RFP-NIH-OD-26-006312.pdf

INTRODUCTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR Subpart 12 and FAR Subpart 13.5, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a separate written solicitation will not be issued.

The solicitation reference number is RFP-NIH-OD-26-006312. This solicitation is issued as a competitive combined synopsis/solicitation for commercial products or commercial services. The Government intends to award a contract or purchase order resulting from this solicitation using full and open competition.

This acquisition is conducted under the statutory authority 41 U.S.C. 1901 for commercial items greater than the simplified acquisition threshold but not exceeding $9 million.

The National Institutes of Health (NIH) seeks to award a Firm-Fixed Price Purchase Order to the responsible offeror whose proposal represents the best value to the Government.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 334510.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) [2026-01], effective [March 13, 2026]. This requirement is unrestricted.

DESCRIPTION OF REQUIREMENT

Project Title Acquisition of one Siemens Vision 600 PET/CT scanner or equivalent.

Statement of Need/Purpose and Objectives

This procurement is urgently needed to replace an existing PET/CT scanner that will be end of service life on 31DEC2026 with a new state-of-the art PET/CT imaging system. The replacement will be used to perform clinical PET/CT scans in Clinical Center adult and pediatric patients with cancer and

COMPETITIVE COMBINED SYNOPSIS/SOLICITATION

other serious conditions. The proposed PET/CT with state-of-the art sensitivity, resolution and field of view renders the current scanner obsolete. The resulting improved image quality allows for better detection and characterization of lesions, which is essential for accurate diagnosis and treatment planning. It is a requirement and responsibility for the Clinical Center to make available state-of-the-art imaging technology supporting its innovative clinical research protocols and to replace obsolete technology.

This procurement is necessary for continuity of safe and quality patient care and is directly related to human safety. There is no alternative to this obsolete PET/CT beyond 31DEC2026. Expedited procurement processing is respectfully requested.

Equipment Requirements

The contractor shall furnish and install a new, state-of-the-art positron emission/ computed tomography (PET/CT) scanner with best available spatial and time resolution.

The new scanner must have performance specifications that include the following:

• Lutetium oxyorthosilicate (LSO) based SiPMs (digital) PET detector

• PET transaxial field-of-view 70 cm or larger

• Dynamic PET

• DICOM connectivity to Picture Archiving and Communication System (PACS) and

Radiological Information System (RIS)

• PET NEMA spatial resolution 3.2 mm or better for detection of small lesions and more accurate localization

• PET coincidence (time-of-flight) timing resolution < 220 ps for improved signal-to-noise maximizing image quality

• PET NEMA sensitivity > 14 cps/kBq for improved signal-to-noise

• Peak Noise Equivalent Count Rate (NEC) at least 280 kcps for concentrations up to 30 kBq/cc

(~ 1 microCurie/ml)

• 26 cm PET axial field of view (minimum)

• PET matrix size up to 880 x 880

• PET motion correction

• Calibration sources (Ge-68) large with large source shield

• Backup UPS (5 minutes for PET gantry and acquisition/recon computer) to enable proper shutdown in event of power loss

• UltraHD PET for improved signal to noise

• ECG monitor for gating

• Cardiac PET gating (list mode)

• Respiratory PET gating

• 64 slice CT

• 78 cm bore diameter (minimum)

• CT Extended Field of View reconstruction allowing visualization of objects with CT FOV up to

78 cm

• CT tube rotation speed of 0.5 s per revolution or less

• Minimum CT reconstructed slice thickness 0.6 mm or less

• CT tube kV: 70 – 140

• CT metal artifact correction

• CT iterative image reconstruction to reduce image noise

• Prompts Gamma Correction for Rb-82, I-124, and Ga-68 imaging

• NEMA XR-29 compliant

• Patient weight capacity at least 500 lbs

• Attenuation correction via CT imaging

• Cybersecurity package

• NEMA 2018 PET Self-test

• PET ACR Quality Phantom

• Continuous bed motion for PET acquisition

• Auto QC

• Project management/Site planning for extended installation (turnkey)

• MEDRAD Flex dual-head CT contrast injector, pedestal mount, with Certegra workstation installation included 12 month warranty beginning from the date of acceptance provided directly by Bayer.

