CSS 75N95023Q00660.pdf

COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

Title: Quality Assurance Service meeting or exceeding the accreditation of the American College of Radiology for three 3T and two 7T scanners.

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; proposals are being requested and a written solicitation will not be issued.

The solicitation number is 75N95023Q00660 and the solicitation is issued as a request for quotation.

This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures and FAR Part 12—Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-04, with effective date 6/2/2023.

The associated NAICS code 541690 and the small business size standard is $19M.

This requirement is a Total Small Business Set-Aside.

The function of the National Institute of Mental Health functional MRI Facility (FMRIF) is to serve as a resource by which all researchers in the National Institutes of Mental Health and Neurological Disorders and Stroke (NIMH and NINDS, respectively) can perform Magnetic Resonance Imaging (MRI) studies that further the understanding of healthy and diseased brain anatomy, function and physiology.

The FMRIF currently operates three 3T (high field) and two 7T (ultra-high field) human MRI systems within the NMR MRI Research Center at NIH.

• FMRIF 3TA (GEHealthcare MR750 3T)

• FMRIF 3TB (GE Healthcare MR750 3T)

• FMRIF 3TD (Siemens Skyra 3T)

• FMRIF 7TA (Siemens Magnetom 7T Plus)

• FMRIF 7TB (Siemens Magnetom 7T Terra)

The performance of all these systems is exquisitely sensitive to all the subsystems of the MRI. The quality of the fMRI research conclusions thus depends on the quality of the fMRI source data, which in turn depends on the performance of the MRI system hardware.

To obtain high quality images, all the subsystems of the MRI system (main magnet, radiofrequency transmit and receive, and gradients) must be operating within very stringent tolerances. This is especially important for the state-of-the-art and bleeding edge research methods being used for high resolution fMRI research, whose requirements are significantly more demanding than those for routine clinical MRI.

The specific objective of this purchase is the acquisition of an independent, comprehensive quality assurance service meeting or exceeding the QA and safety requirements for accreditation by American College of Radiology (ACR accreditation) for FMRIF’s 3T systems, and a comprehensive quality assurance service similar to, and meeting or exceeding the QA and safety requirements for accreditation by American College of Radiology (ACR accreditation) for 1.5T and 3.0T MRI systems, for FMRIF’s 7T systems. A complete system performance evaluation will be performed annually.

The National Institute of Mental Health functional MRI Facility (FMRIF) is a core resource of the National Institutes of Health (NIH) intramural research program mandated to provide researchers with access to state-of-the-art equipment, tools, and techniques for their experiments.

To meet these requirements, it is necessary that the FMRIF have modern, capable, accurate and reliable equipment. Further, it is necessary to perform routine (frequent and regular) quality assurance checks on the MRI equipment to ensure that it is operating safely, meeting performance specifications and thus providing the best possible data for research.

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

The vendor will make an initial visit to the NIH FMRIF and make a baseline evaluation of the performance of the FMRIF MRI scanners to ensure that the scanners meet or exceed the standards required for ACR accreditation for FMRIF’s 3T systems. For FMRIF’s 7T systems, make a baseline evaluation of the performance to ensure that the scanners meet or exceed the standards required for ACR accreditation similar to those for 1.5T and 3T MRI systems. The vendor will help the customer formulate a QA regimen, to replicate as closely as is scientifically possible, QA procedures for 7T MRI scanners, that replicate the system integrity and consistency checks performed for 1.5T and 3T MRI systems.

The performance report shall include the following tests of the MRI equipment.

Main system magnet

• Check main field strength (i.e. center frequency) is within the vendor operational specifications

• Check main field homogeneity within the imaging FOV Patient table

• Check table positioning accuracy (landmark to scanning position)

• Check table positioning reproducibility

RF transmit subsystem

• Performance evaluation for body coil and each transmit RF coil (as applicable)

• Safety evaluation for body coil and each RF transmit coil (as applicable)

• Check inter-frequency cross talk for digitally synthesized RF signals

• Check linearity of RF amplifier and transmit chain

RF receive subsystem

• Performance evaluation for each system receive channel

• Performance evaluation for each RF coil element

• Check for inter-channel noise correlation

• Overall performance evaluation for each receive RF coil

• Check the receive system SNR

Gradient subsystem

• Check accuracy of gradient field strength in X, Y, Z directions

• Check linearity of gradient in X, Y, Z directions

• Check geometric accuracy of images and gradient non-linearity correction performance

• Check slice position accuracy

• Check slice thickness accuracy

MR system environment

• Check MRI magnet room for isolation from extraneous RF signals

• Check MR equipment for isolation from extraneous RF signals

• Check acoustic noise levels during scanning

General Evaluation of Image Quality

• Check uniformity of image intensity

• Check percentage of signal ghosting artifacts

• Analysis of image artifacts

• Image SNR: single and time series SNR

• Echo Planar imaging: evaluation of time series imaging SNR artifacts

• Parallel Imaging (GRAPPA or SENSE): evaluation of SNR and artifacts fMRI Quality Assurance Evaluation Daily QA evaluation reports

The contractor will provide detailed protocol to be acquired as daily QA scan measurements on MRI phantoms.

