J-- Chemistry CPRR 6mts Contract

Attachment 1: Request for Limited Sources Memo Format LIMITED SOURCES JUSTIFICATION ORDER >$3,000 FAR PART 8.405-6 2237 Transaction # or Vista Equipment Transaction #: 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: Ortho Clinical Diagnostics, Inc Manufacturer/Contractor POC & phone number: Mfgr/Contractor Address: 100 Indigo Creek Dr., Rochester, NY 14626-5101 Dealer/Rep address/phone number: 1 The requested material or service represents the minimum requirements of the Government. (1) AGENCY AND CONTRACTING ACTIVITY: Department of Veterans Affairs Aleda E.Lutz Medical Center 1500 Weiss Street Saginaw, MI 48602 VISN: 11 (2) NATURE AND/OR DESCRIPTION OF ACTION BEING APPROVED: A one year FSS order to provide the reagents, supplies, equipment needed for chemistry patient testing for FY2015 on a cost per reportable test basis . (3) (a) A DESCRIPTION OF THE SUPPLIES OR SERVICES REQUIRED TO MEET THE AGENCY'S NEED: Ortho Clinical Diagnostics, Inc. is the current vendor that provides our Vitros 5.1 Fusion Chemistry System analyzer, contract# V797P7126A. Chemistry testing for veteran patients includes chemistry profiles, lipid profiles, metabolic profiles, etc. This contract includes the use of the Vitros 5.1 Fusion Chemistry analyzer, reagents, calibrators, controls, supplies, consumables/ disposables, maintenance and service. A VISN BPA is currently in process and a contract will be awarded in FY2015. This order will discontinue, once the VISN BPA is put in place and the new instrument is placed on-line for patient chemistry testing. (b) ESTIMATED DOLLAR VALUE: $474,000 per year, October 1, 2014 - September 30, 2015 (c) REQUIRED DELIVERY DATE: October 1, 2014 (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) 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. The FSS contract # V797P7126A includes the use of the Vitros 5.1 Fusion Chemistry analyzer, reagents, supplies, consumables/disposables, calibrators, standards, controls, maintenance, and service coverage on a cost per reportable basis. The reagents and supplies used are unique to the Ortho Clinical Diagnostics, Inc. Vitros 5.1 Fusion Chemistry analyzer. Ortho Clinical Diagnostics, Inc. is an excellent company that has been in the chemistry analyzer business for decades. To change vendors includes weeks to months of work that includes, interface connections, correlations studies between new and old analyzers, and between analyzers, analytical measurement range (AMR) studies, linearity studies, assay sensitivity studies, precision studies, reference range validation studies, quality control range studies, etc. New instruments, especially new vendors, include new training in the operation and analysis of specimens, maintenance procedures, troubleshooting procedures, recoding of instruments and tests associated with the College of American Pathologist (CAP) proficiency testing programs, writing of new procedures known as Standard Operation Procedures (SOP). Quality control programs for new chemistry analyzer vendors require new processes to be set up to meet various accreditation agencies requirements: Joint Commission (JC), College of American Pathologist (CAP), Clinical Laboratory Improvement Amendments (CLIA), etc. All of the above requirements and tasks involve cost, in dollars, for various test kits to perform these studies, not to mention the weeks of a medical technologist labor to perform the above studies. No analyzer can be placed online until all validation studies, instrument training, procedure manuals have been done, written and approved. Every time a new piece of instrumentation enters the laboratory all precautions are made to provide the necessary training on the analyzers to prevent delay in testing and operator error(s) that could lead to erroneous results. New instrumentation and new vendors increase the odds of errors mostly due to learning the new system. 0 A patent, copyright or proprietary data limits competition. The proprietary data is: (If FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data. Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.) 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. 1 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. The Ortho Clinical Diagnostics, Inc. equipment is currently installed in our laboratory. Several months are required to execute a competitive procurement and several more months are required to transition from one vendor to another. The transition process is time consuming, requires several days of parallel testing and would involve notable cost. 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 8.4 TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION: In accordance with FAR 8.404 (d), GSA {FSS} has already determined the prices of supplies, fixed-price services, and rates for services offered at hourly rates, under schedule contracts to be fair and reasonable. Therefore, ordering activities are not required to make a separate determination of fair and reasonable pricing. The Ortho Clinical Diagnostics reagents and supplies are unique to the Ortho Clinical Diagnostics Vitros 5.1 chemistry system. (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 prior to contract award. Market research is also an ongoing process to evaluate other vendors on the FSS that offer chemistry analyzers. At the time of market research, other sources could not provide the specific requirements requested for a chemistry analyzer. (7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: A VISN BPA is currently in process and a contract will be awarded in FY2015. (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: (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.)