Introduction: Pursuant to FAR Subpart 13.106-1(b)(1), the U.S. Army RDECOM Contracting Center, Natick Contracting Division, on behalf of the Naval Health Research Center (NHRC), intends to award a firm fixed price purchase order on a sole source basis to: DeNovo Software, Los Angeles, CA 90010. THIS IS NOT A REQUEST FOR PROPOSALS. RESPONSES TO THIS POSTING WILL BE USED FOR REFERENCE FOR FUTURE SOLICITATIONS ONLY. NO SOLICITATION DOCUMENT IS AVAILABLE. 1. Nature and description of the supplies or services required to meet the agency's needs: The Discovery, Early Detection, and Evaluation of Treatment & Prevention in Cancer Research Program at Penn State require software designed for flow cytometry data analysis. The flow cytometry data analysis system should be the most current version and satisfies CFR Part 11 requirements. The flow cytometry data analysis software has the following salient characteristics: Overview: " Integrated reporting, tokens and analysis capabilities for creating high quality/automatic updating reports " Set permissions on the master analysis so technicians/pathologists cannot perform unauthorized tasks in the software " Embed quality control checks directly within the analysis to be able to better guarantee a proper analysis across a diverse set of locations and operator skill sets " Sophisticated analysis features such as quadrant linking and gating Page 1 of 5 " Eventually have all data transmitted directly to the back-end database systems " Training and set up for large scale clinical operations " Satisfies all 21 CFR Part 11 requirements i.e. data encryption, password protection, tamper protection, electronic signatures etc. " FDA Registered for Clinical use Detailed: " Reads FCS data files from any manufacturer " Runs on Windows 2000INTIXPNistaJ7 " 6 different kinds of plot types " Analysis prints exactly as you designed it on the screen " Save your analysis protocols " Undo any previously performed action " Unlimited gates " Copy all objects to the clipboard " Select many plots at once and perform actions once on all plots " See a full set of statistics " Multiple analysis protocols can be open at the same time " Change all files at once using Next and Previous commands " Complete control over the formatting of your plots (line widths and colors, fonts, background, legends, headers and footers are all customizable) " User interface based on graphic presentation type software " Search for FCS files on your hard drive based on keywords in the FCS file " Non-rectangular quadrants " Complete manual, getting started guide and comprehensive online help " Network and standalone licenses available Page 2 of 5 " View and edit FCS header keywords " Export FCS files as text " Batch export FCS files as text " Software Compensation " Advanced features wizard walkthroughs " Batch process many files automatically " Create reports in Microsoft Excel from batch process information " Create Microsoft Powerpoint presentations that look exactly like your analysis " Create reports in Microsoft Word using Mailmerge " Create PDF reports using pre-created PDF forms " Perform parameter math " Calculate the concentration of your sample " Calibrate your fluorescence signal to absolute number of fluorochromes " Calculate the percentage of positive cells in your sample " Insert Tokens " Create Custom Tokens " Use Panels " Create Alerts " Insert keywords and statistics into text boxes using tokens " Create custom sets of parameter labels " Perform DNA analysis (Multicycle) 2. A demonstration that the proposed contractor is the only source available to provide these services or goods (i.e. unique qualifications, proprietary rights, etc.): There are several flow cytometry packages on the market that can fit part of the requirements. The only FDA approved and 21 CFR Part 11 compliant flow cytometry software system available is produced by DeNovo Software. Several flow cytometry software vendors were contacted and their products are not yet capable of meeting the all 21 CFR Part 11 requirements or registered with the FDA. 3. A description of the market research that was conducted and the results, or a statement of the reason a market research was not conducted: A search was conducted between 25 March and 31 March 2010 using Internet search engines, the Central Contractor Registry (CCR) database, and the Small Business Administration (SBA) Dynamic Small Business Search. The CCR and SBA search referenced NAICS code 511210 Software Publishers and keywords Flow Cytometry. The SBA Dynamic Small Business Search returned one small business associated with both the NAICS 511210 and the relevant keywords. The vendor found during the search could not provide the software capable of fulfilling the requirements of the flow cytometry system. Internet research found that the model that best meet the salient characteristics of the Flow Cytometry software system is available from a single vendor. There are Flow Cytometry software systems available from different manufacturers available on the market. Each manufacturer produces a proprietary computer software system to work according to their methods for measuring Flow Cytometry. Only one of the software systems is currently registered with the FDA and satisfies 21 CFR Part 11 requirements. The Flow Cytometry software system sold by De Novo best meets the requirements. 4. Any other facts supporting the use of other than full and open competition: None 5. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required: Based on the results of the research, it appears that the Flow Cytometry software from De Novo best meets the salient characteristics set forth by the principal investigators. De Novo is the sole producer and vendor of their Flow Cytometry software they can also provide system support and set set-up. The De Novo software is 21 CFR Part 11 compliant and other flow cytometry software have not yet completed this process. There does not appear to be any actions that this agency can take to remove or overcome barriers to competition. 6. Interested parties may identify their interest and capability to respond to this requirement to the U.S. Army RDECOM Contracting Center, Natick Contracting Division via e-mail to:
contact@example.gov no later than noon on May 30, 2010. Contracting Office Address: RDECOM Contracting Center - Natick CCRD-NA-SU, Natick Contracting Division Kansas Street, Building 1 Natick, MA 01760-5011 Point of Contact: Steven Streeter, Contract Specialist
+1 (555) 000-0000 contact@example.gov
