request for quote.pdf

REQUEST FOR QUOTE (RFQ)

(1) Action Type: Combined Synopsis / Solicitation

(2) Date: February 24, 2021

(3) Title: X-ray Bi-plane Cardiovascular Intervention Imaging System (Bi-plane X-ray System)

(4) Solicitation Number: 75N92021Q0061

(5) Classification Code: 6525, Imaging Equipment and Supplies

(6) Contracting Office Address:

6705 Rockledge Drive RKL1, 5th Floor Bethesda, MD 20892

(7) Closing Response Date: March 12, 2021

(8) Contact Point: Jonathan M. Lear, Contracting Officer; john.lear@nih.gov; 301-827-7716

(9) Contract Line Item(s):

a. Line Item 1: Bi-plane X-ray System (Qty. 1)

(10) Description:

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

(ii) The solicitation number is 75N92021Q0061 and the solicitation is issued as a request for quote (RFQ).

(iii) The solicitation document and the incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-03 effective February 16, 2021.

(iv) The associated NAICS code is 334510, Electromedical and Electrotherapeutic Apparatus

Manufacturing, and the small business size standard is 1,250. This acquisition is being conducted in accordance with the procedures of FAR Part 12 and FAR Part 13.5.

(v) Contractor Requirements:

NHLBI requires the delivery and installation of a X-ray bi-plane cardiovascular intervention imaging system, with suitable adjunctive imaging, to support pre-clinical mailto:john.lear@nih.gov and clinical research in structural heart interventions. See attached Statement of Work (SOW) for additional information and specific contractor requirements.

(vi) Estimated Delivery:

The contractor shall propose a schedule for potential modification of the space, delivery of the equipment, and calibration.

(vii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition.

(viii) The provision at FAR clause 52.212-2, Evaluation – Commercial Items, is applicable.

An award will be made on a competitive basis using a comparative evaluation of all quotes received. Evaluation will be done to identify all offerors whose quotes demonstrate the ability to provide the equipment listed in section 9 above. The specific evaluation factors are attached.

(ix) FAR clause 52.212-3, Offeror Representations and Certifications – Commercial Items, is applicable. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision.

(x) FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition.

(xi) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition. Including the following clauses and Prohibitions:

i. 52.209-10, Prohibition on Contracting with Inverted Domestic

Corporations 52.219-28, Post Award Small Business Program Representation

ii. 52.233-3, Protest After Award

iii. 52.233-4, Applicable Law for Breach of Contract Claim

iv. 52.222-3, Convict Labor

v. 52.222-21, Prohibition of Segregated Facilities

vi. 52.222-26, Equal Opportunity

vii. 52.222-36, Equal Opportunity for Workers with Disabilities

viii. 52.222-50 Combating Trafficking in Persons

ix. 52.225-13, Restrictions on Certain Foreign Purchases

x. 52.232-33, Payment by Electronic Funds Transfer—System for Award

Management

xi. 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while

Driving

xii. 52.237-1, Site Visit http://www.acquisition.gov/

xiii. 52.244-6, Subcontracts for Commercial Items

xiv. 52.232-39, Unenforceability of Unauthorized Obligations

(xii) Additional solicitation instructions:

If required, a site visit prior to quote submission can be arranged (see FAR 52.237-1, Site

Visit). Offerors or quoters can request to inspect the site where services are to be performed and to satisfy themselves regarding all conditions that may affect the cost of contract performance. The contractor shall submit the request for a site visit by March 2, 2021 so that the visit can be arranged.

Requests for clarification must be submitted to the Contracting Officer no later than close of business on March 4, 2021. Responses to all requests for clarification will be provided as soon as practicable.

Contractors are requested to provide their intent to submit a quote to the Contracting

Officer by March 10, 2021.

(xiii) Quotes shall be submitted via email to Jonathan M. Lear, Contracting Officer at john.lear@nih.gov or through the FedConnect web portal (www.fedconnect.net). The due date for receipt of quotes is 03:00PM EST on March 12, 2021. Late quotes will not be accepted.

Vendors can register with FedConnect at the following address:

https://www.fedconnect.net/FedConnect/default.htm.

