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FBO DAILY - FEDBIZOPPS ISSUE OF MAY 05, 2019 FBO #6372
SOLICITATION NOTICE

Q -- Clinical Support Services for the Research Efforts of the Stroke Branch, Section on Stroke Diagnostics and Therapeutics, NINDS, NIH

Notice Date

5/3/2019
 

Notice Type

Synopsis
 

NAICS

622110 — General Medical and Surgical Hospitals
 

Contracting Office

6001 Executive Boulevard Room 4211, MSC 9559 Bethesda MD 20892-9559
 

ZIP Code

20892-9559
 

Solicitation Number

NIH-NIDA-NINDS-19-5221036
 

Response Due

5/18/2019
 

Point of Contact

Danny Cohn, Contracting Officer, Phone 3014027111
 

E-Mail Address

danny.cohn@nih.gov
 

Small Business Set-Aside

N/A
 

Description

THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION ANNOUNCEMENT ONLY. A REQUEST FOR PROPOSALS (RFP) NO. NIH-NIDA-NINDS-19-5221036, ENTITLED: "Clinical Support Services for the Research Efforts of the Stroke Branch, Section on Stroke Diagnostics and Therapeutics, NINDS, NIH" WILL BE ISSUED VIA FEDBIZOPPS ON OR ABOUT May 20, 2019. It is anticipated that up to two (2) cost-reimbursement contracts will result from the issuance of the solicitation. The government anticipates issuing the solicitation under full and open competition. Purpose: The purpose of this acquisition is to acquire the services of up to two acute care hospital(s) (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 research efforts of the NIH/NINDS Stroke Branch, Section on Stroke Diagnostics and Therapeutics (hereafter identified as NIH Team). The overall program is designed 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. Although the Contractor will not be developing or conducting any of the research under this program, they will be providing clinical services and support including but not limited to: 24/7 standard clinical care for stroke and TBI patients, patient identification and referral; MRI and CT support for imaging of prospective patients for referral and research subjects; vascular neurology physician services; 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; neuro-intensive care and monitoring. This contract will only reimburse the services necessary to support the research initiated and conducted by the NIH Team. Background: This acquisition will provide acute care hospital setting for NIH Team staff to recruit, enroll, study and treat acute stroke and TBI patients. This project 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 with symptoms of an acute stroke or TBI and will employ 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 these sites are designed and performed by the NIH Team. The services provided by the Contractor to the NIH team are standard clinical services, nothing innovative or unique, and Contractor staff will not be required to analyze or interpret data based on the NINDS research protocol objectives. Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the scope of the contract requirement, including the following: 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. 2. Designation as Research Team: 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, and between the NIH Team and private practice physicians. 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, the Contractor's staff shall promptly notify the NIH Team for possible 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 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. c. MRI Facility Location - The state-of-the art 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. Access to the state-of-the art MRI scanner by NIH Team shall include scheduled research time during normal operating hours (M-F 8a-7p), and additional hours may be scheduled for other times. The MRI scanner shall be immediately accessible 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. The neuroradiological services may also, at the NIH Team's designation, be provided by NIH personnel in addition to the Contractor's personnel, and the contractor would not limit granting of clinical privileges or access to required hospital resources to such designees without just cause. 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. The Contractor shall not hire for employment any member of the NIH Team while that member is an NIH employee or within 1 year of termination of NIH employment, without prior permission of the NIH team. 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 clinical care and 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. Non-transfer of Acute Patients: The Contractor shall seek designation with the various HMO plans to be recognized as an acute stroke center for that provider. This will help reduce the number of patients who are transferred from the Contractor's emergency room or within 24 hours of admission to another hospital because of insurance membership constraints. 12. 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. 13. Research Pharmacist Availability: It is anticipated that drug treatment research protocols will require emergency preparation and blinding of study material (drug or placebo) by a pharmacist. Thus, during the activity of such protocols, a pharmacist must be available always in hospital (24/7) to perform the functions required by the protocol on an emergency basis. Only actual effort associated with preparing study materials or providing research pharmacy services as related to implementation of research protocols shall be an allowable cost to the contract. 14. 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. 15. 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. 16. 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. 17. 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. 18. IRB Approval: All research performed by the NIH Team shall be reviewed and approved according to IRB requirements for NIH and the Contractor. 19. 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. 20. 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. 21. Space Requirements: Adequate office space and office furnishings for 8-10 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. 22. 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. 23. 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). 24. 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. 25. 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. The NINDS anticipates awarding up to two (2) cost-reimbursement contracts with a one-year base period and four (4) one-year option periods, for a total period of performance of up to five (5) years, if all options are exercised. There is no obligation for the NINDS to exercise any Option Period; NINDS may end the contract after the Base Period or after any Option Period. Offerors are required to be registered in the System for Award Management (SAM) when submitting an offer or quotation, and shall continue to be registered until time of award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from a solicitation. Processing time should be taken into consideration when registering. Offerors who are not registered in SAM should consider applying for registration immediately upon receipt of this pre-solicitation. See FAR 52.204-7 System for Award Management (Oc 2018) and https://www.sam.gov for information on registration. This is NOT a Request for Proposals (RFP). Request for Proposals (RFP) No. NIH-NIDA-NINDS-19-5221036 will be available electronically and may be accessed through the FedBizOpps (URL: https://www.fbo.gov/) 15 or more calendar days after the issuance of this synopsis. THIS SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THE FEDBIZOPPS (FBO) WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED. All responsible sources may submit a proposal, which shall be considered by the agency. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (03-MAY-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
 

Web Link

Link To Document
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/NIH-NIDA-NINDS-19-5221036/listing.html)
 

Place of Performance

Address: 6001 Executive Blvd Rockville, MD

Zip Code: 20852

Country: US
 

Record

SN05301104-F 20190505/190503230014 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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