HT941024N00121 JA Sole Source FAR13_Redacted.pdf

FOR OFFICIAL USE ONLY - Source Selection Information – See FAR 2.101 and 3.104

DHA PGI 213.5, Attachment 1 (06-21-2018)

Justification for Other than Full and Open Competition Sole-Source Acquisition of Commercial Items

Conducted Pursuant to FAR Subpart 13.5 Below the Simplified Acquisition Threshold

1. Identification of the agency and contracting activity: Naval Hospital Twentynine Palms (NHTP), Healthcare Operations-West (HCO-W), Defense Health Agency Contracting Activity

(DHACA).

2. Nature and/or Description of Action being approved: This is a request for fixed price supply contract to procure reagents, supplies, and maintenance for from sole supplier, Ortho-Clinical Diagnostics, Inc.

3. Description of Supplies/Services: The Laboratory Department requires supplies, reagents, and maintenance for the OrthoVision analyzer which can perform standard blood bank testing, antibody screening, and antibody identification. Automating routine testing will allow time for the technicians to focus on more complex serological workups. Additionally, this analyzer will reduce manual data entry errors and offers a robust testing menu for future initiatives to increase testing capabilities. NHTP lab prefers the acuity and specificity of the gel testing methodology, which minimizes unnecessary workload generated by other testing methods, that result in higher rates of false positive result and greatly decreased efficiency. The OrthoVision analyzer manufactured by Ortho-Clinical Diagnostics is the instrument of choice because this instrument has the capability to perform serial dilutions for titration studies, can test cord bloods, and their traditional reagents are the same as the reagents currently used in this lab.

Deliver By:

1 October 2024

Type of Funding: Operations and Maintenance (O&M)

4. Statutory Authority Cited permitting other than full and open competition: Acquisition of commercial item(s) conducted pursuant to FAR Subpart 13.5 in accordance with 41 U.S.C.

1901 Simplified Acquisition Procedures.

5. Rationale Justifying Use of the Statutory Authority Cited: Naval Hospital Twentynine Palms owns a OrthoVision analyzer; therefore, the required reagents and supplies provided only by Ortho-Clinical Diagnostics, Inc. are compatible with the analyzer. Ortho-Clinical Diagnostics is the only vendor capable meeting the needs of the Government, as it is unique and highly specialized. A letter of sole proprietorship has been provided by the vendor, Ortho-Clinical Diagnostic, as the only known source with no known distributor of the required supplies and reagents. In accordance with FAR 13.106-1(b), Ortho-Clinical Diagnostics, Inc. is the only responsible source of meeting the needs of NHTP’s minimal requirements.

6. Efforts to Obtain Competition: A Notice of Intent to Sole Source will be posted to SAM.gov from 7 August 2024 through 16 August 2024 to ensure there are no other capable vendors. Ortho-Clinical Diagnostics, Inc. is the only option due to nature of the compatibility of analyzers to reagents and supplies. If new vendors are found during this posting, the specialist will change acquisition strategy to competition.

7. Determination that Anticipated Cost to the Government will be Fair and Reasonable:

The contracting officer will determine fair and reasonable pricing by using historical information and comparisons with the Independent Government Cost Estimate (IGCE); in accordance with FAR 13.106-3(a)(2).

8. Market Research: Market research was completed IAW FAR Part 10. A Market Research Report was completed, and the contract specialist found that Ortho-Clinical Diagnostics, Inc.

was the only suitable vendor that can meet the characteristics of the requirement.

Market research was conducted via mandatory sources (AbilityOne, and UNICOR) as well as SBA Quick Search and DLA's Electronic Catalog/Master Medical Catalog (ECAT/MMC) which returned negative results. Naval Hospital Twentynine Palms (NHTP) currently owns an OrthoVision analyzer. After an extensive review of the details of performance characteristics, testing throughput, configuration, and compatibility with current DoD laboratory and hospital information systems, the research has demonstrated that only the reagents and supplies offered by Ortho-Clnical Diagnostic, Inc. will satisfy the needs and requirements of the facility. Ortho- Clinical is the sole manufacturer of the OrthoVision line of reagents and supplies used by those systems in the United States. The CS also reviewed results of recent market research of other previously awarded contracts with same or similar scopes (NHTP #HT941023F0200 dtd 29 Sep 2023 and HT941024F0115 dtd 30 Sep 2024; awarded to Ortho-Clnical Diagnostic, Inc.) as well as GSA Federal Schedules. Market research has determined that this procurement should be made directly to Ortho-Clinical Diagnostics, Inc. The Notice of Intent to Sole Source HT941024N0121 was posted on the System for Award Management website (SAM.gov) from 7 Aug 2024 to 16 Aug 2024 in accordance with FAR Subpart 5.2. No additional sources submitted capabilities statements for the Government's consideration. The proposed acquisition strategy is to justify as a sole-source procurement as Ortho-Clinical Diagnostics, Inc. is the sole manufacturer of the required supplies and reagents.

9. Other Facts: N/A

10. Interested Sources: No other sources.

11. Actions to overcome barriers: N/A