Attachment_4_Statement_of_Work.pdf

STATEMENT OF WORK (SOW)

SERVICES

A. General Information

Title of Project: Clinical Support Services for the Research Efforts of the NINDS, Stroke

The purpose of this contract is to acquire clinical support services from an acute care hospital (hereafter identified as Contractor) located within 15 miles of the NIH campus located at 9000 Rockville Pike, Bethesda, MD 20892 to support the research efforts of the NIH/NINDS Stroke Branch (hereafter identified as NIH Team). The overall program 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. Although the Contractor will not be developing or conducting any of the research under this program, they will be providing support and clinical services including but not limited to: 24/7 standard care of stroke and TBI patients, patient identification and referral to NIH Team; MRI and CT support for imaging of prospective patients for referral and research subjects; vascular neurology physician services and research patient assessment; clinical research nurse coordinator services; emergency preparation and blinding of study drugs by a hospital pharmacist; chemistry and hematological laboratory tests required by the NIH Team research protocols; general radiological services; neurosurgical and neuroradiological services; interventional radiology services; neurointensive care and monitoring. This contract will only reimburse the services necessary to support the research initiated and conducted by the NIH Team.

B. Mandatory Requirements

The following mandatory requirements are applicable to this effort:

1. Location of Contractor: Contractor must be located within 15 miles of the NIH Campus (9000 Rockville Pike, Bethesda, MD 20892). Since the goal of this program is to evaluate acutely ill patients, the proximity of the hospital to NIH is critical to permit scientific staff the ability to travel quickly from NIH to the Contractor’s site..

2. Certification: Contractor shall have achieved Primary Stroke Center Certification or Comprehensive Stroke Center Certification by The Joint Commission and, for hospitals in Maryland, the Contractor shall have the additional certification as Thrombectomy- Capable Primary Stroke Center by the Maryland Institute for Emergency Medicine Services Systems Stroke (MIEMSS) Designation.

3. 24/7 Stroke Coverage: Contractor shall demonstrate their ability to provide 24/7 acute stroke coverage independent of any clinical resources that may be provided by the NIH Team.

4. 3T MRI Scanner: Contractor shall have a 3T MRI scanner 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.

C. Specific Performance Requirements and Commitments

All elements of the performance requirements and commitments shall be in place and operational at the time the clinical support services begin:

1. Elements of Stroke Unit: 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 neurointensive monitoring equipment. Additional equipment specific for the clinical needs for the stroke care may by specified by the NIH Stroke Team.

2. 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 this contract and enhance the research. 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.

3. Patient Referral: The Contractor’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.

4. 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.

5. 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 is critical for the program’s needs.

a. 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.

b. 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.

c. 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 8am through 7pm. The scanner shall be immediately accessible always for emergency evaluation of stroke patients (no greater than 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.

d. 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.

6. 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 will 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. Diagnostic Tests/Supplies/Services: The majority of diagnostic tests shall be performed as part of clinical services and thus not reimbursable cost under this 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 Stroke Team may elect to send their research laboratory tests to an outside facility for processing.

13. Costs of Patient Transfer from Another Facility: The cost of transferring a patient by air or land from another facility to the Contractor’s hospital may not be passed on to the Government unless the primary reason for the transfer is participation in an approved research protocol of the NIH Team and the research participation was initiated (e.g., inform consent obtained) prior to the transfer.

14. Division of Cost Responsibility: The cost requirements of the program that are of clinical necessity (e.g., routine clinical care, maintenance of stroke center certification) shall be the responsibility of the Contractor.

Any cost to establish and maintain emergency and inpatient clinical, laboratory, and radiological services as required to maintain stroke center certification shall be the responsibility of the Contractor. This will include any costs of upgrading or expanding human or equipment resources not currently available or sufficient to meet the needs of the care of stroke patients.

The cost of those elements required by the research protocols of the program shall be the responsibility of the Government and shall be allowable costs under this contract.

Note, if a patient’s insurance company declines to pay for a clinical service the cost of that service will not be reimbursed under this contract.

15. Research Costs: Research patient care costs shall be reimbursed by this contract in accordance with, if applicable, the Contractor’s HHS negotiated research patient care rate agreement. In absence of such agreement the research patient care costs will be reimbursed by this contract at the Medicare reimbursement rate.

16. IRB Approval: All research performed by the NIH Team shall be reviewed and approved according to IRB requirements for NIH and the Contractor.

17. 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.

18. Proprietary Research Data: The resulting research data collected shall be proprietary to NIH Team except for medical necessity. Any use of the research data collected by the NIH Team cannot be used by non-NIH personnel for scientific, academic, educational, commercial or other purposes without the permission of the NIH Team and in accordance with NIH policy.

19. Space Requirements: Adequate office space and office furnishings for 3-5 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.

20. 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.

21. Reporting Requirements: The Contractor shall prepare and deliver written quarterly reports on the numbers and types of patients referred to NIH Team. These reports shall be electronically delivered to the Contracting Officer (CO) and Contracting Officer Representative (COR).

22. Publicizing Relationship: The Contractor shall get prior written approval from Contracting Officer to publicize, or to use for marketing purposes, their relationship or association with NIH/NINDS.

23. Program Management and Control Requirements: The Contractor shall appoint either a senior administrator or Stroke Center Medical Director as Principal Investigator (PI) to serve as a liaison between the NIH Team, Contractor’s corporate management and clinical support staff. In addition, if NIH Team deems necessary, monthly meetings shall occur between the PI and NIH staff to assure referral of patients, contract compliance and support of the NIH clinical and research protocols.

D. Clinical Support – Roles and Responsibilities:

1. Stroke Center Medical Director: 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.

2. Clinical Support Services:

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

b. 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.

c. 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 propose how they will provide this support

d. 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.

E. Period of Performance

The period of performance of the contract will consist of one 6-month base period and four 12-month option periods. The base period is expected to start on or about September 1, 2024.

G. Deliverables

The Contractor shall refer a minimum of 90 percent of appropriate stroke and/or TBI patient admissions to the NIH Team for possible enrollment into NIH Team’s research protocols.

H. Reporting Requirements

The contractor shall be required to submit written quarterly performance reports detailing the number of patients referred to the NIH Team. The reports shall be sent electronically to the COR and to the CO. In addition, the contractor will submit monthly invoices detailing the costs charged to the contract, which will be reviewed by the COR for accuracy.

I. Other Considerations

1. Travel: No travel will be required under the contract.

2. Key Personnel: Local Site PI for NIH Research Support (Stroke Program Medical Director) shall be specified in the contract as key personnel and considered to be essential to work performance. Key Personnel shall be subject to HHSAR 352.237-75 Key Personnel.

3. Information Systems Security Plan: All research data collected by the NIH Team will be stored on NIH services located on the NIH campus.

4. Publication and Publicity: Any use of the research data collected by the NIH Team cannot be used by non-NIH personnel for scientific, academic, educational, commercial or other purposes without the permission of the NIH Team and in accordance with NIH policy. The Contractor shall get prior written approval from Contracting Officer to publicize, or to use for marketing purposes, their relationship or association with

NIH/NINDS.

5. Section 508—Electronic and Information Technology Standards: The only Electronic and Information Technology (EIT) product or service required under this contract is the electronic submission of reports. The contract will require that electronically submitted reports be in a Section 508-compliant format and the appropriate Section 508 Standards will be included in the contract.

6. Confidentiality of Information: The research data collected shall be proprietary to NIH Team except for medical necessity. Any use of the research data collected by the NIH Team.