major applications, minor applications, enclaves, and platform information technologies (to include the subcomponents of each) designed or developed for or on behalf of VA by any non-VA entity. Information systems designed or developed on behalf of VA at non-VA facilities shall comply with all applicable Federal law, regulations, and VA policies. This includes standards for the protection of electronic Protected Health Information (PHI), outlined in 45 C.F.R. Part 164, Subpart C and information and system security categorization level designations in accordance with FIPS 199, Standards for Security Categorization of Federal Information and Information Systems and FIPS 200, Minimum Security Requirements for Federal Information Systems. Baseline security controls shall be implemented commensurate with the FIPS 199 system security categorization (reference VA Handbook 6500 and VA Trusted Internet Connections (TIC) Architecture). Contracted new developments require creation, testing, evaluation, and authorization in compliance with VA Assessment and Authorization (A&A) processes in VA Handbook 6500 and VA Information Security Knowledge Service to obtain Authority to Operate (ATO). VA Directive 6517, Risk Management Framework for Cloud Computing Services, provides security and privacy requirements for cloud environments. VA IT contractors, subcontractors and third-party service providers shall address and/or integrate applicable VA Handbook 6500, VA Handbook 6517, Risk Management Framework for Cloud Computing Services and Information Security Knowledge Service specifications in delivered IT systems/solutions, products and/or services. If systems/solutions, products and/or services do not directly match VA security requirements, the contractor shall work though the COR/CO to identify the VA organization responsible for governance or resolution. Contractors shall comply with FAR 39.1, specifically the prohibitions referenced. The contractor (including producers and resellers) shall comply with Office of Management and Budget (OMB) M-22-18 and M-23-16 when using third-party software on VA information systems or otherwise affecting the VA information. This includes new software purchases and software renewals for software developed or modified by major version change after the issuance date of M22-18 (September 14, 2022). The term software includes firmware, operating systems, applications and application services (e.g., cloud-based software), as well as products containing software. The contractor shall provide a self-attestation that secure software development practices are utilized as outlined by Executive Order (EO)14028 and NIST Guidance. A third-party assessment provided by either a certified Federal Risk and Authorization Management Program (FedRAMP) Third Party Assessor Organization (3PAO) or one approved by the agency will be acceptable in lieu of a software producer's self-attestation. The contractor shall ensure all delivered applications, systems and information systems are compliant with Homeland Security Presidential Directive (HSPD) 12 and VA Identity and Access management (IAM) enterprise identity management requirements as set forth in OMB M-19-17, M-05-24, FIPS 201-3, Personal Identity Verification (PIV) of Federal Employees and Contractors (or its successor), M-21-31 and supporting NIST guidance. This applies to Commercial Off-The-Shelf (COTS) product(s) that the contractor did not develop, all software configurations and all customizations. The contractor shall ensure all contractors delivered applications and systems provide user authentication services compliant with VA Handbook 6500, VA Information Security Knowledge Service, IAM enterprise requirements and NIST 800-63, Digital Identity Guidelines, for direct, assertion-based authentication and/or trust-based authentication, as determined by the design and integration patterns. Direct authentication at a minimum must include Public Key Infrastructure (PKI) based authentication supportive of PIV and/or Common Access Card (CAC), as determined by the business need and compliance with VA Information Security Knowledge Service specifications. The contractor shall use VA authorized technical security baseline configurations and certify to the COR that applications are fully functional and operate correctly as intended on systems in compliance with VA baselines prior to acceptance or connection into an authorized VA computing environment. If the Defense Information Systems Agency (DISA) has created a Security Technical Implementation Guide (STIG) for the technology, the contractor may configure to comply with that STIG. If VA determines a new or updated VA configuration baseline needs to be created, the contractor shall provide required technical support to develop the configuration settings. FAR 39.1 requires the population of operating systems and applications includes all listed on the NIST National Checklist Program Checklist Repository. The standard installation, operation, maintenance, updating and patching of software shall not alter the configuration settings from VA approved baseline configuration. Software developed for VA must be compatible with VA enterprise installer services and install to the default program files directory with silently install and uninstall. The contractor shall perform testing of all updates and patching prior to implementation on VA systems. Applications designed for normal end users will run in the standard user context without elevated system administration privileges. The contractor-delivered solutions shall reside on VA approved operating systems. Exceptions to t...