75N94024Q00019.Combined Synopsis Solicitation.pdf

COMBINED SYNOPSIS / SOLICITATION WORKFORM

(1) Action Code: Combined Synopsis/Solicitation

(2) Date: 11/27/2023

(3) Year: 2024

(4) Contracting Office Zip Code: 20892

(5) Project Service Code: R499 – SUPPORT PROFESSIONAL:

OTHER

(6) Contracting Office Address:

6710B Rockledge Drive Bethesda, MD 20892

(7) Subject/Title: Acquisition of Services of a Contract Biomedical Imaging and Medical Image Analysis Scientist

(8) Proposed Solicitation Number: 75N94024Q00020

(9) Closing Response Date: 12/13/2023

(10) Contact Point: Amber Harris

(11) Contract Award and Solicitation Number: TBD

(12) Contract Award Dollar Amount: TBD

(13) Contract Line Item Number(s): TBD

(14) Contractor Award Date: TBD

(15) Contractor Name: TBD

(16) Description: (Background)

(i) “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; quotes are being requested and a written solicitation will not be issued.”

(ii) The solicitation number is 75N94024Q00020 and the solicitation is issued as a request for quote (RFQ).

(iii) The solicitation document, the incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-01 Effective November 14, 2023.

(iv) The associated NAICS code is 541690, Other Scientific and Technical Consulting

Services, and the small business size standard is $19.0. The acquisition is being conducted in accordance with the procedures of FAR Part 12 and FAR Part 13.

(v) The Contractor Requirements are listed below:

1.0 PURCHASE ORDER TITLE

Acquisition of Services of a Contract Biomedical Imaging and Medical Image Analysis Scientist

2.0 BACKGROUND

Chronic liver disease (from fatty infiltration or infections), with accompanying hepatic inflammation and subsequent fibrosis, affects over 4 million Americans and often progresses to cirrhosis and primary liver cancer with approximately 51,000 deaths per year in the US. Early assessment of inflammation is of the utmost importance for improved liver treatment and recovery. However, inflammation is difficult to diagnose and the progression of inflammation to fibrosis and cirrhosis in chronic liver diseases is a continuous process that requires invasive biopsy to quantify for appropriate medical management. Invasive biopsy provides subjective histopathologic ranked scoring systems that attempt to classify fibrosis and inflammation. Even though biopsy is considered to be the gold standard for quantifying liver fibrosis and inflammation, it suffers from sampling errors that may not reflects the true extent of pathology in addition to being an invasive technique that causes pain and potential complications to patients.

As the liver becomes fibrotic, nodules and abnormal spherical areas of cells form as dying liver cells are replaced by regenerating cells. This regeneration of cells causes the liver to become stiffer. Recent radiological advances allow bedside assessment of liver stiffness with various vibrator-assisted imaging techniques such as Fibroscan, acoustic radiation force impulse (ARFI) and magnetic resonance elastography (MRE). Yet none of these methods has been shown to accurately detect and clinically quantify the amount of inflammation. Furthermore, they neglect the potential effect of tissue inflammation on liver stiffness measurement accuracy.

The accurate non-invasive assessment of liver inflammation in addition to fibrosis assessment has become increasingly important as it allows for individualized early treatment management. The lack of accuracy and reproducibility, and challenges in assessment has been a major limitation for both clinical management and in liver disease research.

Liver damage can be prevented and, in many cases, reversed if liver disease is treated in its early stages in which inflammation precedes fibrosis. Biopsy, while the gold standard is also hardly justifiable in early stages. Biomedical and Metabolic Imaging Branch proposes a project to target this dilemma by offering to develop a safe, non-invasive, and affordable alternative to biopsy to assess liver inflammation and provide adjusted quantification of liver stiffness. Tens of millions of liver disease patients may benefit from these techniques either for early disease assessment and treatment or following up treatment effects, or in longitudinal clinical pharmacological studies in which the effect of new medication can be followed in patients without intervention.

In order to accomplish the goals of this project, The National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Biomedical and Metabolic Imaging Branch has a requirement to obtain services of a scientist with extensive expertise in biomedical imaging and medical image analysis with demonstrated understanding of, and ability to apply principles, concepts, practices and standards associated with biomedical imaging and medical image analysis. The scientist must demonstrate experience and understanding of techniques directly applicable to the Biomedical and Metabolic Imaging Branch research (medical imaging, image processing, machine learning, etc.) and must be self-motivated and driven to achieve milestones and exceed goals with minimal direction. Furthermore, they must possess a PhD with 20+ years of demonstrated expertise in biomedical imaging and medical image analysis research.

