SOLICITATION NOTICE
65 -- Posting J &A - Justification and Approval (J&A)
- Notice Date
- 9/15/2010
- Notice Type
- Justification and Approval (J&A)
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Great Plains Regional Contracting Ofc, ATTN: MCAA GP L31 9V, 3851 Roger Brooke Drive, Fort Sam Houston, TX 78234-6200
- ZIP Code
- 78234-6200
- Solicitation Number
- W81K0010T0329
- Archive Date
- 11/25/2010
- Point of Contact
- Roland Jasso, 210-221-4964
- E-Mail Address
-
Great Plains Regional Contracting Ofc
(roland.jasso3@amedd.army.mil)
- Small Business Set-Aside
- N/A
- Award Number
- W81K0010P0562
- Award Date
- 9/3/2010
- Description
- JA JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION 1. Contracting Agency: Great Plains Regional Contracting Office, Brooke Army Medical Center, and Fort Sam Houston, TX, 78234-6000. 2. Description of Action: Approved is requested to solicit a sole source acquisition with Idaho Technology, Inc., (ITI) for JBAIDS DNA and RNA extraction Kits, and JBAIDS DNA and RNA assay kits for biological threat agents, including disposables and consumables necessary to run the assays, for use on the government-owned JBAIDS Analyzers at the Army Medical Department Center & School (AMEDDC&S), Fort Sam Houston, TX. This action will be accomplished through the use of a firm-fixed price contract for the period of 1 October 2009 through 30 September 2010. Funds availability via reimbursable MIPR of multiyear money will be used for this acquisition. 3. Description of Services: The JBAIDS and ancillary lab equipment and supplies constitute field-deployable sets for each Service in DoD. As such, items specific for JBAIDS must be used in operating the System and its training. The JAIDS extraction and assay kits are used to test various types of biological, environmental, and food samples for the presence of biological threat agents on the JBAIDS analyzer. Extractions kits contain reagent chemicals and reaction containers needed to extract DNA and RNA from bacteria and viruses. Assays kits contain DNA and RNA probes, primers, and reagents necessary to carry out the polymerase chain reaction (PCR) for biological threat agents. This acquisition is for the purchase of the reagents (extraction and assay kits) and consumables associated with the test menu. 4. Authority Cited: The statutory authority permitting other than full and open competition is 10 U.S.C. 2304 (c) (1), as authorized by Federal Acquisition Regulation (FAR) 6.302-1-Only one responsible source and no other supplies or services will satisfy agency requirements. 5. Reason for Cited Authority: AMEDDC&S currently owns and utilizes JBAIDS analyzers in its mission as the multiservice JBAIDS training center for the Department of Defense. Only products that have been validated through the DoD test and evaluation process can be part of the fielded set or approved for use on the JBAIDS; and only ITI analyzer hardware, software, extraction kits and assay kits have been validated. ITI owns some the patents and has licensing agreements for others. ITI holds the clearance from FDA to use JBAIDS for in vitro diagnostics of human specimens. Use of non-ITI products would be contrary to current validation and approvals, and would jeopardize the integrity of the results. 6. Efforts to Obtain Competition: This action will be advertised on FedBizOpps with a notice of intent to award a sole source contract to one and only one responsible source. No other efforts to obtain competition will be made for this requirement. 7. Actions to Increase Competition: Future acquisitions will also be synopsized in FedBizOpps. JBAIDS Joint Program Management Office has advertised in FeBizOpps for other firms that potentially could be licensed to manufacture the reagent kits, but no firms have found it cost effective to attempt to enter the market. It is expected that the life cycle of the current JBAIDS analyzers is through 2016, at which time due to market conditions and changing technologies, the current analyzers may need to be replaced. When the current analyzers become obsolete or beyond economical repair and the Government needs to re-procure, the JBAIDS testing equipment and associated reagents, disposables, and consumables will again be advertised in order to foster any potential competition. 8. Market Survey: Market research via the internet, e-mails, and telephone, indicates that there are no other companies that offer validated analyzer hardware, software, extraction kits, and assay kits that are validated and licensed to identify and quantify biological threat agents using the JBAIDS. 9. Interested Sources: To date, no other sources have expressed an interest in this requirement. Any proposals from interested sources resulting from the synopsis of sole source intent will be considered. 10. Other Factors: the Joint Biological Agent Identification and Diagnostic System (JBAIDS) is the result of the multi-Services process through the DoD joint Requirement Office (JRO) to develop a system to be the sole, common, DoD platform for use in CONUS and field-deployed laboratories for identification and quantification of biological threat agents. The JBAIDS uses the polymerase chain reaction (PCR) methodology to identify and quantify biological threat agents and other infectious agents from numerous biological, environmental, and food sample types. It's acquisition and development was directed by the Joint Program Manager (JPM) - Chemical & Biological Medical Systems which is part of the Joint Program Executive Office for Chemical & Biological Defense )JPEO-CBD). In 2003, contract DASG60-03-C-0094 was awarded to ITI to develop, manufacture, and distribute JBAIDS analyzer hardware, software, extraction kits and assay kits. Only products that have been validated through the JPM and DoD test evaluation process can be part of the fielded set to approved for use on the JBAIDS; and only ITI analyzer hardware, software, extraction kits and assay kits have been validated. ITI owns some the patients and has licensing agreements for others. ITI holds the FDA clearance to use JBAIDS for in veto diagnosis of certain human diseases caused by biological threat agents. Use of non-ITI products would be contrary to current validation, FDA clearance, and approvals, and would jeopardize the integrity of the results. Idaho Technologies, Inc (ITI) is the sole manufacture and licensee of FDA approved JBAIDS analyzer hardware, software, extraction kits, and assay kits.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/MEDCOM/DADA09/W81K0010T0329/listing.html)
- Record
- SN02284094-W 20100917/100916001037-57d14af27d775d1a2447ba909489b312 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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