Laboratory Information Managerment System for USAMRIID, Fort Detrick, MD

REQUEST FOR INFORMATION W23MYC-LIMS RFI_2012 A. In conducting market research analyses, this is a sources sought/request for information synopsis for information and planning purposes only, and is not to be construed as a commitment by the Government. No contract will be awarded as a result of this sources sought synopsis. No reimbursement will be made for any cost associated with providing information in response to this synopsis. The United States Army Medical Research Acquisition Activity (USAMRAA) is soliciting information on behalf of the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) from potentially qualified businesses. The gist of the proposed requirement follows: 1.0 EXECUTIVE SUMMARY U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID), located on Fort Detrick, Maryland currently faces a critical capability shortfall with respect to its ability to manage information generated by increasingly advanced scientific instrumentation. The high content data generated by scientific studies, in combination with information assurance concerns that prevent networking of data-generated instrumentation, is preventing proper archiving and sharing of information. The impact on scientific productivity is direct and detrimental. This document outlines the requirements for a Laboratory Information Management System (LIMS), inclusive of technical, functional and regulatory compliance aspects. Additionally, project archetypes are used to demonstrates the potential utility of a LIMS system through illustration of the typical studies performed at USAMRIID, the inter-Divisional collaboration involved, and the exchange of information that is required. 2.0 PURPOSE AND SCOPE Current Situation and Objectives The mission of USAMRIID is to conduct basic and applied research on biological threats, resulting in medical solutions for the Soldier. The core competency of USAMRIID is working safely and securely with dangerous pathogens in biocontainment, using the unique laboratory facilities available in the institute. The state of the art in biological science and biodefense research increasingly incorporates and relies upon high-content data-generating instrumentation that enable biological systems to be examined in increasingly complex and comprehensive ways. This instrumentation and the information technology which supports it represents a tremendous challenge in data management. Additionally, DoD security requirements are often incompatible with the software and operating systems required to operate the instruments and analyses, causing a decentralized operating environment where each lab contains many data silos. The downstream effect of this is that scientists are burdened with integration of datasets from disparate functional areas, manual execution of downstream analyses and manual data management. The absence of an integrated network and information management system for instrumentation is having tangible and measurable impacts on the rate of progress of research and collaboration. The execution of this proposal would create a system in which a project can be managed effectively across multiple functional areas, deliver workflow tasks to production scientists and technicians, report status and results to scientists and program managers, and reduce the amount of administrative burden on USAMRIID personnel so more resources can be spent executing research. Additionally, the tracking and reporting functionalities will be critical to certification standards like Good Laboratory Practice and the International Standards Organization and the portal dashboard interface will bring new tools for collaboration within the institute. The physical limitations of a secondary network are being addressed in two initiatives: research network intrinsic to the design for the new RIID facility and the research network pilot designed to cover the existing RIID facilities. We have also recently finished the cabling and hardware infrastructure requirements to connect the Genomics and Toxicology divisions later referred to as the pilot stakeholders for this project. The physical limitations of connectivity between the functional areas have been removed or are in the process of being removed but scientists are still burdened with integration of datasets from disparate functional areas, manual execution of downstream analyses and manual data management. Operation Policies and Constraints The requirements listed below include regulatory compliance related to information technology, intellectual property, quality management and information assurance as defined by the Code of Federal Regulations, DoD, DA, FDA and CDC regulations, as well as certification standards defined by the International Standards Organization. - Address major capability gaps identified within USAMRIID related to: o Greater transparency of research projects and their status. o Improved knowledge-sharing (technical & administrative). o Improved communication and teaming. o Avoidance of redundant data exchanges between offices and erroneous data. o Replacement of inadequately defined paper-based processes with automated processes that would reduce the administrative burden on investigators. - Requirements o The System must require user/password based