SOURCES SOUGHT
A -- Limb Loss and Preservation Registry
- Notice Date
- 1/5/2018
- Notice Type
- Sources Sought
- NAICS
- #541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6710B Rockledge Dr., Suite 1124, MSC7000, Bethesda, Maryland, 20892-7510, United States
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-NCMRR-2018-16
- Point of Contact
- Gilberto Perez, Phone: 3014519698, Adelola St John, Phone: 3014356955
- E-Mail Address
-
gilberto.perez-rosa@nih.gov, 202p@nih.gov
(gilberto.perez-rosa@nih.gov, 202p@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought (SBSS) notice. This notice is not a request for proposals, proposal abstracts or quotations and does not commit the Government to award a contract now or, in the future. No solicitation is available at this time. The purpose of this notice is to obtain information regarding: (1) the availability and capability of all qualified small business sources; (2) whether they are small businesses; HUBZone Small Businesses; Service-disabled, Veteran owned Small Businesses; 8(a) Small Businesses; Veteran-owned Small Businesses; Woman-owned Small Businesses; or Small Disadvantaged Businesses; and (3) Their size classification according to the North American Industry Classification System, (NAICS) Code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible or, through full and open competition. Small business organizations must have their size status certified by the small business administration. The NAICS code is 541715 with a size standard of 1,000 employees. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is partnering with the Department of Defense (DoD) on this clinical registry for amputation and amputation prevention: the Limb Loss and Preservation Registry. The National Center for Medical Rehabilitation Research (NCMRR), within NICHD, leads NIH efforts to study recovery of function after limb loss. The DoD leads efforts to document the etiology, care, and follow-on needs of military members who have incurred an amputation because of traumatic injury but lacks information on those Service members who leave the military health system and seek care in the private sector. Additionally, information from the civilian sector will increase the amount and quality of data available on clinical care pathways, surgical techniques, and prosthetic components leading to more conclusive research on Limb Loss and Preservation. The proposed registry will not interface with or collect data from Department of Defense (DoD) or U.S. Department of Veterans Affairs (VA) health systems. The proposed Limb Loss and Preservation Registry will collect data regarding the medical conditions that cause limb loss, clinical efforts to prevent limb loss, limb loss surgical procedures, prosthetic fitting, prosthetic use, rehabilitation and patient reported outcomes. Much of this data will be retrieved from Electronic Health Records (EHRs) although patient reported outcomes are also desired. The contractor would be responsible for all research and information technology systems necessary to successfully build the proposed registry. The contractor will propose a research plan, conduct research, design the registry, select data elements, build the registry, assure the quality of data, and complete any other duties required for a successful registry. The proposed registry will include patients of all ages and etiologies across the spectrum of clinical care. The data for a successful Limb Loss and Preservation registry will come from many sources. NICHD anticipates that the registry will be self-sustaining following the completion of this contract. The contractor will submit a sustainability plan that details a strategy to financially sustain the registry beyond the term of this contract. Potential sources must have the following capabilities: 1.Organizational Capacity to perform the necessary research, and information technology work. 2.Capability to include a team of personnel with appropriate expertise in: scientific and clinical limb loss and preservation care; data elements; registry design; scientific validation; and technical standards. 3.Capability to identify and recruit scientific advisory committee members of the representative experts and stakeholders for the Limb Loss and Preservation registry. 4.Capability to retrieve, utilize, store and disseminate data from electronic health records (EHRs). 5.Capability to identify relevant data elements for the Limb Loss and Preservation Registry. 6.Capability to collect and integrate data from diverse sources, build necessary infrastructure, and share data with a diverse set of stakeholders through a graphical user interface. 7.Capability to comply with federal, state, and local regulations related to health data. 8.Capability to produce analytical and modeling tools for clinical data. 9.Capability to leverage or integrate with existing data systems. 10.Capability to make the registry self-sustaining beyond the term of this contract. 11.Capability to recruit and retain healthcare centers, healthcare providers and individuals that will provide a representative, geographically diverse, sample of the population of individuals (to the greatest extent possible) who experience limb impairments that require preservation or loss. 12.Capability to provide and implement project governance policies and procedures. 13.Capability to disseminate new tools and offer training in their use Capability statements submitted should demonstrate the respondents' qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following: 1.The physical infrastructure necessary to complete the registry. Provide sample workflows that demonstrate a capacity to complete complex, multiyear, multidisciplinary tasks. Provide details of experience with previous medical research projects and previous information technology projects. 