SOURCES SOUGHT
Q -- Hospital Cardiovascular MRI Services
- Notice Date
- 11/16/2012
- Notice Type
- Sources Sought
- NAICS
- 622110
— General Medical and Surgical Hospitals
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHS-NIH-NHLBI-CSB-(HLSS)-2013-010-DDC
- Archive Date
- 12/15/2012
- Point of Contact
- Deborah - Coulter, Phone: (301) 435-0368
- E-Mail Address
-
dc143b@nih.gov
(dc143b@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 disadvantage 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 (622110 with a size standard $34.5M), should not submit a response to this notice. 2. Notice Information a. Background: NHLBI has been developing magnetic resonance imaging (MRI) techniques and applying these methods to patients with acute presentations of ischemic heart disease. Many technical developments have been achieved in making cardiovascular MRI more feasible, specifically advances in how to acquire cine MRI, infarct images, T2 weighted images, and perfusion images have all been achieved over the past 8 years. In addition, substantial advances have been made in developing methods for quantifying myocardial perfusion at rest or during stress. Many of these advances have been made possible through image acceleration techniques related to parallel imaging methods. Three major breakthroughs consist of the following: 1) Fat water separated imaging: Developed imaging method for generating separate images of water and fat which is used for (a) imaging fibro‐fatty infiltration, (b) improved tissue characterization and mass characterization, (c) reduced artifacts related to fat, (d) improved imaging of the pericardium and other thin walled structures in close proximity to fat. 2) Viability: Developed an improved free breathing motion corrected real‐time late gadolinium enhancement protocol that may be used in patients with difficulty breath‐holding and/or with arrhythmias. 3) Extra‐cellular volume (ECV) fraction and T1‐mapping: Developed parametric mapping of T1 and ECV that is useful in tissue characterization, and for the detection diffuse processes such as edema and fibrosis that are challenging to detect and characterize with conventional late gadolinium enhancement. b. Purpose and Objectives: This project will focus primarily in two areas: 1) advanced characterization of myocardial tissue and the relationship between these characteristics and disease processes; and 2) of exploring the role of quantitative MRI measures of myocardial perfusion at rest and during stress. Thus, the proposed project will have the following specific aims: 1. To improve the ability of MRI to differentiate acute and chronic myocardial infarction. 2. To develop more robust MRI methods to determine the ischemic myocardium at risk associated with acute myocardial infarction. 3. To characterize fat and water in myocardium and other tissue, particularly in specific cardiomyopathies. 4. To use T1 mapping to characterize the extracellular volume fraction and diffuse myocardial fibrosis in various cardiomyopathies. 5. To use MRI to predict which patients will respond better to specific interventions (e.g. valve replacement, transmyocardial laser therapy). c. Project Requirements: A. General Requirements 1. Independently, and not as an agent of the Government, the contractor shall furnish all necessary labor, materials, supplies, equipment, and services (except as otherwise specified within) and perform the work set forth below. 2. All work under this contract shall be monitored by the Project Officer, whose position is defined elsewhere in this contract. B. Specific Requirements 1. Specifically, the contractor must: a) Provide a dedicated clinical research cardiovascular MRI facility. b) The clinical research MRI facility needs to be within a facility with a cardiac catheterization laboratory and an echocardiography facility appropriate for acutely ill cardiovascular patients and patients undergoing cardiothoracic surgery procedures. c) Provide the facilities necessary to maintain the NHLBI cardiovascular MRI scanner. d) Develop mechanisms to maintain access to ~150 hospitalized patients per year and ~150 patients undergoing cardiac catheterization within the constraints of applicable HIPAA/Privacy Act standards. e) Provide MRI technologist support (1.5 FTE MRI technologists). One of these technologists must be qualified at an applications specialist level to facilitate training fellows and technologists. Provide staffing appropriate to maintain the cardiac catheterization laboratory and echocardiography facility. f) Provide nursing coverage adequate for monitoring acutely ill patients with cardiovascular disease coming from the emergency department or the Cardiac Care Unit. This coverage will require 2.0 FTE nurses. At least one of these nurses must be qualified at the level of a nurse research coordinator. g) Provide (1.0 FTE) Physician (Cardiology or Radiology Fellow). The physician shall be board certified or board eligible. h) Provide support for medical records, archiving of medical images, and scheduling. i.) 