LIMITED SOUCES JUSTIFICATION FOR ROCHE DIAGNOSTICS

ATTACHMENT 1 LIMITED SOURCE JUSTIFICATION for Acquisitions Conducted Under Federal Acquisition Regulation (FAR) Subpart 8.4 Federal Supply Schedules (June 21, 2018) Limited Source Justification Federal Acquisition Regulation (FAR) 8.405-6 J&A Tracking No. Identification of the agency and contracting activity: Identify the agency and the contracting activity responsible for this action. The Defense Health Agency, Contracting Office - Defense Healthcare Management Systems (CO-DHMS), plans to place an order, on a limited source basis, against a General Services Administration (GSA) Federal Supply Schedule (FSS) contract. Nature and/or Description of Action being approved: This is a supply procurement. This is a limited source action for a Cost-Per-Reportable-Result (CPRR) order for an automated clinical chemistry laboratory analyzer & supply for NMRTCSD. It primarily includes service (to both the leased and owned equipment), deliveries (to both the leased and owned equipment) and instrument lease between 10 Jan 2023 to 30 Jun 2023. This is to ensure no interruption of patient care is experienced while MHS Genesis (or MHSG, the current health information system) completes the instrument build and provides full support for the interface validation of the newly awarded automated clinical chemistry laboratory analyzer system for NMRTCSD. The proposed source is Roche Diagnostics Corporation. Roche is the only vendor that can meet the needs of the government. As the incumbent and current owners of the equipment in place, Roche is the only vendor who can provide the supplies for use without any interruption in patient testing services. Additionally, Roche is the only contractor that can provide consumables and service support to the Module Pre-analytics (MPA) processing system (also a Roche instrument) that is currently owned by NMCSD. The whole Roche system is capable of processing samples for clinical chemistry testing in all phases: pre- analytical, analytical and post-analytical. Pre-analytical phase involves (but not limited to) the sample centrifugation, decapping, recapping, archiving and aliquoting. This phase is solely done by the MPA (owned by the MPA). The aliquoted sample is sent to the actual Roche clinical chemistry instruments for analysis via a belt-line closed system. After analysis by those instruments (analytical phase) and a result is available, the instrument sends the information to the data manager (Data Innovations). This is software that handles the post-analytical phase of the testing and ensures that results passes through accordingly and reached the current laboratory information system (LIS) which is MHS Genesis (MHSG). Description of Supplies/Services required to meet the agency's needs: This is until NMRTCSD's courses of action come to fruition and the new instrument is fully validated for a safe transition without any degradation in capabilities. The estimated cost of this request is $749,000, for a 6-month contract with a POP of 10 Jan 2022-3 to 30 Jun 2023. This is a FAR 16.202 firm-fixed contract with a funding type O&M. This acquisition is conducted under the authority of the Multiple Award Schedule Program, 41 U.S.C. 152(3) and 40 U.S.C. 501, and Regulatory Authority FAR 8.405- 6(a)(1)(i)(C) - In the interest of economy and efficiency, the new work is a logical follow-on to a FSS order, placed in accordance with FSS ordering procedures, and the original order or BPA was not a sole-source or limited-source acquisition. (see FAR 8.405-6 Limited Sources). Rationale Justifying Use of the Regulatory Authority Cited: Roche is the only one who can provide supplies for use with the existing system for our patients as the new equipment gets correctly built in MHSG and undergoes a thorough interface validation, estimated to take an additional 3-5 months from the submission of this request. Roche is the only vendor that meets the minimum requirements of the Government. Determination by the ordering activity contracting officer that the order represents the best value consistent with FAR 8.404(d): This product is currently in use at NMCSD since 2021 and has recently executed an option year with pricing deemed Fair and Reasonable IAW FAR 13.106-3(a)(2)(i) and FAR 13.106-3(a)(2)(ii). These supplies have considered the est value for the Government. 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 October 2022. 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. Other Facts: None Actions to overcome barriers: None NOTE: Review/Approval Requirements are based on dollar threshold and whether or not the action is a Bridge Action (see DHA PGI 208.405-6 for details). Delete all informational and instructional text (i.e., italicized text) in final draft, prior to review and coordination. COORDINATION: Technical/Functional Representative: I certify that the information provided in this justification, is accurate and complete to the best of my knowledge and belief. 6 Jan 2023 Date Laboratory Manaager Requirements Certification: I certify that the information provided in this justification, is accurate and complete to the best of my knowledge and belief. 3 06 JAN 2023 Date Laboratory Department Head Best Value Determination: I have determined that this contract action represents the best value to the Government and that the anticipated cost to the Government is fair and reasonable, in accordance with FAR 8.404(d . -08'00' Date Contracting Officer, Choose an item. Legal Review: I have reviewed this justification and have found it to be legally sufficient. (Note: All J&A's must be reviewed by Office of General Counsel (OGC)/Legal Review.) Date Office of General Counsel APPROVAL: Note: The below approval block(s) shall be moved to - Coordination above, based on the approval level required (see DHA PGI 208.405-6 for the appropriate approval authority). Delete signature blocks for higher level authorities that are not required. For example, if the Competition Advocate is the Approval Authority, delete the Head of Contracting Activity and Senior Procurement Executive signature blocks. Contracting Officer: This certification shall be made by the contracting officer who will sign the contract resulting from this justification and approval (J&A). Include the following statement: I certify that this justification is accurate and complete to the best of my knowledge and belief. [Insert Name] Date Choose an item.