The contractor will provide a secure web/cloud based service to which the DICOM format QA scans can be uploaded electronically; that can process and analyze the scans; and generate result measurements to determine that the scanner is providing accurate, stable and reliable measurements during fMRI timeseries scanning.

The QA analysis will evaluate MRI timeseries data and evaluate system signal, noise, artifact and ghosting from multi-band and echo planar imaging scans. Variations within and between timeseries will be detected and quantified as indicators of fMRI system performance.

GOVERNMENT RESPONSIBILITIES

The Government will provide the contractor access to the NIH Clinical Center at 10 Center Drive, NIH Building 10, NMR Center, where the FMRIF scanners to be evaluated are located.

NIH FMRIF personnel will collect the routine daily QA MRI scans of the MRI phantom using the vendor protocol, and upload the scans in Dicom format to the web/cloud service.

DELIVERY OR DELIVERABLES

The vendor will provide a detailed reports of the scanner performance including the results of the performance checks indicated above, and highlighting aspects of the system that are not performing within the expected specifications. Reports will be provided for the initial evaluation, annual evaluation, and the routine daily QA scans. The reports resulting from processing of the daily QA image scans will be transferred electronically to NIH FMRIF with 24 hours of the upload of the QA images.

The Government anticipates award of a firm fixed price purchase order for this acquisition, and the anticipated period of performance is a base period of twelve months, with options to renew for two additional twelve-month periods.

The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.acquisition.gov/browse/index/far

(End of provision)

The following provisions apply to this acquisition and are incorporated by reference:

• FAR 52.217-5, Evaluation of Options (JUL 1990)

• FAR 52.204-7, System for Award Management (Oct 2018)

• FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug

2020)

• FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial

Services (Mar 2023)

• FAR 52.212-3, Offeror Representations and Certifications-Commercial

Products and Commercial Services (Dec 2022)

• HHSAR 352.239-73, Electronic and Information Technology Accessibility

Notice (December 18, 2015)

The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:

(End of clause)

The following clauses apply to this acquisition and are incorporated by reference:

• FAR 52.204-13, System for Award Management Maintenance (Oct 2018)

• FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug

2020)

• FAR 52.212-4, Contract Terms and Conditions—Commercial Products and

Commercial Services (Dec 2022). Addendum to this FAR clause applies to this acquisition and is attached.

• HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015)

• FAR 52.212-4, Contract Terms and Conditions--Commercial Items (Dec 2022).

Addendum to this FAR clause applies to this acquisition and is attached.

• HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015)

The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal.

• FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)

• FAR 52.204-26 Covered Telecommunications Equipment or Services- Representation (Oct 2020)

• FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (Mar 2023)

• NIH Invoice and Payment Provisions

52.217-9 Option to Extend the Term of the Contract.

• (a) The Government may extend the term of this contract by written notice to the Contractor within 1 day; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 1 day before the contract expires. The preliminary notice does not commit the Government to an extension.

• (b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

• (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 36 (months).

(End of clause)

(ix) The provision at FAR clause 52.212-2, Evaluation – Commercial Items (Nov 2021), applies to this acquisition

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Quoters must address their capabilities to demonstrate how they meet or exceed the below factors in their quotation.

Factors:

1. Experience and knowledge of the systems and work required.

2. Ability to provide a secure web/cloud based service to which the DICOM format QA scans can be uploaded electronically; that can process and analyze the scans; and generate result measurements to determine that the scanner is providing accurate, stable and reliable measurements during fMRI timeseries scanning.

3. Ability to provide periodic system performance evaluations and QAs by personnel that is accredited to perform ACR QAs on MRI systems.

Technical is significantly more important than cost or price.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced.

Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.”>

(x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services (Dec 2022), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer.

(xi) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Dec 2022), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached.

(xiii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

(xiv) Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount.

The Unique Entity ID from SAM.gov, the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All quotations must be received by 3:00pm., Eastern Daylight/Standard Time, on September 6, 2023. Responses must be submitted electronically to Christopher Belt, Contracting Officer, cbelt@nida.nih.gov.

Fax responses will not be accepted.

http://www.sam.gov/ http://www.sam.gov/ mailto:cbelt@nida.nih.gov