SOLICITATION NOTICE
R -- NHLBI Clinical Event Adjudication Committee (CEAC)
- Notice Date
- 6/20/2016
- Notice Type
- Combined Synopsis/Solicitation
- 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
- NHLBI-CSB-HL-2016-186-JML
- Archive Date
- 7/15/2016
- Point of Contact
- Jonathan M. Lear,
- E-Mail Address
-
john.lear@nih.gov
(john.lear@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Solicitation Information: (i)"This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued." (ii)The solicitation number is NHLBI-CSB-HL-2016-186-JML and the solicitation is issued as a request for quote (RFQ). (iii)The solicitation document, the incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-88-1 effective June 15, 2016. (iv) The associated NAICS code is 541990, All Other Professional, Scientific, and Technical Services, and the small business size standard is $15.0M. The acquisition is being conducted in accordance with the procedures of FAR Part 12 and FAR Part 13. (v)The Contractor Requirements are listed below: (vi)Statement of Work Background Information In 2013, the NHLBI developed a novel approach in interventional cardiology to deliver large, vascular introducer sheaths into the aorta. This procedure, known as Transcaval Access and Closure, allows percutaneous femoral vein access into the abdominal aorta to accomplish transcatheter heart valve implantation. The access port is delivered from the inferior vena cava into a predetermined target site in the abdominal aorta using radiofrequency energy to traverse extravascular spaces. It then uses conventional catheterization techniques to deliver a large-bore introducer sheath. At the conclusion of the procedure, the iatrogenic aorto-caval fistula is closed using a nitinol occluder device intended to close muscular ventricular septal defects or to close patent ductus arteriosus. Transcaval Access and Closure was first performed in a patient in July 2013 at Henry Ford Hospital in Detroit Michigan. Since then, the procedure has been performed over 200 times at twenty-seven medical centers. Each attempt to date has been successful. Major complications have included bleeding and endograft therapy. Bleeding requiring blood transfusion has been common, but the frequency of blood transfusion has declined with refinement of the technique. Endografts have been implanted immediately and late to treat possible bleeding or undesirable arteriovenous shunt. NHLBI is developing a purpose-built closure device to simplify and enhance the safety of this procedure. To allow more careful analysis of the outcomes of transcaval procedures, and to facilitate the dissemination of the technique, NHLBI is sponsoring an Investigational Device Exemption (IDE) study of transcaval transcatheter aortic valve replacement (transcaval TAVR), referred to herein as Protocol, consisting of 20 participating sites. Purpose and Objectives In order to assure clinical data integrity, the NHLBI must contract with an independent Clinical Event Adjudication Committee (CEAC). The CEAC will be utilized to generate independent confirmation of important endpoints of the Protocol. Contractor Requirements The contractor shall perform the following tasks: 1.The Contractor shall form a CEAC consisting of three (3) cardiologists including at least two (2) interventional cardiologists to conduct a complete adjudication of the Protocol. 2.The CEAC shall adjudicate predetermined clinical adverse events (AE) during the Protocol to confirm accurate event classification and ascription to the research procedures. The classifications will apply to the first 30 days after the transcaval procedure, or until first hospital discharge. The specific events include the following: a.Deaths, whether cardiovascular or non-cardiovascular b.Device success, which is the primary endpoint of the protocol c.VARC-2 bleeding classification d.VARC-2 vascular complications classification, modified according to the protocol e.Covered stent (aortic endograft) implantation classification f.Major adverse cardiovascular events (MACE) up to 30 days 3.The CEAC shall determine by consensus or majority vote whether each AE is (1) confirmed, (2) refuted, or (3) insufficient evidence is available to confirm or refute. In the event that the CEAC disputes the sponsor's event classification, the dispute will be resolved by verbal and written communication. 