Vitus Bodyscan 3D Scanner Software and maintenance

INTRODUCTION
THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the on behalf of the National Institute of Digestive, Diabetes & Kidney Diseases intends to award a purchase order without providing for full and open competition (Including brand-name) to HUMAN SOLUTIONS OF NORTH AMERICA, INC. for the Vitus Bodyscan 3D Scanner Software and maintenance.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE
The intended procurement is classified under NAICS code 511210 with a Size Standard of $41.50.

REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2022-04 Effective January 30, 2022.

This acquisition is conducted under the procedures as prescribed in FAR subpart 13—Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000).

STATUTORY AUTHORITY
This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1—Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1).

PERIOD OF PERFORMANCE
Base Year:    03/01/2023-02/29/2024          
Option 1*:       03/01/2023-02/29/2024          
Option 2*:       03/01/2024-02/28/2025         
Option 3*:       03/01/2025-02/28/2026         
Option 4*:       03/01/2026-02/28/2027         

Place of Performance
National Institutes of Health 
National Institute of Digestive, Diabetes & Kidney Diseases 
10 Center Drive
Bethesda, MD 20892  
 

DESCRIPTION OF REQUIREMENT

Body composition is a cornerstone of clinical nutrition assessment because it closely represents one’s metabolism. Moreover, many drugs are dosed according to “metabolic size” for optimal safety and efficacy. However, it is unclear what parameter(s) can be used to normalize the vast differences of physical dimensions and/or composition that contribute to metabolic activities of different individuals. Body morphometry (anthropometry, such as weight, height, circumferences, etc) is an important part of body composition research, as it is often easier to assess than imaging techniques for body fat, lean, and bone measures (DEXA, CT, or MRI) and indirect calorimetry for metabolic rates (metabolic carts or chambers). Many classical/historical equations have been developed to use anthropometric measurements for estimating metabolic size, which have been widely accepted in clinical practice despite that some/many of those were developed in very small and homogeneous subject populations. For example, a simple body surface area (BSA) equation developed by Dubois and Dubois in 1916 was based on 9 healthy normal individuals (1 woman, 1 child and 7 men), which only uses weight and height and does not factor in age, sex, or race. Yet it is the most widely applied normalization factor for chemotherapy dose calculation today. The Vitus 3D Body Scanner gives an accurate direct measurement of each patient that allows for better research and clinical applications. 
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PURPOSE AND OBJECTIVES

With advancements of whole-body tomography technologies such as the 3-D laser scanner, the accuracy and precision of estimated BSA models has been questioned in healthy populations. Thus, the goals of our research are to: (1) evaluate the estimation errors in commonly-used estimation equations for healthy participants and for clinical populations with altered body composition (e.g., moderate to severe obesity with and without sarcopenia, patients with chronic kidney disease and cachexia) using gold-standard measurements of BSA (3D laser scanner), body composition (DEXA), and basal metabolic rate (indirect calorimetry); (2) minimize estimation errors and improve treatment by considering drug types/actions, and tailor-fit dose calculations with appropriate anthropometric, body composition, and energy metabolism assessment data to achieve personalized-medicine. 

SALIENT / REQUIRED FEATURES AND SPECIFICATIONS
Human Solutions will provide the R&D software package, as well as hardware and software maintenance for 1 year from the date of purchase.

TASKS AREAS
Independently, and not as an agent of the Government, the contractor shall perform all of the detailed Task Areas listed below:

Task Area 1 – Software to be delivered by 03/01/2022
Task Area 2 – Instructions for software installation will be provided by the vendor. 

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10—Market Research.  Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined HUMAN SOLUTIONS OF NORTH AMERICA, INC to be the only reasonable available source to provide the Vitus Bodyscan 3D Scanner Software and maintenance.   

This acquisition was pursued on a sole source basis centered on the following. The Vitus bodyscan and Anthroscan was purchased by the NIDDK using a previous purchase order, so the requirement for software and maintenance for the instrument can only be provided by HUMAN SOLUTIONS OF NORTH AMERICA, INC.  Thus, HUMAN SOLUTIONS OF NORTH AMERICA, INC is the only vendor that can fulfill this requirement.

The Human Solutions of North America, Inc Vitus bodyscan 3D Scanner is the only market-available system that has been validated for measuring body surface area and total body volume in human subjects with such accuracy and precision.  The Vitus bodyscan 3D scanner is the only human body scanner validated for measuring body surface area and total body volume, which is necessary for reporting measurements in scientific journals.

CLOSING STATEMENT
This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.”

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Thursday, February 10, 2022 to the Contract Specialist, Amber Harris, at amber.harris@nih.gov .

Assessment of Capability
Lowest Price Technically Acceptable