3.0 OBJECTIVE

The objective of this requirement is to procure the services of a scientist with specialized skills beyond what our current resources can provide in order to accomplish the goals of this project. Specialized skills include extensive expertise in biomedical imaging and medical image analysis with demonstrated understanding of, and ability to apply principles, concepts, practices and standards associated with biomedical imaging and medical image analysis.

4.0 SALIENT / REQUIRED FEATURES AND SPECIFICATIONS

The contractor will be performing translational research aimed at developing advanced medical imaging and medical image analysis techniques for cardiac Computed Topography Angiograph (CCTA) and liver Magnetic Resonance Imaging (MRI) to detect and assess the coronary atherosclerosis and the liver fibrosis and inflammation at the early asymptomatic stage.

The contractor must have:

• PhD degree in Biomedical Engineering or any related field with 20+ years of directly relevant experience in medical imaging, or medical image analysis.

• Strong research and presentation skills.

• Ability to define and implement critical studies needed to support hypothesis-based research.

• Ability to write protocols and study reports, produce and maintain accurate records.

• Expert in deep learning methodologies: RNN, CNN, LSTM, DNN, etc

• Proven experience working with Python, Keras, TensorFlow and/or PyTorch.

• Expertise in image processing, computer vision and machine learning theory.

• Proven experience working with OpenCV, ITK, and VTK.

• Excellent analytical and problem-solving skills.

• Excellent knowledge in OOP concepts.

• Experience with Unix/Linux.

The contractor is expected to deliver scientific data and results and implement the following:

• Develop and implement a 3D MRE technique and algorithms to analyze 3D MRE liver.

• Develop and implement analysis algorithms optimized for liver tissue deformation imaging driven by inherent cardiac motion to measure liver tissue biomechanical properties.

• Develop and implement machine learning algorithms to estimate the levels of inflammation and accordingly correct the fibrosis stage using liver tissue biomechanical properties.

• Write well-designed, testable, efficient code

• Interpret, analyze and present data; work in fast-paced, result oriented research environment

• Contribute to project advancement by developing new methods or technologies and troubleshooting existing protocol

• Write protocols and study reports, produce and maintain accurate records

• Prepare manuscripts for journal publications.

Task Areas:

Task Area 1 – Drive discovery and translational research aimed at developing and implementing a 3D MRE technique and algorithms to analyze 3D MRE liver. The Contractor shall create their own research plans with minimum support from the principal investigator. The Contractor shall be able to run research plans independently. Weekly/as needed meetings will be held to evaluate the work and provide directions for next steps.

Task Area 2 – Define and implement critical studies needed to develop analysis algorithms optimized for liver tissue deformation imaging driven by inherent cardiac motion to measure liver tissue biomechanical properties. The Contractor’s progress will be parodically evaluated, and the Contractor will be provided with feedback and directions.

Task Area 3 – The Contractor shall develop and implement machine learning algorithms to estimate the levels of inflammation and accordingly correct the fibrosis stage using liver tissue biomechanical properties.

Task Area 4 – The Contractor shall make contributions to scientific literature and conferences through publication and presentation of research results. The Contractor shall be evaluated based on preparing manuscripts and abstracts for scientific publications.

Task Area 5 – The Contractor shall organize data prior to scientific publication submission. The data will be reviewed and evaluated by the principal investigator.

Task Area 6 – The Contractor shall work 40 hours per week, Monday through Friday, totaling 2080 hours per year.

5.0 PURCHASE ORDER TYPE

This Purchase Order is to be a firm fixed price.

6.0 PERIOD OF PERFORMANCE AND PAYMENT BREAKDOWN

Period of Performance: 2/2/2024 – 2/1/2025

7.0 INSPECTION AND ACCEPTANCE

The Project Officer or the Project Officer Supervisor will perform inspection and acceptance of materials and services to be provided. For equipment orders, inspection and acceptance will be done AFTER All materials are unpacked, installed, and test run for operation. Receiving will be completed no later than 7 days following date of Delivery.

Acceptance and Delivery will be complete once the signed packing slip is provided to the Vendor.

Inspection and acceptance will be performed at the place of installation –

The National Institutes of Health, NIDDK, Bldg. 10, Room 3-5340, 9000 Rockville Pike, Bethesda, Maryland 20892.

For services, invoices will be approved by the Project officer and or COR according to payment terms in the resultant purchase order.

(vi) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition.

(vii) The provision at FAR clause 52.212-2, Evaluation – Commercial Items, is applicable.

Award will be made to the contractor providing the most advantageous quote to the Government. Technical factors and price considered with technical factors outweighing price.

