SOURCES SOUGHT
Q -- CT/Echo Analysis Services
- Notice Date
- 5/26/2017
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHSN-NIH-NHLBI-SBSS-2017-150
- Archive Date
- 6/20/2017
- Point of Contact
- Jonathan M. Lear,
- E-Mail Address
-
john.lear@nih.gov
(john.lear@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a small business sources sought notice. This is not a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of 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 relative 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. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The National Heart, Lung, and Blood Institute (NHLBI) does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this sources sought notice, the NHLBI may issue a request for quote (RFQ). There is no solicitation available at this time. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this sources sought notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. The NHLBI is seeking capability statements from all eligible small business concerns under the North American Industry Classification System (NAICS) code 541990 with a size standard $15.0M. Based on the responses received from this sources sought announcement, the proposed acquisition may be solicited as a total small business set-aside. All eligible small business concerns responding to this sources sought announcement must have the capabilities to provide the services as stated below. Background Transcatheter Mitral Valve Replacement (TMVR) is an option to treat mitral valve failure when no surgical options exist. In as many as half of patients, TMVR can cause life-threatening obstruction of the left ventricle outflow tract by displacing the native mitral valve leaflet towards the septum. Investigators at the National Heart, Lung, and Blood Institute (NHLBI), Emory University, and Henry Ford Hospital developed a novel procedure to prevent this life-threatening obstruction. The procedure, known as Intentional Laceration of the Anterior Mitral leaflet to Prevent left ventricular Outflow Obstruction (aka. LAMPOON), herein referred to as the Procedure is a new catheter technique to split the anterior mitral leaflet and prevent iatrogenic left ventricular outflow tract obstruction immediately before TMVR. It utilizes a Transcatheter Heart Valve (THV) device marketed for implantation in the aortic or pulmonic positions off-label. The THV device has been approved for investigational use in human subjects by the FDA-reference IDE License G160239. Already, the Procedure has been used successfully in a small number of patients. The NHLBI's Division of Intramural Research (DIR) recently launched a careful FDA-regulated investigation of the Procedure in patients through a national clinical trial. Patients enrolled in the clinical trial are carefully monitored by physicians through a variety of medical exams including CT scans and echocardiograms (aka. Echo). The clinical trial requires a single certified cardiologist to analyze results from each CT/Echo test. Purpose and Objectives To assure consistent results and to comply with clinical protocol requirements, the DIR requires a certified cardiologist with specialized experience in CT/Echo and TMVR to perform research-quality analysis of all CT/Echo results obtained for up to 30 patients enrolled in the DIR's clinical trial. Tasks to be Performed •Perform CT analysis for up to 30 patients at the following end-points: oBaseline oPost-procedure within 30 days •Perform analysis on echocardiography, both surface and/or transesophageal, for up to 30 patients at the following end-points: oBaseline oIntra-procedure oPre-discharge o30 days post-procedure oSix months post-procedure o12 months post-procedure •Receive from participating research sites, store locally, and transmit to sponsor, in compliance with all applicable regulations, the CT and echocardiography imaging data above Period of Performance The estimated period of performance of this contract is three (3) years from date of contract award. Capability Statement / Information Sought Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. The following information shall be included in the capability statement: -A general overview of the respondents' opinions about the difficulty and / or feasibility of the potential requirement, and any information regarding innovative ideas or concepts. -Information in sufficient details of the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. -The respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the North American Industry Classification System (NAICS) code: 541990 with a small business size standard of $15.0M. -Any other information that may be helpful in developing or finalizing the requirements of the potential acquisition. Capability statements must demonstrate experience with similar projects and will be evaluated by the following criteria: -The capability statement sites specific examples of experience conducting CT/Echo analysis for multi-site clinical trials. The offeror has experience analyzing CT/Echo results for TMVR/LAMPOON patients. -The capability statement shows the personnel required to conduct the work including at least one certified cardiologist and an experienced CT/Echo technician. The capability statement includes the CV/resumes for required personnel. The required personnel have documented experience analyzing TMVR/LAMPOON patients via CT/Echo. -The capability statement shows that the offeror has access to the equipment required to perform CT/Echo analysis. Closing Statement Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed ten (10) single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. All capability statements sent in response to this sources sought notice must be submitted electronically (via email) to Jonathan Lear, Contracting Officer, at john.lear@nih.gov in either MS Word or Adobe Portable Document Format (PDF), by June 5, 2017 at 12:00PM, EST and must reference synopsis number HHSN-NIH-NHLBI-SBSS-2017-150. All responses must be received by the specified due date and time in order to be considered. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in 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. Confidentiality 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHSN-NIH-NHLBI-SBSS-2017-150/listing.html)
- Place of Performance
- Address: National Institutes of Health / NHLBI, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04524612-W 20170528/170526235119-e66e148f1ad3f6e330e8bc4a07da1ea2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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