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FBO DAILY ISSUE OF JUNE 24, 2012 FBO #3865
DOCUMENT

65 -- MEDICAL EQUIPMENT - Attachment

Notice Date

6/22/2012
 

Notice Type

Attachment
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;Southeast Louisiana Veterans HCS;1555 Poydras Street;New Orleans LA 70114
 

ZIP Code

70114
 

Solicitation Number

VA25612Q1296
 

Response Due

6/27/2012
 

Archive Date

7/2/2012
 

Point of Contact

Gilda M Johnson
 

E-Mail Address

566-8471<br
 

Small Business Set-Aside

N/A
 

Description

NOTICE OF INTENT The Network Contract Activity VISN 16, New Orleans VA Medical Center intends to negotiate on a sole source basis (IAW FAR 6.302-1) with OmniGuide, One Kendall Square, Suite B1301, Cambridge, MA 02139, as the only responsible source that can provide The ENT CO2 Laser System combined with beam technology that is multifunctional, hand-held laser scalpel, capable of ablation and coagulation. That is hand-held with maneuverability that will allow the surgeon to direct CO2 laser energy behind and around target tissue. The laser's operating wavelength must be 10.6 µm with the ability to bend CO2 laser energy through a flexible fiber that will provide increased control through a handheld instrument. System must include two modes of operation continuous wave and superpulse, three exposure modes- continuous, single pulse and repeat pulse, easy-to-use touch screen interface, programmable settings for simplicity in system set up and operation, automated control of cooling throughout the procedure, and must include 2 years 100% uptime guarantee. The system must include laser with cart, gas tanks, regulator, storage and flexible fiber components. This acquisition is being conducted under FAR 12 Acquisition of Commercial Items. The Network Contract Activity VISN 16, New Orleans VA Medical Center has an essential need in acquiring advance surgical technology with capabilities to precisely and accurately address diseased tissue through use of Photonic Band Gap Fibers. Resulting in Surgeons providing the least minimally invasive approach with his/her procedures. Items being purchased in this acquisition: IntelliGuide System. Including Laser, Cart, and Gas Management, US Model. ENT Hand piece Set: Hand piece set for ENT-L Fiber BeamPath ENT-L Fiber Single Fiber This acquisition is being conducted under Commercial Procedures. The intended procurement will be classified under North American Industry Classification System (NAICS) 334510. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice shall submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received by closing of this notification of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. In the event competitive responses are required this procurement will be set aside for small businesses interest only. Based on the above information, the only technically acceptable system is provided by OmniGuide, Inc. Submit email capability statements (using PDF, MS Word, Excel attachments) to Gilda Johnson at gilda.johnson@va.gov. Fax quotes may be sent to 504-56-8482 Attn: Gilda Johnson. Email statements are preferred. Statements are due not later than 10:00 A.M. CST on 18 June 2012. No phone calls accepted. DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition 1. Contracting Activity: Department of Veterans Affairs, Network 16 Contracting Activity, 629/Southeast Louisiana Veteran healthcare System (SLVHCS). Purchase Request #629-12-3-106-0160/Surgical ServiceLine "Justification for Other Than Full and Open Competition." 2. Nature and/or Description of the Action Being Processed: Surgical ServiceLine is requesting a sole source purchase of an ENT CO2 laser system combined with beam technology that is multifunctional, hand-held laser scalpel, capable of ablation and coagulation. This particular equipment allows the surgical physician to to provide a minimally invasive approach with his/her procedures. Due to the flexible nature of the fiber, surgeons are able to gain better access and treat more diseased tissue resulting in better patient outcomes. This ability results in less operative time because the surgeon is now better equipped to address the patient's needs. This sole source award we be made to OmniGuide. A small business firm. This a commodity /supply type contract at a firm fixed-price. 3. Description of Supplies/Services Required to Meet the Agency's Needs: The supplies to be acquired consists of one Fiber enabled laser system($79,900.00), one ENT handpiece set for the ENT-L fiber($3000.00), and ninety-six ENT-L Fiber($81,600.00).The the total estimated value of this acquisition is $164,500.00 with no option years. Expected lead time for delivery is two weeks. Fibers will be shipped every 6 months (or sooner if the medical center requires and earlier delivery) after initial installation and delivery of system until total quantity of 96 is delivered. Equipment will be delivered and installed by the vendor and shall provide a 24 month service plan. Surgical ServiceLine is requesting the purchase of an ENT CO2 laser system combined with beam technology that is multifunctional, hand-held laser scalpel, capable of ablation and coagulation. That is hand-held with maneuverability that will allow the surgeon to direct CO2 laser energy behind and around target tissue. The laser's operating wavelength must be 10.6 µm with the ability to bend CO2 laser energy through a flexible fiber that will provide increased control through a handheld instrument. The system must include two modes of operation continuous wave and superpulse, three exposure modes- continuous, single pulse and repeat pulse, easy-to-use touch screen interface, programmable settings for simplicity in system set up and operation, automated control of cooling throughout the procedure, and must include 2 years 100% uptime guarantee. The system must include laser with cart, gas tanks, regulator, storage and flexible fiber components. 