Sources_Sought_Notice_CV_MRI_Program.pdf

Sources Sought Notice No.: 75N92018R0037

Title: NHLBI Cardiovascular MRI Program

This is a small business sources sought notice. This is not a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

The National Heart, Lung, and Blood Institute (NHLBI) does not intend to award a contract based on responses nor otherwise pay for the preparation of any information submitted. As a result of this sources sought notice, the NHLBI may issue a request for quote (RFQ). There is no solicitation available now.

However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this sources sought notice or the NHLBI’s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement.

The NHLBI is seeking capability statements from all eligible small business concerns under the North American Industry Classification System (NAICS) code 622110 with a size standard $38.5M. Based on the responses received from this sources sought announcement, the proposed acquisition may be solicited as a total small business set-aside. All eligible small business concerns responding to this sources sought announcement must have the capabilities to provide the services as stated below.

Background

The National Heart Lung and Blood Institute (NHLBI)’s Advanced Cardiovascular Imaging Group is dedicated to the development of Magnetic Resonance Imaging (MRI) techniques for the study of cardiovascular diseases in humans. The group has made substantial advances in the field of cardiovascular MRI making MRI more feasible for the diagnosis and treatment of ischemic and non-ischemic heart disease in patients. Currently, the NHLBI is focused primarily on the following research areas:

- Advanced characterization of myocardial tissue and the relationship between these characteristics and disease processes;

- Exploring the role of quantitative MRI measures of myocardial perfusion at rest and during stress;

and,

- Validate methods for quantitative analysis of diastolic function of the heart.

Purpose and Objectives

The NHLBI’s Advanced Cardiovascular Imaging Group requires a state-of-the-art clinical research environment to conduct cardiovascular MRI research. The group seeks to exploit the technical staff, resources and patient network of an established medical center in an effort to improve research outcomes and cut down on operating costs. The purpose of this contract is to 1) secure a dedicated MRI facility wherein the NHLBI may perform its research, and 2) acquire professional services to support the NHLBI’s research. This contract will assist the NHLBI in accomplishing the following specific aims:

- To better understand the MR characteristics of acute myocardial infarction.

- To characterize fat and water in myocardium and other tissue, particularly in specific cardiomyopathies.

- To use T1 mapping to characterize the extracellular volume fraction and diffuse myocardial fibrosis in various cardiomyopathies.

- To use MRI to predict which patients will respond better to specific interventions (e.g. valve replacement, trans-myocardial laser therapy).

- To develop methods for quantifying diastolic function of the heart.

Tasks to be Performed

Contractor shall perform the following recurring tasks under the direction of the NHLBI’s Advanced Cardiovascular Imaging Group:

Task 1. Cardiovascular MRI Facility

Contractor shall provide and maintain a dedicated cardiovascular MRI facility fully equipped with the necessary equipment and supplies in order to facilitate the Government’s research. The cardiovascular MRI facility must be located within proximity of a cardiac catheterization laboratory and an echocardiography facility appropriate for acutely ill cardiovascular patients and patients undergoing cardiothoracic surgery procedures. The facility shall consist of the following components:

Magnet room: The scan room shall have adequate space for IV infusion pumps, power injectors, and monitoring equipment. It shall also have adequate storage space for RF receiver coils, MRI phantoms, and medical supplies routinely used during cardiovascular procedures. The magnet room shall include radiofrequency shielding that is tested periodically and maintained as indicated to meet the scan manufacturer specifications.

Computer room: The computer room shall be able to house all electronic equipment as specified by the scanner manufacturer. This requirement also includes necessary electrical power and a chilled water supply. Proximity to the scan room is necessary to meet manufacturer requirements for cable lengths.

All NHLBI-dedicated space within Contractor’s complex shall be networked by high speed computer lines (1000 MB/s or better).

Operator control room: The MRI operator control room shall contain adequate space to house the operator console, seating for three individuals supervising a cardiovascular study, and adequate space for an independent computer system. The space shall provide direct visualization of the patient within the magnet.

Patient preparation area: The patient preparation area shall be used to prepare, examine, interview, and monitor patients before and after cardiovascular procedures. The area shall be approximately 12ft x 12ft and include patient monitoring equipment installed on the wall.

Cardiology office space: Contractor shall provide two offices to accommodate the clinical research team. One office shall be approximately 4300 sq. ft. The second office shall serve a single occupant with no-less-than 95 sq. ft. Both offices shall be in proximity to the MRI facility and shall be fitted with appropriate office furniture.

Supplies: Contractor shall provide supplies necessary for running a research-grade cardiovascular MRI facility (including but not limited to ECG gating supplies, MRI compatible intravenous injectors and supplies), a patient examination room, a cardiac catheterization laboratory (including but not limited to a bi-plane fluoroscopy unit, catheters, hemodynamic monitoring, intravenous injectors and supplies, quantitative coronary artery capability), and an echocardiography facility (including but not limited to three echocardiography machines, one of which allows transesophageal echo, echo probes, echo compatible intravenous contrast agents), intravenous tubing and associated supplies, scan room supplies, cleaning and miscellaneous supplies, laboratory and pathology services (including autopsies) and supplementary medical testing when indicated (such as x-rays to exclude MRI incompatible devices).

Task 2. Patient Referral

Contractor shall refer and maintain access to 150 new patients each year for cardiovascular MRI studies (e.g. cardiac catheterization) from its in-patient and out-patient units and in accordance with applicable HIPAA/Privacy Act standards. The Government’s research aims to maximize the number of cases with correlation to invasive angiography including measurements of fractional flow reserve; therefore, 50 of the 150 or more new patients referred each year shall exhibit acute myocardial infarction.