authentication. o The System must secure data at multiple levels with a robust roles and rights implementation. o The system must be able to reference project metadata and other information stored in the Institute project management information system of record. o The System must be compliant with, or reconciled with, guidance regarding intellectual property and scientific documentation as expressed in AR27-60 (Intellectual Property). o The System must be compliant with Section 508 of the Federal Rehabilitation Act (amended 1998). o The system must address HIPAA concerns with safeguarding human results in accordance with AR 600-110, 45 CFR Part 160, and Subparts A and E of Part 164. o Any data collected using ELN/LIMS for GLP studies needs to be managed so that it will also be 21 CFR Part 58 and 21 CFR Part 11 compliant. o Any data generated using ELN/LIMS for a GLP studies needs to be attributable in order to be compliant with 21 CFR Part 58 and 21 CFR Part 11. o The System should meet the Information Assurance system security objectives as described in Section 2.4, "Security and Regulatory Compliance". - Future Capabilities o CAC based authentication. o Ability to incorporate with BioBanking technology. Proposed System Overview The diagram above provides an overview of the proposed system. On the right is a representation of the physical infrastructure via different functional areas within the institute including but not limited to those presented. The containment suites represented here as a BSL-4 also include BSL-3 laboratories. In all cases each laboratory and or functional area will have organic computing assets and instrumentation connected via a research network to servers located currently at the NEC (Future location in the new RIID server room). The system will leverage the Information Services Office (ISO) initiative to provide a data backup plan for the research network. The left side of the diagram represents the proposed software solution. The system will gather data from multiple disparate systems and transform the data and metadata into a common format for storage in a relational database. Additionally, the system will digitize notebook entries, gather data and run status information directly, provide analytical tools, provide customizable workflow, automate downstream analyses and provide sample management capabilities. Bio-Banking shown here should be a capability and not a requirement of the system. Through portal views users of the system at this level will provide real-time access to direct and complete research. The views will be customized by roles and rights to provide granularity based on business requirements. Following this methodology project managers, division chiefs, auditors, command staff, etc will have access to the data across a functional area, project, or institute as directed by business requirements. Customers LIMS customers will include the following: - USAMRIID End User: The intent of LIMS is to make the daily life of the end user scientist simpler by providing a single gateway for access to all information related to their research and the research performed by intramural collaborators. This will reduce the administrative burden on the end user, resulting in more time to focus on research and more efficient exchange of information, enabling more rapid and effective progress. - USAMRIID Managers: Managers should be able to access information in LIMS related to their organizational unit and personnel in real-time, in order to make informed decisions. - USAMRIID Commander: The Commander and his Executive Team are responsible for the institute and require timely access to information provided by LIMS needed to make informed decisions at both a tactical and strategic level. - Customers/Sponsors: The customers and sponsors that fund research at USAMRIID are demanding increasing accountability for performance, schedule, funding, and deliverables. LIMS will provide accountability for this information by enabling program managers and the office of Business Plans & Programs to have greater visibility on project progress. The major customers include the following: o Defense Threat Reduction Agency (DTRA): This is USAMRIID's main customer, and accounts for approximately 70% of the institute's funding. DTRA is a Defense-Wide organization responsible for management of the Chemical & Biological Defense Program (CBDP) Science & Technology (S&T) portfolio. o Other Customers: These are other federal agencies, companies, and other research organizations that fund research at USAMRIID. They are also demanding greater accountability for execution of research projects and funding, including receiving invoices as a condition of payment. 