Please note that FedConnect is used by multiple federal agencies and therefore

FedConnect assistance will be provided by Compusearch Software Systems, not the NHLBI OA. More information about registration requirements can be found by downloading the FedConnect Ready, Set, Go! Guide at the following address:

https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_ Set_Go.pdf. For assistance in registering or for other technical questions please call the FedConnect Help Desk at 800-899-6665 or email at support@fedconnect.net.

mailto:john.lear@nih.gov http://www.fedconnect.net/ https://www.fedconnect.net/FedConnect/default.htm https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.pdf https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.pdf mailto:support@fedconnect.net

Biplane X-Ray Angio System 1

STATEMENT OF WORK

Project Title X-ray Bi-plane Cardiovascular Intervention Imaging System (Bi-plane X-ray System)

Project Background The Cardiovascular Branch in the National Heart, Lung, and Blood Institute’s (NHLBI) Division of Intramural Research develops novel non-surgical treatments for structural heart and valve disease and introduces them into early clinical testing and practice.

Such procedures have included transcaval access for transcatheter aortic valve replacement;

LAMPOON and ELASTIC mitral leaflet modification to enable transcatheter mitral valve implantation; and BASILICA aortic leaflet modification to prevent coronary artery obstruction during transcatheter aortic valve replacement, mitral cerclage compressive mitral annuloplasty to treat functional heart failure, and transcatheter cavopulmonary (Glenn) shunt for certain congenital heart diseases. Many of these fall under the rubric of transcatheter electrosurgery.

The lab has led the global introduction of MRI catheterization into standard clinical practice and operates a combined biplane X-ray and MRI intervention suite that includes the first human high-performance low-field (0.55T) MRI using contemporary hardware.

The current installed biplane X-ray interventional f luoroscopy system is nearing the end of its lifecycle and requires replacement. The replacement system must operate seamlessly with the existing interventional cardiovascular MRI equipment by using an appropriate intermodality patient transport system. The replacement system must also be suitably equipped to enable continued development of novel structural heart intervention procedures using imaging guidance including ultrasound (including intracardiac, intracoronary, intravascular, transesophageal, and surface), and electrophysiologic navigation and mapping and ablation.

Project Purpose and Objectives NHLBI requires the delivery and installation of a X-ray bi-plane cardiovascular intervention imaging system, with suitable adjunctive imaging, to support pre-clinical and clinical research in structural heart interventions.

Contractor 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.

I. Bi-plane X-Ray Fluoroscopy System

The system shall support the following:

A. Biplane X-ray with large image detectors ≥ 30cm

1. Mobile ceiling mount of at least one plane.

2. High resolution X-ray fluoroscopy and cineangiography with variable zoom, cone, filters.

3. Roadmap, reference, gantry position recall, parking.

4. Panning to reach head-to-toe using floating table.

Biplane X-Ray Angio System 2

5. Cone-beam CT, preferably multidetector (two-channel or biplane), with table-side reconstruction of static and time-resolved CT images, extraction of heart chamber features-of-interest, and co-registration with bony and cardiovascular landmarks.

6. Image co-registration (aka fusion) with echocardiography, imported CT and MR, time-resolved CT and MR and cone-beam CT.

7. Digital subtraction angiography (DSA) and CO2 angiography and runoff.

8. Radiation dosimetry monitoring and minimization features including cumulative and instantaneous dose display.

9. High-fidelity hands-free (and preferably headset-free) audio communications between control room staff and operators.

10. Lighting option (room-wide, single operative lights for head and foot).

11. Radiation shielding for multiple operators and staff from femoral and jugular positions including fenestrated and flexible shielding solutions, and zero-radiation systems (such as Rampart M1128).

12. Lateral plane (“B-plane”) parking position to allow unencumbered transfer of patients between X-ray and adjacent MR system in 10/2c713.

13. ECG recording overlay option on X-ray images.

14. Preferred solutions provide the program staff with access to real-time image, gantry position, and table position data to facilitate custom co-registration applications.

15. Turn-key installation in NIH Clinical Center Building 10 Room 2c713 (see Section II below).

B. Large primary video display with multiple inputs and outputs

1. Large-screen primary image display, in-lab mobile large-screen display for simultaneous femoral + jugular access, with versatile ceiling mount for repositioning.

2. Additional video displays.

a. In-lab mobile large-screen display for second, or awkward, position (for example jugular) operator. This display should be independent from primary large display and not necessarily mirror the primary display.

b. Full replication of displays in control room and in-lab technologist console (two locations, including A+B plan live + reference, hemodynamics, technologist annotation, EP system, accessory displays).

3. Matrix switch for multiple dynamically-configurable inputs, such as IVUS, ICE, to be displayed on primary and mobile displays and outputs, as required, to auxiliary displays or matrix switches.