• 12 month full warranty on the new PET/CT scanner

• At least a full week of onsite initial applications training, to be followed by at least an additional onsite week of training.

• Trade-in value for the existing Siemens PET/CT in 1C-488A/B

• Weekend delivery of new system

• Weekend rig-out of existing PET/CT

• Layout drawings of new PET/CT in 1C-488A/B

The new scanner shall be installed in room 1C-488A/B located in the Nuclear Medicine Section of the Radiology and Imaging Sciences Department in the NIH Clinical Center. The contractor shall be responsible for all necessary room modifications including those described below.

GENERAL CONTRACT REQUIREMENTS and QUOTE REQUIREMENTS

1. Contractor shall provide trade-in value and perform weekend de-installation/rig-out of the existing

Siemens PET/CT. This is a Turnkey Project with weekend de-installation of the existing system.

2. Site preparation (extended installation) listed as a separate line item with cost

3. Weekend delivery of new PET/CT system listed as a separate line item with cost

4. Trade-in value for existing Siemens mCT (PET/CT) in Room 1C-488A/B listed as a separate line item with a credit

5. Weekend rig-out of existing PET/CT listed as a separate line item with cost

6. Comply with OSHA requirements

7. Contractor (imaging vendor and design/build subcontractor) must follow the NIH Office of

Research Facilities (ORF) requirements of the current Design Requirements Manual (DRM) (nih.gov) NIH FDM v5 Accessible

8. Contractor (imaging vendor and design/build subcontractor) must follow the current NIH Construction Risk Assessment (CRA) requirements. (Ref: NIH Facilities Development Manual).

9. Contractor (imaging vendor and design/build subcontractor) must follow the current NIH Interim Life Safety Measures (ILSM) requirements. (Ref: NIH Facilities Development Manual).

10. Staging area/space outside of 1C-488A/B is not available. If a staging space is needed for de-installation of existing equipment or installation of equipment, it is up to the vendor to plan for and provide.

11. Rigging to be only performed by professional riggers with previous successful rigging performance on similar equipment at the NIH.

SUMMARY SITE PREPARATION

The contractor shall provide all necessary labor and materials (as a turnkey project) to update and modify the proposed location to receive, install and operate safely the new PET/CT scanner in compliance with the equipment manufacturer’s requirements and the NIH requirements.

This turnkey work shall be carried out by qualified contractors according to the noise and environmental hazard abatement regulations instituted by the Clinical Center, OFM and JCAHO.

The specific objective is to modify/upgrade room 1C-488A/B to satisfy both the installation and operational requirements for the new scanner.

This work includes but is not limited to:

1) Provide architectural, MEP engineering and structural drawings, specifications manuals and at least three (3) NIH review submissions. Respond to and address NIH facilities engineering drawing comments.

2) Provide electronic as-built drawings in Revit to NIH upon completion of the project.

3) Lease and install temporary storage pods for imaging equipment vendor use (as necessary).

4) Provide a structural engineering evaluation to determine that the existing concrete deck structure in Room 1C488A can support the new equipment Submit documentation by structural engineer.

5) Apply for, coordinate, receive and comply with required NIH construction activity permits, including but not limited to:

i. Infection control risk assessment and permit (ICRA)

ii. Construction work permit

iii. Hot work permits

iv. Fire protection systems shutdowns

v. Utility outage permits

vi. Road closure permits

vii. Rigging safety plan

viii. Applications for off-hours work permission

6) Engage a qualified and licensed Radiation Health Physicist to evaluate the new imaging equipment in the new location and provide a radiation shielding evaluation report.

7) Furnish and install structural support if deemed necessary by engineering report for supplemental structural support for the new equipment in room 1C-488A/B.

8) Provide evaluation and temporary structural shoring of concrete deck along equipment rigging route from outside to room 1C-488A/B as necessary.

9) Remove and restore any doors, doorframes, cased openings, walls and ceiling-mounted items along the rigging route to accommodate egress and ingress of the old and new equipment.