3.0 REQUIREMENTS USAMRIID requires the vendor to perform requirements gathering, assistance with system design, installation of the software and supporting databases, implementation and integration, testing of one use case, and training of USAMRIID staff for users and administrators of the system. A use case is here described as all system interactions of a single project that integrates one workflow from each functional area, manages and reports across functional areas. A workflow is here described as all the system interactions to perform one assay, store the data, analyze the data and return relevant data points to the system. General Requirements - The System must be capable of interfacing with structured query language (SQL) databases including but not limited to the Oracle database. - The System must be fully compatible with Microsoft programs using either the Windows or Apple platform. - The System must support Role Based Authentication and Access Control. - The System must be able to track/retrieve key information such as project name, author, experimental method, date, and other keywords. - The System must support date-time stamp version control as well as record locking. - The System must support data integrity throughout its entire life cycle (at least 30 years). - The System must have flexibility in supporting unstructured journal style information recording and allow user to revise the notes easily. - The System must support System Level, Application Level, and User Level Accountability (i.e. logging of System, Application, and User activity). - The System must support bidirectional data exchange integration with other data systems. - The System must be able to accept data from a Tablet PC, PDA, or other commonly used electronic communication devices. - The System must have automatic or passive save page features. - The System must be able to attach/embed high content data formats not limited to the following file extensions: gif, xls, txt, ppt, pzf, doc, png, and pdf. - The System must be able to use English as the primary language. - The System must have capability to produce output in PDF format. - The System must allow real-time data access. - The System should allow users to add data as it is available, not full page by full page (i.e. not require completion of a page prior to moving forward).The system must have user customizable home page dashboards. - The System must utilize electronic signature of both notebook author and a second user witness. - The System must provide online help and be accessible to the system users without requiring Internet access. - The system must support a common open-standard for a Service Oriented Architecture (SOA) and workflow. - The system must enable data mining, to include six common classes of tasks: o Anomaly detection (Outlier/change/deviation detection) - The identification of unusual data records, that might be interesting or data errors and require further investigation. o Association rule learning (Dependency modeling) - Searches for relationships between variables. For example a supermarket might gather data on customer purchasing habits. Using association rule learning, the supermarket can determine which products are frequently bought together and use this information for marketing purposes. This is sometimes referred to as market basket analysis. o Clustering - is the task of discovering groups and structures in the data that are in some way or another "similar", without using known structures in the data. o Classification - is the task of generalizing known structure to apply to new data. For example, an e-mail program might attempt to classify an e-mail as "legitimate" or as "spam". o Regression - Attempts to find a function which models the data with the least error. o Summarization - providing a more compact representation of the data set, including visualization and report generation Security and Regulatory Compliance Requirements - The System must be compliant with U.S. Code of Federal Regulations (CFR) Title 21 part 11 to include: secure, computer generated, time-stamped audit trail recording operator entries and actions that create, modify or delete electronic records; ability to generate accurate and complete copies of records in both human readable and electronic form; authority checks to ensure only authorized individuals can use the system, electronically sign or alter a record. - The System should meet the Information Assurance system security objectives of Integrity, Availability, Authentication, Non-repudiation, and Confidentiality. The Department of Defense Information Assurance Certification and Accreditation Process (DIACAP) controls will be used to assess the System security compliance posture. - The System must allow configurable password expiration, password expiration notification, and logon attempt lock-outs. - The System must be capable of providing notifications for system, application and user events. This capability must include the ability to alert administrators when unusual database activity occurs (i.e. security breaches, massive data deletion), or when database maintenance will be required. Data and Application Auditing/Compliance Requirements - The System must provide the ability to track a baseline set of database events including user logins, schema modifications, connect times, and system updates. - The System must provide the ability to create ad-hoc reports. Data Provisioning and Management Requirements - The System must provide tools to conduct the following activities: o Database Management o Instance Management o Schema Management o Security Management o Storage Management o Workspace Management o System should support an Oracle 10g (or later) back end database Implementation Requirements - System design testing will occur offsite. - Installation of core software will occur onsite. - Installation of components required to connect the various software will occur onsite. - Testing of the