4. Statutory Authority Permitting Other than Full and Open Competition: (X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; ( ) (2) Unusual and Compelling Urgency per FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3; ( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5; ( ) (6) National Security per FAR 6.302-6; ( ) (7) Public Interest per FAR 6.302-7; 5. Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Only One Responsible Source (FAR 6.302-1) - In this being a highly specialized piece of equipment, The rationale is to provide surgical physicians with the most highly advanced technological surgical equipment enabling surgical physicians the ability to provide the least invasive approach possible in the performance of this type of surgical procedures. Due to the flexible nature of the fiber, surgeons are able to gain better access and treat more diseased tissue resulting in better patient outcomes. Another unique advantage is that the design of the fiber allows for a divergent beam, which provides the surgeon with a cutting, coagulative and ablative device in one tool. This ability results in less operative time because the surgeon is now better equipped to address the patient's needs. Precision is also a clear advantage that the surgeon has over other energy devices. Being able to precisely dissect tissue results in a "cleaner" margin resulting in a more accurate reading of pathology Surgeons can be more confident in their acquisition of the cancer tissue. Another result, because of the access & precision is that the patient will have less edema (swelling). This has a direct impact on shortening the patient's recovery time and in many cases there will be less narcotic usage. And finally, Compared to a Line of Sight CO2 laser where there is perhaps 30cm of distance between the origin of the laser beam and tissue interaction, the OmniGuide laser fiber origin is close to contact (millimeters)giving the surgeon fine motor control to precisely and accurately address diseased tissue. This acquisition in its description does not specify brand name in its requirements but does specify features of a product, peculiar to one manufacturer. Yet surgical services does deem it to be essential to patient care in the SLVHCS effort in delivering the best healthcare, thereby precluding consideration of a product manufactured by another company. Accordingly, OmniGuide is the only firm capable of providing the supplies and services described in Section III above without the SLVHCS experiencing unacceptable delays in fulfilling its requirements the OmniGuide BeamPath system is a proprietary photonic band-gap flexible CO2 laser surgical system that is only offered by OmniGuide. Conventional CO2 surgical lasers that utilize an articulating arm of pipes and mirrors to deliver the laser energy to tissue are available from numerous surgical companies. However, the delivery of CO2 laser energy through a flexible photonic band-gap fiber delivered through a hand-held surgical tool, flexible endoscope, or rigid bronchoscope is exclusively available from OmniGuide. The technology to deliver CO2 laser energy was developed at the Massachusetts Institute of Technology, and is exclusively licensed to OmniGuide. OmniGuide has further developed this technology and sells the surgical system through a direct sales force. OmniGuide is the sole-source for obtaining this proprietary photonic band-gap flexible CO2 laser system. 6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: No other potential source is practicable under the circumstances. See Section V. 7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: Accordingly to FAR Part 13.106(a) and as the contracting officer I have determined after an extensive search of the market for similar laser systems of compatible quality that the anticipated cost will be considered fair and reasonable. 8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Pursuant to FAR Part 10 market research was conducted to find the equipment on the internet, GSA advantage/EBuy and as a results of that research the items were not found but did determine that there was a distributor for the product although the product was not available on the GSA schedule. Further research through email, phone calls revealed that OmniGuide was the manufacturer as well as the only distributor. As described in Section VI above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties. 9. Any Other Facts Supporting the Use of Other than Full and Open Competition: There are no other facts in support, other than those previously listed. 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: SLVHC feels that the future acquisitions of the supplies or services being acquired here will have more potential for competition after the completion of the new medical center. SLVHCS will be pursuing and fostering competition in its purchasing of more copiously advance surgical equipment which will allow for a higher dollar value and a larger market. 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. Dr. Mary Fazekas-May _June 19, 2012_______ Chief, Surgical Date 13. Approvals in accordance with FAR 6.304 a. Contracting Officer's Certification: (required) I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _Gilda M. Johnson_____________________ _____June 19, 2012_________ Date CONTRACTING OFFICER NETWORK 16 CONTRACTING ACTIVITY b. NCM/PCM: I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ David MillerDate Acting Network Contract Manager Network 16 Contracting Office
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/NOrVAMC/VAMCCO80220/VA25612Q1296/listing.html)
 

Document(s)

Attachment
 

File Name: VA256-12-Q-1296 VA256-12-Q-1296.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=378927&FileName=VA256-12-Q-1296-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=378927&FileName=VA256-12-Q-1296-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: SLVHCS;1601 PERDIDO STREET;NEW ORLEANS, LA.

Zip Code: 70112
 

Record

SN02784438-W 20120624/120622235808-8dd3a36aa66d3c707cadcf3fbbb5eb67 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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