Statement of Work 2 19 2010.doc

STATEMENT OF WORK/TECHNICAL EVALUATION CRITERIA

BIPLANE X-RAY ANGIO SYSTEM

SOLICITATION NUMBER: NHLBI-PB-HL-2010-77-JBM

Background Information

The Translational Medicine Branch (TMB), National Heart, Lung, and Blood Institute (NHLBI) has taken a leading role in developing advanced cardiac imaging methods and minimally invasive interventional procedures. This work has included some of the first XFM-guided (X-ray Fused with MRI) and wholly real-time MRI guided vascular interventional procedures in humans, as well as preclinical development of a novel treatment for ischemic mitral valve regurgitation. The TMB is staffed by a large team of physiologists, engineers, physicists, and physicians spanning a wide range of interests ranging from subcellular metabolism to human diagnostic imaging and catheter-based interventions.

NHLBI requires a new X-ray fluoroscopy system to introduce new capability for image-guided intervention. Flat-panel X-ray detectors are necessary for further development and application of intramural XFM (X-ray Fused with MRI) technology. Biplane X-ray capability is necessary for treatment of structural heart disease, of congenital heart disease, and for sparing iodinated radiocontrast in sick patients at the NIH Clinical Center.

These capabilities are not currently available in the TMB/NHLBI. In fact, the only current bi-plane (Philips BV5000) X-ray system used by NHLBI is in cardiology, but has reached its end of life cycle. This new technology would be combined with the current X-ray and MRI interventional suite (Room 2C713) which was first installed in 2001 and upgraded in 2005. The upgraded X-ray system and patient table must operate seamlessly with the existing inteventional Espree MRI system using either the existing MiyabeMR intermodality patient transport system or with a superior alternative.

The system will be equipped for use by physicians from multiple disciplines including adult interventional cardiologists, pediatric interventional cardiologists, cardiothoracic surgeons, and interventional radiologists.

Objectives

The NHLBI requires the delivery and installation of a Bi-plane X-ray fluoroscopy system. In addition, room renovations are required at the NIH Magnuson Clinical Center, Building 10, Room 2C713.

The equipment shall support pre-clinical and clinical research using flat panel x-ray detectors with XFM (X-ray fused with MRI) technology for the treatment of congenital heart disease.

General Requirements

Independently, and not as an agent of the Government, the Contractor shall furnish all necessary labor, materials, supplies, equipment, and services and perform the work set forth below.

Specific Requirements

The contractor shall deliver and install a Biplane X-ray Angio system that allows for investigational X-ray/MRI fusion. In addition, the contractor shall provide training to NHLBI/TMB staff. Note to Offerors: required maintenance of the system after the first year will be done under a separate purchase order. The system shall support the following:

(1) Clinical

Coronary diagnostic and interventional procedures

Peripheral vascular interventions

Structural and congenital heart clinical and investigational interventional procedures

X-ray interventional procedures guided in part by MRI-derived roadmaps (investigational X-ray Fused with MRI or XFM)

Combined X-ray and Real-time MRI investigational interventional procedures

Cardiac electrophysiology interventional procedures

Image-guided non-cardiovascular tumor ablation procedures

(2) Pre-clinical (large animal investigational transcatheter procedures)

X-ray, XFM, and real-time MRI

Specifications of Biplane AX System

(3) Biplane Angiography System capable of supporting coronary, structural heart, and cardiovascular interventional procedures (details in separate section) from bilateral jugular, radial, femoral, and tibial vascular access positions to all parts of the body

(4) Biplane system shall be able to be integrated with the existing X-ray/MRI intermodality patient transfer system (Siemens Miyabe MRI) between X-ray system and existing Siemens Espree 1.5T MRI including MRI- and AX-compatible patient transport shell

(5) Integration with the following existing adjunctive imaging systems to project real-time images on the “main” image display panel:

Intravascular ultrasound

Intravascular pressure and doppler measurements

Surface (transthoracic and transesophageal) and Acuson intracardiac ultrasound

(6) Image post-processing system for quantitative analysis

Analysis capability includes clinically-validated quantitative coronary and peripheral arteriography and ventriculography with automated or semiautomated contouring; digital subtraction angiography with selectable masks and pixel shift, maximum opacification for iodinated and carbon dioxide angiography, and adjustable background subtraction; display of ECG signal; export of still images and cineangiography movie sequences; anonymization functionality; and image fusion and registration for separate 3D and 2D acquisitions

The system shall allow the clinician the ability to conduct this post-processing analysis live during invasive procedures, controlled at the patient tableside, while sterile-scrubbed.