System's connectivity within CBOE will occur onsite. - Performance of Use Case performance testing will occur onsite. - Updates as necessary to correct any system deficiencies will occur onsite. - Movement of software to production will occur onsite. Training Requirements - The System must accommodate general system training by providing a training environment that is not linked to the live database. - The System training must be provided in English. - The System training must include role-based training. - The System training must be able to be conducted in the following formats: by Video Teleconference (VTC) and/or Instructor-Led. User Management Requirements - The System must allow unique user permission levels based on roles and allow for the configuration of the permission levels. - The System must allow different user rights and access for different studies. - The System must be able to accommodate multiple users with the same roles and with the same access within a given study. Vendor Additional Requirements - Generate the Requirements Mapping Document (RMD) - Define the System interactions and use case testing requirements. - Vendor must transfer knowledge to the USAMRIID support staff to enable them to manage the IT related functions to support the System. This education plan must enable USAMRIID's rapid ownership of the System, including all setup and administrative functions required to support the system. - Vendor must be able to support a full technology transfer of their software and utilities to the USAMRIID, which will result in the USAMRIID being capable of completely independent operation and maintenance. - Vendor will demonstrate other components supported with their proposal. - Vendor must include in their licensing agreements a description of their responsibility for resolving any flaws in the licensed software. - Vendor must include, in the development plans for their software and utilities, how a licensee will gain access to the new versions of the software over time. - Vendor must be able to discuss how their help desk capability may be leveraged by the USAMRIID on a permanent or ad hoc basis. - Vendor must be prepared to demonstrate their capabilities at Fort Detrick, MD without requiring access to Department of Defense network. - Vendor must be able to host an audit by the USAMRIID Quality Assurance & Regulatory Compliance Office (QARCO). - Vendor must have available for review: Quality System documentation, System Development Lifecycle documentation, and Validation documentation during the audit. - Vendor must be able to describe their problem resolution and escalation process. - Support personnel for this system must be United States citizens. - Vendor must be able to provide expert witness (reimbursable) to explain how system works and assure that data is accurate, fixed as of a certain date, and has not been altered. - Vendor must support the Information Assurance security objectives assessment as specified in Section 2.4. 4.0 REFERENCES General Requirements 5.0 ROUGH COST ESTIMATE Besides providing a technical capabilities statement based on the above data, please provide a rough cost estimate as well for implementing a LIMS at USAMRIID based on the following quantities and implementation schedule: FY14: Pilot Program. 100 LIMS Users, utilizing existing server resources. FY15: Full Implementation Architecture Installation. Determine, purchase and implement server resources optimal for a 1000 user environment. FY16-18: Full Implementation. 900 users in Division-sized blocks (~100 Users). Includes integration, testing and training cycles. 1000 Users TOTAL B. Interested parties shall submit a Capability Statement that clearly addresses your corporate capabilities to provide the above services, and at a minimum, shall address the following: 1) Name of Company; 2) Company Address; 3) Point of Contact Information (name, telephone, e-mail address); 4) Company Size - proposed NAICS for requirement is 334516; 5) Address whether the services identified in the requirement described above are of a type offered and sold competitively in the commercial marketplace based on market prices or whether these services are exclusively provided to the Government; 6) If commercially available, identify standard commercial terms and conditions typically associated with these services; 7) Describe experience and past performance with similar types of requirements of similar scope and magnitude and whether they were performed via a performance-based manner, and include the contract number, Government agency name, address, and contract funded amount; 8) Identify qualifications of technical and management personnel. THIS SYNOPSIS IS FOR INFORMATION PLANNING PURPOSES ONLY AND IS NOT A COMMITMENT BY THE GOVERNMENT. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND A CONTRACT WILL NOT BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT AND ANY FOLLOW-UP INFORMATION REQUESTS. All responses must be submitted via e-mail to the point of contact identified below; no other method of transmittal will be accepted. This is a new work effort. In the Subject line of the e-mail, please reference: W23MYC-LIMS RFI_2012. Respondents submitting a capability statement must do so by e-mail NLT 12:00 PM ET, December 17, 2012, attention Tonya Kreps, e-mail: tonya.kreps@us.army.mil.