DXA body composition and bone mineral density review and analyses for the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study

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 Healthy Aging in Neighborhoods of Diversity across the Life Span study (HANDLS) is a multidisciplinary, community-based, prospective longitudinal epidemiologic NIA study examining the influences of race and socioeconomic status (SES) on the development of age-related health disparities among socioeconomically diverse African Americans and whites in Baltimore. This study investigates whether health disparities develop or persist due to differences in SES, differences in race, or their interaction. This study is unique because it will assess over 20-years physical parameters as well as evaluate genetic, biologic, demographic, psychosocial, and psychophysiological parameters of African American and white participants in higher and lower SES. It also employs novel research tools, mobile medical research vehicles, in hopes of improving participation rates and retention among non-traditional research participants. DXA measures of body composition and bone mineral density are among the clinical measures acquired during participants' examinations in every wave. Body composition - the extent of lean and fat mass in various body regions - are important indicators of health. Measures of lean and fat mass are also important correlates required for thorough analyses of every domain examined by HANDLS such as risks for cardiovascular disease, diabetes, and kidney disease, changes in brain health assessed by MRI measures, and the influences of overall activity on health. Bone mineral density - a measure of bone strength - is a primary indicator of osteopenia and osteoporosis, both of which may lead to disabling bone fractures and loss of mobility. PURPOSE AND OBJECTIVES The purpose of this requirement is to procure quality expert services reviewing and analyzing 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. PROJECT REQUIREMENTS I. The Contractor shall review total body, hip, and spine DXA image data provided by the Government from DXA scans acquired from HANDLS participants since 2004. 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. 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. A) Contractor shall have licensed software and current versions of Hologic and GE Lunar software installed on workstations. B) Contractor shall have necessary hardware and software to read data stored on legacy Iomega Zip drives. C) Contractor shall calibrate the validity of acquired measures using standard manufacturers' phantom scans for performing quality control of the stability of DXA measures over time. D) Contractor shall have established methods for scoring whole images as well as anatomical sub-regions for validity of measures (BMD, BMC, Fat, Lean). E) Contractor shall have established methods for scoring the technologist avoidable errors that caused a degradation in study data quality. F) 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. G) Contractor shall have established validation data and statistical methods outlined in an SOP to document the vendor's reader accuracy and quality. H) Contractor shall have established expert review protocol and SOP for vendor expert to periodically review performance of vendor reader. II. Using software tools available to the Contractor or software tools supplied by DXA manufactures, the Contractor shall harmonize data acquired for the Lunar DXA with data subsequently acquired from the Hologic scanner. The goal of this requirement is to create a harmonized data file so that HANDLS investigators can examine change in body composition and bone mineral density from wave 1 for all participants. Data from Lunar scans were stored by the DXA computer in Iomega Zip drives, a technology not readily available since then. Zip drives are a removable floppy disk storage system produced by Iomega in 1994. The Contractor shall have the working means to read data nondestructively stored on Zip drives. This is particularly important because the only source for these data reside on these original Zip drives, which were the backup media for the DXA computer. A) Contractor shall have a variety of archive technology used over the last 30 years in DXA to assure that all archived scans can be read. These media technology include Zip (100, 250, 750 MB formats), Magneto Optical, DVD, and CD drives. B) Contractor shall be able to create new master archive storage for all GE and Hologic study compatible with manufacturer workstations, and transferable to the sponsor on hardwire-encrypted hard drives. C) Contractor shall have demonstrable experience with the creation and use of cross-calibration equations for DXA for spine, hip, and whole body scans. D) 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. III. The Contractor shall perform the following: A. 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. B. 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. C. 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. D. 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. E. The Contractor shall establish procedures for continued quality control checks, re-analyses, and data generation for the on-going scans acquired during wave 5 of HANDLS. i) Must demonstrate experience creating site manuals. ii) Must have training presentations and suitable materials for training site personnel in quality procedures. iii) Must have methods and SOPs for validating site DXA personnel. iv) Must have a set of cross calibration phantoms available for spine, hip, total body suitable for both Hologic and GE systems. F. Contractor shall have a track record of expertise in DXA and quality control for multisite studies as evidenced by publications in peer-reviewed journals. REPORTS/DELIVERABLES The following reports will be required: (1) A semi-annual report. (2) A Quality Assurance Protocol. (3) A final report shall be submitted before the expiration date of this contract. The Final Report shall be prepared in the same format as the semi-annual reports and shall include a summation of the work performed under the entire contract period of performance. ANTICIPATED PERIOD OF PERFORMANCE The period of performance for this acquisition will consist of one 12-month base period and three 12-month option periods. OTHER IMPORTANT CONSIDERATIONS The North American Industry Classification System (NAICS) Code is 621511 with a size standard of $32.5 million. CAPABILITY STATEMENT/INFORMATION SOUGHT Respondents to this notice must provide, as part of their responses, a capability statement to include the following: (1) information regarding the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and, (e) examples of prior completed Government contracts, references, and other related information; (2) respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code; and, (4) any other information that may be helpful in developing or finalizing the OPDIV's acquisition requirement. INFORMATION SUBMISSION INSTRUCTIONS Respondents should provide responses accordingly: (1) submit information electronically. No telephone or facsimile responses will be accepted; (2) format capability statements using Microsoft Word or Adobe PDF including attachments, resumes, charts, etc. Use single space, 12 font minimum and 8 - x 11 size paper; (3) organize material in such a manner that clearly identifies and address capability requirements and provide an executive summary; (4) capability statement should not exceed ten (10) single sided pages including references; (5) respondents must send one electronic copy via email; (6) responses must be received no later than February 28, 2019 at 4:00 p.m. Local Time; (7) include respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses; and (8) send responses to this notice via email to the Contract Specialist, Heather Orandi at Heather.Orandi@nih.gov. 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 pre-solicitation 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). Contracting Office Address: Contracts Management Branch Blue 6001 Executive Blvd, Rm 3166, MSC 9661 Bethesda, Maryland 20892-9661 Primary Point of Contact: Heather Orandi 6001 Executive Blvd, Rm 3166, MSC 9661 Bethesda, Maryland 20892-9661 Heather.Orandi@nih.gov