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). j.) Provide translation services for those patients who require the service (both telephonic, as well as face-to-face interpretation) C. Detailed Description of the Technical Requirements of the MRI facility: a. The MRI facility: The MRI facility is critical to the program needs. The existing NHLBI cardiovascular scanner must be considered 100% dedicated to cardiovascular studies, although it may be used by the stroke team or the contractor at times when not needed for cardiovascular studies. The contractor must provide the following: i) Magnet room: The scan room needs to have adequate space for IV infusion pumps, power injectors, and monitoring equipment. It also must have adequate storage space for RF receiver coils, MRI phantoms, and medical supplies routinely used during cardiovascular procedures. The magnet room must include radiofrequency shielding that is tested periodically and maintained as indicated to meet the scan manufacturer specifications. ii) Computer room: The computer room needs to 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 the contractor's complex must be networked by high speed computer lines (1000 MB/s or better). iii) Operator control room: 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 must provide direct visualization of the patient within the magnet. iv) Patient preparation area: This area is used to prepare, examine, interview, and monitor patients before and after cardiovascular procedures (approximately 12 ft x 12 ft). Area will need to include CCU monitoring equipment installed on the wall. v) Cardiology office space: In general terms, two offices are needed to support the clinical research team. One office should be approximately 400 sq feet. The second office will serve a single occupant with no less than 90 sq ft. Both offices needs to be in close proximity to the MRI facility. b) The MRI scanner: The state-of-the-art MRI scanner must be capable of performing cardiovascular studies as described in this section: i) Magnet/Magnetic field shims a) At least 1.5 T shielded magnet b) Field homogeneity 0.1 ppm over 20 cm DSV. ii) Gradients a) Minimum gradient strength of 40 mT/m b) Must be state-of-the art with regard to reducing short term and long term magnetic field eddy currents during gradient switching. c) Slew rate minimum 150 T/m/s d) Overall clear bore 60 cm or greater. iii) Console a) Digital receiver b) Minimum bandwidth 250 kHz on 8 simultaneous channels. c) Arbitrary wave form generation for radiofrequency gradients iv) Radiofrequency Body and Receiver Coils a) A quadrature coil capable of performing 180 degree magnetization flip angles within 3 ms in the human chest. b) 4-channel and 8-channel phased array coils for the chest. c) 4-channel and 8-channel phased array coils for the carotid arteries. d) Phased array extremity coil e) Assorted surface coils for peripheral and cerebral vascular studies d. Anticipated Period of Performance: One base year with 4 option years beginning 2/28/2013 - 2/27/2018. e. Other Important Considerations: General considerations and overall system performance: i) The system must be capable of collecting state-of-the-art cardiovascular images. ii) Myocardial function: Methods for obtaining cine MRI images of the heart must be available using both fast gradient echo techniques and steady state free precession methods. The system must be capable of acquiring and reconstructing 30 images across the cardiac cycle with a temporal resolution of <50 ms, a spatial resolution of 1.5 x 1.5 x 6 mm, in less than 16 heartbeats. The system must be capable of acquiring and reconstruction 15 independent images per second in real-time with a spatial resolution of approximately 2.5 x 2.5 by 8 mm. Parallel processing or research software may be used to meet this requirement. Velocity encoded phase contrast methods shall be available in 2-D and 3-D velocity encoded methodologies. Myocardial tagging must be available. iii) Myocardial Perfusion imaging: Hardware and software must be capable of imaging multiple slices of the heart each heartbeat and capable of capturing at least 60 consecutive heartbeats. The temporal resolution of each heartbeat must be better than 140 ms. iv) MR angiography: Hardware and software must be capable of performing 2-D and 3-D angiography of the carotid arteries, cerebral arteries, pulmonary arteries, aorta, coronary arteries, renal arteries, iliac arteries, and peripheral arteries. Both contrast enhanced and non-contrast enhanced methodologies must be provided. v) Parallel Processing: The hardware and software must provide parallel processing of 8-32 channels of radiofrequency input to allow acceleration of image acquisition by utilizing parallel processing methods. vi) ECG Gating and Safety Monitoring: The system must be capable of coordinating image acquisition with a variety of physiological signals including the ECG, a pulse oximeter, respiratory bellows, and diaphragm position. In addition, safety monitoring equipment must be provided that allows monitoring of heart rate, blood pressure, oxygen saturation, and end tidal CO2 while the patient is in the magnet. The waveforms, measurements, and control of the system must be displayed and controllable in both the magnet room and the control room. viii) Research Technical Support: The manufacturer of the MRI scanner must provide technical/research support. This support includes software support for pulse programming, scan control, and image processing/display. d) Contractor Location: the Contractor site of work must be within a 10 mile radius of the NIH Bethesda, Maryland campus. The MRI scanner will be placed in close proximity to where patients with cardiovascular disease receive care or undergo diagnostic procedures. The contractor must provide space either close to the emergency department or close to the cardiac care units/cardiac diagnostic. e) MRI Technologist and MR Applications Specialist Support: MRI technologist support must be provided (1.5 FTE). One FTE shall be at the level of a cardiovascular MRI applications specialist to facilitate training other technologists and fellows. • MRI Technologists will be required to perform the following duties for the NHLBI/CPB: Primarily stationed for duty at the contractor site, they may also have direct patient care duties at the NIH Clinical Center up to 20 days per year, or as needed for staffing coverage within the Advanced Cardiovascular Imaging Laboratory, B1NMR Center. • Cardiovascular MR Applications Specialist Job Summary: o The contractor must provide MRI technologists and MRI Application Specialists who will work with members of the NHLBI Heart Program to provide the