MODIFICATION
D -- Pathology and Laboratory Medicine Service National Database
- Notice Date
- 8/16/2023 11:27:33 AM
- Notice Type
- Solicitation
- Contracting Office
- TECHNOLOGY ACQUISITION CENTER NJ (36C10B) EATONTOWN NJ 07724 USA
- ZIP Code
- 07724
- Solicitation Number
- 36C10B23R0024
- Response Due
- 8/18/2023 10:00:00 AM
- Archive Date
- 10/17/2023
- Point of Contact
- Luis Lozada-Santiago, Contract Specialist
- E-Mail Address
-
luis.lozada-santiago@va.gov
(luis.lozada-santiago@va.gov)
- Awardee
- null
- Description
- Pathology and Laboratory Medicine Program Office Database Solution VA-23-00029851 Page 14 of 33 PRODUCT DESCRIPTION (PD) TEMPLATE DEPARTMENT OF VETERANS AFFAIRS Office of Information & Technology Pathology and Laboratory Medicine Pathology and Laboratory Medicine Program Office Database Solution Date: 7-25-2023 VA-23-00029851 PD Version Number: 1.8 BACKGROUND The Department of Veterans Affairs (VA), Office of Information & Technology (OIT), Pathology and Laboratory Medicine (PLM) and National Radiology Program (NRP) strive to provide high quality, effective, and efficient Information Technology (IT) services to those responsible for providing care to the Veterans at the point-of-care as well as throughout all the points of the Veterans health care in an effective, timely and compassionate manner. VA depends on Information Management/Information Technology (IM/IT) systems to meet mission goals. The mission of the Pathology and Laboratory Medicine is to ensure clinical laboratories in the VA perform at high quality and set the standard for the practice of laboratory medicine for our Veterans. The mission of the National Enforcement Office is to oversee and enforce the Clinical Laboratory Improvement Act of 1988 as well as those portions of the Public Health Services Act, Health Insurance Portability and Accountability Act (HIPAA), Health Information Technology for Economic and Clinical Health (HITECH) Act, Maintaining Internal Systems and Strengthening Integrated Outside Network (MISSION) Act, and the Coronavirus Aid, Relief, and Economic Security (CARES) Act related to laboratory services ensuring quality of services provided by VA clinical laboratories are in compliance with regulatory, accreditation, and policy guidelines. This acquisition is necessary to move the program office mission forward and to aid the clinical laboratories in improving their performance and quality. The current PLM database is over 20 years old and no longer can handle the complex issue of the modern accreditation model nor the need for data to drive innovation and performance improvement. The unique nature of the VA accreditation program that not only acts as the VA Clinical Laboratory Improvement Amendments (CLIA) provider but also performs on site audits the VA requires laboratory accreditation software to support these activities. OPTIONAL TASK 1 - COMMERCIAL-OFF-THE-SHELF (COTS) PRODUCT REQUIREMENTS The VA PLM Services require a cloud-based Software as a Service (SaaS) solution to manage the lifecycle of Laboratory accreditation and CLIA processes. This solution must allow for Configuration of up to 160 facility accounts, these 160 facility accounts would organize up to 1100 different CLIA accreditation cycles and audit activities associated within account. Each account would have multiple users with role-based data access. Configuration of a centralized administrative or super user account that can view/manage and manipulate data within all accounts. This account must have up to 20 users. Solution must be able to support up to 10 concurrent users within accounts Configuration or filtering option to view/manage data in VA defined regions Accommodate VA Active Directory synchronization or connection to support account creation. VA Active Directory synchronization must be a native function without additional on premises devices. The migration of current CLIA information The migration of current Laboratory Accreditation data Communication method between central office and facility accounts Uploading of documents into solution associated with laboratory accreditation or CLIA lifecycle, file size may be up to 5 MB Allow storage of lifecycle information and documents that minimally meet VA record retention guidelines. Manage the lifecycle of laboratory accreditation including: Configured VA standards portal/tool Audit scheduling feature Audit findings uploading/access feature Audit workflow process Corrective action response submission method Audit completion communication and tracking Manage the lifecycle of CLIA initiation/change/renewal including: Configured application Submission workflow process Configured VA CLIA certificates/letters of acknowledgement CLIA workflow with notices/alerts when action needed Solution must be combatable with VHA