66--Sole Source Award to BioView USA Inc. for SAVAHCS for the Allegro Plus Automated Scanner - FISH Microscope

DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition 1. Contracting Activity: The agency responsible for this acquisition is: The Department of Veterans Affairs, VISN 18 NCA, 4135 South Power Road, Mesa, AZ 85212. The Department of Veteran Affairs proposes to enter into a contract on the basis of other than full and open competition for the Diagnostic Service Line/Department of Pathology of the SAVAHCS. Purchase Request Number 678-11-4-071-0430. 2. Nature and/or Description of the Action Being Processed: This is a new procurement, and the contract contemplated will be firm fixed price to BioView USA Inc.; located at 44 Manning Road, Billerica, MA 01821. BioView is classified as a small business for NAICS code 423450 - Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers. 3. Description of Supplies/Services Required to Meet the Agency's Needs: The procurement is to provide the Allegro™ Plus Automated Scanner with 8-Slide, a specialized microscope with fluorescence in situ hybridization (FISH) analysis, for the Diagnostic Service Line/Department of Pathology of the SAVAHCS at a price of $129,000.00. This microscope is used for diagnostic and prognostic testing on tissue and blood specimens. FISH analysis is a cytogenetic technique used to find and locate the presence or absence of specific DNA sequences on chromosomes. In addition to the microscope, the following accessories are needed: " Hematological Scanning Applications " Tissue Samples- HER2/NEU " Solo Workstation " Table for the microscope and hardware The total price for the microscope and the accompanying accessories is $145,350.00. BioView USA Inc. is the authorized retailer of the Allegro™ Plus Automated Scanner with 8-Slide Microscope. 4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §253(c) (1), as implemented by FAR 6.302.1 (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): The Allegro Plus Automated Scanner by BioView is the only FISH scanner on the market that offers FDA approved software. This FDA approved software combines applications for UroVysion, PathVysion, and Hematology onto a single platform, which eliminates the need for multiple testing instruments. This software will automatically scan and sort the hematopoietic cells, amniocytes, and cells from voided urine samples, sperm cells, metaphases and tissues by the use of the FISH technique. In addition, this microscope offers a motorized 8 slide stage, which allows a pathologist to leave the slides unattended while the microscope scans and uploads the images of the specimens. Once the slide images are accepted by the pathologist, the system allows the images to be shared with pathologists at the SAVAHCS facility as well as those in other hospitals. The 8 slide stage is only offered by BioView. Comparable microscopes from competitors Olympus America Inc., VS110, and Leica Microsystems, Inc., Ariol SCAN Brightfield and Fluorescence, were unable to fully meet the Pathology department's requirements, and only offered 5 and 4 slide stages, respectively. The 8 slide stage allows for more efficiency in the Pathology lab because more specimens can be analyzed at one time, allowing for faster processing. 6. Description of Efforts made to Ensure that Offers are Solicited from as many Potential Sources as Deemed Practicable: Contract Specialist, Dustin Plastow, released a RFQ to 13 vendors on GSA's e-buy on May 17, 2011, after multiple searches to find applicable vendors on GSA Advantage and e-buy. On May 20, 2011, the RFQ closed with zero quotes received. Contract Specialist, Amanda Anzalone, conducted open market research and found three companies that specialized in microscopes with FISH technology: Leica Microsystems, Olympus, and BioView USA, Inc. After internet research and discussions with representatives from each company, it was evident that only BioView could offer the software platform needed, so offers were not solicited from the other two companies because they could not fulfill this critical product requirement needed by the SAVAHCS. 7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: This is a first time buy for the SAVAHCS, and the anticipated total dollar amount of the proposed acquisition is $145,350.00 based on the Independent Government Cost Estimate. The price is expected to be fair and reasonable to the Government because of the comparison of BioView's pricing against similar market items, IAW FAR 13.106-3(a)(2)(iv). By signing the justification the Contracting Officer makes a determination that the costs/prices to the government are expected 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: FAR Part 10 directs that market research be conducted on each acquisition appropriate to the circumstances. The Diagnostic Service Line/Department of Pathology in collaboration with the VISN 18 NCA conducted market research through multiple sources. Research results only serve to confirm that BioView USA, Inc. is the only company that can provide an automated scanner microscope with FISH technology and FDA approved software. Dr. Margaret Rennels, Dr. Ron Schifman, and Sixto Lopez, cytotechnologist, of the Pathology department conducted market research by calling various vendors to determine if any other microscopes could fulfill their needs. They located one other, the Ariol SCAN Brightfield and Fluorescence by Leica Microsystems, Inc., that could meet some of their requirements but not all. The microscope from Leica was found to be unacceptable because its software is not approved by the FDA, and the price of their microscope was far greater than the price of BioView's. The RFQ released on GSA's e-buy returned a zero bid response, and a conversation with a BioView USA, Inc. representative, confirmed that only their product could deliver the FDA approved platform combining the three testing pieces of software onto a single platform, due to their proprietary rights. 9. Any Other Facts Supporting the Use of Other than Full and Open Competition: If an alternate microscope was purchased, the Pathology department would have to purchase additional instruments to complete all of the testing required of them, and this would significantly increase the total cost associated with fulfilling the department's requirement. 10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Refer to Section 6. 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: Future acquisitions of a similar nature shall be procured competitively, if the vendors meet FDA specifications and the departmental standards. 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. _____________________________ ________________________ Eric T. Erickson Date Administrative Officer SAVAHCS, Tucson 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. _____________________________ ________________________ Keron White Date Contracting Officer VISN 18 NCA b. VISN/PCA QA (Required $3K and above): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ ________________________ Name Date Title Facility c. NCM/PCM (Required $3K and above): I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ Name Date Network Contract Manager VISN/PCA X d. SAO QA (If over 500K): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ ________________________ Name Date Title Facility e. SAO (If over 500K): I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ Name Date Director Service Area Office, West f. VHA HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $10million) or approve ($500K to 10 million) for other than full and open competition. _____________________________ ________________________ Norbert S. Doyle Date Acting Chief Procurement and Logistics Officer VHA Head of Contracting Activity (HCA) g. VA Deputy Senior Procurement Executive Approval (over $10 million but not exceeding $50 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition. _____________________________ ________________________ Iris B. Cooper Date Deputy Senior Procurement Executive (DSPE) Office of Acquisition and Logistics Department of Veterans Affairs h. VHA Senior Procurement Executive Approval (over $50 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition. _____________________________ ________________________ Jan R. Frye Date Deputy Assistant Secretary for Acquisition and Logistics Senior Procurement Executive (SPE) Department of Veterans Affairs