65--BPA LAB Equipment Sebia

LIMITED SOURCES JUSTIFICATION ORDER >$150,000 FAR PART 8.405-6 Acquisition Plan Action ID:__VA263-17-AP-6777______ This acquisition is conducted under the authority of the Multiple Award Schedule Program. The material or service listed in par. 3 below is sole source, therefore, consideration of the number of contractors required by FAR Subpart 8.4 Federal Supply Schedules, is precluded for the reasons indicated below. Restricted to the following source: Provide original manufacturer s name for material or contractor s name for service. (If a sole source manufacturer distributes via dealers, ALSO provide dealer information.) Manufacturer/Contractor: Sebia Inc Mfgr/Contractor Address: 705 Corporate Dr, Norcross GA 30093 Dealer/Rep address/phone number: 800-835-6497 The requested material or service represents the minimum requirements of the Government. (1) AGENCY AND CONTRACTING ACTIVITY: Department of Veterans Affairs NCO 23 Contracting Activity________ St Cloud VA Health Care

System_____ 4801 Veterans Drive St Cloud MN 56303 VISN: 23 (2) NATURE AND/OR DESCRIPTION OF ACTION BEING APPROVED Sole Source procurement of Capillarys 2 Flex Pierce , Sebia Hydrasys 2 with built-in scanner. Capillary Ion Phoresis and Immunotyping instrumentation (Capillarys 2 Flex Pierce) and confirmation testing instrumentation (Hydrasys 2) to be utilized by the Immunology and Special Hematology laboratories for patient testing. (3) (a) A DESCRIPTION OF THE SUPPLIES OR SERVICES REQUIRED TO MEET THE AGENCY S NEED: The Immunology laboratory is currently utilizing the Sebia Minicap analyzer to perform electrophoresis testing on serum patient samples using the Capillary Ion Phoresis methodology. The Immunology laboratory also utilizes Sebia s Hydrasys 2 to perform immunofixations of serum and urine patient samples. Both of these analyzers are on a cost per test (Reagent Rental) contract. Sebia has manufactured a new instrument, called the Capillarys 2 Flex Pierce, using the same methodology (Capillary Ion Phoresis) as the Minicap, which can now automate urine samples for electrophoresis. It also uses new technology (Immunotyping) to perform immunofixations on serum and urine, automating the identification of abnormal monoclonal proteins which is now performed on the Hydrasys 2 and is very labor intensive. Additionally, it can analyze whole blood by this method, so samples for hemoglobin electrophoresis could be run on the Capillarys 2 Flex Pierce (C2FP). (b) ESTIMATED DOLLAR VALUE: $461,106.84 (c) REQUIRED DELIVERY DATE: 10/1/2017 (4) IDENTIFICATION OF THE JUSTIFICATION RATIONALE (SEE FAR 8.405-6), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED CONTRACTOR S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE. (CHECK ALL THAT APPLY AND COMPLETE) Specific characteristics of the material or service that limit the availability to a sole source (unique features, function of the item, etc.). Describe in detail why only this suggested source can furnish the requirements to the exclusion of other sources. Sebia is the only manufacturer which offers FDA approved testing on serum, urine and hemoglobin specimens by Capillary Ion Phoresis an Immunofixation within the U.S. Its operating system meets VA s government mandate of Windows 7 or higher. We are requesting a cost per test agreement with Sebia for one Capillarys 2 Flex Pierce analyzer and one Hydrasys 2 analyzer to be used by the Immunology and Special Hematology laboratories The size of the instrument is also important as there is limited bench space. The dimensions of the instrument cannot be larger than 37 (L) x 25 (W) x 17 (H) inches (5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.4 TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION: Prices are considered fair and reasonable under FAR part 8. (6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED: Market research was conducted and no vendors were found on GSA that can provide the services needed. A search was also conducted on Vetbiz and no SDVOSB s or VOSB s were found. (7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: None (8) A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS MADE: None (9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)