Presol_Notice_of_Intent_75N95019C00044.pdf

PRE-SOLICITATION NOTICE OF INTENT

NON-COMPETITIVE

Notice Number: 75N95019C00044

INTRODUCTION

PURSUANT TO FAR Subpart 5.2—Synopses of Proposed Contract Actions, THIS IS A PRE-

SOLICITATION NOTICE OF A PROPOSED CONTRACT ACTION.

THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A

CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING

BRAND-NAME).

The National Institute of Neurological Disorders and Stroke (NINDS) is part of the National Institutes of Health (NIH). The NINDS is 1 of 27 NIH Institutes and Centers. The NINDS’s mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease for all people.

One of the ongoing programs in the National Institute of Neurological Disorders and Stroke’s (NINDS) Stroke Branch is designed to study the use of Magnetic Resonance Imaging (MRI) in the evaluation of acute stroke and traumatic brain injury (TBI) patients, and to develop acute stroke therapies, which involves many processes including referring some acute stroke and TBI patients to the NIH Stroke Team for possible inclusion in research studies.

The National Institute on Drug Abuse (NIDA) Office of Acquisition, on behalf of the NINDS’s Stroke Branch, intends to negotiate and award a modification to an existing contract (Contract No. 75N95019C00044) between the NINDS and Medstar Health Research Institute.

Clinical Support Services for the Research Efforts of the NINDS’s Stroke Branch for the Period of 9/1/2024 to 9/27/2024

Contract number 75N95019C00044, titled Clinical Support Services for the Research Efforts of the NINDS Stroke Branch, was one of two contracts awarded under Request for Proposals No.

NIH-NIDA-NINSD-19-5221036. This contract ends on 08/31/2024.

The intended modification will extend the period of performance of the above listed contract by 27 days, from 09/01/2024 to 09/27/2024 and increase the total amount obligated by $53,640.90.

This amount will fund the continuation of the services performed under the contract from 09/01/2024 to 09/27/2024 (27 days). There will be no other material changes to the contract.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 622110 – General Medical and Surgical Hospitals, which has a small business size standard of $47.0 million.

REGULATORY AUTHORITY

The resultant modification will include all applicable provisions and clauses of the Federal acquisition Regulation (FAR) in effect through the current Federal Acquisition Circular (FAC).

STATUTORY AUTHORITY

This acquisition is conducted as non-competitive under the authority of 41 U.S.C. 3304(a)(1) under provisions of the statutory authority of FAR Subpart 6.302-1, Only One Responsible

Source and No Other Supplies or Services Will Satisfy Agency Requirements.

DESCRIPTION OF REQUIREMENT

Clinical Support Services for the Research Efforts of the NINDS Stroke Branch

Background: The Stroke Branch of the NINDS has an existing need for clinical support services to be provided by an acute care hospital to supports NINDS’s research efforts under a program designed to study the use of Magnetic Resonance Imaging (MRI) in the evaluation of acute stroke and traumatic brain injury (TBI) patients and to developer acute stroke therapies.

Purpose and Objectives: The current contractor will be required to continue providing support and clinical services including but not limited to 24/7 standard care of stroke and TBI patients, patient identification and referral to an NIH Team, MRI and CT support for imaging of prospective patients for referral and research subjects, vascular neurology physician services, research patient assessments, clinical research nurse coordinator services, emergency preparation and blinding of study drugs by a hospital pharmacist, ordering chemistry and hematological laboratory tests required by the NIH Team research protocols, general radiological services, neurosurgical and neuroradiological services; interventional radiology services; neuro-intensive care, and patient monitoring.

Specific Performance Requirements: The continuation of the clinical support services from September 1, 2024 to September 27, 2024, to support the research efforts of the NINDS’s Stroke Branch will require the contractor to perform some or all of the following:

a. Stroke Unit Elements: The Contractor shall provide beds for patients on the Stroke Service with ICU level and ICU-step with appropriate levels of neuroscience nursing staffing and beds equipped with standard cardiovascular and neuro-intensive monitoring equipment. Additional equipment specific for the clinical needs for stroke care may by specified by the NIH Team.

b. Designation as Stroke Service: The Contractor shall recognize the NIH Team as the designated research team. It is understood that the research activities of the NIH Team may not involve all patients with acute cerebrovascular and/or TBI disease.

Upon approval of the NIH Team, Contractor staff may participate as associate investigators of the NIH Team’s research protocols.

