Inactive

LIMITED SOURCE JUSTIFICATION FOR FEDERAL SUPPLY SCHEDULE ORDER Identification of agency and contracting activity, and specific identification of the document as a “Limited Source Justification (LSJ).”... LIMITED SOURCE JUSTIFICATION FOR FEDERAL SUPPLY SCHEDULE ORDER Identification of agency and contracting activity, and specific identification of the document as a “Limited Source Justification (LSJ).” This justification is executed by the Naval Medical Center San Diego (NMCSD), on behalf of the Navy to meet the requirements of Laboratory Department at Naval Medical Center San Diego. Nature and/or description of contract action being approved. The proposed action is a limited source Justification to award a new Federal Supply Schedule (FSS) order from an existing contract to the contractor identified below. The placement of a Firm, Fixed-Price order is anticipated for a Cost-Per-Reportable-Result (CPRR) contract for automated clinical coagulation laboratory analyzer systems and supplies for NMCSD with deliveries between 1 April 2021 and 31 March 2022 as a 1 year base plus 5 option years. Upon award of the contract, the laboratory will require time for the awardee to deliver, setup, and validate the new equipment without interrupting laboratory testing services. The proposed source is Siemens Medical Solutions, USA Inc., 40 Liberty Boulevard, Malvern, PA 19355. Description of the supplies or services required to meet the agency's needs (including the estimated value). This is a supply procurement. The proposed action is for CPRR order for an automated clinical coagulation laboratory analyzer system and supplies for Naval Medical Center San Diego laboratory starting 1 April 2021 through 30 Sep 2021 and 4 option years. The base year amount of NTE $71,808.90 will be funded with FY 21 O&MN funding. Appropriate funding for any option years will be obtained prior to exercising the option. The contracted units shall be a single primary (CS-5100) fully automated system capable of connecting to an automation/robotics system and a single secondary backup (CS-2500) countertop platforms capable of performing coagulation testing for PT/INR, PTT, Fibrinogen & D-Dimer utilizing an optical endpoint analysis to determine measurements. The units shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America; even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements. Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty is provided and maintained by the OEM. All software licensing and warranty with the equipment/system shall be in accordance with the OEM terms and conditions. The authority and supporting rational (see 8.405-6(a)(1)(i) and (b)(1)) and, if applicable, a demonstration of the proposed contractor's unique qualifications to provide the required supply or service. The statutory authority which permits restricting consideration of schedule contractors to fewer than that required in 8.405-1 is The statutory authority which permits restricting consideration of schedule contractors to fewer than that required is FAR 8.405-1(a)(1)(i)(B), only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized., as implemented by FAR 8.405-6(a)(1)(i)(B)-Only one source is capable of providing the supplies or services required. The proposed requirement is for a CPRR order for an automated coagulation laboratory analyzer systems and supplies. Siemens Medical Solutions is the only source on FSS which has instruments (CS-5100/CS-2500) that are capable of providing an optical end point determination of the various coagulation testing and provide the best value. Instrumentation Laboratory/Werfen also provides instrumentation (ACL Top 750/ACL Top 550) with an optical end point determination, but these instruments capable of meeting all the requirements are not currently on FSS. Roche and Abbott does not have an optical end point determination. They use a mechanical clock detection system which will not work with NMCSD’s system. A determination by the ordering activity contracting officer that the order represents the best value consistent with 8.404(d). GSA has determined the prices of supplies and the schedule orders to be fair and reasonable for the purpose of establishing the schedule order. Therefore, ordering activities are responsible to make a separate determination of fair and reasonable pricing for individual orders. By placing an order against a schedule contract using the procedures in 8.405, the ordering activity has concluded that the order represents the best value (as defined in FAR 2.101) and results in the lowest overall cost alternative (considering price, special features, administrative costs, etc.) to meet the Government's needs. The NMCSD Contracting Officer will determine, using the procedures in FAR 13.106-3 that the prices are fair and reasonable and will document such determination with a level of detail commensurate with the complexity and circumstances of each order. A description of 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 by technical experts in March 2020 in anticipation of competing a new CPRR requirement. This research consisted of reviews of similar previous procurements and a market survey, using search engines to review open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, GSA Advantage and the FPDS-NG. Vendors that can provide automated coagulation laboratory analyzers and related supplies via the FSS include Instrumentation Laboratories (Werfen), Roche Diagnostics, Abbott Laboratories, Siemens Medical Solutions. Although there are multiple vendors on the FSS capable of providing instrumentation for coagulation testing, Siemens Medical Solutions is the only one who can meet the requirements via FSS. Any other facts supporting the justification. This procurement uses a GSA Schedule and will be solicited and awarded in accordance with FAR Subpart 8.4. 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. All future requirements will be handled on a case-by-case basis. Technical and requirements certification I certify that the facts and representations under my cognizance which are included in this LSJ and which form a basis for this justification are complete and accurate.