CLINICAL SUPPORT SERVICES FOR THE CLINICAL AND RESEARCH EFFORTS OF THE NINDS STROKE BRANCH, SECTION ON STROKE DIAGNOSTICS AND THERAPEUTICS, NINDS, NIH

CLINICAL SUPPORT SERVICES FOR THE CLINICAL AND RESEARCH EFFORTS OF THE NINDS STROKE BRANCH, SECTION ON STROKE DIAGNOSTICS AND THERAPEUTICS, NINDS, NIH REQUEST FOR INFORMATION AND SMALL BUSINESS SOURCES SOUGHT - NIH/NINDS-SB-SS 14-01 PURPOSE: The National Institute of Neurological Disorders and Stroke (NINDS) is announcing its plans and intent to pursue continuation, via a full and open competitive Request for Proposals (RFP), of its active and ongoing clinical research investigations of stroke and traumatic brain injury conducted by the NINDS Stroke Branch, Section of on Stroke Diagnostics and Therapeutics, NIH, (hereinafter identified as NINDS SDTS) that have been provided under a series of contracts since 1999. The NIH/NINDS Stroke Diagnostics and Therapeutics Section (SDTS) was formed in 1999 with the mission of performing innovative translational research in acute stroke. In 2008, the SDTS expanded to include the study of TBI. The SDTS has been primarily focusing on studying acute stroke and TBI with magnetic resonance imaging (MRI). The goal of the SDTS is to make scientific advances toward new stroke therapies through the development, validation, and testing of imaging markers for use in clinical trials and practice and to improve the understanding, pathophysiology, and diagnosis of TBI. This project is a continuation of a long-term collaborative effort the NINDS SDTS has had with local hospitals (10+ years) to provide clinical support services conduct clinical research into acute cerebrovascular diseases and traumatic brain injury. Due to the requirement to see patients during the acute phase of their stroke or brain injury the research program cannot be conducted at the NIH Clinical Center (CC). Thus this internal research effort has been supported and conducted at off-site acute care hospitals. We are seeking to identify any acute care facility that might be interested in competing and is capable of performing and providing the requisite services for continuation of this requirement for a five (5) year term. PERFORMANCE REQUIREMENTS: The proposed acquisition is to acquire clinical support services of an acute care hospital (hereafter identified as the Contractor) located within 15 miles of the NIH campus in Bethesda, MD (9000 Rockville Pike, Bethesda, MD 20892) to support the clinical and research efforts of the NIH/NINDS Stroke Branch, Section on Stroke Diagnostics and Therapeutics (SDTS). This acquisition provides an acute care hospital setting for SDTS research staff to access, recruit and study acute stroke and acute traumatic brain injury (TBI) patients. The overall program is designed to study the use of Magnetic Resonance Imaging (MRI) in the clinical evaluation of acute stroke and TBI patients, and to develop acute stroke therapies. Although the Contractor will not be conducting any of the research under this program, they will be providing support and clinical services including but not limited to: patient identification and referral; MRI support for imaging of prospective research subjects; vascular neurologist services; nursing services; neurosurgical and neuroradiological services; interventional radiology services; emergency preparation and blinding of study drugs by a hospital pharmacist; chemistry and hematological laboratory tests required by the NIH/NINDS Stroke Team research protocols and NIH/NINDS Stroke Care Pathway; general radiological services; neurointensive care and monitoring. One of the primary aims of the clinical research efforts of the SDTS is to include MRI procedures in standard clinical care protocols to determine the specificity and sensitivity of MRI in the evaluation of this patient population. These stroke and TBI research studies require high volumes of acute patient populations that can only be found in an acute care hospital. In order to continue to advance this field of research the SDTS needs their research program to be located in a local acute care hospital that has the existing capability to receive and triage patients with acute cerebrovascular disease and the capability to immediately provide 24/7 access to MRI to aid in the diagnosis and study of these patients. The SDTS team will fully integrate with the hospital's medical staff and will be available 24/7 to evaluate patients who present to the Contractor's hospital with symptoms of an acute cerebrovascular disease. The Contractor will not be developing any research trials under this contract. Research trials will be developed by the SDTS team and will be conducted by the SDTS team at the Contractor's hospital subject to appropriate IRB approval. Enrollment and treatment of patients into research studies will be performed by the SDTS team at the Contractor's hospital. The Contractor's hospital staff will aid in the identification and referral of patients to the SDTS team for possible recruitment into research trials. The Contractor will provide clinical support services (nursing, physician, radiology, pharmacist, etc) for these studies. Therefore, at a minimum, there are critical elements that an acute care facility would need to have in place and operational, or be able to establish prior to award. The critical elements are as follows: 1) Demonstrate hospital is located within 15 miles of the NIH campus (9000 Rockville Pike, Bethesda, MD 20892); 2) Demonstrate hospital has MRI scanner (1.5T or 3T) in close proximity to the Emergency Room; 3) Demonstrate hospital can make the MRI scanner immediately available 24/7 for use in the diagnosis of acute stroke and TBI patients; 4) Demonstrate hospital has achievement of Stroke Center Certification by The Joint Commission and, for hospitals in Maryland, the additional designation as a Stroke Center by the Maryland Institute for Emergency Medicine Services Systems Stroke (MIEMSS); 5) Demonstrate stroke admissions of at least 400 stroke patients per year; and 6) Demonstrate hospital has experience with conduct and support of acute care research studies. INFORMATION REQUESTED: Submitted Capability Statements must adequately address the six critical elements enumerated above. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS. The purpose of this announcement is to obtain responses from organizations who might be interested in and capable of meeting the needs of this NINDS requirement. Once a determination is made regarding how best to pursue continuation of this requirement, a separate announcement will be published in advance of release of a Request for Proposals. The applicable North American Industry Classification System (NAICS) code for this requirement is 622110. Therefore, the small business size standard for this announcement is $35.5 million. Submitted Capability Statements must address how the business meets the applicable size standard designated for this project. Please submit 3 copies of your response to the attention of Laurie A. Leonard, Contracting Officer or Annette Carter, Contracting Officer at the address provided by 5:00 PM Local Time on Monday, February 10, 2014. Electronic submittal will also be accepted at ll44s@nih.gov or cartera@mail.nih.gov (please format for printing). You are encouraged to limit you response to fewer than 15 pages and your response must specifically address each aspect of the requested requirement specific information stated above. Generic marketing brochures will not be considered further. This Announcement is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or the Government's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the Government's evaluation of the information received. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this announcement or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Responses will be held in a confidential manner. Any proprietary information should be so marked. All respondents are asked to indicate the type and size of your business organization, e.g., Large Business, Educational Institution, State Owned Institution, Small Business, Veteran-Owned Small Business, Service-Disabled Veteran-Owned Small Business, HUBZone Small Business, Small Disadvantaged Business, Women-Owned Business, or 8(a). Laurie A. Leonard or Annette Carter, Contracting Officer, National Institutes of Health, NINDS R&D CMB, 6001 Executive Blvd., Suite 3287, Bethesda, MD 20892-9531 or via courier to Rockville, MD 20852.