Connection of both AX systems to cathlab PACS and all suitable workstations

(7) Biplane digital flat-panel detector system with detectors approximately 30x40cm (anteroposterior) and at least 20x20cm (lateral)

Collimator for each X-ray suitable for coronary and peripheral arteriography each including two independent wedge filters

Double-oblique gantry and source-image distance accommodates craniocaudal angulation of at least 45o in typical adult patient and > 90o right-left-oblique

X-ray generator and automatic exposure controllers suitable for coronary and peripheral arteriography in adult patients up to 200kg and in pediatric patients (no minimum weight for children)

(8) Gantry geometry, movement, and parking permitting typical advanced coronary, peripheral artery, structural, and congenital cardiovascular interventional procedures

Geometry, movement, and parking also accommodates rapid emergency Bidirectional patient transfer between X-ray and MRI systems using existing Miyabe system or a suitable replacement. This includes a low-profile MRI-compatible patient transport shell.

(9) Cardiac image acquisition of 12-bit to 14-bit 1024-square matrix 7.5-30 frames/second pulsed fluoroscopy, with zoom from maximum field of view to approximately 8 cm square or smaller

(10) Digital subtraction angiography including roadmap, re-mask, pixel-shift, maximum-pixel-intensity (“time-MIP”) for iodinated contrast, minimum-pixel-intensity (“time-MinIP”) for CO2 contrast, variable mask subtraction overlay to reveal underlying anatomy, importation of previous acquisitions to serve as current roadmap

(11) Latency (time from termination of previous acquisition to live fluoroscopy) of less than 1 second

(12) Digital rotational angiography with rotation speed .2 Hz or faster and 3D reconstruction and ECG-gated acquisition

3D or 4D reconstruction of contrast angiograms

Reconstruction of cone-beam computed tomograms

Reconstruction of four main cardiac chambers, main pulmonary artery, ascending aorta, and aortoiliac system Reconstruction of 3D coronary arteriograms, from limited projection views, with interactive review analysis and measurement of selected coronary segments.

(13) Automatic rotation of detector or image display to compensate for double-oblique angulation of acquisitions and maintain constant superior-inferior image orientation

(14) Radiation dosimetry features: instantaneous measurement and display of cumulative dose-area product and skin-entrance dose

(15) Table- or gantry-movement for interactive bolus-chase digital subtraction angiography from the head to the toes, either continuous- or multi-station, allowing as few as one background mask per station

(16) Table supports patients up to 200kg

(17) Image and data display

Ceiling mounted digital flat panel display, single or multiple, to accommodate bi-plane acquisition and roadmaps, in addition to hemodynamic recording display, 3D reconstruction, slave display from research XFM system, slave display of adjunctive ultrasound, and display of tableside acquisition and post-processing controls

Control room display of biplane acquisition and roadmaps, hemodynamic recordings and control, 3D reconstruction, and image post-processing

Secondary in-lab keyboard control and replication of control-room display, in addition to allowing technologists to support the procedure both from the control-room and from inside the X-ray room

(18) Image analysis

Table-side and off-line semiautomated analysis including automatic segmentation for left ventricular volumes and function, validated quantitative coronary arteriography and quantitative peripheral arteriography, both with semiautomatic segmentation and densitometry

Calibration using catheter-fiducials or other geometric fiducial markers

Export of static or cineangiographic images into popular file format standards including JPEG format (static images) and MPEG (cineangraphic images)

A free cardiology DICOM viewer on each saved/exported CD-ROM for referring physicians and for patients

(19) Image fusion tools

Roadmap based on in-lab reconstruction of 3D rotational angiography

Fusion of prior tomographic acquisitions (DICOM data sets) with live X-ray using anatomic or extrinsic fiducial markers

