JandA Phililps 75N93023P00367_Redacted.pdf

diagnostic equipment. This facility is further distinguished by its clinical mission of using a hospital approach to studying the disease processes in animal models exposed to infectious agents.

During the anthrax attacks of 2001, life-saving disease recognition was delayed because a commonly used hospital imaging test was not initially employed. CT of the chest has been widely available since 1976 when the last case of inhalation anthrax occurred in the United States.

Consequently, in 2001, research and medical practitioners had no experience using modern hospital-based tools to diagnose and track the natural history of old infectious like anthrax.

In FY2003, Congress appropriated $105 million Building and Facility funds for the National Institute of Health (NIH) to establish “specialized, high containment lab facilities at Fort Detrick to conduct BSL-4 research, such as vaccine challenge research.” To accomplish this clinical research core mission, the NIAID IRF was to be the first high-containment facility in the world to use common hospital-scale tools as MRI, CT, SPECT/CT, and PET/CT scans. Because whole-body, large scale clinical imaging equipment had never been developed for use under high containment, the requirements for design, modification, and installation were new and unique.

In FY2004, the National Institute of Allergy and Infectious Diseases (NIAID) sought competition from all sources for four off-the-shelf equipment modalities and for feasibility studies, development of concepts and specification for their modification, Customer Requirements Specifications (CRS) to meet BSL-4 containment specifications (Phase I).

Philips was the only company that submitted a proposal. On September 27, 2004, NIAID issued a purchase order to Philips to fulfill the requirement. In FY2006, in accordance with FAR Part 6.302-1, NIAID issued a sole source award to Philips to design, develop, and implement necessary modifications to standard, commercial MRI, PET/CT, SPECT/CT, and X-Ray diagnostic imaging equipment so that the equipment was capable of operating inside BSL-4 containment with the NIAID IRF Imaging Core. Under this contract NIAID also purchased a maintenance agreement for the commercial components and service plan for the non-commercial components.

The NIH has constructed and is now operating a biological high-containment BSL-4 at IRF at Fort Detrick, Maryland. This facility enables NIAID researchers to track disease process and clinical outcomes of select agents and other emerging infectious diseases. The IRF contains BSL - 2, 3 and 4 labs and support space with an advanced imaging core facility inside the BSL-4 containment. Commissioning and operating imaging suites within the BSL-4 containment area is unprecedented. The imaging core is a central point of research activity at the IRF focusing on whole-animal imaging to understand and monitor disease progression.

The medical imaging systems at the IRF-Frederick require yearly maintenance contracts to make sure their performance is stable and to tackle any repairs in a timely fashion, should the need arise. Philips North America is the vendor of the medical imaging scanners installed at the IRF-Frederick and is the only vendor with experience in servicing medical imaging equipment installed within a BSL-4 Laboratory.

This project is a follow-on to maintenance contract (75N93022P00275) with Philips North America which was a noncompetitive award.

Contract/Order: 75N93022P00275 Vendor: Philips North America, LLC (Doing business as Philips Healthcare, a division of Philips North America) Award Date: 01/18/2022 Period of Performance: January 18, 2022 – March 17, Amount: $556,133.30

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. Renewal Maintenance Services for Philips Medical Imaging Equipment at the Integrated Research Facility (IRF) at Fort Detrick, Maryland.

b. Project description. The Contractor shall provide a service agreement for Philips medical imaging systems located at the IRF. The equipment systems contain both commercial and proprietary non-commercial components. The Contractor shall perform preventative, remedial maintenance and repair services to maintain the equipment in good working condition in accordance with the equipment manufacturer’s specification. The Contractor shall provide all service reports, materials, parts, test equipment, transportation, labor, and all other related services for servicing the imaging equipment at the IRF. The IRF imaging personnel will assist in filling of phantoms and placing phantoms on imaging tables during the scheduled preventive maintenance and assist in performing tasks related to service on the high-containment side of the imaging suites. The Contractor and the Government agree that the contractor's personnel will only access high-containment areas if the ill functioning imaging system parts residing within the high-containment environment cannot be serviced by one of the IRF imaging staff members. Due to the security requirements imposed by the government, the contractor personnel shall make appropriate arrangements for escorted entrance into IRF and into the imaging suites to perform diagnostics, preventive maintenance, and service on the equipment. The Contractor will provide Customer Service Mondays through Fridays, 8:00 AM to 5:00 pm Customer local time, excluding Federal holidays ("Service Coverage"). Labor, travel, software patches and updates, and unlimited telephone technical assistance to maintain the equipment is to be included. Contractor must return all calls for service within two (2) hours and must be on-site within four (4) hours for emergency repairs. The Philips North America equipment to be serviced includes:

TF (Positron Emission Tomography (PET) and Computed Tomography Bio-containment system (CT) - Hybrid System) Site

Requirement type.

Research & development (R&D) R & D support services

× Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

New requirement × Follow-on to 75N93022P00275

Other (specify): ______________________

Proposed contract/order type.

× Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number.

c. Total estimated dollar value and performance/delivery period. The total estimated dollar value:

The period of performance: March 18, 2023 – January 17, 2024

4. Identification of the statutory authority permitting other than full and open competition.

× This acquisition is conducted under the authority of 41 United

States Code (U.S.C.) 3304(a)(1) as set forth in Federal Acquisition Regulation (FAR) 13.106-1(b) and 13.501(a).

