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This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.

Background:

The National Institute on Aging (NIA), one of the 27 Institutes and Centers of NIH, leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life. The Intramural Research Program (IRP) of the National Institute on Aging (NIA) provides a stimulating setting for a comprehensive effort to understand aging through multidisciplinary investigator-initiated research, in this regard.

Purpose and Objectives: The purpose of this acquisition is to procure quality expert services for harmonizing newly acquired with existing Dual-energy X-ray Absorptiometry (DXA) body composition and bone mineral density data acquired on participants in the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study.

Description:

The Contractor shall provide the Government with the following:

1. The Contractor shall review total body, hip, and spine DXA image data provided by the Government from unharmonized DXA scans acquired from HANDLS participants beginning in wave 7. Contractor shall manipulate scans, revising them in diagnostic software to insure consistency in the designations of all regions of interest for each participant over time and among all participants using previously harmonized data as standard. The goal is to define the same regions of interest within and among participants so that analyses of demographic differences and longitudinal change are assured that differences are not contaminated by differing definitions of body parts or by artifacts introduced by different metrics.
   
   
   
   1. Contractor shall calibrate the validity of newly acquired measures using standard manufacturers’ phantom scans for performing quality control of the stability of DXA measures over time.
   
   
   2. Contractor shall have methods for scoring whole images as well as anatomical sub-regions for validity of measures (e.g., bone mineral content, bone mineral density, fat-free mass, and estimates of percent body fat) that are reliable and valid that produce data harmonized with existing longitudinal data and ongoing new data
   
   
   3. Contractor shall have established methods for scoring the technologist avoidable errors that cause a degradation in study data quality.
   
   
   4. Contractor shall establish standard operating procedures (SOP) for performing the above analysis as well as outlining the training needed for staff to perform the analysis.
   
   
   5. Contractor shall have established validation data and statistical methods outlined in an SOP to document the vendor’s reader accuracy and quality.
   
   
   
   


2. Using software tools available to the Contractor or software tools supplied by DXA manufacturers, the Contractor shall harmonize data from newly acquired DXA scans with previously harmonized data acquired from earlier waves. The goal of this requirement is to extend the harmonized data so that HANDLS investigators can examine change in body composition and bone mineral density from wave 1 forward for all participants.
   
   
   
   1. Contractor shall have demonstrable experience with the creation and use of cross-calibration equations (across manufacturers and types of scanners) for DXA for spine, hip, and whole-body scans.
   
   
   2. Contractor shall have demonstrable experience in longitudinal correction and calibration of DXA data for each of the scan types using CUSUM and existing phantom data. The Contractor shall also have demonstrable experience and capability to add ongoing newly acquired DXA scan data to existing harmonized DXA data.
   
   
   
   


3. The Contractor shall perform the following:

1. Quality control checks on all DXA image data to insure correct participant alignment in the scanner and complete image acquisition such that participants’ entire bodies are included in the image. These quality control checks shall have scoring methods for each anatomical method that codes the quality problems and validity of the region.


2. Examine each DXA image to check on the appropriate location and accurate positioning of all regions of interest. The Contractor shall re-define all incorrectly located regions of interest. The Contractor shall insure the regions of interest are defined identically in all scans for each participant. Contractor shall have demonstrated experience with studies of similar size (number of participants) as well as timeframe of data acquisition.


3. The Contractor shall define a protocol for insuring consistency within and among participants’ DXA scans. These procedures require a quality assurance protocol and periodic reports to the Government on the extent of consistency achieved by the Contractor’s procedures.


4. Based upon the scans yielded by re-examining the regions of interest, the Contractor shall supply a data file on body composition and bone mineral density measurements with a record for each participant at each examination. These measurements shall consist of the data produced by the software provided by the DXA manufacturer and other measures provided by the Contractor that are meaningful for examining demographic differences and longitudinal change in body composition and bone mineral density. Measures shall include but shall not be limited to lean and fat mass compositions for total body, body without head, abdomen, arms, legs, and torso and bone mineral density of entire spine and the L1-L4 vertebrae of the spine, total hip and anatomical regions of the hip including neck, shaft, Ward’s triangle, and trochanter, arms, legs, ribs. Additional derivations that would be useful: FRAX assessment, TBS measure, NHANES T-scores, NHANES Z-scores, cross calibrated hip axis length.


5. The Contractor shall establish procedures for continued quality control checks, re-analyses, and data generation for the on-going scans acquired beginning with wave 7 including subsequent waves when they occur.


6. Contractor shall have a track record of expertise in DXA and quality control for multisite studies as evidenced by publications in peer-reviewed journals.

Anticipated delivery: 12-month base period w/ (4) option years

Place of Performance:

251 Bayview Blvd

Baltimore, MD 21224

Capability statement /information sought. Contractors that believe they possess the ability to provide the requirement should submit documentation of their ability to meet each of the project requirements to the Contract Specialist. The response should directly and specifically state in the, capabilities statement, which project requirements you can supply. Contractors must also provide their Company Name, DUNS Number, Physical Address, Point of Contact, and Size and Type of Business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements.

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 information submitted must be 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.

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.

The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

All responses (capability statements) sent in response to this Small Business Sources Sought Notice must be submitted electronically (via e-mail) to the Contract Specialist. Facsimile responses are NOT accepted.

The response must be submitted to Andrea Clay, Contract Specialist at e-mail address amcgee@mail.nih.gov

The response must be received on or before May 17, 2023 at 12:00PM, eastern time.

“Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”

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