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FBO DAILY ISSUE OF FEBRUARY 13, 2011 FBO #3368
DOCUMENT

65 -- Zeiss Cirrus HD OCT Machines for M-R VAMC - Justification and Approval (J&A)

Notice Date
2/11/2011
 
Notice Type
Justification and Approval (J&A)
 
NAICS
339112 — Surgical and Medical Instrument Manufacturing
 
Contracting Office
Department of Veterans Affairs;Network Contracting Activity 8;COMMERCE BUILDING;300 East University Ave, Suite 180;Gainesville FL 32601
 
ZIP Code
32601
 
Solicitation Number
VA24811RQ0084
 
Response Due
1/15/2011
 
Archive Date
3/3/2011
 
Point of Contact
Jonathan S Latson
 
E-Mail Address
ct
 
Small Business Set-Aside
Total Small Business
 
Award Number
VA573A10149
 
Award Date
2/1/2011
 
Description
DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition 1. Contracting Activity: Department of Veterans Affairs, Network Contracting Activity 8, North Florida/South Georgia Veterans Health System (NF/SG VHS). Justification for Other Than Full and Open Competition in response to Purchase Request VA 2237 573-11-1-50300005. 2. Nature and/or Description of Action Being Approved: Approval to limit competition to an item peculiar to one manufacturer in accordance with FAR 13.106-1(b) and 6.302-1(d). Approval is for a new, single award, Firm-Fixed Price purchase of commercially available, off the shelf items. 3. Description of the Supplies or Services Required to Meet the Agency's Needs: NF/SG VHS has stated a requirement for the Zeiss Cirrus HD Optical Coherence Tomography instrument (HD-OCT). This instrument is used to perform real-time spectral domain, exquisite micrometer resolution with 3D and 2D cross-sectional tomographic images of the posterior segment of the eyes. It tracks progressive retinal nerve fiber layer loss for enhanced glaucoma management. The items requested are as follows: a) Required Items: 1. Zeiss Cirrus HD-OCT (model 4000), New, Version 5 (Qty 3) i.Assy SD-OCT Accy Kit, Generic ii.Kit SD-OCT 5.0 System Software iii.Printer, Color, HP Officejet 6000 iv.Power Cord, Hospital Grade, Gray, 120V v.Table, Cirrus-Visante, 120V ASSE vi.Cirrus 13D-OCT Anterior Segment Imaging License vii.User Manual, SD-OCT, 5.0, English b) Estimated Dollar Amount: $193,850.00 c) Requested Delivery Date: Immediate'y upon award 4. Statutory Authority Permitting Other than Full and Open Competition: 41U.S.C § 253(c), as implemented by FAR 6.302-1. Only one responsible source and no other supplies or services will satisfy agency requirements. 5. Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the use of the Authority Cited Above (applicability of authority : The Zeiss Cirrus HD-OCT instrument possesses the following unique and essential features that justify brand name justification and warrant the usage of authority granted in FAR 6.3021-1: "The Cirrus HD OCT does a full glaucoma analysis (RNFL and Optic Nerve) with one scan in 1.8 seconds. oThe Cirrus has a FDA Cleared Normative Database for RNFL and the Optic Nerve oRNFL Repeatability is 1.2 microns oThe Cirrus has FDA Cleared RNFL Progression Analysis. RNFL is based on automatic vessel recognition software to ensure precise analysis from visit to visit. oThe Cirrus does a 6 mm x 6 mm cube scan which can detect minor defects around the nerve. oThe Cirrus can image angles and is a standard feature. "The Cirrus does 65,536 A-scans in 2.4 seconds or 40,000 A-scans in 1.8 seconds for evaluation of the Retina. oThe Cirrus has FDA Cleared Normative Database for the Macula, oThe Cirrus has Macular Change Analysis. Macular Change Analysis is based on automatic vessel recognition software to ensure precise analysis from visit to visit. oThe Cirrus comes standard with Advanced Visualization and 3D Volume Rendering for enhanced analysis of Epiretinal Membranes, CME and the Choroid for example. oThe Cirrus is used to reliably measure drusen. oThe Cirrus has an Automatic Fovea Finder to help with difficult patients "The Cirrus has Anterior Segment capabilities. oThe Cirrus has standard Anterior Segment Analysis to evaluate the cornea and angles "The Cirrus OCT has a smaller design allowing for usage in smaller working spaces. "Its software is already compatible with our current VISTA/CPRS imaging software (OIS) "90 degree orientation facilitates observation of patient throughout exam "Auto Patient Recall TM assures patient position and instrument setting are repeated from previous visit "Advanced optics aid in the examination of patients with cataracts. Dilation is not required even for pupils as small as 2.5 mm Accordingly, Carl Zeiss is the only firm capable of manufacturing the Cirrus OCT diagnostic instrument described in Section III above without the Veteran's Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling requirements. 6.Description of Efforts Made to Ensure that Offers are Solicited from as Many potential Sources as Deemed Practicable: Sources Sought Notice VA-248-11-IU-0077 was published to the GPE on December 14, 2010 to determine any small business entities capable of providing this requirement. On January 12, 2011, RFQ VA248-11-RQ-0084 was posted to the GPE as a 100 percent small business set-aside. Metro Medical was the sole respondent. 7.Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost to the government is determined to be fair and reasonable through competition solicited by RFQ VA-248-11-RQ-0084. 8.Description of the Market Research Conducted and the Results, or a Statement of the Reason: Market research has been done by the requesting service, to identify sources capable of meeting NF/SG VHS's patient care requirements. Additional research conducted by the Contracting Officer revealed a very small market for the commodity identified in Section III. A Sources Sought Notice was published to the GPE to identify small business sources capable of supplying the items described in Section III, and only one small business entity, Metro Medical, responded. 9.Any Other Facts Supporting the Use of Other than Full and Open Competition: The requesting service has two existing Zeiss OCT machines that are antiquated and need to be traded in or sold. The value of these trade-in units are approximately $40,000. The usage of Carl Zeiss HID-OCT instruments will facilitate the trade-in process and will reduce the overall price by the Government in meeting NF/SG VHS's patient care requirements. 10.Listing of Sources that Expressed, in Writing, and Interest in the Acquisition: See Section VI above. 11.A Statement of the Actions, if any, the Agency to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the Supplies or Services Required: Available actions to be taken are limited due to the narrow field of competition inherent in the HD-OCT instrument market. 12.Requirements Certification: I certify that the requirement outlined in this justification is a bonafide 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. __//s//________________________________ _01/24/2011_______ Mischelle Pearcy-Baluyot, O.D.Date Chief of Optometry North Florida/South Georgia VHS 13. APPROVALS IN ACCORDANCE WITH FAR 6.304 a) Contracting Officer's Certification: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. ___//s//____________1/25/2011 Brian J. ShepardDate Contracting Officer Network Contracting Activity 8 b)One Level Above the Contracting Officer: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. ___//s//________________________1/25/2011__________ Charles E. HughesDate Product Line Supervisor Network Contracting Activity 8 c)NCM: I certify the justification meets requirements for other than full and open competition. ___//s//________________________1/31/2011__________ Thomas J. MitchellDate Network Contract Manager Network Contracting Activity 8
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VANFSGHS/DVANoFSoGHS/VA24811RQ0084/listing.html)
 
Document(s)
Justification and Approval (J&A)
 
File Name: VA573A10149 VA573A10149_2.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=176132&FileName=-553.docx)
Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=176132&FileName=-553.docx

 
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Record
SN02378690-W 20110213/110211234502-ce05c621429b23a92f9039ac6c4c97f5 (fbodaily.com)
 
Source
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