4. Remote telepresence capability to allow remote users to observe high-fidelity images and enjoy bidirectional audio communications.

C. High-fidelity hemodynamic recording and reporting

1. Dual technologist control stations (1) in lab and (2) in control room as currently configured for NHLBI 10/2c713 Artis Zee system.

Biplane X-Ray Angio System 3

a. Full display of both planes reference & live & hemodynamics & annotation & accessory at each control station.

2. PACS and EHR integration for demographics, hemodynamics, imaging, and reporting.

3. X-ray intervention reporting.

4. Including electrophysiology recording.

5. Interface capability for MRI catheterization, via NIH “PRiME” intercessory system or directly without intercessory system.

6. Clinical cardiovascular catheterization and intervention physician report generation.

D. High performance ultrasound including Intracardiac echo (ICE), Transthoracic echo (TTE), Vascular Access, Transesophageal echo (TEE)

1. Connector for ICE probe.

2. Linear probe for vascular access.

3. Transthoracic probe for transthoracic echocardiography.

4. Option 3D TEE probe.

5. Co-registration and co-display on main video system.

E. Electroanatomic navigation such as Ensite or CARTO including display integration, programmed stimulator, irrigated RF ablation system F. Patient table transfer to NHLBI MRI systems

1. Bi-plane X-ray parking to allow rapid bidirectional patient transfer to/from X-ray without significant table rotation, and that aligns X-RAY isocenter with MRI bore centerline.

2. Patient transfer shell, preferably system-agnostic, to allow safe and rapid transfer of sterile catheter-instrumented patients between X-ray and 0.55T MRI system.

G. Image review workstation including table-side controlled quantitative coronary, vascular, and ventricular measurements (QCA, QVA, LVgram).

H. PACS connection with at least 3 prespecified DICOM send and receive target nodes II. Installation of Biplane AX System

A. PROJECT DESCRIPTION

1. Project Title: Building 10.2C713 Biplane Xray Installation

2. Work Request Number: TBD

3. Location: Building 10, Suite 2C713

4. Design considerations shall support the overall installation effort according to the

Division 50 Specifications.

B. CODES & STANDARDS

This project shall be designed in compliance with applicable codes and industry standards for the location of the facility.

1. Model Building Codes

Biplane X-Ray Angio System 4

This project shall be designed to meet or exceed the applicable model building code(s) for the location of the facility. The design shall use other appropriate codes and industry standards such as: the Life Safety Code (NFPA 101), Fire Protection for Laboratories Using Chemicals (NFPA 45), Standard for the Installation of Sprinkler Systems (NFPA 13), and Healthcare Facilities (NFPA 99), and Guidelines for Design and Construction of Health Care Facilities, The American Institute of Architects Academy of Architecture for Health with the assistance from the U.S. Department of Health and Human Services (Note: The Department of Health and Human Services (DHHS) as an agency of the Government of the United States of America, derives its authority from the Congress of the United States, and is not subject to laws, ordinances, regulations established by state and local governments or authorities of a lesser jurisdiction).

2. Federal Regulations This project shall be designed and constructed in compliance with all applicable Federal Regulations including but not necessarily limited to the following:

Uniformed Federal Accessibility Standards, OSHA 29CFR 1910; The National Environmental Policy Act of 1969 (NEPA); The Endangered Species Act; The National Historic Preservation Act of 1966; The Archeological and Historic Preservation Act; The Wild and Scenic Rivers Act; 40CFR Environmental which includes: Safe Drinking Water Act, Clean Air Act, Clean Water Act, Toxic Substance Control Act, Solid Waste Disposal Act, and RCRA; Executive Order 11990 (Wetlands); Executive Order 11988 (Floodplains); Executive Order 12088 (Compliance with State environmental laws); National Capital Planning Commission (NCPC) "Master Planning Regulations"; Energy Policy Act of 1992;

Executive Order 13423 (Strengthening Federal Environmental, Energy, and Transportation Management), etc.

3. Agency Design Policies

a. This project shall be designed in compliance with the NIH Design

Requirements Manual (DRM).

b. National Institutes of Health - Design Requirements Manual (DRM): The

DRM is available online at:

https://www.orf.od.nih.gov/TechnicalResources/Pages/DesignRequirementsManual 2016.aspx.

c. The Architect/Engineer (A/E) should refer to the revisions page before each use of the DRM to note any updates that have been made since last use as the entire DRM is revised on a three-year cycle.