government furnished equipment. The solution must allow for future customization as needs expand. Training for VA employees provided by a qualified professional. Training must occur no later than 10 days after solution goes live, shall be conducted virtually and be custom to user roles. This solution shall not have any protected health information (PHI/PII) stored or submitted to the solution. Deliverables: SaaS and configuration for laboratory accreditation/CLIA solution OPTIONAL TASK 1 - CONFIGURATION PROJECT MANAGEMENT REQUIREMENTS Configuration Kick-off Meeting The Contractor shall conduct a Kick-off Meeting with the VA Program Manager (PM), COR, and Implementation Manager to discuss configuration schedule. This meeting may be held in conjunction with the post award conference, if applicable. The Contractor shall also present the Master Configuration Scheduled and Configuration Weekly Progress Report format for review and approval by the Government. Master Configuration Schedule The Contractor shall provide a Master Configuration Schedule that outlines the order, estimated time frame, information needed from National Enforcement Office, and other configuration details. The Master Configuration Schedule progress and changes shall be tracked using Configuration Weekly Progress Report and be communicated to the COR and Program Manager as part of the Weekly Progress report. The Master Configuration Schedule shall be submitted in Microsoft Excel Format and shall clearly identify each configuration step. Configuration Weekly Progress Report The Contractor shall provide a Configuration Weekly Progress Report which shall identify the items configured and status of configuration schedule. In addition, the Configuration Weekly Progress Report shall identify any problems and provide a description of how the problems were resolved/addressed. If problems have not been completely resolved, the Contractor shall provide an explanation and status of resolution. Configuration Weekly Progress Reports shall be submitted in Microsoft Excel Format and shall clearly identify the status of each configuration step. Deliverables: Master Configuration Schedule Configuration Weekly Progress Report ASSESSMENT, AUTHORIZATION AND CONTINUOUS MONITORING (BASE PERIOD) Based on FedRAMP classification only one subsection of 3.0 will apply 3.1.1, 3.1.2 or 3.1.3. IF THE SOLUTION IS NOT FEDRAMP AUTHORIZED The information system solution selected by the Contractor shall comply with the Federal Information Security Management Act (FISMA). The Contractor shall comply with FedRAMP requirements as mandated by Federal laws and policies, including making available any documentation, physical access, and logical access needed to support this requirement. The Contractor shall provide a SaaS product as defined by the following criteria: Software as a Service (SaaS) is an application delivery model in which the application is hosted on a cloud infrastructure outside the security boundary of VA and is provided to the Cloud Service Customer (CSC) over the internet. The CSC uses the SaaS offering via a thin-client interface, such as a web-browser or a program interface. The CSC subscribes to the SaaS offering and is only responsible for limited application configuration settings. The Cloud Service Provider (CSP) offering the application is responsible for management of the application, safeguarding of data stored or processed by the application, and all elements of the underlying infrastructure. In order to qualify as SaaS for use at VA, and to align with Federal Risk and Authorization Management Program (FedRAMP) requirements, the hosting for the offering must conform to the NIST 800-145 definition of Cloud Computing and thus contain following key characteristics: On-Demand Self-Service: The CSP fully automates the provisioning of both the customer interface and the underlying cloud components of the SaaS offering. In some cases, to the CSP may provision internal resources manually, while providing the CSC an automated interface to request and track the service. Broad Network Access: The SaaS capabilities are available over the internet or over a network that is available from all access points the CSC requires. The SaaS offering is accessible through common platforms (e.g., mobile phones, tablets, laptops, and workstations). Resource Pooling: The computing infrastructure supporting the SaaS offering is shared among more than one CSC using a multi-tenant model, and resources are dynamically assigned depending on customer demand. Rapid Elasticity: Computing capabilities are automatically provisioned and released in a manner that scales with customer demand. In some cases, the scaling of resources may not be fully automated, but it should be fast enough to support the needs of the CSC, which the