SOURCES SOUGHT
D -- Laboratory Information Management Systems (LIMS) Solutions - FDA-SS-1159742
- Notice Date
- 11/24/2015
- Notice Type
- Sources Sought
- NAICS
- 541513
— Computer Facilities Management Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SS-1159742
- Archive Date
- 12/29/2015
- Point of Contact
- Christopher R. McGucken, Phone: (240) 402-7599
- E-Mail Address
-
christopher.mcgucken@fda.hhs.gov
(christopher.mcgucken@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notice: PDF Format. TITLE: Laboratory Information Management Systems (LIMS) Solutions OPDIV: FDA, Center for Biologics Evaluation and Research (CBER) & Office of Regulatory Affairs (ORA). This is a SOURCES SOUGHT NOTICE to understand the market's technical capabilities for providing the full range of services required to implement multiple complex Laboratory Information Management Systems (LIMS) simultaneously across multiple FDA Centers. It is also to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.104(d). The potential small or large business will need to demonstrate the technical capabilities and various information, data, and materials to perform all facets of the work described below. FDA will use this market research information to assess the market's capability to successfully meet FDA Centers' LIMS requirements described below. FDA welcomes responses from all interested businesses. FDA does not intend to make a selection decision or award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or FDA's use of such information. Acknowledgment of receipt of responses will not be made, no questions will be answered, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties. However, FDA reserves the right to contact vendors if additional information is required. The intention of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. This is not an invitation for bid, request for proposal, or other solicitation, and in no way obligates the Food and Drug Administration (FDA) to award a contract. BACKGROUND The U.S. Food and Drug Administration (FDA) is seeking the continuation, configuration, deployment, and integration of their Laboratory Information Management Systems (LIMS) solutions. This effort shall be used to accomplish the remaining effort to fully implement LIMS for FDA's laboratories. The FDA has at least 14 physical laboratory locations in ORA and 1 physical laboratory in CBER with an average of 5 different disciplines / laboratories at each of these physical sites; the other Centers have labs as well. The LIMS is a COTS application which is designed to accommodate on going changes in requirements and business processes. This highly configurable flexibility allows the FDA to have a foundation for more easily accommodating the transition to high throughput processes and laboratory optimization efforts. LIMS provides a granular look at the work performed at each site and allows for a robust set of data to aid in decision making for optimization efforts not only for the FDA but for each individual site and groups within the sites. The tool provides the necessary knowledge to make good and rational decisions about laboratory optimization. Lab optimization is one of FDA's on-going activities and FDA would like to use LIMS as mechanism where appropriate, to optimize lab's processes, scientific testing methods, and so on. Goals of the ORA and CBER LIMS are to pinpoint where bottlenecks in the process are, where delays in the process occur, optimize resources, and measure impact of changes implemented. During outbreaks FDA typically has unusual samples and use unusual methods. The agility of the LIMS the ability to be quickly configured to meet new requirements - will provide capabilities to the labs that do not exist today. The labs are a type of reservoir for handling the toughest analytical questions. The LIMS puts a modern technological tool in the hands of these scientists; improving their decision making capabilities, increasing their proficiency, and bringing the organization up to a modern standard of science. FDA seeks to deploy the Laboratory Information Management System (LIMS) solution at its laboratories (labs). ORA has a LIMS solution and it currently supports inventory management, equipment management, instrument raw data backup, media preparation, media quality control, and sample management and sample analysis, classification, and reporting for microbiological testing of Salmonella, Listeria, and E.Coli. We are currently assessing the usability and extensibility of our current ORA LIMS configuration approach with StarLIMS COTS for the microbiological testing. The assessment findings will be made available for future decision making purposes. CBER conducted a LIMS pilot in 2012 for its laboratories which was limited to five (5) products covering 27 ISO accredited tests. In 2015, additional modules of LIMS are being configured, developed, and tested in the DEV, TEST, and Sandbox environments only. CBER LIMS is being developed for three laboratories: 1.)Laboratory of Microbiology, In-vivo Testing and Standards 2.)Laboratory of Biochemistry, Virology and Immunochemistry 3.)Laboratory of Analytical Chemistry and Blood Related Products CONTRACTOR REQUIREMENTS Respondent Contractors shall have the capabilities to provide the full range of program management and technical coordination (PMTC) services necessary to successfully achieve the objectives of the LIMS contract. The work shall consist of recurring activities in areas such as program planning, coordination, and scheduling; communications with FDA stakeholders and project teams; risk identification, tracking, and management; project reporting; quality assurance; and performance management. The Contractor shall have the capability to provide contract-level, task order level, and task level project management to establish control, management, monitoring and notification mechanisms, ensuring that LIMS processes and critical tasks stay on track and important milestones are met. Respondent Contractors shall have the capability to complete the development and implementation of LIMS solution for lab disciplines at the FDA labs. The LIMS solution for FDA has to be flexible to allow user-generated reporting directly from the database. The disciplines at these labs include, as an example, Microbiology, Engineering, Medical Devices, and Chemistry disciplines. Chemistry disciplines consist of Chemotherapeutics, Metals, Mycotoxins, Color, Food Additives, Drug Chemistry, Sensory/Decomposition, Persistent Organic Pollutants (POPs), Nutrient Analysis, Drug Shelf-Life, Pesticides, Total Diet Study, Filth, Radionuclides, and Forensics. The Contractor shall develop, enhance, modernize, and configure the LIMS solution for FDA labs. The LIMS solution may include the LIMS foundational components and microbiological sample analysis and sample management components, developed throughout the previous contract. The current solution is based on StarLIMS COTS. The Contractor shall have the capability to improve the solution by including additional enhancements and capabilities to provide a more robust product. The work under this Contract includes planning, requirements analysis, design, development, configuration, test, and deployment for