4. National Institutes of Health - Facility Development Manual (FDM) The FDM is available online at:

https://orfweb.od.nih.gov/policies/Documents/NIH_FDM_ver5.pdf

5. Laboratory Decommissioning Policies When the existing laboratory is vacated, prior to demolition, the site must be cleared and certif ied by the Department of Occupational Health and Safety (DOHS) and the Department of Radiation Safety (DRS).

a. Cleaning and decontaminating of laboratory spaces for Biological, Chemical, and Radiological Considerations.

https://www.orf.od.nih.gov/TechnicalResources/Pages/DesignRequirementsManual2016.aspx https://www.orf.od.nih.gov/TechnicalResources/Pages/DesignRequirementsManual2016.aspx https://orfweb.od.nih.gov/policies/Documents/NIH_FDM_ver5.pdf

Biplane X-Ray Angio System 5

b. Safe movement of Biological, Chemical, and Radioactive Materials.

c. A utility shutdown plan must be in place prior to clearing and certif ication.

6. Procedures The NIH Division of the Fire Marshal [the fire safety "authority having jurisdiction" (AHJ)] as well as the project officers shall monitor renovation and construction areas for compliance.

a. The NIH AHJ shall approve all completed work for compliance with provisions of the National Fire Codes prior to acceptance and beneficial occupancy of the space.

b. Non-compliance with checklist is sufficient cause for a “Stop Work Order.”

C. PROJECT MANAGEMENT

This project is intended to be delivered as a turn-key equipment installation following the Design-Build Methodology. The Design-Build (D/B) entity shall be comprised of an Architect/Engineer (A/E) entity and a Construction (Build) entity providing a continuum of services to the project. The D/B shall have responsibilities concerning project management as defined herein. The D/B shall appoint a Project Manager (PM), who shall be the Government's single point of contact and provide all necessary project representation for the successful accomplishment of the work. The PM shall be thoroughly familiar with all requirements and schedules and identified in the D/B proposal prior to contract award.

Note to the contractor: For solicitation purposes, the contractor shall propose a schedule for potential modification of the space, delivery of the equipment, and calibration.

1. Time of performance

a. Demolition and other noisy activities shall occur during non-business hours

(business hours are defined as 9:00 a.m. to 4:00 p.m. EST, Monday - Friday).

b. A detailed schedule of construction activities shall be established in advance for NIH review, consent, and provide adequate notice to building occupants, prior to the commencement of construction activities.

c. The target date for start of construction and beneficial occupancy is to be determined. Final punch and final acceptance of the work shall occur subsequently, as required.

i. The Target date for start of construction shall depend on issue of NIH Construction Permit and site readiness.

ii. At the date of beneficial occupancy, incomplete work items may not include: drywall, millwork, casework, carpeting, lay-in ceilings, light f ixtures, room power, HVAC, projection screen, functional ceiling-mounted projector, or other items which would render the space un-usable.

iii. At the date of beneficial occupancy, uncompleted work items may include: items which would not render the space un-usable as interpreted by the Project Officer. All remaining items shall be resolved within 5 days of NIH assuming beneficial occupancy.

Biplane X-Ray Angio System 6

iv. The final punch list shall be developed at a date to be determined by the Project Officer, after the D/B submits a written notice of substantial completion, indicating all major work has been completed. The Project Officer may accept this notice, or reject it, pending further work to be completed.

v. The Fire Marshal (DFM) must inspect and accept the work prior to NIH assuming beneficial occupancy.

D. SCOPE OF SERVICES

The A/E shall provide professional services for all architectural and engineering disciplines; material and labor necessary to provide a set of construction documents to facilitate the construction of the subject project. As a turnkey installation project through a Design Build methodology, the General Contractor is responsible for design coordination and quality control.

1. Review of As-Built Drawings Before design, the A/E shall compile and review the necessary as-built drawings.

The A/E shall then field verify the existing conditions.

2. Submittals and Deliverables The A/E shall make two (2) design submittals at the following stages: Construction Documents (65%), and Construction Documents (100%).

a. Construction Documents Phase – 65%

i. Construction documents constituting 65% of design completion consist of but are not necessarily limited to the following in addition to all items required during design development phase:

a. Floor plans indicated with demolition and new work for each design discipline, elevations, cross, interior elevations, reflected ceiling plans drawn to scale, major equipment locations for mechanical and electrical systems, details for each discipline drawn to scale, plumbing raiser diagram, one line electrical diagram, electrical panel schedules, and one line diagrams, preliminary construction dust control system design, outline specifications, and quantity takeoff cost-estimate.

b. See NIH DRM for detailed requirements.

