JA Brand Name FAR 13.5_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)

ATTACHMENT 1

JUSTIFICATION AND APPROVAL (J&A) TEMPLATE

for

Sole-Source (Including Brand-Name) Acquisitions of Commercial Items Conducted Pursuant to FAR Subpart 13.5

(June 21, 2018)

Justification and Approval for Other than Full and Open Competition

Sole Source Acquisition J&A Tracking No.

1. Identification of the agency and contracting activity: Mother Baby Unit (MBU) U.S.

Navy Medical Readiness & Training Command, Guam.

2. Nature and/or Description of Action being approved: Request for approval for a new contract for Philips Avalon FM50 Fetal Monitor for USNMRTC Guam’s Mother Baby Unit.

3. Description of Supplies/Services: The Philips Avalon FM50 Fetal Monitor provides essential fetal heart and maternal physiological monitoring requirements throughout pregnancy across the prenatal, intrapartum, and postpartum periods. The high-quality signal processing combined with the Avalon CL Transducer System minimize interruptions in fetal monitoring while simultaneously providing family-centered care solutions. Some of the features include:

* Fetal Movement Profile (FMP) automatically detects fetal body movements for antepartum applications using an ultrasound transducer.

* Smart Pulse integrated into the Toco MP transducer detects the maternal pulse rate without the need for an additional sensor (SpO2 or MECG), confirming correct fetal heart rate monitoring.

* Cross-Channel Verification (CCV) detects the coincidence between all fetal and maternal heart and pulse rates.

* The Avalon CL Transducer System allowing expectant mothers to be continuously monitored without wires, whether in the bath or shower, in the bed, or while ambulating.

- The equipment being requested for procurement includes the main components (Avalon FM50 Fetal Monitor), components required to operate (base station, cables, accessory connectors), and accessories for patient monitoring (blood pressure cuffs, transducers, SPO2, remote even marker).

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. Item peculiar to one manufacturer with multiple distributors/resellers IAW FAR 13.501(a).

5. Rationale Justifying Use of the Statutory Authority Cited: The use of the specific authority cited under FAR 13.501(a) for a brand name acquisition of the Philips Avalon FM50 Fetal Heart Monitor provides a detailed rationale that demonstrates why this product is essential and why no other product can meet the requirements. The Philips Avalon FM50 is the only monitor that offers automated coincidence detection using Smart Pulse technology. This feature allows for the separate measurement of fetal and maternal heart rates, enhancing diagnostic confidence and reducing the risk of misinterpretation. Other manufacturer’s fetal monitor system, while advanced, relies on a wireless patch that might not be as seamless in differentiating heart rates. The Avalon FM50 can monitor up to three fetuses simultaneously on a single monitor using the same ultrasound frequency. This capability is unique to Philips and is crucial for high-risk pregnancies involving fetuses. Other monitors do not offer the same level of integrated multiple fetal monitoring. The Avalon FM50 provides extensive fetal and maternal parameters, including ultrasound, fetal movement, direct fetal heart rate, Toco, intrauterine pressure, maternal blood pressure, pulse rate, ECG, and SpO2. This comprehensive monitoring is essential for providing high-quality care in complex cases. Other brand focuses more on individual monitoring solutions and while comprehensive, does not cover as many parameters in a single device. The monitor integrates with Philips IntelliSpace Perinatal, an obstetrical surveillance and information management system. This connectivity supports continuous care from the first antepartum visit to postpartum follow-up, ensuring seamless data flow and improved patient outcomes. The Smart Pulse technology and comprehensive monitoring parameters provide clinicians with accurate and reliable data, which is critical for making informed decisions during labor and delivery. The ability to monitor multiple fetuses and integration with IntelliSpace Perinatal ensure that both maternal and fetal health care are continuously monitored and managed, leading to better patient care and outcomes. The Philips Avalon FM50’s user-friendly interface and connectivity features streamline workflow and reduce the time required for data entry and monitoring, allowing healthcare providers to focus more on patient care.

6. Efforts to Obtain Competition: Efforts have been made by conducting an extensive market research to identify potential sources. IAW FAR 5.202(a)(10) The proposed contract action is made under conditions regarding brand name commercial items for authorized resale. Contract specialist conducted market research in August 2024 and determined via internet searches that this requirement is customarily available in the commercial marketplace. Research of mandatory sources AbilityOne, UNICOR, GSA Advantage did not yield any results. A small business dynamic search for additional small business firms meeting the requirement resulted in negative results under NAICS code 339113 and search terms "fetal heart monitor." A search on ECAT and MMC received one positive result; however, the P/Ns were not the same and various parts are not available through the ECAT system. The recommendation is a 100% small business set-aside with a brand name basis.

7. Determination that Anticipated Cost to the Government will be Fair and Reasonable: In accordance with the basis for award procedures at FAR 13.106-3, the Contracting Officer will utilize a comparison of the proposed price found and reasonable on previous purchases and a comparison of the price to the Independent Government Cost Estimate (IGCE) provided by the requiring activity to determine the vendor's quoted price fair and reasonable.

8. Market Research: Several market research methods were used to include the review of mandatory sources, reviews of similar previous procurements, using online engines reviewed by the Naval Hospital Guam and DHA HCD-W. A combined synopsis/solicitation with a small business set-aside under solicitation # HT941024Q2100 will be posted on SAM.gov as a brand name only acquisition. The use of such description in the acquisition is essential to the Government's requirements, thereby precluding consideration of a product manufactured by another company.

9. Other Facts: Philips Avalon FM50 Fetal Monitor possesses unique capabilities and expertise that are essential for the completion of the procurement. No other manufacturers have the necessary qualifications or experience to meet the government's requirements. Due to remote location, market research has shown that there are very few sources capable of meeting the government's requirements. Efforts to identify additional sources have been unsuccessful. These facts justify the use of other than full and open competition, demonstrating that it is in the government's best interest to limit competition in specific circumstances.

10. Interested Sources: Four Point and Alliant Healthcare have expressed their interest in the acquisition.

11. Actions to overcome barriers: Naval Hospital Guam and the DHA Healthcare Contracting Division - West will continue to survey and engage the market of any potential vendors that can provide the fetal heart monitor and accessories and will consider competing future requirement if there are other vendors capable of meeting the requirements. In addition, review and due diligence will be conducted by the Government for any vendor submitting capability statements for the products. Furthermore, making the item available through various distributors or prime vendors will remove and overcome the barriers to competition. Will conduct ongoing market research to identify new potential sources and solicit feedback from vendors on the procurement process and use this information to make continuous improvements.