BioFortis Labmatrix software

National Cancer Institute (NCI), Center for Cancer Research (CCR) seeks to procure BioFortis Labmatrix software, on a sole source basis, from BioFortis, Inc of 10320 Little Patuxent Parkway Suite 410 Columbia, MD 21044. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1 (b)(1)(i) using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System code is 541511 and the business size standard is $30.0M. The Department of Health and Human Services, National Institutes of Health, National Cancer Institute (NCI), Center for Cancer Research (CCR) is dedicated to the continued development and implementation of a state-of-the-art system which will allow clinical and translational researchers to track the research information and tissue biospecimens which are collected as part of their research. This system will allow researchers to flexibly and accurately record data from all stages of the research process, including natural history information, results of research studies, patient-reported outcomes measure responses, and information about tissue and fluid specimens as they progress through the research process and generate results. The NCI CCR requires BioFortis Labmatrix clinical and translational research management software subscriptions, maintenance and development support services, which are critical to provide the specialized scientific and data management needs of the CCR. The scope of work for this requirement includes the purchase of Clinical and Translational Research Management Software Subscriptions - one (1) site license for unlimited CCR use, and one (1) server license for unlimited CCR use - which includes: training, installation, maintenance and upgrades; the development of applications that interact with the site license; and support services for the development, maintenance and enhancement of the CCR's installation of the software. The specific requirements are listed below. MAINTENANCE Assist in the maintenance of the CCR installation of software, including maintenance and adaptation of data access views, maintenance and adaptation of alternate data loading & transformation methods, and any other functionality for which there is no user-accessible application providing control functions. Perform data extraction, matching, transformation, quality assurance, and migration on legacy data which is identified by the CCR as suitable for migration from legacy tissue and result tracking systems into the CCR's software installation. Develop applicable documentation of all work products produced under this requirement.[KM([1] [JEL2] DEVELOPMENT Provide ongoing development and implementation of changes to the data model as specified by the CCR. Provide ongoing development and implementation of changes to the web-based front-end application to support any changes to the data model underlying the CCR system. Provide ongoing development and implementation of data access application programming interfaces (APIs) as specified by the CCR. INSTALLATION AND UPGRADE Provide and install any software system upgrades and security patches as they are identified and released. TRAINING Provide training, analysis, project management and technical consultation to facilitate new labs that start to migrate from their current systems to the software acquired through this request. Provide training and support as needed for any label printing infrastructure which is required by the software acquired through this request. SPECIAL ORDER REQUIREMENTS The following system features are required:[KM([3] [JEL4] System shall provide a robust data model for recording information about human participants in research (e.g., demographics, relevant dates, relationships between humans) System shall provide facility to create and maintain records of studies, and a data model reflecting the way that studies are implemented in clinical research (e.g., information about amendments, consent documents) System shall provide a way to link humans to studies as subject records, in a manner which allows for individual human records to be linked to one or many studies as subject records, and allows data to be recorded about the subject (e.g., custom identifier for a subject on a study, relevant dates associated with a subject's enrollment or disenrollment on a study, etc.) System shall provide a robust data model for biospecimens, including source and derivation information, specimen types and classes, metadata about biomaterials, and storage information System shall provide a mechanism for bulk creation of data in workflows, such that models can be defined which create all data objects that reflect a given business process (e.g., a person, a subject, and multiple derived biomaterials which are all collected in bulk) System shall provide a way for administrators and/or users to define custom data models which can be applied to subjects, biomaterials, and other objects in the system, along with robust field types for data fields in the models, validation rules, ability to customize the views for viewing and editing the data entered into the custom data models System shall provide a robust data model for biospecimen storage, including sufficient detail for defining biospecimen storage sites, containers (and layouts of containers), storage rules, and mechanisms for transferring biospecimens between storage containers and storage sites. System shall provide a robust query engine which allows end users the ability to create queries for any data contained in it, to save queries in a manner in which they can be run again (both as-is and with variable substitution), to save results of queries within the system, and to export results of queries in common data formats (e.g., Excel, CSV/TSV, JSON, XML) System shall provide the ability to assign unique identifiers