Notice ID
8e6708c818d8475d8720dad15a8ebe28
Justification and Approval JA for Other than Full and Open Competition Sole Source Acquisition of Commercial Items Conducted Pursuant to Federal Acquisition Regulation FAR Subpart 135 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 WHCOCD 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 andor Description of Action being approved This is a followon onetime fixed price supply purchase order contract to procure Dual Chamber ICD Ilivia Neo 7 DRT DF1 ProMRI from the current sole supplier Biotronik Inc CAGE CODE 1LD05 3 Description of SuppliesServices 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 DRT DF1 ProMRI This is a Dual Chamber ICD in which will assist to monitor the hearts electrical activity using wires with electrode on the end that are placed in specific areas of the heart The device responds to irregular lifethreatening heart rhythms from the lower chambers of the heart with either antitachycardia 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 DRT DF1 ProMRI Delivery Dates 19 April 2024 Estimated value 2090000 Type of Funding Operations and Maintenance O M Contract Type Firmfixedprice 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 135 in accordance with 41 USC 1901 Simplified Acquisition Procedures 5 Rationale Justifying Use of the Statutory Authority Cited This sole source justification is prepared using the format at FAR 63032 modified to reflect the procedures in FAR Subpart 135 in accordance with 41 USC 1901 Based on market research and previous acquisition history it has been determined that the only vendor capable of meeting the Governments requirements Biotronik Inc CAGE CODE 1LD05 which is the only distributor of the Dual Chamber ICD Ilivia Neo 7 DRT DF1 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 SAMgov FPDSNG DHA Inventory Excess Personal Property Federal Prison Industries FPI Ability One ECATDLA GSA Advantage and the VA to identify potential sources that can meet the Governments requirements Based on the analysis of the market research completed only one 1 vendor Biotronik Inc was found capable of meeting the Governments requirements for LLIVIA NEO 7 DRT 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 SAMgov on 16 April in accordance with FAR Subpart 52 No additional sources submitted capabilities statements for the Governments consideration 7 Determination that Anticipated Cost to the Government will be Fair and Reasonable In accordance with the basis for award procedures at FAR 131063 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 vendors 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 131063a2 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 SAMgov FPDSNG DHA Inventory Excess Personal Property Federal Prison Industries FPI Ability One ECATDLA GSA Advantage and the VA to identify potential sources that can meet the Governments requirements Based on the analysis of the market research completed only one 1 vendor Biotronik Inc was found capable of meeting the Governments requirements for LLIVIA NEO 7 DRT 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 SAMgov on 16 April 2024 in accordance with FAR Subpart 52 No additional sources submitted capabilities statements for the Governments consideration Based on the results of the market research this requirement shall be sole sourced to Biotronik IncSee Market Research Report for detailed information 9 Other Facts A search for the same services in FPDSNG proved that Ilivia Neo 7 DRT DF1 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 DRT DF1 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 DHACA WHCOCD 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 Governments requirements 12 Contracting Officer Fair and Reasonable Cost Determination and Approval This procurement will utilize simplified acquisition procedures under FAR Subpart 135 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 154031b3 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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Department/Ind.Agency
DEPT OF DEFENSE
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Subtier
DEFENSE HEALTH AGENCY (DHA)
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Office
DEFENSE HEALTH AGENCY
