Sole Source Justification - Hematology Reagents (Redacted).pdf

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

CONTROLLED UNCLASSIFIED INFORMATION

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I. Contracting Activity.

48th Contracting Squadron (48 CONS) Bldg 977, Boston Drive Royal Air Force Lakenheath Brandon, Suffolk, IP27 9PN

United Kingdom

II. Nature and/or description of the action being processed.

The 48th Medical Group (48 MDG) requires a follow-on contract for laboratory services, essential supplies, and hematology reagents to be supplied to RAF Lakenheath, United Kingdom. These hematology reagents are essential for accurate diagnostics, treatment monitoring, and ensuring smooth laboratory operations, ultimately improving patient care outcomes. Hematology reagents are particularly vital as they are used to perform assays on blood samples to detect and quantify various blood components and abnormalities in clinical settings. This enables healthcare providers to assess blood health, monitor therapy, and diagnose hematological disorders effectively.

The Contractor shall provide reagents and consumables for the Government-owned Sysmex XN-2000 Hematology Analyzer to conduct accurate hematology assays, monitor blood components, and diagnose hematological disorders.

This procurement will be awarded as a new Firm-Fixed Price (FFP) Indefinite Delivery Indefinite Quantity (IDIQ) contract, funded through the Medical Stock Funds, appropriation 8040.

III. Description of supplies/services required to meet agency needs.

The Independent Government Estimate (including options) for this acquisition is $ The ordering period for this requirement is September 1, 2024 to August 31, 2029.

The Contractor shall provide the following reagents and consumables for the Government-owned Sysmex XN-2000 Hematology Analyzer :

CLIN 0001: Cellpack DCL (P/N: CU228496) - Estimated Quantity: 120 Each per year CLIN 0002: Cellpack DFL (P/N: BT965910) - Estimated Quantity: 10 Each per year CLIN 0003: Cellclean (P/N: 83401621) - Estimated Quantity: 100 Each per year CLIN 0004: Fluorocell WNR (P/N: CP066715) - Estimated Quantity: 20 Each per year CLIN 0005: Fluorocell WDF (P/N: CV377552) - Estimated Quantity: 10 Each per year CLIN 0006: Fluorocell RET (P/N: BN337547) - Estimated Quantity: 10 Each per year CLIN 0007: Lysercell WNR (P/N: BL121531) - Estimated Quantity: 20 Each per year CLIN 0008: Lysercell WDF (P/N: AL337564) - Estimated Quantity: 15 Each per year CLIN 0009: Sulfolyser (P/N: 90411414) - Estimated Quantity: 20 Each per year CLIN 0010: XN-Check L2 (P/N: 213485) - Estimated Quantity: 60 Each per year CLIN 0011: XN-Check L3 (P/N: 213486) - Estimated Quantity: 60 Each per year CLIN 0012: XN-Check BF (P/N: 213510) - Estimated Quantity: 30 Each per year CLIN 0013: Fluorocell PLT (P/N: CD994563) - Estimated Quantity: 4 Each per year CLIN 0014: XN-2000 Maintenance - Estimated Quantity: 12 Months per year CLIN 0015: XN PLT-F License (P/N: ZE000501) - Estimated Quantity: 1 Each per year

IV. Statutory authority permitting other than full and open competition.

DAFFARS 5313.501 - 10 U.S.C. 2302b, Implementation of Simplified Acquisition Procedures (41 U.S.C. 1901).

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

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V. Demonstration that the contractor's unique qualifications or nature of the acquisition requires the use of the authority cited above (applicability of authority).

This procurement requirement is essential for the continuation of services initiated under contract FA558720D0003.

The initial contract included the provision of specialized hematology reagents specifically designed for use with the Sysmex XN-2000 Hematology Analyzer, which was originally acquired through contract FA558716P0030. The estimated life cycle of the Sysmex XN-2000 spans approximately 10 years, ensuring its operational capability until September 20, 2026. This ongoing need underscores the critical importance of maintaining a consistent supply chain for essential consumables to ensure the uninterrupted functionality of this vital medical equipment throughout its expected lifespan.

Sysmex UK Limited is the sole approved supplier of reagents and consumables compatible with the Sysmex XN-2000 Hematology Analyzer. If the U.S. Government were to purchase these items from another supplier, it would assume the legal responsibilities typically borne by the manufacturer. This would result in Sysmex relinquishing all liability for the analyzer, including any guarantees for the prompt resolution of technical issues. Furthermore, any validation of third-party reagents on the system would be the responsibility of the Military Treatment Facility (MTF). Given the lack of technical expertise among government personnel to conduct these validations, this task presents a significant challenge and potential risk to the operational efficiency of the equipment.

Procuring a new hematology analyzer to facilitate full and open competition would incur significant duplicative costs for the U.S. Government, with no anticipated cost recovery through competition. The current Sysmex XN-2000 Hematology Analyzer, purchased under contract FA558716P0030 on July 22, 2016, was valued at $91,083.78. Adjusted for inflation using the Consumer Price Index (CPI) Inflation Calculator provided by the U.S. Bureau of Labor Statistics, this price equates to $118,883.05 as of May 2024. This amount represents 42.77% of the total estimated reagent usage cost for the remaining life cycle of the analyzer, valued at $277,931.83. If a different hematology analyzer were procured, this cost would be added to the acquisition expenses.

The current Sysmex XN-2000 Hematology Analyzer is expected to remain operational until September 20, 2026.

