SOLICITATION NOTICE
Q -- Vitros Chemical Analyzer J&A - Vitros - J&A
- Notice Date
- 2/9/2018
- Notice Type
- Justification and Approval (J&A)
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of the Air Force, Air Force Special Operations Command, 1 SOCONS- Hurlburt, 350 Tully Street, Hurlburt Field, Florida, 32544-5810, United States
- ZIP Code
- 32544-5810
- Solicitation Number
- FA524018S0004
- Archive Date
- 3/11/2018
- Point of Contact
- James McFarland, Phone: 8508841269
- E-Mail Address
-
James.McFarland.8@us.af.mil
(James.McFarland.8@us.af.mil)
- Small Business Set-Aside
- N/A
- Award Number
- FA524018P0007
- Award Date
- 2/9/2018
- Description
- Vitros J&A Single Source Justification (Simplified Acquisition) 20 Apr 2017 Page 1 of 3 Section A: General Contract Information Contracting Activity: 36th Contracting Squadron Project/Program Name: Vitros Chemical Analyzer Purchase Request/Identification Number: F1C4MG7304AW01 Estimated Contract Cost (including Options): Section B: Description of the Supplies/Services Required The 36th Medical Group (36 MDG) requires the ability to perform chemical analysis with a safe Food and Drug Administration (FDA) approved diagnostic analyzer compliant with the federal and College of American Pathologist (CAP). Currently, the 36 MDG uses Siemens Dimension EXL which uses wet technology and currently has an external water source that has been discontinued. In order to keep functionality of the current system, the clinic will need to perform an extensive infrastructure modification to accommodate a new water source to install a new water system that provides the required high quality distilled water. The retrofit of the infrastructure is costly and the work will take up to a year for completion which will impact the 36 MDG's ability to deliver quality health care to their clients. The 36 MDG Clinical Laboratory Services is requesting the reagent rental of the Ortho Vitros 350 Chemistry System for a twelve month base period with two 12-month options periods. The reagent rental agreement will encompass the use of the analyzer, reagents and supplies, training, maintenance, and installation compliant with the FDA 510K, Clinical Laboratory Improvement Amendments of 1988 and CAP standards. A full service contract is included in this reagent rental/purchase program. This is inclusive of all parts and labor. A minimum of two local service personnel will be trained on how to service the VITROS® 350 System. A primary supply of parts will be maintained on island. In the case local service is unable to resolve the problem, service will be dispatched from Japan. Primary Service will be available through the Ortho Clinical Diagnostics Technical Support Center. This hotline (1-800-421-3311) is open 24 hours a day. Primary on-site service will be guaranteed a maximum of 24 hours after identifying the need for service. Secondary manufacturer service from off-island is guaranteed after being identified as necessary by the primary on-island service personnel. The Ortho Vitros 350 instrument will provide Andersen AFB Laboratory with a safe, FDA-approved diagnostic analyzer for the measurement of 22 chemical components in human serum and plasma Section C: Justification for Soliciting from a Single Source or Brand Name The 36 MDG currently utilizes Siemens Dimension EXL which uses wet technology requiring an external water source that has been discontinued. In order to keep functionality of the current system, the clinic will need to perform an extensive infrastructure modification to accommodate a new water source to install a new water system that provides the required high quality distilled water. The retrofit of the infrastructure is costly and the work will take up to a year for completion which will impact the 36 MDG's ability to deliver quality health care to their clients. The Ortho Vitros 350 system does not require an external water supply, a key element in disaster planning and contingencies as well as eliminating a primary cause of technical difficulties, shortens turnaround time, and provides a wide range of menu. Having the Ortho Vitros 350 System will enable correlation of lab results between the 36 MDG and US Naval Hospital, therefore reducing and/or eliminating the need to retest patients. The current system requires additional maintenance due to carryover considerations. Additionally, the MicroSlide technology and calibration stability up to lot change (maximum 6 months) mean labor can Single Source Justification (Simplified Acquisition) 20 Apr 2017 Page 2 of 3 be dedicated to value-added tasks. The current system requires calibrations every 3 months. The shorter sample volume requirement is ideal for use with pediatric and geriatric patients. The Ortho Vitros 350 provides for the use of single-use disposable tips, which eliminates carryover and addresses cross-contamination concerns. The current Siemens Dimension EXL system requires additional maintenance due to carryover considerations. A critical part to the system is the consumable reagent cartridges used by the instrument, which are unique to the system and proprietary of Ortho Clinical. The only known source that can distribute and manufacture the reagent cartridges needed is Ortho Clinical Diagnostics, Inc. Using non approved reagents would invalidate each individual test and the instrument. We would be in violation with the FDA, Joint Commission, Clinical Laboratory Improvement Amendments of 1988, and the College of American Pathologists accreditations. Section D: Efforts to Obtain Competition Other systems were evaluated based on the needs of the facility to include methodology, system dimensions, tests throughput, and maintenance requirements. Additionally, other platforms offered by the current vendor were evaluated and no other systems besides the instrument currently in-house meet the needs of the facility. The Ortho Vitros 350 is the only known source that uses dry technology, which would not require a infrastructure modification to the clinic. There are similar analyzers that fit the size of testing performed at the 36 MDG, however, the use of wet technology makes them more expensive to acquire due to either facility modification or purchase of a standalone water purification system. The only known source that can distribute and manufacture the reagent cartridges needed by 36 MDG and is compatible with USNH's chemistry analyzer is Ortho Clinical Diagnostics. A Sources Sought was posted on Federal Business Opportunities (FBO) on 8 December 2017 for 15 days, however zero responses were received from the posting. Section E: Steps to Preclude Future Single Source or Brand Name Awards The agency is unable to remove the barrier within this acquisition due to the nature and sensitivity of the requirement. The medical field possesses unique, sensitive, and precise characteristics to ensure the health and accuracy of their provided services. Furthermore, market research will be conducted, sources sought notices posted, and examination of the results of the notices for future requirements of similar items. Section F: Contracting Officer's Determination I have determined, in accordance with FAR 13.106-1(b)(1), that the circumstances of this contract action deem only a single source is reasonably available. Date 02-Feb-2018 Typed Name and Rank/Grade of Program Manager Anisa Haney, MSgt, 36 MDG Signature of Program Manager HANEY.ANISA.YDE.1263199410 Digitally signed by HANEY.ANISA.YDE.1263199410 Date: 2018.02.02 17:08:37 +10'00' Single Source Justification (Simplified Acquisition) 20 Apr 2017 Page 3 of 3 Date 02-Feb-2018 Typed Name and Rank/Grade of Contracting Officer John Ballesta, TSgt, 36 CONS Signature of Contracting Officer Date 02-Feb-2018 Typed Name and Rank/Grade of COCO JOHN J. SHARKEY, JR., Maj, 36 CONS Signature of COCO BALLESTA.JOHN.ROBERT.1244373093 Digitally signed by BALLESTA.JOHN.ROBERT.1244373093 Date: 2018.02.02 17:13:10 +10'00' SHARKEY.JOHN.J.JR.1037088826 Digitally signed by SHARKEY.JOHN.J.JR.1037088826 Date: 2018.02.02 17:19:36 +10'00'
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USAF/AFSOC/16CS/FA524018S0004/listing.html)
- Place of Performance
- Address: Andersen AFB, Guam, Yigo, Guam, 96929, Guam
- Record
- SN04819117-W 20180211/180209231626-137812d48dab22957036527a429b2216 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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