3. Construction Documents Phase – 100%

a. Construction documents constituting 100% of design completion consist of but are not necessary limited to the following in addition to all items required during the 65% phase:

i. Floor plans indicated with demolition and new work for each design discipline, elevations, cross, longitudinal and wall sections, interior elevations, reflected ceiling plans drawn to scale, f inish and door schedules, major equipment locations for mechanical and electrical systems, equipment schedules with facility numbers, details for each discipline drawn to scale, plumbing raiser diagram, one line electrical diagram, electrical panel schedules, one line diagrams, construction

Biplane X-Ray Angio System 7 dust control system design, specifications, and quantity takeoff cost-estimate.

b. See NIH DRM for detailed requirements.

4. Construction Documents Phase – Permit Insurance

a. Construction documents constituting final design completion consist of but are not necessarily limited to the following in addition to all items required during construction document 100% phase:

i. All drawings, specifications, calculations and reports shall incorporate previously accepted review comments. The A/E shall provide electronic copy of all Revit drawings in Revit and pdf format;

electronic copy of specifications, calculations and reports.

b. See NIH DRM for detailed requirements.

5. Project Meetings

a. Progress Meetings

Progress meetings shall be conducted in one or more of the following ways: via conference call, virtually through web-based meeting software, or in person at the National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland. The purpose of the progress meetings is to review the progress of the project in accordance with the schedule, status of submittals and resolve any outstanding issues. The D/B shall prepare and provide meeting minutes to the NHLBI Project Architect within 7 working days for all meetings. The D/B shall provide an allotment of time in their proposal to set aside for progress meetings. Progress meetings shall take place biweekly during design and weekly during construction phases.

b. Review Meetings Review meetings shall be conducted in one or more of the following ways: via conference call, virtually through web-based meeting software, or in person at the National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland. The review meetings may be scheduled by the NHLBI Project Architect to clarify review comments from various disciplines. The Government shall provide appropriate representatives authorized to make technical and programmatic decisions necessary to maintain progress. The D/B shall send appropriate representatives consistent with the level of development and the nature of review. The representative(s) shall be qualif ied and authorized to make the technical decisions as required to maintain effective progress. The D/B shall provide an allotment of time in their proposal to set aside for progress meetings.

c. User Meetings Meetings with users shall be scheduled by the NHLBI Project Architect to discuss requirements of any required operational protocol followed by the users and other functional requirements.

E. GOVERNMENT FURNISHED ITEMS

Biplane X-Ray Angio System 8

Legacy drawings are available for most areas, upon D/B request. These documents are expressly NOT warranted for veracity, accuracy, completeness or currency – It is the D/B’s responsibility to field verify all existing conditions necessary to accomplish the project.

F. FACILITY NUMBERS

1. Inventory control of equipment maintained by the Office of Research Facilities is tracked via facility numbers. The Division of Property Management shall issue the facility numbers for all new equipment.

2. On the demolition plan, the A/E shall indicate the designated facility number for all equipment being removed.

3. The A/E shall request facility numbers for all new mechanical, plumbing, and electrical equipment from the Division of Facilities Operations and Maintenance

(DFOM).

G. FIELD SURVEYS

The D/B shall perform field surveys that identify existing conditions to ascertain items necessary to accomplish the project. This may include measurements and metering of the existing utilities within the scope of work prior to demolition, to verify the design conditions shall be obtainable. This SOW specifically includes a minimum of five (5) days of electrical metering and engineering analysis plus a chilled water supply analysis. Pre-demolition readings of supply and exhaust air are also required.

H. PLANNING AND COORDINATION DRAWINGS

If requested, the D/B shall provide planning and coordination sketches and/or drawings showing the proposed connections, circuitry, etc. Sketches and/or drawings shall be submitted to the NHLBI Project Architect for review and approval prior to the start of work.

Utility and Structural capacities must be verif ied during the design phase for projects in existing facilities. Analysis/reports need to be provided to and analyzed by NIH to approve proposed changes to existing systems.

I. SCHEDULE

1. The work shall proceed only after the issuance of the Notice to Proceed (NTP) by the Contracting Officer (CO) or duly appointed representative for the activities indicated.