Analyzing the average annual cost over the 10-year life cycle, the yearly expense of $11,888.305 results in additional redundant costs of $23,776.61 if an alternative analyzer were purchased. Moreover, considering an alternative source would incur further effort and expenses due to the extensive familiarity that 48 MDG personnel have developed over the past 6-7 years with the Sysmex XN-2000 Hematology Analyzer. With increasing demands, it is crucial to prioritize the proficiency of all personnel in handling standardized systems to efficiently support mission requirements, especially on short notice. Introducing different equipment would necessitate comprehensive training sessions, incurring additional costs for the United States Government.

VI. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

On May 9, 2024, the 48th Contracting Squadron posted a Sources Sought notice on SAM.gov to ensure offers were solicited from as many potential sources as possible under notice ID: FA558724Q0046. The objective was to assess whether any vendors in the current marketplace could provide not only the necessary reagents but also comparable hematology analyzers. Additionally, the notice aimed to identify other vendors in the marketplace to enable a cost analysis, determining whether it would be more financially advantageous to continue using the current analyzers until the end of their lifecycle or to invest in new analyzers along with associated reagents and consumables.

The Sources Sought notice aimed to identify potential suppliers who could meet the agency’s requirements and to conduct a cost-benefit analysis comparing the financial implications of maintaining the existing analyzers against the costs associated with procuring new analyzers and the necessary reagents and consumables.

As a result of the Sources Sought notice, Sysmex was the only vendor that responded, demonstrating both an interest and capability to meet the requirements. This response indicated the limited availability of alternative sources, supporting the continuation of a sole source procurement strategy with Sysmex.

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

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VII. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

This procurement requirement represents an extension of services initiated under contract FA558720D0004.

Consequently, the proposed price for the coagulation reagents is anticipated to be regarded as fair and reasonable.

This assessment will be made by comparing the proposed price with prices deemed reasonable in past purchases, as outlined in accordance with FAR 13.106-3(2)(ii).

Furthermore, considering the variability in patient usage from month to month, it becomes apparent that relying on the General Services Administration (GSA) for procurement of reagents may result in delays in meeting urgent delivery timelines. However, despite this limitation, the cost of the reagents sourced through the GSA can still be considered fair and reasonable. This assessment is based on the current price list or GSA catalog pricing, as stipulated by FAR 13.106-3(2)(iii).

VIII. Description of the market research conducted and the results, or a statement of the reasons market research was not conducted.

Market research, conducted in accordance with FAR Part 10, aimed to assess the availability of sources capable of meeting the agency's needs for hematology reagents and consumables. The research revealed that utilizing a contractor within the local trade area offers fiscal efficiency due to the increased frequency of deliveries. This proximity allows for shorter lead times, which is particularly important for fulfilling urgent delivery orders amidst fluctuating patient usage patterns. Sysmex UK Limited was identified as the sole known source within the local trade area capable of meeting the agency's requirements.

Sourcing within the local trade area addresses the necessity for timely and reliable deliveries. The proximity of Sysmex UK Limited facilitates shorter lead times and the ability to respond swiftly to urgent delivery orders. This is crucial in maintaining the continuity of medical services, given the unpredictable nature of patient usage patterns. The localized sourcing strategy ensures that the agency can promptly address any emergent needs without the delays associated with longer shipping distances.

Efforts to identify alternative providers included a search on the GSA Advantage. However, this search did not identify any vendors operating within the United Kingdom, significantly reducing the scope of potential options for sourcing the necessary reagents and consumables. Additionally, a search conducted on the Federal Procurement Data System (FPDS) for hematology reagents did not yield any results for contractors situated in the United Kingdom, further limiting viable alternatives within the local trade area.

In an effort to exhaust all potential sources, several vendors were contacted to determine their capability to meet the requirements outlined in the Statement of Work (SOW). Five vendors— and —did not respond to the inquiries. Among the three vendors that did respond, indicated that they could not obtain contracts to add the required products to their OCONUS (Outside Continental United States) catalog. stated that they do not sell Sysmex products as these are typically sourced directly from the manufacturer. Sysmex responded with a quote for their updated prices for the 2024 calendar year.

IX. Any other facts supporting the use of Other Than Full and Open Competition.

The current hematology system's compliance with accreditation requirements set by regulatory bodies such as the Defense Health Agency (DHA), The Joint Commission (TJC), and College of American Pathologists (CAP) demonstrates its suitability for use in the military treatment facility. Introducing a new system would require thorough evaluation and validation to ensure compliance, potentially delaying implementation and exposing the facility to regulatory risks.

The existing system's accreditation status is a testament to its quality and reliability, providing assurance to patients and healthcare providers. By maintaining continuity with Sysmex UK Limited, the government can uphold its commitment to delivering high-quality healthcare services while minimizing regulatory risks and ensuring compliance with industry standards.

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X. List of any sources that expressed, in writing, an interest in the acquisition.

See Section VI above.

XI. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before making subsequent acquisitions for the supplies or services required.

As the current analyzers at the 48th Medical Group approach the end of their expected lifespan in 2026, there's an opportunity for the Government to consider expanding its acquisition approach. Consequently, the 48th Medical Group and 48th Contracting Squadron will closely monitor the marketplace for technological trends in Coagulation Analyzer Machines once the current machine reaches end of life. This proactive approach allows for informed decision-making regarding potential diversification of equipment brands.

XII. Certification by the Contracting Officer.

As evidenced by my signature above, I have determined this document to be both accurate and complete to the best of my knowledge and belief.

XIII. Certification by the technical/requirements personnel.

As evidenced by my (our) signature(s) above, I (we) certify that any supporting data contained herein, which is my (our) responsibility, is both accurate and complete.