Interdepartmental collaboration will be essential to the goals of the contract. The Contractor shall foster and facilitate an adequate and acceptable collaboration between the NIH Team and the other hospital departments. For conflicts over research issues, priority shall be given to the specifics of protocols approved by NIH and the Contractor's IRB committees. Except for emergency or life-threatening situations, no deviation in the care specified by an approved research protocol shall be instituted (i.e., no orders written) by a physician without prior discussion and agreement by the NIH Team’s research protocol medically responsible investigator.

c. Patient Referral: The Contractor hospital’s Emergency Department and/or Contractor’s 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 ability of the hospital to meet the patient referral will be reviewed quarterly. The NIH Team shall be provided with access to patient demographic and admission information to determine whether compliance with the referral rate is being met. Inadequate referral activity that jeopardizes the success of the NIH research protocols may preclude the Government from exercising any future options under the contract.

d. Support Staff and Ancillary Services: Other hospital-based services shall be provided to support standard stroke care and are essential elements of Joint Commission-certified Primary or Comprehensive Stroke Centers. These include, but are not limited to nursing, neurosurgery, interventional neuroradiology, speech therapy, occupational therapy, and physical therapy. The cost associated with such support is the responsibility of the Contractor.

e. MRI Facility and Equipment: A major research focus of this program is the use of MRI in the evaluation and investigation of stroke and traumatic brain injury patients. Thus, a state-of-the-art MRI scanner (3T) and facility are critical to the program’s needs.

• Patient Preparation Area - This area shall be used to prepare, examine, and interview patients. The room shall be capable of 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. Cardiovascular monitoring equipment and emergency resuscitation equipment (‘crash cart’) will be available in this area. This area will be stocked with sufficient supplies 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 - The state-of-the art 3T MRI scanner shall be located near 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. The scanner shall be available 24/7 for use in the evaluation of acute stroke and TBI patients. Proximity to the Stroke Unit, CCU or other critical patient monitoring areas is desirable. Access to the state-of-the art MRI scanner by NIH Team shall include scheduled research time during normal operating hours, and additional hours may be scheduled for other times. Normal operating hours are defined as Monday through Friday 8 am through 7 pm. The scanner shall be immediately accessible 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). Access to the MRI scanner by the NIH Team for emergency, clinical follow-up, or research scans, will not require approval by the Contractor’s radiologist or other staff. Outside of normal operating hours, the scanner shall be available for NIH Team stroke research studies. Use of the MRI scanner by the NIH Team may not be limited in any manner by the Contractor.

• Scanner Upgrades - Contractor shall be responsible for coordinating and implementing required scanner upgrades as necessary. The NIH Team shall be kept informed of any contemplated maintenance, changes, or upgrades to the MRI system. No changes shall take place without the input and agreement of the NIH Team. Payment of upgrade and maintenance costs with the use of contract funds will be determined on a case-by-case basis.

f. Radiology Services: In addition to MRI unit, the Contractor shall provide 24-hour access for clinical scanning of stroke patients in a state-of-the-art CT scanner for 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 Contractor’s radiologists.

The Contractor shall make available 24-hour interventional neuroradiologist coverage with emergency on-call neuroradiological services for image interpretation or interventional procedures. The requirement for interventional procedures must always be available 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.

g. Medical Staff Privileges and Billing: Upon request and following standard application and review, the Contractor shall grant clinical privileges to NIH personnel to perform clinical services and procedures for which they have adequate training and experience in support of the clinical and research needs of the NIH Team. Such privileges and/or access to required hospital resources shall not be denied for reasons of competition with other Contractor’s staff or clinical services for any reasons other than professional competency.

NIH employed physicians will not charge or bill for their clinical services and the Contractor may not bill for NIH employed physicians either directly or indirectly.

h. Training: The NIH Stroke Program has an Accreditation Council for Graduate Medical Education (ACGME) vascular neurology residency program. The Contractor 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 Contractor’s site. The Contractor 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.

i. Community Outreach: The hospital shall provide, at no cost to the Government, community outreach services to educate the potential patient population in the Contractor’s community about stroke prevention and treatment, about the NIH research programs and to foster a receptive attitude toward participation in NIH research studies.

j. In-service Training: The NIH Team shall be responsible for training Contractor's clinical staff members in the NIH Team’s research protocol requirements. Sufficient time and access to the Contractor’s clinical staff to provide education and training regarding research protocols shall be provided.

k. Patient Follow-up after Hospital Discharge: Patients seen by the NIH Team will be referred to an appropriate physician for follow-up (non-research related) care. The NIH Team will need to maintain contact with the patient once they are enrolled in a research protocol and will contact or see patients in follow-up for the purpose and according to the requirements of the research protocols.

l. Diagnostic Tests/Supplies/Services: The majority of diagnostic tests shall be performed as part of clinical services and shall not be reimbursable under the contract. 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 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 costs for any diagnostic tests related to the research protocols shall be allowable costs under this contract. The NIH Team may elect to send their research laboratory tests to an outside facility for processing.