(20) Save fluoroscopy retrospectively

(21) Staff radiation protection lead-shields to protect the face, body, and extremities of X-ray operators in all operating positions and all common access sites

(22) X-ray dose-reduction tools tailored for pediatric patients

(23) X-ray power injector (ceiling-mounted or table-mounted) to accommodate Miyabe intermodality transfer shell

(24) Restart/Recycle/Cold-start time of < 180 seconds

(25) Power supply to support 20 second power failure and activation of emergency power

(26) Radiation-free repositioning of table position

(27) Radiation-free repositioning of x-ray filters

(28) “Stent-boost” time-averaged acquisition and digital reconstruction to enhance conspicuity of coronary artery stents

(29) Variable pulse-acquisition frame rate as low as 1 frame/second

(30) Automatic recall of prior table and gantry position based on selected image review

(31) 3-dimensional coronary model automated construction from two coronary projection acquisitions or rotational angiogram

(32) Table-side control of post-processing for use by sterile-scrubbed operator

(33) High frequency angiography for pediatrics applications

(34) Integration with electromagnetic catheter tracking systems such as MediGuide.

(35) Hemodynamic recording system

High-resolution hemodynamic recording from at least four invasive blood pressure channels and cardiac hemodynamics analysis package for valvar disease and shunt analysis, noninvasive blood pressure, oximetry, case tracking, 12-lead full-disclosure ECG recording, 64+ intracardiac electrogram recording, and cardiac electrophysiology package

(36) Catheterization laboratory picture archiving (PACS) system and web-server for remote image review

The Biplane system shall include a Cath-lab PACS system and web-server for image processing and review with image acquisition from nearby second monoplane angiography system. On-site and off-site image review, interpretation, and quantitative analysis from at least four concurrent web clients and two concurrent local clients.

The web-server shall provide all or most of the functionality indicated for “image post-processing system for quantitative analysis” above to end users on multiple operating system platforms including Windows, Macintosh, and Linux. The system shall have a capacity to maintain at least 2,000 complete cath lab studies on-line.

The cardiology PACS software shall allow for the use of NIH-extensible hardware, for additional image storage capacity, and of other NIH PACS systems for additional storage and archiving; nonproprietary storage format; incorporation of AX, IVUS, MR, and CT images.

Installation of Biplane AX System

The NIH Magnuson Clinical Center

9000 Rockville Pike

Building 10, Room 2C713

Bethesda, Maryland 20892

The contractor (or subcontractor) shall design and perform all related renovations including, but not limited to, necessary repair/replacement of walls, flooring, ceiling, electrical and mechanical systems, in order to accommodate the new Biplane AX System and associated peripherals. In addition, the contractor shall remove existing Biplane (Philips BV-5000) angiography system in Room 2C609 which shall be used as a “trade-in” toward the purchase of the new Biplane and transfer existing Artis-FC monoplane angiography system from Building 10, Room 2C713 to Building 10, Room 2C609. The access doorway may need to be moved. The existing air conditioning system may need to be evaluated to meet specifications for cooling of the equipment. If not, alternative air conditioning will need to be installed.

As part of the turn-key installation, the contractor shall:

1. Demolish the floor pedestal at the foot of the patient table in Building 10, Room 2C713. The floor mounted pedestal contains medical gas and electrical power services that shall be appropriately disconnected. The affected floor shall be patched to match existing flooring.

2. Supply and install two ceiling booms in Building 10, Room 2C713. The two booms shall supply medical gas outlets and electrical power outlets. These booms shall be similar to the existing medical gas booms in Building 10, Room 2C609. Note to Offerors: Offerors may present alternative boom options that achieve equal functionality.

3. Design and install approximately 6 feet of additional work bench space, in both rooms above. In Room 2C713, an additional sink shall be included in the additional bench space.

4. Supply and install two ceiling mounted operating room light fixtures in Room 2C713.

5. Provide either custom or commercial catheter storage solutions to replace existing catheter storage in both rooms above.

6. Consolidate electrical systems, to the maximum extent possible, within the equipment room in Room 2C713.

The renovations and installation shall be staged to minimize disruption to clinical services: at least one X-ray lab shall be fully operational within two weeks after the second X-ray lab is taken out of service. The renovations and installation shall allow the MRI system to remain in service without interruption longer than two weeks in total.