CSC would have to define. Measured Service: Resource usage, such as storage, processing, bandwidth, and user activity are measured and reported on in a manner that is relevant to the SaaS offering. The SaaS offering must be hosted within the United States and data stored/processed/transmitted within the offering must remain within the United States. CSPs should be aware of FedRAMP and ready to partner with VA through the SaaS FedRAMP Authorization process. Following guidance from the Federal CIO, VA will utilize existing JAB ATO or agency ATO issued by another agency as a starting point for FedRAMP requirements. If neither of those exist, VA will sponsor FedRAMP ATO. VA will be using the FedRAMP baselines as a starting point, since they are specifically tailored for cloud services. The Contractor shall, where applicable, assist with the VA ATO Process at to help achieve agency authorization of the cloud service or migrated application (add Impact level for customer. This should be done by DTC). The Contractor shall complete a FedRAMP System Security Plan (SSP) and supporting documentation within 45 calendar days after contract award. (If Data Security Categorization is High Impact, this will be due 85 calendar days after contract award.) The Contractor shall complete a Third-Party Assessment Organization (3PAO) Security Assessment Plan (SAP) within 90 calendar days after contract award. (If Data Security Categorization is High Impact, this will be due after 130 calendar days after contract award.) The Contractor shall complete a 3PAO Security Assessment Report (SAR) within 140 calendar days after contract award. (If Data Security Categorization is High Impact, this will be due 180 calendar days after contract award.) The Contractor shall afford VA access to the Contractor s and Cloud Service Provider s (CSP) facilities, installations, technical capabilities, operations, documentation, records, and databases. If new or unanticipated threats or hazards are discovered by either VA or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party in accordance with the security addendum B. The Contractor shall not release any data without the consent of VA in writing. All requests for release must be submitted in writing to the Contracting Officer s Representative (COR)/Contracting Officer (CO). For live VA data to be used in this system, a FedRAMP Authorization and Agency ATO will be required. Deliverables: FedRAMP System Security Plan (SSP) and supporting documentation VA Implementation Diagram: This is a VA specific architecture diagram demonstrating the proposed implementation of this system at VA (VAID) 3PAO Security Assessment Plan (SAP) 3PAO Security Assessment Report (SAR) IF THE SOLUTION IS FEDRAMP AUTHORIZED BUT NOT VA FEDRAMP AUTHORIZED The information system solution selected by the Contractor shall comply with the Federal Information Security Management Act (FISMA). The Contractor shall comply with FedRAMP requirements as mandated by Federal laws and policies, including making available any documentation, physical access, and logical access needed to support this requirement. The Contractor shall, where applicable, assist with the VA ATO Process to help achieve agency authorization of the cloud service or migrated application. The Contractor shall provide IRP scenario within 14 days and complete Table-Top exercise within 21 days of award unless current VA IRP can be provided. The Contractor shall provide a System Boundary Diagram that demonstrates implementation and any proposed VA interconnections including required ports and protocols at the time award. The Contractor shall complete a FedRAMP System Security Plan (SSP) and supporting documentation at the time of award. The Contractor shall complete a Third-Party Assessment Organization (3PAO) Security Assessment Plan (SAP) at the time of award. The Contractor shall complete a 3PAO Security Assessment Report (SAR) at the time of award. The Contractor shall afford VA access to the Contractor s and Cloud Service Provider s (CSP) facilities, installations, technical capabilities, operations, documentation, records, and databases. If new or unanticipated threats or hazards are discovered by either VA or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party in accordance with the security addendum B. The Contractor shall not release any data without the consent of VA in writing. All requests for release must be submitted in writing to the Contracting Officer s Representative (COR)/Contracting Officer (CO). In order for live VA data to be used in this system, a FedRAMP Authorization and Agency ATO will be required. Deliverables System Boundary Diagram FedRAMP System Security Plan (SSP) and supporting documentation 3PAO Security Assessment Plan (SAP) 3PAO Security Assessment Report (SAR) IF