JA Phillips_Maint_Services_2.6.2024_Final_Redacted.pdf

its core mission is the incorporation of hospital tools, such as endoscopy, cardiac telemetry monitors, and computed tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) imaging into basic and advanced research studies to systematically evaluate the pathogenic processes and clinical course of disease in animal models exposed to microbes. Research emphasis is on high consequence infections requiring high levels of biocontainment of Category A viral and bacterial pathogens plus newly emerging infectious disease microbes. The IRF is a 147,000-gross square-foot building featuring Biosafety Level (BSL) 2, 3 and 4 laboratories with unique aerobiology and advanced BSL-4 imaging and diagnostic equipment. This facility is further distinguished by its clinical mission of using a hospital medical 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.

In Fiscal Year (FY) 2003, 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 National Institute of Allergy and Infectious Diseases (NIAID) IRF was to be the first high-containment facility in the world to use common hospital-scale tools as 3T MRI, CT, Single Photon Emission Computerized Tomography/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, 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).

On September 27, 2004, NIAID issued an award to Philips Medical Systems (PMS) to fulfill the requirement.

In FY2006, in accordance with FAR Part 6.302-1, NIAID issued a sole source award to PMS 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 could operate 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, 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 has the capability to conduct BSL-2, BSL-3, and BSL-4 research. It is one of the few facilities in the world able to perform medical imaging to evaluate animals in BSL-4 containment. In addition to animal models of disease, the IRF uses innovative approaches—including high-throughput drug screening, targeted genomic sequencing, custom immunological and serological analyses, and organ-chip model development—to examine pathogenesis of viral pathogens.

This project is a follow-on to maintenance contract (75N93023P00367) with Philips North America, which was a noncompetitive award.

Contract/Order: 75N93023P00367 Vendor: Philips North America, LLC (Philips Healthcare, a division of Philips North America) Award Date: March 18, 2023 Period of Performance: March 18, 2023 – March 17, 2024 Amount: $368,719.80

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 IRF requires maintenance services for imaging equipment in the NIAID, IRF. The equipment systems contain both commercial and proprietary noncommercial components. The Contractor shall perform preventive, remedial maintenance and repair services to maintain the equipment in good working condition in accordance with the equipment manufacturer’s specifications. 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 Contractor shall provide 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 and cannot be serviced by one of the IRF imaging staff members. Opening of a high containment area requires performing a decontamination process and approval of entry by the Division of Occupational Health and Safety. While the Contractor’s personnel are at the Government facility, the contractor is responsible for compliance with all the laws, rules and regulations governing conduct at the IRF. The Contractor will follow all Federal, State and local laws related to the safety and health of personnel and property damage. Due to the security requirements imposed by the government, the contractor personnel will 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 shall provide Customer Services 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 shall 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:

• Magnetic Resonance 3T Achieva, Site #532851 (Serial #17226)

• Gemini TF (Positron Emission Tomography (PET) and Computed

Tomography Bio-containment system (CT) – Hybrid System) Site #42392378 (Serial #7010)

• Uninterrupted power supply of the Philips MR Mid-Tier System (Site # 62073790)

• Chloride 80kVA 480V 60Hz PET/CT UPS (Serial #1334373)

• 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): Renewal Maintenance/Service Agreement

• Type of action.

New requirement Follow on to 75N93023P00367 Other (specify): maintenance agreement renewal

• 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. AMBIS # 2203587

• Other acquisition identification number: NIAID-NOI-24-2203587

c. Total estimated dollar value and performance/delivery period.

• Total Estimated Dollar Value:

• Period of Performance: March 18, 2024 – January 17, 2025.

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.) 1901(e) as set forth in Federal Acquisition Regulation (FAR) 13.106-1(b)(2) 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

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 is 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 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. 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. Philips confirmed that due to the remote monitoring, research software, and knowledge of the proprietary design, no other vendor can provide these services 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 in order 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-24-2203587) to award a sole source purchase order was publicized on February 9, 2024, 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 on February 22, 2024.

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

a. The contractor will be required to submit a price quote, which will be compared to commercial prices of this item or similar items.

b. An independent government estimate (IGE) is based on commercial pricing with NIH applicable discounts.

c. NIAID will consider the above information along with the market research, and quoted prices found reasonable on previous purchases as determining factors for price reasonableness. A final determination by the Contracting Officer, will be conducted prior to award of the purchase order.

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. 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 PMS. Without access to PMS 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 worked with PMS 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. If a field service engineer from a source 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.

The NOI (NIAID-NOI-24-2203587) that was posted on February 9, 2024, and closed on February 22, 2024, received one response. Based on the information provided by the company, 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. In an effort to remove or overcome barriers to competition in the future, the market will be scanned frequently for new companies and services 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 services necessary to maintain its instruments and will continue to research the various manufacturers and services that could be in the Government’s best interest. The current