10) Furnish and install one new stainless steel sink with gooseneck faucet per current NIH regulations.

11) Upgrade finishes: Corian countertops with backsplashes, flooring, Acrovyn, ceilings and painting.

This includes:

i. Furnish and install new building-standard ceiling tiles using the existing ceiling grid in the exam, equipment and control rooms.

ii. Furnish and install new flooring (welded sheet vinyl with 4” integral cove base) in the exam room

iii. Furnish and install welded sheet vinyl flooring with 4’ Johnsonite continuous roll 4” cove base in the control and suite vestibule rooms.

12) Level the floor area under and around the PET and CT gantries in the exam room to conform to the manufacturer’s floor levelness specifications. Leveling will be coordinated with the installation of surface-recessed steel supplemental structural support plates.

13) Recessed floor trenches and conduits to be installed as necessary per manufactuer’s requirements.

14) Furnish and install patient observation cameras and intercom systems including:

i. One (1) new patient observation camera in the associated dosing room and one (1) new camera behind the gantry in the exam room:

ii. Two (2) new wall-mounted flat screen monitors in the control room at a convenient location.

iii. Plenum-rated wire and accessories.

iv. Wall-mounted voice-activated intercom in associated dosing room.

v. Intercom base unit on the counter in the control room

15) Air balancing; furnish and install CW supplemental cooling unit(s) for new equipment room; CW service, piping and accessories for the equipment (as needed). This includes:

i. Pre-test and record airflows at supply diffusers and return grilles within the exam and control rooms before starting any work. Provide written report.

ii. Provide final testing and balancing of existing building supply diffusers and return grilles within the work site. Provide certified written report.

iii. Pre-test and record airflows at supply diffusers and return grilles within the exam and control rooms before starting any work. Provide written report.

iv. Furnish and install chilled water supplemental cooling unit in the new equipment room (as needed) including: chilled water taps, valves, gauges, condensation drain line, drip pan, leak alarm, insulation and accessories for the unit.

16) Furnish and install conduits, pull boxes and up to two (2) EPO buttons, two

i. warning lights and power cables per manufacturer’s requirements.

17) Furnish and install LED lighting including:

i. up to eight (8) dimmable 2’ x 2’ LED light fixtures in the exam room controlled by a dimmer switch at the control counter and a 3-way switch at the patient entry door.

ii. Four (4) dimmable 2’x 2’ LED light fixtures in the control room controlled by a dimmer switch at the control counter and a 3-way switch at the control room corridor entry door.

iii. Two (2) LED light fixtures in the equipment room with a light switch by the entry door.

18) Furnish and install electrical work and cabling conduits per the PET/CT manufacturer’s specifications. This includes:

i. Main power circuit breaker in an existing facility panel sized by the electrical engineer of record.

ii. Install equipment manufacturer-furnished Main Disconnect Panel (MDP) near the power supply cabinet (PSC) and UPS (as appropriate)

iii. Dedicated power, neutral and dedicated ground electrical feeder from existing facility panel to manufacturer-furnished appliances.

19) Furnish and install and/or relocate an allowance of up to ten (10) duplex receptacles in the exam, control and equipment rooms.

20) Provide one (1) full-time (40 hours per week) on-site project manager to oversee all aspects of the work from beginning through NIH acceptance.

21) Coordinate all noisy or disruptive work, including all utility shutdowns, with appropriate staff members and occupants of adjacent space.

22) Comply and direct contractors to comply with building security regulations and dress code requirements.

23) Ensure that all construction and subcontractor personnel attend the NIH-provided training session: “NIH Joint Commission Training –Specific and Unique Requirements for Doing Work in the Clinical Center Complex.”

24) Coordinate and obtain approval for infection control and safety plans with/by appropriate NIH personnel.

25) Establish Infection Control barriers and procedures consistent with the requirements of the work and established NIH ICRA Procedures.

26) Infection control barriers will include temporary drywall partitions with temporary doors at the corridor patient entry door.

27) Operate a portable HEPA-filtered air scrubber in the project site.

28) Establish Interim Life Safety Measures and brief all workers.

