65--MRSA Kits IDC

LIMITED SOURCES JUSTIFICATION ORDER >$150,000 FAR PART 8.405-6(g) 2237 Transaction # or Vista Equipment Transaction #: 562-13-1-822-0001 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: Cepheid Manufacturer/Contractor POC & phone number: Josh Tran; +1 (555) 000-0000 Mfgr/Contractor Address: 904 Caribbean Drive, Sunnyvale, CA 94089 Dealer/Rep address/phone number: Christopher Germak; +1 (555) 000-0000 1 The requested material or service represents the minimum requirements of the Government. (1) AGENCY AND CONTRACTING ACTIVITY: Department of Veterans Affairs ____________________________ ____________________________ VISN: 4 (2) NATURE AND/OR DESCRIPTION OF ACTION BEING APPROVED: This is for an Indefinite Delivery Contract (IDC) for MRSA testing kits. The IDC will be for one base year plus four-one year option periods. (3) (a) A DESCRIPTION OF THE SUPPLIES OR SERVICES REQUIRED TO MEET THE AGENCY'S NEED: The volume of patients needing this treatment has increased considerably over the past year and is continually growing. With the current resources and turnover time, we cannot provide the standard of care required and therefore are jeopardizing patient care and safety. With the additional monitors, we will be able to meet our standard practice of care. No additional supplies will be required from our current usage. (b) ESTIMATED DOLLAR VALUE: $39,607.20 (Base Year); $303,655.20 (Total contract value) (c) REQUIRED DELIVERY DATE: 5 days after receipt of award (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. 1 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. Laboratory analysis for the detection of Methicillin-Resistant Staph Aureus (MRSA) is performed using molecular PCR technology. The existing system used to perform these tests is the Cepheid GeneXpert. The requested material is the actual testing reagent pack utilized by this system. There is no known substitute. This requirement is essential to providing patient care as all admitted, transferred, and discharged patients must have MRSA testing performed for infection control. This is the only test kit product that will interface with the existing laboratory equipment currently used by the Erie VA Medical Center. 0 A patent, copyright or proprietary data limits competition. The proprietary data is: 0 These are "direct replacements" parts/components for existing equipment. 0 The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system. 0 The new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures. 0 An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays. (5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.404(d) TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION: FAR 8.404(d) states that federal supply schedule pricing was determined to be fair and reasonable at the time of GSA contract award. Because of this, the price listed for this equipment on GSA is fair and reasonable. (6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED: N/A. (7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: N/A. (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: N/A. (9) 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. 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.) SIGNATURE DATE Bernadette Hall Supervisor Pathology & Laboratory Medicine NAME TITLE SERVICE LINE/SECTION Erie VAMC FACILITY --------------------------------------------------------------------------------------------------------------------- (10) APPROVALS IN ACCORDANCE WITH FAR 8.405-6(h): a. CONTRACTING OFFICER'S CERTIFICATION (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. CONTRACTING OFFICER'S SIGNATURE DATE ______________________________ NAME AND TITLE FACILITY HIGHER LEVEL APPROVAL (For orders over $500,000): 0 REQUIRED 0 NOT REQUIRED b. ONE LEVEL ABOVE CONTRACTING OFFICER: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. SIGNATURE DATE NAME AND TITLE c. NETWORK QUALITY/ASSURANCE COMPLIANCE REVIEW: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. SIGNATURE DATE NAME AND TITLE d. NCM: I certify the justification meets requirements for restricting consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. SIGNATURE DATE NAME AND TITLE e. SAO EAST: I certify the justification meets requirements for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. JEFFREY R. RYAN DATE Director SAO East f. VHA HCA REVIEW AND APPROVAL (over $500,000 to $10 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 restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4 FREDERICK DOWNS, Jr. DATE Head of Contracting Activity (HCA) g. VHA Senior Procurement Executive Approval (over $10 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 Office of Acquisition and Logistics Senior Procurement Executive (SPE)