Task 3. Miscellaneous Services

Contractor shall provide the following miscellaneous services in support of the Government’s research activities:

Medical Records: Contractor shall provide support for medical records, archiving of medical images, and scheduling in accordance with applicable HIPAA/Privacy Act standards and NHLBI policies.

Translation Services: Contractor shall provide translation services for patients on an as-needed basis.

Translation services shall include both telephonic and face-to-face translation and may be required to facilitate scheduling, informed consent, and any other interaction between Contractor/Government personnel and the patient.

Radiology and Other Services: Contractor shall provide ad-hoc consultation and other professional medical services (e.g. radiology, catheterization, etc.) in support of NHLBI-sponsored research protocols.

Task 4. Key Personnel

Contractor shall provide Key Personnel to support the Government’s research activities. The MRI Technologist and Research Nurse positions shall be considered Key Personnel. The requirements for these positions are provided below:

MRI Technologists: Contractor shall provide MRI technologist support equivalent to two and a half full-time (2.5 FTE) MRI technologists. At least one MRI technologist shall be a qualified Cardiovascular MRI Applications Specialist to facilitate training of other technologists and fellows. The MRI technologists shall be primarily stationed for duty at the Contractor’s site; however, the Government may require that the MRI technologists fulfill direct patient care duties at the NIH Clinical Center as needed for staffing coverage within the NHLBI’s Advanced Cardiovascular Imaging Laboratory, B1NMR Center. Contractor’s MRI technologists shall perform a number of research support duties including but not limited to the following:

o work with members of the NHLBI Heart Program to provide the cardiac MRI services required for cardiac research and diagnostic testing;

o provide training to NIH cardiac fellows and other cardiac MRI technologists;

o assist in coordinating research activities/initiatives;

o develop and implement standard operating procedures;

o communicate issues of day-to-day operation of the cardiovascular MRI facility to program associates;

o maintain the cardiac catheterization laboratory and echocardiography facility;

o perform cardiac MRI scans for patients and volunteers; and, o provide clinical coverage at the NIH Clinical Center.

Research Nurses: Contractor shall provide research nurse support equivalent to two full-time (2.0 FTE) research nurses. Research nurses must meet credentialing requirements for monitoring cardiovascular patients either from the emergency department, the cardiac care unit, or the telemetry unit. Research nurses must be able to monitor pharmacological stress tests and be trained and experienced in emergency cardiac care. (Such emergency cardiac care includes but is not limited to airway management, hemodynamic assessment, arrhythmia recognition, and cardioversion/defibrillation).

Contractor shall provide liability insurance for all research nurses. At least one research nurse shall be a qualified Research Nurse Coordinator. The research nurses shall be primarily stationed for duty at Contractor’s site; however, the Government may require that the research nurses fulfill direct patient duties at the NIH Clinical Center as needed for staffing coverage within the NHLBI’s Advanced Cardiovascular Imaging Laboratory, B1NMR Center and Radiology Department. Contractor’s research nurses shall perform a number of research support duties including but not limited to the following:

o provide nursing care for patients with cardiac abnormalities while having MRI and CT procedures;

o help screen patients for possible contraindications prior to having procedures performed;

o monitor patients for complications while administering medications to stress the heart;

o monitor acutely ill patients with cardiovascular disease coming from the emergency department or the Cardiac Care Unit o provide direction in the areas of administration, clinical practice, clinical trial implementation, case management, and training;

o facilitate and document the collection of data for research protocols while anticipating, identifying, reporting, and documenting patient responses to the protocols and clinical interventions;

o provide IRB-related administration for both NHLBI’s and Contractor’s IRBs o act as a liaison between NHLBI Cardiac MRI team and Contractor’s physicians;

o cover simultaneous needs for patient care, scheduling, and research requirements (may require overlap of nurses);

o oversee patient safety and patient-related quality assurance; and, o provide clinical coverage at the NIH Clinical Center.

Period of Performance

The period of performance is May 1, 2018 through April 30, 2023.

Capability Statement / Information Sought

Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm’s own risk. The following information shall be included in the capability statement:

- A general overview of the respondents’ opinions about the difficulty and / or feasibility of the potential requirement, and any information regarding innovative ideas or concepts.

- Information in sufficient details of the respondents’ (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information.

- The respondents’ DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the North American Industry Classification System (NAICS) code: 622110 with a small business size standard of $38.5M.

- Any other information that may be helpful in developing or finalizing the requirements of the potential acquisition.

Capability statements must demonstrate experience with similar projects and will be evaluated by the following criteria:

- In order to be considered for award, the contractor’s site of work must be located in an area local to NIH in Bethesda, Maryland, to allow for NHLBI employees to be in close proximity to the contractor for both routine and emergency trips to the contractor’s location. The offeror demonstrates its capability to provide adequate space for the MRI facility and offices as outlined above. The offeror demonstrates that its MRI Facility, Cardiac Catheterization Laboratory, and Echocardiography Facility locations are adequate. The proximity of the MRI Facility to the Emergency Department, Cardiac Care Unit, the Catheterization Laboratory, and Echocardiography Facility are adequate. And the offeror’s plans for emergency access, patient monitoring, data handling, and overall facility design are adequate.

Closing Statement

Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed five (5) single-sided pages (including all attachments) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern’s name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner.

All capability statements sent in response to this sources sought notice must be submitted electronically (via email) to Jonathan Lear, Contracting Officer, at john.lear@nih.gov in either MS Word or Adobe Portable Document Format (PDF), by February 23, 2018 at 12:00PM, EST and must reference synopsis number 75N92018R0037. All responses must be received by the specified due date and time to be considered.

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in 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 to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

mailto:john.lear@nih.gov