JOFOC stEUS development_RPI20-009670 (002)final.pdf

Attachment C

Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. Department of Health and Human Services (HHS), National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC)

b. Sponsoring organization. Radiology and Imaging Sciences

(RADIS)

c. Project Officer information

Project Officer name: Chiquita Bennett-Clark

Mailing address. 10 Center Dr. Bldg. 10 Room 1C359 Bethesda MD 20892

E-mail address: cbclark@cc.nih.gov

Telephone number. 301-402-5443

2. Nature and/or description of the action being approved.

A validated spatiotemporal enhanced US (stEUS) software program.

Project background. Statement of Work (SOW) is for the details of the project description

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

a. Project title: Validated spatiotemporal enhanced US (stEUS) software program

b. Project description.

The Center for Interventional Oncology seeks to develop novel imaging for many types of solid tumor cancers. The SOW main objective is to develop enhanced US with deep learning for detecting and visualizing tumors during interventional procedures.

mailto:cbclark@cc.nih.gov

A contractor is required to do develop a prototype of a spatiotemporal enhanced US (stEUS) based tumor detection using spatial and time (spatiotemporal) methods at 6 months, testing 6-12 months and at 12 months a validated stEUS software program.

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 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.

HHSN-NIH-CCOPc-20-009670

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

The dollar value for this procurement is $75,000.00. The delivery period for the prostate Ultrasound software is 12 months from order placement.

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.) 253(c)(_7_) as set forth in Federal Acquisition Regulation (FAR) 6.302- _2_.

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).

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

Name and address of the proposed contractor(s).

Dr. Pingkun Yan Assistant Professor, Rensselaer Polytechnic Institute (RPI) Co-Director, Biomedical Imaging Cluster

Department of Biomedical Engineering Rensselaer Polytechnic Institute 110 Eighth Street, Troy, NY USA 12180 Office: CBIS 4231 Phone: 518-276-4476

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

Dr. Pingkun Yan at Rensselaer Polytechnic Institute (RPI) has over 13 years of industrial and academic research experience in various positions worldwide. His expertise is in the areas of ultrasound image analysis and image-guided interventions using machine learning and computer vision techniques. Together with his collaborators, he has made significant contributions to a number of directions, especially on ultrasound based cancer detection and fusion of transrectal ultrasound and magnetic resonance imaging for targeted prostate biopsy.

Recent studies by Dr. Yan and his team at RPI includes verification that temporal enhanced US images contain information for identifying prostate cancer lesions, which can be exploited by deep learning methods. The objective of this project is half way completed as Dr. Yan has the Ultrasound expertise to develop advanced methods using enhanced US through machine learning for detecting and visualizing tumors during interventional procedures to provide image guidance.

http://www.rpi.edu/

Biomedical Imaging Center, CBIS/BME, RPI

The mission of Biomedical Imaging Center/Cluster (BIC) at Rensselaer Polytechnic Institute (RPI) (http://biotech.rpi.edu/centers/bic) is to define imaging frontiers, advance theories and technologies, realize clinical/preclinical potentials, and train scientists and engineers. BIC is directed by Dr. Ge Wang, and Co-Directors Drs. Xavier Intes and Pingkun Yan, and occupies office and laboratory space of ~3,000sf in the Jonsson Engineering Center (http://rpi.edu/tour/jec) and the Center for Biotechnology and Interdisciplinary Studies (CBIS) (Figure R-1, http://biotech.rpi.edu), which ranks among the world's most advanced research facilities.

Deep Imaging Analytics Laboratory (DIAL-Yan)

Dr. Yan directs the Deep Imaging Analytics Laboratory (DIAL), which sits in the Center for Biotechnology and Interdisciplinary Studies (CBIS) building.

DIAL has more than 400 sq. ft. fully equipped laboratory space plus two office spaces for faculty staff and students. The lab has a premium commercial ultrasound scanner Esaote MyLab Twice with an array of ultrasound transducers. For computational tasks, in addition to the access to Rensselaer's new $100M supercomputing center with a supercomputer rated at 100 teraflops/sec, DIAL has 3 dedicated deep learning workstations equipped with NVIDIA Titan Xp GPU computational cards. The lab also has a 40TB data storage server hosted in CBIS server room for managing the scientific data generated and used by the lab, which can be accessed through the 10GB/sec ethernet on campus.

Esaote MyLab Twice Ultrasound Scanner: Esaote offers many technologies for imaging enhancement. With Tissue Enhanced Imaging, the harmonic signal is fully preserved without degradation of the acoustic information. MView and XView improve the quality of ultrasound images by reducing the presence of artifacts, shadowing and speckle. A very useful feature of Esaote scanners is that they allow post-processing of images and video clips previously acquired and saved into the archive. This feature makes it possible for imaging optimization and image analysis in the off-line stage. The scanner supports 2D/3D/4D imaging and is compatible with DICOM and other standards for network data transfer.