29) No sanding, burning, melting or grinding of the lead that might release lead dust or particles into the air will be necessary to install or remove it.

30) Lead sheeting removed from any wall will be sealed in plastic for transportation and salvaged for patching lead shielded rooms at electrical junction boxes, etc. or recycled at a metal salvage yard.

Lead removed from site will not be discarded in any dumpster or landfill.

31) Relocate existing medical gas services as necessary.

32) Correct all existing fire related deficiencies, such as fire-caulking wall and floor penetrations.

33) Relocate and add fire protection sprinklers and piping to accommodate wall and ceiling layout changes. Provide signed and sealed fire protection drawings for review and approval by the NIH Fire Marshall.

34) Furnish and install lead radiation shielding patches where existing shielding is disturbed by new work (with equivalent thickness to existing).

35) Conform to the current NIH Design Requirements Manual (DRM). Apply for, coordinate, receive and comply with required NIH construction activity permits, including but not limited to:

i. Infection control risk assessment and permit (ICRA)

ii. Construction work permit

iii. Hot work permits

iv. Fire protection systems shutdowns

v. Utility outage permits

vi. Road closure permits

vii. Rigging safety plan

viii. Applications for off-hours work permission

36) Relocate existing Unistrut ceiling support structure to new location for new MedRad Injector installation as necessary.

Trade-in

The contractor shall dismantle and remove the existing Siemens PET/CT (mCT) scanner, patient table and associated equipment from rooms 1C-488A/B. Under conditions agreed to by both the Government and the contractor, the contractor shall take possession and provide for weekend rig-out of the old scanner. Separate line items for each the trade-in value and the weekend rig-out cost shall be provided.

Interconnectivity to PACS and RIS

The contractor shall ensure connectivity to the Clinical Center’s PACS archive. DICOM connectivity validation and verification shall be performed by the contractor for the relevant PET/CT scanner components and the NIH Clinical Center’s PACS archive. The following object types shall transmit bi-directionally for both PET and CT DICOM IOD’s: static, dynamic, gated, secondary capture, any compressed syntax supported by the contractor’s device and, if applicable, DICOM raw list mode.

Any issue that may prevent the complete transmission of all images and data generated by the scanners to both the NIH CC PACS system (including the VNA and any viewers associated with PACS or VNA) and the system shall be resolved prior to acceptance and final payment.

Please provide the full IDE Profile Compliance and DICOM Conformance statements as well as supporting documentation for the Clinical Trials IOD or roadmap expectation for support of this capability.

Other Regulatory Compliance

For installation and remote Internet access (remote service), contractor personnel shall be trained (through the NIH security and confidentiality awareness online course) and shall obtain the necessary clearances required by DHHS for accessing sensitive data in a DHSS-controlled facility. The contractor shall abide by DHHS and NIH network conduct and connectivity regulations. Clinical Center requirements supersede those applicable to other NIH campus facilities. NIH security policies and standards are reflected in the NIH Information Security Policy Handbook.

System Interconnection Security Agreement (ISA) and Memorandum of Understanding (MOU)

Systems that interconnect exchange or share sensitive information need to meet the OMB A-130 requirement that "written management authorization (often in the form of a Memorandum of Understanding or Agreement,) be obtained prior to connecting with other systems and/or sharing sensitive data/information. The written authorization shall detail the rules of behavior and controls that must be maintained by the interconnecting systems." To meet this requirement, it is required a System

Interconnection Security Agreement (ISA) and Memorandum of Understanding (MOU) focused on protecting the data exchanged.

An MOU and/or ISA will be required for any remote vendor access the NIHnet to ensure adequate security and the protection of the NIHnet.

Contractor’s Testing

Upon installation, the contractor shall test and confirm the proper operation of the PET and CT scanner components. A test report generated by the contractor shall document that all subsystems meet the required specifications.

Shielding

Lead environmental shielding for the scanner suite shall be sufficient to meet the Nuclear Regulatory Commission (NRC) exposure limits for both x-ray and gamma emissions to the surrounding general and restricted areas.

