This solicitation requests proposals for a Laboratory Information Management System software to serve as the Toxicology Database for the Federal Aviation Administration's Civil Aerospace Medical Institute. Key requirements include customizable modules and data fields, role-based security and cybersecurity compliance, case information sharing capabilities, a full audit trail, and the ability to create and aggregate case data. Offerors must also migrate data from legacy systems, comply with federal records retention, and achieve 99.5% system availability. Proposals are due by January 24, 2022. The selected contractor must deliver software, training, and documentation within 180 days of award. The National Transportation Safety Board and researchers will use the data to enhance aviation safety.
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Other files attached to Toxicology Database (ToxDB) Software, newest first.
The product must be web-enabled so that users can easily access it from the internet and/or the FAA intranet.
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The system must allow system administration by FAA personnel.
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The product must be browser agnostic so that it is fully functional on FAA’s current standard web browser configurations and is adaptable to future changes in web browser technology
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The product must comply with FAA’s standards for Templates and Branding by adding a standard government login screen consistent with other FAA applications. The government will provide the standard text for this login screen.
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The product must provide full functionality whether being used on a desktop workstation, laptop, or tablet.
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The product must be available and usable 99.5% of the time.
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The product must support at least 25 concurrent users.
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The vendor must provide the FAA with the most current version of the software, as well as provide system updates as new versions become available.
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The vendor must map, migrate, and convert data from the legacy system (Access database based with additional functions written in Visual Basic) into the new system without loss of data integrity
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Technical Requirements
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In order for the product to meet the needs of FSS and AUT who use both legacy programs, the product must provide customizable and configurable modules and customizable and configurable fields for data entry.
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The product must provide role-based security and meet cybersecurity standards of the FAA.
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The product must provide the ability to share case information between different user roles.
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The product must provide a full audit trail for all system activity, including but not limited to log-ins, system changes, user information, data entry, and results.
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The product must provide the ability to create unique alpha-numeric identifiers for each case.
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The product must provide any authorized user with the ability to create a case.
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The product must provide the ability to create accident cases that include multiple individual accident victims.
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The product must provide the ability to perform data aggregation for comparison, benchmarking, and trend analysis.
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The product must provide fully customizable workflow.
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The product must provide workload management, including but not limited to, resource availability, specimen tracking, batch production, testing results, QA documentation, reports, and database search functionality
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The product must provide the ability to document case-related information, including, but not limited to, chain of custody, evidence storage and retrieval details, and dates of entry and revision.
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The product must provide the ability to store and retrieve electronic images, documents and other file types, including, but not limited to, Microsoft Word, Excel, PDF, JPEG, PNG, SVG.
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The product must provide the ability to view and search cases, including the ability to search according to the contents of any included data field, at all times following case creation, including after case closure.
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The product must include the ability to create long text fields with more than 4000 characters.
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The product must provide the ability to run queries for data stored within the system. These queries must be simple to perform for persons without a programming background.
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The product must provide the ability to generate and store specimen inventory templates.
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The product must provide a batch analysis function to support the creation of tests for multiple cases or samples.
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The product must provide a table to include numerous drugs and the ability for users to add drugs to tables.
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The product must provide control charts to monitor and evaluate quality control samples. This would include blind and open controls material.
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The product must provide the ability to create medical/injury code tables that include descriptions (e.g., ICD-10-CM, CPT, and AIS codes) and associate them to relevant findings. The tables must provide the ability for search capabilities and drop down selection for recurrent use on all cases within the database. These tables must be accessible for use in multiple data fields.
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The product must provide the ability to create tables for contact information for investigatory personnel. The tables must be editable on all cases.
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The product must provide the ability to create tables with unique drop-down selections for airman certification, aircraft registry, and related information. The table must have the capability for updating, adding, and deleting the aircraft information.
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The product must provide the ability to generate reports. This must include both built-in standard reports and the ability to create and customize reports ad hoc.
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The product must provide the ability to export any report in at least, but not limited to, Microsoft Excel or PDF format.
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As ToxDB is considered a Federal “system of record”, the product must provide the ability to archive records, so personnel can ensure records are appropriately maintained in accordance with Federal record retention regulations. The product must have the ability to auto-create some standardized data collection fields, such as “Date case created”.
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The product must have the ability to share demographic information for accidents so the end-user does not have to re-enter demographic information. For example, it should have the ability to copy the location, city, state, etc., for mid-air accidents or for multiple victims on a single accident.
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The product must have the ability to interface with other databases on a regular basis and will import desired data.
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The product must have the ability to notify the end user about any fatal accidents that the NTSB has issued the findings of the accident. The findings must be easily viewable to the end-user.
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The product must have the ability to allow the end-user to copy and paste data into/from the product
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The product must have the ability to allow the admin user the ability to delete or modify a case or specific information.
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Information System Security Requirements
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The product must support installation on a FedRAMP Authorized Cloud instance, using Platform-as-a-Service (PAAS).
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The system must account for continuity of operations, so the system is recoverable in the event of a disaster, and so that it complies with FAA/DOT/Government regulations such as NIST 800-53.
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The product must support SAML, OATH, or PIV card multi-factor authentication.
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The product must provide role-based permissions based on authorization levels (i.e., researcher, support personnel, supervisory medical officer, etc.).
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The product must comply with the Health Insurance Portability and Accountability Act (HIPAA).
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The product must comply with the Privacy Act of 1974.
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The product must comply with the FAA’s Information Security and Privacy Program & Policy 1370.121.
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The product must comply with Web Content Accessibility Guidelines (WCAG) 2.0 Levels A and AA, in order to meet Department of Transportation (DOT) mandates on accessibility.
