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

SOLICITATION
Solicitation Number: HHS-NIH-NIDA(AG)-CSS-75N95019R00034
Title: DXA body composition and bone mineral density review and analyses for the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study

(i) This is a 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; proposals are being requested and a written solicitation will not be issued.
(ii) The solicitation is issued as a Request for Proposal.
This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures; FAR Subpart 13.5- Simplified Procedures for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items and is expected to exceed the simplified acquisition threshold.
(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2019-01, dated January 22, 2019.
(iv) The North American Industry Classification System (NAICS) Code is 621511 with a size standard of $32.5 million.

(vi) 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.
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.
I) 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.
J) 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.
K) Contractor shall have demonstrable experience with the creation and use of cross-calibration equations for DXA for spine, hip, and whole body scans.
L) 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 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.
TYPE OF CONTRACT
A firm fixed price level of effort type contract is contemplated.
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.
(viii) The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition.
(ix) The provision at FAR clause 52.212-2, Evaluation - Commercial Items, applies to this acquisition.
(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: See Attached Technical Evaluation Criteria.
Technical and past performance, when combined, are significantly more important than cost or price.
(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).
(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.
(x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer.
(xi) The FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition.
(xii) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition.
(xiii) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition.
(xiv) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.
(xv) Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations.
Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount.
In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov."
All responses must be received by 12:00 PM Eastern on May 27, 2019 and reference number HHS-NIH-NIDA(AG)-75N95019R00034. Responses may be submitted electronically to Andrea Clay, Andrea.McGee@nih.gov. Questions can be submitted until 12:00 PM May 6, 2019 and will be answered promptly on FedBizOpps.

Fax responses will not be accepted.
(xvi) The name and telephone number of the individual to contact for information regarding the solicitation. Andrea Clay, (301) 480-2449.

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