Mechanical

The contractor shall provide detailed load (weight) and utility (HVAC) requirements for the scanner to be installed.

HVAC/chiller units must not be located over electronics equipment without a passive physical barrier to prevent leak damage, e.g. from condensate overflow or seal deterioration.

Chilled water supplied by the Clinical Center must be filtered. Mechanical conduits and pipes must be concealed from general view or placed in closed equipment rooms.

Electrical

The contractor shall provide detailed electrical requirements for the scanner to be installed.

Qualifications

Contractors shall have proof of previous experience in hospital scanner installations. All workmen involved shall be licensed and bonded where required by county, state and federal regulations.

Inspection and Acceptance Testing

Inspection of the room modifications shall be ongoing and reviewed during weekly meetings.

After the completion of the room preparation phase and before the installation of the machine, NIH/ORF shall schedule an inspection to ensure that all modifications meet construction and hospital installation codes.

After the completion of the installation and after the contractor has conducted quality and performance tests on the equipment, a period of up to three weeks shall be made available for the RADIS Nuclear Medicine to conduct acceptance tests which include but are not limited to the NEMA standard tests.

During this time, the contractor shall assist in reading proprietary or any non-readily available data that is needed to carry out the NEMA performance tests. This time period shall be extended if the installation still does not pass any one of the standard performance tests, until full and complete acceptance is achieved.

Training

The contractor shall provide operators’ hard and soft copy documentation and training for the safe and efficient operation of the scanner to the physics group, RADIS department technologists. This training shall comprise one separate on-site applications sessions during regularly scheduled patient exams.

Warranty Period

A period of full warranty shall be provided by the contractor for at least 12 months following the successful completion of NIH’s acceptance testing. This warranty shall cover service calls (with less than 24 hours downtime) during normal business hours. Service shall include repair, recalibration, and parts and labor on all the scanner systems, including the x-ray tube and detectors. The room modifications shall be covered for at least 12 months, or the customary warranty whichever is longer.

Project Schedule

The project shall be initiated within six (6) months of the award.

Required electrical or utility shutdowns shall be scheduled in advance to minimize impact on the normal operations of the Department, and shall be coordinated with the NIH facilities manager, ORF, and the project officer.

Work that is potentially disruptive to patient studies must be scheduled in advance and in coordination with the PET chief technologist or be performed after normal PET work hours.

Reporting requirements

Following a ‘kick-off’ meeting, the Gantt chart shall be reviewed and modified as needed during biweekly meetings between the contractor, the NIH project officer, the PET physicist, and ORF personnel. A report of each meeting and any modifications to the schedule shall be produced and submitted to the contracting officer, project officer and the COR.

The provision at FAR 52.204-7, System for Award Management, applies to this acquisition.

The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items, applies to this acquisition.

The provision at FAR 52.212-2, Evaluation—Commercial Items, applies to this acquisition.

The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation represents the best value to the Government, price and other factors considered.

A written notice of award or acceptance of an offer, issued within the time specified in the offer, shall result in a binding contract without further action by either party. The Government reserves the right to accept any offer before the expiration date.

FAR 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition.

SUBMISSION REQUIREMENTS

Responses to this synopsis must include sufficient information to demonstrate the offeror’s bona-fide capabilities for fulfilling the required product or service. Responses must include, at a minimum:

• Product specification sheet

• Unit and total price (including trade-in value)

• Delivery/Shipping and handling costs (including Delivery period after award and

Delivery terms)

• Installation (including weekend rigging)

Additional evaluation considerations may include past performance, warranty, lifecycle cost, maintenance availability, and environmental or energy efficiency.

Responses must include the Unique Entity Identifier (UEI), Taxpayer Identification Number (TIN), and business size certification. All offerors must be actively registered in the System for Award Management (SAM) at www.sam.gov.

All responses must be received by noon eastern time August 25, 2026. Responses must be submitted via email to the POC below and must reference solicitation number RFP-NIH-OD-26-006312 on the subject line.

POINT OF CONTACT:

Chris Ryssa Nix Contract Specialist ryssa.nix@nih.gov http://www.sam.gov/