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The product must show users the standard FAA privacy notice when accessing the system in order to meet FAA/DOT/Government regulations such as DOT Order 1351.33.
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The product must encrypt all Personally Identifiable Information (PII) in transit and at rest using Advanced Encryption Standard (AES)-256 level encryption, in accordance with FAA/DOT/Government regulations on protecting PII.
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The product must use standard FAA access controls, Federal Identity, Credential, and Access Management (FICAM), so user authentication complies with Federal regulations.
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The product must follow modern US Government cybersecurity guidelines according to the National Institute of Standards and Technology (NIST) Cybersecurity framework (https://www.nist.gov/cyberframework).
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Documentation
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The contractor must supply, in English, the documentation needed to enable CAMI personnel to operate the product. All documentation is to meet best commercial standards.
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Agreements concerning documentation must allow a right-to-copy. A documentation review of drafts of all documentation must be held 45 days before final acceptance. Functional draft documentation must be available and will be approved at the time of final acceptance, and the final version of documentation and training materials must be delivered within 60 days after final acceptance.
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Training and Job Performance Aids (JPAs)
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Orientation Training
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The contractor must provide on-site orientation training for FAA users of the system. This training must cover general operation of the software. Orientation training must be provided within 30 days after final acceptance of the product.
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Instructional aids and materials must be provided to facilitate the learning process and to illustrate special relationships, functions, properties and procedures, and are to be employed during orientation training
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Job-Performance Aids
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Job-performance Aids (JPAs) are procedural, highly prescriptive sets of task steps that provide step-by-step guidance to a user in performing a particular task or function. Text and graphics fields must be integrated within a document (either hard copy or computerized) which can be easily used on the job and which can be quickly revised and updated.
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To support this activity, the vendor must provide the government with a Data Dictionary, and other assistance such as access to graphics or screen shots, and program documentation regarding software functions, as needed for the Government to create customized JPAs.
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Acceptance Test Procedure
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The contractor will demonstrate that all functions perform successfully when accessed by FAA personnel on FAA computing equipment. The contractor will document and demonstrate security functions in a manner acceptable to the FAA Chief Information Officer.
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Contractor must provide on-site technical and maintenance support during final acceptance testing.
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Government Furnished Property
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After award of the contract, the Government will provide access to existing ToxDB system, including the ToxFlo and MANTRA applications, for data migration. (Details will be described at the post-award conference.)
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The Government will not provide/supply the contractor with any other government furnished property or supplies in the performance of this contract.
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Period of Performance
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The Contractor must coordinate delivery and installation of the system with the Contracting Officer’s Representative (COR). Contractor must provide on-going system support with appropriate software updates. Customer Support must be available 24/7 telephonically or via email.
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The contractor must provide the software, training, documentation and acceptance testing within 180 business days of contract award.
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Place of Performance
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The Contractor, unless otherwise specified, must provide the deliverables and perform the services for this Contract in the FAA CAMI (5900 S.W. 66th / Building 13) located on the Mike Monroney Aeronautical Center (MMAC) in Oklahoma City, OK. If the contractor is required to be on-site at either location, the contractor’s representatives will be escorted by Federal Government employees at all times and must report to FAA Security with identification.
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Security
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The Contractor must coordinate installation of COTS software with the COR in accordance with the statement of work. The Contractor must be escorted throughout the FAA facility when onsite visits are required. During visits, the Contractor must submit to the COR a list of visiting team members by name no later than seven (7) business days prior to scheduled integration for U.S. citizens, or no later than twenty-one (21) days prior to the scheduled integration for foreign nationals.
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Program Management
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The Contractor must provide a program manager (PM) to manage the program in accordance with the Statement of Work (SOW) and/or contract requirements. The Contractor must provide the necessary program management including, but not limited to, project management, risk, communications, financial, cost, schedule, and resource management to accomplish the requirements of this SOW.
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The Contractor must include, but not be limited to, program management activities such as contract administration, finance, obtaining and retaining qualified personnel, as well as technical support across all phases of the program. The PM must have sufficient corporate resources and authority to direct, execute, and control all elements of the program to ensure efficient and timely program execution. The PM must be the Contractor’s focal point for all required program tasks, including the coordination of all site visits (scheduled and unscheduled). The PM must remain current on related contract activities and be prepared to present and discuss the current program status as well as forecasts related to contract activities with the Government Contracting Officer (CO), the COR, and/or the Government PM.
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Quality Assurance
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The Contractor must perform services in accordance with industry standard quality and/or process management practices, for example, ISO 9000, Agile, CMMI, or ITIL.
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The Contractor must provide evidence of qualified personnel needed to accomplish the requirements of this SOW by submitting resumes of proposed Contractor team members.
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Communication
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Contractor must provide, via contractor’s program manager, status updates every two weeks, including, but not limited to, information on current and projected: technical progress, cost, milestone schedule performance, and action items. Format for this update can be email, PDF, word document, etc., at the discretion of contractor.
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Invoicing
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The Contractor must submit invoices in accordance with the contract provisions per service call. Acceptance and payment is contingent upon FAA’s receipt of acceptable service and the respective acceptable invoice. The Contractor must ensure sufficient funding exists on contract prior to providing service.
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Contract Deliverables
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Contractor must provide, within 30 days of contract award, a milestone plan, outlining the anticipated dates of their development, test, and delivery milestones to meet the requirements of this SOW.
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The contractor must provide documented action items. Open actions must be addressed at each biweekly status update, as described in section 12.
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The contractor must provide the hardware (if applicable) and software in addition to any additional material normally provided during the purchase of the software components.
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Travel
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The contractor must travel as required to integrate existing data from the legacy systems in coordination with the Government. The contractor’s travel expenses will be reimbursed expenses in accordance with the Federal Travel Regulations.
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