Note to Offerors: proposals should include “lifecycle” management specifications, including planned length of service and removal and disposal requirements.

Note to Offerors: Offerors should submit a complete portfolio for the proposed design and construction team (architect, MEP engineers, and general contractor). This portfolio should include past experience in a facility comparable to the complexity of NIH Building 10.

Training of NHLBI/TMB staff

The contractor shall provide appropriate on-site/off-site training to staff skilled in the art of the laboratory, in order to operate all features of the furnished hardware and software.

Warranty of Biplane AX System

During the warranty period, the contractor shall provide upgrades in accordance with industry standards.

Note to Offerors: proposals should provide details for on-site upgrades, maintenance, and business-day service for the initial 12-month warranty period.

Research Requirements The system is to be used for clinical and preclinical research. Access to additional information is critical to the success of this program and mandatory for award of this contract.

NHLBI is willing to assure confidentiality of this information to the offeror, or to enter into a Collaborative Research and Development Agreement (CRADA) for research development of features dependent on this functionality:

AX real-time information to support NHLBI XFM (X-ray Fused with MRI)

· Instantaneous position of the patient table in 3D space, and instantaneous position of the anterior and lateral gantry, source, and image intensifier sufficient to allow instantaneous update of the MRI-derived roadmap registration

· Instantaneous access to the AX digital image data stream for both imaging planes to allow overlay display with the MRI-derived roadmap

These instantaneous data should be available to the NHLBI through hardware and software specifications sufficient to allow an experienced programmer to obtain “live” X-ray images and combine them with prior tomographic images using an NHLBI off-line hardware system.

Technical Evaluation Criteria (100 Points)

The technical portion of proposals will receive paramount consideration in selecting a vendor. However, cost/price will also be a significant factor, in the event that two are more vendors are determined to be essentially equal following the evaluation of technical factors. The Government will award a contract resulting from this solicitation to the responsible offeror whose proposal is most advantageous to the Government, price and other factors considered. The following technical criteria will be used in evaluating proposals.

1. X-ray imaging system (44 points)

Ability to deliver a Biplane X-ray Angiographic system with at least 30x40cm and 20x20cm flat panel detectors suitable for the interventional cardiovascular applications described in the Statement of Work

2. Image Registration (Fusion) Capability and 3D visualization tools (8 points)

A system with the ability to prepare roadmap images from cone-beam CT obtained from the provided X-ray system or from importation of prior tomographic imaging datasets with appropriate registration tools. Evidence in the preparation of 3D coronary arteriograms from limited projection views, allowing interactive physician analysis and interpretation of selected coronary segments.

3. Instantaneous data stream available for NIH-specific research applications (12 points)

A system with the ability to provide computational tools and information to allow proficient NIH scientists to obtain instantaneous patient table and AX gantry position information and digital images to allow low-latency updates of roadmaps with superimposed live X-ray images.

4. Installation, maintenance, training (8 points)

Ability to provide suitable turnkey installation of the system, including removal of one biplane X-ray system and user-transparent relocation of the existing single-plane X-ray system to the nearby location of the old Philips BV5000 Biplane system. Adequacy of plans for comprehensive maintenance including ongoing upgrades, on-site service during business days, and ongoing maintenance renewable annually for at least ten years including the initial 12 month warranty period. Experience in providing training in the use of the Biplane AX system. Experience in managing subcontracts, if proposed.

5. Integration with or replacement of existing Miyabe MRI intermodality patient transfer system (12 points)

Ability to provide a patient table that interacts with the existing Siemens Espree MRI system for rapid intermodality patient transfer. The integration can be accomplished using the existing MiyabeMRI transport system or by providing equivalent functionality including a suitable MRI patient transport shell.

6. Hemodynamic Recording System (8 points)

Ability to provide a high fidelity hemodynamic recording system suitable for the described interventional cardiovascular or contemporary invasive therapeutic cardiac electrophysiology procedures.

7. Image post-processing, PACS, and web-server functionality (8 points)

Ability to provide a cardiology PACS system allowing off-site web-based image review, interpretation, and quantitative analysis of AX and IVUS data as described in the Statement of Work.