cardiac MRI services required for cardiac research and diagnostic testing. o The contractor must provide MRI Application Specialists who will provide education to NIH cardiac fellows and other cardiac MRI technologists. o The contractor must provide MRI technologists and MRI Application Specialists who will coordinate the activities, as they relate to program research initiatives, of the cardiac MRI technologists. o The contractor must provide MRI technologists and MRI Application Specialists who will develop & implement standard operating procedures and communicates issues of the day-to-day operation of the cardiac MRI facility to associates of the program. o The contractor must provide MRI technologists and MRI Application Specialists who will perform cardiac MRI's for patients and volunteers. f) Nursing support: Nursing coverage must be provided (2.0 FTE). Overlap between nurses is needed to cover simultaneous needs for patient care, scheduling, and research requirements. The nurses must meet credentialing requirements for monitoring cardiovascular patients either from the emergency department or the cardiac care unit. The 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. RNs will be functioning under the title of Contractor RN Research Coordinator. Primarily stationed for duty at the contractor site, they will have direct patient care duties at the NIH Clinical Center up to 20 days per year, or as needed for staffing coverage within the Advanced Cardiovascular Imaging Laboratory, B1NMR Center and Radiology Department. The RN's will be performing the following duties for the NHLBI/CPB: • Research Nurse Coordinator Job Summary: • The contractor must provide Nurses who will provide nursing care for patients with cardiac abnormalities while having MRI and CT procedures. Research nurses will help screen patients for possible contraindications to having the procedure performed. Research nurses will monitor patients for complications while administering medications to stress the heart. • The contractor must provide Nurses who will provide direction in the areas of administration, clinical practice, clinical trial implementation, case management, and education. • The contractor must provide Research nurses who will facilitate and document the collection of data for research protocols while anticipating, identifying, reporting, and documenting patient responses to the protocols and clinical interventions. • The contractor must provide Research nurses who will provide IRB-related administration for both the National Heart, Lung & Blood Institute (NHLBI) and Contractor's IRB and acts as a liaison between NHLBI Cardiac MRI team and the Contractor's physicians. • The contractor must provide Research nurses who will act as an overseer of patient safety and patient-related quality assurance. g) Physician: (0.8 to 1.0 FTE) Physician (Cardiology or Radiology Fellow) coverage must be provided. The physician must be board certified or board eligible. Selection of the physician will be by an NHLBI committee. h) Patient Referral: The contractor must refer >150 hospitalized patients per year for cardiovascular MRI studies. The mechanisms for patient referral must fall within HIPAA standards. In addition, mechanisms must be established for referral of outpatients to the program. The research program aims to maximize the number of cases with correlation to invasive angiography including measurements of fractional flow reserve. The research program also aims to recruit >50 patients with acute myocardial infarction per year. f. Capability statement/Information sought: 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 services stated above. Interested small business firms are highly encouraged to respond to this notice. However, firms should understand that generic capability statements are not sufficient for effective evaluation of their capacity and capability to perform the work required. Responses must directly demonstrate the company's capability, experience, and ability to marshal resources to effectively and efficiently perform the objectives described above and include an outline of previous or similar projects so that the Government can perform a proper evaluation of the company's capability. Information regarding 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 written response to this notice should consist of the following items: a. Company Name. b. Company DUNS number. c. Company point of contact, mailing address, telephone and fax numbers, and website address d. Name, telephone number, and e-mail address of a company point of contact who has the authority and knowledge to clarify responses with government representatives e. Date submitted. f. Applicable company GSA Schedule number or other available procurement vehicle. g. Do you have a Government approved accounting system? If so, please identify the agency that approved the system. h. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All respondents must register on the CCR located at http://www.ccr.gov/index.asp i. Not to exceed 20 singled-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12 point font sized 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 business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. j. Common cutoff date: 11/30/2012 8:00 am eastern time l. Delivery point: Submitted (via email) to Deborah Coulter, Contract Specialist at coulterd@nhlbi.nih.gov in MS Word or Adobe Portable Document Format (PDF). All responses must be received by the specified due date and time in order to be considered. 3. 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)..
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-(HLSS)-2013-010-DDC/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02933195-W 20121118/121116235329-62980e561165f89f1f9e758b7f552647 (fbodaily.com)
- Source
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