THE SOLUTION IS FEDRAMP AUTHORIZED AND VA FEDRAMP AUTHORIZED The information system solution selected by the Contractor shall comply with the Federal Information Security Management Act (FISMA) and have a current VA authorization. The Contractor shall comply with FedRAMP requirements as mandated by Federal laws and policies, including making available any documentation, physical access, and logical access needed to support this requirement. The Contractor shall, where applicable, assist with the VA ATO Sustainment Process to help maintain health and quality of agency authorization of the cloud service or migrated application. The Contractor shall provide access to FedRAMP authorized and VA authorized environment. The Contractor shall afford VA access to the Contractor s and Cloud Service Provider s (CSP) facilities, installations, technical capabilities, operations, documentation, records, and databases. If new or unanticipated threats or hazards are discovered by either VA or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party in accordance with the security addendum B. The Contractor shall not release any data without the consent of VA in writing. All requests for release must be submitted in writing to the Contracting Officer s Representative (COR)/Contracting Officer (CO). In order for live VA data to be used in this system, access must be provided to the FedRAMP Authorized and Agency Authorized environment. The Contractor shall participate in monthly Agency and FedRAMP Sustainment meetings. The Contractor shall participate monitoring and reoccurring security artifacts, including monthly POAM reports. Deliverables Dates for current ATO expiration, due at award Most recent monthly POAM (Plan of Action and Milestones) finding reports. OPTIONAL TASK 2 MAMMOGRAPHY ACCREDITATION Expand the VA PLM Services cloud-based SaaS solution to manage the lifecycle of Mammography accreditation. This task configuration must allow for: Adding additional accreditation cycle to existing facility accounts Configuration of a centralized administrative or super user account of the Mammography accreditation process account that can view/manage and manipulate data within mammography accounts. This account must have up to 10 users. The migration of current Mammography accreditation data Communication method between central office and facility accounts Uploading of documents into solution associated with mammography accreditation. Allow storage of lifecycle information and documents that minimally meet VA record retention guidelines. Manage the lifecycle of Mammography accreditation including: Configured application Submission workflow process Audit findings uploading/access feature Audit workflow process Corrective action response submission method Configured VA Mammography certificates Workflow with notices/alerts when action needed The solution must allow for future customization as needs expand. Training for VA employees provided by a qualified professional. Training must occur no later than 10 days after solution goes live, shall be conducted virtually and be custom to user roles. This solution shall not have any protected health information (PHI/PII) stored or submitted to the solution. Deliverables: SaaS configuration for mammography accreditation 5.0 OPTIONAL TASK 3 ADDITIONAL CONFIGURATION Expand the VA PLM/Diagnostic Services cloud-based SaaS solution for additional configuration. The solution may require additional configuration based on user feedback or to comply with changing government needs. The Contractor shall continue to provide improvements through the release of additional software configuration as agreed upon and exercised through the award of optional tasks. Any requirements for additional configuration work shall be coordinated in advance with the government and be mapped to a formal requirement. This optional task may be exercised any time and from time to time up to the not to exceed price throughout the base and option periods of performance. The specific scope of functionality to be delivered for each optional task exercise will be agreed to by the VA PM and COR prior to the exercise of this optional task based on current priorities. Prior to each exercise of this Optional Task, the Contractor shall provide a short description of what work will be completed, a list of all deliverables, and a schedule for implementation including milestones for delivery. The Government will review and agree to the proposed additional configuration, after which a modification will be made to the contract exercising the option and reducing the available ceiling on the line item accordingly. The Contractor shall ensure that the resources provided possess skillsets necessary to analyze business needs and identify solutions compatible with the existing