Specifically, the following technical factors will be evaluated:

i. The vendor will be evaluated on their quoted product meeting the specifications under section 4.0 SALIENT / REQUIRED FEATURES AND SPECIFICATIONS.

ii. The Offeror should note that the evaluation criteria listed in order of importance are:

A. Technical – The services proposed by the vendor meets the requirements in the SOW

B. Cost/Price

The technical factors are as follows:

The evaluation will be based on the demonstrated capabilities of the prospective Offeror in relation to the needs of the project as set forth in the Statement of Work. The merits of the proposal will be evaluated carefully and will be deemed Acceptable or Unacceptable. The proposal must document the feasibility of successful implementation of the requirements of the Statement of Work. The Offeror must submit information sufficient to evaluate the proposal based on the detailed factors listed in section 4.0 SALIENT / REQUIRED FEATURES AND

SPECIFICATIONS.

Evaluation Criteria Acceptable Unacceptable

Technical The services proposed by the vendor meet the requirements in the SOW

Summary Overall Rating (Overall Risk)

Cost/Price Offerors will be evaluated based upon cost/price completeness and accuracy to determine the validity of the price, realism, reasonableness, and risk.

Technical Evaluation Rating Definitions

(viii) FAR clause 52.212-3, Offeror Representations and Certifications – Commercial Items, is applicable. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision.

(x) FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition.

(xi) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition. Including the following clauses and Prohibitions:

i. 52.219-28, Post Award Small Business Program Representation

ii. 52.222-19, Child Labor—Cooperation with Authorities and Remedies

(Jan 2014) (E.O. 13126).

iii. 52.222-21, Prohibition of Segregated Facilities

iv. 52.222-26, Equal Opportunity

v. 52.222-36, Equal Opportunity for Workers with Disabilities

vi. 52.222-50 Combating Trafficking in Persons

vii. 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving

Rating Definition Acceptable Proposal meets requirements and indicates an adequate approach and understanding of the requirements, and risk of unsuccessful performance is no worse than moderate.

Unacceptable Proposal does not meet requirements of the solicitation, and thus, contains one or more deficiencies, and/or risk of unsuccessful performance is unacceptable.

http://www.acquisition.gov/

viii. 52.225-13, Restrictions on Certain Foreign Purchases

Additional Clauses:

i. 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (OCT 2018) (31 U.S.C. 3332).

ii. 52.232-39, Unenforceability of Unauthorized Obligations

(xii) Additional Contract Requirements:

The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required.

One (1) copy of the response is required and must be in Microsoft Word or Adobe

PDF format using 11- point or 12-point font, 8-1/2" x 11" paper size, with 1" top, bottom, left and right margins, and with single or double spacing. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested.

Vendor/Contractor Must be able to accept payments via IPP (Invoice Processing

Platform) The contractor may submit a request for an exception. See below for IPP, IPP helpdesk information and applicable Health and Human Services addendum clause.

INVOICING PROCESSING PLATFORM (IPP) In compliance with the Office of

Management and Budget (OMB) M-15-19 memorandum "Improving Government Efficiency and Saving Taxpayer Dollars through Electronic Invoicing" directing Federal agencies to adopt electronic invoicing as the primary means to disburse payment to vendors. Invoices submitted under any award resulting from this solicitation will be required to utilize the Invoice Processing Platform (IPP) in accordance with HHSAR 352.232-71, Electronic Submission and Processing of Payment Requests" IPP is a secure, web-based electronic invoicing system provided by the U.S. Department of the Treasury's Bureau of the Fiscal Service, in partnership with the Federal Reserve Bank of St. Louis (FRSTL). Respondents to this solicitation are encouraged to register an account with IPP if they have not already done so. If your organization is already registered to use IPP, you will not be required to re-register however, we encourage you make sure your organization and designated IPP user accounts are valid and up to date. The IPP website address is:

https://www.ipp.gov If you require assistance registering or IPP account access, please contact the IPP Helpdesk at (866) 973-3131 (M-F 8AM to 6PM ET), or IPPCustomerSupport@fiscal.treasury.gov Note: Should an Offeror feel that use of the IPP would be unduly burdensome, the response to this solicitation should include an explanation of this position for a determination by the contracting officer.

HHSAR 352.232-71 Electronic Submission of Invoice Payment Requests (Feb 2022) will apply when this requirement is solicited and awarded. As stated: (a) Definitions.

As used in this clause, Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), "Content of

Invoices" and the applicable Payment clause included in this contract. (b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site. (c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures. (d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request. (END OF CLAUSE)

(xiii) The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable.

(xiv) Offers shall be submitted via email to amber.harris@nih.gov and must reference 75N94024Q00020 in the subject line.

(17) Place of Contract Performance:

National Institute of Health, NIDDK 10 Center Drive Bethesda MD 20892

(18) Set-aside Status: This requirement is not set aside for small business.

mailto:amber.harris@nih.gov