the remaining labs and disciplines. In addition, respondent Contractors shall have the capability to provide the O&M services required to support LIMS. The LIMS functionality currently in production is inventory management, equipment management, instrument raw data backup, media preparation, media quality control, sample management and sample analysis, classification, and reporting for microbiological testing of Salmonella, Listeria, and E.Coli (EHEC and ETEC, etc.). As previously mentioned, ORA plans to conduct an internal assessment on the feasibility of overall LIMS solution that has been implemented partially throughout ORA laboratories. The assessment is expected to be complete in Fiscal Year 2016 Quarter 3. The assessment included close examinations of how the StarLIMS COTS was configured and being accepted by the users from both usability and feature perspectives. The assessment also included an exercise to determine how extensible the current configuration approach (i.e. design model) could apply to other microbiology sample analyses similar to the configured analyses currently in production. The outcome of the assessment is a report to senior management to provide a recommendation for ORA's future LIMS program direction based on feedback and results of the assessment from ORA labs. Should the recommendation be to maintain current course, then the high-level scope described above applies to ORA. If however, the recommendation is such that LIMS needs to take a different direction and/or approach, including potential for new COTS and/or solution, then the Contractor shall have the capability to then conduct an analysis of alternatives (AoA) to provide a recommendation on what the new LIMS implementation roadmap should be, including a migration plan from the current LIMS. Upon approval of the roadmap from the AoA, the Contractor shall then perform the development, enhancement, modernization, and configuration of the LIMS solution for all ORA field labs. The Contractor shall have the capability to continue building on the developed and tested modules of CBER and ORA LIMS, while simultaneously designing and building LIMS for other FDA Centers. The Contractor shall have the capability to provide all COTS software licenses, maintenance agreements, and software documentation. CAPABILITY STATEMENTS In addition to the work described above, Contractors responding this this notice shall detail their ability and experiences providing the following: -Capability to ensure communication transparency with packages delivered on schedule and within budget. -Capability to enhance the LIMS products at FDA to meet FDA's needs. -Capability to maintain the overall O&M expenditures within the maximum allowable thresholds for each year during the life of the contract. -Capability to ensure FDA laboratories have support in the area of instrumentation in support of the LIMS projects. -Capability to ensure quality and code reusability through repeatable and managed processes. -Capability to ensure that these processes are equivalent to Capability Maturity Model Integration (CMMI) Maturity Level 2 or above. -Capability to create and develop a repository of high-quality, defect-free LIMS artifacts and deliverables. -Capability to provide the recommendation for future path of ORA's LIMS implementation after reviewing the ORA LIMSs Assessment Report along with ORA Senior Management decision. The recommendations can include potential redesign and/or acquiring different COTS for ORA's LIMS. -Capability to implement and support both StarLIMS and other LIMS COTS products, should the assessment recommendation support a change in ORA LIMS future roadmap. -Capability to produce a variety of high-quality training materials, such as in-classroom training modules, quick reference guides, and computer-based training modules that meet FDA's predefined standard in a timely manner via a collaborative process with FDA. -Capability to advise FDA of common best practices for utilizing the COTS regarding material management, inventory management, equipment management, and media management. -Capability to migrate inventory and materials from other legacy systems by establishing a repeatable and streamlined process that reduces the burden upon the FDA by minimizing the quantity of data to be reviewed, while maintaining a high quality of data. -Capability to simultaneously support Operations and Maintenance, O&M, activities concurrently with configuration, development, and implementation of new LIMS functionality across all ORA labs and disciplines simultaneously while also enhancing CBER's LIMS and simultaneously implementing LIMS for other FDA Centers. -Capability to provide LIMS demonstrations/walk-throughs/dry runs to business stakeholders during configuration and development of new LIMS functionality at predefined configuration intervals. -Capability to demonstrate strong scientific background and a quick understanding of the FDA analyses which are to be incorporated into future LIMS functionality. -Capability to demonstrate clear communication and transparency with high quality, timely system enhancements and documentation deliverables across multiple programs / LIMS implementations and updates simultaneously. -Capability to demonstrate performance of simultaneous tasks where applicable to ensure timely releases while minimizing risk of failure. Capability statements must address each of the requirements outlined above. Please address each in the order listed. Contractor's capability statements shall include a 1 page cover sheet, including the following business information: 1.DUNS Number 2.Company Name 3.Company Address. 4.Company Point of Contact, phone number and email address 5.Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp. 6.Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); 7.Current GSA Schedules appropriate to this Sources Sought 8.Current Government Wide Agency Contracts (GWACs) 9.Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. The Government is providing a list of labor categories it intends to include in this solicitation. If the vendors believe the Government should include additional labor categories, the vendor should include this information in its response. Interested parties having the capabilities necessary to provide the stated requirements may submit capability statements via email or regular mail to the point of contact listed below. Responses shall be limited to 15 pages. Please note that a respondent's failure to provide a complete response to a question will be interpreted to mean that it does not understand the question and does not demonstrate the capability to provide services required. Responses should demonstrate capability through experience, not merely affirm the respondent's capability (e.g.: The response must go beyond the statement that, "XYZ company can provide O&M support.") Responses must be received not later than 3:00PM Eastern Time, December 14th, 2015. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: Christopher.McGucken@fda.hhs.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1159742/listing.html)
- Record
- SN03954402-W 20151126/151124235058-5fa305361d80694a7f29f870145746fb (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |