Inactive Total Small Business Set-Aside (FAR 19.5)

Project Title: Clinical Support Services for the Research Efforts of the NINDS, Stroke Branch This is a Small Business Sources Sought notice. This is NOT a solicitation or request for proposals, propo... Project Title: Clinical Support Services for the Research Efforts of the NINDS, Stroke Branch This is a Small Business Sources Sought notice. This is NOT a solicitation or request for proposals, proposal abstracts, or quotations. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered proposals or quotes. No award will be made as a result of this notice. This notice is strictly for the purpose of obtaining information and identifying small business organizations that are capable of providing the requisite services for the prospective requirement described below. The Government will NOT be responsible for any costs incurred by any respondent to this notice. The NINDS Stroke Branch intends to acquire clinical services and support from two hospitals (Hospital) or acute care facilities (Facility) located within fifteen (15) miles of the National Institutes of Health (NIH) Campus located at 9000 Rockville Pike, Bethesda, Maryland 20892. These clinical support services will support the National Institutes of Neurological Disorders and Stroke’s (NINDS) Stroke Branch’s research to study the use of Magnetic Resonance Imaging (MRI) in the clinical evaluation of acute stroke and traumatic brain injury (TBI) patients and to develop acute stroke therapies. In addition to these clinical support services, the Contractor will be required to provide an acute care hospital setting for NIH Team staff to recruit, enroll, study and treat acute stroke and TBI patients. This program is a continuation of a long-term (15+ years) collaborative effort the NIH Team has had with two local hospitals to provide clinical support services to facilitate research into acute cerebrovascular diseases and TBI. The NIH Team will recruit patients who present to the Contractor's hospital/acute care facility with symptoms of an acute stroke or TBI and will employ the use of non-invasive MRI methodologies to evaluate the disease and help develop new therapies for the treatment of these diseases. The research protocols conducted at the Hospital/Facility site are designed and performed by the NIH Team. The services to be provided by the Contractor’s Hospital/Facility to the NIH team are standard clinical services. Contractor staff will not be required to analyze or interpret data based on research protocol objectives of the Stroke Branch. Although the Hospital/Facility will not be developing or conducting any of the research, it will be required to provide clinical services and support including but not limited to patient identification and referral; patient clinical assessment; 3T 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; general radiological services; and neurointensive care and monitoring. Period of Performance: This clinical services and support requirement has an anticipated base period of performance of September 1, 2024 through February 28, 2024 (6-month base period) with four 12-month option periods. Mandatory Qualifications: At a minimum, there are specific qualifications that a Hospital/Facility would need to have in place and operational at the time the clinical support services begin and throughout the duration they are provided. These mandatory qualifications are as follows: The Hospital/Facility is located within 15 miles of the NIH Campus at 9000 Rockville Pike, Bethesda, Maryland 20892. The Hospital/Facility possesses a Primary Stroke Center Certification or Comprehensive Stroke Center Certification issued by The Joint Commission and, for hospitals in Maryland, the acute care facility also possesses the additional certification as Thrombectomy-Capable Primary Stroke Center by the Maryland Institute for Emergency Medicine Services Systems Stroke (MIEMSS) Designation. The Hospital/Facility has the ability to provide 24/7 acute stroke coverage independently of any clinical resources provided by the NIH Team. The Hospital/Facility has a fully operational 3T MRI scanner in close proximity to the facility’s Emergency Department such that patient transport from the facility’s Emergency Department to the MRI scanner location can readily and routinely be accomplished in less than 5 minutes. The facility’s MRI scanner would be immediately available at all times for use in the diagnosis of acute stroke and TBI patients. Performance Requirements: MRI Facility and Equipment: Patient Preparation Area - This area shall be used to prepare, examine, and interview patients. The room shall be conducive for conducting patient exams, minor procedures, and general patient preparation. Patient Treatment Area - This area shall be used to monitor or treat patients with standard or experimental therapies while within the MRI facility. This area shall include fully functioning cardiovascular monitoring equipment and emergency resuscitation equipment, e.g., crash cart. This area will be stocked with sufficient supplies of medications required by the NIH Team. A nurse will be available whenever needed to assist in monitoring patients undergoing studies in the MRI facility. MRI Facility Location and Access - The state-of-the-art 3T MRI scanner shall be located in close proximity to the Emergency Department such that patient transport from the Emergency Department to the MRI facility can readily and routinely be accomplished in less than 5 minutes. Access to the state-of-the-art MRI scanner by the NIH Team shall include scheduled research time during normal operating hours. Normal operating hours are defined as Monday through Friday 8 am through 7 pm Eastern Time. The MRI scanner shall be immediately accessible to the NIH Team at all times for emergency evaluation of stroke patients (no greater than a 15-minute delay between notification of technologist of emergency stroke case and scanner readiness for the patient). The NIH Team shall have access to the MRI scanner for emergency, clinical follow-up, or research scans, and not require approval by the Contractor’s radiologist or other staff. Outside of normal operating hours, the MRI scanner shall be available at all times for NIH Team stroke research studies. The Contractor shall be responsible for coordinating and implementing required MRI scanner upgrades as necessary. The Contractor will be reimbursed for the cost of required upgrades and maintenance services. The NIH Team shall be kept informed of any contemplated maintenance, changes, or upgrades to the MRI system. Patient Referral: The Hospital/Facility’s Emergency Department and/or Stroke Team shall facilitate the referral of acute stroke and/or TBI patients for possible enrollment into the NIH Team’s research protocols. Upon identification of appropriate patients specified in the NIH Team’s research protocols, emergency room staff (or in-patient unit staff in the case of strokes occurring in hospital) shall promptly notify the NIH Team for recruitment into a research protocol. The NIH Team shall be provided with access to patient demographic and admission information. Radiology Services: The Hospital/Facility shall provide 24-hour access to a state-of-the-art CT scanner for clinical scanning of stroke patients including capacity for CT angiography and CT perfusion. Clinical stroke imaging protocols will be determined through collaboration and agreement between the NIH Team and the Hospital/Facility’s radiologists. The Hospital/Facility shall make available 24-hour interventional neuroradiologist coverage with emergency on-call neuroradiological services for image interpretation or interventional procedures. Interventional procedures shall be available at all times for emergency diagnostic angiography and intra-arterial thrombolysis of cerebral arteries and other endovascular therapies and research collaborations. Contractor’s neuroradiologists shall provide stat reads of emergency CT scans and MRI scans. Diagnostic Tests/Supplies/Services: The majority of diagnostic tests shall be performed as part of the clinical services and support. It is anticipated that research protocols may require chemistry or hematological laboratory tests to be performed and reported urgently (stat) that may not typically be considered stat. Thus, the Contractor’s laboratory shall make available the resources to perform the tests required by the research protocols and in a manner required by the protocols. The Contractor shall provide these tests as required by the research protocols. The Contractor shall be reimbursed for reasonable costs incurred for any diagnostic tests related to the research protocols. The NIH Stroke Team may elect to send their research laboratory tests to an outside facility for processing. Computer Networks The Hospital/Facility shall allow and facilitate the installation of the NIH computer network at the hospital site. The Hospital/Facility CT scanners and MRI scanners shall be made accessible to the NIH computer network. All NIH Team office facilities at the Hospital/Facility site shall require at all times high-speed network access to the NIH’s and Hospital/Facility’s computer networks. Space Requirements: Adequate office space and office furnishings for 3-5 members of the NIH Team shall be provided on Hospital/Facility premises by the Contractor. This space shall be in close proximity to the MRI facility and the Stroke Unit. This office space shall be computer network accessible to both the Hospital/Facility’s and NIH’s computer networks. Clinical Research Infrastructure: The Contractor shall provide the clinical infrastructure to support the research protocols of the NIH Team as discussed in the performance requirements above. In addition, the Hospital/Facility shall provide medical records support to ensure that copies of written consents generated by the NIH Team are incorporated into the appropriate medical records. Medical Staff Privileges and Billing: Upon request and following standard application and review, the hospital or clinical care facility shall grant clinical privileges to NIH personnel to perform clinical services and procedures for which they possess adequate training and experience. Support Staff and Ancillary Services: Other hospital-based services shall be provided to support standard stroke care which include but are not limited to nursing, neurosurgery, interventional neuroradiology, speech therapy, occupational therapy, and physical therapy. The cost associated with such services will be the responsibility of the Contractor. Training: The NIH Stroke Program has an Accreditation Council for Graduate Medical Education (ACGME) vascular neurology residency program. The Hospital/Facility shall agree to enter into a Program Letter of Agreement with NIH to allow the NIH vascular neurology residents to do inpatient and outpatient rotations at the Hospital/Facility site. The Hospital/Facility shall provide vascular neurologist(s), at least one of whom shall be American Board of Psychiatry and Neurology (ABPN) Board Certified in Vascular Neurology, to serve as faculty for this training program and to assist with the education and training of the NIH vascular neurology residents during their inpatient and outpatient rotations. Contractor shall provide sufficient resources (faculty, space and other ancillary support) to ensure the outpatient rotation provides valuable teaching experience for the NIH vascular neurology residents. In-service Training: The NIH Team shall be responsible for training the Hospital/Facility’s clinical staff members in the NIH Team’s research protocol requirements. The Hospital/Facility shall provide sufficient time and access to its clinical staff for this training. Level of Effort The estimated level of effort is as follows: Local Site Principal Investigator (PI) or Stroke Center Medical Director (physician): The position shall assist in facilitating the clinical and research activities of the NIH Team and assist with the education and training of NIH vascular neurology residents. This position will serve as a liaison between the NINDS Contracting Officer’s Representative and the Hospital/Facility’s staff – 50% Research Nurse that is ABPN board certified in vascular neurology: This position shall provide support for the NIH Team’s research activities – 100% Research Coordinator: This position shall provide support for the NIH Team’s research activities – 100% MRI Technologist: The position shall support the MRI scanner facility and act as liaison and optimize communication between NIH Team and the Hospital/Facility’s MRI technologist staff, ensure compliance with technical requirements of scanning protocols. Respondent shall describe how this support will be provided based on percentage of MRI scanner utilization. Responses to this notice must include the respondent's technical and administrative points of contact by name, title, address, telephone number, and email address. The response must also include the respondent's System for Award Management (www.sam.gov) Unique Entity ID (UEI), organization name and address, size and type of business (e.g., 8(a), HubZone, veteran-owned, etc.) under the above listed NAICS code, and any other information that respondent believes may be helpful to the Government in developing or finalizing the acquisition requirements. Respondents must submit their response in Microsoft Word or searchable Adobe PDF format using 11-point or 12-point size font. Responses are limited to 12 pages. All responses must be submitted electronically to Marlene Milgram at marlene.milgram@nih.gov. Faxed responses are not accepted. All responses must reference notice number 75N95024R00085 in the subject line and be received on or before the response due date and time listed in this notice. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in any 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 and capabilities to perform the requirement.