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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. This is a supply procurement. The proposed action is conducted under the authority of the Multiple Award Schedule Program (Title III of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 251, et seq.) and Title 40 U.S.C. 501, Services for Executive Agencies). This is a limited source action for a Cost-Per-Reportable-Result (CPRR) bridge order for automated clinical chemistry laboratory analyzer supplies for NMCSD with deliveries between 1 April 2021 and 30 September 2021 as a 6 month extension to order N0025920F0189 for CPRR automated clinical chemistry laboratory analyzer supplies with deliveries between 1 October 2020 and 31 March 2021 to ensure no interruption of patient care is experienced during the acquisition, installation, and validation processes of a new automated clinical chemistry laboratory analyzer system for NMCSD. A previous bridge request as a follow on to N6264517F0361 was approved by NAVSUP in September 2020 resulting in the award of order N0025920F0189. An additional extension is required as the procurement of the new analyzer system could not be awarded with significant time available for the installation and validation of new equipment prior to the expiration of order N0025920F0189. The proposed source is Roche Diagnostics Corporation, 9115 Hague Rd, Indianapolis IN 46256. Description of the supplies or services required to meet the agency's needs (including the estimated value). The proposed action is for a CPRR bridge order for an automated clinical chemistry laboratory analyzer supplies for Naval Medical Center San Diego laboratory starting 1 April 2021 through 30 September 2021. The contracted units shall be a single platform capable of performing general chemistry, special chemistry, immunoassay, and screening for electrolytes, therapeutic drugs, drugs of abuse, toxicology, diabetes, hepatic, thyroid, cardiac, anemia panels, and autoimmune disease. 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 for a proposed order or BPA with an estimated value exceeding the micro-purchase threshold not placed or established in accordance with the procedures in, 8.405-2, the only circumstances that may justify the action are– (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (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; or (C) In the interest of economy and efficiency, 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 or BPA must not have been previously issued under sole-source or limited-sources procedures. The statutory authority which permits restricting consideration of schedule contractors to fewer than required in 8.405 is 41 U.S.C. 251, as implemented by FAR 8.405-6(a)(1)(i)(B) – Only one source is capable of providing the supplies required. The proposed requirement is for a CPRR order for automated clinical chemistry laboratory analyzer supplies. Roche Diagnostics Corporation is the only source which is capable of providing an OEM CPRR bridge order to ensure continued clinical chemistry laboratory analyzer testing supplies at NMCSD. Roche Diagnostics Corporation is the current order holder for the units installed at NMCSD. Since 2015, Navy Medicine has been working on an open market competitive “strategic sourcing” initiative as an effort to standardize instrumentation within medical treatment facilities (MTFs) for cost-savings and increased familiarization with rotating military personnel. The contracting process for the strategic sourcing initiative has been discontinued and the requirement for testing at NMCSD is still valid. Available options to provide continued clinical chemistry testing upon expiration of the current order are 1) procurement of a new system, 2) continue to procure supplies for use with the existing system via a bridge until follow on award is available for use, and 3) outsource testing using a third party. Test-outsourcing (option 3) is not a viable option for NMCSD. If the testing were outsourced to an offsite facility or service, it would cause potentially life-threatening delays in patient diagnosis and treatment. Regarding option 1, procurement of new equipment requires equipment validation, a process that can take up to 6 months. Thus, it would not be possible to award, install, and validate results on new equipment from a different vendor prior to the end of the current order. This would result in a lapse in patient care between the end of the current order and the completion of validation testing for the new equipment. This would prevent the laboratory from providing adequate services to its patients and result in failure to meet mission. Due to the revised, timeline to procure and validate a new system, a second bridge is required mitigate the hospital’s inability to meet the mission, procuring supplies for use with the existing system (option 2) via a bridge is required. Subsequent replacement of the existing system (option 1) is currently in progress but requires an additional bridge via option 2 to ensure uninterrupted testing and provide overlap during validation of the new equipment. Roche Diagnostics Corporation is the only vendor which can ensure continued onsite testing capability with minimal impact to hospital workflow until the new system base been installed and validated. No other vendor besides Roche Diagnostics Corporation is capable of meeting the minimum requirements. 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. 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 chemistry laboratory analyzers and related supplies via the FSS include Roche Diagnostics, Abbott Laboratories, Beckman Coulter, Ortho Clinical Diagnostics, Siemens Healthcare Diagnostics, and Sysmex America. As such, a purchase request was submitted for routing in March 2020 and approval to NMLC for competition on 10 June 2020. Although there are multiple vendors capable of meeting the minimum requirements, Roche, as the incumbent, is the only one who can provide supplies for use with the existing system via a bridge order for our patients as the validation of new equipment can take up to 6 months and follow on award is anticipated for April 2021. Roche Diagnostics is the only vendor that meets the minimum requirements of the Government. 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. Technical Cognizance CONTRACTING OFFICER CERTIFICATION I certify that this justification is accurate and complete to the best of my knowledge.