4.Additionally, the CEAC shall reclassify AEs as needed under one of the following classifications: a.Clearly related to transcaval access and closure b.Potentially, but not clearly, related to transcaval access and closure c.Unrelated to transcaval access and closure Reporting Requirements and Deliverables The Contractor shall provide reports to the NHLBI's Project Officer according to the specifications and schedule provided below: 1.Project Specification Plan (PSP) The Contractor shall submit a Project Specification Plan (PSP) outlining the CEAC's proposed schedule for completing each task in the adjudication process to the NHLBI within one month of contract award date. The PSP shall be emailed to the NHLBI's Project Officer in PDF format. The Contractor shall adhere to the tasks and schedules set forth in the PSP. The Contractor shall not proceed with the tasks in the PSP until the PSP has been approved by the NHLBI's Project Officer. The NHLBI reserves the right to modify the PSP at any time. 2.Project Management Plan (PMP) The Contractor shall submit a Project Management Plan (PMP) describing the Contractor's Quality and Assurance Surveillance Plan to the NHLBI within one month of contract award date. The PMP shall be emailed to the NHLBI's Project Officer in PDF format. The Contractor shall adhere to the tasks and schedules set forth in the PMP. The Contractor shall not proceed with the tasks in the PMP until the PMP has been approved by the NHLBI's Project Officer. The NHLBI reserves the right to modify the PMP at any time. Government Responsibilities The NHLBI shall provide the Contractor with the AEs for adjudication from NHLBI's Clinical Database Management System (CDMS). If needed, the NHLBI may grant the Contractor limited access to its CDMS for the purpose of gathering and/or entering data. (vii)Period of Performance: The period of performance will be one month from contract award date, and two weeks after the sponsor provides the data classifications and supporting documentation. Place of Performance: National Institute of Health, NHLBI 9000 Rockville Pike Bethesda, MD 20892 (viii)The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. (ix)The provision at FAR clause 52.212-2, Evaluation - Commercial Items, is applicable. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government. The following factors shall be used to evaluate offers: Contract award shall be made to the responsible Offeror whose offer, in conforming to this RFQ, provides the overall best value to the Government, technical, past performance, and cost evaluation factors considered. The Government's objective is to obtain the highest technical quality considered necessary to achieve the project objectives, with a realistic and reasonable cost. Technical and Past Performance evaluation factors are more important than cost. Total points: 100 1.Project Specification Plan (40 points) Offerors must submit a proposed Project Specification Plan for the NHLBI's IDE Protocol as explained in the Statement of Work above. 2.Past Performance (30 points) Offerors must verify past performance in projects involving interventional cardiology. Offerors are encouraged to provide a brief description of past projects/protocols they have facilitated in the field of interventional cardiology. Offerors with greater experience in interventional cardiology projects/protocols will be scored significantly higher than those with lesser experience. 3.Price (30 points) Offerors must submit a comprehensive cost proposal/quote for the work to be performed. (x)FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items, is applicable. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision. (xi)FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. (xii)FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition. Including the following clauses and Prohibitions: i.52.209-10, Prohibition on Contracting with Inverted Domestic Corporations 52.219-28, Post Award Small Business Program Representation ii.52.233-3, Protest After Award iii.52.233-4, Applicable Law for Breach of Contract Claim iv.52.222-3, Convict Labor v.52.222-21, Prohibition of Segregated Facilities vi.52.222-26, Equal Opportunity vii.52.222-36, Equal Opportunity for Workers with Disabilities viii.52.222-50 Combating Trafficking in Persons ix.52.225-13, Restrictions on Certain Foreign Purchases x.52.232-33, Payment by Electronic Funds Transfer-System for Award Management xi.52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving xii.52.244-6, Subcontracts for Commercial Items xiii.52.2232-39, Unenforceability of Unauthorized Obligations (xiii)All responses must be received by June 30, 2016 at 9:00 AM and must reference number NHLBI-CSB-HL-2016-186-JML. Responses may be submitted electronically to john.lear@nih.gov or by U.S. mail to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Room 6151, Bethesda, MD 20892-7902, Attention: Jonathan M. Lear. Phone: 301-451-4470.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-HL-2016-186-JML/listing.html)
- Place of Performance
- Address: National Institutes of Health / NHLBI, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04155683-W 20160622/160620234730-321b92405db6b702c8a57790f1ee3db8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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