m. Computer Networks: The Contractor shall allow and facilitate the NIH network to be installed at their hospital site. The Contractor’s CT scanners and MRI scanners shall be made accessible to NIH computer network. All NIH Team office facilities at the Contractor’s Hospital shall require high-speed computer links with the NIH’s and Contractor’s computer networks.

n. Space Requirements: Adequate office space and office furnishings for 3 to 5 members of the NIH Team shall be provided on hospital premises by the Contractor. This space shall be in proximity to the MRI facility and the Stroke Unit. During the contract period, the clinical and research activities and staffing of the program may grow. If space requirements of the NIH Team increase, sufficient and acceptable space and furnishings shall be made available to the NIH Team. If the Contractor requires relocation of the NIH Team offices, the costs of relocation and renovation to a comparable space shall be the responsibility of Contractor. This office space shall be computer network accessible to both the Contractor’s and NIH’s computer networks.

o. Clinical Research Infrastructure: The Contractor shall provide the clinical infrastructure to support the research protocols of the NIH Team as discussed in the general and specific requirements of this statement of work. In addition, the Contractor shall provide medical records support to ensure that copies of consents generated by the NIH Team are incorporated into the appropriate hospital medical records.

p. Clinical Support – Roles and Responsibilities:

The Contractor shall have a Stroke Center Medical Director. The Director shall help facilitate 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 COR and the Contractor’s staff. Support of this position based on level of effort will be an allowable cost under this contract.

At least one member of the hospital’s stroke center medical staff shall be ABPN board-certified in vascular neurology.

The Contractor shall provide contract dedicated, full-time clinical research nurse coordinator to work with the NIH Team in support of the NIH research activities. Support of this position will be an allowable cost under this contract. Offeror must address timeline and methods to recruit staff for this position if not already existing.

The Contractor shall provide 24/7 MRI technologist support for the MRI scanner facility.

The Contractor and the NIH Team shall jointly designate one MRI technologist to serve as liaison between the NIH Team and the Contractor’s MRI technologist staff to optimize communication and compliance with the technical requirements of scanning protocols.

The Contractor shall maintain standard procedures for training and documenting the competency of MRI technicians in stroke imaging protocols, changes in imaging protocols, or addition of new imaging protocols. NIH reserves the right to provide input regarding the performance of each technologist.

The Contractor shall provide administrative support services to the NIH Team. Only services in direct support of the NIH Team’s activities will be considered as an allowable cost under this contract and must be justified.

Period of Performance The period of performance will be September 1, 2024 - September 27, 2024.

REASON FOR THE NON-COMPETITIVE ACTION

The above-listed contract was originally awarded following a full and open competition. FAR Part 15 source selection procedures were used to determine awardees. The above listed contract includes one base period and four option periods with the fourth and final option period ending on August 31, 2024.

Modifying the above-listed contract to extend the period of performance by 27 days and to fund the services provided during this period is the only feasible way to ensure continuation of these services. The NINDS and NIDA are actively preparing to solicit and award a new contract for these services, but due to changes in requirements, it was not possible to award a new contract by August 31, 2024 and avoid a gap in services provided under the current contract and a new contract. A gap in service will have adverse consequences for the research efforts of the NINDS’s Stroke Branch. Specifically, there is an ongoing Stroke Branch research protocol that recruits subjects from the Contractor’s site (Medstar Washington Hospital Center). Interruption to the conduct of this study will disrupt recruitment targets and interrupt the critical protocol timepoints thus potentially reducing the quality of the research data.

In addition, if there is a gap in services, the current Contractor’s staff working under the aforementioned contract would be unable to continue working, resulting in loss of employment.

Several Contractor staff have worked with the NINDS research investigators for 10+ years. The loss of the expertise of this staff would cause a significant setback in the ability of the Stroke Branch researchers to continue their research.

Moreover, the Contractor (MedStar Health Research Institute) has specific qualifications and certifications required to provide the services and is the only organization able to continue providing the clinical support services at this time without unacceptable delays.

CLOSING STATEMENT

This notice of intent is NOT a request for competitive proposals; however, interested parties may identify their interest and capability to respond to this notice.

Responses to this notice must contain sufficient information to establish the interested parties’ bona-fide capability of fulfilling all requirements described herein. The statement must also include the contractor’s Unique Entity Identifier (UEI) number, Taxpayer Identification Number (TIN), and its certification of business size. All responders must be actively registered to receive awards in the System for Award Management (SAM), accessible at www.sam.gov.

A determination by the Government to not compete the proposed contract action based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purpose of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement for the requirement. The determination of whether to proceed with the proposed contract modification is solely within the discretion of the Government.

All responses must be received by 4:00 PM Eastern Time on August 9, 2024 and reference Notice ID/Notice Number 75N95019C00044 in the Subject line. All responses must be emailed to Marlene Milgram, Contract Specialist, at marlene.milgram@nih.gov.

All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.

mailto:marlene.milgram@nih.gov