CBIS Micro-CT Core: The micro-CT scanner Scanco Viva CT40 resolves dense tissues including bone and contrast-enhanced structures such as vasculature. It is equipped with a micro-focus X-ray source of 5µm spot size and 50-70kVp, 8W (160 µA) to achieve 10µm nominal resolution. It covers a maximum scan length of 145mm and has a field-of-view up to 20-38mm.

Animal husbandry, veterinary, and necropsy facilities are provided through the Bioresearch Core. Histology is done by the Microscopy and Imaging Core.

CBIS Micro-MRI Core: The MRI scanners are ideally suited to perform in vivo studies of animals and ex-vivo studies of excised tissues and samples. There are two state-of-the-art high-field MRI scanners (7T/16cm and 14T/8.9cm Bruker AVIII). These are equipped with an array of imaging coils that includes dedicated high-sensitivity surface and volume resonators for brain and abdomen imaging studies on mice and rats. In combination with high-performance actively-shielded gradients, these systems allow high sensitivity, fast imaging, and great flexibility. Instrument dedicated animal monitoring equipment is routinely used for triggered data acquisition on respiratory and cardio biometric signatures and monitoring of animal well-being. Inhaled anesthesia delivery systems, MRI-compatible blood-oxygen sensor, and a small animal ventilator are also available. The MRI suite has a surgical room.

In addition, the MRI core has current licensing and expertise in many commercial, academic, and in-house software analysis packages and computational resources for analysis of contrast enhanced measurements and diffusion tensor imaging.

CBIS BioResearch Core: The BioResearch Core (BRC) is a state-of-the–art rodent housing and research facility designed to provide a professionally controlled environment. The facility includes nine barriers, three quarantine holding rooms and six procedure rooms for ABSL-1 and 2 work. One holding room is equipped with total control of light for variable or reversed day-night lighting conditions.

Rodents are housed in HEPA-filtered, individually ventilated cage racks. They are provided environmental enrichment and sterile food, water, and bedding, maintaining specific pathogen-free standards. Quarantine holding areas are used for animals with unknown health status or restricted pathogens. Micro isolation units are also available. Procedure rooms are equipped with either chemical fume hoods or biosafety cabinets. Materials are available for rodent survival surgery, blood and tissue collection, euthanasia and necropsy. The Behavioral Core provides space and equipment for analysis of various rodent activities.

The staff members have performed many specialized procedures such as major and minor survival surgery, orthopedic testing, in vivo MRI, fluorescence imaging, behavioral testing, and cardiovascular physiology.

They are skilled in animal husbandry and technical animal procedures. They provide researchers and students with training and support for developing and executing protocols for biomedical research and engineering. A laboratory animal veterinarian is available on-call and for visit. The services include protocol development and IACUC submission, animal identification methods (tattoo, ear tag, etc.), tissue specimen and blood collection, phenotype assessment, drug administration (ip, po, sc, im, etc.), surgical preparation and procedures, anesthesia administration and monitoring, postoperative recovery and care, breeding colony maintenance, embryo, egg and sperm cryopreservation, animal model development, necropsy and euthanasia.

RPI Computing Infrastructure: The Center for Computational Innovations (CCI) at RPI is based on a $100M partnership involving Rensselaer, IBM, and New York State. The CCI is one of the world’s most powerful university-based supercomputing centers, and a top 25 supercomputing center of any kind in the world, and sufficient for us to perform research with high-performance computing techniques.

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.

A Betasam.gov notice will be publicized on 08/07/2020 and closing on 8/15/2020.

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

A requirement was processed in 2019 on purchase award #75N90019P00514 for same cost of $75,000. This new requirement is for additional services using the same protocol used in the 2019 award.

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

This requirement must remain consistent with procedures followed in the 2019 award. Therefore market research would not be applicable.

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

The most compelling reason for choosing the Dr. Yan and Rensselaer Polytechnic Institute (RPI) is two-fold. First the expertise of Dr. Yan who spent 6 years at the NIH, Center for Interventional Oncology developing software for prostate biopsies. Second the labs and computer support at RPI are stellar and offered at a very reasonable price.

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

9. 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.

There are not currently future plans to acquire the same type of services.

However, as the results of the project unfold it may be necessary to re-compete.

10. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Project Officer

Alyson Bennington

Administrative Officer Radiology & Imaging Sciences

Project Officer’s

Immediate Supervisor

Chiquita Bennett- Clark

Senior Administrative Officer

Office of Administrative Management, Office of the Director

Head of the Sponsoring

Bradford Wood, MD

Official Name & Title Signature Date

Program Office

Director, Center for Interventional Oncology

Chief Interventional Radiology

11. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

Anthony Q. Hawley, Section Chief, OPC

12. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Chief of the Contracting

Office

Head of the Contracting

Activity

08-11-2020

13. Competition Advocate signature.

Competition Advocate

14. HHS Senior Procurement Executive signature.

HHS Senior Procurement

Executive