architecture and to successfully deliver the requirements of this Task. Deliverables: Additional SaaS configuration SECTION 508 COMPLIANCE NOTICE OF THE FEDERAL ACCESSIBILITY LAW AFFECTING ALL INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) PROCUREMENTS (SECTION 508) On January 18, 2017, the Architectural and Transportation Barriers Compliance Board (Access Board) revised and updated, in a single rulemaking, standards for electronic and information technology developed, procured, maintained, or used by Federal agencies covered by Section 508 of the Rehabilitation Act of 1973, as well as our guidelines for telecommunications equipment and customer premises equipment covered by Section 255 of the Communications Act of 1934. The revisions and updates to the Section 508-based standards and Section 255-based guidelines are intended to ensure that information and communication technology (ICT) covered by the respective statutes is accessible to and usable by individuals with disabilities. 6.1 SECTION 508 INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) STANDARDS The Section 508 standards established by the Access Board are incorporated into, and made part of all VA orders, solicitations and purchase orders developed to procure ICT. These standards are found in their entirety at: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines. A printed copy of the standards will be supplied upon request. Federal agencies must comply with the updated Section 508 Standards beginning on January 18, 2018. The Final Rule as published in the Federal Register is available from the Access Board: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule. The Contractor shall comply with 508 Chapter 2: Scoping Requirements for all electronic ICT and content delivered under this contract. Specifically, as appropriate for the technology and its functionality, the Contractor shall comply with the technical standards marked here: E205 Electronic Content (Accessibility Standard -WCAG 2.0 Level A and AA Guidelines) E204 Functional Performance Criteria E206 Hardware Requirements E207 Software Requirements E208 Support Documentation and Services Requirements COMPATABILITY WITH ASSISTIVE TECHNOLOGY The standards do not require installation of specific accessibility-related software or attachment of an assistive technology device. Section 508 requires that ICT be compatible with such software and devices so that ICT can be accessible to and usable by individuals using assistive technology, including but not limited to screen readers, screen magnifiers, and speech recognition software. ACCEPTANCE AND ACCEPTANCE TESTING Deliverables resulting from this solicitation will be accepted based in part on satisfaction of the Section 508 Chapter 2: Scoping Requirements standards identified above. The Government reserves the right to test for Section 508 Compliance before delivery. The Contractor shall be able to demonstrate Section 508 Compliance upon delivery. 7.0 GENERAL REQUIREMENTS SOCIAL SECURITY NUMBER (SSN) REDUCTION The Contractor solution shall support the Social Security Number (SSN) Fraud Prevention Act (FPA) of 2017 which prohibits the inclusion of SSNs on any document sent by mail. The Contractor support shall also be performed in accordance with Section 240 of the Consolidated Appropriations Act (CAA) 2018, enacted March 23, 2018, which mandates VA to discontinue using SSNs to identify individuals in all VA information systems as the Primary Identifier. The Contractor shall ensure that any new IT solution discontinues the use of SSN as the Primary Identifier to replace the SSN with the Integrated Control Number (ICN) in all VA information systems for all individuals. The Contractor shall ensure that all Contractor delivered applications and systems integrate with the VA Master Person Index (MPI) for identity traits to include the use of the ICN as the Primary Identifier. The Contractor solution may only use a Social Security Number to identify an individual in an information system if and only if the use of such number is required to obtain information VA requires from an information system that is not under the jurisdiction of VA. INTERNET PROTOCOL VERSION 6 (IPV6) The Contractor solution shall support Internet Protocol Version 6 (IPv6) based upon the memo issued by the Office of Management and Budget (OMB) on November 19, 2020 (https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf). IPv6 technology, in accordance with the USGv6 Program (https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1), NIST Special Publication (SP) 500-267B Revision 1 USGv6 Profile (https://doi.org/10.6028/NIST.SP.500-267Br1), and NIST SP 800-119 Guidelines for the Secure Deployment of IPv6 (https://doi.org/10.6028/NIST.SP.800-119), compliance shall be included in all IT infrastructures, application designs, application development, operational systems and sub-systems, and their integration. In addition to the above requirements, all devices shall support native IPv6 and dual stack (IPv6 / IPv4) connectivity without additional memory or other resources being provided by the Government, so that they can function in a mixed environment. All public/external facing servers and services (e.g. web, email, DNS, ISP services, etc.) shall support native IPv6 and dual stack (IPv6 / IPv4) users and all internal infrastructure and applications shall communicate using native IPv6 and dual stack (IPv6 / IPv4) operations. 