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Philips North America, LLC.

22100 Bothell Everest Highway Bothell, WA 98021-8431 Phone: 240.690.4915

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

NIAID has identified Philips North America as the only contractor that is capable of performing this requirement. Servicing of this equipment is vital to NIAID to carry out its research at the IRF. Philips North America designed, developed, and implemented all necessary modifications to standard, commercial MRI, SPECT/CT, PET/CT, and X-Ray diagnostic imaging equipment, so that the equipment was capable of operating inside BSL-4 containment within the NIAID IRF Imaging Core. This imaging facility inside the BSL-4 biosafety containment at the IRF is not available anywhere and is therefore unique. Philips North America provided testing, internal and external verification of the modified imaging equipment that was installed and validated at the NIAID, IRF in Fort Detrick, Maryland. They also trained the NIAID staff on using the equipment; and coordinated with NIH, NIAID personnel to achieve final system acceptance. Philips designed and modified this 70-million-dollar commercial imaging equipment uniquely for NIAID, Division of Clinical Research (DCR) lab purposes. No other vendor can provide services on Philip’s equipment or have the knowledge of the proprietary design. All service to be performed must be provided by a certified Field Service Engineer with original equipment manufacturer (OEM) parts. All parts furnished by the manufacturer must be OEM certified to not void any warranties and ensure compatibility.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

As required by FAR Subpart 5.2, a Notice of Intent (NIAID-NOI-23- 2156080) to award a sole source purchase order was publicized on February 14, 2023, on SAM.gov announcing the Government’s intent to obtain renewal maintenance services for imaging equipment located at the IRF on a non-competitive basis. Responsible sources who could provide these services were provided an opportunity to respond with a capability statement. The announcement indicated the reasoning for awarding this requirement without competition. The notice closed and no responses to the NOI were received.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The techniques identified at FAR 13.106-3(a)(2) will be used to ensure award will be at a fair and reasonable price. The open market rates are comparable to rates on similar contracts and historical pricing for the same services. NIAID will consider market research, comparison with similar items in the marketplace, and quoted prices found reasonable on previous purchases as a determining factor for price reasonableness. A final determination by the Contracting Officer will be conducted prior to award of this contract.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

The Program Office conducted the initial market research by reviewing the IRF’s existing Philips instruments and their maintenance agreements.

After scanning the market for alternatives, their research concluded that Philips is the only source that can meet the IRF’s requirements. Market Research for renewal maintenance / service agreement for x-ray diagnostic imaging equipment was conducted by the Contract Specialist by reviewing the Required Sources, Federal Supply Schedules, NIH Strategic Sources, and Commercial Websites. Philips was found to be the only vendor to provide the required maintenance/service agreement. As the original equipment manufacturer (OEM), Philips has proprietary rights to the design and software utilized and is the only company with access to performance verified OEM component parts, spare parts, software, technical support, upgrades, and engineering resources to maintain the original operating specifications. Additional market research by the Contract Specialist included reviewing previous purchases for similar requirements, contacting knowledgeable Government and Industry professionals. Philips confirmed that due to the remote monitoring, research software, and knowledge of the proprietary design, no other vendor can provide these services. Additionally, the NOI did not reveal alternative sources that could meet NIAID’s minimum technical requirements for these maintenance services. In conclusion, the market research supports a sole source award to Philips North America as the only source available to the Government for this requirement.

9. Any other facts supporting the use of other than full and open competition.

The development and production of the imaging equipment was a highly complex scientific endeavor, especially where the manufacturer applied their own technical means and methods. NIAID purchased the imaging equipment and CRS for modifications by Philips. Without access to Philips intellectual property and patented technologies, no other vendor would be able to provide the maintenance services needed on the imaging equipment located at the NIAID IRF.

Very Importantly, on March 11, 2020, the World Health Organization declared the COVID-19 outbreak a global pandemic, and on March 13, 2020, the United States issued a Presidential Proclamation declaring the COVID-19 outbreak to be a national emergency. The IRF is working with Philips in upgrading their proprietary software, operating systems, computers, and hardware of the PET/SPECT/CT in support of COVID-19.

It would not be feasible to obtain a service / maintenance agreement to perform repair and maintenance from another vendor while upgrades will be performed to these instrumentations. If a field service engineer from other than Philips performed repair or maintenance to these instruments and a mechanical failure resulted and made the machines irreparable and not compatible with the planned required upgrades, then it would be very costly to the government to remedy.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

One vendor submitted a capability response to the NOI, and they do not meet the minimum technical requirements.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

It is the policy of NIAID to promote the use of competitive procedures whenever and wherever possible. To remove or overcome barriers to competition in the future, the market will be scanned frequently for new companies and products that could satisfy the Government’s requirement.

The DCR, IRF staff meets periodically to discuss various changes to scientific products and processes. Vendor, trade magazines, and scientific publications are scanned for new, open scientific changes that can satisfy various on-going protocols. The agency will continually re-evaluate the instruments functionality and will continue to research the various manufactures and products that could be in the Government’s best interest. The current situation continues to require a service maintenance agreement for imaging equipment with Philips, which is the only vendor that can perform maintenance services because they are the