2. The D/B shall schedule and staff the project as necessary to deliver the project substantially complete and ready to move in by a future target date to be determined. The D/B shall submit a schedule at the bid reflecting this target date if the D/B feels it is reasonably achievable.

3. The D/B may elect to propose an alternative schedule in addition to the required schedule, with accompanying modifications in costs for a non-rush schedule for review.

4. The actual performance of the work and the delivery of the required documents shall be in accordance with the following submittal schedule which also indicates the performance time for each review stage.

Biplane X-Ray Angio System 9

SUBMITTALS AND QUANTITIES

ESTIMATED PERFORMANCE TIME

(WORK DAYS)

SUBMITTAL PAPER

COPIES Total D/B GOV

Submittal #1 12 40 25 15

(Construction Document 65%) Submittal #2

12 35 20 15 (Construction Document 100%)

Permit Insurance 12 5

(Issue For Construction Set)

J. AS-BUILT DRAWINGS

The D/B shall keep a current set of prints noting thereon any deviations or clarif ications generated by D/B supplemental instructions. Any changes during construction shall be made on the contract drawings and changes made in Revit f iles. Changes shall be published from updated Revit files. Before completion of construction, the D/B shall provide the D/B with as-built maintained in the field. The D/B shall correct the contract drawings and update the Revit f iles to reflect changes indicated on both D/B and Contractor marked-up prints. Marked-up construction prints and corrected drawings plus two sets of CDs or DVDs of the as -built formatted as “Revit f iles of Record, As-Built” and as “pdf Documents of Record, As-Built” shall be forwarded to the NHLBI Project Architect.

K. CONSTRUCTION SCHEDULE

Provide an updated construction schedule with each submission. The baseline schedule shall include Work Breakdown Structure and milestones. This baseline construction schedule shall be used as the Government baseline to be utilized to compare with the Construction Contractor baseline schedule at the time of construction bidding.

L. CLOSE-OUT

At the close of the project, the D/B shall package all documents related to the project (including submittals) in an orderly manner and send them to the NHLBI Project Architect for archiving. The project closeout documents shall, at a minimum, consist of the following documents:

1. As-Built Revit Files

2. As-Built PDF Files

3. As-Built PDF Specifications

4. PDF of Accepted Submittals

5. Scanned PDF of Final On-Site Construction Drawing Set

6. O&M Manuals

7. Training Documents

Biplane X-Ray Angio System 10

8. Punch Lists

9. Warranties

10. Certif icates Of Occupancy

M. CONTRACTOR HEALTH AND SAFETY REQUIREMENTS:

Refer to the ORF Contractor Safety Policy for guidance. The most current version is available at the following link:

http://orf.od.nih.gov/PoliciesAndGuidelines/ORFPolicies/Documents/ORF%20Contractor %20Safety%20Policy%20Nov%202012-508.pdf

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

IV. Warranty of Biplane AX System

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

http://orf.od.nih.gov/PoliciesAndGuidelines/ORFPolicies/Documents/ORF%20Contractor%20Safety%20Policy%20Nov%202012-508.pdf http://orf.od.nih.gov/PoliciesAndGuidelines/ORFPolicies/Documents/ORF%20Contractor%20Safety%20Policy%20Nov%202012-508.pdf

EVALUATION CRITERIA

Topic Notes Points

X-ray imaging system Ability to deliver the specified biplane X-ray angiographic system suitable for the interventional cardiovascular applications described in the Statement of Work.

X-ray imaging system features User assessment of the features and usability based on site visits and/or other available information

Image registration (fusion) capability and 3D visualization tools

A system with the ability to prepare roadmap images from cone-beam CT obtained from the provided X-ray system and from importation of prior tomographic imaging databases (CT, MR) with appropriate registration tools. Includes the ability to correct for cardiac and respiratory motion

Instantaneous data stream available for NIH-specific research applications

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

Installation, maintenance, training

Ability to provide suitable turnkey installation of the system with minimal downtime.

Intermodality patient transfer system

Ability to provide a patient transfer system that interacts with the specified MRI systems in the 10/2c713 interventional suite, and that allows safe transfer of sterile instrumented patients between X-ray and MRI systems.

Hemodynamic recording system High fidelity hemodynamic recordings and annotations during X-ray procedures and MRI procedures

Image post-processing and PACS integration

Ability to analyze acquisitions without interfering with live studies. Rapidity of automated query/retrieve to NIH PACS systems.

Total 100