2.Submit resumes of proposed personnel and identify specific roles for proposed personnel. Include a proposed reporting structure that demonstrates a capacity to administer a complex, multiyear, multidisciplinary project. 3.Working relationships with experts in the field of limb loss and preservation that could serve on a Scientific Advisory Committee (SAC). Demonstrate previous success recruiting subject matter experts for similar projects. 4.Demonstrate previous experience retrieving, utilizing and storing data directly from EHRs by providing examples of previous successful efforts. Demonstrate working relationships with clinical sites, individual medical professionals, professional organizations or EHR vendors that could assist with gaining access to EHR data. 5.Demonstrate the capability to identify, create and/or utilize data elements with well-defined standards by providing examples from previous efforts. Demonstrate the capability to reach consensus among a diverse group of stakeholders. 6.Demonstrate the capability (through example workflows; personnel qualifications; knowledge of industry standards and best practices; and experience) to collect data from clinical centers, validate the data, clean the data, harmonize the data, integrate data from multiple sources, and share the data via a standardized data system with a graphical user interface. 7.Demonstrate previous experience complying with federal, state and local regulations that apply to data systems, data transfer, data display, personally identifiable information. Examples include, but are not limited to: FISMA, Section 508, Common Rule and Privacy Rule. 8.Demonstrate a capacity to produce analytical and modeling data for clinical studies. Include experience with producing reports for distribution to non-scientific audiences and the ability to make user-friendly interactive tools to assist in data analysis. 9.Demonstrate the capacity to improve products through iterative development. Provide examples of capacity to establish novel connections between previously unconnected information technology resources. 10.Identify potential sources of non-governmental revenue for the proposed registry and how that revenue could make the registry self-sustaining. 11.Demonstrate working relationships with clinical centers and care providers. Demonstrate previous experience recruiting and retaining clinical centers and healthcare providers to participate in a registry or other research projects. Demonstrate previous experience or current relationship with Electronic Health Record vendors and their respective EHR systems. 12.Demonstrate the proposed team of personnel that have the expertise to produce and implement project governance policies. 13.Demonstrate experience in disseminating novel tools through educational resources and training techniques. Past Performance: Past performance is considered essential. In addition to demonstrating that your organization has met the above qualifications. Interested parties must identify at least three other projects of similar size and complexity. The anticipated contract type will be an Indefinite Delivery Indefinite Quantity Task Order contract with an ordering period of 5 years. The RFP is anticipated to be posted on or about March 9, 2018 on FedBizOpps (FBO) website: http://www.fedbizopps.gov. Disclaimer and Important Notes : This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDIENTIALITY : No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Businesses that believe they possess the capabilities necessary to undertake this project should submit electronic copies of their capability statement, addressing the areas above. Please limit responses to 15 pages or less (inclusive of all material). Responses will be evaluated on the basis of experience, expertise, and capabilities in the areas cited above. Any proprietary information should be so marked. Capability Statements should be received by the Contracting Officer by no later than 2:00 PM Eastern Time on January 19, 2018. Capability statements must identify the business status of the organization (i.e. educational institution, non- profit, large business, small business, 8(a), or other corporate or non-corporate entity). Information submitted should be pertinent and specific in the technical area under consideration, on each of the following qualifications (1) Experience: an outline of previous projects, specific work previously performed or being performed and any in-house research and development effort;(2) Personnel: Name, professional qualifications and specific experience of scientist, engineers and technical personnel who may be assigned as principal investigator and/or project officer: (3) Facilities: Availability and description of special facilities required to perform in the technical areas under consideration, and a statement regarding industrial security clearance. Any other specific and pertinent information as pertains to this particular area of procurement that would enhance our consideration and evaluation of the information submitted. Information in the anticipated RFP supersedes any information in this pre-solicitation announcement.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-NCMRR-2018-16/listing.html)
- Record
- SN04782676-W 20180107/180105230912-707e6a8430bcfe46cae904dcd2164e72 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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