to all data objects stored within, and to generate and print labels with these identifiers encoded into 1D and 2D barcodes (along with other relevant data related to the data object, e.g., biospecimen name, subject identifier, etc.) System shall provide the ability to manage access groups and permissions roles such that users access can be partitioned and restricted; these roles should be specific to classes of information (e.g. subject information, biomaterial information, given custom data forms) and should include the ability to perform administrative functionality, the ability to see protected health information (PHI), the ability to edit data, the ability to delete data System shall provide an application programming interface (API) such that CCR can program external applications to be able to access and interact with (query, modify, delete) all data contained within, as well as access business rules contained within (e.g., access biospecimen workflows or label printing) System shall provide a primary, web-based interface for use by end-users and system administrators for all built-in functionality System shall provide facility for importing data into any data object contained within it System shall maintain audit logs such that all data entry, modification, and deletion can be tracked at the field level back to individual actions and users System shall be installable in the CCR's own infrastructure, and maintainable by CCR's operations and administrative staff System shall provide the ability to authenticate users based on both central NIH credentials and on locally configured credentials System shall provide the ability for users and administrators to restrict vocabulary for the object fields for which it is needed by the proper scientific data model (e.g., biomaterial type, biomaterial pathologic status, human participant race, human participant ethnicity) System shall provide the ability to de-identify and anonymize data according to clinical research and human protection standards (e.g., create de-identifying links to data which can be linked back to identifiable information by users with the proper rights and roles, but also transition data through an anonymization process which prevents any user, at any time, from being able to re-identify the source of the data) REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE All deliverables shall be delivered to the system owner, the CCR Office of Information Technology, Deliverable Description Quantity/Media Date Due Software installation media Software media sufficient to install the software on CCR's own server(s) 1, electronic delivery sufficient On date of award: 8/26/2016; and on 1st day of each option period as specified in section 5.0 Software site license License which allows all CCR users to access and utilize the full functionality of the software, without limitation on number of concurrent or overall users Appropriate method of license delivery for the software product's licenses (e.g., software license, USB key, etc.) On date of award: 8/26/2016; and on 1st day of each option period as specified in section 5.0 Software API license (if separately provisioned) License which provides the ability to utilize an API to interact with the software, without limitation on number of concurrent or overall connections Appropriate method of license delivery for the software product's licenses On date of award: 8/26/2016; and on 1st day of each option period as specified in section 5.0 Development support for software Support provided by vendor for tasks including but not limited to software customization, data migration and import, training, manual data entry, system integration, and feature development Sufficient hours to support the needs of the CCR's investigators and research data [KM([5] [JEL6] Beginning on date of award: 8/26/2016 - 8/25/2017; through each option period as specified in section 5.0 Documentation for all work products Documentation of functionality and usage of all work products developed under this SOW Electronic delivery As work products are delivered Access to support request and issue reporting system Access to a system run by the software vendor which allows CCR to report bugs and other support requests and monitor them on an ongoing basis Sufficient accounts/licenses to support all of CCR's administrative users of the software system On date of award: 8/26/2016; and on 1st day of each option period as specified in section 5.0 PERIOD OF PERFORMANCE The period of performance shall consist of a 12-month base period: 8/26/2021 through 8/25/2022 PLACE OF PERFORMANCE Services shall be performed at CCR's site, at the following addresses: NCI Shady Grove 9609 Medical Center Drive Rockville MD 20850 NIH main campus 10 Center Drive Bethesda MD 20892 CCR Software Installation Site: Advanced Technology Research Facility Frederick National Laboratory for Cancer Research 8560 Progress Drive Frederick MD 21701 NCI CCR has an on-going need for BioFortis Labmatrix software. NCI has had an annual contract for Biofortis Labmatrix license and software support for their systems since 2015. This is a follow-on procurement for HHSN261201600015A. Based on the aforementioned information, Biofortis, Inc is the sole known source capable of fulfilling the requirements of this procurement. This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a capability statement for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 12:00 PM ET, on August 06, 2021. All responses and questions must be via email to Miguel Diaz, Contracting Officer at contact@example.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must be registered and have valid certification through SAM.GOV and have Representations and Certifications filled out. Reference: 75N91021Q00199 on all correspondence.