8.0 POINTS OF CONTACT VA Program Manager: Name: Anne Chenoweth Voice: (202) 891-9038 Email: Anne.Chenoweth@va.gov Contracting Officer s Representative: Name: Jill Hancock Voice: (202) 549-4592 Email: Jill.Hancock@va.gov Contracting Officer: Name: Matthew Newell Voice: 848-377-5170 Email: matthew.newell@va.gov Contract Specialist: Name: Luis Lozada-Santiago Voice: 848-377-5245 Email: luis.lozada-santiago@va.gov 9.0 INFORMATION SECURITY CONSIDERATIONS: The Assessment and Authorization (A&A) requirements do not apply and a Security Accreditation Package is not required. All VA sensitive information shall be protected at all times in accordance with local security field office System Security Plans (SSP s) and Authority to Operate (ATO) s for all systems/LAN s accessed while performing the tasks detailed in this Product Description. A prohibition on unauthorized disclosure: 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). A requirement for data breach notification: Upon discovery 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, the Contractor/Subcontractor shall immediately notify the COR and simultaneously, the designated ISO, and Privacy Officer for the contract. 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. See VA Handbook 6500.6, Appendix C, paragraph 6.a. A requirement to pay liquidated damages in the event of a data breach: In the event of a data breach or privacy incident involving SPI the contractor processes or maintains under this contract, the contractor shall be liable to VA for liquidated damages for a specified amount per affected individual to cover the cost of providing credit protection services to those individuals. However, it is the policy of VA to forgo collection of liquidated damages in the event the Contractor provides payment of actual damages in an amount determined to be adequate by the agency. Based on the determinations of the independent risk analysis, the Contractor shall be responsible for paying to VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: Notification; One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; Data breach analysis; Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. A requirement for annual security/privacy awareness training: Before being granted access to VA information or information systems, all Contractor employees and Subcontractor employees requiring such access shall complete on an annual basis either: (i) the VA security/privacy awareness training (contains VA security/privacy requirements) within 1 week of the initiation of the contract, or (ii) security awareness training provided or arranged by the contractor that conforms to VA s security/privacy requirements as delineated in the hard copy of the VA security awareness training provided to the Contractor. If the Contractor provides their own training that conforms to VA s requirements, they will provide the COR or CO, a yearly report (due annually on the date of the contract initiation) stating that all applicable employees involved in VA s contract have received their annual security/privacy training that meets VA s requirements and the total number of employees trained. See VA Handbook 6500.6, Appendix C, paragraph 9. A requirement to sign VA s Rules of Behavior: Before being granted access to VA information or information systems, all Contractor employees and Subcontractor employees requiring such access shall sign on annual basis an acknowledgement that they have read, understand, and agree to abide by VA s Contractor Rules of Behavior which is attached to this contract. See VA Handbook 6500.6, Appendix C, paragraph 9, and Appendix D. Note: If a medical device vendor anticipates that the services under the contract will be performed by 10 or more individuals, the Contractor Rules of Behavior may be signed by the vendor s designated representative. The contract must reflect by signing the Rules of Behavior on behalf of the vendor that the designated representative agrees to ensure thatall such individuals review and understand the Contractor Rules of Behavior when accessing VA s information and information systems.
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