Dual Chamber ICD Ilivia Neo 7 DR-T DF-1 ProMRI

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Justification and Approval (J&A) for Other than Full and Open Competition

Sole Source Acquisition of Commercial Items

Conducted Pursuant to Federal Acquisition Regulation (FAR) Subpart 13.5

1. Identification of the agency and contracting activity:

This justification is executed by the Defense Health Agency Contracting Activity (DHACA), Western Healthcare Operations Contracting Division (WHCO-CD), San Diego, CA, on behalf of the Navy to meet the requirements of Naval Medical Center San Diego (NMCSD), Directorate of Medical Services (DMS), Pulmonary Department (PD), 38400 Bob Wilson Dr. San Diego, CA 92134.

2. Nature and/or Description of Action being approved:

This is a follow-on one-time fixed price supply purchase order contract to procure Dual Chamber ICD Ilivia Neo 7 DR-T DF-1 ProMRI from the current sole supplier, Biotronik, Inc. CAGE CODE: 1LD05.

3. Description of Supplies/Services:

Naval Medical Center San Diego (NMCSD), Directorate of Medical Services, Cardiology Department located at 38400 Bob Wilson Dr. San Diego, CA 92134 is requesting to purchase an Ilivia Neo 7 DR-T DF-1 ProMRI. This is a Dual Chamber ICD in which will assist to monitor the heart’s electrical activity using wires with electrode on the end that are placed in specific areas of the heart. The device responds to irregular life-threatening heart rhythms from the lower chambers of the heart with either anti-tachycardia pacing consisting of low energy impulses to promote a normal heartbeat, or shock therapy with high energy impulses. This will prevent sudden cardiac arrest. This device can record and store information about the heart rhythm and therapies delivered by the device for the provider to review. Biotronik, Inc. CAGE CODE: 1LD05 is the only authorized distributor for the Ilivia Neo 7 DR-T DF-1 ProMRI.

Delivery Dates:

19 April 2024

Estimated value: $20,900.00

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

Contract Type: Firm-fixed-price

Location: Naval Medical Center San Diego (NMCSD), Directorate of Medical Services,

Cardiology Department 38400 Bob Wilson Dr. San Diego, CA 92134

4. Statutory Authority Cited permitting other than full and open competition:

This acquisition of commercial items is 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:

This sole source justification is prepared using the format at FAR 6.303-2, modified to reflect the procedures in FAR Subpart 13.5 in accordance with 41 U.S.C. 1901. Based on market research and previous acquisition history, it has been determined that the only vendor capable of meeting the Government’s requirements Biotronik, Inc. CAGE CODE: 1LD05, which is the only distributor of the Dual Chamber ICD Ilivia Neo 7 DR-T DF-1 ProMRI. To ensure the proper health and safety for patients, Biotronik, Inc. is the only vendor who can supply the requirement with in three days.

6. Efforts to Obtain Competition:

Market research was conducted by technical experts in April 2024. This research consisted of reviews of similar previous procurements, using search engines in an effort to find open market contractors, reviewing mandatory sources, and posting a Notice of Intent to Sole Source. Search engines utilized include SAM.gov, FPDS-NG, DHA Inventory, Excess Personal Property, Federal Prison Industries (FPI), Ability One, ECAT-DLA, GSA Advantage, and the VA to identify potential sources that can meet the Government's requirements. Based on the analysis of the market research completed, only one (1) vendor, Biotronik Inc., was found capable of meeting the Government's requirements for LLIVIA NEO 7 DR-T DF- PROMRI dual Cardioverter Defibrillator. Market research had determined that only manufacturer identified who can provide the required Dual Chamber ICD.

The Notice of Intent to Sole Source HT941024N0052 was posted on the System for Award Management website (SAM.gov) on 16 April in accordance with FAR Subpart 5.2. No additional sources submitted capabilities statements for the Government's consideration.

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 with prices found reasonable on previous purchases and a comparison of the price to the independent Government estimate provided by the requiring activity to determine the vendor's quoted price fair and reasonable. Additionally, the Government has historical pricing information from similar contracts that provided similar services. The cumulative data available to the Contracting Officer provides for the ability to determine a fair and reasonable price in accordance with FAR 13.106-3(a)(2)

8. Market Research:

Market research was conducted by technical experts in April 2024. This research consisted of reviews of similar previous procurements, using search engines in an effort to find open market contractors, reviewing mandatory sources, and posting a Notice of Intent to Sole Source. Search engines utilized include SAM.gov, FPDS-NG, DHA Inventory, Excess Personal Property, Federal Prison Industries (FPI), Ability One, ECAT-DLA, GSA Advantage, and the VA to identify potential sources that can meet the Government's requirements. Based on the analysis of the market research completed, only one (1) vendor, Biotronik Inc., was found capable of meeting the Government's requirements for LLIVIA NEO 7 DR-T DF- PROMRI dual Cardioverter Defibrillator. Market research had determined that only manufacturer identified who can provide the required Dual Chamber ICD. Western Healthcare Operations Contracting Division requested to make a GPC purchase off of VA IDIQ 36C10G23D0063 but was not authorized to utilize their contract vehicle. The Notice of Intent to Sole Source HT941024N0052 was posted on the System for Award Management website (SAM.gov) on 16 April 2024 in accordance with FAR Subpart 5.2. No additional sources submitted capabilities statements for the Government's consideration. Based on the results of the market research, this requirement shall be sole sourced to Biotronik Inc.See Market Research Report for detailed information.

9. Other Facts:

A search for the same services in FPDS-NG proved that Ilivia Neo 7 DR-T DF-1 Dual Chamber ICD was awarded to Biotronik, Inc. CAGE CODE: 1LD05.

10. Interested Sources:

The only interested source was Biotronik, Inc., which is the only producer of the Ilivia Neo 7 DR-T DF-1 Dual Chamber ICD. Market research and the posting of a Notice of Intent to Sole Source did not identify any additional interested parties.

11. Actions to overcome barriers:

The NMCSD and the DHA-CA, WHCO-CD will continue to survey and engage the market of any potential vendors that can provide INO gas and will consider competing future requirements if there are other vendors capable of meeting the Government’s requirements.

12. Contracting Officer Fair and Reasonable Cost Determination and Approval:

This procurement will utilize simplified acquisition procedures under FAR Subpart 13.5. are commercially available and have been previously procured, which establishes current and historical information that will be used as a basis for fair and reasonableness. Certified cost or pricing data will not be required in accordance with FAR 15.403-1(b)(3). I have determined that the anticipated cost to the Government for this contract action is fair and reasonable, and I certify that this justification is accurate and complete to the best of my knowledge and belief.

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