Nano Particle Characterization System

Added: May 18, 2011 8:56 am Modified: Jun 01, 2011 3:34 pmTrack Changes DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval

For

Other Than Full and Open Competition





1. Contracting Activity: Department of Veterans Affairs, VISN 12, Milwaukee Medical Center. 695-11-3-140-0189.



2. Nature and/or Description of the Action Being Processed: Justification and approval for other than full and open competition for the purchase of a Nanosight Nanoparticle Characterization System for the VA Medical Center in Milwaukee, WI research department. This procurement will proceed on a sole source basis with Nanosight. New purchase of equipment, firm fixed price.



3. Description of Supplies/Services Required to Meet the Agency's Needs: NANOSIGHT LM1O-HSBF Nanoparticle Characterization System has the ability to visualize nanoparticles and viruses of the size of 1 0-1 00 nanometers. The Nanosight equipment is unique in that it can size and count nanoparticles. The optics of the system has a long working distance 20X objective that is precisely matched with the viewing unit. The Nanosight has an integrated blue laser (405 nm) which allows for antibody coating of particles to determine the protein makeup of the particles. The instrument can accurately size and track the Brownian motion of nanoparticles in liquid suspension on a particle-by-particle basis. This instrument uses Nanoparticle tracking analysis (NTA) instead of dynamic light scattering (DLS).The Nanosight can: Visualize particles less than 100 nanometers, track particles less than 100 nanometers, count particles less than 100 nanometers, size particles from '10-100 nanometers, distinguish particles that are stained with fluorescent dyes that are 10-100 nanometers in size, be able to enumerate a polydispersed sample, and provide concentration information of particles 10-100 nanometers in size.



4. Statutory Authority Permitting Other than Full and Open Competition: FAR 6.302-1(a)(2). The VA's minimum needs can only be satisfied by unique supplies or services available from only one source. (41 U.S.C. 253 (c)(1)).



5. Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): lf the VA did not obtain this particular product the VA would not be able count and size the particles found in osteoarthritis. There is no other product that will allow the VA to perform this task.



There is no other approach that can accomplish the enumeration and sizing of small particles

in osteoarthritis. We have tried using Flow cytometry but the size of the particles is well below

the detection limits of flow cytometry machines. Other enzymatic ways of characterizing these

particles is very inaccurate.



Accordingly, Nanosight is the only firm capable of providing the supplies described in Section III above without the Veteran's Health Administration experiencing unacceptable delays in fulfilling its requirements.



6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The end-users conducted market research and have collected quotes and have evaluated the equipment and its capabilities. Other competitors were determined not to meet the VA's specific needs. One competitor could not meet the VA's needs and could not detect particles smaller that 250 nm.



Contracting Officer will post an intent to sole source on FBO.



7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: In accordance with the other quotes, for similar equipment, the end users collected, the anticipated cost of this equipment is determined to be fair and reasonable.



8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: End users and Contracting Officer both conducted extensive research. Contracting Officer searched VetBiz and revealed zero Veteran Owned Small Businesses using the 334516 NAICS code along with keywords "nanoparticle" and "Optical Microscope" A search of CCR's Dynamic Small Business Search revealed no small buisnesses, using the same keywords.



Research department collected three quotes in addition to Nanosight. All three competitors did not meet the VA's needs. The competitors equipment could size the nanoparticles but could not also count. Nanosights equipment can do both.



Through the market research it was verified that not only is there not an alternate sources, but also on alternate equipment or substitutes would not fill the government needs with only minor modification. No other qualified sources exist.



In accordance with FAR Part 10, market research was conducted and the VA will post a synopsis of the proposed acquisition, advising industry of the pending acquisition, and soliciting inquiries from interested parties.



9. Any Other Facts: The treatment of osteoarlhritis in the veteran population is increasing annually as the veteran population continues to age. Osteoarthritis is the most common form of arthritis in adults and

affects 40 million Americans. lt is currently untreatable, and often results in significant loss of

independence and increased medical costs for affected people. Risk factors for OA, including advanced age, prior trauma, and obesity are particularly prevalent in the US veteran population and OA is a leading source of disability in veterans. This proposal deals with the role of small extracellular vesicles, called articular cartilage vesicles (ACVs) in OA. ACVs carry RNA and protein that can be transferred to chondrocytes. Transfer of ACV contents to chondrocytes mimics changes seen in OA. Understanding the role of ACVs in cartilage and ultimately manipulating the contents of ACVs could lead to novel therapies for OA. This particular instrument will greatly aid in our understanding of these small vesicles in osteoarthritis and the role that they play in the progression of the disease. Once we understand the type, size and numbers of these small particles in osteoarthritis, new treatments can be investigated. We have never been able to clearly enumerate the number of particles because of the lack of technology to be able to count them. This valuable information about number and sizes of ACVs cannot currently be accomplished with other tools



10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: See Section VI above.



11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required: This procurement is being funded by a Grant for this research. Regardless, Research Department still conducted market research to see what was available. All competitors were determined to not meet the VA's needs.



Again, in accordance with FAR Part 10, market research was conducted and the VA will post a synopsis of the proposed acquisition, advising industry of the pending acquisition, and soliciting inquiries from interested parties.







12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.



(This signature is the requestor's supervisor, fund control point official, chief of service, someone with responsibility and accountability)





_________________________________ _________________________

NAME DATE





_________________________________ _________________________

TITLE FACILITY







13. Approvals in accordance with FAR 6.304



Contracting Officer's Certification: (required) I certify that the foregoing justification is accurate and

complete to the best of my knowledge and belief.









_________________________________ _________________________

NAME DATE





Contract Specialist VA Milwaukee, GLAC

TITLE FACILITY









NCM/PCM: I certify the justification meets requirements for other than full and open competition.









_________________________________ _________________________

NAME DATE



Network/Program Contract Manager



VISN 12